Document 85m9oDzD6LrN8q036JZDmwZzd

APPLICANTS ASSISTANCE FOR PERMITTING HAZARDOUS WASTE MANAGEMENT FACILITIES: Applicant's Training Course - This course is a one-day session for permit applicants. It ex plains how the permit should be structured and what kind of infor mation the permit writer needs on the application before a permit can be written. - All applicants whose Part B's are called in will be invited to attend the training course. - The course has been given in several states for storage facility permit applicants. It has not yet been developed for incineration or land disposal permit applicants. Applicant's Guide - This publication gives a brief description of the kind of infor mation needed to satisfy each section of the RCRA regs. The Guide also includes information on the application review and decision process. - The draft Applicant's Guide for Storage Facilities is included in today'S'handouts. The Guides for incineration facilities and for land disposal facilities have not yet been prepared. They will include the information that has already been developed for satis fying the storage requirements. Model Application - This publication is a companion to the Applicant's Guide. It covers all of Part A and Part 3 of the permit application and trans laces the information from the Guide into a permit application. - The permit application is divided into functional areas. These are the same divisions that are used in the Training Course and the Applicant's Guide (e.g. Facility Description, Waste Charac teristics, Process Information , e tc .) . - The Applicant's Guide and the Model Application will be given to applicants who attend the Applicant's Training Course. Copied for distribution to the CMA 047467 - The draft Model in your handouts, disposal have not tion on storage. Application for Storage Facilities is included The Model Applications for incineration and land yet been prepared, but will include the informa- permit Writer's Guide and Training Course - The guide aids permit writers in evaluating an application and preparing a permit. - It gives key words or phrases for each permit requirement fol lowed by a list of technical references for that requirement. The technical references are intended to help the permit writer in determining if the application is reasonable and in writing the permit conditions. - The training course is conducted for permit writers to give them experience in writing a permit. A permit is written based on a mock application that has both obvious and subtle errors and upon the information in the Permit-Writers Guide. - A Guide has been written for storage facility permits but has not been cleared for distribution. The Guides for incineration and storage facilities have not yet been written. Model Permit - This shows what form a permit should take. The Model permit consists of boilerplate and general and specific permit conditions. - The philosophy behind the Model Permit is that the permit itself may not need to be highly technical. The permittee in his appli cation has demonstrated whether or not he can operate his facility in accordance with RCRA. The permit can reference the application as necessary. It can also be highly specific where necessary. This is a decision for the permit writer based on his judgement and the complexity of the facility. - A draft Model Permit has been prepared for storage facilities; model permits for incineration and land disposal facilities have not yet been prepared. The draft Model Permit for storage facili ties is among today's handouts. Model permits for incineration and land disposal would include the same language for their storage operations. CMA 047468 WHAT DO WE WANT FROM YOU? - Comments on the Applicant's Training Course , the Applicants Guide and the Model Application for storage f acilit ies. Comments should include estimates of the time necessary to pr epare a permit application and the costs of preparing the a pplica tion. We are also interested in determining who should be prese nting the Applicants Training Course - EPA, the states, indu stry g roups? - Similarly, as- the permitting documents for incineration facili ties and land disposal facilities are being written, we will ask for your inputs on the drafts of those documents. 9 CMA 047469 RCRA PERMIT STRATEGY RCRA Permit Process -Existing facilities (ie., facilities with interim status) submitted Part A of permit application by November 1980, must submit Part B of permit application within six months of EPA request. -New facilities submit both Part A and Part B of permit application at least 180 days before construction is expected to begin. (New facilities can not be con structed or operated without a permit.) -EPA conducts a completeness review within 30 days of receipt of application from new facilities (60 days for existing facilities). -EPA prepares draft permit and fact sheet for public comment. -RCRA requires EPA to notify public in local vicinity of facility and hold a local hearing if requested. -EPA issues final permit with maximum duration of 10 years. Status of Permit Standards -Storage and Treatment Facilities: Permits can be issued to "a 1 1 facilities except for certain underground tanks. -Incineration Facilities: Permits can be issued to all tacititles. -Land Disposal Facilities: Permits can be issued to new faci I ities. EPA will be able to request Part B permit applications and issue permits to existing facilities as of January 1983 (except for underground injection wells). CMA 047470 ROLE of the STATES Phase I Interim Authorization -State programs must be substantially equivalent to federal program -Covers: -Identification and listing of hazardous wastes -Regulation of generators and transporters -Enforcement of interim status standards -32 States have been authorized Phase II Interim Authorization -Permitting of hazardous waste facilities -Four States have been authorized Final Authorization -State programs must be equivalent and consistent with federal program -States may now begin to apply for final authorization -Interim authorizations expire in January 1985 Relationship of State and EPA Hazardous Waste Programs -Authorized State programs operate in lieu of federal program -Both EPA and State programs apply in a State without authorization. In order to avoid confusing duplication with State programs, EPA is: -Involving States in development of permitting priorities and permit conditions -Encouraging joint public hearing and permit issuance procedures -Establishing mechanisms to transfer pending RCRA permit applications to States at time of authorization and to allow State to assume full responsibility for admin istering previously issued Federal permits PROJECTIONS FOR RCRA STATE AUTHORIZATION NumDer ot States RCRA PERMIT ISSUANCE 047473 RCRA PERMIT ISSUANCE 047474 RCRA PERMIT ISSUANCE CMA 047475 Permit Assistance Activities Applicant Assistance -Model application -Detailed applicant guidance -Pre-application meetings Permit Writers Assistance -Model permit -Permit writers guidance -Training -permit assistance teams -contractor support -Agency technical expertise New Concepts in Permitting -Class permits -Mobile permits Permitting Task Force -Goal -Identify ways to improve permitting process PTiRT.Tr! NEETXN3 CN THE EPA HAZARDOUS WASTE PERMIT PROGRAM July 22, 1982 Roan S353 Waterside Mall Meeting Agenda PRESENTATION Introductory Remarks RCRA Permitting Strategy o Status o EPA program priorities Hazardous Waste Ad Hoc Advisory.. Corrmittee o Charter o Proposed Task Forces o Mentoership Assistance for Permit Applicants o Scope and status of o Guides for preparing permit applications o Model permits o Applicant trainirg Class Permits o Background, concept, applicability Mobile Treatment Units o Background, cone^31, applicability SPEAKER Rita M. Lavelie, Assistant Administrator for Solid Waste and Emergency Response (202) 382-4610 John H. Skinner, Acting Director, Office of Solid Waste (202) 755-9107 David B. Sussnan, Program Manager (202) 382-4692 Chaz Miller, Environmental Protection Specialist (202) 382-5435 David B. Sussman Jeffrey E. Detlefsen Environmental Protection Specialist (202) 382--4500 COMMENT PERIOD CMA 47477 CONCEPT OUTLINE CLASS PERMITS The current regulations treat every hazarous waste management facility as being unique and highly complex. However, some classes of hazardous waste management facilities, particularly those that store or treat hazardous waste in tanks, piles, and containers, are neither unique nor complex. Such facilities employ relatively simple and well - proven technology which varies little with the locality. Thus, a permit issued to one such facility, in most respects, would be quite similar or even identical to permits issued to many other such facilities. EPA believes it will be able to develop "class permits" reflecting the standard accepted practices for the storage and treatment of hazardous waste in tanks, piles, and containers. The conditions of such class permits could be established at the national level through rulemaking procedures which provide for public notice and opportunity for comment. Under the current provisions of RCRA class permits could be developed using the following steps: Step 1 - EPA proposes a class definition, national permit conditions, and abbreviated application procedures. - The public comments on the definition, conditions and application procedures. - SPA promulgates final definition, national permit conditions and abbreviated application procedures. Step 2 - Applicants submit abbreviated applications. - EPA issues a public notice in each community where a class permit applicant's facility is located. - EPA accepts public comment and holds an informal local public hearing if one is requested. - As the general technical issues would have been resolved in the development of the national permit conditions, the public comment and local hearing could focus on the following three issues: - is the facility really in the class specified? -1- CMA 047479 - Can the applicant comply with the class permit conditions? - Are there any additional site-specific factors which must be considered? Step 3 EPA issues a permit. The advantages of a class permit process are: It reduces the burden on permit applicants through a much streamlined application and review process. It reduces paperwork through standardized permit conditions. It establishes the general technology permit conditions in advance and therefore reduces the number of issues likely to be raised at the local hearing. RCRA Amendment EPA is developing a statuatory amendment to RCRA authorizing the development of Class Permits and and streamlining the public review process. 0 Avoids the repetitive review of identical general technical permit conditions for each permit. a Allows the Regional Administrator to hold public hearings focusing on those issues not addressed in the general technical permit conditions. The major questions that need to be resolved are: Can we define classes that include a significant number of facilities? - Is it worthwhile to setup a special process for just a few hundred facilities or can classes be more generally defined? -2CMA 047480 EPA RECCOMENDED ADMENDMENT ON CLASS PERMITS "Sec. 3005 (g) CLASS PERMITS. -- (1) After notice and ODportunity for hearing, the Administrator may promulgate permit conditions applicable to owners and operators of a class of facilities if he determines that the facilities in the class should be subject to similar design, operating and management requirements. Such classes shall not include hazardous waste incinerators or facilities which dispose of hazardous waste on the land. "(2) If, after notice and opportunity for an informal hearing, the Administrator determines that a facility in any class designated under paragragh (1) meets the require ments and conditions' promulgated under that paragragh, he may issue a class permit for such facility containing such permit conditions. These notice and hearing procedures may be used in lieu of the procedures in section 7004 (b) (2). "(3) Notwithstanding the foregoing, the Administrator may, in establishing requirements and conditions under paragragh (1), provide that certain permit conditions shall be established for each facility on a site-specific basis. CMA 047481 Class Permits Suggested Points to be Made in Legislative History Under the current hazardous waste regulations, each applicant must submit information adequate to demonstrate, in detail, how his facility will achieve compliance with the regulations. Each bit of information, each plan, and each management strategy is then reviewed by the permit writer. The public must be notified of the permit by notices in local newspaper and radio stations and the public must be provided an opportunity for comment and a local public hearing, according to Section 7004. The class permit concept recognizes that certain classes of facilities share common features and practices. Further, the permit conditions necessary to assure adequate protection of public health and the environment are not affected by the location of the facility or other site-specific features. As a result, permits issued to these facilities under the existing regulations would be essentially identical* An amendment is desirable that would provide the authority for EPA to identify classes of facilities and to establish through informal rulemaking a specific set of standards and permit conditions for those facilities. Upon promulgation of those standards, facilities within the class would not be re quired to complete detailed permit applications. Rather, each ~appl-ic.ant_wQuld-Only need to submit a minimum amount of informa tion about the facility and. certify that he will comply with the class permit conditions. EPA does not intend to use the class permit process for issuing permits to land disposal facilities, incinerators or other facilities where site specific concerns are of paramount importance. Rattier, it is the intent of EPA that the class permit process be applied to those facilities having lower environmental and public health concerns such as facilities which treat or store hazardous waste in tanks or containers. Thus paragraph (1) excludes hazardous waste incinerators and land disposal facilities from these class permit provisions. Paragraph (2) of the amendment requires that the Administra tor provide notice and opportunity for an informal hearing on his decision to grant or deny a class permit. It is EPA's intenc that, for class permits, these notice and hearing pro cedures be used in lieu of the more detailed procedures in Secnon 7004(b) of the Act. CMA 047482 2- - 3ecause most terms and conditions of class permits will have been established by regulation, the matters at issue in individual permit proceedings, including factors to be con sidered when deciding whether to grant requests for public hearings, shall be limited to (1) whether the facility is a member of the class, (2) whether the facility meets (or will meet) the requirements and conditions promulgated by the Administrator and (3) the appropriateness of any terms and conditions established by the Administrator on a case-by-case basis. The narrow focus of these proceedings should expedite the issuance of class permits, thus allowing the Agency to concentrate its resources on more environmentally sensitive and complicated individual permits. EPA recognizes that a few*`terms `and conditions of a class permit (e.g., closure cost estimates) may need to be crafted on a site-specific basis. Thus, paragraph (3) of the amend ment provides that in promulgating class permit conditions, the Administrator may designate certain conditions to be deter mined on a case-by-case basis. It is EPA's intent that States which have class permit regulations which are equivalent or substantially equivalent to those issued by the Administrator be considered eligible for final authorization and interim authorization, respectively, under Section 3006. However, class permit regulations are not necessary for full authorization. CMA 047483 Mo da 1 Storage ? . / -2 5 ^ 2 into 3 ,"1033' 5 * : * a 3 e p 3 ' :n i t h -3 S b 3 3 i - i : e -"i i t -.; r~. a t for f 3 0 i 1 i ti ir t a n k 5 , c o n c 3 1 n 3 r 3 and piles 7 a .0 0 d j 1 a 3, d e / a 1 0 p e d t0 p r 0 /J c a 5 that s t c r a h a: i" d;3 The model is d i 7 i 0 a d m 0 ( - 3 t a 1 d 3 " d Conditions - Covers the c 0 " d i t i 0 r s raq0irad of parm i t s found in 40 C F P. Part 122. M r\ si Facility C c n d 1 t i 0 n s ~ C 0 v a r 3 the conditions required of all permits -found in 40 CF?, Part 254, Sub parts 3, C, D, E, 0 Module III - Container Storage ~ Covers the conditions required in 4 0 CFP. Part 254, Sub part I for facilities that store hazardous wastes in containers. 0 Module IV - Tank Storage - Covers the conditions required by 40 CFR 264, Subpart J for facilities that store hazardous wastes in tanks. 0 Module V - Waste Pile Storage - Covers the conditions required by 40 C F R Part 254, Sub part L for facilities that store hazardous wastes in piles. The conditions in this module reflect the existing requirements for waste piles. Waste piles permitted after the effective data of the land disposal regulations must meet the revised requirements for waste piles found in those regulations. I n d e v 2 1 op 1 n g t h i s mo d 0 1 , wa us a d cur best judgement in d e c i d * n g w h i c h re g u 1 at 0 ry p r 0 v i s i 0 n 3 should be written out v e r s u s those wh h may b a r a f e r e n c e d Some provisions must be w r i tten out be causa the s tan da rds offers options or t r, e pa Pm' t condi t i ons must b e mo r 3 a x p 1 i s* it than the regul at i o.n 10 b 9 art fore e a b 1 e I n ot h a r cases , r eaulatory provisions are 2 p el 1 a d out b e c a u sa of Jia i * 1 m gort a n c e to the permittee or the public. The modal identifies conditions that a * a 9 xc1u si / e to existing, as' opposed to new, facilities; where 0 p t i 0 n a 1 methods of meeting the regulatory requirements are allowed; and which conditions may be waived in accordance with the regulations. The model a 1 so identifies 'where p a r 0 s of the a p p 1 i cation may be i nc 0 r p0 r a t a d in 10 the permit by reference. For e x a m p 1 e the condition eg CFP 2 5 4.5' f b) _ Implementation of cont i 1 g e n p y clan may re a d: CMA 047485 2 /* ' . / t h a permittee shell i :r--! a 2 i 2 t a 1 y c 2 r ^y 0 t the p r c v i s i 0.0 3 of the c 0rtinga0 cy plan (;:02ch nan: _} w h a n a v a r t. h are is a ; 1 " a , explosion, 0 r r a 1 a 2 s a of i a : a r i 0 2 3 ./ a s: a or c c n s t i t u e ^: 3 w nip'"! tcreate ns or "0 11 d t u ^ ^ a z - n r; - n " -1 a1 P P or ^ n ^ n , 1 r ] " n J 11 , cases v/n. ^a ni O a - i on' the a p p 1 i c 2 t i 0 n , w n a: on a r e r does r, 01 w i s n *^ h * the permit must s ? e 1 1 0 to meet the r 5 g u 1 a t try r e q u01 " a m a n t. not appear in the permit. notes (in brackets) foil owl ; explain how they d " 2 ^ 0 b i the p e r m11 writer's use, i t Two conditions required by 40 CFR Part 122 have not bean incorporated into the modal. 122.10 da a Is with com pliance schedules and should be used on a case-by-case basis. Such schedules should be specified in the parts of the permit where they are needad, 122.11 concerns recording and report ing of m0ni10ring results. C0nditi0n3 addressing this requirement should else be inserted in the parts of the permit where they are needed. A permit document of course is the end result of the permit process. Once a permit ap?1ication is submitted, the permit writer reviews the application and any subsequent revisions to ensure that the facility will meet all the requirements , in the regulations. If it does not and the permit can not be conditioned to bring the facility into compliance, then the permit must be denied. ERA is preparing guidance documents to aid applicants in submitting acceptable a p ? 1 i` c a t 1 0 n 5 and to assist permit writers in making decisions about w h 3 t ft 3 r the application is sufficient to meet design and p; nc3 standards required by a regulations. Lh3 T 1 h e t app 1 r 0 a n J- g m1 u 0 a n g 0p has r 0 w v a i m d 0 ed ns 1n he mode 1 0 0^ m i t a337 e3 t ft a 4p Up a ; 0 d that t h 3 f a c " 1 1 y w 1 11 M 0 0 A 11 - ft 0 r 3 c U 1 ~em n t s i n -^ w> > 0 r ds - u 1 a t 1 on s to the a pro 4 a t 0 > eve I 0 f d 0 t a i 1 . Ti 1 h e mo C 3 n1 p 0 r m i t doe 3 71 0 J` 0 < p 1 3 i n h 0 w ec h n i u- 2 1 d e qua c y pj.j ; i s i 0 1 1 s e r s 0 f t ft i s mo ,4 a 1l s hou 1 d s 'V 1 1v 1 iLfcV' e m a d 3 u n d e r 51 a 1,,1 uJ t ft 5 ^ v tn e pe rm i t w r1 0 3 r many 0 7 1. n e ? 0 p - f Oman /* 0 S "3 andar d s r i ted h 0 re 7 n mu s t 0 p amp 1 i f i e b y con d i i on 5 pec i f 1 C t 0 jb h e 1 a c i 1 i ty i n que 31 i 0 n . T ft i s mode i 5 design e d Vr 0 p no 7 i H 0 '-a4 f 0- m 3 hu. 7 V 1 s t and a r i p e r m i +Up condition s d n d t 0 a id P3 m ant s .71 0" 'j 0 M' 1 | 1f*> th 0 j "0r5 71 c-a n3 u 1 i & a n en su r i n i 0ns a0a 3 a that a 1 '-i d res s e d J the ap0I by t he 0e ) c a su i* m i 1 0 ^ -d u i r3 mU5t r* h h3 4 0 3 a i mp0 r /* egu L 1 a a n w t 0 t rj 0 0 n a 0 AL, si 10* t h at a 1 1 a n w k wl a t p a 2 1 rn 1 1a t pp c0nd 1 i ca i ti 0ns b ; e ?1 " a- 7^ ,j, n1 3- - ory r 0 0 j 1 r 0.71 an t i >71 7 s t b a d d r e ss ed i n t ft 0 0 3 rm i 0 , h0 s t at 3 m A n r 0 4b a s s 0r fact 3 ft e a t (s e e 40 /*> ^ r R 12A , 7 and 1 2 4 , 3) S h 0 u Id 0 0 3 c r i b a h A r 5 4 j on a ] 3 f 0 r t n e CO 0 d 7 t i 0 n s i n ft 0 CMA 047486 \ ' >3- permit 2nd 2 ny waivers t n a t a r e '! h e n a 0 e 0 m i t condition r 2 f;e ct3 an 0 n a m b i c u 0 0 s r e q j * r e n ? 11 , the fact sheet/atatam* n t of basis need merely r 3 f ^ r ^ n c i t> 1 r eq: 1:raren:. 512 n d 2 r d , the Whan fa :t a p 3 r -1, i t she ccrc'cicn fj1 ~i ] 1 s a jarfor`T\*r\z* nI 1j *^ ,A, w .1 y c r h 0 w t r a t cord i C ion sat tne ra0u1 a the rego 1210ry basis f or a p 2 r mit condition is not 0 b / i0 j 3 the fact sheet,/s t a t e m 2 n t of basis s h 0 u1d clearly support i n c 1 u d i n g that c 0 n d i ti O n . In most oases, t .0 fact sheet/s t a t amen t of basis for a storage permit will be quite brief. The attached cns;'< list may be used as a guide co or an index for the fact sheet/ statement of basis. I lengthy explanations are needed for permit conditions, the permit writer nay prefer to summarize those explanations in the fact sheet/statement of basis and reference the administ native record for the complete documen- tation. CMA 047487 "ul'CU'jijOUt C'0U^UjijUUU0UUUL'uCl:ijUL^U(;UUUuOL:UjUUUUU^LuUv'jULUcU0Uu'jUUuCUL^ cri^ = x.>,*,`' T J i Vk7 i ',-. -O '*L ssoii-'/ *i'\ 't .-I*--'i,Fr--r*j1'-.?yW-Ty* --JV^ii*v/l>/l,^ ' / A.1A5 0 a / -- J - " ^a I . 0 . Nunbsr Permit Number' Pursuant to the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act, as amended (42 USC Section 5901 et, seq., commonly known as RCRA) and attendant reigulations pproommuuTI ggated tt.hneerreeuunnddeer by the U.S. Environmental Protection Agency (EPA) and codified in of the Code of Federal Regulations, a permit is issued to the , hazardous waste storage facilitylocated i n o nRoad, at latitude and longitude i n e ? e mi 11 a e m u s ' comply with ai terms and conditions of 7 " a 1 i nit. This pe rmit consists of the conditions discussed i n Pants I and II and the applicable regulations contained i n 00 CFR Parts 250 through 254 and 122 and 124 as s p e c i f i e d the permit. Applicable regulations are those whic h the data of issuance of : m s (" 0 012 2 j(2) ) . s p e m i t is b; s ed on the assumption u ,n a . up mi C* i u A mitt ed 1 att8r a ne 0 p , m 3 r ' n a pi A ff` n i h e p s r m i t ape i c a tio n attached t o ! ( A ___________ as modi f i e d da" a d j re; to a and o n is a; t in a *1 t il i t y will be constructed and o p e r a t i n t i on. Any i n a c c u r a c i e s fourc i n c c o u 1 d ' 1'e a d t o t h e t e r min a tio n or modification of and o o t al en fore smart action (4 0 CFR 122.15 12 1 7 Th; ? ermittea shall inform EPA of any r r on o r *ou 1 d a ng: k s in the information in the a p ?1 i c h e Permittee's aoility to comply w a p p 1 i ca o l r e ul at ions or Dermic conditions. forma 11 on rm i tt v sub S 5 0 U 3 i rate and as s psci fi ed s inf ormat his p e r m i t 12 2. 15 an e v i a t i on ion w h i ch ii the oermit is effective as or anw sna I e u l i n 11 i, unless revoked A n H or i e rm i n a t e d v1 A p ^^ rr- R 12 2 5 ) or c o n t i ,n u e a in orda n : e wish 122. 5(a). r, n n a a n r, n n a n a a n a a a CAAAAAf (\ r\ p, i V'vvVVVv'A/yvVV.J'/Wm IfifiOfiOOQ I CMA 047488 I MODULE I J I l1 ndi'icns - ; A . ? i 3 :! I T j ,n a : 21 1 0 w e d ; ) s:: r a ,. j _ a r >_ u i- ^ '' a j - r d -j C ** `* 1 " H t :"1 c 0": i : i 0 r 3 0 : h - s p e r ~ i t. A -n y s t 0 hazard:..: w a 3t C 0 r, 3 1 i a n c a with ,a*1 u^ * I J , . U I 1 - - '` m1 this panit const this pe'-nit is p: O :1 ' t u t e s compliance ^0 r our pose 3 c r" en f 0 rc en 9 n t , h S ij 01 i1 1 a C of 3 C3 A. I s s ua 0c e or this parr it does not c: ey r 1* --i ^,w -i r Z y "ights of any sort or any exclusive privilege n 0 r doe s 1 1 authorize any i n ' u r v ri ti 0n$ . to 0 e - s 0 1 s 0 r p r,0 p 2 r any i n T r 1 n 7 l!> mart ompl i arc & w i th the y j S n > i n v a s ion 0 f other private of St at 3 0 r local law or reg u1 a terms of this permit does not c 0 n 51 i t u t e a d a fa n se 10 any action brought under Section 700 3 0* CPA, ` Sec i on 105 (a of the Comprehensive Environmen^ n s a, C om p en s a t i 0 n , and Liability Act of 1530 (42 U.S.C. 9501 et.seq., commonly other law governing protection of^ pknuoI bwH lnic_ asIheCa1Elt. 3hCLoAr), or jt_h!_ e any environment for any imminent and s ubstanti a 1 endangerma.ot to human health, or the envir0nman t. PE3MIT ACTIONS Inis permit may be modified, revoked and reissued, or termi rated for cause as s p_e_c ified in 40 C F 3 122.15, 122. 1 5 , and 122.17. The filing of a request for a permit mogification , revocation and reissuance, or termination or the notifica tion of planned chances" dr a n td 'cTp a t~ e c n 0 n cam ? I TTh c e on the part of the permittee does not stay the applicability or enforceability of any pe rmi t condition c. sev: y p r 0 v i s i 0 n s of this permit a re save able, and ir any p r 0 - vis on of this permit or the app1icat ion of any pr 0 v i 5 i 0 n of ' his pernio to any circumstance, is held invalid, the a c p i c a fi0n of such p r 0 visi0 n to 0 thheanr circumstances, and the remain de r of this permit shall not be affected there0v DU AND 1 Duty to Comply. The permittee shall comply with a 11 condi - tiers 0: this permit, except to the extent and for h e d u r a - ti0 n such noncon?Iiante is a ut h0 riz e d by an emergen y permit. Any permit ncncomp 1iance constitutes a vio a t i 0 n 0^ 3 0 3 A and is grounds for enforcement action, perm term'nation, revocation and reissuance, m 0 gific a t i 0 , or for Genial of a p e r mit r e n ewal application. T1 CMA 047489 '\ C7 y* I* 53 '2.1 00 2 "/ 3 2 r 1' 1 3. '"lit S < Z ' Cl r* a 0 ;1 - i 1 0 a 0 o d t n a permit 1 tt e d a t i m 2 1 j n ti 1 0__->_ Uji a3 on a 1 02- t 0 2 d;n i o i s t r 3 o r 2 S n oi 1 3 3 'J 2 d 3 I - J -1 r- w r A 124.15 `o Ha Or Reduce No A D, r s na i ba a defense for a permittee in an enforcement action that it would have been necessary to halt or reduce the permitted activity in order to maintain compliance with the conditions of this permit. 5. Duty to Mitigate. The permittee shall take all reasonable steps to minimize or correct any adverse impact on the environment resulting from non com clianca with this permit. Pro per Op ra L i 0 n and M a i n 12 n a n c a. time s pr 00 3 r 11 y op era t a and m ai n t a i n The per n i 112 e all fa ci T1 i t i es shall a u a 1 and sys em 5 0 f t re a t n a n t and con t ro1 (and re 1 at ad aopurt e n a n c a s ) which era i n s al 1 9 d 0 r used by the permi tt ae to achiev a COmpl iarea w th con d i t i on 3 0 t h i s p a rmit, P r open 0 p a r a t i 0 n and m a i n t e n a n r i n c 1i u d es a f f P c t i v e performance , a d e q u a t a fun A i ng , a d e q u a 12 ope tor s t a f f i rg and t ra i nin g , and adeq u a t e 1 a b 0 * story and pro /* ess con Jr ro Ts , i n C 1 udi 'id aopropriat a qua 1 i ty a s s u n anca p r 0 c e d u r 0 s. rh i s p ro v i 5 " 0 r*> f A qui ras the op e r 31 i on of bac V; -up or a u x 1 1 > a ry faci ] tV r> 0p 5im1 1 zf systems on 1 y w h en recess b ry t0 ach 1 ev2 com j -] a n c 9 w 1 t h t h e conditions oft he permit 7. Duty to Provide Information, The permittee shall furnish to the' Reg i ona 1 A cm i n i s t'rator within a reasonable tine, any re1evan t information v/hic'"1 the R3sengiio~n a 1 Administ rator may " a q u a s t to d e t e r m i n e -whether causa e < i s t s for m C d i f y 1 n g , e v oki in and ra issuing, or terminating this permit, te d e: e r m i n e c o m o 1 i a n c a with this permit. 'h2 permittee s h a Iso furnish to the Regions - d mnis t r a to r , upon rac u a s t , copies a : o n d s eo:.nred to be kept by this pa rmit. 3. Inspection and Entry The permittee shall allow the Regional t ra to r, or an authorized rapra s enta t i v a, upon the pr2s en of credentials and other documents as may be repaired by Enter at reasonable times upon the permittee's premises where a regulated facility or activity is located or de ducted, or wha r; tores m u s1 0 e i n c e i n e c, ci 0 n s 0f this permit; CMA 047490 ' V,. / 4 ` Hav= access to and copy, at reason able times, any r e c o r d s that irjs: b a 'opt ends' t h a conditions o f this perms ; Inspect as reasonable ti- a s ' a c n i s ' a s, a: u i : m e n z (including n o n i t 3 " i n g arc c c n trot e q n i p r. a - c as or operations sgulated or required under phis permi and Sample or nonitor, at reasonable tines, for the purposes of a s s u r i n g p e r m i t to m p 1 i a i c a or as o t h e r w i s e authorised by <CRA, a-v sjbs:2.ncas or p 5 r ; -fj i ^ i ^ ^ ^ a y 1 C i * 1 0 r 5. Monitoring and Records. (a) Samples and measurements taken for phe purpose of moni toring shall be representative of the monitored activity The method used to obtain a representative sample of the waste to be analyzed must be the appropriate method from Appendix I of 40 CFR Part 261. Laboratory methods must be those specified in Test Methodsfor Evaluating Solid Waste: Physical/ Chemical Methods S'W-8 45 ri nsert date of puo 1 i cati on] , Stan card Methods 'of Wastewater Analysis [insert reference number and date of publication.!'; or an equivalent method as speci fied in the attached Waste Analysis Plan. The permittee shall retain records of all monitoring information, including all calibration and maintenance records and all original strip chart recordings for continuous monitoring instrumentation, copies of all reports and records required by this permit, and records of all data used to complete the application' for this permit for a period of at least 3 years from the date of the sample, measurement, report or record. T h e s e periods may be extended by request of the Pegion Adnini strator at any time and are automatically extend during the course of any unresolved enforcement action regarding this facility. fO l-i> Seconds of monitoring i r, f o "m a t i on shall include: (i) The date, exact place, and time of sampling or measurements; (ii) The individual's) who performed the sampling or measurements; >e aa te a n a i y s e s wera performed; n d i v i d u a 1 (s) who o e r f J r m e d the a ra 1y s 'he a n a 1 v t i t e c n niq u e s or m e t n o ds used; ind T. 3 CMA 047491 ne results or sucn a n a . v s a s. > }' 13. 2 e ~ c r t i n a Pierre; en je3 . The pe ni:;e e s re 1 1 g e * : ; e So ore ?, e : 1 o r a , A 0 i n ' s o r a 0 o r 33 poor as pass o' 2 ? y Dia.ii^: : 3 * ~ 3 * J r 2 * ; J .Vi ^ : e r r i 10 e 0 f a c i 1 i 0 v . J Certification of Construction c r ! c d i f i ion. P s rmittee nay not c cm erne so o rape A 3 O 3 " a O J 3 ' 3 3 0 e 3 a re wly permitted facility nor i n a 'ied p o r c i o n o * an e xis 0in3 f a ci1i0 j until: (a The permittee has submitted to the Regional Adminis trator by certified mail or hand delivery a letter signed by the permittee and a registered professional engineer stating that the facility has been c--o---n--structed or mod "ied in compliance with the permit; and (i The Regional Administrator has inspected the modi fied or newly constructed facility and finds it is in compliance with the conditions of the permit; or (11) The Regional Administrator has either waived the inspection or has not within 15 days notified the permittee of his or her intent to inspect. 12. Anticipated Non c o m p1ia n c e, The permittee shall give ad vance notice to the Regional Administrator of any planned changes in the permitted facility or activity which may result in noncompl i e.nce with permit requi remen ts . ansfer of Permits. This permit may be transferred to a ne w o w n a r or operator only if it is modified or revoked and r ei 5 3 u 9 d pursuant to 40 CFR 122.15(d)(2) or 122.17(d). Before t r a n s f e r rin g ownership or operation of the f a ci1it y a j r i n g its operating 1 if e , the permittee s h a 1 1 notify z h e new o w n ar or ooerator in writing of the requi renents of ^0 CFR 25^ and' 40 CFR 12 2. Con o1ia n c a Schedules. Reports or comp ranee or in com o , i - a o c e with, or any progreissss rreeptoorrttss oonn,, inn tteerrimi m aani a final r eq u i reme.nt s contained in any compliance schedule of this permit shall be submitted no later than 1- days following each schedule date. 15. Twenty-four Hour Reporting . The remittee shall retort to tne Region endanger he a' A a minis t r a t o r any noncompliarea which n a v o r e env i ro nme ' A n v i n f o r m; on sc nh = 1 1 L. d CMA 047492 ,m n ' i i y . \ d e o " 3 v i d = d orally w'tMn 2^ hours f " orn tee bee o.i a s aware of the ci "cunsfarces shall oe ir dudad as ; n f o r~ a t i o r .'/rich o r a 1 / /1 t h i n 2 t hours: the time in a permit Ire * o ; 1o win g so be resorted [ n f .t r n 3 o. i v j 11 u e i ! ! u d 1 ; ; c o f a o y h a 2 a r d c ^ s / a s t e kb U` *'+ lay cause an andanceroent . o p u o : i n < i r, o w a t e r s u o o 1 i e s. Any : n r o r n a p i o n or a r e , e a s e or : : s c r a - g e or r. a ; a r a o u s w a s t e , or of a fire or" explosion from the facility, n t - S ^ 0 11 1 ^ h ^ a l * - f| u ti s ^ f' "*'**', ;n a * ^ r* S ^ h 8 ' 1 * "! outside the facility. The description of the occurrence and its cause shall include: (i) Name, address, and telephone number of the owns r or operator; (ii) (iii) Name, address, and telephone number of the faci lity; Date, time, and type of incident; (iv) Name and quantity of material(s) involved; (v) The extant of injurias, if any ; (vi) An assessment of actual or potential hazard to the environment and human health outside the facility, where tnis is applicable; and ( vii ) Estimated quantity and disposition of recovered material that resulted from the incident. A w r i t: e n s u b m i s s i on s h a 11 a 1 S 0 b a p r o v i d e d w i h * rt 5 days o f t n s t i me the pe rm i t a 8 be c o n a s a w are of ^ h 8 c - cum stan c 8 3 * The wri c ten s u b mis 3 100 5 ha 1 1 con <* a i -1 a desc rip i on or* the n on comp 1 i anc e and i t s cause ) the pe r i ods of n o ,n com p 1 i a n c 8 (i n c 1 u u i ng exact d a t es 5 n d i m e s ; 3 a 1u 17 Z n e n A n c Oil p 1 i an c 8 has not been corrected t th anti C i' ^ r1 a ted tin e i I s 3 X pact t 0 conti cue; and s taps f 2 N 1 0 " p i a n red to red and p r e v ant r? o c c u r e n c A o f k h -1 n j n c C m ? 1 i a r. c c- ) *h 8 a 1 i m ; n a ^- s- 3 Pi emit 4W. 8 8 nee d not comply wi t h t h r 1 7 a day w i z t 8 n n o w i p equ i ram a n t i f the R e gio n a 1 Ad mini s ra .b or wa i v e 5 that r equ i a m e n t and the p e rm i 11 a e s u b m i t s a w r i -b ten r epo r t with 1 i f i i b a an day 3 o f t h a t i m e the p e rm i t k 8 0 b 0 cone s a w are d? the c 1 * cum Stan C es. 3 CMA 047493 ,* ' f ) ' > / ; /\ 1 .1 / 'f* --.4 w"' -V.i {.; , 5 r !CF ZC^` The permittee h a 1 1 r e p 0 r t all 01 n 9 r 1 n 3" a n c 9 s of 10 n c 3101 i a r ; e 10 c otherwise re q - i r 2 d ported a t t ft e t i m e - 311 z 0 r 1 n: reports are sjj n i 11 e d . T h e reoerss stall c 0 112 ' t t " e ;tf: -- a t i 0 n 'isted it Condition .1,1 e r e t r, e cones aware that he f a i 1 e 0 to submit any relevant "acts in the p e "ft i t a p 01ic a ti0n , cr 3 ub ti11 e d incorrect i ^f 0rn a t"c n it a permit application or in any report to the Regional A a :n i n i s t r = p 0 r , t ft e p e r m i 11 e e s ft a11 p r onp11y submit such fa c t s or information. ?. Signatory R eo u i r erne n t. All reports or other i n f 0 rm 31 i on requested by tna Regional Administrator shall be signed and certified according to 40 CFR 122.6. F. Documents To Be Submitted Prior to Operation. [Mote: Include here the requiramant to submit any documents not complete or ready at time of permit issuance with the schedule for such submission (e.g./an updated contingency plan or the financial assurance instruments}.] G. Documents To Be Maintained a*t Facility Site. The permittee sha 11 maintain at the facility, unti 1 c10sure is completed and certified by an independent registered professional e n g i n e e r , the f 01 1 0 ,v i n g documents and amendments, r e v i s i 0 n s and modifications to these documents: (1) Waste analysis plan submitted in accordance with AO CFR 264.13. (2) Personnel t r 5ining documents and records submitted in accordance with a q c F R 264.15 (d). t i \1 r on tingency plan submitted in accordance with 40 CFR 254.53(a). Closure plan submitted in a cc0 r d a nc e with 40 CFR 254.112(a) / \ z51 Cost estimate fan facility closure submitted in accordance with 40 CFR 254.114(a).6 (6) Operating record required by ao CFR 264.73. (7 inspection sc.-hhei i'ullIe s developed in a c c 0 r d a n c a wit 2 5 a . 15 ( 0 ). ,11 11FR All amendments, revisions and m 0 di fic a ti0 n s to any plan or cost estimates - e q uir e d by this 0 e r mit shall be submitted to the Regional Ad mi .0 i s t ra t 0 r for approval ana permit modification. CMA 047494 PART il '. ' ! MODULE :: - O'-.IL " FACILITY CONDITIO N S - 'j *'-! c t i zed Was 12 . - K ermittee is authorized to store. OW ' .( g ;UZ;r'3C'J3 w. 2a 5* t = 3r nazarcous waste : o 3 : c o r* c a ; e -t' t h t ,i e conditions s p a c 1 f i 2 d ' ^ * o ! r Waste Description [Module] ote: The permit may alternately list the authorized wastes in each module of the permit.] Design and Operation of Facility. The permittee shall rnTTlTTiTn and operate the facility to minimize the possibility of a fire, explosion, or any unplanned sudden or non-sudden release of hazardous waste constituents to air, soil, or surface water which could threaten human health or the environment. Required Notice. (1) The permittee shall notify the Regional Administrator in writing at least four weeks in advance of the date the permittee expects to receive hazardous waste from a foreign source. Notice of subsequent shipments of the same waste from the same foreign source is not r e quired. (2) when the permittee receives hazardous wests from an off site source (except where the permittee is also the gen erator), he must inform the generator in writing that he has the appropriate permit(s) fo", and will accept, the waste the generator is shipping. The permittee shall keep a copy of this written notice as, part of the operating record. [Mote: This condition is only applicable if t n e f a c i 1it y receives waste from off-site.] S e n e r 31 Waste Analysis, The permittee she 1 follow the procedures descrioed in the waste 2 n a 1y 5is p an. Attach- ment The permittee shall verify its wa ste analysis as part of the Quality assurance program. T he quality assurance p r 0 c r a n will be in accordance wit h current ERA practices (Test Met nods for Evaluating Soli d Waste: ? ,1 y s i c a 1 / C h e m i c a 1 Met h ocs SW-3^3 lT ns e r t cate of p u 0 1 i : a t i 0 n j ) cTr 3 q u i v a 1 ant me t n 0 d s a ? p r0 v e a by the R e gi0 na 1 A d mini31 r a t 0 -; and at a minimum insure that the p e r mi11 s 9 main t a i t s proper functions instruments, uses approved sampli n g and analytical methods, assures the validity of sampling and analytical pr 0 c a du re s, and performs correct calculations II. I CMA 047495 S 3 c 'jr i t y. The pa rmi11 ee shall comply with the s a c u r i t" y 2 r o v i s i o r. s of iO CFR 254 14(b) [select either (1) or (2) b 2 s a: p o n the applicant 5 submittal] and {:) . r;|Q*fJr *03 5 S u< a s s - .; 1 1 d e m o n s t accordance with i j CFR 2 54.14(3} chat tea s a c u n t j require- marts 25-. 14(b) and (c) 3 r e not nec as sa ry, no s a c u r i t y permit condition is need ed. This d emon s t ra tio n u s t be do c u n a n t a d in the a d m i n i s t r a t ive record. If an specific security provisions are a -- ^ Cl d :o meet the parf standard in 264.14 ( a ) , t h sy should be so noted example, s pa cify 1 i ng u a c e of signs required by ror 1 11 if necessary.] General Inspection Requirements. The permittee shall follow the inspection schedule (Attachment ) and shall comply with 40 CFR 254.15 (c) and (d). Personnel Training, The permittee shall conduct personnel training Tn accordance with 40 CFR 264.15. This training program shall follow the attached outline (Attachment _____ ). General Requirements for Ignitable, Reactive, or Incompatib 1 e ha s te". t h s"' perm i"t t a e s h a 11 comply" wi tin The requi ram ants of 4 0" CF'k 264.17(a) and the documentation requirements of 264.17(c). [hots: This condition applies only ignitable, reactive or incompatible cific to different types of storage or piles) are specified later.] if the permittee handles wastes. Conditions spe(i.e. , tanks, containers, Location Standards. T M o t e : Seismic Considerations - If the proposed facility is 1 oc a t e d in an are a 1 i s ted i n A p p 0 n d i x V I o f 40 nL, FR Part 26 4 , the c p p 1 leant n u s *u hav e dam o n s t r a ted c o m p1i a f* r 0 w i th 40 CFR 254 * 1-30 \f a ) . T in i s must be documen + ed in the a a i n i s ^ r a t i v e record. wh L ;`l J t 5 ` F1 o o d p 1 a i ns f th e pro posed ( n aw } t a c I l ty i 3 n o t 1 oc a t e d i n t h a f1ood p 1 a ^ , t h ere is n o e rm i c on d i t i o n nee ded . record . iThis mu s t b e documented i n the a ami n i s r a t i v e For f aci i t i e s 1 oc at ed ' n the 100- VV ear ! | oodp 1 a i n , p r o visi on by w h i c h the p e rm i 11 e e must meet t h e r O u i r em an t s of not ac 40 i on n p C 1 FR 25 4 comp!i lance .13( b) ance w sc he du i 1 n t 3 u h st be 40 C (see spec FR 2 5 40 CF i i R ei ed. .13{b) 12 2.2 4x i mus 5(a) s / tin be ii) 3 / f pi V) ac i ac3 )] 1 d i ties on 1 `J II, 2 CMA 047496 Ra -u i red E2u i pner t . At a mi n * .tiu.n , the p 3 rm i 11 ee shall a - ;j i 0 t r, e f _ c t i 11 j with the e q u 1 p n e n t set f o r t h in the c on t i r ; a i c y pie r, { Acte c h m e n t ~i i t: e 5 hss success'-' s c c o r: a n c e -m t i -u _ j '-.32 :iac V/ is not r e q u i r e .1 the a e c 1 s i o n should be 3 i m i n i s t r at i v e r a c o n d . ] J rionsur;^': in ^ ' a V : J *> 'V-3 ^ documented in t n e Testing and Ma i n t e'* an ce of E c u i c m a n t . 7ns permittee s h a 1 1 t ast and m a i n t a~^~i the equipmen t s p a c i f i s d in the p-evious psrmit concision as necessary to assure / - S proper operation in time of emergency. b% [Note: If any specific testing and maintenance of the equipment is needed, the permit should so specify.] Access to Communications or Alarm System. The permittee sna 11 maintain access to the communications or alarm system as required by AO CFR 26A.3A. [Note: If the permittee has successfully demonstrated that such a device is not required under 40 CFR 254.32, the decision should be documented in the administrative record.] Required Aisle Space. At a minimum, the permittee shall maintain aisle space as required by 40 CFR 254.35. [Note: If the permittee has successfully demonstrated that aisle space is not needed for any of the purposes specified in the regulations, the decision should be documented in o r s ? e c i f i cations 1 1 meet t h is r e g u1 a 11 a <: h e d ' to the permit.] A rr a n g s m e n t s with local Authorities. I f State or local oTrTcTTTs refuse to e ,o t a r f n to prep a r e d n ass and P r e v a n t i arrangements with the permittee, the p -mittee must document this refusal in the operating re c o r d . [Note: The permittee is required to describe arrangements witn local authorities in the contigency plan (See 40 CFR 264.52(c)). If the permittee cannot submit these arrange ments with his c o .o 11 n g.er, cy plan, the permit must be condi tioned to req uire such a r r angement s prior c a op e r ation . See Standard Condition F, ] Contingency Plan.1 1. Implementation of Plan. The permittee shall im ine rt "lately carry out tne provisions of the contingency p1 an (Attachment _______ ) whenever there is a fire, explosion, or release of hazardous waste or constituents CMA 047497 w h i c h threatens 2 n v i r 0 n m e n t. r could : h r 0 a 13 n 'nun in h 3 a cr 4h2 C 0 0 1 2 s oT` 3 1 a r . r 2 o u i r ;i 2 0 : 5 of 4 0 C FR 2 5-.;;. :cm ,v i t t 0 e 2. A,1-; 2 r c i2 r 0 3 to Plan . i imaa"' a t a 1 y amend, if r r, 2 sc pa as rm; t t 5 ary, e 2s the n a c .i 01t r i 2 n /12,/ : an cy j.;j p_ '1lan, in accordance vied 40 C F R 25^.54. 4. Emergency Coordinator, The permittee shall comply -,r. z h c r, e" raoui "aments of a g C F R 2 5 4,55, c r n : = " n i n g the emergency coordinator, [Mote: For new facilities, the names, addresses, and phone numbers of all persons qualified to act as emer gency coordinators shall ba supplied to the Regional Administrator at the time of certification (Sea 40 CFR 254.52(d).] Manifast System. The permittee shall comply with the manifest requirements of 40 CFR 254.71, 264.72, and 254.76. [Mote: This condition applies only to facilities accepting off-site waste.] Recordkeeping and Reporting. 1. Operating Record. The permittee shall maintain a written operating record at the facility in accordance with 40 CFR 254.73(a), (b)(1), (3), (4), (5), (7) (off-si da only), and (8}. Annual Report. The permittee shall comply with the a n 0 u a"l report requirements of 40 CFR 2 54.75, If 40 CFR 254.7 5 is amended, c0m?1ianca wi0h the amended regulation will be deemed compliance with this permit condition. Cl 0 s u re. Performance Standard. The permittee shall close the TTcTTTty T*n acc0r3ance with the closure plan, Attach ment Amendment to Closure Plan. The permittee 5 h a 1 amend the closure plan in accordance wit n a 0 CFR 25-. 11 2;b ) . Modification of Closure. "he permittee shall notify t ne Regional Acmims t r a 10 r at least 130 days p i0 r to the date ha a ane c t s to b e cin closure. Time Allowed For Closure. c eivin a the CMA 047498 i n a /o 1 je of hazardous .vasta, she permittee shall t r a a t or r a :n o v a f r o m sits all hazardous waste in accor dance with the schedule specified is the closure p 1 a r, ( A11 a c* h: dS r ' t ^ r r 9 c -1 /" j <* * * t a T ja c 7 n 2 z 3 r CiJ s W * 3 > -- ,-h a -j ^- ' "* : a 1 5- j a : t: v i * i a 3 i * accordancea wish the 3cec* - f i a d in the closure plan (A11 a c n ~e nt 5. Disposal or Decontamination o f n uio mar t. The permit- Tie rrm Con^T7~rTTn t Ha r e~q u i r e':n"e"n 13 c f 40 CFR 2 6-4. 114 o . Certification of Closure. The partittee shall certify tn'at the faci 1 i~ty "has oeen closed in accordance with the specifications in the closure plan as required by 40 CFR 264.115. Cost Estimate for Facility Closure. The permittee shall comply with the requirements of 40 CFR 264.142, including the requirements to adjust and revise the cost estimates, when necessary. Financial Assurance for Facility Closure. The permittee s ha 1 1 demonstra t e con t i n uou s con pi i a nee ~w ith 40 CFR 254.1 43 and .145, or where applicable with 40 CFR 254.145, .149, ,150 and .151 by providing documentation of financial assurance in at least the amount of the cost estimates required by permit condition II.S, Liability Requirements. The permittee shall comply with the requirements of 4o CFR 254.1 47 , including the require ments to have and maintain liability coverage for sudden and accidental occurrences in the amount of at least 31 million per occurrence with an annual aggregate of at least 32 million, exclusive of legal defense costs, and must have and maintain liability coverage for non-sudden accidental occurrences in the amount of at least 33 million per occurrence with an annual aggregate of at least $5 million exclusive of legal defense costs. Demonstration of coverage of non-sudden and accidental occurrences shall be made by [date]. Incapacity of Owners or Operators, Guarantors, or Financial Institutions. The permittee shall comply with cq CFR 254.143. CMA 047499 MODULE such container to a container that is in good condition / a s 12 in sene other way that c o n p 1 i a s with r.ts Qf the conditions of this permit. Compatibility- of Waste with Containers. The permittee shaTl comply with 40 CFR 254.172 and assura that the ability of the container to contain the waste is not impaired. [Note: If any specific procedures or equipment are required to assure compliance with this standard, the permit should so specify (e.g., liner specifications, testing procedures, etc.).] Management of Containers. The permittee shall manage containers in accordance with 40 C F R 264.173. Inspections. The permittee shall inspect container storage areas in accordance with 40 C F R 264.174. Containment. 1 . The permittee shall comply with the requirements of. a containment system found in 40 C F R 254.175(b)(I)-(3), including having a base which is free of cracks and gaps and able to contain leaks, spills and accumulated rain fill until such time that the material is detected and removed, be designed for efficient drainage and having sufficient capacity to contain 10^ of the vol ume of containers. The permittee shall construct and maintain the containment system in accordance with the attached plans and specifications (attachment _____ }. 2. The permittee shall comply with the requiraments of 40 C F R 254.175(b)(3)' and ( 5 ) . [.Note: If a waiver under 40 C F R 2 6 4 . 1 7 5 ( o ) ( 4 ) is granted, it should be so documented in the a d minis t ra tiv e record.] :: i. i CMA 047500 T n a permittee and m a i ta i n a r s t o r a g a a r a a i plans and s : a c i f i c a t i coma I i anc a w i t h -0 CF / i o 1 d i n g Tgn i table or react!vs waste within 15 m a t e r s (50 feet) of the facility's property line. Special Requirements for Incompatible Vlasta. (1) The permittee shall not place incompatible wastes in the same container, (2) The permittee shall not place hazardous waste in an unwashed container that previously held an incompatible waste or material. (3) The permittee shall not store a container of hazardous waste that is i ncompatioie, witn any waste or material stored nearby in other containers, piles, open tanks or surface impoundne.nts unless the container is separated from the other materials by a dike, beam, wall, or other device. [Note: If specific procedures or designs are specified by the permittee in the application to meet these standards, they should be incorporated into the permit. Also, if the permittee has successfully demonstrated that he has complied with 40 CFR 264.17(b), that decision should be documented in the administrative record.] Closure. The permittee shall comply with the closure p lYn fattachment _______ ) . I I 1. 2 CMA 047501 MODULE 17 - STORAGE IM .I/O e O' rV [ I n ^ of the ta ~ .< o 5 ( i U i *J 9 W3 , sc i f j t ii u:i2r, type t h e o3"C': t c- e scc 0 s s 1 g n of Tanks. The p s r :n i t f a e shall c o n s t r u c t all tanks in accordance with t n a attached plans and s p a c i f i c a: i o n s f a 11 a c h n s .o t The o e r m i 11 a a shall :n a i n t a i n f h e m i n i m um shell thickness specified in thasa.plans and specifications at all times to ensure sefficient shell strength. [Note: The minimum shell thickness must be specified in the permit.] 3. General Operating Requirements. 1. The permittee shall comply witn 40 CFR 254.192(a) [select either (1) or (2) based upon the applicant's submittal]. 2. The permittee shall comply with 40 CFR 264.192(b) [select (1) and/or (2) based upon the applicant's submi1131j. [Note: If any 'plans these standards will into the permit. 40 uncovered tanks.] or s pe c i f i c a t i o n s indicate how be met, they should be incorporated CFR 264.192(b)(2) applies only to C. Ins?ections. The permittee shall comply with the inspec tion requirements -set forth in attachment [Note: 40 CFR 254.194(a)(3) only applies to uncovered tanks. If tank ins p e c tio n is addressed in the 1ns p a c tio n schedule, it need not be addressed here. 40 CFR 2 5 4 . 1 9 4 ( o ) must be addressed in the inspection schedule. 40 CFR 264.194(c) must be addressed in the Contingency Plan.] D. Closure. The permittee shall comply with the closure pTTri ["attachment _______ ). E . Soecial Reouirements for Ignitable or Reactive Wastes. The parmit tee sinail not pi a c e i g n i tab le or react: waste i n a te n k , [Note : I T the perm i tt e e d e m o n s w < J t e s comp! i a n c e the a ppl i c a t i o n w i t n 4 0 u i i\ 264 . 1 9 3 (a )(i), (2) or (3) , the 0 e rm i t she u 1 d set f o ~ t h t h e cor,di t ions u nhi ch i gn 1 table o r reac t i v a was t 5 may be' pi a c e d i tank. 3 17.1 c* 041502 '> V' ) ; \ 2. The permittee shall comply with the req u i reta ,11 s of -0 Z?R 2 5 4 . 1 93 ( b) . [Note: This condition a p p1 ;e s only to facilities chat store h a ; a r j o u s = s t a s in covered t a n ;< s . 1 Special ^ecuiremants for Incompatible Wastes 1 . The pe rm i e e s h a 1 1 n o f i n t h s same a n '<. 2. The p e rm i L . ee sheil 1 not unwashed tank wh ii ch p r e w a s t e or ma t e r i a 1 * [Mo t a : iT J1 the pe rmi t;tee ha comp 1ia nee h i t h 40 CfrR 264 . should set fort h the approp IV. 2 CMA 047503 MODULE V STORAGE w'ASTE PILES i '< ~1 [Note: a n -j i t i pi I 3s. n0i ci ths t store weassttes i app 1 :ha t ?o1 i es * r-* ) * n,j conbtain ty pes 0 -i ] j * 0 2nd . E apply to f n s 9 liquids. C of wa s t a piles.] 1 J - ,, A Free Liquid 0 i 1 e s. 1. The permittee shall not place liquids or ;n a t a r i a T s containing free liquids in piles. 2. The waste pile shall be constructed and operated in accordance with the attached plans and specifications (attachment _} which provide for (a) that run-off or leachate is not generated; (b) that the waste pile is protected from surface run-on; (c) that wind dispersal is controlled by other means than watting and (d) that leachate will not be generated by decomposition. General Design Requirements. The permittee shall cons truct and operate the waste piles in accordance with the attached plans and specifications (attachment _J. [Note: The attached plans and' specifications must address the design requirements of 40 CFR 254.251 and the require ments of 40 CFR 254.253.] General Operating Requirements. Tha permittee shall control wind dispersa dous waste from tha piles. nazar- [Note: The permit shall specify control practices where nscsssarv to meet this condition 40 CFR 2 6 4. 2 52*(a )). ] 2. The permi 11 e e shall diver waste p i 1 e. 3 . The permi tt ee s h a 1 1 c o 1 1 e run-off from the waste pile. [Note: Plans and s p e cific a tio n s addressing the latter two conditions should be referenced or attached.] V. 1 CWK 1. The permittee shell activate the containment system evaluation and repair plan (Contingency Plan, attachment ), whenever there is any indication of a possible 7ailure of the containment system, as specified in 40 CFR 254.255(a). 2. The permittee shall comply with 40 CFR 264.255(b) and (c) regarding removing a waste pile from service, with 40 CFR 254.255(e) regarding restoring a waste pile to service and with 40 CFR 26 4,. 255(f) regarding closing a waste pile, F. Special Requirements for Ig.nltable or Reactive Wastes. T nT'p'a r n it tee shall n ot place i gn i'tabl or react i v e 1 wasta in a waste pile. [Note: If the permittee has demonstrated compliance with 40 CFR 254.255(a)(1) or (2) the administrative record must so document and the permit must specify the circumstances under which this coodition is waived.] 0. Special Requirements for Incompatible 'Wastes. 1. The permittee shall not place incompatible wastes in the same pile. 2. The permittee shall not store a pile of hazardous waste that is incompatible with any waste or other material stored nearby in other containers, piles, open tanks, or surface im p o u n d m e n t s unless the waste pile is separated from the otha^ materials by a dike, berm or wall. V. 2 CMA 047505 ... V ' (lt W J. The permittee shall .not pii 1 a 'j pi 2 : h a 0 i r 0 C 'J S w 2 3 , on t in 3 same bass wh 3 r e 1i n c 0 "i n 2t i 01 s ,v 3 312 s or wer-2 o-avious1/ piles 0- stored t'lots in the I" the permittee has successfully demo; 3 . ** ^ - a H permit application . hat he , need ,,neaot me, eat ,7t'rh* a ,, ,?n,; rements or' to C?R 254.2oo an: eu uFF nnminis''eti'/a record must so document and tna perm,- =tra*et u*ar coni-^ons are waived.] Closure. The permittee shall comply with the closure plan"] [attachment ______). V.3 CMA 047506 Checklist For RCRA P 3 r*~i t Conditions J > .1 ons Sj ?* --^ 9 ^* C on c : nation or E x p i r i m a Permits 122.5(a) CO '/ER, 122.6 Si on at ores to Per,-nit Ap p1ic a tion and Reports 12 2.5 T , 0.13 122.7 Conditions A o o 1 i c a d 1 e t o all Permits 122.7(a) 122.7(b) 122.7(c) 122.7(d) 122.7(e) 122.7(h) 122.7(i) 122.7(j) 122.7(1) 122.7(1)(2) 122.7(1)(5) 122.7(1)(6) 122.7(1)(7) 122.7(1)(3) I. D. 1 I. D. 2 I. D. 4 I. D. 5 I. D. 5 I. D. 7 T7" o; "3 I. D. 9 I. D. 10 I. D. 12 I. 0.14 I. D . 15 T7 0 . l'S I. 0.17 122.9 Duration of Permits 122.9 COVER 122.10 Schedule o' Compliance 122.10 122.11 Requirements for Record in g and Repo rtin g of Monitoring Results 122.11 122.13 Effect of a Permit 122.13 T . A. 1 2 2 . 1 1 Transfer of Permits 122 .1 A I. D . 13 CMA 047508 2 5 Modification or Revocation and R e i s s u a n c e of Permits 122.15 II 22 o Termination of Permits 122.15 I . 3. 512 2 Min o r Modifications of Permits 122.17 ^'22.22 Applications for a Permit 122.22(d) I. 0. 2 122.23 Additional Conditions Applicable to all RCRA P ermits 122.23(a) 122.23(c) 122.23(d) I. D. I I. D. 11 I. 0,15 Severability c [Mote: The severability clause has no foundation in the 40 CFR Part 122. However, it has become standard practice to provide this clausa in other permits (i.a., NPD5S). B. Specific Facility Conditions .25 4.1 2 Reoui red Notices 264. 12(b) 254. 12(c) II.C. r II.C 2 I. I) .13 Gene ra 1 Waste 264. 13(a) 25 4 . 13(b) 254 . 13(c) Ana 1 ys i s I I ,, D . 11,. D. I I .,0. Sec u r i ty 264 . 14(a) 26 4 . 14(b) 2 54 . 14(c) S 2 5 3 0 a r a 1 I n s p e:: t i 3 n Requirements 254 . H(a) 254 . 15(b) 254 . 15(c) 254. 15(d) II ,. E . I I ,. c . 11 , Cu- II .r# I I ,. F . II .F. II p 25-.15 Personnel Training 4 0 CFR 122.25 (a) (12) requi'es the preparation of introductory and continuing training programs to demonstrate comoliance witn 40 CFR 25-.15, specifically 254.15(a)(3).1 254.15(e) TuT . oC CMA 047509 4 .53 C o oie5 : o n : i n g e n c y Plan II. 0. ro 254,,54 Ame n 4 n ; ^ * of C0ntin jen;y Plan . 5- ; n s 4 .55 2na " g a n c v Co oralnator [.Note: The responsibilities of the emergency coo rd i n a 13 r shoo'd be .more fully spelled out pursuant to 4 0 CFR 2 5 4.55 2nd the c 0 n : i r g a n cy pi an (40 CFR 25 4.5 1 (a ). ] 25 4 . 5 5 emergency Procedures [Note: The contingency plan developed pursuant to 40 CFR 264.5(a) must address the requirements of 264.56.] t* .i . G.3 Tr X** 0.4 II . 0.1 26 4.7 1 tlse of Manifest 254.71(a) 264.71(b) 254.71(c) System II.P. 11 . P. II.P. [Note: These requirements applies only to facilities receiving wastes from off-site.] 7 2 Manifest Dis c r e p a n cia s I"1 254.7 2 (0) [Nol^e: This requirement applies only to facilities receiving wastes from off site.] II. 6254.73 Ooarating Record 254.73(a) 264.73(b)(1) 254.73(b)(3) 254.73(b)(4) 254.73(b)(5) 264.73(b)(7) 264.73(d)(3) I I- .0. I I .. 0. I I ,.0. I I .* rws * i i..0. 11,.0. 11 .0. [Note: 254.73(c)(7) applies only to off-site facilities,] 254.74 Avail abilty, Restention, and Disposition of Records 25 4.74 (a) 254.7 4 (o) -i" 0T -- 254.75 Annual Report 254.75 11 . c. 264,75 'J n m a n i fasted W a s c a R a p 0 r t 254.75 11. P . CMA 047511 f 4ot e : This requirement a pp1ie s on 1y to fact'1 i t i e s recai/ing wastes from off-site.] } 264 .111 Closure Performance Standard 254.111 II. R. 1 S26 - ] ' 5 C1 nsure ?1 an 254 . 1 1 2 < a ) 254.112(b) 254.112(c) 1 o e n d m e ' t of ^ 1 a n - 11 . . II . R . 11 . R . 7 2 3 S 2 -- o .113 C'os ure Time; Time Allowed f o r C1o sure 254.113(a) 264.113(b) 254 .114 Dispoa! or Decontamination of Equi p m e n t 254.114 II.?.. d II.?. : II.R. 0 264.115 Certificate of Closure 264.115 II .R. 7 254.142 Cost Estimate for Facility Closure 264 .1 42 (a) 264.142(b) 254.142(c) I I . S. II.5. I I . S. 254.143 Financial Assurance for Facility Closure 25-i. 1 43 11 . [Note: In addition to meeting this requirement, the permittee shall demonstrate continuous compliance with 40 CF3 264.145, (Use of mechanism for financial assurance of both closure and parc el o s ur e care, .149 (State financial mechanism), .150 (State assumption of responsibility) and .151 (Working of instruments, where applicable.] 254.1 Liability Requirements 254.147 I I ,U . 254.1-3 Incapacity of Owner or Operators, Guarantors, or Financial Institution 2 5 4.1 43 I I .V. C. Use and Management of Containers 254 ,,171 Condition of Containers 254.171 III.A. 254 ,,172 Conoa t i bi 1 ity of Waste w izh Centaln e r s 254 .172 III.3. CMA 0475X2 -0 - \i i \i : ? f __ i 17 3 " 51 a o e m e n t of C o n t a i n e r s 254.173 I!I .C. $j ?- z- j. i0: . i on 2 5 - . 1 7 -1 I I I .0 . 5254.175 Concaii-isnt 254.175(b) 254.175(c) TTI .E.1. ,2 I I I . E. 3 [Mote: 254.175(b) applies only to container s t o r a g e a r e a s boat s t o " e containers with wastes that contain free liquids, whereas 254.175(c) applies to storage areas that store containers holding only wastes that don't contain free liquids.] 254.175 Special Requirements for Ignitable or Reactive Waste 264.176 11 I.F. 254.177 Special Requirements for Incompatible Waste 264.177(a) 264.177(b) 254.177(c) III.G.l III.GT2 ' iii.g73 [Note: Compliance with 40 CFR 26 4 . 1 7 7 (a) may be waived, if the permittee has provided a successful demonstration under 43 CFR 2 5 4 . i 7(b ) . ] 254.173 Closure 254.173 0. Tanks 264.191 Design of Tanks 254.191 2 5 -1. 1 9 2 General Operating 254.192(a)(1) or, 254.132(a)(2) 254.192(b)(1) 254.192(b)(2) Rea j i remen t $ ['lota: 264.1 92 (b)(2) applies only to uncovered tanks.] III .H. IV .A. IV . B-. IV.3. IV . 3 . IV. 3. l1 1 2 2 CMA 047513 7 jJ 25 Inspections 25- . 1 9- ( 3 ) 2 5 4. i 9 i ( o ) 2 54.1 9 4 ( :) r 'l_o__t_e_ 2 5 4 .151(c) .iuusset boe a du_resse 2 pursuant to tne contingency plan (40 C F R 2 5 4 . 5 i ( a ,< . ] 01 o s u r a 254.197 7 - 1 C 'J T 19 3 5 p e : ia Pastes R a q u i r aments for I a n 1 tab"; a or Reactive 264.193(a)(1) or, 264.193(a)(2) or, 254 . 1 93 (a) (3) 254.193(b) [Mote: Compliance with 40 CFR 264.198(a)(1) may be waived, if the permittee have provided a successful demonstration under 261.21 or 261 . 2 3 and 264 . 1 7 (b).] 254 . 199 Special Requirements for Incompatible Wastes 254.199 wasftae ? i I 9 : 254 . 250 Apo1icabi1ity 254.250(b) [Mote: Waste piles used to treat or store hazardous wa st e that do not contain free liquids are not subject to the requirements under 2 5 4.251 , 254.252, 254.253, 261.254 and 254.255.] 2 5 4 251 General Design Requirements 254.251(a) 254,251(o) 254.252 ' General Operating 264.252(a) 251.252(b) 254.252(c) Requirements 5254.253 Containment 3'/stems 2 5 4. 2 5 3 (a)(1), and eit n e r 264.253(a)(2); or 251.253(a)(3) 254.253(b)(1) 264.253(0)(2) 245.253(c) 251.253(d) I'/. C. IV . C. I V . c. IV.0. IV . E . 1 TvTTT 1 IV . E . 1 IV.E. 2 IV. F . V. A. v. b. y. b. V. c. 1 V. c. 2 V. c. 3 7., 3 ,. a c. V ., 3., SC . 7 ,. ro> ,. ac. V ., B ,,sc. V..3,.sc. V,. B ,,&c. 7 ,. B.. sc. CMA 047514 1 3V > -, .; 254.254 Inspections and Tes tino 25-l'. 2 54(a) { / 2 5 4.2 5 4 (a) ( fV"1 J ' J 3 1 n ~ e * t S 2 5 4,,255 (2) 2 5 4,.255 (0) 25 4,,255 (C)(1) 2 54,.255 (d)(1) 2 5 4,,255 (d)(2) 254,,255 U) 25 4,.25 5 (0 01 ^ 1. D . ,11. W 4 B. )ii L. ft J, 7. E. 2 V. E. 2 II4 C\ U II. 0 V. E. 2 V. i. 2 [ N o t a : 254.255(d)(1) and (2) must be addressed pursuant to the contingency plan (40 CFR 254.51(a)).] 254.256 Special Requirements for Ignitable or Reactive Waste 264.256(a) 2S4.256(a)(1) or, 264.256(a)(2) [Note: Compliance with 40 CFR 254.256(a) be waived, if the permittee has provided successful demonstration under 264.17(b) 254.256(a)(2) has been complied with.] may a on 254.257 Special Requirements for Incompatible Waste 264.257(a) 264.257(b) 254.257(c) V. F. 7. F. V. F. [Note: Compliance with 40 CFR 264.257(a) and ( may be waived, if the permittee has provided a successful demonstration under 254.17(b).] 254.258 Closure 254.253 V. H. CMA 0475X5 CONCEPT OUTLINE MOBILE TREATMENT UNITS A Mobile Treatment unit (MTU) is a transportable device which can physically, biologically, chemically or thermally treat hazard ous waste. This treatment generally results in waste reduction or waste detoxification. An MTU can treat wastes at several sites' in a year and may return to a site on a regularly scheduled basis. Under the current regulations, MTUs require a RCRA permit for each site where waste is to be treated, even though the MTU has operated in the same manner at another site at which it has a permit. Under existing procedures, MTUs must obtain a RCRA permit at each site. Since the technical operations of the MTU will not vary substantially from site to site, a large part of each site's permit may be identical. In order to assure that repetitive development of non site-specific permit conditions does not occur, EPA will encourage MTU applicants to submit copies of their original permit application and the resulting permit conditions, in any subsequent application. Only site specific permit conditions would need to be developed for each site. An MTU's first permit will serve as a model for all sebsequent permits. EPA is considering th.e use of the Class Permit concept permitting MTUs that treat hazardous wastes in tanks. Such permitting procedures should reduce repetition and expedite permitting of mobile treatment units. for the CMA 047517 draft A GUIDE FOR PREPARING * RCRA STORAGE PERMIT APPLICATIONS Note: This preliminary guidance document is intended to assist owner or operators of hazardous waste storage facilities in developing RCRA Part B Permit Applications. It is being distributed to prospective permit applicants and others for their, review, comment and use. EPA is interested in receiv ing comments on the usefulness of the guide and suggestions as to how it may be improved. It was developed by a contrac tor in concert with EPA permit writers in Region I and Head quarters but has not yet been reviewed by applicants or other persons outside of the Agency. This guide was prepared by A. T. Kearney, Inc. P.0. BOX 1405 699 Prince street Alexandria, Virginia 22313 and by PEDCo Environmental, Inc. 11499 Chester Road Cincinnati, Ohio 45246 U.S. ENVIRONMENTAL PROTECTION AGENCY 1982 CMA 047518 DISCLAIMER This Industry Guidance Document has been developed to assist hazardous waste storage facilities in preparing Part B of the RCRA Permit Application. It is intended that permit appli cants will use the document as a guide to prepare their own applications in a format and level of detail acceptable to the u".S. Environmental Protection Agency. The model permit appli cation contained in the document was developed for a typical representative storage facility. Therefore, some sections of the model may net be applicable to all facilities. The U.S. EPA urges applicants to contact their EPA Regional Office to discuss the applicability of this guide to their facility and other facility-specific requirements. li 041519 PREFACE The purpose of this guide is to assist hazardous waste management facilities in the preparation of their RCRA Permit Applications. Its intent is to provide sufficient information and detail to enable a facility to submit an application; however, in some situations certain regulations may not apply to every facility. When this is the case, the applicable regional office of the u.s. Environmental Protection Agency should be contacted to arrange a preapplication meeting to discuss RCRA permit application needs that are not covered or understood. CONTENTS Pace List of Figures.................................................................................................. List of Tables.................................................................................................. Preface vi ix iii PAST 1 GUIDANCE MATERIAL 1 Section I INTRODUCTION .......................................................................... -1 Section II ADMINISTRATIVE PROCEDURES IN THE PERMITTING PROCESS ................................................................................... 4 Coordination with States ....................................... 4 Submitting RCRA Part 3 Permit Applications 6 Claims of Confidentiality .................................. 7 EPA's Review of Part 3 Applications ... 9 Draft RCRA Permits and Permit Denials . . 10 Public Notice, Comments, Informal Public Hearings, Panel Hearings ........................... 11 Final Permits........................................................ 12 Appeal to the Regional Administrator ... 12 Section III INSTRUCTIONS FOR PREPARATION OF A RCRA' PERMIT APPLICATION......................................................................... , RCRA Permit Application Format ........................ Suggested Permit Application Format . . . Detailed instructions and Content Recuirenents ................................................................ 14 14 15 21 PART 2 MODE . RCRA PERMIT .APPLICATION A - Part A Application . 3 - Facility Description C - Waste Characteristics D - Process Information Ground Water Monitoring Systems . . . c Procedures to Prevent Hazards . . . . G Contingency Plan ................................................. w Personnel Training ............................................ I Closure Plan, Post-Closure Plan and Financial Requirements ............................. J Other Federal Laws ....................................... Ce cation References 90 91 100 118 135 151 162 131 222 23 5 254 255 256 iv CMA 047521 CONTENTS (continued) Appendix A Appendix B Appendix C GENERAL INFORMATION AND HAZARDOUS CHARACTER ISTICS OF WASTES........................................................... INSPECTION LOG SHEETS ................................................... TRUST AGREEMENT .................................................................. 261 266 278 CMA 047522 Number 1 2 3 4 5 5 7 8 9 10 11 12 13 i i5 * 17 FIGURES Flow Diagram of the RCRA Permitting Process A Topographical Map of Tankopile Finishing Company and Surrounding Area Facility Photograph, June 2, 1980 Facility Map of Tankopile Finishing Company Facility Map With 5-Foot Contour Intervals of Elevation (feet MSL) Facility Map Showing 100-Year Floodplain Surrounding Land Use Wind Rose Federal Insurance Administration (FIA) 100-Year Floodplain Map Traffic Flew Laboratory Analysis Results - 1,1,1-Trichloroethane Laboratory Analysis Results for Rickie Licucr Laboratory Analysis Results for Vinyl Acetate Sludge Laboratory Analysis Results for Vinyl Chloride Sludge Laboratory Analysis Results for Pickle Licucr Sludge Laboratory Analysis Results for Metal Grindings Laboratory Analysis Results for Metal Hydroxide Sludge Pace 5 98 99 102 103 104 106 107 111 116 122 123 124 125 126 127 123 vi 0^523 C^A FIGURES (continued) Number IS 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 B-l B-2 B-3 Flan View of Container Storage Area Cross-Sectional View of Container storage Area waste Storage Tanks Process Flow Diagram Piping and Instrumentation Diagram for Hazardous Waste Storage in Tanks Containment System Section Containment System Plan Log Sheet Overview of Emergency Plan of Action Emergency Plan of Action Rally Points in the Event of Fire or Explosion Interceptor Trench Interceptor Trench (Cross-Section) Location of Emergency Equipment Sample Reporting Form for Emergency Events Organization Chart for Tankopile's HWM Facility Outline of Hazardous Waste Training Manual Level of Training for Hazardous Waste Personnel Anticipated Closure Schedule Monitoring Equipment Inspection Log sheet Safety and Emergency Equipment Inspection Log Sheet Security Devices Inspection Log Sheet 137 133 143 147 149 152 153 164 187 188 191 201 203 210 220 223 228 232 247 267 268 270 vii CKK 047524 FIGURES (continued) Pace Operating and Structural Equipment Inspection ' leg Sheet 271 5-5 Container Storage Area Inspection Leg Sheet 3-6 Tank Storage Area and Ancillary Equipment Inspection Log Sheet 272 274 3-7 External Tank Inspection Log Sheet 275 3-3 Internal Tank Inspection Log Sheet 276 3-9 Waste Pile Area Inspection Log Sheet 277 VI11 CMA 047525 TABLES Number X 2 3 4 5 6 7 8 9 10 11 12 13 14 Implicit Price Deflators 1972 Weights, for Cross National Product Waste Pile Construction Schedule Wastes, Associated Hazards, and Basis for Hazard Designation Parameters and Rationale for Their Section Parameters and Test Methods Methods Use to Sample Hazardous Wastes Frequency of Analysis Physical Characteristics of Storage Tanks Properties'of Chlorinated Polyethylene (CPE) Oil-Resistant Liner .* Inspection Schedule Emergency Coordinators Emergency Contacts Materials and Equipment for Spill Containment and Cleanup Closure Cost Estimate Page 70 114 120 129 130 132 134 144 157 167 183 184 212 249 ix CMA 047526 PART 1 GUIDANCE MATERIAL SECTION I INTRODUCTION Under Subtitle C of the Resource Conservation and Recovery Act of 1976 (RCRA), the U.s. Environmental Protection Agency (EPA) established regulations to insure the protection of human health and the environment through the proper management of hazardous wastes. These regulations require certain facilities that treat, store, or dispose of hazardous wastes to submit RCRA permit applications to EPA. These applications should contain sufficient information to assure that the management practices at those facilities will provide adequate levels of protection. This Guide has been written specifically for owners and operators of storage and treatment facilities that have hazardous wastes in tanks, containers, or piles. It provides detailed technical instructions covering' the required content of the RCRA permit applications and explains the administrative procedures that the EPA will use in the RCRA permitting program. The intent of this Guide is to minimize the effort and time required of industry to apply for and obtain RCRA permits. The detailed explanations provided in this Guide will help to pre vent applicants from developing and presenting more information than needed to evaluate the applications. The suggested appli cation format is presented as a guide for organizing submissions. 1 CMA 047527 1 The information presented concerning ZTA's administrative and confidentiality procedures in the RCTA permitting program is intended to assist applicants in an understanding of Agency requirements. Ultimately, this Guide should serve to improve communications and cooperation between industry and the ETA in the RCJLA permitting program and increase the effectiveness and timeliness with which ETA carries out its regulatory responsi bilities . The second section of this Guide describes the administrative procedures that will be followed in the TCTA permitting program. It includes discussions of how applications will be requested, the two-stage process that ETA will use for reviewing applica tions, public participation procedures, permit issuance pro cedures, and the timing of these events. This section also describes the procedures that should be followed in requesting protection from public disclosure of confidential "business 9 information. It provides details of the types cf information i that will receive confidential treatment by ETA and how the lecitimacv of ccnfidentialitv claims will be determined. r>s a action of the Guide presents an accepted format for structuring a RCRA permit application and provides detailed explanations cf the information that must be included in the aco .ion. Tart 2 of this document presents n example of a complete RCTA permit application for a hype the' cal storage facility, This example provides a model cn vhic. actual applications can 2 CMA q4,7528 be based. It is structured to assist RCRA permit applicants in determining the appropriate level of detail and the proper presentation of that material. Applicants should be aware, however, that the level of detail will also be related to the size and complexity of the facility. 3 CMA 047529 SECTION II ADMINISTRATIVE PROCEDURES IN THE PERMITTING PROCESS This section outlines the activities entailed in applying for and obtaining a RCRA permit for a hazardous waste management (HW!) facility (figure 1). An understanding of these procedures will allow applicants to deal effectively with ERA in the permit ting program. Most facilities that treat, store, or dispose of hazardous waste must obtain a RCRA permit. The application for this permit consists of two parts,-Part A and Part 3. Certain facili ties (i.e., those in existence before November 19, I960) have Part A. These facili ties have been ;us" that allows them to continue to operate until final administrative action is taken on their permit. To obtain a RCRA permit, however, these facilities must submit Part 3 applications. The ERA Regional Administrators have the authority to request owners and operators of existing HWM storage and treatment facilities to submit Part 3 of their RC-A permit application, but any facility may submit the Part 3 application voluntarily. Coordination with States An aoolicar.t for a RCRA remit should be aware that the ERA and the states share restcnsibilities for administration o: Cm 047530 0 Figure 1 Flow diagram of the RCRA permitting process. 047531 nhe RCR.V permit program. Each state's role in the permitting process varies according to the status of its authorization to administer the hazardous waste permit program. Applicants should familiarise themselves with the state's permitting process and he aware that EPA permit writers will be communi cating with the states at appropriate stages in the permit process. Submitting RCRA Part 3 Permit Applications The E?A Regional Office may request submission of Part B of the RCRA permit application from an existing facility, or a facility may voluntarily submit Part 3. The letter of request will generally include a list of the items in Part B that are applicable to the permit applicant's facility type, a copy of the Part 264 and Part 122.25 regulations, notice of the appli cant's right, to claim confidentiality, notice of the right to question Che ERA Regional staff about application requirements and the names and phone numbers of the appropriate contacts, information on the number of copies required and where the applicant is to submit them, and a recommendation that the applicant contact the appropriate state authority. An existing facility that has been requested to submit Part 3 of the RCRA permit application is allowed at least 6 months to gather, organize, and send the required data to EPA. During this time, the facility can contact the EPA Regional Cf fi C $ *0 2T clarificati on or assistance Depending on the depth and plaxity cf the issues, the EPA cr the a?plicant may find It. 6 CMA 047532 n o a useful to schedule a conference. Such a meeting can facilitate the permitting process by identifying problems early and enabling the applicant to resolve them. Claims of Confidentiality At the time of submittal, applicants for a RCRA permit may assert a claim of business confidentiality for proprietary information included in their application. General EPA regula tions governing claims of confidentiality are found in Title 40 of the Code of Federal Regulations (40 CFR), Fart 2. Specific provisions for claims of confidentiality submitted with permit applications are found in 40 CFR 122.19. In these regulations, "business information1* means "...any information which pertains to the interest of any business, which was developed or acquired by that business, and which is possessed by EFA in recorded form." "Commercial information" refers to processes, operations, style of work, or apparatus. "Financial information" refers to the identity, confidential statistical data, amount of source of any income, profits, losses, or expenditures of the applicant. An applicant may claim that business information is entitled to confidential treatment for "reasons of business confidentiality." This includes trade secrets and commercial or financial information, that, if released, would be likely to cause substantial harm to the competitive position of the applicant. Claims of confidentiality must be asserted when the permit application is submitted. If no claim is asserted at that time, the EFA may make the information available to the public without further notice to the applicant. 7 C&A 047533 To assart, a claim, the applicant must attach a cover sheet to the information, or stamp or type a notice on each pegs of the information, or otherwise identify the confidential portions of the application. Words such as "trade secret", "confidential business information", "proprietary", or "company confidential" should be used. The notice should also state whether the appli cant desires confidential treatment only until a certain date or a certain event. Prior to releasing any information for which a claim of confidentiality has been made, the Agency will give the applicant an opportunity to substantiate its claim and will then determine whether the information warrants confidential treatment. Applicants should limit their requests for confidential treatment to such material that if released, is likely to cause substantial harm to the competitive position of their respective companies. Claims of confidentiality should not be asserted for information that is reasonably obtainable without the applicant's consent (for example, standard engineering designs). It is important not to claim confidentiality for the entire permit application, as such claims will significantly delay the permit ting process. Whenever possible, the applicant should separate the informa tion contained in the application into confidential and ncncor.fidential units and submit them under separate cover letters. Claiming confidentiality for a large portion of the information in the permit application and failing to separate the application into 3 047534 CM& confidential and nonconfidential units may result in significant delays in processing the permit application because the EPA lacks the in-house resources for expeditiously separating out the information entitled to confidential treatment. EPA's Review of Part B Applications When the EPA Regional Office receives a RCRA permit applica tion, it reviews the application for administrative and technical completeness. The administrative review involves a check of the timeliness of the submittal, general data items, correct signa tures, and certification of relevant technical data by registered professional engineers. If the application is incomplete, the EPA requests the missing information through a "Notice of Deficiency" (NOD) letter. This letter details the information needed to complete the application and specifies the date for submission mf-these ---- data. When the EPA has received all the necessary information, they will notify the applicant in writing that the application is complete. The EPA then performs a technical review of the application to determine whether the facility under review has satisfied the requirements of the standards promulgated under Title 40 of the Code of Federal Regulations (40 CFR), Part 264, and should be granted a RCRA permit. A site inspection may be conducted during the RCRA permit application review process to verify the information contained in the application. 9 CMA 047535 The Agency may choose to use state officials or a contractor to provide technical expertise and assist in the technical review of a permit application or to conduct onsite visits to verify information pertinent to the issuance or denial of a RCRA permit. Draft RCRA Permits and Permit Denials Upon completion of the technical review, the EPA Regional Administrator tentatively decides whether to issue or deny a RCRA permit. If the tentative decision is to issue the permit, the EPA regional staff prepares a draft permit for public review. The draft RCRA permit specifies all the limitations, require ments, and conditions to be placed on the facility. The Regional Office also prepares a "fact sheet" or "statement of basis," which explains in simple language the reason for each condition included in the draft permit. When writing a RCRA permit, the EPA may specify a schedule for compliance rather than requiring the facility to be in full compliance at the time of permit issuance. A compliance schedule allows the facility to operate while it is upgrading its opera tions to meet all the regulatory requirements. Such a compliance schedule is used only when it is clear that temporary nonccm.pllance will have no unacceptable effects on human health orthe environment. In its decision regarding a schedule for compliance, the Agency also considers such factors as availability of any materials required to upgrade the facility, construction time, and the time racuired to contract for such services. 10 CMA 047536 A permit may be denied if it is determined that an applicant cannot meet the requirements of the standards set forth in 40 CFR 264, that activities at the facility will endanger human health or the environment, or that an applicant either has not fully disclosed all relevant facts in the application or during the RCRA permit issuance process or has misrepresented any relevant facts at any time. If the Regional Administrator tentatively decides to deny a RCRA permit, a notice of intent to deny a permit is prepared. This notice is considered a type of draft permit and follows the same procedures as any draft permit. These procedures include preparation of a statement of basis or fact sheet containing reasons supporting the tentative decision to deny the permit, public notice of the denial, acceptance of comments, a possible hearing, preparation of a final decision, and possible receipt of a request for appeal. Public Notice, Comments, Informal Public Hearings, Panel Hearings All draft RCRA permits are subject to public notice, public comments, and public hearing (if the Regional Administrator finds a significant degree of public interest). Public notice provides interested persons a minimum of 45 days to comment on the draft permit. If written opposition to the Agency's intent to issue a permit and a request for a hearing are received during the comment period, a public hearing will be held. Notification of the hearing is issued at least 30 days prior to the scheduled 11 CMA 047537 data, ar.d the public comment period is extended until the close of the public hearing. The EPA Regional Office also has the option of conducting more formal "panel he arings" when the issuance of a draft RCRA permit is complicated enough to justi fy such a proceeding. Also, any person may reguest a panel hearing. The panel hearing enables the ETA to obtain facts on objectionable aspects of the draft permit and to receive evidence to support suggested alter native permit conditions and to aid in the preparation of a final decision on a permit. Final Permits After the close of the public comment period (which includes the public hearing period or any panel hearing), the Regional Office either prepares and issues a final RCRA permit or denies the permit application. In either case, the applicant and interested parties will receive public noticer which, includes---------- information regarding appeal procedures. Unless a later date is specified, uncontested terms and conditions of the draft RCRA permit become effective 30 days after the date of the public notice. At the time the final RCRA permit is issued, the Regional Office also issues a response to any significant public comments received and indicates any provisions of the draft permit that have been changed and the reasons for the changes. The response to comments becomes part of the administrative record. Anneal -to the Regional Administrator Persons wnc surmittec comments the draft RCRA permit or oarticioa: m any puolic nearing ar< allowed 30 days after the CMA 047538 final permit decision to file a notice of appeal and a petition for review with the Regional Administrator. The Regional Admin istrator then grants or denies the petition within a reasonable time. If the Administrator decides to conduct a review, the parties are given the opportunity to file briefs in support of their positions, within the 30-day period, the Administrator also may decide to review the decision to grant or deny a hearing on his/her own motion. The Administrator then notifies the parties and sets up a briefing schedule. On review, the Admin istrator has several options regarding the final decision. It may be summarily affirmed without opinion, modified, set aside, or remanded for further proceedings. This petition for review by the Administrator is a prerequisite for judicial review of the Administrator's final decision. 13 CMA 047539 SECTION III INSTRUCTIONS FOR PREPARATION OF A RCRA PERMIT APPLICATION This section attempts to simplify preparation of a RCRA permit application by describing in detail the information required. It also includes a suggested permit application format. The information presented is based on RCRA regulations dealing with Part 3 permit requirements (40 CFR 122.25) and the technical standards in 40 CFR 254. Using the suggested format and meeting the detailed requirements should enable the applicant to complete the RCRA permit application in a timely and cost- i effective manner. When submitting an application, the applicant should be sure that the# document is presented in a manner that will allow for major and minor revisions during the subsequent review by EPA (e.g., a three-ring binder). RCRA Permit Abdication Format The suggested permit application format presented in the following pages includes all information required for a permit .application, host sections of the application must be completed by all facilities, but a few sections do not apply to ceruain * a ^ i i ~* e s For exam; the seismic standards etc lie ?.h Hi-v* of such that follows the outl CMA 047540 The format and explanations presented in this section are supplemented by a model RCRA permit application for a hypotheti cal plant, which appears as Part. 2 to this document. This model carefully follows the outline and provides a practical illustration of how to approach the RCRA permit application process. Suggested Permit Application Format A. Part A Application B. Facility Description B-l General description [40 CFR Section 122.25(a)(1)] B-2 Topographic map [40 CFR Section 122.25(a)(19)] B-3 Location information [40 CFR Sections 122.25(a)(11), and 264.18] B-3a Seismic standard (reserved) B-3b Floodplain standard B-3b(l) Demonstration of compliance B-3b(l)(a) Flood proofing and flood protection measures B-3b(l)(b) Flood plain B-3b(2) Plan for future compliance B-4 Traffic patterns [40 CFR Sections 122.25(a)(10)] C. Waste Characteristics C-l Chemical and physical analyses [40 CFR Sections 122.25(a) (2) and 264.13(a))] C-2 Waste analysis plan [40 CFR Sections 122.25(a)(13) and 264.13(b) and (c)] C-2a Parameters and rationale C-2b Test methods C-2c Sampling methods C-2d Frequency of analyses C-2e Additional requirements for waste generated offsite D. Process Information D-l Containers [40 CFR Sections 122.25(b)(1), 264.171, 264.172, 264.173, 264.175 and 264.176] D-la Containers with free liquids D-la(l) Description of containers D-la(2) Container management practices 15 Cma 7 5a 1 Succestad Permit Application Format (continued] D-2 D-3 D-4 D-S D-la(3) Secondary containment system design and operation D-la(3)(a) Requirement for base to contain liquids D-la(3)(b) Containment system drainage D-la(3)(c) Containment system capacity D-la(3)(d) Control of run-on D-la(4) Removal of liquids from containment system D-lb Containers without free liquids D-lb(l) Test for free liquids D-lb(2) Description of containers D-lb(3) container management practices D-lb(4) Container storage area drainage Tanks [40 CFR Sections 122.25(b)(2), 264.191, 264.192} D-2a Description of tanks D-2b Tank corrosion and erosion D-2c Tank management practices Wastes piles [40 CFR Sections 122.25(b)(4), 2S4.250, 264.251, 264.252, 264.253] D-3a Waste piles with free liquids D-3a(l) control of wind dispersal D-3a(2) Control of run-on D-3a(3) Collection of leachate and runoff D-3a(4) Foundation D-3a(5) Waste pile base D-3a(5)(a) Containment system design D-3a(5)(b) Leachate detection, collection, and removal system D-3a(S) Vegetation and rodent control D--3a(7) Equipment and procedures for waste pile movement D-3b Waste piles without free liquids D-3b(1) Test for free liquids D-3b(2) Control of wind dispersal D-3b(3) Protection from precipitation and run-on D-3b(4) Demonstration that no free liquids are placed on pile Surfaci impoundments incinerators Ground Water Monitoring Systems (Reserved) Procedures to Prevent Hazards F-i Security [40 CFR Sections 122.25(a)(4) and :-la Security procedures and equipment F-la(l) 24-hour surveillance system F-la(2) Barrier and means to control er try F-la(2)(a) Barrier ?-la(2)(b) Means to control entry io CMA 047542 J Suggested Permit Application Format (continued) F-la(3) Warning signsF-lb Waiver F-lb(l) Injury to intruder F-lb(2) Violation by intruder F-2 Inspection schedule [40 CFR Sections 122.(a)(5), 264.15, 264.33, 264.174, 264.194, 264.254, 264.255] F-2a General inspection requirements F-2a(l) Types of problems F-2a(2) Frequency of inspection F-2b Specific process inspection requirements F-2b(l) Container inspection F-2b(2) Tank inspection F-2b(2)(a) Construction materials F-2b(2)(b) Surrounding area F-2b(2) (c) Overfilling control equipment F-2b(2) (d) Monitoring data F-2b(2)(e) Level of waste F-2b(2)(f) Tank condition assessment F-2b(2)(g) Tank interior inspection F-2b(3) Waste pile inspection F-2b(3)(a) Liner systems F-2b(3)(b) Manufactured liner materials F-2b(3)(c) Containment system F-2c Remedial action F-2d Inspection log F-3 Waiver of preparedness and prevention requirements [40 CFR Sections 122.25(a)(6), 264.32, and 264.35] F-3a Equipment requirements F-3a(1) Internal communications F-3a(2) External communications F-3a(3) Emergency equipment F-3a(4) Water for fire control F-3b Aisle space requirement F-4 Preventive procedures, structures, and equipment [40 CFR Section 122.25(a)(6)] F-4a Loading/unloading operations F-4b Runoff F-4c Water supplies F-4d Equipment and power failure F-4e Personnel protection equipment F-5 Prevention of reaction of ignitable, reactive, or incompatible wastes [40 CFR Sections 122.25(a)(9), 122.25(b)(1) (iii), 122.25(b)(2)(vi), 122.25(b)(4) (i)(c)(4), 122.25(b)(4)(ii)(b)(1), 264.17, 264.21, 264.23, 264.176, 264.177, 264.198, 264.199, 264.256, 264.257] F-5a Precautions to prevent ignition or reaction of ignitable or reactive wastes F-5b General precautions for handling ignitable or reactive wastes or accidently mixing incompatible wastes 17 CMA 047543 Suggested Permit Application Format (continued) F-5c F- 5d F-5e F-5f F-5g F-5h Management of ignitable or reactive wastes _ m+ containers Management of incompatible wastes in ccntai .cars Management of ignitable or reactive wastes in tanks Management of incompatible wastes in tanks Management ox ignitable or reactive wastes in waste tiles Management of incompatible wastes in waste piles G. Contingentoy Plan G-l G-2 G-3 G-4 U-3 G-o G-7 G-3 General information [40 CFR-Section 122.25(a)(7)] Emergency coordinators [40 CFR Sections 122.25(a)(7), 264.52(d), and 264.55] Implementation of the contingency tlan [40 CFR Sections 122.25(a)(7), 264.51(b)] Emergency response procedures [40 CFR Sections 122.25(a; (7), 264.52(a), 264.56, 264.171, 264.194(c), 264.255, and 264.258] G-4a Notification G-4b Identification of hazardous materials G-4c Assessment G-4d Control procedures G-4e Prevention of recurrence or spread of fires, explosions, or releases G-4f Storage and treatment of released material G-4g Incompatible wastes G-4h Post-emergency equipment maintenance G-4i Container spills and leakage G-4j Tank spills and leakage :k Waste piles G-4k(1) Indication of ;ts pile containment system failure G-4k(2) Elements of a < itainment svstem evaluation and repair G-4k(3) Criteria and ?: pile from Lse of j failure of th< system G-4k(4) Restoration of G-4k(5) Course of a ctii from sarvi cs Emergency squicment [40 CER Sections 122.25(a)(7) and 264.52(e)] Coordination agreements [40 CER Sections 122.25(a)(7), 264.52(c) and 254.37] Evacuation clan [40 CPR Sections 122.25' 254.32(f) Required reports [40 CPR Sections 122.25(a)(7), 254.56(c), 2S4.5S(i), and 264.73(b)(4)] 13 CMA 047544 Suggested Permit Application Format (continued) H. Personnel Training H-l Outline of training program [40 CFR Sections 122.25(a)(12) and 264.16] H-la Job titles and duties H-lb Training content, frequency, and techniques H-lc Training director H-ld Relevance of training to job position H-le Training for emergency response H-le(l) Procedures for using, inspecting, repairing, and replacing facility's emergency and monitoring equipment H-le(2) Key parameters for automatic waste feed cutoff systems H-le(3) Communications on alarm systems H-le(4) Responseto fires H-le(5) Responseto groundwater contamination incidents H-le(6) Shutdownof operations H-2 Implementation of training program [40 CFR Sections 122.25(a)(12) and 264.16] I. Closure Plans, Post-Closure Plans and Financial Requirements 1-1 Closure plans [40 CFR Sections 122.25(a)(13), 264.111, 264.112, 264.113, 264.178, 264.197, and 264.258 I-la Closure performance standard I-lb . Partial closure I-lc Maximum waste inventory I-Id Disposal or decontamination of equipment I-ld(l) Closure of containers I-ld(2) Closure of tanks I-ld(3) Closure of waste piles I-le Schedule for closure I-If Extensions for closure time 1-2 Post-closure plans* 1-3 Notice in deed and notice to local land authority* 1-4 Closure cost estimate [40 CFR Sections 122.25(a)(15) and 264.142] 1-5 Financial assurance mechanism for closure [40 CFR Sections 122.25(a)(1), 264.143, and 264.151] I-5a Closure trust fund I-5b Surety bond I-5c Closure letter of credit I-5d Closure insurance I-5e Financial test I-5f Combinations * These items apply only to disposal facilities. 19 CMA 047545 Suggested Permit Application Format (continued) I-5f(1) Multiple financial mechanises I-5f(2) Use of financial mechanism for multiple facilities I-5g Proof of financial coverage by an equivalent state financial mechanism 1-6 Post-closure cost estimate* 1-7 Financial assurance mechanism for post-closure* I-S Liability recuirements [40 CFP. Sections 122.25(a) (17), 264.147, and 264.151] I-3a Sudden insurance I-3b Non-sudden insurance** I-3c Financial test for liability insurance I-Sd Variance procedures I-8e Adjustment procedures 1-9 State mechanisms I-9a Use of state-recuired mechanisms [40 CFR Sections 122.25(a)(13), *264.149, and 254.150] I-9b State assumption of responsibility Other Federal Laws [40 CF3, Sections 122.12 and 122.25(a)(20) Certification [40 CF3 Sections 122.6(a) and (d)] These items attlv only to distosal facilities. ** Pecuired for surface impoundments, landfills, or la facilities. 20 eatment CMA 047546 Detailed Instructions and Content Requirements The detailed instructions provided herein encompass the content requirements of each permit section identified in the suggested RCRA Permit Application Format and cites the Federal regulation from which they were developed. Sources of information applicants may use to prepare por tions of the permit application are identified by reference numbers in parentheses at the end of each section. Certain technical data submitted in the permit application must be certified by a registered professional engineer; these include design drawings and specifications and engineering studies. A. PART A APPLICATION (CFR Sections 122.4(d) and 122.24] Submit a revised Part A application if corrections to your original submission are necessary because of changes at your facility, inaccuracies in your submission, or changes in the RCRA regulations. Unless a revised Part A application is received, your original submittal will be used for review purposes. B. FACILITY DESCRIPTION 1 B-l General Description [40 CFR Section 122.25(a)(1)] Provide a general description of the hazardous waste manage ment facility in sufficient detail to familiarize the reviewer with its overall operation. Include the facility name, contact, mailing address, and location. Briefly 21 CMA 047547 describe -the nature of the business (e.g,, products or services offered). Provide a company brochure if one is available. Offsite facilities should identify the types of industries serviced. Onsite facilitie: should briefly describe the process(es) involved in the generation of hazardous waste (Reference 1). 3-2 Totccraohic Mao [40 C7R Section 122.25(a)(19 ) ] Submit a topographic map with a scale in which 1 inch ecuals no more than 200 feet and with contour intervals that are sufficient to clearly show the- pattern of surface water flow in the vicinity of the hazardous waste units. The map must cover an area extending 1000 feet beyond the facility property line. The map(s) must show the scale, date, 100-year floodplain area, surface waters (including intermittent streams) and direction of their flow, surround ing land uses, a wind rose, wind speed and direction, map orientation, legal property line boundaries of the facility, access control, injection and withdrawal wells, buildings, structures, the location of each intake and discharge structure, sewers, loading and unloading areas, fire control, flood control or drainage barriers, and location cf hazard ous waste operations 'units. More than one map may be used to indicate the items listed above. On a case-by-case basis the Agency nay accept maps with contour intervals or scales other than those specified in the regulations. Consult your I?A. or state agency for further guidance. 22 CMA 047548 1 I The Part B topographic map will differ from the map submitted with the Part A of the application in area of coverage and level of detail (References 2, 3, 4, 5, 6, 7, i 3). B-3 Location Information B-3a Seismic Standard [40 CFR Section 264.18(a) and 122.25(a)(11) (i) and (ii)] Existing facilities are not required to comply with the seismic standards. B-3b Floodplain Standard [40 CFR Sections 122.25(a) (ll)(iii) and 264.18(b)] Provide documentation identifying whether the facility is located within a 100-year floodplain. The Federal Insur ance Administration,' through the National Flood Insurance Program,* is the prime supplier of floodplain maps. Other Federal agencies (e.g., the U.s. Army Corps of Engineers, the Soil Conservation services, and the U.S. Geological i Survey) supply maps or information that will help you determine the boundaries of the 100-year floodplain. If FIA maps are not available, equivalent mapping techniques must be used. Facilities located within the 100-year floodplain must identify the 100-year flood level and any other special flooding factors (e.g., wave action) that must be considered to prevent,washout (References 9, 10, 3, 4, 5, 7, 8, 11). National Flood Insurance Program, P.O. Box 34294, Bethesda, Maryland 20034. 23 CMA 047549 De~or.5t.ra (iv) 1 n cf Compliance [40 CTR Section 122.23(a; If your facility is located within the 100-year floodplain, describe hew the facility is designed, constructed, oper ated, and maintained to prevent washout of any hazardous waste in the event of a flood by either of the following methods. b(l)(a) Flood Proofing and Flood Protection Measures [40 CTR .Section 122.25(a)(11) iv (A) and (3)] Provide structural or other engineering studies showing the design of the tanks, containers, or waste piles and the flood-proofing and protection devices (i.e., freeboard, fencing, diversion structures) at the facility and how they will prevent washout. The study should include an analysis of the structural integrity of the waste units and/or the flood protection devices to withstand 'the various hydro- dynamic and hydrostatic forces expected as a result of a lOC-year flood (References 10, 12, 13, 14, 15, IS, 17, 13, 19, 20, 21, 22, 22, 24, 25). b (1) (b ) Flood Plan [40 CFR Section 122.25(a)(11)(iv)(C)] Describe the procedures for removing hazardous waste to safety before the facility becomes flooded. Include the timing cf such movement related zo flood levels (mcludi <3 estimated time to move the waste) to shew that can re ccrr; ^ a ^ A r* before floccwaters reacn tne oaciaity; a res triction of the location!s) to which the waste will meved and trocf cf the elzcibolztv cf these vocations to *5 J. CMA 047550 receive hazardous wastes (i.e.-, RCRA Interim Status Facili ties or RCRA Permitted Facilities); the planned procedures, equipment, and personnel to be used and the means of ensuring that these resources will be available when needed; and the potential for accidental discharges of the wastes during movement. B-3b(2) Plan for Future Compliance (40 CFR Section 122.25(a) (ll)(v)] If your facility is not in compliance with the floodplain regulation, provide a plan showing how and when it will be brought into compliance. (Existing facilities located in the 100-year floodplain that do not have a flood plan or are not designed to withstand a washout are not in compli ance with the floodplain regulations.) B-4 Traffic Patterns [40 CFR Section 122.25(a)(10)] Describe the means of transporting hazardous waste material on your facility's property; include traffic pattern, traffic control, and estimated volume. List the weight of trucks transporting hazardous waste (state the maximum weight of fully loaded trucks), the load bearing capacity of the roads, and the road surfacing. i For facilities receiving hazardous waste from offsite, also describe the movement of the waste material to the facility from the point where it leaves the nearest major highway. Provide a diagram indicating traffic route, traffic controls, and land use (commercial or residential streets) (Reference 26). 25 CMA 047551 CHARACTERI STIC5 C-l chemical and Physical Analyses [40 CFR Sections 122.25(a) (2) and 254.13(a)] Provide the following information on each hazardous waste stored or treated at the facility: (1) general descrip tion; (2) hazardous characteristics (corrosive, toxic, igritable, reactive); (3) basis for hazardous designation. (For a listed waste, identify the E?A hazardous waste number; for an ignitable waste, specify the flash point; for a reactive waste identify under what conditions the waste reacts; for a corrosive waste, identify pH; for an E? toxic waste, identify the E? toxic constituents and their concentrations.) Include a copy of the laboratory report(s) detailing chemi cal and physical analyses of representative samples of the , - -- hazardous waste, and give the date these analyses were performed. The analyses may include existing published or documented data on the hazardous waste or on hazadouswastes generated from a similar process. Offsite facili ties may submit information supplied by the generator (References 27, 23, 29, 30). Waste Analysis Plan (40 CFR Sections 122.25(a)(3) and 264.13(b) and (c)J Provide a copy of the waste analysis plan indicat ing how the facility will ensure that analysis of hazardo us waste is accurate and up to date (i.e., that includes a vy changes 26 CMA 047552 in the process that generated the hazardous waste) (Refer ences 1, 3, 28, 45). The plan should include a description of how the waste analyses will be performed; a list of the parameters chosen for analysis and an explanation of the rationale for their selection; a description of the test methods used to test for the chosen parameters;* a list of the sampling methods used to obtain a representative sample of each waste;* a description of the frequency at which the analyses will be repeated; and for facilities handling waste generated offsite, a description of the procedures used to inspect and/or analyze wastes generated offsite (including procedures to determine their identity and the sampling methods used). D. PROCESS INFORMATION D-l Containers D-la Containers with Free Liquids D-la(l) Description of containers [40 CFR Sections 264.171 and 264.172] Describe the facility's primary containment devices for hazardous waste storage. The description should include types, dimensions (including usable volume), and liner specifications, and whether the containers are new, reused, Refer to methods in EPA S.W. 846, Test Methods for Evaluating Solid Wastes, Physical/Chemical Methods or 40 CFR Part 261, Appendix I, II, and III where applicable. 27 CMA 04755 recycled, or' reconditioned. Include container manufac turer's specifications, if available. Types of containers can include, but are not restricted to, metal drums, fiber drums, barrels, kegs, bags, multiwall paper, polyethylene (?) film, small bags, pouches, folding boxes, corrugated cartons, bulk boxes, carboys, plastic drums, bottles, cans, pails, and wrap materials. Indicate container markings (in the form of labels, placards, tags, or stencils). Document the compatibility of the wasts(s) with the storage container in use at the facility. This documentation can consist of references to published scientific or industrial engi neering literature, data from trial tests (e.g., bench-scale or pilot-scale tests), waste analyses, or the results of the storage or treatment of similar wastes under comparable operating conditions, when information on experience with similar wastes and materials (structural materials and linings) is not available, corrosion tests are highly recommended. Only wastes that significantly accelerate corrosion or deterioration (as opposed to normal expected container corrosion) are considered incompatible with the nmen material. (2) Container Management Practices [40 CTa Section 254.173] Describe what container management practices are used to ensure that containers holding has .rdcus waste are always closed during storage (except when adding cr reraov S waste). Provide assurance that containers are net handled, cr stored in a manner that may rupture th r-e 23 CMA 047554 or cause it to leak.' Include a detailed exhibit (facility drawing) and discussion of the container storage area. The facility drawing must show the layout of the container arrangement for both outdoor and indoor locations. Specify the maximum number of containers in the storage area, the type and volume of containers to be stored, separation and aisle spacing distances, and the location of various waste types. Clearly show the storage locations of incompatible, reactive, and ignitable wastes. Also indicate possible ignition sources of the facility (e.g., open flames). If containers are stacked, indicate the maximum number of containers and the height of the containers. Also, distin guish between the location of container storage areas and container staging areas by clearly defining the design, function, and operation of the staging areas. On the facility drawing of outdoor storage areas, indicate loca tions that typically receive full sunlight. Describe the machinery, equipment, and procedures used to move containers containing hazardous waste to and within storage locations. Indicate the frequency with which storage containers con taining hazardous waste are opened to add or remove waste during the container's useful storage life at the facility. If a system of tracking the age of drums and other con tainers is included in the container storage management practices, state whether the dates are actually marked on the drums and other containers or placed on the schematic of the container storage area. 29 CMA 047555 D-la(3) Secondary Containment System Design and Opera tion [40 CTR. Sections 122.25(b)(1) and 254.175(b)] Describe tbe design and operation of the secondary contain ment system in the container storage area. The description should clearly demonstrate the system's adequacy to hold spills, leaks, and precipitation until detection and removal. Include a drawing of the secondary containment system design; show the dimensions of the containment system, location of the storage area containers on the base/liner, leachate collection system, slope characteristics, base grading, height of auxiliary structures (curbs, dikes, berms, ditches, trenches), and the location of the sum? or collection area. D-la(3)(a) Requirement for 3ase or Liner to Contain Liquids [40 CFR Section 264.175(b)(1)] Demonstrate that the containers of free liquids are located on a base free of cracks or gaps and sufficiently imper vious to contain leaks, spills, and accumulated preci pitation until the collected material is detected and removed. Include the base or liner characteristics and specifications for ail concrete, asphaltic, and membrane linings. Indicate the construction material used for the base or liner, provide iir.er/base manufacturer's specifica tions and information, and include engineering data used as the basis for construction of the base. This information should be sufficient to verify that the base material and thickness are adequate to support the weight of the container Document that the types of waste stored are compatible witr. the liner or base to be used. CMA 047556 D-la(3)(b) Containment System Drainage {40 CFR Sections 122.25(b) (1)(i)(B) and 264.175(b)(2)] If the containers are stored in direct contact with the base, state how the base is sloped or how the containment system is otherwise designed and operated to drain and remove liquids resulting from leaks, spills, or precipita tion. Included in the various designs that comply with this requirement are drains that lead into a sump under the base, a sloped base that directs liquids into a sump, or a system by which accumulated liquids are pumped out of the containment area shortly after being detected. If the containers are elevated or otherwise protected from contact with accumulated liquids (i.e., a roof over the drain area), you only need, to describe the storage practice used 'l to accomplish this protection (i.e., how containers are stacked on pallets, plywood sheets, and/or racks). D-la(3)(c) Containment System Capacity [40 CFR Sections 122.25(b) (1)(i)(C) and 264.175(b)(3)] Document that the containment system has sufficient capac ity to contain 10 percent of the volume of all the containers or the volume of the largest container, whichever is greater. Describe how the containment system has fared during extreme precipitation events. D-la(3)(d) Control of Run-On [40 CFR Sections 122.25(b)(1)(i)(D) and 264.175(b)(4)] Describe how run-on into the containment system is pre vented, unless the collection system has sufficient capac ity in excess of that required in the previous "Containment 31 CMA 047557 System Capacity" discussion [D-ia(3)(c)] to contain any run-on that might enter the system. Describe the role of containment system auxiliary structures and other engi neering land-grading designs in preventing run-on into the containment system, and in promoting drainage away from the containment area (e.g., drain tiles installed at the out side perimeter of the containment curb to drain any coli lected water to the sewer system). D-ia(4) Removal of Liruids from Containment Svstem [40 C7R Sec tions 122.25(b)(1)(i)(S) and 264.175(b)(5)] Describe how spilled or leaked waste and accumulated preci pitation will be removed from the collection area or sump in as timely a manner as is necessary to prevent overflow of the collection system. Include sump pump design and operating capabilities, piping specifications, and dia grams. Describe the management procedures for accumulated liquids and the ultimate fate of such liquids removed from the containment system. D-lb Containers Without Free Liquids D-lb(l) Test for Free Licuids (40 CFR Section 122.25(b) (1)(ii)(A)] Describe the test rocedures and results or provide other documentation or i formation to shew than the containerised wastes do not cent ee liquids. A proposed test prouocci for free liquids is provided on page 3311 of the February 25, 1332, Federal Register. T. protocol calls for a representative sarnie of the waste 32 CMA 047558 from a container to be filtered .and the filtrate to be collected in a beaker or cylinder. If free liquid passes through the filter, then the waste is considered to hold free liquids. D-lb(2) Description of Containers [40 CFR Sections 264.171 and 264.172] Provide a description similar to the one used for free liquid container's, D-la(l). D-lb(3) Container Management Practices [40 CFR Section 264.173] Provide a description of container management practices similar to the one used for free liquid containers, D-la(2). D-lb(4) Container Storage Area Drainage [40 CFR Sections 122.25(b)(l)(ii)(B) and 264.175(c)] Provide a description of the container storage area drain age similar to the one used for free liquid containers, -- D-l a D-2 Tanks ---------------------- --- 0 --- D-2a Description of Tanks [40 CFR Sections 122.25(b)(2) and 264.191 Describe all facility storage, overflow, and processing tanks used for hazardous waste management. The description should include the number and types of tanks, the type of waste they contain, and whether the tanks are covered. In- elude manufacturer's literature or other engineering infor mation, if available. Tank design specifications should include specific data on dimensions (height, diameter, 33 CMA 047559 measured uniform shell thickness), capacity, and the mate rial and method of construction. Include design operating temperature and pressure information. Stare that the tanks are designed in accordance with the design standard codes of the American Petroleum Institute (API), the American Society of Mechanical Engineers (ASMS), Underwriters' Laboratories, the American Concrete Institute Standard, or seme other standard design code. Provide the applicable standard code section and year. Indicate the specific gravity of the liquid in the tanks and the maximum height of the liquid level in the tank(s) during storage. Provide detailed engineering drawings for each tank con taining a hazardous waste. Give specifications for the foundation, structural support, seams, and pressure controls to demonstrate that the tanks will not collapse or rapture. 2b Tank Corrosion and Erosion (40 CFP. Sections 122.25(b) (2 ) (ii ) and 264.192(a)] Describe the lining and coating materials (if any) used to protect tank construction materials from corrosion or erosion. Demonstrate the compatibility of the hazardous gwaste with the tank ccnstructi cn and the lining and coatin materials. This documentation can consist of references t o published scientific cr incuserial engineering literature, data from trial tests (e.g., b er.ch-scale or pilot-scale tests), waste analyses, or the results of the storage or treatment of similar wastes un.car comparable operating conditions. When information cn experience with similar 34 C14K wastes and materials (structural materials and linings) is not available, corrosion tests are highly recommended. Provide information on the type of gaskets in use and their material of construction. Describe how the shell thickness will be maintained when the tank is built or converted to store hazardous waste. Provide information on the rate of tank corrosion or erosion actually detected by measurement. Include information about any treatment reagents used in all of the facility tanks. D-2c Tank Management Practices [40 CFR Sections 122-25(b)(2)(iv), 122.25(b)(2)(v) and 264.192(b)) Describe tank operating practices and control devices to prevent overfilling and overtopping. For covered tanks, submit engineering process flow diagrams indicating the location, numbers, and types of pressure and overfilling controls and feed systems. For uncovered tanks, submit engineering process flow diagrams indicating the location and operational practices of the safety cutoffs or bypass systems and the amount of freeboard. Describe what moni toring will be done to ensure that each tank is operated according to design. Describe the procedures used to measure the following process variables: temperature of waste, pressure, flow level, and specific gravity; indicate how frequently these measurements are taken. The process flow diagram should show the flow direction of liquid or vapor within the facility and (if available) flow rates. The flow diagram must indicate any waste streams in the 35 CMA 047561 flow process that vent directly to the atmosphere or dis Provide a piping and instrumentation diagram (?&ID) that shows instruments such as valves, level and pressure con trols, and temperature and pressure indicators that are used to control and monitor the operation of the tanks. Provide a plot plan of the facility with each piece of equipment (drawn to scale), and locate each piece of equip ment in relation to the entire facility. Include the location of tank diking and drainage systems for tanks, space requirements between equipment, and receiving areas for wastes. D-3 Waste Piles D-3a Waste Piles with ree Liquids [40 C~P Section 122.25(b)(4)(i)] 9 D-3a(l) Control of Wind Disoersal [40 CTP. Sections 122.25(b)(4) (i)(A), 254.251(a) and 264.252(a)] or each v pile siting; pile slope design and compaction; the use water soravs, dust suppressants ether than water, and dispersal). If the waste pile is situated in a totally enclosed building, des he dust avacuat: 3 CMA 047562 D-3a(2) Control of Run-on [40 CFR Sections 122.25(b)(4)(B)(1) and 264.252(b)] Describe measures for preventing water from flowing into the pile. Discuss the diversion of run-on by describing the location and construction of such structures as berms, dikes, walls, curbs, trenches, or other manmade or natural barriers in the waste pile area. D-3a(3) Collection of Leachate and Runoff [40 CFR Sections 122.25(b)(4)(B)(2), 122.25(b)(4)(i)(C)(2), 264.251(b), 264.252(b) and 264.253(a)(1)] Describe the waste pile leachate and runoff collection and control system. Show how accumulated leachate and precipi tation will be removed from the collection area or sump, as necessary to prevent overflow of the leachate collection system. Include sump pump design and operating capabili ties, piping specifications, and diagrams. Indicate the leachate management procedures and the ultimate fate of accumulated liquids removed from the containment system. D-3a(4) Foundation [40 CFR Sections 122.25(b)(4)(B)(3) and 264.253(b)(2)] Provide engineering data to demonstrate that the foundation is capable of holding the weight of the base or liner, the pile, and any equipment to be used. Also describe the foundation construction material (i.e., soil, concrete, or asphalt). (Refer to the Model Permit Application, Section D on Waste Piles - Foundation, for a specific example.) D-3a(5) Waste Pile Base 37 CMA 047563 D-3 a 5)(a) ' Containment Svstem Design [40 CF3. Sections 122.25(b) (4)(3)(4), 254.253(a), '264.253(b), and 254.253(d) Present containment system engineering plan drawings de picting ail control systems and structures associated with the waste pile. Provide information to demonstrate that the waste pile will be located on a base that is free of cracks or gaps and sufficiently impervious to contain leachate and accumulated precipitation until the collected material is detected and removed. Include the base or liner characteristics and manufacturers' specifications for all concrete, asphaltic, and membrane liners. Document that the types of waste to be stored in the pile will be compatible with the liner or base. Discuss which wastes will be contained and how these will be combined. State the estimated life of the hazardous wa'ste pile and show that the containment system will have a containment life equal to or greater than the life of the pile. < 5 ) (b) Leachate Detection, Collection and Removal System [40 C7R Sections 122.25(b ) (4) (i ) (3) (6 ) and 2S4.253(a; If the base liners are not of sufficient strength and thickness to prevent failure due to physical damage from equipment used to clean and expose the liner surface for inspection, describe the leachate detection, collection, and removal system situated beneath the base to detect, contain, collect, and remove any discharge. Demonstrate that the system under the base is above the water table, or describe any necessary efforts to control the water table. 33 04*7564 CM* D-3a(6.) Vegetation and Rodent Control [40 CFR Sections 122.25(b) (4)(i)(C)(l) and 264.253(c)] Describe precautions taken to protect the waste pile base or liner and its components from plant growth that might puncture it and cause a failure. Indicate any precautions provided to prevent puncture by rodents or other ground burrowing animals. D-3a(7) Equipment and Procedures for Waste Pile Movement [40 CFR Sections 122.25(b) (4)(i)(C)(3)] Describe all the facility equipment and operational pro cedures used to add waste to the pile or to remove waste from the pile, or to expose the liner surface for cleaning. D-3b waste Piles Without Free Liquids [40 CFR Section 122.25(b) (4) (ii) ] D-3b(1) Test for Free Liquids [40 CFR Section 122.25(b)(4) (ii)(A) Provide test procedures and results or other documentation or information to show that the piled wastes do not contain free liquids. Also show that the wastes will not generate leachate by decomposition or other reactions during the time they are managed in the waste pile. D-3b(2) Control of wind Dispersal [40 CFR Sections 122.25(b)(4) (ii)(C) and 264.250(b)(4)] Provide descriptions similar to those for controlling wind dispersal for waste piles having free liquids, D-3a(l). D-3b(3) Protection from Precipitation and Run-on [40 CFR Sec tions 122.25(b) (4)(ii)(B), 264.250(b)(2)], and 264.250(b)(3) Describe how the pile is protected from precipitation and run-on by a structure or cover so that neither runoff nor 39 04*7s65 CViA- leachate.is generated. Include a detailed description of the structure. Also describe how the pile is protected iron surface water run-cn. D-3b(4) Demonstration That No Tree Liquids .Are Placed on Pile [40 CFR Sections 122.25 (b ) (4) ( ii ) (D ) ( 2 ) and 264.250(b) (1)] Describe procedures to insure that liquids or materials containing free liquids are not placed on the pile; i.e., by performing a waste analysis test for free liquids [see D-ib(i)l or testing the waste upon receipt at the facility and handling it appropriately before placement on the pile (Reference 31). D-4 Surface Imooundments (40 CFR Sections 122.25(b)(3) and 264.220-254.223} This section has been reserved until this document is expanded to address existing facilities that treat or store hazardous wastes in-surface impoundments. t 2-5 Incinerators [40 CFR Sections 122.25(b)(5) and 264.240264.351] This section has been reserved until this document is expanded to include requirements for existing incinerators. GRCUNDWADDR MONITORING [40 CPR Section 255.90-255.54' This section has been reserved until this document is expanded to induce information on land disposal facil ities . 40 CMA 047566 F. PROCEDURES TO PREVENT HAZARDS F-l Security Describe the security procedures and equipment identified below, or provide a request and substantiation for a waiver of any of these requirements. F-la Security Procedures and Equipment [40 CFR Sections 122.25 (a)(4) and 264.14] The permit applicant has the option of fulfilling the requirements of either F-la(l) or F-la(2). F-la(l) 24-hour Surveillance System [40 CFR Section 264.14(b)(1)] Describe the system used to monitor and control entry to the active portion of the facility. If possible, all related structures and equipment should be indicated on a plot plan. If a 24-hour surveillance system is used, de scribe all facets of the system, including personnel, procedures, structures, and equipment used (Reference 32). F-la(2) Barrier and Means to Control Entry [40 CFR Section 264.14 (b) (2)(i) and (ii)] If a fence or wall is used to control entry, indicate height, type of material, and locking devices of the barrier. Describe how entry is controlled at all times (Reference 32). F-la(3) Warning Signs [40 CFR Section 264.14(c)] Indicate the location of required warning signs. If the facility is in an area where any language other than English is commonly used, indicate the language and include the legend of posted signs. Indicate that warning signs are legible from at least 25 feet. 41 CMA 047567 lb Waiver [40 CFR Section 264.14(a)] If you belive a waiver of ary of the requirements of 254.14 is appropriate, you rust demonstrate that unknowing or unauthorized persons or livestock would not injure them selves or cause a RCRk violation upon entering the active portion of a facility. Both these points may be demon strated by showing that the nature and duration of the hazard potential from the hazardous waste onsite does not warrant the required security procedure or equipment. In addition, if you can show that your facility provides certain features, such as cover materials or containers, that would prevent contact with the waste or potentially hazardous contact with equipment or structures, certain security procedures and equipment might not be needed. Finally, a waiver justification could show that safety or operating practices related to equipment and structures would eliminate the potential for an intruder to cause a spill, mix incompatible wastes, ignite ignitable or reactive waste, damage containment or monitoring systems, etc. The circumstances under which a waiver will be granted are limited (Reference 28). z Inspection Schedule [40 CFR Sections 122 .25(a)(3), 264.1 5] Provide a copy of the general inspection schedule (see Table 3 of the Model Permit Application in Part 2 of thi document). The inspection schedule shcu.Id be broken cow into general inspection requirements and 42 O'l'lS68 inspection requirements, as shown. For both general and specific inspection requirements, reference in the schedule any inspection procedures or frequencies the manufacturer has recommended for any equipment or structures. In addition, state that the inspection schedule will be kept at the facility. F-2a General Inspection Requirements [40 CFR Sections 264.15(a) and (b) and 264.33] The inspection schedule should indicate the safety, emer gency, and security devices and monitoring, operating, and structural equipment to be inspected. Examples of the this equipment are flow and liquid level monitors, leachate monitors, hazardous gas detectors, respirators, alarm and communication systems, emergency power and lighting, fire protection and control equipment, smoke detectors, first aid equipment, decontamination equipment, surveillance---------- -- systems, barriers surrounding the facility, locking devices, fire and explosion barriers, ventilation equipment, and spill detection, control, and collection equipment. The inspection plan must include areas inside and outside buildings where hazardous waste is handled (References 33, 34, 35, 32, 36). F-2a(l) Types of Problems [40 CFR Section 264.15(b)(3)] The schedule must identify the types of problems that are to be looked for during the inspection (e.g., malfunctions, deteriorations, inoperative sump pumps, leaking fittings, and eroding dikes). 43 CMA 047569 2) Frequency of Inspection [40 CFR Section 264.15(b)(4)] The schedule rust identify the frequency of inspection for the items on the schedule. The frequency m=y very; it should he based on the rate of possible deterioration of the equipment and the probability of an environmental or human health incident if the deterioration, malfunction, cr any operator error should go undetected between inspections. Areas subject to spills (e.g., loading and unloading areas) must be inspected daily when in use. Specific Process Inspection Requirements b)(l) Container Inspection [40 CFR Section 264.174] Describe in detail how at least weekly inspections are performed in areas where containers are stored. Describe procedures and elaborate on methods used to detect leaking containers. Indicate how the inspection includes careful status checks for the deterioration of containers and the containment svstem as a result cf corrosion or ether fac- b)(2) Tank Inspection [40 CFR Sections 264.194(a) and (b)] Describe in detail how each cf the tanks and its related facility components are inspected on a scheduled weekly or daily basis, as required. Provide a I ist of equipment and parts to' be inspected. Describe how the tank construction materials of the above-ground external portions cf the tank are inspected weekly (while the tank r emains in service) to detect corrosion or erosion and leakin x es ar.c seams. Discuss hew the area immediate o uu. 047 57 tank is inspected weekly to detect obvious signs of leakage, specify how tank overfill control equipment, such as waste feed cutoff systems and bypass systems, are inspected daily to ensure good working order. Describe the daily inspection procedures undertaken to ensure that the tank is being operated according to' its design {by types of data gathered from tank monitoring equipment). For uncovered tanks, describe how the level of waste is measured daily to ensure maintenance of sufficient freeboard to prevent overtopping . by wave or wind action or by precipitation. Elaborate on the schedule, and document the methods used for comprehensive inspection of the tank interior to detect cracks, leaks, corrosion, or erosion that may lead to wall thinning to less than sufficient shell strength. Discuss established procedures for emptying the tank to allow entry and inspection of the interior. The frequency of these inspection assessments must be based on the tank's material of construction, the type of corrosion or erosion protection used, the rate of corrosion or erosion observed during previous inspections, and the characteristics of the waste being treated or stored (References 37, 38, 39, 40, 41). F-2(b)(3) Waste Pile Inspection [40 CFR Sections 264.254(a) and 264.255] Describe how liner systems were inspected for uniformity, damage, and imperfections during the construction or instal lation of the waste pile base, and how manufactured lin'er materials are inspected to ensure tight seams and joints 45 CMA 047571 and tha absence of tears and blisters. Describe how the containment system is inspected whenever there is any indication of possible failure (Reference 42). R-2c Remedial Action [40 CTR Sections 264.15(c) 264.194(c) and 264.255] t Describe procedures for ensuring that any deterioration or malfunction of equipment or structures revealed by the inspection will be remedied on a schedule that prevents an environmental or human health hazard. Procedures identi fied in the contingency plan that describe remedial actions to be taken in the event of potential hazard can be refer enced in this section. ?-2d Inspection Log [40 CFR Section 254.15(d)] Provide a copy of the inspection log. (Example is provided in Supplement 1-3 of the Model Permit Application in Part 2 of this document. ) At a minimum^these records must include the date and time of the inspection, the name of the ir.spector, a notation of the observations made, and the date and nature of anv retairs or other remedial actions. Waiver of Preparedness ar.c Prevention ?.ac Sections 122.25(a)(6), 264.22, and 254.35 emer.ts [40 CFR. If you wish to request a waiver for prepa. ness and pre- vention recui ments, you must provide the followi F-2a Equipment Reqiiremen .3 [40 CFR Section 264.32] Justification showing waste handled at the wi a SwSciz"--si sL~z7*'**ti4 s- a w ..U3 45 04^-72 equipment, spill- and fire-control equipment, decontamina tion equipment, and water at adequate volume and pressure for fire control (References 28, 33, 35, 36, 43). F-3b Aisle Space Requirement [40 CFR Section 264.35] Justification showing that aisle space is not needed for unobstructed movement of emergency personnel and equipment. F-4 Preventive Procedures, Structures, and Equipment [40 CFR Sec' tion 122.25(a)(8)] Applicable procedures, structures, and equipment addressed in other sections may be repeated or referenced to demon strate compliance with any of the following requirements: F-4a Unloading Operations [40 CFR Section 122.25(a)(8)(i)] Describe the procedures, structures, and equipment that will be used to prevent hazards in unloading hazardous waste (Reference 28). F-4b Runoff [40 CFR Section 122.25(a)(8)(ii)] Describe the procedures, structures, and equipment that will be used to prevent runoff from hazardous waste han dling areas to other areas of the facility or to prevent flooding (References 44, 45). F-4c Water Supplies [40 CFR Section 122.25(a)(8)(iii)] Describe the procedures, structures, and equipment that will be used to prevent contamination of water supplies. F-4d Equipment and Power Failure [40 CFR Section 122.25(a)(8) (iv)] Describe procedures and equipment for mitigating the ef fects of equipment failure and power outages, such as waste feed shutoff systems or emergency lighting. 47 CMA 047573 Personnel Protection Equipment [40 C7R Section 122.25(a) (8)(v)] Describe procedures, structures, and equipment for prevent ing undue exposure of personnel to hazardous waste, such as ventilation equipment or protective clothing. If the facility must meet any applicable 0SEA requirements, state them (References 34, 46). f -3 Prevention of Icniticn or Reaction of Zonitable, Reactive, or Incompatible Wastes 5a Precautions to Prevent Ignition or Reaction of Ignitable or Reactive Waste [40 CPR Sections 122.25(a)(9) and 264.17(a)] List each of the ignitable and reactive wastes to be stored at the facility. Describe the precautions for preventing sparking of ignitable or reactive wastes handled on site. Describe how the wastes are separated and protected from sources of ignition or reaction, such as open flames, smoking, cutting and welding, hot surfaces, frictional heat, sparks (static, electrical, or mechanical), and spontaneous ignition (e.g., from heat-producing chemical reactions and radiant heat). Describe hew smoking = oo en flames are confined to specifically designated locations when ignitable or reactive wastes are being handled, and hew "No Smoking" signs are conspicuously placed wherever there is a hazard from such wastes (References 7, 23). : -oo General Precautions for Handling Ignitable or Reactive Waste or to Prevent Accidentally Mining Incomeatible waste [40 CPR Sections 122.25(a)(9), 264.17(b)] Describe onsite precautions taken for handling ignitable or reactive wastes and measures taken to prevent the mining of 43 047574 CM& incompatible wastes or the mixing of other materials and wastes that are incompatible. Reactions that must be pre vented are those that (1) generate extreme heat, pressure, fire, explosions, or violent reactions; (2) produce uncon trolled flammable fumes, dusts, or gases in sufficient quantities to threaten human health or the environment; (3) produce uncontrolled flammable fumes or gases in sufficient quantities to pose a risk of fire or explosions; (4) damage the structural integrity of the device or facility; (5) through other like means may threaten human health or the environment (References 47, 48). F-5c Management of Ignitable or Reactive Wastes in Containers [40 CFR Sections 122.25(b) (1) (iii) and 264.176] Use sketches, drawings, or data to demonstrate how con tainers of ignitable or reactive waste are located at least 15 meters (50 feet) from the site property line (Reference 33). F-5d Incomtatible wastes in Containers [40 CFR Sections 122.25(b) (1) (iii), and 264.177] Describe the specific controls and/or practices utilized to ensure that incompatible wastes or wastes and other materials that are incompatible are not placed in the same container unless precautions are taken to prevent the reactions described in section F-5b - General Precautions for Handling Ignitable or Reactive Waste or to Prevent Accidentally Mixing Incompatible Waste. Inc'ude any documentation of compliance based on references to published scientific or engineering literature, data from trial tests, waste analyses, or the 49 CMA 047575 results of the treatment of similar wastes by a cor.?arable treatment process and under similar operating conditions. Discuss hew storage containers holding a hazardous waste incompatible with any other waste or materials that are stored nearby in other containers, piles, open tanks, or surface impoundments are separated or protected from the other materials by means of a dike, berm, wall, or other structure. Include a drawing to show separation of incom patible wastes (Reference 43). 5e Management of Ignitable cr Reactive Wastes in Tanks [40 C~R Sections 122.25(b)(2)(vi) and 264.153] Provide specific information of hew ignitable or reactive wastes destined for tank storage are treated, rendered, or mined before or immediately after placement in the tank. Indicate the general precautions that are taken for handing either ignitable cr reactive waste when such wastes are destined for tank storace or hew these wastes are stored or treated to protect them against any materials cr conditions that may cause their reaction or ignition. Stare if the tank is reserved solely for use in emergencies. Demonstrat: compliance with the National Tire Protection Association's buffer rone requirements contained in Tables 2-1 and 2-6 of the "Flammable and Combustible Code - 1977" for covered tanks used for the treating or storing of reactive cr ignitable wastes (Reference 33). 50 CMA 047576 F-5f Management of Incompatible Wastes in Tanks [40 CFR Sections 122.25(b)(2)(vi) and 264.199(b)] Describe operating procedures to insure that a hazardous waste will not be placed in an unwashed tank that previ ously held an incompatible waste or material unless precau tions are taken to prevent the reactions described in Section F-5b - General Precautions for Handling Ignitable or Reactive Waste or to Prevent Accidentally Mixing Incom patible Wastes (Reference 33). F-5g Management of Ignitable or Reactive Wastes in Waste Piles [40 CFR Sections 122.25(b)(4)(ii)(D)(l), 261.21, 261.23, 264.17(b),. 264.256] Describe operating procedures to insure that an ignitable or reactive waste is placed in a pile only if the addition of that waste to an existing pile results in the waste or mixture no longer meeting the definition of ignitable or reactive waste. The waste pile must be shown to comply with Section F-5b - General Precautions for Handling Ig nitable or Reactive Waste or to Prevent Accidentally Mix ing Incompatible Wastes. Alternatively, describe the preventive measures that are taken to protect the waste from conditions that might cause it to ignite or react. F-5h Management of Incompatible Wastes in waste Piles [40 CFR Sections 122.25(b)(4)(i)(C)(4), 122.25(b)(4)(ii)(D)(1), 264.17(b) and 264.257] Describe operating procedures ensuring that incompatible wastes are placed in the same pile only when in compliance 51 CMA 047577 with section F-5b - C-er.eral Precautions for Handling Icr.it? h 1 e or Reactive Waste or to Prevent Accidentally Mixing Incompatible waste. Describe precautions for adequate buffer or protection of incompatible waste piles from other wastes or material stored at the facility. If the bases are to be reused for hazardous waste, describe how any bases on which incompatible wastes or materials previously had been piled are sufficiently decontaminated to ensure compliance with section F-5b - General Precautions for Handling Irritable or Reactive Waste to Prevent Accidental ly Mixing Incompatible Wastes. I G CCNTINGZNCY PLAN [40 CFFt Sections 122.25(a)(7) and 254.50-254.56 ] The contingency plan should describe the actions to be taken by facility personnel in response to fires, explo sions, or the release of hazardous waste. The following sections outline the requirements for describing tnese actions and other regulatory requirements. If a Spill Prevention, Control, and Countermeasures (SPCC) Plan (m accordance with 40 CFP. Part 122 or Part 151) cr seme ether contingency plan has already been prepared, the plan need only be amended to incorporate hazardous waste management provisions that are sufficient to comply with the require ments of this cart. Demonstrate that the contingency plan will be reviewed and amended under any of the following conditions: whenever the facility permit is revised, n the clan should fail in an eneresnev, if the facility's CMA 04757 operations should change in a way that would alter the con tingency plan, or if the list of emergency coordinators or emergency equipment should change. G-l General Information Give the name and location of the facility and the oper ator's name. Include a site plan and description of facil ity operations. ' G-2 Emergency Coordinators [40 CFR Sections 264.52(d) and 264.55] Give name, address, office and home phone numbers of pri mary and alternate emergency coordinators, and a statement of authorization for them to commit necessary resources to implement the contingency plan. If more than one person is listed as Emergency Coordinator, one must be named as . primary Emergency Coordinator and others listed in the order in which they will assume responsibility. G-3 Implementation of the Contingencv Plan [40 CFR Section 264.51(b)]---------------- --------------------------- ----------State criteria for implementation of the contingency plan for any potential emergency. G-4 Emergency Response Procedures G-4a Notification [40 CFR Section 264.56(a)] State methodology for immediate notification of facility personnel and required state and local agencies in the event of an emergency (Reference 50). 53 CMA 047579 4b Identification of Hazardous wastes [40 C~R Section 254.S< (o)] Describe procedures for identification of hazardous mate rials involved in the emergency (Reference 50). 4c Assessment [40 CRR Sections 254.56(c) and (d)] State the policy for assessment of possible hazards to the environment and human health and the need for evacuation of residents and notification of authorities. Authority notification should include the appropriate local authori ties and the government on-scene coordinator for that area or the National Response Center (use their 24-hour toll free number 800/424-3302) (References 28, 50, 51, 52, 53). 4d Control Procedures [40 CFR Section 264.52(a)] Describe the specific control procedures to be taken in the event of a fire, explosion, or hazardous waste release. The contingency plan should examine potential emergency situations and outline planned responses (Reference 31, 50, 4e Prevention of Recurrence or Screed of "ires, Ixplos Releases [40 CPR Section 254.55(e)] or Describe the necessary steps to be taken to ensure t fires, explosions, or hazardous waste releases do no occur, recur, or spread to ether hazardous wastes at facility. This should include stopping processes and operations, isolating the materials involved in the emer gency, and containing and collecting any wastes that have CMA 047580 been released- In addition, if the facility stops opera tions in response to an emergency, the emergency coor dinator-must monitor for leaks, pressure buildup, gas generation, or ruptures in valves, pipes, or other equip ment, wherever appropriate (References 50, 53). G-4f Storage and Treatment of Released Material [40 CFR Section 264.56(g)] Discuss provisions for treatment, storage, or disposal of any material that results from a release, fire, or explo sion at the facility. G-4g- Incompatible Wastes [40 CFR Section 264.56(h)(1)] Discuss provisions for preventing incompatible wastes from being treated, stored, or disposed of in the affected areas before cleanup procedures have been completed. G-4h Post-Emergency Equipment Maintenance [40 CPR Section 264.56 (h)(2)] Describe procedures for ensuring that all emergency equip ment listed in the contingency plan is clean and fit for its intended use before operations are resumed, G-4i Container Spills and Leakage [40 CFR Section 264.171] Describe the procedures for response to container spills or leakage, including remedial procedures and timing for expeditious removal of spilled waste and repair or replace ment of the container(s). Describe the availability of machinery, equipment, and personnel to be used as cleanup resources and how they will be utilized. Discuss the procedures for repair or disposal of the damaged containers, the management of spilled or leaked waste, and the decon tamination process during.incident mitigation. 55 CMA 047581 Dark Spills and Leakage [40 CFR Section 254.154(c)] Describe the procedures for response to tank spills or leakage, including remedial procedures and timing for expeditious removal of leaked or spilled waste and repair or removal of the tank. At a minimum, address the following kinds of incidents: 0 Overfilling of tanks 0 Rupture of tanks 0 Leaks in tanks, pipes, valves and fittings 0 Leaks in containmentdikes Water flow from diked area through open dike valve 0 Leaks from pump seals and maintenance 0 Level instrument failure that allows tank over o filling Piping damage from collision with mobile equip ment o Spills from tank bottom cleanout and sludge 0 disposal Spills from pipe and tank changes Describe the availability of machinery, equipment, and oersonnel to be used as cleanuo resources and how they will be utilized Discuss e manacement of soilled or leaked iszs and the decontamination process during incident miti gate on (Re es 53 ) . 'VaS iles (1) Indication of Waste Pile Co: [40 CFR. Section 254.255(a)] nment Svstem Failures Describe the mechanism bv which dcations of ocssible zailure o was .rsc- :icn , -m * Wea--t sys cf a eenta s vs airmen svstem res in _ =, w w - S me oroves ions de- ca s of ocssible ament svstem ; oo CMA 047582 include appearance of liquid in the leachate detection system, erosion of the base, evidence of leakage or po tential of leakage in the base, and the apparent or poten tial deterioration of liner(s) (based on observation or test samples of liner materials). G-4k(2) Elements of a Containment System Evaluation and Repair Plan (40 CFR Section 264.255(d)(2)] Provide a containment system evaluation and repair plan that describes testing and monitoring techniques and pro cedures to be followed to evaluate the integrity of the containment system in the event of a possible failure. Include a schedule of actions to be taken in the event of a possible failure and a description of the repair techniques to be used in the event of leakage due to containment system failure or deterioration that does not require the removal of the waste pile from service. G-4k(3) Criteria and Procedures for Removal of Waste Pile from Service in Case of Positive Failure of the containment System [40 CFR Sections 264.255(b) and (c) and 264.255 (d)(1)] Show that provision is made for the waste pile to be removed from service whenever there is a positive indication of a failure of the containment system. Describe a procedure for removal of the waste pile from service, and give details of the cleanup resources to be implemented and how they will be utilized. G-4k(4) Restoration of a Waste Pile to Service [40 CFR Section 264.255(e)] Describe the conditions under which a waste pile that has been removed from service will be restored to service. 57 047583 CMA Shew that a qualified engineer will certify that the con tainment system meets the design specifications approved in the RCRA permit. 4A(5) Course of Action After Waste Pile is Removed From Service [40 CFR Sections 264.255(f) and 264.258] Describe what happens to a waste pile containment system that is no longer in use and will not be used in the future. Show that you either are meeting or will meet closure requirements for this system (Reference 54). 5 Fmercer.cv Scuioment [40 CFR Section 254.52(e)] Give the location, description, and capabilities cf all emergency equipment available. If possible,, indicate the location cf emergency equipment on a site plan or plant layout. Such equipment includes, but is not be limited to, fire extinguishing equipment, spill-control equipment, alarm systems, communication systems, decontamination equipment, and personal protection equipment (References 28 5 3 - 50) . Coordination Acreemer.ts [40 CFR Se ions 254.52(c) and 264.37] Describe any coordination agreements with local agencies, contractors, or hospitals involved in emergency response that have been made or refused pursuant to Section 264.37. The contingency plan must list these organizations, detail what information (facility layout, vasue properties, ere.) has been made available zo them, describe potential situa tions ul neces ?ucn es s i sZ3,r.cs, 58 CMA 047584 the lines of authority that will be followed in each situa tion. G-7 Evacuation Plan [40 CFR Section 264.52tf)] Provide a detailed description of the evacuation plan, including planned and alternate evacuation routes (if necessary) and the signals for beginning an evacuation. G-3 Required Reoorts [40 CFR Section 264.56(d), 264.56(i) and 264.73(b)(4)] Discuss provisions for submission of written reports of emergency incidents within 15 days of occurrence and the maintenance of records identifying the time, date, and details of any emergency incident. H.' PERSONNEL TRAINING H-l Outline of Training Program [40 CFR Sections 122.25(a)(12) and 264.161 Provide an outline of both the introductory and continuing training programs used to prepare persons to operate or maintain the facility in a safe manner. Describe briefly how training will be designed to meet actual job tasks. Supervised on-the-job training may be used to comply with requirements in this section (Reference 55). H-la Job Titles and Duties [40 CFR Sections 264.16(d)(1) and (2)] Indicate the name, job title, duties, and job description of each employee filling a position related to hazardous waste management at the facility. 59 CMA 047585  -- * V Training Content:, Schedules, and Techniques [40 CTR Sections 254.16(c) and 254.16(d)(2)] Describe the content, frequency, and techniques used in both introductory and continuing training, including an annual review of the initial training for each employee. You must present and discuss the following points: person nel safety training; release prevention and response; decontamination procedures for personnel, equipment, and tools; facility operation and maintenance; high-hazard operations; maintenance of required facility documentation; hazards associated with each waste; and applicable RCRA and state hazardous waste regulations (Reference 55). H-Ic Training Director [40 CTR Section 254.16(a)(2)] Shew that the program is directed by a person trained in hazardous waste management. Specify the training direc tor's experience and qualifications. Relevance of Trainma to Job Position [40 CTR Section 254.15(a)(1)] Show that the program includes instruction on hazardous waste management procedures (including contingency plan implementation) relevant to the positions held by per sonnel . " w 1 A Traininc for Dmerger.cv Restonse r40 CTR Section 264.16(a) (3)] Shew that the program is designed to ensure that facility oersennei are able to restend effectively to emergencies by familiarizing them with the followinc: contingency clan and emergency procedures, including inspecuanc, repairing, 60 o*1SBS041586 cfc and replacing facility emergency and monitoring equipment; key parameters for automatic waste feed cutoff systems; communication and alarm systems; response to fires, explo sions, or releases; responses to groundwater contamination incidents; shutdown of operations and evacuation (Refer ences 34, 55). H-2 Implementation of Training Program (40 CFR Sections 264.16(d)(4) and 264.16(b)J For existing facilities, indicate that training has been given to and successfully completed by facility personnel within 6 months after the date of their employment or assignment to a facility, or to a new position at a facil ity, whichever is later. Employees hired after the effec tive date of these regulations must not work in unsupervised positions until they have completed the training require ments. Explain the methodology used by the facility to verify that employees have successfully completed training. Records documenting that facility personnel have completed the required training must be maintained. Indicate that training records on current personnel must be kept until closure of the facility, and records for former employees must be kept for 3 years after they leave. I. CLOSURE PLANS, POST-CLOSURE PLANS AND FINANCIAL REQUIREMENTS [40 CFR Sections 122.25(a)(13) and 264.110-120] 61 CMA 047587 Closure Plans [40 CFR, Sections 264.112 and 122.25 ( a) (13 ) ] A written closure plan rust re submitted with the remit application. The closure plan rust identify the steps necessary for complete or partial closure of the facility at any point curing its intended operating life and for complete closure of the facility at the end of its intended operating life. If changes in the operating plans or facility design affect the closure plan or if there is a change in the expected year of closure, the closure plan must be amended. For example, changes in any of the following should result in a modification of the closure plan: facility size/capacity; types and quantities of wastes on site at maximum closure inventory*; schedule for partial and final closure; and schedules .for periodic maintenance and inspection activities. Changes in tech nical considerations also can result in closure plan modi fication; for example, the application of new technology or changes in monitori requirements, operating contingencies, land-use cateams a Regie: A>dm hi a and the facilitv, and the response of s to petitions by srs/cperatcr= A copy of the approved plan and a_! revisions to the plan must he kept on site until the cerei fication cf closure cemrataness has been submi tted and accented by the TPA. The owner or operaror muse notify th e Regional Administrator at lease 130 days prior to ehe date closure is expected to ;omtietion of cite closure, :: is necessary 52 04*7588 submit to the Regional Administrator a certification by either the owner or operator and an independent registered professional engineer that the facility has been closed in accordance with the specifications in the approved closure plan. A permit modification may be required for a closure plan amendment. The elements in the sections that follow should be included in the closure plan (References 54, 56). I-la Closure Performance Standard [40 CFR Section 264.111] Describe how the facility will be closed in a manner that minimizes the need for further maintenance and controls; minimizes or eliminates threats to human health and the environment; and avoids post-closure escape of hazardous waste, hazardous waste constituents, leachate, contaminated rainfall, or waste decomposition products to ground or surface waters or to the atmosphere. I-lb Partial and Final Closure Activities [40 CFR Section 264.122(a)(1)] Describe any plans for partial closure and the circumstances under which the facility will undergo partial closure. Partial closure applies when a portion of the hazardous waste facility is to be closed at any time during the operating life of the facility (e.g., removal of a tank or waste pile from service or capping of portions of a landfill as they are filled). The procedures you will follow for partial or complete closure of the facility at any point 63 CMA 047589 during ids intended operating life, and for complete closure of the facility an the end of its intended oper ating life. Identify the date of final closure.' Identify the maxim_m extent of the hazardous waste facility that will remain open during the life of the facility (Refer ences 54, SS). c Maximum Waste Inventory (40 CT'R Section 254.112(a)(2)] Describe the maximum inventory of wastes in storage and treatment at any time during the life of the facility. Actual amounts of waste should be indicated in the appro priate 'units for each type of facility (References 54, 56 ). d Ir.ventorv Removal, Distosal, or Decontamination of Dcuirnent [40 CRR Section 254.112(a)(3)] Describe the steps needed to decontaminate facility equip ment during final closure, the labor force you intend to use to perform decontamination (in-house or outside con tractor), and your criteria for determining contamination. Name each piece of equipment and/or structures (e.g.,- waste feed systems, bypass systems, drainage systems, conveyors, transport containers, piping, pumps, valves, heat exchangers, compressors, discharge confinement structures such as dikes) and procedures for cleaning (e.g., steam-cleaning, hydroblasting). Describe the amounts of contaminated soil to be disposed of on and off the site, and describe the criteria used to determine the amount of contaminated soil. Describe the method for processing, treating, or disposing of residues from decontamination (includin' decontaminant 04*7590 solutions, wastewater, and liquid wastes). Describe the testing program to be used to determine if decontamination has been effective for each piece of equipment and/or ( structure and surrounding soils (e.g*, laboratory procedures, kits, mechanical, electrical, or visual methods). Describe the method of transport to the disposal site (e.g., truck, rail, water), the distance of transport to the disposal site, and the final disposal method (e.g., facility type such as a secure landfill) (Reference 57). I-ld(l) Closure of Containers [40 CFR Section 264.173] Describe in detail how, at closure, all hazardous wastes and hazardous waste residues will be removed from the container storage area, and how containers and the contain ment system will be removed or decontaminated. Describe safety precautions and procedures to protect the labor force during the operation. Show how the effectiveness of decontamination will be determined. Also describe the fate of all removed hazardous waste and waste residues and .how containers, containment linings, contaminated solids, and decontamination washes will be handled and disposed of. Provide an estimate of the maximum inventory of waste stored in containers at any time during the life of the facility. I-ld(2) Closure of Tanks [40 CFR Section 264.197] Describe in detail how, at closure, all hazardous wastes, hazardous waste residues, and flammable or toxic vapors 65 CMA 047591 will be relieved from tanks, associated piping, discharge control equipment, and the discharge confinement structure. Describe how all components will be decontaminated. Describe preparation steps before testing and cleaning (after the waste has been removed from the tanks) such as ventilation and gas testing, assurances for safe entry and exit, and safety protection for the cleaning crews. Also describe the fate of ail hazardous wastes and hazardous waste resi dues removed from the tanks and associated structures and hew decontamination washes and contaminated soil will be handled and disposed of. Describe any waste processing or treatment methods, if required, prior to transport or disposal (e.g., neutralization, stabilization, solidifica tion) . Describe the volume of waste that will be processed or treated and the volume of waste that will result from such processing/treatment (Reference 53 Previze an estimate or the maximum mventc of wastes in s tor age tanks and in tank treatment at any time during the life of the facil ity. d) ( 3 ) Cic sure of w asta Riles rue CFR Section 254.,233 ] Descries in detail hew, at waste pile closure, all haz- ardcus waste and b zardcus waste residues will be removed and hew anv ccmoc WA --b *V" *V* :ainmer.t svstem c: or contaminated wito oe remove? ons wastes ~ 2--i us waste =3 047592 the fate of all hazardous wastes and waste residues removed from the pile and associated structural containment compo nents,, and how linings, contaminated soils, and decon tamination washes will be handled and disposed of. Provide an estimate of the maximum inventory of wastes stored in piles at any time during the life of the facil ity. I-le Schedule for Closure [40 CTR Section 264.112(a)(4)] Provide an estimate of the expected year of closure. The closure schedule must include the total time required to close the facility and a milestone schedule depicting the time required for intervening closure activities. This will allow tracking of the progress of closure. Include provisions in the plan for scheduling several periodic inspections-during the closure period. 9 The milestone schedule should show that all hazardous wastes will be treated, removed from the site, or disposed of on the site within 90 days of receipt of the final volume of waste and that all closure activities will be completed within 180 days from receipt of the final volume of waste. I-lf Extensions for Closure Time [40 CTR Sections 264.113(b) (264.113(a)] In the event a longer period of closure time is needed than that specified in 40 CFR 264.113(a) and (b), you must 67 CMA 047593 demonstrate cr.a 0o1f the following: the activities will necessarily take longer than 130 cays to complete; the facility has the capacity to receive additional wastes; a person other than the owner or operator will recommence operation of the sits; or closure of the facility would he incompatible with continued operation of the site. You must also demonstrate that ail steps have been and will continue to be taken to prevent threats to human health and tie environment from the 'enclosed but inactive facility. 2 Post-Closure Plans These requirements apply only to disposal facilities that are net addressed in this manual. 3 Notice in Deed and Notice to Local Land Authority These requirements apply only to disposal, facilities that are not addressed in this manual. 4 Closure Cost estimate f40 C7R Sections 122.25 ( a) (13) 264.142) Provide a written, dated estimate, n current dollars, toe cost of closing the facility in accordance with the closure plan. The closure cost est .mate must equal the cost of closure at the point in the facility's operating life when the extent and manner of >06. ration would make closure the most extensive, as ir.di sure zc OV759* plan. Adjust the closure cost estimate for inflation within 30 days after each anniversary of the date on which the first closure cost estimate was prepared. Revise closure cost estimates annually to adjust for infla tion by using a factor derived from the annual Implicit Price Deflator for Gross National Product, as published by the Department of Commerce in the survey of Current Business. An illustration of the calculation is shown in the following hypothetical example, which uses the price deflators given in Table 1 adopted from the Survey of current Business. (See next page). Previous year cost estimate - $50,000 Previous year deflator = $177.36 Current year deflator * $193.71 * After rounding off to the nearest whole number, the infla tion factor is computed as 194/177 = 1.096. The current year cost is then: 1.096 x $50,000 = $54,300 The closure cost estimate must also be revised whenever a change in the closure plan increases the cost of closure and the revised estimate must be adjusted for inflation in the previously described manner. The owner or operator is required to keep the following items at the facility throughout the operating life of the 69 CMA 047595 I Allll 1. IMPL lOl I I'HICL ntriAIOHS 19/2 WLIfilllb, Kill ( H0SS NAH0NAL PltOIMICI Imp!icit price deflators. 1972 = 100 Seasona11y adjusted 1900 190i 1900 IV 1 1901 11 111 1902 IV V dross national product Personal consumption expend!tures On rati le rjuods Nondurable yoods Services 177.36 170.9 156.0 100.6 170. 1 193.; rl 193.} 166. 4 2*2.4 199.2 103.01 104.9 160.5 195.2 104.3 100.14 100.5 162.3 199.2 100.4 191.06 191.5 165.4 200. 4 192.2 195.61 195. 7 160.3 203.7 197.6 200.10 199.3 170.1 206.2 202.3 201.00 201.0 171.9 207.2 206.3 dross private domestic Investment i ixed irivesfluent Nonres idenlia1 Structures Pr oducers ` durable ei|Ut|)iiienL Ites ideiiL i a 1 Hunt arm sline tores 1 arm structures \ Producers' durable equipment Cliamje in business inventories 194.2 106.0 224. 1 17(1.2 210.6 221. / 219. 9 149.4 209. 2 202.]5 246.3 102.^ 233.3 236.0 239.5 159.4 199.9 192.4 233.3 174.5 223.3 226.3 224.2 152.4 203.1 195.0 236.2 176.0 220.7 231.0 229. 6 155.2 200.4 201.4 244.1 102.0 231.0 235.0 233.4 150.0 210.9 204.5 249.2 214.7 200.0 255.3 104.0 235.4 239.1 237.6 106. 7 230.0 242.9 241.2 161.5 163.1 215.5 209. 3 250.4 106.2 242. 0 246. 1 245.3 166. 1 Met exports of rjoods and services ( xporl.s Imports 211.0 290. J 229.0 295. 219.9 296.4 226.1 303. 1 220.0 301.2 229,0 209.0 232.2 200.5 233.6 209.3 CMA 047596 TABLE 1 (continued) Government purchases of goods and services Federal National defense Nondefense State and local 1980 184.4 183.9 165.6 180.6 184.7 1981 implicit price deflators, 1972 - 100 Seasonally adjusted 1980 1981 IV I 11 III IV 202.7 206.4 208.8 201.7 200.3 392.8 197.4 196.8 198.7 190.0 196.4 199.4 201.2 195.9 194.5 199.5 201.9 204.2 197.3 198.0 204.2 206.6 208.3 203.1 202.8 210.6 217.2 220.8 210.3 206.1 1982 V 212.3 216.2 223.1 203.3 209.8 aSource: Adapted from Department of Commerce Survey of Current Business, Gross Product by Industry 1981, Table 7.1-7.2. -4 Q 5 o ^4 Ukol facility: the latest closure cost estimate ( as previously defined) and, when thi s estimate has been adj usted for inflation , tr.e latest adjusted closure cost e stimate. 1-5 Financial Assurance Mechanise for Closure [40 CFF Sections 122.25(a)(1) and 254.143] State which of the following mechanisms is used. 1. Closure trust fund 2. Surety bend guaranteeing payment into a closure trust fund 3. Surety bond guaranteeing performance of closure 4. Closure letter- of credit 5. Closure insurance 5. Financial test and corporate guarantee for c 2 c SU-- $ A fully executed financial assurance mechanism( s ) must be mace available at the time of permit issuan In states tnat have only Phase I authorisation, provi ce a ccrrtu 1 but unexecuted copy o f financial assu rar.ee mecna s) for closure in the Fart E application. Originally signed copies of each of the chosen ir.scru: must be delivered to the Fag icr.al Administrator. Whe; a mechanism is used for multip le facilities, submit cri of financial assurance to th e Regional Administrator each region where the meohan ism is applied; include a shewing the IF A ider.tificati on number, name, address, ana the amount c: funds for clos ure ass'imed by the mechar. sm for each covered facility. 72 CMA 047598 In states that do not have Phase I authorization, existing facilities were required to submit a copy of financial assurance mechanism(s) by July 6, 1982. In states that have Phase I or Phase II authorization, facilities must comply with the applicable state laws and regulations. (Note: An owner or operator of a new facility must have the chosen instrument delivered to the Regional Administra tor by certified mail at least 60 days before the date on which hazardous waste is first received, and the instrument must become effective no later than the date of first receipt.) Instruments must be revised as appropriate, and evidence must be submitted to the Regional Administrator within 60 days of the revision to the current cost estimate for closure of a facility (Reference 59). I-5a Closure Trust Fund [40 CFR Sections 264.143(a) and 264.151(a)(1)3 A trust fund is a mechanism whereby the site owner or * operator sets aside funds in the form of cash or marketable securities to pay for the proper closure of the site. The trustee, a financial institution, controls the fund and invests the money in low-risk assets. All income earned by such investments is retained in the fund and reinvested along with fund principal. Upon closure of the facility, monies in the fund are avail able to reimburse authorized expenditures for closure when itemized bills are submitted to the Regional Administrator. 73 CMA 047599 Funds regaining after all closure recuirenents have beer* fulfilled are returned to the facility's owner or operator. During interin status, payments into the trust are nade annually over 20 years or over the remaining life of the facility, whichever is less. (This is referred to as the "pay-in" period.) After a permit has been issued, the pay-in period is reduced to the life of the initial permit. A Federal permit may be written for a maximum of 10 years. *<: The trustee will furnish annual valuations at least 30 da before the anniversary data of establishment of the fund to both the grantor (i.e., facility owner or operator) anc hfi Regional Administrator of the closure trust fund at each facility. Valuations are based on market values no more than 60 days prior to the anniversary date of estail ishment o f the .d. During the pay-in period, the minimum annual payment is equal to the unfunded liability cf the facility (the esti mated closure divided by the number of years remaining in the pay-in period): Minimum annual oavment = Cl Y CV the current cost estimate for closure, CV is the current value of the trust fund, V is the number of vears remaining in the '"O'-* * CMA 047600 The first payment should be made at the time the trust fund is established and subsequent payments , no later than 30 days after each yearly anniversary date of the trust fund. After the pay-in period is completed, the funding level of the trust fund must be revised within 60 days of any change in the cost estimates. After the pay-in period is completed, the owner or operator must maintain the value of the trust fund at a level equal to or greater than the CE value. Release of amounts from the fund requires written.instructions from the Regional Administrator to the trustee. The trustee must be a bank or other financial institution that has the authority to act as a trustee and whose trust operations are regulated and examined by a Federal or state agency. The trustee may accept written directions from the grantor concerning investment guidelines and objectives; however, the trustee must abide by the "prudent man" doctrine for investments and may not include securities or other obligations of the grantor in the trust fund port folio. All expenses of the trust, including taxes, broker age commissions, legal services, and trustee compensation-- to the extent not paid directly by the grantor--are paid by the fund. The trustee must notify the Regional Administrator within 10 days following the expiration of the 30-day period of the failure of the grantor to make the required annual payments during the pay-in period. 75 CMA 047601 Prospective grantors should review all tax aspects of trust fund operations with their accountants or tax advisors. Under present statutes, payments into a trust fund are not considered expenses (and are therefore not deductible) on Federal income tax returns. (The IPA is awaiting an IRS ruling on this.) Payments by the trust fund for closure or post-closure care expenses, however, are deductible in the year of closure or post-closure care when such expenses are incurred. Income earned by the trust fund is taxable, even though it is not distributed to the grantor in the year earned. The grantor's Federal income tax liability will be credited (reduced), however, to the extent of any Federal income taxes paid by the trust fund on a fiduciary return. The trust fund is terminated and remaining monies 2.--S retu o th s grants r when one of two conditions been met: i* tr 1) The r ecui rements for closure have been satisf ied. 2) An al tern ative fi.narcial assurance instrument previ ced to subst itute for ail or tart of the trus fund. Only the R egic nal Admi rsltr ^5 wSS from tni s cbli gaticr.s unte The wording oz tr+e trust agreement must re izt to tne wording specified in 40 CFR Section 264.131(a] trust agreement must be accompanied by a ideation of acxncwiedcnsnt. i0 CMA 047602 I-5b Suretv Bond [40 CFR Sections 264.143(b), 264.143(c), 264.151(b), and 164.151(c) A surety bond is a contract whereby a surety company guar antees to pay the amount of closure or post-closure care costs should thfe owner or operator fail to meet his obli gation. A standby trust fund must be established in con junction with the surety bond. Payments from a surety company would be made directly into the standby trust. The owner or operator need not make any payments into the standby trust fund. After obtaining the surety bond from, at a minimum, a federally acceptable surety company (per Treasury Circular 570), the owner or operator delivers the bond and standby trust fund documents to the Regional Administrator. The penal sum of the bond is adjusted yearly to correspond to adjustments in the closure cost estimate. Adjustments to the penal sum must be made within 60 days after any changes in the cost estimate. The bond remains effective until cancelled with the consent of the Regional Administrator. The cost to the owner or operator of providing financial assurance by means of a surety bond includes the cost of the bond itself plus the incremental opportunity cost of any capital required to be set aside as collateral. The direct cost of the surety bond is generally between 1.0 and 2.0 percent of the face value of the bond per year and is deductible for tax purposes. The EPA expects the use of 77 CMA 047603 surety bonds dor financial assurance to be limited (based on discussions with the Surety Association of America). Wording for the surety bond is specified in 40 CFR Section 264.151(c). 5c Closure Letter of Credit [40 C?R Sections 264.143d) and 264.151( d )" j A letter of credit is an instrument issued by a financial institution on behalf of the owner or operator of the hazardous waste facility that gives I?A the right to draw from the issuing institution to cover the costs of closure in the event the firm fails to meet its obligation. In a sense, the financial institution substitutes its credit for that of the facility. The owner or operator establishes a standby trust fund in conjunction with a letter of credit in an amount equal to or greater than the current closure cost estimate. Both instruments are delivered to the Regional Administrator and are updated annually, as appropriate. Adjustments to the value of the letter of credit must be made within 60 days cf anv chances in the closure cost estimate. The institution issuing the letter cf credit must be a bank or other financial institution that has authority to issue letters of credit and whose ccerstior.s for this purpose are elated and examined by a federal or agency letter cf credit is irrevocable; it is issued for a period cf at least one veer, with automatic extensions for at 73 CMA 047604 least one additional, year unless 90-day notification is given to the Regional Administrator. Upon determination, under Section 3008 of RCRA, that the owner or operator has failed to meet his closure obli gations, the Regional Administrator may draw on the letter of credit. Drafts under the letter of credit are deposited into a standby trust fund, from which payments are made for approved closure expenses. The cost to the owner or operator of providing financial assurance by means of a letter of credit includes the cost of the letter of credit itself plus the incremental oppor tunity cost of any capital required to be set aside as collateral. The annual direct cost of the letter of credit is generally between 0.25 and 2.0 percent of the value of the letter of credit, depending on the credit-worthiness of the firm. Such costs are deductible for income tax pur poses. Collateral required for letters of credit typically averages 20 percent of the value of the letters of credit, wording for the letter of credit is specified in 40 CFR Section 264.151(d). I-5d Closure Insurance [40 CFR Section 264.143(e) and 264.151(e)] A firm may purchase an insurance policy for the amount of the estimated closure cost. The insurance company will pay the cost of closure up to the full amount of the policy whenever closure occurs. 79 CMA 047605 The face value of the policy is at least the amount of current closure cost. Premiums paid during the active life of the site serve to fund the full.amount of the policy, although it may not have a cash value. At the end of site life, the insurer will pay out funds, up to the face amount of the policy, to reimburse authorized expenditures for closure. The face amount of the insurance must be adjusted accordingly within 60 days of any change in the cost esti mates. The policy cannot be cancelled except for failure to pay the premium, and then only 120 days after providing notification of such failure to both the Regional Admin istrator and the owner or operator. The owner or operator submits a certificate of insurance [worded as specified in 40 CT3. Section 264.151(e)] signed by the insurer and indicating the face amount of the 9 policy. The insurer must be licensed to transact insurance business or eligible to provide insurance as an excess or surplus line insurer in one or mere states. Either the face amount of the insurance must be adjusted to equal or exceed the covered cost of closure, or ether forms cf financial assurance must be provided to naxe up the dif ference . 04-7606 CMA of fund .payments. Until the tax issue is resolved, how ever, it is doubtful whether any significant interest in this option will develop. Currently, no insurance firms are offering to issue this kind of policy. I-5e Financial Test and Corporate Guarantee [40 CFR Sections 264.143(7), 264.151(f), and 264.151(h)] The owner or operator can establish financial assurance for closure of one or more facilities by passing a financial test. The test [wording at 40 CFR Section 264.143(f)(1)] is based on the facility's most recent audited financial statements, and it must be recertified on an annual basis. The test takes into account the current adjusted cost of closure and post-closure care of all facilities that are not covered by an alternative financial' mechanism. If a facility passes the financial test, it need not provide any additional assurance that it can meet its closure cost obligations. A parent company that passes the financial test can provide a guarantee of its subsidiary's obli gations . To certify satisfactory financial conditions under the financial test, the owner or operator supplies to the regional administrator: (1) a letter from the facility's chief financial officer [wording in 40 CFR Section 264.151(f)]; (2) an auditor's report confirming the results of the test; (3) the auditor's opinion; (4) a letter from a guarantor corporation, if applicable [wording in 40 CF3. Section 264.151(g)]; (5) any other information requested by 81 CMA 047607 the Regional Administrator. The auditor must he an inde pendent certified public accountant. If a facility fails to provide certification of satisfactory financial condi tion at any time prior to termination of its closure obli gations, an alternative financial assurance mechanism must be supplied within 30 days. 1-5f Combinations I-5f(l) Use of Multiple Financial Mechanisms [40 CFR Section 264.143(g)] A facility's use of multiple financial mechanisms requires a copy of a combination of trust fund agreements, surety bonds guaranteeing payment into a trust fund, letters of credit, insurance, and state guarantees. Neither the financial test nor surety bonds guaranteeing performance cf closure can be used to provide partial financial assurance for closure cf a single facility. The combined financial assurance provided for a facility must equal or exceed the facility's current (adjusted) closure cost estimate. 1-552) Use of Financial Mechanisms for Multiole Facilities [40 CF*' Section 254.143(h)] A single financial mechanism may be used to provide finan cial assurance for closure cf more than one facility. Total funding of the mechanism must equal or exceed the sum rscuired for each facilitv considered separately. Zvocer.ce of financial assurance must be supplied to the Regional Administrator in each regoon where covered facilities are locaned; it should include a list shewing the 17A identi fication number, name, address, and amount cf funds for closure assured by the mechanism for each facility. 32 CMA 047608 1-6 Post-Closure Cost Estimate [40 CTR Sections 122.15(a) (16) and 264.144] These regulations only apply to disposal facilities. 1-7 Financial Assurance Mechanism for Post-closure [40 CFP Sections 122.15(a)(16) and 264.145] These regulations only apply to disposal facilities. I-3 Liability Requirements [40 CTR Section 122.15(a)(17) and 264.147j In states that have only Phase I authorization, provide evidence that the liability coverage will be effective at the time of permit issuance. This may be done by stating which mechanism will be used and providing a copy of the proposed mechanism. In states that do not have Phase I authorization of liability coverage, existing facilities must submit evidence by July 17, 1982, for sudden and nonsudden (for surface impoundments, landfills, or land treatment facilities only) accidental occurrences that cause injury to persons or property. Evidence may be provided by submitting a certificate of insurance, by passing a financial test (self-insurance), or any com bination of the two. Coverage amounts apply to all facil ities owned or operated by the insured. Only states and the Federal government are not required to provide lia bility coverage. In states that have both Phase I and II authorization, facilities must comply with state laws and regulations that are or will be in effect at the time of application submitted. Coverage must be maintained until certification of closure of all facilities. S3 CMA 047609 a. Sudden Ir.surar.ee [40 CFR Sections 254.147(a), 164.151(i), and 2 54.1510)j All facility owners and operators must have coverage for sudden occurrences (accidents that are not continuous or repetitive in nature) in the amount of at least SI million per occurrence, with an annual aggregate of $2 million, exclusive of legal defense costs. If insurance is used to cover all or part of this lia bility, you must summit proof with your permit application to each the SPA Regional Administrator in each Region in which covered facilities are located. Such proof may be in the form of a signed duplicate original of either (1) the policy's Hazardous Waste Facility Liability Endorsement [wording in 40 CFR Section 254.151(g)], or (2) the Cer tificate cf Liability Insurance [wording in 40 CFR 254.151(j)]. Alternatively, a facility may use a financial test or any combination cf insurance ar.c a financial test as evidence of liability. Existing facilities must submit the recuired documents by July 15, 1982, in states that do not have Phase I authori sation, 1 and according to state law and regulations, in states that have Phase I or Phase II authorisation, b h'onsudden Insurance ,r40 CFR Sections 254.147(b), :hese recuiraments scclv surface impcuncments, 34 04761 landfills, or land treatment disposal facilities that are not addressed in this manual. I-8c Financial Test [40 CFR Sections 264.174(f), 264.151(J)] Owners or operators may provide assurance for all or part of their financial liability requirements by passing a financial test. The test [wording in 40 CFR Section 264.147(f)] is based on the facility's most recent audited financial statements and must be recertified on an annual basis. To certify satisfactory financial condition under the financial test, you must supply the Regional Admin istrator with (1) a letter from your Chief Financial Officer [wording at 40 CFR Section 264.151(g)]; (2) an auditor's report confirming the results of the test; (3) the auditor's opinions; (4) any other information requested byt the Regional Administrator. ! The auditor must be an independent certified public ac countant. If a facility fails to provide certification of satisfactory financial conditions for any portion of the required liability coverage, such coverage must be provided within 30 days through an insurance policy. I-8d Variance Procedures [40 CFR Section 264.147(c)] An owner or operator may obtain approval from the Regional Administrator for a reduction in the required liability amounts under this section. Such approval depends on an .'.valuation of the degree and duration of rislts associated with the ownership or operation of each facility or group 85 CMA 047611 of facilities and cr. other technical and engineering infor mation as determined necessary by the Regional Admin istrator . Adjustment Procedures [40 CTR Section 254.147(d)] The Regional Administrator may elect to increase the amounts of liability coverage required for any facility or group of facilities, and may elect to impose ncnsudden liability coverage requirements on treatment of storage facilities. Such a determination is based on an evaluation of the degree and duration of risks and what is deemed necessary to protect human health and the environment. Any adjustment of the level of required coverage for a facility that has a permit is treated as a permit modification under 40 CTR Sections 122.15(a)(7 ) (iii) and 124.5. I-S State Mechanisms - Use of State-Recuired Mechanisms [40 CfR Section 122.15 (2 ) (IS), 264.149] If a state has hazardous waste rsqulaticns equivalent to or greater than federal liability requirements or financial assurance for closure, submit a copy of the state-required financial mechanisms and a letter requesting that the state mechanism be acceptable. Include the facility's IfA identi fication number, name, and address and the amounts of cov erage. If the state coverage is less than federal require ments , the owner cr operator must provide proof of addi tional financial assurance mechanisms to scual federal -Scru" -- srr*sn^s 36 CMA 047612 To obtain approval for state-assumed coverage, the owner or ' operator must submit a letter written by the state to the Regional Administrator describing the nature of the state's assumption of responsibility, together with a request that such assumption be considered acceptable. The letter must include the facility's ERA identification number, name, and address and the amount of funds for closure or liability coverage that are guaranteed by the state. I-9b State Assumption of Responsibility [40 CFR Section 264.150J A state may assume either the owner's or operator's legal responsibility for closure and liability or the financial responsibility to cover those requirements in accordance with the Federal standards. If state guarantees for finan cial responsibility are less than the amounts estimated for closure, the owner or operator of the facility must supply additional financial assurance mechanisms to cover the shortfall. J. OTHER FEDERAL LAWS [40 CFR Sections 122.25(a)20 and 122.12] The EFA must ensure that RCRA permits are consistent with the requirements of applicable Federal laws, such as the wild and Scenic Rivers Act, National Historic Preservation Act of 1966, Endangered Species Act, Coastal Zone Manage ment Act, and the Fish and wildlife coordination Act. Therefore, it is necessary to consider the potential impact of the facility on these special environmental areas, and information related to the facility's compliance with other Federal laws in the RCRA permit application. 87 CMA 047613 TFTIF!CATION [40 OFF Sections 122.5(a) and (d)] Applications must be accompanied by a certification letter reading as follows: a "I certify under penalty of law that I have personally examined and am familiar with the information sub mitted in this document and all attachments and that, based on my inquiry of those individuals immediately responsible for obtaining the information, I believe that the information is true, accurate, and complete. I am aware that there are significant penalties for submitting false information, including the possi bility of fine and imprisonment." The required signatures are as follows: (1) for a corpo ration, a principal executive officer (at least at the level cf vice-president); (2) for a partnership or sole proprietorship, a general partner or the proprietor, respectively;"$(3) for a municipal, state, Federal, or other public agency, either a principal executive officer or ranking elected official. 3 PART 2 MODEL RCRA PERMIT APPLICATION 89 CMA 047615 PART 2 MODEL RCRA PERMIT APPLICATION Par* 2 preserves a medal of a Part A application, a ? art 3 application, and certification for a fictitious hazard :cus waste management facility. Appendix A contains general information and haze, rdous characteristics of waste; Appendix 3 contains inspect Lon log sheets; and Appendix C contains a Trust Agreement. 30 CMA 047616 Date: 2/26/82* Revision No.: 1 A SECTION A PART A APPLICATION . The Part A application includes the completed forms that follow, a facility map (Figure 2), and a facility photograph (Figure 3). * This is a suggested notation to facilitate revisions to the Part B Permit Application. 91 CMA 047617 Revision No A 0 32 CM& 047618 Revision No A muni? is ?h Maafacttir* of *ot*i oucb * oucaaotlvo body port* tad bouMbold applliaea taotiata** and part*. My(M> 93 CMA 047619 i Revision No.: 0 A* 94 CMA 047620 Mm r-- *m Date: 2/26/82 Revision No.: A 7v^n?ii?Tio?orM7I7RDorTnftJ^BBBB A. IU *1141004 itARt MUUUR - !. , P*mW45 CBMBi^oBerB: Jj'Bi i mm m *m mm * 40 CM. tmmm Q.mmmm m ww-fy *m40C?4. J y iftavmp B. tmAATKO IWMI, QUAMTTTY - 4* * I i C gMTt 0# WiJMW - > Mt 4 t mm mm m* * .s ML<a* ue.IT ne * >*e JBfiL MCTRIC UWLOf Hi fctttflf 0. i MMfl oeisseoQd im r 0W yew tM k mm ma/ mw -COfit wmw y* m> y tvm ivcm.yia U) lew * 3 *N0CttSOimifriON W>^seiewyfrMww*iif*wvw.i wort. MAZA0OOUI >*um 0fttt9 tmt t**m one V4 mazaaooui waotv mjmt* * --> mm mm mm wm my* m* ve (Pa Mwnm Maw mey M frv aiawBw a* i** am * fyiam \ Imr yw y rtw cpa wmmw Maw Nmhwri im mt a mw a. Q* m am ww mmm wmm ft,C> M 0 aaawnwc m m m awwiw y m maw mm Manwa w* aw mm a* ia iwa. m*% mmm naat y m 2. w iwwwb a y tw* me m m aw amr ipa mm m mem mi m b a y mmm m ern. w mm* 0<3i aw mm mt 3. >2l*i r(*> aVI *00 tPimq rTW rv ytam *mm* an J* f. jr-x M mm x* mi - a mum ** am w* wm y m aimy CS m m y am am<" warn mm y*n m fm ^ aawatw*. t#i mmnw*. m miwy * tmi ma awaaw y tnrm *m niaa m*wa > m rm y tarn mi tf yw m * wm m ym ma mu mi b m 4 M A. *FA HA214D io WArrcHe aX A DT1MATC9 ANNUAL UANTtTT OP WAOTC aa*.wmme i t i. mwciww cam *mmn X-l X 0 J 4 x-z D 0 0 2 900 400 / 7 0 3 D SO i( / T 03Di 0 o. octo m1m. FmMasCmIeNat fm w Otin X-3 D 0 0 1 X-4 D 0 0 2 100 70 3DS 0 ii iJ i> tHcludtd ir* a6orr 95 CMA 04*7621 Revision No.: A aaoa l ___or '-j '3" *r" rtf *** ; i* j****s*** **** 53 CMA 047622 rv QUCXIFTlon Of N*2a*OOV-'S WASTti imrimm. , "T.'ull fxii T5 wilf a66iT1nai mocuicoo" Data: 2/26/82 Revision No.: A i. ai <<* * rIaI > !,is! afj'Iort I aI ^a, i rr? V FaCIUTY P1AWIKC k* p*m*ma * warn S H* wwi*i a* m* tas>r* n Mnwt'k tmt "*** VI. FttOTOCFUrHi^ HBBMHHBi AJl txitDAq faetiiiM mu>< mew** >iowyi>*. (**ri*i or (WbW >iW) trtn OMriy mhd *U taminf iinietur*. m* mi a< W. not***- wiwm o. *noom) m to* Wu?OAt to m* vn. f aciuty ctociAfmc uocatioa 3 1 wor9t l--i vm ***^ i r a* "T" a <** Mt S W * final --mat A <i a--ii iHM * Am VIM >w* 1. maw -- i **a *# i. itattr am *, ** *. er?* am iw1 S ****** ma '** /aw 4 # 1 P l ! -ULL |% i a 4 It* ( I cnrtitr iMr wmiv f IM fAM / Am* aartenatly ****** me *m tamilm Wittt rn* ntormmion momitna m t** *nc A// mrmnro itoirtiawK an* sMf * on m* mmeff of Mo* imtototo. iMmaaiarMv WM to aetmnm* m* tMommen I amt*** rAar m* AOIWTW toam*tK * tm. www. tmt canto*!*. I mu ni*tfia< tow* ** mmafmant M"Mi* to atonmany to* mtonwrien, awuto* am pomditto* at fin* mat X. OMJUTOt CtimiCATWA / *to >xM*f a*n*fly at tom mat I Am* partonau* a* am ftmrtir mm m* totoimmien umt* in ms M * mat*** *wm an* iam amaa an m* mmnrv at mem imrntdimmv '*mtmette tar aOtmtun* m* ntarmanan / amine mm m* lanurra*mm* ptoowwtMotoaomf tmo,*A*1Wiw. --csmiLetoa. / am tmeta mm Sto* ma V*nficjm ammtm tat tuammin* tmm ntormmmn. a- a** <a*mt ^ rtmt Htry ?. Jn< 1 1. HM*TWt Yyyfatys# (j*~**us . lari 06/01/80 IfA ! 3*1*4 MM PAGi 4 or i CSATIMUt On >.sfT 97 CMA 047623 ua ue < 4^ / ** w / v . Revision Mo. : 0 A Figure 2, A ococcracnica' zzo of Tankcoi'a rinisning Corroany and surrounding area. o4T624 Date: 2/26/82 Revision No.: 0 A (An actual photograph would include existing structures and future hazardous waste storage areas.) Figure 3. Facility photograph, June 2, 1980. 99 CMA 047625 Date: 2/26/32 Revision No.: 0 3 SECTION S FACILITY DESCRIPTION This section provides a general description of the hazard ous waste management facility as required by 40 CFR 1122.25(a). This description is intended to acquaint the permit application reviewer/pemit writer with an overview of the facility. More complete derails can be found in other parts of this permit application. 3-1 General Description (40 CTR 122.25(aHD1 Tankopile Finishing Company, Inc., is located 3 miles east of the city limits of Ar.ytown, Rhode Island. The street address is: Tankopile Finishing Company, Inc. 3100 West llth Street Washington County Anvtown, Rhode Island 02331 The mailing address is: Tankocile Finishing Ccnvoanv, Inc. P.O. Box 1932 Ar.ytown, Rhode Island 02331 This facility is primarily a manufacturer of neta_ automo tive parts (i.e., body parts, hubs, and trim) and household appliance housings and parts. Hazardous wastes are gen erated by metal fabrication, cleaning, finishing and 100 CMA 047626 i Date: 2/26/82 Revision Ho.: 0 B coating operations. Fabrication and machining of metal parts generates metal grindings. Cleaning of metal parts in hydrochloric acid generates pickle liquor sludge and spent pickle liquor, vinyl acetate and vinyl chloride sludges are generated by the metal coating operations. The waste trichloroethane results from vapor degreasing of metal parts. The metal hydroxide sludge is generated as a byproduct from recycling wastes from chromium and lead plating operations. The contact and party responsible for the hazardous waste management activities at Tankopile is: John Q. Smith Environmental Engineer' (401) 555-6789 B-2 Topographic Map f40 CFR 122.25(a)(19)1 Figure 4 is a topographic map showing the facility bound aries, buildings, waste storage areas, and other details. Figures 5 and 6 are topographic maps showing 5-ft contour intervals of elevation and the 100-year floodplain area, respectively. These maps also show surface waters. The scale on these maps is 1 in. equals 880 ft. whereas the regulations request a scale of 1 in. equal to not more than 200 ft. This was discussed with the permit application reviewer at EPA and this submission was considered accept able (see letter to J. Q. Smith dated 12/1/81 from C. Siegel submitted separately). 101 CMA 047627 udce : i/ iu/ oi Revision No.: 0 B W> 0A7I: 3/'0/31 figure ity or " i " < c 3'7 ^ ' n i s n i r,i .ctTcanv. 047628 CMA Date: 2/26/82 Revision No.: 0 B. 130 SCALE DATE: 1/10/81 5. Facility map with 5-foot contour intervals of elevation (feet MSI). 103 CMA 047629 uaca: 1/ a/a z P.avision Me. : 0 3 CMA 047630 Date: 2/26/82 Revision No.: 0 B Land Uses: Figure 7 shows surrounding land-use areas. Other industry lies south of the facility; the rest of the surrounding area is undeveloped* Zoning maps of the area may be obtained from the City of Anytown Planning Com mission. Hazardous Waste Management Facility Boundary: The haz ardous waste management facilities consist of the drum storage area (100 55-gallon drums), two 7500-gallon storage tanks, and one 50-yd3 waste pile (Figure 4). The figure also shows the location of the future waste pile area which is outside the 100-year floodplain. The existing waste pile area is within the 100-year floodplain (Figure 6). Wind Rose: Figure 8 shows an annual wind rose of meteor ological data collected from 1965 through 1974 at the nearest weather station, approximately 5 miles west of the Tankopile facility in Anytown, Rhode Island. Access Control: The facility is surrounded by a fence, and a guard house is situated at the only entrance to the plant. Employees must show identification to obtain ac cess; visitors must sign in and out and wear a visitor's badge. Access control is discussed in further detail in Section F-la. Injection and withdrawal wells: The site has no injection wells. One withdrawal well is located north of the electric substation (see Figure 4) and is used to supply cooling water for vapor degreasers at the facility. No other wells are located on-site or off-site within 1000 feet of the facility. 105 CMA 047631 Data: 2/26/32 Revision Ho.: C 3 "isura 7. irrcur.cir.g * and use. 047632 CMA Date: 2/26/82 Revision No.: 0 B Figure 8. Wind rose. 107 CMA 047633 Data: 2/25/82 Revision No. : 3 Build!.-:cs; Treatment, Storage, and Disposal Areas; Other Struct'-ires: Figure 3 shows the building and structures on the pr:;perty as well as the waste storage areas. Recreat:ion Areas: Not applicable. Runoff Control Systems: A combined sewer system with collectlion drains located throughout the facility collects runoff from the processing and warehouse areas (Figure 4). Rune f f from the container and waste pile storage areas is collect:ed in holding tanks prior to discharge to the sewer system Section ?-4b discusses runoff control in greater detail, Access and Internal Roads: Figure 4 shows the roads wi"hin the plant area and the one road leading into the plant. Storm, Sanitary and Process Sewers: Tankcpile's combined sewer system, which collects sanitary sewage and store. water, has drains located in the office building, lunch room, first aid building, processing area, and warehouse area. The svstem also extends to the container storage area and waste pile storage area receiving runes:. Ru collected in the container storage area and -asoe pole storagea area dees not mix wiuh sanitary w=sce until it passes through the holding tanks as discussed in section The combined sewer system is shown in Figure 4. There are no process sewers at this facility 133 CMA 047634 Date: 2/26/82 Revision No.: 0 B loading and Unloading Areas: Concrete loading/unloading areas are provided on the east side of the tank storage area and at the warehouse. A loading/unloading area is provided on the west side of the container storage area and a loading/unloading area will- be located on the south side of the future waste pile. Fire Control Facilities: The three fire hydrants provided are located near the lab, the processing area, and the warehouse. Surface waters: The only surface water within 1000 feet of the facility is the Queen River shown in Figures 4 through 6. Flood Control/Drainage Barriers: General drainage on the property is toward the river. A fence surrounds the con tainers to keep them within the storage area during a minor flood. Alternatively, when a 100-year flood is evident, the containers will be removed to a disposal facility. Current plans call for the waste pile to be moved outside the 100-year floodplain. The tanks are already located outside the floodplain. 3-3 Location Information [40 CFR 122,25(a)(11) and 264.181 3-3a Seismic Standard Because this is an existing rather than a new facility, the seismic standard does not apply. 109 CMA 047635 Date: 2/25/32 Revision No.: 0 Floodplain Standard The Tanhcpile Finishing Company, Inc., facility is located immediately west of the Queen River and 1.3 miles east of the Chipuxet River. The 12C-yesr floodplain elevation at the facility is 123 feat mean sea level (M.SL). Figure 9 shows a portion of the Federal Insurance Adminis tration (FIA)- flood map for the city of Anytowr.. The cones labeled "AQ" on the map indicate areas of 100-year shallow flooding with depths between 1 and 3 feet. (This refers to depth of flooding in a given area rather than rise of the river by one to three feet.) The Zone 3 portions of the facility property indicate areas between the limits of the 100-year flood and the 500-year flood or areas subject zo 100-year flooding with average depths of less than cne foot. The remainder (the most northern and western sections cf the property, desigr.acsd as Zone C, is an area chan is su :o lucccm Mere to.an na>lrd- ^ C property is located within che 100-year floodplain an subject to floods cf cne to chree feet in depth. (1) Demonstration cf Compliance (1) (a) Flood Proofing and Flood Protection Measures The slow-flowing Queen Purer may subject the property occasional shallow (cne no chree foot depths) floods, no w78 senior* cdir, r2iscr*5-il7 . * E 3 w: :or.tair.ers (35-gallon m area 1ocatec m 1 ' - - r-' 110 CMA 047636 LEGAL BOUNDARIES \ / OF FACILITY X. yU I.e f fc/ / Wk Revision No.: 0 B SCALE MAP DATE: A/20/79 ZONE AO - AREA OF 100-TEAR FLOOD; FLOOD ELEVATION OF 125 fttt MSL. ZWE 1 - AREA BETWEEN LIMITS OF 100-TEAR ROOD AND SQOTEAR a000; OR AREAS SUSJECT TO 100-TEAR aOOOING WITH AVERAGE DEPTHS LESS THAN ONE (1) FOOT OR WHERE THE CONTRIBUTING DRAINAGE IS LESS THAN ONE SQUARE MILE. FLOOD ELEVATION OF 130 Te*l MSL. ZONE C - AREAS OF MINIMAL FLOODING. Fiaure 9. Federal Insurance Administration (FIA) 100-year floodplain map. Ill CMA 047637 Date: 2/26/S2 Revision No.: B ;sct to floods, the closed drums would be conhe fence should a flood occur. In the event of flood, the drums will be removed to a disposal ^ Plan sr storage area located in the east comer of y, in zone AO, is in the 100-year floodplain, t of a 100-year flood, the drums will be moved s Spills Cleaned (CSC), Inc. (ERA I.D. No. 0 ) 1200 East Twelfth Street, Ar.ytown, Rhode Ace Storage, Inc., 4700 West Eleventh Street, ode Island (ERA I.D. No. RI009S99999) . as contracted with CSC, Inc., a firm that m hazardous waste transport and hazardous uo activities. Tanhooile has entered into a agreement with CSR that guarantees that CSR he necessary personnel and equipment available 112 04763 CM&- Date: 2/26/82 Revision No.: 0 B It is estimated that it would take 8 hours to move 100 drums' (4 per pallet), which is well within the warning time before the occurrence of a 100-year flood. Some small likelihood of a potential accident is possible when moving the drums from the storage area and loading them onto the flat-bed trucks. Therefore, Tankopile's emergency coordinator will be responsible for ensuring that the contractor personnel follow all necessary safety procedures. 3-3b(2) Plan for Future Compliance The waste pile currently located in the east corner of the property, in Zone AO, would be subject to washout should a 100-year flood occur. Plans are being completed for constructing a storage area for the waste pile in the northern most corner of the property along the eastern boundary. This is a Zone C area, not subject to flooding (100-yr). The planned waste pile storage area will be constructed according to the production schedule provided in Table 2 and will meet the same design specifications as the exist ing waste pile storage area. Moving the waste pile from its current location will prevent material washout from the pile due to flooding. (See Section D-3a for design of waste pile.) The old waste pile will be closed in accord ance with the procedures specified in the closure plan. 113 CMA 047639 Date: 2/25/32 Revision Mo.: 0 3 -i- - - - : :; A CChSTRUCTION schedule ; =- Sec - iWP.*W,-1 V - -i - * -- s> s:=- 1 1 1# - L8iC"*-*i -- 51* ' " s y $ * 3" F z , r z 3 1 * !" Li r,e- LSS1*!":*.: ; " 2 ~ - ~ \ ' Z Z * * ? C " ' 5VS1S- Sc : 3 Sun-:- : 3-3 r' Se:;- -T-. ; : : = `.es 1 | ! i1 ! Data of completion March 1, 1932 March 25, 1382 Acril 15, 1932 April 23, 1382 April 30, 1982 May 14, 1982 May 21, 1982 Dune 7, 1982 June 15, 1982 CMA 047640 Date: 2/26/32 Revision No.: 0 B This facility will be in- compliance with 40 CFR Section 264.18(b) by June 1983 When the waste pile is moved to a nonflooding area. B-4 Traffic Patterns f40 CFR 122.25(a)(10n Access to Tankopile Finishing Company is from Interstate 95 to State Highway 102 east and right on River Road. After a distance of approximately 5 miles on River Road, a left-hand turn is made at West Eleventh Street, and the plant entrance is on the left about 1/2 mile from the intersection. Figure 10 shows the onsite traffic pattern. The main road, parking lots, and dead-end roads are two-way; the two main loops within the property axe one-way. Most cars are confined to the parking* lot and entrance road, within the plant, traffic vehicles consist mostly of front-end loaders and trucks. About five semitrailers enter the plant each day. Four front-end loaders are used throughout the plant on a constant basis; and two additional front-end loaders are used as needed. Traffic Control: Traffic is controlled by one-way direction and stop signs. These are also indicated in Figure 10. Access Road Surfacing: All roads are constructed of 5 in. of bituminous concrete pavement (blacktop), composed of 3H in. of bituminous concrete base material and 1H in. of bituminous concrete surface material; this overlays 9 in. of compacted aggregate base. 115 CMA 047641 -c . a/ *. v/ <j -- Revision No.: 0 3 N <> S7CP SIGN (lTTTI lcao:ng/-nlc-:: -s CMA 047642 Date: 2/26/82 Revision No.: B Load-3earing Capacity: All roads are capable of bearing loads up to 50,000 pounds per axle. The bulk tanker truck used to remove inventory fr<_,n the tank storage area has a curb weight of 28,000 lbs. Assuming removal of 7,500 gal from either of the storage tanks, the tanker will weigh approximately 91,000 lbs. The flatbed truck used to remove drums from the facility has a curb weight of 30,000 lbs. Assuming removal of 100 drums at 500 lbs/drum, the loaded flatbed truck will weigh about 80,000 lbs. Therefore, the facility roads can bear the weight of the trucks. Traffic Control Signals: Not applicable. 117 CMA 047643 O O '* 0 SECTION C WASTE CKAPACTE3I ST I 05 This section describes the chemical and physical n = the hazardous wastes stored at the Tankopile facility a: Waste .Analysis Plan for sampling, testing, and evaluati: wastes to assure that sufficient information is availed! their safe handling. The information suzrittez is in a; with the requirements of 40 CEP 3 122 . 23 a ` ( 2 ) and (3). tan.ce C--l CJismi.csl P'^vsiceI Ansi. vsss f 43 3TT* 122 . Z 5 ( s ) ( Z List of Hazardous Wastes Stored at "acility: Haza; wastes are stored at this facility m 33-gallcn dr-. tainers, 7500-gallcn tanks, and a -aste tils. Cur: inventory consists of 100 containers ( ; v - g a -- or. oruns Two 7 5 00-call on tanks Cue SO-yd* waste pile The containers (35-gallcr. drums - oar. :e broadly cl into Group A, 3, and C containers grouted aeparat to incompatibility of the wastes. The contents of group are listed below: Croup A Yellow drums 3io.ua liquor sludge Grout 3 Blue drums Metal onrdirrs (TCI CMA 047644 Date: 2/26/82 Revision No.: 0 c Group C White drums Vinyl acetate sludge (D001) Vinyl chloride sludge (D001) The pickle liquor sludge is corrosive, and it is toxic because of its extractable lead and hexavalent chromium content. The vinyl acetate and vinyl chloride sludges are ignitable; both have flash points below 60 aF. The metal grindings are toxic; they contain large amounts of extract- able lead and hexavalent chromium. Spent pickle liquor [hydrochloric acid (HCl)] and spent 1,1,1-trichloroethane solvent (also referred to as methyl chloroform) that have become contaminated and diluted through use in metal cleaning and finishing operations are stored separately in tanks. Spent pickle liquor is a listed hazardous waste, assigned hazardous waste number KQ62 (40 CFR 261.32) because of its corrosivity and EF toxicity. It is corrosive because it has a pH of less than 2; it is toxic because of its extractable hexavalent chromium and lead content. The 1,1,1-trichloroethane is also a listed hazardous waste, assigned number F001 (40 CFR 261.31) because of its toxicity. A 50-yd3 (maximum) waste pile is used to store metal hydroxide sludges which are toxic due to their extractable lead and hexavalent chromium content. The ERA hazardous waste numbers assigned to these sludges are D007 and D008. waste Analyses: Table 3 lists the hazardous wastes stored 119 CMA 047645 ?.av1sor. N'c . : TABLE 3 WASTES, ASSOCIATED HAZARDS, AND BASIS FOR HAZARD DESIGNATION Chemical Tan* s ? i C it 1 9 lieu or (hydrochloric acid) 1,Z,1* trichiorcethane Or'.'.its Vinyl acetate sludge Vinyl chicriae sludge Ricxie liquor sludge Metal grindings Waste oi'e Metal hycroxice sludge Hazard Basis for hazard ces;grsc*'cr Corrosive,, Toxic Toxic Listad waste <052 nas o- of 1 EP toxic, leac anc hexava:er.t chrcmium Listed waste F001 Ignitibla Ignitible Corro $ive , Tox*: c Toxic Flash point of pure v'-yl acetate is 1SF. Tested flat" :c;^c *':* waste is 2;F. Flasn point cf pure v'->: on';--: is -iCSr. Testae '*asr cc;"t for waste is S0;. Has pH of 1; E? tox^c, leac arc re>.a'.a'e-c enrem i um E? toxic, laac anc chromium Toxic S ? toxic, 'sac arc " e - = , = ' s -1 enremi i* CMA 047646 Data: 2/26/82 Revision No.: 0 C at the Tankopile facility, their associated hazard classi fication, and the basis for the hazard classification. In most cases the classification is based on known charac teristics of the wastes, such as ignitability, reactivity, corrosivity, or EP toxicity analyses. For listed wastes, the classification is based on the listing. Figures ll through 17 show the waste analysis results. Waste Handling: All wastes (except those in the waste pile) are labeled; the label describes the contents of each tank or container and its associated hazard (corrosivity, toxicity, or ignitability). This practice informs workers handling these wastes of the associated hazards so that appropriate precautions can be taken. Details regarding the tanks, containers, storage areas, and personnel train ing are presented in other sections of this application. General information and hazardous characteristics of the waste types are included in Appendix A. C-2 Waste Analysis Flan [40 CFR 122.25(a)(3)] C-2a Parameters and Rationale Table 4 shows the hazardous wastes stored at the facility, the analytical parameters that apply to each, and the rationale for their selection. C-2b Test Methods Table 5 shows the test methods that are used to measure the analytical parameters. All test methods are from Test 121 047647 Data: 2/2b/%2 Hevision Me.: 0 C CVENT _ ON __ KZ ANALYS* , DATE LASCAA1 SY DATA '>i '33 AN AL V3'S ^eYnCO nuMSEa CHECK'S _________ :;cure 11. Labcratorv analysis ras'j" crce CMA 047648 Date: 2/26/32 Revision No.: C KM HACAHD ASSESSMENT TEST JUtPORT Client: Tinkoplls Finishing Company PNi uv* Senpl* IP* (fiq)f fiquor) . - " _ _ - --j------------- PEDCo LAP fls.i iri03 DU Socoivodi 12/1/61 Dote Reported: 1261.21 IflWlTAlIUTY riash point *r (Mon allowed I40*r> 1261.32 CORROSIVITY pH 1,0 MACE corroaion goto ~~ (2< pH <12.S allowed) /yr (Mo*, allowed 6.35 an/yr) 1261.23 REACTIVITY Acid labile eyonido Acid labile sulfide ........ *261.24 EP TOXICITY Sample typo: Solid . _ Soaioolid . _ Liquid _ x If liquid or ooaioolid, non-filtarabla solids 2% MOTE: If sample contain* loss than 0.56 nonfiltrable solids, tb* filtrate is the extract. Analytical Hosults Valuas sr* concentrations of constituent in extract. Constituent Concentration, sq/1 Arsenic barium Cadmium Chromii, total Chromium, bexavalent Lead Mercury Selenium Silver Eadxln Liiid&Jift Metboxychlor Toxapbene 2,4-D 2,4.5-TP <0.01 30.01 |Ti-OP. Maximum concentration allowed, sq/l 5.0 100.0 1.0 5.0 5.0 5.0 0.2 1.0 5.0 0.02 0.4 10.0 0.5 10.0 1.0 PEDCo Environmental, Inc. Submitted by: Figure 12. Laboratory analysis results for pickle liquor. 123 CMA 047649 I ua:5 : i/ in/ 3 u Revision No.: 0 C RC3A iAlAAS ASSISStfSHT TOST S2?077 CIitn*i * -. % > y^; Sanpit IS: PIPCo Lab He . : r "- f * '3*gg.: v*d : y_? : ^_^22L_ ___ Sate Retorted: )' i'1:? i:6:.2i ics:TX3:i:r? flah ?oi.'.: . ?t *y (h*x. allowed iao'd i:5i,2: csrpcsivity pH MACS corrosion rate (2< pH <12.5 allowed) _______ zet/yr Uua. allowed 5.3! a/yr) 1261.2: CAPTIVITY Acid labile cyanide Acid labile auidide 1251.24 ;? rcx:::Tn Sar.ple type: Solid Semitoltd _ Id liquid or. semeolid , ncr.-iilteraol* actios Liquid .HOTS; Id t***?!* contain* 1*** than 0.5\ noniiltrabie tclida, the iiltrats i* the extract. Analytical Result* Value* are concentrations ot csn*titunt in extract. Constituent Cancentntien, sq/1 Ar *er.ie 3ariu.T. Cadmur- Chronu-us, Lead Mercury Seleni'bc Silver hexavaier.t On dr in Lindane Methcxychlor Toxaphene 2,4-0 2,4,5-77 Xaxmun csr.cer.trmen allowed, sq/1 ?IOCo invirsnrwntal, Inc. Sunauttad by: Figure 13. Latcrstcry analysis results *cr vinyl acetate sludge. 047650 CMA Date: 2/26/82 Revision No.: C JC*A HAIAAS ASSISSKTNT TZST XE?OXT Cliant s Tanfcenils Finishing Carartv Sampl# IP: *661 (vinyl cMnritfg Quest1. TtSCo 1*b Ho.i CF 105 Bit toeiivti: 12/WB1 ___ >m iftfin Bata kaportad: 1/12/12 I26i.il iqiitabiuty yiaab point 6'T (tux. allowed 140*n 1261. i2 CSAAOSIVTTY pH ^ ma corrosion rata (2< pH *12.5 allowed) om/yr (Max. allowed (.35 a/yr) 1261.23 INACTIVITY Acid labila cyanide . Acid labila aulfide - 1261.24 tf TOXICITY Saspla typai Solid SeJaiaolid Liquid If liquid or eemiaolid. non-filterable eolida - ___ MOTS: If aaapla contains laaa than 0.5% nonfiltrable solids, tba filtrata ia tha extract. Analytical Results Values are concentration* of constituent ia extract. Constituent Concentration, oq/1 Arsenic Sanaa Cadaiuo ChrsoaTM, total CbrotBiuo, hexavalent Lead Mereury Seleniua Silver In dr in Lindane Metbaxvehlor Toxaphene 2,4-0 2,4,5-T? Maxiansn concentration allowed, wj/1 5.0 100.0 1.0 5.0 5.0 5.0 0.2 1.0 5.0 0.02 0.4 10.0 0.5 10.0 1.0 PSSCo Environmental, Inc. Subedited by: Figure 14. Laboratory analysis results for vinyl chloride sludge. 125 CMA 047651 uace: i/db/a^ Ravi a ion N'a. : 0 C SCPU SiADAAD AS5iSSXE.,r TEST REPORT Client'-____ Tim:cn *irvih:rc Ccmparv Jaltple - t ;2 *~ i `'JC v ? 7ZZZI Lac Mo.: C- ,Cc Z-nic Received: ____ PS: 1C0Q__________ Oitt Xeoorted; i / 1 1 /TT 1241.21 ISNITAJILITY ri**h point*T (Hax. allowed H0*T) 1251.:: CCR-RCSIVITY pH 1 , 3(2< pH <11. S allowed) war" corrosion rate sm/yr (Hex. Allowed 6.35 Ka/yr) 1251.23 REACTIVITY Acid latile cyanide Acid laSile sulfide ---- 1241.21 E? TCXICITY Sample type Solid Semisolid * Li^vid ---------- If liquid or semisclid. non-filcerable solid* SA * HCTT: If sample contains less than 3.St nonfiltraile solids, the filtrate i* the extract. Analytical Results Values are concentraticns of constituent *n extract. Constituent Concentration, mq/1 At ler.ic 3ariu.t. Cadmium O. rest: urn, O.rcni urn, Lead Mercury Selenium Silver total hexavalent Er. dr in Lindane Hethcxychlor ,Toxaphene 2 1-0 2,1,5-T? <'j ?! 2. .C Maximum concar.tration allowed, sig/1 5.0 100.0 1.0 s.o 5.0 5.0 0.2 1.0 5.0 0.02 0. 1 10.0 0.5 10.0 1.0 PEECs Inviroruaental, Inc Suhnittid iy: rlCUCS iC. Liberatery analysis rssults r Dick's 1iquer siudge. 12S CMA 047652 Date: 2/26/32 Revision No.: 0 C RCRA HAZARD ASSESSMENT TEST REPORT Client; Tmkoo'lt Finishing Comcmy Sample ins 46cs qnnoino) PEDCO Lab Ho.: C* *q? Pate tociivii; X 40G0 Pats Reported: 1/1*/E2 12*1.21 ismitasility Plash point *T (** lilwwi 140*T) 1261.22 CORROSIVITY pH _______________________ mace corrosion rata (2< pH <12.5 allowed) i/yr (Max. allowed 6.35 wn/yr) 1261.23 REACTIVITY Acid labile cyanide Acid labile sulfide - 1261.24 t? TOXICITY Sample type: Solid X Samisolid -- Liqvid --------- If liquid or semisolid,a6n-fAlterable solids 4 HOTS: If temple contain* leaa than 0.54 ncnfiltrable solids, tbe filtrate is the extract. Analytical Results Values are concentrations of constituent in extract. Constituent Concentration, mg/1 Arsanie barium Cadmium Chromium, total Chromium, hexavalent bead Mercury Selenium Silver Cadxia Lindane Methexyehlor Toxaphene 2.4-0 2,4,5-TP <0.01 TITTr as. 6 *0-001 <0.01 <<L.0M Hexianan concentration allowed, g/l 5.0 100.0 1.0 5.0 5.0 5.0 0.2 1.0 5.0 0.02 0.4 10.0 0.5 10.0 1.0 PSCs Environmental. Inc. Submitted by: Figure 16. Laboratory analysis results for metal grindings. 127 CMA 047653 Data: 2/25/32 Revision No.: 0 C HCXA P.ASAA3 AS3E33MZ.V :st si?oar Client: Tinkcoile <:rnsMng Company Sample IS: -m; meu: i>ar:iu: i'.laoei PZZZs \ No.: -- iCe Sate Seceived: It.-1 - Si iisi.31 ictitasiiitt TN: 4000 Pete Sepcrttd: 'i/'ofT Tlath point *T (Max. allowed 140*T) 1351.22 CCaaSSTVCT? pH (2< ?H <12.5 allowed) NACS sarrotion rate s/yr (Max. allowed 5.35 sar./yr) 1251.23 ^ACTIVITY Acid labile cyanide Acid labile tuldide 1251.:< s? toxicity Sample type: Solid $mi*olid X liquid ____ Id liquid or temtolid, non-dilteraole 'sc.ics J \ NCTZ: Id temple contain* lea* than 0.54 ncr.diltrable tolids, the diltrate it the extract. Analytical Sesulta Value* art concentration* of cc.-.atitue.-.t in extnct. Con* uer Canctntraticn, sq/l Ar*eni= 3ariun Cadmium Chromium., Chromium, Dead Mercury Selemizn Silver total hexavaler. Sndrm lindane Me themythic Toxaphe.ne 2,4-D 2,4,5-7? Maximum concentration allowed, og/l 5.0 00.0 1.0 5.0 5.0 5.0 0.2 1.0 5.0 0.02 0.4 10.0 0.5 10.0 1.0 ?r In v .al ed by: / , `llcrv ir. d.-'S'.( *5Su1 IS ",V S:ccce. 123 CMA 047654 Date: 2/26/82 Revision No.: 0 c TABLE 4 PARAMETERS AND RATIONALE FOR THEIR SELECTION Hazardous waste Parameter Rationale Pickle liquor (hydrochloric acid) pH, EP toxicity (Pb, Cr ) The waste is a listed hazardous waste (K062) due to its toxicity (lead and hexavalent chromium) and due to its corrosivity (pH <2). 1,1,1-trichioroethane 1.1.1trichioro ethane This is a listed toxic waste (FQ01). There is no reason to believe this waste will contain any other toxic constituents in significant concen trations. Vinyl acetate sludge Flash point This waste Is ignitible. Practical grade vinyl acetate has a flash point of 18F, Knowledge of this value helps to ensure the safe handling of these wastes. Vinyl chloride sludge Flash point The waste is ignitible. Practical grade vinyl chloride has a flash point of -108aF. Knowledge of this value helps to ensure the safe handling of these wastes. Pickle liquor sludge pH, EP toxicity (Pb, Cr 8) The waste has an estimated pH value of less than 2, making it a corrosive waste. Also it may contain toxic levels of lead and hexavalent chromium. Metal grindings EP toxicity The grindings contain lead and (Pb, Cr ) hexavalent chromium compounds. Metal hydroxide sludge EP toxicity The sludge contains lead and (Pb, Cr 8) hexavalent chromium compounds. 129 CMA 047655 Data: 2/25/82 Revision No.: 0 C TABLE 5 PARAMETERS AND TEST METHODS Parameter pH Test method Electrometric Flasn point i? toxicity 1,1,1-trichioroethane Pensky-Martens closed-cap tester EP toxicity test procedure GC/FID Lead Atomic absorption Chrcmiurn Atomic absorption- Reference Test Metrods for Evaluating Solid Waste. Physical/ Chemical Methods U.S. EPA SW-846 ASTM Standard 0-93-79 or 0-93-SC 40 CFR 251, Appendix II Test Methods for Evaluating Solid Waste. Physical/ Chemical Methods U.S. EPA SW 346. Methods for chemical analysis of water and wastes, SPA-SG0/4-73/020, March 1979. Methccs for chemical analysis of water ana wastes EPA-500/4-7S/020 March 1979 130 CMA 047656 Date: 2/26/82 Revision No.: 0 C Methods for Evaluating Solid Waste, Physical/Chemical Methods (EPA Office of Water and Waste Management, SW-846, 1980), or other EPA-approved methods. c-2c Sampling Methods Table 6 lists the hazardous wastes stored at the facility and the methods used to sample each. C-2d Frequency of Analyses As Table 7 shows, each waste is analyzed yearly. Because wastes generated at this facility do not change significant ly, this minimum frequency will continue as long as the quality control program indicates that the products are within 1 percent of specifications. Additional analyses will be performed if a process change should affect the hazardous characteristics of a waste. These analyses will be conducted at the discretion of the plant manager or the regulatory agency. C-2e Additional Requirements for Waste Generated Offsite This facility only handles on-site generated wastes; there fore, requirements for wastes received from off-site gener ators do not apply. 131 CMA 047657 LAME f> MflHODS USEIl 10 SAMPLE HAZARDOUS WASTES Hazardous waste Sampling method fltfhcrrinl ion Pickle 1 iguor Sampling a Storage lank from "Samplers and Sampling * Procedures for Hazard ous Waste Streams," EPA-Gmi/2-00-018. page 30, which appears in reference for sampler Composite sample using a Coliwasa sampler from 3 grab samples aL top, middle, and bottom of tank Test Methods for the Evaluation of Solid Waste. Physical/Chemical Methods EPA-SW-U46 ^ 1,1,1 " tr icliloroethane IO Sampling a Storage Tank from "Samplers and Sampling Procedures for Hazard ous Waste Streams," EPA-60l)/2-110-01fl. page 311, which appears in referente for sampler Composite sample using a Coliwasa sampler from 3 grab samples at top, middle, and bottom of Lank lest Methods for the Evaluation of Solid Waste. Physical/Chemical Methods EPA-SW046 Vinyl acetate sludge ASTM Standard 0340-lb. Soi1 or rock-1ike materia 1 llepresentative composite sample from 3 grab samples at top, middle, and bottom of drum using a split tube thief sampler Test Methods for the Evaluation of Solid Waste. Physical/Chemical Methods, CPA-SW-046 Section 3.2.4 J"r n> Vinyl chloride sludge ASIM Standard 11346-75. Representative composite Test Methods for the i Soi 1 or rock-1ike material sample from 3 grab samples at Lop, middle, and hot tom of drum using a split tube Lvatuation of Solid Waste. Physical/Chemical Methods, EPA-SW-fl4b oJ thief samplers Section 3.2.4 (continued) 2 /2 6 /3 2 859^ IAllll 4 (continued) 1! k i .i i it-no. \J.t1 e P u k le l i i(iicn s lodge !||l|l 1 HU] Itn 1 li<'fl AMM SI.mil.till Il l'll. /!>. Soil or rock-like materia) Metal grindings ASTH Standard DT40-70. Crushed or powdered material Metal hydroxide sludge ASTM Standard D346-75. tJ Soil or rock-like U material lli'M i' 11> 1 i mi <i I '..imp I i m Keprosoiil.it ivo torn)ns i te sample from 3 yrab samples at top, middle, and bottom of drum using a split tube thief sampler Representative composite sample from 3 grab samples at top, middle, and bottom of drum using a Trier scoop Composite sample using a Trier scoop from 6 grab samples through three different points near the top of the pile to points diagonally opposite the point of entry lit* I ri i*fi< i` fdi l> lest Methods lm (he Evaluation ol '.nI id Waste. Physital/ChoinicaI Methods, EPA-SVf-846 Section 3.2.4 Test Methods for the Evaluation of Solid Waste. Physical/Chemical Methods, EPA-SW-846 Section 3.2.5 Test Methods for the Evaluation of Solid Waste. Physical/Chemical Methods, EPA-SW-846 Section 3.2.5 n Date: 2/26/82 R evision N o.; 047659 n o Data: 2/2S/S2 Revision Ho.: 0 C Hazardous '*asta Pickle licucr (hydrochloric acid) 1,1,1-trich1oroethane Vinyl acetate sludge Vinyl chloride sludga Pickle liquor sludge Metal grindings Metal hydroxide sludge TA3LE 7 FREQUENCY OF ANALYSIS Analysis pH, E? toxicity (Pb, Cr) 1,1,1-trichloroethane Flash point Flash point pH, EP toxicity (PS, cr) EP toxicity (Pb, Cr) E? toxicity (Pb, Cr) Frequency Annually Annually Annually Annually Annually Annually Annually CMA 047660 Date: 2/26/82 Revision No.: 0 D SECTION D PROCESS INFORMATION a tier. prrvided in this section is submitted in the reruirements of 40 CFR Fart 122.25(b)(1), Other re relations addressed to complete this 40 CFR 264.17, 264.175, 264.176, 264.177, 192, 294.198, 264.199, 264.252, 264.253, on dis ses specific process, information for the miners anks, and waste piles. The Tankopile ry has a^ 1125-ft2 container storage area, two .s. and one 50-yd3 waste pile. The waste ^ sys. tontainer storage area, and tank storage 2 ster rations were all certified by a registered r.eer. [40 CF"- 122.25(b)(1)) 5 m invent:ry of drums in storage at any given time eperatir.r life of the facility is not expected 100 drums. The container storage area, which is .tdoers at the northeast end of the facility, cur ds this a-runt. Drummed waste includes vinyl Date: 2/25/32 Revision No.: 0 D acetate sludge, vinyl chloride sludge, pickle lienor sludge, and metal grindings, all cf which contain dree liquids. Consequently, specific information provided in this section will follow a format required for containers storing free liquids. There is 1125 ft2 in the container storage area, 225 ft2 for ramp areas providing forklift access to each cf the storage sections, 27 ft2 for sump areas, and 469 ft2 for aisle space. The remaining 404 ft2 is actual storage area, and is divided into three sections (storage areas A, 3, and C) separated by curbs to permit the storage of incompatible wastes. A plan view and cross-sectional view^ of the con tainer storage area is provided in Figures 13 and 19. Storage areas A, 3, and C presently hold 44, 34, and 22 drums, respectively. Stacked three drums high, storage areas A, 3, and C have the capacity to hold as many as 210, 102, and 51 drums, respectively, or a total of 363 drums, however 100 drums or less are stored in this area at any given time. 1) Description of Containers Steel 55-gallon drums are used at the facility to store the wastes listed above in D-ia. The drums are color coded and constructed cf lew carbon steel that meets C.S. Department of Transportation Specification No. 17C. The igr.i table vinyl acetate and vinyl chloride sludges are contained in drums tainted white to reflect solar heat as a possible 136 CMA 047662 WQ we 4 */ * V / Revision No. : D 0 X CMA 047663 o ft Cuo < ft O ei s: i o n2 / 2 6 /3 2 No. : 10 ft ! * Q 047664 ignition source. These drums are or: - sored scisist -orro- sion by epoxy phenolic linings. Yellow drums ar;a u ed to store pickle liquor sludge are ; vdi pd;/at -lyene liners. Blue drums used to store metal grindings= do not require a liner for chemical protection. D-la(2) Container Management Practices Prior to transfer to the container storage area, sludge and grinding wastes generated in the processing area are placed in the proper color-coded drums, sealer, and larialed accord- ing to Department of Transportation regulations ::or hazard- ous materials. Transfer of drums to tie contain:ar storage area is performed by a forklift truck. The fork..ift operator accesses the storage area with a key and places -:be yellow (corrosive sludge) drums in storage area A, the :due (toxic metal grindings) drums in storage area 3, and th-a white (ignitable sludges) drums in storage area c. z :irg the * transfer of drums from the process area to the : :ttainer storage area, the yellow, blue, and write drums :are always transferred separately from the other odors be - arse of their incompatibility. At Tankorile there are r. sources of ignition such as an open flame. The drums are stored on pallets to elevate them, :rom contact with standing liquids, and if necessary, t.i a drums are stacked as high as 12 ft (3 drums). -rimary ais..a space of at least 5 ft is maintained at all tires, and t/ - container storage area is inspected regularly ,==e Section F-2). 139 CMA 047665 Date: 2/2S/S2 Revision No. : D ccndary Containment System Design and Operation The container storage area pad is constructed of concrete, designed for loads of 25 lb/in2. A 5-in.-high concrete curb lines the perimeter of the storage area to provide a holding capacity of 3276 gallons, or more than 50 percent of the total volume held by the estimated maximum inventory. Below are the calculations involved in determining holding capacity: 1125 ft2 - 225 ft2 (ramp areas) = 375 ft2 750 ft2 x 0.5 ft (curb height) = 443 ft3 1 ft3 = 7.48 gal 438 ft3 x 7.43 gal = 3276 cal The concrete pad is presently in good conditio f . of any-^gaps-iioies-cr-crachs . The concrete pad in area A is specially coated with e^foxy to prevent damage m tr.e event of a spill. Two other 6-in. curbs within the storage area were constructed as partitions to permit the s torage of incompatible wastes in the same storage area, The base of the storage area is constructed of 6-in.-thick and the surface in each storage section is sic csd 2 oercen t towards its resoective sump area. ad will be regularly i ec as case in Se n o ensu na 'CCC c ticn. Automatic suni? our*ps ac..va * iC. 5v ievsj. svit: .es S.Z- instailed 01 s each o m .u sumo areas 3 3---- C ec 3c 33 140 CMA 047666 separata secondary holding tanks (see Section 1-la;4 This prevents any possible overflow of the collection system from precipitation, leaks, or spills. To dace the secondary containment system has been able to hold ram fall from the most severe thunderstorms without risk of rising above the curb. . Run-on is prevented from entering the containment area by several means. Besides the presence of a 6-m. curb at the perimeter of the storage area, the land immediately sur rounding the containment area is graded to encourage drainage away from the area. In addition, drain tiles at the rerimete of the containment curb drain any collected water to me sewer system. A 12-ft-high, chain-link fence with two lockable gates was installed to ensure safety and security (Figure 13,. D-la(4) Removal of Liquids From Collection System Storage areas A, B, and C have separate sum? areas a.cd sump pumps to allow for the removal of any leaks or stills to three secondary holding tanks located just west of me processing area (Figure 4). A 10,000-gallon holding tank receives precipitation, leaks, or spills from storage area A, a 35,000-gallon holding tank receives discharges from storage area B and leachate runoff from the -aste pile area, and a 5,000-gallon holding tank receives discharoes from storage area C. These collection systems tisigned 141 CMA 047667 Date: 2/25/32 Revision No.: C D to handle the maximum 24-hour rainfall recorded in Anyd own (in 24 years). Discharges remain in the holding tanks until laboratory analyses indicate whether they are either hazardous or acceptable for release to the municipal sewer system. If laboratory analyses indicate that a holding tank contains hazardous waste, the material will be removed from the tank, drummed, labeled, and transferred to the appropriate container storage (A, 3, or C). D-lb Containers Without Free Liquids The Tankcpile Finishing Company does not currently manage containers without free liquids. Therefore, Permit Applica tion Sections D-lb, D-lb(l), D-lb(2), D-ib(3), and D-lb(4) are not applicable. D-2 Tanks f40 CFR 122.25(b ) (2 ) 1 D-2a Description of Tanks Two 7500-gallon vertical tanks with a total holding cape< '-i of 15,000 gallons provide storage for wastes generated f: :m the degreasing, painting, and metal finishing operations. The two storage tanks, designated as ST-101 and ST-102, contain spent hydrochloric acid (pickle liquor) and 1,1,1trichloroethane solvent, respectively (Figure 20). The pickle liquor waste has a specific graviuy of 1.0507, and the 1,1,1-trichloroethane solvent waste has a specific gravity of 1.299. 3oth tanks have been fabricated and stamped in accordance with A5ME Code Section VIII, 19"!. Table 3 gives the individual tank dimensions and capacities. 142 04-7668 LEGEND 1 - NOZZLE FOR LEVEL TRANSMITTER 2 - PRESSURE SAFETV VALVE 3 - SPARE 4 - INLET 5 - MANHOLE uate : * 0/ R e visio n No. 047669 o Figure 20. Waste storage tanks. a Data: 2/26/32 Revision No . : 0 D TABLE 8 PHYSICAL CHARACTERISTICS OF STORAGE TANKS Item Capacity, gal Shell thickness, in. (design) Shell thickness, in. (present) Dimensions, in. Straight side Diameter Tank identif ication No. ST-101 ST-102 7500 7500 0.703 0.639 0.703 0.700 200.4 118.1 2C0.4 113.1 0476T0 Date: 2/26/82 Revision No.: 0 D The shells of Tanks ST-101 and ST-102 are constructed of standard A285 Grade B carbon steel (0.22% carbon) with a tensile strength of 50,000 to 70,000 psi. Each tank is structurally supported in eight equally spaced locations on the concrete slab. The supports are raised 6 in., and each is secured to the slab by four No. 4 rods with three No. 3 ties. The tanks are secured to supports with 4-3/4-in. Type AB-3 anchor bolts. Tanks ST-101 and ST-102 are both equipped with an 18-in. manhole, a conser vation vent, a liquid level transmitter, an inlet and outlet, and spare nozzles. The pad is designed for loads of 250 lb/in2. D-2b Tank Corrosion and Erosion Storage tanks ST-101 and ST-102 are glass-lined (3/32-inch or 2 mm) for chemical and corrosion resistance. Glass-lined tanks have been shown to be very resistant to a variety of chemicals in a wide range of concentrations, including hydrochloric acid. Furthermore, water absorption is minimal, and organic liquids such as 1,1,1-trichloroethane produce no measurable chemical effect on the glass lining. According to manufacturer specifications, glass linings exposed to boiling hydrochloric acid solutions (20 percent) exhibit low corrosion rates of 0.01626 and 0.02108 mm/yr. At the range of rates, the expected lifetime for a 0.91 mm thick lining would be 43 to 56 years. Since Tankopile's tanks 145 CMA 047671 Data: 2/25/32 Revision ho. : . 0 D * 1 7a 0 C * IT. 2 tut. of glass, thei: 0scsci 1* rcuchlv 90 20 vears. Wald seams cn tanks 5T-101 and ST-102 were examined by radiography and liquid penetrant. The radiographic inspec tion detected no discontinuities in the weld seams, such as porosity, tungsten inclusions, incomplete penetration, slag inclusions, lack of fusion, cracks, icicles, burnthrough, or undercut, that were judged unacceptable to the code. The liquid penetrant also failed to detect any aiscontinui- ties in the weld were spark-teste none were found. D-2c Tank Management Practices A simplified process flow diagram is shown in Figure 21. Spent 1,1,1-trichlcroethane solvent wastes and spent hydro chloric acid wastes generated from the degreasing and metal finishing operations are pumped directly to ST 102 and ST101, respectively, storage tanks through separate piping systems (3-inch lines). When the tanks ace filled to near capacity, the spent hydrochloric acid is pumped to a tanker (by use of a positive displacement pump) and transported to a local publicly owned treatment works (PCTV) for treatment. The 1,1,1-trichicroethar.e solvent is pumped to a tanker in a similar manner, arc trarsoortec to a reclama- tion facility. CMA 047672 S ATMOSPHERE D ate: 2/26/82 R evision N o.: 047673 Figure 21. Process flow diagram. o 9 o Dai 2/25/32 Revision No, me: :n ciagram showing :ar..<s, menial ar.c waste seed cm vaives is 22. Inlet valves manuai-v ct :o control was' .aw and orevsnt overfill fasts storage tanks a: rated on a 44-ft by 22- concre: :ad. TS e pad is 1 ft thick and reinforced with No. 5 rods at the ton and bottom soaced 12 in. apa: ores si sa: Installed on the storage tanks re Teflon-coated and spring-set to relieve pressures at r5 .n. K20 (0.22 psig). The required capacity of the vents is r500 sef/h and they are pressure set at 110 percent over- pressu: rom the vent connected directiv to the mosphere, which provides a constant back pressuu Unds icrmai ccncitions tne vs oce: it 5i rough is 0Q~ to 110* ivio: ;42: .cu: .s a remote seal instrument that measures liquid levels from 0 to 200 in. H20. The treasure differential in a closed tank actuates the transmitter and converts the differential pressure measurement into an electrical signal (level indicator) by a resistance-strain gage circuit. The trans mitter is powered by 247 d.c. and has an output range of 4 to 20 nA d.c. Calibration accuracy of the instrument is z 0.3 percent of spar. (0.25 percent ultimate capability). CMA 047674 10 AINOSPIIEBE D ate: 2/26/82 R e visio n N o .: Li LEGEND LI * Level Indlcelor LAH * Level Indicator Alira Figure 22. Piping and instrumentation diagram for hazardous waste storage in tanks. i o o U"l o o Date: 2/25/82 Revision No.: 0 D -40*? to 300?, whereas the transmitter housing can with stand tame natures of -40F to 185s?. The exolosion-prco: transmitter housing is mace of aluminum with a low copper content and is mounted directly to the tank. As discussed in Section F-2a(2), the tank level indicators are 'inspected daily. Since the tanks are slowly filled two to three times per year, the daily inspection should allow ample time to prepare for emptying the tanks. As a back-up precaution, level indicator alarms (LAH) have been added to each tank to warn of high fill levels. In such an unlikely event, the tank inlet valves can be manually closed to prevent the tanks from overfilling. D-3 Waste riles The waste pile area presently located in the northeastern section of the facility, approximately SCO ft from the warehouse building, was installed in May 1973. This pile will be moved by June 1932 to a new location on the site which will meet the same design specifications and oper ating procedures as the existing waste pile. Wastes generated by the processing operations at Tankopile Finishing Company and destined for the waste pile area consist of metal hydroxide sludge, which is classed as a toxic hazardous waste because of its hexavalent chromium and lead content. The waste pile contains free liquids; ccnsecuentlv, specific information creviced m this section 150 CMA 047676 Date: 2/26/32 Revision No.: 0 D follows the format required for waste piles with free liquids. Several control systems and structural features of the waste pile area are discussed throughout this section; therefore, reference to section and plan views of the waste pile area (Figures 23 and 24) will greatly assist the reader. Some of the control systems and structures addressed are control of wind dispersal; control of run-on; collection of leachate and run-off; foundation; waste pile base; containment system design; vegetation and rodent control; and equipment and procedures for waste pile move ment. D-3a Piles with Free Liquids D-3a(l) Control of Wind Dispersal Two design factors were addressed to control wind dispersal of the hazardous waste pile. First, the slope of the pile was reduced to 7:1, which creates a relatively flat pile with less resistance to air flow. Second, the banks of the containment area, which were built to protect the liner and foundation, further reduce pile exposure to wind currents, because they rise one foot above ground level. As a result of both of these factors, only about 1H ft of the waste pile is exposed to air flow. Furthermore, as a result of regular inspections, the waste pile will be moistened by a water truck before the waste pile becomes dry and fugitive emissions develop. 151 47&77 L9 0^ \ 1 figure ?i. Conta tiwient sys tern section. CONTAINMENT- SYSTEM SECTION =* /ll ^ a-s ottuuiM Aimocmruu *HCMITHCT *1 Afao MNdlNNtlM* tun orwtw< no, CwCmMAK. r >4i 'nt 'tft 4 *1 ill l*i j^.5 -V> D ate: 2/2S/S2 D ate: 2/26/82 R e visio n N o .: o Date: 2/25/32 Revision No.: 0 0 D-3a(2) Control of Run-on The run-cr. diversion system consists of a ditch (diversion canal) surrounding the waste pile containment system. The ditch is 10 ft wide and has 4:1 sloped banks. The banks of the diversion canal are lined with several inches of clay soil with a permeability of 10~3 cm/s (measured using a Double Ring Infiltreneter) to reduce infiltration (which could possibly reach the leachate and ground water collec tion systems). In addition to the moderate slope of the diversion canal banks, riprap was applied to the banks to reduce erosion. The diversion canal is sloped away from the waste pile area and drains by gravity directly to the Queen River. D-3a(3) Collection of Leachate and Runoff The leachate and runoff collection system is composed of a network cf 6-in.-diameter, vitrified clay, perforated pipe connected together and then inserted through the liner and foundation to a sump area. Ripe leaving the foundation to the sump area is 6-in.-diameter, vitrif iec clay, ncr.perforated pipe that allows conveyance of runoff to tne sump area without contaminating the soil and ground water. The piping network consists of three parall el sections cf pipe at the bottom cf the pea gravel, parpen dicularly connected at one end by another section of pipe, leachate and runoff collected in the termer.dicular time is gravity-fed to an adjoir.ir.e nte and carried throuch the liner and foundation 154 o4T680 Date: 2/26/82 Revision No.: 0 D' to a sump area where it is automatically pumped to a 35,000gallon holding tank.' Waste in the holding tank will be analyzed for lead and hexavalent chromium and subsequently discharged to the sewer system if found not to be a hazard ous. If the waste is hazardous, it will be trucked to Waste Treatment, Inc. located in Anytown, Rhode Island. D-3a(4) Foundation The foundation supporting the synthetic liner, base, runoff collection and removal system, and the waste pile is con structed of a Bentonite-treated soil 4 in. thick. The floor of the foundation covers 1600 ft2 (40 feet square) and the walls are sloped 3:1, which results in an upper foundation opening of 4096 ft2 (64 feet square). The manufacturer of the Bentonite material used for this waste pile projects that it will last for a period of 20 years. D-3a(5) Waste Pile Base The base material supporting the waste pile consists of 2S. ft of coarse sand on top of 1H ft of pea gravel. The base materials serve several functions. First, the sand and gravel combination permits rapid percolation of runoff through the base to a holding tank via the runoff collec tion and removal system. This prevents precipitation and free liquids from overflowing the banks of the containment system. Secondly, the base material reduces both the concentration and contact time between contaminated runoff and the chlorinated polyethylene (CPE) liner, which in turn 155 CMA 047681 Date: 2/25/S2 Revision No.: 0 D increases the longevity or the liner. Finally, the base permits movement of mechanical equipment in the waste pile area without damage to the liner and prevents exposure of the liner to direct sunlight which can dry the liner and significantly reduce its life. After periodic removal of the waste pile to a disposal site, any lost sand will be replaced to the original design depth. The waste pile base is designed for loads up to 15 Ib/in2. D-3a(5)(a) Containment System Design Adjoined to the foundation with adhesive and mechanical fasteners is a chlorinated polyethylene (C?I), oil-resistant, reinforced liner (primary liner) 45 mil in thickness. The C?E liner, which has a permeability of less than 10' '1 2 cm, was specifically recommended for the metal hydroxide sludge by the manufacturer because they are compatible. The existing liner has a project life of 10 years, which expires in May, 1998. The new liner, scheduled to be put under the waste pile when it is moved m June, 1982, is also projected to last 20 years, until June, 20C2. Other pertinent character istics of the C?I liner are provided in Table 9. D-2a(S)(b) Leachate Detection, Collection, and Removal System Directly underneath the foundation is a layer cf sand and pea gravel, under which is a network of 6-in.-diameter, vitrified clay, perforated pipes. Under the pipes is a 5-in.-thick layer of bentonite clay. This backup leachate collection system is desimed to operate in the event cf ZQ CMA 047682 Date: 2/26/82 Revision: 0 D TABLE 9 PROPERTIES OF CHLORINATED POLYETHYLENE (CPE) OIL-RESISTANT LINER Property Minimum manufacturing specifications Test method 1. Fabric (polyester) Denier, 24 tpi 2. Laminate thickness 10% of specified thickness A5TM 0-751 3. Cold bend (36 mil) -25F No cracks ASTM 0-2136 1/8 in. mandrel 4. Tensile strength, lb Grab method 200 ASTM 0-751 5. Tear strength, lb Tongue tear method - - 80------- -------------------- - --ASTK-D-751 6. Puncture resistance, lbs. NAa FTM-1013 2031 7. Hydrostatic resistance 250 ASTM 0-751 8. Dimensional stability 2 h at 150F 1 h at 212aF < 2% ASTM 0' 1204-54 9. Ozone resistance No effect ASTM 0-1149 3 ppm at 30% strain at 104F for 72 h 10. Seam strength, lb 170 ASTM 0-751 a NA - not available. 1S7 CM& 047683 liner failure. Date: 2/26/32 Revision No.: 0 D If a leak develops in the containment system, the leachate will percolate rapidly through the sand and gravel to the leachate collection system and provide an early warning of liner failure. The piping network of the leachate collection system consists of seven 60-ft parallel sections of pipe spaced approximately 10 ft apart and an additional perpendicular pipe that connects all the pipes. The perpendicular pipe drains any collected leachate to a leachate-monitoring manhole. The perpen dicular pipe, which extends from the sice of the sand and pea gravel to the manhole, is glazed and has lipped connec tions secured with caulk. If the pipe were not impervious groundwater could penetrate the system and indicate false negative leachate quantities. The 4-ft-diametar manhole is ecuipced with a 2-ft-deeo collection sumo and ladder for manual measurement of leachate collection. The sump area has a capacity of 138 gallons. If leachate is collected and removal is desired, a portable sump pump is used to evacuate the manhole to 35-gallon drums for analyses, and if necessary, to storage and disposal. D-3a{6) Ground Water Table Control As described 'under separate cover in the "Hydrogeologic Evaluation Report", the ground water table in the Anyncvn, Rhode Island area is typically 10 ft below ground surface. Therefore, Tankcpile Finishing Company constructed the following ground warer table ccnzrol system in an effort no 153 CMA 047684 Date: 2/26/82 Revision No.: 0 D prevent the ground water table from rising to the leachate collection system (giving false positive leachate quanti ties). A network of 6-in.-diameter, vitrified clay, per forated pipes (subdrains) were installed at a depth of 10*s ft within 3-ft-wide cutoff trenches filled with crushed stone. The cutoff trenches extend vertically from a foot below ground surface to a depth of 11 ft. The network consists of five subdrain sections, four forming a square (80 ft to a side) around the containment area and another connecting two of the sides. All of the subdrains drain together, by gravity, to a ground water-monitoring manhole and sump. Ground water in the sump is automatically pumped to the outlet of the run-on diversion canal for discharge into the Queen River. Ground water discharged from the i, manhole is metered for informational purposes. D-3a(7) Vegetation and Rodent Control Prior to the construction of the waste pile containment system in May 1978, isopropyl N-phenylcarbamate (herbicide) was applied to the immediate area. If vegetation is observed during the life of the waste pile, weeds will be removed by hand or another herbicide treatment will be applied. In an effort to control rodents in the area, chloralose (rodenticide) was applied in the vicinity of the waste pile ->rea. 159 CMA 047685 Date: 2/26/82 Revision No.: 0 D Equipment and Procedures for Waste Pile Movement The waste pile is moved by using a front-end loader and a dump true/. The dump truck is equipped with sides and a cover to ensure that the load will not overflow or be exposed to wind or precipitation during loading, unloading, and transport. One front-end loader is used on the pile to ensure that the liner is not punctured by the dump truck. D-3b waste Piles without Free Liquids Presently, the Tankcpile Finishing Company dees not manage a waste pile without free liquids, therefore, Sections D-2b, D-3b(1), D-3b(2), D-3b(3), andD-3b(4) are not appli cable. D-4 Surface Impoundments Presently, the Tankcpile Finishing Company dees not manage a surface impoundment, therefore, Section D-4 is net appli cable. Inci.n5r2.-C-S Presently, the Tankcpile Finishing Company does not manage an incinerator, therefore, Section D-5 is net applicable. ISO 6^6 Date: 2/26/82 Revision No.: 0 E SECTION E GROUND WATER MONITORING SYSTEMS The requirements for ground water monitoring are not applic able to a storage facility such as Tankopile Finishing Company, which stores containers and tanks and operates a waste pile (not intended for disposal). 161 CMA 047687 Date: 2/25/32 Revision No.: 0 SZCTICN F PROCEDURES TO PRSVZNT HAZARDS The information provided in this section is submitted in accordance with the 'equiraments of 40 CFR Part 122.25(a)(4), { 5 ),(5),(3), and (9) Other regulations addressed to complete this section include 40 CFR 264.14, 254.15, 264.17, 264.174, 2 A , and 254.254. Tankcpile Finishing Company will address the following subject areas (referenced above): general securi ty provisions inspection schedule; request for a waiver of prep aredness and prevention requirements; spill prevention, cental nrner.t, anc countermeasures plan; and prevention of accider.ta -i ig or reaction cf ignitible, reactive, or incompatible i. F-l Security F-la Security Procedures and Equipment In addition to the general security provisions of fencing, CMA 047688 Date: 2/26/82 Revision No.: 0 F base station -for the public address system is located in the plant manager's office. An internal telephone system (with phones in most plant areas) is provided. The same telephone system is used for communications outside the plant. Employees are required to show identification cards when reporting for work, and visitors and contractors entering the plant must sign a log sheet (Figure 25) and obtain visitor passes. F-la(l) 24-hour Surveillance System Security at Tankopile Finishing Company is maintained by a staff of trained security guards, who primarily monitor entry and exit from the active portion of the facility and provide security measures within the plant premises. The main entrance gate at the east end of the facility is operated by remote control from the guard house, which is occupied by two armed guards 24 hours a day, 7 days a week, except during plant shutdowns for holidays at which time the gates remain locked. Guards normally work an 8-hour shift with a crew of six guards per day. During each shift, one of the guards makes a walkthrough of the facil ity at scheduled intervals while the other remains in the guard house. F-la(2) Barrier and Means to Control Entry 163 CMA 047689 Date Ti me In Out 1ANKOPILE FINISHING COMPANY ANYIOWN. RHODE ISLAND Visitor/Contractor Entry Log Sheet Name Aff11iatton Contact Purpose of visit ZS/SZ/Z :3a*a CMA 0 4 7 6 9 0 Figure 25. Log sheet. o Date: 2/26/82 Revision No.: 0 F F-la(2)(a) Barrier Except for two company parking lots, the entire facility is enclosed within a 7-ft-high, chain-link fence topped by three strands of barbed wire. The fence has two gates; on located at the southwest end of the facility, which is locked at all times, and the other at the east end of the facility, which serves as the main entrance to the facil ity. In addition, a 12-ft-high, chain-link fence with two lockable gates was constructed around the container storage area to restrict unauthorized entry and to prevent drums from being washed downstream in the event of a minor flood. F-la(2)(b) Means to Control Entry As discussed in Section F-la(l), entry to the facility is controlled by two armed guards stationed at the main entrance gate. Employees are required to show identi fication cards when reporting for work, and visitors and contractors entering the plant must sign a log sheet and obtain visitor passes. F-la(3) warning Signs Signs which are legible from a distance of 25 feet are posted at all fence gates and several other fence locations around the active portion of the facility; these signs are visible from all angles of approach, and bear the legend "Danger - Unauthorized Personnel Keep Out." Also, "No Smoking" signs which are legible for a distance of 25 feet have been placed in the container storage area. 165 CMA 047691 Date: 2/26/32 Revision No.: 0 Waiver The Tanxooiie Finishing Con?any does not request a waiver of the requirements stated in Part 264.14(a)(1) and (2) regarding injury to intruder and violation by intruder. Inspection Schedule General Inspection Requirements The Tankopile Finishing Company conducts regular inspec tions of the facility for equipment malfunctions, struc tural deterioration, operator errors, and discharges that could causa or lead to the release of hazardous waste con stituents and adversely affect the environment or threaten human health. 1) Types of Problems Table 10 presents the schedule for inspecting monitoring equipment, safety and emergency equipment, security devices, operating and structural equipment, the container storage area, the tank storage area, tanks (internally and extamall and the waste pile area. The items listen in the table are considered important because of their role in preventing, detecting, or responding to environmental or human health hazards. Provided with each item is a lisp of problems normally encoi A a) .-rsquer.cy c: inspection Also provided in Table 10 is a recommended frequ oi -- cr. izzy sdcii CMA 047692 D ate: 2/26/82 R evision N o .: 047693 TABLE 10. INSPECTION SCHEDULE Aree/egulpnent Muflltorlng tqulftatnl Siftlf Mf tatrgnc)r equipment Oi ^.1 O 5 (continued) Specific Hca liquid li1 IrMtallliri (lanit) Conserve!Ian vent* icichiU dtUctlM, collection, end renovel lyiUe {west pile) Ground water table control ipitn (waste pi lei types of prebit** f rtqucnt y of Inipectlen Irmeilttr ilpiil, electrical circuitry, power Sprlitj) idJutlMAt er slicking troindMtir cellacted, groundwater contaminated, ' ki^p pimp failure, paternal evidence ef malfunction 9My Djlly DeMy level of groundwater, K|er*a! evidence of ami function, Dally nap pimp failure Runoff collactlan and remevel ipitn (watte pi lei Ground water table water neter (located In simp) Standard Industrial absorbents (Sorb-All, Venalcullte, etc.) Sandbags Sand Absarbant boon Absorbent pads Straw Submersible pimp flaalble boset wltb pilch couple fittings $$-paI Ion druns (steel, stainless steal) Emergency sbower and eyewetb face shields and eatra protective eyeglasses Disposable respirators Chemical cartridge respirators wltb cartridges far organic vapors and acid gases; ball* and full-face types Cbest-neunled gas mask cannlsters Self^contained breathing apparatus (SCDA) Portable sump punp fire blankets fire e*tInpulsbers fire alar* systa* lalaphona systen Public address (PA) system Genarators fmergency lighting sysla* first aid equipment and supplies SI ran cleaner Protective clothing (laprrwdile full body coveralls, gloves and foal coverings) OaconleulnatIan facility (shower*, dirtyrow*, clean room) IrowdiaUr collected, froundwater coottwine ted. tunp pimp failure, paternal evidence ef malfunction Dally Clapping, malfunction af digital display, rotor stickInp, wearing af peart Dally Out of stock lor* or worn Out of stock Out of stock Out of stock Power, clapping Cracks or holes, fittings stick Corrosion, structural damage Water pressure, leaking, drainage broken or dirty equipment Out of Stock Spent cbenlcal adsorbent, seals Cannlsters beeone exhausted Air quantity In reserve, air delivery systen, moisture 1* lank (cold weather) Power, clogging Dispensing Deeds recharging Power failure Power failure Power failure, speakers fuel supply, spark plugs, oil attery failure, lights Iteni out of stock or Inoperative Water supply, fuel supply Holes, normal wear and tear Honthly/as needed At use Honthly/et needed Mont My/a needed HonlMy/et needed Monthly/** needed Monthly Hoot My Monthly Weakly Manlbly Monthly/** needed Honthly/after each use Monthly/altar tech use Monthly/aftor each use Monthly As used MonlHy/afler each use Par NT PA Par Ml PA Par MPA At used Per NfPA As used As used As used Water pressure, leaking, drainage, upkeep As used o lAHl.t 10 {root iiiueil) Specific Um My <ltvUri facility fane* | bI yit (iln ttr(iKr) West flal* and loik i'MiUlutir tl0iy* are* lenCa fiuitalner slurey* eiea gal* and Inri flomU (bntiot t ri( get* IwM W*y r4l|Jb Updating and itiiKtoial Sn*p pu*ps | automat lc) 14 |il 11 >c ill 1) 1 k 4 l biit t o fuattiiti Ion* <i\ Ol> Simp areas lanb Structural supports Cunltlmr ilunijt araa Hptng ti holding lenkt lloUlny Unit Storage *k*i funlilibtr |jUi'|Miit and ilHhlmj Staling af containers t*lwility ut citnlalnei* Cunt a I 41* 4 % Srij* y*l toil of t4Hiix*4l ttil wastes ^tuu !**(, gate *J lock i)t or found a Han OUii area EIIh I1 and itlut* o JUftfll Warning tlyiit ^69^ ((.out i lined) lypti of problems t 1 *4|IIV Itl y of i IIV|II 1 I (lit Corrosion. denayc to ihil<rl(iO feme or b*ib*4l wire Cnrrtf|l(Hit to chaln-Huk feme ur butfil ulu Currovlim, iljwaij* to dukirtliit lame or bathed wlr sticking or corroding tori Corrosion. d*ft*i|t to chain'fink Irm* m barbed wlrt (oi < o ton. d*K*ye to (tulji'llnt Unit or La* Led wire lUillmj or luribillui) loti tren*nitli o mtlvvr, t(lctlni) of gat* lriitialtUr or receiver Week ly Weekly Week I y WfHy UtrS ly iJpnn fat ti*i t failure Setting itjuil*tiil, power, clbij^ing Craiks, de lei'lor a l Ion (roslon; uneven ieUltnl; craCfcl and concrete pails. bale rings i>il ytmt detertorat loo of water reel between lank. IiuIIm and foundation, wel Weekly Weekly Weekly Weekly Wrrkfy tower, clogging Weekly (roslon. uneven ttUttMtnl, cracks end tattling In Weekly concrete (fiiiluA, uneven ttlHtMiil, Creeks end spelling In Weekly concrete, wel spoil tonciete deter to*el ton end creeling, corrosion of ptpe Weekly support* lots of ftetsl thickness, leaks, corrosion or U*kly deter I or el Ion CoMotlon, discoloration, creels, buckles, end bulges Weekly leeks. spills daily Aisle space, height of sleeks Weekly Open lids Weekly |(ifopf Identification, del* elsilAf Weekly Corrosion, leakage, structural defer Is Weekly It4eye of Incompatible wastes In iaa erae Weekly (a g , btolen wood, warping, nails nlstlng) Weekly Corrosion, damage to chain-link feme, sticking or Weekly corroding lock Cracks, spalling, uneven settlement. erosion, wet tysli Weekly Cracks, deterioration Weekly Creeks, spalling, uneven settlement, erosion, wetspots Weekly letting nlJinlMtnt, power, clogging Weekly Clog iuy |nv, aesthetics, possible reaction with Weekly leaks Craiks. spelling, unroot settlement, erosion Weekly Oanaijed Weekly 'l O Data: 2/25/32 R evision N o.: D ate: . 2/26/32 R evision N o.: 047695 taox O$ TABLE 10 (continued) Specific lie* fin! ilortgi ere* end ancillary equlpnenl Olka Mu or fnu^itIm Swap (oenuel) Sunp ore* Warning sign tip** .. . Valves fHt logs Overfill control valve (oenuel) end level ledlcelor lnh (externally) lank (Internally) ladder foundetlen/struclurel support* Mpe conned lees Protective coating Tank shall lank roof lank belle* Anchor ho Its Houles lank roof Internal support* lank shell Vatla pile area Vank hotton Plata joint* Houle connection joint* Glee* lining tlvat* Pipecell support Pun*an diversion ditch Intranet road and guard rail* iuneff divers Ian canal and drain Hind dlspenol control tystao foundation Synthetic liner tat* lIner teeet Joints fypo* of problaes frequency f Inspection Crack*, datorIorottoo Crack*f spalling, uneven salt tenant, oration, wet spats Power, clogging Crocks, spelling, uneven settlencnt. erosion, wet spots Dauoged toss of oetol thickness, leaks, corrosion or detor Iore!Ion toss of a<t1 thickness, leeks, cerroslon or deterleratlen toss of oetol thickness, looks, corrosion or deterloretIon toss of oetel thickness, look*, corrosion or deter lore!Inn, clicking, denaged handle Weekly Weekly weekly Weakly Weekly Weekly Weekly Weekly Oelly Denagad. structural stability Cracks, spalling vwne saltlanant, eras Ian, wet spats literati corrosion, crack*, distortion Putt spot*, blisters, file lifting Corrosion, discoloration, crocks, buckle*, bulges Hal fund Ion of seels, blockage ef water drains on roof. cerroslon Corrosion, discoloration, cracks, buckle*, bulge* distortion, corrosion Crock*, corrosion Weekly Weekly Weekly Weekly Weekly Weekly Weekly Weekly Veekly Malfunction of roof** seels, corrosion, loss of oetel thickness Oeterlore!Ion, depression* Corrosion of vapor space, end liquid level lino, crocking, bulges, holes, less ef netol. thickness, teens Corrosion pH*, sprung leans, rivet*, depressions, batten thickness, unevenness of hollo* Cracking Cracking Cracking, bubble* lightness, corrosion Depressions ****** Jfl.rl, **rr *er1* yearly pyreearrllyy yearly yearly Obstructions to flow, bank orosloo, tooio riprap loss of gravel, fugitive eolations, corrosion end lightness of guard roll* Obstructions, drain clogged frequency ef water application, dryness and slope of pile Creeks or breaks Veers, holes, sepereilen of loyort, thin spots, cracks, shrinkage, hardness, evctttlve pemeabtltty. blisters (fusion, eeposed area to liner, depth leer, lightness ef seen light nest ef connection ______________ Weekly Weekly Weekly Oelly At Installation At Installation Weakly At Installation At Installation *1 O Data: 2/25/32 Revision No.: 0 Specific ?rocess Inspection Requirements 1) Container Inspection Inspections of the container storage area will be conducted per the inspection schedule provided in Table 10. Results of each inspection will be recorded on inspection log sheets entitled, "Operating and Structural equipment Inspec tion Log Sheet," "Security Devices Inspection Log Sheet," and "Container Storage Area Inspection Log Sheet" (Supplement 1-3). Information requested on the log sheets, similar to that of log sheets for tanks, waste piles, etc., includes the inspector's name and title, date and time of inspection, item of inspection, typical problems encountered, status of the item, observations, and the data and nature of repairs ana remedial action. Typical problems encountered with each item of inspection, included in the inspection schedule, are provided on the log sheet to serve as a reminder to the inspector and ensure a ccmulete msoecti: `he mscectcr is required to check the status of each item and indicate whether its condition is acceptable or unacceptable. Regardless of the status, observations are made as to the number of containers, aisle space, height of container stacking, inventor/' quantities, storage tank levels, observa tion of runoff in waste tile area, and more. If the status a oarticular it m is una: sonata arc .p_ate information is recorcsc, irciucirg r. a = 5 reoairs and remedial action. -/0 CMA 047696 Date: 2/26/82 Revision No.: 0 F F-2b(2) Tank Inspection Tank inspections will be conducted per the inspection schedule provided in Table 10. Results of each inspection will be recorded on inspection log sheets entitled, "Moni toring Equipment Inspection Log Sheet," "Operating and Structural Equipment Inspection Log Sheet," "Tank Storage Area and Ancillary Equipment Inspection Log Sheet," "External Tank Inspection Log Sheet," and "Internal Tank Inspection Log Sheet" (Appendix). Upon completion of the inspec tion log sheets, they will be inserted in the inspection log three-ring binder previously discussed in Section F-2b(1). F-2b(3) Waste Pile Inspection During the installation of the waste pile liner system, strict quality assurance of the workmanship was part of standard installation procedure. The liner was inspected for uniformity, damage and imperfections. The waste pile inspections will be conducted per the inspection schedule provided in Table 10. Results of each inspection will be recorded on inspection log sheets entitled, "Monitoring Equipment Inspection Log Sheet," "Operating and Structural Equipment Inspection Log Sheet," and "Waste Pile Area Inspection Log Sheet." Upon completion of the inspection log sheets, they will be inserted in the inspection log three-ring binder previously discussed in Section F-2b(l). 171 CMA 047697 Date: 2/25/82 Revision Me.: 0 R am edi 2.i Action I i inspections reveal that non-emergency .maintenance is needed, they will be completed as soon as possible to preclude further damage and reduce the need for emergency repairs. If a hazard is imminent or has already occurred during the course of an inspection or any time between inspections, remedial action will be taken immediately. Tankcpile Finishing Company personnel will notify the appropriate authorities per the Contingency Plan (see Section G) and initiate remedial actions. In the event of an emergency involving the release of hazardous constituents to the environment, efforts will be directed towards contain ing the hazard, removing it, and subsequently decontaminate g the affected area. Refer to the Contingency Plan fer Inspection Log An inspection log is maintained 'or each calendar year in' a three-ring binder that is subdiv ded by sections for each area/equipment. After an inspec ;icn, each log sheet is filed in the binder according to area/equipment, which provides a case history of a par hcular item. The mscec- tion log notebook is always kept with the inspection sched- ule in the Znvircnmental Zncineer's cffic* eg. c, .r.soectrcn; vea: m ne Late o: msuectrc A. c: eC <9 sneets mav our.d :c 172 047698 Date: 2/26/82 Revision No.: 0 P waiver of Preparedness and Prevention Requirements The applicant does not wish to request a waiver of the preparedness and prevention requirements under 40 CFR 264 Subpart C. Requirements of this Subpart are primarily addressed in Section D, Section F, and Section G of this application. Equipment Requirements Internal and external communications, emergency equipment, and fire control equipment are discussed in Section F and Section G. Aisle Space Requirements Aisle space requirements are addressed in Sections D-la(2), F-5c, and G. Preventive Procedures, Structures, and Equipment loading/Unloading Operations loading operations at the facility, other than removal operations at the container, tanX, and waste pile storage areas, taXe place in the processing area. Except for tanX storage wastes, wastes generated in the processing area are collected in hoppers and loaded into drums or front-end loader for transport to the appropriate storage area, luring loading operations spills are unliXely; however, in the event of an accident the material will be contained with sandbags, standard industrial absorbents, absorbent room and pads, or dirt. Contaminated materials will be contractor-hauled to a permitted hazardous waste landfill, 173 CMA 047699 Date: 2/26/32 Revision No.: 0 areas cz he facility and eguipme decontaminated will he The only areas thah involve unloading operations at Tankopile Finishing Company are the container storage area and the waste pile area, Wastes stored in the tank area are tired directiv from the processing area to tha storage tanks. Several precautions have been taken to reduce the pctenti al for hazards during unloading operations in the container storage area. First, three ramps were designed and construtted to facilitate the smooth and acc essible movement of a forklift truck in and out of each of the storage are sections (Figure 13)-. Sec c r*d / d- -- least 5 feet of aisle so ace--is- maintained a.t all times. Third, pallets are use in the transtort of drum containers. Unloading operations m the waste pole area involve the transport or wastes from tne trocessmc area me wast ime via rrcnt-enc leaner or cunt true*. mu,* f-oTi t-ard loader is ecuipped with a cover to prevent hazardous waste dispersal. Entrance to the waste pile area is by a gravel road, which slopes away from the pile to prevent run- from entering the waste trie area intersection of the road entrance Figure 24). nc s At the -- on c2.*i -- --/ a guard rail was installed on both sides of the road to prevent the front-end leader from driving into the canal and spilling the waste. The front-end loader is driver, u: 174 CMA 047700 Date: 2/26/82 Revision No.: 0 F the access ramp where its contents are emptied onto the waste pile. F -4b Runoff Runoff from the container storage area and waste pile area is collected and automatically pumped to three holding tanks located just east of the container storage area (Figure 4). Runoff from Storage Area A is diverted to Holding Tank A, runoff from storage Area B and the waste pile area is collected in Holding Tank B, and runoff from storage Area C is diverted to Holding Tank C. Runoff con tained in Holding Tanks A and C is discharged to the munici pal sewer system if no leaks or spills from containers are detected during inspection. Contents of Holding Tank B, which consists of runoff from Storage Area B and runoff and leachate from the waste pile area, will be examined by laboratory analyses and either discharged to the sewer system (if denermined not to be a hazardous waste) or drummed and stored onsite for later disposal at a facility authorized to accept the waste types. In the event that a spill or leak is detected in Storage Areas A or C, runoff collected in their respective holding tanks will be managed similarly to waste received in Holding Tank B discussed above. Runoff from all other areas of the facility drains directly into the municipal sewer system. 175 CMA 047701 Date: 2/26/S2 Revision No.: 0. Because the Tar.kopile finishing Cose any is located in a ICO-yaar floodplain, provisions have been made -to minimize flooding, and emergency procedures have been established for the possible but unlikely occurrence of a flood. These procedures are discussed in the Emergency Procedures section of the Contingency Plan (Section G). c Water Supplies Ground water contamination is prevented by eliminating the discharge of hazardous materials onto the unprotected ground. The container storage area is constructed of a concrete base, dikes, sump areas, sump pumps, and holding tanks to contain leaks, spills, and precipitation. The waste pile area is also designed and constructed to prevent water supply contamination. Refer to Section D-3a for a complete description of the design and construction of the waste pile area, including a leachate collection system, wind dispersal control system, and runoff and run-on collec tion svstem. In the event of a brief pow er interrupticn, emergency generators will be started to maintain process eperat, and the emergency lighting system will activate autem. ally supplying lighting to all facility buildings and feed lines to is a prolonged power outage, the waste ar.u :race are: na. 3 eraticns will be s CWA o 4-7 TO 2 Date: 2/26/82 Revision No.: 0 F shutdown, maintenance personnel will check for malfunction and equipment failures, and the Anytown Power and Light will be contacted immediately for assistance. Refer to Emergency Procedures in the Contingency Plan for more details. F-4e Personnel Protection Equipment General information on the major chemical components of the wastes in the container, tank, and waste pile areas is provided in the Appendix under General Information and Hazardous Characteristics of Wastes. The sheets present information on various chemicals regarding toxicity, fire and explosion hazards, protective equipment recommenda tions, and first aid. Available protective equipment is presented under Emergency Equipment and Provisions of the Contingency Plan (see Secticr. G). Use of protective equip ment is covered in the initial and annual Personnel Train ing Programs (see Section H), which satisfies the Occupa tional Safety and Health Standards of 29 CFR Part 1910 Subpart I - Personal Protective Equipment. F-5 Prevention of Reaction of I mitable, Reactive, and Incompatible Wastes ~ F-5a Precautions to Prevent Ignition or Reaction of Ignitable or Reactive Wastes The container storage area is the only area on the facility property where ignitable wastes are stored. No reactive wastes are stored at the facility. The containers, as dis cussed in Section D-la(l), are compatible with the contained 03 Data: 2/26/32 Revision No.: 0 wastes; therefore, the only source of ignition is external to the containers. orevent a rcssible source of extern: ignition, drums containing ignitable wastes are tainted white to reflect solar heat and signs are placed in the container storage area clearly narked with the legends, "No Sticking" and "Danger - Unauthorized Personnel Keep Out." Sparkproof tools (brass hammers, wrenches, etc.) are used on all containers aha tanks storing ignitable materials. b General Precautions for Handling Ignitable or Reactive Wastes or Accidentally Nixing Incompatible Wastes General precautions for handling ignitable or reactive wastes were discussed above. Incompatible wastes are not mixed at Tankopile Finishing Company. c Management of Ignitable or Reactive wastes in Containers Precautions taken in the container storage area to prevent accidental fire and explosion include the proper storage of containers (e.g., stacking, aisle space, and labeling and sealing of containers), dikes, sump areas and sump pumps, and appropriate warning signs. Prior to storage, each container is sealed and labeled. This prevents precipitation from entering the drum, and identifies the contents of the container and the data wastes were generated. Containers are stored or. pallets to minimize contact with precipitation, leaks, cr spills, and they are never stacked mere than three containers high. A minimum of 5 ft is maintained in the aisles to allow access 173 0 4-7704 Cl4k Data: 2/26/32 Revision No.: 0 ?* for a forklift without risk of damaging containers by scraping or puncturing. The container storage area is located ?CC ft from the closest company property line (Figure 4), which is in compliance with the National Fire Code Standards for out door storage of containers holding igr.i table or reactive wastes. F-5d Management of Incompatible Wastes in Containers Drums used at Tankopile Finishing Company are color-coded white for vinyl acetate and chloride sludges, yellow for pickle liquor sludges, and blue for metal grindings. This system prevents an operator from placing waste in a container that previously held an incompatible waste. Incompatible wastes stored in the container storage area are separated by 6-in.-high curbs, and each of the three storage area sections has a separate sum? area, sump pump, and holding tank to prevent mixing of the wastes. F-5e Management of Ignitable or Reactive Wastes m Tanks Hazardous waste properties of storage tar./, waste materials generated from the finishing operations at the Tankopile Finishing Company are corrosivity and toxicity. No ignit able or reactive waste materials are stereo m the tanks. The location of the waste storage tanks complies with the buffer zone requirements for stable liquids i,operating pressure 2.S psig or less) contained in the National Fire 179 CMA 047705 Data: 2/25 52 Revision No . 3 G SECTION G CONTINGENCY PLAN The information contained herein is submitted in accordance with the requirements for a Contingency Plan, as contained in 40CFR122.25(a)(7) and 264 Subpart D. Contingency Plan f40 CFR 122.25(a)(7)] The intent of 264, Subpart D (Contingency Plan and Emer gency Procedures), of RCRA is to ensure that facilities that treat, store, or dispose of hazardous wastes have established the necessary planned procedures to follow m the event an emergency situation--should arise-r-- The intent of the requirements under 40 CFR 264, Subparr 2 (Preparedness and prevention), which was described in Section F, is to ensure that the facility is properly designed and equipped to minimize the possibility of acci dents and prevent the occurrence of emergency situations. The requirements under 40 CFR. 264 Subpart D address the actions that are to be taken if an accident should occur. 181 CMA 047707 Date: 2/26/52 Revision No.: o G Gene raj,_I roc nation .his C3ntir.aar.cy c 1 an * _dr.xwCi^s r Si'in* pany, Inc., located at 3100 West 11th Street, Anytcwn, Rhode Island 02331. Tankopila is primarily a manufacturer of metal automotive parts (i.e., body parts, hums, and trim) and household appliance housings ar.d parts. Mary ?. Jones is the owner and operator of the facility. Ms. Jonas may be reached at (401) 555-5739 from 9 a.m. to 5 p.m. on weekdays. Mr. John Smith, Environmental Engineer, is the primary emergency coordinator at the facility and may be readied at (401) 555-3219 from 9 a.m. to 5 p.m. on week days. Other emergency coordinators may be reached at this telephone extension during other hours. Tankopila stores harardous waste in three locations. A waste pile with a maximum storage of 50 vd2 is used to store metal hydroxide wastes. Two 7,S0Q-gallor. tanks are used to store 1,1,1-trichioroethane waste solvent and spent pickle liquor. A container storage area has an estimated maximum storage capacity of 100 drums. A general site plan and a full description of the facility is contained m Section 3. A description of the wastes is contained m Section C. Included in the copies of the Contingency plan provided to emergency organisations, these two sections (3 and C) have been added as Appendices. 132 CMA. 047708 Date: 2/26/32 Revision No. : 0 G G-2 Emergency Coordinators If an emergency situation develops at the facility, the discoverer should contact an emergency coordinator listed in Table 11. John Smith, primary Emergency coordinator, should be contacted first, and if he is not available, the others should be called (in the order listed) until someone is reached. The primary Emergency Coordinator and alternates have complete authority to commit all resources of the company in the event of an emergency. Table 12 lists organizations that could possibly be contacted by the Emergency Coordinator in the event of an emergency. TABLE 11 EMERGENCY COORDINATORS Home NameTitleaddress John Smith Environmental Engineer 453 Elm St. Joseph Williams Plant Manager 911 Sth St. Albert Brown Vice President,Operations 1101 Main St. Work Home phone No. phone No. Ext.3219 221-2932 Ext.3225 862-3801 Ext.3220 921-4410 G-3 Implementation of the Contingency Rian The decision to implement the contingency plan depends upon whether or not an imminent or actual incident could threaten human health or the environment. The purpose of this section is to provide guidance to the emergency coordinator in making this decision by providing decision-making criteria. 133 CMA 04770 Data: 2/25/32 Revision: 0 G TABLE 12 EMERGENCY CONTACTS Emergency Injury Fire/axplosion Hazardous materia? spi11 or release If spi?? reaches navigacle water Natural cisastar Potential flood All of the above Qrgani2ation/3gency Anytown Hospital Washington County Hospital Rhode Island Medical Collage Poison Control Canter Washington County Fire Oept. Anytown Fire Oept. Anytown Fire Dept. Washington County Fire Dept. U.S. EPA Region I Response Center Rhode Island Emergency Management National Response Center Washington County Emergency Management Agency* Army Corp of Engineers Engineer Rhode Island Emergency Management Agency* American Red Cross Emergency No. 911 Ambulance - 3S3--SC0 Info. - 353-3232 321-3305 724-3050 733-5813 722-5351 722-5351 733-6313 24-nr. emergency No. ` 517/472-2315- # 401/702-4395 - 300/424-3302 911 or 724-444-1 401/704-4352 24-hr. No. 401/325-4739 722-1321 * This agercy may also be cor,'acted in ary emergency event if necessary. They will coordinate t.na proper agenc:es/organitaticns as reeoec. 0 4*7110 CtfB- I Data: 2/26/32 Revision No.:- 0 G The contingency plan will be implemented in the following situations: 1. Fire and/or Explosion a. A fire causes the release of toxic fumes. b. The fire spreads and could possibly ignite materials at other locations onsite or could cause heat-induced explosions. c. The fire could possibly spread to offsite areas. d. Use of water or water and chemical fire suppressant could result in contaminated runoff. e. An imminent danger exists that an explosion could occur, causing a safety hazard because of flying fragments or shock waves. f. An imminent danger exists that an explosion could ignite other hazardous waste at the facility. g. An imminent danger exists that an explosion could result in release of toxic material. h. An explosion has occurred. 2. Spills or Material Release a. The spill could result in release of flam mable liquids or vapors, thus causing a fire or gas explosion hazard. b. The spill could cause the release of toxic liquids or fumes. c. The spill can be contained onsite, but the potential exists for ground water contamina tion. d. The spill cannot be contained onsite, result ing in offsite soil contamination and/or ground or surface water pollution. 135 CMA 04'7Ti^- Da-2! 2/25/32 Revision. No. : 0 G 3 . Floods a. The potential exists for surface wader contamination. G-4 Imercer.cv Response Procedures G-4a Notification [40 CFR 254.56(a)] In tie event of an emergency situation the emergency coor dinator will be notified first; subsequently, all facility personnel, appropriate federal, state, or local agencies, and fire or police departments will also be notified. See Figures 26 and 27. G-4b Identification of Hazardous. Wastes (40 CFR 254.56 (b)] The emergency coordinator will immediately identify the character, exact source, amount and area extent of the release. The initial identification method will be to utilize visual analysis of the material and location of the release. The containers are color coded as to their con tents and are in distinct separate locations. The tanks and piping from the process area to the tanks are labeled to identify whether they hold waste pickle liquor or tri- chioroethane. The waste pile area would only have metal hydroxide sludge. If fo 1 seme reason the released material cannot be identified, visual samples will be taken for chemical analysis. G-4C Assessment [40 CFR 254.56(c) and (d)] The emergency coordinator will assess cossi natarts, both direct and indirect, to human health o t - t- ** T"t 4 men*. CMA 047712 D ate: 2/25/32 R e v is io n No..; 047713 CO n Figure 26. Overview of emergency plan of action. o Daee: 1/is rat Revision Me . : 0 G 1 0^ C^ Data: 2/26/82 Revision No.: 0 G D-4d Control Procedures [40 CFR 264.52(a)] Potential accidents fall under three general classifica tions: (1) fire and/or explosions, (2) spills or material release, (3) floods. Natural disasters such as earthquakes or hurricanes are assumed to fall into one of these three classifications. An overview of the emergency plan of action is outlined in Figure 26. Figure 27 is a more detailed emergency plan of action, including phone numbers. Fire and/or Explosion The storage tank, container, and waste pile areas can be easily accessed by fire-fighting and other emergency vehicles and equipment. A paved blacktop road, about 25 ft in width, passes within 100 ft of each of these areas. This road is kept clear at all times. A company fire brigade will be on standby during all general plant emergencies. During times of power failure or severe weather, fire protection personnel will be assigned to protect personnel and property. If a fire should break out, concentration will be placed on preventing the fire from spreading to nearby areas. The fire-fighting effort will be carried out by the fire brigade until outside assistance has arrived. The following actions will be taken in the areas affected by the fire or explosion: 189 CMA 047715 Data: 2/25/32 Revision No. : 0 G 1. "ire doers in buildings will 'be closed. 2. Hazardous work in all areas will be shut down immediately. 3. All feed lines and additional equipment will be snub down, as necessary and practical. 4. The Emergency Coordinator will be contacted (See Table 10. ) 5. The area will be cleared of all personnel not actively involved in fighting the fire. These persons are to report to the designated rally points for accountability. Rally points are designated in Figure 23. All persons in Section 1 on Figure 23 proceed to Rally Point 1; those in Section 2 to Rally Point 2. 6. All injured persons will be removed, and medical treatment will be administered by qualified personnel. 3ecause fire is always a potential hazard in spills of flammable materials, possible sources of ignition have been eliminated. Vehicular traffic and hazardous work in the area will cease until the spill is contained and safety is restored. If spilled materials are flammable, the fire brigade will respond with foam equipment and hoses. Fiush- ng with large quantities o: water or coaming oc the soil! will be performed if advised by the fire brigade chief. If a highly flammable material is released (e.g., propane or natural gas), all persons within at least a cuartar-mile radius of the release will be notified. All ignition sources within this area will be eliminated. Cse of motor vehicles within this area will be restrictec ojr eliminated to avoid tze vapor, which can cause a flashback to tr.e source ar.c an imtia_ expiosion or wits 150 CMA 047716 uace; </^o/ Revision No.: 0 G rvrl UP OAU: 9/10/SI Figure 28. Rally points in the event of fire or explosion. 191 CMA 047717 Data: 2/2S/82 Revision No.: o mer.sicr.s & C " 3 n - : **-- / --2 2-22 W will ice evacuated. 3e 3a scores If a fire is involved and is concentrated at the source, people will be evacuated up to a half-nils downwind. Fire fighting will not be done at the risk of injury to the persons involved; however, early containment of firas can significantly decrease total damage. Notification pro cedures are given in Figure 27. nec The guard house or the plant receptionist will^be called unless absolutely necessary so that they remain free to handle only emergency calls. Area or plant evacuation will be necessary in case of major fire or explosion. Specifics are outlined under general evacuation procedures. All personnel have been trained in evacuation procedures and means of exit from their a c r* -- tive work areas. Until evacuation is signaled, personnel who are not in an affected area will stay in their respective work areas. Contract personnel and visitors will be cleared from the area and instructed to report to a guard house or office area. The fire brigade chief will be responsible for all fire fighting efforts until outside help arrives. The fire 192 047'71 Date:- 2/26/32 Revision No.: 0 G brigade chief is always the lead,shift foreman. Super visors of unaffected areas will stay with their personnel and be ready to evacuate and account for the persons under their supervision. An "all clear'1 signal will be given when the fire has been extinguished and the safety of personnel is no longer endangered. The fire brigade chief will determine when the emergency has passed and consult with the Emergency Coor dinator before the "all clear" signal is given. All emer gency equipment used in the emergency must be cleaned and fit for use prior to resumption of plant operation in the affected areas. Spills or Material Release In the event of a major emergency involving a chemical spill, the following general procedures will be used for rapid and safe response and control of'the situation. Emergency contacts found in Figure 27 provide a quickreference guideline to follow in the event of a major spill. If an employee discovers a chemical spill or process upset resulting in a vapor release, he or she will immediately report it to the area supervisor. The area supervisor will contact the designated Emergency Coordinator at the time of the incident. When contacted, 193 CMA 047719 Data: 2/25/32 Eevisicn Kc. : 0 G the designated Emergency Coordinator will obtain ir.formatton pertaining to the following: 1. The material spilled or released 2. Location of the release or spillage of hazard ous material 3. An estimate of quantity released and the rate at which it is being released 4. The direction in which the spill or vapor or smoke release is heading 5. Any injuries involved 5. Fire and/or explosion or possibility of these events 7. The area and materials involved and the intensity of the fire or explosion. This information will help the Emergency Coordinator to assess the magnitude and potential seriousness of the spill or release. If the accident is determined to lie within the company's emergency response capabilities, the Emergency Coordinator will contact and deploy the necessary inplant personnel. If the accident is beyond plant capabilities, the Emergency Coordinator will contact the appropriate agencies. A list of agencies and phone numbers can be found in Table 12. The initial response to any emergency will be to protect human health and safety, and then the environment. leant: fication, containment, treatment, and disposal assessment will be the secondary response. 134 CMA 047720 Date: 2/26/S2 Revision No.: 0 <3 In the event of a leak or spill in the tank area,- all feed lines to the storage tanks will be closed. The dike sur rounding the tank storage area has the capacity to hold the largest tank and any rainfall. Immediately after the spill is detected, a local contractor will be summoned to remove any standing liquids and haul the spilled material to a facility approved to handle that particular waste. If for some reason a chemical spill is not contained within a dike or sump area, an area of isolation will be established around the spill. The size of the area will generally depend on the size of the spill and the materials involved. If the spill is large and involves a tank or a pipeline rupture, an initial isolation of at least 100 ft in all directions will be used. Small spills or leaks from a tank or pipe will require evacuation of at least 50 ft in all directions to allow cleanup and repair and to prevent exposure. When any spill occurs, only-those persons in volved in overseeing or performing emergency operations will be allowed within the designated hazard area. If possible the area will be roped or otherwise blocked off. If the spill results in the formation of a toxic vapor cloud (by reaction with surrounding materials or by out break of fire) and its release (due to high vapor pressures under ambient conditions), further evacuation will be enforced. An area at least 500 ft wide and 1000 ft long 195 CMA 047721 Data: 2/26/32 Revision No.: 0 G vill be evacuated downwind id volatile materials are spilled. Because the distance to the closest urban area is about 5 miles, it is'unlikely that evacuation of its population will be necessary in the event of a release of toxic nate- rial. Industrial areas within a mile of the plant will be notified, however, if a large quantity of spilled aaterial ignites. 3ecause winds in the area tend to vary, the quickest and most accurate assessment of meteorological conditions is accomplished by calling the National Weather Service at 798-5553 or Anytovn Airport at 351-5610. If the control and cleanup of a spill, release, or fire is within the capabilities of company personnel and local response teams, the Rhode Island Department of Environmental Management or the National Response Center will not be notified unless one of the following occurs: 0 A spill discharges to the Queen River and the quantity of hazardous material spilled is equal to or greater than the reportable quantity specified under 40 CFR Part 117. * One thousand gallons or more of oil is spilled in a single event. If a lesser quantity has been spillad but has entered a storm sewer leading to the Queen River, it is advisable to contact local and state authorities for assistance if it is not possible to intercept the spill at the outfall or prevent the oil slick from moving downstream. 6 The spill invo Ives other hazardous materials not listed but used at the plant if they pose an actual or ootential hazard to life cr property. 195 CMA 047722 Date: 2/26/32 Revision No.: 0 G As called for in regulations developed under the Comprehen sive Environmental Liability and Compensation Act of 1980 (Superfund), our practice is to report a spill of a pound or more of any hazardous material for which a reportable quantity has not been established and which is listed under the Solid Waste Disposal Act, Clean Air Act, Clean Water Act, or TSCA. We also follow the same practice for any substances not listed in the Acts noted above but which can be classified as a hazardous waste under R.CSA. If the Emergency Coordinator determines that the company is unable to handle the emergency, then local, state, and Federal authorities will be notified of the situation. Evacuation of all potentially affected plant areas will be initiated as soon as possible. The following guidelines will be used in case of an acci dental episode involving waste materials. These are general guidelines, and circumstances may dictate some alterations to these procedures. Most waste spills and leaks are easily contained within the dikes and sumps provided in the tank area. Small spills occurring in a diked area are flushed with plenty of water, to the sump provided in that area. If necessary, a portable sump pump is used to pump the diluted waste material into 55-gallon drums. Procedures for handling large spills were discussed earlier in this section. 197 CMA 047723 Date: 2/25/32 Revision No. : 0 G or all large spills or serious leaks the following guide- ires will be followed as closely as possible: 1. If a leak develops or a spill occurs from a waste storage tank, pipeline pump, etc., the person discovering the discharge will leave the immediate area and contact the Emergency Coordinator. The Emergency Coordinator will obtain the following information: a. ?erson(s) injured and seriousness of injury. b. Location of the spill or leak, material involved, and source (tank, pipeline, etc.). c. The approximate amount spilled, an estimate of the liquid and/or gas discharge rate, and the direction the liquid flow or gaseous cloud is moving. d. Whether or not a fire is involved. ------2-:------- Next, the-Emergency Coordinator will: a. Initiate evacuation of the hazard area. For small spills or leaks, isolate at least 50 ft in ail directions. .For large spills, initially isolate at least 100 ft in all directions and keep ail persons upwind of spill. % b. Obtain medical attention for any injured persons. It may be helpful to instruct the caller in initial first aid pro cedures. Then call the hospital. c. Call the fire department if a fire is involved that canncc be extinguished by plant personnel. Eight small fires with dry chemicals, C02, or foam, and large fires wish water spray, fog, or foam. Keep heat-exposed containers coded with water spray and remove them from the fire if possible. IE A RISING SC'JN"D COMES FROM A VENDING DEVICE CR THE TANK BEGINS TO DISCOLOR, WITHDRAW FROM THE AREA IMMEDIATE!'.: . 193 CMA 047724 Data: 2/26/32 Revision No-: 0 G d. Dispatch emergency personnel to the site to take the appropriate action. e. Contact the proper authorities (Figure 27 and Table 11) if the spill or release is large. Contact local authorities first so that, if necessary, downstream water users and/or persons downwind of the vapor can be notified and, if necessary, evacuated. If a large spill occurs, the initial evacuation area downwind should be 0.2 mile long (=1000 ft) by 0.1 mile wide (sSOO ft). If a tank containing waste becomes involved in a fire, isolate an area S mile in all directions. 3. Cleanup personnel will: a. Make sure all unnecessary persons are removed from the hazard area. b. Put on protective clothing and equip ment. c. If the flammable waste is involved, remove all ignition sources, and use spark and explosion proof equipment and clothing in containment and cleanup. d. If possible try to stop the leak. Special materials will be kept on hand for temporary repairs. e. Remove all surrounding materials that could be especially reactive with materials in the waste. Determine the major components in the waste at the time of the spill. f. Use absorbent pads, booms, earth, sandbags, sand, and other inert mate rials to contain, divert and clean up a spill if it has not been contained by a dike or sump. Most spills contained within the dike or sump can be pumped back into the appropriate storage tank or drum. g. If wastes reach a storm sewer, try to dam the outfall to the Queen River by using sand, earth, sandbags, etc. If 199 CMA 047725 Cats: 2/25/32 Revision No.: C this is done, dilute wastes in the storm sewer with large quantities c: water and pump this material cut into a temporary holding tank or drums as scon as possible. Id a spill enters the river or has entered a storm drain, use absorbent booms and sweeps around the outfall to contain and absorb waterinsoluble organics. h. Place all containment and cleanup materials in drums for proper disposal. Some items, such as absorbent rags or booms may have to be cut up. i. Place all recovered liquid was' as and contaminated soil in drums for removal to an approved disposal site. Following are procedures to follow if a large amount o material spills onto unprotected ground and g: ound vat is contaminated. Because the water table level onsite is only about 10 ft below the ground surface, cleanup and contain ment of spills reaching or likely to reach the groundwater will be accomplished by construction of interceptor trenches Ground water flew is in the general direction of the 2teen River. The trench will be constructed across the encore front of the migrating body of material (i.e., the trench will be a few feet wider on either side of the spill boundaries as can be determined from surface observations). Figure 29 illustrates this. This trench will be as narrow as tre excavating equipment will allow. *t will be cor.- structad to a deoth of 1 to ce_cw tre vat a ^ ^ V* ^ suriac rhe downstream wall of the -ranch will be lined with an impermeable and resistant material or ever.' further .deration of the soilled material. 200 CM& 047726 uate: Revision No.: G Figure 29. Interceptor trench. 201 CMA 047727 Data: 2/25/32 Revision No.: 0 G is daep enough, the contaminated water will collect in the ditch and will be pumped out as required. A pump to create a tone or depression will be used to increase speed of recovery. This is accomplished by first placing a 16- to 13-in. diameter galvanized culvert pipe, slotted or perforated and capped on the bottom, in the bottom of the trench about midway from each end. Fiberglass or steel window screening is then wrapped around the pipe where it is slotted and then secured with wire. The trench is then backfilled within 2 ft of the ground surface with gravel and finished with native soil. Figure 30 shows a cross section of an interceptor trench, when pumping is required to prohibit contamination of the water table, a submersible pump is lowered into the culvert. Pumping will be dene continuously to prevent the contaminant from moving around the ditch. When recovering a flammable material from the ground-water, explosion- and spark-proof pumping equipment, tools, and clothing is used because of the possible presence of explosive vapors. Smoking, and heat sources in the area will be eliminated. All emergency equipment used in the emergency must be cleaned and fit for use prior to resumption of plant opera- i.n ^pa Floods Approximately half ; o tne :acuity within the 130-vear flood plain sr.c 2C2 ;ertv is 1c ~ *'er' act to ;_occs CMA 047728 Revision No.: 0 G figure 30. Interceptor trench (cross-section). 203 CMA 047729 Data: 2/25/32 Revision No.: 0 G 1 to 3 feet in depth. The present waste pile and dr-on storage areas are within the 100-year flood plain. The dr-on storage area and waste pile are both s-object to flooding. The long-tsm solution is to move these func tions to higher ground. If a flood occurs before this relocation, the following steps should be taken: 1. Check with the National Weather Service in Providence, Rhode Island, or the Amy Corps of Engineers for a projected flood crest. 2. If the crest will result in less than 1 ft of water in the waste pile or drun area, the areas will be diked with sandbags up to a level 1 ft over the projected level. 3. If the crest will result in more than 1 ft of water in the waste pile and drum areas, the waste will be removed to a waste disposal facility. It is estimated the drums will - ........ - take 3 to 4 hours to remove. The waste pile is expected to take up to 3 hours to remove; therefore a sandbag dike will be constructed to protect the site during the removal time. 4. Should a fire, explosion, spill or material release occur during the flooding, the sections addressing these occurrences will be consulted. G-4e Prevention of Recurrence or Screed of "ires, Releases (40 CTR. 264.55(e) ] or.s or Actions to prevent the recurrence or spread of fires, explosions or releases include stoppi:r.g processes and operations, collecting and ccntainir.g released waste, recovering or isolating containers. ---- ^ manual addresses the specific actions zo he zzkaz m an emergency. in addition, if the facil izy szsps ecera* i *^ 204 04nn^ Date: 2/26/82 Revision No.: 0 G in response to an emergency, the emergency coordinator will monitor valves, pipes, and other equipment for leaks, pressure build up, gas generation or ruptures. G-4f Storage and Treatment of Released Material [40 CFR 264.56(g)] Immediately after an emergency, the emergency coordinator will make arrangements for treatment, storage, or disposal of recovered waste, contaminated soil, surface water, or any other contaminated material. G-4g Incompatible wastes [40 CFR 264.56(h)] The emergency coordinator will ensure that wastes which may be incompatible with the released material are treated, stored or disposed of until cleanup procedures are completed. G-4h Post-Emergency Equipment Maintenance [40 CFR 264.56(h)(2)] After an emergency event, all emergency equipment listed in section GS will be cleaned so that it is fit for use or it will be replaoed. Before operations are resumed an inspection of all safety equipment will be conducted as discussed in section F-2. The Regional Administrator, state, and local authorities will be notified that post-emergency equipment maintenance has been performed and operations will be resumed. G-4i Container Spills and Leakage [40 CFR 264.171] Refer to section G-4d for a discussion of emergency response procedures for container spills and leakage. G-4j Tank Spills and Leakage [40 CFR 264.194(c)] Refer to section G-4d for a discussion of tank spills and leakage emergency response procedures. 205 CMA 047731 Data: 2/25/32 Revision No.: G G-4k Waste Piles G-4k(l) Indication of waste Pile Containment System Failures Per the inspection schedule discussed in section F-2, the waste pile storage area will be inspected on a weekly basis. If during an inspection liquid is detected in the leachate monitoring manhole a sample will be collected and analyzed for lead and hexavalent chromium. If lead and/or hexavalent chromium is detected, the containment system evaluation and repair plan will be implemented. If inspec tion of the membrane liner indicates there are tears, holes, separation of layers, thin spots, cracks, shrinkage, hardness, excessive permeability, or blisters, the plan will also be immediately implemented, other indications of waste pile containment system failure which would require implementation of the plan include: deterioration or loosening of the joint holding the liner to the foundation, loss of base material or soil covering liner, exposing the liner to direct sunlight, or foundation deterioration or cracxmg. C--4k(2) Elements of a Containment S ystem Evaluation and Pep air Plan If there are indications of was te pile containment syst am failure, the containment system evaluation and repair p 1 an will be implemented immediately . Che plan clearly outl the steps necessary to evaluate the extent of damage to containment system and measures necessary to correcu a containment deficier.cv. Structtires involved in the 206 CMA 047732 Date: 2/26/82 Revision No.: 0 G containment system evaluation include: the foundation, liner, leachate, and runoff collection system, waste pile base, leachate monitoring manhole, and perimeter soil embankment. The most vulnerable unit of the containment system is the liner which will undergo the following tests to ensure integrity*. 0 visual inspection for cracks, holes, etc. 9 laminate thickness 9 cold bend * tensile strength a tear'strength 9 puncture resistance 0 hydrostatic resistance 9 dimensional stability 9 ozone resistance a seam strength other structures will require thorough visual inspection for deficiencies. Also included in the plan is a schedule of actions in the event of containment failure and a descrip tion of repair techniques. G-4k(3) Criteria and Procedures for Removal of Waste Pile From Service in Case of Positive Failure of the Containment System [40 CFR 264.255(b), 264.255(c), and 264.255(d)(1)] In the event there is a positive failure of the containment system the waste pile will be removed from service. Front- end loaders will be used to remove the waste pile from the containment system and load the haul trucks, waste will be disposed of at a facility approved to handle that particular waste. Newly generated waste will be stored in 3 cu. yd. dumpsters until the containment system is repaired. G-4k(4) Restoration of a Waste Pile to Service [40 CFR 264.255(e)] After removing the waste pile from service and disposing of the waste pile, the containment system will be repaired as 207 CMA 047733 Data: 2/25/32 Revision No.: 0 G soon as possible. Depending upon the severity cf the repair work, a registered professional engineer will certify that the containment system still meets the design specifica tions approved in the RCRA permit. k(S) Course of Action After Waste Pile is Removed From Service (40 erR 254.255(f) and 254.253] When the waste pile containment system is permanently removed from service the following steps will be necessary to close the facility and restore the grounds to their original appearance: 1. Remove hazardous waste pile to a facility approved to handle that particular waste. 2. Remove base, liner, foundation, underdrains, underdrain collection sump, leachate collection system, and leachate monitoring manhole, and dispose 'of at a facility approved to handle that particular waste. 3. Remove any contaminated soil and dispose of at a facility approved to handle that particular waste. 4. Remove groundwater surerains and sto or resale. reuse 5. Fill diversion ditch and pit from waste pile containment system with onsite soil and grade. 5. Apply seed and straw in an effort to reclaim the area. 7. Decontaminate frent-end leaders, haul trucks, pumps, etc. an the container storage area and dispose cf resulting wastes appropriately. 3 An independent registered professional engineer will certify closure of the waste pile contain ment svstem. 2G3 CMA 047734 Date: 2/26/32 Revision No.: 0 G G-5 Emergency Equipment Location of emergency equipment is shown on Figure 31. The plant employs several mechanisms for fire control. First, three fire hydrants are located in the plant area Each hydrant will deliver 500 gal/min of water. Approximately 1000 ft of hose is stored in the warehouse. Also available for fire control are portable fire extin guishers; at least one extinguisher is located in each of the following areas: 9 Drum storage area 9 Storage tank area 0 Processing are;. 0 Warehouse 9 Electric suhsraoion 9 Lab 9 Offices These fire extinguishers are dry chemical Types A, B, and C. Type A is capable of extinguishing fires involving ordinary combustible materials such as wood, cloth, paper, rubber, and many plastics; Type B is capable of extin guishing fires involving flammable liquids, oils, greases, tars, oil base paints, lacquers, and flammable gases; and Type C is capable of extinguishing fires involving ener gized electrical equipment. All extinguishers comply with National Fire Code standards for portable fire extinguishers, and they are inspected after each use or at least monthly. Records of these inspections are kept in the operating log. Equipment for use in containing and cleaning up spilled hazardous wastes is stored in the warehouse. A list of 209 CMA 047735 Data: 2/25/32 Ksvision Mo.: 0 G Ficurs 31. Location or' emergency acui?~ent. 4 * 'J CWA 04T736 I<t . ui iU . I;l*l j 1/1 Data: 2/26/32 Revision No.: o G equipment and materials stored and maintained in the ware house is listed in Table 13, along with the function of each. First aid supplies at the first aid station include the following: / j 9 Bandage materials - bandw4'ids - gau2e pads and rolls - adhesive tape - butterfly bandages 9 Antibacterial ointments 9 Splints 9 Aspirin 9 Emetic - Syrup of Ipecac 9 Local and topical anesthetics 9 Eyewash bottle and solution Emergency eyewash fountains and showers are located at the east and west ends of the waste storage tank area. Each unit consists of a drench showerhead with "panic bar'*-operated frost-proof valve and an eyewash with a dirt cover and "panic bar"-operated frost-proof valve. A sign reading "EMERGENCY SHOWER AND EYEWASH FOUNTAIN" is posted at each unit. A hose station is also located near the eyewash/shower station at the west end of the tank storage area. Protective clothing and equipment is provided to protect employees during normal and emergency operations. Hard hats, protective eyewear, and steel-toed boots or shoes are the minimum protective clothing required. Other protective clothing equipment available on site include: Clothing - Plastic aprons and gauntlets - Rubber and Neoprene boots 211 ^37 lAllLE 13. MATERIALS AND EQUIPMLNI fOJt SPILL CONTAlNMENE AND CLEANUP Ma t erial(s)/equi pment Quantity Substances contained/ ahsorhed/cleaned up Notes Standard industrial absorbents (Sorb-Al1, Vurmlculite, etc.) A drum should be placed in all plant areas where small' spills are suspect. for small spills of oil, solvents, aqueous mate rials. Do not use for acids or caustics unless first neutralized. Each drum should be accom panied wiUi broom (or shovel) and dustpan. Sandbags fiOO-1000 Sand is unreactive with most any chemical except hydrofluoric acid. Keep in readily acces sible area(s) near most concentrated area(s) of tanks or drums. Sami 50-100 yd:* Sand is unreactive with most any chemical except hydrofluoric acid. Use primarily for contain ment or large spills. Containment and cleanup of small spills. Also, keep in barrels In areas where small spills may occur more frequently (drum sturage areas, process pads etc.). Keep covered if outside. Absorbent boom, we ighted or wi ID curtain or skirt I 2 In water, most insoluble or slightly soluble organics. Most materials on land. Oo not use for acids. Employ one boom around out-fall discharge on permanent basis and one for backup. D ate: 2/25/32 R e v is io n }fo. : 047738 (coni inueil) D ata: 2/26/82 R e visio n ; 0 213 TABLE 13 (continued) Materia)(s)Zequipment Absorbent pads Quantity Carton (100 padsConwed) Straw 15-20 bales Submersible pump 1 (continued) Substances contained/ absorbed/cleaned up In water, most insoluble or slightly soluble organics. Most materials on land. Do not use for acids. Petroleum, distillates, oil, organic solvents. Do not use for acids or caustics. See manufacturers (Gould, Flygt, Peabody) for specifications on mate rial-handi ing capabili ties. Notes Will float on water so are most helpful in cleaning up materials contained within the boom boundaries or in diked areas where a chemical sheen has formed on water collected within. Also, place around equipment or in areas where leakage or spillage occurs frequently (i.e., pumps, loading/unloading areas). Can be used for diking and absorption for land spills. If booms become saturated, can be tied together and used to con tain and absorb water spills. Since they sink partly below water surface, they are useful for substances slightly heavier than water. Can be used to remove diked Q liquids, etc. TAUI-E 1 * (continued) MdteHal(s)/equipment Flexible (Neoprene) buses with quick couple fittings. Quantity 75 ft minimum 55-gallon drums; steel. Variable stainless steel 1A-+ Substances contained/ absorbed/cleaned up Notes N.A. Neoprene is resistant to most acids and solvents, but not all. For instance, benzene will degrade Neoprene. Host organics (steel); acids, caustics, contaminated absorbent materials (stainless steel). ojoa n> a* < UHHk f*t OJ IO X o a* Xoo 047740 Date: 2/26/32 Revision No.: 0 G - Short and long rubber gloves - Rain suits - Chemical-resistant suits (Tyvek, polyurethane, polyethylene) - Polyethylene gloves Equipment - Face shields and extra protective eyeglasses - Disposable respirators - Chemical cartridge respirators w/cartridges for organic vapors and acid gases; half- and full- face types - Chest-mounted gas mask cannisters - Self-contained breathing apparatus (SCBA) operated in pressure-demand mode This equipment is located in the warehouse for easy access by personnel. G-6 Coordination Agreements Tankcpile has made the following arrangements to assist in response to emergency situations. 1. An agreement has been made with a local dis posal facility to provide a tank truck on a 24-hour basis. 2. Copies of the contingency plan have been 9 given to the local police and fire depart ments, the hospital, and the state and local Emergency Response Teams. These agencies were asked to review and comment on the plan and have detailed the actions they will take in response to any emergency. The following organizations have been sent copies of the contingency plan: Fire Chief Charles Lang Anytown Fire Department 6th and Main Streets Anytown, Rhode Island 02831 Fire Chief David Kuntz Washington County Fire Department 11934 State Route 43 Brixton, Rhode Island 02881 215 CMA 04774 Data: 2/25/32 Revision No. : 0 G Dr. Joyce Henderson Anytovn Hospital 2914 Him Street Anytown, Rhode Island 02331 Dr. Joseph Smyth Washington County Eostital 1293 State Route 43 Georgetown, Rhode Island 02S31 Mr. Robert Burns Rhode Island Emergency Management Agency 1200 Washington Boulevard Providence, Rhode Island 02503 Ms. June Davidson Washington County Emergency Management Agency 11350 State Route 43 Srixton, Rhode Island 02331 G-7 Evacuation Plan All emergencies require prompt and deliberate action. In the event of any major emergency, it will be necessary to follow an established set of procedures. Such established procedures will be followed as closely as possible; however, in specific emergency situations, the Emergency Coordinator may deviate from the procedures to provide a mere effective plan for bringing the situation under control. Che Emergency Coordinator is responsible for determining which emergency situations require plant evacuation. The facility employs a warning system with a specific alarm signal to initiate evacuation of all plant areas. In addition to the alarm, the internal telephone .system is used to notifv hev olar.t tersonnel as to the nature of the emergar.cv and recommended olan o: r- aa rc -' 3: :a_ o. evacuation is initiated only by an Emergency Coordinator. 215 CMA 047742 Data: 2/2S/32 Revision No.: 0 G A fire alarm system is installed with alarm boxes located at critical areas throughout the plant. The fire alarms can also be used to summon aid in other emergency situations. All applicable employees are familiar with alarm box locations. In the event plant evacuation is called for by the Emer gency Coordinator, the following actions will be taken: 1. The signal for plant evacuation will be activated. 2. The guards will immediately open the gates. No further entry of visitors, contractors, or trucks will be permitted. All vehicle traffic within the plant will cease to allow safe exit of personnel and movement of emergency equipment. 3'. ALL personnel, visitors, and contractors will immediately leave through the exit gate. 4. No persons shall remain or reenter the location unless specifically authorised by the person or persons calling for the evacu ation. In allowing this, the person in charge assumes responsibility for those persons within the perimeter. Those withinthe fenced area will normally only include fire brigade personnel or emergency teams. 5. ALL persons will be accounted for by their immediate supervisors. Supervisors will designate certain gates as the safest exits for his or her employees and will also choose an alternate exit if the first choice is inaccessible. To assist in this endeavor, the Emergency Coordinator will use the internal telephone system to call the area supervisor, to inform him or her of the nature .of the emergency. 6. During exit, the supervisor should try to keep his or her group together. Rally points for specific areas are shown in Figure 23. Immediately upon exit through the gate, the highest ranking supervisor 217 047743 Data: 2/25/92 Revision No,: 0 G will prepare a list of all personnel at the exit gate. All other personnel who have persons reporting to then should report immediately to the front gate for final accounting. 7. Upon completion of the employee list, the supervisor in charge will hanc-carry the list to the Emergency Coordinator. All other tersonnel will remain at the gate area. 3. Contract personnel should also he listed with the name of their company. Contract foremen should report to the front gate. 9. .The names of fire brigade and/or other emergency team members involved in emergency response will be reported, in writing, to the' front gate by designated response team personnel. 10. A final tally of persons will be made by the Emergency Coordinator. 11. No attempt to find persons not accounted for will involve endangering lives of others by reentry into emergency areas. 12. A plant guard at each gate will also main tain an updated list of all personnel to aid in the accountability procedure. 13. Reentry into the fenced area will be made only after clearance is given by the Emer gency Coordinator. At his direction, a signal or other notification will be given for reentry into the plant. 14. In all questions of accountability, immedi ate supervisors will be held responsible for those persons reporting to them, visitors will be the responsibility of those employees they are seeing. Contractors are the respon sibility of those persons administering the individual contracts. Truck drivers are the responsibility of the warehouse supervisor or the area supervisor where the truck is Icading/ur.ioadmg. The guards will aid in accounting for visitors, contractors, and trackers by reference to the srgn-m sheets. 213 CMA 047744 Data: 2/26/32 Revision No.: 0 G 15. Drills are held to practice all of these procedures and are treated with the same seriousness as an actual emergency. a Required Retorts f40 CFR 264.56(d) and 264.56(i)1 As required by 264.56(J), any emergency event (e.g., fire, explosion, etc.) that requires implementing the contingency plan will be reported in writing within 15 days to the ERA Regional Administrator. A reporting form for emergency events is shown in Figure 32. In addition to these reporting requirements for state and Federal authorities, Tankopile also has internal reporting requirements. The following incidents require that an incident report be completed and returned to the safety director within 5 working days and made part of the oper ating record: 1. All fires 2. Rupture disc releases 3. Unusual gas or vapor releases 4. Chemical spills of more than 10 gallons (or smaller volumes if highly toxic materials are involved) 5. All injuries except minor cuts and bruises (all bums and chemical irritations) 6. All equipment damage due to malfunction or operating error 7. All "near misses" of the above variety that could have had serious consequences 219 CMA 047745 REPORTING FORM FOR EMERGENCY EVENTS Data; 2/25/32 Revision: 0 G Name, acdress, and pnone numoer of owner or operator Name, address, and phone numcer of facility data, tine, and type of incident (a.g., fire, explosion, etc.) Name' anc quantity of matenal(s) involved Extant of injuries (if any) Assessment of actual or potential haiarcs to human health or the environment (if applicaole) Estimated quantity ana disposition of material recovered from tna incident Sena to: (Name) U.S. EPA, Region I Regional Acminisenator (EPA) JFK Federal 3'dg. Boston, Massachusetts C2203 (Name) Chief Environmental Emergency Branc.n U.S. EPA, Region I JFK Facers! 31dg. 3oston, Massachusetts C2203 Figure 22. Sample reporting form for emergency events. 220 O^46 Date: 2/26/82 Revision No.: 0 G Amendments to the Contingency Plan The contingency plan will be reviewed and immediately amended, if necessary, whenever: 1. The facility permit is revised 2. The plan fails in an emergency 3. The facility changes in its design, construction, operation, maintenance, or other circumstances in a way that materially increases the potential for fires, explosions, or releases of hazardous waste or hazardous waste constituents, or changes in the response necessary in any emergency 4. The list of emergency coordinators change 5. The list of emergency equipment changes G-9 Amendments to the SPCC Plan The Tankopile Finishing Company, prior to the submission of this application, did not have a Spill Prevention, Control and countermeasure (SPCC) Plan. Therefore, 264.52(b) is not applicable, and the requirements for spill prevention, control and countermeasures were addressed in various . sections of this contingency plan. 221 CMA 047747 Data: 2/25/32 Revision No.: 0 SECTION H PERSONNEL TRAINING The information contained in this -section outlines the personnel training program for TanJcopiie' s hazardous waste storage facility in accordance with the requirements of 40 CfR 122.25(a)(12) and 254.15. H-l Cutline of Training Program f4Q CTR 122.25(a1(12)1 E-la Job Titles and Duties figure 33 shows the organization of personnel at the facility. Only four employees are directly involved with the handling of waste: The environmental engineer, the environmental operations foreman, and two operators... Management responsibilities involving compliance with f.CRA regulations but .not involving actual handling of the wastes are split between the environmental engineer and the plant manager. Maintenance personnel (i.e., electricians and mechanics) vers in the waste handling area, but they do not handle wastes directly. The duties, responsibilities, and qualifications of each position follow: CMA 047748 Date: 2/26/32 Revision No.: H Indicates those personnel directly involved with hazardous waste activities. Figure 33. Organization chart for Tankopile's HWM facility. 223 CMA 047749 Data: 2/25/32 Revision No. : 0 H Position Title: Environmental Engineer Name of employee: John Q. Smith Position Responsibilities and Duties 0 Emergency Coordinator for ail hazardous waste activities. 4 Training of plant personnel in the proper handling of raw materials, intermediates, finished products, and waste byproducts. o- Responsible for all air, water, and solid waste control systems on the site. 0 Obtains all required permits and licenses or modifications of same from local, state, and Federal regulatory bodies. 9 Resolves problems involving permits and licenses from local, state, and Federal regulatory agencies. JO Notifies proper authorities in emergency situa tions . 0 Reports to Plant Manager. 0 Regularly inspects plant grounds and all facili ties for*status of air, water, and solid/ hazardous waste emissions and controls. d Consults with maintenance foreman on questions involving emergency action. 0 Drafts and submits to plant manager all required reports to EPA or the "state. Expierier.ca and Qualifications: 9 3.S. degree in Chemical, Civil, or Environmental Engineering. 3.3. Degree in Chemistry also acceptable. 9 1-3 years experience in industrial or municipal pollution control management. 0 m-a-i -iand/or ar.c2 in hazardous waste management is cesireable. 224 CMA 047750 Date: 2/26/82 Revision No.: 0 H Position Title: Environmental Operations Foreman Name of employee: Stephen S. Ray Position Responsibilities and Duties: * Overall operation and maintenance of the hazardous waste storage facility. 9 Maintains facility compliance with RCRA and other permits. 9 Oversees operators and reviews their performance. 9 Trains operators to: Operate materials/drum handling equipment safely and effectively Handle leaks, spills, and emergency situa tions a Maintains operating log, monitoring records, maintenance records, inspection records, per sonnel training records, and all other required records. 0 Notifies plant environmental engineer, plant manager, and if so directed, proper authorities in emergency situations. .9 Schedules all maintenance and repairs to struc tures and equipment for HWM facility. 9 Oversees mechanic/electrician doing both scheduled and unscheduled maintenance and repair work to be sure he is not releasing hazardous wastes to the environment or contaminating himself. 9 Reports to environmental engineer. Experience and Qualifications: 9 Associate (2-yr) degree in Chemical, Civil, Environmental, or Mechanical Engineering. * 2-3 years experience in plant operation. 0 Hazardous waste management experience helpful but not required. 225 CMA 047751 Data: 2/25/32 Revision No.: 0 H Nota: If applicant has no hazardous waste exper ience, special training in the functions and operation of a hazardous waste storage facility will be required before assuming job responsibil ities. This training will be provided by Tanked le. Position Title: CDerator Names(s) of enployee(s): Michael H. Alwood Jerry I. Slate Position Responsibilities: a Reports to environmental operations foreman. a Cperatas waste handling equipment. 9 Reviews all incoming wastes and assigns wastes to proper storage location. 9 Inspects tanks, drums, and other storage equip ment, and any gauges, dials, and recorders as required for proper operation and structural integrity. 9 Inspects drum storage area for evidence of leaks and spills and inappropriately placed drums. 9 Inspects emergency equipment on a regular basis. 9 Assists in training of new operators and mechanics to handle hazardous waste spills and leaks safely and in such a way as to avoid exposures. a Makes appropriate entries into operating log, monitoring records, inspection records, and maintenance records, and files them according to established system. a Notifies foreman and other plant authorities as necessary in emergency situations. 3 Takas emergency action on own authority in accordance with established procedures. 225 CMA 047752 Date: 2/26/32 Revision No.: 0 3 Experience and Qualifications: 9 High school diploma 9 2-3 years experience as plant operator with related activities. Note: Operator will also be required to maintain and inspect other pollution control equipment on the site. H-lb Training Content, Frequency, and Technique The program developed at Tankopile for training employees in the safe handling of hazardous wastes has been organized into a "training manual." Provisions are made for updating or revising the text as necessary to ensure compliance with the terms of the RCRA permit. Each employee has his or her own copy of the manual. An outline of the training manual is shown in Figure 34. This training manual is kept on file at the facility, and is available to EPA officials for review. During the training program, employees are instructed'on (1) the hazardous nature of chemicals and chemical wastes in general, (2) the purpose of RCRA and importance of maintaining compliance with RCRA regulations, (3) the hazardous nature of the wastes being stored in the facility, (4) proper handling and storage procedures for wastes, (5) emergency procedures and contingency plan. The manual is used as the basis or framework for training Tankopile personnel in the proper procedures, equipment, and systems to be used in managing hazardous wastes. 227 CMA 047753 Data: 2/25/22 Revision No.: 0 H Ft cure 3t. n,u: 11na or r^zirzz^i *ds r. i ng Manual, 223 CMA 047754 I Date: 2/25/32 Revision No.: 0 H For key personnel, Tankopile plans to supplement the train ing outlined in the manual with attendance at one or more technical seminars or training programs on hazardous mate rials. A list of such seminars or programs is included in Appendix C of the training manual. A brief description of each section of the training manual follows: Section 1 - Introduction This section of the manual introduces Tankopile employees to the general classes and characteristics of chemicals and chemical wastes that can be hazardous.to health and property. In this context, the terms toxicity, reactivity, corrosivity, and ignitahility are defined. It is Tankopile's policy that each employee handling chemical substances (raw materials, finished products, byproducts, and wastes) respect them and t be aware of these potential hazards. The company's policy on the use of protective clothing and safety equipment to prevent accidental worker exposures and releases to the environment of hazardous chemicals and wastes is introduced. The authority for regulating hazardous wastes under the Resource Conservation and Recovery Act (RCRA) also is discussed. The regulatory framework for classifying haz ardous wastes, setting operational standards, and per mitting procedures and achieving compliance is explored. The RCRA permit for Tankopile (once it is received) will 229 CMA 047755 also be studied to be sure that each s.t.? with its tarts. Date: 2/25/32 Revision No.: 0 H > is familiar Section 2 - Storage of Hazardous Wastes at Tankcpile This section focuses on. the types of hazardous wastes that are handled and stored at Tankcpile, nomai/rcutine' s orace operations, and procedures for maintaining compliance the RCRA permit (e.g.; waste analysis, recordkeeping, inspections, and security). A site diagram showing the dimensions, capacity, and relative position of each storage area (tanks, containers, and piles) is included. Training for normal or routine operating conditions includes the following topics: 0 Proper operation and maintenance of the storage facility 0 Scheduled inspections 0 Purpose and use of security and communications systems a Monitoring requirements for tracking and recording the operation of the facility a Recordkeeping requirements andprocedures Section 3 - emergency and Contingency Plans The third section of the .raining manual provides detailed instruction on steps to b : taken in the event of an emergency such as a waste spill or `ire, power outage, or damage from wind and storms. The erne gency coordinator is clearly identified, as are emerge icv ohor.e numbers and directions 230 CMA 047756 Date: 2/26/32 Revision No.: 0 H for locating and using onsite emergency equipment, alarms, and communications. Contingency plans are also detailed. This manual is used in classroom training for both intro ductory training and annual review. All personnel involved with hazardous waste are required to complete 20 hours of classroom training in addition to 6 weeks on-the-job training. Also personnel receive an 8-hour classroom review training session once a year. This is supplemented with attendance by the environmental engineer at seminars and conferences involving hazardous waste management. H-lc Training Director The personnel training program is directed by Mr. John Q. Smith, the plant Environmental Engineer. Mr. Smith has been with Tankopile for 10 years. He received a M.S. degree in Environmental Engineering from the University of Cincinnati in 1971. He has been trained in all aspects of Hazardous waste Management and attended various seminars on this subject. Records of his previous and ongoing training are kept on file at the personnel office. H-ld Relevance of Training to Job Position Mr. John Q. Smith, the plant Environmental Engineer, is responsible for teaching hazardous waste management procedures, including contingency plan implementation, to all waste handling personnel. The training program is tiered (Figure 35) in some areas to provide training to personnel at levels that are relevant to their positions within the 231 CMA 047757 Personal safety ile lease prevent ion and re Continue (icy sponse plan Emergency procedures Hazardous waste man agement and prac Record tices keeping fnv iroiwicnta 1 Eng inter U it 11 U 11 11 Lnv iionmenla) Opera t ion s i oi'cm.in il 11 il 8 GL Opera tors i) 11 L li L L Hazardous waste handling and operations !i (i 11 H - Inoad insLrucLion w 1 = I uni led instruction figure 35. Level of training for hazardous waste personnel. q tuan 01 m < fl !' ID : 2/25/32 S ion No. : 047*758 Date: 2/26/82 Revision No.: 0 H plant. For example, the foreman receives training in recordkeeping and other procedures required for compliance, whereas the operators do not. Operators are more specifical ly trained to maintain proper and safe operating procedures and to respond effectively in the event of a spill or other emergency. H-le Training for Emergency Response This training program is designed to ensure that personnel not only handle hazardous wastes in a safe manner but also properly respond to emergency situations. The program trains hazardous waste handling/management personnel to maintain compliance under both normal operating conditions and emergency conditions. Training elements addressing nonroutine and emergency situations (unscheduled shutdowns and startups related to storms, power outages, fires, explosions, spills) include: * Procedures for locating, using, inspecting,repairing, and replacing facility emergency and monitoring equipment * Key procedures for automatic waste feed cutoff systems* * Emergency communication procedures and alarm systems Response to fires or explosions * Response to ground water contamination incidents and procedures for containing, controlling, and mitigating spills * Shutdown of operations and power failure procedures * Procedures for evacuation of nearby areas 233 CMA 047759 Data: 2/25/92 Revision. No . : 0 H In addition no the hazardous waste management personnel, a company dire brigade is on standby for response to all fires and other general plant emergencies. This fire brigade is trained both with classroom training methods and fire drills. The classroom training is required for intro ductory training and as an annual review for each member assigned to the fire brigade. The fire brigade training is not addressed in the hazardous vasts training manual. For more information contact Tankcpile's safety officer, George Shoe at 553-6750. The fire drills occur at a minimum of six times a year and are unannounced. Implementation of Training Program The director of the training program and all current wastehandling personnel have been fully trained at the time of this submittal In the future, all new personnel will complete this training program within 6 months of assignment to tne hazarzcus waste storage racility cr within 5 months of their data of employment, whichever is later. No employe hired to work at this facility will wer :< unsupervisad prior to completion of the training program. Employees are reouired to maez annually for review and update of this; training program and to the following subj ecus: 1) All hazarzcus wastes current! v W 3 rs J 1 a W 3 - the facility, noting any chan,ges in waste type, volume, source, characterise:. cs, or location chat have occurred durtr.c the oasz year. CMA 047760 Date: 2/26/32 Revision No.: 0 M 2) The status of storage and operating conditions and procedures, noting any areas where there are problems or potential for problems. Employees participate in developing effective solutions. 3) The requirements contained in the facility's RCRA permit, noting any changes that have occurred during the past year. Areas where maintenance of compliance is a problem axe identified and dis cussed, and effective solutions are sought. 4) Incidents that have occurred in the past year that warranted use of contingency plans and/or emergency action. This review focuses on the cause of the incident and identification of steps to be taken to prevent or to ensure better han dling of such events in the future. The annual review will also utilize the facility's annual report to EPA as a working document for the review. Records documenting the job title for each position, job descriptions, names of employees, and completed training programs (both introductory and review) will be kept onsite in the personnel office of Tankopile Finishing Company. These records will be kept until closure of the facility for current employees and for 3 years from the date of the individual employee's termination for former employees. 23S CMA 047761 Date: 2/26/82 Revision No.; o T SECTION I CLOSURE PLAN, POST-CLOSURE PLAN, AND FINANCIAL REQUIREMENTS This Section is submitted in accordance with the require ments of 40 CFR 122.25 ( a) (13'), 284.112 through 115, 254.173, 254.197, ana 254.253. This plan identifies all steps that will be necessary to partially close the facility at any point during its intended operating life and to completely close the facility at the end of its intended-operating life. The plan also addresses the conditions and reasons under which partial closure will occur. A post-closure plan is not required because this is not a disposal facility and all wastes are being removed at closure Tankopile will maintain an onsite copy of the approved closure plan and all revisions to the plan until the certifica tion of closure completeness has been submitted ar.c accepted by EPA, Region I. The Tankopile owner will notify the Regional Administrator at least 130 days prior to the date we expect to begin final closure. The closure date for closure of the entire facility will be 2002. Upon completion of closure, the Tankopile owner will submit to the Regional Administrator a certification by both the Tankopile owner and by a local independent registered professional engineer that the facility has been closed m accordance with the specifications in the approved closure plan. 235 04T? Date: 2/26/82 Revision No.: 0 I 1-1 Closure Plan f40 CFR 122.25(aW13)1 I-la Closure Performance Standard [40 CFR 264.111] This closure plan was designed to ensure that the facility will not require further maintenance and controls, minimizes or eliminates threats to human health and the environment, and avoids escape of hazardous waste, hazardous waste constituents, leachate, contaminated rainfall, or waste decomposition products to the ground or surface waters or to the atmosphere. If there is evidence of any spills or leaks, samples will be taken and analyzed to determine the extent of contamination in the soil and if necessary, in groundwater. Any contaminated soil will be excavated, removed, and disposed of at a proper disposal facility. Any contaminated groundwater will be remedied. The entire site will be regraded subsequent to closure to prevent erosion. The following sections discuss in detail efforts to be made at Tankopile to satisfy the closure performance standard. I-lb Partial and Final Closure Activities Tankopile expects to perform partial closure when we remove our waste pile from its current location in the eastern portion facility to a new location in the northern portion facility. Final closure activities on the waste pile will occur in 1982. Our procedures for final closure of the waste pile, including waste removal, cleanup and decontam ination activities, are described in Section I-ld(3) of the 237 CMA 047763 Data: 2/25/82 Revision No.: 0 I closure plan. Partial closure of the container storage and tank storage operations ara not planned. However, in the event that future circumstances or decisions force us to discontinue our hazardous waste tank storage or hazardous waste container storage activities, Sections I--Id(2) and I-ld(i) of the closure plan present cur procedures for final closure of each of the two storage areas. Any modifi cations to our existing facility equipment, structures, instruments or procedures related to the management of the three distinct portions of the facility will result in Tankopile updating the partial closure plan, and revising the closure plan accordingly. At a maximum we expect the operation to consist of storags of 100 drums, 2 tanks and 1 waste pile during the life of the facility, section I-ic of the closure plan describes the maximum inventory of wastes in storage at any given time during the operating life of Tankopile. Tankopile will secure permission to dispose of its wastes and enter into contractual agreements with XTC (an off-site surface impoundment) and the PZI hazardous waste landfill, c Maximum Waste Inventory The following table shows the maximum inventory of wastes in storage at any giver, time during the operating life of Tankcoiia for 1 waste pile, ICO ntair.ers, anc CMA 047764 Date: 2/26/32 Revision No.: 0 I Waste pile: metal hydroxide sludge 50 vd3 50 ydJ total Containers: metal grindings vinyl acetate sludge vinyl chloride sludge pickle liquor sludge 1370 gal 605 gal 605 gal 2420 cal 5500 gal total Tanks: pickle liquor 1,1,l-trichloroethane 7500 gal 7500 cal 15000 gal total I-ld Inventory Removal and Disposal or Decontamination of Equip ment Following waste removal, all piping to and from the two storage tanks will be disconnected, dismantled and decontam inated. The work will be supervised and performed using qualified Tankopile personnel. Personnel will be equipped with acid/solvent resistant coveralls (olefin material, -- coated-wi-th-heavy-polyethylene, film} , head protection, neoprene-coated glove! and boots resistant to solvents and acids. Both the wrists and ankles will be taped (electrical tape) to protect against upward and inward splash. Full face respirators with organic vapor and acid gases filter cartridges that seal directly to the mask will be used. Chemical neutralizers and spill control pillows will be employed in the event of any spills resulting from pipe drainage during the disconnection and dismantling process. Spill saturated spill control pillows will be placed in a 55-gallon polyethylene-lined, steel recovery drum located at the dismantling area for temporary storage. 239 047765 CMA Data: 2/26/32 Revision No.: 0 Since contact cf hydrochloric acid with sene metals produces explosive hydrogen gas, extreme caution will he taker, to utilize nen-sparking tools and equipment during ail cleanup and decontamination activities. Strict supervision will include provision for no open flames, hot surfaces, or smoking to be present in and surrounding the work areas. TH A 3-in lines which transport the waste from the plant to storage tanks will be dismantled. Positive displacement pus,ps, used to pump the wastes to tankers, and valves will be disconnected. In cases when it is difficult to remove all liquid or solid residues as these residues may be trapped behind heavy scale or rust or may be too viscous for' pumping,, the pipes, valves, pumps, dump trucks, and kiift trucks will be steam-cleaned to remove the residues. All contaminated wash waters, generated as a result of the sam-cIeaning process, w n TL i_ 1 e. J pumped by a positive di; placement pump into a tanker truck and transported to the XDC facility (an off-site surface impoundment) located 20 miles from Tankcpiie in Kranvilie, Rhode Island (?A I.D. Number RIGG000200CO) . Soi ..c - 7a zy he was s orace a no ex arxocii: o be c iewsver, ma oo s siri ^ i1 of contamination oc :u. men ana s c s exists An allowance :as naan made m the c_os St 3 ai ar.c cis: :sai ? oV^66 Date: 2/26/82 Revision No.: 0 X of approximately 20 yd3 using a front-end loader* If evidence of possible areas of soil contamination (in the form of soil discoloration or odor) exists, a soil sampling program will be instituted to determine the extent of soil contamination in those areas. At least one soil sample will be taken from the waste-pile area (after removal of the liner) and one sample near the container storage area, where unloading operations occur. Augor soil borings with collected samples will be transported to a laboratory with GC/MS and atomic absorption capabilities. If contamination is found in the soil, those areas will be excavated to the depth at which no contamination is detected. All soils, contaminated equipment to be disposed, and solid residues will be loaded and transported by truck to the PEI landfill located 10 miles east of this facility in Newburg, Rhode Island (EPA I.D. Number RI0000010000). Prior to leaving any of the site locations undergoing, decontamination, decontamination of personnel protective clothing will be conducted by removing all bulk material from the boots and spraying, washing, and scrubbing with detergent solution all outside protective clothing mate rials as well as exposed skin surfaces (i.e., facial area). I-ld(l) Closure of Containers All the drum containers in the Tankopile container storage area will first be removed for transport to the PEI landfill. Because of the incompatibility of the types of wastes, the 241 CMA 047767 Data; 2/25/32 'Revision No.: 0 corrosive sludge drums, toxic metal grindings dorms, end ignitable sludges drums will each he transported along with the pailets on separate truck trips to the landfill. The drums will be moved utilizing a forklift. The container storage area will then he decontaminated with a series of solvent washes and all waste water and residues generated will be collected in the sumps and pumped to the holding tanks for immediate analysis and, if laboratory analysis indicates that the waste is hazardous, the material will be pumped from the holding tanks into tanker trucks and sent for off-site disposal at the XTC surface impound ment. If laboratory analysis shows no evidence of contam ination, waste water and residues in the holding tanks will be discharged to the sewer system. The automatic sum? pumps in each of the sump areas will then be removed and decontaminated as described in Section I-Id. Approximately 350 gallons of waste water and residue are anticipated to result from the container storage area decontamination process. I-ld(2) Closure of Tanks The final spent hydrochloric acid waste load stored in the tan/-; is pumped to a tanker (by use of a positive displace ment pump) and transported no the local publicly owned treatment works (PCTV) for treatment. The 1,1,1-trichloro ethane solvent is pumped to a tanker in a similar manner, and the waste is transformed to a reclamation facility. CMA 047768 Date: 2/26/32 Revision No.: 0 I 1,1,1-trichloroethane, upon contact with acid or acid fumes, can evolve highly toxic chloride fumes and HC1 may react with water or steam to produce toxic and corrosive fumes. For safety considerations due to the proximity of the two tanks to each other, Tankcpile elects not to perform dismantling, cleaning and decontamination of the two tanks and associated piping concurrently, but in a sequential manner. Using properly qualified Tankopile personnel protected as described in I-Id, the following procedures will be used to decontaminate each of the two tanks: First, the waste outlet valve will be opened to allow waste residuals remaining on the bottom to drain from the tanks. The waste will be drained from the tanks into 55-gallon polyethylene-lined, steel recovery drums located directly beneath the outlet. When filled, the drums will be sealed and sent off-site by truck to the PEI landfill for disposal. The waste outlet valve will then be closed. A 2,000 gallon-per-hour steam cleaning unit (capable of washing a 16,000-gallon area of storage capacity/hour) will be rented to decontaminate the tanks. This process will generate residues in the form of contaminated wash waters. The waste outlet valve will again be opened and contaminated wash waters will be drained into 55-gallon steel recovery drums, sealed, and sent off-site by truck to the XTC surface impoundment for disposal. Approximately 2000 gallons of 243 CMA 047769 Data: 2/25/82 Revision No.: o T contaminated wash waters ar anticipated to he generated during the steam cleaning o all tanks and equipment. Ail the ancillary equipment associated with the tank will be detached from the tank. The equipment to be disconnected includes the nozzle for the level transmitter, piping inlets and piping exits. The pipes will be decontaminated by steam cleaning. Any visible spills or leakage detected during the disconnection process will immediately be remedied by spill saturation pillows, as discussed in Section I-ld. To assess whether the tank steam cleaning process has been successful for the 1,1,1'-trichlorcethane storage tank, a member of the clean-up team will enter the tank with full protective gear and a combustible gas/oxygen detector. The team member will assess the hazard of the tank by local diffusion measurement of the percent of lower explosive limit of any residual 1,1,l-trichlorcethane vapor in the tank. The detected presence of measured oxygen levels below 19.5%, or of com ustible gas will result in rswashir.g the tank. For the HC1 tank, litmus paper will be used for sampling the pH of the last drainage wash water. A neutral pH reading will Indies .a decontamination is complete. Next, the concrete slab supporting the tank will be steam cleaned. The tank will then be dismantled from the founda tion structure suttorts and either sold for scrap or resold, 2 44 CMA 047770 Data: 2/26/82 Revision No.: 0 I r-ld(3) closure of Waste Pile The waste pile presently located in the northeastern sec tion of the facility will be removed by June 1932. Closure of the waste pile will involve removal of the metal hydrox ide sludge from the waste pile area. Tankopile personnel dressed in protective equipment described in Section I-Id will participate in the closure of the pile. Due to the design of the containment system of our waste pile storage area, the 2'6" of sand and the 1'6" of pea gravel underlying the pile must be removed since the waste pile has in all probability contaminated these layers. Extra precaution will be taken in removing the pea gravel to avoid damaging the CPE liner and the 4'*-thick bentonite layer liner beneath the pea gravel. The waste materials, excavated by a frontend loader, will be loaded onto a dump truck equipped with equipment to avoid release of hazardous material over the sides. The material will be transported to the PEI landfill for disposal. To avoid contamination of soils surrounding the piping due to cracking or stresses due to excavation, the surface of the bentonite liner will be flushed with water to drain and clean the perforated clay underdrains and remove residual materials from the pipe that goes to the collection sump. Leachate collected in the sump will be pumped into a tanker truck for transport to the XTC surface impoundment. After several flushings in this manner, the clay layer will be 245 CMA 047771 Data: 2/25/32 Revision No.: 0 excavated with a baciccs and the leachate collection piping system, waste pile ur.derdrair.s, and the submersible pump will be removed. The materials (except for the pump) will be transported to the PEI landfill :or disposal. The pump will be steam cleaned for reuse. Soils in the excavated cone and within the perimeter ditch will be examined for. signs of contamination and at least one soil core sample taken, as discussed in Section I-Id. If there is no proven contamination of the area, the excavation will be backfilled with fill soil from local sources and regraded. The collec tion sump will be backfilled to prevent collection of rainwater and erosion. Schedule for Closure Within SO days after receipt of the final volume of hazard- wastes, final closure activities will be initiated laticn of closure will be within 130 days of this rrance. All financial calcuiatic ns are b asad on a closure date in the year 2002. The Regional Administrator will be notified by Tankcpile 130 days before beginning final closure. The proposed schedule for closure is shown in Figure 25. Tina! closure will be supervised and certi fied by a professional engineer, in addition mo the owner or operator. Extensions for Closure Time (40 CFR. 254.113(a) and 254.112 (b Tankcpile Finishing Company will not require an exmer.sion for closure time. ItC q47T72 CMA D ata: 2/26/32 R evision N o.: 247 Activity 1. Receipt of final volume of hazardous waste 2. Removal/disposal of final waste Inventory 3. Solvent wash of tank storage and piping system pile liner 4. Removal /disposal of solvent washings 5. Dismantling and scrapping or selling of storage tanks and piping. Removal of pile liner. 6. Soil sampling 7. Removal of contaminated soil 8. Completion of closure and certification submittal to EPA Regional Administrator Days 10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170 180 i - A Figure 36. Anticipated closure schedule. O Data: 2/25/32 Revision No.: o IO Post-closure Plans f40 CTR 122. 25 (aH 13)1 Post-closure care will not be needed for this facility ; not a disoosal facilitv. 1-3 Notice in Deed ar.d Notice to Local Land Authority [40 :jr 122.25(a)(14)j Because Tanxopile is only a hazardous waste storage facility and not a disposal facility, notation is not necessary in the deed indorsing potential purchasers of restrictions associated with, a disposal site, as required by 40 C7R 254.120. 1-4 Closure Cost Tstimata (40 C7R 122.25 ( a ) (15 ) and 264.1421 The closure cost information presented is submitted in accordance with the requirements of 40 C7R 122.25(a) (15 ), 254.142, and 254.143. An estimated 357,500 (March 1932 cost estimate) will be needed to close the Tar.kopile hazardous waste storage facilities. The closure costs are presented bv activity m Table 14. Activities include removal of waste inventory, decontamination, disposal of wash solvents, disposal of contaminated soil, and closure certification. 3 3 U^Ttp **CnS TiaCS 1",'6 ssrmara are as Removal of final vasta i rv/anro r". raame vcl'i?,a is ICO druns of asscroac vasnas; 7500 gallons of wasoa --C*, ToOO ga^i.cn.3 cz **asoa i, . - -- i - 1* o ro a on an a anc 50 yd3 of metal hydroxide sludges. Disposal cost estimates are based :n land disposal o: tne arums ar.d waste pickle liquor, incinaratic: the waste 1,1,1- "'** ch' o --o-h.3"a 243 04r7'7- i Date: 2/26/32 Revision No.: 0 I TABLE 14. CLOSURE COST ESTIMATE3 A. Tanks 1. Removal of final waste inventory a. Disposal cost (7,500 gal HC1 waste 9 SO.10/lb) b. Disposal cost (7,500 gal 1,1,1-trichloro- ethane 9 SO.15/lb) c. Plant labor (8 h 8 $12/h) d. Hauling (2 trips 9 S350/trip) $ 5,000 9,000 96 700 Subtotal $15,000 2. Decontamination of storage tanks, piping, and pipe liner a. Solvent (100 gal 9 $2/gal) b. Supervision (20 h # $2Q/h) c. Labor (40 h 9 $12/h) d. Dismantling of two 7500-gal tanks and ancillary equipment (80 h 9 $12/h) e. Oisposal cost of solvent, water washes and spill control pillows (35 drums 9 $40/drum) f. Discharge cost to the city sewer system S 200 400 480 960 1,400 ___260 Subtotal - --------- . S3.7QO-- B. Containers 1. Removal of final waste inventory a. Oisposal cost (100 drums of various chemicals 9 S40/drum) $ 4,000 b. Plant labor (8 h 9 S12/h) 96 c. Hauling (3 trips 9 S350/trip) 1,050 d. Disposal of contaminated container storage area decontamination washes (1 trip 9 $250/trip) 250 Subtotal S5.400 C. Waste Pile 1. Removal of final waste inventory a. Oisposal cost (50 yd3 metal hydroxide sludges 9 580/ton) b. Plant labor (24 h 9 S12/h) c. Hauling (1 trip 9 S350/trip) S 4,000 288 350 Subtotal S 4,700 (continued) 249 CMA 047775 (continued) Z. Disposal'or contaminated base matarial , liner, foudnaticn, and contaminated soil a. Removal (50 tons: SO h 3 SS2/n) b. Hauling (2 trips 3 $350/trip) c. Oisposal (50 tons 3 530/ton) d. Oisposal of residual liquid from sump Subtotal 3. Cecontamination of equipment a. Rental of steam cleaner (2 day 3 575/day b. Oisposal of decontamination residues (5 drum 3 5-0/drum) Subtotal Soil Sampling and Analysis 1. Core samples 2. Core analyses Subtotal Closure Certification 1. Labor (P.E. as h 3 SSO/h) 2. cjcoenses (5 days 3 575/day) 3. Transportation (300 mi 3 50,23/mi Subtotal Sub* otal 1. Plus 1535 administration 2. Plus 15% contingencies Tota 1 Closure Cost 32 dollars. Data: 2/25/32 Revi sicr. Mo. : 0 I 5 4,350 700 4,000 250 55,900 5 150 200 5 350 S 400 500 5 1,000 S 2,330 4:0 53 S 3,400 544,300 5,500 5,500 557,500 250 CMA 04777 Date: 2/26/82 Revision No.: 0 X. 2. Decontamination of storage tanks, piping, and pile liner. Tanks and piping for the HC1 tank will be washed with water, whereas the 1,1,l-trichloroethane tank will be washed with an alcohol wash. After removal of the waste pile, the pile liner will also be removed by plant personnel. 3. Removal of solvent washings. It is estimated that two drums of water wash and two drums of alcohol solvent wash will require disposal. Cost is estimated at 540/drum. 4. Disposal of soil in contaminated area. Although the soil is not expected to be contaminated by the waste storage at Tankopile, an allowance has been made in the closure costs for removal and disposal of approxi mately 20 yd3. It is assumed that 1 yd3 of soil will weigh approximately 1 ton. 5. Closure certification. The cost of certification of closure by a professional engineer (P.E.) is estimated on the basis of a labor rate of $40 per hour and an estimate of other expenses for a 6-day period. 6. Total costs were calculated by adding IS percent administrative costs and 15 percent for contingencies. This closure cost estimate will be kept on file at the Tankopile facility. It will be revised whenever a change in the closure plan affects the cost of closure. It will be adjusted annually (from the date of its original develop ment) to reflect changes in closure cost brought about by inflation. The Department of Commerce's Annual Implicit Price Deflator for Gross National Product* will be used to make this adjustment. Published by U.S. Dept, of Commerce in its monthly publication "Survey of Current Business." 251 CMA 047777 Data: 2/25/32 Revision No. : 0 I 7ir.ar.ci a 1 Assurers Mechanism fcrtOlcsur 5 ruo CTR 122.25(a)(1), 254.143, and 234,150 1 "' w^S Closure Trust Fund [40 CFR Sections 254.143 (a) ar.d 254.151(a),(1)] Tankopiie will establish a closure trust fund as rite selec ted financial assurance mechanism at the Anytcwn National Bank. An originally signed duplicate of the trust agree ment will be sent to the Regional Administrator by certi fied mail. A copy of the agreement is attached as appendix C. A oavment of one-tenth of the estimated closure cost will be deposited annually in this account. Although the expected life of the facility is 20 years, the duration of the permit is expected to be 10 years, consequently, the payment period will be 10 years. Combinations Post-Closure Cost Estimate f40 C7R Sections 122.2 (a)(15) and 254.1441 Since all wastes will be disposed of offsit nc cost-closure activities or costs. Financial Assurance Mechanism for Pcst-Clos Sections 122.25(a)(15) and 2 54.145 i Since ail wastes will be disposed of offset no cost-closure activities or costs. CFR Liability Insurance f40 CFR Sections 12225(a)'1?) and 25-! Sudden Insurance [40 CFR Sections 254.147(a), 254.1 = 1 (i), and 254.151(j)] Tankcpile has obtained liability insurance for succen and accidental occurrences in the amount of si million per 252 CMA 047778 Date: 2/26/32 Revision Ho.: 0 I occurrence with an annual aggregate of $2 million exclusive of legal defense costs- An originally signed certificat of liability insurance has been sent to the Regional Admin istrator by certified mail. The certificate is worded as specified in 40 CFR 264.151(g). I-8b Nonsudden Insurance [40 CFR 264.147(b), 264.151(i), and 264.151(3)] Tankopile is a storage facility, therefore, no liability insurance is required for a nonsudden accidental occurrence. I-8c Financial Test [40 CFR 264.147(f) and 264.151(j)] Tankopile has an insurance policy for sudden and accidental occurrences, therefore, the financial test is not necessary. I-Sd Variance Procedures [40 CFR Section 264.147(c)] Tankopile will not request the Regional Administrator for a reduction of liability amounts. I-8e Adjustment Procedures [40 CFR Section 264.147(d)] If the Regional Administrator increases the amounts of liability coverage or elects to improve nonsudden liability coverage requirements, Tankopile will immediately seek an adjustment to the insurance policy discussed above. 1-9 State Assumption of Responsibility [40 CFR 264.150] Tankopile will not request state assumption of the legal or financial responsibi1ities. 253 CMA 047779 Data: 2/25/32 Revision No.: 0 SECTION J OTHER FEDERAL LAWS Information will be provided in accordance with the re quirements of 40 CFR Part 122.25(a) (20) at the request of the EPA Region I office. At this tine, however, we believe this facility is in compliance with the following Federal laws; wild and Scenic Rivers Act, National Historic Preservation Act of 1965, Endangered Species Act, Coastal Zone Management Act, and the Fish and wildlife Coordination Act. 04*7780 CMA Date: 2/26/32 Revision No.: 0 CERTIFICATION I certify under penalty of law that I have personally examined and am familiar with the information submitted in this document and all attachments and that, based on my inquiry of those individuals immediately responsible for obtaining the information, I believe that the information is true, accurate, and complete. I am aware that there are significant penalties for submitting false information, including the possibility of fine and imprisonment. Date: 0 /9$2 Signature: t. 255 CMA 047781 REFHRiDfCZS U.S. Department of Commerce. Standard industrial classifi cation manual. 1S72 with 1977 supplement. U.S. Department of Commerce, National Oceanic and Atmo spheric Administration, Environmental Data and Information Service, National Climatic Center, Federal Building, Asheville, North Carolina 23301. U.S. Geological Survey, Topographic Maps. 1100 South lads Street, Arlington, Virginia 22202. U.S. Geological Survey, Topographic Maps. Box 2S2S5 Federal Center, Denver, Colorado 8022$. National Flood Insurance Program. FIA flood maps. P.C. 3ox 34294, Bethesda, Maryland 20034. Start, A. C. Air Pollution, Vol. 1, air pollutants, their transformation and transport, 1976. . _ ____ Water Resources Council. Guidelines for determining flood flow frequency. Bulletin No. 17A. Hydrology Committee. Washington, D.C. 1377. Federal Insurance Administration. The floodway: a guide for community officials. Number 4 in the community assist ance series. Federal Emergency Management Agency. September 1973. General Facility Standards for location of Facilities. Background document; Standards applicable to owners and operators of hazardous waste treatment, storage, and dis posal facilities under RCRA, Subtitle C, Section 3004. 40 CFR. 264, Subpart B, Section 264.13. December 30, I960. Office of Coastal Zone Management. National Oceanic and Atmospheric Administration, Department of Commerce, Wash ington, D.C. Dean. L. F. Floodplain development pressures and Federal programs, Part II; Methods used by Federal programs to reduce flcodolair. develoome.tt oressures. Research Grouo, Inc., Atlanta, Georgia. ' ZPA Publication 12C/1-79/CC13, Mav 1373 . 25c A CMA 047782 12. American Petroleum Institute Recommended Rules for Design and Construction of Large, Welded, Low-pressure Storage Tanks. 6th ed. (current through Revision 2). Standard 620, API 2101 L St., N.W., Washington, D.C. 20037, 1978. 13. American Petroleum Institute. Welded Steel Tanks for Oil Storage. 7th ed. Standard 650. 14. American Water Works Association. Standard for Steel Tanks - Standpipes, Reservoirs, and Elevated Tanks for water Storage. D100-79. Denver, Colorado, 1979. 15. American Society of Mechanical Engineers. Boiler and Pressure Vessel Code, Section VIII. Hew York, 1974. 16. Underwriters Laboratories. Standard for Steel Above-ground Tanks for Flammable and Combustible Liquids. 4th ed. Publication UL142. Northbrook, Illinois, 1972. 17. American Society for Testing and Materials. 1981 Annual Book of ASTM Standards, Pressure Vessel (35) Plate and Forging, Part 4. 18. Department of the Army. Flood-Proofing Regulations. EP 1165-2-314. June 1972. 19. Perry, R. H. and C. H. Chilton. Chemical Engineers Hand book. 5th Edition, McGraw-Hill Book Co., 1973. 20. U.S. Department of the Army. Design and construction of levees. 1978. 21. U.S. Bureau of Reclamation. Design of small dams. 1973. 22. Department of the Army. Wall design: floodwalls. 1948. (Note: new edition should be available in fall of 1981.) 23. Tchobanoglous, G. 5., Theisen, and R. Eliassen. Solid wastes: enginerring principles and management issues, McGraw-Hill, Inc., New York, New York. 1977. 24. Linsley, R. K., and J. B. Franzinc. Elements of hydraulic engineering. McGraw-Hill Book Company. New York, New York. 1955. 25. Settig, M. Landfill disposal of hazardous wastes and sludges. Noyes Data Corporation. Park Ridge, New Jersey. 1979. 26. American Concrete Institute. ACI Manual of Concrete Prac tice, Part 2. 1980. 257 CMA 047783 27. Office of Solid Waste Management Progress. Pest Methods for evaluating solid waste. Physical/Chemical methods. Environmental Protection Publication sw-345. Washington, L'.S. Government Printing Office, 1930. 23. San, N. I. Dangerous Properties of Industrial Materials, Van Mostrand Rei.thcld Co., 1979. Kational Institute for Occupational Safety and Health. NIOSH/CSEA Occupational health guidelines* for chemical hazards, Publication Mo. 31-123, January 1931. 30. Proctor, N. H., and J. ?. Hughes. Chemical hazards of the workplace. 1973. 31. Touhill, Shuckzow and Associates, Inc. Management of hazardous waste leachate. Environmental Prot action Publication SW-371. Washington, U.S. Government ? rinting Office, 1980. 32. Industrial security systems and procedures, book 70-2 of plant protection manual. Plant Engineering. Technical Publishing Co. 1930. 33 . National "ire Protection Association (NTPA). Flammable and Combustible Liquids Cede. 3ostcn, 1977. 34. National Institute of Occupational Health and Safety. A Guide to Industrial Respiratory Protection. 1976. "ire protection bock 70-1 of Plant Protection manual. Plant*Engineering. Technical Publishing Co. 1981. Elements of industrial fire control, book 70-5 of plant protection manual. Plant Engineering. Technical Pub lishing Co. 1980. 37 . Schupack, M. How to inspect and evaluate prestressad concrete tanks. Public Works, September 1931. c. 83-39. se . Vaiach, D., and A. Gaines. Corrosion monitoring in chiorosolvents plant saves over SS0,00G per year. Chemical Processing, March 1931. ?. 20. Earley, D. E. Source assessment: Pail tank car, tank truck" and drum cleaning - state-of-the-art. Publication EPA-6GC/2-73-CC4g. Cincinnati, Ohio, April 1973. California Deoartmer if Health Services. samples and sanding orocedures for hacarcous waste. Publication EPA-600/2-3C-G13. January 1930. 253 CMA 047784 in 41. National Board of Boiler and Pressure Vessel Inspectors. National Board Inspection Code, A manual for boiler and pressure vessel inspectors. 1155 North High Street, Colum bus, Ohio. 1973. 42. Matrecon, Inc. Lining of waste impoundment and disposal facilities. Environmental Protection Publication SW-870. Washington, U.s. Government Printing Office, 1980. 43. Tryon, G. H., and G. P. McKinnon. Fire protection hand book, 13th ed. National Fire Protection Association. 1969. 44. Office of Solid Waste Management Programs. Hydrologic simulation on solid waste disposal sites. Environmental Protection Publication SW-868. September 1980. 45. Huibregtse, K. R., et al. Manual for the control of haz ardous material spills. Volume I, Spill assessment and water treatment techniques. Publication EPA-600/2-77-227. 1977. 46. OSEA Standards, 29 CFR 1910. 47. U.S. Army Engineer Waterways Experiment Station. Guide to the disposal of chemically stabilized and solidified waste. Environmental Protection Publication SW-872. Environmental Laboratory. Washington, U.S. Government Printing Office, 1980. 43. National Fire Protection Association. Fire protection guide on hazardous materials. 6th ed. 1975. 49. U.S. Environmental Protection Agency. A method for deter mining the compatibility of hazardous waste. Publication EPA-600/2-80-076. Cincinnati, Ohio, April 1980. 50. Robinson, J. S., Hazardous chemical spill cleanup, Noyes Data Corporation, Park Ridge, N.J., 1979. 51. Environmental Protection Agency Background document Listing of hazardous wastes. (40 CFR 261) Sections 261.31 and 261.32, and its Appendix A. Health and Environmental Effect Profiles. 52. Weiss, G. Hazardous chemicals data book. Noyes Data, 1981. 53. Smith, A. J., Jr., Managing hazardous substances accidents. McGraw-Hill Book Company, 1981. 259 CMA 047785 54. Acurex Corporation and Metcalf Eddy, Inc. Closure of hazardous waste surface impoundments. Environmental Pro tection Publication 3V-373. Washington, U.S. Government Printing Office, 1930. 55. Bureau of Law and Business, Inc. Employer's handbook of hazardous waste training orograns. Stanford, Connecticut. 1S32. 55. Southwest Research Institute, Department of Special Studies. Technical Resource Documents - Land Disposal-and Other Pacilities. 57. American Petroleum Institute. Guide for inspection of refinery equipment, chapter 5, third edition. December 1978. Washington, D.C. 53. National Tire Protection Association. Cleaning small tanks and containers. NFPA No. 327, 1975. Boston, Massa chusetts . 59. Financial Assurance for closure and post-closure care: requirements for owners or operators of hazardous waste treatment, storage or disposal facilities. Guidance Docu ment. ICF, Inc., SW-955. May 1982. CMA 047786 Date: 2/26/32 Revision: 0 APPENDIX A GENERAL INFORMATION AND HAZARDOUS CHARACTERISTICS OF WASTES Excerpted from: Dangerous Properties of Industrial Materials, Fourth Edition, 1975 by N. Irving Sax 261 CMA 047787 Data : 2/25/32 Sev.isis ;n No . : 0 BYDHOCHLOR1C ACID Cutni ti/oiuiM SyoccrTru: aurtuuc aod; ciktrohydrie add; hydrogen chloride. Caiorini pa be coidrleev fuavint liquid; aTontir W- ^ * K'malr*r'*. Mol t: 344?, =p: -M4J-C. bp: -W,J*C d: 1.439 */TiUf (jaa) u rC; '..ISA u -Jrf'C (liquid'), rap. pro.; 4.0 tia u IT.J'C Iljrird Ajttyj Tone Haiard -tidsx: Acuta LmI; Lmuuit 1. Acuta Srauuue: lapettioo 3; Inhalation 3. Connie Lout; Ifnunl Z. Ciroorc Sytutruc: U. To*icoo*y: Hydrochloric icd a ia irriuai to tie *"* scmirim ed bba era wd rupirucrr tract tod > scoemuntioa at 33 ppm eauaea im- tauco of tia threat tftxr tbort ttpc-iure, Ccncsn- trauona of 30 ip 100 ppta art tcknole (or t hour. Mora ttitrt ttpoturea rsauit in puirocoary dmi, led often iarynjeai ipeas Coocaotriuota at 1.CC0 to 1X0 ppta Ln djrt*ero<ra. ewes for bnef ex- pcaurtv Miiu at hydrochloric tad in considered 1st harmful this tit ihiydnsu* Sydretcn silo hdt. usa tin droplets bi't .so dehydrating lelioe. la peneriL hydrochloric ted au*a littl* trouble a iodo<17, other tiro from accidental tplashei ind bum. t( i> used a 4 tsnersl purposa toed tddiUT* (Seetica 10), It a i xosn air ssstxai- aaat. Cdour Harari: Danyerota; mm shloridea; vtU naa with water at Hum to product tout and correut* furmea. VTVYL ACXTATE Geocral lotoraitioe Caiorieai. aobtie liquid, potrsrnia* to solid sa a- pOlU'e to lilht. Formula. CH,CCCCHCH* Mol wt: ii 93.943.3333. aupt3T-:aCU*luCtotbcpt.: 7t3e'Cpp..:las1h00p`F.:. U*7. tip. prea.: 100 as it IIJ'C. lei 14%, del * 13.4%, rip. i.: 3.0. Haaard Aojlydi Tone Hauard Aatittt: Acuu Local: tmtaal 1. Acuta Systemic: Inheiiuja t. Chrome Local; IrTtuaa l. Cixouie Sritoaus; U. Tauoploty: Miy us. a a tiia uritaot by to tcttrc.it Kttoa. Hits toncifliriuaru at tpor ui ptrsuc but art tarmwl aeiy 'i to Inhibitor 3 prnapt. Firt Hrard: Hitiiy diotarau* ba tipmcd to beat or lioa Scoatnesui Hutcit- Mo- uploiiaa Htoard; L'ninctm Ctuitar Heard: Dtntcraui: bca betted to dccstooo- aoao. it hurts tnd tmta tcid .'u.iwu; au :tssx mii audipooy ititraia. o-ntlCrTLO * omu.vs C*3*ni latanuds* Jyooorsu: l.l,i-tnbiiorottiao< sttiyl sbiorctsr^ CpJorlna liquid. Famuli: ClH.Cdv Mol rc 130-40. bp: JAl'C .*7! -3U*C luh d: iJAr* u ar/4*c Tip. .o*c. ICO =s Saaard Ajrlydj Toxic Haard R1t3.it: Aetna Local: Imur.t 1: Ln patios l. Anna Syatcaic: Liitiiuca Z. Otrome Local: Irritant 1. Cirsoic Sotctrjc: Lipitso I: loiaiaups 1. Tandy: Htrsotie m biph ainetsiriuona. Otacatar Haaard: Dinieraun; Sat ailondo. vt>tl CHLOume Ciatnl Ularudaa SrnonTtna: ahlarotanyltac: :!tlara*ihn. Cclorlcia bqutd pr pa (vies nijautdl; lastly nut odor. Famula: Mol wt: iZC.SrtC,C. HbCp:3.-13.4*C !la4%, aai-^%. !iah p.: -104'F ICOC.). bar -!3.9*C. fp: -139.7`C. d Squad: 0.9193 at 13' 4'C. rtp. prtst.. 3100 at M'C. Tap. d.; L1J. autotaa. tosp- HZ'F. Hatnrd AAolyai Taut Heard Saitnj: Acuta Local: Lmunt 1 Acuta Sysamtc: Inhalatioa L Cbromc Orsme Local: Imtant Z. jpMnrje: Initlaiion 3. Tovicoiocr: la iai ssncsr.t.'ioona h tct s to isc* ticue. Cate ttit. burro by rtpid tTtporatwo tod aaeacquest freesed. Cirorue tapenura. la tioss litty orary In raa and raacita. Codtilatary tod bon* aianpta j tic iatcr 'ubi rtportsd a arifrt ietdlinj unpolymensd mienila, A :a=5{hii=i aarctocypn iSection 3), at tie li,y. Caution: Mi' :iua< locai irritatieo at frostbit: due to rapid e'tparatian from li.n or truua. Firt Hioard: Ctnaerots, when ttponed to beat or iam. Lurie hrs pf tip maiertii art prtcuoafly trveian rjuhtile, Soomtnecud Heaun(t Mo. Euplotion Htoard: Sererc la tie fpm o/ raper wbeo eapned 'p heat or fame Duuter Httard: Very deitcrotn; when beaud to b smpotiuotu n ttruta iiiaiy 'otic fumee at pbow* tenet an react urorsutly vi^: aud.dir,; paia- r.iu. 3efsre uortnt at hardlint tita aatertii m- itnucucna for ita oe ilvbuid be poitined from be nspuer. roue buiuho aurrwc coot /> r*<t-r :uw>ih, -- i^e *> I MwuCtK'Xan:da<ra)4Mauaju.Wi rva^amoo*uarr sM<jnoai; Hu^ui sle tr.tntn net erwre mouta p tauie ant s pestnmi JiiufY t SLICHT. Ciu^M miulr ipeav ta4 si uwoia * WOCIX^T-: Mv AiAfva iia* 3 Hw^ioCrtHi.ioo<urr y y>K>C,Ar,g \9N<i ir*t3 sr jtforsiiioq t* jrr^iibLt tad ,ii> 9-Mi4 J7 wiXrti 4,vrr *Am *07 252 047788 CMA Date: 2/26/32 Revision No.: 0 l rin Gtami Synonym: plumbum. BluivU-triy. mtt maulFormula: Pv At t: 307.21, *: J3T41*C M>: l30*Ci 4 MJSI 30*/30'Cwmprw.:lmm*m*C Haw* !*!* Tout Hazard JUum: Aetna Loot: & Acuta Syutmia: ttOalariim J. Qianic l<al; a Quomt Srmatc: hpaia); Infcilawa J. Tmua*oc: St* kad compound*. A lamoum air coolamwam. hot usptnod carooofta 01 Ifet ha* tad kidney (SaetMa 14. Radiation Hazard: Far parmiaaifeh Imb m iidiw S. TaM* 1. Andioal aetopt mTt, TV* 53k. Decaya is uaoit "Tl By afccuon capture. Earn y'a at 0.40 MtV tad X-rayv Nataril s*ope "?* (Radium* D. Uranium Santa), TV* 21 y. OaaniandMearn "Si by <nuxun( ft at 0.013 (tl*). OJMI (1**) MaV. Alto mia yl at 0.0*4 M*V. "Tb mualiy tura in mutltbrium witb is laurhtan "Si tad "Fa. Natural amopt "A (Tbuniim-B. Tbonum Santa). Tv 10.Wa CUcart ta radioactne Si by namiac ft at 0.1* (J*). 004 (II*). 031 (14*) MtV. Alas tows T'a at 03A 030 MtV and X-rayv Fat Hamrd: Modanta, ia tbt farm at diaa *bn o> petod to bait at Sam*. Sat alto poodtrad awala. gaploama Hazard: Modtrait, tht form at dial vboa cioottd ta htti at Stmt. Ootattr Hazard: Danftroia: whan haatad it amita bitbiy toxic fumm; cas rata ntorowly aid) tai- 263 CMA 047789 <u 0 ctomiux covtrotrxDs Board Ajac* Time Hacard ^Jua^r Uaut Local: Irritant 3; la^tiano 1: Inhiiaocu }, .Loot Sptteiwe: U. Chronic Loctl: Imuri 3; Inpstuett 3: Inhalation 3. Ci/onie S.nimc lasnuaa 3: Inhalation 3. tcmicv: Chromic tod tod iu taita bare t airoiin action on til* ii:n ind mucout .Twmbfinci. The icuoro trt onrtned to the tiposed para, iJanut e.'iMlty the tim :f the banda and fartarmt tnd the mudoua membrane* of the uul aeptum. The chartctrbuc lesion it i deep, perw.m^it ulcer, which, /or he mow part, ic*n act tend to Hippyrat*. tad which a tlow in bealint Small ulean, about tie tia o/ > siatchhead or tnd o/ i kid penal may be found. chidy irouod Lb* bate 9/ the aiiU, on the Inueijes, dontua ot An handa tod forearm*. These ok*n tend to be dean, tod pro*re*t Ucwlp. They an frwtuentiy puniest, rren thouah curte deep. 7be7 beat slowly, tod leave lean. On the mucous tnembrine 0/ tbc petal leptuat the olein art usually lecair.piniwd bp purulent ducharte tod crtau.it U exposure con tinue*. perfonuco sf the cutl upturn nap fault, but produces 50 deformity at the note. Chromate taita trt reeocursd cardnoasm of the lurjj. nual canty trtd paranatal tinta tito eapwrirpcnui casein* Ofen of the uoctadt tod larpu (Section >3. Heiavaknt esmeoundt trt laid :o be more tone than the trivikm Eccamatote dermauut due to tri- valent chromium ccopouoda bat ben reported. CMA 047790 LLO COMPOUNDS I11M AulrM Tone Hoard Battac: Acute Local: 0. Acta* Systemic'- lnauoa 3: Inhalation l Clronac Lorsl: 9. Chrome System*: lnpatioa 3; InhaJuioa 1; Shut Ah* torpuoa S. Tsueolofy: Lead poaonioc `a on* al the oomtimisaat at occupational 'latnr TV a of lesd-haarnu materials a* had compounds in an industrial pilot doa act wmnri> rwiuit in ripoaur* oo '-ha part at tha workmao. Tb* laad must ba ia lock fora, md a distrtbutod, as to tain aouand* into vha body m usaua at tbt workmao ia nsaaunbk Ooaoury. alana no exposure caa ba laid to uat. It ia --pawad tamtnnpa at At laooi and kidney* (Sanaa I). Mod* of tour mto body: 1. By mhateuoo at the don. tea, km or vapor*. (Cvnnawi air contaminants!. 1. By swung of load compounds trapped a tfet upper mapiratory not or rntroduod into A* mouth oa loot, tohateg Sayan or other obtacis. 3. Throunh vba skin; this rout* at tpabai an- portinc* a tbt oaa of oryuia eoaopeoada at had. ia laad tetraethyl. la tba earn of tba Aoriaae fora of load, tba mm a cd ao practical wpor- taooe. AyMofoaml Acam aad Toaiaty: Whan load a ia> p i t much od it pun tbrouyb tba body onah- lorbed tod a eliimiwrd a tba fa. TV* fraaior portion of tba load that it abaorbad a audit by tbs Uv*r aad titrated, ia pan, ia tba bite. Far tba raatom laryar taoism of laad sra amaty to aiat ponottm* if ibtorptim a by tba maa. tad a leottr period of npotur* a usually oarontry to produce tywptbma Oa tba otbor band, whan load a abated, absorption taka placa taaily (root tbo mpiratory tract aad symptoms trad to develop more quickly. Fron tba pooh of view of jadiautai poooruna. tnbalauoa of had ia mob mora mpor- loot tbaa a ibfcatioo. Laid a a eumuisu** potaog. lacrcaaim anounta bold up at tba body aad eventually a potat a rvaithad when tympton and disability area*. Laad produtm a bfittitnaa of tbt rod blood alia to that tbry btmohrm with bat ilipht trauma: tba baoiodobui ia not tfftcMd. Dua to tbatr amoaaad fraplity, tba rad alb art dttuayad nor* rapidly in tba body than aomally. produemi an aotoua *bkb < riraly trvar*. Tba 1cm of arcuUoad rod a111 unnulsta tbo production of oaw young alb which, oa astennt tbo blood stream. an acted upon by tba drenlaiiat had. With rawtium cDefulatJoo of their basophilic mattnaL Thaw ealb after tunable nunui*. x* raeppumd a "wipplad alb* A* retards tba affect of had oa tba whit* blood oils. there ia ao uniformity at opiwoo. la addtuoo to in riTtct oa tba rad sdb of tbt blood, had pro- duca a damapiat aflam m tba orfirm or Aoio* with which a tnam to aoatacL No ipacdr at sharaeteriatie baa b produced. Autopaai of daatba attributed to had poiserun* aad npm- mental work oo animals. have thowa pathofapoi leuor* of tbo kidneys Bvor. taab ponadt nervous lyoom blood vouob and other tatuai. Norn of thorn cbaitpah bowavur. Bavo bean bad m MoassJy. la am of lead ponottin*. tba ueaimt of had found la tbo blood ia frequently ia axcaaa of 0.07 mq per 100 a af whole blood TV* urinary hid as* art>oa generally tioordi (kl ids par tiler of urioa. Tba loirdty of tba varioua had compounds a^ pears to depend upon tavaral factora: (11 tba to!la bility of tha compound ia tbt body Auida: (3) tba l cnees of tba panicles of tba ampouad; sola btlity is irtticr. of course, ia proportion to tba Sao* aau of tb* partidoa: (3) conditions under which tba aoipotuid h bains u**d; where a had sc pound ia used a a powder, contamination of tbo iimaphart will ba much lam whan tba powder is lapt damp Of the varioua laad aampouadn tba sarboaaia, tba monoxide aad uiifit* ue conaidarwd Date: 2/26/32 Revision No.: to ba aers toaia tbaa metallic had or ocher had sotnpnunrh. Lead arsenice ia very toam dua to tba prsaanct at tba anaaic radicaL Utm tod Symptom*: Indtatrial had ponoaihS mamooiy occur* foiiowinf proioofad cipovure to had at it* cuntannul* Tb* catamoa dimcal typa at load pouoauts may ba daaaiflad Kcordin* to tbair diatcal puaure u (a) aliowaury: (bt neuroraotor: aad () sacapItalic. Soon cam stay tbow a earn biaaaoa of clinical typea. Tba alimentary type oc cur* moat froqueotiy. aad a ebaractahmd by th* dotmaal discomfort a pain. Sevan mam may pra wns scruai colic Other compUiau in onMipattoo am/at dianbaa, Icaa at ippeun, matadia tasu, Mima and rootitias, lanimdc inaomm*. nilrncii jmaa aod mwda patns. muabtlity, headache tad itiranmi Fiilor, had liaa on tb* fume, pyorrhea, lorn at watsbti abdomuial tandernati. baaophiiic ippliam aaantia, tiisbi afbuouaric tocnaaad unoary taepupo, aad an iaoua* ia tb* lead eon* m of tb* wbal* blood, an tipna which may a* company tba abowa tympsoota. Ia tb* neuromuscular type, tb* chief aomplaiat ia weaknet*, frequently at tb* extensor muscles of tba wrht aad band, unilateral or bdaural. Other mds troop* which an tubytet to constam ia* may ba aftaciad. Gsatrmmanc symptom in tm* ally promt. huiMa seven a* in tb* al*maatary type of pptaootap. Joint tad muscle pains an likely m be man wvata. Heidich*. dimneic aad insomnia ire frequently proatiaatu. True paral* no ia uncommon, tad usually a tba result of proloopsd sxposure. Lead taeapbalapatbj is tba moat sovan but the mnm maai/tstaiioa of hsd poboaiap la tb* adua* trial worker it follow* rapid sad heavy |*ad ab*or> uoa. Ortatuc had oompeundv inch a tetraethyl ham an absorbed rapidly through tb* tkia a* w*u m tbroufh tb* iunm. sad an wtemtveiy sbaorhad bp tba centra! aervout lyttatn. Tba diatcal picture in those case* is usually so aaopbalepatby. With iaorfsruc had compound*, sotoperah1* eencnira* tiota ia tba antral nervexo tysieim ere reached only wbaa the workplsc* is btavtiy coMinuasisd with rapor. Aw sad dust Hncapbalopstby beputs sbruptly. sod is chancuruad by utna at cartbral od awmaptal involvaaaat. Than ia vauaily stupor, proarassinp to ooma, with at whbout aovuiitotu and often iarminauc( in daub. Excttauoo. cnofts* tion snd manta art leu cammed la milder cam of short dursitoo, than may b* tyraptoms of head ache, dicsiwsa. lotnnolaac* sad irtaoouud Tba artbropmal prmiim* may ba inaaarod. Sa alao ipactAc compound. DU(nota: A die(hosts of had pobooint should oot ba made on the baste of arty unite diatcal or lahorstory Sadia* Than must ba t history of umuicam aipoaurd uana. aad symptom* (ia doenbad shove) opiapaubte antb tba diaBada sad condrsstory laborstory tats. lucres** of stippled rad blood aite. mild loemid sod ttevtiad had in Mood sad wind iau mera than lOT mp/100 mi blood and similar value* par liter of uruw. An merest* of coproporpbynoi and oruin untno acids m uho* may be present. Dissoostic mobilisation of had with calcium EDTA may ba useful ia questionable Treatment at Lead Fptsooiap: It ba boon bund that tba cheistint s<*ttt, alcium etbytcMdiatmm* tatisortata, and reined compounds an hisftiy tf* Irsaaw ia raoavuif absorbed had from tb* ustuea of the body. (The therapeutic itng of tha poup an aha known as venue, venenaid adithaod and Ca EDTA.) Ca EDTA is tAtetin only when adoinntrrvd intravenously. Various doses* acbeduJa hive we* proposed. An elective rv*uo* h ) to f (rxtss ci N* Ca EDTA in TOO ec to 300 a of 5 perms slued** by intrivcneai* drip over * period of 1 ia I hour*. Treatment may ba liven duly for 5 to 10 dan with sa interval at on* week between esunat. Another plan it to five tre*orient at intervals of ] to 3 day* until delaadin* ha been accomplished Disaster Haaard: Sa had 2S5 CMA 047791 Data: 2/25/32 Revision: 0 APPENDIX B INSPECTION LOG SHEETS # 30 CMA 047792 MMIIOtIM fqillPWMI INtmilM lOt UKfI LInspector't neat/tllle _________ Pete al InipecUon (nonth/d*y/y*ar| line el Inspection _ lallllery IIh) Itea liquid level trantaillert (tanks) Coatervallan vents (teal*) leachate detection. collection, end reaevel tytlea (well# pile) Ground ueler letile control tytlea (vesli pill) Runofl ioIIkIIm end reaavel tytlea (utile pile) Ground ueler table ueler otter (located In nap) lyptl el problem Stalu Acceptable Unacceptable Irentaltier signal, electrical circuitry, poucr Spring edjutlatat or flicking Irofcea pip* ar coantcllon, lack el gravel In plpti, clogged ho let In pipe, angle al drainage, ground ueler collected, tuap puap lei lure Broken pipe er connection, leek al gravel In pipe, clogged halet la pipe, angle at drainage Broken pipe or cannectlon, lack of gravel In pipe, clogged ho let In plpt, angle of drainage, tuap puap tenure Clogging, a*Ifunci Ion af digital display, rotor flicking, utarlng of gears Observations *lt ftftd Nture ol rep*lri/ree<lUI tcllon Date: 2/26/32 R evision N o .: CMA 047793 Figure B-l. Monitoring equipment inspection log sheet. o iAflllf and tHIHGiMV f(|*J|FH{Nl lwmCl|Jm IOC iMf 11 Int^iitur'l U*l of lit* _______ _________/ ________ ______ _ (Im of IntptUloH_________________________________________ |IUl*iy tlucl lyj>l of problnt U*lo * tij_____ iatptiblt LimccrpItMt Itulutlf lit {i-ui ti * A11, VirMkullli, ii( ) Out of Modi loro or Huro Out of itOCh AbtotUnt ItltOM Out of tloth AtitoMtcM puJt Oul of tlach VlUH Uul of block |m\A % Itil* ptMJ* Power, cloyylfiy iu tlcll>l hcut* with quKk coupl* CiiUi or holit, fllllugi tilth Mil h>ui ^ (jtlluh ilruM) ()Ull, tlllulllt CorfuttiMi, MruiVtiril i|tay Ob*erw*tIon* f*lu<oCy ilmw<r ioJ ptwfc Iwt iMcldi *ml ikIu pioltLlliHt Utter prciiud, lethlmj, i|riln|| Broken or dirty ccju1|*ci*l llhpotiltlc roplrtlon Uut of lot It Ll>t<tlil tiilr|J<jt mplrtloft wllh ilrt<U}<) fm iitytolt u4|ion util ii 111 ijiui, half mil full fin V|itnl (lirolttl iihutluol, vttli 0*1* and i|urc of rtptlrt/remedial at 1 luo Hijure 11 -2. Safely and emergency equipment Inspection log sheet. n tno O(vi < tt iJm n* i4- o 2/25/32 o Figure ll-2(continued) llta ftKil-asunUd 911 Mih cannlstert kelf'cantained breathing epparaltil IUM) fttrltbli 91*9 lyttt of problem CiMtitart Wca*# iihautlail Air quantity la mirvt, *lr dlHviry lyilta. Mlflvrt In Ltnl (cold utalhtr) tawar, clatglni f In blwnu Hr* *aUAuliNrl fir* alar* sytleo telephone tirttii wa\ Public addrait lyiia* ip GiMralari (argancy Haling lyilaa ftltpaai1*0 Raadi rckar|lat fovar failure Power fat lure ftwar failure, tptalari fuel supply, iparl tints, oil laltary failure, llfhlt flrit aid egulpnent and supplies llaai eut of stock r laopanlUt Sltaa claanar Haler sapply, fuel supply fralwtlv* cletblng <lapr*bla lull-body caatralli, gloves, ad toot revering*) Dicanlal4l(M facHlly (showers, dirty roaa, Uim roM| Holes, nornel wear and tear Hater pressure, leaking, drainage, upkeep *tctftifScUUtutti(nJt|cttplUilt Observation* O ss Date iihI nature of repirt/rc*eMal action o D ata: 2/26/82 R evision N o .: 047795 IFCUtm DfVltfi IttKClIOK 104* UUC |n}|iec lor* t Aa*c/l It It__________________/ 0U of ImpctHon______________________________________ ___(oonHtAlty/yeer) lint ill Inificilfuo_______________________________(IllUfy tl-c) lithtlllly feme lypci cif (irotiltM Cur mi tun, damage lo ihaln link f tnf ar Itiibej win IkctpUbie lintcceptelile y*it i**U (IllfAtlU | Cor mi Ion ,, Jimije to (Inin link feme ur barbed wire Util y*U uni luk K O Cuiitcliitr ilcreye crti fence Curroilon, daaage to chain link feme ur baibeil wire; itirktnij ur curigdlmj luck Corruilon, d**nje (o (Inin link feme ur batbrd wire Container iloreye ire* gale and lock Conation, datuy* lo (lulu link ItNft or bitbtd wire; tilt king or Corroding lock letute iuni rut tu call yclt Fwu wiy radio* IriniNlUer or irceivrr; tllikliiy of yeti ImnalUer or receiver ObifvUtic ilite tnJ mture of rtfi*Jrt/icacillet tcllon D ate: 2/25/32 047796 Figure U-l. Security devices inspection log sheet. G ornut 11mu *m ciruciihmi iquimon mcrtcuon 101 mti iInspector'* mm/IIIIi date <1 Inspection (nonth/day/yior) I lot ef Intpec l Ion ______________________________________ |l l Itory line) IlM .............. ........................... types of protoloot lotllnto adjustment, power, tlegging Stslv* (V> -- Acceptable itneccapt title Swap puapt (MMiil \ Power, clogging Plkel lim or fftumlat loot Crack*, deterioration (rotlon; uneven selllenonl, cracks and Ifel ling In cnncitle pads, toaia ring* and piers, deteriora tion al ualtr teal between lank bo Iton and Inundation, sal spot* fret Ion, uneven setltenant. crack* end spoiling In cnncrelc luap trail (rotlon. uneven tell tenant, crack* end spelling In concrete, wet spot* faak structural support Cencrele delerleratten end crock ing, corrosion of pipe tupperl* let* of net*! thickness, leek*, corrosion, or deterioration Helitlny Until Corrosion, dlscolorttless, crack*, toucklat, and toulgat ... Observations 0U and nalura f rc(ilrt/r*tdtal icUm gn Figure B-4 Operating and structural equipment inspection log sheet. Date: 2/26/32 R evision N o .: 047797 o 047798 UIHUINjl IHJMW.t MU INmtlJOH I (Hi S*K f I I mpet I or4t ii*o/liil# __________________________________/ title of itit|iitUun___________ (oonlh/doy/ytr| | t*c of fn|ictllou________________________ (Hilary (let) iU- lyp* of prutilitt Stilt * W) Atc|iUblt Unacceptable Container platenenl nd decking fill* Ittlyiil of tilth* Sealing of ionlclikcr* Open lid* lake liny of tonlelntrt l4iru|itr MtiillMttduN, date rIm tog Container* CurrmliMi, ii*UC It ilructoial Sey eijal Ion uf 1 m. ofi*l 1 L 1* oatlet SUnyt of witUt In ro tint are* -1 Owytil (t-9 . Irulcn wood, wr|i* lay, nail* IttliH)} Itntl, ytl* mil lot ft Curroilua, daoayc lo (lulu tin* ftU, tlliHtiy or corroding loth |vt uf fuunJit tea (riiki, i[tlkli)y, uneven tclllmcnl erosion, wel tpolt UUct (mil, deter lord Ion Sif> aSca Creek*. tpillliiij, unrvtA ttlll*' ten! <ios Ion, wel tpolt luwft jliopl {aoluoattl) Selling nljutlifiil, power, (logging (IlntrviliuHi tide end iiiUk of r|ii lrt/rc*ll *1 at 11on figure I)-!). Container storage area inspection log sheet. O g w(t a& t<ID` fm..t HO TJ tv> 'O< \ru*i \ fat* o Figure tt-5(continued) IsJ ns o rf ~O4 VO VO 0tcrv*t Ml 0*1* **4 fftlur* *f r*p*lr/r*dl*t icIIm O n tu H<U) -f>t H OP K) SK \ro O at .. \m Kl O ooetvo w o I MW AAU MU) AHOUUI fqUimttV Jniptt0r*i _/ llt f Im^atuA__________________________(Motft/ilay/jrearl 11m | tnipet-ifuji _ iHltry IIm) |ln <f prot>l*t tiu* btf ir (vu*idUu Cri(U, deltrlttfiUnA CratM, ipetllny, unavco uUI` ent* truHuo, kiI tpoU SlMJ* (IlMV (**IM*0 ra I-J4 t/emlny thjibi i- Hpe i Power. cloyylny CrafH, ipalllii), ihicvia tcUli' went, truiion, wet ipoti Damaged toil of aUl tliUUitu, leaht, toireiluii, or tMtirlonllon Valve* lull of adal llildmait, leafc*, iurrotlon, or dtUrlortllon Hit Inyi loti if ll iMtkncn, laakl, torroiloit, or diUrtonlliM Uv*Mll luiilml vilvt (Ainutl) latt 41 f <|al IhUknati, Uakl, torroilon, or deterioration, llUHon, d**yrJ ininlU IDG Mllll 'Ft(jure b-6. Tank storage area and ancillary equipment Inspection log sheet. 2 /2 5 /3 2 tu a (V fit H<* frtt o U iod o iMfmut iwt nnruiim ik umi iMfUtw'l oaoa/tlII* L h(| || lM|WIilU llW*l/|Hlf) 1 Im if iatpactla* ______________________________ (allllarp IIm| lit* - 11 ~ lypai ( prablt** ktatut (J) Accapliil* UMCIptlbl| UiMtr fiimdillm/ilnictiril iippird OaaaptP, ttruclural liability tract*, tpalllap unavaa HI ratal. arailaa, act tpatt Ip* (WlMCtfHI fataraal carraiiaa, crack*. Pittarllaa holHlIvt cutlkg hut tpat*. blltltr*. rita lift lap Unk iImII Carractaa, PUcalartllaa, crack*, bucklti, bulptl (Mi roof Malfuaclloa af wait, black*#* at water Praia* aa roai, carrot Ion tank bait** Carratlaa, dticalaratto*. crack*, buck la*, bul#a* intlur toHt NoitUt fHiUrtlw, cirrAiloA (rack*, carratlaa Obtartatlaa* lU aim! htlurc tf r#klri/rt^a( action Data: 2/26/32 R evision N o.: 047801 Figure B-7. External tank inspection log sheet. o 08^ tMlMHAI IAKJ( mMCIJOH IOC IMiJ h^ipcilur'i itw/lllU____________ ___ /_____ _ 1)U if Ihi|>UU __fmMvIk/iUy/year) t Ibk tit liiipci. I Ium_______ .___________ (HIUrif 1 <lk |U(lf U*m lulu n*l lujipiirU l*<iA kttcM |s> link UKo* 'J o\ Hite Jvliiti Null I* ituuitttUn Jtiluli Clm llvcti Hptc.ll lujiptirl figure [1-H. Internal tank inspection log sheet. Q J ! m i 2 /2 5 /3 2 mm a(u < rt H- IV J'l. o U A o o tUVIf UK MIA INKUIION IOG tl Inlftttar'l mm/MM< _______________________________t at Intpati ln (olfc/4y/y*r| 11m at IniruIlM ______________________________ (MU*ry Mm) Date: 2/26/82 R evision N o .: Figure B-9. Waste pile area Inspection log sheet. o Date: 2/25/32 Revis ion No.: 0 A??ZXDIX C TRUST AG32SMSNT CMA 047804 f- Trust , _ :nit tM *x*xesMnt,' him Admtaiairuto* from fa* Toad for doaoro aad Uta 4. at July 10. 1*13 by wo m*mi post-cJoeur* expenditure* la such amount* aa xtMtatriyM'ift.iiltJtUonnM*.;**,., 4 woO" a fund laiytriiiM. )j^ qpa Rnonil A4ouautntsr lUl dbid uMil *--TSrSa.kti*Se^*0*' ** *****"*< writing.1* addlocw. fa* Trust** shall rclund to fa* Crsnior twfa smouats a* fa* Where**. fa* United 3U(a* Environmental Protection Agrocy, "SPA.* ta agency of th# Uoitad State* Government. baa **tabtotod EPA Reposal Administrator ipeafise ia writing. Upon refund. such fund* stoil ao lo>n*f mnarituta pan of fa* faad a defined orism reguiafloo* applicable to fa* Grantor, harem. rxjainra that a owner or operator of a hazardous waste aaaaaaaaat fatality (hail provide uaunaoe that fund* will bo available when needed Tor deems tad/or Section Z .Ftiymonfo Coeiprding tha /hnfa Payment* made to tho Tmalee to tho Fuad fasti eoosist fa eaah securities aeeaptobfa tho Tnnioo. poat-dorare eara of tha ftolity. Wtmu fa* Gnoter baa elected to establish a tram to provtfaa ill or pan d rack' Sntnctl ssewxnc* far tha fartllttoa Stout Thiafae Afonogegsenc The Truster shell faveat and reioveet tho prtnnpal and incoora fa tho Fund and hoop tho Fuad Inverted aa a single hind, without dtatinehoa idene/Iad bernm between prinfapai and tornra fa "---- Where**. tha Grantor. acting farosgh fta with general iawsstmuru poddee aad duty aethorirad offload. baa selected fat - gmiielines which tho Craator may Tie**** to be fa* treat** under fata commamcate fa writiag ta tba Truataa beau grsentent aad the Twataa la willing to to time ta tune, subied, however, fa tbo 44 TUSt**. Now. Thereto*. tha Grantor tad tha Trust** agree u follow*: Soettan 1. DafUution*. Aa aaad la tbfa Agreement; (al Tba term "Craator'* meant tha owner or operator who tatan fata thla Agreemrat and any successor* or assign* of tha Creator. fbt Tba term Tnates" Man* tha Treat** who toara fata thia Agreement aad toy uccesav Trustee. Sacttoo Z Identification ofFodUtim msrf Cast Eitimoua. Thia Agreement paruma to the facilities and eoat astunatea idanttflad no attached Schedule A [on .Schedule A, far each taaitty Uit the 7A IdraflficaOoa Number, asms. eddrsa*. aad tha current closure aad/ or poat-doowa coat aeoaatao or porton# tha taut to which fiaanoal assurance ia damooatratad by thia Agreement). Siezaii 1 Zitebluhmant of Food. The Grantor and tha Truataa hereby aetabliah a treat fund, tha 'fund." to tha benefit of EPA. Tha Creator and tha Truataa intend that ao third party have acease to tha Fuad except aa barrio provided. The fund la aatabiiahod initially aa constating of tha property, which is acceptable to tha Trustee, described ia Schedule 8 attached hereto. Such propip and any other property subsequently transferred to the Trustee ia referred to as the Fuad, together with ail taming* and profits thereon, leas *ny paymaata or diamtotlaa* audo by tho '* ruatee pursuant to thia Ag*eejnent Tba Fund shall bo held by tba Trustee: IN TRUST, aa hereinafter provided. The Trustee shall not bo responsible aor faail it undertake any raapotobility far tho mount or adequacy of. nor any duty fa collect from tho Grantor, any poysanta accessary to discharge any IfahaUttoa fa tba Grantor aatabiiahod by SPA. Section a Payment far Qbraro andFord Caturw Cara. Tho Trustee thail make payments boos fae Fund aa tho EPA Kafaooal Admmitoetor shall direct, fa writing to provide to the payment of tho seats fa doeure and/or pow-docura care fa the (actinia* covered by thia Agraranat. Tho Trustee shall reunburse the Craator or other persons is specified by the SPA Regional pfavtoom fa fata Section. fa insetting, retnvesung. exchanging. --ittf and faOMgtng tho Fofa tho Truataa shell discharge bio duties with respect fa the Suet fund solely ia tho latereet fa tho baaefidory and wtlh tho care. akilL prurience, aad diliftoct "tuitr th# dttiiBitAflfiM tbfli prevailing which persona fa prurience, acting fa a like cspeaty and familiar with such manase would era fa tho conduct fa an enterprise of a Uhe character rad with lilta asm*; exfltpt tteb (I) Secartoe* or other obligations fa the Creator, ar soy other owner or operofar fa tho faciUlioo. or say fa their aAliatra ao defined fa tbo lavestment Company Act fa laea as amended. U U^C K)o-(ab ahall not be acquired or beid. oaleee they are tecurttice or other obiigatietm fa die Fodaral or a Stata tovenaant: (U) The Truataa Is authorized fa faveat tbo Fund fa time or demand deposits fa tho Truataa. to tho extent insured by aa agency fa the Federal or State government: aad (ill) T7te Truataa la authorised to bold cash awaiting investment or distribution uiuovesttd to reasonable time and without liability to tbs payment fa interest thereon. Stoiea T, Commingling and Invattmmnc Tho Trustee ie expressly authorized fa ita discretion: (a) To trefaer boa time to tlae any all fa the aaaeta fa the Fund to any commingled, or collective mot fund seated by the Trustee fa which thoFtfad ia eligible to partiopato. >ubtact to ell fa the provisions thereof to bo commingled with tho aaaeta fa other trusts participating therein: and (b) To purchase tharee fa any investment company registered under the Investment Company Aa fa lMd. IS UfikC Ua*l a aeq. faduding one which may be created, aanaged. imderwntten, ar to which favoatmont advira le rendered or the aharea fa which are aoid by the Truetoo. Tho Trustee may vote such sharee ta ita discretion. Stoide ft Sxflima Pawere of tom Without fa any way limiting the powers aad diwTeuooa imoferred upon tha TtusIm by the other provisions fa this Agreement or by law. tha Trustee ia txpnoaly authorized and 279 (al To sail techange- convey. Ounafer. os^^B otherwise diipoee fa any property held by by public ar private tele. No person dealing with the Trustee shell be bound to see to the application fa the purchase money or to Inquire fate fae validity ar expediency fa any such sale or otbm disposition: (b| To make, sxscuts. acknowledge, sod deliver any aad all docaaents fa transfer and conveyance end any and ail other faatrumanta that My be necessary ar appropriate ta carry mi the peworu hertia pentad; (cl To regular any aeontics bold ia the Fund fa ita own asms ar fa fae name fa a nranmaa sad to bold any security in bearer tout or fa booh ratry. or to aoahiae cardfleaim representing such securities with mruficaiee fa tho same iasuo bold by the Trustee fa other fidafaary capacities, or fa dopoest oe strange to the deposit fa such tecanties fa a qualified entrul depositary era though, siheo so deposited, such securities may be merged aad beid fa bulk fa fae nese fa the ooaunee fa such depositary with other securities deposited (hereto by another person, or to deposit or arrango to fae deposit fa any securities issued by fae United States Government, or any agency or instrumentality thereof, with s Federal Reserve bank, but the books and records fa fae Trustee shall at all time* show that ail such aecurldee are pert fa fae Fuad: (d] To deposit any rash in the Fuad fa Intereet'besring accounts msfatained or saving* certificate* leaned by fae Trustee, in its trpente corporate capacity, or in any other banking institution affiliated with thj^^^ Truataa. to the extent insured by an ageneJ^V tho Federal or State government: and (el Te compromise or otherwise sdfust ail claim* fa Tavor of or igatnat the Fund. Station A Foxes and All taxes of any kind that My be assessed or levied gainst or in respect fa the Fund and ail brokarago onmniuiinns incurred by th* Fund shall be paid from the Fund. Ail other txpeaae* incurred by the Trustee in connection with the administration fa this Trust, faduding fae* to legal servicss rendered to the Trustee, the eompenieuna at the Trustee to the sxtettt not petd directly by the Creator, and ail other proper charge* and disbursement* fa the Trustee shell be paid boa the Fund. Suction 10. Annual Valuation. The Trustee toil annually, at least 30 day* prior to th* anniversary deia fa establishment fa the Fund, ftimiah to fa* Grantor sod to fa* appropriate E7A Regional Administrator a tatamrat eonfirnring the value of fa* Trust. Any securities in the Fund shall be valued at market value a* fa so mors than SO days prior tn th* anniversary data of establishment of fa* Fuad. Th* failure of fa* Grantor to object in writing to the Trust** wtthin 40 dav* after th* statement baa been furnished to fa* Grantor and fa* CA Regional Administrator shall constitute t conclusively binding assent by fa* Greator. barriag fae Craator from ts**ruag say claim or liability gainst th* Trust** with respuct to msitsre disciorad in th* stetamrat. CMA 047805 f Section Acnz* of Gattmtl The Traet** atv front t:m* (0 M< soniui! wiP counsel. ao nay o* counsel to p* Grantor, np --ipeei *o Aar cueetion ansm^ to Pe w.-.iirac:.or, of 'Jin .Mficaeni or coy tenon 10 be ta*<o hemnder. The Trust** shall b* fui.'y orotrited. to 'Pe extent permitted by Uw. U1 ICUA) OPCS 'Pi* AtjviC* 01 OOUCiei. Secneb :z. r.'jLfr Ciaifitnaauan. Tat Trait re 1.-.1U be entitled to rsaicnebl* caciper-iation for iU urvice* u upon ia writing from iiio* to time with p* Grantor. Section .'J. Successor Trjji**. Tat Tra*(** any restpp or Lb* Crantor aiy raplie* 'P* T.-jite*. out iu*h raei^netioo or rrpuexsMSt shall oat be tffeci:** 'A3oi 'Pi* Creator ia* ippamted t raeoeeaef braai#* end Pia ueewsor iccrpu ta* tspewmeac. The lucceuor p*aii** wail Pat* p* H3< power* And dutiei Lhei* conferred upco P* Train* hereunder. Upon P* uce**r suit**! acieptar.ci of P* appciaeaent `it Traatt* t-Soii ini trxaafer. tad py oeer to tin mcoenor trait** the fund* and properpe* ties conmtuan* it fund. If for any reinsa the Crantor cannot or do** not act to P* rre.it of Lie .-raipnitisn of P* Trait**. p* Trot:; ipsy ippiy !o * court of ccspeirat junidicnon for p* ropoifluorot of 1 succeitcr trait** or for tajtriedoo*. 7h ruooiMcr ranee mail ipJy P date on which it itiumei adaunutricoa of P rat in writing im to th Gr*otor. P Z?A Refionai Adnuniatritar. tnd tb orrrent Trail** by cinified .mil 10 day* oefer* inch cr.tr. ft became! ifleetrra. Any tiprain incurred by tb* T.-uiter * riuJt of any of tht act* car.ttnoiated by 'Put Sweden thail b* pud ii provtcei a Section 8. oeoiio.i n. Irstnctiam to lA* fraac**. .All order*, rnunii. And 'niiractioni by 'P* Grams; to '-it T.-litre mail be in writing, nomo bv such perioni n ire d*i'^t*t*d a t.`.t itui.iec LiPttoii A or mo other sei.zneei at tat G.-ir.'.Of aey deitjr.At* by intendment to Subibit ,A Tie Traeiee ided bt protected .n lordly wttbsut inquiry ;n icoordi.-.c* witr. pt* C.-mtor'i orden. rrpueiti ind .r.itraouon*. .Ml orden. mu-iti. ir.d tnitraohon$ by the S>A Res onai Acmuiutrator to Lb* Truete* ihU be in mtt.it. itjrted by tie SPA Reytonei Ad.tu.iiiira.'ori of Lb* Reyiom ia *bieb Lb* fic;::,ei irt ioejitd- or tbetr deiifneev lad Pie Trane* inoP ir, ind lheil be .raiiy protected ut ictmj in icurdenc* with tuca orden. :rpj*iti, tnd inic-icbes*. Tb* Trait** mill :.i*i tie ,-tjht to must, ia tbt ibeer.c* of wntt*n .-.cue* to tb* esatrary. pit no evtm conititutmg * mint* ~r * tennirition of tb* mLbonty of iny penon to ic: on oifttlf of the Grantor or E?A hereunder in occurred. Tat T.raitee ihiil iv* oo iury *o ict n tb* ib**ne* of tuca ori*ri. ,'eoueiii. me .-.iL-icttoni frnai ube Grantor i.id/or i?.A. txcapt u pnmd*d for beretn. Section !S. .Voticor of.VonpoyareitA Toe T.raitee ihuf notify Lb* Grantor ind ta* tpproprt*t* 3*A Reytonii AdsttnuLnar, by certified anil unpin 18 deye fcUowi.i} -Jt* mptrsuoo of Lb* JLdiy period after at* inrjvenery of Pa titaciiai-seitl of at TraiL 'f ao peyeeut received iraea Lb* Grantor durr-4 'ait period. .After p* pey-p penod t eantoietrd. Lb* Traete* ihiil ant be required to lend i nonce of ocr.oeyser.L Section id .Afl)end.nent of .i&tvmtni. Til* Agreement stay be amended by in uiatruaem ut wmtia* aiecuted by Lb* Grantor, lb* Trait**, and tb* appropriate Z?A Rt'unf Adsimacitsr. or by P Trait** tad Lbe apprapr.it* S?A Rescaa) .tcanuntor tf lie Grantor ceaiei to rani. Section if Irrtyocabiiicy end 7trmsnsusn. Juotret to Lb* .nifli of P* paraee to as end Pia .Ap-rament aa provided in Section !S. Pi* Traet taiil be JTTvocaal* and mail arntmu* mdi temnatad at P* wnttea agreement of P* Crantor. p Trait re. aaa P SPA Rrjtppai Adauntitratpr. or by P Trait** aad Pe SPA RrposaJ Adzinunior. if P* Grantor aim ta tuiL Upon lenasadoo of P* Trait, iff rtnusinj trial proper-/, 1*** Saif trait loiruntatratton rtrpeaiei. ia*il b deifv*nd 'a P* Grantor. Secrion :<t Isnannity and Indtaimf:=stiati. Tb* Traet** ibail sot sour p*roonJ hebdity of any .ia rare p connecaon wtp my Id or otniaiion. aid* in jrxid futb. p P aaoumetnuon of Pia TraiL or a cirrytnj out any di-eebooi by Pe Crantor or p S?A .Ue^unei Adnunutrator Liiued la tccnrdaacp wita Pi* AireeraeoL The Trait** mail be Indeairaiied and taeed baralei* by p* Grantor or frem pe Trait retd, or both, bras end itatnit any penonai liability to vrtuch Pe Trait** say be lubitcted by rat non of any as or tsnduct m tu offisal capacry, Pdudir.j ail tsprun mionebiy Lnccired a !ia defetia* s'the tint Lb* Grantor fiila to proud* tucb dife.i**-. Section 13. Ootcr of Uow. This .Agreement mall be idsir.ti'.ered. oattitrued. and iru'orced according to p* iim of Pc Stall of [insert name of State). Stcucn PI tnurpmatisn. Ai ui*d a 'Pi* A^retment. wordi m Pa iinfaJar aeiud* p plursi and words m Pi plural utciude pe itayular. The deaertptiv* heedimji far each Section of hia Agreement ir.aiJ not affect Pe interpretation or p* irjal tfficaoy of 'Pi* A-p-iement. p Witneia Whereof Lbe parte* iav* cauaed 'Pit Abetment to be executed by Petr raspte-Jv* pffietri daiy euPomtsd and Pair cprporxt* ltaii ta be hereunto i5ixed and incited as of Pe date first above *mn*rt- Th* pane* beiow art:/y Pat P* eordtr.j of `r.n Agreement i identical to P* 'orbing ipecified ;n AO C73 i34 iili'a;)'.) aa iuch reyjlationi wer* eonattrjted on P* data ant above virtties. 7? TlAACyl.4 ?M4hLA1 Cd. ylsioetic. anytsen laVonal leni SUPERFUND REGULATIONS The following are regulations required or authorized by the Superfund law. In addition to these regulations, the statute requires revision of the National Contingency Plan. It is likely that this will be the responsibility of the Council on Environmental Quality in consultation with the National Response Team. Those listed below which have an asterisk (*) are regulations EPA is planning to initiate. 102: Requires promulgation of regulations designating hazardous substances and reportable quantities (but contains interim procedure). Authorizes promulgation of regulations specifying records to be kept regarding sites. Types of records are statutorily described. Requires promulgation of regulations on waiver of recordkeeping requirements. 104: *Claims of confidentiality may be raised by designating those records believed entitled to protection when submitting them. Designation must be made in accordance with regulations promulgated by the President. Upon determination that emergency procurement procedures are necessary the President must promulgate regulations detailing the circumstances and procedures. 107: Liability limits may be adjusted by the President. If done, it must be by regulation. Within 18 months, the President must, by rule, determine feasibility of optional insurance for post closure. If the system is feasible, the President must publish minimum standards within 6 months of the determination. 108: Requires vessels to establish financial responsibility in accordance with regulations promulgated by the President. Requires DOT to promulgate regulations for denial of entry and detention of vessels without financial responsibility certification. Beginning 5 years after enactment, the President must promulgate financial responsibility requirements for classes of facilities (excluding RCRA); but classes must be identified in Federal Register within 3 years. 111: *The President may promulgate regulations designating those who may obiigate funds. CMA 047807 112: 301: 302: -2- Requires promulgation of regulations concerning notice to potential injured parties by responsible parties (provides for Interim procedures). *Requires that President prescribe appropriate forms and procedures for claims. Requires President's designee under the NCP to promulgate regulations for natural resource damage assessment. Requires Treasury to promulgate regulations providing for termination of taxes at $1.38 billion. * In addition, EPA plans to promulgate a regulation regarding State programs under Superfund. For further information contact: Sylvia Lowrance -- (202) 382-2188 Coke Cherney ------- (202) 755-0760 047808 CMA PUBLIC PARTICIPATION IN SUPERFUND POLICY DEVELOPMENT 1. The Deputy Assistant Administrator and the st;aff of the Office of Hazardous Emergency Response will make every effort to continue the current practice of responding to requests for meetings from interest groups and individuals affected by or interested in Superfund. 2. The Office of Hazardous Emergency Response will have weekly informal meetings at its offices in Waterside Mall, 401 M Street, SW. at 12:00 p.m. every Friday. The format will be as follows: o A Superfund Manager will present a brief (10 minute) update of a key Superfund activity. o During the second half hour of the session, attendees (by pre-arrangement with EPA) could make a presentation. 3. The Deputy Assistant Administrator will schedule regular meetings with State and local government interest groups, environmental, and business interest groups. 4. In the next several months, we plan to hold two meetings similar to the January 19th meeting: o In mid-April, a meeting to discuss early draft copies of Suoerfund regulations. o In mid-May, a meeting to discuss a draft of the revised National Contingency Plan. 5. Toward the end of the formal public comment period for Superfund regulations we will hold a series of public meetings around the country to discuss the proposed regulations and the National Contingency Plan. These sessions will be information exchange meetings. 6. After these public meetings are completed, we will hold a single, public hearing in Washington to receive comment on the regulations. 7. In accordance with current EPA policy, we will invite and carefully consider written comments on the regulations and all other issues. CMA 047809 Subject Area: Public Participation/Community Relations Basic Premises A. Public participation or community relations is as major element of the Superfund program. B. Community relations functions will be organizationally integrated within the operational units of the Superfund organization. C. In many communities, abandoned hazardous waste sites are extremely serious political issues, and the subject of considerable local concern. D. The public does not always have a clear understanding of the abandoned site issue, the precise nature of the hazardous waste threat, and the nature of the Superfund program. E. An inadequate community relations program will hamper overall program implementation. In order to insure sensible policies, EPA needs to actively consult with all individuals and groups affected by the policies. F. EPA has a great deal to learn about managing community relations during environmental emergencies. Working Assumptions A. Information should be released to the public rapidly, accurately, and in comprehensible form. B. Local governments, interests, and citizens will be consulted as often as possible during Superfund planning. C. National interest groups and interested members of the public should be consulted as often as possible during Superfund planning. D. Community and local government involvement is a major program element under Superfund, and resources adequate to carry out this program element should be provided. E. We must develop a program to train EPA personnel responsible for public involvement. F. We need to research citizen-government interaction during hazardous waste incidents in order to learn from past mistakes and successes. G. The attitudes and perceptions of local residents and officials will be carefully considered when planning response actions. H. EPA Headquarters should publish understandable descriptions of the Superfund program. CMA 047810 Rationale If we wish to ensure a successful Superfund program we must recognize that abandoned waste sites and spills of hazardous materials are not simply environmental problems but are political, economic, psychological, social and health problems as well. EPA will be judged on its ability to deal with all aspects of the hazardous waste problem. Although we might prefer to limit our activities to engineering technical solutions to environmental problems, such a narrow focus Is politically and practically unreal iStic. The existence of uncontrolled hazardous wastes or a spill of chemicals or oil is an environmental emergency for the affected community. When responding to environmental emergencies government must act both rapidly and effectively. Our response actions must both remove the peril to the environment and human health, and address the perceived threat to human and ecological well-being. Source of Additional Information Steve Cohen, (202) 755-9685 CMA 047811 SUBJECT AREA: Interagency Cooperation Basic Premises Interagency cooperation Is crucial to effective Superfund Implementation. The National Response Team (NRT) of the National Oil and Hazardous Substances Pollution Contingency Plan will serve as the focus for national Interagency communication and the Regional Response Teams (RRT) for local Interagency communication. Preliminary Program Decisions A. The President will Issue an Executive Order which will delegate general areas of responsibility of each agency. B. The National Contingency Plan will be revised and republished to reflect the legislative mandates cited In P.L. 96-510. The revised National Contingency Plan will be the primary mechanism for defining specific Agency responsibilities. C. Interagency Agreements (IAG) and Memoranda of Understanding will be used only to supplement the NCP, particularly when the transfer of funds or use of personnel are Involved. Source of Additional Information Bonnie Casper, 755-9685 CMA 047812 Subject Area: State Programs Basic Premises A. The more States contribute and participate the better off the Superfund program win be. B. Generally, existing State resources and1capabil1 ties are not yet adequate. As a result, only a few States will play a major role during the first few program years, and EPA will need to assist the States in developing their programs. C. State and local governments will end up bearing responsibility for dealing with the qreat majority of spills and abandoned hazardous waste sites. 0. Superfund implementation must avoid, to the extent possible, competlnc with or undermining other State environmental programs, especially RCRA. Working Assumptions/Preliminary Decisions A. EPA will develop a strong Federal proaram to ensure effective action at major problem sites during the initial years of program implementation. B. A proaram for upgrading State and local capabilities must be developed within the first two years after legislative enactment. C. EPA Regional offices will have primary responsibility for evaluating State readiness, negotiating agreements or contracts, and providina program development support to State and local governments. D. States must play a major role In setting reponse priorities. EPA will reauire an Initial list from the States within three months of enactment. E. States will be able to assure they will meet the cost-share and other support preconditions for remedial action in several ways. They will be able to enter into formal contracts for specific sites or In general, or they can arrange less strict working agreements, again for specific sites or in general. F. State governments will conduct emergency or remedial actions with Superfund money wherever feasible. Money from the fund will be available for paying overhead costs for State programs similar to those which would be paid to a contractor. Rationale There is a tremendous demand for prompt action under Superfund. The Federal Government must be ready to shoulder the large part of the burden Initially. However, the hazardous waste spill and abandoned site problem is much bigger than the Federal Government alope can handle. Consequently, the Superfund program must be designed to enable EPA to take advantage of whatever State and local capabilities exist. Encouraging State and local participation Is critical to effective program Implementation. Thus, EPA will be as flexible as possible In setting requirements for State participation so that It can secure the maximum amount of cooperation. Source of Additional Information Harry Butler, 245-3045 CMA 047814 Subject Area: Contracts - Operating Contracts to Support and Carry Out ' Emergency and Remedial Response Action Basic Premises A. Most of field work performed under Superfund (investigation, lab analysis, design, construction, etc.) will bedone by contractors supervised by deputy project officers situated in EPA's Regional offices. B. EPA staff for field operations work will be severely limited. C. EPA staff for management staff resources will be most effectively utilized if we have management contracts with the activities to be perfomed under contract. Working Assumptions A. Federal emergency response activities will be carried out primarily by a single, national management contract with prenegotiated subcontractors for specific geographic areas. The national management contractor will be required to provide up to ten deputy managers to work with Superfund field personnel at the regional level. The on-scenecoordinator and deputy managers will select the proper mix of subcontract response skills needed in each particular emergency situation. Consistent with the emergency nature of the activity, subcontractors must have the capability to respond immediately when the OSC or deputy project manager requests services. B. The Technical Assistant Team (TAT) contract will continue to be used to provide certain types of technical support to the emergency response actions performed under the emergency response national management contract. These services provided under the TAT contract primarily will consist of the following: rapid lab analyses, hot lab analyses, and natural resource and economic damage assessments. C. The Remedial Response Program will obtain contract support from several contracts, each primarily devoted to assisting different phases of the program. (1) The Field Investigation Team (FIT) contract will continue and a second, large FIT-type contract will be let. These two contracts will handle field work up throuqh preliminary investigation and site inspection. (2) Lah analyses will continue to be obtained from a numb^.labs through Invitations for Bids (IFBs). A national laboratory service; management contract may be let if needed. CMA 047815 (3) A national remedial response management contract, managed at the regional level by deputy project officers, will provide full field investigation, engineering feasibility, design work, environmental analysis, public Involvement, construction monitoring and construction contract administration. The method of subcontracting within the national remedial response contract framework Is still under study. Two possibilities are prenegotiated or prequalified subcontractors. (4) Construction work at remedial sites will be contracted directly by regional deputy project officers using IFBs based on detailed plans and sepcifications produced under the remedial response management contract. Larger sites will be bid separately or bundled into one IFB. (5) A national expert technical and scientific support contract will be let to provide OSC's with uniquely qualified expert advice at especially difficult sites or spills. D. No decisions have been reached on a disposal contract for "EPAowned" wastes acquired by the Agency from emergency response actions. E. To the extent possible. States will be able to use Federal contracts for the work they are managing. (The precise mechanism for this has not been determined). Rationale The contract network described above was developed after considering limitations on EPA resources, the types of contracting mechanisms available, and the structure of the private sector from which services must be obtained. It is intended to compensate for expected limitations on Federal personnel while meeting emergency needs for extremely rapid response, remedial response needs for timely and cost-effective provision of site containment, and the total program's needs for effective prevention or mitigation of health and environmental hazards. Sources of Additional Information Harry Butler, 245-3045 Bill Hanson, 245-3154 CMA 047816 SUPERFUND A SUMMARY OF THE COMPREHENSIVE ENVIRONMENTAL RESPONSE, COMPENSATION AND LIABILITY ACT OF 1980 CMA 047817 0 Notification: Spills: Requires notification to the National Response Center for releases of reportable quantities (RQ) of designated substances. RQ's of 1 lb. or^existing 311. Sites: Requires notification by persons disposing of, owning, or transporting for disposal (but not interim or final RCRA sites). Stop during transportation is not a site. Records on facility must be kept for HO years. EPA can designate what must be kept, and will promulgate waiver procedures. o ^Response:" -~ " Allowed to releases or substantial threats (hazardous substances only - no oil) or to pollutants or contaminants presenting an imninent and substantial endangerment. Hazardous substances includes: RCRA 311 CV/A, 112 CAA, 307 CWA toxics, 7 of TSCA, and any others designated under Superfund. Remedial action or removal is authorized If consistent with the NCP and the responsible party takes inadequate or no action. Whenever response authority is used, j)r the President believes a release has occurred or illness, etc., may be caused, he may monitor, investigate, etc., and may take action to plan and direct response actions (these actions are not subject to the 6 month $1 million limitation). Two or more related facilities may be treated as one. o Conditions for Response (State Programs) Response cannot continue after $1 million or 6 months in absence of a cost sharing agreement unless there is a continuing need to prevent or limit an emergency, there is an immediate risk to public health or the environment or response would not otherwise be provided in a timely manner. States must be consulted on remedial action, but none may be taken until the State assures all future maintenance (for the expected life), availability of an acceptable disposal facility, and 10% cost sharing (50% for government owned). CMA 047818 -2- A credit for direct, documented costs from January 1, 1978, to enactment is provided (NTE response costs). States may take over the program through contract or cooperative agreement if they have the capability. o Public Health: A new agency Is created to coordinate activities Including a national registry, literature inventory, medical testing, and screening. o National Contingency Plan: Must be promulgated within 180 days includes a new sites section. Hazardous Substance Plan must include: 1. Methods for discovery and investigation. 2. Methods for evaluation and remedy of releases. 3. Methods and criteria concerning the appropriate extent of response. 4. Roles of all parties including private entities. 5. Provision for equipment and supplies. 6. Provision for Federal facilities (reporting). 7. Cost-effectiveness. 8. Priority Criteria - to be based on a variety of health, environmental, and other appropriate factors. Priority List - is part of plan - State must submit a list for consideration within one year based on criteria in Plan. President will revise list at least annually. At least 400 will be designated. One in each State must be in the top 10.0. o Enforcement: Relief may be sought by AG when there is an imninent and substantial endangerment. President may issue orders necessary to protect public health and the environment (violation costs up to $5,000 a day). Consolidated guidance on use of irminent hazard, enforcement and emergency response must be published within 180 days (EPA in cooperation with AG). CMA 047819 -3- 0 Liability - Owners, operators (including those at time of disposal, persons who arranged for disposal or transported for disposal) are liable in accordance with Section 311 of the Clean Water Act, for (1) responsible costs not inconsistent with the NCP, and (2) natural resource damage. Defenses include: (1) an act of God, (2) and act of war, and (3) third party actions (but not employees, agents, contractors, etc.), if the defendant can show due care and precautions against foreseeable acts. Monetary limits to liability are provided for vessels, motor vehicles, aircraft, pipelines, and rolling stock. The President is authorized to establish other limits by regulation. Defenses and limits are lost in cases of willful misconduct or willful negligence; knowingly violating standards or regulations or refusing to cooperate under the NCP. Contains a good Samaritan provision. o Financial Responsibility: DOT will enforce for vessels. Other facilities must be classified within 3 years; then requirements must begin to be promulgated 5 years after enactment. o Fund: Approximately $1.6 billionover 5 years; at least 85% clean up; no more than 15% claims. Approximately 86% tax, 14% appropriations. o Uses (all subject to appropriations in theaggregate): 1. Response costs. 2. Claims for response costs by any persons consistent with the NCP. 3. Outstanding 311 claims. 4. Assessment, restoration, and rehabilitation of natural resources. Fnforcement and abatement (specifically limited to appropriations). 047820 CM?*- -4- Epidemiologlc studies, registry, and diagnostic testing (not otherwise available). Equipment and similar overhead for this act, and 311 (subject to appropriations). Worker health and safety program. > No remedial action funds for Federal facilities (except under #4 above). There Is authorized to be appropriated advances to the fund, subject to certain limitations. o Cl alms: - Procedure: a. First presented to RP, If unsatisfied in 60 days, claimant may go to court or to the fund. b. Upon receipt of a claim. President will expeditiously seek to negotiate a settlement between claimant and RP (settlements are final); if there is not RP, the fund will negotiate a settlement with claimant. c. Upon payment, the fund Is subrogated claimants' rights to recover costs paid by the fund. - No claims for natural resource damage occurring wholly before enactment or for ambient air. Claims will be paid first come, first serve. - Statute of limitations is 3 years from the date of enactment or discovery of the loss, whichever is later. o Preemption: No contribution can be required to any State fund for claims for response or damages which may be compensated under Superfund. No double compensation, o Post Closure: A post closure fund is created. CMA 047821 -5Liability under the act Is transfered to a post closure fund when facilities close properly and have been monitored for 5 years. Effective 90 days after. Secretary of Treasury must conduct a study and submit a report on the feasibility of an optional private insurance system. CMA 047822 I. SITE MANAGEMENT PLAN A Discovery 1 Site Search a) Obtain and review State Inventory - Access national Inventory developed under the National Contingency Plan and review information relevant to the site. b) Compile and search remote sensing data - Analyze avail able aerial reconalssance data available for site. c) Search existing data bases - Ouery other existing sources for site relevant Information. - Federal/State/local - SIA/RCRA 2. Notification - Design and implement notification system as required under the Act. a) Design and issue notification forms - Develop, obtain approval and issue forms. b) Process notifications - Receive and encode information Into national data base as received from the following sources. - Public - Government - Industry 3. Sites into national inventory of potential sites Consolidate information fran all known sources on sites Into a comprehensive list. B. Screen Incident Discovery 1. Compile/review data - Analyze Information for accuracy and completeness, as received. 2. Assess need for emerqency action/NO action/legal action/or further study - Evaluate reported Incident to determine disposition. 3. Assign initial ranking for preliminary investigation evaluate adequacy of data to determine position of site for later preliminary investigation, 4. Initial assessment of risks/danages - Based on limited information, appraise potential threat to health and safety. C. Preliminary investigation consists primarily of review of exist ing documents, possible interviews, and visually examine site. CMA 047823 1) Search records and Interview - Review all existing Federal, State, local and other data bases which nay contain relevant information on the site and conduct personal interviews with individuals who may be familiar with the site. 2) Identify potential responsible party - For site, locate an Individual or firm which may undertake voluntary clean-up or be liable fbr legal action. 1 3) Determine permit status - The effort to determine if an EPA or State permit Is Involved, which may provide a basis for actlng. 4) Define problem - technical - fiscal - 1egal - environmental - Institutional 5) Conduct visual Inspection of site - A visual Inspection which may take place on or just outside the site/spill. 6) Conduct remote sensing - Aerial or other physically removed 1nspectlon. 7) Characterize preliminary risks/damages - Based on new Informatlon. 8) Assess need for Immediate action (emergency or enforcement)/ no action/or further study - Evaluate reported incident to determine appropriate disposition. 9) Rank site for preliminary assessment - Based on additional information, rerank sites for inspection. 10) Control site access - limit all unauthorized access to site. 11) Determine need for emergency action -- Yes - If no, deter mine appropriate disposition. D. Preliminary Assessment 1) Assign initial priority for site inspection - Evaluate data to determine position of site in ranking scheme. 2) Initial assessment of risks/damages - 3ased on limited information, appraise potential threat to health and safety. CM& 047824 E. Site Inspection 1) Plan Inspection parameters - Determine methodology under which site Inspection will be conducted. - Structure sampling and Inspection to satisfy both potential remedial and enforcement needs. 2) Acquire permission to enter site - Display official ID and obtain permission to enter site. 3) Inspect and sample - Collect, analyze, quality assure and quality control In order to meet both enforcement and remedial needs. - characterize waste - track samples - ensure chain of custody for potential evidentiary uses 4) Develop project schedule - Develop milestone calendar for controlling site Inspection; Includes provision for manage ment decision on additional activities. 5) Continue responsible party search - Review new or updated Information In order to establish ownership and/or liability. 6) Assess risks/damages - Estimate current danger to public health and safety and natural resource damage. 7) Complete Initial priority ranking forms - encode data for input Into national information system. 8) Determine need for anergency action/no action/enforcement/ or full-field investigation. F. Assign to national priority list - Assign priority based upon relative risk or damage to health or welfare or the environment; population at risk; potential of hazardous substances; potential Impact on drinking water supply; potential for direct human contact and potential for destruction of sensitive ecosystems; State readiness to assume responsibilities; and other appropriate factors. 1) Evaluate against priority criteria - Determine condition relative to the above criteria. 2) Set priority and review with State - Upon determination of ranking, review with State prior to public notice. CMA 047825 G Use Fund or Enforcement Actions 1) Determine threat to public health or the environment Decide on need for snergency action, normal process or Inactive status based on available Information. 2) Make legal judgment regarding responsible party - Identify existence of deep pocket party. 3) Assign Initial site ranking - Rank site based upon assess ment of risks/damages. 4) Direct responsible party to take action and negotiate consent decree-assuming voluntary action, negotiate course of action and monitor implementation of solution. 5) Designation and advertising of financial responsibility Identify responsible party and indicate process for filing claims. 6) Select use of fund or legal remedy, if no voluntary action Invoke fund using Federal directed action or State directed action. H. Field Investigation - Determining In detail the environmental health problems. 1) Conduct field studies to further specify problem - Investi gate fully the extent of the environmental problem requiring remedy. (Sample and evaluate across all media; from soil samples to monitoring wells; modeling). a. For all media, collect information on: - detailed site conditions (includes samples) - activities of potentially responsible parties - nature of pollution problem b. Perform lab analysis - collect samples to satisfy both remedial and cost recovery needs - track to ensure chain of custody and quality control - analyze and report results 2) Prepare required reports - Prepare labs reports, ADP systems Input and reports to management. I. Feasibility studies - Develop remedial measures (e.g., construc tion, relocation, transportation of waste) to mitigate site hazards. 1) Develop options - Develop appropriate alternative courses of action to mitigate site hazards. - least cost analysis - remedial level attained - risks associated with each option, including no action. CMA 047826 2) Prepare and disseminate Statement of Environmental Assessment. ' v> 3) Conduct preliminary design and feasibility studies - For a limited number of options, develop tentative site solutions. 4) Develop State cost sharing provisions - Develop State participation requirements. J. Select remedy - Decision point through which remedial measures to mitigate site is selected. 1) Review feasibility studies - Comprehensive review of feasibility studies developed above. 2) Provide for public participation - Hold informal public meeting with governmental and citizens groups to Inform public on alternative and obtain preferences. . ' 3) Finalize State cost-sharing and monitoring - Negotiate agreement with State government on State share of costs and role In monitoring site. 4) Select remedy - Choose mitigation option to be Implemented, and determine Implementation phases. K. Final site Improvement design - For selected option, develop full project schedule. 1) Develop contingency provision - Construct back-up plans for possible accidents on site. 2) Develop site improvement schedule - Construct project schedule with milestones. 3) Secure required permits - Obtain all necessary Federal, State and local permits. 4) Prepare required reports - Provide periodic reports on status of site Improvement design. L. Site Improvements - Implement solution developed under design phase. 1) Complete procurements - Obtain bids for provision of service(s). 2) Prepare and contain site(s) - Engineer and construct site Improvement through contractors). 3) Manage/oversee construction - Perform oversite function of various phases of construction. 4) Process payment requests for construction work - Disburse funds and audit final project. q4782'7 5) Operation and maintenance of site 6) Monitoring site condition - Provide for continuous monitor ing (wells, remote sensing, etc.) of site. M. Recover costs for Federal remedial action under fund - Take enforcement actions to recover Federal expenditures. N. Post-Closure Monitoring 1) Monitor State or responsible party maintenance - Provide oversite of long term operation and maintenance of site. Source of Additional Information Bill Hanson, 245-3154 CMA 047828 OVERVIEW OF REPORTING REQUIREMENTS UNDER THE COMPREHENSIVE ENVIRONMENTAL RESPONSE, COMPENSATION, AND LIAIBILITY ACT OF 1980 (PL 96-510); OUTLINE OF FEDERAL REGISTER NOTICE Information on Federal Register Notice 1. The notice is not a regulation, but rather is designed to provide information to the public on the notification requirements of Section 103(a) and (b) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (P.L. 96-510) (hereafter referred to as "the Act". 2. The intent of the notice is to provide helpful information on when notification of a release is required, is required to notify, and what hazardous substances are subject to reporting requirements. who 3. The notice will present an initial preliminary interpretation of the notification requirement. Additional informational notices will be published in the Federal Register as required. Why is Notification of a Spill Required 1. Notification is designed simply to "trigger" an emergency response. Early warning of a release can often or mitigate potential damage to public health and the environment. avoid 2. The Agency's spill response and prevention program has been in place for a number of years, and the notice provisions of the Clean Water Act have been very successful. The statutory requirements of the Act contain the same basic mechanism for notification, but substantially expand the coverage for release of hazardous substances to all media. To Whom is Notification Required? Notification must be made to the National Response Center. 800-424-8802 For Washington, D.C. area: 202-426-2675 When is Notification Required 1. Notification is immediately required whenever there is a release of a hazardous substance into the environment in amounts equal to or greater than the reportable quantity. This is to all media: air, land, water, and applies to releases which may enter groundwater. 2. The term "release" includes virtually all ways that substances may enter the environment. The Act defines CMA 047829 "release" to mean any spilling, leaking, pumping, pouring, emitting, emptying, discharging, injecting, escaping, leaching, dumping, or disposing into the environment. 3. Such notification should be made immediately upon knowledge of the release. A 24-hour time frame is utilized determination of the amount of substance released. for > 4. The "Reportable Quantity" of each listed substance is set forth in the "Comprehensive Hazardous Substance List" which will be attached to the Federal Register Notice. Who is Required to Notify? 1. Anyone in charge of a vessel, or onshore or offshore facility, unless specifically exempted. The definition of onshore facility includes, but is not limited to motor vehicles and rolling stock. 2. Certain discharges are excluded from the definition of a release (See Section 101(22) of the Act): (a) workplace exposures for which persons may assert claims against the employer or other persons; vehicle, station; (b) emissions rolling stock, from engine exhaust from a motor aircraft, vessel, or pipeline pumping (c) releases of source, byproduct, or special nuclear material from a nuclear incident subject to Nuclear Regulatory Commission (NRC) requirements for financial protection under Section 170 of the Atomic Energy Act of 1954; (d) any release of source, byproduct or special nuclear material from a processing site designated under Section 102(a)(1) or 302 (a) of the Uranium Mill Tailings Radiation Control Act of 1978; (e) the normal application of fertilizers. 3. The following releases are exempted from the reporting requirements: (a) Federally permitted releases as defined in section 101(10) (b) the under the Federal (Section 103(e)); application of pesticide products registered Insecticide, Fungicide, and Rodenticide Act (c) releases of hazardous waste subject to the notification provisions of the Resource Conservation and Recovery Act as defined in Section 103(f)(1) and which have been reported to the National Response Center; C*A 047830 (d) continuous releases for which section 103(a) and (b) notification has already been given for a period sufficient to determine continuity, quantity, and regularity of such release (See Section 103 (f)(2)); (e) continuous releases from sites notifying pursuant to Section 103(c) of the Act (relating to sites of hazardous substances) See Section 103(f)(2)). What Hazardous Substances are Included 1. Hazardous Substances (a) Those Substance List. At following lists: listed on the present, this Comprehensive Hazardous list is compiled from the 1. Clean Water Act, Section 311 2. Clean Water Act, Section 307(a) 3. RCRA, Section 3001 4. Clean Air Act, Section 112 5. Toxic Substances Act, Section 7 Additions to the list may be made by future regulation under Section 102 of the Act. (b) In addition to hazardous wastes listed under Section 3001 of RCRA, hazardous substances include any waste meeting the characteristics set forth in regulations implementing Section 3001 of RCRA for flammability, corrosivity, toxicity and reactivity. 2. The term "Hazardous Substances" does not include petroleum (including crude oil or any fraction not otherwise listed), natural gas, natural gas liquids, liquified natural gas or snythetic gas useable for fuel (or mixtures of natural gas and such synthetic gas). CMA 047831 COMPREHENSIVE HAZARDOUS SUBSTANCES LIST To be used in the implementation of the reporting requirements of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (P.L. 96-510) Emergency Response Division U.S. Environmental Protection Agency January 19, 1980 CMA 047832 COMPREHENSIVE HAZARDOUS SUBSTANCE LIST In defining hazardous substances the Congress was specific in defining the initial list of hazardous substances. Section 101(14) calls for the list to be comprised of those materials already designated as being hazardous under any one of five statutes. Specifically, these substances are designated pursuant to: (a) Section 311(b)(2)(A) of the Clean Water Act (b) 300 1 ) Section 3001 of the Solid Waste Disposal Act (RCRA (c) Section 307(a) of the Federal Water Pollution Control Act (CWA 307(a)) (d) Section 112 of the Clean Air Act (CAA 112) () Se ction 7 of the Toxic Substances Control Act (TSCA 7) Additional substances can be added to the list by the EPA Administrator under Section 102 of the Act. Substances that have designated reportable quantities (RQ) under Section 311 of the Clean Water Act retain those designations for all media. A reportable quantity of one (1) pound will be assigned initially for all other hazardous substances. Requirements for the comprehensive list are therefore set until superseded by future regulation. For the convenience of the reporting community and the agencies involved in spill response, a master list has been compiled. This list is attached. This preliminary list of hazardous substances is provided at this time in draft form for information only, and should not be considered to be a final document until it is published in theFederal Register. Part I of the list contains those specific ch emicals designated as hazardous substances, and show the applicable reportable quantity and the list(s) in which each material was originally designated. Both the CWA 307(a) list and the RCRA 3001 list contain numerous general categories of materials. Wherever possible these were broken into a comple te designation of compounds (e.g. chlorinated ethanes --> chloro ethane, dichloroethane, trichloroethane, tetrachlorothane ) . For "infinite" categories (e.g. phthalate esters), se lected compounds already appearing on the individual lis ts were included. No effort has yet been made to determi ne whether the applicability of additional compounds should be i ncluded on the list. The Agency believes that a finite list of compounds provides a more useful tool to all involved parti es than one including large generic groups of substances. Th is list is intended to be only interim, pending investigatio n into the CMA 047833 designation of additional compounds and the adjustment of reportable quantities. Part IX designates the specific hazardous wastes defined by RCRA regulations. Any waste, however, that meets the EPA characteristics of hazardous waste (i.e. corrosivity, ignitability, reactivity or toxicity), while not specifically delineated in this part, is subject to the reporting requirements. It must be recognized that this list has been compiled in a short period of time and that typographical errors or duplication or omission of compounds may still be present. In particular the designations as to the appropriate source lists may not be completed in this draft of the list. Future versions of the list will also be cross-referenced to Chemical Abstracts Services (CAS) Registry Numbers. Comments on the list, the format, and the designation of reportable quantities will be solicited in the upcoming Federal Register Notice. CMA 047834 047835 PART I COMPREHENSIVE HAZARDOUS SUBSTANCE LIST MATERIAL CATEGORY Acenaphthene Acenaphthalene Acetaldehyde Acetic aclde Acetic anhydride Acetone cyanohydrin Acetonitrile 3-(a1pha-Ace ton ylben zy 11 -4-hydroxycoumarIn and salts 2-Acetylaminofluorene Acetyl bromide Acetyl chloride 1-Acetyl-2-thioure Acrolein Acrylamide Acrylonltr lie Adipic acid Af1 a to x L ns A1 drin Ailyl alcohol Al 1 yi chlor tde A1 um 1 num pliosph tde Aluminum sulfate 4-Aminobiphenyl 6-Amino-1, la,2,8,9a,8b- hexa hydro-8 -( h ydroxynethy 1) - n Ba - me tlio xy -5-methyl cacbanate azlrlno(2',]1i3,4) pyrrolo 9 ( I,?-a!indole-4, 7-dlone(ester! (Mitomycin C) 5 - f Ain 1 n one t h y l 1 - 3-i ao xa zo lo 1 4-Asninapyridine Am 11 ro I e Ammo n La X X C C C A X X X F> D X X X D D X X B C X D X X X X X 8 RQ IN POUNDS (KILOGRAMS! 1 1 1,000 1,000 1,000 10 1 (0.454) (0.454) (454) (454) (454) (4.54) (0.454) 1 5, 000 5,000 1 1 too 5,000 i 1 100 1,000 1 5,000 t (0.454) < 0. 454) (1,270) (2,270) (0.454) (0.454) (0.454) 145. 4) (2,270) (0.454) (0.454) (45.4) (454) (0.454) (2,270) (0.454) CBRCLA CWA CMA ___ 102______ 3 J_1K_______ 30 7 a X X X XX X X V X XX X X X X X X I 1 1 1 100 (0.454! (0.4541 <0.4541 (0.4541 (45.4) DliAFf RCRA CAA 30(M______1J2 X X X X X X X X X X X X X X X X TSCA 7 X X X X Sl3 s'C j -ii HftTERXM TEGORY RQ IH POUNDS (RILOGRAH9) CERCLA 102 CWA 31 IK CWA 307a RCRA 3001 Ammonium acetate Ammonium benzoate Ammonturn bica rbona te Ammon 1 um b l chr ornate Ammonium bi f luo r ide Ammon Ium bisulfite Ammonium carbamate Ammonium ca rbonate Ammon 1um chlorIda Ammonium chromate Ammonium citrate Ammonium fluoborate Ammonium fluoride Ammonium bydroxide Ammonium oxalate Ammonium a lllcofluortde Ammonium aulfamate Ammonium sulfide Ammonium sulfite Ammonium tartrate Ammonium thiocyanate Ammonium thiosulfate Amyl acetate Ani11n e An thracene Anti tnony O Ant Imo ny pentachloride D 0 D C D n D D D c D D D C D C D D D E> D O c c X X c 5,000 (2,270) 5,000 (2,270) 5, 000 (2,270) 1 ,ooo (454) 5t 000 (2,270) 5,000 (2,270) 5, ooa (2,270) 5,000 (2,270) 5,000 (2,270) 1,000 (454) 5,000 (2,270) 5,000 (2,270) 5, 000 (2,270) 1,000 (454) 5,000 (2,270) 1,000 (454) 5, 000 (2,270) 5,000 (2,270) 5, 000 (2,270) 5,000 (2,270) 5,000 (2,270) 5,000 (2,270) 1,000 (454) 1,000 (454) 1 (0.454) 1 (0.454) 1,000 (4S4) Mn t e s Tlie a lit) revlatlon ff.O.S. elgnlfies those members of the general class "not otherwise specified" by name In this listing. 047836 047837 MATERIAL Antimony potaaaiun tartrate AntiRiony tr lbronlde Antimony trichloride Antimony trifluoride Antimony trioicide Aramite Arsenic Arsen 1c ac 1 d Arsenic disulfide Arsenic pentoxide Arsenic trichloride Arsenic trioxide Arsenic trisulflde Ashes tos Auramine Azaserlne Ba r 1 um Barium cyanide Oenzfc)acrldlne Benzfalanthracene Danzene Benzenearsonic Acid Benzenethlol Ben z1d1n e Benzo(a)anthracene Renzolb)fluoranthene Oenzofjt flnoranthene Ben zo (an i ] |>erylene Benzol a|pyrene CATEGORY C C c c D X X X t) D D D D X X X X A X X c X X X X X X X X no in POUNDS <KILOGRAMS 1 t, ooa 1,000 1,000 1,000 5,006 1 1 1 5,000 S, 000 5, 000 5,000 5, 000 t 1 1 1 10 1 1 1,000 1 1 t 1 1 1 1 1 (454J (454) (454) (454) |2,270) (0.454) (0.454) (0.454) (2,270) (2,270) (2,270) (2,270) (2,270| (0.454) (0.454) (0.454) (0.454) (4.54) (0.454) (0.454) (454) (0*454) (0.454) (0.454) (0.454| (0.454) (0.454) (0.454) (0.454) CERCLA 102 CW A 3 1 IK X X X X X CW A 307a X X X X X X X X XX X X X X X X RCRA 3001 X X X X X X X X X X X X X X X X X X X X uiiAr;'t' 047838 H A T E RI MaCATEGORY Denzolc XcM 0 Benzonltr lie C nenzoqulnone (all isomers) X BenzotrIchlor He X Benzoyl chloride C Benzyl chloride B Be r y 1 11 uni X Beryllium chloride D Beryllium fluoride D Beryllium nitrate 0 8 i s ( 2-ch 1 o roetho icy ) me thane X Bla(2-chloroethyl) ether X M,N ~n1b(2-ch1o roe thy1)- 2-naphthy1amine X BlsI2-chloro1aopropy1) ether X Bls(ch1oronethy1) ether X Bis(chloroethyl) ether X Rl s( 2-ethy 1 he*y 1 1 phthalate X Bromoacetone X Bromomethane X 4-Bromophenyl phenyl ether X Or uc1ne X 2-Butanone peroxide X Butyl acetate T* O Butyl benzyl phthalate X 2-sec*-Biityt-4,6-dlnltrophenol(DNBP) X n-flutyl phthalate B Bu L y a at i n e C Butyrlcacid D BQ IN POUNDS (KILOGRAHS) 5, 000 1,000 1 1 1,000 ion i S, 000 5,000 5, 000 t 1 (2,270} (454) (0.451) (0.454) (454) (45.4) (0.454) (2,270) (2,270) (2,270) (0.454) (0.454) i i 1 i 1 i i 1 1 i 5, 000 i 1 100 1,000 5,000 (0.4541 (0.454) (0.454) (0.4541 (0.454) (0.454) (0.454) (0.454) (0.454) (0.454) (2,270) (0.454) (0.454) (45.4) (454) (2,270) CERCLA 102 CH A 31 IK X X X X X X X X X X X CWA 307a X X X X X X X X X RCRA 2001 X X X X X X X X X X X X X X X X X X X CAA 1 12 TSCA 7 047839 MATERIAL CATEGORY Ca dm1un X Cadmium acetate n Cadmium bromide B Cadmium chloride B Calcium arsenate C Calcium arsenlte C Calcium carbide D Calcium chromate C Calcium cyanide A Calcium dodocylbensenesu1fonate C Calcium hydroxide D Ca1c1 urn hypochloride B Ca 1 c 1 urn ox ide D Capta n A Ca rbaryl B Ca rbo f ur an A Carbon disulfide n Carbon tetrachloride D Ch1orda ne X Chlor a mhuc i 1 X Chlordane (alpha and qamma isomers) X Ch1o rine A Chloroacetaldehyde 1 n p-Chloroan lllne Chlorobenzene 9 Chlo robe n z 11 a t e X B X lx RQ IN POUNDS (KILOGRAMS) 1 100 too too 1,000 1,000 5, 000 1,000 10 1,000 5,000 100 5,000 in 100 10 St 000 5,000 1 1 1 10 1 t 1 00 1 (0.454) 145.4) (45.4) (45. 4) 1 454) (454) (2.270) (454) (4.54) (454) (2,270) (45.4) (2,270) (4.54) (45.4) (4.54) (2,270) (2,270) (0.454) (0.454) (0.454) (4.54) (0.454) (0, 454 I (45.4) (0.454) CERCLA 102 CWA 31 IK X X X X X X X X X X X X X X X X X X X X CWA 307a X X RCRA 3001 X X X X X X X X X X CAA 112 TSC A 7 047840 MATERIALCATEGORY 1-( p-Ch lorobenzoyl >-5-methaxy2-methy1indole-3-acetIc acid p-Chloro-m-creso 1 1- ChIoro-2f 3-epoxyhutane Chloroethane 2- Ch1oroethy1 vinyl ether Chloroform Ch1oromethane Chloromethyl methyl ether Ch1oronaphtha1ene (all ieomers) 2-Chioronaphth alend Chlorophenol 2-Chloropheno1 4-Chlorophenyl phenyl ether 1 - ( o-ChlorophanyUthiourea 3- Ch1o roproplonitrile Chlorpyrlfos Chloroflutfonlc acid Chloroto1uene (all iaomers) a 1pha-Ch1orotoluene Ch r omiurn Chromic acetate Chrom1c acid Chromic sulfate Chronmia chloride Chrysene Citrus red Ho. 2 o Co a 1 t a R Cabal toils bromide Cohaltons formate Cohaltous eulfamate Copper Copper cyanide Coumaphos Cresol Creosote CresylicAcid X X X X X D X X X X X X X X X X C X X X C C C C X X X C C C X X X C X X RQ 1H POUNDS ( KILOGRAMS 1 t i i i t 5,000 t t 1 1 1 1 1 1 1 1 1,000 1 1 1 1, ooo 1,000 1,000 1,000 1 1 t 1,000 1,000 1,000 1 1 10 1,000 t 1 (0.454) (0.454) (0.454) (0.454) (0.454) (2,270) (0.454) (0.454) 10.454) (0.454) (0.454) (0.454) (0.454) (0.454) (0.454) (0.454) (454) 1 0. 454) (0.454) (0.454) (454) (454) (454) (454) (0.454) (0.4541 (0.454) (454) (454 ) (454) (0.454) (0.454) (4.54) (454) (0.454) (0.454) ti "Vi CERCLA 1 02 CNA 3 1 tit CH A RCRA CAA TSC A 307a ____ 30(H___ ___ 112___ _______ 7 X X X XX X X X X X X X X X X X X X X X X X X X X X X K X X X X X X X X X X X X X X X X X X X X <N c <- -<J 1 047841 MATERIAL CATEGORY Crotonaldehyde B Cupric acetate B Cuprlc acetoarsenlte B Cupric chloride A Cu prlc nitrate D Cupric oxalate B Cupric sulfate A Cupric sulfate ammoniated B Cupric tartrate B Cyan Ides (soluble salts and complexes) ,N .O, S . X Cyanogen X Cyanogen bromide X Cyanogen chloride A Cyc a s i n X Cyclohexane c 2-Cycloh exy 1 -4,6-dinit ropheno1 X Cyclophosphamide X 2,4-0 Acid B 2,4-0 Es te ra B Da un omycin X ODD X DDE X DDT X Dial late X Dl a r 1 non X Dibenx(a,hJ acridine X Dlbenz(a,j]acridine o X % RQ IN POUNDS ( KII.OGRAMS ) 100 100 100 10 100 100 10 100 100 (45.4) (45.41 (45.4) (4.54) (45.4) (4 5. 4) (4.54) (45.4) (45.4) 1 1 1 10 1 1,000 1 1 too 100 1 1 1 1 t 1 1 1 (0.454) (0,454) (0,454) (4.54) (0.454) (454) (0,454) (0.454) (45.4) (45. 4) (0,454) (0,454) (0.454) (0.454) (0,454) (0.454) (0.454) {0.454) CBRCLA 102 CW A 3 1 IK X X X X X X X X X CM A 307a X X X X X X X X RCRA 300 1 X X X X X X X X X X X X X X X MATERIAL CATEGORY Dihenz(a,h)anthracene (Dibenzo fa,h]anthracene) ?ll-Dihenzo|c,9)car ha sole Olbenzo(a, e 1 pyrene Dlheri2o[a,h1pyrene DJbenzo(a,1)pyrene 1, 2-Dibromo-3-chloropropane 1,2-Dlbromoethane Dibr omomethane Dl-n-butyi phthalate Dlcamba Diehlohenl1 Dl chi fine DJchlorobenzene (all Isomers) Dlchlorobenzudlne (all isomers) 3, I'-Dichlorobenzidlne Dl chlarobromomethane Oich1oroethne (all Isomers) 1.1-Dichloroethane 1t2-Dlchloroethane trans-1,2-Dlchloroethene 01chloroethy1ene (all isomers) 1.1-Dlchloroethylene Diehl oroietha ne Di ch1oroaaphthalene (all 1 some ra) Dich1 oropheno1 (all Isomers) 2 t 4-Dlchlo r nphenol 2 t 6-t)ichlorophenol Diehl oropli cnyta rsine Dlch1oropropane (all Isomers) DiehloropropeneDichloropropane Mixture X X X X X X X X X c c X B X X X X X X X X X X X X X X X D D hQ IN POUNDS OERCLA (KILOGRAMS )1^02 CWA CWA RCRA 111E___ 307a30<M 1 1 1 t 1 t 1 1 1 i.aoo 1,000 1 100 1 1 t 1 1 1 1 1 1 1 1 1 1 1 5,000 to.454) (0.4541 (0.454) (0.454) (0.454) (0.454) (0.454) (0.454) (0.454) (454) (454 ) (0.454) (45.4) (0.454) (0.454) (0.454) (0.454) (0.454) (0.454) (0.454) (0.454) (0.454) <0.454) (0.454} (0.454) (0.454) (0.454) (0.454) (2,270) 5,000 (2,270) X X X X X X X X X X X X X X X X X X X X X x X X X X X X Vftliki CA A 111 TSCA 7 047842 MATERIAL CATEGORY nlcbloropropanoK b) Call isomers) X Dlchloroptopenef s) { all Isomers) 0 1,3-01 chioropropene X 2,2-DichloropropIonlc acid D Plchlorvos A Pieldrln X Diepoxybutane X 01ethylamine C Dl methy1amlne C Diethylarsine X 0 t 0-Dla thy1-S-(2-~ethylthlo)ethyl ester of phosphorothiolc acid X 1, 2-Diethyl h yd ratine X 0,O-Diethyl-S-methyleater phosphorod1thloic acid X 0,0-0lethy1phosphorlc acId, 0-p-n 11ropheny1 ester X Diethyl phthalate X 0,O-Diethyl-O-lZ-pyrazinyl) pho s pho ro th ioa te X Diethylst11beatro1 X Dlhydrosafrole X 3,4-Dlhydroxy-alpha~fmethylamlno)- methyl benzyl alcohol X Dl-1sopropy1fluorophosphata (DPP) X Dime tho ate X 3, 3* -- DJmet boxybenzidine X o p-Dlmethylamlnoazo benzene 7f12-Dtmethylhenz|a|anthracene X X RQ IH POUNDS j_KILOGRAMS_) 1 5,000 1 5,000 10 1 1 1,000 1,000 1 (0.454) ( 2. 270) (0.454) ( 2,2T0) (4.541 (0.454) (0.454) (454) (454) (0.454) 1 (0.454) 1 (0.454) 1 (0.454) 1 (0.454) f (0.454} t (0.454) 1 (0.454) t (0.454) 1 (0.454) 1 (0.454) 1 (0.454) 1 (0.454) 1 (0.454) 1 (0.454) CERCLA 102 CWA 31 1K X X X X X X CWA RCRA 307a______ 30QJ X XX XX XK X X X X X X XX X X X X X X K X X CAA 112 TSC A 7 047844 MATERIAL CATEGORY 3, 3 '-Dimethy1benzldine X Dlmethylcarbamoyl chloride X 1.1-Dlmethy1hydraz1ne X 1.2-Dlmethy1 hydrazlne X 3.3-Diethyl-l-(methylthio)-2- hutanone-O'-f (methylamlno) carbonyl)oxime X Di me thyln lt.ro so amine X alpba,alpha-Dimethy1 phene thy1 amine X 2.4-Dimethy1pheno1 X Dimethyl phthalate X Dimethyl sulfate X Dtnitrobenzene (all isomers) C 4,6-Dlnltro-o-creso1 and salts X Dinttrophenol (all Isomers) C Dtnltrotoluene Call Isomers) C 2,4-Dlnltrotoluene X 2,6-Dlnitrololuene X Di-n-octyl phthalate X 1.4-Oioxane X 1,2-Dlphenyl hydrazine X Dl-n-pr op y1nitr oa amine X D1 q n a t C Dl s ulfo ton 2.4-Dlthlobluret X X Dluron Dodecylbenzeneaulfonlc acid D C Endosulfan (all Isomers) Q Endnsulfeun sulfate X X Emit In and metabolites X Up i ch 1 o roh yd r 1 n C Et h 1 o n A RQ IN POUNDS (KILOGRAMS) 1 (0.454) 1 ( 0.454 > 1 (0.454) 1 (0.454) 1 1 1 1 1 1 1,000 1 1,000 if ono i 1 1 1 1 1 t, 000 1 1 100 1 , ooo 1 1 1 1,000 10 (0.454) (0.454) (0.454) (0.454) (0.454) (0.454) (454) (0.454) (454) (454) (0.454) (0.454| (0.454) (0.454) <0.454) (0.454) (454) (0.454) (0.454) 145.4) 1 454) (0.454) (0.454) (0.454) (454) (4.54) CERCLA 102 CM A 3 ( IK CWA 307a RC ft A 3001 X X X X X X X XX X X X X XX X XX X X X X V X X X X X X X X X X X X X X X X X X bfcAi-i TSCA 7 047845 _ Ethylbenzene C Ethyl cyanide X Ethylenedlanlne C Ethylene <11br onlde C Ethylene dichloride D Ethylene bis dithlocarbamate (EBDC) EOT A x 0 Ethyleneimlne X Ethylene oxide ( I ) X Ethylenethlourea X Ethyl methanesulfonate X Ferric ammonium citrate c Ferric ammonium oxalate c Ferric chloride C Ferric fluoride B Ferric nitrate C Ferric sulfate C Ferrous ammonium sulfate c Ferrous chloride B Ferrous sulfate c Fluoranthene X Fluorena X Fluorine X 2-FluoroacetamIde X Fluoroacetic acid, sodium salt x Formaldehyde C Formic acid t> Fumer1c ac id 0 o Furfural C HQ IN FOUNDS CATEGOR(YKILOGRAMS) 1,000 (454) 1 to.454) 1,000 (454) 1,000 (454) 5,000 (1.170) 1 (0.454) 5, 000 <2,270) 1 (0.454) 1 (0.4541 1 (0.454) 1 (0.454) 1,000 (454) 1,000 (454) 1,000 (454) 00 (45.41 1,000 (454) 1, ooo ( 4 54 ) 1, oon (454) 100 (45.4) 1,000 (454) 1 (0.4541 1 (0.454) 1 (0.454) 1 (0.454) 1 (0.454) 1,000 (454) 5,000 (2,270) 5,000 (2.270) 1,000 (454) CERCL.A 102 CM A 3 1 IK X X X X X X X X X X X X X X X X X X CWA 307a X X X RCR A 300 1 X X X X X X X X X X X X CAA 112 TSCA 7 047846 MATERIAL CATEGORY G1 y c i fly 1 aldehyde Guthion Heptachlor lleptachlor epoxide (alpha, beta. and gamma i somere) Mexachlorobenzene Hex a ch1orobotad1ene Mexachloroc yc1oh exan e (all 1 some ra Hex a ch1o rocyclopentadlene llexa ch lo roe t ha ne llexach l orophen e Hexachloropropane Hex a ethyl tet r aphoa phate Hydrazine lly d r och lorlc acid Hydrocyanic acid Hydrofluoric acid Hydrogen cyanide Hydrogen sulfide Indenof 1,2,3-cd)pyrene Io dome tha ne Iron Rextran Teocyancl acid, methyl eater Isopbrone I a opr en e tflopropanolamlne dodecy 1 benzenes ii 1 fonate Ino9afro 1 e X X X X X X * X X X X X X 0 X D A B X X X X X c c X O hq in POUHR9 (KILOGRAMS) i (0.454) i (0.454) i (0.454) f i 1 1 1 1 1 1 f i 5,000 1 5, 000 10 100 1 t 1 1 1 1,000 (0.454) (0.454) (0.454) (0.454) (0.454) 1 0.454 ) (0.454) (0.454) (0.454) (0.454) (2,170) (0.454) (2,270) (4.54) (45.4) (0.454) (0.454) (0.4541 10.454) (0.454) (454) 1,00 0 1454) 1 (0.454) CERCLA 102 CWA 31 IK X X X X X X X X X CWA 307a X X X X X X RCR A 3001 X X X X X X X X X X X X X X X X X X X X 047847 MATERIAL Kelthane Kepone La siocarpin Lead Lead acetate Lead arsenate Lead chloride Lead fluoborate Lead fluoride Lead Iodide Lead nitrate Lead phosphate Lead stearate Lead subacetate Lead eulfate Lead sulfide Lead thiocyanate Lindane Lithium chromate Malathion Ma tele acid Maleic* anhydride Malononltrtie Melphalan HercaptoJlmethur Mercury Mercuric cyanide o Mercuric nitrate 5 CATEGORY O X X X D D D D C 0 D X D X D D D X c A D D X X B X X A RQ IN POUNDS (KILOGRAMS) 5, 000 1 1 i 5,000 5,0 00 5 000 5, 000 1 ,000 5,000 5,000 1 5,000 i 5, Cl 0 0 S, 000 5, 000 t 1 000 to 5,000 5, 000 1 t 1 on i t 10 (2,170) (0.454) (0.4541 (0.454) (2,270) (2,270) (2,270) (2,270) <454 ) (2,270) (2,270) (0.454) (2,270) (0.454) (2,270) (2,270) (2,270) (0.454) 1 454) (4.54) (2)270) (2,270) (0,454| (0.454) (45.4) (0.454) (0.454) (4.54) CERCLA 102 CWA 31 IK X X X X X X X X X X X X X X X X X X X X X CWA 307a X X RCRA 3001 X X X X X X X X X X CAA 1 12 X TSCA 7 047848 CATEGORY Mercuric sulfate Mercuric thiocyanate Mercurous nitrate Metlioicychlor Methapyrilene Met horn y 1 2-Methylazlridlne 3-Methylchlolanthrene 4,4*-Me thylene-bi-(2-chloroanlline > Methyl ethyl ketone (MEK) Methyl hydrazine 2-Methyllactonitr lie Methyl mercaptan Methyl methacrylate Methyl methanesulfonate Methyl parathlon 2-Methyl-2-{methylt hlol propIon aIdehyde-of me t h ylcarhonyl} oxime N-Methyl-N'-nltro-N-nltrosoquanidine Methylthlouracll Mevinphoa Me xacarhate Honoethylaraine Mo nomethylamine Mustard gas Na led Naphthalene A A A X X X X X X X X X B D X B X X X X c c c X A t> n 5 KQ IN POUNDS (KILOGRAMS) 10 10 10 1 1 1 1 1 1 1 1 1 100 5,000 1 100 (4.54) (4.54) (4.54) (0.454) (0.454) (0.454) (0.454) (0.454) (0.454) (0.454) (0.454) (0.454) (45.4) (2,270) (0.454) (45.4) 1 1 1 1 1, 000 1 000 1,000 1 10 5,000 (0.454) (0.454) (0.454) (0.454) (454) (454) (454) (0.454) (4.54) <2,270) cencLA 102 CWA 3 1 IK X X X X CWA 307a X X X RCRA 3001 X X X X X X X X X X X CAA 112 TSC A 7 X X X X X X X X X X 047849 MATERIAL CATEGORY Naphthenic acid 1,4-Napht hoguinone 1-Naphthylamine 2-Naphthyl amine 1-NaphthyL~2-thiourea Nickel Nickel ammonium sulfate Nickel chloride Nickel carbonyl Nickel cyanide Nickel hydroxide Nickel nitrate Nickel sulfate Nicotine and salts Nitric acid Nitric oxIde p-Nltroanlllne Nitrobenzene Nitrogen dioxide Nitrogen mustard and hyd rochloride salt Nitrogen mustard N-oxide and hydrochloride salt Nitrogen peroxide N11 roge n tetroxide N1 tr ogiycerlne { R 1 Nltrophenol fall Isomers) a 2-N1t r ophenol i 4-Nltrophenol 4-Nit r oqulnollne-1-oxlde B X X X X X D D X X c D D X C X X c c X X X X X c c c X RQ IN ROUNDS ( KILOGRAMS) 100 i t 1 1 1 5,000 5,000 i t 1,000 5,000 5,000 1 1,000 1 1 t, 000 1,000 (45.4) (0.454) (0 . 4 54.) (0.454) (0.454) (0.454) (2,270) (2,270) (0.4541 (0.454) (454) (2,270) (2,270) (0.454) (454) ( 0. 454 ) (0.454) (454) (454) 1 (0.454) 1 1 1 1 1,000 1 r 000 1,000 1 (0.454) (0.454) (0.454) (0.454) (454) (454) (454) (0.454) ti!H ' iVi * CERCLA 102 CWA 31 IK X X X X X X X X X X X X K CWA 307a X X X X X RCR A 30 0 1 X X X X X X X X X X X X X X X X X X X X X CA A 1 12 TSCA 7 MATERIAL H-Witroaodl-n-buty1 amine tl -N11 rosodiethanolanLne M-Nitroeoriiethylamine N-Nitrosodimethylamine N-NI troso diphenylamine N-Nitrosodi-n~propylamine H-Nitroso-N-ethylurea N-Hitr osome th ylethy1amine N-N1t roso-N-me thy1 urea W-Kltroso-H-methyl ore thane N-Nitrosomethylvinylamine N-NItrosoraorpholine N-Nitrosonornicotlne H-Hitrosopipertdlne N-Nltrosopyrrolldine N-Nltroaosarcoeine 5-N11ro-o-to Inidine Nitrotoiuene Oc tachloronaphthalene Ootamethylpyrophosphoramide Oleyl alcohol condensed with 2 moles ethylene oxide Osmium tetroxlde 7-Oxab1cyclo t 2.2* 1)heptane-2, 3- dicarboxyl 1c acid Para formaldehyde Pa rathIon Penhachlorohcnzene CATEGORY X X X X X X X X X X X X X X X X X C X X X X X C X X 1. RQ IN POUNDS CERCLA XKILOGRAHS|1^02311K 1,000 (0*454) (0*454) (0*454) (0,454) (0.454 t (0.454) f0.454) (0.454) (0.454 1 (0.454) (0*454) (0.454) (0.454) 10.454) (0.454) (0.454) (0.454) 1454) (0.454) (0.454) fQ. 454 ) (0.454) 1,000 (0.454) (454) (0.454) (0.454) CHA X X X CWA RCRA CAA TSCA 2-307a30 0J_______________ 112 X X X Xx XX XX X X X X X X X X X X X X X X X X X 047851 MATERIAL CATEGORY Pentachloroethane X Pentachloronltrobenzene (PCNB| PentachIorophe no1 X A Phenacetin X Phenanthrene X Phenol c Phenyl dlchloroarsine X Phenylenedtamine Phenylmercury acetate X X N-Phenylthiourea X Phos ge ne Phoaph ins D X Phosphoric acid Phosphorothloic acid, 0,0-dimethyl D ester, 0-aster with N,H-dinethy1 benzene sul fonamlde Phosphoru s Phos pho rus oxych1orlde X X D Phosphoru s pentasulFi.de Phos pho rus trichloride S D Phth alic anhydrlde X 2-Picollne X Polychlorinated bipheny1(s) (PC8s1 Po t a s slum arsenate A C Potass!un arsenite C Potasslurn hichromate Potassium chromate O Potassium cyanide c c A f "Q in POUNDS (KILOGRAMS> 1 (0.454} 1 (0.4541 to (4,54) 1 (0.454) t (0.454) 1000 (454) 1 (0.454) 1 (0.454) 1 (0.454) 1 10.454) 5,000 (1.270) t (0.454) 5, 000 (2,270) 1 i 5,000 100 5, 000 i 1 10 1,000 1,000 1,000 1,000 10 (0.454} (0.454) (2,270) (45. 4) (2,270) (0.454) (0.454) (4.54) (454) (454) (454) (454 ) (4.54) l. \ >. .. V: CERCLA 102 CWA 31 IK X X X X X X X X X X X X X X CWA 307a X X X X RCRA 3001 X X X X X X X X X X X X X X X X CAA 112 TSCA 7 047852 MATERIAL_____________________________________________ CATEGORY Potassium hydroxide Potassium permanganate Potassium silver cyanide (it} Pronanlde 1.2-Propanediol 1.3-Propane sultone Propargite Propionic acid Propionic anhydride Propion11r 11 e Propylene Oxide Prop ylthiouracil 2-Propyn-l-ol Pyrene Pyrethrins Pyrid1ne Quinoline Radionuclides Reserpine Resorcinol Sa ccha r1n Sa f roIe Selenious acid Selent um Selenium oxide Selenium sulfide (R> n Se 1 e n our ea Sliver 5 Silver cyanide Silver nitrate C B X X X X A D O X D X X X C X C X X C X X X X C X X X X X l RQ IN POUNDS (KILOGRAMS) 1,000 100 1 1 1 1 in 5, 000 5,000 1 5,000 t i i 1,000 1 1,000 1 1 1,000 1 1 1 1 1, 000 1 1 1 1 1 (454) (45.4) (0.454) (0.454) (0.454) (0.454) (4.54) ( I,2701 (2,270) (0.454) (2,270) (0.454) (0.454) (0.454) (454) CO.454) (454) (0.454) (0.454) (454) (0.454) (0.454) (0.454) (0.454) (454) (0.454) (0.454) (0.454) (0.454) (0.454) CERCLA 102 CWA 3 1 IK X X X X' X X X X X X X CWA 307a X X RCRA 3001 X X X X X X X X X X X X X X X X X X CAA 112 X TSCA 7 047853 Sodium Sodiun arsenate So d i i)m arsenite Sod L tun hi chromate SodiUfR hi fluoride Sodium bisulfite So d i um ch r oma te Sod I urn cyan 1 de Sodium dodecylbensnneaulfonate So di um f1uor1de Sodium hyd roa ul f 1 de Sodium h ydroxide So diun hy poch1 or 1te Sodium methylate Sodium nitrite So d 1 um phosphate , dibasic Sodium phosphate, tribaslc So d 1 um selenite St r ep to zotocln Stront1um chroma t e Strontium sulfide St rychn ine and salts Styrene Sul fiirlc acid Sulfur mo nocli I or ide 2, 4,5-T* acid 2,4,5-*l' amines CATEGORY C C c c n D c A c 0 D c B C B D D C X c I A C c c B n HQ 1H POUNDS f KILOGRAH3) 1,000 1,000 1,000 1,000 5, 000 5,000 1,000 ID (454) (454) (454) (454) (2,270) (2,270) (454) (4.54) 1,000 5,000 5,000 1,000 100 1,000 too 5, 000 5, oon 1,000 t 1,000 1 to 1,000 1,000 1,000 100 100 (4 54) (2,270) (2,270) (454) (45.4) (454) (45.4) (2,270) 12,270) (454) (0.454) (454) (0.454) (4.54) (4541 (454) (454) (45.4) (45.41 CERCLA m2 CWA 31 m X K X X X X X X X K X X X X X X X X X X X X X X X CWA 307a RCRA 3001 CAA 112 TSCA 7 047854 CATEGORY 2,4,5-T esters 2,4,5-T salts 2,4,5-TP aci4 2,4,5-TP acid esters Te t rachlorobenzene 1,2,4,5-Tetrachlorobenrene 2,3,7,8-To tr achlorodlbenzo-p-dloxin Tetrachloroethane (all Isomers) 1, 1, 1,2-TetrachV o roe thane 1, i,2,2,-Tet rachto roethan e Tetrachloroethene (Te tr achloroethylene) Tetrachlorone thane Tetrachloropheno1 (all Isomers) 2,3,4,6-Te tra chior ophe no 1 TDE Tetraethyl 41thipyrophosphate Tetraethyl lead Tetraethylpyrophosphate Th al 1 i um Th a1 l lc oxide Thallium (1) acetate Thallium 11) carbonate Thallium (I) chloride Thallium (I) nitrate Thallium selenite Thallium (I) sulfate Th loacetamide Th losemlcarbazlde Th1our ea B B B B X X X X X X X X X X X X B B X X X X X X X c X X X RQ IN POUNDS (KILOGRAMS ) 100 100 1 00 too 1 1 1 1 1 1 115.1) (15.1) (45.41 (45. 4) (0.4541 10.454) (0.4541 (0.454) (0.454) (0.454) 1 1 1 1 1 1 100 too 1 1 1 1 1 t 1 1,000 t 1 1 (0.454) (0.454) (0.454) (0.454) (0.454) ( 0. 454 ) (45.4) (45.4) (0.454) (0.454) (0.454) (0.454) (0.454) (0.454) (0.454) (454) (0.454) (0.454) (0.454) CBRCLJk 102 CWA 31 IK X X X X X X X X CWA 307 a RCRA 300 1 X X X X X X X X X X X X X X X X X X X X X X X X CAA t 12 TSCA 7 MATERIAL CATEGORY Thluran Toluene Toluenedianlne o-Toluidine hydrochlorlde Tolylene diisocyanate Toxaphene Trib rononetha ne Tr(chlorobenzene fall isomers) ',2,4-TrIchlorobenzene Tric hlo r ton Trichloroethane (all Isomers) 1,1,1-Trichioroethane 1,1# 2-Trtchloroethane Trichloroethylene Trich1oromethanethiol Trtchloropheno 1 fall Isomers) 2.4.5-Trich1oropHanoi 2.4.6-Trlchlorophenol 1,2, 3-Trichloropr ops ne Triethanolamine dodecytbenrenesulfonate Trlethylamine 0,0,0-Triethyl phosphorothioate Tr Imethylanlne Tr initrobetuene Tri a ( 1-azridinyl Jpliosphlne sulfide Tr ia(2,3-dib romopr op yl) phosphate Trypan blue Uracil mustard Uranyi acetate Uranyl nitrate Vanadlc acid, ammonium salt X C K X X X X X X c X X X c X A X X X c b x c X X X X X D t> X RQ IK POUNDS (KILOGRAMS) 1 1,000 1 1 t 1 1 1 1,000 t t 1 1,000 1 10 1 1 1 10,454) (454) (0.454) (0.454| (0.454) (0.454) (0.454) (0.454) (0.454) (454) (0.454) (0.454) {0.454) (454) (0.454) (4.54) (0.454) 1 0. 454) (0.454) 1,000 5,000 1 1,000 1 1 t 1 1 5,000 5,000 1 (454 ) (1,270) (0.454) (454) (0.454) (0.454) (0.454) (0.454) (0.454) (2,270) (2,270) (0.454) CEftCLA CWA ____ 102______ 31IK CWA 307a XX XX X XX X X Xx XX X X X X X [s': ' i ' M Sj RCRA CAA TSCA 30(M______ 112_________ X X X X X K X X X X X X X X X X X X X X X X X X 047856 MATERIAL Vanadium pentoxide Vanadyl sulfate Vinyl acetate Vinyl chloride Vlnylldene chlortde Xyle ne Xy 1 e no 1 Zinc Zinc acetate Zinc annonlun chloride Zinc borate Zinc bron1de Zinc carbonate Zinc chlor1de Zinc cyanide Zinc fluoride Zinc f o mat a Zinc hydroeulfite Zinc nitrate Zinc phenolsulFonate Zinc phosphide Zinc sI1icof1uoride Zinc sulfate zirconium nitrate Zirconium potassium fluoride Zirconium sulfate Zirconium tetrachloride i CATEGORY C C c X D c c X c D C D C D A C C C D D C D C D D D O RQ IN POUNDS C KILOGRAHS) 1,000 (454) t, 000 (454) 1,000 (454) 1 (0.454) 5,000 t,ooo 1,000 1 1,000 (I,270) (454) ( 4 54 ) (0.454) (454) 5,000 (2,270) 1, 000 (454 ) 5,000 (2,270) 1,000 (454) 5,000 10 1,000 1,000 1,000 (2,270) (4.54) (454) (454) (454) 5, 000 (2,270) 5,000 (2,270) t, ooo (454) 5,000 (2,270) 1,000 (454 ) 5, 000 (2,270) 5,000 (2,270) 5,000 (2,270) 5, 000 (2,270) CERCLA 10 2 CWA 31 IK X X X X V X X X X X X X X X X X X X X X X X X X X CNA 307a RCRA 300 1 X X X X CAA 112 TSCA 7 X PART II LIST OF HAZARDOUS WASTES DRAFT , Hazardous waste from nonspecific sources 1 1 ----------------------------------------------------------------------------------------------------r Industry 1 EPA Hazardous 1 Hazardous Waste I Hazard I Waste Humber 1 Code --------------- r1 i\ 1 1 11 1 1 | Generic 1 F001 1 The following spent halogenated solvents used in | (T) degreasing: tetrachloroethylene, trichloroethylene, methylene chloride, 1,1,1-trichloroethane, carbon tetrachloride, and chlorinated fluorocarbons; and sludges from the recovery of these solvents in degreasing operations F002 F003 Tne following spent halogenated solvents: tetra- I c'nloroethylene, methylene chloride, trichloroethylene, I 1.1.1-trichloroethane, chlorobenzene, 1,1,2-trichloro-I . 1.2.2-trifluoroethane, ortho-dichlorobenzene, and tri-I chlorof luoromet'nane; and the still bottoms from the I recovery of these solvents > I I The following spent non-halogenated solvents: xylene, | acetone, ethyl acetate, ethyl benzene, ethyl ether, | methyl isobutyl ketone, n-butyl alcohol, cyclo- I hexanone, and methanol; and the still bottoms from | the recovery of these solvents | (T) (1) 1 7004 . The following spent non-halogenated solvents: cresols and cresylic acid, and nitrobenzene; and the still bottoms from the recovery of these solvents (T) F005 The following spent non-halogenated solvents: toluene, methyl ethyl ketone, carbon disulfide, isobutanol, and pyridine; and the still bottoms from the recovery of these solvents (I,T F006 Wastewater treatment sludges from electroplating operations except from the following processes: (1) sulfuric acid anodizing of aluminum; (2) tin plating on carbon steel; (3) zinc plating (segregated basis) on carbon steel; (4) aluminum or zinc-aluminum plating on carbon steel; (5) cleaning/stripping associated with tin, zinc and aluminum plating on carbon steel; and (6) chemical etching and milling of aluminum (T) CMA 047857 DRAFT i Industry 1 I I 1 1 1 |1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 i I | 1 1 1 1 | 1 1 I 1 | I 1 1 ,----------------------------------------------------------------------------------------------------- 1- EFA Hazardous | Waste Number ) Hazardous Waste 1 F019 1 | Wastewater treatment sludgesfrom the chemical 1 conversion coatingof aluminum | 1 Hazard | Code ! i | (T) | 1 F007 . F008 F009 F010 F011 F012 F014 F015 1 Spent cyanide plating bath solutions from electro- | 1 plating operations (except for precious metals elec- 1 1 troplating spent cyanide plating bath solutions) | 11 I Plating bath sludges from the bottom of plating baths | 1 from electroplating operations where cyanides are | 1 used in the process (except for precious metals | 1 electroplating plating bath sludges) 11 | 11 1 Spent stripping and cleaning bath solutionsfrom | 1 electroplating operations where cyanides are used in 1 1 the process (except for precious metals electroplating| 1 spent stripping and cleaning bath solutions) 1i | 11 ! Quenching bath sludge from oil baths from metal heat 1 1 treating operations wherecyanides are used in the 1 1 process (except for precious metalsheat-treating | 1 ouenching bath sludges) 11 1 ti 1 Spent cyanide solutions from salt bath pot cleaning 1 1 froo metal heat treating operations (except for | 1 precious metals heat treating spent cyanide solutions | 1 from salt bath pot cleaning) | 1 1 Quenching wastewater treatment sludges from metal 1 | 1 heat treating operations where cyanides are used in | 1 theprocess (except for preciousmetals heat treating 1 1 quenchingwastewater treatmentsludges) 11 1 i1 1 Cyanidation wastewater treatment tailing pond sediment| 1 from mineral metals recovery operations 1 1 1 Spentcyanide 1 recoveryoperations i bath solutions from mineral metals| 1 11 11 (R,T) (K.T) (R,T) (R,T) (R,T) . (T) (T) (R,T) 04*7858 draft Hazardous waste from specific sources Industry EPA Hazardous Waste Number Hazardous Waste Razar Code Wood Preservation 1 . Inorganic Pigments [ 1 1 1 1 1 1 1 1 I t1 ! i 1 i I 1 1 Organic Chemicals X001 K002 K003 K004 K005 X006 K007 K008 K009 K010 K011 Bottom sediment sludge from the treatment of wastewaters from wood preserving processes that use (T) 1 1 Wastewater treatment sludge from the production of 1 chrome yellow and orange pigmenti 1--------1 (T) 1 | ! Wastewater treatment sludge from the production of 1 molybdate orange oigments ! (T) 1 i 1 Wastewater treatment sludge from the production of 1 zinc yellow pigments i (T) 1 | 1 Wastewater treatment sludge from the production of 1 chrome green pigments 1 Wastewater treatment sludge from the production of I chrome oxide green pigments (anhydrous and hydrated) ! (t: i i1 l ct: i 1 Wastewater treatment sludge from the production of I (t: 1 iron blue pigments l i1 1 Oven residue from the production of chrome oxide greenl (!' I pigments 1 Distillation bottoms from the production of acetalde hyde from ethylene (T Distillation side cuts from the production of acetal- I dehyde from ethylene | Bottom stream from the wastewater stripper in the production of acrylonitrile I | | (T (P. CMA 047859 1 Industry! EPA Hazardous J 1 Waste Number 1 I1 1 KOI 3 I 11 11 DRAFT Hazardous Waste Bottom stream from the acetonitrile column in the production of acrylonitrile 1 Hazard 1 Code 1 1 (K,T) 1 | 1 KOI 4 1 1 1 Bottoms from the acetonitrile purification column 1 in the production of acrylonitrile 1 1 (T) 1 | 1 KOI 5 1 1 Still bottoms from the distillation of benzyl chlorid el (T) | 1 KOI 6 1 1 1 KOI 7 1 1 1 Heavy ends or distillation residues from the proI duction of carbon tetrachloride 11 1 Heavy ends (still bottoms) from the purification 1 column in the production of epichlorohydrin 1 (T) 1 | 1 (T) 1 i 1 KOI 8 1 1 1 KOI 9 ! 1 [ K020 1 1 ! Heavy ends from the fractionation column in ethyl 1 chloride production 1 1 Heavy ends from the distillation of ethylene 1 dichloride in ethylene dichloride production 1 1 Heavy ends from the distillation of vinyl chloride 1 in vinyl chloride monomer production 1 1 (T) 1 j 1 (T) 1 | 1 (T) j 1 K021 i 1 I K022 I 1 1 K023 1 i K024 ! i I Aqueous spent antimony catalyst waste from fluoro1 methanes production 1 1 (T) 1 | 1 Distillation bottom tars from the production of 1 (T) 1 phenol/acetone from cumene 1 1 | 1 Distillation light ends from the production of 1 (T) 1 phthalic anhydride from naphthalene 11 1 ! Distillation bottoms from the production of phthalic ! (T) 1 anhydride from naphthalene 1 1 K093 1 i 1 Distillation light ends from the production of 1 phthalic anhydride from ortho-xylene 1 1 (T) 1 | 1 K094 1 1 Distillation bottoms from the production of phthalic 1 (T) I anhydride from ortho-xylene 1 1 CMA 047860 1I Industry 1 EPA Hazardous 1 I Waste Number 1 I1 I1 1 K025 1 I1 11 1 K.026 1 1I 11 Hazardous Waste Distillation bottoms from the production of nitrobenzene by the nitration of benzene Stripping still tails from the production of methyl ethyl pyridines 1 K027 1 1 1 Centrifuge and distillation residues from toluene 1 diisocyanate production 1 K025 1 1 I K029 ! 1 1 K095 1 I1 1' K096 1 1 1 Spent catalyst from the hydrochlorinator reactor in i the production of 1,1,1-trichloroethane 1 1 Waste from the product steam stripper in the 1 production of 1,1,1-trichloroethane |I 1 Distillation bottoms from the production of 1,1,1t trichloroethane |1 1 Heavy ends from the heavy ends column from the 1 production of 1,1,1-trichloroethane 1 K030 1 1 1 K083 1 1 K103 1 1 Column bottoms or heavy ends from the combined pro1 duction of trichloroethylene and perchloroethylene 1 ! Distillation bottoms from aniline production 1 i Process residues from aniline extraction from the 1 production of aniline I I K104 I 1 1 Combined wastewater streams generated from nitro1 benzene/aniline production I K085 I I i Distillation or fractionation column bottoms from 1 the production of chlorobenzenes 1 1 K105 ! 1 Separated aqueous stream from the reactor product 1 washing step in the production of chlorobenzenes 1---------------1 Hazard 1 Code 1 1 1 (T) 1 | 1 (T) 1 | I (*,T) 1 | 1 (T) 1 j 1 (T) 1 | 1 (T) 11 1 CT) 1 | I CT) I| 1 (T) | 1 (T) ! 1 1 (T) 1 | 1 (T) 1 | I (T) 1 CMA 047861 i Industry ZPA Hazardous Waste Number Hazardous Waste Haz Code Inorganic Chemicals 1 1 1 1 l1 1 t K071 K073 |I I K106 ! 1 T~ Pesticides 1 K031 ! i1 1 K032 1 Ii 1 K033 1 i1 I K034 ! i1 1 K097 1 i1 1 K035 1 1i 1 K036 1 i1 1 K037 1 I1 1 K038 "1----------------------------------------------------------------------------------------------------- i----------- 1 Brine purification muds from the mercury cell 1 CT) 1 process in chlorine production, where 1 1 separately prepurified brine is not used 1 1 | 1 Chlorinated hydrocarbon waste from the purification 1 CD 1 step of the diaphragm cell process using graphite I 1 anodes in chlorine production 11 ! 1 Wastewater treatment sludge from the mercury cell 1 process in chlorine production ! (T) 1 I! 11 1 By-product salts generated in the production of MSMA 1 (T) 1 and cacodylic acid |1 1 | 1 Wastewater treatment sludge from the production of 1 chlordane 1 1 (T) 1 I 1 Wastewater and scrub water from the chlorination of 1 (T) 1 cyclopentadiene in the production of chlordane |1 1 1| 1 Filter solids from the filtration of hexachloro- 1 cyclopentadiene in the production of chlordane 1I I Vacuum stripper discharge from the chlordane chlor-- 1c 1 I 1 (T) I inator in the production of chlordane |i 1 | ! Wastewater treatment sludges generated in the pro- t CT) 1' duction of creosote 1I 1 Still bottoms from toluene reclamation distillation 1 1 1 CD 1 in the production of disulfoton 11 1 Wastewater treatment sludges from the production of 1 | 1 CT) I of disulfoton 11 1 | I Wastewater from the washing and stripping of phorate 1 CT) production CMA 047862 *ndustry EPA Hazardous Waste Number Hazardous Waste Hazar Code 1 1 1 1 1 1 1 1 f 1 1 Explosives 1 I 1 1 1 1 Ii 1 J1 1 1 1 1 ! 1 1 1 1 1 1 1 1 Petroleum Refining 1 1 1 1 1 1i 1 K039 K040 K041 K098 K042 K043 K099 K044 K045 K046 K047 K048 K049 "1---------------------------------------------------------------------------------------------------1 1 Filter cake from the filtration of diethylphosphoro) dithioic acid in the production of phorate 1 I Wastewater treatment sludge from the production of 1 phorate 1i 1 Wastewater treatment sludge from the production of 1 toxaphene I Untreated process wastewater from the production 1 of toxaphene |1 1 Heavy ends or distillation residues from the 1 distillation of tetrachlorobenzene in the production 1 of 2,4,5-T 11 ! 2,6-Dichlorophenol wasze from the production of. 2,4-D I 1 Untreated wastewater from the production of 2,4-D ! I I Wastewater treatment sludges from the manufacturing 1 and processing of explosives 1 1 Spent carbon from the treatment of wastewater con1 taining explosives 1 1 Wastewater treatment sludges from the manufacturing, 1 formulation and loading of lead-based initiating 1 compounds 1 1 Pink/red water from TNT operations I 1 1 Dissolved air flotation (DAF) float from the petro1 leum refining industry 11 1 Slop oil emulsion solids from the petroleum refining industry (T) (T) CT) CT) (T) (T) (T) 00 00 (T) (TO (T) (T) CMA 047863 Industry Iron and Steel Primary Copper primary Lead Primary Zinc Secondary Lead 1 EPA Hazardous | 1 Waste Number | 1 n i 1 K050 1 | 1 1 1 1 1 1 1 K051 1 | 1 K052 1 1 1 K061 1 I1 1 K062 1 1 1 K064 I 1 1 1 1 |f I 1 j 1 1 1| I 1 i 1 1 1 1 I X065 1 1 1 1 1 K066 1 | 1 K067 1 | 1 1 1 1 1 1 1 11 1 I 1 I K068 1 1 1 | ICO6 9 1 | 1 Kino 1 1 1 1 1 1 "1 1 1 I1 I I 1 I 1^ Hazardous Waste 1 Ha 1C 1 1------ 1 Heat exchanger bundle cleaning sludge from the petroleum refining industry API separator sludge from the petroleum refining industry Tank bottoms (leaded) from the petroleum refining industry 1 1 |I 1 1 |1 1 1 C C c Emission control dust/sludge from the primary production of steel in electric furnaces 1 1c 1 1 Spent pickle liquor from steel finishing operations Acid plant blowdown slurry/sludge resulting from the thickening of blowdown slurry from primary copper production 1 (C 1 1-----1c 1 1 Surface impoundment solids contained in and dredged from surface impoundments at primary lead smelting facilities Sludge from treatment of process wastewater and/or acid plant blowdown from primarv zinc production Electrolytic anode slimes/sludges from primary zinc production Cadmium plant leachate residue (iron oxide) from primary zinc production Emission control dust/sludge from secondary lead smelting Waste leaching solution from acid leaching of emission control dust/sludge from secondary lead smelting If 1 1 1 1-- 1 (' ! i1 1 (' 1 1t IC 1 1 1 1( 1 iI 1( 1 1 1 CMA 047864 ndustry 1 1 z?A. Hazardous 1 Waste Kumber Veterinary Pharmaceu ticals ! 1 1 ! I |1 [ i ! 1 i1 ! 1 K084 noi K102 Ink Formu lation Coking 1 1 t 1 I I I 1 1 |1 ! i K.086 K060 K087 Hazardous Waste lt r.V. F-- y-'-y &_v Mg 1 1 Haza Co Wastewater treatment sludges generated during tbe pro-1 duction of veterinary pharmaceuticals from arsenic ] or organo-arsenic compounds 1 (t: Distillation tar residues from the distillation of aniline-based compounds in the production of veterinary pharmaceuticals from arsenic or organoarsenic compounds 1 (T' 1 1 1 Residue from the use of activated carbon for decolori-l zation in the production of veterinary pharmaceuticals 1 from arsenic or organo-arsenic compounds ] (T Solvent washes and sludges, caustic washes and sludges, or water washes and sludges from cleaning tubs and equipment used in the formulation of ink from pigments, driers, soaps, and stabilizers containing chromium and lead Ia 1 1 ! 1 Ammonia still lime sludge from coking operations Decanter tank tar sludge from coking operations |c | CMA 047865 EMERGENCY RESPONSE UNDER THE "SUPERFUND ACT" OF 1980 047866 EMERGENCY RESPONSE PROCEDURES REPORT OF INCIDENT NOTIFICATION OF NATIONAL RESPONSE CENTER ACTIVATION OF ON-SCENE COORDINATOR MONITORING OF REMOVAL BY RESPONSIBLE PARTY * DECLARATION OF FEDERAL REMOVAL ACTION * ACCESS TO APPROPRIATE FUND * USE OF SUPERFUND I ASSESSMENT OF PENALTIES & DAMAGES PO 047867 REPORT OF INCIDENT OLD REPORTING REQUIREMENT OIL AND DESIGNATED 311 HAZARDOUS SUBSTANCES REPORTABLE QUANTITIES NAVIGABLE WATERS AND ADJOINING SHORELINES NEW REPORTING REQUIREMENT OIL TO NAVIGABLE WATERS AND ADJOINING SHORELINES COMPREHENSIVE LIST OF HAZARDOUS SUBSTANCES INTO ALL MEDIA (WATER, LAND, AIR, GROUNDWATER) REPORTABLE QUANTITIES FAILURE TO NOTIFY CAN RESULT IN ASSESSMENT OF CRIMINAL PENALTIES 047868 NOTIFICATION OF NATIONAL RESPONSE CENTER RECEIVES REPORTS OF ALL DISCHARGES OIL TO NAVIGABLE WATERS HAZARDOUS SUBSTANCES TO ALL MEDIA (WATER, LAND, AIR, GROUNDWATER) DISSEMINATES REPORT TO APPROPRIATE RESPONSE AGENCY/ON-SCENE COORDINATOR TOLL FREE CALL WITHIN CONTINENTAL U.S.A. 1-800-424-8802 69 8 l$ o ACTIVATION OF ON-SCENE COORDINATOR COASTAL AREAS (EXCEPT SITESl USCG OSC INLAND AREAS ERA OSC n O LS ^ DECISION BY OSC MONITOR REMOVAL EFFORT BY RESPONSIBLE PARTY DECLARE FEDERAL REMOVAL ACTION FAILURE OR INABILITY OF RESPONSIBLE PARTY TO RESPOND PROPERLY DISCHARGER IS UNKNOWN CAUSED BY AN ACT OF GOD, WAR, OR THIRD PARTY ACCESS TO APPROPRIATE FUND BEFORE SUPERFUNP--DOLLARS AVAILABLE 31100 FUND OIL AND "311 DESIGNATED" HAZARDOUS SUBSTANCES REPORTABLE QUANTITIES AFTER SUPERFUND---- DOLLARS AVAILABLE NAVIGABLE WATERS AND ADJOINING SHORELINE OIL IN REPORTABLE QUANTITY 31100 FUND NAVIGABLE WATERS AND ADJOINING SHORELINE SUPERFUND COMPREHENSIVE HAZARDOUS SUB STANCES LIST IN REPORTABLE QUANTITIES SUBSTANTIAL THREATS BY ANY SUBSTANCE ALL MEDIA (WATER, LAND, AIR, GROUNDWATER) CMA 0 4 7 8 7 2 USE OF SUPER FUND FOR EMERGENCY RESPONSE REMOVAL EVALUATION, MONITORING, AND INITIATION OF ACTION CONTAINMENT, SECURITY, AND COUNTERMEASURE CLEAN-UP, MITIGATION, AND DISPOSAL EVACUATION AND EMERGENCY ASSISTANCE DOCUMENTATION AND COST RECOVERY DAMAGE ASSESSMENT AND RESTORATION BROADENED USE OF DIRECT FUND PAYMENTS ASSESSMENT OF PENALTIES AND DAMAGES CLEAN WATER ACT lOIL) CRIMINAL PENALTY FOR FAILURE TO NOTIFY"$10,000 OR 1 YEAR IMPRISONMENT OR BOTH CIVIL PENALTY FOR EACH DISCHARGE = $5,000 REIMBURSEMENT OF FEDERAL REMOVAL AND NATURAL RESOURCES' RESTORATION COSTS INCURRED SUPERFUND ACT (HAZ SUB) CRIMINAL PENALTY FOR FAILURE TO NOTIFY - $10,000 OR 1 YEAR IMPRISONMENT OR BOTH REIMBURSEMENT OF FEDERAL REMOVAL AND NATURAL RESOURCES' RESTORATION COSTS INCURRED PUNITIVE DMAAGES FOR FAILURE TO PROVIDE REMOVAL - 3 x AMOUNT OF FEDERAL REMOVAL COSTS DESTRUCTION OF RECORDS = $20,000 OR 1 YEAR IMPRISONMENT OR BOTH n 047874 BEFORE THE UNITED STATES DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION WASHINGTON, D.C. In Re: ) ) ) The Proposed Regulation of the United ) States Occupational Safety and Health ) Administration for the Identification, ) Classification and Regulation of Toxic ) Substances Posing a Potential Occupa- ) tional Carcinogenic Risk to Humans. ) ) OSHA Docket No. H-090 POST HEARING BRIEF FOR THE AMERICAN INDUSTRIAL HEALTH COUNCIL Of Counsel: Cleary, Gottlieb, Steen & Hamilton 1250 Connecticut Avenue, N.W. Washington, D.C. 20036 (202) 223-2151 ROBERT C. BARNARD ERIC SCHWARTZ PRICE 0. GIELEN ROBERT L. GLICKSMAN Counsel for the American Industrial Health Council October 23, 1978 CMA 047875 TABLE OF CONTENTS Preliminary Statement ................................................................................... Statutes Involved ............................................................................................. Introductory Statement ................................................................................. Significant Post-Hearing Developments ........................................ ARGUMENT .................................................................................................................... Introduction ........................................................................................... PART ONE .................................................................................................................... I. THERE IS NO OCCUPATIONAL CANCEREPIDEMIC ....................... II. OSHA'S AUTHORITY DOES NOT EXTEND TO PROMULGATION OF AN INFLEXIBLE "GENERIC'* RULE FOR A WIDE VARIETY OF SUBSTANCES FOUND IN DIVERSE INDUSTRIES ..................................................... A. The Inclusion Of Laboratory, Construction And Maritime Workplaces Makes The Proposed Regulation Unreasonably Broad ...................................... B. OSHA's Sweeping And Inflexible Proposed Regulation Is Unauthorized Under the Statute ............................................................................................. C. The Provisions In The Proposed Regulation For Waiver Or Amendment AreInadequate ................... D. The Proposed Regulation Violates The Due Process Clause ............................................................................ E. The AIHC Alternative Satisfies The Criteria For A Valid Generic Regulation .................................... III. SINCE OSHA INTENDS TO ENLARGE THE PROPOSED REGULATION IN UNDISCLOSED BUT SIGNIFICANT WAYS, A HEARING ON THE INCOMPLETE REGULATION IS WITH OUT MEANING AND DENIES DUE PROCESS ...................................... A. IRLG Work Group Activities Closely Parallel And Involve Subjects Which Are Under Consideration In This Proceeding ............................... B. Key Issues Are Unlawfully Being Decided In Another Forum ....................................................................... p*2 1 4 5 6 15 15 18 18 36 37 41 46 48 51 53 55 60 - i- CMA 047876 Page IV. THE PROPOSED REGULATION IS AN OPEN-ENDED ASSERTION OF REGULATORY AUTHORITY LACKING IN THE NECESSARY CONSTRAINING CRITERIA AND GUIDELINES WHICH MIGHT LIMIT ARBITRARY AGENCY ACTION ........................................................................................... 63 V. THE PROPOSED REGULATION MANDATING A STANDARD OF NO EXPOSURE IF THERE ARE "SUITABLE SUBSTITUTES" IS INVALID, AND SHOULD BE ABANDONED BY OSHA ........................................................ 68 A. The Terms Used In The Proposed Regulation AreImpermissiblyVague .................................. 68 B. The Proposed Requirement Of "No Exposure" If A "Suitable Substitute" Exists Or In Other Circumstances Is Tantamount To Banning A Substance And Is BeyondOSHA's Authority ........................................... 73 C. The Toxic Substances Control Act Makes The OSHA Substitute Provision Unworkable ......................... 79 D. A Grant Of Authority To Ban Without Guiding Standards Would Be An Un constitutional Delegation Of Legis lative Authority .......................................................................... 80 Conclusion ................................................................................................... 81 VI. OSHA HAS FAILED TO COMPLY WITH THE NATIONAL ENVIRONMENTAL POLICY ACT ......................................... 82 Introduction .............................................................................................. 82 A. OSHA Has Failed To Prepare A Detailed And Comprehensive Statement .............................................. 85 B. OSHA Has Violated NEPA's Mandate For Early Consideration Of Environmental Issues ................................................................................................... 92 C. OSHA Has Failed To Adequately Assess The Generic Issues ..................................................................... 93 D. OSHA Has Made And Continues To Make Irretrievable Commitments To The Proposed Regulation .................................................................. 94 Conclusion ................................................................................................... 95 - ii - CMA 047877 VII. OSHA HAS FAILED TO MEET ITS LEGAL OBLIGA TIONS TO ASSESS THE POTENTIAL ECONOMIC IMPACT OF THE PROPOSED REGULATION AND ALTERNATIVES THERETO ....................................................................... Introduction ........................................................................................... A. The Legal Basis For Economic Analysis Is Clear ........................................................................................... 1. The Occupational Safety And Health Act ........................................................................... 2. The National Environmental Policy Act ............................................................................ 3. Executive Order No. 11821 (Inflationary or Economic Impact Statements) ........................................................ 4. Executive Order No. 12044 (Regulatory Analysis) ........................... B. An Economic Analysis Will Be Meaningful And Is Feasible ......................................................................... C. The Potential Economic Impact Of The Proposed Regulation Is Significant ......................... 1. The Snell Report ............................................................. 2. Other Studies .................................................................... 3. The Broader Pictures ................................................... D. Criticism Of The Snell Report Is Without Support .......................................... Conclusion ........................................................................ PART TWO .................................................................................................................... VIII. THE METHOD OF CLASSIFICATION AND THE CRITERIA FOR OSHA'S CATEGORY I ARE IMPERMISSIBLY VAGUE AND ARBITRARY .................................... Introduction .................................................................................. A. There Should Be An Independent Scientific Evaluation Of The Data .......................... Page 96 96 98 98 100 101 102 104 105 105 107 108 110 114 115 115 116 117 - iii - CMA 047878 1. The AIHC proposal for Independent Scientific Data Evaluation and Classification Panel ................................................. 2. OSHA's intermixture of scientific and regulatory functions .................... B. The Criteria For OSHA Category I Are In Many Instances Arbitrary, Inflexible And Unwarranted ..........................,........................................... 1. Human epidemiology ...................................................... 2. Animal data -- an overview ................................. 3. Maximum tolerated dose studies ....................... 4. Pharmacokinetics, metabolism and DNA repair .......................................................................... 5. Statistical significance ...................................... 6. Tumor prone species ................................................... 7. Mouse data .......................................................................... 8. Factors affecting animal test results ................................................................................. 9. Positive/negative results .................................... 10. Single species or two species .......................... 11. Replication ....................................................................... 12. Short term tests .......................................................... 13. Route of exposure ..................................... C. OSHA Is Correct In Rejecting Structure Similarity And Physical Induction Such As Injection Site Sarcomas As A Basis For Regulatory Action ........................................................ 1. Molecular structure or similarity ............... 2. Injection site sarcomas and other instances where induction due to physical causes, e.g., implants, stones or calculi ....................................................... Conclusion .............................................................................................. Page 118 121 124 124 128 131 137 141 144 147 153 157 159 166 168 179 181 181 182 183 - IV - CMA 047879 Page IX. THE PROPOSED REGULATION WOULD IMPERMISSIBLY "FREEZE" THE PRESENT STATE OF RELEVANT SCIENCE BY FORECLOSING RECONSIDERATION OF THE VALIDITY OF THE CLASSIFICATION SYSTEM AND OTHER POLICY ISSUES IN RULEMAKING ON INDIVIDUAL SUBSTANCES, AND BY ERECTING UNREASONABLE BARRIERS TO OSHA'S OWN CONSIDERATION OF RELEVANT NEW SCIENTIFIC DEVELOPMENTS ......................................................................................... X. CATEGORY IV SHOULD BE ELIMINATED BECAUSE OSHA LACKS STATUTORY AUTHORITY TO CREATE IT AND BECAUSE IT IS OTHERWISE UNWISE AND INAPPROPRIATE ...................................................................................... A. OSHA Lacks Statutory Authority To Establish Category IV................................................ B. OSHA's Resources Could Be More Effectively Channeled ........................................................ C. There Is A Strong Possibility That The Decision To Classify A Substance In Category IV Could Be Arbitrary And Without Due Process .......................... D. Listing A Substance In Category IV May Create Misconceptions With Many Unintended Adverse Effects ........................................... Conclusion ............................................................................................. PART THREE ............................................................................................................... XI. QUANTITATIVE RISK ASSESSMENT IS ESSENTIAL TO A DETERMINATION OF THE REASONABLE NECESSITY OF A REGULATION ............................ A. Risk Assessment And Quantification Are Necessary Components of Regula tory Decisions ......................................................................... B. The Prevalence Of Uncertainties Underline The Need For Risk Quantification So Far As Possible .......................... C. Animal Data May Be Used For Quanti fication Risk Assessment ...................... D. Interchangeability Of Carcinogens Has Not Been Demonstrated .............................................. 187 192 193 193 194 195 196 197 197 199 203 205 206 -v- 0^ Page E. Epidemiology Can Greatly Assist In Making Risk Assessments ........................................... 208 F. Methods Are Available For Extrapolating To Low Doses ........................................... 209 G. Time-To-Tumor Concepts Should Be Used In Making Risk Assessments ............................... 211 Conclusion............... 213 XII. UNDER THE STATUTE OSHA MUST DETERMINE NOT ONLY THE FEASIBILITY OF A STANDARD BUT WHETHER BENEFITS COMPARED TO COSTS DEMON STRATE THE STANDARD IS REASONABLY NECESSARY ........... 215 Introduction ......................................................................................... 215 A. The Definition Of Feasibility ............... 216 B. The Proposed Regulation Should Be Amended To Provide For Consideration Of Economic Feasibility ................................................... 218 C. The Record Supports The Conclusion That Exposure Levels Should Be Established On The Basis Of Acceptable Risk ....................................................................... 221 D. Costs And Benefits Must Be Consi dered In Regulatory DecisionMaking ............... 224 E. The AIHC Alternative Provides A Reasonable Procedure For Identify ing An Acceptable Level OfRisk .................................. 230 F. A Risk/Benefit Analysis Is Required Under The National Environmental Policy Act .................................................................................... 232 Conclusion .............................................................................................. 233 XIII. THE PROPOSED REGULATION UNLAWFULLY REQUIRES ISSUANCE OF EMERGENCY TEMPORARY STANDARDS WITHOUT APPRAISAL OF RISK ...................................................................................................... 234 XIV. OSHA HAS A LEGAL AND MORAL OBLIGATION TO SET REGULATORY PRIORITIES ................................................ 238 A. The Statute Requires OSHA To Establish Priorities ........................................................... 240 - vi - CMA 047881 B. OSHA Should Not Allow Persons Outside The Agency To Dictate Its Priorities ......................................................................... C. OSHA Should Heed The Advice Of The Interagency Task Force On Priorities .................... PART FOUR .................................................................................................................. XV. THE PROPOSED REGULATION SHOULD PROVIDE THAT IN SETTING STANDARDS IN SUBSEQUENT RULEMAKINGS AN EXCLUSION FOR MIXTURES CONTAINING SMALL QUANTITIES OF A CARCIN OGEN WILL BE MADE AND AN ACTION LEVEL WILL BE ESTABLISHED ....................................................................... A. A Mixture Exclusion And An Action Level Should Be Incorporated Into The Standard ............................................................ B. A Mixture Exclusion And An Action Level Could Materially Reduce Cost And The Number Of Establishments Regulated ............... Conclusion ..................................... XVI. THREE MATTERS SHOULD NOT FOR PRACTICAL AND LEGAL REASONS BE PART OF THE PROPOSED REGULATION: (1) RATE RETENTION, (2) A PERMIT SYSTEM OR (3) LIMITATIONS ON THE USE OF COMPANY DOCTORS IN MEDICAL SUR VEILLANCE ................................................................................................ A. Rate Retention Provisions Should Not Be Incorporated Into The Proposed Regulation ................................................................................... B. The Permit System Has Been Insuffi ciently Considered In This Hearing And Is Not Authorized By Law ..................................... C. The Proposal To Restrict Use Of Company Doctors In Medical Sur veillance Programs Is Unsound For Practical And Legal Reasons And Without Support In The Record .................................... Conclusion ............................................................................................. XVII. KEY WORDS IN THE PROPOSED REGULATION ARE IMPERMISSIBLY VAGUE ............................................................. - vii - Page 243 245 247 247 247 248 250 251 252 254 258 261 262 CMA 047882 Page A. Critical Terms In The Proposed Regula tion Are Vague And Inadequately Defined ........... 262 B. Critical Terms In The Proposed Regula tion Are So Vague As To Preclude Effective Public Comment On the Proposed Regulation ............................................................. 263 C. If Adopted In The Form Proposed, These Vague Provisions Of The Proposed Regulation Would Deprive Affected Parties Of Due Process Of Law ..................................... 267 PART FIVE ............................................................................................................... 270 XVIII. OSHA'S MODEL STANDARDS ARE UNLAWFUL AND INAPPROPRIATE .............................................................................. 270 A, The Act Prohibits The Kind Of Inflexible Model Standards OSHA Has Proposed ............................................................................... 270 B, Because The Model Standards Will Be Applicable In Enforcement Actions, Their Meaning Must Be Clear ................................................................................................. 273 C, The Model Standards Are In Need Of Revision ................................................................................. 273 1. Scope and application (Subsection (a)) .. 273 2. Definitions (Subsection (b)) ............................ 274 3. Permissible exposure limit (Subsection (c)) .......................................................... 274 4. Exposure monitoring (Subsection (e)) .... 276 5. Methods of compliance (Subsection (g)) .. 279 6. Respiratory protection (Subsection (h)).. 280 7. Emergency situations (Subsection (i)) ... 281 8. Protective clothing and equipment (Subsection ( j ) ) 281 9. Housekeeping (Subsection (k)) 282 10. Hygiene facilities and practices (Subsection (m)) 284 - viii - CMA 047883 Page 11. Medical surveillance (Subsection (n)) ... 12. Signs and labels (Subsection (p)) ............... 13. Recordkeeping (Subsection (q)) ....................... D. Several Provisions Of The Model ETS Are Not Authorized By The Statute ............................ XIX. THE LABELING PROVISIONS OF THE MODEL STANDARDS ARE NOT AUTHORIZED BY LAW ................................. Conclusion ............................................................................................................... 284 286 287 290 291 297 APPENDICES Appendix A - Statutes Involved Appendix B - The Decision by the United States Court of Appeals for the Fifth Circuit Setting Aside the Occupa tional Safety and Health Standard for Benzene, American Petroleum Institute v. Occupational Safety and Health Administration, F. 2d 80 (5th Cir. 1978) Appendix C - AIHC, A Proposal To Achieve A Cohesive, National Cancer Policy, Exhibit 62 Appendix D - AIHC, Guidelines For Evaluation And Use Of Occupational Epidemiologic Cancer Studies Appendix E - Tabular Comparison Of EPA's 17 Prin ciples And OSHA's "Policy Determina tions" And "Concepts" Appendix F - AIHC, An Excerpt From The AIHC Alter native Entitled "Health Program Manage ment" Appendix G - AIHC, AIHC Alternative Supplement On Risk/Benefit Analysis Appendix H - AIHC, Proposed Procedure for Prioritiz ing Substances on NIOSH List Tentatively Classified in OSHA Category I by Clement Associates - ix - CMA 047884 BEFORE THE UNITED STATES DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION WASHINGTON, D.C. In Re: ) The Proposed Regulation of the United States Occupational Safety and Health ) ) ) Administration for the Identification, ) Classification and Regulation of Toxic ) Substances Posing a Potential Occupa- ) tional Carcinogenic Risk to Humans. ) ) _________ ) OSHA Docket No. H-090 POST HEARING BRIEF FOR THE AMERICAN INDUSTRIAL HEALTH COUNCIL Preliminary Statement On October 4, 1977, the Occupational Safety and Health Administration ("OSHA") published the Proposed Regulation for the "Identification, Classification and Regulation of Toxic Substances Posing a Potential Occupational Carcinogenic Risk", 42 Fed. Reg. 54148 [hereinafter referred to as the "Proposed Regulation"], under the Occupational Safety and Health Act, 29 U.S.C. 651 et seq. [hereinafter referred to as the "Act"]. -1- CMA 047885 1976. OSHA began work on the Proposed Regulation in January 1/ (Wrenn Tr. 164.) In October 1976 a contract was entered into with Clement Associates, Inc. ("Clement"), a consulting firm to, inter alia, "examine and furnish alternative approaches and policies for the regulation of carcinogens . . . ." (Ex. 12A.) The contract also provided that Clement would "[djevelop prototype regulations for controlling employee exposure to 2/ carcinogens found in the occupational environment." Id. In January 1977 OSHA released a draft of proposed regulations substantially identical to the Proposed Regulation for comment by the National Advisory Committee on Safety and 1/ References to the transcript of the hearing will be in dicated as "Tr. ____." Exhibits to the Preamble to the Proposed Regulation will be indicated as "Preamble Ex. Exhibits offered at the hearing will be indicated as "Ex. The statements filed on or before February 28, 1978, by persons wishing to testify, written statements by members of the public, and statements by OSHA witnesses were offered together as a single exhibit, Ex. 6. Additional statements or comments were filed during the hearing and as post hearing evidence was filed. For convenience the written statements of individual witnesses and written prepared testimony by witnesses will be referred to as "S. ____ ." Post hearing evidence will be identified by the person submitting the data as follows, e.g., "AIHC P. H. " 2/ The National Institute for Occupational Safety and Health ("NIOSH") is designated under Section 20 of the Act, 29 U.S.C. 669, as the research arm of OSHA. NIOSH is charged with, among other things, developing criteria for dealing with toxic materials, but was not consulted by OSHA when the Proposed Regulation was being drafted. (Tr. 2979.) 2 CMA 047886 1/ Health ("NACOSH"). This draft was not published in the Federal Register but was made available to the public on request. Two brief public meetings of NACOSH were held at y which public comments were invited. 42 Fed. Reg. 54182- 54183. At these very brief hearings testimony was received 3/ from a number of witnesses. On May 5, 1977, NACOSH adopted a resolution recommending that the draft be published for "in formation gathering and that neither the document nor the process be engaged for a rulemaking purpose at this time." 4/ 42 Fed. Reg. 54183. 1/ NACOSH is an advisory committee established under Section 7(a) of the Act. 29 U.S.C. 656(a). 2_/ NIOSH received notice of the draft regulation when it was released to NACOSH. NIOSH filed a letter with NACOSH stating its intention to comment on the draft, but no such comments were filed. 3/ The transcript of the proceedings of the Subcommittee on Environmental Carcinogenesis of the National Cancer Advisory Board was filed as part of the record in the NACOSH proceedings. 4/ The NACOSH resolution stated: "1. The document can be adopted by OSHA as an ad ministrative policy, and there should be such flexibility. 2. The document, even if adopted as a policy through the rulemaking process, would not deprive due pro cess challenges when subsequent standards are promulgated. 3. The document identifies those issues upon which much debate has evolved and should continue, including the concept that some substances, although not always scienti fically definable as carcinogens, must be addressed because of a regulatory obligation. (Footnote continued on p. 4) -3 CMA 047887 On July 13, 1977, OSHA entered into another contract with Clement to undertake a preliminary classification of substances in the 1976 Edition of the NIOSH Subfile of Suspect Carcinogens of the Registry of Toxic Effects of Chemical Sub stances ("NIOSH List" or "NIOSH Subfile") into OSHA's proposed Categories I, II, and III. (Ex. 12C.) On July 14, 1978, OSHA released the lists prepared by Clement placing substances in the NIOSH subfile in the OSHA categories on a tentative basis. (Ex. 132.) The hearing began May 16, 1978, and ended July 25, 1978. Statutes Involved The relevant statutory provisions of the Act are Sections 3(8), 6, 7, 8(c), 8(g), 9, 13, and 20. 29 U.S.C. 652(8), 655, 656, 657(c) and (g), 658, 662, and 669. The text of these sections of the statute is set out in Appendix A to this brief. (Footnote continued from p. 3) ISSUES WHICH NEED TO BE EXPANDED 1. Address adequacy of classification system. 2. Address carcinogenicity of impurities and mixtures. 3. Expand discussion on "other than animal testing" routes. 4. Anatomic and metabolic fate. 5. Decision on rate retention issue." 42 Fed. Reg. 54183. 4 CHA *7888 Introductory Statement The American Industrial Health Council ("AIHC") was formed with the objective of cooperating with government, labor, and the public in developing a sound policy for the control of 1/ exposure to carcinogens in the work place. To that end the AIHC developed "Recommended Alternatives to OSHA's Generic Carcinogen Proposal" [hereinafter referred to as "AIHC Alternative" or "the Alternative"]. The Alternative was originally released in draft form on January 9, 1978, to OSHA, unions, and the public for comment. A final copy reflecting comments on the draft was filed in these proceedings on February 28, 1978. At the time of publication of the Proposed Regulation, OSHA published a one and one-half page pro forma Environmental Impact Statement. OSHA did not undertake an economic analysis of the Proposed Regulation. OSHA stated that such an analysis would be made in rulemaking on individual substances. 42 Fed. Reg. 54182. In AIHC's view, an economic analysis of the Proposed Regulation should have been undertaken not only in compliance with the requirements of the National Environmental Policy Act of 1969, 42 U.S.C. 4321 et seq. {"NEPA"), but also pur- 1/ The membership of AIHC as of June 26, 1978, appears as Exhibit 81. A number of companies have joined AIHC since that date and membership is now approximately 120 com panies. In addition to these member companies, AIHC has cooperative relationships with some 50 trade associations. -5- CMA 047889 suant to directives of the President in Executive Orders No. 11821, 39 Fed. Reg. 41501 (November 28, 1974) and No. 12044, 1/ 43 Fed. Reg. 12660 (March 27, 1978). Consequently AIHC com missioned the Foster D. Snell Division of Booz, Allen and Ham ilton, Inc., to undertake such an analysis. That analysis,discussed infra, at 105, is entitled "Preliminary Estimates of Direct Compliance Costs and Other Economic Effects of OSHA's Generic Carcinogen Proposal on Substance Producing and Using Industries" [hereinafter referred to as the "Snell Report"]. Significant Post Hearing Developments Regulatory Analysis. As pointed out above, OSHA did not undertake an economic analysis of the Proposed Regula tion. On June 14, 1978 Organization Resource Counselors ("ORC") wrote to the Office of Management and Budget ("OMB"), the agency responsible for the implementation of the President's Regulatory Analysis Program, pointing out that OSHA's position that an eco nomic analysis was not required under Executive Order 12044 was erroneous and requesting OMB to use its good offices to require OSHA to prepare an economic analysis. On July 25, 1978 OMB notified ORC that OSHA had "agreed that a regulatory analysis will be done for the generic standards and that [OMB] will 1/ OSHA's failure to comply with NEPA and the Executive Orders is discussed infra, at 100. 6 CMA 047890 continue to work with [OSHA] on the design of the analysis. (AIHC P.H.) In a memorandum to Assistant Secretary Bingham dated August 3, 1978, Messrs. Morris and Wrenn summarized the agreement by OSHA to undertake a regulatory analysis of the Proposed Reg ulation, including an examination of "realistic alternative approaches." (AIHC P.H.) The memorandum continued: "In addition to this comparison of alter native approaches, the analysis would also look at alternative criteria for the categorization of substances within the generic standard. OSHA also will set forth for review the parameters which are included in a determination of feasibility. We think the analysis will demonstrate what issues are intended in the generic approach to be foreclosed from further rulemaking." Id. As of the date of this brief, neither the regulatory analysis nor a draft or outline of the analysis has been made public. The Benzene Decision. On October 5, 1978 the Fifth Circuit Court of Appeals unanimously decided to set aside the Occupational Safety and Health Standard for Benzene (the "Benzene Standard"). American Petroleum Institute v. Occupational Safety and Health Administration, ____ F.2d 80 (5th Cir. 1978). (A copy of the decision is attached as Appendix B. The decision will here inafter be referred to as the "Benzene decision".) The decision bears directly upon many of the policy determinations being considered as part of the Proposed Regulation and demonstrates that OSHA should withdraw the Proposed Regulation and repromul gate a new proposal which complies with the statute. Because -7- CMA 047891 of the importance of the decision, we are discussing it at the outset rather than piecemeal in various sections of the brief. The core policy determination of the Proposed Regula tion -- the control of exposure to confirmed or suspected car cinogens to the "lowest feasible level" -- was incorporated into the Benzene Standard and was the primary focus of the Fifth Circuit's decision. The factual premise for that policy deter mination in the Proposed Regulation -- that there presently ex ists no known safe level for exposure to a carcinogen -- also was the basis for the control of benzene in accordance with that policy. The provisions of the Benzene Standard clearly track the provisions of the model standards found in the Proposed 1/ Regulation. The Court's ruling is particularly germane to the Proposed Regulation in light of the assumptions the court made in deciding to set the Benzene Standard aside. The Court accepted OSHA's determination that benzene is a leukomogen and that it is impossible to determine a safe or no-effect level for exposure to benzene or any other carcinogen. The Court accepted OSHA's cost estimates for industry implementa- 1/ Compare 43 Fed. Reg. 5918 (February 10, 1978) with 42 Fed. Reg. 54148 (October 4, 1977) regarding adoption of policy to control exposure to lowest feasible level; 29 C.F.R. 1910.1028(c)(1) and (c)(2) (published at 43 Fed. Reg. 5964) with Proposed Section 1990.160(c)(1) and (c)(2) (published at 43 Fed. Reg. 54189) regarding control of exposure from airborne concentrations and from dermal con tact; and 29 C.F.R. 1910.1028(k)(2)--(5) (published at 43 Fed. Reg. 5966) with Proposed Section 1990.160(p)(3) regarding labelling. -8- CMA 047892 tion of the Benzene Standard and did not reach or discuss the petitioners' arguments concerning the infeasibility of the standard. The decision thus is based on statutory grounds rather than the particular facts pertaining to benzene. In setting aside the Benzene Standard, the Fifth Cir cuit rejected OSHA's effectuation of the policy determination "to limit employee exposure to carcinogens to the lowest feasi ble level" where (as is the case with benzene and the Proposed Regulation) that determination is based simply upon factual findings that the substance is a carcinogen and that there is no known safe or threshold effect level of exposure for the substance. __ F.2d at 88. The Court found that for an occupa tional safety and health standard to be "reasonably necessary and appropriate to provide safe or healthful employment and places of employment," as required by Section 3(8) of the Act, 29 U.S.C. 652(8), OSHA must "assess the expected benefits" from the standard and "determine whether [those benefits] bear a reasonable relationship to the costs imposed by the standard." _ F.2d at 90-91. In other words, OSHA must conduct some form of cost/benefit analysis, as advocated by AIHC and others. The Court specifically found that in making the assess ment of benefits OSHA could not assume "appreciable" benefits would accrue to employees by lowering exposure to a carcinogen, in this case benzene. Rather, OSHA must make a factul deter mination, supported by substantial evidence, as to the benefits to employees from the reduction of exposure required by the -9- CMA 047893 standard: "Until OSHA can provide substantial evidence that the benefits to be achieved by reducing the [PEL] from 10 ppm to 1 ppm bear a reason able relationship to the costs imposed by the reduction, it cannot show that the standard is reasonably necessary to provide safe or healthful workplaces." __ F.2d at 92. In short, OSHA must "regulate on the basis of knowledge rather than on the unknown." Id. The Court explained that sufficient "knowledge" of the benefits provided by a standard could be secured through 1/ appropriate risk assessment and quantification. While recognizing that "OSHA's assertion that present knowledge is insufficient to construct a valid dose-response curve for benzene may be correct," the Court found that "the record 1/ Because the word "risk" was used with different meanings by the Fifth Circuit and various witnesses in this pro ceeding, it is important as a preliminary matter to define "risk" as that word is used in this brief and to distinguish "risk" from "hazard". "Risk" is used in this brief to re fer to the scientific evaluation of data to determine its validity to establish qualitative human risk of cancer. "Risk" also encompasses evaluation of potency in relation to human risk, identification of the scientific extrapola tion techniques, and an evaluation of the probability of occurrence. "Hazard", in contrast, is used in the regulatory context, to mean the social danger presented by exposure to the sub stance. The determination by the Agency whether to regulate or not is based on the analysis of the Agency of the "hazard "Hazard" thus encompasses the number of workers exposed, the level of exposure, and the characteristics of the substance to which the worker is exposed - both the physical character istics and the relative potency of the substance. Hazard assessment is the function of the Agency. See generally AIHC Alternative at 78-82. 10 CMA 047894 reflects that preliminary assessments are now being made and that valid extrapolations will be possible as more is known about the effects of past exposure at higher levels." __ F.2d at 92 n. 23. Furthermore, until "rough but educated estimates of the extent of benefits" from reducing exposure could be developed based on human exposures or animal data, there would be insufficient evidence upon which to find a standard reason- 1/ ably necessary. __ F.2d at 93. The PEL for airborne concentrations of benzene was the primary focus of the Court's opinion, but challenges to the dermal contact and labelling provisions in the standard were considered and the Court's ruling setting aside these provisions was significant. The disposition of these challenges clearly demonstrates that each provision in a standard must be the sub ject of a finding, supported by substantial evidence, that the provision is "reasonably necessary" to provide workers protec tion . The dermal contact provision in the Benzene Standard was set aside upon a finding that OSHA failed to demonstrate that it was "reasonably necessary" for the protection of workers: "Since entry to the body by dermal contact was not established, the record will not support a finding that the prohibition of all dermal contact with benzene will result 1/ The court's decision underlines the conclusion (see dis cussion beginning infra, at 197) that OSHA should modify the Proposed Regulation to provide for risk quantifica tion and hazard assessment. - 11 - CMA 047895 in quantifiable benefits in terms of a reduced risk of leukemia justifying the costs of the provision. Thus reasonable necessity is lacking here too." __ F.2d at 94 (emphasis added).1/ The Court stated that it would have applied the same criterion to the labelling provisions of the Benzene Standard but such an analysis became unnecessary once the provisions con cerning the reduction of the PEL and the prohibition of dermal contact were set aside. These provisions were correctly viewed by the Court as tied to all the Benzene Standard's other require ments. However, in an effort to provide guidance to OSHA in promulgating future standards, the Court addressed the labelling issue. The Fifth Circuit opined that OSHA could forbid em ployers from removing caution labels upon containers of benzene and benzene-containing products sold, distributed or otherwise leaving the employer's workplace; that authority, however, is limited to circumstances where "the labelling requirement as a whole is shown to be reasonably necessary to provide safe work places." F.2d at 99 (emphasis added). In short, just as for exposure limits and restrictions on dermal contact, OSHA must 1/ It is notable that the Court reached this determination having before it information on costs which was made un certain by OSHA's amendment of the Benzene Standard (prom ulgated on June 21, 1978, the day before oral argument) exempting from the scope of the standard work operations where the only dermal exposure to benzene is from liquid mixtures containing 0.5 percent or less of benzene by volume Thus, the lack of a supportable finding of appreciable benefits was the primary basis for setting the provision aside. - 12 - CMA 047896 find on the basis of substantial evidence that labelling will achieve a quantifiable health benefit for workers and that the benefits achieved will be reasonably related to the cost of such labelling. As in the Court's analysis of the PEL and dermal con tact provisions, the Court stressed that a valid finding by OSHA that appreciable benefits would accrue to workers was the indis pensable predicate to regulation. Thus, OSHA must as a threshold matter find that labelling is reasonably necessary or appropriate to inform employees of the danger of the substance found in the container and second, that it is reasonably necessary or appropri ate for the labels to remain on the container to inform downstream employees of the danger of the substance found in the container. Another aspect of the Court's decision is of great im portance as it bears on OSHA's obligation to take affirmative action to secure data upon which to act. The analysis performed by the Court in determining that OSHA failed to establish dermal contact as a mode of entry of benzene into the body strongly suggests the invalidity of the primary procedural concept em bodied in the Proposed Regulation. The Court recognized that there was evidence in the hearing record providing some support for OSHA's determination that benzene could enter the body through the skin. But testimony also established that through modern testing techniques a definitive answer could be provided to the question regarding the conditions under which skin absorp tion might occur and the nature of the substance which actually could be absorbed. The failure of OSHA to conduct the tests - 13 - CMA 047897 necessary to answer these questions was viewed by the Court as directly contrary to the will of Congress: "OSHA's decision to regulate on the basis of dated, inconclusive data when modern experimental methods can quickly and efficiently provide reliable information contravenes the directive from Congress to promulgate standards on the basis of the 'best available evidence,' 'research, demonstrations, experiments, and such other information as may be appropriate,' and 'the latest available scientific data in the field.' 29 U.S.C.A. 655(b)(5)." __ F.2d at 96. Thus, the primary procedural concept in the Proposed Regulation -- OSHA's expressed intention to generically resolve many principles and concepts in this proceeding and to rigidly apply these principles and concepts in future rulemaking pro ceedings on specific substances -- flies in the face of the Fifth Circuit's ruling. It is clear that not only significant new data, but data reasonably obtainable must be considered by OSHA in promulgating occupational safety and health standards. Further more, assuming the answers to factual questions, such as whether a carcinogen may be absorbed through the skin, will be grounds for invalidating a standard. Rather than create such rebuttable presumptions, OSHA must find on the basis of substantial evi dence that the carcinogen may be absorbed through the skin. The Benzene decision underlines basic weaknesses of the Proposed Regulation. OSHA must find on the basis of valid sup porting evidence that there are benefits in terms of reduced risk from control to the lowest feasible levels and those benefits must be quantified. OSHA has not done so. OSHA must then make the - 14 - CMA 047898 determination whether the benefits justify the costs, of the Proposed Regulation. OSHA has not done so. Finally, OSHA has the obligation to consider the best available evidence and to take affirmative steps to secure data reasonably available before making regulatory decisions. OSHA has done the opposite; the proposed policy decisions and presumptions of fact are de signed to exclude new data and there is no procedure to secure reasonably available data. In short, if OSHA wishes to speed up its regulation of carcinogens in a valid manner, it must withdraw the Proposed Regulation and create a new regulatory scheme. OSHA has been provided such a scheme in the AIHC Alter native . ARGUMENT Introduction The AIHC Alternative and OSHA's Proposed Regulation agree on a number of very important points. However, in AIHC's view, the record shows that OSHA's proposal is deficient both legally and scientifically. The purpose of this brief is two-fold: First, to point out the shortcomings of the Pro posed Regulation and to indicate how the regulation can be brought into conformity with the law. Second, to demonstrate that the AIHC Alternative avoids the shortcomings of the Pro posed Regulation. The discussion in this brief is divided into five - 15 - CMA 047899 general parts In Part One (Sections I - VII) we shall discuss the statutory and constitutional issues arising under OSHA's pro posal. As a background to this discussion and in order to clarify the nature of the problem OSHA is addressing, we shall discuss briefly the evidence in the record as it bears on the issue of whether there is an occupational cancer epidemic due to industrial exposure of workers. In Part Two of the brief (Sections VIII - X) we shall discuss the shortcomings, both scientific and legal, of OSHA's proposed classification system. We will address the evidence in the record which demonstrates that OSHA's proposal to make generic scientific decisions by 'administrative fiat is unsound and would "freeze" science in a way inconsistent with the stat ute . Part Three (Sections XI - XIV) addresses the issues which arise by reason of the automatic and inflexible way in which OSHA proposes that regulatory action be taken. We shall discuss OSHA's lack of authority to issue an Emergency Temporary Standard without an appraisal of the risk as required by law. We shall review the evidence in the record which demonstrates that OSHA should undertake a quantitative risk analysis and con sider how such an analysis should be used in setting exposure levels. And we shall also refer to the record and the statute regarding OSHA's obligation to establish priorities. Part Four (Sections XV - XVII) deals with the impor- - 16 - CMA 047900 tance of providing in the regulation for a determination in sub sequent standards for exclusion of mixtures containing small quan tities of a carcinogen and for determination of an action level. It also discusses three matters which are inappropriate in the Proposed Regulation: rate retention,' a permit system and limita tions on the use of company doctors. Finally, we point out that key words in both the Proposed Regulation and the proposed stan dards are impermissibly vague. Part Five (Sections XVIII - XIX) will address the in adequacies of the proposed model standards. AIHC believes that the defects in the Proposed Regulation are fundamental. Significant issues such as risk assessment are being decided in the Interagency Regulatory Liaison Group, not in this proceeding. The Agency's interpretation of the basic concept of feasibility will only be made public when the Regulatory Analy sis is made public. Similarly, the Agency has not indicated clear ly which issues it proposes to decide generically. To make these basic disclosures only in the Regulatory Analysis, as the Agency proposes, renders the notice meaningless since the record is closed. OSHA has commenced overlapping proceedings on access to medical records. AIHC believes that the only prudent course is for OSHA to propose a new revised regulation which corrects the deficiencies of the present proposal and allow public comment on that new pro posal . 17 CMA 047901 PART ONE I THERE IS NO OCCUPATIONAL CANCER EPIDEMIC In the Preamble to the Proposed Regulation OSHA discusses the increase in cancer since 1900. 42 Fed. Reg. 54150. Unfortunately, the ambiguous way in which OSHA used the term "environmental factors" as the cause of cancer, to gether with the way in which OSHA discussed exposure to "man made chemicals" in the context of a burgeoning "environmental" cancer problem, created the impression that OSHA was attri buting the growth in cancer since 1900 to industrial exposure. This has lead to a significant volume of testimony addressed to the issue of whether there is an epidemic of cancer related to workplace exposure to man-made chemicals. It is not our purpose to review this testimony in any detail. While cancer from industrial exposure is only a small part of the total cancer problem, nonetheless the part industrial exposure plays is important because any cause of cancer is important. It is AIHC's position that whenever a confirmed or highly probable cause of cancer is found in the workplace, there is good and sufficient reason to take prompt and stringent protective action prior to OSHA's promul gation of a standard. Should OSHA conclude that protective action taken by industry is insufficient, it can then insti- 18 CMA 047902 tute regulatory proceedings. It is unnecessary to show that there is an actual or threatened epidemic in order to jus tify control over worker exposure to identified carcinogens. Until the post hearing filing by OSHA on September 15, 1978, the statements in the record of government officials (not industry representatives) indicated that the relative contribu tion of occupational exposure to the total cancer burden was 1/ small: 1% to 5% was the most frequent estimate. Dr. Gori of the NCI and Dr. Wynder of the American Health Foundation in a study prior to this controversy concluded that most of the can cer burden was attributable to life style: diet, tobacco, alco hol and sunbathing, and attributed only about 4% to industrial 2/ exposure. 1/ The British Royal Society Study Group on Lay Term Toxic Effects, of which Sir Richard Doll is chairman, issued a report dated July, 1978. (A copy has been filed in Doc ket 090). That report states: "Many specific hazards of cancer have been traced to occupational exposures to chemicals in industry, though such hazards are not likely to account for more than about 1% of all cancers now occuring in the U.K, A few other cancers could be attributed to pollution by industrial products or industrial waste (e.g. respiratory cancer attributable to asbestos dust). New rapid tests for the detec tion of the carcinogenic potential of chemicals should enable sources of hazard to be reduced even further." (Id. at 7)(emphasis added). 2/ Ernest L. Wynder and Gio B. Gori "Contribution of the En vironment to Cancer Incidence; an Epidemiologic Exercise," 58 J. Natl. Can. Inst. 825, 831 (1977). Reprint in AIHC Bibliography. - 19 CMA 047903 On September 15 OSHA filed a document in the record entitled "Estimates of the Fraction of Cancer in the United States Related to Occupational Factors" [hereinafter referred 1/ to as the "Estimates Paper"]. This paper purports to set forth a basis for revising the estimated cancer burden attributable to occupational exposure and concludes that an estimated 20% of cancer mortality will be occupationally related in forth- y coming decades. (Estimates Paper at 24.) AIHC believes that the Estimates Paper is fundamentally flawed and presents a false picture. It is doubly unfortunate that such a new frightful forecast should be presented on the last day for filing evidence without opportunity to question the contributors or to demonstrate the flaws in the estimate. A separate memorandum [hereinafter referred to as the "AIHC Reply"], filed with this brief, contains an analysis by AIHC of the Estimates Paper. In this brief we will summarize the 1/ The contributors are: Kenneth Bridbord, M.D., NIOSH; Pierre Decoufle, Sc.D., NCI; Joseph F. Fraumeni, Jr., M.D., NCI; David G. Hoel, Ph.D., NIEHS; Robert N. Hoover, M.D., Sc.D., NCI; David P. Rail, M.D., Ph.D., NIEHS, Director; Umberto Saffiotti, M.D., NCI; Marvin A. Schneiderman, Ph.D., NCI; Arthur C. Upton, M.D., NCI, Director. Contributor to the Appendix: Nicholas Day, Ph.D., NCI, IARC. 2/ This figure was selected without explanation as a con servative estimate from a range of estimates of cancer as occupationally related varying from 18% to 38%. The Estimates Paper appears to conclude that there is no way to ameliorate this tragic and frightful forecast. The estimates are "future consequences of past exposure (Estimates Paper at 16, emphasis in the original). Thus apparently no action by OSHA or any other agency can alter this terrible forecast. - 20 - CMA 047904 points made in the AIHC Reply. At the outset it is important to point out tht the Estimates Paper rejects the "one effect-one cause" explanation of cancer and embraces the concept of associated risk while calling it attributable risk. An inevitable consequence of this approach is that attributable causes of cancer exceed 100%. (Estimates Paper at 23.) Thus, for example, worker A who had exposure to asbestos and in uranium mining would have his death of lung cancer attributed both to asbestos and radioacti vity exposures. Assume a ten worker cohort with workplace ex posure as indicated in the following table and that all died of lung cancer: Worker 1 2 3 4 5 6 7 8 9 10 Smoker? + + + + + + Asbestos? + + + + + Uranium? + + 653 Six deaths would be attributable to smoking, five to asbestos and three to uranium - a total of 14 attributable deaths in 10 workers. The Estimates Paper would claim smoking accounted for 60% of the deaths, asbestos for 50% and uranium for 30%. We now have "attributed" 140% of the deaths without taking into account the attributable risk from genetic susceptibility, diet, alcohol, or exposure to other natural or synthetic carcinogens - 21 - CMA 047905 1/ in the environment or the body, Since cancer has attribut- able causes exceeding 100%, the 20% estimate of occupationally related cancer should not be considered in relation to 100% of the cases of cancer, as is the case with most previous esti mates, but to some higher percentage number of all attributable causes. If one conservatively assumes that the total of attri butable causes do not exceed 500%, the 20% figure translated to the normal 100% usage would be 4%. In addition, the Estimates Paper has not addressed the critical question of prevention: whether removal or reduc tion of one attributable cause has any meaning, if the remain ing attributable causes still exceed 100%. In the same discussion, the Estimates Paper urges that the focus be on "causative factors". (Estimates Paper at 23.) However, the methodology of the Estimates Paper injects a note of confusion with regard to recommendations that OSHA make a risk estimate of the causative factors as part of the regulatory process. No meaningful risk estimate can be made 1/ Several of OSHA's post hearing filings, including one by Dr. Saffiotti, a contributor to the Estimates Paper, were designed to show that the bionutrients, selenium, cobalt, calcium and estrogens which are essential to life are also contributors to the human cancer burden even at low essen tial levels. In addition, the calculations by Dr. Nisbet in his comment filed as part of the OSHA post-hearing evi dence would indicate a very high risk for non-smokers from exposure to sidestream smoke. Thus each individual inherently has attributable risks from essential bio nutrients and an inevitable risk from exposure to tobacco directly as a smoker or indirectly from sidestream smoke. 22 CMA 047906 until a clear distinction is made between associated risk and attributable risk, between association and causation, and be tween preventable and attributable. An increased associated risk does not necessarily mean the risk is attributable to exposure in a certain industry. Thus, hypothetical workers in a certain industry may have an increased relative risk of stomach cancer. If the etiological agent is diet, then the deaths are not attributable to occupa tional exposure. If the stomach cancer were truly attributable to occupational exposure, the mortality should drop by correct ing the work environment. In this hypothetical example, correct ing the work environment would have no effect because the workers carry an excessive relative risk which is associated with, but not caused by, workplace exposure. Removal of exposure would not prevent the cancer, but adding refrigeration might. The lack of differentiation between relative risk and attributable risk must be eliminated in a sound methodology of risk analysis. Moreover, the methodology of quantification in the Estimates Paper has the following serious flaws which must be corrected before a sound risk assessment can be made: (1) The Estimates Paper virtually disregarded doseresponse relationships. The estimates were based on relative risk observations in select very high exposure cohorts and then that same risk ratio was applied to all potentially exposed workers without regard to the duration or level or probability of exposure for those individuals. - 23 - CMA 047907 (2) The estimates of the number of individuals exposed are inappropriately large. The Estimates Paper relied largely on estimated numbers of potentially exposed workers from the National Occupational Hazard Survey ("NOHS") conducted by NIOSH between 1972 and 1974. The NOHS numbers are based on a survey of 5000 establishments and extrapolated to the entire workforce. The NOHS made no distinction between potentially and actually ex posed workers or of levels of exposure. (3) The calculated incidence rates are used in the Estimates Paper to approximate mortality without adjustments for cure rate, or competing causes of death, or shifts in the age structure of the U.S. population. (4) The methodology of the Estimates Paper makes no attempt to eliminate multiple counting. The NOHS study identi fied 4.38 billion exposures for 38.2 million employees - an average of 115 potential exposures per worker out of the 198 hazards investigated. The Estimates Paper made no attempt to deal with this multiple counting. If the exposed population numbers in Table II are multiplied by the factor of 5 suggested in the Estimates Paper (Estimates Paper at 13), 59 million workers over 20 have been exposed to the six substances alone. In 1970, the total U.S. worker population over 20 was about 75 million. (5) The risk ratios were calculated from select highly exposed cohorts and estimates on recent workplace conditions were ignored. 24 CMA 047908 Asbestos. The principal example used for the analysis in the Estimates Paper is asbestos. This analysis is based on an estimated 8-11 million population exposed since World War II ("WW II"), including a cohort of 4,500,000 of WW II shipyard 1/ workers. Of this 8-11 million, 4,000,000 are estimated to have been heavily exposed and "probably" one million have died. (Estimates Paper at 8-9.) The invalidity of the methodology embraced by the Estimates Paper can be demonstrated by applying that methodology to the WW II cohort of shipyard workers. Assuming conservatively that all the "probable" million deaths occurred in the WW II cohort, one would conclude that 3.5 million exposed workers are still alive. While it appears prob able that the WW II cohort was heavily exposed, it is reasonable to allocate the 3.5 million by assigning only 4/10 or 4/7 as 2/ heavily exposed and the balance as lightly exposed. The heavily exposed sub-cohort then is between 1.4 million and 2 million. Using standard mortality rates and assuming the shipyard cohort had the same distribution of men and women workers as the WW II civilian workforce there would be 131,000 deaths expected in 1/ The basis for the figure of 8-11 million exposed workers has not been explained. In the Estimates Paper the number is referenced through reference (9) to reference (11), which is a speech by Secretary Califano, a rather unusual form of circular reference. 2/ Total exposed 8-11 million less one million dead leaves 7-10 million of which 4 million were heavily exposed. 4/10 of 3.5 million equals 1.4 million; 4/7 of 3.5 million equals 2 million. - 25 - CMA 047909 1/ this cohort in 1976. The period since WW II is a long enough latency period (see Estimates Paper referfence 15) for a signi ficant number of deaths to have occurred as a result of asbestos exposure. Seven-to-ten percent of the deaths would be expected to be due to mesothelioma, the "marker" disease for asbestos exposure. On this assumption there would have been 5,200 deaths predicted from mesothelioma among the heavily exposed and over 900 among the less heavily exposed for a total of more than 2/ 6,100 deaths annually in the WW II cohort. This projected epi demic has not materialized. Surveillance Epidemiology and End Results ("SEER") data for total incidence of mesothelioma for all sites, sexes and races are as follows: SEER Areas Total 1973 1974 1975 1976 Connecticut New Orleans Atlanta Detroit Iowa Hawaii New Mexico San Francisco Seattle Utah Total 52 12 2 63 43 6 21 95 41 17 352 9 -- 3/ -- 10 10 1 5 26 -- 2 63 13 1 -- 22 15 1 5 22 11 4 94 16 7 -- 14 11 4 7 20 15 6 100 14 4 2 17 7 0 4 27 15 5 95 1/ On this assumption one third of the shipyard cohort would be women, a conservative estimate since women live longer than men. The detailed calculations to derive the number of deaths is set out in the analysis in the AIHC Reply. 2_,/ This is the lower bound depending on whether 7% or 10% is used and depending on whether the total exposed population is 7 mil lion or 10 million. The range is about 6,000 to nearly 9,000. 3/ Dashes indicate the area was not in the SEER program in that year. - 26 - CMA 047910 The SEER population represent about 10% of the U.S. population. Disregarding the fact that the SEER population may have an un usually large number of cases of mesothelioma since five of the areas have a significant shipbuilding industry, these data would indicate a national incidence in 1976 of about 900-1000 cases of mesothelioma, compared to the 6,000 expected deaths in the WW II 1/ cohort alone forecast by the methodology in the Estimates Paper. While the gross cancer statistics may not be "inconsistent" as the Estimates Paper asserts with its total estimates of occupation ally related cancer (Estimates Paper at 22), it is extremely diffi cult to reconcile the forecast of mesothelioma incidence using the methodology in the Estimates Paper with the SEER data. If one assumed that the WW II cohort had a higher pro portion of heavily exposed workers the number of mesotheliomas forecast for 1976 could easily exceed 10,000. However, the assump tion that a large number were heavily exposed would also lead to 2/ the conclusion that most of the cohort would now be dead. In 1/ See "Lung Cancer After Employment in the Shipyards During World War II" published by Blot, Harrington, Toledo, Hoover, Heath and Fraumeni, September 21, 1978 in the New England Journal of Medicine. The authors, two of whom are contri butors to the Estimates Paper, found an excess of lung among shipyard workers but the incidence of mesothelioma was no higher than the national average, thus indicating that something other than asbestos exposure may be involved. 2/ See Selikoff, I.J, and Hammond, E.C. "Multiple Risk Factors In Environmental Cancer", "Persons at High Risk of Cancer" at 467-483 (1975). Dr. Selikoff reported that 71% of his cohort of New Jersey asbestos insulation workers on the union rolls in 1943 had died by 1973 and 56% of the cohort of amosite workers first employed in 1941 had died by 1973. - 27 - CMA 0479U that event, predictions for the future in the Estimates Paper are in error, since the predicted number that "probably" died before 1978 would exceed 1,000,000. Moreover, if the shipyard cohort had the high risks attributed to the heavily-exposed sub-cohort in the Estimates Paper, mesothelioma should have appeared in epidemic proportions in the Third National Cancer Survey, which was not the case. Chromium (VI). The risk ratio used by the Estimates Paper is questionable. The risk ratio is based on studies of workers heavily exposed between 1945-1955 in the manufacture of chromates from chrome ore using the alkali roasting process. Such exposure conditions no longer exist. Moreover, the Enter line study (referenced in the Estimates Paper) showed a steady decline in the Standard Mortality Rate ("SMR") over the period of observation from 2090 in 1941-1955 to 475 in 1956-1960. Fur ther, the NIOSH Criteria Document for chromium (VI) confirms the pattern of decreased risk at Allied's Baltimore chrome works. There the SMR declined from 680 in 1932-1941 to 160 1/ in 1952-1961, with no cases observed for the period 1961-1974. The Estimates Paper uses the NOHS figure of 1.5 million workers exposed to chromium. The NIOSH Criteria Docu- 1/ A recent report on chrome pigment workers found no excess risk among workers with "low exposure" in two factories (exposure dates 1932-1954 and 1948-1967); nor was excess risk found over all exposure levels in a cohort employed during 19551967. Some excess of respiratory cancer was found in men with early and heavy exposures. Hayes, R., "A Study of Chromate Production Workers" 1978 Ph.D. (Epidemiology) Thesis,.the Johns Hopkins University (I. Press) (1978). 28 CMA 047912 ment (1975) concluded that only 175,000 workers are directly exposed to chromium (VI). Even that figure includes exposure to chromium (VI) compounds where carcinogenesis is merely "in- 1/ ferred". (Criteria Document Table III-5.) There is no reasonable basis for using a risk ratio derived from a cohort of workers highly exposed under conditions not found in the industry for many years and apply that risk ratio to a highly inflated exposed-population figure. y Arsenic. In 1974 OSHA instituted regulatory proceed ings to set exposure standards for arsenic. After extensive hearings a standard was published May 5, 1978. 43 Fed. Reg. 19583. The Estimates Paper neither referred to nor cited the extensive data in that record. ~In the Inflationary Impact Analy sis filed April 28, 1976, OSHA made the following estimates of employee exposure to arsenic: "4. Employment and Exposure Figures Employment in all industries directly or indirectly involved in the commercial cycle of arsenic is about 660,000 employees. About 70 to 75 percent of these are production workers and, therefore, potentially exposed to inorganic arsenic. However, a large number of employees included in these figures work in areas where exposures to inorganic arsenicals are very low or non-existent. Relatively few employees are 1/ The NIOSH Criteria Document (Table XI-3) lists a large number of occupations where there is potential chromium exposure including downstream users where exposure is low and of shorter duration. The National Academy of Sciences study on chromium (1975) found no increased lung cancer risk in the user industries. 2/ There is scientific controversy as to whether arsenic is a carcinogen. - 29 - CMA 047913 directly exposed to inorganic arsenicals. Esti mates of the affected industries at any one time currently ranges from 1500-1700, for exposure levels of 0.1 mg As/m3 and above, to almost 7000 for expo sure levels of 0.004 mg As/m3 and above. Most of the exposed workers are in the copper smelters (especially ASARCO-Tacoma) and wood preserving indus tries, where exposure levels are also the highest." OSHA considered and rejected the NOHS 1,500,000 exposed population figure used by the Estimates Paper. That number, OSHA noted, may include some industries that have discontinued use of 1/ arsenicals or which involved exposure to organic arsenic. It is also apparent from the range of exposures which OSHA found that use of a risk ratio derived from smelter workers grossly overstates the risk to "the large number of workers" in OSHA's 660,000 exposed worker population where OSHA found exposures "to inorganic arsenicals are very low or non-existent." The error is doubled by the use of the NOHS estimate in the Estimates Paper. Nickel. The risk factor used in estimates for nickel is also exaggerated. A 1977 study by Doll, a reassessment of the study referenced in the report, states that the 6-fold excess was confined to persons exposed before 1930 and that no signi ficant excess was seen among persons first exposed during the 2/ period 1930-1944 after process changes had been implemented. 1/ The use of arsenic in agriculture and glassmaking has sig nificantly declined in recent years. Organic arsenic has not been implicated as a carcinogen. 2/ Doll, R., Matthews, J.D., Morgan, L.G. "Cancers of the Lung and Nasal Sinuses in Nickel Workers; A Reassessment of the Period of Risk," Brit. J. of Industr. Med, 34:102-105 (1977 ) . - 30 - CMA 047914 Moreover, recent work on U.S. workers exposed to nickel since 1/ WW II has found no increased association with lung cancer. Benzene. The Estimates Paper uses the NOHS figure of 2,000,000 as the exposed population. However, only 48,500 of that population are employees with "full time" exposure. Moreover, the Economic Impact Statement in which Arthur D. Little assesses the economic impact of an OSHA proposed regula tion of benzene, estimates that there are 800,000 employees in service stations where exposure is "well below 1 ppm on an 8-hour basis" (at D-4, 4-21). The Estimates Paper proposes to apply a single risk ratio derived from a single study of highly exposed workers to this heterogeneous population. That study of some workers exposed in a pliofilm plant in Ohio 1940-1949 has been severely criti cized. Seven cases of leukemia of various cell types were found among 746 workers. The study, however, did not report the absence of cases among 404 other workers at the plant. There is serious doubt as to the level of exposure at the plant. Records from the Ohio State Laboratory indicate levels of 500 ppm in places where workers spent considerable amounts of time and testimony at the OSHA hearing indicated clothing of workers were drenched, containers of benzene were open and direct con tact with benzene was frequent. This would indicate an exposure 1/ Bernacki ej: al. , "Investigation of Exposure to Nickel and Lung Cancer Mortality: Case Control Study at Aircraft En gine Factory," Am. Clin. Lab. Sci. 8(3);190--194 (1978). - 31 - CMA 047915 considerably above 10-15 ppm assumed in the study, a level which requires sophisticated equipment for detection. Thus a risk ratio derived from a flawed study was applied to a population with widely varying exposures, a large segment of which had exposures at very low levels. Petroleum Products, Including Aromatic Hydrocarbons. The Estimates Paper uses an estimate of 3,900,000 as the exposed 1/ population. On the assumption that this population coincides with the HOHS category, this population includes only about 60,000 workers with a "full time" exposure in about 30 different industries. The unreliability of an estimate using a risk ratio derived from a study of coke workers exposed to arsenic, aromatic amines, and ammonia in addition to PNA's, across industries with very different exposures is apparent. The observations in ref erence 16 are based merely on association in a survey of Los Angeles County. A cross section study of this kind provides no basis for extrapolation across the United States. Thus an inappropriate risk ratio was applied across a wide range of industries with unexplored ranges of exposure. 1/ This number is stated to be derived from reference 16 but there are no such estimates in that article. Reference 18 gives 2.9 million as the estimated exposed population, a number which is taken from the NOHS data. The Draft Summary of the Estimates Paper released four days earlier gives 3,000,000 as the estimated exposed population. - 32 - CMA 047916 Four days before the Estimates Paper was made part of the record a "Draft Summary" was released. There are significant unexplained differences between the Draft Summary and the final document. Most important, the Draft Summary contained estimates for excess deaths from exposure to (1) coal tar pitch volatiles and coke oven emissions, (2) vinyl chloride, and (3) iron oxide. The Estimates Paper states that these were excluded from the final document because of difficulty in matching data on rela tive risk to the number of workers exposed, (Estimates Paper at 15.) Vinyl chloride illustrates why the Estimates Paper had difficulties relating relative risk to the number of workers ex posed. On the basis of a NOHS exposed population of 2,260,000, the Draft Summary predicted 1949 excess cancers per year most of which would be hemangiosarcoma, the "marker" disease for vinyl chloride monomer exposure. The NOHS data used in the Draft Sum mary include exposure in some 30 to 40 industries most of which are downstream handling polyvinyl chloride rather than the monomer. The forecast in the Summary of yearly deaths using the NOHS popu lation exceeds by a factor of almost 30 all the known cases of angiosarcoma world wide (about 70) since vinyl began to be manu factured more than 30 years ago. It is to be regretted that the data on other substances in the Estimates Paper were not also re examined since those data suffer from the same difficulties which led to the withdrawal of estimates on the three substances. Finally, the Estimates Paper asserts that the increase in production of synthetic organic chemicals is too recent to be - 33 - CMA 047917 reflected in current cancer statistics. The chart prepared by Professor Jandl indicates that there is no detectible relation ship between cancer mortality in the D.S. and the spectacular growth in the chemical industry since 1930. A chart reproduced on page 35 prepared by Dr. Jandl compares the annual production of chemicals and allied products (using the Federal Reserve Board indices rather than simple poundage) and cancer mortality in the United States. The chart shows that the growth of the chemical industry in the United States has not been associated in any way with an in crease in cancer mortality. 34 CMA 047918 EIGI7RE 10B. ANNUAL PRODUCTION 01 CHEMICALS (1933-L975) VS. ANNUAL CANCER MORTALITY 0-935-1975) CMA 047919 II OSHA'S AUTHORITY DOES NOT EXTEND TO PROMULGATION OF AN INFLEXIBLE "GENERIC" RULE FOR A WIDE VARIETY OF SUBSTANCES FOUND IN DIVERSE INDUSTRIES The Proposed Regulation is broad and sweeping. It proposes to establish a single generic classification for all substances which under its inflexible criteria present a human carcinogenic risk. It would apply to all employment covered by the Act, "including general industry, construction, mari time and agriculture." 42 Fed. Reg. 54148. It purports to cover not only this enormous diversity of workplaces, but substances which range in form from solids, liquids, dusts and gases, and range in potency by a factor of a millionfold and more. 42 Fed. Reg. 54165. (Dr. Upton Tr. 318-319.) There are more than 2,400 substances in the NIOSH subfile of "Suspect Carcinogens" to which the Preamble to the Proposed Regulation refers. The variety and range are enormous. Moreover, the Proposed Regulation proposes to estab lish a rigid and inflexible set of regulatory consequences which will flow automatically from the classification system without regard to the enormous diversity of workplaces and substances. No distinction is made in the regulatory scheme between exposure to the substances themselves as distinguished from exposure to minute quantities of the substance which may be present in mixtures. While AIHC believes that it is appropriate for OSHA to issue generic regulations within the limits and subject to 36 CMA 047920 the criteria approved by the courts (see discussion infra, at 43), the OSHA proposal fails to comply with those limitations and criteria. A. The Inclusion Of Laboratory, Construction And Maritime Workplaces Makes The Proposed Regulation Unreasonably Broad OSHA proposes to treat laboratory workplaces, both research and other types, and construction and maritime work places, in precisely the same manner as other industrial work places. OSHA offered no evidence concerning the application of these regulations to the construction industry, maritime industry or agriculture. AIHC believes, and we believe the record shows, that there is a need to exempt these kinds of workplaces from this regulation and deal with these workplaces in appropriate separate regulations. Laboratories. Industrial and academic quality control and research laboratories, unlike most industrial workplaces, typically handle many substances in very small quantities for short periods of time. It is these conditions which make the 1/ Proposed Regulation inappropriate for laboratories. 1/ For a discussion of the laboratory problem, see the comments filed by the University of Rochester, University of Minne sota, the California Institute of Technology, Johns Hopkins University, Mayo Clinic, Association of American Cancer Institute and Johns Hopkins University School of Medicine. See also NIOSH Answer to OSHA Question 8; AIHC Tr. 3836-- 3839. Further, the persons working in laboratories are usually well-educated scientists who appreciate the hazard with which they are working. See, e.g., Upjohn Tr. 42334239, 4265-4273; Uniroyal Tr. 8260-8261. - 37 - CMA 047921 If the Proposed Regulation is adopted without modifi cation of its scope, laboratories, which typically handle many of the substances that might be subject to this regulation, apparently would be required to monitor each time a carcinogen (typically in a very small quantity) is introduced into the lab oratory workplace; they would be required to keep innumerable records and to file innumerable notices of use with OSHA; they would be required to have separate vacuums for each substance used in the laboratory; and further, they would be required to 1/ clutter the laboratory with dozens of signs. It is requirements such as these which independent, university and other laboratory representatives stated would significantly impede their research efforts; including, ironically,"in some instances cancer research See, e.g. , American Industrial Hygiene Association Tr. 8492. Not only would these provisions reduce laboratory productivity, they would also be extremely costly. See Snell Report, Chapter vil; see also Dr. Campbell Tr. 3306-3308. AIHC is not suggesting that laboratory workplaces are not in need of regulation. We are, however, suggesting that what is appropriate for a large chemical plant may not be appro priate for an academic or industrial research or quality con trol laboratory. Representatives from labor also acknowledged 1/ Many of the provisions of the standards are inappropriate for most laboratory situations, such as the provisions requiring a compliance program for each substance even though it may be used infrequently and in very small quantities. 38 CMA 047922 that it might be more appropriate to set vertical standards for laboratories rather than proceed in the manner suggested by OSHA, (Tr. 5765.) Dr. Squire also favored separate regu lations for laboratories which do not regularly use a particu lar chemical. (S. 31-32.) In this connection it is significant that the Committee to Coordinate Toxicology and Related Programs of the Department of Health, Education and Welfare ("DHEW") has just released a document entitled "Guidelines for the Laboratory Use of Chemical Substances Posing a Potential Occupational Carcinogenic Risk." (AIHC P.H.) An open meeting for comment was held on September 25, 1978 and written comments have been invited. It is clear that the special problems of laboratories are being addressed by DHEW. Certainly OSHA should await the results of the work of that committee before adopting any regulation for labora tories. OSHA offered no evidence to show that this inflexible generic standard is appropriate for control of exposure in laboratories. Those organizations which operate laboratories presented facts showing that the Proposed Regulation was un reasonable in its application to laboratories. See also AIHC P.H. (Dr. Campbell's submission). The special problems of labor atories are being addressed by DHEW. Upon this record, it is un reasonable to apply the Proposed Regulation to laboratories. OSHA should publish a new proposed regulation for laboratories and provide a reasonable opportunity for comment. - 39 - CMA 047923 Construction and Maritime. The National Constructors Association, the Asbestos Information Association of North America and the West Gulf Maritime Association presented evi dence demonstrating that construction and maritime workplace characteristics differ markedly from typical industrial work places. Construction workplaces and workforces are often tem porary and transitory. Turnover rates may be as high as 600% per year for large industrial contractors and even higher for smaller construction contractors. Workplace conditions also vary considerably depending on the precise nature of the project and the particular task in question. (Nat'l Constructors Ass'n Tr. 7123-7124; Asbestos Info. Ass'n Tr. 7696-7714; West Gulf Maritime Ass'n Tr. 7171-7172.) ~ Among the many provisions which seem out of place are those which require employee notification and recordkeeping, without regard to the transitory nature of the workforce. (Asbes tos Info. Ass'n Tr. 7709-7710.) In addition, for construction workplaces, particularly remote ones, the kinds of hygienic facil ities demanded by the model standards are simply often not real istically available. Certainly it is not possible to maintain, as the regulations would require, construction surfaces free of accumulations. Further, it seems to make little sense to re quire, as the regulations would, a separate compliance report reviewing engineering controls for each substance in such workplaces. OSHA has in previous standards recognized the need 40 CMA 047924 for special consideration for construction and other workplaces. Indeed, OSHA has appointed a separate Advisory Committee on Construction Safety and Health to address the peculiarities of this industry. 1/ given here. We would urge that similar consideration be Agriculture. The record is virtually barren of evi dence by OSHA concerning the need for, or the reasonableness of, the Proposed Regulation as it applies in agriculture. There is no discussion of agricultural workplaces in the Preamble nor are the special problems of agriculture addressed. If in a separate proceeding OSHA presents facts showing the need for, and reason ableness of, a generic regulation applicable to the agricultural workplace, a generic regulation jnay be authorized. No such show ing has been made here. B. OSHA's Sweeping And Inflexible Proposed Regulation Is Unauthorized Under The Statute As its authority for promulgating the Proposed Regula tion, OSHA has cited Sections 6(b), 8(c), and 8(g) of the Act, 29 U.S.C. 655(b), 657(c) and (g). 42 Fed. Reg. 54148, None of these sections (except to the extent that Section 8(c) permits OSHA to promulgate general rules on recordkeeping and notices) speaks to OSHA's authority finally to decide in one massive pro ceeding the many technical, scientific, procedural and legal 1/ OSHA has dealt with exposure to asbestos in the maritime and construction industries. 29 C.F.R. 1910.1001. Regul ation of exposure to other specific substances may be appro priate prior to the issuance of a generic standard for these industries. ^ 41 - CMA 047925 issues underlying the Proposed Regulation. To the contrary. Section 6(b) requires that OSHA proceed, as it has consistently in the past, to resolve these issues in the context of the prom ulgation of occupational safety and health standards for speci fic toxic substances. While there is room, as we shall discuss infra, at 51, for OSHA to issue limited generic regulations, any such regulations must be based on the statutory plan embodied in Section 6(b), under which issues as to the regu lation of specific substances will be resolved in the context of the promulgation of standards for each of those substances. OSHA cannot depart from the statutorily mandated procedure under which it must consider each standard in' the light of feasibility and on the basis of- the "latest available scientific data" with respect to the particular substance. Moreover, by excluding evidence on generically determined issues in subse quent Section 6(b) rulemakings for the issuance or modification of standards, OSHA will deny affected parties their legal right to comment upon, or offer evidence on, these issues as they relate to specific toxic substances. In view of the diversity of the underlying subject matter, OSHA does not have authority, under the Act. or other wise, to adopt a generic regulation of the type that it has proposed, in which inflexible standards are set for all sub- 1/ stances meeting predetermined criteria. The Proposed Regu- 1/ The present rulemaking differs fundamentally from situations in which agencies have promulgated rules of (Footnote continued on p. 43) - 42 - CMA 047926 lation fails to comply with the provisions of Section 6(b)(5) of the Act, 29 U.S.C. 655(b)(5), regarding the promulgation of standards for toxic materials, which require specific consideration of "the latest available scientific data in the field, the feasibility of the standards, and experience gained under [the Act] and other health and safety laws." In the Preamble to the Proposed Regulation, OSHA cites three cases as authority for its departure from the statutory pro cedure set forth in Section 6(b). 42 Fed. Reg. 54154. These are United States v. Storer Broadcasting Co., 351 U.S. 192 (1956), Federal Power Commission v. Texaco, Inc., 377 U.S. 33 (1964), and Airline Pilots Association v. Ouesada, 276 F.2d 892 (2d Cir. 1960). These cases, however, deal with situations fundamentally different from the present rulemaking. Each of these cases cited by OSHA involved an agency to which Congress had delegated broad powers of control over an area of economic acitivity to which access was made subject to agency authorization by license or permit. The reviewing courts found the broad rulemaking authority exercised by the agencies to be within Congress' intent. In contrast, nothing in the Act or in its legislative history suggests that Congress (Footnote continued from p. 42) general application to cover a variety of items or situa tions that are essentially uniform in the features affected by the rule. Whether OSHA has authority to make inflexible rules for a particular category of substances where true uniformity in fact exists would depend on the facts in the particular case. - 43 - CMA 047 927 intended to delegate sweeping and unrestricted authority to OSHA to regulate by an inflexible generic scheme all industrial and business activity without adherence to the carefully delimited procedures and criteria set forth in Section 6(b) of the Act. In each of the cases cited by OSHA, the administrative agency, after affording opportunities for interested parties to comment, issued a regulation relating to a single specific act: ownership of a sixth television station (Storer), inclusion of certain price escalation clauses in contracts for sale of natural gas (Texaco), and piloting a commercial airliner after age sixty (Quesada). The situations covered by the regulation in each case, while not totally identical, are both simple and uniform. The interested parties could easily determine the effect of the regulation upon their businesses or profession and frame their comments accordingly. Thus, each of the regulations in question was adopted after the agency received as complete a picture as possible concerning its effect on the regulated parties, who were easily identified. The reviewing courts found the parties' hearing rights satisfied because they could be identified and hence had an opportunity to effectively comment upon the proposed regulation as it would apply to then. The present case stands in stark contrast. Rather than a single specific prohibition, OSHA has proposed a complex regulation which effectively would decide in an inflexible manner a myriad of scientific, technical, procedural and legal issues to be 44 CMA 047928 automatically applied in the subsequent promulgation of occupa tional safety and health standards for specific substances which are in no fashion uniform, or even similar. It is therefore vir tually impossible for interested parties in these circumstances to anticipate fully the potential effect of the Proposed Regula tion on their business. OSHA has compounded the difficulties faced by inter ested persons wishing to meaningfully comment upon the Proposed Regulation by failing to identify clearly the many principles and concepts which OSHA intends to generically resolve in the proceeding. OSHA's stating that its forthcoming regulatory analysis "will demonstrate what issues are intended in the generic approach to be foreclosed from further rulemakings" is a clear admission by OSHA of its failure to date to provide such information to the public. (Memorandum from Messrs. Morris and Wrenn to Ms. Bingham and Mr. Wellford, dated August 3, 1978 (AIHC P.H.).) Thus, the public has been forced to comment upon the broad-ranging Proposed Regulation in a general manner, with out any real notice as to the specific issues OSHA intends to resolve generically in this proceeding. The fact that OSHA failed to make a regulatory analy sis of the significant issues involved in the Proposed Regula tion, as required by Executive Order 12044, also denied members of the public the benefit of OSHA's discussion of the particular issues and alternatives which OSHA considered. The fact that OSHA has agreed after the hearings were closed to make an - 45 - CMA 047929 analysis of the regulatory issues and "realistic alternatives" (see supra, at 6-7) underlines the inadequacy of the notice which the public received and their inability to participate meaningfully in a hearing on generic issues. In its proposed review, OSHA will also "look at alternative criteria for the classification of substances within the generic standard." There was no way that participants could meaningfully partici pate in these hearings without this information. C. The Provisions In The Proposed Regulation For Waiver Or Amendment Are Inadequate In both Storer and Texaco, supra, the Supreme Court found that the parties' statutory hearing rights also were satisfied, in part, by the agencies' providing procedures by which parties could seek waivers or amendments to the respective regulations. United States v. Storer Broadcasting Co., supra, at 201, 205; Federal Power Commission v. Texaco, Inc., supra, at 40-41. OSHA has made no comparable provision in the Proposed Regulation. It is difficult to conceive how OSHA could entertain such requests in view of its expressed intention to foreclose future discussion of the many issues being generically addressed in this proceeding. It is equally difficult to conceive how a fair waiver procedure could be created in the face of the vast range of carcinogenicity issues, the great diversity of physical properties exhibited by substances, and the wide variations among workplaces (including farms, ships, factories, laboratories and 46 CMA 047930 and construction sites) in which the Proposed Regulation would be applied. OSHA has stated in a footnote in the Preamble to the Proposed Regulation that it "will encourage petitions for amendments to these regulations, including the model standards, as conditions so warrant." 42 Fed. Reg. 54149 n.2. OSHA has issued no guidelines indicating how it will handle amendments. More importantly, however, Mr. Wrenn's testimony clearly demon strates that OSHA has no intention of considering requests for waivers or amendments in the context of a rulemaking proceeding for a specific substance. Rather, such requests would be consi dered in a separate rulemaking proceeding convened for considera tion of the requested waiver or-amendment. (Wrenn Tr. 148-149, 151.) By definition the classification system would apply to a particular substance unless there was an amendment to the Pro posed Regulation. While the standard setting proceedings on the substance and the proceedings to amend the Proposed Regulation could be parallel, the person involved in the standard setting proceeding could not seek an amendment to the Proposed Regulation which his facts justify in the proceeding on the individual sub stance. The proposed procedure is legally improper under the Storer and Texaco decisions since the affected parties would be denied the right to seek an amendment or variance as to a particular substance, an essential element of a valid generic regulation. - 47 - CMA 047931 D. The Proposed Regulation Violates The Due Process Clause The conclusion that the Proposed Regulation is unlawful is reinforced by the decisions of the Supreme Court holding that a regulation based on irrebuttable presumptions of fact which do not give parties adversely affected an opportunity to demonstrate the incorrectness of the presump tion is a violation of the Due Process Clause of the Consti tution. Stanley v. Illinois, 405 U.S. 645 (1974); Vlandis v. Kline, 412 U.S. 441 (1973); Cleveland Board of Education v. La Fleur/ 414 U.S. 632 (1974). The Vlandis case involved an irrebuttable presumption of non-residence for a student who initially matriculated as a non-resident, thus charging the student at the higher non-resident tuition rate. Rejecting this presumption which barred the student from showing he had become a resident, the Court said: " [I]t is foribdden by the Due Process Clause to deny an individual the resident rates on the basis of a permanent and irrebuttable presumption of non-residence, when that presumption is not necessarily or universally true in fact, and when the State has reasonable alternative means of making the crucial determination." 412 U.S. at 452. Many of the generic administrative policy decisions proposed by OSHA are irrebuttable presumptions of fact under the Proposed Regulation. Thus the policy determination that a safe level or threshold cannot be determined for a carcinogen is a presumption of fact which is not necessarily universally true. But the policy determination will prevent presentation - 48 - CMA 047932 of evidence that as a matter of fact there is a threshold for a particular substance until the generic policy has been amended. Thus Grover Wrenn testified that a scientific break through, such as "strong evidence" of a threshold for a particu lar substance, would be rejected in a rulemaking on that sub stance; the data would be considered only after the generic regulation had been amended. (Tr. 148-149, 151.) OSHA's posi tion on this amendment procedure effectively prevents presenta tion of evidence of a threshold, even if the regulatory action on the particular substance and the petition to amend are con ducted simultaneously. There is no realistic possibility of an amendment to the generic regulation within the mandatory sixmonth time frame for regulatiorr of particular substances under the proposal. The generic determinations therefore become ir rebuttable presumptions of fact which violate the Due Process Clause. Moreover, as the Supreme Court recently held, administra tive convenience is not a valid basis for disregard of Constitu tional rights. Marshall v. Barlows, Inc., ____ U.S. ___ 44 L.W. 4483 (decided May 23, 1978). In addition, the Benzene decision confirms that the use of a generic standard to exclude data con trary to the generic policy determinations violates the Act. Apart from the constitutional issues raised by the irrebuttable presumptions of fact incorporated into the Pro posed Regulation, the classification procedure inherently re sults in the denial of due process to affected persons. Under that procedure, classification of substances will occur based - 49 - CMA 047933 on generically resolved and woodenly applied criteria prior to a scientific evaluation of the evidence of carcinogenicity. Considerable adverse publicity and a substantial drop in busi ness may occur for any substance labeled a carcinogen, yet OSHA demonstrates an intent to apply such labels before an appropri ate scientific review is undertaken. The AIHC Alternative avoids this violation of due process rights by providing for review of the evidence of carcinogenicity by the Data Evaluation and Classi fication Panel prior to any provisional classification. The putative classification of substances in the NIOSH "Suspect Carcinogens" list by Clement issued July 14, 1978 (Ex. 132) well demonstrates the violation of due process rights which is inherent in the classification procedure in the Proposed Reggulation. Persons now producing or using the substances found on that list face great uncertainty regarding the future produc tion and distribution of their products. The use of these sub stances, many of which serve valuable functions, could be effec tively restricted or banned as industry and the public reacts to the listing of these substances as carcinogenic. Errors in the Clement list may eventually be demonstrated but significant, irreparable harm to industry and to the public may have been done in the interim. In short, the Clement list is likely to operate as a carcinogen "blacklist". Similarly, proceedings on individual substances will "blacklist" those substances for the months between provisional classification and the operation of the artificial rebuttal process where an appropriate scienti- 50 CMA 047934 fic review will first be undertaken. E. The AIHC Alternative Satisfies The Criteria For A Valid Generic Regulation_________________ _____________________________ The AIHC Alternative, while it has the same objective as OSHA's proposal -- regulation of workplace exposure to carcinogens -- differs from the OSHA proposal in significant ways relevant here. First, the AIHC proposal would apply only to indus trial workplaces. Until OSHA proposes valid generic standards, regulation of workplace exposure in agricultural, transpor tation, and construction industries and in laboratories would be on an individual substance basis under Section 6(b). Second, in contrast to the Proposed Regulation, the AIHC Alternative sets forth a system for identifying and regu lating suspected carcinogens in the industrial workplace which would operate expeditiously while maintaining sufficient flex ibility to regulate substances in light of their different properties. The Alternative would not attempt to freeze science nor exclude relevant facts from consideration in a rulemaking proceeding. The criteria for categorizing substances set forth in the Alternative would require the proposed Data Evaluation and Classification Panel to exercise scientific judgment on the basis of all the relevant evidence, rather than by applying rigid, overly simplistic criteria which are proposed for their supposed ease of administration. - 51 - CMA 047935 Nor does categorization under the AIHC Alternative dictate an automatic regulatory response. Instead, sufficient flexibility is maintained by calling for risk/hazard/benefit analyses, providing for mixtures and action levels, and not mandating the control of exposure to the "lowest feasible level" regardless of the factual showing as to the danger of exposure. Finally, the Alternative specifically authorizes the Panel to propose revisions of the catgorization scheme or the criteria in light of scientific advancements, additional information, or experience with the categorization scheme. Reasonable notice of intended changes and an opportunity to comment are to be afforded the public, in accordance with the Administrative Procedure Act. Thus a reasonable method of providing for variances and amendments is provided as required by Storer and Texaco. 52 CMA 047936 SINCE OSHA INTENDS TO ENLARGE THE PROPOSED REGULATION IN UNDISCLOSED BUT SIGNIFICANT WAYS, A HEARING ON THE INCOMPLETE REGULATION IS WITHOUT MEANING AND DENIES DUE PROCESS In his opening statement Mr. Wrenn stated that "OSHA's proposed classification scheme involves the development of cri teria for conducting and ultimately evaluating animal and human studies." (Wrenn S. 4.) During his testimony Mr. Wrenn expressed the hope that ambiguous terns would be clarified and criteria be more firmly set after the hearing. He agreed that to the extent criteria for well conducted tests can be identified, it would be desirable to set forth such criteria in the regu lations. (Tr. 227.) However, Mr. Wrenn was unable to identify the criteria being considered or to indicate how the impact of the criteria could be examined in the course of the hearing. None of OSHA's witnesses 1/ these criteria. It is apparent was able to describe or 2/ from Exhibit 34 that identify the criteria 1/ With respect to risk assessment procedures. Dr. Albert stated that he had reviewed a first draft being considered by the Interagency Regulatory Liaison Group on risk assess ment, but was unwilling to describe the draft because it was being changed significantly and a second draft was being circulated. (Tr. 2319.) See discussion of risk assessment infra, at 56. 2/ Exhibit 34 consists of the prepared statements of Douglas M. Costle, Administrator, Environmental Protection Agency, Eula Bingham, Assistant Secretary of Labor for Occupational Safety and Health Administration, John Byington, Chairman, Consumer Product Safety Commission, and Donald Kennedy, (Footnote continued on p. 54) - 53 - CMA 047937 which are being considered by OSHA are in fact of great signi ficance and could have a major impact on the operation of the Proposed Regulation. On August 2, 1977, OSHA, the Environmental Protection Agency ("EPA"), the Food and Drug Administration ("FDA") and the Consumer Product Safety Commission ("CPSC") entered into an agreement to form an Interagency Regulatory Liaison Group ("IRLG") to coordinate the activities of the four 1/ agencies. In the written agreement dated September 26, 1977, the four agencies agreed to endeavor to develop, inter alia, "common, consistent, or compatible": "1. Testing protocols, criteria for inter pretation, quality assurance procedures, and other policies relating to the test ing of toxic and hazardous substances; 2. Epidemiological practices and procedures; 3. Approaches to the assessment of risk presented by a toxic or hazardous sub stance and to the estimation of benefits associated with a substance." (Footnote continued from p. 53) Commissioner, Food and Drug Administration before the Subcommittee on Environment and Atmosphere, House Committee on Science and Technology, April 25, 1978. Attached to the prepared statements are materials furnished by the witnesses as supporting materials consisting of the Inter agency Agreement, President Carter's letter to the IRLG, the IRLG work plans set out in the Federal Register for February 17, 1978 (43 Fed. Reg. 7174), a memorandum entitled "Examples of IRLG Accomplishments," and press clippings and news releases. 1/ The agreement is included as supporting materials in Exhibit 34. 54 CMA 047938 Thus two months before the Proposed Regulation was published, OSHA, as part of the IRLG, was participating in an inter-agency program to develop outside this regulatory pro ceeding criteria and standards essential to the operation of the Proposed Regulation. The progress of the IRLG toward these objectives is apparent from the IRLG work plan published Feb- 1/ ruary 17, 1978. In that Work Plan, the IRLG disclosed the formation of eight working groups and detailed the functions of each group. Mr. Costle described the objectives of the IRLG at the hearing on April 25, 1978: "Based on their investigation and discussions, the IRLG presented us with a report suggesting seven possible initiatives which they felt would contribute to the goals we had set ourselves. They included an attempt to evolve common, con sistent, or compatible approaches to testing criteria and policies, risk assessment, infor mation acquisition and exchange, research and development policies (possibly including methods of sharing costs and facilities), joint regula tion and regulatory development activities, com pliance and enforcement procedures and policies, and public communication and education. We added an eighth, the coordination of epidemiological practices and procedures. We decided to imple ment them all." (Ex. 34, Costle S. 3.) A. IRLG Work Group Activities Closely Parallel And Involve Subjects Which Are Under Consideration In This Proceeding The objectives of three IRLG work groups are of 1/ The Work Plan as published in the Federal Register on February 17, 1978 (43 Fed. Reg. 7174), is attached as supporting material in Exhibit 34. - 55 - CMA 047939 particular interest here: Epidemiology, Risk Assessment, and Testing Standards and Guidelines. Epidemiology. The objectives of this work group are described in the IRLG Work Plan as follows: "While it is not intended that a standard model would be developed against which epidemiologists would mold their research, we believe it is necessary to develop minimum criteria by which submitted studies can be objectively evaluated." (Ex. 34, 43 Fed. Reg. 7186.) Mr. Costle advised Congress that the IRLG hopes to have the epidemiology criteria complete by late 1978. (Ex. 34, Costle S. 8.) Risk Assessment. In the Preamble to its Proposed Regulation OSHA invites comments on the question whether a risk assessment should be employed by OSHA. 42 Fed. Reg. 54167. There has been extensive testimony in the record on risk assessment and the methods and procedures to be used. See the discussion of risk assessment beginning infra, at 197. In the meantime the IRLG Risk Assessment Group under the chairmanship of Assistant Secretary Bingham is pursuing the following objective: "The Risk Assessment Work Group will develop procedures and criteria that can be uniformly applied by the four agencies for purposes of characterizing and quantifying human health risks associated with certain chemicals." (Ex. 34, 43 Fed. Reg. 7195.) The task of the Work Group was described as follows: 56 CMA 047940 "5. Task of the Work Group - An objective of the Work Group might be the development of systems to insure that the agencies routinely work together to conduct risk assessments on specific substances of mutual interest. How ever, the Work Group holds that such an ob jective is far less important than the broader one of developing and selecting general proce dures and criteria for risk assessment that can be uniformly applied to all chemicals regulated by the agencies, including those sub stances for which only one agency is responsible. Until the rules for risk assessment are clearly laid out and agreed upon, efforts to reach a consensus of the type and degree of risk associated with specific substances of mutual concern will in many instances be thwarted. Furthermore, in the absence of uniform criteria and procedures, the risks associated with chemicals that are the responsibility of only one agency will con tinue to be estimated in a different manner than those associated _with chemicals regu lated only by a second agency. This undesir able situation will not be remedied if the task of the Work Group is limited to the joint conduct of risk assessments on sub stances of mutual interest." Id. This work group is addressing specific subjects being considered in this hearing. "R.A.1.3 - Procedures for Quantifying Carcinogenic Risk. Output; Procedures for treating available dose-response relationships to estimate risk at expected or known levels of human exposure. Task - The subgroup will survey the risk estimation procedures currently in use by the agencies. Reasons for the use of specific procedures, including relevant legal matters, will be detailed. An updated review and discussion of all current mathematical models will be undertaken, including consideration of time-to-tumor analyses as a preface to the final selection of a model(s). The final document will in clude procedures for combining data from - 57 - CMA 047941 several experiments, use of human data, and modifications based on metabolic and kinetic data." (Ex. 34, 43 Fed. Reg. 7197.) In her testimony before the House Committee Dr. Bingham said: "This Work Group is now developing a carcino genesis risk assessment guideline that is to be reviewed by the IRLG member agencies next month. The guideline will then be published in the Federal Register for public comment. We expect the final document to be ready by October. The carcinogenesis guideline is a general educational device to alert the public to the dangers of chemical carcinogens as well as a manual for Federal agency scientists. This guideline will contain specific criteria for judging the liklihood that a chemical is a human carcinogen, pro cedures for treating available data to estimate human exposure to suspect chemicals, and proce dures for attempting to quantify carcinogenic risk." (Ex. 34, Bingham S. 3 (emphasis added).) The progress made by the group is set out in the 1/ memorandum entitled "Examples of IRLG Accomplishments." In that memorandum the carcinogenic risk assessment was described 1/ as follows: "The carcinogenesis document contains three parts: (1) criteria for judging the likelihood that a chemical is a human carcinogen, including a review of the significance of various types of data; (2) procedures for treating available data to estimate type, level, and extent of human exposure to suspect chemicals, including a survey of approaches used by the four agencies; and 1/ Attached as supporting materials to Exhibit 34. 2/ _Id . at 5 . - 58 - CMA 047942 (3) procedures for quantifying carcinogenic risk, i,e. , procedures for treating available doseresponse relationships to estimate risk at expected or known levels of human exposure." In a joint letter dated June 8, 1978 to Mr. W. Bowman Cutter, Executive Associate Director for Budget, Office of Management and Budget, the heads of the four IRLG agencies described the objective of the Risk Assessment Group: "As mentioned previously, procedures and criteria for identifying carcinogens are being developed by the IRLG Risk Assessment Work Group; a draft docu ment will be circulated to the agencies this summer and to the public in early fall. The docu ment will define the criteria for the use of sci entific evidence in determining carcinogenic risk as a basis for establishing regulatory policies. It will deal with at least the following issues: 1. The extent to which, and the circumstances under which, mammalian animal studies will be relied upon in identiifying potential carcinogenic substances and in evaluating their impact upon human health. 2. Appropriate species of animals for carcino genic testing. 3. Whether threshold or safe levels of exposure to carcinogens can be established. 4. 'The types of tumors and other lesions that indicate a carcinogenic effect or potential. 5. The appropriate routes of administration used in animal testing and the circumstances under which the route of administration affects the extrapolation of data from animals to humans. 6. The circumstances under which the use of high doses in animal tests is appropriate and valid. 7. The implications of similarities in chemical structure. - 59 - CMA 047943 8. The relative weights that should be given to different types of evidence (e.g., epidemiological and animal studies) where the results reinforce or contradict each other. 9. The extent to which results from various in vitro tests can be applied to the assessment of risk." (AIHC P.H.) Testing Standards and Guidelines. The Work Group on Testing Standards and Guidelines has the following objectives: "The Work Group has agreed that the following tenets will be applied as it proceeds with the task to develop testing guidelines, criteria for interpretations, quality assurance procedures, and other policies relating to the testing of toxic and hazardous substances." (Ex. 34, 43 Fed. Reg. 7197.) The work of this group is supplemented by the Risk Assessment Group: "As a first task, the subgroup will address the significance of various types of data including those from epidemiologic studies, animal bio assay studies, short term, _in vitro tests, chemi cal structure, metabolic data, etc. Statistical procedures for treating animal data to establish significance will also be detailed. The subcommittee will identify those problems attendant to the evaluation of data as evidence that an agent poses a carcinogenic risk and, where guidance is not available, will make recommenda tions for resolving difficult issues. A parti cularly troublesome issue to be treated is that of deciding the extent of testing required before a chemical can be classified as posing no carcino genic threat. This matter is important for sub stances (e.g., food additives) requiring pre market clearance." (Ex. 34, 43 Fed. Reg. 7196.) B. Key Issues Being Decided In Another Forum Will Be Unlawfully Applied Here It is perfectly plain from this brief summary of the - 60 - CMA 047944 work of the IRLG that the criteria, methods and procedures of risk assessment and quantification being developed by the IRLG go to the heart of the Proposed Regulation. In a speech entitled "Goals of the Risk Assessment Work Group of the Interagency Regulatory Liaison Group," Dr. Rodericks (Special Assistant to the Bureau Director for Science Policy, Food and Drug Administration, Bureau of Drugs) stated: "We intend to provide detailed guidance on the evaluation of the various types of scientific data. Several such guidelines are available, but they do not supply the specificity needed to ensure a high degree of uniformity in the evalua tion of test data. For example, some guidelines state that animal bioassays can be profitably evaluated only if they have been 'adequately designed and conducted.' We have no disagree ment with such a guideline, but, if it is the only guidance available, it is almost certain that different scientists will have different notions of the term 'adequately'. Uniform evaluation of bioassays cannot be achieved without develop ment of guidelines with greater specificity. We are attempting to add the necessary specificity and a large part of our guideline will be devoted to fairly detailed discussions of the dozen or so important bioassay variables and how they are each to be evaluated in reaching conclusions about the evidential value of a bioassay." (Ex. 147 at 6-7 (emphasis added).) Until it is possible to examine these criteria and standards, there is no way to assess the Proposed Regulation. The hearing therefore is being held in a vacuum. While witnesses are addressing the questions, the key issues are being decided in another forum. No adequate or valid hear ing can be held until the parties know what criteria and stan dards essential to the operation of the Proposed Regulation are being considered and adopted in the IRLG. - 61 - CMA 047945 Nor can the participants be afforded due process by being provided with an opportunity to comment on the work product of the IRLG at some later date. There will be no opportunity in such a hearing to demonstrate that the Proposed Regulation should, upon consideration of the new criteria and risk assessment procedures, be amended. Thus, for example, while risk assessment, as OSHA recognizes, is relevant to the level of control for a particular substance (42 Fed. Reg. 54167), comment on the use of risk assessment for that purpose would be frustrated by the policy determination that control shall uniformly be imposed to achieve lowest feasible exposure. 42 Fed. Reg. 54166. Similarly, comment on the criteria for car cinogenicity adopted by the IRLG would have no meaning if OSHA has already adopted the criteria for its categories. 62 CMA 047946 IV THE PROPOSED REGULATION IS AN OPEN-ENDED ASSERTION OF REGULATORY AUTHORITY LACKING IN THE NECESSARY CONSTRAINING CRITERIA AND GUIDELINES WHICH MIGHT LIMIT ARBITRARY AGENCY ACTION The foregoing section discussing the work of the IRLG makes clear that the Proposed Regulation is skeletal and incom plete. No standards or criteria are set forth for judging the validity of animal tests or human epidemiological studies. The need for such criteria is underscored by the provisions in 1990.110(b) and 1990.120(b) which permit categorization of a substance on an open-ended basis of "evidence sufficient to convince" the Secretary that the substance should be classified in Category I or II. This open-ended unrestricted basis for classification finds no support in law or in the record. The need for criteria for the conduct of tests and for identification and evaluation of data is made clear by the IRLG 1/ Work Plan discussed supra, at 55. Nor does OSHA lack the resources to set out relevant criteria. In July 1977, three months before the Proposed Regulation was published, OSHA entered into a contract with Clement Associates to screen the NIOSH list of suspect carcinogens and to evaluate, prioritize and categorize 1/ In a post-hearing statement Dr. Heston listed environmental factors which influence the incidence of tumors in inbred mice: age, hormonal status, diet, temperature, parasites, etc. (Ex. 224-G.) He stressed the importance of perfor mance standards in relation to validity of the test results. - 63 - CMA 047947 suspect workplace carcinogens. (Ex. 12.) The Agreement dated July 13, 1977 provides: "Within six (6) months from the approval of the initial plan, the contractor shall have ini tially screened the substances to determine the preliminary OSHA Categories I, II, and III. In the interest of orderly regulation, those that exhibit extreme and/or confirmed carcinogenic effects should naturally take primary importance, but those with weak effects should also be thoroughly screened to reduce uncertainty. Scientific expertise and judgment will play a great part in this step of the process. . . . (1) Contractor's experts in chemical carcino genesis shall establish criteria for categoriza tion, with the realization that this material does not lend itself to rapid systemization. Again, expert judgment will largely determine these criteria. (2) The scientists will then critically analyze and review all. carcinogenicity and other data. These data will be systematically screened and evaluated on the following points: * the appropriateness of the method and route of exposure to test animals for indicated occupa tional exposure risk in humans and the suit ability of the experimental animal species used * the adequacy of test protocols for determining carcinogenicity, particularly with regard to: -- the experimental design and its conformity to accepted protocols -- sample size -- the quality of the pathology review -- statistical significance of positive results -- adequacy of reporting results * for epidemiological studies in humans: -- adequacy of medical records and diagnoses 64 CMA 047948 -- statistical significance of positive results -- reliability of data on degree of exposure to the suspected carcinogen and to any other material which could affect results * the degree to which animal results can be extrapolated to human risk from occupational exposure, and where appropriate, review of of comparative metabolism The contractor will attempt to deveop a semiquantitative scale, upon which each chemical will be ranked according to several independent, rele vant factors. The weighted sum of the rankings may then establish an order of chemicals. The factors to be ranked may include, but may not necessarily be limited to, the following: * qualitative and quantitative presence (when available) of the toxic material in the work place, data to be drawn from several sources mentioned in contractor's proposal * degree of confidence to be placed in results of studies, e.g. has the study been duplicated?" Thus OSHA has instructed its contractor to develop the very criteria which are necessary to evaluation of the scienti fic data: ootency, risk quantification, criteria for evaluating y tests and human studies, priorities, etc. As a member of IRLG, OSHA is working on the prepara tion of criteria which would have a major impact on the substance and operation of the Proposed Regulation. Some clue to the type of criteria for the conduct and evaluation of animal data being considered by the IRLG is provided by the rule proposed by EPA 1/ Recommended procedures for chronic animal tests are set out in the National Cancer Institute's "Guidelines for Car cinogen Bioassay in Small Rodents," NCI Carcinogenesis Technical Report Series No. 1 (February 1976). - 65 - CMA 047949 to establish guidelines and criteria for this purpose in con nection with the Federal Insecticide, Fungicide and Rodenticide 1/ Act. 43 Fed. Reg. 37336 (August 22, 1978) (AIHC P.H.). These criteria govern acute, subchronic and chronic testing, includ ing oncogenic, teratogenic and mutagenic testing. These same test criteria were made applicable "for the most part" to the Premanufacture Notification under Section 5 of the Toxic Sub stances Control Act, 15 U.S.C. 2005. (Appendix I to Premanu facture Notification Draft Guidelines, September 1978, BNA Chem ical Regulation Reporter, at 1118-1119 (September 22, 1978).) The Work Plan of the IRLG and the Clement contract demonstrate that OSHA recognizes the need to establish criteria and standards as part of the Proposed Regulation. Until that is accomplished, the Proposed Regulation is an open-ended assertion of regulatory authority with none of the required criteria or standards to govern that authority so as to avoid unpredictable and inconsistent action by the agency. AIHC clearly recognized this deficiency in the Proposed Regulation, and the AIHC Alternative sets out criteria for the conduct and evaluation of animal experiments and human studies y and for the identification and evaluation of those data. The 1/ Drafts of the EPA proposed guidelines were published on June 25, 1975 (40 Fed. Reg. 76802), Ex. 150. 2/ See also the discussion of criteria in "The Design Criteria and Application of Dose Response Relationships to Inter pretation of Carcinogenic Bioassay," Morris F. Cranmer, Ph.D. (1978) (Ex. 37). - 66 - CMA 047950 lack of such criteria in the Proposed Regulation renders it unreasonable and invalid. - 67 - CMA 047951 V THE PROPOSED REGULATION MANDATING A STANDARD OF NO EXPOSURE IF THERE ARE "SUITABLE SUBSTITUTES" IS INVALID, AND SHOULD BE ABANDONED BY OSHA Section 1990.112(b) of the Proposed Regulation provides in part: "When it is determined by the Secretary that there are suitable substitutes for certain uses or classes of uses that are less hazard ous to humans, on the basis of best available evidence, the proposal shall permit no occupa tional exposure for such uses or classes of uses." 42 Fed. Reg. 54185. A. The Terms Used In The Proposed Regulation Are Impermissibly Vague Nowhere in the Proposed Regulation or in the Preamble are there any criteria for determining what constitutes a "sub stitute," nor are there any criteria for measuring "suitability" of a substance as a substitute. OSHA has not consulted NIOSH regarding the criteria for determining a "suitable substitute". (Tr. 3056-3057.) Mr. Wrenn candidly admitted that OSHA had not moved beyond the conceptual stage in developing factors for de termining what is a "suitable substitute". (Tr. 117-118.) Nor was Mr. Wrenn able to identify a witness other than himself who would testify directly regarding the issues of substitution and suitability. (Tr. 49-50.) A request for OSHA to produce such a witness was made during the course of the hearing (Tr. 3056-- 3059), however, no such witness appeared in the proceedings. 68 047952 CMA A number of witnesses addressed the complexity of the decision to substitute products. As AIHC witnesses pointed out, "[s]ubstitution , . . would be dramatically costly and dis ruptive if forced where no technological alternative now exists." (Tr. 3823.) The Shell Oil Company commissioned Charles H. Kline to assess the economic impact of both a price increase as a re sult of controls imposed on an industry and the consequences of a ban by a no exposure standard upon a finding that a "suitable 1/ substitute" exists with respect to three basic petro-chenicals: ethylene oxide, benzene, and vinyl chloride. The huge irreversi ble shifts in the economy from such a price change or ban under line the great economic significance of this issue. (Tr. 5547- 5550.) Foster D. Snell, in its economic analysis of the impact of the Proposed Regulation on the producer and user industries prepared at the request of AIHC, studied the effect of substi tution with respect to certain uses of two substances: ethylene oxide and perchlorethylene. As the perchlorethylene instance 2/ illustrates, the complexity and cost are great. The ethylene oxide case raises issues as to the suitability of the substitute, with the added complexity of proprietary control over the tech- 1/ Charles H. Kline & Co., Inc., "An Assessment of the Economic Impact of OSHA's Proposal For the Identification, Classifi cation and Regulation of Toxic Substances Posing a Potential Carcinogenic Risk to Ethylene Oxide, Benzene and Vinyl Chloride" (April 11, 1978). 2/ See also id. at 215-230. - 69 - CMA 047953 1/ nology for use of a substitute for one use (ethylene glycol). A major factor in the competitive process is commer cial pressure to find new and better materials. The substitutes for existing substances used in the manufacturing process have already been examined and the most useful and cost effective substances selected. (Tr. 4020-4021.) Substitution by OSHA man date will require use of less desirable materials. (Tr. 70457049, 7751, 7756-7757, 7842, 7847, 7913-7915, 8348-8349, 83818383, 8405.) OSHA has provided no clue as to how it proposes to measure substitutability in terms of the efficiency of the substitute process or in terms of equivalency of product. On the record we are left completely in the dark re garding how economic factors figure in the decision. What if the proposed substitute costs two, three, fifteen or twenty times more At what level is it economically suitable? What role do energy requirements play in the determination? What expenditure for process modification will be considered reasonable? What steps does OSHA propose to take if the substitute product or process is proprietary? Does OSHA believe it has authority to require compulsory licensing of proprietary or patented products or processes? Similarly, the record is blank as to the criteria 1/ AIHC Economics Panel Tr. 4024; Snell Report at 260. See also Kline Report at 23-24 cited supra, at 69 n. 1. See Statements of Dry Cleaning Industry Council, International Fabricare Institute, Neighborhood Cleaner's Association Association and Cleaning and Laundry Association Executives. 70 CMA 047954 for technological substitutability, although that is what OSHA "primarily had in mind." (Tr. 38-39.) What if a whole process must be scrapped to use the substitute? Is a substance tech nologically suitable if the product produced using the sub stitute lacks important qualities of the original product? How will OSHA weigh the impact on users of the product by reason of the new and different qualities? If the product is an inter mediate for downstream users, how will OSHA weight the impact of the changes in the product on downstream users? If the substance is manufactured from different raw materials, what analysis will OSHA make of the raw material supply and availability? How will OSHA assess the environmental impact of increased production of the raw materials? What will be the conclusion if the raw materials are in whole or in prin cipal part imported, thus creating a reliance on foreign sources? Similarly, OSHA has provided no clue as to the method or criteria it will use to determine that the substitute is less hazardous than the original substance. What form of risk analy sis does OSHA propose to use in such a determination? What are the elements which will demonstrate the less hazardous charac ter of the substitute? What difference in hazard is significant? Will OSHA assess the hazard associated with the original sub stance subject to controls with the hazard from use of the substitute, or will the assessment be made on the assumption that the original material is unregulated? What if the sub stitute requires controls; how will the comparative cost of - 71 - CMA 047955 controls be assessed? We believe it is clear that the terms used in the Pro posed Regulation are impermissibly vague and OSHA's failure to define the terms or to offer any witness who could define the terms or the criteria to be applied leaves the proposal without any support in the record. See EPA Intra-agency Memorandum from Walter Barber to Andrew Breidenbach, dated November 29, 1977 (API P.H.). Moreover, the "no exposure" limit, which is required automatically when a "suitable substitute" exists, also fails to give due consideration to economic feasibility. The failure of the Proposed Regulation to provide for specific consideration of the economic costs in determining whether there is a suitable substitute is likely to affect not only the enterprise in whose workplace the substitution would be required, but also customers and suppliers of that enterprise. It is not only possible, but even probable, that the "suitable substitute" requirement will lead to unreasonable results. For example, even an extremely weak carcinogen can automatically fall in Category I if the defi nitional criteria are met. Such a substance may well have a sub stitute that is technically and economically adequate within the context of the industry manufacturing that substance and which is marginally less carcinogenic. Under the Proposed Regulation these facts apparently would automatically trigger the imposition of a "no exposure" limit, even if the marginal benefits to be attained were at the cost of devastating another industry which - 72 - CMA 047956 supplied the substance in question. B. The Proposed Requirement Of "No Exposure" If A "Suitable Substitute" Exists Or In Other Circumstances Is Tantamount To Banning A Substance And Is Beyond OSHA's Authority The term "no exposure" is undefined. Does OSHA in tend "no exposure" as measured by today's standard industry monitoring equipment or does OSHA intend to use the most sen sitive testing devices to determine no exposure? Moreover, "no exposure" is a moving target. (Koppers Co. Tr. 77807781.) In the recent past measuring to one part in a million was difficult. Today measurements to parts per billion are feasible and OSHA has imposed a standard of parts per billion (DBCP). Tomorrow we may be able .routinely to measure parts per trillion or parts per quadrillion. If a plant is engineered and achieves control at parts per billion, a test sensitive to a part per million would register "no exposure". That plant, however, is faced with violation of the standard as a suffi ciently sensitive test is devised. As a practical matter there fore, a "no exposure" limit is in effect a ban on the product. Indeed, Dr. Holaday stated that it is not possible to eliminate all exposure even in a completely enclosed system. (Tr. 2626.) OSHA proposes to use the no exposure limit when it finds that there is a "suitable substitute". In addition, Mr. Wrenn said the Proposed Regulation did not preclude the imposi tion of a "no exposure" limit even when there are no suitable substitutes. (Tr. 114.) Mr. Wrenn acknowledged that OSHA has - 73 - CMA 047957 prepared no criteria as to when the no exposure limit would be imposed when there are no substitutes. (Tr. 114.) Thus OSHA is proposing a regulation which purports to grant to it broad and undefined authority to ban substances on a finding that a suitable substitute exists or when OSHA makes the judgment on the basis of undisclosed and undefined criteria that a substance should be banned even if there are no substitutes. OSHA has no authority under the Act to impose such a ban. OSHA's powers to prevent worker exposure to a sub stance by closing down a plant are carefully defined in Sections 9 and 13 of the Act, 29 U.S.C. 658, 662. Section 9 provides for citations for violation of a standard, rule or order. Section 13 establishes a carefully defined procedure under which the Secretary may seek an injunction against imminent dangers "which could reasonably be expected to cause death or serious physical harm. ..." The injunction may "prohibit the employment or presence of any individual in locations or under conditions where such imminent danger exists, except in dividuals whose presence is necessary to avoid, correct, or remove such imminent danger or to maintain the capacity of a continuous process operation to resume normal operations without a complete cessation of operations, or where a cessation of operations is necessary, to permit such to be accomplished in a safe and orderly manner." 29 U.S.C. 662(a). No authority to issue a "no exposure" ban on a sub stance can be found in these provisions. The legislative history confirms that these provisions were adopted to define - 74 - CMA 047958 the limits of OSHA's authority to ban exposure to a substance. One of the major issues considered during the debates on the bill was the extent of authority, if any, the Secretary should have as an administrative matter to order a plant closing. The Conference Report rejected a grant of administrative authority 1/ to ban exposure by ordering a shutdown. Thus the provisions of Sections 9 and 13 are the only authority under the Act to ban exposure to a substance. Usery v. Whirlpool Corp., 416 F. Supp. 30 , 34 (N.D. Ohio 1976 ) . A ban on a substance by a "no exposure" standard is clearly not a "feasible" means of implementing the Act. Congress' intent in passing the Act was to protect employees, but not by putting their employers out of business or completely eliminat ing hazardous occupations. AFL-CIO v. Brennan, 530 F.2d 109, 120-121 (3d Cir. 1975); AFL-CIO v. Hodges, 499 F.2d 467, 477478 (D.C. Cir. 1974). Similarly, Section 3(8) of the Act, 29 U.S.C. 652(8), requires that any standard or provision of a standard must be "reasonably necessary or appropriate" to provide a safe work place. There is nothing in the record to support a conclusion that OSHA's attempt to assert authority to ban a substance is 1/ The difference between the House bill, which insisted on judicial proceedings to ban exposure, and the Senate bill, which favored a grant of administrative authority, was resolved in Conference in favor of the House position. H.R. REP. No. 1765, 91st Cong., 2d Sess. 401 (1970) in Legislative History of the Occupational Safety and Health Act of 1970 [hereinafter cited as "Legislative History"]. - 75 - CMA 047959 "reasonably necessary or appropriate." The Benzene decision clearly sets out the meaning of reasonable necessity in the Act. Affirming the construction given the same term, "reason ably necessary", found in the Consumer Product Safety Act (see Aqua Slide 'N' Dive Corp. v. Consumer Product Safety Commission, 569 F.2d 831 (5th Cir. 1978); D.D, Bean & Sons Co. v. Consumer Product Safety Commission, 574 F.2d 643 (1st Cir. 1978)), the Court stated: "Before it regulates, the agency must show that a hazard exists and that its regula tion will reduce the risk from the hazard, for 'no [occupational safety and health] standard would be expected to impose added costs or inconvenience . . . unless there is reasonable assurance that the frequency or severity of injuries or illnesses will be reduced.' 569 F.2d at 839. More im portantly for today's case, Aqua Slide also requires the agency to assess the expected benefits in light of the burdens to be im posed by the standard. Although the agency does not have to conduct an elaborate costbenefit analysis, 569 F.2d at 840, it does have to determine whether the benefits expected from the standard bear a reason able relationship to the costs imposed by the standard. 569 F.2d at 842." ____ F.2d 90-91. OSHA has conspicuously failed to make any cost assessment justifying the "suitable substitute" provision and indeed has not indicated that cost would be a factor. To the extent that OSHA's conceptual thinking has been revealed, OSHA was thinking solely of technological substitutability. (Wrenn Tr. 38-39.) For this additional reason the "suitable substi tute" provisions are unauthorized under the statute. - 76 - CMA 047960 In the absence of an explicit grant of authority to ban substances, such a power cannot be created in OSHA by impli cation. Statutes allegedly authorizing administrative agencies to utilize the drastic remedy of banning substances must be strictly construed, and there is no freedom to add to the lan guage of the statute as written by Congress. 62 Cases of Jan v. United States, 340 U.S. 593 (1951); United States v. Lexing ton Mill & Elevator Co., 232 U.S. 399 (1914). The Act is a de tailed piece of legislation, and the presumption should be that Congress defined the limits of OSHA's authority in the express 1/ terms of the statute. This rule of strict construction is clearly demonstra ted in 62 Cases of Jam v. U.S.,'supra, where the Supreme Court ruled that the Federal Food, Drug and Costmetic Act, 21 U.S.C. S 301 et seq., did not "implicitly prohibit" the marketing of a product labelled as "imitation jam", as the government had con tended when it seized the product. The Court stated that its "problem is to construe what Congress has written. It is for us to ascertain -- neither to delete nor to distort. ... In our anxiety 1/ The Report of the Comptroller General to Congress dated June 16, 1976, entitled "Federal Efforts to Protect the Public from Cancer-Causing Chemicals are Not Very Effective", concluded "OSHA sets and enforces occupational safety and health standards, which pertain to a wide variety of areas, such as farm vehicles and a chemical worker's exposure to a carcinogen. OSHA cannot ban production or use of a hazardous chemical but can protect a worker from exposure to them." Ch. 2, at 8. 77 CMA 047961 to effectuate the congressional purpose of pro tecting the public, we must take care not to extend the scope of the statute beyond the point where Congress indicated it would stop." Id. at 596, 599-600. Similarly, in United States v. Lexington Mill & Ele vator Co., supra, the Court ruled that the government lacked the power to condemn sacks of flour admittedly containing poisonous substances, since it had not been proved, as required by statute that these substances rendered the flour "injurious to health". The Court stated that "where a law is expressed in plain and unambiguous terms, whether those terms are general or limited, the legislature should be intended to mean what they have plainly expressed, and consequently no room is left for construction. . . . [I]f Congress had intended to enact the statute in [a particular] form, it would have done so by choice of apt words to express that intent." I_d. at 410. Similarly, if Congress had intended that OSHA have the authority to ban substances, it would have said so expressly in the statute. Where Congress intended to vest in an administra tive agency the authority to ban substances, it has indicated and effectuated that intention by explictly granting the power to do so. See, e.g., the Toxic Substances Control Act, 15 U.S.C 2601 e_t seq.; the Federal Hazardous Substances Act, 15 U.S.C. 1261 et seq.; the Federal Insecticide, Fungicide and Rodenti- cide Act, 7 U.S.C. 135 et seq.; the Consumer Product Safety Act, 15 U.S.C. 2051 et seq.; and the Food, Drug, and Cosmetic Act, 21 U.S.C. 301 e_t seq. It is thus clear that where Con gress intended to grant the authority to ban substances, it knew 78 CMA 047962 how to do so using explicit terms. No such explicit grant is contained in the Occupational Safety and Health Act. Comparison with the recently enacted Toxic Substances Control Act is particularly instructive. That statute expressly grants the Environmental Protection Agency the authority to ban toxic substances upon a finding, following a carefully specified administrative procedure, that the substance poses an unreason able risk of injury to the health or environment. The legisla tive history of that statute indicates that Congress assumed OSHA had no such authority. See H.R. Rep. No. 94-1341, 94th Cong., 2d Sess. 2, 6, 32-40 (1976); 122 Cong. Rec. E 5585 (October 1, 1976). C. The Toxic Substances Control Act Makes The OSHA Substitute Provision Unworkable As Mr. Dominguez stated "the whole question of substi tution is now an entirely different issue than it was histori cally" due to passage of the Toxic Substances Control Act. (Tr. 4063.) When the inventory of existing substances is published later this year pursuant to that Act, significant new substances and significant new uses of existing substances will be subject to pre-market notification and screening under Section 5 of the Act, 15 U.S.C. 2605. Thus before a manufacturer could use a substitute, the substitute substance could be subject to the constraints of Section 5 pre-market notification. Review of the pre-market notification will require 90 to 180 days. Thus it will be virtually impossible to determine within the six- - 79 - CMA 047963 month period OSHA has allowed for the rulemaking whether the substitute OSHA has identified can in fact be used. To identify and appraise the economics, technology, comparative risk and environmental impact of using a substi tute is a time consuming processs. If, in addition, the sub stitute must be subject to pilot tests, and downstream users are allotted time to appraise the product, the process is cer tain to take longer than the six months allotted for setting individual standards under this proposal. See, e -g., Refrac tories Tr. 6399-6400. The substitute provisions are therefore unrealistic and the process of nominating substitutes so fore shortened as to be arbitrary on its face. D. A Grant Of Authority To Ban Without Guiding Standards Would Be An Unconstitutional Delegation Of Legislative Authority Even if it were assumed arguendo that OSHA does have the authority to ban substances under the Act, the manner in which such authority has been granted to the agency by Congress would constitute an unconstitutional delegation of legislative policy making functions. A delegation of legislative authority is un constitutional in the absence of standards to guide the dele gatee's actions, Yakus v. U.S., 321 U.S. 414, 425-26 (1944), and in no circumstances is Congress permitted to abdicate the task of determining the policy of the law. See id. at 424; Panama Refining Co. v. Ryan, 293 U.S. 388, 421 (1935); Alexander v. Thompson, 313 F. Supp. 1389, 1395 (C.D. Cal. 1970). The Pro posed Regulation allows OSHA, rather than Congress, to formu - 80 - CMA 047964 late difficult policy choices by authorizing the banning of sub stances without reference to whether the benefits of the ban are outweighed by the costs and the detriment that will be done to the economy. As such, the power to ban in these circumstances con stitutes an unconstitutional delegation of legislative authority to OSHA. Cf. , Stearns Electric Paste Co. v. EPA, 461 F.2d 293, 308-309 (7th Cir. 1972 ) . Conclusion The AIHC Alternative would avoid all of these legal difficulties. Unlike the OSHA proposal, the AIHC Alternative would not call for OSHA to decide whether substitutes are avail able for a chemical being regulated as a carcinogen. (Tr. 36143615.) Nor would the Alternative impose a zero-exposure limit (tantamount to a ban of the substance) where substitutes are thought to be available. The AIHC Alternative would rely upon the incentives to industry of cost efficiency and health factors to provide replacements for materials discovered to be carcino genic. See AIHC Alternative at 43-45. As Dr. Selikoff eloquent ly urged, the matter of substitutes should be left to the market place. (Tr. 1739-1740.) - 81 - CMA 047965 VI OSHA HAS FAILED TO COMPLY WITH THE NATIONAL ENVIRONMENTAL POLICY ACT Introduction OSHA has violated the provisions of Section 102(2)(C) of the National Environmental Policy Act {"NEPA"), 42 U.S.C. 4321 et seq., by failing to prepare and circulate for comment a detailed and comprehensive draft environmental impact statement ("EIS"), by failing to publish and circulate such a draft prior to the first significant point of agency decision, and by making irretrievable commitments of resources to the Proposed Regulation prior to issuance of an adequate draft or final EIS. Pending full and adequate compliance with its NEPA obli gations, OSHA should not promulgate its final regulations. OSHA's failure to comply with NEPA has deprived interested parties and other Federal agencies of the opportunity to submit the critical commentary and objective data which OSHA is required to consider prior to taking any action. Section 102(2)(C) of NEPA requires OSHA to issue not only a final but also a draft statement assessing in detail the environmental consequences of its proposed action. See CedarRiverside Environmental Defense Fund v. Mills, 422 F. Supp. 294, 323 (D. Minn. 1976). Full and adequate compliance with NEPA at the draft stage is a prerequisite to an agency's implementa tion of the NEPA mandate at the final stage, since adequate 82 CMA 047966 weight cannot be given to environmental factors when data appear in the final EIS without being subject to the critical evalua tion that occurs through public scrutiny at the draft stage. Appalachian Mountain Club v. Brinegar, 394 F. Supp. 105, 121122 (D. N.H. 1975); see Realty Income Trust v. Eckerd, 564 F.2d 447, 453-454 (D.C. Cir. 1977); Jones v. District of Columbia Re development- Land Agency, 499 F.2d 502, 511 (D.C. Cir. 1974), cert, denied, 423 U.S. 937; Atchison, Topeka & Santa Fe Railroad Co. v. Callaway, 431 F. Supp. 722, 728 (D. D.C. 1977); Maine Central Railroad Co. v. ICC, 410 F. Supp. 653, 656 (D. D.C. 1975 ) . In purported compliance with its obligation to issue a detailed draft EIS, OSHA has included in the Preamble to its Proposed Regulation a two-page discussion entitled "Environmen tal and Economic Impact Assessment." 42 Fed. Reg. at 5418054182. The agency styles this discussion, along with the rest of the proposal, as its draft EIS. This draft purports to set out the agency's complete thinking on the environmental impact of a regulation which will directly impact, by the agency's own admission, several hundred substances. This draft, however, does not contain the detailed comprehensive and objective analysis of environmental factors required by Section 102(2)(C) of NEPA, OSHA's own regulations, and the CEQ Guidelines. OSHA's recent release of Clement's tentative categori zation of substances on the NIOSH List of Suspect Carcinogens underscores the need for a comprehensive EIS. This new infor- - 83 - CMA 047967 nation which OSHA should have had in its posssession at a very early point in its decision-making process should assist OSHA considerably in more precisely quantifying the environmental impact of its proposal which it has heretofore stated was so difficult to quantify. The same reasons which lead OSHA to change its original position that a regulatory analysis of the Proposed Regulation under Executive Order 12044 was not required (see supra, at 6-7) demonstrate that OSHA's decision to prepare an Environmental Im pact Statement only in individual substance rulemaking is invalid. In the letter to ORC giving the reasons why a regulatory analysis was required, OMB stated: "As Dr. Bingham has noted, it is difficult to conduct meaningful analyses for a generic standard when specific definitions have not been published. However, when generic stan dards will, upon promulgation preempt later regulatory decisions, then the economic effect of significant regulatory alternatives may never be analyzed." (AIHC P.H.) In the memo to the Assistant Secretary, Messrs. Morris and Wrenn stated that the regulatory analysis being prepared would examine "realistic alternative approaches." Thus unless a comprehensive EIS is prepared now, the Agency will never consider, and the pub lic will never have an opportunity to comment on the environmental impact under NEPA in later regulatory decisions on issues which are preempted by the generic standard, nor on the "realistic al ternative approaches" to be discussed in the forthcoming regula tory analysis. - 84 - CMA 468 A. OSHA Has Failed To Prepare A Detailed And Comprehensive Statement_______________ OSHA has totally failed to measure up to the rigorous standards of Section 102(2)(C) of NEPA. Its draft EIS is couched in conclusory language and its vague generalizations are often un supported by objective data. In no sense can the draft be consi dered a "detailed" inquiry into the analysis of the environmental impact of the Proposed Regulation, and OSHA has therefore violated its duty to comply with NEPA "to the fullest extent possible." The provisions of Section 102(2)(C) establish "a strict standard of compliance." Calvert Cliffs' Coordinating Committee, Inc. v. U.S. Atomic Energy Comm'n, 449 F.2d 1109, 1112 (D.C. Cir. 1971). Nothing less than a comprehensive and objective treatment of environmental issues by the responsible agency will suffice. Environmental Defense Fund, Inc, v. Corps, of Engineers, 348 F. Supp. 916, 927 (N.D. Miss. 1972), aff'd, 492 F.2d 1123 (5th Cir. 1974). A detailed statement serves three important purposes: (1) It permits a court to ascertain whether the agency has made a good faith effort to take into account the values NEPA seeks to safeguard, and to that end the EIS must explicate fully its course of inquiry, its analysis, and its reasoning; (2) It serves as an environmental full disclosure law; and (3) Perhaps most cru cial, it "helps insure the integrity of the process of decision by precluding stubborn problems or serious criticisms from being swept under the rug." Sierra Club v. Morton, 510 F.2d 813, 820 (5th Cir. 1975); State of Alabama ex rel. Baxley v. Corps, of - 85 - CMA 047969 Engineers, 411 F. Supp. 1261, 1267 (N.D. Ala. 1976). The draft EIS issued by OSHA is neither a comprehensive nor an objective treatment of the environmental consequences of its Proposed Regulation. Rather, OSHA's EIS contains just the sort of superficial consideration of environmental factors that NEPA was meant to preclude. It fails to serve the three impor tant purposes which the courts have interpreted NEPA as demand ing . OSHA's failure to comply with its obligation to file a "detailed" draft EIS mainifests itself in a number of areas. The statement omits a description of the present baseline work place environment, fails to substantiate the alleged beneficial environmental impact of the Proposed Regulation on that workplace environment, and inadequately discusses the secondary environmen tal consequences of the proposed action. The interrelationships and cumulative environmental impacts of the Proposed Regulation and other related Federal projects are not adequately analyzed, nor is the relationship between local short term uses of the en vironment and the maintenance and enhancement of long term produc tivity. Moreover, OSHA's discussion of alternatives to its pro posed action is woefully deficient. Some of these points are discussed in greater detail below. Scope. In July 1977, OSHA entered into a contract with Clement to screen and categorize the substances in the NIOSH sus pect carcinogen subfile. The draft EIS, however, fails to mention or list the suspect chemicals being evaluated by OSHA and its 86 CMA 047970 contractor for regulation under the proposal. It fails to dis cuss the alternative chemicals which are or may be used to sub stitute for the chemicals foreclosed from use by the regulations, or the environmental consequences of using these alternative chem icals. Baseline. OSHA's draft EIS contains no description of the baseline workplace environment. There are no data or analy ses, for example, of the number of employees exposed to the sub stances to be regulated, or of current conditions and practices in workplaces which might be covered by the regulation. Without an analysis of existing conditions such as these, there is no basis for evaluating the alleged beneficial environmental impact of the proposed generic standards. Environmental Impacts and Benefits. OSHA's analysis of the potential environmental impact of its proposal and the poten tial benefits falls far short of NEPA's requirements. The draft EIS is replete with examples of OSHA's incer tainty as to its ability to substantiate the beneficial environ mental impact of its proposed generic standard. The primary im pact of the Proposed Regulation is "expected to impact on the work place by reducing worker exposure to Category I and Category II toxic substances." 42 Fed. Reg. 54182 (emphasis added). OSHA declares that "[t]he specifics of potential impacts, expected as a result of the promulgation of [the Proposed Regulation] cannot . . . be foreseen and is somewhat speculative." 42 Fed. Reg. 54182. The best that OSHA can offer is an "overview" giving "a - 87 - CMA 047971 general idea of some of the types of impacts which may result." Id. The requirement that an EIS be detailed places a heavy bur den on the responsible agency to gather and include in the EIS enough information to show that compliance has been genuine, not perfunctory. Brooks v. Volpe, 350 F. Supp. 268, 276 (W.D. Wash. 1972), aff1d, 487 F.2d 1344 (1973). OSHA's reliance on conclu sions and assumptions without reference to supporting objective data prevents it from meeting that burden. Adverse Impacts and Irretrievable Commitments. OSHA's failure to discuss in detail the adverse environmental consequences of its proposal, including irreversible and irre trievable commitments made, is another serious deficiency in the EIS. Among the significant adverse impacts of the proposal on the physical environment which have not been adequately examined are the following: (a) unnecessary use or depletion of energy resources by OSHA's (1) requirement to reduce workplace exposure limits to the lowest level feasible without regard to what is an adequate level and without regard to the cost of such controls and (2) mandated preference for energyintensive engineering controls as the method for complying with permissible workplace exposure limits even though less energy intensive personal protection and administrative controls may accom plish the same end result; and (b) air, water, solid waste and land use impacts likely as a result of the proposal's provisions (1) to ban substances where there are "suitable" less hazardous alternative substances and (2) to require reduction of exposures to the lowest level feasible without regard to economic cost or effects on inter national trade. - 88 - CMA 047972 OSHA does purport to address the issue of possible energy resources depletion. Its conclusions/ however/ are not only vague, conclusory, and unsupported by objective data, but also contradictory. OSHA states in the draft EIS that its pro posal "might result in an insignificant increase in energy con sumption." 42 Fed. Reg. 54182. It does not provide any support for this assertion. Later in the draft, however, OSHA admits that potential impacts upon energy "cannot readily be quantified." Id. The treatment in the draft EIS of the potential adverse impact on air, water, solid waste, and land use is also inadequate and unilluminating. OSHA admits that various engineering and hy gienic controls "may result in increased contamination of water and increased sludge production, representing a potential negative impact on both water quality and the amount of solid waste." Dust collection methods, for example, "could impact water quality, solid waste and land use categories." 42 Fed. Reg. 54182. OSHA also ad mits, however, that it has little data which quantify these poten tial impacts." Id. Without such data, the balancing of beneficial and adverse environmental effects which NEPA demands prior to agency decision cannot take place. Secondary Impacts. The indequacy of the draft is fur ther reflected in OSHA's failure to discuss in detail the second ary environmental consequences of its proposal. Among the matters which should have been considered in detail was the possibility of plant redundancies and dislocations caused by a ban or very - 89 - CMA 047973 restrictive limits on a chemical, especially in circumstances where no alternatives are practically available, with attendant secondary environmental impacts in local communities. OSHA states only that the potential impact of its Proposed Regulation upon "hu man resources . . . cannot readily be quantified." 42 Fed. Reg. 54182. Besides these possible domestic unemployment effects, the draft EIS should certainly have discussed the probable impairment of the international balance of payments position due to the stan dards. There is no indication that this factor was considered at all. OSHA should also have addressed more adequately the impact of its Proposed Regulation upon medical research and on care and industrial hygiene resources. The draft EIS confines its discus sion of this issue to the conclu-sory assertion that n[t]he exposur levels and compliance methods chosen should have no effect on the amount of monitoring and medical surveillance required." Id. Alternatives. OSHA has said that its forthcoming regu latory analysis will "examine realistic alternative approaches for regulating these hazards" as well as "alternative criteria for the categorization of substances within the generic standard." The draft EIS contains only the most cursory discussion of possible alternatives to the proposed regulatory action and the environ mental impacts of such alternatives. OSHA, however, is required to consider these matters as thoroughly at the draft as at the final stage. Natural Resources Defense Council, Inc, v. Nuclear Regulatory Commission, 539 F.2d 824, 842 (2d Cir. 1976); Natural Resources Defense Council, Inc, v. Hughes, 437 F, Supp. 981 - 90 - CMA 047974 (D. D.C. 1977). This requirement has not been satisfied. OSHA's statement omits altogether discussion of such crucial alternatives as the "no action" alternative, without which no EIS can be consi dered complete. Monroe County Conservation Council, Inc, v. Voice, 472 F.2d 693, 698 (2d Cir. 1972). Even the discussion of those al ternatives which are included is largely vague and uninformative, indicative of OSHA's failure to comply with the obligations of Section 102(2)(C) "to the fullest extent possible." OSHA states, for example, that the choice of alternative levels of exposure compliance is expected "to have impact in some way" on every cate gory of the external environment. Such statements are neither sup ported by scientific data nor adequately explained. In no sense is OSHA's discussion of alternatives an adequate compliance with NEPA' requirement of a thorough consideration of alternative regulatory approaches and their environmental impacts. Interrelationships With Other Federal Agency Actions. OSHA's failure to adequately discuss the interrelationships and cumulative environmental impacts of the Proposed Regulation and other Federal activities is also violative of NEPA. As was made clear by Messrs. Wrenn, Byington, Kennedy, and Jellinek, OSHA and other Federal agencies have embarked on a coordinated program to deal with toxic substances, including carcinogenic substances. The forums for these programs have been principally the IRLG and the Toxic Substances Strategy Com mittee where there is little or no opportunity for public parti cipation. The deliberations of these bodies are intimately in - 91 - CMA 047975 tertwined with the OSHA regulatory program and accordingly merit full discussion in the EIS. AIHC believes it is incumbent on the IRLG to prepare an EIS before agreeing on the criteria, standards, etc. to be developed under the IRLG work plans. In any event, OSHA should prepare such an EIS with reference to this Proposed Regulation and those decisions being made in the IRLG context. B. OSHA Has Violated NEPA's Mandate For Early Consideration Of Environmental Issues OSHA's failure to publish and circulate an adequate draft EIS for comment prior to the first significant point of decision is also violative of NEPA. Contrary to the require ments of NEPA and the CEQ Guidelines, 40 C.F.R. 1500.7(a), OSHA waited until a number of significant decisions had already been made before publishing its draft EIS. An EIS is meant "to serve as the means of assessing the environmental impact of pro posed agency actions, rather than as a justification for deci sions already made." Id. OSHA had begun work on the generic proposal in January 1976. (Tr. 164.) In January 1977, OSHA publicly circulated and made available to NACOSH for comment a proposal essentially identical to that published in the Federal Register. The purported EIS was not, however, released until October 1977. The course of action taken by OSHA undermines the intent of NEPA because it deprivesgovernment agencies and the public of a meaningful opportunity to comment and lends an irreversible momentum to the Proposed Regultion before an analy- 92 CMA 047976 sis of environmental factors is ever undertaken. See Jones v. District of Columbia Redevelopment Land Agency, 499 F.2d 502, 511 (D.C. Cir. 1974), cert, denied, 423 U.S. 937 (1975); Natural Resources Defense Council, Inc, v. Hughes, 437 F. Supp. 981, 991 (D. D.C. 1977); Atchison, Topeka & Santa Fe Railroad Co. v. Calla way , 431 F. Supp. 722, 728 (D. D.C. 1977). C. OSHA Has Failed To Assess Adequately The Generic Issues Since this rulemaking purports to resolve certain cri tical issues and to foreclose their later consideration, it takes on added significance. To imply as OSHA does that it is "unable" (Wrenn S, 6) to make such an analysis now because the potential impact is difficult to analyze and to suggest therefore that it is better to wait until subsequent rulemakings on individual sub stances to make such analyses is akin to closing the barn door after the animals have fled, a fact which OSHA has acknowledged in its post-hearing agreement to prepare a regulatory analysis under Executive Order 12044. There is a long line of judicial precedent which sup ports the need for a thorough NEPA analysis at the outset of a generic or programatic government action which will result in a series of environmental impacts. See, e.g. , Scientists Institute for Public Information v. AEC, 481 F.2d 1079, 1088 (D.C. Cir. 1973); Jones v. Lynn, 477 F.2d 995 (1st Cir. 1973); see also Natural Resources Defense Council Inc, v. Nuclear Regulatory Com mittee, 539 F.2d 824, 839 (2d Cir. 1976). - 93 - CMA 047977 D. OSHA Has Made And Continues To Make Irretrievable Commitments To The Proposed Regulation OSHA has also violated and is continuing to violate NEPA by making irretrievable commitments of resources to the Proposed Regulation prior to the issuance of an adequate final EIS. The agency has, for example, already begun implementing the Proposed Regulation by relying upon it in the formulation of standards for particular substances. The economic feasibility studies for acrylonitrile and DBCP were prepared by OSHA con tractors under instructions from OSHA to treat the generic stan dards as applicable. This course of action is clearly impermis sible, for it prevents an EIS from serving as an input to the decision-making process before the final decision has been made 1/ by the agency. A full environmental impact analysis must occur prior to an agency's commitment to a project. Inman Park Restora tion, Inc, v. Urban Mass Transportation, 414 F. Supp. 99, 119 (N.D. Ga. 1975). Reliance by OSHA upon the Proposed Regulation prior to issuance of an adequate final EIS is improper because such activity involves irretrievable commitments of resources which serve to tip the balance away from environmental concerns and to prejudice the final agency decision. Subsequent broadscale assessment of alternatives is also foreclosed. See Natural 1/ in addition, OSHA seems to be moving forward on record keeping rules in a separate proceeding without considera tion of evidence developed in these proceedings and, of course, without NEPA compliance. See 43 Fed, Reg. 31329, 31371 (July 21, 1978) . 94 CMA 047978 Resources Defense Council, Inc, v. U.S. Nuclear Regulatory Commis sion , 539 F.2d 824, 843-844 (2d Cir. 1976); Realty Income Trust v. Eckerd, 564 F.2d 447, 455 (D.C. Cir. 1977). Conclusion Section 102(2)(C) of NEPA requires that prior to the implementation of the Proposed Regulation in any manner, a full, comprehensive and adequate consideration of the probable environ mental consequences of agency action be made and set forth in a detailed draft and final EIS. To date, OSHA has failed to under take such a comprehensive analysis. A two-page analysis of a pro posal of this importance on its face violates NEPA. In order to insure that the interest in informed decision making is preserved and that the agency's NEPA obligations have been fully complied with, OSHA should not issue final regulations and should prevent further commitment of resources thereto until an adequate NEPA analysis has been made. - 95 - CMA 047979 VII OSHA HAS FAILED TO MEET ITS LEGAL OBLIGATIONS TO ASSESS THE POTENTIAL ECONOMIC IMPACT OF THE PROPOSED REGULATION AND ALTERNATIVES THERETO Introduction OSHA has a legally-binding obligation to consider the economic impact of all aspects of this regulation and alterna tives thereto. This obligation is triggered in this rulemaking, not, as OSHA suggests, in subsequent rulemakings on individual substances when the important issues will already have been decided. If economic analysis is to be a useful decision-making tool, as mandated by the Congress and the President, it must be utilized in this rulemaking. Studies submitted by Foster D. Snell and others demonstrate that such studies are possible and can meaningfully be done. Indeed, Appendix A to the Snell Report sets out a methodology which OSHA might utilize for such a study. Further, these studies demonstrate that the costs associated with the proposal are likely to be very substantial. AIHC and others have urged OSHA to prepare an economic analysis of the Proposed Regulation since its first public release in January 1977. Only now, nearly three years after OSHA began working on the proposal and long after the hearing has closed, has OSHA agreed to undertake an economic analysis. In response to a letter from Organization Resource Counselors ("ORC") dated June 14, 1978, requesting the Office of Management and Budget ("OMB"), the agency responsible for imple- - 96 - CMA 047980 mentation of the President's Regulatory Analysis Program, to use its good offices to require OSHA to prepare a regulatory analysis of its proposal, OMB, in a letter dated July 25, 1978, advised that OSHA has "agreed that a regulatory analysis will be done for the generic standards and that [0MB] will continue to work with [OSHA] on the design of the analysis." (AIHC P.H.) In its letter 0MB recognized, as AIHC and others have, that "when generic standards, will, upon promulgation, preempt later regula tory decisions, then the economic effects of significant regula tory alternatives may never be analyzed" if they are not analyzed in the generic proceedings. OSHA has not released an outline or detailed descrip tion of the analysis being undertaken. In the memorandum which Messrs. Morris and Wrenn sent to the Adminstrator, there is some indication of the kind of analysis OSHA is making. (AIHC P.H.) As part of its analysis of "realistic alternative approaches," OSHA plans to use quantitative data from economic impact analyses of substances already regulated by OSHA. In the analysis OSHA will also "set forth for review the parameters which are included in a determination of feasibility." The review was to have been completed by October 1, 1978, but has not yet been made public. AIHC welcomes OSHA's agreement to undertake a regula tory analysis. It is our hope that the analysis will have the objectives and content outlined by the President's Regulatory Analysis Review Group ("RARG"). In the analysis of the proposed acrylonitrile standard, the RARG described the analysis in - 97 - CMA 047981 these terms: "But simply knowing that the lower the per missible exposure level (PEL), the lower the risk of cancer, is not information enough upon which to base a standard unless it is intended to eliminate immediately all risks regardless of the consequences. Although as a long range goal this may describe the intent of the OSH Act, as an operational procedure it is empty, since in order to eliminate all risks forthwith, industry would have to shut down. Just as there is no absolute 'safe' level, there is no absolute 'feasible' level. Thus decisions must be made by regulators as to how far it makes sense to us as a society to go and how fast. To use the criterion that we should reduce risk to the point just before the industry would be forced to shut down is illogical since the goal of the OSH Act is to protect workers, not industries. The proper procedure should be to promulgate regulations that provide greater gains to society than burdens." (AIHC P.H.) We urge that a thorough airing of all of the economic aspects of this proposal and alternatives thereto with sufficient, meaningful opportunity for public notice and comment be had prior to final agency action. A. The Legal Basis For Economic Analysis Is Clear There are several independent legal bases upon which required analysis of economic impact rests. Each emphasizes the need for the use of such analyses as a tool at an early stage in the decision-making process. 1. The Occupational Safety and Health Act The principal statutory bases for the Proposed Regula- tion are Sections 3(8), 6(b)(5) and 6(b)(7) of the Act. 42 Fed. 98 CMA 047982 Reg. 54153-54154, 54183. These sections require OSHA to promul gate "reasonably necessary", "feasible", and "appropriate" stan dards or regulations. An integral element embodied in these con cepts, as recognized by OSHA, the courts, and Congress, is an eco nomic impact analysis. See Tr. 3796; American Iron & Steel Insti tute v. OSHA, 6 OSHC 1451 (3rd Cir.); Turner Co, v. Secretary of Labor, 561 F.2d 82 (7th Cir. 1977); AFL-CIO v. Brennan, 530 F.2d 109 (3rd Cir. 1975); Industrial Union Department, AFL-CIO v. Hodg son , 499 F.2d 467 (D.C. Cir. 1974); Florida Peach Growers Ass'n v. Department of Labor, 485 F.2d 120 (5th Cir. 1974); Aqua Slide 'N1 Dive Corporation v. Consumer Product Safety Commission, 569 F.2d 831, 840, 845 (5th Cir. 1978); D.D, Bean & Co. v. Consumer Product Safety Commission, 574 F.2d 643 (1st Cir. 1978); Legisla tive History at 147, 148, 197, 464, 471-472. The Court in Turner, adopting a decision of the Occupa tional Safety and Health Review Commission, underlined the impor tance of economic considerations in determining feasibility and emphasized that in determining economic feasibility both costs and benefits must be weighed. The Court held: "It was, therefore, after thorough consider ation of the relevant legislative history that the Commission formulated the standard which we presently adopt: '* * * we conclude that the standard should be interpreted to require those engineering and administrative controls which are economically as well as technically feasible. Controls may be economically feasible even though they are expensive and increase production costs. See Arkansas-Best Freight Systems, Inc., 529 F.2d 649, 653 [3 OSHC 1910] (8th Cir."Jan. 29, - 99 - CMA 047983 1976); Industrial Union Department, AFL-CIO v. Hodgson, supra [162 U.S.App.D.C. 311,] 499 F.2d [467] at 477. But they will not be required without regard to the costs which must be incurred and the benefits they will achieve. In determining whether controls are economically feasible, all the relevant cost and benefit factors must be weighed.' (Id.)" 561 F.2d at 85. The Benzene decision demonstrates the basic importance of OSHA's determination of both costs and benefits in reaching the conclusion that a regulation is "reasonaably necessary". OSHA must be able to show both costs and benefits, for without these findings OSHA cannot demonstrate the reasonableness of the cost in relation to the benefits. The court underlined the im portance of both determinations when it said: "OSHA's failure to provide an estimate of expected benefits for reducing the per missible exposure limit, supported by sub stantial evidence, makes it impossible to assess the reasonableness of the relation ship between expected costs and benefits. This failure means that the required sup port is lacking to show reasonable neces sity for the standard promulgated." ___ F.2d at 93. 2. The National Environmental Policy Act As discussed in the preceding section of this brief, NEPA and implementing CEQ guidelines and OSHA regulations require that a detailed environmental impact statement be prepared for major federal actions significantly affecting the quality of the human environment. Such statements must examine costs and bene fits and consider economic impacts of contemplated government action. See, e.g., Chelsea Neighborhood Ass'n v. Postal Service, 100 CMA 047984 516 F.2d 378, 386-387 (2d Cir. 1975); Sierra Club v. Morton, 510 F.2d 813, 827 (5th Cir. 1975); Calvert Cliffs' Coordinating Comm. v. AEC, 449 F.2d 1109, 113 (D.C. Cir. 1971); Texas Comm, on Natural Resources v. Bergland, 433 F. Supp. 1235, 1252 (D. Tex. 1977); Citi zens Against Toxic Sprays, Inc, v. Bergland, 428 F. Supp. 903, 934- 935 (D. Or. 1977). CEQ's most recently proposed NEPA implementation regula tions summarize NEPA's requirements as follows: "When an environmental impact statement is prepared and economic or social and natural or physical environmental effects are inter related, then the environmental impact state ment will discuss all of these effects on the human environment." 43 Fed. Reg. 25229, 25245 (June 9 , 1978 ) , 3. Executive Order No. 11821 (Inflationary or Economic Impact Statements) Executive Order No. 11821, 39 Fed. Reg. 41501 (November 20, 1974), as amended by Executive Order No. 11949, 42 Fed. Reg. 1017 (January 5, 1977), and as implemented by OMB (Circular No. A-107) and agency directives, including a directive of the Secre tary of Labor, Secretarial Order No. 15-75, 40 Fed. Reg. 54484 (November 24, 1975), required "Inflationary" or "Economic" Impact 1/ Statements for "major" proposed regulatory actions. 1/ The Executive Order, as implemented, defined "major" actions as those which would result in (1) a net increase in costs to consumers, businesses, federal, state or local govern ments of $100 million or more; or $10 million or more for any industry or level of government (certain specified pro ductivity parameters were required to be considered in mak ing such cost analyses); (2) energy demand increases of (Footnote continued on p. 102) - 101 - CMA 047985 Executive Order No. 11821 was in effect at the time the OSHA proposal was first published. 4. Executive Order No. 12044 (Regulatory Analysis) Executive Order No. 12044 (43 Fed. Reg. 12660 (March 24, 1978)) requires "Regulatory Analyses" for significant proposed 1/ regulatory activities. To be included within the scope of this order are all pending regulatory proceedings for which inflation ary or economic impact statements have not been issued pursuant to Executive Order No. 11821 as amended. Section 3, 43 Fed. Reg. at 12663. "Closely related sets of regulations" are required by the Executive Order "to be considered together." Section 6, 43 Fed. Reg. at 12664. The Executive Order has recently been imple- 2/ mented by proposed Department of Labor regulations. 43 Fed. Reg. 22915 (May 26, 1978) . (Footnote continued from p. 101) 25,000 barrels of oil per day or its equivalent; (3) reduc tion of the national supply of critical materials by 3 percent or more; (4) reduction of labor demand by 0.2 percent at the national level or 10,000 workers at the industry, state or local level; or (5) substantial (a) limitations on market entry, (b) market concentrations, or (c) potential for monopoly in a line of commerce. 1/ Pursuant to this Executive Order, a proposed action is to ~ be considered "significant" where the action will result in an annual effect on the economy of $100 million or more or a major increase in costs or prices for individual industries, levels of government or geographic regions. Section 3(a)(1), 43 Fed. Reg. at 12663. 2/ The proposed regulations require an analysis where the regulation is likely to result in; (1) an increased cost of $100 million or more in any one year for the (Footnote continued on p. 103) - 102 - CMA 047986 We quoted earlier from the comments filed by the Presi dent's Regulatory Analysis Review Group on the proposed acrylo nitrile standard. More recently on September 5, 1978 the Council on Wage and Price Stability ("CWPS") in comments on EPA's proposed drinking water standard described the reason for, and the contents of, a regulatory analysis under Executive Order 12044 in words directly applicable here: "Because the resources available for healthrelated programs are limited, it is important that those resources be allocated in a way that maximizes the benefits (in terms of lives saved or cases of illness or injury avoided). This in turn requires that the incremental cost per case avoided be at least approximately equated for different regulations or different adopted standards. To ignore this fact is to allow more deaths than necessary for a given expen diture on health-related programs. It is there fore incumbent upon EPA to suport its proposed regulations with careful risk-assessment and cost-benefit analyses, employing the best esti mates available regarding uncertain variables, parameters, and relationships. There is a considerable amount of uncertainty about both the costs and the benefits of these alternatives, but it makes little sense to act on uncertain evidence by imposing costly regula tions on local communities while, at the same time, eschewing cost/benefit analyses because of this uncertainty." (At 1-2, AIHC P.H. (empha sis in original).) (Footnote continued from p. 102) nation, (2) a $50 million or more increase in costs or total revenues in any one year for a specific segment of the economy, (3) a direct dislocation of 10,000 jobs, or (4) a substantial limitation on competition, marketing, market information or an increase in concentration in a market doing $100 million of business a year or more. 43 Fed. Reg. at 22918. - 103 - CMA 047987 B. An Economic Analysis Will Be Meaningful And Is Feasible While it may be difficult to cost or precisely quantify all aspects of the Proposed Regulation, the preliminary economic analysis of the generic proposal made by Foster D. Snell, Inc., a division of Booz, Allen & Hamilton, Inc., for AIHC demonstrates that a meaningful analysis can be made. While the Snell Report was principally a "scoping" effort prepared under severe time contraints, it points the way for a full analysis. Appendix A to the Snell Report sets out a suggested methodology OSHA might use for a comprehensive analysis which Snell believes is both feasible and meaningful. Moreover, the tentative categorization of substances on the NIOSH List of Suspect Carcinogens by OSHA's contractor, Clement Associates, released July 14, 1978, should greatly facil itate such analysis by removing some of the uncertainty associ ated with which substances will fall into which categories. The release of this document makes even clearer the need for an eco nomic analysis. While the application of the Proposed Regulation, as any regulation, will obviously be uncertain, this should not be an excuse to avoid an economic analysis. The use of alternate regulatory scenarios and case studies, standard economic analy sis tools frequently utilized by OSHA itself, can overcome much of the uncertainty. Only through such analyses can opti mal cost-effective regulation be assured. Such analysis will permit better understanding of how various aspects of the pro- - 104 - MA 047988 posal and alternatives thereto might impact costs. The CWPS in its comments on EPA's drinking water standard quoted above underlines the mistake of an agency's acting on uncertain evi dence by imposing a costly regulation and at the same time fail ing to make a cost/benefit analysis because of the uncertainty. OSHA should not make the same mistake here. C, The Potential Economic Impact Of The Proposed Regulation Is Significant Studies by Snell and other participants in these pro ceedings demonstrate the substantial potential impact of the OSHA proposal, particularly when viewed in the context of the broader costs of compliance with a wide variety of government regulations of this sort. These substantial costs which are, in effect, costs to the entire nation (AIHC Economic Panel Tr. 3802-3803, 3825-3835), impose an obligation on OSHA to take a very close look at the economic costs of the Proposed Regula tion and the alternatives thereto. 1 The Snell Report 17 The Snell Report is an effort, within the limited time and resources available, to roughly estimate some of the poten tial compliance and other costs associated with the OSHA pro- 1/ The Proposed Regulation was published October 4, 1977. AIHC was formed and Snell retained by the end of October. Written comments were originally due by December 8, 1977. Although two extensions of time were thereafter granted by OSHA, those extensions were not granted in a way which allowed sufficient time to substantively change the scope or direction of the Snell Report. (Tr. 3810.) - 105 - CMA 047989 1/ posal. The Report was not commissioned with a view toward bal ancing lives against dollars or assessing risks against benefits, but rather toward examining how best to use society's limited re sources, how best to render a "meticulous accounting". (Dr. Zeck- hauser Tr. 4352, 4410). It was, and is, AIHC's view that the Snell Report is useful in pointing out that the costs associated with the OSHA proposal are substantial, that certain aspects of the proposal might be particularly costly and that there may be ways to achieve similar goals more economically. The main conclusion of the Snell Report lies not in the costs developed themselves, but rather the inescapable fact that the costs are likely to be substantial and the Proposed Regulation and alternatives thereto therefore merit careful economic analysis by OSHA. Snell examined the costs of compliance for three regula tory scenarios with alternate mandated control levels. The direct compliance costs, estimated by Snell were as follows: Direct Compliance Costs ($ Billion, 1977) Scenario Low scenario (38 high volume substances) Medium scenario (1,870 substances) High scenario (2,415 substances) Capital Cost 10 ppm to 1 ppm 9-23 17-47 30-88 Annual Cost 10 ppm to 1 ppm 6-11 10-20 18-36 (Snell Report at 3.) 1/ Exhibit 66 briefly summarizes Snell's methodology and conclusions. - 106 - CMA 4477S9S9o0 Snell found that smaller businesses and user industries were those most likely to bear the brunt of the economic burden. Snell Report at 494-495. This view was shared by numerous other participants in the hearing. See, e.g., Chamber of Commerce Tr. 8345-8349; PMA Tr. 7041-7051. Snell also concluded that certain features of the Proposed Regulation were particularly costly. These in cluded monitoring, medical surveillance, OSHA's mandated prefer ence for engineering controls, the absence of an exemption for mixtures or of an action level and the substitution requirements. (Tr. 3795, 3804.) In addition to the compliance costs noted above, Snell also concluded that there would be other potential macroeconomic effects, including reduced labor and capital productivity, in creased operating costs making U.S. firms less competitive with 1/ their foreign counterparts and increased market concentrations with particularly adverse effects for small businesses. Snell estimated that the Proposed Regulation has the potential to add in excess of one percent to the annual rate of inflation. 2. Other Studies Hearing participants other than AIHC also offered evidence supporting the view that the OSHA proposal could have substantial economic impact. In a study prepared for the Shell Oil Company, Charles H. Kline & Co., concluded that there could very well be significant 1/ See also Dr. Zeckhauser's comments on these points. (Tr. 4326.) - 107 - CMA 047991 economic impact associated with a price increase as a result of OSHA-imposed controls or a ban by a requirement of "no exposure" due to a finding that "suitable substitutes" were available. (Tr. 5549-5550.) In a study done for the Refractories Institute, Arthur D. Little, Inc. concluded that a regulation for crystalline silica similar to the one proposed by OSHA for a Category I substance could have a far-reaching impact on the refractories industry. (Tr. 6433-6435.) See also comments of other hearing participants, e.g., Chamber of Commerce Tr. 8345-8349; National Association of Chemical Distributors Tr. 8421-8424; Crane Packing Company Tr. 7559 7561; National Manufacturers Association Tr. 7661-7668, 7674-7676; Society of American Wood Preservers, Inc. Tr.. 7750-7757; Sun Chem ical Company Tr. 7840-7841; Muskegon Chemical Company Tr. 7312-7313 Mallinckrodt, Inc. Tr. 7419-7421, 7433-7438. 3. The Broader Picture The broader cumulative economic impact of the Proposed Regulation and similar proposals by other federal agencies make the need for a thorough analysis of this proposal even clearer. Glenn Schweitzer of Cornell University and formerly Director of EPA's Office of Toxic Substances expressed serious reservations about, and submitted a report on, the cumulative impact of OSHA and other agency proposals on the growth of our economy and on innovation and technological advances. (Tr. 7108-7109, 7116-7119; Ex. 124.) Studies by Edward Denison of the Brookings Institution - 108 - CMA 047992 (Ex. 64) and Robert DeFina of Washington University (Ex. 65) also review the dramatic impact federal regulatory programs, includ ing OSHA programs, have had on the economy. Denison concludes that by 1975 the output per unit input was 1.8 percent smaller than it would have been if business had operated under 1967 condi tions. DeFina conservatively estimates the cost to the nation for job safety and health to be $4.5 billion annually. (Ramey Tr. 8400-8402. ) In a recent memorandum dated June 26, 1978, to the President's Economic Policy Group, the Director of the CWPS states that regulations pending before OSHA and the Department of Transportation alone would require a total $35 billion in capital costs. The Director cautions, however, that the eco nomic costs may even be greater "because in several areas these decisions will set guidelines for future detailed regulations . . . [in such areas as] carcinogens, toxic substances, noise, air and water quality." The Director observes that "the esti mated cost of proposed [OSHA] regulations suggests a cost impact in the future that approaches that for environmental improvement," the inflationary impact of which he notes EPA estimates at 0.4 to 0.8 percent annually. According to the Director, based on infor mation from available studies, regulations by OSHA and other agen cies "have contributed to about a 25 percent reduction in the rate of productivity growth within the private nonfarm economy." These kinds of broader considerations add considerable urgency to the need for a thorough airing of the cost of the - 109 - CMA 047993 Proposed Regulation and alternatives thereto. D. Criticism Of The Snell Report Is Without Support The Snell Report was criticized on several grounds, principally by OSHA's consultant. Southwest Econometrics, and by the AFL-CIO's consultant, Ruth Ruttenberg. A detailed com mentary on these criticisms prepared by Foster D. Snell was filed as part of the AIHC post-hearing filing. The response by Snell to the post-hearing comments filed by Econometrics is being filed concurrently with this brief. The first major criticism was that the underlying raw data were not made available. As pointed out by AIHC, it was not possible within the limited time available for sub missions to the hearing record to collect meaningful data with out a guarantee of confidentiality. (Tr. 3811.) Further, as noted by Snell, provisions for confidentiality are not unusual in studies of this kind. (Tr. 3811.) Indeed, the Bureau of the Census and the International Trade Commission follow similar confidentiality procedures in gathering their data. OSHA's soli citor argued that Wirtz v. Baldor Electric Co., 337 F.2d 518 (D.C. Cir. 1964), precluded OSHA reliance on studies for which the underlying data were not available. Whatever merit this decision may have in another context, it certainly is inappro priate here, for AIHC does not argue that the Snell estimates are hard numbers upon which regulatory decisions should be made, but rather that they are indicators of the need to take 110 CMA 047994 a closer look. The second principal objection to the Snell Report is that it fails to examine several other impacts of the Proposed Regulation, including the benefits of reduced medical care, ex penses associated with reduced disease incidence and the dif- 1/ ferential economic impact of the AIHC Alternative. (Tr. 5737.) As pointed out by the AIHC Economics Panel, the Snell Report was only intended to be a "first step". AIHC and Snell both acknowledged the need to consider many of the additional factors suggested by its critics. Indeed, Appendix A to the Snell Report, which George Taylor of AFL-CIO said was an appro priate methodology for economic assessment (Tr. 5748-5759), set out a methodology for a complete study considering all the suggested factors. (Tr. 5747-5748.) The third principal criticism directed at the Snell Report was that it was just industry "crying wolf". Vinyl chloride was again cited as the example of a regulation which industry, in a report prepared for it by Arthur D. Little, Inc. 1/ Snell and AIHC were also criticized for failing to analyze the potential cost impact of the AIHC Alternative. As was pointed out at the hearing, in addition to the problem of AIHC's own finite resources, it was not possible to examine the Alternative within the deadlines for filing in this proceeding since the Alternative was being developed in parallel with the Snell effort. In addition, as AIHC understands the law, it is OSHA1s obligation, not AIHC's, to examine the impact of its Proposed Regulation and all reasonable alternatives thereto, including the AIHC Alter native. We might add in passing that almost three years have passed since work on the Proposed Regulation began without economic analysis of any sort by OSHA. - Ill - CMA 047995 ("ADL") (Ex. 69), said it could not live with and in fact did live with, according to some, very comfortably. Those who re lied on the vinyl chloride "story", principally Ms. Ruttenberg and Dr. Epstein, however, obviously did not understand the assumptions built into the ADL analysis. (Tr. 5799-5800; 125053.) ADL surveyed the potential economic impact of a vinyl chloride regulation requiring no detectable exposure, which would shut down the industry. (Tr. 5800.) The regulation adopted by OSHA imposed a much more lenient permissible expo sure limit of 1 ppm with a 5 ppm ceiling, not a no-detectable exposure limit. In fact, under questioning, Ms. Ruttenberg acknowledged she had not even read the ADL study upon which she so heavily relied. (Tr. 5799-5780.) It was obvious that she was confusing a study of the regulation prepared by Snell for OSHA (Snell's client) with the ADL study. Id. Another example of "crying wolf" cited by Dr. Epstein was industry's compliance estimates for the Toxic Substances Control Act ("TSCA"). In his testimony, Dr. Epstein, however, mistakenly quotes Snell as estimating costs of $12 billion. In fact, Snell estimated costs would range from $360 million to $1.3 billion depending on various assumptions and scenarios. Further, Dr. Epstein confuses EPA's budget for TSCA with the cost of TSCA compliance to the nation. (Epstein S. 72.) While on the issue of "track" records, it may be useful to examine EPA's own record on this issue. EPA originally estimated the costs of TSCA to the economy to be $40 million which was 112 CMA 047996 raised to $45 million; EPA later raised the estimate to $80 mil lion, and then to $140 million. In 1975 EPA estimated an TSCA annual operations budget of $10 million. EPA now is discussing an annual TSCA budget of $50 million. To further put the allegations of industry overestimates and "crying wolf" into perspective, it may be helpful to examine the Snell data more closely. Snell estimated a compliance cost of $1.1 billion for regulating the manufacture (as distinguished from downstream use) of 1,870 subtances to 1 ppm. The MIT retro spective vinyl chloride study upon which Ms, Ruttenberg so heavily relied (Ex. 70) estimated the cost of compliance with vinyl chlor ide alone at $350 million. This on its face certainly does not seem to be a case of industry crying wolf. Finally, a number of methodological flaws were cited in the Snell Report which purportedly undermined it. Putting aside the fact that the stated significance of the Snell Report was not in the particular numbers set out therein but rather in illustrating the need to take a hard look at the OSHA pro posal, it is clear that those criticizing the methodology did not adequately understand or take the time to understand the Report. For example, Ms. Ruttenberg criticized Snell for fail ing to take into account technological advances in the chemical industry which might result in cost savings. In fact, Snell had done so by relying heavily upon the data derived from its vinyl chloride case study, a substance for which significant techno logical control advances resulted in considerable economies. - 113 - CMA 047997 Ms. Ruttenberg also criticized Snell for using an annual 10% employee turnover rate in its study. Ms. Ruttenberg argued, based on Department of Labor statistics, that the rate should have been only 1.8% annually. As pointed out in questioning, Ms. Ruttenberg mistakenly assumed her 1.8% figure was an annual one, when in fact it was a monthly figure. (Tr. 5801-5802.) Further, Ms. Ruttenberg criticized Snell for failing to take into account the purported cost savings of substitution. In fact, Snell did consider substitution cost savings and used substitition costs where applicable. See Snell Supplemental Statement at 12 {AIHC P.H.). Again in questioning, Ms. Ruttenberg's failure to study and understand this aspect of the Report was evident. (Tr. 5802-5806.) - Despite the criticisms of the Snell Report, one fact remains unalterably correct: the OSHA proposal will have signi ficant economic impacts, a fact which Southwest Econometrics, Inc. acknowledged. For this reason alone, the Proposed Regulation and alternatives thereto should be carefully analyzed from an economic perspective. Only through such analyses can societal resources be maximized. Conclusion Prior to publishing a final regulation in this rulemaking, OSHA has an obligation to conduct a thorough economic analysis of the proposal and allow meaningful public comment on its analysis. 114 CMA 047998 PART TWO VIII THE METHOD OF CLASSIFICATION AND THE CRITERIA FOR OSHA'S CATEGORY I ARE IMPERMISSIBLY VAGUE AND ARBITRARY "Science deals in probabilities, and carcinogen esis bioassays give results that may fall anywhere on a continuous spectrum of probabilities, extend ing from 2 or 3% at the lowest to nearly 100% at the highest. Division of this spectrum into dis crete categories may be necessary for regulatory processes, but is necessarily arbitrary from a scientific point of view. Thus the recommenda tions of a scientist would be to make the cri teria for categorization flexible, and to apply as much scientific judgment to each case as is compatible with legal and regulatory require ments." (Dr. Rail S. 14.) "The complexity of the problem dictates that the evaluation of the potential human hazards of a given agent must be individualized in terms of the chemical and metabolic aspect of that agent, its intended use(s), and data available at the time the decision must be made, and other factors pertinent to the case under consideration. Each case must be considered on its own and the cri teria appropriate to one agent may not necessarily apply to another."1/ "The judgment of carcinogenicity needs to be made by competent, experienced and objective profes sionals after analysis of all the relevant evi dence. It goes without saying that this judgment should be objective and immune from conflicts of interest." (Dr. Saffiotti S. 7.) "We believe that some flexibility is important to OSHA's categorization scheme both to avoid 1/ "General Criteria for Assessing the Evidence for Carcinogenicity of Chemical Substances; Report of the Subcommittee on Environmental Carcinogenesis, National Cancer Advisory Board," 58 J. Natl. Cancer Inst, 461 (Preamble Ex. 71) [hereinafter referred to as NCAB General Criteria]. - 115 - CMA 047999 unreasonable results and to separate clearly scientific from regulatory judgments. The greater the degree to which regulatory judgments flow from scientific judgments, the greater is the possibility that the scientific judgments could become biased. Conversely the more discretion the policy maker has to determine what regulatory action to take, the less likely is it that policy judgments will enter into scientific opinions." (EPA S. 4.) "As a check on the reliability of the experiment and for the quantification of carcinogenicity, a positive test is generally not considered adequate unless the frequency of cancers is found to be dose dependent." 1/ Introduction The regulation of carcinogens in the workplace involves two separate decisions. First, whether or not the substance is a carcinogenic risk to man. Second, whether or not regulatory action should be taken. These are separate and distinct deci sions as a number of the OSHA and other witnesses recognized when they clearly separated their comments on scientific issues from matters of regulatory authority or policy. See, e.g., Upton Tr. 276-277, 297; Rail S. 2; Griesemer Tr. 894, 922; Lave Tr. 7013; EPA S. 4, quoted at the beginning of this section; and Meselson Tr. 1488. In this section of the brief, AIHC will address the issues relating to the determination that a substance presents a human cancer risk. In subsequent sections of the brief we will address the issues that relate to regulatory action. 1/ The National Academy of Sciences Report, "Contemporary Pest Control Practices and Prospects" NAS (1975), at 65 (attached to Dr. Kennedy's statement). - 116 - CMA 048000 A. There Should Be An Independent Scientific Evaluation of The Data______ _________________________________________________________ The scientific evaluation process for both epidemio logical studies and animal tests involves evaluation of the soundness of the design and conduct of the study and a deter mination as to whether the conclusions of the study are justi fied by the data. There are, of course, major differences in the evaluation of animal and human studies; a basic differ ence being that an animal study requires extrapolation across species to man while an epidemiological study does not. AIHC believes that it is fair to say that OSHA wit nesses agreed that the evaluation of human risk calls for exer cise of scientific judgment by experts in several disciplines. Dr. Upton said "many experiments raise specific problems of inter pretation. The resolution of these problems requires evaluation by experienced professionals in several disciplines and cannot be reduced to a formula." (Upton S. 12; see also Tr. 276-277, 292-293, 329-332.) Similarly, Dr. Rail said the evaluation process was one which demanded scientific judgment. (Tr. 358, 362.) In his prepared statement. Dr. Saffiotti (one of whose statements is quoted at the beginning of this section) referred to "judgment" fifteen times. (Saffiotti S. 6, 7, 13, 15, 16, 25, 27, 37, 38, 39, 41; see also Tr. 854, 896, 900; and see Dr. Griesemer Tr. 961, 971-974.) Most witnesses also agreed that the scientists making the judgment wanted all available facts. See, e .g. , Schneiderman Tr. 818-819; AISI 4669, 4671; Rail Tr. - 117 - 048001 380, 4X7; NIOSH Tr. 2981-2982, 3075; see also Dr. Golberg Tr. 6488; Dr. First Tr. 6885; Dr. Kessler Tr. 6920; and Dr. Lave Tr. 6935. The weight to be given the data would be determined by the ex ercise of informed scientific judgment, not by any pre-judgment or prior administrative policy decision. We addressed earlier in this brief (see supra, at 4151) the legal question whether OSHA's "freezing" of science by its proposed policy determinations on scientific issues is valid under Section 6(b)(5) of the statute, 29 U.S.C. 655(b)(5), which requires OSHA to consider the "best available evidence," includ ing the "latest scientific data in the field," and whether OSHA's proposed process of amendment of the generic standard to accommo date new scientific information-is valid or whether it denies due process. In this portion of the brief we are addressing the ques tion whether foreclosing consideration of data bearing on the sci entific evaluation of a substance is scientific. 1. The AIHC proposal for an Independent Scientific Data Evaluation and Classification Panel OSHA's error stems in part from the intermixture of the scientific evaluation of the data on a substance with the separate issue as to what regulatory action should be taken. Each question is separate and distinct and the former should precede the latter. The AIHC proposal for the creation of an independent, unbiased scientific Panel to evaluate the data and its rele vance to man is a clear recognition of the fact that evaluation - 118 - CMA 048002 of the data involves scientific rather than regulatory judgments. AIHC proposes that the determination by the scientific Panel be final and binding on the regulator for three reasons: to bring the scientific evaluation to a speedy conclusion, to avoid inter mixture of that evaluation with the regulatory determination, and at the same time to provide a basis for judicial review. The second step in the process is a determination by the regulator of the nature of the hazard -- number of workers exposed and level of exposure -- and a determination as to what action, if any, is warranted based on the hazard evaluation. AIHC agrees with EPA and Dr. Saffiotti in the state ments quoted at the beginning of this section of the brief, that the scientific evaluation should be objective, unbiased and immune from conflicts of interest. For this reason, the selection process for membership in the independent scientific Data Evaluation and Classification Panel proposed by AIHC in volves nomination by scientific institutes and associations, with selection of members of the Panel by the National Academy of Science. To assure objectivity, no member of the Panel would be employed by any other executive agency or independent regulatory agency during his term on the Panel, except in an academic, teaching or research capacity. The National Academy 1/ A description of the function and operation of the proposed scientific panel, together with a memorandum regarding authority to establish a panel is set out in Exhibit 62 (a copy of which is attached as Appendix C). - 119 - CMA 048003 would be instructed to screen very carefully for conflicts of interest persons nominated for membership on the Panel who are employed by private industry. A proposed plan for the establish ment and operation of the Panel is set out in Appendix C. The idea of an independent panel is not new. The National Cancer Institute Ad Hoc Committee on Testing for En vironmental Carcinogens in its report dated August 31, 1973, recommended the formation of a scientific panel to ensure rea sonable standards for evaluation of tests and test results, "in order to insure, insofar as possible, the validity of the experimental data and the inter pretations placed upon them." (Ex. 14 at 4.) Dr. Epstein also recommended an independent scientific panel, with functions considerably larger than those proposed by AIHC. (Epstein S. 103-105; see also NIOSH S. 7.) AIHC believes its proposal is better suited to the function of scientific evaluation in this context than the pro posals mentioned above. The AIHC proposal will assure consis tent application of the best scientific judgment in the identi fication and evaluation of substances which pose a human carcino id genic risk from exposure in the workplace. 1/ AIHC has suggested that an independent scientific panel of the stature and quality envisaged might also serve the other regulatory agencies: EPA, CPSC and FDA -- thus, assuring uniformity of scientific evaluation of the data for regula tory purposes. The establishment in the IRLG of a Toxic Substances Data Committee to identify and share data needed by the four regulatory agencies underscores the need for an agency such as the scientific Panel advocated by AIHC to serve as a source of reliable, uniform, scientific informa tion and evaluation to the regulatory agencies. See Ex. 34, 43 Fed. Reg. 7186; Tr. 1418. 120 CMA 048004 2. OSHA's intermixture of scientific and regulatory functions_______________ OSHA's proposal to pre-determine scientific issues by policy decisions is based on a failure to recognize that scientific evaluation of data should be separate from societal 1/ decisions which are part of the regulatory process. The in tertwining of the two functions in one regulator creates prob lems of the kind recognized by EPA in its statement quoted at the beginning of this section. When the two separate processes are combined, the scientists are constrained and the regulator does not have the essential freedom to make the regulatory judg ment on the basis of a separate unbiased scientific evaluation. (EPA Intra-Agency Memorandum from Roy Albert, Chairman, Carcino gen Assessment Group, to Andrew Breidenbach, dated November 25, 1977 (API P.H.).) OSHA's confusion of the regulatory and scientific func tions led OSHA to construct its Proposed Regulation on an arti ficial presumption/rebuttal process which is inconsistent with the process of scientific evaluation. As Dr. Griesemer said "[r]ebut is not a word in our vocabulary." (Tr. 941.) Under the OSHA conception, positive results in animal tests create the presumption and the scientific evaluation follows as a rebuttal process. Dr, Rail's description of the scientific 1/ The IRLG Risk Assessment Work Plan carefully distinguishes the scientific problem on risk assessment from the policy decision as to the level of acceptable risk. See Ex. 34, 43 Fed. Reg. 7195. - 121 - CMA 048005 evaluation process makes clear that a presumption/rebuttal model does not fit: "The scientific decision as to whether a chemical has been shown to be carcinogenic in an animal species requires consideration of all aspects of the experiment, including not only the statistics of the number of tumors but also the pathological diagnoses, exposure regimens, health and nutri tion of the animals, and many other factors. Once a chemical is established as a carcinogen in an animal species, there follows a presump tion of risk to exposed humans, but the precise degree of risk depends on consideration of other factors, including routes of exposure, metabolic pathways, structure-activity relationships, etc. It is difficult to reduce these manifold consi derations to a formula." (Dr. Rail S. 13.) Positive results in animal studies before evaluation establish only that a potential for human risk exists. As both Dr. Upton and Dr. Rail made clear, it is only after the full sci entific evaluation is made that a determination as to probable 1/ risk to man can be made. In his testimony, Dr. Upton also referred to some of the factors which must be considered before 1/ The Subcommittee of the National Cancer Advisory Board des cribed the scientific evaluation as follows: "Quantitative extrapolation from animal studies for the purposes of evaluating human risks en tails large uncertainties at the present time. Each case must be individually evaluated, taking into consideration such factors as adequacy of experimental design, statistical significance of the data, dose-response relations, duration of exposure, route of administration, metabolism (including species variations), host suscepti bility, co-factors and other modifying factors, and the amount of the material to which humans will be exposed. The criteria for extrapola tion may vary depending on the agent in ques tion." NCAB General Criteria at 463. 122 CMA 048006 a conclusion can be reached as to the risk to man: Dose response Ability of humans to detoxify, metabolize or excrete the substance Mechanism of action and the way the substance is handled in human tissue Adequacy of pathology Route of exposure Validity of test procedures (Tr. 322-325.) See also Dr. Griesemer Tr. 936; Dr. Gross Tr. 8320. OSHA's presumption/rebuttal procedure has turned the whole evaluation process upside down. Until the evaluation has shown that there is a human risk there is no basis for classi fication for regulatory purposes. OSHA's misunderstanding of the evaluation/extrapolation process is shown by its reluctance to add the fifth "rebuttal criteria": that for some scientific reason the results in animals "are not scientifically relevant to man." 42 Fed. Reg. 54171. When asked whether such evidence should be considered. Dr. Rail gave the unequivocal answer "al ways". (Tr. 364.) Dr. Saffiotti concurred. (Saffiotti S. 41.) See also NIOSH Tr. 3075; EPA Tr. 2366; and Dr. Gross Tr. 8315- 8319. The Proposed Regulation needs to be re-oriented. Eval uation must take place at the outset, not as an afterthought. Fur ther, the relevant issue is human risk. Until such risk is estab lished after scientific evaluation of all the evidence, there is no basis for regulatory action and categorization of substances. Only when the human risk is scientifically evaluated and presented to the regulator can the regulator assess hazard and reach the - 123 - CMA 048007 1/ appropriate regulatory conclusion. It is precisely for this reason that AIHC proposed the creation of the Scientific Data and Evaluation Panel. A sub stance would not be categorized under the AIHC proposal until the evaluation is complete. B. The Criteria For OSHA Category I Are In Many Instances Arbitrary, Inflexible And Unwarranted Both OSHA (Category I) and AIHC (AIHC Categories I and II) agree that a substance may be determined to present a carcino genic risk to man on the basis of human epidemiology or mammalian animal data. There is agreement further that a substance which is a confirmed oncogen in two mammalian species should be subject to regulation as a probable human carcinogen. AIHC also agrees with OSHA that injection site sarcomas and chemical structure do not provide a basis for classifying a chemical. These are major areas of agreement. There are, however, major areas of disagreement and, as we shall show, the record sup ports the AIHC Alternative as being the more scientifically sound. We shall discuss each of the areas of disagreement. 1. Human epidemiology AIHC agrees with OSHA that positive epidemiology is 1/ If evaluation follows categorization, a great disservice is done. Not only is the product and the manufacture subject to increased burdens but the public may be unnecessarily alarmed. A serious due process issue arises if materials are categorized and stigmatized as a carcinogen before a reasonable opportunity to present evidence is afforded. (See discussion supra, at 48-51.) - 124 - CMA 048008 the best evidence that a substance is a hunan carcinogen; indeed human experience is the only evidence that a material is a human carcinogen. (Dr. Van Raalte S. 12-22.) To underline the signi ficance of this identification in man, AIHC proposed a separate category (AIHC Category I) which includes those substances iden tified by positive epidemiology as human carcinogens. There are major differences, however, between OSHA and AIHC concerning the weight or importance of negative epi- 1/ demiological studies. In the Preamble OSHA details the diffi culties associated with the design and conduct of epidemiological studies (42 Fed. Reg. 54155-156) and concludes that, as a "prac tical rather than a theoretical matter, positive animal data should supersede negative human'data, in general, because of the inherent defects in such human studies, as pointed out above." Id. at 54161. The record shows that OSHA for "practical" reasons is disregarding evidence which should be evaluated as a scienti fic matter with respect to any substance. Perhaps the clearest statement of the role of negative epidemiology is in the Report of the Subcommittee of the National Cancer Advisory Board entitled "General Criteria for Assessing the Evidence for Carcinogenicity of Chemical Substances." In this very careful report subject to 1/ On September 11, 1978, as part of its post-hearing filing AIHC furnished to OSHA a copy of "Guidelines for Evaluation and Use of Occupational Epidemiologic Cancer Studies" pre pared by AIHC. A copy of the guidelines is attached as Appendix D. - 125 - cMA 048009 extensive peer review, the Committee concluded: "Negative epidemiological data may not estab lish the safety of suspected materials. Nega tive data in a given agent obtained from ex tensive epidemiologic studies of sufficient duration are useful for indicating upper limits for the rate at which a specific type of exposure to that agent could affect the incidence and/or mortality of specific human cancers." NCAB General Criteria at 462. Dr. Rail agreed with the NCAB as to the appropriate role for epidemiology. (Tr. 366.) Dr. Hoover and Dr. Bates also agreed that a valid negative study could identify the upper boundary of a potential hazard. (Tr. 794; Bates S. 11.) Dr. Berg urged OSHA not to reject a valid negative study. (Tr. 1679.) Dr. Epstein testified that negative studies should be weighed in the regulatory process. (Tr. 1462.) NIOSH testi fied flatly that "[a] negative epidemiological study should receive the same weight as a positive one but, in either case, this weight is a function of the scientific quality of the research. ... It is obvious that if well designed and executed negative epidemiological studies are given little weight in sci entific decision making, then no industry will conduct them," (NIOSH supplemental answer to OSHA question 5(3); see also Tr. 2954; Dr. Upton Tr. 317-318; AISI Tr. 4662; Dr. Gehring Tr. 4152; and Dr. Gross Tr. 8322; Dr. Robert Morgan written state ment at 11 (AIHC P.H.).) Dr. Morgan testified to a methodology for weighing negative and positive studies. (Tr. 3619-3622.) His statistical methods are set out in his paper. (AIHC P.H.) Thus OSHA has - 126 - CMA 048010 available statistical methods for weighing positive and nega tive studies. Other witnesses set out alternative methods of evaluation of positive and negative studies. See, e.g, , Hooker Chemical Tr. 4116-4140. There are physiological and metabolic differences be tween rodents and man and substances which may be carcinogenic to animals may not be carcinogenic to man. There is evidence in the record that epidemiology can identify substances shown to be carcinogenic in animal tests which do not present a carcinogenic risk to man at the levels to which man is exposed. Dr. Clemmesen and Dr. McLean referred to phenobarbitol (Tr. 3553-3556; 4804 1/ 4805). DDT and saccharin were cited by Dr. Olson (Tr. 3226). Dr. Golberg referred to dinitrotoluene (Tr. 6511-6513), and DDT and aldrin/dieldrin were cited by Dr. Van Raalte (Tr. 3556-3558, Ex. 53) and Dr. Astolfi (S. at 3-5). Dr. Murray also referred to his extensive practical experience with a number of substances (S. 4) . Negative epidemiology can also serve to correct risk estimates based on positive animal data. Perhaps the best ex ample in this record is ethylene dibromide where on the basis of an epidemiological study of 158 exposed workers, EPA was led to modify its risk assessment from exposure to that com pound based on positive animal data. (Ex. 43, Tr. 2336; "Risk 1/ The NCI announced that its bioassay of DDT in OsborneMendel rats and B6C3F1 mice found no evidence of carcino genicity. 43 Fed. Reg. 46585 (October 10, 1978). - 127 - CMA 048011 Assessment for Ethylene Dibromide (EDB)," API P.H.) EPA also testified that negative epidemiological data are particularly useful where a positive animal study involves a route of exposure different from human exposure. (Tr. 2383.) Another example in the record of the use of human epi demiology to adjust or correct a risk assessment based on animal data is the FDA risk assessment of aflatoxin in peanut butter. (Ex. 38.) The FDA relied on epidemiological data in reaching the conclusion that humans are biologically closer to aflatoxin resistent mice than the more aflatoxin susceptible rats. Id. at 3-4. The data were also used to calculate the potential health benefits from an additional reduction in aflatoxin level. Id. The record does not support OSHA's administrative re jection of negative human studies. On the contrary, the record makes clear that such studies can have significant value. 2. Animal data -- an overview Perhaps the most concise and clear statement regarding animal data was made by Dr. Rail. He testified: "I believe that most scientists will be happy to see the introduction of something like Cate gory II, recognizing that some experiments give inconclusive results and allowing us to escape from the dilemma of having to assign all chemicals into 'Yes' or 'No' categories. On the other hand, scientists always feel unhappy about the applica tion of rigid criteria to complex questions. The scientific decision as to whether a chemical has been shown to be carcinogenic in an animal species requires consideration of all aspects of the experiment, including not only the statistics of the number of tumors but also the pathological diagnoses, exposure regimens, health and nutri tion of the animals, and many other factors. Once a chemical is established as a carcinogen - 128 - CMA 048012 in an animal species, there follows a presumption of risk to exposed humans, but the precise degree of risk depends on consideration of other factors, including routes of exposure, metabolic pathways, structure-activity relationships, etc. It is difficult to reduce these manifold considera tions to a formula. On the one hand, there are cases where a single well-conducted experiment giving clearly positive results should suffice to establish a chemical as a carcinogen and to justify strin gent measures to reduce occupational exposure. On the other hand, there are cases where two or even three less conclusive positive results would still leave some doubt. The fact is that scientific experiments never give results that are 100% positive, nor 100% negative. Science deals in probabilities, and carcinogenesis bio assays give results that may fall anywhere on a continuous spectrum of probabilities, extending from 2 or 3% at the lowest to nearly 100% at the highest. Division of this spectrum into discrete categories may be necessary for regula tory purposes, but it'is necessarily arbitrary from a scientific point of view. Thus the recom mendation of a scientist would be to make the criteria for categorization flexible, and to apply as much scientific judgment to each case as is compatible with legal and regulatory re quirements." (Rail S. 13-14.) In addition, OSHA "recognizes that the results of a single study in a single species can be in error." 42 Fed. Reg. 54170. This is an acknowledgement of the more general principle cited by the National Academy of Science in the study "Drinking 1/ Water and Health" [hereinafter referred to as "NAS Drinking Water Study"] where it noted: "Any series of experiments will yield false positive and false-negative results." NAS Drinking Water Study at 27. 1/ (NAS 1977). Appendix I to the prepared statement of Dr. Rail. - 129 - CMA 048013 Dr. Furst discussed at length the problem arising because many tests performed in the past are invalid. Thus early positive tests on a number of substances are not reliable bases for regu latory decisions. (Tr. 6924-6926.) Dr. Peto explained the statistical possibility that an erroneous positive result can be a matter of chance. (Tr. 25472550.) If the confidence level is 95% then there will be one posi tive study as a matter of chance in twenty studies of the same sub stance. (Peto S. 5.) See discussion infra, at 143, 163-164. Pro fessor Zeckhauser made a similar explanation. (Tr. 4334.) See also Dr. Robert Morgan's written statement at 5 (AIHC P.H.). Dr. Greisemer did a calculation as to the probabilities of a false positive under conditions of the NCI bioassay, a calculation which has to be made for each study based on the conditions of that study. (Greisemer S. 8-10.) Thus, the issue at the outset is the degree of certainty that a substance is an animal oncogen. The second question is the degree of certainty that the animal data may be validly extra polated to man. Unfortunately, OSHA has not disclosed the criteria which it and the IRLG are considering for evaluating animal tests and thus a number of issues remain open and in doubt; they cannot be usefully commented on in this proceeding. It is clear, however, that OSHA should supplement or modify its criteria for Category I with respect to the following; -- maximum tolerated dose studies -- pharmacokinetics, metabolism and DNA repair 130 CMA 048014 statistical significance tumor prone species mouse data factors affecting test results -- positive/negative results -- single species or two species replication short term tests route of exposure 3. Maximum tolerated dose studies The Proposed Regulation speaks of positive results in animal studies without any distinction between studies conducted at maximum tolerated dose ("MTD*1) or at levels more nearly simi- 1/ lar to those to which humans are exposed.- This is a misuse of these animal data for regulatory purposes. It is important to understand the very limited con clusion which NCI believes can be drawn from an MTD test. Dr. 1/ The NCI Guidelines for Carcinogen Bioassay in Small Rodents defines MTD as follows: "The MTD should be the highest dose that causes no more than 10% weight decrement, as compared to the appropriate control groups, and does not produce mortality, clinical signs of toxicity, or pathological lesions (other than those that may be related to a neoplastic response) that would be predicted to shorten the animal's natural life span." (NCI Guidelines for Carcino gen Bioassay in Small Rodents, at 14-15, quoted in Dr. Saffiotti S. 9-10.) The Guidelines limit the amount of a substance in a feeding trial to 5% of the diet. Id. at 18. - 131 - CMA 048015 Upton explained that the NCI bioassay based on MTD is intended as a screening procedure to identify a substance with the poten tial to cause cancer, not as a test to measure the frequency of 1/ induced cancer at a particular level of exposure. (Upton S. 11 Tr. 322; see also Bates Tr. 642-644.) Dr. Greisemer described 1/ the results of the program in the same way. See also Tr. 4295- 4296; Dr. Lijinsky S. 29. NCI's Clearinghouse has itself recog nized that the "studies are a screen to provide a yes/no indica3/ tion of carcinogenicity in animals." Dr. Upton and Dr. Rail both made clear that in order 1/ In earlier testimony. Dr. Upton described the NCI bioassay program to the House Interstate and Foreign Commerce Commit tee as follows; "The NCI animal bioassay efforts from chemical carcinogens can merely detect the chemical's potential for causing cancer in humans. Its results cannot tell us whether a particular chemical will cause human cancer, but they may alert us to the presumptive risk, and thus serve as a basis for further studies of the chemical in question." (Tr. 322.) 2/ "The results of animal experiments conducted with the high est possible doses should not be used for quantitative risk assessments. By themselves, they provide little information about dose response and none that can be directly extrapo lated to man. Such experiments, however, do provide a starting point for exploring dose response relationships in the experimental animals." (Dr. Griesemer S. 6; see also Tr. 958-959.) 3/ Report of the Clearinghouse on Environmental Carcinogens on the Review of the Bioassay Backlog and Data at 21 (May 1978) (emphasis added) [hereinafter referred to as "Report of the Clearinghouse"] (AIHC P.H.). 132 048016 CM&- 1/ to evaluate the human risk. additional data are needed, (Tr. at 322-325, 487-488.) The NCI multidisciplinary evaluation process, which includes an independent review by the National Clearinghouse for Environmental Carcinogens, was described in detail by Dr. Griesemer. (Tr. 971-977). NIOSH similarly has a full multidis ciplinary review of test data before reaching conclusions as to animal carcinogenicity and extrapolation to man. (Tr. 2884-2893, 2895-2898.) Other witnesses indicated the particular weaknesses of the MTD test as an indication of human risk. Dr. Van Duuren expressed concern that only weight loss was considered by the NCI as a limiting parameter of MTD. He said "an acceptable and more agreeable maximum tolerated dose is when the animals grow normally and healthy and gain weight normally unless they come down with a tumor." (Tr. 1808; see also Tr. 1814.) 1/ In an article by Dr. Rail entitled "Species Differences in Carcinogenic Testing," attached as Appendix E to Dr. Rail's testimony, Dr. Rail set out in tabular form the factors to be assessed as follows: Table 1 Assessment of Environmental Chemicals for Carcinogenicity Differences between Test Animals and Man I. II. III. Sensitivity of laboratory animals as compared to man A. pharmacological differences B. receptor differences C. temporal differences D. size differences Population differences A. size B. heterogeneity C. selected nature of test population Environmental differences A. nutritional B. physical C. chemical - 133 - CMA 048017 He urged that a MTD be selected which did not damage organs or result in metabolic overloading. Dr. Gehring stressed the im portance of the fact that repair mechanisms are overwhelmed at high doses. (Tr. 5034-5036, 5131-5132.) Similarly, Dr. McLean testified that large doses can alter metabolic pathways and in jure tissues making it difficult to extrapolate from MTD doses. (Tr. 4845-5846.) Dr. Olson also emphasized that MTD can incapa citate or injure organ systems leading, for example, to renal damage as well as neoplastic lesions. (Tr. 3238.) Dr. Olson referred specifically to the MTD bioassay on trichloroethylene where there was evidence of renal and cardiac damage. (Tr. 3244.) Exhibit 83 is a statement by Dr. Bernard Oser, presented to the National Academy of Science committee evaluating saccharin, in which he refers to the organ damage which raised questions about the results of the experiments on saccharin. Similarly, Dr. Furst discussed the consequences of physical damage from an excessive dose. (Furst S. 7-9, Tr. 6931-6932, 6947-6948.) Dr. Kotin stated that using high dose as an equivalent or substitute for large numbers of animals is "subject to very serious question," since the use of high doses may result in a series of chemical pathways resulting in the formation of endproducts with contrasting biological effects. (Tr. 8615, 8716.) High doses, he added, interfere with DNA repair mechanisms as well as change metabolic pathways. (Tr. 8722-8723; see also Dr. Skalsky Tr. 7589-7590.) Dr. Golberg testified in detail regarding the complexi- 134 CMA 048018 ties of MTD testing. (Golberg S. 3-6, Tr. 6484-6491.) He pointed out the difficulties of choosing the correct MTD -- not too toxic or too low. Ij3. He called attention to the criteria of the Food Safety Council for selection of MTD: "1. Induces no overt toxicity, i. e ., appreciable death of cells or organ dysfunction as determined by appropriate clinical, pathological, or bio chemical methods. 2. Induces no toxic manifestations which are predicted to shorten the lifespan of the animals except as the result of neoplastic development. 3. In two generation studies, is not detrimental to conception rates, fetal or neonatal survival, or postnatal development. 4. Does not retard weight gain during the sub chronic test by greater than 10% as compared to control animals. 5. Takes into consideration metabolic and pharma cokinetic data, and if dose-dependent qualitative or quantitative differences occur, at least one test dose should be set above the metabolic shift (provided the level(s) does not exceed the criteria listed above 1 through 4)." (Golberg S. 3-4.) Thus, Dr. Golberg testifed, if the MTD is not selected properly, massive nonspecific tissue damage can result. _Id. at 4. This can lead to carcinogenic results by a "secondary mechanism" -- tissue damage. (Golberg S. 4-6, Tr. 6484-6491.) The questionable rele vance of a positive result from secondary carcinogenesis was re cognized, Dr. Golberg said, by the Food and Drug Administration in the case of selenium and by investigators in the case of anti thyroid action of substances in rats which have no counterpart in man. (Golberg S. 5-6.) - 135 - CMA 048019 The IRLG Risk Assessment Group also recognizes the phenomenon of secondary carcinogenesis as a result of stresses to physiological systems of the test animals to the point that the altered physiology itself leads to cancer. (Ex. 147.) Despite these limitations on data from MTD experiments, the OSHA proposed categorization does not distinguish between MTD and lower dose experiments. This omission is not cured by the "rebuttal" criteria of Section 1910.111(a). If the route of exposure in the animal experiment was different from the route of exposure to man, it must be shown to be "grossly in appropriate", Section 1990.111(a)(2), a term undefined in the regulations. There is no definition of "suggestive" in Section 1910.111(a)(3) nor is there any .indication as to how one could demonstrate the data are "totally inadequate" to establish con clusions under Section 1990.111(a)(4). Similarly, "some other reason" is not defined in subsection 5, Section 1990.111(a)(5). To eliminate this ambiguity with respect to the MTD data, AIHC set out to establish criteria to identify these data and give them the meaning consistent with the NCI description. Thus experiments conducted at excessive doses are placed in Category III in the AIHC Alternative as substances for further testing which may be regulated in the meantime for acute or chronic toxicity other than carcinogenicity. This is sub stantially the same treatment as for substances OSHA classi fied in OSHA's Category II. Criteria to identify excessive dose experiments have 136 048020 CMA been proposed by the American Conference of Government and In dustrial Hygienists before this proceeding began. Since these were independently derived criteria, AIHC adopted them as guide lines for its Alternative. AIHC recognizes that such criteria can be refined to serve the purpose of identifying the MTD bio assay results so that on the basis of such tests substances would be classified in OSHA Category II and AIHC Category III. 4. Pharmacokinetics, Metabolism and DNA repair The validity of animal tests as a basis for extrapola tion to man depends on the similarity between the metabolism of man and the test species with respect to a particular sub stance. Despite similarities between mammalian species with respect to metabolic processes,-there are also differences. (Dr. Hart Tr. 3491-3492, 3499-3501; Dr. Kotin Tr. 4890-4891, 4908-4909, 8653-8654; Dr. Golberg Tr. 6498, 6511-6514; Dr. Yang Tr. 6799-6827; Dr. Rousch Tr. 4978-4979; Dr. Olson Tr. 3242-3241; 1/ Gross Tr. 8320). As we have pointed out supra, at 121-123 and 128-131, many witnesses, including Dr. Rail and Dr. Upton, testi fied that a scientific evaluation of animal data to determine risk to man includes an appraisal of differences in metabolism and pharmacokinetics of the test animal and man. Dr. Albert 1/ A recent example of an instance in which an expert body took into account metabolic differences between species in assess ing carcinogenicity is a 1978 report of a joint FAO/WHO com mittee on pesticide residues in food. (Ex. 53.) The commit tee concluded that aldrin and dieldrin were not carcinogens for man despite certain mouse data to the contrary. The committee discounted the mouse data on the basis of a thorough review of metabolic data. _Id. at 11-12. - 137 - CMA 048021 testified that EPA would evaluate metabolic data. (Tr. 2369.) Much of the criticism of the relevance of metabolic differences between man and test animals turned on two points: 1) little is known about metabolism of substances, and uncertainties are great; 2) any delay to secure metabolic data would delay the regulatory processes unreasonably. There is little doubt that the study of comparative metabolism is a science which has not yet developed to a level which allows careful interspecies analysis. On the other hand, experimenters like Dr. Hart and Dr. Yang make clear that the science of comparative metabolism has made great strides. (Dr. Hart Tr. 3481-3483; Dr. Yang Tr. 6799-6827.) Comparative meta bolism provides results which are not only useful now when the data are available, but also holds enormous promise for the future if OSHA and other regulatory agencies recognize its value and en courage development of the data. A number of witnesses addressed the subject of DNA repair, which is barely referred to by OSHA in the Preamble to the Proposed Regulation. DNA repair can be regarded as a phen omenon having a bearing on thresholds since DNA repair system atically and effectively can overcome deleterious effects of exposure to chemicals. (Dr. Hart S. 14-28, Tr. 3459-3462, 3477-3484; Dr. Skalsky Tr. 7584-7592.) Further, species dif ferences in DNA repair capacity provide a number of insights as to man's ability to repair carcinogenic insults and acti 138 CMA 048022 1/ vate compounds to their carcinogenic state, Dr. Kotin referred to DNA repair as one of the areas in which the most important discoveries of recent years have been made. (Tr. 8752-8753.) In the present context, DNA repair is being dis cussed in the context of metabolic differences and similari ties between animals and man. Dr. Hart discussed and referred to the literature on the newly developing science of comparative studies of species differences in DNA repair. (Dr. Hart S. 14-28, Tr. 3459-3462, 3477-3482.) This work, like that of Dr. Yang, opens the door to the possibility of identifying the species whose metabolism is closest to man. The experimenter could use these data to select the species whose test results would be more relevant to man and the scientist could use the data in the risk evaluation with confidence. Indeed, Dr. Hart held out the prospect that test systems developed by this emerging science may enable sci entists to identify, monitor and indeed quantify exposure of in dividuals to suspect sustances, (Tr. 3473-3476, 3495-3496.) AIHC joins with Dr. Hart in urging that OSHA encourage the development of data on metabolism and DNA repair. While these data serve a purpose now, their promise for the future is 1/ Dr. Hart noted that there was some emerging evidence to support the view that longer-lived species such as man are less able to electrophilically activate substances to their carcinogenic state and better able to repair carcinogenic insults than shorter-lived rodents. (Dr. Hart S. 28 . ) - 139 - CMA 048023 great. Any refusal by OSHA, under the guise of administrative determination of scientific issues, which cuts off use of these data in individual substance proceedings can only be described as tragic. There is an additional aspect of metabolism analysis which should also be noted. As we have pointed out supra, at 133- 137, MTD testing may lead to metabolic overloading and organ dam age. This in turn can lead to what Dr. Golberg and Dr. Skalsky referred to as "secondary" carcinogenesis. Thus, metabolic an alysis can offer new interpretive tools which will enable the scientists to distinguish the "secondary" results whose relevance to human risk may be slight. See Dr. Gehring Tr. 5034-5035, 5186- 5191. Several witnesses have testified that the science of metabolic differences and pharmacokinetics have reached the stage in development where it is reasonable to include the data in mathe matical extrapolation models. (Dr. Hoel Tr. 2145-2148; Dr. Peto Tr. 2538-2540; see also Dr. Skalsky Tr. 7590-7591, 7597-7599.) AIHC does not suggest that OSHA require that metabolic data be available before a risk assessment is made based on ani mal data. However, in view of the developments in the science of comparative metabolism and the development of tests which promise relatively speedy metabolic comparisons (Dr. Hart Tr. 3473-3476, 3495-3496; Dr. Yang Tr. 6802-6807, 6811-6812; and Dr. Skalsky Tr. 7591-7602), OSHA should encourage the development and use of metabolic data - 140 - CMA 048024 (1) to select the test animals whose metabolism of a particular substance is extrapolatable to that in man; (2) to evaluate test results obtained when compar ative metabolism data was not examined before selecting the test species or strains; (3) to evaluate test results for "secondary" carcinogenesis; (4) in the qualitative and quantitative risk assessment and in determining the permis sible exposure limit. Certainly it would be unreasonable for OSHA to exclude such comparative metabolic data from evaluation when such data are available. 5. Statistical significance OSHA recognizes in the definition of "toxic substance" in Section 1990.102 that statistical significance is an important ingredient in the evaluation of animal and human data. However, that recognition is ambiguous in two respects and should be clari fied . In the Preamble to the Proposed Regulation, OSHA com ments : "5. Statistical significance. For an adequate demonstration of carcinogenicity of a substance in test animals, it is generally necessary that the increased incidence of neoplasms in one or more of the experimental groups should be evalu ated statistically for significance (NCAB Report, p. 5; MRAK Commission Report, p. 465)." 42 Fed, Reg. 54162. However, in the Proposed Regulation OSHA refers to statistical significance only with reference to decreased latency, and does not refer to statistical significance in connection with induc - 141 - CMA 048025 tion of tumors except by implication. The definition of "sug gestive" in Section 1990.102 refers to results which are not statistically significant, thus implying that statistical signi ficance is required for Category I purposes. Moreover, as Dr. Saffiotti points out, the reference to statistical significance is ambiguous in that if fails to specify the value of the statistical significance required. (Saffiotti S. 25.) Dr. Saffiotti would solve the problem of this ambiguity by dropping rather than defining the term "sta tistically significant" and would rely on the much vaguer word "cause" as implying "adequate criteria". (Saffiotti S. 25-26, Tr. 908.) Rather than clarifying the meaning of the regulation, Dr. Saffiotti's proposal would introduce greater uncertainty and vagueness. We believe it is clear from the record that "statisti cal significance" is an essential element in the evaluation of any animal or human study. Indeed one of the criteria of a valid study is that the results are statistically significant. See NCAB General Criteria at 463; Dr. Rogers Tr. 8565-8566. Thus, to leave out the evaluation criterion of statistical significance is "unscientific" in the sense that an essential part of the eval- 1/ uation process is ignored. 1/ Statistical significance is discussed in a memorandum from John Gart to Albert Kolbye dated July 11, 1978. (AIHC P.H.) See particularly the discussion therein of the Bonferroni correction factor. See also articles following the refer enced memorandum in the AIHC post-hearing filing. 142 CMA 048026 AIHC urges OSHA on the basis of this record to include statistical significance in its proposed criteria for the conduct and evaluation of animal and human studies. Whether or not a single common level of confidence should be selected in advance for all studies is controversial. Thus, NIOSH recommends that "statistically significant" be defined as "at the 95% confidence level" without any distinction as to the use to be made of an evaluation at that level of confidence. (NIOSH S. 5.) Dr. Peto, on the other hand, testified that significance levels of .05 (95% confidence level) should not be taken as strong evidence of car cinogenicity. (Tr. 2517.) It is AIHC's view that it is not only important to retain the concept of statistical significance; it is also im portant to recognize that the level of statistical significance selected for a particular evaluation depends on the use to be made of the data. If the 95% level such as NIOSH recommended were to be selected by OSHA, OSHA should recognize three points relevant to that selection: (i) Since 1/20 of the tests may be random false positives under this confidence criterion (Dr. Peto Tr. 2548), confirmatory evidence becomes a natter of prime importance. (ii) There will be circumstances where a much higher level of confidence is required, as is discussed in a succeeding section of this brief. See infra, at 163-164. (iii) Different levels of statistical significance may be relevant in evaluating an experiment which produces rare tumors as distinguished from one which induces an increase in the tumors to which a tumor prone species is sub ject. - 143 - CMA 048027 Dr. Upton made clear that statistical significance is not solely reliance on a bare arithmetic concept. We need to know also, he said, whether the controls behaved in accordance wtih the characteristics of the strain (Tr. 284); and the test results must be significant in light of the overall scientific evaluation of the test. _Id. As Dr. Shimkin notes "[statistics must make biological sense first and not be a mathematical exer cise." (Report of the NCI Clearinghouse at 74, AIHC P.H.) 6. Tumor prone species The record makes clear that one of the significant developments in cancer research has been the development of inbred strains of rodents. As several witnesses testified, these strains have been created to make the rodents more "sensitive" and hence better detectors of carcinogens. However, there have been consequences of this development which are not reflected in the Proposed Regulation. The inbreeding has resulted in a varying but high degree of spontaneous tumor incidence. Dr. Jandl referred to the cata logues which enable the experimenter to select animals with parti cular spontaneous tumor rates. (Jandl Corrected S. 26-30.) He pointed out that inbred strains are not only less resistant to carcinogenesis (e.q, , defects of DNA repair mechanisms, detoxi fying mechanism, etc.) but, in addition, may be defective in their ability to excrete, to metabolize and may have other non specific defects which increase their susceptibility to poten tially injurious agents. Id.. at 34-36. Dr. Van Duuren testi- 144 CMA 048028 fied that he preferred random-bred animals with a low incidence of spontaneous tumors because results of inbred species, parti cularly the mouse, are difficult to interpret. (Tr. 1814-1815.) We have pointed out above the need for OSHA to clarify what is meant by the term "statistical significance". With respect to the tumor prone strains, this becomes a matter of prime importance. Dr. Griesemer's testimony as to the statis tical probabilities of a false positive in an NCI bioassay under lines the need for a separate calculation where conditions of the experiment are different from the NCI bioassay. Dr. Olson referred to the unexpected changes in the basal spontaneous tumor rate in the mouse, thus making a mouse experiment in such a strain difficult to interpret. (Tr. 3239; see also Dr. Crampton S. 5.) Nor can there be assurance that randomization will cure the de fect. Since the qualities which lead to the change in the basal rate are not known, it is difficult to randomize for such a change. (Dr. Olson Tr. 3241-3245.) Dr. Furst testified that if the con trols develop more spontaneous tumors than is "normal" for the 1/ particular strain, the experiment should be regarded as invalid. (S. 22-23.) 1/ Thomas R. Fears, Robert E. Tarone, and Kenneth C. Chu, "False-Positive and False-Negative Rates for Carcinogeni city Screens" 37 Cancer Research, 1941-1945, 1941 (1977) (Attachment to Statement of Dr. Griesemer): "The implementation of a number of chemical carcinogen screening programs has been accompanied (Footnote continued on p. 146) - 145 - CMA 048029 One of OSHA's witnesses, Dr. Robert Squire, gave con sideration to the significance for classification purposes of whether the tumors induced were rare (i.e, , tumors with spontane ous rates in controls of no more than 5%) or were an increase in spontaneous tumors. (Squire S. 27-28.) Dr. Squire concluded: "The categories, as they are currently defined, are too restrictive and do not allow for considera tion of all pertinent evidence. The determina tion of potential carcinogenicity must allow for some degree of judgment -- both in determining what data is relevant and in objectively evaluat ing that data. I fear that otherwise we may on occasion regulate on the basis of false positives and false negatives. I propose therefore that the categories be redefined to allow a greater role for scientific judgment in assessing the evidence." _Id. at 27. Based on these comments. Dr. Squire made suggestions for modi fication of the OSHA Category I criteria which would take into account the difference (in evaluation terms) of induction of rare (Footnote continued from p. 145) by the observation that some screens might have high false-positive error rates. With designs presently used at the National Cancer Institute and historical spontaneous tumor rates based upon control animals in previous experiments, we compute upper bounds on the false-positive error rates for several screening strategies. False-positive re-sults are much less likely to occur at tissue sites with low spontaneous tumor rates; hence the site at which a significant tumor increase occurs is important. There is dan ger in relying solely upon the finding of statis tical significance without incorporating biological knowledge and corroborative evidence such as the presence of a dose-response relationship or experimentally consistent results in different species or sexes. A report by the National Cancer Institute Carcinogenesis Program demonstrates these concepts." (Emphasis added.) - 146 - CMA 048030 tumors as compared to an increase in spontaneous tumors. Id. at 27-28. Dr. Dubin stated he would not use a strain with a 1/ 25% spontaneous tumor incidence. (Tr. 1188.) Nowhere in its classification system does OSHA take into account the consequences of the physical and genetic defects y of the inbred strains of rodents. If a scientific evaluation panel of the kind proposed by AIHC were adopted, these factors could be evaluated in the appropriate scientific atmosphere. 7. Mouse data In addition to the problems presented by tests con ducted on tumor prone species discussed above, there are special problems with reference to the mouse which deserve discussion. Dr. Crampton and Dr. Grasso testified as to the ex tensive analysis they have made of published mouse data under the auspices of the British Industrial Biological Research Asso ciation. See Tr. 6557-6568, and publications listed in Ex. 138. Drs. Crampton and Grasso concluded that the mouse is a satisfac- 1/ For an interesting analysis of spontaneous tumor incidence in NCI bioassay animals, see letter from Thomas Cameron to Eric Schwartz dated September 13, 1978 and Report of the Clearinghouse at 84 (AIHC P.H.). Of particular interest is the comparatively high incidence of spontaneous tumors in mice at the lung (11.0) and the liver (19.7) and the comparative increase over time for these two sites. See also analysis of mammary pituitary and testes tumors for certain rat strains. 2/ The influence of environmental factors on incidence of tumors in inbred mice is discussed by Dr. Heston in a post hearing statement. (Ex. 224-G.) - 147 - CMA 048031 tory test animal if actual malignancy is induced by exposure to a chemical. Id. However, they have raised doubts as to the validity for extrapolation to man of four types of mouse tumors: (i) Lymphomas which are associated with a virus which is activated in a manner not found in man; (ii) Hepatomas to which the mouse is particularly prone and which can be induced by dietary changes and stress; (iii) Pulmonary adenomas which develop spontaneous ly because of genetic factors; and (iv) Mammary tumors which are associated with a virus not found in man. Id. Similar objections as to mouse data were raised by Dr. Butler (Tr. 5384-5386, 5400-5401) and Dr. Vesselinovitch (Tr. 5391-5397 ), Dr. Butler offered -as support for his views a mono graph edited by himself and Dr. Paul Newberne of MIT on an in ternational workshop called to address the problem of mouse hep- patic neoplasia. Dr. Vesselinovitch offered into evidence a re cent NAS analysis of data relating to the pesticides heptachlor and chlordane which validated a number of the views expressed by Dr. Crampton and Dr. Grasso with respect to the mouse. (Dr. Ves selinovitch Tr. 5390-5392.) Two international peer groups meeting under the aus pices of the International Agency for Research on Cancer ("IARC") have also recently had occasion to evaluate certain mouse data. A reprint of an article which appeared in Cancer Re search , April, 1978, entitled "Evaluation of the Carcinogeni city of Chemicals: A Review of the Monograph Program of the 148 04*0^ CV^ International Agency for Research on Cancer (1971-1977)" by Dr. Tomatis and others was attached as an appendix to the state ment of Dr. Tomatis filed in this proceeding. In that article Dr. Tomatis notes that the IARC Monograph program had been criticized for failing to assess human risk of exposure to car cinogens (_id. at lines 350-362 ), and as a consequence an ad hoc working group was convened jointly by IARC and the World Health Organization in October 1977 "to update and revise the criteria on which carcinogenicity of chemicals to humans and/or experi mental animals is assessed and on which the evaluation of the possible carcinogenic risks that they may represent for humans is made." Id^. at lines 363-369. As a result of the delibera tions of the committee, the changes made in the Preamble were described as follows: "While it was recognized that no adequate cri teria are presently available to interpret ex perimental data on carcinogenicity directly in terms of their carcinogenic potential to humans, it was also noted that extrapolation to a possi ble human risk can be reasonably approximated by utilizing data from appropriate animal tests. These data, however, may represent different degrees of evidence, this drawback being mainly due to our present insufficient knowledge of the mechanisms of carcinogenesis. Thus it was tenta tively agreed that the carcinogenicity data may represent strong evidence of carcinogenicity when they indicate the unquestionable production of malignant neoplasms or 'weak evidence1 when they solely indicate the appearance of neoplastic lesions such as lung adenomas or hepatomas in mice. In the presence of appropriate experi mental carcinogenicity data and in the absence of adequate human data, it is reasonable to re gard chemicals for which there is strong evidence of carcinogenicity as if they were carcinogenic to humans. Chemicals for which there is weak - 149 - CMA 048033 evidence of carcinogenicity in experimental animals will, m general, require more experi mental and epidemiological investigation." Id. at lines 381-402 (emphasis added). A second ad hoc group was convened by the IARC earlier this year to review the work of the first ad hoc group. (Dr. Griesemer Tr. 926-927.) The revised criteria as they are to be published in IARC Monograph 17 appear in Exhibit 135. In this second peer review in a scientific rather than adversarial atmosphere, the criteria were discussed as follows: "The term 'carcinogenic risk' in this IARC MONOGRAPH series is taken to mean the prob ability that exposure to the chemical will lead to cancer in humans. Many chemicals induce both benign and malig nant tumors; few instances are recorded in which only benign neoplasms"are induced by chemicals that have been studied extensively. Benign tumors may represent a stage in the evolution of a malignant neoplasm or they may be 'endpoints* which do not readily undergo transition to malignant neoplasms. If a substance is found to induce only benign neoplasms in experimental animals, the chemical should be suspected of being a carcinogen and requires further investi gations . **# In general, the evidence that a chemical produces tumors in experimental animals is of two degrees: (1) sufficient evidence of car cinogenicity is indicated by the production of malignant tumors; and (2) limited evidence of carcinogenicity reflects the qualitative and/or quantitative limitations of the experimental results. *** In the present state of knowledge, it would be difficult to define a predictable relation ship between the dose (mg/kg bw/day) of a parti- 150 CMA 048034 cular chemical required to produce cancer in test animals and the dose which would produce a simi lar incidence of cancer in humans. The avail able data suggest, however, that such a rela tionship may exist, at least for certain classes of carcinogenic chemicals. Data that provide sufficient evidence of carcinogenicity in test animals may therefore be used in an approximate quantitative evaluation of the human risk at some given exposure level, provided that the nature of the chemical concerned and the physiological, pharmacological and toxicological differences between the test animals and humans are taken into account. However, no acceptable methods are currently available for quantifying the possible errors in such a procedure, whether it is used to generalize between species or to ex trapolate from high to low doses. The method ology for such quantitative extrapolation to humans requires further development. (Ex. 135 at 15.) ** Evidence for the carcinogenicity of some chemicals in experimental animals may be 1imited for two reasons. Firstly, experimental data may be restricted to such a point that it is not possible to determine a causal relationship be tween administration of a chemical and the devel opment of a particular lesion in the animals. Secondly, there are certain neoplasms, including lung tumors and hepatomas in mice, which have ^een=ons>i^er^=_of==les[;gj^^^ni_f^ancen_thian neoplasms occurring at other sites for the pur pose of evaluating the carcinogenic risk of chemicals to humans. Such tumors occur spon taneously in high incidence in these animals, and their malignancy is often difficult to establish. An evaluation of the significance of these tumors following administration of a chemical is the responsibility of the particular Working Group preparing the individual mono graph, and it has not been possible to set down rigid guidelines; the relevance of these tumors must be determined by considerations which in clude experimental design and completeness of reporting. Some chemicals for which there is 1imited evidence of carcinogenicity in animals have - 151 - CMA 048035 also been studied in humans with, in general, inconclusive results. While such chemicals may indeed be carcinogenic to humans, more experimental and epidemiological investiga tion is required. Hence, 'sufficient evidence' of carcinogeni city and 'limited evidence' of carcinogenicity do not indicate categories of chemicals; the inherent definitions of those terms indicate varying degrees of experimental evidence, which may change if and when new data on the chemi cals become available. The main drawback to any rigid classification of chemicals with re gard to their carcinogenic capacity is the as yet incomplete knowledge of the mechanism(s) of carcinogenesis." Id. at 21 (all footnotes omitted)(italics in original, double emphasis added) . Thus, two separate international peer review commit tees of the IARC have identified specifically as "weak" or "limited" evidence of carcinogenicity two of the mouse lesions whose weight and relevance Dr. Crampton and Dr. Grasso questioned. Both peer groups concluded that such lesions in the mouse were merely an indication that further investigation was required and not sufficient evidence for classification of a substance as a 1/ human carcinogen. We urge that on this record the Proposed Regulation should be amended to make clear that certain mouse data do not satisfy the criteria of OSHA Category I. Evaluation of these 1/ Another recent report raising questions about the relevance of mouse liver data is the report of the December 1977 meet ing of a joint FAO/WHO expert committee. The committee concluded that, for the compound in question, "[c]ompared to other animal species, [the mouse] reacts rather anomal ously and the mouse, therefore, may not be an appropriate model for man in this case." (Ex. 53 at 12.) - 152 - CMA 048036 data is strictly a scientific matter. No policy decisions with respect to these data are warranted. 8. Factors affecting animal test results In addition to the problems presented by tumor prone species, there are a number of other factors which can have a bearing on the outcome of an experiment. Dr. Furst testified that animal tests can be manipulated to give positive results. (Tr. 6932-6933, Furst S. 25; see also Dr. Roe S. 67, 74.) Dr. Furst spoke of inattention to diet and dietary deficiencies, to y contamination of the test agent or diet, to variations in the test agent, and hormonal stress, as factors which could influence the outcome of the study. Id.; see also Dr. Kotin Tr. 4893-4894 , 1/ The question of nitrosamine contamination in diet fed animals in NCI's bioassay program recently received considerable attention at an American Chemical Society (ACS) meeting. See W. Leary, "Nitrosamine, in Animal Feed May Affect Tests for Cancer", Washington Post September 13, 1978 (AIHC P.H.) The paper presented at that meeting concludes as follows; "The highest NDMA level found was 52 ppb in the new National Institutes of Health open formula rat and mouse ration. * ** The presence of appreciable levels of so toxic an animal carcinogen as NDMA in the diets of laboratory animals which are being used for long-term carcinogenesis studies represents an awkward problem, particularly when possible cancer causing compounds are being tested at low levels. We recommend that the N-nitrosamine level of the con trol diet be reported in future carcino genesis studies." (Footnote continued on p. 154) 153 CMA 048037 4911-4912. The bias may not be intentional but rather simply the result of error in design or conduct of the experiment. Dr. Golberg testified that because of the complexities of selecting an MTD which does not produce tissue toxicity (other than carcinogenesis), tests are sometimes run with fluctuating dose levels. (Golberg S. 3, Tr. 6494-6495.) He cautions that evaluation of such test results should be examined with great care and preferably be redone with a valid protocol. Id. Dr. Squire discussed the particular problems of hor mone carcinogenesis and the possibility of experimental mani pulation : "Hormone carcinogenesis will be an issue of major concern under these proposed regulations. Hormones represent an "unusual class of carcino gens and they require special regulatory atten tion. Hormones may not be carcinogens in the classical sense of being initiators; rather, they may act as promoters with dose-dependent, reversible cellular effects. Furthermore, in some cases, because of the fundamental differ ences between species in endocrine and repro ductive physiology, test animal results may not be relevant to the human situation. The FDA Toxicology Advisory Committee on the Carcino genic Risk of Antipsychotic Drugs (FDA 1977) concluded a discussion on the findings of mammary carcinogenesis in test animals with the follow ing comments: A. By using the rats and mice and manipu lating variables associated with ovarian function and prolactin production, it is (Footnote continued from p. 153) D.H. Fine et al. , "N-nitroso Compound Impurities in Consumer and Commercial Products", presented at the American Chemical Society Meeting September 11, 1978, at 2, 3 (AIHC P.H. (Supplemental 9/25/78)). 154 CMA 048038 possible to design experiments that would demonstrate either a positive or negative carcinogenic effect or a protective effect against mammary tumor induction. B. It is, therefore, inappropriate to con sider the studies under review according to their design or whether mammary cancer was or was not induced. C. There is, at present, insufficient evi dence to extrapolate from mice and rats to humans with respect to the role of prolactin in human mammary carcinogenesis. D. The rodent studies are not relevant to determination of the magnitude of human risk from mammary career. E. The relevance to humans of rodents or other models requires additional pharmaco logical and physiological studies. The present classifications require estrogenic substances to be Category I. I question whether estrogens used in drug formulations should be categorized and regulated in the same way as vinyl chloride, bis(chloromethyl)ether, and other confirmed occupational carcinogens." (Dr. Squire S. 30-31.) Dr. Roe and Dr. Olson discussed in some detail the impact of caloric intake on the cancer incidence in rodents. (Dr. Roe S. 31-41; Dr. Olson S. 16-19.) Differences in calor ic intake significantly affected the incidence of tumors, with restrictions on caloric intake markedly reducing the tumors. Id. Dr. Roe referred particularly to a pathogen-free colony of random-bred Swiss mice established by Imperial Chemical In dustries, Ltd. ("ICI") in England. The colony established in 1960 had a natural tumor incidence of 10%. Ten years later on the same diet and under the same conditions the spontaneous tumor incidence had risen to 80%. When an experiment was performed - 155 - CMA 048039 in which the diet was reduced slightly in one group of test animals from 5.8 grams (a_d libitum) to 5 grams per day, there was an 8 fold reduction in tumor incidence before the animals were 18 months of age in the animals on the restricted diet. (Dr. Roe S. 33-34.) A, subsequent life time experiment by ICI on both mice and rats indicated that dietary restriction extended the average life span of the animals. In addition, despite the fact that most of the difference in survival occurred after 18 months -- the period when tumors are most likely to arise -- the overall incidence of tumors in the animals on a restricted diet was sig nificantly less. (Dr. Roe S. 35-39.) Dr. Roe cautions against assuming that caloric intake alone was responsible. An animal on a restricted diet tends to consume its food quickly and be without food until the next ra tion, Ad 1ibitum fed animals nibble throughout the day. As a result, the bacterial flora in the gut of the animals differ. In addition, the strain of looking at an empty food basket can induce a stress in the animals on restricted diet. (Dr. Roe S. 34.) Thus, unless close attention is paid to caloric intake by the experimenter, the results could be misleading. Dr. Roe also points out that laboratory animals are left in an environment which results in unnatural hormonal status. (Dr. Roe S. 42.) Temperature, number of animals per cage, and lack of exercise have been shown to have an influ ence on the induction of tumors. Id. - 156 - CMA 048040 Finally, we noted supra, at 148 that rodents are sensi tive to viruses which are not oncogenic to man. Dr. Roe discusses at some length the prevalence of these tumor viruses in rodents. (Dr. Roe S. 62-65.) 'Thus, depending on the level of confidence, the tumors induced in the treated animals as compared to the controls could be a matter of chance or diet. It could also be due to activa- 1/ tion of a virus or to hormonal imbalance or other mechanisms not relevant to man. Since OSHA has not disclosed the criteria it is con sidering with respect to the conduct and evaluation of animal tests, it is not possible to know whether OSHA will take into account the factors referred to'above in evaluation of the test results. AIHC submits that any sound evaluation must take into account these factors which influence the outcome of ani mal studies. As Dr. Kennedy pointed out, no conclusions should be drawn from a poorly designed test. (Tr. 521-522.) For the same reasons it is imprudent to act on the basis of a single animal study without adequate confirmatory evidence. See discussion infra, at 162-166. 9. Positive/negative results In the Preamble to the Proposed Regulation, OSHA dis cusses the relevance of negative and positive results in ani mal species. 42 Fed. Reg. 54161. OSHA concludes that positive 1/ See V. Riley et al, "The LDH virus: An Interferring Biological Contaminant," Science (AIHC P.H.). - 157 - CMA 048041 results should generally supersede negative results because of the insensitivity of the animal studies. OSHA should re-examine this proposed administrative determination in light of the testi mony in the record. OSHA's statement as to positive and negative results is stated in terms of tests of equal soundness from an experi mental point of view. _Id. There is, however, a general recog nition that tests are of varying quality and, as many witnesses pointed out (e.g. , Dr. Griesemer Tr. 930; Dr. Furst Tr. 6924- 6926, 7159-7160), the tests in the literature are recognized to be of very uneven quality. See discussion supra, at 128-131. Thus, OSHA's administratiave determination is based on an assump tion as to validity which is essentially unrealistic. Indeed, as Dr. Golberg pointed out in his testimony, analysis of the results of tests under the NCI Bioassay pro gram point to a wide variety in quality; even though these tests are more uniform than most, many are defective for a variety of reasons. (Ex. 113 at 3-5, Table II; Tr. 6487-6492.) He con cluded : "I know that changes have been made in an effort to correct some of these deficiencies. Never theless, the heritage of just this one program has provided a record of hundreds of tests whose results cannot be taken at their face value for automatic decisions on carcinogenic poten tial. For purposes of assessment of risk to man, the full data forthcoming from each test will need careful evaluation by appropriate experts who will consider them in the context of all the available information on the com pound in question, not solely on the basis of 158 CMA 048042 the test results forthcoming from the carcino genesis bioassays." (Golberg S. 3.) Thus, negative studies may raise questions as to the validity of positive results. (Kimbrough Tr. 1795-1796.) A careful analysis of negative and positive results may show that the studies are not inconsistent. (Dr. Hoel Tr. 2159-2160.) However, it is also possible that the positive result was random depending on the level of confidence required in the statistical analysis of the results (see supra, at 143), or that such a re sult may be an artifact of the design or conduct of the test (see supra, at 153-157). None of the witnesses were willing to exclude examination of negative data to provide administrative convenience. Indeed, Dr. Furst took the position that if a substance is positive in one species but negative in others, much less stringent regula tion is warranted. (Tr. 6929-6930 S. 20; see also Dr. Roe S. 68.) In a paper filed as an exhibit to his written statement. Dr. Mor gan discussed in detail the statistical analysis which can be used to determine the probability of carcinogenesis when there are num erous tests, some positive and some negative. (AIHC P.H.) See also "Guidelines for Evaluation and Use of Occupational Epidemio logic Cancer Studies" (AIHC P.H.), Appendix D hereto. While as an administrative matter it may be convenient to reject negative results in the face of a positive test, the record demonstrates that any such conclusion is inconsistent with the scientific evaluation process. 10. Single species or two species Generally it is AIHC's position that in a regulation - 159 - CMA 048043 of this kind where interspecies extrapolation is made, it is sound to have as basic criteria for OSHA Category I and AIHC Category II the requirement that the substance be shown to be carcinogenic in two mammalian species. The basic uncertainties in animal data discussed in the preceding sections of this brief point to the conclusion that it would be unwise as a general mat ter to rely on a single test in a single species for a generic classification scheme. There is an additional compelling reason for requiring tests in two species. As Dr. Saffiotti said, one cannot exclude the possibility that a carcinogenic response is species specific. (Tr. 857-858; see also Dr. Lamm Tr. 4598; Dr. Kotin Tr. 86798680.) Dr. Rail pointed out that a substance may affect one species but not another. (Tr. 486.) While such an event may be rare, there are numerous instances cited in the record where a substance is oncogenic to one species or strain, but not to an other. The differences go both ways. Arsenic may be carcinogenic in man, but not in rodents. The reverse situation also has been shown. There has been no demonstration that DDT, aldrin/dieldrin or phenobarbitol cause excess cancer in man. See discussion of negative epidemiology, supra, at 127. Indeed, the possibilities of species differences are sufficiently real that the NCI bioassay calls for the screen ing test to be conducted in two species to reduce chances of a false negative. The same reasoning leads to the possibility that rodent data in one species gives a false signal of human risk - 160 - CMA 048044 because of metabolic or other differences between man and the rodent. (Dr. Rail Tr. 391, 487-488; Dr. Meselson Tr. 1542; see supra, at 127, 137-141.) These differences between man and ani mal are not taken into account when testing to determine whether a substance is an animal carcinogen. (Dr. Griesemer Tr. 935.) Differences between man and the rodent are particularly apparent when man is compared to the tumor prone rodent species, especially the mouse. A test with a sick, genetically defective animal subject to the unusual stresses of the test conditions raises particularly difficult problems of evaluation. More over, substances may be activating viruses in animals which are not oncogenic in man. See discussion, supra, at 148. Finally, there are dif-ferences in sensitivity to sub stances between species and strains in a single species. (Dr. Peto Tr. 2674-2565; Dr. Kotin Tr. 8679-8680.) Both in extrapo lating to man and particularly in quantifying the risk, a more reliable and accurate evaluation can be made if data from two species are available. Since a regulatory decision in most cases is a $100 million plus decision (Benzene $500 million. Vinyl Chloride $200 million plus), it is important that the agency act on the best information for making such a decision. The fact that a substance is not carcinogenic in one of two species is a signal that other differences in response may be found, Man may respond the way the animal in the negative test reacted. AIHC is not suggesting that OSHA do nothing during the - 161 - CMA 048045 period while a second test is being conducted, nor does AIHC suggest that OSHA await a comparative metabolic analysis before taking regulatory action when there are positive results in a single species. To the contrary, under AIHC Category III the agency might take action to lower exposure pending the develop ment of more complete data. The single test exception. During the hearings a num ber of witnesses suggested that OSHA was too conservative and should be willing to regulate a substance on the basis of a sin gle positive animal test. Such statements usually referred to a "well conducted" or a "well designed and conducted" test and com monly the test was described as "clearly positive". E.g., Dr. Rail Tr. 386-387, 448; Dr. Bates Tr. 631. NIOSH testified that there may be an "exception" to the requirement that a test result be replicated when "highly significant results are obtained in an adequately conducted and biologically appropriate test." (Tr. 3030.) Discussion of this proposed reliance on a single posi tive test can be assisted by reference to the statement of Dr. Rail: "The fact is that scientific experiments never give results that are 100% positive, nor 100% negative. Science deals in probabilities, and carcinogenesis bioassays give results that nay fall anywhere on a continuous spectrum of prob abilities, extending from 2 or 3% at the lowest to nearly 100% at the highest. Division of this spectrum into discrete categories may be necessary for regulatory purposes, but it is necessarily arbitrary from a scientific point of view. Thus the recommendation of a scientist - 162 - CMA 048046 would be to make the criteria for categorization flexible, and to apply as much scientific judg ment to each case as is comparable with legal and regulatory requirements." (Dr. Rail S. 1314. ) He also said: "On the one hand, there are cases where a single, well-conducted experiment giving clearly positive results should suffice to establish a chemical as a carcinogen and to justify stringent measures to reduce occupational exposure. On the other hand, there are cases where two or even three conclusive positive results would still leave some doubt." Id. Dr. Peto has probably the most complete comment on the problem of reliance on a single test. (Dr. Peto S. 13; Tr. 2548-2551.) He pointed out that in most experiments the separate incidence of tumors at different sites is independently documented and some of the many significance levels will be less than p. 0.05 by chance. In his testimony he elaborated on the ran dom chance of a positive result when the confidence level is 0.05. In his statement he concluded: "... for a single animal experiment to be convincing without such support, a P-value of well under 0,01 (perhaps even 0.001) should usually be required. Unless this policy of requiring rather extreme P-values is adopted, an unacceptably large number of misleading results will emerge by chance alone." (Dr. Peto S. 13) (emphasis added). Thus, the reliance on a single positive test is highly qualified by those witnesses who addressed the subject. Amplifying somewhat on Dr. Peto's argument, one might naively assume that a statistical finding of significance at the 5% level indicates that there is only one chance in 20 that the - 163 - CMA 048047 data is "false positive", If, however, 10 or more criteria are applied to the same set of data, the probability that at least one criterion will appear to be statistically significant is no less certain than the toss of a coin. Should 20 criteria be applied, there is a high probability that at least one will be found statistically positive. The blind application of multi ple criteria to the same set of data without recognition of this mathematical truth is bound to place OSHA in an untenable position. Using OSHA's own criterion of relying on a single positive test without reference to the total body of scientific knowledge of a given material, one can demonstrate that any substance is carcino genic merely by repeating the same test frequently enough. In addition to the statistical criterion suggested by Dr. Peto, AIHC believes that OSHA should press for comparative metabolic data when it is proposed that regulation be undertaken on the basis of a single animal study. See discussion supra, at 137-141. The AFL-CIO acknowledges the importance of these com parative metabolic data when it proposes that a substance be regu lated upon a showing that it is metabolized in man into a metabo lite which has been shown to be carcinogenic. (AFL-CIO S. 6.) The same reasoning leads to the conclusion that a showing of meta bolic differences between man and the test animal are equally relevant and should be evaluated when such data are available. The fact that such data are being developed experimentally should encourage OSHA to press for such data, particularly when regula tion on the basis of a single test is being considered. - 164 - CMA 048048 However, AIHC believes that the issue of regulation on the basis of a single test may be largely an academic one. It is very unlikely that information other than a bare test result will not be available regarding the substance in question and that OSHA would have to decide whether to act on the basis of this test result alone. It is for this reason that AIHC has proposed that any regulatory action based on a single test should be outside the classification scheme and be handled as a regular administrative proceeding under Section 6 of the Act. OSHA would not be precluded from using an ETS in such a proceed ing if there were a basis for the statutory findings. To include this probably highly unusual situation in the classification scheme would require separate treatment and separate criteria which would add complexities of interpretation. It is AIHC's suggestion that the Proposed Regulation should not refer to the single test exception nor foreclose OSHA's beginning a regular administrative proceeding to estab lish standards in reliance on the results of a single animal study meeting the extraordinary criteria described above. By definition, animal studies which do not meet the single test exception criteria discussed above have a lower confidence level and the results give a lower probability of 1/ risk to man. In Dr. Rail's scale of probabilities, these tests 1/ The NCAB Subcommittee on Environmental Carcinogens states: "The extrapolation of experimental carcinogenicity data to the human situation is strengthened by obtaining results in more than one species." NCAB General Criteria at 463. - 165 - CMA 048049 fall in a range that does not approach the 100% level and range down to the 2-3% level. AIHC believes that it is both prudent policy and consistent with the scientific evidence in the record to require confirmation of such tests. AIHC urges adoption by OSHA of a positive test in a second species as the sounder basis for confirmation. 11. Replication Section 1990.110(a)(3) of the Proposed Regulation pro vides that a substance shall be classified in Category I on the basis of a positive test in a single species "if those results have been replicated in another experiment." We have addressed in the previous section the reasons why we believe it is impor tant for OSHA, except in rare cases, to require positive results in two species before classifying a substance in Category I. It is unsatisfactory to attempt to argue away the need for a twospecies test by confirming "replication" of a positive test in a single species. Should OSHA, despite the soundness of the view to the contrary, decide to rely on a single species, OSHA should require at a minimum the confirmation of "replication". (NIOSH S. 5. ) However, a number of problems remain. As NIOSH points out, the meaning of replication as used in the regulation is not clear. I<3. at 5-6. Does OSHA mean replication by the same re searcher; with the same strain; at the same dose levels; in the same laboratory; with separate controls? NIOSH proposed: "We would hope that where researchers have the option, such confirming experiments would be 166 CMA 048050 performed in a different laboratory, perhaps using a different sex or strain of test animal, additional dose levels, or a different route of administration to provide for a more com prehensive and accurate measurement of the substance." _Id. at 6. Dr. Weinstein and Dr. Furst made similar recommendations (Tr. 2249-2250, 6928), as did Dr. Squire (Dr. Squire S. 29). Dr, Squire stated: "OSHA should make explicit what it means by the replication of a finding in a second experiment. I suggest that the second ex periment be defined as one conducted at a different laboratory by a different investi gator, or one conducted at a different time." (Squire S. 29.) As NIOSH points out, "simple replication using the exact same study design may not be particularly definitive." (NIOSH S. 5-6; see also Dr. Crampton S. 8.) It is imperative that if OSHA decides, incorrectly AIHC believes, to rely on replication of a test as confirmatory evidence, OSHA should clarify the ambiguous term "replication". The protocol or study design should be clear ly defined. AIHC urges that OSHA adopt the NIOSH recommendations and require replication in a separate laboratory with separate con trols. AIHC also recommends that a different strain and additional dose levels be required. If the route of administration is not the same as the route of exposure of humans, the replication should use the same route of exposure as humans: "To properly evaluate carcinogenicity the suspect agent should be administered to ani mals by the same route as humans are exposed, namely, via the lungs, gastrointestinal tract, dermally and in some cases intramuscularly, intradermally and subcutaneously." (NIOSH response to Q. 31.) - 167 - CMA 048051 12. Short term tests Section 1990.110(a)(4) of the Proposed Regulation pro vides that a substance will be classified in Category I on the basis of positive results in a single mammalian species "if those results are supported by short term tests." The term "short term tests" is defined in Section 1990.112 as follows: "'Short-term tests' includes, but is not limited to, positive results in more than one of the following assays for: (1) the induction of DNA damage and repair ; (2) mutagenesis in bacteria, yeast, or Drosophila melanogaster; (3) mutagenesis in mammalian somatic cells; (4) mutagenesis in mammalian germinal cells; or (5) positive results in tests for neoplastic transformation of mam malian cells in culture." Not adequate confirmatory evidence. The end result of most short term tests is mutagenicity, not carcinogenicity. Mutagenesis and carcinogenesis are not biological equivalents. (NIOSH Answer to Q. 28; Dr. Kotin Tr. 8703.) Dr. Griesemer pointed out that the end point of long term animal experiments is the induction of cancer and that cancer is discovered by methods used by a pathologist. (Tr. 981.) Thus, any use of short term tests in connection with the Proposed Regulation must depend on a relationship between the different end points achieved and the difference between carcinogenicity and mutageni city. In August 1977, the Chemical Industry Institute of Toxicology ("CUT") conducted a workshop on "Strategies for Short- Term Testing for Mutagens/Carcinogens" at which more than 50 ex- - 168 - CMA 048052 perts from academia, government and industry met to assess the status and usefulness of the principal short term tests and to produce a set of practical guidelines for dealing with the re sults of those assays, (Golberg Tr. 6527-6528; Golberg, Trans cript of Proceedings.) The meeting produced agreement on several points. Dr. Golberg described the results of the workshop as follows; "Our own efforts to date, coupled with famili arity with the work of others in this field, lead to the conclusion that short-term tests have potential value but require a great deal of further investigation and validation before they can be considered reliable indicators of carcinogenic or mutagenic potential. Moreover, it is fundamental that no single test of this sort can yet be relied upon exclusively to reach a conclusion regarding carcinogenesis/ mutagenesis. A battery of tests should be used, but there is no general consensus of the com ponents of the battery, nor are all the neces sary, currently available tests adequately developed and validated for inclusion in such a battery." (Golberg S. 2.) Dr. Golberg in summarizing the conclusions of the workshop, cautioned against such statements as; "The results of the test correlate 90 per cent with animal carcinogenicity studies." Such statements are misleading because the measure of correlation can be manipulated by judicious selection of the y chemicals tested. (Tr. 6533-6534.) The workshop cautioned 1/ Dr. Marvin Legator (University of Texas), a participant in the CUT workshop, criticized generalized statements that a system was "validated"; "Legator; In the literature, although we often refer to the 90% figure, in terms of correlation (Footnote continued on p. 170) - 169 - CMA 048053 against commonly accepted deviations from defined procedures in the conduct of the tests. 1^3. Only one test, the Ames test, has published criteria for the conduct and evaluation of the test. (Tr. 1521-1522.) However, in the course of the CUT workshop, Dr. Marvin Legator of the University of Texas outlined "some serious limitations" to the Ames test because of questions about the S9 (activator) portion of the test: "(1) Inability to standardize in vitro activa tion systems. (a) Insufficient understanding of the rela tionship of enzymes to mutagenicity. (b) Variability with the amount of S9 fraction used. (c) Variability with chemical inducer of liver microsonal enzymes, administered beforehand to the animal. (2) Inability of _in vitro systems to detect promuta gens activated by means other than by liver microsomes." (Footnote continued from p. 169) between the Salmonella system, and known carcino gens, the truth of the matter is that one can find in the literature correlations ranging from 44% to 90+%. In our own analysis of these studies, we can, in part, attribute the variation in cor relation either to the number of classes or num ber of compounds studied. The high correlations reported in the literature are probably not valid for one or more of the following reasons: (1) Failure to establish uniform and meaningful cri teria for what is a carcinogen, (2) Failure to establish meaningful criteria for the response in the Salmonella system, (3) Failure to code samples, and (4) Using literature studies to derive correlations." (Proceedings II 27.) 170 CMA 048054 In the same workshop, there was a report of the NCI validation process by Dr. Virginia Dunkel who is in charge of of the NCI validation program (Dr. Golberg Tr. 6531)): "b. Status of NCI validation studies. While it is anticipated that many of the proposed assays will become useful short-term tests, it must be remem bered that substantial work remains to define sys tems and correlate results for most of the assays. Dr. Dunkel described the correlation studies that are in progress by the NCI; Dunkel: The ^n vitro carcinogenesis program is currently both developing and validating a series of microbial and mammalian cell systems. The microbial assays include (1) mutagenesis in Salmonella typhimurium strains and E. coli WP2; and (2) DNA repair in E. Coli and pol A+ and pol A- strains. The mammalian cell assays include mutagenesis in the L5178Y mouse lymphoma cell line at the thymidine dinase locus; (2) DNA repair in primary rat liver hepatocytes; and (3) transformation in systems using BALB/c 3T3 mouse cells, early passage Fischer rat embryo cells, Fischer rat embryo cells infected with Rauscher leukemia virus, hamster embryo cells either treated directly in cell culture or exposed to the chemical transplacentally and then placed in culture and liver and skin epithelial cells. As now structured approximately 90 compounds will be tested blind in all assays. Cline: How long will it be before we know the results of the study? Dunkel: It may be two years before we know the results of the blind studies." (Proceedings 11-2728.) Dr. Ray discussed the standardization and validation process: "c. The standardization and validation process. Dr. Ray expressed the concern of many that some tests could be brought to regulatory status before they were sufficiently characterized. Ray: I'd like to make a few comments on the stan dardization and validation process. Currently, a - 171 - CMA 048055 number of mutagenicity assays have been proposed for use in safety evaluation studies to evaluate chemicals already marketed, or being made ready for introduction into man's environment. However, many of these assays have not been validated to the extent where their sensitivity and reprodu cibility have been established. Further, even the most thoroughly studied procedures, such as the Ames test, have not been analyzed to the ex tent that positive and negative compounds can be identified routinely by rigorous tests of statis tical significance. Also, there are many forms of these assays, depending upon the laboratory in volved. Clearly, the time has come to establish procedural standards in the performance of each assay. Especially so, since regulatory agencies are now considering guidelines which may impose requirements for these tests. Criteria must be established which define the validation process itself, and statistical methods adopted which permit all test substances to be evaluated by the same set of rules. Unfortunately, some tests are being made ready for adoption before a critical analysis has been performed on the available literature data. Correlative studies are being quoted in which one or more components lack standards of performance. Because short term mutagenic tests hold considerable promise for identifying both the mutagenic and carcino genic potential of chemicals, it is mandatory that they be developed in a rigorous scientific manner. The good which can come from the appli cation of these assays will be hampered consider ably if the standardized validation process is not adopted soon. This process not only vali dates individual assays, but must involve inter test results and a comparison to relevant human experience when available. When one considers the cost of programs which are being proposed for implementation using these assays, surely the critical analysis suggested here will, in the long run, save millions of dollars and pre vent many useless debates over test utility and reliability. A program which includes critical analysis of existing data, establish ment of standard procedures, identification of proper statistical models and which requires examination of a minimal number of chemicals of diverse chemical classes for validation purposes, should be implemented, I believe, at the international level. This program 172 CMA 048056 should be so constructed as to engender parti cipation and support from industrial, govern ment and academic organizations, and have a broad base of information exchange." (Pro ceedings II 28-30 (emphasis added).) In response to OSHA question 28 calling for a full scientific discussion of short term tests, NIOSH stated: "For scientific purposes, justification of the use of short-term tests for the purpose of screening thousands of chemicals for their suspected carcinogenic activity and for the purpose of prioritizing these chemicals for long-term animal bioassay, appears to be ade quate. However, the original intent for uti lization of these tests was only for these two objectives and not for use of a confirma tion test for long-term animal bioassay. It is inappropriate at this time to attempt to substitute a short-term test for a long-term animal bioassay for at least two reasons: (1) Validation procedures are not complete and correlations between the test systems have not been adequately performed; and (2) The outcome of the short-term tests as compared to the long-term bioassay are not biological equivalents. In one case the end point is mutagenesis, in the other case, carcinogenesis. However, one (mutagenesis) may often cause the other (carcinogenesis)." The Clearinghouse on Environmental Carcinogens adopted a resolution on October 31, 1977 describing the role of short term tests as follows: "Notwithstanding the limitations imposed by the current state-of-the-art, there still appears to be an immediate, practical application for short-term assays. At present, microbial muta genicity assays offer a rapid and inexpensive approach to acquire information useful in select ing and ranking chemicals for long-term carcinogen bioassay. The concomitant or sequential use of - 173 - CMA 048057 DNA repair and mammalian cell transformation systems should enhance the selection process. Results from these short-term assays should eventually provide important information that may be useful in assisting in the evaluation of marginal data on carcinogenicity. It is recognized that short-term assays are still in the process of evaluation. Further, it is acknowledged that short-term assay data, by themselves, are inadequate to define the car cinogenicity or lack of carcinogenicity of a given chemical. Still, it is the sense of the Clearinghouse on Environmental Carcinogens that short-term assays are sufficiently developed to provide information useful in the selection of chemicals for carcinogen bioassay and in their later evaluation. It, therefore, is recommended that the Carcinogenesis Testing Program take the necessary measures to integrate short-term assays into the chemical selection and experimental design processes in a manner consistent with the tone and tenor of this resolution." Clearinghouse Resolution at 2. There was also general agreement that short term tests alone are not a sufficient basis at the present time for regula tory of a substance as a carcinogen. (Dr. Upton Tr. 289-290; Dr. Griesemer Tr. 946; Dr. Epstein Tr. 1412; Dr. Fishbein Tr. 1868; Dr. Brusick S. 16, Tr. 5011-5012; Dr. Lijinsky S. 25; Dr. Revson Tr. 4220; Dr. Skalsky Tr. 7592-7593; Dr. Lawrence Tr. 778-7779; Mr. Gibbons Tr, 7389-7390; Dr. Gottesman Tr. 7487.) EPA in its Interim Cancer Policy treats mutagenicity and _in vitro cell trans formation as only "suggestive evidence" of carcinogenicity. 41 Fed. Reg. 21404 (May 25, 1976). Similarly, the Subcommittee of the National Cancer Advisory Board concluded; "At present none of the short term tests can be used to establish whether a compound will or will not be carcinogenic in humans or experi mental animals. Positive results obtained in - 174 - CMA 048058 these systems suggest extensive testing of the agency in long-term animal bioassays, especially if there are other reasons for testing." NCAB General Criteria at 463. The same reasons which lead to the conclusion that short term tests alone are not a satisfactory basis for regula tory action, point to the conclusion that the tests should not be used as confirmatory evidence in the regulatory process. The tests are in various states of development with agreed criteria for conduct and evaluation of the tests only in the case of the Ames test. (Dr. Meselson Tr. 1471; Dr. McCann Tr. 1551-1552.) However, Dr. Golberg testified that the workshop last year con cluded that even the Ames test was not sufficiently standardized (Tr. 6550.) All of the tests are currently being validated. (Dr 1/ Upton Tr. 289-290; Dr. Rail Tr. 369; IARC Ex. 135 at 26-27.) The i_n vitro tests produce false positives and false negatives. (Dr. Bates Tr. 6455.) The mechanism of mutagenesis is believed 1/ Dr. Valcovic of NIEHS described the state of validation of such assays in an article entitled "Mutagenesis Test ing Program", 20 Environmental Health Perspectives 253 (1977)(AIHC P.H.) as follows; "Until recently, mutagenicity testing was done on preselected compounds in a manner in which the testing laboratories know the identity of the substances under test and the 'expected' results, i.e., positive for compounds selected because of their carcinogenicity and negative for food additives. There is no completed study in which substances were tested blind using a standardized protocol. Also, little attention has been placed on reproducibility and variability within and between laboratories. These aspects are currently under investigation in microbial systems by NCI but the results will not be avail able for 1-2 years." - 175 - CMA 048059 to be related to the mechanism of carcinogenesis in the cases where the substance (or metabolite) bind to the DNA. However, there is still great uncertainty about the mechanism even when DNA damage is involved and about whether the same mechanism is involved in mutagenesis and carcinogenesis. Dr. Greisemer concluded: "I think it is premature to attempt to utilize short term data as a very large component of the decision making process. At present I do not find short term tests very useful." (Tr. 946.) Dr. Epstein concluded that the Ames test should not be used for regulatory purposes. (Tr. 1412.) The Commissioner of the Food and Drug Administration summarized in the decision banning chloroform the reasons why short term tests are not an appropriate basis for regulatory action: "Regarding the reported findings of Uehleke in the 'Ames study,' which used a bacterial system, the Commissioner recognizes that rapid progress is being made in the devel opment of mutagenicity test sytems. He is aware of a number of reports indicating a mutagenicity-carcinogenicity correlation us ing these test systems. However, a number of 'false positives' as well as 'false negatives' have been observed in these test systems. Such tests using non-mammalian systems have not been validated for establishing correla tions and are not considered an appropriate basis for regulatory action." 41 Fed. Reg. 26842, 26843 (June 29, 1976). The conclusions of the International Agency for Research on Can cer are similar. (Ex. 135 at 26, 27.) - 176 - CMA 048060 Criteria and need for battery. If in the future short term tests are sufficiently validated and a correlation between the test results and carcinogenesis is established, criteria should be set out and a full battery of tests should be required. Dr. McCann recommended that a full battery of tests should be used. (Tr. 1562.) Dr, Fishbein recommended that sub stances should produce positive results in two types of tests be fore reliance can be placed on them: microbial and mammalian cell tests. (Tr. 1888.) Dr. Brusick also recommended that a battery of at least four tests would be necessary to reach a conclusion regarding genetic activity. (Dr. Brusick S. 15, Tr. 5014.) The CIIT workshop also recommended a battery of tests. (Workshop Proceedings II 3-4.) Dr. Furst-testified that a single positive test was not enough. (Tr. 6932.) Dr. Squire recommended that at a minimum a battery of tests be used. (Dr. Squire S. 9.) Dr. Rail urged OSHA to adopt criteria and guidelines for short term tests and recommended the "Guidelines" produced by the DHEW Committee to Coordinate Toxicology and Related Pro- 17 grams as a source for those criteria and guidelines. (Tr. 368 369, 457-462; see also Dr. Saffiotti Tr. 943-945.) The evalua tion criteria used by Litton Bionetics are set out in the con tract forms for the various tests. (Ex. 136.) 1/ DHEW Committee to Coordinate Toxicology and Related Programs, "Guidelines for the Laboratory Use of Chemical Substances Posing a Potential Occupational Carcinogenic Risk" (August 1978) (AIHC P.H.). - 177 - CMA 048061 Both Dr. Peto (Tr. 2593) and Dr. Brusick (S. 15, Tr. 5014) urged that, if OSHA is going to use results of short tern tests, criteria of mutagenicity should be established. Other wise experimenters will reach different conclusions from the same data and consistent results cannot be achieved. Criteria to evaluate inconsistent results in in vitro tests also need to be established. The Environmental Defense Fund also favored establishment of guidelines as criteria for short term tests. (Tr. 7348.) The IARC similarly recommended a battery of tests and criteria for their use: "The present state of knowledge does not per mit the selection of a specific test(s) as the most appropriate for identifying potential car cinogenicity. Before the results of a particular test can be considered to be fully acceptable for predicting potential carcinogenicity, cer tain criteria should be met: (1) the test should have been validated with respect to known animal carcinogens and found to have a high capacity for discriminating between car cinogens and noncarcinogens, and (2) when pos sible, a structurally related carcinogen(s) and noncarcinogen(s) should have been tested simultaneously with the chemical in question. The results should have been reproduced in different laboratories, and a prediction of carcinogenicity should have been confirmed in additional test systems. Confidence in positive results is increased if a mechanism of action can be deduced and if appropriate dose-response data are available. For optimum usefulness, data on purity must be given. ** * An adequate assessment of the genetic acti vity of a chemical depends on data from a wide range of test systems. The monographs include, therefore, data not only from those already - 178 - CMA 048062 mentioned, but also on the induction of point mutations in other systems, of structural and numerical chromosome aberrations, including dominant lethal effects, of mitotic recombina tion in fungi and of sister chromatid exchanges." (Ex. 135, at 27 (footnotes omitted).) The CUT workshop discused supra, at 168 similarly recommended a battery of tests and urged that criteria be es tablished for those tests. As noted in the earlier section, we believe short term tests should be used only as screens for further testing and prioritization of future testing. When short term tests have been validated and shown to be accurate predictors of car cinogenesis ; 1. The tests which can be used should be identi fied and supporting validation supplied. 2. The battery to be used should be specified. 3. Criteria for the tests and for evaluation of results should be established. 4. Replication of the tests should be required. 5. Before relying on short term test results, an evaluation by geneticists and toxicolo gists with experience in short term tests should be performed. 13. Route of exposure The record is clear that route of exposure is an essential element to be considered in the extrapolation of human risk from animal data. (Dr. Upton Tr. 324-325; Dr. Rail Tr. 485; Dr. Kennedy Tr. 579-580; Dr. Griesemer S. 8, Tr. 957-958; Dr. Claus S. 40; Dr. Gross Tr. 8315-8317, 8323.) Perhaps the most complete statement regarding the significance of the - 179 - CMA 048063 route of exposure in the evaluation of animal data and the extrapolation to human risk was by NIOSH: "Another consideration in evaluating a predic tive model for human carcinogens is the route of administration. Although the route of ad ministration might not be important in deter mining whether or not an agent is carcinogenic for research purposes, it is important from a preventive health standpoint. To properly evaluate carcinogenicity, the suspect agents should be administered to animals by the same routes as humans are exposed, namely, via the lungs, gastrointestinal tract, dermally and subcutaneously. The latter condi tions would apply, for example, to those agents such as metal fragments that might become embedded in skin or muscles. In industrial exposures to particulates, oral exposures are frequently as important as pulmonary exposures in as much as the parti culates that are trapped in the upper res piratory tract are usually swallowed." (NIOSH first answer to Q. 31; see also answer to Q. 1(a).) Many witnesses (Dr. Rail Tr. 485; Dr. Van Duuren S, 5; Dr. Claus S. 40) expressed serious reservations concerning the use of animal data except for qualitative purposes where the route of exposure of man is different from that in an animal 1/ experiment. The importance of the same route of exposure for humans and in animal experiments was emphasized by the NAS: "Before extrapolation is attempted, consider able attention must be given to the appropriate ness of the experimental data. Bioassay proce dures must be of high quality in order to avoid 1/ NIOSH points out the difficulties when the route of exposure used in an animal experiment is different from that by which man is exposed in the workplace. However, such a test may yield valid qualitative data. In evaluating human risk from a different method of exposure each case would have to be evaluated individually. (NIOSH first answer to Q. 6 and second answer to Q. 6(b)). - 180 - CMA 048064 misleading risk estimates. Also oral administra tion of the carcinogen is necessary because we are concerned with estimating the risks associ ated with drinking water consumption." Id. at 48-49 (emphasis added). The scientific reservations as to the risk assessment for man when the human route of exposure is different from that in animal experiments means that OSHA should be reluctant to regulate where the animal data are not relevant to the human route of exposure until there is, as Dr. Rail proposed, a risk assessment defining as precisely as possible the magnitude of the risks and defining the uncertainties in the estimate. (Tr. 456-457.) C. OSHA Is Correct In Rejecting Structure Similarity And Physical Induction Such As Tnjection Site Sarcomas As Bases For Regulatory Action 1. Molecular structure or similarity In the Preamble to the Proposed Regulation, OSHA sets out the reasons for concluding that structure similarity between known carcinogens and an untested substance does not provide a basis for regulating the untested substance as a carcinogen. 42 1/ Fed. Reg. 54168. OSHA's conclusion is supported by the record. While two witnesses thought that investigators with years of experience and research could arrive at a conclusion 1/ The issue is not whether structure similarity would be considered along with other data in evaluating a particu lar substance. Numerous witnesses listed structure as one factor to be included in the evaluation. The issue dis cussed here is whether structure similarity is a valid basis for classification. - 181 - CMA 048065 that on the basis of structural similarity a compound is likely 1 to be carcinogenic (Drs. Van Duuren and Fishbein Tr. 1825-1828), a number of witnesses testified that structure similarity is not a valid basis for classifying a substance as a carcinogen. E.g., Dr. Lijinsky Tr. 1048; Dr. Meselson Tr. 1526-1528; Dr. Weinstein S. 9; NIOSH answer to Q. 29; Dr. Hart Tr. 3467-3468; Dr. Furst S. 27-29, Tr. 6932, 6943; Dr. Holmberg S. 4. In EPA's Interim Cancer Policy chemical structure is included in the risk assessment among "ancillary reasons which bear on judgments about carcinogenic potential." 41 Fed. Reg. 21404 (May 25, 1976). Others described structure similarity as useful for prioritization for further testing. (Dr. Rail Tr. 446; Dr. Weinstein Tr. 2273-2275; NIOSH answer to Q. 29.) 2. Injection site sarcomas and other instances where induction due to physical causes, e.g., implants, stones or calculi In the Preamble, OSHA discusses the reasons why parti cular routes of exposure should not be considered applicable to man: injection site sarcomas and other instances where there is reason to believe the tumors that occurred may not be due to a specific effect of the compound, e.g., bladder implant. 42 Fed. Reg. 54164. We believe the record supports the conclusion that tumors induced by the physical damage at injection site or the physical action from an implant do not provide an adequate 1/ According to Dr. Fishbein "hundreds" of chemicals could be identified as probable carcinogens on the basis of structure similarity. (Tr. 1829.) - 182 - CMA 048066 basis for extrapolating the risk to man. (NIOSH answer to Q. 6 (b); Dr. Rail Tr. 484; Dr. Furst Tr. 6925.) The same reasons should apply to other instances where the induction is from physical causes such as stones or calculi. (Dr. Rail Tr. 455; Dr. Roe S. 68; Dr. Grasso S. 3.) The same principles should lead to rejection of test results where the lesion is due to "secondary carcinogens" and organ damage, supra at 133-137. Conclusion It is apparent from this discussion that the scientific knowledge of carcinogenesis is far from complete; it is also apparent that significant advances in knowledge are being made almost daily. It behooves OSHA, therefore, to structure a regu lation so that it acts always on the basis of the "latest avail able scientific data in the field." 29 U.S.C. 655(b)(5). It is apparent, moreover, that carcinogenesis is a com plex area and that no simple or simplistic statement can serve as a satisfactory summary for regulatory purposes. Prior to the issuance of its Interim Cancer Policy, EPA published first 9, later 16, and later 17 "principles" of carcinogenesis drafted by Dr. Saffiotti. These "principles" were widely criticized and on November 10, 1975, the NCAB subcommittee discussed these "principles" which Dr. Saffiotti described as "a sort of personal and somewhat informal summary of state of the art of points that - 183 - CMA 048067 1/ had been previously debated and discussed in great detail." The NCAB subcommittee, after discussion, concluded that the "principles" were not "an adequate definition of a carcinogen for use by a regulatory agency for regulatory pur- 27 poses. " The 17 principles rejected by the NCAB subcommittee bear a striking resemblance to the "Policy Determinations" and "Concepts" on which OSHA relies in the Preamble. Appendix E of this brief is a tabular comparison of the "principles" and 1/ Proceedings National Cancer Advisory Board Subcommittee, November 10, 1975, at 23. (These proceedings were filed with NACOSH at the time the draft of this Proposed Regu lation was being considered-by NACOSH.) 2/ A motion was made by Dr. Weinstein with references to the "principles" as follows: "DR. WEINSTEIN: Is a motion in order? DR. SHUBIK: Yes. DR. WEINSTEIN: I would move that the draft by Dr. [Umberto] Saffiotti, titled 'Statements on Principles of Chemical Car cinogenesis in Relation to the Evaluation of Carcinogenic Hazards,' be considered as a useful background for discus sions on the definition of a carcinogen, but that we do not feel that it is an adequate definition of a carcinogen for use by regulatory agencies for legislative purposes. This Committee should, therefore, consider de novo the problem of deriving a definition of carcinogen and that if necessary a subcommittee of this group, recruiting additional exper tise, be appointed for this purpose. DR. SHUBIK: Thank you. Do we have a second to that? DR. NELSON: I second it. DR. SHUBIK: All in favor? (There was a chorus of "Ayes".) (Proceedings at 28.) - 184 - CMA 048068 the "determinations" and "concepts". Two examples illustrate the similarity. Principle Policy Determination or Concept 12. "Since many benign tumors can develop into cancers, for the purposes of carcinogenicity testing there is no valid distinc tion between the induction of benign or malignant tumors and they should be considered synonymous." OSHA "proposes to place as much weight on an experiment in which only benign tumors are observed, as upon experiments in which both malignant and benign tumors are induced." (42 Fed. Reg. at 54163-54164) 15. "There is no scien tific basis for the exis tence of a "no effect" level for carcinogens. In principle no dose of a chemical carcinogen is too small to induce tumors in susceptible individuals." "[A] no-effect or threshold level may theoretically exist for any specific carcinogen. As yet, however, there is no satisfactory scientific basis for determining such levels for any given popula tion. Thus, as has been proposed any human exposure to a carcinogen '. . . would be considered by OSHA to present a potential cancer risk as a policy matter." (42 Fed. Reg at 54174) Elizabeth Anderson, Executive Director of EPA's Carcino gen Assessment Group, in a recent speech traced the history of EPA's 17 principles. She explained that the agency had decided to establish a Cancer Review Group with a two-step approach to regulation, rejecting the 17 principles because "[s]uch a simpli fied approach received broad and general criticism by the scien tific community, a substantial part of the private sector and the 1/ Congress." 1/ E. Anderson, "Risk Assessments and Regulatory Approaches to Carcinogens", presented at the Symposium on Risk/ Benefit Decisions and the Public Health Third FDA Office of Science Symposium, at 2 (February 15, 1978). - 185 - CMA 048069 The reasons which lead to the rejection of the EPA principles as a basis for regulatory action are equally appli cable to the "Policy Determinations" and "Concepts", which bear 1/ a striking similarity to the rejected "principles". AIHC submits that its Alternative minimizes the errors outlined above and offers a reasonable, workable basis for regu latory action based on the "latest available scientific data in the field." 1/ For the same reasons the "principles" proposed by NRDC (NRDC S. 18-19) which were patterned on the EPA prin ciples do not provide an adequate basis for regulatory action. 186 CMA 048070 IX THE PROPOSED REGULATION WOULD IMPERMISSIBLY "FREEZE" THE PRESENT STATE OF RELEVANT SCIENCE BY FORECLOSING RECONSIDERATION OF THE VALIDITY OF THE CLASSIFICATION SYSTEM AND OTHER POLICY ISSUES IN RULEMAKINGS ON INDIVIDUAL SUBSTANCES, AND BY ERECTING UNREASONABLE BARRIERS TO OSHA'S OWN CONSIDERATION OF RELEVANT NEW SCIENTIFIC DEVELOPMENTS "I feel that the criteria proposed by OSHA for classifying chemicals into Categories I, II and III are somewhat too rigid, and that the preamble introducing then does not adequately reflect the complexity of the processes involved in chemical carcinogenesis. ... If regulations are to be rational, they should be firmly based on up-to-date scientific knowledge." (Dr. Farber S. 1-2.) Section 6(b)(5) of the Act requires that OSHA formu late standards dealing with toxic materials or harmful physical agents "on the basis of the best available evidence," including "the latest available scientific data in the field." 29 U.S.C. 655(b)(5). Despite this statutory mandate, OSHA proposes, once its generic standard is promulgated, to foreclose consi deration of scientific and other evidence by preventing the introduction in subsequent individual rulemakings of evidence concerning the "validity of this classification system and most other policy determinations made in this proposal, including the procedural structure intended to be followed." 42 Fed. Reg. 54154. Such a "freezing" of scientific and other evidence as of the date of the promulgation of the generic standard is clearly improper and a violation of the Act. Moreover, by foreclosing discussion of the underlying issues in subsequent Section 6(b) rulemakings, OSHA will deny to - 187 - CMA 048071 affected parties their legal right under both the Administra tive Procedure Act and the due process clause of the U.S. Con stitution to comment upon these issues as they relate to speci fic toxic substances. This issue is discussed more fully in the portion of this brief dealing with OSHA's lack of authority to establish generic rules where an inflexible set of regula tory consequences automatically flow from the classification. See discussion supra, at 44-51. It is particularly inappropriate to preclude consider ation of newly available evidence or data in a field which is undergoing as rapid an evolutionary change as the study of the causes and mechanisms of cancer. The testimony of a number of witnesses explored the ongoing or expected development of major 1/ advances in carcinogenesis reasearch and theory. See, e.g., Dr. Hart Tr. 3457-3458, 3468-3469; Dr. Snyder Tr. 4696-4697, 4734-4735; Dr. Yang Tr. 6799-6827; Dr. Rogers Tr. 8585; Dr. Kotin Tr. 8751-8753. Many of these witnesses testified that it would be improper, unwise, and indeed, arbitrary and capri cious, for OSHA to ignore these developments by foreclosing consideration of the factual premises and policy grounds on which its generic standard is based; premises and policies 1/ In addition to those areas of research discussed earlier in the brief, one such area is immunotherapy research. See J. Kuahenbul and J. Remington, "Belligerent Blood Cell: Immunotherapy and Cancer," Human Nature 52 (January 1978) and W. Stockton, "A New Clue in the Cancer Mystery," The U.S. Times Magazine 18 (April 17, 1978) (AIHC P.H.). 188 CMA 048072 which even if valid today could become obsolete in the very near future. See, e .g. , Mr. Gideon Tr. 3050-3051; Mr. Dominguez Tr. 3924-3925; Mr. Janous Tr. 4114-4115; Mr. Woolrich Tr. 4231, 42964298; Dr. Synder Tr. 4683-4684. The need for consideration of all relevant evidence in the development of a rational approach to the regulation of carcinogens was constantly stressed during the course of the hearings, as was the need for providing a means by which the regulatory scheme can be modified to include new in formation as it becomes available. See, e .g., Dr. Hart Tr. 3469 , 3484; Dr. Thorpe Tr. 4582; Dr. Swanson Tr. 4597-4598; Dr. Synder Tr. 4696-4698.) Glen Schweitzer admonished OSHA (Tr. 7112) to heed the words of caution issued by the court in Ethyl Corp. v. EPA, 541 F. 2d 1 (D.C. Cir. 1976 k: "By its nature, scientific evidence is cumulative: the more supporting . . . evidence available, the more likely the accuracy of the conclusion." 541 F. 2d at 38. However, OSHA proposes not only to foreclose consider ation of newly available evidence presented by employers subject to regulation in the individual rulemakings conducted pursuant to Section 6(b) of the Act; it also intends to erect formidable bar riers to its own ability to take advantage of improvements or developments in relevant learning by preventing modification in proceedings on individual substances of the scientific princi ples administratively adopted in this generic rulemaking pro ceeding. Mr. Wrenn testified that the objective of the Pro posed Regulation is to identify and establish generic policy - 189 - CMA 048073 determinations. (See Wrenn S. 8, 9, 12 for examples of "generic" policy determinations.) When the policy considerations of a "generic" nature are made, no evidence contradicting those admin istrative conclusions would be admissible in individual substance rulemaking. Thus, for example, in a subsequent rulemaking strong evidence of a threshold would not be considered; the policy deter mination that there is no safe level would prevail. (Mr. Wrenn Tr. 148-149, 151.) EPA, on the other hand, testified that "we believe that opportunity should always be available for presenta tion of substantial genuine new evidence." (EPA S. 9, Tr. 2361.) In contrast, under the OSHA proposal such new evidence would only form the basis for a petition to amend the generic regula tion, but until that amendment was made, the evidence would not be receivable despite its strength or validity. (Wrenn Tr. 148151.) This time-consuming and ponderous mechanism for incor porating into the regulatory standards newly available evidence or data concerning heretofore unresolved issues surely does not satisfy OSHA's obligation to premise its standards on "the best available" and "latest available" evidence in the field. The AIHC proposal, on the other hand, "proceeds on the basis that if a categorical approach is desirable and necessary to enable OSHA to deal effectively with potential carcino gens, there is still no statutory authority-- or need--to preclude interested parties from presenting evidence, with respect to any parti cular chemical, to counter any conclusion of carcinogenic risk that might otherwise be 190 CMA 048074 drawn on the basis of the general principles on which the OSHA proposal intends to rely." AIHC Alternative at 29. AIHC's Alternative, unlike the Proposed Regulation, provides a mechanism by which all relevant evidence of new scientific developments will be considered in determining appropriate cate gorization and regulatory responses to particular substances. The Data Evaluation and Classification Panel recommended by AIHC could, from time to time, propose revisions of the cate gorization scheme or its criteria, in light of the latest sci entific advancements, newly available information, or knowledge derived from experience with the categorization scheme. In addi tion, reasonable public notice of intent to make such changes would be provided, in accordance with the Administrative Proce dure Act, as well as an opportunity for interested persons to comment on such changes. See AIHC Alternative at 60-61. Further, the AIHC Alternative would permit any interested party to peti tion the Panel for reclassification of a chemical on the basis of significant data or scientific learning not considered at the time of prior classification. See AIHC Alternative at 69-70. The absence of provisions such as these in OSHA's proposal will prevent the agency from complying with its statutory obligation to consider the "best available" and "latest available" scienti fic evidence. - 191 - CMA 048075 X CATEGORY IV SHOULD BE ELIMINATED BECAUSE OSHA LACKS STATUTORY AUTHORITY TO CREATE IT AND BECAUSE IT IS OTHERWISE UNWISE AND INAPPROPRIATE _________ The Proposed Regulation would require OSHA to publish a Category IV list of substances which meet its definition of toxic substance but which are "not found in the American work place ." It is our view that OSHA lacks statutory authority to create such a list and that it would serve no useful purpose within the context of this rulemaking. Furthermore, the arbi trary inclusion of substances on such a list could unnecessarily inhibit technical innovation, cause unwarranted damage to foreign industry, establish a new non-tariff barrier to chemical trade and potentially affect adversely our relations with foreign countries. This view was expressed by numerous participants in these proceedings (e.g., AIHC International Committee comments) including NIOSH, which stated in its written submission: "We do not recommend a Category IV in this classification system since U.S. workers would not have the potential for exposure to these agents and hence they would fall beyond the regu latory responsibility of OSHA as we understand it. Should these substances enter the U.S. workplace, they would automatically become eligible for classification into Categories I, II or III." (NIOSH S. 3.) See also Environmental Defense Fund S. 10 recommending that Category IV be eliminated. - 192 - CMA 048076 A. QSHA Lacks Statutory Authority To Establish Category IV OSHA lacks any authority to classify or to regulate toxic substances which are not currently found in and may never enter American workplaces. The Act grants to OSHA the authority to assure safe and healthy working conditions only in the domes tic workplace. In enacting the Act, Congress declared its purpose to be "to assure so far as possible every working man and woman in the Nation safe and healthful working conditions." 29 U.S.C. 651(b) (emphasis added). Section 4 of the Act states that it applies only with respect to employment performed in a State, the District of Columbia, and various U.S. territories and possessions. This statutory grant of authority does not extend to substances which have not yet entered the American workplace. Where Congress intended to vest an agency with such authority, it has expressed that intent in clear statutory language. Such is the case, for example, with the Toxic Substances Control Act ("TSCA"). 15 U.S.C. 2601 et. seq. Absent explicit authoriza tion in the Act to classify toxic substances which are not cur rently found in any American workplace, such authority cannot be implied in OSHA. B. OSHA's Resources Could Be More Effectively Channeled OSHA suggests that the listed foreign toxic substances may become subject to future regulation if they are introduced into American workplaces, and notes that OSHA intends to enter - 193 - CMA 048077 into an agreement with EPA with respect to implementation of the TSCA so that if such substances are introduced into the American workplace OSHA will be able to develop an appropriate standard. 42 Fed. Reg. at 54169. OSHA therefore apparently recognizes that TSCA is the appropriate vehicle for monitoring the introduction of poten tially toxic substances into the American workplace. The pro visions of Section 5 of TSCA, 15 U.S.C. 2604, regarding premanu facturing and preimportation screening for new chemicals are ade quate to enable EPA to monitor and obtain information concerning toxic substances before they are introduced into American work places. There is certainly no demonstrated need for OSHA to blacklist such substances before they have been subjected to the screening mechanism which Congress has established for that purpose. To follow the course of action suggested by OSHA would be a poor allocation of precious resources that could better be channeled to regulate substances already found in the domestic workplace. To the extent that the purported purpose of this generic rulemaking is to make the regulatory process more effi cient, the proposed Category IV provision does the opposite. C. There Is A Strong Possibility That The Decision To Classify A Substance In Category IV Could Be Arbitrary And Without Due Process OSHA states with regard to the listing of foreign toxic substances that "OSHA does not intend to review the evi- - 194 - CMA 048078 dence concerning carcinogenicity at [the] time [of listing]." 42 Fed. Reg. 54169. OSHA thus proposes to add substances to this list simply on the basis of unevaluated studies, whether or not they are scientifically sound. Witness after witness at the hearing has cautioned that studies are often of very uneven quality ranging from worthless to exceptional. To use unevaluated studies for the intended purposes can lead to inumerable problems. This is further complicated by the fact that the pro cedures OSHA contemplates utilizing will be "without the formality of rulemaking, per se." 42 Fed. Reg. 54173. Because the al legedly toxic substance will not be used in the United States at the time of classification, all of the regulatory activity could unfold without any substantive review of the evidence concerning carcinogenicity. As a result, there is a strong possibility that the decision to classify a substance in Cate gory IV could be wholly arbitrary and without due process. D. Listing A Substance In Category IV Hay Create Misconceptions With Many Unintended Adverse Effects Blacklisting a substance may create misconceptions among the public and press which, even if mistaken, are difficult to correct. The public and press misunderstanding of the NIOSH List of Suspect Carcinogens is an example of how lists such as these can create problems. Condemnation of a chemical product by listing it will certainly adversely affect the U.S. market for that product and will deter both domestic and foreign - 195 - CMA 048079 companies from engaging in further development of that product, often without justification for such actions. Such a classi fication will also discourage a foreign company from exporting the substance to the United States. Category IV classifications have the clear potential to cause considerable problems with foreign industry and governments. The likely foreign view would be that a U.S. government agency has seen fit to blacklist prod ucts not found in the United States, over which that agency has no jurisdiction or statutory mandate, without making a careful review of the evidence. Indeed, this may be viewed by some as a non-tariff trade barrier to exclude potentially competitive products from the American market. Conclusion Rather than create a Category IV list, the authority for which is non-existent, and the wisdom of which is doubtful, OSHA should enter into an agreement with EPA whereby EPA will inform OSHA of the introduction of substances which might meet its definition of toxic substances into the American workplace. When and if such a substance is introduced into the U.S. work place, OSHA can take appropriate action. - 196 - CMA 048080 PART THREE XI QUANTITATIVE RISK ASSESSMENT IS ESSENTIAL TO A DETERMINATION OF THE REASONABLE NECESSITY OF A REGULATION____________ "It [OSHA] contends the standard promises appreciable benefits at a cost which indus try can absorb. This justification is de ficient in one crucial way: substantial evidence does not support OSHA's conclusion that benefits are likely to be appreciable. Without an estimate of benefits supported by substantial evidence, OSHA is unable to justify a finding that the benefits to be realized from the standard bear a reasonable relationship to its one-half billion dollar price tag." 1/ "There is needed some simple measure of cost and benefit that would make widely different risk situations comparable so as to attempt to maintain, in different areas, roughly similar standards for spending government and indus trial funds to save lives. Without such a standard, as economists will sense immediately, cancer-avoiding expenditures cannot be spent efficiently. And, in addition, the public will have the greatest difficulty distinguish ing minimal risks from large ones." 2/ "The societal need must be balanced against the estimated risks to society, for this is the only way any rational decision may be made. With the plethora of synthetic organic chemicals in use today, it will be a major task to develop the data base to allow risk estimations. But it must be done, for how can society intelligently 1/ The Benzene decision, ____ F.2d at 91. 2J Federation of American Scientists, "Public Interest Report," at 7, May 1976. - 197 - CMA 048081 regulate chemicals which pose human benefits and human risks without having an estimate of the risk?" 1/ (Emphasis supplied.) "We believe that a risk assessment using the best data and techniques available, is needed as part of an adequate regulatory analysis." 2/ In the Preamble to the Proposed Regulation OSHA dis cussed briefly the matter of quantification of risk. 42 Fed. Reg. 54167. In that discussion OSHA proposes that quantification of risk be applied, if at all, only at the point of determining the feasibility of the regulatory provision of a particular standard, 3/ not to risk as determined by the classification system. Id. OSHA concluded its brief discussion with a request for comments on the question of whether quantitative risk estimate should be made and, if so, the methods to'be employed in the standard set- 1/ Dr. David P. Rail, "The Role of Laboratory Animal Studies in Estimating Carcinogenic Risks for Man," at 12, November 30, 1977. Appendix B to Dr. Rail's statement. 2/ Regulatory Analysis Review Group, Council on Wage and Price Stability, Report on OSHA Proposed Permanent Standard on Acrylonitrile, at 4, May 22, 1978 (Ex. 45). 3/ It is important to note that the term "risk" is used in the Preamble with two different meanings: qualitative human risk and quantitative human risk. A full scientific evalua tion of human and animal data must address a determination not only of qualitative but the methodology of quantitative risk assessment to man. Under the OSHA proposal a substance will be classified in OSHA Category I prior to the scientific evaluation of the data, particularly animal data, to determine its relevance to human risk. Thus metabolic, physiological and other differences between man and the test animal is considered after classification. Under the AIHC Alternative, the qualitative risk and quantitative risk to man is assessed by the Data Evaluation and Classification Panel as part of the classification process. - 198 - CMA 048082 ting process on a particular substance. Id. A. Risk Assessment And Quantification Are Necessary Components Of Regulatory Decisions________ The Benzene decision provides a clear answer to the question OSHA posed. OSHA must provide a reasonable estimate supported by evidence to demonstrate that "neasureable benefits will result." ____ F.2d at 91. The court specifically rejected OSHA's speculation that the benefits "may be appreciable" based on the assumption that exposure to benzene was unsafe at any level and that lower levels would be safer than higher levels. The court recognized the logic of OSHA's speculation but held that "[T]his finding and deduction, however does not yield the conclusion that measureable benefits will result. . . Aqua Slide requires OSHA to estimate the extent of expected benefits in order to determine whether these benefits bear a reasonable relationship to the Stan dard's demonstrably high cost." ____ F.2d at 91-92. Without a risk assessment there can be no determination of the measureable benefits, the indispensible predicate for regulatory action. The record also provides a clear answer to the question 1/ OSHA posed: identification of the techniques for quantification 1/ We shall discuss in another section of the brief what factors other than risk estimations OSHA should take into account in determining the level of control (see infra, (Footnote continued on p. 200) - 199 - CMA 048083 of the risk is an essential element of the scientific evaluation and risk quantification should be used by OSHA in the hazard analysis and in the regulatory determination of the degree of 1/ control appropriate to a particular substance. Dr. Upton, Dr. Rail, Dr. Kennedy, the witnesses for EPA and numerous other witnesses urged OSHA to make a quantitative risk assessment. Dr. Van Duuren testified that there are scientific bases for making a risk assessment and agreed that such an assessment should be made by OSHA. (Tr. 1879-1880.) Dr. Albert has expressed the view that the failure to provide for risk quantification in the Proposed Regulation is a defect which "could in the long run seriously jeopardize the Federal regulatory effort against car cinogens," (EPA Intra-Agency Memo from Dr. Roy Albert to Andrew Breidenbach, dated November 25, 1977, (API P.H.).) The method ology of an assessment of relative risks was discussed by Dr. Wilson, Professor Zeckhauser and Professor Lave. EPA and FDA routinely make risk assessments and examples of these quantitative risk assessments are in the record. (Ex. 38, API P.H.) Other exhibits discuss the principles of, and ex amples of, risk assessment. (Exs. 13, 43, 45, 78, 85). The (Footnote continued from p. 199) at 215); in this section of the brief we are addressing the issue of risk assessment and the elements and methods involved in such an assessment. 1_/ A risk quantification is implied in the OSHA proposal to identify suitable substitutes; unless a comparative risk analysis were made, OSHA would have no way of knowing whether it was increasing or decreasing the risk from use of the substitute. 200 CMA 048084 quantitative risk assessment methods used by the NAS/NRC are set out in considerable detail in the chapter entitled "Chemical Contaminants, Safety and Risk Assessment" in the NAS Drinking Water Study. See Dr. Rail S. Appendix I. We believe it would be difficult to state more suc cinctly or persuasively the need, despite the uncertainties, for such quantitative risk assessment and hazard evaluation than was set forth in the Work Plan of the Risk Assessment Group of the IRLG of which Dr. Bingham is a member: "1, Introduction - A common objective of the four agencies is the assessment of human health risks associated with chemicals, devices, consumer goods, etc. to which the population of the United States is exposed in a variety of ways. In general the goals of risk assessment are to characterize the types of health hazards that may result from such exposures and to quantify the expected risks. For the present, the Work Group intends only to treat the problems associated with health risks due to chemicals. It is in this area that the greatest commonality of purpose exists among the agencies. Moreover, it is the area in which the greatest con fusion now exists, not only among the public, but also within the regulated industry. It is also the subject presenting one of the greatest oppor tunities for success-achievement of the broad ob jectives of the IRLG. 2. The Scientific Problem. - Characterizing and quantifying health risks are scientific tasks. The data necessary to accomplish such tasks derive from toxicity testing and/or epidemiological studies. * Because of serious gaps in scientific knowledge, there are often alternative and conflicting views of the risks associated with chemicals to which people can be exposed. The Risk Assessment Work Group will examine the available scientific tools used in such assessments and select for use by the four agencies those currently having the strongest - 201 - cMA 4808s experimental and theoretical support. Unless selections of these types can be made and agreed upon, conflicting views of risk will continue to cloud regulatory decision-making. 3. Role of the Policy-Maker - Whether a par ticular type or level of risk may have to be accepted in certain circumstances is a policy decision, but this issue should not become entangled with the scientific problem of risk measurement. *** 4. Need for Uniform Procedures and Criteria The public and the regulated industry are ill-served when the agencies assess risk in different ways. Policy decisions made by the four agencies on the degree of acceptable risk in different circumstances create substantial confusion (in part brought about by differences in legal mandate and inter pretation) and this confusion should not be compounded by differences in approach to the scientific assessment of risk. 5. Task of the Work Group - An objective of the Work Group might be the development of systems to insure that the agencies routinely work to gether to conduct risk assessments on specific substances of mutual interest. However, the Work Group holds that such an objective is far less important than the broader one of developing and selecting general procedures and criteria for risk assessment that can be uniformly applied to all chemicals regulated by the agencies, including those substances for which only one agency is responsible. Until the rules for risk assessment are clearly laid out and agreed upon, efforts to reach a consensus on the type and degree of risk associated with specific substances of mutual concern will in many instances be thwarted. Furthermore, in the absence of uniform criteria and procedures, the risks associated with chemicals that are the responsibility of only one agency will continue to be estimated in a different manner than those associated with chemicals regulated only by a second agency. This undesirable situation will not be remedied if the task of the Work Group is limited to the joint conduct of risk assessments on substances of mutual interest. 202 CMA 048086 6. Output of the Work Group - Several projects are envisioned (Section IV). Out of each will cone a document detailing a set of procedures and criteria that can be adopted by each agency as acceptable for assessing risk. After appropriate internal review, these documents will be jointly published in some form and will become part of the scientific operations of agencies. *** Of the several types of health risk projects that could be undertaken by the Work Group, a project on cancer risk assessment presents the highest probability for relatively short-term, successful accomplishment. A good portion of the necessary background documenta tion and study has been done, and the remaining tasks of bringing together the necessary information and making selections among the available approaches to carcinogenesis risk assessment should prove relatively straightforward. *** RA 1.3 - Procedures for Quantifying Carcinogenic Risk Output: Procedures for treating available doseresponse relationships to estimate risk at expected or known levels of human exposure. Task - The subgroup will survey the risk estima tion procedures currently in use by the agencies. Reasons for the use of specific procedures, including relevant legal matters, will be detailed. An updated review and discussion of all current mathematical models will be undertaken, including consideration of time-to-tumor analyses as a preface to the final selection of a model(s). The final document will include procedures for combining data from several experiments, use of human data, and modifications based on metabolic and kinetic data." 43 Fed. Reg. 7195-7197 (February 17, 1978). B. The Prevalence of Uncertainties Underlines The Need For Risk Quantification So Far As Possible There can be no doubt that there are uncertainties associated with risk assessment, as virtually all witnesses - 203 - CMA 048087 pointed out, but the record shows that the existence of uncer tainties should not lead to the nihilistic conclusion that no risk assessment should be attempted. There are uncertainties associated with all scientific matters; as Dr. Rail emphasized, scientists are dealing in probabilities, not certainties. (Dr. Rail S. 14.) Dr. Wilson and Professor Lave urged that the existence of the uncertainties makes a risk quantification and hazard evaluation more urgent and necessary. (Dr. Wilson Tr. 3364-3372; Dr. Lave Tr. 7002.) To the extent that any elements in the risk assessment can be quantified, the elements which must be evaluated by judgment can be identified and the decision made easier. Id. Underscoring these points, Dr. Lave emphasized strongly that a careful quantification of risk and benefits is the only rational way to speed up the administrative process. (Tr. 70007003.) It is only by this process that the issues can be sharp ly defined so that testimony at the hearings will be directed at the areas of uncertainty, thus speeding up the administrative determination. Id. Sheldon Samuels (AFL-CIO) testified that risk analysis is improving in accuracy and indeed proposed a permit system for the most "virulent" carcinogens in OSHA Category I. (Tr. 7256-7257, 7270-7274, 7290, 7300.) Any such distinction between carcinogens must of necessity be based on a risk analysis, as Mr. Samuels recognized. (Tr. 7300.) - 204 - CMA 048088 C. Animal Data May Be Used For Quantitative Risk Assessment AIHC believes that the record shows that animal test results, properly done and evaluated can provide a valid basis on which to assess the risk to man. As Dr. Kennedy said: "Animal tests may be used to predict within confidence limits human risks. The hypothesis is tested by going through the exercise of making some human risk predictions and then turning to human data and assessing whether the predictions are accurate." (Tr. 505.) Dr. Rail discussed this problem and expressed the view: "There is very good general correlation between the carcinogenic activity of chemicals in animals and that in humans." (Dr. Rail S. 8.) 1/ After reviewing several studies in which comparisons were made between the response of animals and the response of humans to particular substances, including an NAS study entitled 1/ "Contemporary Pest Control Practices and Prospects," (Dr. Rail S. 8-11), Dr. Rail concludes: "Weighing all this evidence, it appears that carcinogenic responses of animals can be used both qualitatively and quantitatively to predict carcinogenic risks in humans." (Dr. Rail S. 10.) Similarly, Dr. Upton described the information necessary in assessing the risk as including the relative potency of the 1/ In addition to the studies referred to by Dr. Rail, Dr. Meselson described his efforts to find correlation among in vitro results and the reaction of animals and man. (Tr. 1492-1497.) 2/ Appendix H to Dr. Rail's testimony. - 205 - CMA 048089 carcinogen and the mechanism of action of the carcinogen. (Tr. 1/ 267-268.) While there are uncertainties, he concluded - and recommended - that a quantitative risk assessment should be part of the regulatory decision on the level of control. (Tr. 268- 269, 296-297; see also IARC Ex. 135, at 20.) D. Interchangeability Of Carcinogens Has Not Been Demonstrated Several witnesses raised objections to a risk assess ment, arguing that carcinogens are interchangeable and all ex posures are additive. Dr. Hoel and Dr. Peto acknowledged that the supposed interchangeability of carcinogens was merely an assumption. (Dr. Hoel Tr. 2133; Dr. Peto Tr. 2513, 2512.) The record clearly establishes that -there are no experimental or human data supporting a general assumption that exposure to submanifestational doses of several carcinogens either simul- 1/ taneously or sequentially is additive. (Dr. Stewart Tr. 620-621; Dr. Saffiotti Tr. 928-929; Dr. Greisemer Tr. 928-929.) The record does demonstrate that both in animals and in human experience (smoking and asbestos and smoking and radon) there are instances of additive or synergistic action between carcinogens or between a carcinogen and a potentially carcino genic substance. However, this is far from a demonstration that 1/ Dr. Bates said that quantification of risk included con sideration of potency. (Tr. 608-610.) 2/ See also the discussion by Dr. Mantel on the lack of -- evidence for the interchangeability of carcinogens set out in a letter attached to the statement of Dr. Gross. 206 CMA 048090 cancer is a "multifactorial disease", in the sense that some use the term, and that exposure in the workplace is additive to the cancer burden from exposure to environmental carcinogens from diet, lifestyle, etc. On the contrary, the record shows that in many instances subtances are inhibitory and indeed that some carcinogenic substances inhibit other carcinogenic substances. (Dr. Kaufman S. 21? Dr. McLean Tr. 4824, 4825? Dr. Kotin Tr. 8691.) This inhibitory action of one carcinogen on another is the basis of many drugs used in chemotherapy. Exhibit 42 contains a discussion of inhibitors of carcinogens. Several witnesses testified to the inhibiting effects of Vitamin A and Vitamin C. E.g, Dr. Kaufman S. 20? Dr. Upton, Ex. 82 at 3. Dr. Kennedy, describing the work of the Research Plan ning Work Group of the IRLG in testimony before Congress, said: "The inadequacy of scientific information to support regulatory decisions, and the lack of enough capability to produce more, present major problems for FDA and other agencies that share in the regulation of toxic sub stances." (Ex. 34, Kennedy S. 1.) He identified areas where little or no research was being supplied by the four agencies, including "methods to measure total ex posure and body burdens of chemicals." _Id. at 3. Attached as Appendix A to Dr. Kennedy's statement is a list of High Priority Research areas including "^ Interaction of hazardous substances develop and validate for regulatory use, rapid, effective tests to predict inter active effects between two or more hazardous chemical substances. *** - 207 - CMA 048091 4. Methods to measure total exposure and body burden on chemicals. Develop and validate for regulatory use a systematic approach to the determination of total exposure and body burden for chemical substances." (Kennedy S., Appendix A at 1.) Dr. Saffiotti said that NCI is beginning some experi ments with the objective of demonstrating whether exposure to submanifestational doses of several carcinogens either simul taneously or sequentially is additive. (Tr. 928-929.) The NIOSH statement on this subject demonstrates that a supposed in terchangeability of carcinogens cannot be the basis for regula tory decision. NIOSH stated: "Present knowledge does not permit development of a consistent and rational basis for decisions on additive and synergistic effects. Complicating this problem is the question of promoting agents and co-carcinogens, widely and variously used terms without the same meanings to everyone. Additive effects should be assumed when two agents cause cancer at the same site, especially when the two agents also have chemical similari ties, such as PN's or aromatic amines. Synergis tic effects should be assumed only when there are data or principles suggesting in the specific case that potentiation is likely. Similarly, co-carcinogenicity and promotion should not be assumed except in a specific case where there are data or principles that apply." (NIOSH first answer to Q. 10.) The argument that risk assessment is undermined by a supposed interchangeability of carcinogens is without support in the record. E. Epidemiology Can Greatly Assist In Making Risk Assessments The value of epidemiology in identifying and quantifying 208 CMA 048092 risk has been discussed supra and that discussion will not be repeated here. Epidemiology can be used to identify the human risk. Negative epidemiology is useful to indicate "upper limits for the rate at which a specific type of exposure to that agent 1/ affect the incidence and/or mortality of specific human cancers." As NIOSH points out, by using epidemiological studies and animal data in a coordinated way, the "benefits of each can be maintained and many of the individual methodological weaknesses can be over come." (NIOSH first answer to Q. 5(c).) F, Methods Are Available For Extrapolating To Low Doses A basic problem in risk assessment arises from the fact that animal studies are normally conducted at doses signi ficantly higher than those to which man is exposed and it is necessary to extrapolate resultant animal data to quantify human risk at low levels of exposure. Chapter II of the NAS Drinking Water study contains a discussion of various mathematical models used for extrapolating risk at low doses. Dr. Hoel and Dr. Peto discussed the mathematical models and attached to their written statements articles discussing various models. Dr. Gross discus sed the Mantel Bryan model and attached a statement by Dr. Corn field discussing that model. The record points to the conclusion that the methods of extrapolation are in a period of development. It would be 1/ NCAB General Criteria at 462. - 209 - CMA 048093 inappropriate therefore to select a single method now; to the contrary, the scientists working on the extrapolation should be alert to use improvements and new developments as they occur. The complexities which seem to be presented in selecting the method with the best data fit and most appropriate for the mechanism of action of a particular substance underlines the importance of the Agency's calling for development of data at multiple dose levels and for the development of metabolic and pharmacokinetic data to facilitate the selection of, and the refinement of, extrapolation techniques. Both Dr. Hoel and Dr. Peto suggested that pharmacokinetic data should be incorporated into extrapolation models. (Dr. Hoel Tr. 2145-2148; Dr. Peto Tr. 2538-2540; see also Dr. SkalskyTr. 7590-7591, 7597-7599.) In the interim, it seems wise to use more than one model, as does EPA. (Tr. 2289-2290.) However, this puts the responsibility for identifying the best model or the best tech nique on the scientists, an additional reason in support of the Scientific Panel proposed by AIHC. This will help to avoid the tendency of a regulator to choose the most conservative model, however inappropriate scientists may believe such a model may be for a particular human exposure. These extrapolation techniques must be designed to be used by the Agency in its hazard evaluation. Properly done, the scientific risk analysis is an integral part of the apprai sal of regulatory alternatives which the agency must consider as part of its decision to regulate and to what level. Thus, 210 CMA 048094 selection of the appropriate method of extrapolation is one of the most important parts of a quantitative risk assessment, a fact which underlines the importance of the creation of the Scientific Panel proposed by AIHC. G. Time-To-Tumor Concepts Should Be Used In Making Risk Assessments___________________________________________________________ The definition of toxic substances in Section 1990.102 of the Proposed Regulation (42 Fed. Reg. 54184) includes sub stances exposure to which "(2) in a statistically significant manner decreases the latency period between exposure and the onset of neoplasms in (i) humans or (ii) in one or more experimental species." This is a recognition by OSHA that the latency period for a parti cular substance is a function of both time and dose. As Dr. Jones pointed out, with a sufficiently small dose the time to first tu mor will exceed man's lifetime, thus producing an effective carcin ogenic threshold. (Dr. Jones S. 2-3; see also McArdle Laboratory for Cancer Research Comment at 2). The extension of time-to-tumor if the dose is lowered is shown by the draft report of the NCTR "megamouse" study. (Ex. 36.) Figure 9 of that report shows that a 24 months exposure at three levels (150 ppm, 100 ppm, and 75 ppm) had induced bladder neoplasms; however, exposure at four lower levels (60 ppm, 45 ppm, 35 Ppm, and 30 ppm) had produced no tumors. See also Kaufman S. 5; Ex. 46. Dr. Hoel discussed this question and while he agreed that on a statistical basis the time to first tumor will increase with - 211 - CMA 048095 decreasing dose in the multistage model, he argued that some risk will still exist. (Dr. Hoel S. 7.) However, this conclusion is the result of the use of linear through zero extrapolation, which Dr. Peto frankly acknowledges is based on an "assumption" that some "asymptotic effectiveness" exists so that there is risk at any dose. (Dr. Peto S. Part I.) In light of these analyses it seems appropriate to approach the matter of time-to-tumor as an important part of the risk assessment. Dr. Hoel also acknowledges this point when he says that "the choice of time-to-tumor model can greatly change any estimated low dose effects." (Dr. Hoel S. 7.) Further refinement of the data may demonstrate that Dr. Jones is correct: there is an effective threshold at the 1/ dose level when time-to-first-tumor exceeds man's lifetime. It is important that the Proposed Regulation does not prevent presentation of such data when appropriately developed. In 1/ Zapp, J.A., "An Acceptable Level of Exposure," 38 Am. Ind. Hyg. Assoc. J., at 425-421, 430 (1977) (AIHC Bibliography): "We know that there is a dose: disease effect for carcinogens, as there is a dose: effect relationship for other toxic manifestations. We see it in the laboratory. As the dose of carcinogen is increased, the proportion which does not get tumors is decreased. As we lower the dose, the proportion of the animals which get tumors is decreased. In the laboratory one can find a dose which does not produce any excess of tumors within the lifetime of the animals under test." (Footnote continued on p. 213) 212 CMA 048096 the interval, there is no doubt that evaluation of these data are an important part of the risk assessment. The risk may be over stated because of the "assumptions" made in the particular extra polation method, but if the regulator recognizes the consequences of the assumption, a risk analysis which includes these data can make an important contribution in the administrative process. Conclusion The record strongly supports the need for a risk quanti fication by OSHA as an integral part of the regulatory process. The work of the IRLG in developing methods of risk assessment is a step in the right direction, but it is impossible to comment on these efforts since no public information is available. Risk assessment is indispensible to a determination of the measureable benefits which various possible regulatory meas- sures offer. It affords a reasonable basis for determining goals (Footnote continued from p. 212) Roe, F.J.C., "The Principles of Cancer Prevention," 19 Gazetta Sanitaria, at 51-62, 53, (1970)(AIHC Bibliography): "In animal experiments the risk of cancer develop ment increases with dose. With increase of dose the average induction time tends to approach a minimal, seemingly obligatory, period. When this point has been reached, further increase in dose is without effect on induction tine. At the other end of the scale, however, reduction in exposure dose is associ ated with prolongation of the induction time until within the limits of a particular experiment, none of the exposed animals develop cancers before they die from other causes ... We have demonstrated these dose response relationships in mice exposed just once at birth, to a po.tent chemical carcinogen." 213 CMA 048097 for risk reduction by assessing the degree of risk presented in the workplace as contrasted with the degree of risk that we all face from chemicals (natural or man-made) in our everyday lives. The big problem for risk assessment arises from selec tion of an appropriate model for extrapolating animal dose/response data to man. The most conservative approach is a strictly linear extrapolation, which some have asserted to be scientifically sup portable in a limited number of cases but which frequently leads to totally impractical and inappropriate exposure levels for occu pational, environmental, or personal care considerations. Broadly applied, this would place an unjustified and excessive inflationary burden on the American public through loss of or increased cost of products. In many cases a linear model is not the best fit to ex perimental data and should therefore not be used for extrapolation 1/ purposes. AIHC believes that other methods may be more applicable in many cases. In no event should an agency foreclose the use of the best tool available in this period of rapid scientific advances. 1/ See J. Totter, "Discussion of the Use Of Thresholds in Regulatory Processes" (AIHC P.H.). CMA 048098 214 XII UNDER THE STATUTE OSHA MUST DETERMINE NOT ONLY THE FEASIBILITY OF A STANDARD BUT WHETHER BENEFITS COMPARED TO COSTS DEMONSTRATE THE STANDARD IS REASONABLY NECESSARY "Because resources are limited, eschewing explicit cost/benefit analyses can result in more deaths and or cases of disease or injury; the costs imposed by a certain regulation might save more lives or pre vent more cases if spent in other ways." 1/ Introduction One of the most important and controversial provisions of the Proposed Regulation is that which requires the lowest feasible levels of exposure to be achieved for all Category I substances. Section 1990.112(b), 42 Fed. Reg. 54173. This provision embodies a proposed policy determination which "will not be permitted to be changed in the subsequent substance-by substance rulemakings." 42 Fed. Reg. 54173. There are two bases for objection to the single lowest feasible criterion. First, OSHA has never clarified what it means by "feasible" but has promised to do so in the forthcoming Regulatory Analysis. More important, the Benzene decision demon strates that OSHA has disregarded the criteria of Section 3(8) which require that standards be "reasonably necessary and appro priate." 29 U.S.C. 652(8). 1/ Evaluation of EPA's new drinking water regulations by the Council on Wage and Price Stability: Ivy Broder, "Analy sis of EPA Proposed Drinking Water Regulations," at 910, September 5, 1978 (AIHC P.H.). - 215 - CMA 048099 We will not repeat here the discussion of the Benzene decision which establishes that OSHA must quantify the benefits as an essential part of the regulatory determination that the costs involved are "reasonably necessary". See supra, at 7. We will discuss in this section OSHA's failure to define feasi bility in a manner compatable with the Act. A. The Definition of Feasibility Unfortunately OSHA has not released its Regulatory Analysis so that participants in this proceeding could comment on whatever definitions or criteria of feasibility OSHA derives. Indeed it is not possible in this brief to do more than point to the considerations which the courts and other agencies have indi cated are an essential part of determining feasibility. The President's Regulatory Analysis Review Group in its comments on the proposed acrylonitrile standard pointed out that "tj]ust as there is no absolute 'safe' level, there is no absolute 'feasible' level." (Ex. 45 at 5.) The process of deter mining what is the "feasible" level in a particular situation was described by the CWPS in its comments on EPA's proposed drinking water standard: "Regulatory agencies, within their legal constraints, may exercise much flexibility in the choice of specific activities or substances to be regulated and the type of standards to employ. Many alternatives, which produce varying health-related and economic impacts, are possible. That is, there are different costs and benefits to be derived from different regulatory alternatives. 216 CMA 048100 In order to ensure that the regulatory pro cess is efficient, an agency needs to perform cost-benefit analyses for proposed regulations. The benefits to be derived from many social reg ulations can be stated in terms of lives saved or cases of a disease avoided. Many regulators are reluctant to translate those benefits into dollar terms. However, the efficiency of the regulatory process cannot be improved upon with out putting a 'dollar value on life.' One can, through a risk-assessment proce dure, calculate the number of lives saved or cases of a disease avoided by various regulatory alternatives. In particular, calculating the cost per life saved for the least stringent alternative and for more stringent regulatory levels yields estimates of the incremental costs of imposing increasingly stringent stan dards. Efficiency requires that these incre mental costs be equated across regulatory actions that save lives and/or prevent cases of disease or injury. Although the 'lumpiness' of design standards and other factors make it impossible to arrive at exact equality of these costs per case avoided, it is sensible to avoid letting these values be unreasonably disparate. Because resources are limited, eschewing ex plicit cost/benefit analyses can result in more deaths and/or cases of disease or injury; the costs imposed by a certain regulation might save more lives or prevent more cases if spent in other ways." (CWPS Comments supra, at 9-10, AIHC P.H.) We believe the record clearly shows and the statute requires that the factors and methods outlined by the OMB should be considered in determining feasibility. Alternate methods of control should be analyzed from a technical and economic point of view. The incremental health benefits can be examined in the manner suggested by CWPS and a realistic determination made of feasibility in light of costs and benefits. AIHC hopes that in its Regulatory Analysis OSHA will - 217 - CMA 048101 realistically deal with those factors to be considered in deter mining feasibility. Since we cannot comment on OSHA's proposed definition or listing of factors, we shall in this section of the brief discuss briefly those elements which we believe should enter into a determination of an appropriate exposure level. B. The Proposed Regulation Should Be Amended To Provide For Consideration of Economic Feasibility Section 6(b) of the Act requires the Secretary of Labor to consider feasibility in promulgating standards pursuant to the Act. Mr. Wrenn in his prepared statement and in his testi mony recognized that feasibility involves consideration of both technology and economics. (Wrenn S. 6, 11, Tr. 34.) In addition, Mr. Wrenn stated that the agency makes decisions on the basis of judgments as to cost effectiveness. (Tr. 35.) In the preamble to the acrylonitrile standard OSHA acknowledged the need to eval uate economic as well as technological feasibility. 43 Fed. Reg. 45762, at 45779-45789 (October 3, 1978). Both the courts and the Occupational Safety and Health Review Commission have construed the feasibility criterion as re quiring a balancing of costs and benefits. See discussion supra, at 98-100. Dr. Rail as well as other witnesses urged OSHA that in selecting a "feasible" level, health risks, resources costs, economic costs and benefits should be taken into account. (Tr. 364 . ) It is significant in this connection that the AFL-CIO recognized that economic analysis plays a significant role in 218 048102 CMA the regulatory process. (Tr. 5816-5826.) Indeed the AFL-CIO recommended that OSHA's economic capability be enlarged to analyze costs in the regulatory context and urged the development of a "respected methodology for cost benefit analysis" by OSHA. (Ruttenberg S. 5-9.) Mr. George Taylor endorsed the utility of a cost/benefit analysis. (Tr. 5748-5749, 5832.) Speaking for the Steelworkers, Mr. Wright said that if there are to be economic studies the Steelworkers wanted them done "right". (Tr. 5822.) Despite this background, the Preamble and the Proposed Regulation itself are silent as to how costs are to be weighed in the light of benefits. Given complete freedom an engineer can always spend more to decrease exposures further. But the incre mental gains drop significantly-and costs rise exponentially as lower and lower levels are fixed. It is precisely this relation ship between incremental gains and incremental costs which the Regulatory Analysis Review Group established by President Carter pursuant to Executive Order 12044 concluded was part of an "ade quate regulatory analysis". (Ex. 45 at 4.) Yet nowhere in the Preamble nor in the Proposed Regu lation does OSHA indicate how economic considerations will be taken into account in setting standards. Until AIHC can review the Regulatory Analysis being prepared by OSHA it cannot know whether OSHA will clarify its position on this point. AIHC agrees with EPA in urging OSHA to set forth clearly in the Pro posed Regulation how feasibility will be determined and what role cost and benefits will play in reaching that decision. - 219 - CMA 048103 (EPA S. 5, 27-30.) The Proposed Regulation would foreclose consideration in future standard-setting procedures of the most cost and health effective combination of engineering controls, work practices, personal protective devices and administrative controls. The inflexibility of OSHA's position is particularly obvious in the construction industry. The most effective combination of engi neering controls, administrative controls and personal protective systems requires consideration of the special problems of the con struction industry -- the transitory nature of the work, the high labor turnover, and the complexity of using engineering controls. See the discussion supra, at 40. The same principles apply in protecting workers in a plant. It is for this reason that AIHC urged that OSHA set per formance standards, and require each plant to prepare a plan de tailing the reasons why each part of the plan was adopted. At tached as Appendix F are pages from the AIHC Alternative describ ing the nature of the plan and guidelines for the plan. The existence of the plan in no way excuses the plant from failure to meet the PEL. But it does permit a plant owner to take into account the special problems of his plant without requiring an inflexible approach to the method of control, thus giving real meaning to the term "feasible". The OSHA policy decision that mandates engineering controls even if they will not achieve the desired level is not consistent with the requirement that OSHA take economic 220 CMA 048104 1/ feasibility into account. While AIHC recognizes that engineer ing controls are the preferable means of control, to mandate such an inflexible policy for all future standard-setting procedures conflicts with the requirement that economic feasibility be con sidered in each area. This conclusion is reinforced by consideration of Sec tion 3(8) of the Act. A standard must be demonstrated to be not only feasible but "reasonably necessary." 29 U.S.C. 652. The Benzene decision makes clear that if OSHA mandates control of ex posure to the lowest feasible level without a careful balancing of benefits and economic considerations, OSHA is failing to make the determination of "reasonable cost" required by the Act in order to show that a standard is "reasonably necessary". C. The Record Supports The Conclusion That Exposure Levels Should Be Established On The Basis Of Acceptable Risk Much of the testimony in the record has been aimed at OSHA's rejection as a policy matter of the concept of "threshold" 1/ The AFL-CIO suggested that the model standard for Category I substances requires control of exposures in particular plants to lower than the specified PEL -- i. e., lowest possible limit -- when such control is possible. (AFL-CIO S. 13, Tr. 5710-5711.) The AFL-CIO recognized that a requirement for "all feasible engineering controls" even where the PEL is not exceeded presents a statutory problem. (Tr. 5710.) This may be a matter for collective bargaining, it is not a basis for regulatory action. - 221 - CMA 048105 1/ or "no-effect" levels for carcinogens. Dr. Claus and Dr. Olson testified that a "threshold" can be demonstrated on the basis of the biomolecular phenomenon of the number of molecules of a substance necessary to interact with cells of the target organ. (Dr. Claus S. 22-39, Tr. 3508-3511; Dr. Olson S. 31-34.) Many others testified on the basis of the principles of biology and toxicology that "threshold" is a universal concept in nature and there is no reason to conclude that a threshold does not exist for carcinogens. See, e ,g., Dr. Skalsky Tr. 7588-7589, 7630; Dr. Goldwater S. 4-8; Dr. Lu S. 9-10. Dr. Upton testified that the possibility of a threshold cannot be excluded. (Tr. 347.) Dr. Kotin stated that a no-effect level can be predicted quantitatively in a variety of animal models for a variety of organ or organ system targets. (Tr. 8646.) Others testified that while a "threshold" has not been experimentally demonstrated, should such a demonstration be made, it should be considered by the agency in evaluating the human risk from exposure to a sub stance and in fixing levels of control. E.g., Dr. Upton Tr. 272; NXOSH Tr. 3075; see also EPA S. 9. Indeed failure to consider such evidence would be contrary to the requirement in Section 6(b)(5) that OSHA consider the latest scientific data available. 1/ -- , A number of OSHA witnesses recommended the lowest feasible level of exposure on the ground that carcinogens are interchangeable and that exposure to a carcinogen in the workplace is added to the existing "burden" and nay put an individual over the threshold. As we have shown supra, at 206-208, this concept of interchangeability is an assump tion for which there is no data. 222 CMA 048106 The fact that scientific debate continues on this subject does not alter in any way the fact that the record shows that OSHA should reconsider the policy decision upon which the unvarying low--as-feasible determination was made. That chemical substances which will be classified in Category I will vary widely in potency is a conclusion which OSHA itself recognized (42 Fed. Reg. 54165) and which the record amply supports. In deed, it is this wide variation which makes quantitative risk assessment an essential part of the regulatory process. See the discussion supra, at 197-203. There is no way to achieve zero risk in the workplace short of banning substances, unless a threshold is recognized and not exceeded. Even assuming that OSHA cannot identify a threshold for exposure to a carcinogen, it can assess the risks involved and take that risk into account in determining what is a permissible level of exposure, recognizing that some level of risk may be associated with the exposure. But it makes no sense in advance of such a risk evaluation to mandate lowest feasible for all y future individual substance rulemakings. It requires no scientific evaluation to conclude that risks from exposure are different when a worker is exposed to 1/ Dr. Rail endorsed generally the principle set out in the NAS Drinking Water Study, attached as Appendix I to Dr. Rail's statement: "4. Material should be assessed in terms of human risk rather than as 'safe' or 'unsafe'." (S, 8 . ) - 223 - CMA 048107 aflatoxin or bischloromethyl ether on the one hand or to nickel dust on the other when, for example, a cashier handles coins in making change. It is equally clear that the level of control of exposure should be different in light of the differences in risk. E.g., Dr. Jellinek S. 5-6; see also Mr. Samuels Tr. 72597271, 7272; Dr. Rail Tr. 385-386. The fact that such extremes exist suggests that a care ful evaluation of level of control can utilize a risk assessment in determining an acceptable level of risk for different sub stances. This will be possible when a systematic method of risk assessment such as that recommended by EPA and FDA, and which hopefully the IRLG is in process of formulating, is made part of the regulatory process. D. Costs And Benefits Must Be Considered In Regulatory Decision Making____________________________________________ ______ __________________________ ___ Risk and hazard constitute half of the essential evalu ation which should be made in the regulatory process. The Benzene decision makes clear the other essential considerations are cost and benefits. Nowhere in the Proposed Regulation does OSHA indi cate how costs will be taken into account or what factors are part of a cost consideration. There was resistance on the part of some witnesses to consider benefits at all. Others shied away from the analysis of benefits because of the complexities and difficulties of quan tification. AIHC believes these objections are based on a mis 224 CMA 048108 conception of the evaluation which should be made. Costs in this context mean health and resources flowing to or from different groups - workers, taxpayers, consumers and industry. (Zeckhauser Tr. 4321-4322; Dr. Lave Tr. 7003-7005.) What one may view as a benefit, the other views as a cost. It is for this reason that Dr. Ashford recommended that a risk/benefit analysis be made to identify what he called "trade-offs". (Tr. 2429.) Dr. Zeckhauser called this "a meticulous accounting". (Tr. 4352, 4410.) The position of the AFL-CIO is instructive. In their testimony they urged that OSHA's economic capability be increased and that where economic analysis is called for under the regula tions, the analysis should be done "right". (Tr. 5822.) George Taylor stated that a cost/benefit analysis of the kind outlined by Snell was an appropriate part of the regulatory process on par ticular substances. (Tr. 5748-5749, 5745, 5751.) Sheldon Samuels testified that cost/benefit analysis was at an early stage of de velopment; while many items in the analysis could not be quantified he agreed that the items which could be quantified should be quanti fied to assist the regulator. (Tr. 7283-7285.) As an alternative to cost/benefit analyses, Mr. Samuels discussed "necessary" and "unnecessary" risks, unnecessary risks being those encountered in producing socially unnecessary products. (Tr. 7286-7287.) How ever, Mr. Samuels recognized this was in effect a different name for a cost/benefit analysis. (Tr. 7287-7289.) - 225 - CMA 048109 While OSHA can and should never lose sight of the fact that the objective of regulation is to protect worker health, it cannot escape consideration of the effects which its regulations have on the worker's job and on workers in other industries. Thus, as Dr. Wilson pointed out, if compliance with a regulation requires construction, OSHA should not lose sight of the historical fact that one worker loses his life for every $36 million in construction. (Dr. Wilson S. 47-49, Tr. 3372.) Dr. Rail made the same point in a different way when he said: "Ultimately, however, the selection of a 'feasible' level depends on a judgment as to when the costs of control (which may include health risks and resource costs as well as economic costs) are justified by the magnitude of the carcinogenic risks posed by unregulated exposure." (Dr. Rail S. 1-2.) The fact that OSHA does not make such an overt analysis should not conceal the fact that OSHA is making the societal judgments without acknowledging that it is doing so. (Dr. Lave Tr. 7003-7004, 7011-7013.) If a cost/benefit evaluation is made, regulatory judgment would be made on the basis of the best facts available; on the other hand, if OSHA does not make such an analysis, the judgment is being made by OSHA in ignorance and without consideration of the societal costs and benefits. The fact that such an analysis is difficult should not stand in the way of attempting the assessment. FDA makes such 226 CMA 048110 analyses as a regular part of its regulatory function. Many of the analyses involve drugs where the same person is both the per son at risk and the one who receives the benefits. But FDA also makes analyses of risks and benefits where the costs, risks and benefits involve different groups. A good example is the analysis which FDA recently made in regulating the amount of aflatoxin which will be permitted in peanut butter. (Ex. 38.) EPA regularly makes cost/benefit analyses at various levels of control under the Fed eral Insecticide Fungicide and Rodenticide Act and will make such analyses under the Toxic Substances Control Act. (Tr. 2357.) Another example of a risk/cost assessment is that under taken by the Nuclear Regulatory Commission. (Ex. 67.) As a part of its determination of the nume'rical guides for design objectives and limiting conditions for operation required to meet the criteria "as low as practicable", the Commission adopted a monetary value for reducing exposure of $1000 per total-body man-rem. 40 Fed. Reg. 19439 (May 5, 1975.) On the basis of the interim value of $1000, the Commis sion has prepared evaluations of the cost/benefit analyses in sup port of nuclear power reactor applications. (Ex. 67.) This ex perience, evaluated in the light of applicable EPA environmental standards, lead the Commission to reconsider the need for further efforts to redefine the worth of reducing radiation exposure to X/ In December 1975, the Commission changed the terminology "as low as practicable" to "as low as is reasonably achievable" to conform to the International Commission on Radiological Protection. 40 Fed. Reg. 58845 (December 19, 1975). - 227 CMA 048111 the general population. _Id. The Commission cancelled the pro posed rulemaking to review the interim value, stating: "The cancellation of this rulemaking should not be interpreted as an abandon ment by the Commission of the concept of a quantified cost-benefit analysis for defining as low as is reasonably achiev able levels of radiation exposure. The Commission believes that the Appendix I rulemaking proceeding (Docket No. RM-50-2) and the subsequent experience with the Appendix I rule show that this concept has considerable merit and utility. In this regard, the Commission notes the opinions of the Advisory Committee on the Biological Effects of Ionizing Radiation of the National Academy of Sciences National Research Council 6/ that: Such analyses could facilitate rational and cost-effective safety and control procedures and the avoidance of health hazards and economic dislocation associ ated with excessive or inadequate expen ditures in relation to risk. Health benefit/cost assessments, even though present data are incomplete, can provide some guidance to decision makers, direct attention to gaps in knowledge, indicate priorities for research, and stimulate the accumulation of needed data and analysis, and contribute to public under standing of the relevant issues and problems *** (page 6). * 6/ National Academy of Sciences - National Research Council Advisory Committee on the Biological Effects of Ionizing Radiation. 'Considerations of Health Cost-Benefit Analysis for Activities Involving Ionizing Radiation Exposure and Alternatives.1" Issued as EPA Report in EPA 520/4-77-03 (1977). The reasons why the NRC found a risk/benefit analysis useful should be persuasive that a similar analysis should be 228 CMA 048112 made by OSHA. Based on his experience in radiation. Dr. Upton said that the principle of "diminishing returns" is generally valid: "In connection with radiation, it has been suggested that beyond a certain point, the costs to society involved in further reducing the dose and hence the presump tive risk may outweigh the costs associ ated with that hypothetical risk. So I think the principle that one may reach a point of diminishing returns is a valid principle. And I would suppose that a regulatory decision would weigh in arriving at the concept of feasibility all of the factors that have to go into a socially acceptable judgment." (Tr. 271; see also Tr. 283.) As Dr. Wilson and Professor Lave pointed out, to the extent it is possible to quantify even partially the complex factors in a regulatory proceeding, the proceeding is facilitated because the number of factors which must be evaluated on judgment alone will be identified and their number reduced. (Dr. Wilson Tr. 3374; Professor Lave Tr. 7001-7002.) Indeed, as Professor Lave emphasized, making such a cost/benefit analysis is the best way to speed up the administrative process. (Tr. 7000- 7002.) The CWPCs comment on uncertainty in determining costs and benefits emphasizes the urgency of making the analysis: "There is a considerable amount of uncer tainty about both the costs and the bene fits of these alternatives, but it makes little sense to act on uncertain evidence by imposing costly regulations on local communities while, at the same time, es- - 229 - CMA 048113 chewing cost/benefit analyses because of this uncertainty." 1/ AIHC believes that the record strongly supports the conclusion that OSHA should undertake a cost/benefit analysis as part of the regulatory process to determine the level of con trol. This may not necessitate an elaborate formal cost/benefit analysis but it does mean that OSHA will have sufficiently iden tified the societal costs and benefits that it can more reason ably determine an acceptable level of risk - the reasonably necessary level - in setting particular standards. Section 3 B(l) of Executive Order 12044 requires that such an analysis be performed; it directs the agency to identify alternatives and assess their economic consequences. See discussion supra, at 102-103. Some form of risk/benefit analysis is being developed by the IRLG. AIHC applauds this development in principle but cannot comment in greater detail because the recommendations of the IRLG are not available for comment. We do not know whether the proposals will or will not be reasonable and adequate. E. The AIHC Alternative Provides A Reasonable Procedure For Identifying An Acceptable Level Of Risk The AIHC Alternative spells out the procedure for determining the reasonably necessary and acceptable level of 1/ CWPS comments on EPA's proposed drinking water standard, September 5, 1978 (AIHC P.H.). - 230 - CMA 048114 1/ risk. An orderly method of risk quantification is set out and the analyses of the risks and societal costs and benefits of alternative methods or levels of control is described. Under the AIHC Alternative an orderly and logical sequence for administrative determination of an acceptable level of risk for both emergency temporary and permanent standards would be established. Costs and quantified benefits are examined as the court directed in the Benzene decision. Emergency Temporary Standards ("ETS"). Under AIHC Category I (known human carcinogens) and Category II (confirmed animal oncogens) the initial step is a determination whether the facts justify an ETS. If an ETS is issued, the level of exposure is set based upon all the data available. If sufficient data are available to quantify risks and to perform the cost/ benefit analysis, the acceptable level will be identified and the method of attaining it described. If sufficient data are not available for the necessary analysis, the temporary standard will specify a permissible exposure level which can be achieved through a practical combination of readily available engineering controls and personal protective equipment. The Interagency Testing Committee established under the Toxic Substances Control 1/ AIHC Alternative at 70-84, (Appendix G to this brief is a supplementary statement of the principles AIHC believes should be followed in a risk/benefit analysis) . - 231 - CMA 048115 1/ Act would be notified of the desirability of further testing. Permanent Standard. Under AIHC Categories I and II the Alternative provides that where data are available to quantify risks, the acceptable exposure level will be set after evaluating the risks, costs and the benefits in the manner provided. Where data are not sufficient to quantify risks, a five-year "interim permanent" standard would be fixed upon the basis of the best data available. If data became available in the five year period, the "interim permanent" standard will be reviewed in light of the data and a permanent acceptable level fixed. If data do not become available, the permanent standard will be fixed at the lowest level economically and technologically feasible. We believe that AIHC's proposal satisfies the statutory standard of feasibility in Section 6(b)(5), read in the light of the "reasonably necessary" criteria in Section 3(8), F. A Risk/Benefit Analysis Is Required Under The National Environmental Policy Act Finally, the statutory requirements of the Act must be considered in light of OSHA's obligations under the National Environmental Policy Act, 42 U.S.C. 4321 et seq. (See supra, 1/ Both the temporary and permanent standards provide for exclusions of mixtures containing low concentrations of the substance and for an "action level". The mixture exclusion level and the action level would be determined based on the risk/cost/benefit analysis. 232 CMA 048116 at 100 for a discussion of OSHA's obligations under that statute.) It is sufficient to note here that unless OSHA makes the risk/cost^ benefit analysis of the kind discussed above, it will have neither the necessary basis upon which to weigh the broad environmental impact of alternative control levels in devising a particular stan dard, nor the data to analyze the resource commitment as required under Section 102 of NEPA, 42 U.S.C. 4332. Conclusion Compliance with these statutory requirements cannot be made without a risk/cost/benefit analysis of the kind embodied in the AIHC Alternative. The fact that other agencies make such analyses demonstrates that while the analysis may have uncer tainties and may indeed be complex, such analyses can be made and do contribute to rational decision making. - 233 - CMA 048117 XIII THE PROPOSED REGULATION UNLAWFULLY REQUIRES ISSUANCE OF EMERGENCY TEMPORARY STANDARDS WITHOUT APPRAISAL OF RISK The Proposed Regulation would require, in every case of a Category I classification within its scheme, automatic issuance of an ETS. This requirement clearly contradicts the plain language of the statutory authorization for the issuance of an ETS, the Congressional intent behind the grant of authorization, and the court decisions construing this authorization. Section 6(c)(1) of the Act, 29 U.S.C. 655(c)(1), re quires that prior to the issuance of an ETS the Secretary of Labor must make a determination that "employees are exposed to grave dan ger" from toxic and physically harmful substances, and that an ETS is "necessary to protect employees from such danger." The Proposed Regulation would not require these specific, prescribed factual findings to be made prior to the issuance of an ETS. In fact, no assessment of the degree or significance of carcinogenic risk posed by a particular substance is provided for, either in the classifica tion process or subsequent thereto. The proposed automatic issuance of an ETS for every Cate gory I substance is contrary to the intent of Congress that the power to issue an ETS be used sparingly and only in unusual circum stances: "Congress considered that . . . emergency temporary stan dards should be considered an unusual response to exceptional cir cumstances ." 234 CMA 048118 Drv Color Manufacturers Ass'n v. Department of Labor, 486 F.2d 98, 105 n. 9a (3d Cir. 1973). In like fashion, the Court of Appeals for the Fifth Circuit has stated that "[the extraordinary powers] granted to the Secretary in Section 6(c) of the Act should be delicately exercised, and only in those emergency situa tions which require it." Florida Peach Growers Ass'n v. Department of Labor, 489 F.2d 120, 129-30 (5th Cir. 1974). See also Taylor Diving and Salvage Co. v. Department of Labor, 537 F.2d 819 (5th Cir. 1976). OSHA's purported justification for the wholesale issu ance of ETS is that any substance which has been shown to cause cancer in animals, ipso facto, presents a grave danger to humans. The courts, however, have not supported this contention when offer ed by OSHA in the past. In Dry Color Manufacturers Ass'n, Inc, v. Department of Labor, supra, the United States Court of Appeals for the Third Circuit stated that, "[a]lthough the danger of cancer is surely 'grave,' Subsection 6(c)(1) of the Act requires a grave danger of exposure to substances 'determined to be toxic or physically harm ful.'" ^d. at 104. For a valid ETS to issue, there must be a show ing of "more than some possibility that a substance may cause can cer in man." I_d. The court then stated that the record before it failed to show "more than some possibility that DCB (3,3' Dichlorobenzidine] and El [Ethyleneimine] may cause cancer in man," and that the "most that can be said is that DCB and El pose a 'poten tial' cancer hazard to man," indicating that the record did not - 235 - CMA 048119 1/ support issuance of an ETS. Id. at 105 (emphasis added); see also Florida Peach Growers Ass'n v. Department of Labor, supra, at 131. The evidence then before the court included the reports of laboratory rodent experiments on DCB and El which OSHA and NIOSH regarded as constituting clear evidence of carcinogenicity in two species, far more evidence than the OSHA proposal would require for an ETS. In interpreting the requirements for issuance of an ETS, the court stressed the value Congress had intended that the normal rulemaking procedure would have, noting that it was clear that Congress "considered that the ordinary process of rulemaking would be that provided in subsection 6(b), dealing with permanent standards;, emer gency temporary standards should be considered an unusual response to exceptional circumstances. The courts should not permit temporary emergency standards to be used as a technique for avoiding the procedural safeguards of public comment and hearings required by subsection 6(b). Especially where the effects of a substance (on man] are in sharp dispute, the promulgation of standards under subsection 6(b) is preferable since the procedure for permanent standards is specifically designed to bring out the relevant facts." Dry Color Manu facturers Ass'n Inc, v. Department of Labor, supra, at 104 n. 9a. Consistent with the statutory language, Congressional intent, and relevant court decisions, the AIHC Alternative would not require automatic issuance of an ETS. Instead, it calls for 1/ Having clearly indicated its views that an ETS would not generally be warranted on the basis of animal data alone the court set aside the ETS on another ground. Dry Color Manufacturers Ass'n Inc, v. Department of Labor, supra, at 104-105. - 236 - CMA 048120 the exercise of informed judgment and discretion exercised on the basis of an evaluation of all the evidence of potential carcinogenic risks (e.g., carcinogenic potency as indicated by the epidemiologic data, animal experimental data, where avail able, such as dose-response relationships, metabolism, duration and amount of exposure, route of exposure) and an evaluation of actual hazards, (e.g. , physical and chemical properties, degree of occupational exposure, likelihood of a carcinogenic event.) In short, the AIHC Alternative fully complies with the statutory requirements. The Secretary will not only appraise the facts to determine if there is "grave danger," but also to determine, as the Act requires, whether an ETS "is necessary to protect employees from such danger." 29 U.S.C. 655(c)(1). The Benzene decision underlines the need for specific findings of benefits before an ETS can be shown to be "necessary". - 237 - CMA 048121 XIV OSHA HAS A LEGAL AND MORAL OBLIGATION TO SET REGULATORY PRIORITIES "The more we spend on safety, the less we have with which to fight poverty and disease or to spend on those goods and services which make life worth living, for ourselves and others. Whatever money we make available for safety we should spend in such a way that it produces the maximum benefit. There is nothing humanitarian in spending lavishly to reduce a particular hazard which has been brought to our attention and ignoring the others." 1/ In the Preamble to the Proposed Regulation OSHA dis cusses various procedures by which it can systematically classify and regulate the substances in the NIOSH list of "Suspected Car cinogens". 42 Fed. Reg. 54169.- Several proposals are discussed, including the possibility that the substances be taken in alpha betical order. This discussion must be considered in the perspec tive of Section 1990.103(a) of the Proposed Regulation, which would require the Secretary to initiate the regulatory process whenever information is presented by a public petition. The issue of priorities was brought into sharp focus during the hearings on July 14, 1978. On that date OSHA released a preliminary list of chemicals classified according to the sys tem in the Proposed Regulation. (Ex. 132.) The lists were pre- 1/ Kletz, T. A., "The Application of Hazard Analysis to Risks to the Public at Large," at 1. Presented at World Congress of Chemical Engineering, Amsterdam, July 1, 1976. AIHC Bibliography. 238 CMA 048122 pared by Clement pursuant to contract. The NIOSH list was screened by Clement to identify commercial products on the NIOSH list. Two computer comparisons were made: one with the EPA tentative inventory of existing chemicals under the Toxic Sub stances Control Act; and the second with the International Trade Commission data on commercial organic chemicals. The chemicals on the NIOSH list identified as commercial were then screened by review of articles cited in the NIOSH list; review of the U.S. Public Health Service survey of chemicals tested for carcino genesis; a check of the National Library of Medicine's Cancer Line data base; and review of the IARC monographs. As a result of the screening process the chemicals were presumptively assigned to the OSHA categories as shown in the following table: List I (Based on EPA TSCA Candidate List) List II (Based on USITC Data Base) Category I 269 116 Category II 218 72 Category III 396 181 In a memorandum accompanying the press release, and in the press release itself, participants in the hearing were asked to propose a system of priorities for regulation of those sub stances and to explain the criteria they would use. AIHC has responded to this request in a separate communication. (Appendix H to this brief.) In this section of - 239 - CMA 048123 the brief, we address the more general question of priorities under a generic regulation such as that proposed by OSHA. A. The Statute Requires OSHA To Establish Priorities Section 6(g) of the Act directs the Secretary to establish priorities. 29 U.S.C, 655(g). That section provides: "(g) Priority for establishment of standards. In determining the priority for establishing standards under this section, the Secretary shall give due regard to the urgency of the need for mandatory safety and health standards for particular industries, trades, crafts, occupations, businesses, workplaces or work environments. The Secretary shall also give due regard to the recommendations of the Secretary of Health, Education and Welfare regarding the need for mandatory standards in determining the priority for establishing such standards." Congress has specifically directed that OSHA "shall give due regard to the urgency of the need for mandatory safety and health standards for particular industries, trades, crafts, occupations, businesses, workplaces or work environments" in determining the priority for establishing standards. 29 U.S.C. 655(g). Clearly, Congress intended that OSHA first address those health problems presenting the greatest hazard to workers. A decision by OSHA to regulate substances in the random fashion suggested would constitute a flagrant denial of this intent. Perhaps of greater practical significance, a failure to prioritize substances for regulation on the basis of the poten tial risk for human carcinogenicity and the degree and extent of employee exposure to the substances, could result in a serious - 240 - CMA 048124 waste of OSHA's and industry's manpower and resources. Surely the state of scientific knowledge allows for this rational ap proach to regulation, as recognized by the FDA, EPA, and CPSC. Donald Kennedy, U.S. Commissioner of Food and Drug, Food and Drug Administration, testified at the hearing that haz ard assessment should be employed for setting agency regulatory priorities. Commissioner Kennedy described the factors considered in such an assessment as the relative carcinogenic potency of the substance, the number of workers exposed and the dosage of ex posure. (Tr. 493-497, 514.) EPA utilizes a similar system for setting regulatory priorities. The Assistant Administrator for Toxic Substances for the EPA, Steven Jellinek, testified that the agency priori tizes substances for regulation on the basis of an analysis of relative potencies and the number of persons exposed. (Tr. 2359, Jellinek S. 2.) Finally, both the testimony of Chairman Byington in this hearing and the recently published Interim Statement of Policy and Procedure for Classifying, Evaluating, and Regulating Carcinogens in Consumer Products, 43 Fed. Reg. 25657 (June 13, 1978), demonstrates that the CPSC will utilize quantitative hazard assessment in establishing regulatory priorities, with the extent of exposure being a major consideration. (Tr. 2095, 2088-2089). The Interim Statement of Policy and Procedure specifically states that: - 241 - 04812 "In determining the order in which products containing classified substances will be evaluated by the staff, the Commission recognizes that it may need to set priori ties among substances. Generally, priority will be based on the relative certainty of the evidence concerning the substance (i.e., the category to which it is assigned), the apparent potency of the substance, the extent of consumer exposure to products containing the substance, including the approximate number of products and the amount of the sub stance contained in each, and the potential for human uptake. This may lead in some cases to the allocation of resources to the investigation and possible regulation of high priority Category B or C substances rather than low priority Category A sub stances." 16 C.F.R. S 1040.31 (published at 43 Fed. Reg. 25664). The past actions of OSHA demonstrate its concurrence in the approach of the FDA, EPA and CPSC, As discussed supra, at 65, in their contract OSHA has instructed Clement to develop criteria for, inter alia, potency and risk quantification for the purpose of "ranking" substances: "The contractor will attempt to develop a semi-quantitative scale, upon which each chemical will be ranked according to several independent, relevant factors. The weighted sum of the rankings may then establish an order of chemicals." Presumably, this ranking is to serve as the basis for prioritiza tion of substances for regulation. In addition, the affidavit executed by Grover Wrenn in Textile Workers Union of America v. Usery, Civil Action No. 75-2157 (D.D.C., filed March 1976) demonstrates that historically NIOSH has prepared criteria documents on a priority basis and that OSHA has set regulatory priorities "based on severi ty of 242 CMA 048126 the hazard and extent of employee exposure . . . (Wrenn Affidavit at 2, 4). In fact, the Wrenn affidavit flatly states that it is a function of Mr. Wrenn's job to determine priorities. The affidavit specifies the factors involved in past prioriti zation : "One major function of my job is determining priorities for health standards development. In making such determinations I consider among other things the type of hazard involved, its extent and severity, whether it is seasonal or continuous, whether it is already meaningfully regulated in whole or part, and the number of employees exposed. These factors must also be balanced against my manpower capabilities and those of the Solicitor's Office, since no em ployee will be protected if we undertake so many proceedings we cannot effectively complete any." Wrenn Affidavit at 10 (emphasis added). Materials that are kno'wn or seriously alleged to be human carcinogens or highly potent animal carcinogens surely present a much more manageable number of substances for regula tory and compliance purposes than the "universe" described by the NIOSH subfile, and are very likely to account for the great majority of the potential occupational hazards being encountered in domestic workplaces. Regulating these substances first would enable greater benefits to be achieved, and ensure greater acceptance by those being regulated, in view of its manifest reasonableness. B. OSHA Should Not Allow Persons Outside The Agency To Dictate Its Priorities At any rate, OSHA should retain the flexibility to exercise informed judgment and to consider regulating first the '- 243 - CMA 048127 most potent human carcinogens to which the greatest number of employees are exposed. Regulating substances not currently on the NIOSH subfile of "suspect carcinogens" in the order that information is received by OSHA from any source would deprive OSHA of the ability to exercise judgment in establishing priorities for rulemaking. For example, under the OSHA pro posal, the filing of a "citizen petition" could force OSHA to give equal priority to such seemingly unequal problems as selenium, an essential human nutrient, asphalt, and carbon tetrachloride, compared to bischloromethyl ether and aflatoxin. In addition to being irresponsible, allowing citizen petitions to force automatic regulatory responses would be a clear ab dication by OSHA of its duty to -set priorities in accordance with the guideines set by Congress in Section 6(g) of the Act, 29 U.S.C. 655(g). EPA has testified that OSHA would lose control of its processes unless it established priorities and reserved discretion to decide not to regulate a particular substance. (Jellinek S. 6; EPA S. 20-22.) The CPSC Interim Statement of Policy and Procedures does not provide for "citizen petitions" which would trigger automatically the regulatory procedure, despite the close adherence of the Statement to OSHA's Proposed Regulation. In short, other federal agencies have recognized the inadvisability of placing their regulatory responsibilities in outside persons. We believe OSHA should do so also on both policy and statutory grounds. - 244 - CMA 048128 C. OSHA Should Heed The Advice Of The Interagency Task Force On Priorities ____________ The Interagency Task Force on Workplace Safety and Health has recommended that OSHA better utilize its limited standard-setting and enforcement resources and maximize worker protection by issuing criteria for determining which hazards will become the subject of proposals and of final standards: "The new Administration has taken significant steps to make OSHA enforcement more rational, remove unnecessary paperwork and compliance burdens, and provide workers neglected health protection. The more the agency gears up to issue health standards, however, the more it will need a system for determining priorities to insure that maximum worker protection is obtained and that standards begun are completed in time. The universe of job safety hazards is relatively finite; chemical threats to health expand by hundreds of substances each year and are unlikely to be completely covered even through rulemaking aimed at generic chemicals or processes rather than single substances. The need to carefully select areas for which regulation will produce the greatest health and safety gains at the least cost to the government is clear. Lack of such a priority system leaves the agency vulnerable to pres sures against as well as for particular stan dards. It has in the past delayed standards completion and demoralized both standard setting and enforcement staff, who have found themselves flung from one project to the next on a crash-and-wait basis. It has in the past put the agency on the defensive with respect to NIOSH, which has a formal priority system and pursues it with some rigor, generating dozens of criteria documents to which OSHA has been forced to respond ad hoc. Perhaps more im portantly, it hampers the long-range standards planning a priority system will provide. This recommendation proposes that OSHA estab lish formal criteria for determining when particular hazards should trigger full-scale rulemaking, including: - 245 - CMA 04812 - number of workers exposed extent of their exposure potential severity of resulting injuries and illnesses - alternative means of controlling the hazard practical aspects of enforcing the standard costs to the government of developing and enforcing the standard. The recommendation also proposes that based on these criteria, OSHA should develop a weighted numerical index for ranking hazards being con sidered for protective rulemaking; that it should publish an annual list of such candidates for public comment; that it should disclose the reasons for deciding which hazards to regulate; and that it should set up a separate office, building on current plans for an Office of Carcinogen Classification, to set, monitor, and revise resulting priorities. Because of present deficiencies in available data, it is the systematic consideration of the listed criteria, rather than the numbers emerging from that consideration, which will probably prove most productive over the short run. It should also be emphasized that this recommendation will afford OSHA continued flexibility by enabling it more productively to select not only topics for rulemaking at the initial stage, but aspects of proposed standards to press to completion after rulemaking has begun. Finally, it should be noted that this recommendation merely pro poses to systematize factors which OSHA has long used to make similar decisions on a more ad hoc basis. Making those criteria expli cit offers a significant opportunity to better manage standards setting and efficiently com ply with the President's recent order on im proving government regulations." ("First Recommendation Report" August 1, 1978, at IV-24 - IV-25 (AIHC P.H.).) - 246 - CMA 048130 PART FOUR XV THE PROPOSED REGULATION SHOULD PROVIDE THAT IN SETTING STANDARDS IN SUBSEQUENT RULEMAKINGS AN EXCLUSION FOR MIXTURES CONTAINING SMALL QUANTITIES OF A CARCINOGEN WILL BE MADE AND AN ACTION LEVEL WILL BE ESTABLISHED The Proposed Regulation does not contain provisions on two subjects which would have a material impact on the cost of compliance with particular standards and yet would not impair worker health protection: (a) exclusion of mixtures which contain a small quantity of a carcinogen as a constituent or contaminant; (b) establishment of-an action level below which a number of the requirements of the standards, particularly monitoring and medical surveil lance, are significantly reduced. The Proposed Regulation should be amended to provide that in setting individual substance standards an appropriate ex clusion will be made for mixtures and an action level established. A. A Mixture Exclusion And An Action Level Should Be Incorporated Into The Standards Any conceptual difficulty which OSHA may have with a mixture exclusion and an action level stems from two administra tive policy determinations which, as we have shown, should on the basis of the record be modified. These policy determinations are: (i) There is no safe exposure level and any exposure is associated with risk. - 247 - CMA 048131 (ii) Therefore, lowest feasible exposure is mandated in all cases. When the concepts of risk analysis, and an evaluation of the reasonable necessity of controls following a risk/cost/bene fit analysis of the kind described above replace the two inflexible policy determinations proposed by OSHA, the conceptual difficulties vanish. An acceptable level of "contamination" of mixtures by a carcinogen can be established in the same way that an accept able risk level of exposure is determined. The level will vary with the substance and the risks associated with the level of con tamination. The same reasons that a mixture cut-off was set in the proceedings involving the fourteen carcinogens, and more re cently in the standards for benzene and acrylonitrile, point to the conclusion that the Proposed Regulation should authorize such a mixture "cut-off" in individual substance standards. There is no conceptual difficulty with an action level if the standard is set at a feasible, reasonably necessary level. When controls are engineered, they are generally engineered to achieve a level below the PEL. Otherwise the normal operation of a plant would lead to continued violations or changes in control methods as production and control efficiencies changed. Thus an action level is in reality a recognition of this engineering "fact". B. A Mixture Exclusion And An Action Level Could Materially Reduce Cost And The Number Of Establishments Regulated Since the proposed model standard provides that it is - 248 - CMA 048132 applicable whenever a substance is "introduced" or is "present" in the workplace, (Section 1910.000(d)), the workplaces subject to the standard will include every workplace where a mixture containing any amount of the substance is opened or used. By fixing a mixture cut-off, the number of regulated workplaces will drop dramatically without in any way endangering employee health. Similarly, the use of an action level makes it possible to reduce dramatically the cost of compliance since monitoring and medical surveillance, which make up a large part of the cost of compliance, will be reduced. Snell testified that the mixture exclusion would have a material effect on costs of compliance and costs of enforcement. (Tr. 3837-3838, 3890; Snell Report at 520-521.) An action level would not adversely affect worker health since the worker ex posure would be below the PEL. Without such exclusions for mix tures and an action level Snell estimated that the entire work force of the United States could be covered by standards promul gated pursuant to the Proposed Regulation with costs of compli ance "significantly higher" than those estimated in the Report. (Snell Report at 5, 520-521.) Further, it would eliminate from the standards requirements many persons with infrequent and mini mal exposure who might otherwise be unintentionally and needlessly covered, such as delivery men, telephone repairmen and safety in spectors. See Air Products S. App. 9-10. - 249 - CMA 048X33 Conclusion AIHC, SPI and a number of witnesses recommended that OSHA include the action level concept and mixture exclusion in the Proposed Regulation. See, e. g. , NIOSH Tr. 3133-3136; Dr. Harris Tr. 3170-3171; Dr. Billings Tr. 2866-2867; Mr. Holaday Tr. 2321-2324. The AFL-CIO did not oppose the principle of an action level and indeed made proposals as to the level of an action level and as to monitoring. (AFL-CIO S. 17-18.) Absent such provisions all of the requirements of the stan dards arguably would apply even where only a single molecule is present. Indeed, amounts which are at the part per trillion level would be deemed "present" by Mr. Wrenn for purposes of the model standards. (Tr. 67-68.) The Proposed Regulation should be amended to provide that an appropriate mixture exclusion and action level may be set in rulemaking on individual sub stances . - 250 - CMA 048134 XVI THREE MATTERS SHOULD NOT FOR PRACTICAL AND LEGAL REASONS BE PART OF THE PROPOSED REGULATION: (1) RATE RETENTION, (2) A PERMIT SYSTEM OR (3) LIMITATIONS ON THE USE OF COMPANY DOCTORS IN MEDICAL SURVEILLANCE Three matters have been addressed by union representa tives which should not be included in the Proposed Regulation: (1) rate retention; (2) the proposal first made by Mr. Samuels on July 18 that OSHA adopt a permit system for potent carcino gens; and (3) the suggestion first made by union representatives on July 14 that severe limitations be imposed on the use of com pany doctors in the medical surveillance programs. (1) Mr. Wrenn said at the opening of the hearings that rate retention would be considered for this Proposed Regulation in a subsequent hearing after OSHA has evaluated the earnings retention hearings held last fall in the context of the proposed lead standard. (Tr. 9698; see 42 Fed. Reg. 46547 (September 16, 1977) .) (2) At the hearing on July 18, 1978 for the first time Mr. Samuels presented a permit program for "particularly virulent carcinogens". (Tr. 7256-7258, 7270-7273, 7290, 7300-7301.) This was a revival of a proposal made in 1973 in the proceedings involv ing the 14 carcinogens (Ex. 131.) and rejected by OSHA at that time Mr. Samuels' proposal was in fact a modification of the earlier pro posal but without details as to the modification, (3) In their prepared statement the AFL-CIO urged that physical examinations be given by a doctor of the worker's choice. - 251 - CMA 048135 (Notice No. 71, attachment at 15.) On July 14 and 15, union repre sentatives greatly enlarged this proposal by the surprise suggestion that severe limitations be imposed on the use of company doctors in the medical surveillance programs. (UAW Tr. 5723-5724, 5778-5781, 5791-5795; Steelworkers Tr. 5993-5995, 6032, 6050; Teamsters Tr. 5842-5843.) On practical and legal grounds, none of these pro posals should be part of the Proposed Regulation. A. Rate Retention Provisions Should Not Be Incorporated Into The Proposed Regulation It has been suggested in these proceedings that OSHA adopt a provision which would require an employer to ensure no loss of employee wages, seniority or other benefits where that employer removes an employee because of a medical determination which indicates that further exposure to the subtance in question would seriously increase the employee's health risk. AIHC believes such a provision to be unwise and without legal foundation. We support Mr. Wrenn's suggestion that this issue be addressed in a subsequent rulemaking after OSHA has had an opportunity to consider its record on this matter in the earn ings protection hearings held last fall in the context of the pro posed lead standards. (Tr. 96-98; see 42 Fed. Reg. 46547 (Septem ber 16, 1977).) Without belaboring the point, we should point out that the problem of rate retention is a complex one, varying from situ ation to situation and not readily amenable to uniform nationwide - 252 - CMA 048136 solution. Further, we believe there is no sound evidence to sup port the proposition that there is a serious problem which requires such drastic measures. Finally, and perhaps most importantly, we do not believe the Congress intended that OSHA venture into the area of economic protection but rather intended the agency to focus its efforts on providing a safe workplace. The explicit provisions of the Act, its legislative history, and other legislative efforts all clearly indicate that economic protection is an area beyond OSHA's statu tory authority. Section 27 of the Act, 29 U.S.C. 676, recognizes the problems associated with employee economic security. However, rather than authorizing OSHA to deal with the inadequacies of avail able economic assistance, the Congress decided in that section that a national commission should be established to review and report oi^J the adequacy of worker's compensation laws. The commission's report, published in 1972, has, in fact, led to many legislative amendments at both the state and federal levels. (See OSH Rep. (BNA - Cur. Dev.) 1448 [1976]; and Director, Office of workmen's Compensation v. Bouqhman, 545 F.2d 210, 215 n.15 (D.C. Cir. 1976). See also Section 4(b)(4) of the Act, 29 U.S.C. 653(b)(4). In addition, the Congress has considered and continues to consider legislative matters pertaining to economic compensa tion for work-related injuries and diseases. See, e ,g. , OSHA Rep. (BNA - Cur. Dev. -- Workmen's Comp.): H.R. 8689, 95th Cong., 1st Sess. (1977) (asbestos) and H.R. 3480, 95th Cong., 1st Sess. 253 CMA. 048137 (1977) (cotton dust); BNA, supra, August 3, July 7 and March 17, 1977 at 313, 178-179 and 1311-12? H.R. 3630, 95th Cong, (hear ings were held September 1978). Such matters are perceived by the Congress to be and are appropriately within the domain of the legislature, not OSHA. The legislative history of the Act further demon strates that Congress did not intend that OSHA become involved in economic protection. Indeed, an earlier bill approved by the House Committee on Education and Labor would have permitted a form of earnings protection. The bill as passed by both the House and Senate, however, contained no such provision. See Legislative History at 416, 842, 860, 985-86, 1008-1009 and 1089. Where the Congress has intended that an agency step into the area of economic protection, it has clearly spoken out. For example, the Coal Mine Health & Safety Act, enacted a year prior to the Act, explicitly provides a federal directive on economic compensation for individual workers. See 30 U.S.C. 901. Further, the Clean Air Act Amendments of 1977 explicitly include authorization for worker protection. See 42 U.S.C. 7410(a)(6). The fact that no such provisions are contained in the OSH Act is highly significant. B. The Permit System Has Been Insufficiently Considered In This Hearing And Is Not Authorized By Law___________________ The suggestion was made in the course of these proceedings that OSHA should include in its Proposed Regulation 254 CMA 048138 a system whereby an employer would be required to seek a use permit prior to any use in his workplace of a regulated carcino gen. Such a permit system would require the employer to be in spected and licensed by OSHA before employees are allowed to work in the area of exposure. Shutdown orders would be issued by OSHA to employers operating without a permit or to permit holders who fail inspection. In addition, permit applicants would have the burden of proving the absence of a safe or tech nologically feasible alternative to the regulated substance. (AFL-CIO Tr. 7256-7258; see also Dr. Wolfe Tr. 6353-6354). AIHC strongly believes that the establishment of a use permit system is not only unwise, but is beyond the scope of OSHA's legal authority. The primary rationale voiced in favor of a use permit system is that such a system is "the only way to ensure that zero level exposures will be implemented." (Dr. Wolfe Tr. 6353.) In deed, pre-approval inspection as a means of ensuring that no ex posure will result from the activity inherently raises the concept of zero tolerance. However, AIHC believes that it would be im proper for OSHA to set uniformly a lowest feasible level of expo sure, no less a zero exposure level. Imposition of any such single level of exposure would disregard the potency and risk of exposure to a particular substance. Therefore, AIHC supports, and the record demonstrates the propriety of the establishment of exposure levels on the basis of acceptable risk, after the risk/cost/benefit assessment, which must be an indispensable - 255 - CMA 048139 part of OSHA's regulatory decisions, has been made. Moreover, the establishment of a use permit system would clearly exceed OSHA's statutory authority. Nowhere in the statute is OSHA explicitly granted the power to impose a permit system on employers. OSHA's authority is limited under Section 6 of the Act, 29 U.S.C. 655, to the promulgation of occupational safety and health standards, to be uniformly applied to places of employment as a means of protecting the safety and health of affected employees. Where such standards could not be met, Congress provided the Secretary with authority to grant variances from standards issued under the Act under specified circumstances. 29 U.S.C. 655(b)(6) and (d). It must be recognized "that the authority to impose a permit system is equivalent to the authority to prevent a busi ness from getting started, to close down an existing operation, or, at the very least, to ban production of a particular sub stance from an operation, simply by denying a permit or refus ing to renew a permit. However, both the Act and its legislative history demonstrate that OSHA does not have and was never intend ed to have such authority. The section of this brief dealing with the "suitable substitute" provisions demonstrates OSHA's lack of authority to completely ban the production of substances. Simi larly, the agency cannot order a particular plant to cease its operations. Rather, the statute contemplates that an employer shall conduct his business in accordance with duly promulgated standards in order to provide safe and healthful working condi 256 CMA 048140 tions for his employees. If, after an investigation (pursuant to Section 8 of the Act, 29 U.S.C. 657), the Secretary deter mines that the employer is in violation of a standard, a citation may be issued (pursuant to Section 9, 29 U.S.C. 658). The em ployer is provided with a "reasonable time" to correct the viola tion or fifteen days to contest the citation. 29 U.S.C. 658, 659. The Act does not, however, provide for the cessation of operations during the time in which the employer seeks to correct the violation or contest the citation. In fact, the legislative history of the Act indicates that when it was proposed that the Secretary be vested with the power to shut down an operation for up to 72 hours if he found that an "immiment danger" existed, such a suggestion was re jected. See 116 Cong. Rec. 38,379 (1970), U.S. Code Cong. & Admin. News, 91st Cong., 2d Sess., at 5236 (1970). Under Section 13 of the Act, the Secretary may seek a cessation of operations in the case of an "imminent danger", but such an order can only be issued by a United States District Court. See 29 U.S.C. 662. OSHA itself has no direct authority to order a shutdown. Thus, "[i]t is obvious that Congress considered the shut-down of an operation such a serious matter that nothing short of the judicial process with its full complement of due pro cess protections was acceptable as a means of accomplishing it." Usery v. Whirlpool Corp., 416 F. Supp. 30, 34 (N.D. Ohio 1976). A use permit system such as that proposed during these proceedings would vest in OSHA the very authority which Congress intended to be exercised, if at all, by the courts, and not by the agency. - 257 - cMA 048141 Had Congress intended that OSHA have the power to issue permits ordering a cessation of operations (or a ban on production) it would have granted such authority expressly in the statute. In a number of other statutes, Congress has ex plicitly granted administrative agencies the authority to issue permits or licenses. These statutes include: the Federal Food, Drug and Cosmetic Act, 21 U.S.C. S 301 et seq.; the Federal Water Pollution Control Act, 33 U.S.C. 1151 et seq.; and the Communications Act of 1934, 47 U.S.C. 151 _et seq. Absent such explicit authorization in the Act, the power to establish a use permit system cannot be implied in OSHA. The Supreme Court has clearly stated that "[w]hen Congress passes an Act empowering administrative agencies to carry on government activities, the power of those agencies is circumscribed by the authority granted. Stark v. Wickard, 321 U.S. 288, 309 (1944). Finally, it should be noted that this issue was not raised in the OSHA proposal nor has it been adequately discussed in the proceedings to date. To move forward as suggested, pre sents, in addition to all the other problems outlined, serious questions of procedural due process. C. The Proposal To Restrict Use Of Company Doctors In Medical Surveillance Programs Is Unsound For Practical And Legal Reasons And Without Support In The Record_____ In its prepared statement, the AFL-CIO proposed that physical exams be given by a doctor of the worker's choice. (AFL-CIO Notice No. 71, attachment at 15.) At the hearing. 258 CMA 048142 however, union representatives proposed' a surprising new and sweeping limitation on the use of company doctors in medical surveillance. (Tr. 5723-5724, 5778-5781, 5791-5795, 5842-5843, 5993-5995, 6032, 6050.) This proposal by the unions late in the hearings presents serious practical and legal problems. A major underlying purpose of the medical surveillance program is to enable the company and the government to do pros pective epidemiology. There is no way that this objective can be achieved unless full information regarding workers' health and exposure can be appropriately recorded. Indeed, this pro cedure may be the only effective way to identify susceptible individuals whose exposure would present significant problems. Thus, for example, if smoking increases the risk of lung cancer by orders of magnitude when the worker is exposed to asbestos, knowledge of smoking habits is the only way to protect the worker. See Dr. Lamm S. 4-5 (AIHC P.H.). Some of the union representatives complained about the incompetence of company doctors. E.g., Tr. 5991-5993. This is not, however, a matter for general regulation. The reason able way to deal with incompetence, if indeed it exists, is to enlist the State medical authorities and the medical societies and to make the medical program a matter of collective bargaining. Under some circumstances, moreover, incompetence in performing medical surveillance could be a basis for an QSHA enforcement proceeding. To use the isolated instances cited by the unions as a ground for sweeping condemnation of company medical sur - 259 - CMA 048143 veillance programs is totally unjustified. Post-hearing filings by Dr. Alan A. McLean, President of the American Occupational Medical Association (Ex. 209), Dr. Harold R. Imbus, Medical Director of Burlington Industries, Dr. M. A. Johnson, Administrator Environmental Health Projects of the B. F. Goodrich Company, Dr. K. D. McMurrain, Medical Direc tor of the Procter & Gamble Company, and Edward C. Dalglish, General Manager of Hughson Chemicals, provide cogent reasons why the union's belated proposal to restrict company doctors is un sound . First, the very high worker participation in voluntary medical examination programs demonstrates that workers do not distrust or have concern about the position of company doctors. Second, the quality of the medical surveillance would suffer because the majority of physicians lack training in occu pational medicine. When there is an examination of workers at regular intervals by a trained company doctor, earlier detection of industrially caused disease is enhanced. When the examinations are done by one physician or several physicians in close commun ication, it is possible to arrive at useful conclusions which would not occur if examinations were not standard and records scattered. Thus, the observation that vinyl chloride is a human carcinogen was made by a doctor who noticed three cases of an unusual tumor. Had separate doctors seen the workers it is unlikely that the connection would have been made. Third, unless medical records are assembled centrally, 260 CMA 048144 it will be much more difficult to conduct the epidemiological studies which are an essential objective of medical surveillance programs. These post-hearing filings also demonstrate the signi ficant efforts that are being made to upgrade the standards of occupational medicine and the high level of ethics observed by company doctors. It would do workers a disservice were OSHA to take steps which would set back occupational medicine by promoting the dispersal of medical surveillance among untrained general physicians. Finally, despite the post-hearing filings discussed above, there is a serious question of notice and due process. This proposal was made long after the hearing began and at a time when many company witnesses had already testified and had no opportunity to respond. Others had no notice of the union demand and thus no reasonable opportunity to comment. Conclusion For the foregoing practical and legal reasons, there should be no provision in the final regulation requiring rate retention, establishing a permit system or restricting company medical surveillance. - 261 - CMA 048145 XVII KEY WORDS IN THE PROPOSED REGULATION ARE IMPERMISSIBLY VAGUE The Proposed Regulation is impermissibly vague in its failure to define a number of key terms. For example, OSHA's pro posal provides no definition of the term "suitable substitutes" (Section 1990.112) or of the phrases "as low as feasible" (Sec tion 1990.112) and "lowest feasible level" (Section 1990.160(c)). Other impermissibly vague aspects of the regulations include the lack of definition of "suggestive" (Section 1990.102), trie "any other evidence" criterion (Section 1990.110), whether a substance has "unique" properties or uses (Section 1990.113(d)), and the rebuttal criteria of Section 1990.111(a), including the terms "grossly inappropriate" (Sections 1990.111(a)(2) and 1990.121(a) (2)), and "totally inadequate" (Sections 1990.111(a)(4) and 1990 .121(a)(4)), The vagueness of these terms effectively deprives the public of a meaningful opportunity to comment on the Proposed Regulation. Moreover, the vagueness of these terms would render he Proposed Regulation invalid as a denial of due process. A. Critical Terms In The Proposed Regulation Are Vague And Inadequately Defined________________________________________________ __ A number of critical terms in the Proposed Regulation have either been inadequately defined or not defined at all. For example, the regulations provide in Section 1990.112(b) that, upon a finding by the Secretary of Labor that there are "suitable - 262 - CMA 048146 substitutes" for certain uses or classes of uses that are less hazardous to humans, no occupational exposure shall be per mitted for such uses or classes of uses. However, nowhere in the Proposed Regulation or in the Preamble thereto are there any criteria for determining what constitutes a "substitute", nor are there criteria for measuring "suitability" of a sub stance as a substitute. Mr. Wrenn, candidly admitted that OSHA had not moved beyond the conceptual stage in developing factors for determining what is a "suitable substitute". 122.) (Tr. 121- Similarly, the other key terms in the Proposed Regula tion referred to above suffer the same defect of vagueness and inadequate definition. The AIHC, on the other hand, provides a full and precise explanation for each of the critical terms and concepts included in its Alternative. For example, in place of the vaguely defined concept of "lowest feasible level", the AIHC recommends the determination of an "acceptable risk level" for each Category I and II substance, to be determined by a process of risk and benefit assessment fully described in the AIHC Alternative. See AIHC Alternative at 33-34, 78-84. This is the procedure approved by the Benzene decision. B. Critical Terms In The Proposed Regulation Are So Vague As To Preclude Effective Public Comment On The Proposed Regulation Section 4 of the Administrative Procedure Act, 5 U.S.C. 553(b)(3), requires that prior to the promulgation of a final - 263 - CMA 048147 rule, the agency must publish either the terms or the substance of the proposed rule or a description of the subject and issues involved. The courts have ruled that an agency's notice of proposed rulemaking must describe sufficiently the subject matter of the rulemaking so that informed comment and criti cism can be offered by interested parties. See Portland Cement Association v. Ruckelshaus, 486 F.2d 375, 392-394 (D.C. Cir. 1973), cert, denied, 417 U.S. 921 (1974); Mobil Oil Corp. v. FPC, 483 F.2d 1238, 1249-1251 (D.C. Cir. 1973). The courts have not hesitated to invalidate final regulations where the agency did not give adequate notice of the subjects and issues involved and thereby deprived the public of an opportunity to submit effective and meaningful'comments. See, e .g. , Wagner Electric Corp, v. Volpe, 466 F.2d 1013, 1019-1020 (3d Cir. 1972); Natural Resources Defense Council v. SEC, 389 F. Supp. 689, 698-700 (D. D.C. 1974). Without more detailed knowledge of the criteria which OSHA proposes to apply in determining what constitutes a "suit able substitute", "lowest feasible exposure" or "other evidence convincing to the Secretary, or how the presumption that a sub stance should be classified as a Category I substance can be rebutted, it is impossible for manufacturers or users of poten tially affected substances to offer meaningful comment on the impact of OSHA's proposed method of controlling Category I toxic substances. If, for example, the public were advised whether and how OSHA proposes to take into account such factors - 264 - CMA 048148 as differences in cost .and availability of supply in determin ing adequacy of substitutes, manufacturers and users could sub mit detailed factual and legal arguments and appropriate scienti fic and economic data for OSHA's consideration. Use of vague and insufficiently detailed criteria thus defeats the purpose of Section 4 of the Administrative Procedure Act, to provide for informed public participation in the rulemaking proces and to enable the agency promulgating the rule "to educate itself before establishing rules and procedures which have a substantial impact on those regulated." Texaco v. FPC, 412 F.2d 740, 744 (3d Cir. 1969); see also Natural Resources Defense Council v. SEC, supra, at 699. If the Proposed Regulation was adopted as a final regu lation, manufacturers and users could be precluded from challeng ing the validity of the consequences of classification of a substance as a Category I toxic substance, including a ban on production if a "suitable substitute" exists. While the defini tion of "suitable substitute" and other vaguely-defined terms may be fleshed out on an ad hoc basis in a series of individual rulemakings, such rulemakings cannot afford industry in general an adequate opportunity for comment and hearing on OSHA's defini tion of these critical terms. The issues in these individual rulemakings will be limited to the principal question whether the substance was correctly classified as a Category I toxic sub stance and, secondarily, to various ancillary issues viewed in the context of the particular substance. Thus, there will be - 265 - CMA 0481^9 little or no opportunity to comment on the more detailed cri teria which OSHA will presumably adopt to give meaning to these vague and insufficient terms. Moreover, it is unlikely that parties not directly concerned with the substance at issue will be able to participate effectively, even though their interests may be vitally affected by the implicit or explicit development of precedent as to the meaning of key terns. The courts have rejected agency attempts to circumvent the notice requirement of Section 4 of the Administrative Proce dure Act where the agency has adopted ambiguous rules and evaded proper rulemaking procedures when the ambiguous rule later was clarified. In Saint Francis Memorial Hospital v. Weinberger, 413 F. Supp. 323 (N.D. Cal. 1976), the Department of Health, Education and Welfare ("HEW") adopted unclear rules on account ing for interest paid on certain construction loans and subse quently sought to "clarify" its rules, both retroactively and prospectively, without conducting a rulemaking. The court fol lowed Pharmaceutical Manufacturers Ass'n v. Finch, 307 F. Supp. 858 (D. Del. 1970), in holding that a rulemaking was required because the clarification was not interpretative. The court observed in St. Francis that a rule is substantive and not interpretative where "there is such genuine ground for differ ence of opinion on the wisdom of the policy embodied in the rule as to make the hearing process a meaningful and important requirement." Saint Francis Memorial Hospital v. Weinberger, supra, at 329. The court rejected HEW's argument that its 266 CMA 048150 "clarification" was not a substantive rule because, prior to its issuance, HEW's regulations were ambiguous: "In essence, defendants' argument seems to be that because the Secretary created an ambiguity in the regulations he need not adhere to the proper rulemaking procedure when he clears up that ambiguity. Without reaching the issue of whether there was any ambiguity in the regula tions as they existed at the time section 206 was promulgated, the court rejects this argu ment as fundamentally inconsistent with the purposes of the rule-making requirements of the Administrative Procedure Act. The Medicare Act conferred on the Secretary the authority and duty to promulgate regulations governing re imbursement of providers of medical services. He could not fulfill that duty by enacting am biguous regulations through the proper proce dure and then 'clarifying' them behind closed doors thereafter." ^d_. at 330. Similarly, OSHA may not properly seek to insulate its proposed standards for regulation of Category I toxic substances from a rulemaking which provides for public comment on the merits of the proposed standards by subsequently adopting criteria which define "suitable substitute", and "lowest feasible occupational exposure", and other critical terms without effective opportunity for public participation. C. If Adopted In The Form Proposed, These Vague Provisions Of The Proposed Regulation Would Deprive Affected Parties Of Due Process Of Law By reason of the defects referred to above, the Proposed Regulation is so vague and indefinite as to allow the agency vir tually unlimited discretion in severely limiting or even banning the manufacture and use of Category I toxic substances. The breadth of this discretion violates the constitutional require- - 267 - CMA. 048151 ment that administrative action be guided by regulations setting out standards which are sufficiently definite to confine agency 1/ discretion within predetermined bounds. Without such standards, affected parties are deprived of due process of law, and meaning ful judicial review of agency action is impossible. In Environmental Defense Fund v. Ruckelshaus, 439 F.2d 584 (D.C. Cir. 1971), the court reviewed EPA's refusal to sus pend the registration of DDT as a pesticide. The court noted that it had neither an evidentiary record, nor scientific ex pertise to aid its review of the agency's actions, but that it had "an obligation to ensure that the administrative standards conform to the legislative purpose, and that they are uniformly applied in individual cases." Id, at 596. The court remanded to EPA for an explanation and formulation of standards to guide agency discretion: "Judicial review must operate to ensure that the administrative process itself will confine and control the exercise of discretion. Courts should require administrative officers to arti culate the standards and principles that govern their discretionary decisions in as much detail as possible." _Id. at 598 . See also Holmes v. New York City Housing Authority, 398 F.2d 262, 265 (2d Cir. 1968) . These decisions were followed in City of Santa Clara v. Kleppe, 418 F. Supp. 1243 (N.D. Cal. 1976), a case in which 1/ See generally Papachristou v. City of Jacksonville, 405 U.S. 156, 170 (1972); Kenneth Culp Davis, Administrative Law of the Seventies, supplementing Administrative Law Treatise, 2.00 - 2.04 (1976); Amalgamated Meat Cutters v. Connally, 337 F. Supp. 737, 758-759 (D. D.C. 1971). 268 CMA 048152 the Bureau of Reclamation's decision withdrawing low-cost federal hydroelectric power from the City of Santa Clara was remanded for failure to provide procedural due process: "Procedural due process has a function beyond that of encouraging enlightened, informed administrative decisions. Courts have with increasing frequency recognized that due process means that administrators must do what they can to structure and confine their discretionary powers through safeguards, stan dards, principles and rules ... It is all the more imperative that courts require admin istrators to articulate the standards that guide their discretion where, in cases such as the one at bar, the court lacks the scien tific expertise that would permit meaningful review." Id. at 1260-1261. Similarly, regulation of carcinogens involves complex and highly technical determinations. If the Proposed Regulation is adopted in the form proposed, OSHA's vague and indefinite standards for controlling Category I toxic substances would en courage arbitrary and inconsistent determinations by OSHA. By the same token, the lack of content of many key terms in the Proposed Regulation would effectively prevent meaningful judi cial review both of the Proposed Regulation itself and of sub sequent regulatory actions taken pursuant thereto. - 269 - CMA 048153 PART FIVE XVIII OSHA'S MODEL STANDARDS ARE UNLAWFUL AND INAPPROPRIATE A. The Act Prohibits The Kind Of Inflexible Model Standards OSHA Has Proposed In describing health standards that OSHA must promulgate, among the benchmarks used by the Congress were that standards be "appropriate", "reasonably necessary or appropriate", "feasible", and based on the "best available evidence". See 29 U.S.C. 652 (8), 655(b)(5) and 655(b)(7). To establish rigid, inflexible model standards in this rulemaking without regard to their need or ade quacy in the context of particular substances and workplaces flies in the face of OSHA's statutory mandate. Any model standards should be in the nature of guide lines and should be sufficiently flexible to accommodate disparate properties, hazards and workplaces. There is a great danger in deciding these matters, a priori, in this rulemaking for all sub sequent rulemakings. OSHA's professed need for expedition should be no bar to a considered analysis in subsequent rulemakings of language appropriate to the matter then at hand. Certainly OSHA can, as it has in the past, and as it has in the proposed model standards, draw heavily (and expeditiously) from language used in past standards. There is no need to lock the agency in, at this time or in the foreseeable future, to specific language in a model standard. 270 CMA OSHA urges that there is sufficient flexibility in the model standards because it will consider in subsequent rulemakings the "unique properties or uses" of substances to deter mine whether the standards are "inappropriate" or "infeasible". (Section 1990.113(d), 43 Fed. Reg. 54173.) This position is not persuasive, however, for several reasons. First, none of these critical terms is defined so there is no way of knowing how OSHA will implement this provision. Second, in looking for exceptions to what should be required rather than looking to what should be required, OSHA is turning the statute on its head and proceed ing in a most unscientific manner. In addition, while there may be an opportunity in a subsequent rulemaking to argue that a model standard is " inappropr ia-te" or "infeasible" because of the "unique" properties of the substance, this, in practice, will put a very heavy burden on the proponent of such a proposition. Moreover, while there may be some opportunity to argue the merits of permanent model standards in subsequent rulemakings, this opportunity will be considerably more limited with respect to the model emergency temporary standard which will go into effect promptly after categorization. (Hygiene Panel Tr. 2693-2694.) Thus, while OSHA argues that there is sufficient flexibility to accommodate future concerns, we do not agree. Even if the model standards are to be used only as guidelines, there is need for significant revisions. Because AIHC believes a "fill-in-the-blank" approach is inappropriate, it has recommended in its Alternative to the - 271 - CMA 048155 OSHA proposal that the basic principles applicable to model standards be elucidated in this rulemaking which would then be addressed in the context of particular risk/hazard combina tions in subsequent rulemakings. AIHC Alternative at 50-52. See Appendix F to this brief. NIOSH and others have also expressed concern about the inflexibility of the standards. In particular NIOSH recommended that OSHA seriously consider an approach to the model standards which would set out several alternate options within each subsection of the standard tailored to particular characteristics and properties of the substances to be regulated. See letter from Edward J. Baier to Docket Officer dated June 7, 1978. For example, there might be three alternate sections on personal protection from which OSHA could select the bestsuited provision for a particular substance. This, as NIOSH notes, is an approach that OSHA and NIOSH have used in their joint Standards Completion Project. Unfortunately, the proposed model standards seem to proceed on the assumption that the sub stances to be regulated present similar hazards and risks and therefore require similar monitoring, medical surveillance and housekeeping. In fact, as discussed earlier, this is clearly not the case. Indeed as API very ably points out in its post hearing comments, OSHA's previous standards for carcinogens have frequently varied from the rigid requirements embodied in the proposed model standard. 272 CMA 048156 B. Because The Model Standards Will Be Applicable In Enforcement Actions, Their Meaning Must Be Clear Because the model standards proposed in this rulemaking may be the subject of compliance action by OSHA's field enforcement staff, the standards must, to the extent possible, be crystal clear both to the regulated and to the OSHA field staff. Any possible ambiguities, as noted by OSHA's industrial hygiene panel, should be clarified now to avoid future contro versy and litigation. (Hygiene Panel Tr. 2620-2621, 2698-2699.) The purpose of many of the following comments on the model standards is to do just that. C. The Model Standards Are In Need Of Revision 1. Scope and Application (Subsection (a)) The model standards should provide for an "action level" below which certain provisions of the standards, such as medical surveillance and monitoring, are not required and should provide a cutoff for mixtures containing small amounts of the regulated substance. In the absence of such provisions, all of the require ments of the standards arguably would apply even where only a single molecule of a regulated substance is present. The regulations should also exempt laboratory, mari time, construction, and agricultural workplaces from its scope. These workplaces should be handled separately by OSHA. See discussion supra, at 37-41. - 273 - CMA 048157 2. Definitions (Subsection (b)) In order to avoid ambiguity, certain terms used in the model standard are very much in need of definition. Among these are the terms "feasible", "suitable," "occupational exposure" (Wrenn Tr. 37-38, 67-68), "present" and "work area" (Hygiene Panel Tr. 2813-2815). Further, the definition of the term "emer gency" is too broad. It should include only occurrences which result in massive releases. See Air Products S. App. 15-16. 3. Permissible Exposure Limit (Subsection (c)) a. General The model standard provisions requiring lowest level feasible exposures or mandating substitution should be modified as noted earlier in this brief. b. Dermal and Eye Exposure As proposed, the model standards for Category I and II would require that the employer "assure that no employee is ex posed to eye contact or skin contact" with the substance. Sec tions 1910.160(c)(2) and 1910.170(c)(2). Such a seemingly abso lute prohibition is logically inconsistent with permitting finite airborne exposures in the workplace. (NIOSH Tr. 3140-3141.) Moreover, even protective clothing and equipment cannot eliminate all skin and eye contact. (Dr. Holaday S. 6-7, Tr. 2838-2839.) The provisions of the model standard are also at variance with the Preamble to the Proposed Regulation which states that the provision is directed only at "repeated" skin contact. 42 Fed. Reg. 54174. 274 CMA 048158 The preferable approach to requiring what appears to be zero exposure is, as noted by NIOSH, to tailor the require ments to the hazard for eye and skin contact. Varying physical properties and hazards require varying regulatory responses. (NIOSH Tr. 2634.) Some substances may require substantial safe guards, others only minimal safeguards. (NIOSH Tr. 3138-3140; Dr. Murray S. 4-5.) The concept of the significance of the hazard presented should, according to NIOSH and Dr. Soule, be factored into this aspect of the regulation. (NIOSH Tr. 31403141? Soule Tr, 2813-2832.) A sensible approach suggested by NIOSH is to specify protective clothing which is designed to meet a particular goal rather than require an absolute prohibi tion (e.g., require protective clothing sufficient "to prevent prolonged or repeated contact"). See NIOSH submission on Standards Completion Project Decision Logic at 82. Further, Dr. Holaday suggested OSHA's permanent standard should be clarified and explicitly state for substances to be regulated "why protective clothing is required and what ex posures are sought to be avoided or reduced." (Dr. Holaday S. 6.) c. Category II Substances OSHA has invited comment on that aspect of its proposal which requires for Category II substances that permissible ex posure limits be established or reduced where necessary to that level which protects against acute or chronic non-carcinogenic effects. - 275 - CMA 048159 AIHC is of the view that in such situations (OSHA Category II, AIHC Category III), the substance should be referred to the Interagency Testing Committee ("ITC") for possible testing. Further, we believe OSHA should have the authority to issue a notice of proposed rulemaking to set the PEL at the present OSHA standard or establish a new or reduced PEL based on the 1/ acute or chronic non-carcinogenic effects of the substance. AIHC Alternative at 85. 4. Exposure Monitoring (Subsection (e)) a. Representative Monitoring The model standards require representative employee monitoring. The Preamble makes clear that any form of monitoring which is "representative" is permissible. 42 Fed. Reg. 54175. This would include both biological monitoring and area sampling. It may include sampling one employee or many for several hours or for a full 8-hour shift. The model standard is, however, sus ceptible to a different interpretation; particularly Section 1910 .160(e)(3)(ii) , which requires in the case of exposures exceed ing the PEL limit that the employer repeat monitoring for "each 1/ We do not subscribe to the AFL-CIO suggestion that a sub stance remain in Category II for no more than three years. We believe no arbitrary time limit should be set but rather that the ITC should determine the relative urgency and need for testing the substance in question. Given the limited testing resources available in the nation, it would not be possible to test within three years the large number of substances which might fall into Category II, a number which Clement has estimated to be as high as 218. 276 048160 CMA such employee monthly." Some have taken this to mean that bio logical samplinq of each exposed employee is necessary, a clearly 1/ unnecessary allocation of manpower and resources. See Reynolds Metals Co. S. 2-3. The standard should make clear that that the "representative" which is used only in Section 1910.160(e)(1)(i) is intended to be applicable throughout subsection (e) and that biological monitoring and area sampling are permitted forms of monitoring. Further, it should be made clear that what is "rep resentative" may vary considerably depending on the properties of the substance and the nature of the workplace and the exposure, b. Initial Monitoring Where the regulated substance is "present", the model standard requires initial monito'ring. While this may be a generally sensible provision, an exception to this requirement should be made where exposure is not reasonably foreseeable as in the case of materials locked into products in such a way that their release is not likely. See, e .g., Johns-Manville S., Exhibit A at 4, on fibers locked into asbestos products. The standard should permit the use of an initial "determination" in the place of initial "monitoring" in such situations, as well as in other appropriate situations. See NIOSH/OSHA Standards 1/ If, for example, an employer has fifty employees who per form the same job, and industrial hygiene monitoring has confirmed that in the group of employees all have approxi mately the same type and level of exposure, the employer should be permitted to comply with the standard by moni toring three or four employees on a monthly basis. - 277 - CMA 048161 Completion Project, 40 Fed. Reg. 20201, 20203 (May 8, 1975). c. Additional Monitoring The model standards require additional monitoring when ever there has been a production, process, control or personnel change which may result in new or additional exposure. Section 1910.160(e)(4). This provision is susceptible to an overly broad interpretation requiring additional monitoring when there is any change in production, process or control, however minor. The in tent of the provision would appear to be to reach only matters of significance and, accordingly, A1HC suggests that the word "signi ficant" be added before the word "exposure". OSHA should not lose sight of the fact that our national industrial hygiene and analytical resources are limited and that these resources should not be overburdened with unnecessary chores. (Hygiene Panel Tr. 2827-2828.) d. Employee Notification The Act requires that notice be given only to those em ployees exposed in excess of the PEL, not to those exposed below the PEL. 29 U.S.C. 657(c)(3). The model standard should be re vised accordingly. Rather than requiring written individual employee noti fication in all situations, the standards should permit other rea sonable means of notification, such as posting. An unintended but, we believe, serious possible ramifi cation of the burdensome requirement for employee notification proposed by OSHA is that employers may be discouraged from using 278 CMA 048162 automatic monitoring devices because minor deviations may more frequently trigger onerous notification requirements. 5. Methods of Compliance (Subsection (g)) The OSHA proposal requires the use of engineering con trols or work practices to reduce exposures to the extent feasi ble. Further, the proposal requires the use of engineering con trols even when they will not reduce exposures below the PEL. While AIHC subscribes to the view that in many situa tions engineering controls are the best means of compliance, the model standard should be flexible enough to permit other effective means of control where appropriate. For example, it may be that relatively simple and inexpensive protective clothing may as adequately serve OSHA's goals as expensive engineering equipment where the hazard is skin contact. See Dr. Murray S. 4; API Alternative Panel Tr. 4539-4541. Further, if engineering controls will, in any event, have to be supplemented by other means of control in order to achieve compliance, it makes little sense from a health or econ omic perspective to require installation of expensive engineering controls which cannot do the job anyway. (API Alternative Panel Tr. 4540-4543.) In its economic study, Snell concludes that the mandated preference for engineering controls is one of the single most costly aspects of the OSHA proposal. See Snell Report at 496, 503, 519. The President's Regulatory Analysis Review Group ex pressed similar reservations to OSHA's mandated preference for - 279 - CMA 048163 engineering controls in its analysis of OSHA's acrylonitrile proposal. (Ex. 45 at 21-24). The Group urged consideration be given to wider use of non-engineering controls, where appro priate, to achieve the desired end. Finally, if respirators and protective clothing are relegated to the subsidiary role envisioned by OSHA there will be little, if any, incentive for industry to develop better respira tors and protective clothing, a most unfortunate development. We concur in the recommendation of the Environmental Defense Fund that for OSHA Category II substances OSHA should require only a practical combination of administrative, work practice and readily available and economical engineering con trols. (EDF Tr. 7328-7330.) Since Category II is essentially a transitory stage, it makes little sense to require installation of expensive engineering controls for substances which are likely to be reclassified shortly as Category I or III. 6. Respiratory protection (Subsection (h)) As noted in the preceding section, AIHC is of the view that means other than engineering controls or work practices, including respiratory protection, may be appropriate in certain limited circumstances. While AIHC and other industry participants do not be lieve that regular 8-hour per day use of respirators is gener ally a sound approach to control (Tr. 3820, 4516), there nay be situations where brief exposures occur regularly or irregularly 280 CMA 048164 for which respirator usage seems appropriate but which none theless do not appear to fall strictly within OSHA's limited exceptions for respirator use. For example, a brief exposure of a few minutes duration, a couple of days a week, for an employee entering a production room from a quality control room where there are engineering controls would seem to be a situation in which it makes more sense to use a respirator than to install very expensive engineering controls. (Mr. Douglas Tr. 2776.) There is a need for maintaining flexibility concerning the use of respirators. NIOSH suggested an approach for respira tor use similar to that in the Standards Completion Project, which permitted respirator use for one hour per week (see, e.g., 40 Fed. Reg. 20201, 20211 (May 8, 1975)) over and above the exemptions OSHA has already suggested in this proposal. (NIOSH Tr. 3145-3146.) We believe such an approach would be a useful starting point. 7. Emergency situations (Subsection (i)) Subsection (i)(2)(i) requires the installation of alarms to alert employees to emergencies. This provision should be suf ficiently flexible to permit means of alerting employees to hazards other than by sound alarms. 8. Protective clothing and equipment (Subsection (j)) OSHA's proposed model standard is susceptible to the construction that whenever eye or skin contact "may occur" pro tective clothing is necessary. - 281 - CMA 048165 This provision of the model standard should be clarified to assure that such equipment is required only where there is a reasonable likelihood of significant exposure which may affect the worker's health, (NIOSH Tr. 3141, 3143.) Dr. Holaday recommended use of protective clothing to protect against the "demonstrated risk of skin cancer, or even where the risk is subject to debate, where employees are subjected to repeated insults to the liquid form of Category I substances presenting the possibility of skin absorption." (Dr. Holaday S. 5-6.) He did not recommend protective clothing wherever any con tact "may occur" with a Category I substance. Indeed, he noted some of the difficulties of extended usage of such clothing. (Dr. Holaday Tr. 2839.) 9. Housekeeping (Subsection (k)) a. Surfaces OSHA's proposal requires that all surfaces be maintained "free of accumulations". It is, as OSHA's own witnesses recognized, of course, not possible to keep surfaces absolutely free of con taminants where finite airborne exposures are permitted. (Hygiene Panel Tr. 2626.) Among the options the Hygiene Panel suggested should be considered were that a quantitative parameter or a "visibility" criterion be used as benchmarks where appropriate. (Hygiene Panel Tr. 2627-2629, 2633, 2695, 2809-2810.) Even OSHA's recent cotton dust and inorganic arsenic standards require only that 282 CMA 048166 surfaces be maintained as free "as practicable" of accumulations. See 29 C.F.R. 1910.1018(k)(1) and 29 C.F.R. 1910.1046a(c)(1) (i); 43 Fed. Reg. 19583, 19627 (May 5, 1978); 43 Fed. Reg. 27349, 27434 (June 23, 1978). By requiring adequate decontamination pro cedures, AXHC believes OSHA should be able to obtain the same work place objective without the attendant difficulties associated with the words "free of accumulations", b. Vacuum The standards appear to require separate portable vacuums for each regulated substance. This is an unnecessary burden for employers who may have many regulated substances in their work place. The burden would be particularly heavy on laboratories and batch operations. Absent a'showing of hazard associated with the use of the same vacuum for multiple substances, we see no need for such a restrictive requirement. (Nat. Constructors Ass'n., Ex. 125 at 10-11.) c Waste Disposal The model standards require waste from regulated sub stances to be disposed of in sealed bags or closed containers. While this again is generally sensible, where such wastes, because of their characteristics, e.g. , having been incorporated in another substance, are not likely to present a hazard, disposal in this manner seems unnecessary. (Johns-Manville S., Ex. A at 89.) Fur ther, disposal of large equipment in sealed bags is an obvious impossibility. Adequate decontamination procedures should be allowed as a substitute. See Air Products S. App. 13. - 283 - CMA 048167 10. Hygiene facilities and practices (Subsection (m)) The standards require employers to provide lunchroom facilities which have a temperature controlled, positive pressure, filtered air supply whenever food and beverages are consumed in the "workplace". The term "workplace" is not defined. If it is defined to mean anywhere in the entire place of employment, a severe hardship may occur. See Polyurethane Manuf. Ass'n S. 12. The requirement for showers should be tailored to the needs of the workplace in such a way that the showers requirement could be less onerous if one is, for example, dealing with volatile sub stances. See, e.g., Benzene Standard, 43 Fed. Reg. 5954 (Febru ary 10 , 1978 ) . The model standards also require employers to "assure" that employees wash their hands and face prior to eating. Apart from providing training, education, facilities and opportunity for use of facilities, it is not reasonably possible for employers to "assure" that employees wash their hands or face. If the word "assure" means the foregoing, then it should be so defined. If it means more, we think serious questions of personal freedom and physical compulsion are raised. The use of the word "assure" in this section (and in other sections) of the model standards should be deleted and the word "require" substituted therefore with an appropriate definition to exclude compulsion. See JohnsManville S., Ex. A at 9. 11. Medical surveillance (Subsection (n)) The need for an action level is particularly evident in 284 CMA 048168 this subsection which would require medical surveillance where there is any exposure whatsoever even for guards or delivery personnel who might enter a facility only a few times a year. (Hygiene Panel Tr. 2833-2835; Johns-Manville S., Ex. A at 9- 10.) Such an approach to regulation would be an extremely wasteful allocation of the limited medical resources available to our nation. The model standards do not appear to require medical exams at specified periodic intervals. AIHC endorses the need to retain this flexibility and the need for tailoring the fre quency and nature of periodic exams to the substance and work place in question. To set an arbitrary limit makes little sense since many medical procedures themselves involve inherent risks. (Dr. Lynch S. 3.) The standards also require that a medical exam be made available to an employee who has not had an exam within six months of the termination of his employment. Such examinations do not seem to be a useful expenditure of limited medical resources parti cularly where periodic exams are required. The matter should be left in the sound discretion of the employer who will take into account his medical surveillance program and the medical surveil lance needs for the particular substance in question. This is not a matter which should be dealt with "across the board" in a regu lation. (Johns-Manville S., Ex. A at 11.) In addition, the standards require the employee's phy sician to state whether the employee has "any detected medical 285 CMA 048169 condition which would place [him] at an increased risk of material impairment" from exposure to the substance. Such a requirement is an unreasonable one to place on a physician, particularly in times such as these when malpractice plays such a significant role in a physician's professional life. The standards provide no guidance whatsoever to the physician in making the Solomonlike determination as to what is an "increased risk of material impairment." Finally, the standards prohibit physicians from dis closing to employers findings or diagnoses unrelated to occupa tional exposure discovered in the course of medical examinations. This provision should make clear that a physician may advise the appropriate supervisor of the employee (e.g., plant manager) of restrictions which should be placed on the employee's work acti vities, if any, for medical reasons without disclosing the mediical reasons therefore. To do otherwise would deny the employer information essential to maintaining a safe workplace. See Reynolds Metal S. at 5. 12. Signs and labels (Subsection (p)) For reasons set forth infra, at 291, AIHC believes OSHA does not have authority to promulgate the proposed standards deal ing with labeling. The record includes no evidence to support the use of the legend which OSHA proposes for its signs and labels. When OSHA's industrial hygiene panel and the NIOSH panel were queried 286 CMA. 048170 on this issue, neither were able to offer any evidence in support of the OSHA position. (Hygiene Panel Tr. 2699-2715; NIOSH Tr. 3052-3053.) Indeed, they were totally unfamiliar with the exten sive literature on the subject cited by counsel for the Polyure thane Manufacturers Association. (Tr. 2699-2715.) Although counsel for PMA requested that OSHA present the evidence upon which it relied on this issue, OSHA failed to do so. (Hygiene Panel Tr. 2731-2732.) As Dr. Chapanis noted, a sign with the legend "cancer" merely creates fear-in employees and does not provide those employees with any understanding of the nature of the hazard to which they are exposed. (Dr. Chapanis Tr. 7076.) Dr. Chapanis was particularly critical of OSHA's failure to provide a positive instruction about what to do in the presence of the hazard. (Dr. Chapanis Tr. 7073-7077, 7084, 7090-7091.) 13. Recordkeeping (Subsection (g)) The model standards evidence no thought with respect to what OSHA intends to do with the voluminous records it has asked to be kept and no forethought as to what purpose these records will serve. Further, there is no evidence of any effort to attempt to minimize paperwork burdens by coordinating these requirements with other federal agency requirements. Dr. Berg noted critically that the time to plan the analyses of data is before collection begins, not after masses of material are accumulated. (S. 25.) He recommended that outside expertise be used in the design - 287 - CMA 048171 of a minimally effective system to determine which administra tively desirable goals are feasible, as well as to help deter- 1/ mine how best to achieve feasible goals. Id., at 26. We whole heartedly endorse this concept. The ever-increasing paperwork burden has been the subject of much discussion by the Federal Commission on Paper work, the President in Executive Order No. 12044 (published at 43 Fed. Reg. 12660, 12668 (March 24, 1978)) and others. JohnsManville suggested that pilot recordkeeping programs be inaug urated to insure efficient, meaningful data compilation. See Johns-Manville S., Ex. A at 13-15. Some such system would appear to be necessary to insure that the right data are being collected in the right way. NIOSH's response to a question about whether it has made any effort to study the voluminous records collected to date for carcinogens is most illuminating. In response to a question as to what kind of analysis and study has taken place to date with respect to the records accumulated by NIOSH on the 14 carcinogens, the Director stated that no studies have taken place but that they have been "looked at a couple of times." (NIOSH Tr. 3144-3145.) Much to our consternation, at the very time this rulemaking is going forward OSHA has decided to publish yet another rule and proposed rule dealing with the question of medical and 1/ Testimony was presented by Diamond Shamrock on an innovative system they were well on the way to develop ing which they had offered to share with OSHA. (Tr. 7742-7749.) - 288 - CMA 048172 1/ exposure recordkeeping and access thereto, It is not clear whether this newly proposed regulation "preempts" the issues on this matter so that they will be resolved in another forum. In view of the strange double method of addressing the issue of these records and access thereto, we will make only a brief comment despite the importance of the matter. Medical records contain much private information and access to them should not be given to anyone without the individual's consent. There is no doubt that these records are covered by the right to privacy. DuPont v. Finklea, CCH, OSHD, 1978 1! 22398 (S.D. W. Va. 1970). To protect that privacy, access should be given only to another licensed physician and confined to information supplied by the employee himself, as distinguished from third parties. If OSHA or NIOSH are to have access, it must be sub ject to the safeguards the court imposed in the DuPont case. Exposure records present a different but equally important problem. These records frequently contain confiden tial trade material. To allow unlimited access to exposure records without restriction on disclosure, use or sale of con fidential trade material raises very serious problems. While it may be reasonable to provide exposure information to an em ployee, that disclosure must be made under circumstances which prevent disclosure of confidential information. Similarly, there must be carefully designated regulations to prevent dis- 1/ 43 Fed. Reg. 31329, 31371 (July 21, 1978). - 289 - CMA 048173 closure of any such secrets which may get into the hands of OSHA or NIOSH. In view of the unusual procedure adopted by OSHA where by two overlapping rules are being proposed on the sane subject, we believe OSHA should consolidate the records so that comments filed in Docket HO. H-112 are considered also in this proceeding. To eliminate the confusion as to which rule is being considered by OSHA and which docket should be selected for filing comments, we urge that the only reasonable course is for OSHA to consider the comments in Docket No. H-112 as applicable in this proceed ing . A decision on the scope and nature of OSHA's authority to have access to, or to grant NIOSH access to, medical records is expected soon in General Motors v. Finklea, Civil No. C-3-77339 (S.D. Ohio). That decision should clarify the statutory issue. In the meantime, OSHA should eliminate the overlapping proceedings. D. Several Provisions Of The Model ETS Are Not Authorized By The Statute_____ Several provisions of the model ETS standard are not authorized by the Act. Among these are those dealing with labels, training and extensive monitoring and medical surveillance. As API correctly points out in its post-hearing comments, the Congress did not intend for such provisions to become a part of the short lived, limited purpose ETS envisioned by it. 290 CMA 048174 XIX THE LABELING PROVISIONS OF THE MODEL STANDARDS ARE NOT AUTHORIZED BY LAW OSHA's proposed model standards for Category I and Category II substances require that employers affix precautionary labels to containers of such substances and of products containing such substances, and that the labels remain affixed when the sub stances or products containing such substances are "sold, distri buted, or otherwise leave the employer's workplace." Sections 1990.150(p)(3), 1990,160(p)(3)and 1990.170(p)(3). Because the scope of OSHA's authority is limited to the issuance of standards designed to protect an employer'_s own employees while in the em ployer's own workplace, these proposed labeling provisions are beyond OSHA's jurisdiction. The language of the Act demonstrates that OSHA's author ity is limited to the regulation of workplaces, not products. Section 4(a) provides that the Act "shall apply with respect to employment performed in a workplace . . . ." 29 U.S.C. 653(a) (emphasis added). Section 2 declares the Congressional purpose to assure "safe and healthful working conditions" by encouraging employers and employees to reduce "occupational safety and health hazards at their places of employment." 29 U.S.C. 651(1) (em phasis added). Similarly, Section 5(a), the "general duty clause", requires that each employer "... shall furnish to each of his employees employment and a place of employment which are free from recog- - 291 CMA 048175 nized hazards that are causing or are likely to cause death or serious phy sical harm to his employees." 29 U.S.C. 654 (a)(1) (emphasis added). Thus, OSHA's regulatory mandate is limited to the workplace it self, and does not extend to products once they have left the workplace. More specifically, it is clear that Section 6(b)(7) of the Act, which sets forth OSHA's only authority to promulgate standards requiring labeling, was intended to provide for signs, notices, and other forms of warning (collectively referred to as "labels") in the workplace for the benefit of employees working with substances in that workplace. Section 6(b)(7) was not meant to confer any labeling authority upon OSHA outside of those work places. Where Congress intended to grant to administrative agen cies such broad and general labeling authority, it has, in other statutes, explicitly granted that authority. Absent such expli cit authorization in Section 6(b)(7), the power to require label ing outside the workplace cannot be implied. Section 6(b)(7) provides that: "[a]ny standard promulgated under this subsection shall prescribe the use of labels or other appropriate forms of warning as are necessary to insure that employees are apprised of all hazards to which they are exposed ..." 29 U.S.C. 655 (b) (7*) . The statute does not explicitly grant to OSHA the authority to require the affixing of labels to substances once they have left the employer's workplace (i.e., the place of manufacture or use) 292 CMA 048176 or to require labeling as a means of protecting anyone other than one's own employees. Rather, the reference to the protection of employees clearly indicates that OSHA's standards can require labels only in the employer's workplace for the benefit of his employees working with a substance in that workplace. The limited scope of OSHA's labeling authority is also demonstrated by the legislative history of Section 6(b)(7). The Conference Report on the Act, after summarizing the provision of the Senate bill that had required labels for employee protection, states: "The House amendment similarly required the posting of labels and warnings to apprise employees of the existence of hazards and of the suggested methods of avoiding or allevi ating them." Legislative History at 1188 (emphasis added). The quoted language indicates Congress' intention that OSHA require those types of labels and warnings that could be "posted". By their very nature, such labels are limited to an employer's workplace. Similarly, other references in the legislative history indicate Congress' concern that employers apprise their employees of hazards. See, e.q., Legislative History at 431, 1004. There are no references to imposition of labeling requirements for the benefit of "other persons". Section 6(b)(7) also authorizes OSHA to promulgate standards prescribing suitable protective equipment and control or technological procedures, appropriate requirements for the monitoring or measuring of employee exposure, and the type 293 CM& 048177 and frequency of medical examinations or other tests to be made available by the employer to employees. These protective measures are clearly intended to be provided by an employer for his own employees as a safeguard against hazards in the plant of manufacture or use. Absent clear Congressional indication to the contrary, the provision authorizing OSHA to require labeling is similarly limited in scope. That OSHA has no authority to require an employer to affix labels to substances once outside the workplace as a means of protecting employees other than his own is also indicated by the variance provisions of the Act. Section 6(b)(6)(A) provides that an employer may obtain a temporary variance from a standard only if he shows that "he is taking all available steps to safe guard his employees against the hazards covered by the standard." 29 U.S.C.A. 655(b)(6)(A). In addition, the employer must noti fy "his employees" of the application, so they can petition the Secretary for a hearing. 29 U.S.C.A. 655(b)(6)(B). Section 6(d) provides for the issuance of a permanent variance to an employer demonstrating that "the conditions, practices, means, methods, operations, or processes used or proposed to be used by an employer will provide employment and places of employment to his employees which are as safe and healthful as those which would prevail if he complied with the standard." 29 U.S.C. 655(d) (emphasis added). Congress would not have allowed an employer to obtain a variance by showing that his employees would be protected if it had in- 294 048118 tended OSHA's standards to require employers to protect other people's employees as well. In a number of other statutes, Congress has explicitly granted administrative agencies general labeling authority, en compassing the power to require labeling of products distributed in interstate commerce. These statutes include: Consumer Pro duct Safety Act, 15 U.S.C. 2051 et seq.; Toxic Substances Con trol Act, 15 U.S.C. 2601 t seq.; Federal Food, Drug, and Cos metic Act, 21 U.S.C. S 301 et seq.; Federal Hazardous Substances Act, 15 U.S.C. 1261 et seq.; Poison Prevention Packaging Act, 15 U.S.C. 1471 et seq.; and Federal Insecticide, Fungicide and Rodenticide Act, 7 U.S.C. 135 et seq. Absent such explicit authorization in the Occupational Safety and Health Act, such broad and general labeling authority cannot be implied in QSHA. As the Supreme Court stated in Stark v. Wickard, 321 U.S. 288, 309 (1944): "When Congress passes an Act empowering administra tive agencies to carry on governmental activities, the power of those agencies is circumscribed by the authority granted." See also Zuber v. Allen, 396 U.S. 168 (1969); Exxon Corp. v. Train, 554 F. 2d 1310 (5th Cir. 1977); Textile and Apparel Group v. F.T.C., 410 F. 2d 1052 (D.C. Cir. 1969); State Highway Commission of Missouri v. Volpe, 479 F. 2d 1099 (8th Cir. 1973); National Association of Regulatory Utility Commissioners v. F.C.C., 533 F. 2d 601 (D.C. Cir. 1976). The Benzene decision, relying principally on cases dealing with multi-employer construction worksite cases, con- - 295 - CMA 048179 eluded that if OSHA can validly require the affixing of labels to benzene and benzene products, OSHA can forbid the removal of those labels from the containers which leave the workplace. This is a far cry from a finding of a general labeling authority in OSHA. Moreover, the court made clear that OSHA must make a valid finding of quantifiable benefits to the workers in the employer's workplace from a labeling requirement and relate those benefits to the costs or detriments in order to show the requirement is reasonably necessary. A second similar cost bene fit analysis is necessary to determine whether OSHA can reasonably require the employer not to remove the labels when the containers leave the workplace. Thus, under the standards of the Benzene decision, it would be unreasonable to require labels on mixtures containing small amounts of the regulated substance in the absence of the requisite finding of measureable benefits with a reasonable relation to cost. Even when it is reasonable to require labeling of containers in the workplace, it may be unreasonable to prohibit removal when the containers leave the workplace if, for example, the labels "have such deleterious effects on sales that it affects the reasonable necessity for this feature of the regu lation." Benzene decision, ____ F.2d at 99. The Benzene decision provides no basis for arguing that OSHA has general labeling authority. That case deals only with removal of labels which OSHA has validly found are reason ably necessary for the particular workplace. - 296 - CMA 048180 Conclusion The OSHA Proposed Regulation is substantively and pro- cedurally defective. OSHA is just now making the Regulatory Analy sis of the Proposed Regulation. AIHC believes that OSHA should also conclude that an Environmental Impact Statement should be prepared. The results of the IRLG Work Group in areas relevant to the Proposed Regulation will become available in the near fu ture. AIHC believes that in view of these developments, OSHA should withdraw the Proposed Regulation and repropose a regulation modified to correct the deficiencies in the Proposed Regulation. The AIHC Alternative provides a reasonable guide for a reproposed regulation. At a minimum, OSHA must provide an adequate opportun ity to comment on the new developments before publishing a final regulation. Respectfully submitted, / Robert C. Barnard Eric Schwartz Price 0. Gielen Robert L. Glicksman Attorneys for the American Industrial Health Council Of Counsel: Cleary, Gottlieb, Steen & Hamilton 1250 Connecticut Avenue, N.W. Washington, D.C. 20036 (202) 223-2151 October 23, 1978 - 297 - CMA 048181 CMA 048182 Appendix A - Statutes Involved Section 3(8) (29 U.5.C. 652(3)) The term "occupational safety and health standard" means a standard which requires conditions, or the adoption or use of one or more practices, means, methods, operations, or processes, reasonably necessary or appropriate to provide safe or healthful employment and places of employment. Section 6 (29 U.S.C. 655) Standards l'rornulfftttlftit by Secretary of nntlonnl Atanrinrri* and e^tahtNIieri Kcdcrul standard*; time for promulffntloni conflicting utimdurtl* (a) Without regard to chapter 5 of Title 0 or to the other sub sections of this section, the Secretary shall, as soon as practicable during the period beginning with the effective date of this chap ter and ending two years after such date, by rule promulgate as an occupational safety or health standard any national consensus stand ard, and any established Federal standard, unless he determines that the promulgation of such a standard would not result in im proved safety or health for specific-all.' designated employees. In the event of conflict among any such standards, the Secretary shall promulgate the standard which assures the greatest protection of the safety or health of the affected employees. Procedure for t>roniulj?jtl)otiv modification, or revocation of Htnnd'irdx (b) The Secretary may by rule promulgate, modify, or revoke any occupational safety or health standard in the following manner: (1) Whenever the Secretary, upon the basis of information submitted to him in writing by an interested person, a represen tative of any organisation of employers or employees, a national ly recognized standanls-producing organization, the Secretary of Health, Education, and Welfare, the National Institute for Oc cupational Safety and Health, or a State or political subdivision, or on the basis of information developed by the Secretary or otherwise available to him, determines that a rule should be promulgated in order to serve the objectives of tins chapter, the A-l CMA 048183 Section 6 (29 U.S.C. 655) Secretary may request the recommendations of an advisory com mittee appointed under section G56 of this title. The Secretary shall provide such an advisory committee with any proposals of his own or of the Secretary of Health, Education, and Welfare, together with all pertinent factual information developed by the Secretary or the Secretary of Health, Education, and Welfare, or otherwise available, including the results of research, demon strations, and experiments. An advisory committee shall sub mit to the Secretary its recommendations regarding the rule to be promulgated within ninety days from the date of its appoint ment or within such longer or shorter period as may be pre scribed by the Secretary, but in no event for a period which is longer than two hundred and seventy days. (2) The Secretary shall publish a proposed rule promulgating, modifying, or revoking an occupational safety or health standard in the Federal Register and shall afford interested persons a pe riod of thirty days after publication to submit written data or comments. Where an advisory committee is appointed and the Secretary determines that a rule should be issued, he shall pub lish the proposed rule within sixty days after the submission of the advisory committee's recommendations or the expiration of the period prescribed by the Secretary for such submission. (3) On or before the last day of the period provided for the submission of written data or comments under paragraph (2), any interested person may file with the Secretary written objec tions to the proposed rule, stating the grounds therefor and re questing a public hearing on such objections. Within thirty days after the last day for filing such objections, the Secretary shall publish in the Federal Register a notice specifying the oc cupational safety or health standard to which objections have been filed and a hearing requested, and specifying a time and place for such hearing. (4) Within sixty days after the expiration of the period pro vided for the submission of written data or comments under paragraph (2), or within sixty days after the completion of any hearing held under paragraph (3), the Secretary shall issue a rule promulgating, modifying, or revoking an occupational safety or health standard or make a determination that a rule should not be issued. Such a rule may contain a provision de laying its effective date for such period (not in excess of ninety days) as the Secretary determines may be necessary to insure that affected employers and employees will be informed of the existence of the standard and of its terms and that employers affected are given an opportunity to familiarise themselves and their employees with the existence of the requirements of the standard. A-2 CMA 048184 Section 6 (29 U.S.C. 655) (5) The Secretary, in promulgating standards dealing with toxic materials or harmful physical agents under this subsection, shall set the standard which most adequately assures, to the ex tent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the haz ard dealt with by such standard for the period of his working life. Development of standards under this subsection shall be based upon research, demonstrations, experiments, and such other information as may be appropriate. In addition to the at tainment of the highest degree of health and safety protection for the employee, other considerations shall be the latest avail able scientific data in the field, the feasibility of the standards, and experience gained under this and other health and safety laws. Whenever practicable, the standard promulgated shall be expressed in terms of objective criteria and of the performance desired. (6) (A) Any employer may apply to the Secretary for a tempo rary order granting a variance from a standard or any provi sion thereof promulgated under this section. Such temporary order shall be granted only if the employer files an application which meets the requirements of clause (B) and establishes that (i) he is unable to comply with a standard by its effective date because of unavailability of professional or technical personnel or of materials and equipment needed to come into compliance with the standard or because necessary construction or altera tion of facilities cannot be completed by the effective date, (ii) he is taking all available steps to safeguard his employees against the hazards covered by the standard, and (iii) he has an effective program for coming into compliance with the standard as quickly as practicable. Any temporary order issued under this paragraph shall prescribe the practices, means, methods, operations, and processes which the employer must adopt and use while the order is in effect and state in detail his program for coming into compliance with the standard. Such a temporary order may be granted only after notice to employees and an opportunity for a hearing: Provided, That the Secretary may issue one interim order to be effective until a decision is made on the basis of the hearing. No temporary order may be in effect for longer than the period needed by the employer to achieve compliance with the standard or one year, whichever is shorter, except that such an order may be renewed not more than twice (Ij so long as the requirements of this paragraph are met and (II) if an application for renewal is filed at least 90 days prior to the expiration date of the order. No interim re newal of an order may remain in effect for longer than ISO days. A--3 CMA 048185 Section 6 (25 U.S.C. 655) (B) An application for a temporary order under this para graph (6) shall contain: (i) a specification of the standard or portion thereof from which the employer seeks a variance, (ii) a representation by the employer, supported by repre sentations from qualified persons having firsthand knowl edge of the facts represented, that he is unable to comply with the standard or portion thereof and a detailed state ment of the reasons therefor, (iii) a statement of the steps he has taken and will take (with specific dates) to protect employees against the haz ard covered by the standard, (iv) a statement of when he expects to be able to comply with the standard and what steps he has taken and what steps he will take (with dates specified) to come into com pliance with the standard, and (v) a certification that he has informed his employees of the application by giving a copy thereof to their authorized representative, posting a statement giving a summary of the application and specifying where a copy may be examined at the place or places where notices to employees are normally posted, and by other appropriate means. A description of how employees have been informed shall be con tained in the certification. The information to employees shall also inform them of their right to petition the Secretary for a hearing. (C) The Secretary is authorized to grant a variance from any standard or portion thereof whenever he determines, or the Sec retary of Health, Education, and Welfare certifies, that such variance is necessary to permit an employer to participate in an experiment approved by him or the Secretary of Health, Educa tion, and Welfare designed to demonstrate or validate new and improved techniques to safeguard the health or safety of work ers. (7) Any standard promulgated under this subsection shall prescribe the use of labels or other appropriate forms of warn ing as are necessary to insure that employees are apprised of all hazards to which they are exposed, relevant symptoms and ap propriate emergency treatment, and proper conditions and pre cautions of safe use or exposure. Where appropriate, such standard shall also prescribe suitable protective equipment and control or technological procedures to be used in connection with such hazards and shall provide for monitoring or measuring em ployee exposure at such locations and intervals, and in such manner as may be necessary for the protection of employees. In addition, where appropriate, any such standard shall pre- A-4 CMA 048186 Section 6 (29 U.5.C. 5655) scribe the type and frequency of medical examinations or other tests which shall be made available, by the employer or at his cost, to employees exposed to such hazards in order to most ef fectively determine whether the health of such employees is adversely affected by such exposure. In the event such medical examinations are in the nature of research, as determined by the Secretary of Health, Education, and Welfare, such examinations may be furnished at the expense of the Secretary of Health, Education, and Welfare. The results of such examinations or tests shall be furnished only to the Secretary or the Secretary of Health, Education, and Welfare, and, at the request of the em ployee, to his physician. The Secretary, in consultation with the Secretary of Health. Education, and Welfare, may by rule promulgated pursuant to section 553 of Title 5, make appropriate modifications in the foregoing requirements relating to the use of labels or other forms of warning, monitoring or measuring, and medical examinations, as may be warranted by experience, information, or medical or technological developments acquired subsequent to the promulgation of the relevant standard. (8) Whenever a rule ^promulgated by the Secretary differs substantially from an existing national consensus standard, the Secretary shall, at the same time, publish in the Federal Register a statement of the reasons why the rule as adopted will better effectuate the purposes of this chapter than the rational consen sus standard. Emergency temporary Atandurdsi (c) (1) The Secretary shall provide, without regard to the re quirements of chapter 5 of Title 5, for an emergency temporary standard to take immediate effect upon publication in the Federal Register if he determines (A) that employees are exposed to grave danger from exposure to substances or agents determined to be toxic or physically harmful or from new hazards, and (B) that such emer gency standard is necessary to protect employees from such danger. (2) Such standard shall be effective until superseded by a stand ard promulgated in accordance with the procedures prescribed in paragraph (3) of this subsection. (3) Upon publication of such standard in the Federal Register the Secretary shall commence a proceeding in accordance with subsec tion (b) of this section, and the standard as published shall ai.-o serve as a proposed rule for the proceeding. The Secretary shall promulgate a standard under this paragraph no later than six months after publication of the emergency standard as provided in para graph (2) of this subsection. Variance* from Atandardt*; procedure (d) Any affected employer may apply to the Secretary for a rule or order for a variance from a standard promulgated under this A-5 CMA 048187 Section 6 (29 U.S.C. 655) section. Affected employees shall be given notice of each such ap plication and an opportunity to participate in a hearing. The Secretary shall issue such rule or order if he determines on the record, after opportunity for an inspection where appropriate and a hearing, that the proponent of the variance has demonstrated by a preponderance of the evidence that the conditions, practices, means, methods, operations, or processes used or proposed to be used by an employer will provide employment and places of employment to his employees which are as safe and healthful as those which would prevail if he complied with the standard. The rule or order so issued shall prescribe the conditions the employer must main tain, and the practices, means, methods, operations, and processes which he must adopt and utilize to the extent they differ from the standard in question. Such a rule or order may be modified or re voked upon application by an employer, employees, or by the Secre tary on his own motion, in the manner prescribed for its issuance under this subsection at any time after six months from its issuance. Stritemefit of reason* for 5eeMlnrj,,M determination*; publication in Federal RecUter (e) Whenever the Secretary promulgates any standard, makes any rule, order, or decision, grants any exemption or extension of time, or compromises, mitigates, or settles any penalty assessed under this chapter, he shall include a statement of the reasons for such action, which shall be published in the Federal Register. JudlcJnl review l^<f) Any person who may be adversely affected by a standard is sued under this section may at any time prior to the sixtieth day after such standard is promulgated file a petition challenging the validity of such standard with the United States court of appeals for the circuit wherein such person resides or has his principal place of business, for a judicial review of such standard. A copy of the petition shall be forthwith transmitted by the clerk of the court to the Secretary, The filing of such petition shall not, unless otherwise ordered by the court, operate as a stay of the standard. The determinations of the Secretary shall be conclusive if support ed by substantial evidence in the record considered as a whole. Priority for etahllhmmt of HtandorO* (g) In determining the priority for establishing standards under this section, the Secretary shall give due regard to the urgency of the need for mandatory safety and health standards for particular industries, trades, crafts, occupations, businesses, workplaces or work environments. The Secretary shall also give due regard to the recommendations of the Secretary of Health, Education, and Wel fare regarding the need for mandatory standards in determining the priority for establishing such standards. Pub.L. 91-596, G, Dec. 29, 1970, 84 Stat. 1593. A-6 CMA 048188 Section 7 (29 U.S.C. 656) Administration National Advisory Committee on Occupational Safety and Health* estab lishment; membership; appointment; Chairman! functional meet ing*} compensation! secretarial and clerical personnel (a)(1) There is hereby established a National Advisory Commit tee on Occupational Safety and Health consisting of twelve members appointed by the Secretary, four of whom are to be designated by the Secretary of Health, Education, and Welfare, without regard to the provisions of Title 5 governing appointments in the competitive service, and composed of representatives of management, labor, oc cupational safety and occupational health professions, and of the public. The Secretary shall designate one of the public members as Chairman. The members shall be selected upon the basis of their experience and competence in the field of occupational safety and health. (2) The Committee shall advise, consult with, and make recom mendations to the Secretary and the Secretary of Health, Education, and Welfare on matters relating to the administration of this chap ter. The Committee shall hold no fewer than two meetings during each calendar year. All meetings of the Committee shall be open to the public and a transcript shall be kept and made available for public inspection. (3) The members of the Committee shall be compensated in ac cordance with the provisions of section 3109 of Title 5. (4) The Secretary shall furnish to the Committee an executive secretary and such secretarial, clerical, and other services as are deemed necessary to the conduct of its business. AdvUory committee*; appointment; dutfe*; jnemherMhlp; compensation; reimbursement to member'* employer; meeting*; availability of record*; conflict of Interest (b) An advisory committee may be appointed by the Secretary to assist him in his standard-setting functions under section 655 of this title. Each such committee shall consist of not more than fifteen members and shall include as a member one or more designees of the Secretary of Health, Education, and Welfare, and shall in clude among its members an equal number of persons qualified by experience and affiliation to present the viewpoint of the employ ers involved, and of persons similarly qualified to present the view point of the workers involved, as well as one or more representatives of health and safety agencies of the States. An advisory commit tee may also include such other persons as the Secretary may ap point who are qualified by knowledge and experience to make a use ful contribution to the work of such committee, including one or more representatives of professional organizations of technicians or professionals specializing in occupational safety or health, and one or more representatives of nationally recognized standards-producing organizations, but the number of persons so appointed to any A-7 CMA 048189 Section 7 (29 U.S.C. 656) such advisory committee shall not exceed the number appointed to such committee as representatives of Federal and State agencies. Persons appointed to advisory committees from private life shall be compensated in the same manner as consultants or experts under section. 3109 of Title 5. The Secretary shall pay to any State which is the employer of a member of such a committee who is a repre sentative of the health or safety agency of that State, reimbursement sufficient to cover the actual cost to the State resulting from such representative's membership on such committee. Any meeting of such committee shall be open to the public and an accurate record shall be kept and made available to the public. No member of such committee (other than representatives of employers and employees) shall have an economic interest in any proposed rule. lint of irrvtcM, facllltle*, and per*onnel of Federal* State, and local amende*; reimbursement; employment of expert* and consultant* or organization*; renewal of contract*; compensation; travel expenne* (c) In carrying out his responsibilities under this chapter, the Secretary is authorized to-- (1) use, with the consent of any Federal agency, the services, facilities, and personnel-of such agency, with or without reim bursement, and with the consent of any State or political sub division thereof, accept and use the services, facilities, and per sonnel of any agency of such State or subdivision with reim bursement; and (2) employ experts and consultants or organizations there of as authorized by section 3109 of Title 5, except that contracts for such employment may be renewed annually; compensate individuals so employed at rates not in excess of the rate speci fied at the time of service for grade GS-18 under section 5332 of Title 5, including traveltime, and allow them while away from their homes or regular places of business, travel expenses (in cluding per diem in lieu of subsistence) as authorized by sec tion 5703 of Title 5 for persons in the Government service em ployed intermittently, while so employed. Pub.L, 91-596, 7, Dec. 29, 1970, 84 Stat. 1597. Section 8(c) (29 U.S.C. 657 (c)) Maintenance, preaervatlon* and availability of record*; Uauance of regula tion*; eope of record*; periodic Inapectlon* by employer; ponting of notice* by employer; notification of employee of corrective uction (c)(1) Each employer shall make, keep and preserve, and make available to the Secretary or the Secretary of Health, Education, and Welfare, such records regarding his activities relating to this chap ter as the Secretary, in cooperation with the Secretary of Health, Education, and Welfare, may prescribe by regulation as necessary A-8 CWA 04819 Section 8(c) (29 U.S.C. 657(c)) or appropriate for the enforcement of this chapter or for developing information regarding the causes and prevention of occupational accidents and illnesses. In order to carry out the provisions of this paragraph such regulations may include provisions requiring em ployers to conduct periodic inspections. The Secretary shall also issue regulations requiring that employers, through posting of no tices or other appropriate means, keep their employees informed of their protections and obligations under this chapter, including the provisions of applicable standards, (2) The Secretary, in cooperation with the Secretary of Health, Education, and Welfare, shall prescribe regulations requiring em ployers to maintain accurate records of, and to make periodic re ports on, work-related deaths, injuries and illnesses other than minor injuries requiring only first aid treatment and which do not involve medical treatment, loss of consciousness, restriction of work or motion, or transfer to another job. (3) The Secretary, in cooperation with the Secretary of Health, Education, and Welfare, shall issue regulations requiring employ ers to maintain accurate records of employee exposures to poten tially toxic materials or harmful physical agents which are required to be monitored or measured under section 655 of this title. Such regulations shall provide employees or their representatives with an opportunity to observe such monitoring or mfeasuring, and to have access to the records thereof. Such regulations shall also make appropriate provision for each employee or former employee to have access to such records as will indicate his own exposure to toxic materials or harmful physical agents. Each employer shall prompt ly notify any employee who has been or is being exposed to toxic materials or harmful physical agents in concentrations or at levels which exceed those prescribed by an applicable occupational safety and health standard promulgated under section 655 of this title, and shall inform any employee who is being thus exposed of the cor rective action being taken. Section 8(q) (29 U.S.C. 657(g)) Compilation, finolynl*, and publication of report* and information; rule* and regulation* (g)(1) The Secretary and Secretary of Health, Education, and Welfare are authorized to compile, analyze, and publish, either in summary or detailed form, all reports or information obtained under this section. A-9 cm 048191 Section 8(g) (29 U.S.C. 657(g)) (2) The Secretary and the Secretary of Health, Education, and Welfare shall each prescribe such rules and regulations as he may deem necessary to carry out their responsibilities under this chapter, including rules and regulations dealing with the inspection of an employer's establishment. Pub.L. 01-596, 8, Dec. 29, 1970, 84 Stat. 1598. Section 9 (29 U.S.C. 658) Citations Authority to |*urj proundt; content*; notire In lieu of citation for tie minimi* violation* (a) If, upon inspection or investigation, the Secretary or his au thorized representative believes that an employer has violated a re quirement of section 654 of this title, of any standard, rule or order promulgated pursuant to section 655 of this title, or of any regula tions prescribed pursuant to this chapter, he shall with reasonable promptness issue a citation to the employer. Each citation shall be in writing and shall describe with particularity the nature'*bf the vio lation, including a reference to the provision of the chapter, stand ard, rule, regulation, or order alleged to have been violated. In addi tion, the citation shall fix a reasonable time for the abatement of the violation. The Secretary may prescribe procedures for the issuance of a notice in lieu of a citation with respect to de minimis violations which have no direct or immediate relationship to safety or health. I'OttillK (b) Each citation issued under this section, or a copy or copies thereof, shall be prominently posted, as prescribed in regulations issued by the Secretary, at or near each place a violation referred to in the citation occurred. Time for l*uance (c) No citation may be issued under this section after the expira tion of six months following the occurrence of any violation, Pub.L. 91-596, 9, Dec. 29, 1970, 84 Stat. 1601. A-10 CMA 048192 Section 13 (29 U.S.C. 662) Injunction proceedings Petition by Srftary to restrain imminent danger** scope of order (a) The United States district courts shall have jurisdiction, upon petition of the Secretary, to restrain any conditions or practices in any place of employment which are such that a danger exists which could reasonably be expected to cause death or serious physical harm immediately or before the imminence of such danger can be elimi nated through the enforcement procedures otherwise provided by this chapter. Any order issued under this section may require such steps to be taken as may be necessary to avoid, correct, or remove such imminent danger and prohibit the employment or presence of any individual in locations or under conditions where such imminent danger exists, except individuals whose presence is necessary to avoid, correct, or remove such imminent danger or to maintain the capacity of a continuous process operation to resume normal opera tions without a complete cessation of operations, or where a cessa tion of operations is necessary, to permit such to be accomplished in a safe and orderly manner. Appropriate Injunctive relief or tcmpor/iry restraining order rending outcome of enfori'emf'nt'pri'CrediiiK; applicability of rule G 3 of Federal Hutrx of Civil l*rocedure (b) Upon the filing of any such petition the district court shall iave jurisdiction to grant such injunctive relief or temporary reitraining order pending the outcome of an enforcement proceeding pursuant to this chapter. The proceeding shall be as provided by Rule 65 of the Federal Rules. Civil Procedure, except that no tem porary restraining order issued without notice shall be effective for a period longer than five days. Notification of affected employee* tmil employer* by Inspector of danger nnd of recommendation to Secretary to peek relief (c) Whenever and as soon as an inspector concludes that con ditions or practices described in subsection (a) of this section exist in any place of employment, he shall inform the affected employees and employers of the danger and that he is recommending to the Secretary that relief be sought. Faljurc of Secretary to deck relief! >vrlt of miiodaraux (d) If the Secretary arbitrarily or capriciously fails to seek relief under this section, any employee who may be injured by reason of such failure, or the representative of such employees, might bring an action against the Secretary in the United States district court for the district in which the imminent danger is alleged to exist or the employer has its principal office, or for the District of Columbia, for a writ of mandamus to compel the Secretary to seek such an or der and for such further relief as may be appropriate, Pub.L. 91-596, 13, Dec. 29, 1970, 84 Stat. 1605. A-ll CMA 048193 Section 20 (29 U.S.C. 669) Research and related activities Authority 0f 'Secretary of Health, Education, and Welfare to conduct renearch, experiments* and demonatrntlortM, develop plans* cntahlinh erlterlo* provaulicute rcffiilatlons* authorise program*, and publish results and Industrywide studiest consultations (a)(1) The Secretary of Health, Education, and Welfare, after consultation with the Secretary and with other appropriate Federal departments or agencies, shall conduct (directly or by grants or con tracts) research, experiments, and demonstrations relating to occupa tional safety and health, including studies of psychological factors involved, and relating to innovative methods, techniques, and ap proaches for dealing with occupational safety and health problems. (2) The Secretary of Health, Education, and Welfare shall from time to time consult with the Secretary in order to develop specific plans for such research, demonstrations, and experiments as are necessary to produce criteria, including criteria identifying toxic substances, enabling the Secretary to meet his responsibility for the formulation of safety and health standards under this chapter; and the Secretary of Health, Education, and Welfare, on the basis of such research, demonstrations, and experiments and any other informa tion available to him, shall develop and publish at least annually such criteria as will effectuate the purposes of this chapter. (3) The Secretary of Health, Education, and Welfare, on the basis of such research, demonstrations, and experiments, and any other in formation available to him, shall develop criteria dealing with toxic materials and harmful physical agents and substances which will de scribe exposure levels that are safe for various periods of employ ment, including but not limited to the exposure levels at which no em ployee will suffer impaired health or functional capacities or di minished life expectancy as a result of his work experience. (4) The Secretary of Health, Education, and Welfare shall also conduct special research, experiments, and demonstrations relating to occupational safety and health as are necessary to explore new problems, including those created by new technology in occupa tional safety and health, which may require ameliorative action be yond that which is otherwise provided for in the operating provisions of this chapter. The Secretary of Health, Education, and Welfare shall also conduct research into the motivational and behavioral factors relating to the field of occupational safety and health. (5) The Secretary of Health, Education, and Welfare, in order to comply with his responsibilities under paragraph (2), and in order to develop needed information regarding potentially toxic substances or harmful physical agents, may prescribe regulations requiring em ployers to measure, record, and make reports on the exposure of em ployees to substances or physical agents which the Secretary of Health, Education, and Welfare reasonably believes may endanger A-12 CMA 048194 Section 20 (29 U.S.C. 669) the health or safety of employees. The Secretary of Health, Educa tion, and Welfare also is authorized to establish such programs of medical examinations and tests as may be necessary for determining the incidence of occupational illnesses and the susceptibility of em ployees to such illnesses. Nothing in this or any other provision of this chapter shall be deemed to authorize or require medical examina tion, immunization, or treatment for those who object thereto on religious grounds, except where such is necessary for the protection of the health or safety of others. Upon the request of any employer who is required to measure and record exposure of employees to substances or physical agents as provided under this subsection, the Secretary of Health, Education, and Welfare shall furnish full fi nancial or other assistance to such employer for the purpose of de fraying any additional expense incurred by him in carrying out the measuring and recording as provided in this subsection. (6) The Secretary of Health, Education, and Welfare shall publish within six months of December 29, 1970, and thereafter as needed but at least annually a list of all known toxic substances by generic family or other useful grouping, and the concentrations at which such toxicity is known to occur. He shall determine following a written request by any employer or .authorized representative of employees, specifying with reasonable particularity the grounds on which the request is made, whether any substance normally found in the place of employment has potentially toxic effects in such concentrations as used or found ; and shall submit such determination both to em ployers and affected employees as soon as possible. If the Secretary of Health, Education, and Welfare determines that any substance is potentially toxic at the concentrations in which it is used or found in a place of employment, and such substance is not covered by an occupational safety or health standard promulgated under section 655 of this title, the Secretary of Health, Education, and Welfare shall immediately submit such determination to the Secretary, to gether with all pertinent criteria. (7) Within two years of December 29, 1970, and annually there after the Secretary of Health, Education, and Welfare shall conduct and publish industrywide studies of the effect of chronic or low-level exposure to industrial materials, processes, and stresses on the po tential for illness, disease, or loss of functional capacity in aging adults. Authority of 'iprrfdiry of Hfiiltli, FducHtion, ami Wplfnrp to make InMptTtioiiM nnd and employ*** (b) The Secretary of Health, Education, and Welfare is author ized to make inspections and question employers and employees as provided in section 657 of this title in order to carry out his functions and responsibilities under this section. * A-l 3 CMA 048195 Section 20 (29 U.S.C. 669) Contracting authority of Secretary of Labori cooperation het^eeen Secre tary of Labor and Secretary of Health. Education, and Welfare (c) The Secretary is authorized to enter into contracts, agree ments, or other arrangements with appropriate public agencies or private organizations for the purpose of conducting studies relating to his responsibilities under this chapter. In carrying out his re sponsibilities under this subsection, the Secretary shall cooperate with the Secretary of Health, Education, and Welfare in order to avoid any duplication of efforts under this section. DiM*ctnntioii of Informndmi to Interested portlet* (d) Information obtained by the Secretary and the Secretary of Health, Education, and Welfare under this section shall be dissemin ated by the Secretary to employers and employees and organizations thereof. Delegation of function* of Secretary of Health, Education, and Welfare to Director of National Institute for Occupational Safety and Health (e) The functions of the Secretary of Health, Education, and Wel fare under this chapter shall, to the extent feasible, be delegated to the Director of the NationaMnstitute for Occupational Safety and Health established by section G71 of this title. Pub.L. 91-596, 20, Dec. 29, 1970, 84 Stat. 1610. A-14 CMA. 048196 APPENDIX B - THE BENZENE DECISION AMERICAN PET. INSTITUTE v. OCCUPATIONAL SAFETY 80 The AMERICAN PETROLEUM INSTITUTE et al., Petitioners, The Manufacturing Chemists Associa tion and the Chemical Specialties Manufacturers Association, Interve ne rs, v. OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION et al.. Respondents, regulation was based upon dated, incon clusive data, and unrefuted evidence re vealed the existence of modern experi mental methods which could provide ac curate information on factual issues which were unresolved by past studies, and (3) Administration had authority to prohibit employer from removing warn ing labels from containers of benzene and benzene products when those con tainers leave his work place. Petition for review granted. Industrial Union Department, AFL-CIO, Intervenor. Nos. 75-1253, 78-1257, 78-1486, 78-1676, 78-1677, 78-1707 and 78-1745. United States Court of Appeals, Fifth Circuit. ' Oct. 5, 1978. Producers of benzene filed petition for review of a new health standard pro mulgated by the Occupational Safety and Health Administration limiting occu pational exposure to benzene. The Court of Appeals, Charles Clark, Circuit Judge, held that: (1) regulation requir ing employers to assure that no employ ee is exposed to airborne concentration of benzene in excess of one part benzene per million parts of air averaged over an eight-hour day would be set aside, in absence of substantial evidence indicat ing that measurable benefits to be achieved by the reduction of permissible exposure to benzene bore a reasonable relationship to the one-half billion dollar cost of such regulation for affected in dustries; (2) regulation requiring em ployers to assure that no employee i3 exposed to dermal contact with liquid benzene would be set aside, since such 1. Labor Relations =27 In reviewing regulations promulgat ed by the Occupational Safety and Health Administration, substantial evi dence standard is applicable with respect to factual findings subject to evidentiary development; legislative-like policy judgments, though not so susceptible to verification or refutation by record, must nevertheless be scrutinized on judicial re view for consideration as to whether such judgments are consistent with stat utory language and purpose and within decision-making power of Secretary of Labor within limits imposed by Congress, Occupational Safety and Health Act of 1970, 6(f), 29 U.S.C.A. 655(f). 2. Labor Relations =*27 The Occupational Safety and Health Act of 1970 imposes on the Occupational Safety and Health Administration the obligation to enact only standards that are reasonably necessary or appropriate to provide safe or healthful work places; if standard does not fit in that defini tion, it is not one that the Administra tion is authorized to enact. Occupational Safety and Health Act of 1970, 3(8), 29 U.S.C.A. 652(8). 3. Labor Relations <s=27 The Occupational Safety and Health Act does not give the Occupational Safe- Synopses, Syllabi and Key Number Classification COPYRIGHT & 1978, by WEST PUBLISHING CO The Synopses, Syllabi and Key Number Claaaifi' cation constitute no part of the opinion of the court 3-1 CMA 048197 81 AMERICAN PET. INSTITUTE v. OCCUPATIONAL SAFETY ty and Health Administration unbridled discretion to adopt standards designed to create absolutely risk-free work places regardless of cost, but rather, the Act requires standards to be feasible, and contains a number of pragmatic limita tions in the form of specific kinds of information the Administration must consider in enacting standards dealing with toxic materials; the conditions and other requirements imposed by standards dealing with toxic materials must be rea sonably necessary or appropriate to pro vide safe or healthful employment and places of employment. Occupational Safety and Health Act of 1970, 3(8), 6(b)(5), 29 U.S.C.A 652(8), 655(bX5). 4. Labor Relations =*27 Before it regulates, the Occupational Safety and Health Administration must show that hazard exists and that its reg ulation will reduce the risk from the haz ard, and the Administration must also assess expected benefits in light of bur dens to be imposed by standard; al though the Administration does not have to conduct an elaborate cost-benefit analysis, it does have to determine whether benefits expected from standard bear a reasonable relationship to costs imposed by standard. Occupational Safety and Health Act of 1970, 3(8), 6(b)(5), 29 U.S.C.A. 652(8), 655(bX5). 5. Labor Relations <^=27 Occupational Safety and Health Ad ministration's regulation requiring em ployers to assure that no employee is exposed to airborne concentration of benzene in excess of one part benzene per million parts of air averaged over an eight-hour day would be set aside, in absence of substantial evidence indicat ing that measurable benefits to be achieved by the reduction of permissible exposure to benzene bore a reasonable relationship to the one-half billion dollar cost of such regulation for affected in dustries. Occupational Safety and Health Act of 1970, 3(8), 6(bX5), 29 U.S.C.A 652(8), 655(bX5). 6. Labor Relations ^>27 Judicial review of Occupational Safety and Health Administration regu lations must be of the reasoning process of the Administration at the time it pro mulgated the standards based on the rec ord before it. Occupational Safety and Health Act of 1970, 6(f), 29 U.S.C.A. 655(f). 7. Labor Relations =27 When available evidence before Oc cupational Safety and Health Adminis tration is of equivalent quality and is conflicting, a finding in accordance with one view or the other should be con sidered to be supported' by substantial evidence. Occupational Safety and Health Act of 1970, 6(f), 29 U.S.C.A. 655(f). 8. Labor Relations =27 Occupational Safety and Health Ad ministration's regulation requiring em ployers to assure that no employee is exposed to dermal contact with liquid benzene would be set aside, since such regulation was based upon dated, incon clusive data, and unrefuted evidence re vealed the existence of modern experi mental methods which could provide ac curate information on factual issues which were unresolved by past studies. Occupational Safety and Health Act of 1970, 3(8), 6(b)(5), 29 U.S.C.A. 652(8), 655(b)(5). 9. Labor Relations =27 Occupational Safety and Health Ad ministration had authority to prohibit employer from removing warning labels from containers of benzene and benzene products when those containers leave his B-2 CMA 048196 AMERICAN PET. INSTITUTE v. OCCUPATIONAL SAFETY 82 work place, in view of purpose of Occu pational Safety and Health Act to pro tect every worker in nation, the express and broad statutory authorization for Administration to prescribe warning la bels, and in view of fact that presence of benzene in product is often a concealed hazard; Administration's authority to re quire labeling of products containing benzene was not preempted by the Con sumer Products Safety Commission which had promulgated regulations un der the Federal Hazardous Substances Act. Occupational Safety and Health Act of 1970, 4(b)(1), 6(b)(7), 29 U.S. C.A. 653(b)(1), 655(bX7); Federal Hazardous Substances Act, 2 et seq., 15 U.S.C.A. 1261 et seq. On Petitions for Review of an Order of the Occupational Safety and Health Administration. Before COLEMAN, CLARK, and TJOFLAT, Circuit Judges. CHARLES CLARK, Circuit Judge: This case presents consolidated peti tions for review 1 of a new health stan dard limiting occupational exposure to benzene2 * promulgated by the Occupa tional Safety and Health Administration of the Department of Labor (OSHA), pursuant to the Occupational Safety and Health Act, 29 U.S.C.A. 651 et seq. (1975) (the Act). The basis for the stan dard is OSHA's determination that ben zene is a carcinogen for which there is no known safe level of exposure. Brief ly, the standard requires employers to assure that no employee is exposed to an airborne concentration of benzene in ex cess of one part benzene per million parts of air (1 ppm) averaged over an eight-hour day;2 it requires employers to assure that no employee is exposed to dermal contact with liquid benzene;4 * * * * and it requires employers to assure that caution labels are affixed to all contain ers of products containing benzene and that the labels remain affixed when the product leaves the employer's work place.9 In addition, the standard impos- 1. The petitioning or intervening producers of benzene and benzene-containing products are the American Petroleum Institute on behalf of itself and member companies; the American Iron and Steel Institute on behalf of itself and member companies; the independent Petrole um Association of America on behalf of itself and member companies; and the Manufactur ing Chemists Association on behalf of itself and member companies. The petitioning or intervening users of benzene and benzene-con taining products are the Rubber Manufactur ers Association on behalf of itself and member companies; the Armstrong Rubber Company and Uniroyal, Inc.; E. I. du Pont de Nemours and Company; and the Chemical Specialties Manufacturers Association on behalf of itself and member companies. The grouping of the petitioners into the producer or user category was made in order to coordinate the briefing and arguing of this case, and this opinion will continue to refer to those categories. 2. The standard, to be codified at 29 C.F.R. 1910.1028, and OSHA's statement of reasons in support of the standard are published at 43 Fed.Reg. 5918-70 (1978). 3. The ceiling limit is 5 ppm as averaged over any fifteen minute period. 4. OSHA promulgated an amended standard the day before oral argument of this case which exempted from the scope of the stan dard all work operations where the only expo sure to liquid benzene or its vapor* is from liquid mixtures containing 0.5 percent (0.1 per cent after June 27, 1981) or less of benzene by volume. 43 Fed.Reg. 27,962-71 (1978). The original standard's absolute prohibition of der mal contact with any liquid containing any amount of benzene is therefore no longer in existence. The effect of this amendment on the issues in this case will be discussed infra.. 5. Not only does the scope of the amended standard affect the labeling requirement, but B-3 CMA 048199 83 AMERICAN PET. INSTITUTE v. OCCUPATIONAL SAFETY es numerous compliance requirements for "each place of employment where benzene is produced, reacted, released, packaged, repackaged, stored, transport ed, handled, or used," with certain ex ceptions. These requirements include initial and continual exposure monitor ing, engineering and work practice con trols to reduce and maintain exposure below the permissible level, respiratory protection to prevent excessive exposure in limited situations, protective clothing and equipment to prevent dermal con tact with liquid benzene, initial and con tinual medical surveillance, employee training programs, and retention of rec ords regarding exposure monitoring and medical surveillance. The petitioning producers and users of benzene and benzene-containing products principally attack the reduction of the permissible exposure limit to 1 ppm,` the prohibition of dermal contact with liq uids containing benzene, and the labeling requirements for such liquids. The peti tioners also attack several of the ancil lary provisions of the standard, including its broad scope, the monitoring and medical surveillance requirements, and the specification of mandatory engineer ing and work practice controls. I. The Act authorizes the Secretary of Labor7 to promulgate occupational safe ty and health standards. 29 U.S.C.A. 655. An "occupational safety and health standard" is defined as "a stan- dard which requires conditions, or the adoption or use of one or more practices, means, methods, operations, or processes, reasonably necessary or appropriate to provide safe or healthful employment and places of employment" 29 U.S.C.A. 652(8). In promulgating standards dealing with toxic materials, such as benzene, the Secretary is required to set the standard which most adequate ly assures, to the extent feasible, on the basis of the best available evi dence, that no employee will suffer material impairment of health or func tional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life. Develop ment of standards under this subsec tion shall be based upon research, demonstrations, experiments, and such other information as may be appropri ate. In addition to the attainment of the highest degree of health and safe ty protection for the employee, other considerations shall be the latest avail able scientific data in the field, the feasibility of the standards, and expe rience gained under this and other health and safety laws. Whenever practicable, the standard promulgated shall be expressed in terms of objec tive criteria and of the performance desired. 29 U.S.C.A. 655(b)(5). When necessary or appropriate, standards may prescribe labels or other forms of warning, protec tive equipment, control or technological procedures, exposure monitoring, and the amended standard also exempts from the labeling requirement liquid mixtures contain ing 5.0 percent or less benzene by volume which were packaged before June 27, 1978. 6. Presently the permissible exposure limit for benzene is 10 ppm. 29 C.F.R. 1910.1000 Table 2-2 (1977). This standard has been in existence since 1971. 7. This authority has been delegated to the As sistant Secretary of Labor for Occupational Safety and Health, the chief executive officer of OSHA. References to the Secretary and OSHA are used interchangeably in this opin ion. B-4 048200 CMR AMERICAN PET. INSTITUTE v. OCCUPATIONAL SAFETY 84 medical examinations. 29 U.S.C.A. of New York, Inc. v. United States De 655(b)(7). partment of Labor, supra, 487 F.2d at [1] Judicial review of occupational safety and health standards is authorized by 29 U.S.C.A. 655(f), and on review "[t]he determinations of the Secretary shall be conclusive if supported by sub stantial evidence in the record considered as a whole." Several courts, including this one, have pointed out the problems involved in attempting to apply the tra ditional substantial evidence test in as sessing OSHA standards resulting from informal rulemaking. E. g., Associated Industries of New York State, Inc. v. United States Department of Labor, 487 F.2d 342, 347-50 (2d Cir. 1973); Florida Peach Growers Association, Inc. v. Unit ed States Department of Labor, 489 F.2d 120, 127-29 (5th Cir. 1974); Industrial Union Department, AFL-CIO v. Hodg son, 162 U.S.App.D.C. 331, 336-340, 499 F.2d 467, 472-76 (1974); Synthetic Or 348. Although the courts have differed in their articulation of the standard of review of these policy judgments, they have required the Secretary's action to be consistent with the statutory lan guage and purpose. Synthetic Organic Chemical Manufacturers Association v. Brennan, supra, 503 F.2d at 1159. As this court stated in assessing an emer gency temporary standard in Florida Peach Growers, "it seems clear that even with the required substantial evidence test, our review basically must determine whether the Secretary carried out his es sentially legislative task in a manner reasonable under the state of the record before him." 489 F.2d at 129. This in cludes, of course, a review of whether the Secretary exercised his decisionmak ing power within the limits imposed by Congress. ganic Chemical Manufacturers Assoc/a t/on v. Brennan, 503 F-2d 1155, 1158-60 II. (3d Cir. 1974). The problem centers not Benzene is a ubiquitous hydrocarbon on how to apply the test to factual find compound (CH) that is manufactured ings subject to evidentiary development, for a wide variety of industrial uses. but rather on how to review legislative The petro-chemical and petroleum refin like policy judgments. With respect to ing industries are responsible for 94 per the former, the substantial evidence cent of the total domestic production of standard provided in the statute clearly benzene, and the steel industry produces is applicable. See, e. g., Industrial Union the remaining 6 percent primarily as a Department, AFL-CIO v. Hodgson, su by-product of the coking process. The pra, 499 F.2d at 474; American Iron & primary use of benzene is as a feedstock Steel Institute, et a1. v. OSHA, 577 F.2d in the manufacture of other organic 825, No. 76-2358 et al. (3d Cir., filed chemicals; it is also used in the manu March 28, 1978). Policy choices, though facture of detergents, pesticides, sol not so susceptible to verification or refu vents, and paint, and as a solvent and tation by the record, must be scrutinized reactant in chemical laboratories. Indus nevertheless. See Associated Industries8 tries currently using benzene include the 8. Although benzene does occur naturally in small quantities (a few parts per billion) in certain substances, including the ambient air, it is produced in substantial quantities by the petroleum and steel industries. The produc- tion of benzene is rapidly expanding, and at present only eleven other chemicals and only one other hydrocarbon are produced in greater tonnage in the United States. See 43 Fed.Reg. 5918. B-5 CMA 048201 85 AMERICAN PET. INSTITUTE v. OCCUPATIONAL SAFETY chemical, printing, lithograph, rubber ce ments, rubber fabricating,' paint, var nish, stain removers, adhesives, and pe troleum industries. Among the products that contain benzene are motor fuels such as gasoline, which contain up to 2 percent benzene. Benzene has been recognized since 1900 as a toxic substance capable of pro ducing acute and chronic nonmalignant effects in humans. When benzene va pors are inhaled, the benzene diffuses rapidly through the lungs and is quickly absorbed into the blood. Acute circula tory failure resulting in death within minutes often accompanies exposure to benzene concentrations as high as 20,000 ppm. Other acute effects of exposure to milder, though still high (250-500 ppm), concentrations of benzene include verti go, nervous excitation, headache, nausea, and breathlessness. When exposure is stopped, rapid recovery from these symp toms usually occurs. The most common nonmalignant ef fects of chronic exposure to low 910 ben zene concentration levels are a non-func tioning bone marrow and deficiencies in the formed elements of the blood.11 The degree of severity of such disorders ranges from mild and transient episodes to severe and fatal effects. Chromosom al aberrations have also been associated with chronic benzene exposure, and der matitis or other dermal infections can be caused by direct bodily contact with liq uid benzene. As a result of its toxicity, benzene's history has been one of regulation. In 1946, the American Conference of Gov ernmental Industrial Hygienists recom mended a threshold limit value for ben zene exposure of 100 ppm. This value was reduced to 50 ppm in 1947, to 35 ppm in 1948, to 25 ppm in 1963, and to 10 ppm in 1974. The American National Standards Institute adopted a threshold limit value of 10 ppm in 1969, which OSHA adopted in 1971 without rulemak ing under the authority of 29 U.S.C.A. 655(a).12 This standard, codified at 29 C.F.R. 1910.1000 Table 2-2 (1977) and still in effect, was based on the nonmal ignant toxic effects of benzene exposure and not on any possible leukemia hazard. Widely scattered through the benzene literature are studies suggesting a link between benzene exposure and leukemia, a usually fatal cancer of the blood-form ing organs. During the 1970's several additional studies reported a statistically significant increased risk of leukemia among workers occupationally exposed to high levels of benzene and concluded 9. According to the rubber companies, the man ufacture of tires requires the use of petroleum solvents which generally contain small amounts of benzene. 10. These toxic effects were documented at ex posure levels above 23--40 ppm, and a few studies showed nonmalignant blood abnormali ties at levels below 23 ppm. 43 Fed.Reg. 5924-25. 11. A decline in the red blood cell count (ane mia) results in a decreased capacity of the blood to carry oxygen to various parts of the body and is characterized by fatigue. A de cline in the white blood cell count (leukopenia) reduces the capacity of the body to defend against disease and is characterized by recur rent infections. A decline m the platelet count (thrombocytopenia) results in an impaired clotting of the blood and is characterized by bleeding tendencies. 12. 29 U.S.C.A. 655(a) directed the Secretary, within two years after the effective date of the Act and without rulemaking, to promulgate as an occupational safety or health standard any national consensus standard that he deter, mined would result m improved safety or health for employees. The purpose of this power was to make the Act effective immedi ately, and the power expired on April 28, 1973. B-6 CMA 048202 AMERICAN PET. INSTITUTE v. OCCUPATIONAL SAFETY 86 benzene was a leukemogen.13 As a re sult of this new evidence, OSHA began procedures which culminated with the present proposal, among other things, to reduce the permissible exposure level from 10 ppm to 1 ppm. In January 1977 OSHA issued volun tary Guidelines for Control of Occupa tional Exposure to Benzene recommend ing exposure not to exceed an eight-hour time-weighted average of 1 ppm. An Emergency Temporary Standard for Oc cupational Exposure to Benzene also pro viding for a reduction in the permissible exposure limit to 1 ppm 14 was issued in May 1977, but this standard never went into effect because of judicial challenges. The proposed permanent benzene stan dard, which was based on OSHA's deter mination that the available scientific evi dence established that employee expo sure to benzene presents a leukemia haz ard and that exposure therefore should be limited to the lowest feasible level, was published on May 27, 1977, This proposal provided for a reduction in the permissible exposure limit from 10 ppm to 1 ppm and established requirements relating to dermal and eye contact,15 ex posure monitoring, medical surveillance, methods of compliance, labeling, and re cordkeeping. Public hearings were held July 19 through August 10, 1977, at which 95 witnesses testified. In addi tion, numerous exhibits and documents were submitted to OSHA as part of the rulemaking record. The resulting per manent benzene standard was promul gated on February 3 and published on February 10, 1978, with a March 13, 1978 effective date. III. The American Petroleum Institute on behalf of itself and member companies 13. One such study was reported in 1975 by Dr. Enrico Vigliani. In 1963, Dr. Vigliani partici pated in a study of workers exposed to resins, inks, varnishes, and glues containing various amounts of benzene, and found a risk of leuke mia among these workers twenty times great er than that for the general population. Tolu ene was substituted for benzene in 1964 in one of the industries studied, and the 1975 study showed no new cases of leukemia among workers in that industry. A second study was reported in 1972 by Dr. Muzaffer Aksoy. a hematologist who testified at the rulemaking hearing. In this study Dr. Aksoy reported four leukemia deaths among Turkish shoemakers resulting from their expo sure to benzene concentrations in excess of 150 ppm for periods ranging from six to four teen years, and at the hearing he estimated that the incidence of leukemia among the pop ulation he studied was twice what would have been expected for the population as a whole. Dr. Aksoy also noted a decline in leukemia cases after other solvents were substituted for benzene. The study most heavily relied upon by OSHA was one reported by Dr. Peter Infante of the National Institute for Occupational Safe- ty and Health, a body created to conduct re search and recommend occupational safety and health standards. See 29 U.S.C.A. 669-71. Dr. Infante studied workers ex posed to benzene in the production of Pliofilm at Goodyear's Akron and SL Mary's plants be tween 1940 and 1949 and found among them a five-fold increased risk of dying of leukemia when compared to two control groups. No specific exposure level during the period cov ered by the study was established, but testimo ny at the hearing indicated that exposure was probably around 100 ppm during most of the period studied with occasional exposure levels as high as several hundred parts per million. 14. Both the Guidelines and the Emergency Temporary Standard exempted work opera tions where the only exposure to benzene was from liquids containing 1 percent or less of benzene by volume. 15. The proposed permanent statement also ex empted work operations where the only expo sure to benzene was from liquid mixtures con taining 1 percent (0.1 percent after one year from the effective date of the standard) or less of benzene by volume. B-7 CMA 048203 87 AMERICAN PET. INSTITUTE v. OCCUPATIONAL SAFETY filed petitions for review of the standard the ancillary provisions of the standard, in this court on February 2 and Febru including its broad scope, the monitoring ary 3, 1978. The American Iron and and medical surveillance requirements, Steel Institute, the Independent Petrole and the specification of mandatory pri um Association of America, the Manu mary means of compliance, as not being facturing Chemists Association, the Rub supported by substantial evidence that ber Manufacturers Association, the Arm they are reasonably necessary or appro strong Rubber Company and Uniroyal, priate to provide safe or healthful em Inc., E. I. Du Pont de Nemours and ployment The attack of the petitioning Company, and the Chemical Specialties users of benzene and benzene-containing Manufacturers Association subsequently products is two-fold: (i) They contend either intervened on behalf of the Amer ican Petroleum Institute or filed original petitions for review in other circuits that were transferred to this circuit and con solidated with the American Petroleum Institute case. In addition, the Industri al Union Department, AFL-CIO, inter vened on behalf of OSHA in support of the stand ard.1* that substantial evidence and the best available evidence do not show that the dermal contact prohibition is reasonably necessary or appropriate to provide safe or healthful employment, and that the dermal contact prohibition is not feasi ble; and (ii) they contend that substan tial evidence does not show the labeling requirement to be reasonably necessary The petitioners filed motions for a or appropriate to provide safe or health stay of the standard pending review on* ful employment, that the labeling re March 10, 1978, and on March 13 a judge quirement is not feasible, and that the of this court issued a temporary stay of the standard pending a hearing before a three-judge panel. The issues concern ing the stay were fully briefed by the parties on an expedited basis, and after hearing oral argument a panel of the court on April 18, 1978, ordered a stay of the standard to be continued pending disposition of the petitions for review.1176 labeling requirement is beyond OSHA's jurisdiction. OSHA, in addition to argu ing that substantial evidence, the best available evidence, feasibility considera tions, and its statutory mandate to pro tect workers justify the standard in its entirety, contends that Congress imposed on it no substantive requirement to The principal argument of the peti tioning producers of benzene and ben zene-containing products is that substan tial evidence and the best available evi promulgate only standards that are rea sonably necessary or appropriate to pro vide safe or healthful employment and places of employment. dence do not show that the reduction of On June 21, 1978, the day before oral the permissible exposure limit from 10 argument, OSHA promulgated an ppm to 1 ppm is reasonably necessary or amended standard to exempt from the appropriate to provide safe or healthful scope of the benzene standard work op employment and places of employment. erations where the only exposure to ben These petitioners also attack several of zene is from liquid mixtures containing 16. Although we speak generally m this opinion about the contentions of the petitioners and the contentions of OSHA, the Industrial Union Department was an active participant in this case and offered considerable support to OSHa's position. 17. The issuance of a stay pending judicial re view is authorized by 29 U.S.C.A, 655(f) B-8 048204 AMERICAN PET. INSTITUTE v. OCCUPATIONAL SAFETY 88 0.5 percent (0.1 percent after June 28, 1981) or less of benzene by volume, and to exempt from the labeling require ments liquid mixtures containing 5.0 per cent or less benzene by volume which were packaged before June 27, 1978. 43 Fed.Reg. 27,971 (1978). Although the proposed emergency temporary standard and the proposed permanent standard had exempted work operations where ex posure to benzene resulted only from liq uid mixtures containing 1 percent or less of benzene by volume,18 1t9he* permanent standard that was promulgated con tained no such exemption. As a result, the permanent standard prohibited all dermal contact with liquids containing any amount of benzene and it imposed the labeling requirements on all such liq uids. Several industry groups petitioned OSHA for a stay of the dermal contact prohibition and labeling requirements as they applied to liquids containing small amounts of benzene.1* OSHA subse quently granted a stay as to work opera tions where the sole exposure to benzene was from mixtures containing 0.1 per cent or less of benzene and instituted a new rulemaking proceeding which result ed in the June 21, 1978 amendment. The court called for supplemental briefing to address the effect of this amendment on the issues already briefed and argued. This briefing has been com pleted, and it appears that the major effect of the amendment is on the argu ments regarding the feasibility of the dermal contact and labeling provisions. Since the considerations associated with the feasibility of those provisions have been significantly changed by the amendments, we do not address the mer its of the feasibility arguments in this opinion. IV. OSHA justifies the reduction of the permissible exposure limit for benzene from 10 ppm to 1 ppm by coupling two factual findings, which it contends are supported by substantial evidence in the record, with a regulatory policy which OSHA contends' is required by its man date to protect workers. The factual findings are that benzene causes leuke mia and that there presently exists no known safe level for benzene exposure. The regulatory policy is to limit employ ee exposure to carcinogens to the lowest feasible level. The producer petitioners, in addition to attacking the factual finding that no known safe level for benzene exposure exists,10 contend that OSHA has failed to meet a burden which the Act imposes of determining that the reduction of the permissible exposure limit from 10 ppm to 1 ppm is "reasonably necessary" to 18. As noted above, the exemption in the pro posed permanent standard fell to 0.1 percent after the first year. 19. These petitioners, who generally were among the user petitioners in this case, sought relief on the grounds that OSHA failed to pro vide adequate notice that the final standard might contain no exemption for work opera tions where the only benzene exposure was from liquid mixtures containing small amounts of benzene, that the dermal contact prohibition was not based on the best available evidence, and that the dermal contact prohibition was not feasible. With respect to feasibility, the rubber industry contended that the manufac ture of tires was impossible without some der mal contact with solvents containing trace amounts of benzene. 20. This argument is based on the fact that all studies associating benzene and leukemia in volve high benzene concentration levels, that a substantial body of the scientific community subscribes to the 'theory that safe threshold levels exist for exposure to carcinogens, and that empirical evidence shows that low-level exposure to benzene does not cause leukemia B-9 CMA 048205 89 AMERICAN PET. INSTITUTE v. OCCUPATIONAL SAFETY provide a safe workplace. In support of sumer Product Safety Act, on the basis the latter contention, these petitioners that the "reasonably necessary" lan point to this circuit's recent decision in guage in that Act appeared as a part of Aqua Slide `N' Dive Corp. v. Consumer the sections which dealt with the agen Product Safety Commission, 569 F.2d 831 cy's process of setting standards, 15 U.S. (5th Cir. 1978), and assert that OSHA C.A. 2056(a), 2058(cK2XA), whereas failed to assess benefits expected to be the "reasonably necessary" counterpart achieved by the standard in light of the in the act it administers appears only in expected costs of compliance. The peti the section which defines the type of tioners argue that by defining an "occu standard it may promulgate. pational safety and health standard" as one requiring conditions "reasonably nec essary" to provide safe or healthful places of employment, 29 U.S.C.A. 652(8), Congress recognized that safety and health resources are not unlimited and required OSHA somewhere in its de cisionmaking process to (1) attempt to determine the extent to which its stan dards will benefit workers, and (2) decide whether the projected benefits justify the costs of compliance with the stan dard. Only if all standards are subject ed to such assessment, argue the peti tioners, can OSHA assure maximum ben efit from the finite amount industry can expend on safety and health and thus carry out Congress' overriding policy "to assure so far as possible every working man and woman in the Nation safe and healthful working conditions." 29 U.S. C.A. 651(b). Since OSHA has not made a valid determination that reduc ing the permissible exposure level of benzene from 10 ppm to 1 ppm is reason ably necessary to protect workers from a risk of leukemia, the producers ask us to set that part of the standard aside.11 [2] In authorizing the Consumer Product Safety Commission to promul gate safety standards, Congress provided that "[a]ny requirement of such a stan dard shall be reasonably necessary to prevent or reduce an unreasonable risk of injury associated with such product." 15 U.S.C.A. 2056(a). It also required the Consumer Product Safety Commis sion to make a specific finding that its rules were "reasonably necessary to eliminate or reduce an unreasonable risk of injury." 15 U.S.C.A. 2058(cX2XA). Rather than following this format, the Occupational Safety and Health Act defines the occupational safety and health standard it authorizes as one "which requires conditions, or the adoption or use of one or more practices, means, methods, operations, or processes, reasonably necessary or appropriate to provide safe or healthful employment and places of employment" 29 U.S.C.A. 652(8). We decline to construe the precisely similar requirements of these two Acts differently or to read words out of the OSHA legislation. The Act imposes on OSHA the obligation to enact OSHA denies that the "reasonably only standards that are reasonably nec necessary" language imposes any sub essary or appropriate to provide safe or stantive obligation on it in promulgating healthful workplaces. If a standard does standards. OSHA would distinguish not fit in this definition, it is not one Aqua Slide, which dealt with the Con21 that OSHA is authorized to enact. 21. As a corollary, they ask us to set aside all other provisions designed to effectuate the 1 ppm permissible exposure limit. B-10 AMERICAN PET. INSTITUTE v. OCCUPATIONAL SAFETY 90 OSHA next argues that even if the conditions required by occupational safe ty and health standards must be reason ably necessary to provide safe or health ful places of employment, the Act still imposes on OSHA no obligation to un dertake a cost-benefit analysis with re spect to the standards it promulgates. OSHA argues that 29 U.S.C.A. 655(b)(5) defines when conditions im posed by a standard dealing with toxic materials are reasonably necessary. It urges that the emphasis of that section on making of a standard "which most adequately assures . that no employee will suffer material impair ment of health . [from] regular exposure . .for the period of his working life," overcomes any require ment to make a cost-benefit analysis. Nevertheless, OSHA contends that it did undertake economic analyses of "both costs and benefits associated with the standard as required by Aqua Slide, and that after assessing those analyses it promulgated the standard. [3] Although 29 U.S.C.A. 655(b)(5) requires the goal of attaining the highest degree of health and safety protection for the employee, it does not give OSHA the unbridled discretion to adopt stan dards designed to create absolutely risk free workplaces regardless of cost. To the contrary, that section requires stan dards to be feasible, and it contains a number of pragmatic limitations in the form of specific kinds of information OSHA must consider in enacting stan dards dealing with toxic materials. Those include "the best available evi dence," "research, demonstrations, exper iments, and such other information as may be appropriate," "the latest availa ble scientific data in the field," and "ex perience gained under this and other health and safety laws." Moreover, in standards dealing with toxic materials, just as with all other occupational safety and health standards, the conditions and other requirements imposed by the stan dard must be "reasonably necessary or appropriate to provide safe or healthful employment and places of employment." 29 U.S.C.A. 652(8). [4] Since the purpose of the Act to protect workers from dangerous condi tions of employment is parallel to the purpose of the Consumer Product Safety Act to protect consumers from danger ous products, we must be guided by Aqua Slide in determining whether OSHA has met its burden of showing that the benzene standard is reasonably necessary to protect workers from a leu kemia hazard. There we said: In evaluating the "reasonable neces sity" for a standard, the Commission has a duty to take a hard look, not only at the nature and severity of the risk, but also at the potential the stan dard has for reducing the severity or frequency of the injury, and the effect the standard would have on the utility, cost or availability of the product. 569 F.2d at 844; see also D. D. Bean & Sons v. Consumer Product Safety Com mission, 574 F.2d 643 (1st Cir. 197S). Be fore it regulates, the agency must show that a hazard exists and that its regula tion will reduce the risk from the hazard, for "no [occupational safety and health] standard would be expected to impose added costs or inconvenience unless there is reasonable assurance that the frequency or severity of injuries or illnesses will be reduced." 569 F.2d at 839. More importantly for today's case. Aqua Slide also requires the agency to assess the expected benefits in light of the burdens to be imposed by the stan dard. Although the agency does not have to conduct an elaborate cost-benefit B-ll CMA 048207 91 AMERICAN PET. INSTITUTE v. OCCUPATIONAL SAFETY analysis, 569 F.2d at 840, it does have to Slide. It contends the standard promises determine whether the benefits expected appreciable benefits at a cost which in from the standard bear a reasonable re dustry can absorb. This justification is lationship to the costs imposed by the deficient in one crucial way: substantial standard. 569 F.2d at 842. evidence does not support OSHA's con [5] The only way to tell whether the relationship between the benefits and costs of the benzene standard is reasona ble is to estimate the extent of the ex pected benefits and costs. See 569 F.2d at 843. OSHA did this with respect to costs by engaging a consulting firm to clusion that benefits are likely to be ap preciable. Without an estimate of bene fits supported by substantial evidence, OSHA is unable to justify a finding that the benefits to be realized from the stan dard bear a reasonable relationship to its one-half billion dollar price tag. assess the expected compliance costs and OSHA's assumption that the standard economic feasibility of the proposed is likely to result in benefits is not un standard. 43 Fed.Reg. 5934-39. Based supported. The divided opinion in the on this study and other evidence, OSHA scientific community over the existence estimated compliance costs for all affect or not of safe threshold levels of expo ed industries to be $187-205 million first sure to carcinogens provides substantial year operating costs, $266 million engi evidence which would support the find neering control costs, and $34 million re ing that exposure to benzene at the curring annual costs.n OSHA deter present level of 10 ppm poses some leu mined these costs to be feasible since kemia risk. The general agreement in they would not threaten the financial the scientific community that exposure welfare of the affected firms or the gen to carcinogens at low levels is safer than eral economy. However, OSHA dis exposure at higher levels permits the claimed any obligation to balance these further factual deduction that reducing costs against expected benefits. 43 Fed. the permissible exposure limit from 10 Reg. 5940--41. Rather than attempting ppm to 1 ppm will result in some bene to measure the extent to which the leu fit. This finding and deduction, how kemia hazard of benzene exposure would ever, does not yield the conclusion that be reduced by lowering the permissible measurable benefits will result, and exposure limit from 10 ppm to 1 ppm, OSHA is unable to point to any studies OSHA merely assumed that benefits or projections supporting such a finding. from the reduction "may be apprecia As we noted in Aqua Slide, mere ration ble." It based this assumption on a find ing that benzene was unsafe at any level and its conclusion that exposures to low er levels of toxic materials would be saf er than exposure to higher levels. ality is not equivalent to substantial evi dence that conditions required by stan dards are reasonably necessary. 569 F.2d at 841. The lack of substantial evi dence of discernable benefits is high OSHA's fail-back position attempts to lighted when one considers that OSHA is justify its standard as being reasonably unable to point to any empirical evidence necessary within the meaning of Aqua22 documenting a leukemia risk at 10 ppm 22. Although the petitioners do not seriously challenge OSHA's estimate of costs in this suit, they refer to the promulgation of this standard as a $1 billion decision. Neither OSHA's estimate nor the petitioners' estimate takes into account the effects of the amendment, which narrows the scope of the standard. B-12 CMA 048208 AMERICAN PET. INSTITUTE v. OCCUPATIONAL SAFETY 92 even though that has been the permissi ble exposure limit since 1971. OSHA's assertion that benefits from reducing the permissible exposure limit from 10 ppm to 1 ppm are likely to be appreciable, an assumption based only on inferences drawn from studies involving much high er exposure levels rather than on studies involving these levels or sound statistical projections from the high-level studies, does not satisfy the reasonably necessary requirement limiting OSHA's action. Aqua Slide requires OSHA to estimate the extent of expected benefits in order to determine whether those benefits bear a reasonable relationship to the stan dard's demonstrably high costs. We are not persuaded by OSHA's ar gument that this standard should be up held since the lack of knowledge con cerning the effects of exposure to ben zene at low levels makes an estimate of benefits expected from reducing the per*. missible exposure level impossible.23 The statute requires all conditions imposed by a standard to be reasonably necessary to provide safe or healthful employment, and it requires decisions to be based on "the best available evidence," "research, demonstrations, experiments, and such other information as may be appropri ate," "the latest scientific data in the field," and "experience gained under this and other health and safety laws." By requiring the consideration of such kinds of information, Congress provided that OSHA regulate on the basis of knowl edge rather than on the unknown. But see Society of Plastics Industry, Inc. v. OSHA, 509 F.2d 1301, 1308 (2d Cir. 1975), Until OSHA can provide substan tial evidence that the benefits to be achieved by reducing the permissible ex posure limit from 10 ppm to 1 ppm bear a reasonable relationship to the costs im posed by the reduction, it cannot show that the standard is reasonably necessary to provide safe or healthful workplaces. This does not mean that OSHA must wait until deaths occur as a result of exposure at levels below 10 ppm before it may validly promulgate a standard re ducing the permissible exposure limit. See Florida Peach Growers Association, Inc. v. United States Department of La bor, 489 F.2d 120, 132 (5th Cir. 1974). Nevertheless, OSHA must have some factual basis for an estimate of expected benefits before it can determine that a one-half billion dollar standard is reason ably necessary. For example, when stu dies of the effects of human exposure to benzene at higher concentration levels in the past are sufficient to enable a doseresponse curve34 to be charted that can 23.Although OSHA asserts that risk quantifi cation at low exposure levels and therefore estimates of expected benefits from the stan dard cannot presently be made, OSHA has provided us with a Preliminary Report on Pop ulation Risk to Ambient Benzene Exposures, recently released by the Environmental Protec tion Agency, which attempts to extrapolate from the results of the Infante study a deter mination of the risk of leukemia to the general population at the exposure level of 1 part per billion. In addition, the petitioners introduced at the rulemaking proceeding a preliminary risk assessment for occupational exposure to benzene at 10 ppm and 1 ppm based on the studies at higher exposure levels relied on by OSHA Finally, OSHA's economic consultant testified that it could perform a cost-effective ness analysis for the benzene standard, an analysis which would have included some kind of risk quantification. Although OSHA's as sertion that present knowledge is insufficient to construct a valid dose-response curve for benzene may be correct, the record reflects that preliminary assessments are now being made and that valid extrapolations will be pos sible as more is known about the effect: of past exposure at higher levels. 24. A dose-response curve shows the relation ship between different exposure levels and the risk of cancer associated with those exposure B-13 CMA 048209 93 AMERICAN PET. INSTITUTE v. OCCUPATIONAL SAFETY reasonably be projected to the lower ex posure levels, or when studies of the ef fects of animal exposure to benzene14 are sufficient to make projections of the risks involved with exposure at low lev els, then OSHA will be able to make rough but educated estimates of the ex tent of benefits expected from reducing the permissible exposure level from 10 ppm to 1 ppm. Until such estimates are possible, OSHA does not have sufficient information to determine that a stan dard such as the one under review which it can only say might protect some work er from a leukemia risk is reasonably necessary. We will not attempt to reconcile our decision with the cases from other cir cuits which uphold other standards regu lating exposure to carcinogens. See In dustrial Union Department, AFL-CIO v. Hodgson, 162 U.S.App.D.C. 331, 499 F.2d 467 (1974) (asbestos dust standard); So ciety of Plastics Industry, Inc. v. OSHA, 509 F.2d 1301 (2d Cir. 1975) (vinyl chlo ride standard); American Iron & Steel Institute et a1. v. OSHA, 577 F.2d 825, No. 76-2358 et al (3d Cir., filed March 28, 1978) (coke oven emission standard). Those opinions did not address what Congress meant by requiring the condi tions imposed by standards to be reason ably necessary' to provide safe or health ful places of employment. In this cir cuit, under our Aqua Slide decision, sub stantial evidence must support a finding that those conditions are reasonably nec essary, a showing that OSHA has not made. In addition, those cases were de cided on their own records. Without critical analysis of what was established in those proceedings, we hold in today's case that Congress intended for OSHA to regulate on the basis of more knowl edge and fewer assumptions than this record reflects. OSHA's failure to provide an estimate of expected benefits for reducing the permissible exposure limit, supported by substantial evidence, makes it impossible to assess the reasonableness of the rela tionship between expected costs and ben efits. This failure means that the re quired support is lacking to show reason able necessity for the standard promul gated. Consequently, the reduction of the permissible exposure limit from 10 ppm to 1 ppm and all other parts of the standard geared to the 1 ppm level must be set aside. V. OSHA's prohibition of dermal contact with benzene is based on "OSHA's policy that, in dealing with a carcinogen, all potential routes of exposure (/. e., inhala tion, ingestion, and skin absorption) be limited to the extent feasible." 43 Fed. Reg. 5948. OSHA, w'hile acknowledging that the record evidence on the effect of benzene on the skin is "extremely limit ed" and that the few studies in the area "are not definitive as to the extent of benzene that is absorbed through the in tact skin or as to the comparative rate of absorption through damaged skin," 43 Fed.Reg. 5948-49, nevertheless decided to prohibit dermal contact with liquids containing benzene. In arriving at this decision OSHA relied on animal studies levels. Generally, exposure to higher levels carries with it a higher risk, and exposure to lower levels is accompanied by a reduced risk. 25. Although there have been attempts to dem onstrate the development of leukemia in ani mals exposed to benzene, those attempts for the most part have been unsuccessful. Those studies do not even establish that benzene ex posure causes leukemia, much less the degree of risk associated wuh various exposure levels. See 43 Fed.Reg. 5930-31, 5932. B-14 04821C AMERICAN PET. INSTITUTE v. OCCUPATIONAL SAFETY 94 and one human study suggesting that The user petitioners contend that sub benzene is absorbed through intact skin, on the assumption that benzene would more readily be absorbed through dam aged skin than undamaged skin, and on the belief that substances containing benzene are readily absorbed through the skin and act as vehicles for absorp tion of benzene. stantial evidence and the best available evidence do not support a finding that the dermal contact provisions are reason ably necessary to provide safe or health ful employment, and in addition they contend that the dermal contact prohibi tion is not feasible since it is impossible for certain industries to operate without some dermal contact with liquids con [6] OSHA now seeks in part to justi taining small amounts of benzene. Since fy this prohibition as an adjunct to the permissible exposure limit for airborne concentrations of benzene and because of a concern for dermatitis. To the extent that the dermal contact prohibition is an adjunct of the permissible exposure lim it, it would have to be set aside along with the permissible exposure limit. The concern for dermatitis, on the other hand, appears to be a post hoc rationali zation for the dermal contact prohibition since it was not a significant part of OSHA's reasoning process that led to this provision.2 The requirements of this standard were based on the possible leukemia hazard associated with expo the amendment to the standard on June 21, 1978, significantly affects the feasi bility issue, we will not address that is sue in this opinion. We agree with the users, however, that OSHA has not shown the dermal contact prohibition to be reasonably necessary to protect work ers from contracting benzene-related leu kemia since readily available evidence of the kind Congress required OSHA to consider was neglected. The record therefore fails to support the finding that benzene is absorbed through the skin. Since entry to the body by dermal contact was not established, the record will not support a finding that the prohi bition of all dermal contact with benzene sure to benzene, 43 Fed.Reg. S91S, 5948, will result in quantifiable benefits in and our review must be of the reasoning terms of a reduced risk of leukemia jus process of the agency at the time it pro tifying the costs of the provision. Thus mulgated the standard based on the rec reasonable necessity is lacking here too. ord before it. Dry Color Manufacturers' Studies of whether benzene is ab Association, Inc. v. Department of La sorbed by the skin of animals, conducted bor, 486 F.2d 98, 104 n.8 (3d Cir. 1973).26 in the first half of this century, are re- 26. At one point in the statement of reasons for the benzene standard OSHA did state that "(o]ne purpose of the protective clothing and equipment requirement is to protect employees ftom dermatitis and bums." 43 Fed.Reg. 5953. The reason for this standard as a whole, however, and the primary reason for the absolute prohibition of dermal contact with benzene (to which the protective clothing and equipment provision is tied), is to protect workers from a suspected carcinogen. It is within the context of OSHA's policy of reduc ing exposure to carcinogens to the lowest fea- sible level that we must review the dermal contact prohibition. Dermal diseases can pose significant haz ards in the workplace, and regulatory action following proceedings specifically focusing on such hazards may be appropriate. OSHA recently announced the formation of a stan dards advisory committee on cutaneous haz ards to "identify- the occupational exposures in industry which pose a hazard to the skm and/or the use of the skin as a portal of en try." 43 Fed.Reg. 10.647-48 (1978). B-15 CMA 048211 95 AMERICAN PET. INSTITUTE v. OCCUPATIONAL SAFETY ferred to in this record during the course of expert testimony and as background material in later studies of whether ben* zene can be absorbed by human skin. Though these studies reached different conclusions, their relevance with respect to the issue of absorption of benzene by human skin has been questioned since there are important differences between the permeability of the skins of animals and humans. The studies concluding that benzene penetrates skin of certain animals have also been criticized since the possibility of benzene inhalation was not excluded and since there was no guarantee that the skin remained intact through the course of the experiment. Between 1946 and 1961, experiments were conducted to determine whether human skin absorbed benzene. Although the first several of these studies conduct ed in the late 1940's and mid-1950's had negative results, one study published in 1961 found that some absorption had oc curred and concluded that "the absorp tion of benzene throughout the skin must not be neglected." The record re veals problems in the interpretation of all of these studies, however. In partic ular, the 1961 study reporting positive results used a technique, compressing benzene-soaked cotton against the skin with a glass plate for prolonged periods, "that is recognized today as an efficient way to drive molecules into the skin. The oral testimony on the issue of skin absorption of benzene is very limited. Representatives of the National Institute of Occupational Safety and Health testi fied that they were of the opinion that benzene can be absorbed through the skin, and that absorption is more likely when the skin is damaged or when the benzene is contained in a solvent which itself is absorbed. Except for a passing reference to what appears to be the 1961 positive study, these witnesses did not attempt to support their opinions by ref erence to empirical data. The one expert dermatologist who tes tified in depth on the issue of skin ab sorption of benzene. Dr. Howard Maibach of the University of California Medical Center, after summarizing and discussing critically the studies that have been conducted to date, concluded that "in 1977 it is extremely difficult, if not impossible, to balance all of the informa tion that is available. Admittedly, the overwhelming majority of the observa tions suggest that benzene does not pen etrate the skin. One observation sug gests that it does." Dr. Maibach testi fied that he did not know whether ben zene is absorbed through the skin; that he did not know whether benzene would be more readily absorbed through dam aged skin than intact skin, although the assumption, unsupported by any data, is that it would be; and that he did not know whether benzene would be ab sorbed more readily if it is in another solvent. [7] Were this the extent of the rec ord on the issue of skin absorption, OSHA's finding that dermal contact with benzene poses a cancer risk could pass muster. When available evidence of equivalent quality is conflicting, a finding in accordance with one view or the other should be considered to be sup ported by substantial evidence. See Uni versal Camera Corp. v. NLRB, 340 U.S. 474, 488, 71 S.Ct 466, 465, 95 L.Ed. 456 (1951). This record speaks further on the issue of skin absorption, however, and in light of OSHA's statutory com mand this additional evidence removes the support for OSHA's actions. [8] Dr. Maibach, following his conclu sion that the studies conducted to date were not definitive on the issue of B-16 CMA 048212 AMERICAN PET. INSTITUTE v. OCCUPATIONAL SAFETY 96 whether human skin absorbed benzene, stated: Today we have a much simpler and a much more direct way of answering this . . because now radioac tive benzene is available, and one sim ply would apply radioactive benzene, some Carbon 14 benzene, to the skin of the arm of an appropriate animal that has permeability characteristics similar to the people in this room and then would simply look for the radioactivity excreted into the urine, the feces and the breath. This is a simple technique. It has been done for over 100 organic com pounds in the last decade, measuring the amount of transport to the skin, and it would then tell us definitively, without argument, and efficiently, just how much of any benzene penetrates the skin. Dr. Maibach testified that this experi mental technique can answer a number of questions other than whether any benzene penetrates the skin, including demonstrating any differences in exist ence and extent of absorption of various parts of the body which may be exposed; whether benzene applied to the skin has the same toxic potential as benzene in haled; whether multiple exposures result in correspondingly greater absorption than a single exposure; whether it is possible for one to protect himself by wearing protective clothing; whether and to what extent the amount of ben zene absorbed through the skin is de pendent upon benzene concentration; whether, because of its volatility, ben zene splashed onto the skin evaporates more rapidly or goes through the skin more rapidly; and whether benzene is absorbed more readily if it is in another solvent. Dr. Maibach testified that the experiment would be relatively short term in length (six to twelve weeks), that the techniques are straightforward and reliable, and that the experiment could be done by anybody having the analytic facilities available. This testi mony about the availability and reliabili ty of modern experimental techniques is unrefuted in the record. OSHA's decision to regulate on the ba sis of dated, inconclusive data when modem experimental methods can quick ly and efficiently provide reliable infor mation contravenes the directive from Congress to promulgate standards on the basis of the "best .available evidence," "research, demonstrations, experiments, and such other information as may be appropriate," and "the latest available scientific data in the field." 29 U.S.C.A. 655(b)(5). This is not a case where there is testimony that additional sophis ticated research could be attempted, but might not shed new light on a subject. To the contrary, unrefuted testimony re veals the existence of simple experimen tal techniques, tried and proved effective for over 100 organic compounds, that can provide accurate information on the fac tual issues OSHA admits are unresolved by the past studies.*7 When such factual information is so readily available, 29 U.S.C.A. 655(b)(5) requires OSHA to acquire that information before promul gating regulations which would require an established industry to change longfollowed work processes that are not de monstrably unsafe. In light of unrefuted testimony on the ready availability of conclusive evidence 27. In their brief the petitioners represent that Dr. Maibach is now conducting one such study. B-17 CMA 048213 97 AMERICAN PET. INSTITUTE v. OCCUPATIONAL SAFETY on the subject, OSHA's choice to rely on old and inconclusive evidence that there is a possibility of absorption of benzene through the skin which might cause can cer is in clear disregard of the congres sional directive as to the kinds of evi dence OSHA is required to consider. Therefore, the provision of the standard prohibiting dermal contact with liquid benzene cannot stand on the present rec ord. VI. (9] The reduction of the permissible exposure limit and the prohibition of dermal contact are the provisions of the benzene standard to which all the stan dard's other requirements are tied. Since neither of these provisions can be upheld on the present record, it follows that the standard as a whole must be set aside. Although we vacate the labeling provi sion in conjunction with the rest of the standard", this or some similar require ment is sure to be considered by OSHA on remand. Therefore, we address the user petitioners' jurisdictional attack on one aspect of that provision. The label ing provision generally requires the em ployer to assure that caution labels are affixed to all containers of benzene and benzene-containing products. In the as pect of the provision under attack, OSHA further requires each employer to ``assure that the caution labels remain affixed when the benzene or products containing benzene are sold, distributed or otherwise leave the employer's work place." By requiring caution labels to remain affixed when benzene products leave an employer's workplace, OSHA intended to assure that all employees along the prod uct's distribution chain are apprised of the hazardous nature of benzene expo sure. 43 Fed.Reg. 5960. It relied on the authority given to it by 29 U.S.C.A. 655(bX7) to require the use of warning labels in standards, and it concluded that this authority was not limited to requir ing an employer to warn his own em ployees of the hazardous products he manufactures. Since the manufacturer of a product containing a toxic substance (and subsequent employers who have been informed of the hazard) is in the best position to know of the hazard and warn others down the distribution chain, OSHA concluded that the protective pur poses of the Act would best be served by requiring the manufacturers to refrain from taking steps designed to withhold information concerning the dangers of the products from downstream workers. The petitioners, contend that the Act gives OSHA the jurisdiction to regulate workplaces, not products. They argue that OSHA here is claiming the authori ty to regulate finished products leaving the workplace, an authority that would transform what was intended to be a federal workplace safety code into a fed eral product safety code. The petition ers contend that Congress intended to place the responsibility for protecting each employee on his or her own employ er, an allocation of responsibility that has proved workable in all but unusual circumstances such as the multiemployer construction worksite; and that, since all employers would be required to assure that benzene-containing products in their own workplaces are labeled, and the usu al allocation of responsibility for labeling would be workable and effective. Cases involving multiemployer con struction worksites have recognized a duty on an employer to comply with OSHA standards in order to protect the employees of another employer. See Brennan v. Occupational Safety & B-18 CMA 048214 AMERICAN PET. INSTITUTE v. OCCUPATIONAL SAFETY 98 Health Review Commission and Under quire employers to eliminate all fore hill Construction Corp., 513 F.2d 1032 (2d seeable and preventable hazards." [ci Cir. 1975) (Underhill); Marshall v. Knut tation omitted] We agree with the son Construction Co., 566 F.2d 596 (8th Commission that this policy can best Cir. 1977); Beatty Equipment Leasing, be effectuated by placing the responsi Inc. v. Secretary of Labor, 577 F.2d 534 bility for hazards on those who create (9th Cir. 1978). These cases involved ci them. tations for violations of 29 U.S.C.A. 654(a), which imposes two duties on employers: Each employer-- 577 F.2d at 537. The duty on one em ployer to comply with OSHA standards for the benefit of employees of another employer, however, has only been ex (1) shall furnish to each of his employ pressly recognized in the multiemployer ees employment and a place of em construction worksite context. ployment which are free from recog nized hazards that are causing or are likely to cause death or serious physi cal harm to his employees; (2) shall comply with occupational safety and health standards promul gated under this chapter. In deciding whether an OSHA stan dard can require an employer to assure that a warning label remains affixed when a benzene-containing product leaves his workplace in order to protect downstream employees, we too must keep in mind the Act's overall purpose In holding that the 654(a)(2) duty "to assure so far as possible every work could be violated even though the*cited ing man and woman in the Nation safe employer's employees were not shown to have been exposed to the hazard created by the violation, the Underhill court em phasized that the 654(a)(2) duty, unlike the 654(a)(1) duty, was "in no way limited to situations where a violation of a standard is linked to exposure of his employees to the hazard." 513 F.2d at 1038 (emphasU in original). In reaching its conclusion, the court relied on the broad remedial purpose of the Act and on the fact that the cited employer had and healthful working conditions." 29 U.S.C.A. 651(b). In this light the pro vision of the statute requiring OSHA to prescribe labeling of hazards is broad in scope: Any standard promulgated under this subsection shall prescribe the use of labels or other appropriate forms of warning as are necessary to insure that employees are apprised of all haz ards to which they are exposed . . . created the hazard and maintained the area where it was located. In agreeing with this analysis, the Beatty court stat ed: [This interpretation of the statute] fa cilitates the broad remedial purpose of the Act which Congress declared is "to. 29 U.S.C.A. 655(b)(7). Unlike some sections of the Act, this provision does not expressly limit the employer's obliga tion of informing employees of hazard ous conditions to the employer's own em ployees. assure so far as possible every working The ability of downstream employers man and woman in the Nation safe to protect their own employees is also an and healthful working conditions." 29 appropriate consideration in determining U.S.C.A. 651. As this court has stat where the duty to warn should lie. Cf. ed, "Congress clearly intended to re Anning-Johnson Co. v. Occupational B-19 CMA 048215 99 AMERICAN PET. INSTITUTE v. OCCUPATIONAL SAFETY Safety and Health Review Commission, is understandable. Such a consideration 516 F.2d 1081, 1086-91 (7th Cir. 1975). may even be shown to have such delete This record reveals that the presence of rious effect on sales that it affects the benzene in a workplace is often a hidden reasonable necessity for this feature of hazard. Some industries refer to ben the regulation. See, Aqua Slide, 569 zene under code or trade names, and F.2d at 840-^13. In such a case, OSHA many products containing benzene are may choose to eliminate the requirement sold only under trade names with no list ing of contents. Under such circum stances it is apparent that the manufac turer of a benzene-containing product is in a far better position to warn down stream employees in operations using the benzene-containing product of the ben zene hazard than is a downstream em ployer. Considering the purpose of the Act to protect every working person in the na tion, the express and broad statutory au thorization for OSHA to prescribe warn ing labels in standards, and the fact that the presence of benzene in a product is often a concealed hazard, we agree withOSHA that it has the authority to pro hibit an employer from removing the warning labels from containers of ben zene and benzene products when those containers leave his workplace. This is not a situation where OSHA is imposing a heavy regulatory burden on an em ployer solely for the benefit of the em ployees of another. Rather, the regula tion says no more than that an upstream employer may not take affirmative steps to withdraw from downstream employ ees a protection that he must furnish to altogether. It may also choose to mod erate the label's description to more pre cisely describe the nature or extent of the hazard. Placing the responsibility to warn downstream employees of concealed haz ards on those upstream employers who create the hazards and know of the haz ards is consistent with the remedial pur pose of the Act and is within OSHA's broad authority to prescribe warning la bels. If on remand OSHA decides to promulgate a new benzene standard which includes warning labels, OSHA may require an employer in the chain of distribution of those products to assure that such warning labels remain affixed when the product leaves the employer's workplace, provided, of course, the label ing requirement as a whole is shown to be reasonably necessary to provide safe workplaces. The user petitioners also contend that OSHA's authority to require labeling of products containing benzene has been preempted under 29 U.S.C.A. 653(b)(1)* by the Consumer Product Safety Commission, which has promul his own employees. The obvious reluc gated regulations under the Federal tance of the maker of a product to inti Hazardous Substances Act, 15 U.S.C.A. mate or suggest to his consumers that 1261 et seq.,a requiring the labeling of his product is less than totally desirable products containing benzene. See 16 28. 29 U.S.C.A. 653(b)(1) states: Nothing in this chapter shall apply to working conditions of employees with re spect to which other Federal agencies . exercise statutory authority to prescribe or enforce standards or regulations affecting occupational safety or health. 29. The Consumer Product Safety Commission has authority to promulgate regulations under the Federal Hazardous Substances Act by vir tue of 15 U.S.C.A. 2079. B-20 CMA 048216 AMERICAN PET. INSTITUTE v. OCCUPATIONAL SAFETY 100 C.F.R. 1500.14(a)(3), (b)(3) (1977). We reject this argument. The preemption provision was intended to avoid the "du plication that would result where anoth er federal agency was also providing for the occupational safety of a class of workers." Organized Migrants in Com munity Action, Inc. v. Brennan, 172 U.S. App.D.C. 147, 153, 520 F.2d 1161, 1167 (1975), It applies only when the preemp ting regulation is "directed at a working condition," Southern Pacific Transporta tion Co. v. Usery, 539 F.2d 386, 391 (5th Cir. 1976), which the promulgating agen cy has authority to regulate. The Con sumer Product Safety Commission's reg ulation is not designed to protect a class of workers and it is not directed at the working conditions of employees. Al though an existing requirement for la beling under another act may affect the reasonable necessity for an OSHA re quirement, 29 U.S.C.A. 653(b)(1) does not prohibit OSHA from requiring con tainers of benzene products to bear the warning labels authorized by 29 U.S.C.A. 655(b)(7). Conclusion The petitions for review are granted. The reduction of the airborne permissible exposure limit from 10 ppm to 1 ppm is set aside since the present record does not show that such a reduction is reason ably necessary to provide safe or health ful employment. The dermal contact prohibition is set aside since this provi sion was not based on the best available evidence or the latest available scientific data in the field. The remaining provi sions of the standard are also vacated since they are ancillary to the permissi ble exposure limit reduction and the der mal contact prohibition. Adm. Office, U.S. Courts--West Publishing Company, Saint Paul, Minn, B-21 CMA 048217 Appendix C - AIHC, A Proposal To Achieve A Cohesive, National Cancer Policy, Exhibit 62 A PROPOSAL TO ACHIEVE A COHESIVE, NATIONAL CANCER POLICY Summary: The essence of AIHC's proposal for achieving a more cohesive, national cancer policy is to recognize that the determination of whether a material is carcinogenic or not, and its potency, involve scientific, rather than regulatory judgments. We believe these determinations should be made by a panel of eminent scientists selected by the National Academy of Science. This panel would be located somewhere in govern ment (e.g., HEW, OSTP, etc.) to serve on a continuing basis with appointed members serving terms of two-to-four years. The panel would have its own staff. While not making a specific recommendation as to where the panel should be housed, AIHC believes that the panel should be located separate from the various agencies whose regulatory actions would be affected by the panel's determinations. The panel's cancer determinations would be binding upon the various regulatory agencies, but these determinations would be limited to scientific issues and would not intrude upon the regulatory responsibilities of the individual agencies involved. We recognize that these regulatory responsibilities, quite properly, do differ from one agency to another. American Industrial Health Council 5/24/78 C-l CMA 048218 A PROPOSAL TO ACHIEVE A COHESIVE, NATIONAL CANCER POLICY Data Evaluation and Classification Panel: Determinations of carcinogenicity and potency are scientific, not regulatory issues. These determinations should be made: 1. Outside of regulatory authorities, such as OSHA. 2. Based on the critical, scientific evaluation of all available data. 3. By a panel of appropriately qualified and experienced scientists. The American Industrial Health Council (AIHC) proposes that a Data Evaluation and Classification Panel ("the Panel") should be established to ensure the scientific validation of the determinations and to promote efficiency, consistency, and accuracy in the regulatory process. At the outset, the Panel would serve OSHA's purposes, but AIHC intends that it would come to serve other regulatory agencies as well in determining whether a material is carcinogenic or not, and its potency. Ideally, new legislation would be the best method to create the Panel. It could, however, without awaiting legislation, be created by Executive Order issued pursuant to the Reorganization Act of 1977, 5 U.S.C. 901 et seq. (See Attachment I). The Panel's determination of carcinogenicity classification would be administratively final (subject to appropriate judicial review). OSHA (and other regulatory agencies) would then proceed to assess occupational health hazards, and other perti nent matters and define necessary controls or priorities for regulation based on the Panel's determination and the agency's hazard assessment. The Panel would consist of nine members, representing a crosssection of expertise and experience in disciplines such as toxicology, pharmacokinetics, cancer research and therapy, epidemiology, and occupational medicine. Candidates would be proposed on the basis of scientific expertise and professional qualifications by relevant professional groups such as: National Cancer Institute The Society of Toxicology .American Chemical Society C-2 CMA 0482X9 American Academy of Occupational Medicine American Academy of Veterinary Pathologists American Occupational Medical Association ' American Cancer Society 'American Industrial Hygiene Association American Academy of Industrial Hygiene Panelists would be selected from the candidate list by the National Academy of Science to serve with staggered appointments for terms from two-to-four years. They would not serve on any. other government panel, committee, or agency during their service on the Panel. The Panel would have a staff. The Panel and staff would be housed within HEW, OSTP, the NAS or, perhaps, some other organization agreeable to the Interagency Regulatory Liaison Group (IRLG). The Panel would be substantively indepen dent of whatever organization in which it may be housed. It is proposed that the Panel would apply the Classification Categories and criteria recommended by AIHC 1/, but could revise them from time to time, upon public notice and opportunity to be heard in accordance with the rulemaking provisions of the Admin istrative Procedure Act. The Panel would, in appropriate circumstances, classify, reclassify, and declassify chemical substances. Categorization: The Panel shall determine whether to assign a chemical substance to one of the following categories: Known Human Carcinogen; Confirmed Animal Oncogen; and Substances for Further Testing. Such assignment shall be accomplished as soon as possible following receipt of information, by petition or otherwise, that the Panel judges warrants consideration of mak ing an initial categorization or of changing an existing categorization. In deciding the order in which to categorize various chemical substances, including those listed in the NIOSH subfile of suspect carcinogens, the Panel shall give priority to those alleged or appearing to be known human carcinogens or confirmed , potent animal carcinogens, and shall consider the total available literature and industrial history for the substance. 17-------------------------------------- AIHC Recommended Alternatives to OSHA's Generic Carcinogen Proposal, February 24, 1978 (pp. 60-85). OSHA Docket No. H-090, C-3 CMA 048220 It is suggested that the Panel shall use the criteria developed in AIHC's Recommended Alternatives to OSHA's Generic Carcinogen Policy proposal (pages 60-85), for categorizing chemical substances or other agents. The Panel may from time to time propose revisions of the categorization scheme or the criteria, in light of scientific advancements, additional information, or experience with the categorization scheme. F.easonable notice of intended changes and an opportunity to comment are to be afforded the public, in accordance with the Administrative Procedure Act. Operating Procedures.- Requests for an initial categorization or to change an existing categorization are to be submitted to OSHA, and OSHA will initially determine whether any proposal warrants fruther consideration. In' having OSHA rather than the Panel make the initial determination of the merit of a submission AIHC is concerned that the Panel not be overburdened with frivo lous submissions. If OSHA determines that data submitted warrants consideration of an initial categorization, it will publish notice of receipt of that data in the Federal Register together with a request for written comments or data bearing on the categorization. (OSHA can also initiate a Panel classification in the absence of a request.) After an adequate comment period, time would be allowed for responses to comments submitted by other persons, although on a more expedited schedule (perhaps like a briefing schedule). The Panel may also seek its own data from other government agencies, private and other public sources, etc. With respect to the time periods allowed for submission of comments and for Panel decisions, AIHC is concerned that there be adequate time for valid scientific deliberation and felt it would be preferable that a fixed time limit not be prescribed. Rather, AIHC recommends that as much time as practicable be allowed in each instance with the intention that the Panel is to make its decision as expeditiously as possible, consistent with the urgency of the review, the quality of the data availa ble, and as allowed by procedures developed to guide the Panel in its efforts to achieve scientifically sound, equitable determinations. AIHC does not recommend that the Panel hold public hearings, because such hearings could impose additional time demands upon Panel members and potentially subject the Panel's determinations to undue influence. While not explicitly recommended, it is recognized that the Panel's meetings will, in all likelihood, be public, and procedures will have to be developed so the Panel's determinations have a public record (e.g., summary minutes), but AIHC recommends against transcribing Panel deliberations^. The Panel should have the right to close certain meetings. However, AIHC believes that operating procedures for the Panel are C-4 CMA 048221 extremely important, both In making changes in criteria and in determining individual categorizations. The operations of NCI can serve as a possible model. AIHC expresses strong concern for the confidentiality of information submitted to the Panel; however, AIHC recognizes that confidentiality of information may be limited by the pro visions of the Freedom of Information Act, the Government in the Sunshine Act, and other statutes. Status of Panel Recommendations: The Panel's categorization of a chemical substance would be administratively final, subject to appropriate judicial review. The Panel's determinations and the reasons therefor would be provided to OSHA and published in the Federal Register. Future Panel Activity: AIHC recommends that the Panel initially make carcinogenicity determinations only with respect to OSHA. However, it believes that the Panel should be structured with a view towards having it at some future time make carcinogenicity determinations for other agencies (such as FDA, EPA, and CPSC) in order to promote consistency. (It is recognized the Panel will have a major role in structuring its own operating proce dures. How the Panel operates in executing its responsibilities will depend to a great extent on the nature, background, and composition of its members.) Location: AIHC does not recommend a particular organization for locating the Panel within government, believing this can be better decided by the Administration. However, the National Research Council has recommended the following: "The decision to inform those in affected workplaces of the hazard of a chemical is not to be taken lightly, as it involves the commitment of substantial resources. For that reason we believe it essential that a single national source, such as DHEW, be charged with making the decision that workers are at risk. This source should be, to the extent possible, credible to both management and labor; therefore, it should not be in volved in the regulatory process. But, it must not be so remote from the realities of the workplace that it cannot make an appropriate assessment of risk, or at least announce its decision in a form that can be trans lated to a specific occupational situation." 2/ 27 U.S. Department of Commerce: NTIS; P3-269-599 Informing Workers and Employers About Occupational Cancer (Prepared for OSHA): NRC -""6/77. C-5 CMA 048222 Ic may be that the concept for coordinating regulatory action, now served by IPLG, should become institutionalized, in which case the Panel could become a part of the resulting structure. Again, the Administration is probably in a better position to decide than industry is to recommend whether the function could be better located in HEW, OSTP, NAS or the Domestic Council,'1 etc. ; but the concept of separating the Panel from the regulatory bodies needs to be continually emphasized. Organization: For a panel of nine rotating members, a perma nent staff of three doctoral level professionals (e.g., toxicologists, epidemiologists, etc.), one lawyer, and two professional support technical personnel (e.g., writers, researchers, etc.), along with appropriate clerical and secre tarial support, would seem a reasonable estimate for an organization formed to aid the Panel in its determinations. Considering salary, benefits, travel, supplies, and space, as well as some allowance for consulting fees and computer time, it is estimated that the total cost to the government for the Panel would be about two-million dollars per year. C-6 CMA 048223 cat c. SAAMAflO /CO 0. TU*NAC i. miChaCU 3UXCAN OOMALO L, MORGAN CHAALCS . WAMA//1E. JA, j.EUOCMC maAam9 OOU4WAA C. HUCVCA KCNNCTM l. MCaman.^A. chaalcs r. LCTTOW tC***0 CMC, HIMOS RC*t0<*r *AAfCM MAtTwfW MALC WAAMIAAtVR COWMACL SARA 9. ICMOTl-AN CA'C SCWWAAT? JQHN S, MAflhCt MCNAY J. ALO. /A. COwAAO 9. MOOCLJ IC^AAO R.OAAOWCA LCC C. UC***!T JOHN W, WIL/4CA./*. CUOCNC M. OOOTT RAlCC O. OlCLCX o. AMN NORN CAT W.OWlCHJMAH Cleary, Gottlieb, Steen a Hamilton 1250 CONNECTICUT. AVENUE, N. W. WASHINGTON, Q. C. 200 36 dot! iaa*tisi C*L: ClCMOk* W.*IM4TOM Tm 7IOattOIQ May 9, 1973 acoAcc w. ball Nfw tOR O'T'Dt QNC STATE ST* C et *uu NEW TOM* IOOO* RAAiS "'Ct A|, AVCNUC oc 'IICSUNO 7SOOR RAAtS,rANCC BRUSSELS orrICC AUC OC t-* LO < BTC $ o*o irusUls, HaSiUM LONDON orncc WINCHESTER nOuSC 7Y LONDON WALL LOnQON CCJn iOa.CnClanO Dr. Elwood P. Blanchard Chairman, Alternatives Committee American Industrial Health Council 1075 Central Park Avenue Scarsdale, New York 10583 Dear Dr. Blanchard: This letter is in response to your request for our opinion on whether the process of executive branch re organization could be utilized to transfer the authority to classify and categorize chemical substances with respect to carcinogenicity from those agencies which would otherwise exercise such functions to an independent panel of scientists located somewhere within the executive branch. While the panel would be headquartered within an existing governmental entity, it would be independent of regulatory bodies such as the Occupational Safety and Health Administration, the Con sumer Product Safety Commission, the Environmental Protection Agency, and the Food and Drug Administration, and its deter minations would be binding upon all such agencies. On the basis of our research, we have concluded that those classification and categorization functions currently vested in a regulatory agency within the executive branch, such as OSHA, could be transferred to the panel, provided the panel were not established as a new "executive department or independent regulatory agency." We have also concluded that the President's authority under the Reorgani zation Act of 1977 (the "Act"), 5 U.S.C.A. 901 et sec., includes the power to transfer functions vested in an independent regulatory agency such as the Consumer Product Safety Commission, provided the reorganization plan does not abolish that agency, transfer all its functions to another agency, or consolidate it with another independent regulatory agency. r_7 CMA 048224 *2- The President's power to reorganize the executive branch is derived from the Reorganization Act of 1977, 5 U.S.C.A. .S 901 et seq. Section 903 (a) of the Act authorizes the President, after investigation and whenever he finds it necessary "to carry out any of the policies enunciated in S 901(a),=/ to prepare a reorganization plan. Such a plan may provide for: 1/ Section 901(a) provides: Th Congress declares that it is the policy of the United States -- (1) to promote the better execution of the laws, the more effective management of the executive branch and of its agencies and functions, and the expeditious administration of the public business; (2) to reduce expenditures and promote economy to the fullest extent consistent with the efficient operation of the Govern ment; (3) to increase the efficiency of the operations of the Government to the fullest extent practicable; (4) to group, coordinate, and consolidate agencies and func tions of the Government, as nearly as may be, according to major purposes; (5) to reduce the number of agencies by consolidating those having similar functions under a single head, and to abolish such agencies or functions thereof as may not be necessary for the efficient conduct of the Government; and (6) to eliminate overlapping and duplication of effort. Centralization of all authority to classify and categorize chemical substances for carcinogenicity in the panel would arguably further a number of these policies, including the promotion of economy and efficiency, the coordination and consolidation of governmental functions according to major purpose, and the elimination of overlapping and duplication of effort. C-8 CMA 048225 -3- (1) the transfer of the whole or a part of an agency, or of the whole or a part of the functions thereof, to the jurisdiction and control of another agency; (2) the abolition of all or a part of the func tions of an agency, except that no enforcement func tion or statutory program shall be abolished by the plan; (3) the consolidation or coordination of the whole or part of an agency, or of the whole or a part of the functions thereof, with the whole or a part of another agency or the functions thereof; (4) the consolidation or coordination of a part of an agency or the functions thereof with another part of the same agency or the functions thereof; (5) the authorization of an officer to delegate any of his functions; or (6) the abolition of the whole or a part of an agency which agency or part does not have, or on the taking effect of the reorganization plan will not have, any functions.!/ Section 903(a) does not explicitly authorize the President to prepare a reorganization plan which creates a new entity such as the classification panel. The President can transfer the functions of an "agency"!/ to the juris diction and control of another agency, or consolidate and _2/ A reorganization plan becomes effective sixty calendar days of continuous Congressional session after the President transmits the plan to Congress, unless either house passes a resolution disaporoving the plan within that time. Section 906 (a). 3/ "Agency" is defined, for purposes of the Reorganization Act, as "(A) an executive agency or part thereof; and "(3) an office or officer in the executive branch". 902(1). It appears that OSHA, CPSC, EPA, and FDA would all constitute "agencies" under the Act, and that their functions could therefore be transferred to the panel. The question of whether the Act authorizes the President to transfer functions vested in independent regulatory agencies such as CPSC is considered in more depth below. The National Academy of Sciences however, probably does not constitute an "agency", as is also discussed more fully below. C-9 CMA 048226 -4- coordinate agencies and their functions with the whole or part of another agency or its functions. Whether such a transfer or consolidation can be made with respect to a new entity as well as an existing agency is not apparent on the face of the statute. 'We believe, however, that the President's authority under 903(a) does encompass the transfer of functions to a newly created entity such as the classification panel. The Act, in S 905(a)(1), clearly prohibits a reorganization plan from creating a new "executive department or independent regula tory agency." Since you do not propose that the panel be established in the form of a new "executive department or independent regulatory agency", but rather as an independent body housed within an existing department or agency,!/ the 4/ It should be noted that the National Academy of Sciences Ts probably not an "agency" for purposes of the Reorganization Act, and thus 903(a)(1) would not authorize the transfer of agency functions to a subdivision of that corporate entity. This conclusion is based on Judge Sirica's opinion in Lombardo v. Handler, 397 P. Supp. 792 (D.D.C. 1975), affirmed, 546 F.2d 1043 (l!76), cert, denied, 431 U.S. 932 (197TT The court held there that NAS was not an "agency" for purposes of either the Federal Advisory Committee Act ("FACA"), 5 U.S.C.A. App. I, or the Freedom of Information Act ("FOIA"), 5 U.S.C.A. 552. Both statutes define the term "agency" broadly. Under the FACA, which incorporates the definition used in the Administrative Procedure Act, 5 U.S.C.A. 551(1), an "agency" is "each authority of the Government of the United S tates , whether or not it is within or subject to review by another agency." Under the FOIA, an "agency" includes "any executive department, military department, Government corporation, Government controlled cor poration, or other establishment in the executive branch of the Government (including the Executive Office of the President), or any independent regulatory agency." 5 U.S.C.A. 552(e). Despite the fact that NAS was established by Act of Congress, reports to Congress, is obligated to perform investigations for the departments of the federal government when requested, and is subject to limitation by Congress with respect to the amount of real estate it may acquire, the court held that it was not an agency for purposes of either the FACA (and thus, by extension, of the APA) or the FOIA. The Court found it signi ficant that NAS' decisions were not binding on EPA (another reason why NAS appears to be an inappropriate place in which to locate the classification panel), that it does not exercise "substantial independent governmental authority", that it neither functioned under nor was created by Congress or the President, and that no significant government control of the corporation could be shown. C-10 CMA 048227 -5- limitations of 905(a)(1) would not seem to apply.--^ The legislative history of the Act supports this analysis. Senator Ribicoff, one of the floor managers of S. 626, which was eventually enacted as the Reorganization Act, expressed the view that the legislative purpose was to grant broad reorganization authority to the President. He stated in floor debate that * "[b]y authorizing the President to propose plans to reorganize the government any way he deems best, the Act permits the President to change the way the government operates. He may transfer and consolidate any functions he wishes, or make any other chances in the government's organization short of abolishing the programs themselves."i/ (123 Congressional Record S. 3438 (March 3, 1977) (Emphasis added).) 5/ It should be noted that the Reorganization Act contem plates that a private group such as the American Industrial Health Council may suggest a reorganization plan to the President, since 901(c) provides that [i]t is the intent of Congress that the President should provide appro priate means for broad citizen advice and participation in restruc turing and reorganizing the executive branch. 6/ The House debate reflects the same sentiment. For example, Mr. Brooks responded affirmatively to the following question of- Mr. Kazen: "[Can] the President reorganize several agencies, either put them together or separate functions or do whatever he wants to, but reorganize various agencies at one time under one pack age that he would submit to the Congress?" Id. at H. 2668. (Emphasis added). C-ll CMA 048228 -6 that: More specifically, Senator Ribicoff also stated "[u]nder the reorganization authority that would be renewed by this bill, the President ,may propose to create or eliminate agencies, 'and transfer functions between agencies. The Act specifically prohibits the use of the reorganization authority, however, to create or abolish cabinet-level departments of the government. For that, regular legislation will continue to be required." (Id. (emphasis added).) Senator Muskie agreed that the bill "will give the President the authority to create or abolish agencies and to transfer functions between agencies unless one house of Congress dis approves within 60 days."2/ (Id. at S. 3445). Thus, it would appear that the President has suffi cient authority under the Act to vest classification and cate gorization functions with the independent panel, provided it is established as an executive agency or part thereof or as an office in the executive branch, but not as a new execu tive department or independent regulatory agency. You have also asked us to consider whether 'the President's reorganization authority includes the power to transfer to the panel functions currently vested in indepen dent regulatory agencies, such as the Consumer Product Safety Commission.8/ it is our conclusion that the President is 1/ Senator Percy, the other floor manager in the Senate, stated that reorganization plans "cannot create, abolish, or transfer an executive department or an independent regulatory agency," id. at S. 3440, but he did not say the President was prohibited from creating a body like the proposed classi fication panel at other than the cabinet level, as a division of another department or agency. Moreover, Senator Percy clearly stated that realignment of functions "within or among agencies was permissible. Id. 8/ It is the opinion of the Office of Management and Budget that CPSC, but not EPA, is an "independent Federal regulatory agency," at least for purposes of the Federal Reports Act, 44 U.S.C.A. 3502. See 0MB Circular No. A-40 and Attachment A thereto (November 5, 1976). C-12 CMA 048229 -7- authorized by the Act to transfer, functions vested in an in dependent regulatory agency to another agency, provided the reorganization plan does not abolish the independent regulatory agency, transfer all its functions to another agency, or con solidate it with another independent regulatory agency. As we have discussed above, the President is authorized by the Act to prepare a reorganization plan which provides for "the transfer of the whole or a part of an agency, or of the whole or a part of the functions thereof, to the jurisdiction and control of another agency." ( 903(a)(1)). The term "agency" is defined to mean "(A) an Executive agency or part thereof; and "(B) an office or officer in the executive branch." (S 902(1)). Since an independent regulatory agency is an Executive agency,%f the President is authorized by 903(a)(1) to transfer the functions of such an agency to another agency. The Act's express limitations on the President's power do not alter this conclusion. A reorganization plan may not provide for or have the effect of "abolishing or transferring an...independent regulatory agency, or all the functions there of, or consolidating two or more...independent regulatory agencies, or all the functions thereof." (5 905(a) (1)) . However, this provision appears to prohibit only those re organization plans which transfer all of the functions of an independent regulatory agency to another agency. The trans fer of less than the totality of such functions would thus be appropriate. This interpretation of the limiting provisions of S 905(a)(1) is confirmed by the discussion of that section contained in the House Report on the Act. (H. Rep. No. 95-105, Extension of Reorganization Authority of the President, 95th Congress, 1st Session (1977), hereinafter referred to as the "House Report"). The Act's treatment of independent regulatory /1 Acron Investments, Inc, v. Federal Savings and Loan Insurance Co., 363 F.2d 236 (TTth Cir.), cert, denied, 385 ~U.S. 9To (1966) Tconcluding that because FSLIC was subject to more than "custodial or incidental" congressional control, and was deemed by statute to be included within the Home Loan Bank Board, an "independent agency" and "an instrumentality of the United States", FSLIC was an "agency" for purposes of 28 U.S.C. S 1345, which establishes jurisdiction in federal district courts of all civil actions commenced by any "agency" of the CMA 048230 -8- agencies was explained as follows: "Under the expired reorganization authority, independent regulatory agencies were treated as other agencies in the executive branch, ,and they were subject to reorganization in the same manner. The bill recognizes the unique status of independent regulatory agencies and their special relationship to the Congress by providing that the whole of independent regulatory agencies or all of their functions may not be abolished or transferred nor may two or more such agencies or all their functions be consolidated. This does not mean that such agencies are totally exempt from reorganization authority, but such authority is limited as described heretofore." (House Report, at 8 (emphasis added).) Thus, the President can transfer functions currently vested in an independent regulatory agency, as long as the r organization plan does not abolish that agency, divest it of all its functions, or consolidate it with another such agency. The authority granted to the President under the Reorganization Act is, with some modifications, an extension of the same authority granted to previous presidents periodi cally since enactment of the Reorganization Act of 1949. Past use of reorganization authority may thus be an indication of the scope of power granted by the present Act. For example, in the Senate Report on the extension of reorganization authority enacted in 1971, a letter from OMB to the Senate is quoted, stating that among the significant uses the Presi dent had made of this power in the past was the creation of: a new Office of Telecommunications Policy in the executive office of the President.through the transfer of certain functions from the Office of Emergency Preparedness; a new Domestic Council to deal with questions regarding the authority of OMB; a new separate Environmental Protection Agency bringing together key programs for setting environmental standards and abating pollution; and the National Oceanic and Atmospheric Administration in the Department of Commerce, assembling major programs for dealing with environmental problems. The letter further states that Congress allowed all these measures to become effective. (S. Rep. No. 920485 92d Cong., 1st Sess., reprinted in [1971] U.S. Code Cong. & Ad. News 2081, 2089-90). C-14 CMA 048231 -9- One further point in favor of broadly construing the 1977 Act to allow the establishment of the classification panel is that if the Congress feels that the President has exceeded the scope of the authority delegated to him, it can reject the plan by passing a resolution of disapproval in either house. Very truly yours. CLEAHY, GOTTLIEB, STEEN & HAMILTON C-15 CMA 048232 Appendix D AMERICAN INDUSTRIAL HEALTH COUNCIL 1075 CENTRAL PARK AVENUE SCARSDALE, NEW YORK 10583 (914) 725-1492 September 11, 1978 GUIDELINES FOR EVALUATION AND USE OF OCCUPATIONAL EPIDEMIOLOGIC CANCER STUDIES The evaluation of human data is becoming increasingly important in determining when and how to regulate exposure to suspected carcinogenic materials. As described in the AIHC Alternative proposal, epidemiologic studies are invaluable in determining the fact of human carcinogenicity and in assessing the actual risk under occupational exposure conditions. The following guidelines are intended to describe major factors in assessing the strengths and limitations of epidemiologic studies^ the use of which in turn will assure maximum and appropriate utili-^ zation of valid human data. The guidelines are not intended as a check list for accepting or rejecting a study. All data on human exposure to a substance should be considered in attempting to reach a judgment on the human health risks from occupational exposure. Although studies that satisfy all of these guidelines should receive greatest attention, studies that do not should receive attention commensurate with their strengths and weaknesses. There is no substitute for the evaluation of individual studies by highly qualified experts, such as the Data Evaluation and Classification Panel recommended in the AIHC Alternative. These guidelines have two objectives: 1. To describe the major study design features and analytic methods necessary to allow for the evaluation D-l CMA 048233 of the quality and results of an epidemiological investigation and/or report. 2. To describe appropriate use of epidemiologic studies in evaluating human risk from occupational exposure. Part A includes the description of the major study features and analytic methods of a study. It also identifies the major factors in evaluating the results and interpretations of a specific study. It will be useful for OSHA in stimulating a dialogue with the investigators and for assuring the submission of a complete information package to the expert panel. Part B indicates areas of concern for professional evaluations in determining the utility of a specific study in reaching a judgment on the likelihood of a significant health risk from a specific exposure. It stresses the need for examining the consis tency of epidemiologic and biologic data and seeking explanations or investigations of apparent inconsistencies. The demonstration of a dose-effect relationship and the calculation of a human occupa tional exposure risk assessment assist judgmental determinations. Thus, OSHA can be provided with information and judgment essential to regulatory decision-making, particularly the need for and degree of control of specific substances. PART A - Description, Analysis, and Evaluation of a Specific Study I. Description of Study Features An epidemiologic study needs to be adequately described so that the reviewer can understand which population was studied and with whom they were compared, what exposure was under investigation, D-2 CMA 048234 what health effect or outcome was evaluated, and how the study was carried out to assure validity and precision. A. Population Characteristics 1. Study Population - The description of the study population should clearly indicate the criteria necessary for inclusion in the study cohort and the reasons for choosing those criteria. Methods used to assure that all individuals meeting those criteria are included and that only those individuals are included should be described, including demographic and other appropriate characteristics. Any deviations from these criteria should be clearly described, justified and interpreted in considering the actual conduct of the study. 2. Comparison Population - Ideally, the comparison population should differ from the study population only in that it lacks the exposure under consideration. Rarely is this the case. Internal comparison groups are generally preferable to external comparison groups. Consistent findings based on several comparison groups, including external comparison groups, usually strengthen the acceptance of the results. 3. Sampling Procedure and Sample Size - When all individuals satisfying the criteria of the study population are not included in the study, the method used to select the members who are studied should be described. The method used should assure that the group actually studied is representative of the study population. The size of the total study population and of the group actually studied should be indicated. D-3 CMA 048235 4. Observation Period - Dates of beginning and terminating of the observation period should be stated and should be similar for the study and comparison populations. The number of individuals observed and the person-years of observation (when appropriate) consistent with the latency period under consideration should be stated. The experience at different time periods during the period of observation (5 or 10 year periods, that are appropriate for the particular study) should be analyzed. B. Exposure Characteristics 1. Occupational Exposure Under Study The evidence or reason for identifying the study popula tion as an exposed group should be clearly specified. Sufficient information on exposure characteristics should be presented to assure the reasonableness of this study population and comparison population to test the hypothesis. Environmental measurements or personal monitoring data greatly assist in defining the exposures. Methods and instruments used for measuring exposures should be described in detail. Division of the study population into groups of different levels of exposure is preferable so that analysis can examine for dose-effect relationships. 2. Confounding Variables Each individual is exposed to more than the item being studied. Within the workplace, other exposures are present contemporarily and these other exposures may be different for the D-4 CMA 048236 various occupational groups. Different jobs within the same employment include different sets of exposures. Prior employment and subsequent employment often introduce other exposures. These other occupational exposures cannot always be documented but should be considered in the investigation. Every effort should be made to obtain information about them which may be verified. Individual lifestyle habits affect one's exposures. Alcohol consumption and smoking histories, for instance, may greatly affect one's risk of developing certain types of cancers and other diseases. Analysis should consider the effects of each variable that may have an independent effect on the health outcome under consideration. Confounding variables such as sex, age and race may be dealt with in the comparative analysis of the comparison group. Confounding variables, whether or not handled in the design or analysis, should be discussed in the interpretation. C. Health Effect The definition of a "case", or of an individual with the health effect under study, should be clearly indicated. It will be dependent upon the data source used. However, the same definition and data source should be used for both the study population and the comparison population. The classification of health effects should be the same for study and comparison populations. The methods used in making a diagnosis in each case in the study D-5 CMA 048237 and comparison groups should be described. Further investigations may determine the validity of diagnosis for each case. D. Procedures A full description of the procedures used in the conduct of the study will assist the judgment as to the study's validity and allow for its replication if necessary. Data sources should be identified, particularly those that are used to determine who is in the study population, the level of exposure, and the health outcome. Methods used to standardize the data collection and preparation should be determined before data collection and should be described, along with methods used to verify the data. Follow-up procedures and degree of completeness of follow-up for each subgroup should be indicated. The investigators responsible for the professional work should be identified. E. Case Presentations A case history should be given for each "case" in the study indicating demographic variables, exposure variables, confounding variables, and clinical variables. Sufficient details should be given to indicate both that each case satisfies the study criteria and that alternative exposures and etiologies do not explain the case's occurrence. II. Analytic Method The term analytic method is herein used to include all procedures and techniques by which data are handled, examined and D-6 CMA 048238 presented for the purpose of drawing conclusions or inferences. The analytic method should be presented clearly and in sufficient detail to enable the reader to fully understand the calculations and to accept, as appropriately applied, the procedures or tech niques utilized. The following categories are suggested as a guideline for use in describing the analytic method employed in an epidemiologic investigation or report being critically evaluated. A. Data Presentation 1. Summary data and their derivation supporting the major conclusions reached in the text should be adequately presented in tables, graphs, etc. 2. Data displays (graphs, tables, etc.) should be clearly defined and labeled. 3. Data presented should be internally consistant. B. Data Analysis A description of the rationale for the major analytic procedures used should be provided, either in the text or in noted references. These procedures may include: 1. Statistical methods used - rates, proportions, personyears, indices of association, and summary statistics such as, standardized mortality ratios, proportionate mortality ratios, relative risks, attributable risks, standardized morbidity ratios and confidence limits. 2. Significance tests employed - Chi-square, "t" test, etc. 3. Statement of the *4 and error levels selected and the D-7 CMA 048239 minimum excess risk the study is designed to be able to detect. 4. Analytic methods - analysis of variance, regression, survivorship analysis, etc. 5. Methods for handling confounding variables - matching, adjustment (direct or indirect), stratification, etc. Ill. Evaluation of Results and Their Interpretation A. Hypothesis Testing - The author's conclusions and interpre tations should be clearly stated. The hypothesis to be tested should be appropriate to the data base and the analytic method used. Additional hypothesis tested from the same data base should be indicated. The findings should be internally consistent and presented in sufficient detail to allow for judgment of the validity of the results. The description of the study population and comparison groups and their exposures should justify a reasonable conclusion that their significant difference is the result of their exposure to the item under consideration. The individual case histories should relate closely to the tested hypothesis. The reviewers should be able to determine whether the hypothesis the author is actually testing is the same as the hypothesis that was initially stated. B. Limitations - All studies have limitations inherent in the type of data collected and the analytic methods used. Further limitations are introduced in the carrying out of the study because of the inability to collect all the desired data and D-8 CMA 048240 because of the difficulties of adjusting for confounding variables. The analytic method and data reduction may limit the testing of the desired hypothesis, assuming that the study has sufficient power (defined in D below) to test the hypothesis. The authors should frankly discuss the limitations of their own study. C. Bias - Bias may be introduced in a study by the choice of the criteria that define the study population and observation period, the looseness of definition of the health effect evaluated, the procedural differences in counting health effects among the various risk groups to be compared, the care with which each aspect of the study is professionally carried out. It is of utmost importance that the criteria defining the study population and the observation period be established independent of know ledge of the characteristics of the individuals demonstrating the health effect and prior to the conduct of the study. D. Power - The power of a study is dependent upon the size of each population, the frequency of the event being observed, as well as the difference in frequency of events among the various groups to be compared. The power of a study is the likelihood that it could observe a given frequency of an event or outcome at a given level of statistical significance. A typical power statement might be that, if the real frequency in the study population were twice that of the comparison population, the study would have had an 80% chance of observing a difference that is significant at the 0.05 level (two-tailed test). D-9 CMA 048241 whether a study observes an excess or not, it should indicate the confidence limits of its result. These confidence limits will indicate the probable range of values which might exist for the real frequency (based on the observed frequency) and will indicate the probability that the real frequency will be within that range. A study is classically considered to be "positive" (show an effect) when the upper confidence limit of the frequency in the comparison population falls below the lower confidence limit of the frequency in the study population and this difference is not explained by the study's limitations, biases, or confounding variables. PART B - Use of Epidemiologic Studies in Evaluating Human Risk from Occupational Exposure I. Judgment on Utility of Specific Study Based on a review of the description of the study conducted and the analytic methods used and an evaluation of the study's results and interpretation, it may reasonably be concluded that a particular study has been well conducted and has demonstrated a rejection or acceptance of a specific hypothesis. An additional judgment has to be made placing this study in the context of the results of other epidemiologic studies, bio logical knowledge (particularly concerning the health effect of this substance) and knowledge of use and exposures of the substance under consideration. Such professional judgments are necessary for deter mining the likelihood of a significant health risk for a specific exposure. D_10 CMA 048242 An individual study may or may not demonstrate that an increased risk of a specific health effect is statistically associated with a specific exposure. Additional studies may indicate the effect to be attributable to the exposure. Judgment on the causal and dose relationships of a substance depends upon the totality of epidemiologic, toxicologic, biologic, and industrial hygiene data. The utility of each specific study in assisting in that judgment must be determined. II. Consistency with Other Epidemiologic Data - The conclusions based on published and unpublished reports and studies of human experience with the compound must be compared. Inconsistencies and contradictions must be identified and explained. "Positive" epidemiological studies can be used to estimate the magnitude of risk of a specific health outcome from a specific exposure. "Negative" epidemiological studies can be used to calculate an upper limit to the estimate of human risk. "Positive" and "negative" epidemiologic studies may be compatible, based on their exposure ranges and their sensitivities. A critical review of "positive" and "negative" studies may identify situations in which excess risk may be observed, situations in which excess risk is unlikely to be observed, and situations in which the evidentiary probability would indicate that either there is a small likelihood of the substance causing the health effect or that the substance is only weakly able to cause the health effect. D-ll CMA 048243 III. Biologic Consistency - A specific study may indicate a particular substance is associated with an excess frequency of a certain health effect. Before concluding that the excess frequency is attributable to that exposure or caused by that substance, it is necessary to develop additional information demonstrating the biological reasonableness of the hypothesis. Consistency with animal studies or other laboratory studies including human pathology must be considered and inconsistencies explained. Cases where human epidemiologic studies do not support the conclusions of laboratory studies, particularly of non-human animal studies, call for further evaluation of each study. The laboratory studies should be reproduced and extended. Additional epi demiologic studies should explore various human experiences with the substance. Differences in human and non-human animal responses to exposure may reflect differences in exposure dose or route or differences in metabolic handling or sensitivity, the further study or which may be necessary. Until such dif ferences are resolved an estimate of human risk or at least an upper limit to the estimate of human risk can be calculated from the human epidemiologic data. IV. Dose-Relationships - The totality of human and animal studies should be reviewed to determine the degree of relationship between the dose of the substance and the frequency of the observed health effect. A direct dose-effect relationship showing increased excess frequency of health effect with increasing dose of substance D-12 CMA 048244 would greatly strengthen the judgment that the substance is responsible for the excess health effect. Linear or curvilinear characteristics of the relationship should be evaluated. Additionally, review of the dose-effect relationship may indicate exposure levels at which an excess frequency of the health effect would be very unlikely. Judgments have to be made as to when exposures may have effects whose significance may be theoretical, statistical, biological, or clinical. V. Risk Assessment - The final determination of the health effect risk of occupational exposure to a given substance will depend upon: (1) a determination that there is a specific increased risk of an identifiable health effect from exposure and that this risk increases with increased exposure level; (2) an estimate of the magnitude of the health risk at specific exposure levels; and (3) an estimate of the number of workers who would be occupationally exposed to the substance at different levels. An estimate can be made of the magnitude of the total risk from occupational exposure and from exposures above certain levels. Thus, an estimate can be made of the magnitude of the benefits to be gained (reduction of risk) from establishing different levels of maximally permitted exposure. These potential benefits can be compared with the estimated feasibility and cost of their attainment. D--13 CMA 048245 048246 Appendix E */ EPA's Seventeen "Principles II / 1. "Cancer is a major and increasing cause of death and morbidity in man. It im poses upon society an immense burden of death, suffering and economic loss." 2. "Cancer may be induced by many factors including exposure to chemicals." --* / These principles are set out in a Motion TO Take Official Notice of Certain Facts filed by EPA on June 27, 1975 in a proceeding to suspend the registrations of pesticides containing heptachlor and chlordane in In Re Velsicol Chemi cal Corporation, FIFRA Docket No. 336 et al. The principles are also set out in a slightly revised form in the EPA Administrator's Notice of Intent to Suspend the Registrations of Pesticides Con taining Heptachlor and Chlordane, 41 Fed. Reg. 7552, 7554 (February 19, 1976). "Policy Determinations" and "Concepts" on Which^, OSHA Relies in its Cancer Policy Proposals^' "Cancer is a particularly dreaded and costly disease." (42 Fed. Reg. at 54149) "The economic and social impacts of cancer in the United States are massive. . . ." (42 Fed. Reg. at 54150) "[Hjeart disease and cancer . . . now lead the nation's list of killers." "Among the causes of cancer, those most prominent are believed to be traceable to environmental factors singularly or in conjunction with genetic or other substitutes." ** "The extent to which the observed in cidence of cancers are attributable to man made chemicals cannot be es timated with any precision." (42 Fed. Reg. at 54150} --/ 42 Fed. Reg. 54147 (October 4, 1977). E-l 048247 3. "Chemical carcinogenesis is character ized by a long latency period which in humans may be as long as 20, 30 or 40 years between exposure and the appear ance of symptoms of the disease." 4. "Once a carcinogenic response has been triggered the development of cancer is irreversible." 5. "Given the long latency period of can cer and its irreversibility, in the case of a chemical for which there is widespread human exposure and thus no adequate control group it is virtually impossible to determine a carcinogenic effect by direct observation in man." 6. "The use of experiments with animals to test chemicals for carcinogenic hazard to humans is accepted by the scientific community and by public policy-making agencies in the United Q States." 7. "Mice and rats are preferred experi mental animal species for carcinogenesis "In man . . . the latent period of chem ical carcinogens is often as long as a major portion of a lifetime ... It has been found to be as long as 15, 20, 30 or more years in man. ..." (42 Fed. Reg. at 54152) "Following [initiation of a neoplastic change in a target cell] , exposure to the carcinogen is no longer required to maintain the initial alteration that leads ultimately to a cancer cell, which is then capable of autonomous growth. Thus a single biological event produced by a very small number of molecules of the carcinogen may be sufficient to initiate the irreversible development of a tumor." (42 Fed. Reg. at 54152) "The long latency period between expo sure and symptoms [in man] and the irreversibility of the disease often makes it medically and scientifically impossible to identify carcinogens in the environment." (42 Fed. Reg. at 54156) "The validity of using animal data as a qualitative indication of potential human effects has long been recognized by scientific advisory committees and other governmental bodies. ..." (42 Fed. Reg. at 54157) "OSHA relies in general only upon re sults found in testing of mammalian E-2 i 048248 testing because their relatively short lifespan permits lifetime testing cover ing the entire latency period of tumors within a reasonable time, and because the development of tumors in these species is well known." 8. "All chemicals known to cause cancer in man with one exception have been shown to cause cancer in animals, especially mice and rats." 9. "Pathological development of chemically induced tumors in experimental animals and in humans is very similar." 10. "Since the number of animals used in laboratory tests is extremely small when compared to the hundreds of millions of people who are involuntarily exposed to widespread chemical contaminants and since the variability of human response to chemical carcinogens is generally greater than that of laboratory animals, a positive oncogenic effect in any test animal is sufficient to characterize the chemical as posing a cancer risk to man and negative results in animal tests have only limited significance and should normally be superceded by positive results." species. In that regard, the rat and mouse (and to a lesser extent the hamster) have traditionally been the species of choice for carcinogenicity testing. . . ." (42 Fed. Reg. at 54160) "All chemical substances or mixtures that have been proven carcinogenic by direct observation in man have also been shown to be carcinogenic in experimental animals (with the possible exception of arsenic and benzene, still under experi mental study)." (42 Fed. Reg. at 54146) "The choice of the rat and mouse is not only dictated by considerations of con venience but because of their known susceptibility to agents known to be carcinogenic in humans as well as the similarity in mechanisms of tumor induction." (42 Fed. Reg. at 54160) "[Pjositive results in tests with experi mental animals . . . should generally supercede negative results, both because of the aforementioned insensitivity of laboratory bioassays conducted with limited number of animals, which may frequently lead to false negative results, and also because of interspecies dif ferences in susceptibility." (42 Fed. Reg. at 54161) E-3 l CMA 048249 11. "A carcinogenic substance is one which increases benign or malignant tumors or neoplasia in exposed animals; shortens the latency period between the exposure and the development of tumors or neo plasia; or which results in unusual tumors." 12. "Since many benign tumors can develop into cancers, for the purposes of carcinogenicity testing there is no valid distinction between the induction of benign or malignant tumors and they should be considered synonymous." 13. "Chemical carcinogenesis is a specific biological process which is induced by a relatively few classes of chemicals. Thus, it is not true that all chemicals induce cancer at sufficiently high doses." "[A] toxic substance will be classified qualitatively as a 'potential occupa tional carcinogen' if . . . OSHA believes that it has been shown (a) to cause . . . an increased incidence of malignant or benign neoplasms . . . , or (b) . . . decreases the latency period between exposure and onset of neoplasm formation." (43 Fed. Reg. at 54169) "A presumption exists that a toxic sub stance shall be classified by the Secretary as a 'Category I Toxic Sub stance' if . . . the Secretary finds that any other evidence is sufficient to convince him that the toxic substance should be classified as a Category I Toxic Substance." (43 Fed. Reg. at 54185) "This basis is meant to include evidence, for example, of those substances that might possess a unique property, e.g., a substance that generates nonstatistically significant but extremely rare or unusual tumors. ..." (43 Fed. Reg. at 54171) OSHA "proposes to place as much weight on an experiment in which only benign tumors are observed, as upon experiments in which both malignant and benign tumors are induced." (42 Fed. Reg. at 54163-64) "[T]here has been [a] tendency for some to suspect that all chemicals are capable of causing cancer if administered to experimental animals at sufficiently high doses. This claim appears to be based on the belief that carcinogenesis E--4 i 048250 i 14. "High doses are administered in animal carcinogenicity tests because limited numbers of animals render the tests relatively insensitive to carcinogenic effects. Consequently, a substance which induces tumors at any dose level represents a warning signal of great significance." 15. "There is no scientific basis for the existence of a "no effect" level for carcinogens. In principle no dose of a chemical carcinogen is too small to induce tumors in susceptible individuals." is a non-specific kind of biological process associated with any substance under the right conditions, namely that test animals, bred for their sensitivity to carcinogens, when fed maximum tolerated doses of a substance for their lifetime become very ill and may be more sus ceptible to carcinogenic effects. However, there is evidence that renders this suspicion very unlikely to be true. *** [T]he available evidence provides strong indication indeed that not all chemicals are capable of causing cancer and that only a small number of the total is so capable." {43 Fed. Reg. at 54151) "The testing of chemicals at constant high exposure levels, at or approaching the maximum tolerated dose level, is not inappropriate and is indeed required to overcome the statistically insensi tivity of laboratory bioassays conducted with the limited number of animals that can be handled in practical laboratory conditions." (43 Fed. Reg. at 54161 [see also definition of "potential occupational carcinogen" as a substance which is oncogenic "at any level of exposure or dose" -- Proposal 1990.102] "[A] no-effect or threshold level may theoretically exist for any specific carcinogen. As yet, however, there is no satisfactory scientific basis for determining such levels for any given population. Thus, as has been proposed. E-5 I 16. "Carcinogens are not specific to particular test species, nor are they specific to certain strains of test species." 17. "Most carcinogens are not organ specific. Thus, a carcinogen which induces liver tumors in mice might, for example, produce mammary tumors in rats and lung tumors in humans." any human exposure to a carcinogen . . would be considered by OSHA to present a potential cancer risk as a policy matter." (42 Fed. Reg. at 54174) . "[A] chemical that causes cancer in one animal species is likely to do so in most other species tested." (42 Fed. Reg. at 54157) "There can be no presumption that the organ affected in animal experiments would be that at risk in man." (43 Fed. Reg. at 54162) 048251 E-6 I Appendix F - An Excerpt From The AIHC Alternative Entitled "Health Program Management" M. Health Program Management The AIHC recognizes that there will be combinations of carcinogen classifications and risks/hazards that may differ for different chemicals - or will differ in each workplace for simi lar chemicals. In fact, the AIHC classification proposal, which contains 7 categories, when cross-referenced with only two risk/ hazard levels will contain 14 different possible situations to be covered by a standard. For this reason the AIHC feels that the 2 or 3 model standards using a rigid format as proposed by OSHA are not appropriate. As an alternative we present basic princi ples which should be addressed in any standard, but which must be tailored to the classification - risk/hazard combinations which will be encountered in the workplace. To ensure prompt and reasonable action to limit employee exposure to know or suspect carcinogens, and to ensure compliance with a permanent standard, each employer should prepare and imple ment a written plan. Because workplaces vary substantially in terms of how a substance is used, the number of employees present, the age of the plant, the duration, intensity, and frequency of exposure, and many other variables - it will often be appropriate for different employers to take different actions to reduce em ployee exposures to known or suspect carcinogens. A plan for com pliance addresses the following item and delineates the actions to achieve the performance objectives stipulated therein. AIHC recommends that for each workplace the employer use the best practicable combination of engineering, administrative, and work practice controls, and personal protection. - 50 - CMA 048252 Once regulatory action has been taken and OSHA has promulgated permissible exposure levels, OSHA should require em ployers to determine, for each workplace where a regulated sub stance is present, whether exposure levels higher than an action level are likely to be experienced. If the determination indi cates the action level is likely to be exceeded, the employer should make measurements to confirm this estimate; if confirmed, he should prepare a plan which assures compliance with permissi ble exposure levels. A plan shall require use of engineering controls to the extent technically and economically feasible, augmented by administrative controls and personal protective equipment as appropriate. Where engineering controls are not incorported, the plan must show why that action was not practicable or applicable and thus show that the action had been considered. The plan should be made available upon request to any affected employee or his designated representative. It should be made available to an OSHA compliance officer upon request dur ing his inspection. Compliance with such a plan would not excuse failure to comply with a permissible exposure level. The re quirement to prepare a written plan would be in addition to the requirement to comply with a permissible exposure level. The plan should include training potentially exposed employees to ensure that they are informed of the nature of the potential hazard. Restricting certain areas to authorized per sonnel may be necessary. The indiscriminate use of signs and the word "cancer" on signs designating each such area can be - 51 F-2 4/78 CMA 048253 counter-productive with respect to health and safety. Any well-conceived plan would consider additional fac tors such as qualified personnel placement and training, house keeping, medical monitoring, protective equipment, emergency pro cedures, and exposure records, along with the engineering controls, monitoring and administrative controls mentioned above. For employees who are exposed above action levels, the employer should include in his plan a medical program prepared with the guidance of a trained physician. The employer must in form the physician of the nature and category of any substance, and of the evidence underlying the classification. Where speci fic effects of a substance have been identified, medical tests for those effects should be integrated with any general medical program already provided by an employer. N. Special regulatory approaches to laboratories construction, agriculture and transportation In general, regulations appropriate for the industrial workplace are not appropriate for laboratories, whether qualitycontrol, pure research, or some admixture of both. OSHA's failure to distinguish between laboratory and non-laboratory workplaces is unreasonable. OSHA's proposed requirements for laboratory workplaces could lead to the unintended consequences of impeding important research on cancer and other serious health problems. AIHC believes that special regulations for laboratories are appropriate. Probably a single work-practices oriented regu lation for laboratories would be sufficient. - 52 T-3 4/78 CMA 048254 Appendix G - AIHC Alternative Supplement On Risk Benefit Analysis_______________________ AIHC ALTERNATIVE SUPPLEMENT RISK/BENEFIT ANALYSIS AIHC accepts the appropriateness of the regulatory process to deal with the problem of cancer control. OSHA's generic control initiative articulates but one response to its perception of a cancer problem. However, this proposal does not include adequate risk evaluation procedures. We agree that except in a very few in stances where reliable human epidemiology is available, workplace cancer risk to humans must be assessed on the basis of available animal experiments. The first step in any regulatory attempt to deal with workplace cancer risks must be to conduct a risk assessment on individual chemicals. An established risk assessment policy within OSHA (but applicable to other agencies as well) which demonstrates a sound scientific and regulatory approach is essen tial to reduce the incidence of challenge by litigation. A risk assessment conducted on all chemicals that have been judged carcinogenic in test animals by the Evaluation and Classification Panel will permit prioritization of these chemi cals by comparing relative risks of each. This comparison in cludes consideration of potency, numbers of workers exposed, and exposure levels. Regulatory efforts to reduce workplace can cer risks must begin with the higher priority risks and proceed systematically to the lower priority risks. Risk assessment will also permit government and industry to determine the extent to u-1 CMA 048255 which various possible regulatory measures can in fact reduce the risk. It will afford a reasonable basis for determining goals for risk reduction by assessming the degree of risk presented in the workplace as contrasted with the degree of risk that we all face from chemials {natural or man-made) in our everyday lives. The big problem for risk assessment arises from selec tion of an appropriate model for extrapolating animal dose/ response data to man. The most conservative approach is a strictly linear extrapolation which some have asserted to be scientifically supportable in a limited number of cases but which frequently leads to totally impractical and inappropriate exposure levels for occupational, environmental, or personal care considerations. Broadly applied this would place an unjustified and excessive in flationary burden on the American public through loss of or in creased cost of products. In many cases a linear model is not the best fit to experimental data and should therefore not be used for extrapola tion purposes. AIHC believes that different models may be more applicable in many cases. In no event should an agency foreclose the use of the best tool available in this developing period of scientific advances toward better understanding. In the animal to man extrapolation process, considera tion of equivalent dosages per body weight or surface area, frac tions of food and water intake, appropriate multipliers for route of administration, and relating the length of exposure to life t span for man and animal is in order. G-2 CMA 048256 Whenever confronted with a large group of chemicals classed as carcinogens, OSHA should be able to estimate a degree of risk for a broad range of chemicals rapidly and to publish an ordered listing of relative risks. This would provide in dustry and employees alike the opportunity to evaluate their particular situation at an early date to make the most effective use of resources in taking corrective actions. Starting with the higher priority substances, OSHA and industry would then direct their efforts to exploration of all objective and subjective benefits and risk reduction methods for regulating any particular chemicals. These efforts would include a written statement by the agency of the magnitude of the risk, how it compares with other risks whether from chemicals or other sources in our society, the benefits from the chemical, and the incremental costs of various degrees of risk reduction. Support for this logic process in regulatory matters concerned with human health is contained in several recently published deliberations of other government agencies. The Nuclear Regulatory Commission specifically embraced the concept of reasonably achievable health risk reductions on the basis of quantified cost-benefit analyses. (1) A further example is that contained in the Food and Drug Administration's risk assessment 1. "Low Level Radiation Exposure," Federal Register, 42 (101), 22253-22254, May 24, 1978. CJ-3 CMA 048257 for aflatoxins wherein epidemiologic data were combined with ex trapolated animal data and benefit-cost analysis to arrive at an acceptable tolerance level for those toxic materials in food. (2) Finally, most recently the Council on Wage and Price Stability has published a review of OSHA's analysis of the proposed permanent standards for occupational exposure to acrylonitrile. (3) The Regulatory Analysis Review Group confirms the need for method ologies cited above as a critical element of the regulatory process for the reduction of health risks. 2. "Assessment of Estimated Risk Resulting from Aflatoxins in Consumer Peanut Products and Other Food Commodities," Bureau of Foods, FDA, January 19, 1978. 3. Letter from the Director of the Council on Wage and Price Stability to the Assistant Secretary of Labor, May 19, 1978, transmitting the report of the Regulatory Analysis Review Group on the "Proposed Standard for Occupational Exposure to Acrylonitrile - OSHA Docket No. H-108." G-4 048258 CM& Appendix H AMERICAN INDUSTRIAL HEALTH COUNCIL 1075 CENTRAL PARK AVENUE SCARSDALE, NEW YORK 10583 (914) 725-1492 October 16, 1978 Mr. Grover Wrenn Occupational Safety and Health Administration Department of Labor Third Street & Constitution Avenue, N. W. Washington, D. C. 20210 Dear Mr. Wrenn: On July 14, 1978 OSHA released a preliminary list of chemicals tentatively classified by Clement Associates, Inc. according to the system OSHA proposed on October 4, 1977 for regulating cancer-causing substances in the workplace. Simul taneously you asked each participant in the proceedings to submit to OSHA suggestions as to how to establish priorities for OSHA examination of the tentative list. Attached is a memorandum prepared by the American Industrial Health Council in response to your request. You noted in your memorandum accompanying the list that the final regulation may contain different criteria than those in the regulation as initially proposed. AIHC believes strongly that the proposed regulation should be modified for the reasons to be stated in our Post Hearing Brief. However, in view of your request for comments before the final regulations are issued, we have undertaken as an exercise to outline the procedure based on the AIHC Alternative which AIHC believes is the most expeditious way to establish priorities. The steps outlined in the attached memorandum may be summarized as follows: 1. The Scientific Panel proposed by AIHC would be established. 2. OSHA would immediately start to gather information on the number of employees and levels of exposure to substances for which there are human epidemiological data or two or more positive animal studies. H-l CMA 048259 Mr. Grover Wrenn 3. OSHA acting jointly with the Panel would screen the list of substances based on exposure data and a preliminary evalua tion of the human and animal data in the literature to select for priority scien tific evaluations those substances which it appears may present the greatest em ployee hazard. 4. As the Panel completes the evaluation and classification of the priority sub stances, OSHA will make a hazard evalua tion to determine regulatory priorities. 5. On a continuing basis, OSHA and the Panel would re-evaluate the selected list of substances to identify the next and sub sequent priorities. Sincerely, Elwooa P. Blancl^rd Enclosure H-2 CMA 048260 AMERICAN INDUSTRIAL HEALTH COUNCIL 1 I 11 1 I "Ti1 mr'ii'L'M'jMr^riinr" -- 1075 CENTRAL PARK AVENUE SCARSDALE, NEW YORK 10583 (914) 725-1492 Proposed Procedure for Prioritizing Substances on NIOSH List Tentatively Classified in OSHA Category I by Clement Associates On July 14, 1973 OSHA released the results of a review by Clement Associates of the 1976 NIOSH subfile on suspect car cinogens. Based on a literature review, Clement tentatively assigned substances to the OSHA categories in the proposed regu lations as shown in the following table: List I List II (based on EPA TSCA candidate list) (based on U.S.I.T.C. data for organics and EPA list for inorganics Category I 269 116 Category II 218 72 Category III 396 131 The selection of substances from these lists for pri ority consideration by OSHA presents a number of complex prob lems. A prescreening method must be utilized to select for full scientific review those substances that present the high est carcinogenic risk and the highest relative hazard based on number of employees exposed, the exposure level and the rela tive potency of the substance. In this situation there will have to be an interaction between the scientists making the preliminary scientific review and those responsible for deter H-3 CMA 048261 minations of regulatory action to assure that the selection is made for priority consideration of those substances present ing the greatest relative hazard. The need for interaction between the scientific and regulatory appraisal stems from several considerations. NIOSH has stated in a memo published in the BNA Chemical Regulation Reporter that the list used by Clement may contain errors both as to substances now in the registry and as to substances de leted. Moreover the literature cited in the NIOSH list is not evaluated but is uncritically listed. In addition, the litera ture cited is biased in the sense that many negative studies are not published. The Clement screening process involved re view of the literature but did not purport to be a full scien tific evaluation. Clearly, steps will have to be taken to assure that the scientific evaluation is based on all available data. Moreover, the differences between List I and List II make it apparent that many substances on List I are of negli gible commercial importance. Finally, the Clement list was based on the criteria in the proposed regulation which AIHC believes should be re-evaluted for the reasons stated in the AIHC Post Hearing Brief. The purpose of this memo is to demonstrate how the AIHC Alternative offers a reasonable and expeditious means of establishing priorities for administrative review of substances tentatively classified by Clement in Category I. -2H-4 048262 Introduction It is important also to point out that this memoran dum is based on a clear distinction between (a) the scientific function of data evaluation and risk assessment and (b) the regulatory function of assessing hazard and determining what regulatory action, if any, is appropriate. Assessment of risk in this context means: (i) eval uation of the data to determine whether the quality of the epi demiological study or animal test provides a valid data base for a determination that a human cancer risk is presented by exposure to the substance; and (ii) evaluation of the potency of the substance with respect to human risk. This latter func tion includes selection of appropriate extrapolation techniques and consideration of the relevant metabolic and pharmacokinetic data as available. The regulatory function is to assess the hazard and determine the appropriate regulatory action. The "hazard" in volves determination of the number of employees exposed, levels and types of exposure and the degree of potential danger to those employees. If regulatory action is warranted, the agency would proceed in the regulatory process to consider the factors involved in determining a reasonably necessary and feasible level of control. Procedure This memorandum assumes that OSHA has recognized the need for independent scientific evaluation by a Panel of dis- -3 H-S CMA 048263 tinguished scientists such as that proposed by AIHC. The fact that OSHA has used Clement in the preliminary evaluation of the NIOSH list is a recognition by OSHA of the need for a scienti fic evaluation. The Scientific Panel proposed by AIHC accom plishes the objective of speedy and scientifically valid eval uation of this large number of substances and assures that this evaluation will be accomplished on a scientific rather than adversarial basis. This provides assurance that substances pos ing the highest relative hazard will be selected for priority consideration. 1. AIHC urges that OSHA immediately take the first step in assuring reasonable prioritizing of these substances by requesting the President to establish the Scientific Panel so as to permit the process of selecting members to begin promptly. While the Panel is being appointed and getting ready to begin its functions, much necessary preparatory work by OSHA described below can be undertaken. OSHA should request the cooperation of NIOSH and the National Library of Medicine in gathering copies of articles on all substances tentatively classified in Category I, II or III for use by the Panel. A procedure should also be estab lished to provide all references on the substances as currently published. 2. Clement screened the 1976 NIOSH subfile of sus pect carcinogens. The 1977 list is expected to be published shortly and, in any event, is available to OSHA on tape from -4H-6 CMA 048264 NIOSH. In order to do an orderly job on the NIOSH list, OSHA should immediately request NIOSH (or a contractor) to screen the substances added to the NIOSH list and to review the sub file for substances deleted and for the additional information in the new literature references for substances in the 1976 list. The revised list of substances should be computer checked with EPA's revised inventory under TOSCA and with I7C data to identi fy the commercial substances. This revised list should be up dated currently as additional information becomes available from NIOSH or other sources. 3. OSHA should begin immediately to gather informa tion on employee exposure. Nearly 200 of the substances were identified by Clement as substances on which there were human epidemiological data (AIHC Category I) or which had been the subject of two or more positive animal studies (AIHC Category II). When the list is revised as described in (2) above, there may be other substances where the literature would tentatively appear to meet the criteria for AIHC Category I and AIHC Cate gory II. We recommend that the OSHA efforts to collect employ ee exposure data concentrate on such substances. 4. There are four possible sources of information on employee exposure: The Department of Commerce, the International Trade Commission, NIOSH and the Environmental Protection Agency. These sources will have some, but probably incomplete, informa tion as to the number of employees and levels and types of ex posure for all the substances identified in (3) above. In -5H-7 CMA 048265 addition to employee exposure information, AIHC suggests that OSHA consider securing also to the extent available the names of producers and importers of the substances from these sources. AIHC recognizes that production volume has only a limited value in assessing employee exposure, but that data will be of assis tance in identifying the insignificant products in the revised list. OSHA should also enlist the aid of trade associations in collecting these data. 5. Using the list of producers and importers referred to above, OSHA should begin a census of those companies request ing the following information: (1) Number of employees exposed and the levels and types of exposure at the producer and importer establishments. (2) Many producers may be able to give information on estimated employee exposure of down stream user plants. OSHA should also request cooperation of trade associations in gathering these data. (3) NIOSH facilities may be available to collect the information. 6. Using the information collected on each substance OSHA should publish for comment the list of substances and the agency's best estimate of employee exposure. This list should not identify tentative classification since the data are uneval uated but should be identitified as substances in which OSHA is CMA 048266 H-8 gathering data to determine if regulatory action is warranted. In order to avoid unwarranted stigma, we suggest this list be entitled "List of Substances To 3e Evaluated For Carcinogenic Hazard Potential," 7. As soon as the Scientific Panel is selected, OSHA should furnish to the Panel the list of substances for which OSHA has gathered exposure data. The Panel should be requested to make a preliminary screening of the literature so as to deter mine validity of the scientific data and the potency of the sub stances for which there are valid data. Through an iterative process, OSHA and the Panel should jointly select in an orderly and sequential manner, those substances presenting the highest relative hazard considering number of employees exposed, nature and type of exposure, physical and chemical properties, expo sure level and potency of the substance. 8. The list of substances selected for priority sci entific evaluation should be published by the Panel for comment. The notice would request information and unpublished data on the substances. The Panel should request EPA to furnish nonconfidential information in health and safety studies, relevant to carcinogenicity, which have been filed with EPA under Section 8 of TOSCA on commercialized chemicals. The Panel will also take such reasonable steps it deems appropriate to secure addi tional scientific data and scientific comment from the public during the evaluation process. -7H-9 CMA 048267 9. The Panel will complete the evaluation of the data as promptly as possible and prepare a qualitative risk assess ment of carcinogenicity. When the Panel concludes that the data provide a valid basis for a qualitative evaluation of human risk, the Panel shall evaluate all of the elements necessary to pre pare a quantitative risk assessment in such form as to enable OSHA to assess hazard at current levels of exposure, and at the PEL if one is established. The evaluation shall be based on the weight of the sci entific data and shall include evaluation of all epidemiological studies and animal data. In the risk assessment the Panel will identify the extrapolation techniques most compatible with the biological mechanism to the extent known. A reasoned statement of the grounds for identification of a particular extrapolation technique and any uncertainties associated with it will be re ported. Metabolic and pharmacokinetic data should be considered in the extrapolation process to the extent available. 10. (a) Upon receipt of the Panel evaluation, OSHA will publish the list of substances and the evaluation and clas sification by the Panel. OSHA will also issue voluntary guidelines for all substances identified as presenting a significant human risk at occupational exposure levels. The guidelines would con template preparation by each producer or user of the substances of a site-specific plan for reducing employee exposure promptly by economic and readily available means which would include: 8- H-10 CMA 048268 work practices clean-up and housekeeping determination of frequency and type of moni toring or other exposure determination containment of leaks and open operations provision for personnel protection and medical surveillance notification and training of employees This plan would be available to employees and to NIQSH or OSHA upon request. (b) Immediately upon receipt of the evalua tion from the Panel, OSHA will prepare a hazard analysis of the substances. Upon review of the hazard analysis, OSHA will deter mine regulatory priorities which will include a determination whether the guidelines have resulted in sufficient control, con sidering the employees' potential danger at then current levels of exposure. The evaluation of hazard for each substance would include a determination whether an Emergency Temporary Stan dard is justified and necessary under the statute. Where an ETS is not warranted under the statute, a standard setting pro cedure would be instituted in those cases where OSHA concludes regulation is necessary and appropriate. 11. During the time the Panel is reviewing the initial priority list, OSHA would continue to gather data on other sub stances on the list described in (3) above with particular atten tion to those substances which OSHA and the Panel agreed, based on preliminary screening by the Scientific Panel and available exposure data, indicate may present the highest relative hazard potential. As additional information becomes available, OSHA will consult the Panel to determine whether the new data changes -9 H--11 CMA 048269 the relative priority, for "scientific, evaluation. 12. When the scientific evaluation of the'-first prior ity' substances is complete or nearing completion, OSHA in coopera tion with the Panel will make a determination as to" which sub stances should next be selected for scientific evaluation. - 10 H-12 CMA 048270