Document 0JOeN96ZjneJVnVdw43XZBr8b

V I V. J5 * To make penalty assessment reasonably uncomplicated and consistent, while leaving some discrotionary judgment in the Regional Administrator, this Bystem*requires an initial assignment of a violation to one of four levels of gravity. The initial penalty assessment will be at a fixed amount for each level of gravity. .Following the initial assessment several adjustment factors, as specified in the statute, are utilized to raise or lower the initial penalty. The four gravity levels are as follows: Level I - This violation is of the type which could cause only localized harm, such as failure to promptly dispose of PCB contaminated rags, minor leaks in stored transformers, etc. The initial assessment for a Level I violation will be 51000/day/violation. Where such a violation meets the criteria discussed on page 3 for issuance of a Notice of Non-compliance, the penalty may be waived. Level II - These violations are generally serious iit nature. This level may include general recordkeeping and marking violations, and storage violations where exposure is more hazardous than at Level I. The initial assessment for a Level II violation is $5000/day/violation. Level III - This level applies to violations of a very serious nature. Such violations may include failure ef incinerators to maintain proper tempera tures for sufficient periods of time, and leakage front a chemical waste landfill not resulting in permanent environmental damage. In many cases, the differences between Levels II, III and IV violations are largely only ones of degree, depending on such factors as the extent of possible haem. The initial assessment for a level III violation is $15000/day/violation. Level IV - These violations are the most egregious, both in terms of blatant disregard for the requirements of the standard and damage caused. 'Such violations would include significant spilling and dumping of FCs resulting in large scale contamination and operating an unapproved disposal facility. The initial assesssent for Level IV is $25,000/day/ violation. In determining the gravity level for a violation, the Violation Coordinator, in accordance with regional procedures, should incorporate the statutory factors of nature, circumstances and extent of the vio lation, i.e. , rather than computing separately for nature, circumstances, extent and gravity, all four factors should be considered in the initial lovel assignment which is termed gravity". In arriving at this deter mination, the Coordinator should consider factors such as the extent of exposure, both in terms of numbers, (i.e., number of people, volume of water) and possible severity and permanence of harm. It must be kept in line that the examples of levels of gravity as used above and in the attached Appendix I should not be rigidly applied, since the circumstances behind an otherwise miro^r violation could render it a more major violazier, e.g*, minor leaks in stored transformers where the leak could degrade AC* GCalt1 1. there is a PCB spill or lenk which poses a risk of injury to health or the environment, and our immediate concern is the cleaning up of the spill or leak rather than the assessment of civil penalties (of course, such an action may also be commenced under the Act's imminent hazard pro visions (7)); or 2* we have reason to believe in the case of a particular violator, based on prior actions or other inforrstion, that abatement of his violative practices can only be accomplished by a court orderi or 3* the relief desired is that certain PCBs be seized and condemned. Where the violation coordinator determines that a civil court action is necessary, he must inform the Headquarters Regional Coordination Unit, No such action may be taken without approval from Headquarters* 0 Criminal Court Action A criminal court action may be brought pursuant to 16(b), where the alleged violation vas a taowing or willful one. These actions will most often be brought where the circumstances of the violation indi cates a fla^rent disregard for the PCB Regulations. Any contempled criminal proceeding should be brought to the attention of Head quarters throu<^ the Regional Coordinator, Headquarters approval is necessary before a U, S. Attorney is contacted to initiate criminal proceedings, 3. If the Action taken Against the Alleged Violator is Assessment of the Administrative Civil Penalty, How Much Should the Pro posed Crvil Penalty Be? This section provides some guidance and sets parameters for the assess ment of civil penalties, pursuant to 7SCA 16(a), for violations of Section 15(a). The only penalty guidelines provided in Section 16(a) are that penalties of up to $25,000 may be assessed for each day of each violation, and that in assessing the penalty "the Administrator shall take into account the nature, circumstances, extent, and gravity of the violation or viola tions and, with respect to the violator, ability to pay, effect or ability to continue to do business, any history of prior such violations, the degree of culpability, and such other matters as justice may require." Tr.e following guidelines are intended to assure nationwide consistency in penalty assessment, and to assure that violation of 7SCA should not only bring no economic benefit to the violator, but should be the cause of one financial loss, i.e., there should be a strong econaaic disincentive to violate the Act. This section describe^ how to compute a penalty for the purpose of serving a written notice*of proposed assessment of civil penalty under Section 16(a)(2). ACH CC6766 -J3- Notice of Non-Compliance Notice of non-compliance may be issued in lieu of a civil Penalty, where; a the violation does not constitute a significant threat to health or the environment; L. the violation is the first such violation of the FCB Marking and Disposal Regulation on the part of the particular violator; c. the violation is not a by a disposal facility, whether approved or unapproved, of any of the regulatory require ments governing such facilities under the FCB Marking and Disposal Regulation; d. the violation does not involve the illegal actual disposal of PCSs on the part of the violator (this does not include insignificant leaks}/ and e. the alleged violation does not appear to have been a willful one. However, even though the violation uatisfies the above tests, the administrative penalty remedy should not be sumnarily dismissed unless the violation coordinator determines the issuance of a notice of non-compliance will be sufficient to induce the violator to cease violation of.the Regulation. The lesser remedy of issuance of a notice of non-compliance should be employed only where the Violation Coordinator deter mines, in his discretion, that the violation "passes" the above tests and that issuance of a notice of non-compliance will be sufficient to induce the violator to cease violation of the regulation in those respects stated in the notice of noncompliance. Civil Court Action A civil court action pursuant to 17 may be brought against an alleged violator, in addition to or in lieu of assessment of administrative civil penalty, where it is determined that the mere issuance of a civil penalty will be insufficient to obtain compliance with the regulation. Section 17 allows the Agency to seek injunctive relief, both to restrain violations of the Act and to compel a person to actually follow the Act. Since thiE injunctive type rer.edy is not available under 16 civil penalty actions, a civil court action under 17 will allow the Agency to enforce the regulation against the violator who is willing to pay civil penalties bit refuses to continue to comply with the PCB Marking and Disposal Regulation. Thus, a civil court action may be appropriate in the fell owing instances: \ ACM C7C5 1, Is there a probable.violation? . J2- To determine whether.or'not there is a probable violation the Violation Coordinator must examine all the evidence provided in the Inspector's Report. In addition, the Violation Coordi nator should take all other reasonable steps (such as speaking with the Inspector, personnel of the laboratory performing any relevant sample analysis, and appropriate Regional attorneys) which he deems necessary for a determination of the existence and extent of a violation. If the Violation Coordinator determines that there is insufficient evidence to indicate a violation he shall take reasonable steps to gather sufficient evidence if he believes that: 1. such evidence may be obtained without unreasonably intensive resource efforts, and 2. the violation, if substantiated, is mot an insigni ficant one. ^ If the Violation Coordinator determines that there is suf ficient evidence to indicate a violation, he shall determine in accordance with the following criteria, what action, if any, should be brought against the alleged violator. 2. What action, If any, should be brought against the alleged violator? There are several types of actions which may be brought against the alleged violator. These are: 1. notice of non-compliance 2. administrative civil penalty 3. civil court action 4. criminal court action. The starting point for the Violation Coordinator should be that most violations will be handled via administrative civil penalty. Thus, when the Violation Coordinator determines, based upon review of an Inspection Report and other review, that there is a violation he should assume at the outset that an adminis trative civil penalty should be assessed against the violator. After making this initial assumption he should comply with the following guidelines in determining whether another enforcement action should be taken in lieu of, or in addition to, adminis trative assessment of a civil penalty. \ ACR CCfc7e<t  J1- A. Wrap-up Activities of the Inspector After each inspection the inspector shall write an Inspection Report based upon information on the Violation Worksheet and his Field Notes. The Inspection Report shall detail all violations which the inspector believes he found during the inspection and shall describe all relevant supporting evidence. After completing the Inspection Report, he shall submit that document, a copy of his applicable Field Notes and other relevant supporting- documents, in accordance with Regional procedures, to the designated Regional FCB Marking and Disposal Regulation Violation Coordinator. The inspector shall keep the original Field Notes in his files and shall mate and keep on file copies of all other rater!al sent to the Violation Coordinator. B. Wrap-up Activities of the Laboratory. After the laboratory performs its analysis on the FCB samples collected at the disposal site, the appropriate laboratory personnel shall send a copy of all laboratory records relevant to such sample analysis, along with a copy cf the relevant Chain of Custody Record, to the Regional FCB Violation Coor dinator. All originals of the above documents shall be maintained by the laboratory as permanent records until required in an enforcement action. C . Decision Making bv the Regional PCS Marking and Disposal Regulation Violation Cooramator Each Regional Administrator shall appoint a FCB Marking and Disposal Regulation Violation Coordinator. All FCB Marking and Disposal Regulation Inspection Reports shall be sent to such Violation Coordinator, in accord ance with Regional procedures, by the inspector who made the inspection pursuant to the FCB Marking and Disposal Regulation. It should be emphasized that the Violation Coordinator may be ary person whom the Region designates for such position. It is anticipated that the Regions shall integrate the fraction cf the FCB Violation Coordinator into ejdsting decision making structures. The Violation Coordinator shall examine each Inspection Report and determine the answers to the follotdng questionsi 1. Is there a probable violation? 2. Zf yes, Wiat type of action, if any, should be brought against the alleged violator? 3. If the action is one for administrative civil- penalty assessment, how much should the proposed civil penalty be? Criteria and guidelines for decision making in each of the above three areas are provided below. \ ACH CC6763 9 ENFORCEMENT PROCEEDINGS MANUAL * \f * ACf* CC7t2 99 Annex VI: Records and Monitoring REGl'lATORV REQUIRMKNTS '_______________________ INSPECTION PROCEDURES________________________ DOCUMENTATION____________ (d) when PCB conainera or PCB substances or mixture contained in a tranaformer/ are transferred to other storage or disposal facilities/ failure to include the identi iflcatlon of the facility to which such PCBa ere transferred ($761.45(b)(3)) Check for the inclusion of oil infor(nation required* Document non-compliance in field book. i( (I) The total number of any PCB articles or equipment/ not in PCB containers, / 1) received during the calendar year/ and 2) remaining on the facility year, respectively/ including the identifi cation of the apecific types of PCB articles and equipment received/ trans ferred or remaining on the facility site. O CC6761 o When PCB articles and equipment are transferred to other storage or disposal facilities/ failure to include the ldentlfiatlon of the facility to which sUch PCB articles and equipment were transferred. (}761.45(b) (4)) 761.45(d): In add!ton to the Information required to hr maintained by y761.45(b) above, each ovner or operator of a PCB dis[iosal or storage site collect and maintain, for the period described In H2 above, the following Information: Prior to a records inspection, the site approval file located at the EPA Regional Office should be reviewed for the pre sence of any documents listed under . "regulatory requirements". If the EPA file contains any correspondence or permits not found in the records at the site, a violation exists. Document non-ccmplaince field book. VIi Records end Monitoring REGULATORY REQUIREMENTS INSPECTION PROCEDURES (2) Failure to Include in the annual document: Check for the inclusion of all information required* (a) The date tdien any PCBs ere received by the facility during the previous calender year for storage or disposal# and the identification of the person end facility from whom such PCBs were received (761*45 (b)(in. (b) The date when any PCBs are 1) disposed of at,the disposal facility# or 2 ) trans ferred to another disposal or storage facility# Including the Identification of the specific types of FCB substances# mixtures# or articles in containers# PCB transformers# and PCB equipment or PCB articles not In containers tdiich were stored or disposed of (761*45(b)(2)) (c) The total wel<it# in kilograms# of any PCB containers kilograms of any PCB substances or mixtures contained in any FCB transformers# 1) receiving during the calendar year# 2) transferred to other storage or disposal facilities during the calendar year# and 3) remaining on the storage or disposal facility site at the end of the calendar > c year respectively# including# tdiere applicable, the Identification of PCB container contents such as liquids# n o capacitors#'' etc- O' o rI iO o> DOCUMENTATION Document non-complainee in field book. -15- rV*.'. 'v> ; ) Annex Vli Records and Honitoring: Disposal and Storage Facilities (761.45(b) 6 (<f)) Records anl rr-nitorlng requirements for storage and disposal facilities are desgined to 1) identify the type* amount and location of (CDs In various storage and disposal facilities, 2) enable FPA to compare stor^* age and disposal records with those of facilities with PCBs in service, for the purpose of detecting dis crepancies (which may indicate violations), and 3) to enable EPA to trace back to original user, so that any "in service" facilities that had prevlcxiely escaped EPA notice may be Identified. * REGtJLATCWY REQUIREMENTS INSPECTION PROCEDURES DOCUMENTATION Beglnlnnlng July 1, 1979, failure of any owner or operator of a facility used for the storage or disposal of PCBs to pre pare and maintain, by July 1 of each year, a document which sumarlzes FCB activities at the facility during the previous calendar year, and to make such documents available at the fac ility for inspection by EPA. (761.45(b) ) Check for presence of document. Copy or photograph document for later comparison of records. Document non-compliance field book. Failure to retain such documents at each facility for at least 5 years after the facility is no longer used for the storage or disposal of PCBs, except In the case of chemical waste landfills, where such documents shall be maintained for at least 20 years after the landfill la no longer used for disposal of PCBs (761.45(b)). Check for presence of document to Document non-compliance in field book. Failure of the owner or operator of the facility to notify the Agency R.A. of the Region in which the facility is located when the facility ceases storage or disposal operations. (761.45(b)). If the facility has ceased operations, check EPA records for presence of the notification and the specification of where all documents are located. Document non-compliance in field book. I o A L* ut / i */ & ) \ Ar.nex vit Records end Monitoring REGULATORY REQUIRHENTS INSPECTION PROCEDURES____________ ___________ DOCUMENTATION (d) For owners and operator with ore than one facility which contain PCBs in the quantities prescribed in #1, and maintaining the records and documents at a single location* fallur to Insure that the Identity of this location is available at each facility containing PCBe that is normally manned for B hours a day. (761.45(a)). Call all facilities manned for 8 hours a day and ask where records and documents for the facility are kept. This require ment la designed to eliminate the heed for EPA to go on "wild goose chases" looking for records. If we know the location of records for a firm* wc do not need to determine if all facilities of the firm know the location. If we encounter facilities that do not know the records location and we need to know it * then it should be considered a possible vio lation. Document non-compliance in field book, ACH CC67 ir a a j- -13- r* v^.'' * # I. Records and Monitoring 761.45 Annex VI: The general purpose at records and monitoring requironnts is to (1) enable EPA to keep track of the types, amount, and location of PCBs and (2) to provide further impetus for stores and disposers to keep track of PCBa handled at the particular facility. Records and Monitoring: PCBa in service or projected for disposal (761.45(a)) Records and monitoring requirements for PCBs in service projected for disposal are designed to (1) iden tify the type, amount, and location of PCBa currently in service at a particular location and (2) enable EPA to trace PCBs through storage, transportation and disposal, in order to identify those people/fscillties who receive PCBs when they are removed from service. Once receivers are identified, EPA may (a) compare records for the purpose of detecting discrepancies, (which may indicate violations), and (b) discover any storage and disposal facilities that had previously escaped EPA notice.*1 RF.GUI.ATORY REQUIREMENT__________________________INSPECTION PROCEDURES___________ ;____________DOCUMENTATION (1) 761.45(a) PCBs in Service (a) Begin!ng July 2, 1978, for any owner Determine amounts of PCB chemical sub or operator of a facility containing stances, mixtures transformers and any of the following: large high or low voltage capacitors fay inquiry and direct observation. (1) 45kg (99.4 lbs) or more PCB If numbers equal or exceed regulatory chemial substances or PCB requirements, check for the presence mixtures, of records on the disposition of PCBa. Document non-compliance field book. (11) one or more PCB transformers, (ill) 50 or more PCB large high or low voltage capacitor, failure to develop and maintain records on the dispool ton of ECBs. (761.45(a)). (b) Failure to prepare an annual Check for (1) presence of document, and document, based on the above records (2) the inclusion of all data specified of dls|x>3ltlon, by July 1, covering in (a) and (b). the previous calendar year, which includes the Eollowing Information: Copy or photograph document for later vO i.i comj>arioon of records. Document non-compliance field book. When data has been emitted, photograph or copy document if pos sible. CM CG 75 7 r r~\ t* Annex VIi Records and Monitoring REGULATORY REQUIRMEMTS INSPECTION PROCEDURES DOCUMENTATION (1) The dates when PCS* are removed from service# are placed in storage for disposal and are placed into transport for disposal. (11) Total quantities of PCBe remainlng in service at the end of the calendar year* The quantities of such PCBs In 2(a) and (b) shall be indicated using the following: Obtain copies or mate note of locations and names of all storage sites and finil disposal sites* ,i 1 e Total weight. In kilograms, of any PCB substances or mixtures In FCB containers, including the identi fication of container contents, such as liquids or capacitorsi .o total number of PCB transformer and total weight, in kilograms, of PCB substances and mixtures con tained in the transformers/ and o total number of PCB large hiejh or low voltage capacitors* ((761.45(a)(1) A (3)). (ill) For PCBs removed from service, the location of the initial disposal or storage facility and the name of the owner or operator of the facility (761.45(a)(2)). (c) Failure to maintain records and If facility has ceased operations, ask Document non-compliance documents for at least 5 years former owner or operator where the docu field.book. When data has after the facility ceases containing ment is located, and Inspect for presence been emitted, photograph PClin in the pi escribed quanltaties of all information required. and copy document if pos (ll)(7fal. 45(a)). vo to sible. i s n i o wav RECORDS AMD MONITORING 9 l "V } 91 ACM CC6755 ,v \ r\ x Annex IV: Deconton!nation ({761-43) REGULATORY REQUIRHENTS INSPECTION PROCEDURES (c) Has the solvent properly disposed of Observe procedures to verify as a PCB mixture ({761-10(b)(2)), compliance- when the level of FCBs in the ool- vent reached 0-5 percent? (d) Here all Materials used in the decon Check to insure that all liquids tamination procedures properly dis and solids used in decontamination posed of as PCB mixtures are placed in a properly marked con" (761.10(b)(2))? tainer and transferred to a storage area that complies with Annex III. (2) Equipment ({761.43(b)) (a) Has all moveable equipment used in storage areas decontaminated by swabbing surfaces exposed to PCBs with a 3o1vent meeting the criteria of paragraph (a) above Observe procedures to verify compliance- DOCUMENTATION OF VIOLATIONS' Document non-compliance 1 > in field book- &ke sample- Document non-compliance in field book. Document non-cotnplianc in field book- % W3V v> O -!I2 t . . '> W / Annex XV: Decontnination ($761.4.1) The decontamination requirements are designed to bring the level of FCBs remaining in a container or on R'li'ipnent after use down to a minimal level, in order to prevent other liquids or articles placed in the con** tainer or put in contact with equipment, from becoming contaminated with FCBs* . As decontamination is usually performed when fresh containers or equipment are needed, not at regular intervals, it la unlikely that the inspector will be able to observe decontamination procedures directly. However, it is possible to get a general idea of whether decontamination procedures are conducted in compliance with the regulation by asking "leading" questions such as: 1 -Are containers and equipment decontaminated after they have been in contact with jPCBs? -What is the normal decontmaination procedure? ' j i If the facility representative outlines the procedures listed under "Regulatory Requirements", It can be assumed that he/she is at least familiar with the decontamination requirements of the regulation. If the representative does not outline the decontamination requirements of the regulation, it is unlikely that he/she is aware of proper decontamination procedures. In this case, the inspector should leave written instructions (based on the "Regulatory Requirements" column) describing proper methods of decontamination. If, however, decontamination procedures can be observed directly, an inspection should be conducted as outlined below. ri~GULATQRy REQUIREMENTS_________________________ INSPECTION PROCEDURES________________________ DOCUMENTATION OF VIOLATIONS (1) Containers ($701.43(a)) (a) W,*.9 the container flushed three ts Observe procedures to vertify compliance. times with a solvent containing less than 0.05 percent PCB chemial sub- . stance in which the solubility of PCBs was five percent or more (by weight)? Document non-compliance in field book. . (b) . Has the rinse volume of the dllutenOtbserve the filling or emptying of sol- equal to approximately ten percent vent ir.to/out of the container. of the container's capacity? Measure amount of solvent used and determine internal volume of container. Compute to determine whether volume of uolvontis equal to 10 percent of container's capacity. Document non-compliance In field book. -Ill- P O O *13* DECONTAMINATION o REGULATORY REQU1HEMEHT8_______________ (iv) Number of PCB articles or equipment not In PCB con tainer received, transported to other storage or dis posal facility, and remain ing on facility site at end of calendar year. Identi ffletion of facility trans ferred to shall be included. (j) Special Records Retention (i) All documents, correspondence and data provided by State or local government agency pertalning to storage.1 (11) All documents, correspondence, and data provided by facility to State or local government agency pertaining to storage. U) ACM CC 675 1 O INSPECTION PROCEDURE r DOCUMENTATION OF VIOLATIONS Examine facility records. Document non-compliance by noting lack of, or inadequate records in Field Book. -07- .} fI > s f ) REGUtTQRY REQUIREMEWTS _________________________ INSPECTON PROCEDURES__________________________ DOCUMENTA ION OF VIOLATIONS o Total number of PCB large hlgh or lov voltage capaitors. 1 (1) Owners or operators document on PCB handling at facility for previous calendar year* Effec tive date of regulation May 1* 1979. Documentation must be available July 1 of each year. Request copy of report or inspect report at site. Documents must be retained at site for 5 years after facility no longer used for storage. Obtain copy of records. Document non-compliance in field book. (i) Date PCBs received and .^-Identification of person and facility from whom PCBs ere received. (ii) Date PCBs disposed of or transported to another disposal or storage faci lity, including identi fication of types of PCBs in containers and not in containers. ACM CC675C ( H i ) Weight of PCB containers, and eight of PCB chemical sub stance or mixture contained Jn transformers received, transported or disposed Identify PCB containers con tents such as liquids', capa citors, etc. Identification of facilities to which PCB containers or PCB chemical substances or mixtures in 11tinsforirere ate transported. to -C*th r REGULATORY REQUIREMEHTS INSPECTION PROCEDURES (9) Owners or operators maintain annual records# effective July 2, 1978- Inspect records and determine com pliance with Annex VI. (I) Dates when FCBs removed from service and placed Into storage- Quantities indicated as follows: o Total weight# in kilogram# in containers and ldanti!ication of FC3 much as ^liquid or capacitor. o Itotal number of tranformers and eight# in kilograms# of any FCB mixture contained in transformers- o,Total number of PCB large high or low voltage capacitors (II) PCBb ronoved from service, location of initial disposal or storage facility and name of owner or operator- (ill) Total quantities of FCBs re maining in service at end of calendar year. o Total weight, In kilograms, of. PCBs in contaners in cluding identification of container contents such as liquids or capacitors- o T o ta l number o f tran t)form ers and w eight, in kilogram s, of--'" cn ut any Pell c o n t a in e d i n t h e t I'ttmi (o rn u r s . DOCUMENTATION OP VIOLATIONS Documentation of non-compi lance In field book or obtlan copy of record /- r" ( REGULATORY REQUIREMENTS________________ (b) Storage of non-leaking and structurally undamaged PCB large high voltage capacitors on pallets Is permitted next to storage facility meeting the requirenents of 761.42b until January 1, 1973. Capaitors checked for leaks teekly* (c) Storage areas are mkrked. (d) Movable equipment handling PCBa which contact PCB chemical sub stances or mixtures shall not be removed from storage facility unless it has been decontaminated! (e) All K B containers and articles must be checked for leaks once every 30 days. All such leaking containers and articles and their contents shalljbe transferred immediately to properly marked non-leaking containers. Any spilled or leaked material shall be immediately cleaned up and disposed of sc per the*regulation (f) PCB containers shall comply with DOT specifications 49CFR173.346 revised Dec* 31/ 1976* (g) PCB article:: and containers must be dated when placed in storage* Stora<p area must be managed to locate ittil: by date. /' 'I k/ INSPECTION PROCEDURES__________________ Determine if storage facility has immediate available unfilled storage space equal to lot of volume of capa citors stored outside of faci lity. Check all capacitors for leaks* Verify marking to comply with 761.20(a)(6). Prepare or obtain list of all movable equipment used in storage facility. Inspect for contamination. Verify decontamination procedures. Check inspection records. Determine if leaking containers are placed in properly marked non-leaking containers and if spilled or leaked materials are properly disposed ot. `ieck specification numbers where available. Measure guage. Compare to DOT specs. Inspect- records and storage area. DOCUMENTATICB OF VIOLATIONS Calculate volume of unfil led storage space and vol ume of capacitors. Docujment all leaks if leaking, capari tor can be placed in unfilled storage spaceT Document non-ccopllance regplat ion Photograph (if possible). Document where decontamina tion procedures deviate from method described in Annex IV. May need to collect samples of sol vents. Document in field book note compliance of markings leaking containers; and improper disposal of leak material and absordents. Collect samples- Document non-compllance field notebook. Obtain container equivalent to in non-conplianco. Photo graph (if possible). Document in field book quantity Of articles and containers not dated. Ob tain pltotoooplea of records .- ACK Storage (Annex III) Inspection Procedures REGULATORY KEQUIRFHENTS_____ _______ (c) NO drains valves expansion joints or other openings within curbed area* (d) Floors and curbing constructed of continuous snooth and impervious materials* (e) Storage prohibited at site below 100 year flood water elevation* il.42(c) (a) Temporary storage of non-leaking PCB articles and equipment per mitted for up to 30 days frcm date of removal from service in area not complying with (701.42(b) (Not containers) INSPECTION PROCEDURES Visual inspection of containment area* Review all piping and sewer blueprints* Visual inspection material usually concrete or metal (metal storage bins) Determine fren geological records elevation of storage facility. DOCUMENTATION OF VIOLATIONS Provide exact location^ detail in field book with' measure einents to station objects. Determine dra inr age path and ultimate dis posal location* Obtain photocopies of blueprint showing openings of area Verify blueprints by visual inspection. Photograph (if possible). Describe material used exact location of cracks or expansion joints which permit penetration of PCBs. Photograph (if po sible) Obtain of 100 year flood elevation and topographic maps of storage area. Determne accurate elevation of storage area above ground level. Determine date when equipment or arti cles removed from service* Inspect all equipment or articles for leaks. Obtain records when equip ment removed from service. Describe leaks number of containers condition of equlparent drainage path and ultimate disposlton. Photograph (if possible) Collect sample of 1;a keel mat trrJal - - c ^_J G * Storage (Ahnex III) REGUI.ATORY REQUIRMENTS___________________________ INSPECTION PROCEDURES__________________________ DOCUMENTATION OF VIOLATIONS (1) Period of Storage: 761.42(a) PCB article or container stored before January 1, 1973 shall be removed fron storage and disposed of before January 1, 1984. PCB article or container stored after January 1, 1903 must be disposed of within one year from date placed Into storage* Check records for date of storage Confirm that disposal occured by Inspection of storage area* PCfl article or container* still In storage area* Record observations in ' field book, obtain photo graph (if possible) of stored material; list quantities,of material, type of containers, etc. (2) Storage Facility: 761.42(a) (a) Adequate shelter to prevent rain reaching PCBs. Visual inspection for leaks and gen eral condition of structure* Record observation in detail in field book, provide exact location by measurement from stationary object such as floor, wall, or. ceil ing where leak occurs, objects water contacts, and drainage path of water. Photographs (if possible (b) Adequate floor with 6 inch high continuous curbing* Containment must provide 2 time Internal volume of largest PCB article or container or 25% of total Internal volume of all PCB equipment or containers stored therein whichever la greater* Determine volume of all stored equiment or containers and volume of largest container by direct measure ment or from records. Measure surface dimensions and curb height* Calculate total volume of containers, largest con tainer, and storage area If in violation verify all measurements* Obtain photocopies of ell records describing container dimensions and volumes. 9*71990 W3V -G2tu r.j INTRODUCTION TO STORAGE INSPECTIONS Storage areas play a key role in pre^nting PCBS fran reaching the environment prior to their disposal. The function of the storage requirements in the regualtions is to assure effective containment of PCBS until they are sent on to a disposal facility. .To assure environ mental protection/ the regulations ^ o v i d e for the construction of protective structures for the storage of PCBs The essential concerns cf the regulation are that storage faciliti-t avoid potential migration of PCBs into watercourses and that they be able to contain possible spills. These concerns do qot necessarily require construction of an elaborate structure* The principle requirements/ an adequate roof and vails, impervious flooring and adequate containment capacity, may be met with fairly simple structures and some ingenuity. A steel tub for instance could suffice for meeting the floor and curbing requirements if it were of sufficient capacity. The tub then could be placed In any building for weather protection, and the storage facility require ments would be satisfied. The operations of the storage facility should canply with the requirements cf the 761.20 marking regulation as well as Annex III' and Annex IV. With respect to marking, all PCBs which are required to be placed in a storage facility should be marked and dated* In addition, once marked and dated, the PC3s in storage must be carefully organized according to the regulation bo as to permit easy access* At all facilities, PCBs in storage should be accurately recorded in the PCB records for the facility. The quantity of PCBs in storage should relate directly to the quantity of PCBs removed from service or received fran other facilities* As a vital part of each Storage facility inspection the inspector should assess, as a guide to the likelihood of seriaia violations, the general housekeeping of the facility operation* Poor or non existent reccords and loppy operations are good indicators of breaches of other significant requirments and should be carefully noted in the inspector's field book* Every facility which owns or uses PCBS should either have an Annex III storage facility or be capable of sending Its PCSs directly to a renote storage or disposal site. This sug^sts that inquiries as to the existence and location of Btorags facilities should be a part of nearly every PCB inspection. V I AC* CCS 7*t5 STORAGE REQUIREMENTS O Atif* CCtlH** 3 STORAGE REQUIREMENTS ACM CCS7A3 .> s' , ` \ /* t* REGULATORY REQUIREMENTS INSPECTION PROCEDURES DOCUMENTATION (b) Failure to dispose of non-liquid PCBs in the form of a) contaminated soil, rags or other debris, and b) soils and debris contaminated with PCBs as a result of a spill or as a result of placement of PCBs in a disposal site prior to February 17, 1978, in an incinerator that complies with Annex I, or in chemical waste landfill that complies with Annex 11 (for items specified in a), disposal in a chemical waste landfill is permitted untUnduly 1, 1980. After that date, these items must be incinerated (761. 10(b)(2),(3)). Inspect and sample wastes to determine if non-liquid, (does nto flow freely or is not readily pumpable) and contains 500 ppm or greater. . Properly identify sample, and analytical result?, Field notes on physical ' nature of wastes (liquid vs. non-liquid1). (c) Failure to dispose of PCB trans formers and other PCB articles in an incinerator that complies with Annex I, or in a chemical waste landfill that complies with Annex II. Determine If articles contain PCB mixtures chemical substances. For transformers use direct sampling. Properly identify sample and analyze results, < AC.I*. 0007*2 -F7- -i ai ^ -. ** y Transformer Manufacturers: Inspection Procedures A. General Procedures: .the following facility areas or activities should be inspected* ii 1. Storage for disposal areas containing any waste PCB lquide or solid wastes generated by manufacturing operations This applies to most current wastes generated by manufacturers* 2* Materials handling systems used for PCBs* Residual PCBa in the systems could contaminate other substances* Such contamnated substances must be handled as PCB mixtures* !- 3* Dumps, landfills, or pits used in the past for disposal of manufacturing wastes* Leachate and other indic ators of contamination should be sampled* 4* Pacllity drainage systems should be Inspected and sampled for PCB contanination* NPDES or other EPA or state programs nay already be examining this problem* 5* Record?! should be reviewed in accordance with the methods outlined in Chapter 5, Appendix D. (Note: Former manufacturers may not be required to keep records)* RSGL1ATORV REQUIREMENTS_________________________ INSPECTION PROCEDURES________________________ DOCUMENTATION ______ (1) 761.10 Disposal of PCBs ACM CC6 7 M (a) Failure to dispose of liquid PCBs in an Incinerator that complies with Annex I* (761.10(a), (b)). Direct observations of illegal disposal when it occurs would be the most convlncing evidence, but is is unlikely this will be possible* Direct obser vation and sampling of residues fras an illegal disposal activity can be acheived in some cases, and such evi dence should .be obtained whenever pos sible. Direct evidence (soils etc.) of illegal PCB disposal should be sampled to determine if dilution was used to get concentrations below 500 ppm. Special samples and notes should be obtained whenever there is suspicion that U.S* waters or adjoining shorelines have been contaminated* Photo graphs should be taken whenever possible and locations should be pre cisely referenced and loc ated on maps or plots. -j 4 -Kit- ) RFTAJIATOKY RBQUTREMEHTS _______________ (h) Failure to dispose of-liquid PCBs resulting from spill incidents in accordance with $761.10(e).* (761.10(e)). (i) Failure to properly store prior to disposal PCS liquid or nonliquids described in 1-10 above in storage area that compiles with Annex III. (761.10(a)(2)(b)(5), (c)(4)(d)(2)). (j) For an# person who is required to incinerate any PCD and who contends that there is available a means of destroying PCBs which is as effi cient as the incineration procedures provided in Annex I, failue to ob tain written permission (and fail ure to comply with any limitations specified therein) from the R.A. be fore employing any method of dis posal cf any PCD other tnan incin eration in a facility which complies with Annex I. (761.10(1)). INSPECTION PROCEDURES Follow up spill reports. Direct inspection or contacts with spill official will indicate degree of camp]iance. Non-campliance will require procedures similar to 1 and 2 except for records review. See 9 above. DOCUMENTATION OF VIOLATION Samples of contamination Zones and removed mater ials. Third party report or direct observation of 1 final disposal. See 9 above. ACh CCfc7*tC -F5- i CJt Capacitor Manufacturen aaiiiJVTJBY PEQUrk e m e w t s INSPECTION PROCEDURES (d) For any large hitfi or low voltage Similar to A3, except that burden is capacitor owned by any person, failure on owner to furnish other evidence if to dispose in an incinerator that he contends PCHa are not present. This ccmplieo with Annex I, or In a chemi . requirement is intended to force manu cal waste landfill that complies with facturers of new large capacitors to Annex II, unless it 13 known frost mark their products "Non PCBs" if no label information, manufacturer's FCBs are used. literature or chemical analyeia that the capacitor does not contain PCB chemical substances cr PCB mixtures* (761.10(c)(2)(i),(il)>. (e) Un lessee contaminated in accordance with Annex IV, failure to dispose of PCB containers in an incinerator that complies with Annex I, or in a chemical waste landfill that compiles with Annex II. (761.10(d)(1)). Detezreine that containers contained FCBs by direct samples of residuals or frcn records review or third party statements. (f) Failure to drain the PCB container of liquid prior to disposal in a chemical waste landfill that com plies with Annex II. (761.10(d)(1)). Observe to determine if any physical evidence of FCBs Is present Inside or outside of container. If PCBs are observed or if other information sug gesting Inadequate decontamination is obtained. Investigate, decontamina tion process. (g) For PCB articles other than trans former and capacitors, if incinera tion is thought to be technologically infeasible, failure to obtain written permission (and to comply with any 'limitations specified therein) from the R.A. granting }>erir.lEslon to use a chemical waste landfill for disposal. (761.10(c)(3)). Examine documents fremi R.A. granting permission. Countinue investigation to determine If special conditions accompanying R.A. permission are being complied with. DOCUMENTATION OF VIOLATIONS Similar to A,3. Field notes, photographs, analytical results, copies of records and. statements from employees or third party observers. Field notes, photographs, statements frpm employees or third party observers Copies of documents, documentation based on special conditions in R.A permission. ACM CG73S *i Wl -F4- feguiatory requirements INSPECTION PROCEDURES (b) Failure to dispose of non-liquid PCBs Inspect and sample waters to deter In the form, of a) contaminated soli mine if non-liquid (does not flow rags Qr'bther debris and b) soils and freely or is not readily pumoable) debris contaminated with PCBs as a and contains 500 ppm or greater. result of a placement of PCBs in a disposal site prior to February 17 ; 1978 In an Incinerator that complies with Annex 1 or in a chemical waste landfill that complies with Annex II. (For Ittsns specified in a) disposal in a chemical waste landfill is per mitted until July 1 I960* After that date these items oust be incinerated. (761.10(b)(2),(3)). *n) Failure to dispose of FOB articles in an incinerator that complies with Annex 1 or in a chanleal waste land fill that complies with Annex II (761.10(c)(3)). Determine If articles contain FOB mixtures or chemical substances. For transformers use direct sampling. For capacitors manufacturers reports can be used. DOCUMENTATION should be taken whenever there is suspicion that 17.S. waters or ad joining shore lines have been con,tciminated. Photographs sltould be taken Whenever possible and sample loca tions should be precise1 referenced and located on maps or plots. Properly Identify sample and analytical results. Field notes on physical nature of waste (liquid) vs. non-liquid). Properly identify sample and anlaytlcal results, Copy manufacturers report Capacitor Manufacturers: Inspection Procedures and Documentation A. General: The following facility areas or activities should be inspected. * 1. Storage for disposal areas containing any waste PCB liquids or solid wastes generated by manufacturing operations. This applies to most current manufacturers. ., 2. Materials handling systems used for FCBs. Residual FCBs in the systems could contaminate other sub stances. Such contaminated substances must be handled as PCB mixtures. . 3. Dumps, landfills, or pits used In the past for disposal of manufacturing wastes. Leachate and other indicators of contamination should be samples. 4. Facility drainage systems should be inspected and sampled for PCB contamination. NPDES or other EFA or state prograns may already be examining this problem. ^Records should be reviewed. (Note: former manufacturers may not be required to keep records). 6. Any small PCB capacitors owned by manufacturers, pest or present, will have to be disposed of in accordance with Annex ll(761.10(c)(2)(iv). These are the only disposal requirements for small capacitors. B. Specific Procedures REGULATORY REQUIREMENTS INSPECTION PROCEDURES DOCUMENTATION (1) S761.10 Disposal of PCBs (a) Failure to dispose of liquid PCBs in an incinerator that complies with Annex 1. (761.10(a),(b)). Direct observations of illegal disposal when it occurs would be the most con vincing evidence, but it is unlikely this will be possible. Direct obser vation and sampling of residues from an illegal disposal activity can be acheived in some cases, and such evi dence should be obtained whenever pos sible. Direct evidence (soils etc.) of illegal P posal should be to determine if any resi dual concentrations of 500 ppm. or greater are present, or if dilution was used to get concen trations below 500 ppm. ACM GC67 -F2- i ,r~ ' .- ... v ... I. Introduction 60 PCB Capacitor and PCB Transformer Manufacturing -FI- Manufacturers of PCB capacitors and PCB transformers have been identified as major discharges of PCBs to U.S. waters: the contamination resulting from such discharges has forced the closing, of a number of major rivers t-n fishing. Due to environmentalist pressure and new laws and regulations, the manufacture of PG3 capacitors in the U.S. is expected to terminate by mid-1978. As far as EPA is aware, PCB transformer manu facture!.'^, has already ceased. Nevertheless, PCB discharges resulting from complex materials handling systems, poorly constructed drainage systems, and general poor housekeeping practices will probably continue to contaminate U.S. waterways for some time after all PCB transformer and capacitor manufacturing has cecsed. Signi ficant volumes of PCB solid wastes, in the form of defective snail capacitors, have been disposed of improperly in dumps, and FCB discharges fran such dimps continue to contaminate both water systems and municipal sewage sludge. II. Reccrmended Approach for Conducting PCB Capacitor and PCB Transformer Manufacturing Facility Inspections Inspection Priority The highest inspection priority should be those few capacitor nanufacturers who still use PCBs. They will have large amounts of highly concentrated liquid PCBs on hand, and thus have the greatest potential for PCB contruination. Storage and handling of PCB wastes fran the manufacturing process will also be a major problem. The second priority should be former PCB capacitor manufacturers. Transformer manufacturers should be the third priority. All facilities should be physically inspected. Note: Those facilities for which third party reports on illegal disposal or storage have been made should receive priority. Those reports can come from competitors, environmental "watchdogs", transporters, or the general public. These potential sources of information can be effectively used only if the sources are aware of the general requirements.of the regulation and the potential harm that can result fran non-canpliance. Third party reports should be convereted into permanent evidence via signed statements or, prefer ably, affidavits. v o At> CC 7.3 1 INSPECTION PROCEDURES $ FOR TRANSFORMER AND CAPACITOR MANUFACTURERSV V\ *i t AtF CC6735 y KDGULATORY R E Q U I R E M E N T S ____________________ INSPECTION PROCEDURES (k) Failure to properly store, prior to See Chapter on storage disposal, any PCB liquids or non- for procedures, liquids described in 1-10 above, in a storage area that complies with Annex III. (5761.10(a)(5),(c)(4)(1)(2)). (l) For any person vho Is required to incinerate any PCB and who contends that there is available a means of destroying PCBs which is as effi cient as the incineration proce dures provided in Annex 1, failure to obtain written permission (and fail ure t6 comply with any limitations specified therein) from the R.A. before enploying any method of dis posal of any PCB other than incinera tion in a facility *hich complies with Annex 1. (5761.10(f)). See 9 above, DOCUMENTATION See Chapter on storage for documentation. See 9 above. -El 3- REr/IIJTORY REQUIREMENTS INSPECTION PROCEDURES DOCUMENTATION (g) Unless decontaminated in accordance with Annex IV, failure to d i s u s e of PCS containers in an incinerator that complies with Annex I, or in a chemical waste landfill that complies with Annex II* (|761.13(d)(1)). Determine that containers contained PCBs by direct samples of residuals or from records review or third party statements. Field notes, photographs a n a l y t i c a l results, conies of records, and statements from employees or third party observer^. (h) Failure to drain the PCB container of liquid prior to disposal in a chemical waste lanfill that complies with Annex II. (761.10(d)(1)). Observe to determine if any physical evi dence of PCBs is present inside or out side of container. IF PCBs are observed or if other information suggesting in adequate decontamination is obtained, investigate decontamination process. See Filed notes, photographs statements from employees or third party observers (i) For PCB articles other than trans formers and capacitors, if incineration is thought to be technologically infeasible failure bo obtain written permission (and to comply with an limitations specified therein) fren the R.A. granting permission to use a chemical waste landfill for dis posal. ({761.10(c)(3)). Examine documents from R.A. granting per mission. Continue investigation to determine if special conditions accom panying R.A. permission are being complied with. Copies of documents or other documents based on special conditions in R.A. permission. j).Failure to dispose of liquid PCBo resulting from spill incidents in accordance with 1-9 above. (5761.10(c)(3)). Follow up spill reports. Direct in spection or contacts with spilf* officials will indicate degree of compliance. Non-compliance-will require procedures similar to 1 and 2, except for records review. Samples of contamination zones and removed mater ials. Third party report or direct observation of final disposal. e 3 0 3 pH ? lu n j -E12- r RECIIATOBY REQUIREMENTS INSPECTION PROCEDURES DOCUMENTATION (c) Failure to dispoMi of PCB trans formera and other PCS articles in an incinerator that complies with Annex I, or in a chemical waste landfill that complies with Annex II. (761.10(c)). Determine if articles contain PCB mixtures or chemical sub-jtances. For transformers, use direct sampliny. For capacitorB, manufacturers reports can be used. Sample and analytical re suits should be noted In t l 4(1 book. Copied of manufacturers reports should be included Iff . possible. (d) Failure to, prior to disposal In a chemical waste landfill, drain each transformer of all free flowing liquid, fill the transformer with solvent and allow 18 hours before solvent is drained. ^ 7 6 1 . 10(c) (Hi)). Open drain valves on transformers and collect any free flowing liquid. If liquid volume .collected is greater than 5% of the transformer volume, then ade quate draining did not occur. If no solvents are present in the liquid, then a solvent flush did not occur. If the facility has not completed adequate draining, they could claim that the dis posal site is responsible. Follow up may be necessary. (e) Failure'to dispose of PCB chemical Interviews with personnel to determine substances and PCB mixtures which are familiarity with proper draining pro- removed from the transformer, (including cedurea as indicators of proper draining, solvent), in an Incinerator that complies with Annex I, or in a chemical waste landfill that complies with Annex II <$761.10(c)(ii)). Field notes and statements from workers. Obtain serial numbers or other direct identity of trans former. f) For any large high or low voltage Similar to A,3. except that burden is on Slumilar to A,3. capacitor owned by any person, failure owner to furnish other evidence if he to dispose in an incinerator that contends PCBe are not present. This re complies with Annex I, or In a chemical' quirement is Intended to force manufac waste landfill that compiles with turers of new large capacitors to mark Aqnex II, unless it is known iron label their products "Non-PCBB" If no PCBo are inrormation, manufacturer's literature used. or chemical analysis used that the capacitor does not contain PCB chemical Capacitors may be found on some new r.iiV^'tanccB oi ICR mixt ure. (}761.1U(c>(2)(l){ii)). a\ OJ motors and In building electrical syr.tima. Subway systems may have than for [xjwer factor correction. -nil- Railroad and Subway Systems* Specific Inspection Procedures end Documentation t-'ote: PCDa will generally be found in locomotive and self propelled car maintanence f a d lit 1tes. REGULATORY REQUIKHENT9 INSPECTION PROCEDURES DOCUMENTATION 11) | 761.10 Disposal of PCBs (a) Failure to dispose of liquid PCBs in an incinerator that complies with Annex I (761.10(a),(b)) Direct observations of illegal disposal when it occurs would be the most con vincing evidence, but it is unlikely that this will be possible. Direct observation and sampling of residues from an illegal disposal activity can be achieved in some cases and such evidence should be obtained whenever possible. Direct evidence (soils, etc.) of illegal FCB dis posal should be.sampled to determine if any residual concentrations of dilution was used to get concentrations below 500 ppm. Special samples and notes should be obtain ed whenever there is suspicion that watercourses have been contaminated. Photographs should be taken whenever possible and sample locations sliould be precisely referenced and located on maps or plots ACK CQ672 (b) Failure to dispose of non-liquid Inspect and sample wastes to determine PCBs in the form of a) conta if non-liquid (does not flow freely or minated soil, rags or other is not readily pumpoble) and contains debris, and b) soils and debris 500 ppm or greater. contaminated with PCBs as a result of a spill or as a result of placement of PCBs in a disposal site prior to February 17, 1978, in an incinerator that compiles , with Annex !, or in a chtsnical wastes landfill that compiles with Annex II (for items specified in a), disposal in a chemical waste landfill is perrltted until July 1, 1900. After that date, these items must be in cinerated (761.10(b)(20(3)). Properly identify sample arid analytical results. Field notes on physical nature of waste (liquid non-liquid).. -j t'EIO- a REGULATORY REQUIREMENTS (j) Faillie b properly store and dispos of liquid P OE s resulting frcna spill incidents. (k) For any person Uio i? required to incinerate any PCD and who contends that there is avail able a means of destroying PCBs ,^v,tuch is as efficient as the incineration procedures pco- ^ vided in Annex I, failure to obtain written permission (and failure to comply with any limi tations specified therein) from the R.A. before other than inciner ation in a facility which com plies with Annex 1. (5761.10(f)). a\ ACM CC673C INSPECTION PROCEDURES Follow up spill reports. Direct inspection or contacts with spill officials will indicate degree of compliance. Non-compi iance will require procedures similar to 1 and 2, except for records review. See 8 above DOCUMENTATION Sanples of contamination and rcnovcd materials, third party 1 reports or direct observation of final disposal. See 8 above. REGULATOR* REQUIREMENTS INSPECTION PROCEDURES (e) Failure todlspoae of PCB chemical subAtar.ceo or mixtures which are removed from the transformer, (iniuding solvent), in an incinerator that complies with Annex I, or in a d i a i c a l waste. Interviews with personnel to determine familiarity with proper draining procedures as indicators of proper draining. (f) Unless decontaminated in accor dance with Annex IV, failure to dispose of PCB containers in an Incinerator that complies with Annpx 1, or in a chemical waste landfill that complies with ' Annex II. (761.10(d)(1)). Determine that containers contained PCBs by direct samples of residuals or from records review or third party reports. (9) Pei lure to drain the PCB con tainer or liquid prior to dis posal in a chemical waste land fill that complies with Annex II. (761.10(d)(a)) Observer to deteimien if any physical evidence of PBs is present inside or outside of container. If PCBs are observed or if other information suggesting inadequate decontamination is obtained, investigate decontamina tion process. See Cf* CC67*S (h) For PCB articles other than transformers and capacitors, if incineration is thought to he technologically infeasible, failure to obtain written permission (and comply with any limitations specified) to use a chemical waste landfill for - disporal. (761.t0(c)(3)). Examine documents from R.A. granting permission. Continue Investigation to determine if special conditions accompanying R.A. permission are being complied with. Hill seldom apply to transformer repair facilities. (i) Failure to properly store, prior See Chapters on storage tci disposal, any liquids or non- for procedures. llijuM described, in 1-B above. In a :-inra<n; area that complies CTi with Annex 111. ( 761.10(a )(2) UJ (I M S ) , ( c ) ( 4 ) , ( d ) ( 2) ) . DOCUMENTATION Field notes and statements from workers.' Obtain serial numbers or other , direct identity of trans- formers. * 1 Field notes, photographs analytical results, copies of records, and statements from employees or third party observers. Field notes, photographs statements from employees or third party observers Copies of documents and other documents based on special conditions in the R.A. approval. See Chapters on storage for procedures. -EH- 't. , ) V./ Transformer Repair Facilities PEGUIAOHY REQUIREMENTS__________________INSPECTION PROCEDURES____________________ DOCUMENTATION (b) Failure bo dispose of non- Inspect and sample wastes to deter liquid FCBs in the form of mine if non-liquid (does not flow contaminated soil, rags or freely or is not readily pumpable) other debris contaminated and contains 500 ppm or greater. with FCBs as a result of a spill or as a result of place-; ment of FCBs in a disposal site trior to February 17, 1978, in an incinerator that conplies with Annex I, or in a diemical waste landfill that conplies with Annex II (for items specified in (a), disposal in a chemical waste landfill is permitted intil July 1, 1960. After that date, these items must be incinerated). (5761.10(b)(3)). Properly identify sar;ple a.v2 analytical ro-ull Field notes on physital nature of wa$te (liquid) vs. non-liquid). (c) Failure to dispose of PCB trans formers and other PCB articles in an incinerator that conplies with Annex I, or in a chemical waste landfill that complies with Annex II. ($761.1)(c)). Determine If articles contain mix tures or chemical substances. Fbr transformers, use direct sampling. For capacitors, manufacturers reports can be used. Sample and analytical results and copies of manufacturers reports. 'O id) Failue to, prior to disposal In Open drain valves on transformers and WOV a chemical waste landfill, drain collect any free flowing liquid. If each transformer of all free liquid volute collected is greater flowing liquid, fill the trans than 5% of the transformer volume, former with solvent and allow then adequate draining did not occur. 18 hours before solvent is If no solvents are present in the drained. (7C1.10(c)(ii)). liquid, then a solvent flush did not occur. Since transformer facilities can either serve as agents for final disposal or decide bo dispose ' of a transformer after testing or. examining it, proper draining of trans CTt formers will be an important activity. i- (..JL v -V 9. After July 1 1978, all K B transforme re at a transformer repair facility will have to be properly marked in accordance with Annex V (see Chapter 5, Appendix C). This also applies to PCB con tainers storage for disposal areas. II. Railroad and Subway Systems: All of the above and locomotive and self -prop-'led car maintenance facilities B. Specific Inspection Procedures and Documentation Transformer Repair Facilities REGULATORY REQUIREMENTS_____________________INSPECTION PROCEDURES________________________ DOCUMENTATION (1) 761.10 Disposal of PC9a (a) failure to dispose of liquid PCBs in an incinerator that compiles with Annex 1# (761.10(a), (b)). Direct observation of illegal disposal when it occurs would be the most con vincing evidence, but is unlikely that this will be possible. Direct obser vation and sampling of residues from an illegal disposal activity can be achieved in some cases, and such evid ence should be obtained whenever pos sible. Direct evidence (soils, etc.) of illegal PCB dis posal should be sampled to determine if there are any residual concentrations below SOOppm. Special samples and notes should be obtained whenever possible and -sample locations should be precisely referenced or located on maps or plots. AC* CC6727 - E 6- a\ io Railroad and Subway Systems H I . Transformer Repair and Maintenance Facilities: A. General Inspection Procedures 1. Transformer repair and maintenance facilities Potential Violations, Inspection Procedures and Documentation *a '' , For those transformer maintenance and repair facilities selected for inspection a thorough physical inspec tion should be performed with records review as outlined In Chapter 5, Appendix D, as a secondary priority. The following facility areas or activities should be Inspected: >, 1. Storage lot or area where incoming transformers are placed. Inspector should look for leaking units and evidence of significant ground contamination. If storm runoff of PCBs into storm drains or steams is suspected samples of contaminated aoil and stream or storm dra:m bottom deposits should be taken. 2. Storage for disposal area(s) should be inspected for compliance with 761.42 (see Chapter 5 Appendix A). 3. Scrap metal areas should be inspected for PCB contaminated wiring or other internal parts. No dis mantled or intact PCB transformer casing should be here. They must be in storage for disposal areas. 4. General housekeeping conditions should be observed. PCB contaminated rags and other debris must be placed in proper containers for disposal. Poor housekeeping is indicated by PCB contamination of drainage systems and the general facility environment. Drainage, systems samples should be taken. 5. PCB storage and handling areas within the facility should be carefully inspected. Although the regulation provisions apply only to storage for disposal serious hazards can be addressed under emergency powers. v AC CC8726 6 . The degree of worker knowledge about occupational hazards of PCBs should be determined. The.availa bility of protective clothing should also be determined. These factors are not potential violations per se but are good indicators of the degree of knowledge that exists regarding environmental con cerns. 1 Determine the amount of activity in retrofilling PCB transformers with substitute fluids. If this is a major activity at this facility then expect large quantities of waste PCBs to be generated. 8. Records as required by Annex III (see Chapter 5, Appendix D) should be reviewed to determine the nam;s and locations of all storage for disposal and final disposal site locations. If out.ilde transformer repair firms are acting as middlemen In the transformer disposal-chain from original u'icr to final disjxiunl, adequate records should be available indicating the origin of the trans formers or wu:;te lCH fluids. -E> -ZAperformed,- the facility should be physically inspected. Any facilities for vhich a third party report or "tip-of" has been made relating to* illegal disposal or storage should receive priority. These reports can come fron competitors, environmental "watchdogs," transporters, or the general public. These potential sources of information can be effectively used only vhen these urces are aware of the general requirements of the regulation and the potential harm that can result fron non-conpliance. Third party reports should be converted into permanent evidence via signed statements or, preferably, affidavits. 0 \ AC* CC6725 -sa il ~Significant quantities of waste PCBs will be generated, and adequate storage and disposal must be provided for; 3* Since dismantling and repair operations occur in a number of locations within the facility, housekeeping problems can be serious* If wide spread contamination occurs within the facility, drainage systems can readily become contaminated with PCBs* Railroad Maintenance Operations These operations are similar to the transformer repair facilities with two major exceptions; 1. The transformers must be removed from the locanotives or serviced on the locomotives in the same work pits that are used for other locomotive maintenance operations* This often results in very cramped working conditions and an intermixing of PCB operations with other operations* 9 2* The railroad shops almost never open a transformer for repairs to internal apparatus* For these services, the transformers are sent to outside transformer repair facilities* Railroad repairs are usually similar to the on-site repair and maintenance operations discussed above* Repair operations unique to the railroad.units include repair or replacement of FCB motors used to re-circulate PCBs for cooling, and repair or replacement of cooling radiators that may be damaged by stones or other roadbed projectiles* The most significant risks at these railroad maintenance facili ties are as follows: 1 General housekeeping contamination, parltcularly in work pits* Drainage to sanitary or storm sewers from the pits could be a significant contamination pathway; 2* Although some quantities of waste PCBs will be generated, Increased filtering and reclamation may reduce this* II* Recommended Approaches for Conducting Transformer Maintenance Repair and Railroad and Subway Facility Inspections* Inspection Priority , Headquarters is providing a basic list of transformer repair facilities and railroad and aubway systems that may handle PCB units* The facilities should bo contacted to determine if they are engaged in PCB activities. If there is any possibility or suspicion that FCB maintenance is being V AU* CC724 I 60 * *\ - ; -- G (b) Acdlng a small amot of PC5s to bring the level up to the full lin (topping off); (c) Replacement or resealing of bushings, insulators, or gaskets (the PCB level of the transformer is lowered below the affected part and then refilled to the full line after repairs have been made); (d) Removal, filtering {clay filter or paper cartridge) and return of PCB liquids into the transformer (filter media and any waste PCB liquids will require special disposal); (e) Removal of PCB liquids from a transformer and refilling with new or reclamed PCB liquids (unusable PCB liquids will require special disposal). Off-site operations are conducted at the transformer repair facility and include an operations sequence like the one below. 1. Ihe tranformer is delivered to the shop, probably containing P OE liquids; * 2. If minor repairs are all that are required, then a series of steps similar to the on-site operations above are performed; 3. For major repairs, the PCB liquids are drained and probably retained for re-use after filtering, unless the liquids are grossly contamin ated; particularly with carbon particles from an electrical failure. These contaminated liquids would go to PCB disposal;- 4. Before opening the transformer for major repairs, the unit may be flushed with solvent to lower the residual PCB content. The spent solvent should go to PCB disposal; 5. After the top is opened, the internal coils and other electrical apparatus are probably removed for examination and/or repair. These devices may contain significant quantities of residual PCBs; 6. Depending' on the condition of the coil, rewinding with new wire may be performed. The scrapwire should be disposed of as a PCB solid. PCB contamination from such transformer salvage operations is considered to be a serious problem; 7. The internal workings are replaced, the transformer resealed, and PCBs (either new or reclaimed) are added to the unit; 8, The transformer is tested and, if satisfactory, returned to service. The risks these operations pose come fran three activities: 1. Newly arriving transformers may be leaking and contaminating trans port vehicles, storage areas or building; \ ACM C087Z3 59 -El- E. introduction to Transformer Maintenance and Repair Facilities'and Railroad and Subway Systems. One of the major sources of .PCS exposure for the environment and to workers occurs during transformer repair ani maintenance activities, as these operations often involve handling large volumes of highly concentrated liquid PCB's. The internal windings and other electrical apparatus within the transformer can hold significant residuals of PCB's, and major transformer disassembly often results in repeated leakage and drainage of PCB's. As with eleeti.ical utility- companies, electrified railroads and, to lesser extent, subway systems, perform significant PCB transformer repair and maintenance operations that may be performed by a facility-owned operation or by a contracted outside firm. Electric railroad locomotives and self propelled commuters receive their electric power fran overhead high voltage A.C. current distribution lines. This high voltage current is then reduced to a lower, working voltage by transformers on the locomotives for use by the electric motors that power the locomotives or cars. These transformers are subjected to severe working conditions in that the cramped space available on the locomotives and the heavy electrical load, result in high maintenance requirements viien compared to other PC3 transformer installations. In addition, many of the railway transformers are located on the undercarriage of the locomotive and are subject to damage fran objects throve up fran the track roadbed. This damage may cause a leak of PGJs vhich will require transferral of the locomotive to a repair facility. Subway systems are also electrically powered, but receive their power through a third rail which delivers direct current at a working voltage for the electric motors on the subway cars. Transformers are used in the electric distribution system vdiidi regulates the voltage to the proper level, and since much of the electrical system is underground, the transformers are often PCB units. The transformers are basically standard distribution system units and are reasonably reliable. The subway systems do not usually have special repair organizations for transformers, but instead contract with traiifuij[<er repair firms. Transformer Repair and Maintenance Facility Functions transformer repair and maintenance fuctions are often split between on site and off-site activities. Since PCB transformers are heavy, bulky units and the transporation of them does pose some risks, many service operations . are performed on-site. Some examples of these on-sitc operations are:, (a) Removing a sanple (one pint to one quart of PCBs) for testing dielectric strength (the presence of water, carbon, or other contaminants lowers dielectric strength); v > . .. ; ACM CC6722 INSPECTION PROCEDURES 0 FOR TRANSFORMER MAINTENANCE AMD REPAIR FACILITIES AND RAIL SYSTEMS V AM C C 6 7 a i REGULATORY RETIREMENTS INSPECTION PROCEDURE failure to obtain written permission (and failure to comply with any limitations noecified therein) from the R.A. before employing any method of disposal of any PCB other than inciner ation in a facility thich complies with Annex 1. (5761.10(f)). DOCUMENTATION REGULATORY REQUIREMENTS INSPECTOR PROCEDURES (h) Failure to drain the PCS container of liquid prior to disposal In a chemical waste landfill that complies with Annex II* ((761.10(d)(2)). Observe to determine If any physical evidence of PCD.? is present inside or outside of container. If PCBs are observed or if other information suggesting inadequate decontamination obtained, investigate decontamin ation process. See (i) For PCS articles other than Examine documents from R.A. granting transformers and capacitors, permission. Continue investigation if incineration is thought to.determine if special conditions to be technoglcally infeasible, accompanying R.A. permission are failure to obtain written being complied with. permission (and to comply with an^lImitations specified therein) from the R.A. granting permission to use a chemical waste landfill for disposal. ($761.10(e) ) ()) Failure to dispose of Liquid PCBs resulting from spill incidents in accordance with 1-9 above, (|761.10(e)). Follow up spill reports. Direct inspection or contacts with spill officials will indicate degree of compliance. Non-compliance will require procedures similar to 1 and 2 , except for records review. (k) Failure to properly store, prior to disposal, any PCD liquids or nonliquids described in 1-10 above, in a storage area that complies with Annex III. ($761.10(a) (2),(b),(5),(c)(4)(d)(2)). s ,(1) For an/ person who la required to lnci lierate any PCB and who contends that there is available a mrang of destroying PCBs which is .is efficient as the inclnerpioceduree provided in Annex I, See 9 above, DOCUMENTATION Field notes, photographs ctatanents from employee or third party observers Copies of documents. Other documentation based on special conditions in R.A. permission. Samples of contamination zones and removed material Third party reports o r , direct observation of field disposal. See 9 above. O REGULATORY REQUIREMENTS__________________ (dj Failure to prior to disposal in a chemical waste landfill, drain each transformer of all free flowing liquid, fill the trans former with solvent and allow 10 hours before solvent is drained. (761.10(cMii) ). INSPECTION PROCEDURES_______________ ________ DOCUMENTATION Open drain valves on tranformers and collect any free flowing liquid. If liquid volume collected is greater than 5% of the transformer volume, then adequate draining did not occur. This may apply more to disposal sites. If a utility has not completed adequate draining, they could claim that tha disposal site is responsible for that , operation. Follow up may be necea- (e) Failure to dispose of PCS chemical substances and PCB mixtures which are ronoved from the transformer, (Including solvent), In an Incinerator or that complies with Annex I, or in a chemical waste landfill that complies with Annex II ($761.10(c)(li)). Interviews with personnel to determine familiarity with power draining pro cedures as indicators of proper draining. Field notes and statements from workers. Obtain serial numbers or other direct Identity of trans former. (f) For any large high or voltage Similar to A,3. except that burden is capacitor owned by any person, on owner to furnish other evidence if failure to dispose in an Inciner he contends FCBs are not present. This ator that complies with Annex I, requirement is intended to fgree manu or in a chemical waste landfill facturers of new large capacitors to that complies with Annex II, un mark their products "non-PCBa" if no less it is known from label inform PCBe are used. ation manufacturer's literature or chemical analysis that the capacitor does not contain PCB chcmial sub stances or PCB mixtures. (761.10(c)(2)(l),(il)). Similar to A,3. (g) Unless decontaminated In accordance Determine that containers PCBa by with Annex IV, failure to dispose direct samplss of residuals or of PCB Containern in an incinerator iron records review or third party that compiles with Annex I , or a statements. en 4. chiinlcdl waste landfill that complies with Annex II. Field notes, photographs analytical results., copies of records, and statfsnenls from employees or third party olwervera. ACH CG671 PJ^ULATORY R E M U E M E N T S INSPECTION PROCEDURES (b) Failure to dispose of non-liquid Inspect and sample wastes to determine PCBs in the for?, of (a) contamin- if non-liquid (does not flow freely or ated soil rags or other debris, is not readily pumpable) and contains and (b) coils and debris oontamin- 500 ppta or greater PC8s. ated with PC8s as a result of a spill or as a result of placement of PCBs in a disposal^site prior to Pebruary 17, 1978, in an incinerator that complies with Annex 1 or in a chemical waste landfill that complies with Annex II (for itens specified in (a), disposal In a chemical waste landfill is permitted until July 1, 1980. After that date, theae Items must be incinerated) (761.10(b) (2)(3)). (c) Failure to dispose of FCB trans Determine if articles contain PCB formers and other PCB articles mixtures or chemical substances- in an incinerator that complies For transformers, use direct with Annex I, or In a chemical sampling. For capacitors, manu waste landfill that complies with facturers reports can be used- Annex. II. (761.10(c))- DOCUMENTATION shoreLines have been contmninated- Photo graphs should be taken whenever possible ahd sample locations should be precisely referenced ahd located on maps or plotsProperly identify sample and analytical results Field notes on physical nature of waste (liquid' vs- non-liquid). Properly identify sample and analytical results in field book. Copy any manufacturer's reports. -D6- I J ( "} Utility Compliancies: Potential Violations, Inspection Procedures and Documentation A. General InapectIon Procedure For those utilities selected for inspection, an Investigator should (1) <jb to the central location ^or PCB records, (2) conduct a records' examination as outlined in Appendix D (Annex VI), and (3) based on the findings of this examination, determine the need for physical inspection of utility facilities. If the records are legally sufficient, and do not indicate that the utility has a violation, no further inspection should be perfo med at the site. If records either do exist or do not meet the minimal legal requirements of the regulation, o indicate that the utility has violated the regulation, a full inspection should ensue. The records review may indicate specific facilities where violations might be expected, but In the absenc of specific leads, inspections should be directed in the following priority. (1) Transformer repair and maintenance facilities located at the utility (2) Long term PCB storage for disposal facilities (3) In use facilities such as major substations and coal fired power generation facilities (4) Storage areas for serviceable PCB articles (5) Temporary storage for disposal facilities (6 ) PCB transport vehicles B. Specific Inspection Procedures and Documentation REGULATORY REQUIREMENTS____________________ INSPECTION PROCEDURES_____________ DOCUMENTATION (11 $161.10 Disposal of PCBs (a) Failure to dispose of liquid PCBs Direct observations of illegal disposal Direct evidence (soils In an incinerator`that complies when it occurs would be the most con etc.) of Illegal PCB dis with Annex 1. (761.10(a)(b)). vincing evidence, but it is unlikely posal should be sampled this will possible. Direct observa to determlne if any tion and sampling of residues from an residual concentrations, illegal disposal activity can be are below 500 ppm. achelved in some cases, and such Special samples and notes evidence should be obtained whenever should be otrtalned when possible. there is suspicion that watercourses are being contaminated. Ul IO -1)5- 3T S D D rft.V -D4(2) Previous inspection histories (TSCA as well as other environ mental health statutes) which may indicate corporate attitude toward canpliance with environmental regulations. (3) Utilities for vhich a third party report or "tip-off" has been, made relating to illegal disposal or storage. These reports can cane from competitors, environmental "watchdogs", trans porters, or the general public. These potential sources of information can be effectively used only if the sources are aware of the general requirements of the regulation and the potential harm that can result from non-compliance. (Note: all third party reports should be converted into permanent evidence via signed statements, or, preferably, affidavits). 9V V AC* CCS 715 -D3- (c) Replacement or resealing of bushings, insulators, or gaskets (the PCB level of the transformer is lowered below the affected part and then refilled to the full-line after repairs have been made); (d) Removal, filtering (clay filter or paper cartridge), and return of PCB liquids into the transformer (filter media and any waste . K B liquids will require special disposal); (e) Removal of PCB liquids into the transformer and refilling with ' another batch of PG3 liquids (unusable PCB liquids will require special disposal) PCB transformer repair and maintenance operations that are performed off site will usually be conducted at a transformer repair facility oper ated by the electric utility or by a separate transformer service com pany under contract. 9 Special Electric Utility Operations Related to PCBs In addition to the above activities related to the actual use of KBs, the PCB marking and disposal regulation will probably require electric utilities to perform several ancillary activities. Most utili ties will establish long term, ($761.42) and temporary PCB storage for disposal sites (S761.42(c)(1). Special markings will be required: for K B transformers and large capacitors in use or in storage, for containers of PCBs in use or in storage sites, and for vehicles used to transport PCB transformers and .containers to storage. Special records will have to be kept by utilities on PCT activities. These records will permit the utility to keep track of PCBs to storage for disposal or final disposal. The records will identify locations of storage areas and disposal sites ar4 will enable PCBs to be traced to determine if final disposal is performed in accordance with the regulation. II. Recanmended Approaches for Conducting Electric Utility Inspections Inspection Priority and Records Review Before initiating an inspection of an electric utility the following factors should be investigated and evaluated:1 (1) The relative size of the utility in terms of the number of kilowatt hours sold annually should be determined along with scope of activities (as descibed in the preceding sections) conducted by the utility. k ACM CC071<f 3u -D2- In soto cases, the utility may own large capacitors or transformers that are located within buildings or other facilities owned or operated by final users. The capacitors will probably be PCB units and the transformers may also be PCB units because of fire codes. It should be noted that fire codes do not require PCBs in transformers, but rather require fire protection in the event of an electrical failure that could ingnite the transformer coolant. A fire proof vault could serve the purpose, but the use of non-flarrmable coolants has.been the simplest solution. Silicon based coolants, other newly developed coolants, or even air cooled transformers (usually much larger than oil cooled rnits) are alternatives that may be used to meet fire code requirsnents. Construction, Maintenance, Repair Construction, maintenance, and repair activities performed by utili ties will be the primary activities involving both direct contact with PCBs and opportunities to comply with the marIcing and disposal require ments for PCBs. Construction operations will probably not involve the Installation of new PCB transformers or capacitors, but the removal or relocation of existing, PCB units may occur. PCB disposal may result from these construction activities. Capacitor Maintenance PCB capacitor-repair and maintenance operations will take place either at the location where the PCB units are used, or at a remote repair faci lity vfcere the PCB units are delivered for repair or maintenance. Main tenance of large capacitors is relatiively straightforward. They either function properly, or they are replaced. When capacitors fail to functionproperly it is usually because of a short circuit within the unit. This condition may cause the capacitor casing to bulge because of internal pressures due to the short circuit and the casing may rupture, in which case some of the PCB liquid may leak cut. Short circuited or damaged ' capacitors re never repaired, just replaced. The old units are usually disposed. Transformer Maintenance Maintenance or repair of PGB transformers is more varied. Cn-site or in-place maintenance can include the following: (a) Removing a sample (one pint to one quart) of PCBs to test dielectric strength (the presence of water, carbon, or other contaminants lowers dielectric strength); (b) Adding a small amount of PCBs to bring the PCB level up to th full-line (topping off); ACM CCS 7 13 -D l- D. . Introduction to Electric Utility Operations Electric utility operations consist of four primary activities: (1) generation of power, (2) distribution of bulk, high voltage power, (3) distribution and sale of electricity to direct users, and (4) con struction, maintenance, and repair acitivities. Power Generation ' Electric power can be generated using a variety of methods, including as hydroelectric units, nuclear reactors, and coal or oil fired generators. Generating methods have little bearing on PCS use except for coal fired generating facilities that use electro static precipitators for air pollution control. Precipitators frequently use PG3 transformers for voltage control because of the location of the transformers on the roofs of buildings, (fire codes may require non-flammable PCB transformers and-large capacitors may be used for other applicat within the generating facilities, but such uses are analogous with those in any other large industrial facility. Bulk Power Distribution Bulk power distribution occurs vhen large electric utilities such as the Tennessee Valley Authority provide power to smaller electric utilities such as Rural electric co-operatives or municipally owned electric utilities. These smaller electric utilities directly dis tribute and sell power to final consumers. Bulk distributors will probably own fewer PCB transformers, and large capacitors, as they are less involved in providing lower voltage or power factor correc tion for final customers. Large high voltage capacitors, however, are frequently used in substations that distribute power to snail utilities. Distribution and Direct Sale to Customers Electric utilities involved in the direct distribution and sale to end users will be the most common type of electric utility. These utilities may generate their owi power, but the most important factor is the design of the distribution system. Substations used for vol tage changes or other distribution corrections will contain racks of large high voltage capacitors (all will be PCB units except for recent replacements). Snail transformers used for will also be found in some substations. Larger PCB. transformers are seldom found at sub stations unless special fire code considerations or unusual space constraints dictate the use of PCB transformer fluids. Powar poles within the distribution system will have both large capacitors and transformers. These should contain mineral oil and not PCBs unless special fire requirements or other factors, such as personal preference, dictated PCBs. i ACt*. CC6712 aa INSPECTION PROCEDURES FOR ELECTRIC UTILITIES V ACM CC6711 S' I <J V ' REGULATORY REQUIREMENTS_____________ (2) Items which must be marked ee of January 1, 1970 (a) All PCB Transformera (b) All PCB large high voltage capactors (c) All PCB equipment con taining email PCB capa citors muet be marked according to (761.20(a) (4 ). (3) As of Oct. 1, 197B all vehicles for transporting PCBs must be marked. (4) Certain non PCB equipment (see (761.20(a)(b)) must be marked "No FCB*s." f5) Improper use of Hark INSPECTION PROCEDURES All PCB Items shall be checked for required label. All vehicles includes fork lifts etc. used at facilities Not expected to arise at pre sently projected inspections. o s> n o o rr o u DOCUMENTATION Photograph unmarked item explain why mark lis required In field notes. Photographs of vehicles used in transport of PC - r >_ J C larking Requirements REGULATORY REQUIREMENTS_______________ INSPECTION PROCEDURES (1) Items to be marked ML as of July 1, 1978 (a) all PCB containers (b) PCB Transformers (a) at the time of manufacture (b) at the .time of distribution in caimerce (c) when removed from service (c) PCB High Voltage Capacitors (a) at the time of manu facture <b) at the tine of distribution in commerce fc) vhen removed fron ser vice. Look for unmarked PCB items. Obtain legal justification for failing bo mark any PCB item Where requirement exists, and item is not marked, document violation. Many PCB items must be marked upon removal fran service but need not be marked thile in service wtil January 1, 1978. Between July 1, 1978. (d) Equipment containing a PCB transformer or large high voltage capacitor (a) at the time of manufacture (b) at the time of distri bution in commerce and (c) when removed from service. (e) PCB large low voltage capacitors when removed from use. (f) PCB motors. (g) PCB Hydraulic systems. (h) PCB Heat Transfer Systens. (1) PCB Article containers containing marked PCB itans. (j) PCB Storage Areas. Cf* CC67C5 J* Uk DOCUMENTATION Photograph, to document lack of label. Sample or otherwise establish that itan is a PCB itemr Note in field book rea sons why items should be marked, and status of item which Imposes marking requirement. 9 MARKING REQUIREMENTS o AL* cce7ct *' V.' * REGULATORS REQUIREMENTS ________ (ii) Date PCBs Jllposed of or trans- ported to another disposal or storage facility, including identification of types of PCBs in containers and those not in containers. (ill) Weicfit of PCB containers, and wight of PCB chemical substance or mixture con tained in transformers received, transported or diposed of. Identify PCB container contents such as liquids, capacitors, etc. .identification of facilities to vhich PCB containers or PCB chemical substances or mixtures in transformers are transported. (iv) Number of PCB articles or equipment not in PCB con tainers received trans ported to other storage or disposal facility, and remaining on facility site at end of calendar year. Identification of specific type PCB article and equipment and identification of facility transferred to shall be included. At* CC67C7 (c) Special Records Retention (i) All docume*nts, correspondence and data provided by facility to State or local government agency pertaining to disposal aie retained at the site for annropriate lornth of time. INSPECTION PROCEDURES DOCUMENTATION Examine Facility records. Document non-compliance. RBOULATORY RBQUIRMEUTS (il) PCBs removed fraa service, loca tion of initial disposal or storage facility and name of owner or operator. (ill) Total quanities of PCBs remaining in service at end of calendar year. o Total weight in kilograms of PCBs in containers including identification of container contents such as liquids or capacitors. * o Total number of transformers and wight in kilograms of PCB contained in the trans former. o Total number of PCB large high, or low voltage capaci tors. (b) Owners or operators document on FOB handling at facility for previous calendar year. Effective date of regulation May 1, 1979. Document must be available July 1 of each year and include:1 (1) Date PCBs received and identification of person and facility from whan PCBs were received. NJ ACK CC67C6 INSPECTION PROCEDURES DOCUMENTATION l Itequest copy of report or inspect report at site. Documents must be retained at site for 5 yearsnafter facility no longer used for storage. Docuoent non-ccmpllance, O *I Chemical Haste Landfills -- Section 761.41 REGULATOR* REQUIREMENTS ________ ________ o Site shall be operated and maintained in a manner to prevent safety problems or hazardous conditions resul ting fron spilled materials or wind blown materials. (3) Particular Record Keeping Requirements for Chemical Haste Landfills (a) Owners or operators maintaiff annual records, effective July 2, 1978. (i) Date when PCBs removed from service and placed into storage. Quantities indicated as follows: o Total weight in kilograns of PCBs in containers including identification of containers contents such as liquids or capa citors. o Total number of transformers and weight in kilograns , .of any PCB mixture con tained in transformers. o Total number of PCB large high, or low voltage capa citors. t * AC* OC67C5 o INSPECTION PROCEDURES Inspect operations for gen eral good housekeeping as specified in the operational plan \ J DOCUMENTATION Observe and photograph violations and make detailed field notes.' < Inspect records and determine canplianoe with Annex VI. Document non-ccmpllance in field book or obtain copy of records. Inspect records and determine canplianoe with Annex VI. Document non-ccmpl iance field book or obtain cop of records. -B7- Chemical Waste Landfills - Section 761.41 nBQUIREMENTS______ ______ . ______________ INSPECTION PROCEDURES_________ (vii) Chemical Haste Landfill Operations Visually observe handling o FCBs shall be placed in the operations. Check for broken landfill in a Banner that will or ruptured containers in prevent damage to containers holding and disposal areas.- and articles. Other wastes, incompatible with FCBs and PCB containers, shall be segregated f r a FCBs through out the waste handling and disposal process.(f761.41 (b)(7)(D). 0*900 MOV vlll) Supporting Facilities ^ o A six-foot woven Be ah fence, tall, or similar device shall be provided around the site.' Inspect the fence or barrier for integrity, o Roads shall be maintained to and on the site adequate Inspect road visually for ruts, to operate and maintain the bumps. Road surface la inadequate Site without causing s o that it is too muddy in raining nuisance, or hazards. weather. It is not properly cleaned ($761.41(b)(0 )). of s n o w , it is properly surfaced CJ C'.) as to minimize dust control. DOCUMENTATION Operations observed that could damage c o n - ` tainers is observed (e. g* dropping than, push ing than, pushing than with bulldozer, inappro priate stacking unless transferring, malfunc tioning handling equip ment), actual damaged containers seen. Pud dies of PCBe seen in areas. Analysis of sur face soil shows exces sive PCB content. Incan patlble wastes identified in PCB areas. Take soil samples in areas or leaks from containers. Identif other wastes in handling and disposal areas. Make detailed notes In field book. Fence or barrier is in disrepair or la damaged. Photographs and detailed field book notes as approp priate. Photograph conditions of roads. Make detailed notes in field book;. -ne- { \ J o. Choolcal Haste Landfills REGULATORY R H Q U I K E H E N T S ______________ INSPECTION PROCEDURES (lv) If landfill Is above the 100year floodweter elevation; the operators shall provide di version structures capable of diverting all surface ester runoff from a 24-hr, 25-yr tor*. (761.41(b)(3)(ill)) Examine permit for 100 year floodwater elev- and diversion require ments. Inspect diversion struc tures if appropriate. (v) Monitoring Systems- Monitor wells shall be cased and the annual or space between 'cone of saturation and sur face shall' be completely backfilled or plugged with cement to prevent intrusion of surface water into well zone- The well shall have removable cap- (|761.41(5) (ii)(5)). Check general Integrity of m i l s . Check for cover. Insure that well is not plugged or filled with soil or debris. Take amaplea from wells (vi) Leachate Collection must be monitored monthly for qual ity of leachate produced. (1761.41(b)(6)). Check permit to determine leachate collection requirements. Check general integrity of leachate collection systoi. 3*009 W3V Id DOCUMENTATION Photographs showing that structure does not meet requirements of permit, maintenance is poor, or structures have been damaged, or erosion has occured. Make detailed notea in field book. Annual space la not completely backfilled or concrete in space ia crack ed or crumbling. Well Is plugged, buried, damaged flooded, or otherwise umiseable. Samples cannot be retrieved from well. Analysis of well indicating excess PCBs content. Obtain photos. Make detailed notes in field book.. Leachate system Is not properly maintained. There Is visible evidence that system ia plugged, or damaged. Samples cannot be retrieved from system Analysis of sytem sample show excess PCBs content Take samples from system Photo as appropriate. Make detailed field note J ' Che*a chi Haste Landfills REGULATORY REQUIREMENTS INSPECTION PROCEDURES (1) For any person who disposes of PCDs under an exemption from chemical taste landfilling, failure to give at least 30 days prior written notice of such disposal to the State and local governments within whooe jurisdiction the dlspoaal is to tala place. ((761.10(g)(2)). Request copies cf notice. Verify receipt if necessary. (2) Sec. 761.41 Operation Requiraents for Chemical Waste Landfills (a)(1) Soils meet certain paraasters (parts i through vi). Liners shall be coapatible with PCBe and liner integrity maintained. Soil underlining shall be provided as well as soil cover. (761.41(b)(1)). Check to see if cover has been put on completed burial areas or does not cover entire area used to bury PCBa to an adequate depth, or if soil cover has been eroded, damaged, or ranoved. Photographs of incom plete cover should be taken. Note in field book. (11) Hydrology. There shall be Inspect site for flowing or no hydraulic connection between standing surface water and site and standing or flowing for existence of useable moni surface water. Site shall toring wells and leachate col?* have monitoring wells and lection systems. leachate collection (761.41 (b)(2 )). 70900 -<m (ill) Flood Protection if .landfill is below 100 year floodwter elevationt opera tor shall provide division dikes around landfill a minim vim height of 2* above (fc9( T H U )ld elev. 761.41 Inspect for 100 year flood*ter elevation and dike require ments. Inspect Integrity of dikes if appropriate, and deter mine height. U CO u DOCUMENTATION Note absence of actual notice in field notea. I Photograph inadequate cover. Note In field book details of cover appear ance. . Photographic -documenta tion that flowing or standing surface water exists. Make detailed notes in field book show that monitoring wells or leachate system la not workable. Photographic documenta tion and field book note stating that dike maint enance ia poor, or that dike has been eroded or damaged by operations1so that, gaps, cracks, or height loss has resulted. ,-D 4-- ' O anical Haste Landfills v/ REGULATORY RBQUIRMENTS___________ _______ INSPECTION PROCEDURES (i) Faillie to store, prior to dis posal, any PGB liquids or nonliquids described above, in a storage facility that complies with Annex III. ($761.10(a)(2), (b)(5),(c)(4)). See storage procedures. (j) Failure to store and dispose of liquid PCBs resulting frcvn spill incidents in accordance with 1-5 above. (S761.10(e)). See storage and disposal pro cedures. (k) For each operator of a chenlcal waste landfill or alternative to incineration approved ixider (6 ) above, failure to give the following written notices to the State and local governments within those jurisdiction the disposal facility is located: Check records of PCS disposal, ask to see copies of written notices. (i) Notice at least 30 days before a facility is first used for disposal of PCBs, and () At the request of any State or local govern ment, annual notice during the time the faci lity is used for dis posal of PCBs of dis posed of during the year, not more than 30 days after the end of the year covered. ($761.10 <g)(l)(i)Ui)). o ACK C C c 7 C i i*j "j \j DOCUMENTATION See storage procedures. See storage and disposal procedures. Obtain copies of records written notices. Note discrepancies in field book. -B3- j- o Chanical Haste landfills REGULATORY REQUIREMENTS________________ (e) Failure to properly dispose of PCB chaalcal substances and PCB Mixtures, Milch are raiioved from transformers* (76110(c)(11)) (f) Unless decont I n a ted In accordance with Annex IV, failure to properly dispose of PCB containers* (|761* 10(d)(1)). (g) Failure to drain the PCB con tainer of liquid and flush it if necessary so that re maining PCB chemical substances and PCB mixtures consi tute no lore than 0*5 per cent of the total volume of the container, prior to dis posal in n chemical waste landfill that complies with Annex XI. (5761.10(d)(1)). (h) For all PCB articles other than transformers, and capac itors i if Incineration Is thnu<it to be technologically infeasible, failure to obtain written permission (and fail ure to comply with any limita tions specified therein) from ,, the R.A. to use a chemical waste landfill tor disposal* (5761.10(c)(3)), INSPECTION PROCEDURES Check on procedures for handling drained mixtures from transformers* Observe transformer, drainage opera tion* See incineration, chemical, and waste landfill procedures* Check landfill site for PCB con tainers that contain noticeable amounts of residual materials* Obtain samples of material* Measure the size of the container and the total volume of residual* Check landfill site for PCB articles other than tranformers or capa&ltors Ask to see R*A.*s written permission to use chemical unite landfills* ACF. CC 7CC cn j DOCUMENTATION Photographic documentation of improper procedures* Record detailed observa tions in field notebook* See incineration and chemical waste land fill' procedures. Calculate volume of residual as percent of volumne of container* Document samples* Determine if residual volume exceeds 0*5 per cent of total container volume* Obtain photographs of PCB articles disposed in land fill* Obtain copies of records* Record observa tions in detail in field book* --B 2-- y Qo B. Cheat cal Stoat Landfill REGULATORY RBQUIHMENTS____________________ INSPECTION PROCEDURES 1. Sec- 761.10 Disposal of PCBa (a) Failure to properly dispose of liquid PCB Chemical Substance and PCB Mixtures In an incin erator that complies with Annex Z. (761.10(a)(b)). Observe for liquid PCB wastes designated for disposal, and for improper disposal of liquid PCB. (b) Failure to properly dispose of non-liquid FCBs in the fore of a) contaminated soil, rags or oher debris (permitted until' July 1, 1980), b) soils and debris contaminated with PCB as a result of a spill or of placement of PCBa in a disposal site prior to February 17, 1970, and c) sew age treatment sludges that are PCB mixtures- (761.10(b) (2)(3)(4)). Determine whether PCB items are placed in areas of the site which are approved for PCB disposal. Look for peculiarly placed items. (c) Failure to properly dispose of PCB articles- ($761.10(c)). (d) Failure to, prior to disposal in a chemical waste landfill, drain each transformer of all free flowing liquid, fill the transformer with solvent, and allow 10 houra before solvent ,, is drained. See ((761.10(c)(ii))- Look for anaaolous discarded and improperly placed items. s Check on procedures for handling transformers at the landfill. Obaerve transformer handling opera tion. Check transformer draining areas, solvent filling areas. Check landfill notes for undrained trans formers o DOCUMENTATION Photograph and sample sus pected areas of illegal disposal. * Note or copy records which indicate items arc improerly place. Photograph items or sample areas suspected of being cont aminated. Photograph improperly placed item. Locate on map Photographic documentation of improper procedures. Record detailed observa tions in field book. -Bl- ACM CCbcS u Ul INSPECTION PPOCEDCJ^ES F CHEMICAL WASTE LANDFILLS ACM CC 6696 Liquid PCBs - Incineration REGULATORY REQUIREMENTS____________ (c) Total weight in kilograms of any solid residues gener ated by the incineration of PCBs during the calendar year, the total weight in kilograms of any solid residues disposed of by such facility in chemical waste landfills, and the- total weight In kilograns of any solid residues remaining on the facility site shall be ,, retained for 5 years. (d) When PCBs are being incin erated, additional periodic data shall be collected and maintained as specified by .the Regional Administrator pursuant to Annex I. ($761. C0(d)(4)). (e) A document shall be pre pared on any suspension of the operation of any inclftr ator by the owner or operator thereof, as required in Annex I - ($761.40(a)(3)). The document shall, at a mini-- o mum, include the date and cr time of the suspension and J an explanation of the cir- -j - cumstances causing the sus- pension- c>f operation. The document shall be sent to ^ the appropriate Regional Administrator. U1 UJ INSPECTION PROCHJURES DOCUMENTATION * n -AIO #-*. i / REGULATORY REQUIREMENTS__________________INSPECTION PROCEDURES (b) In addition to the records and monitoring requirements specified in Annex VI, (See 761.45(b)) failure of each owner of a PCB Incineration facility to collect and maintain the following Infor mation. (i) Wien PCBs are being incinerated, the following contln- ,, uous and short-interval data shall be collected and maintained for a period of 5 years fra the date of collection. Check records, o Rate and quantity of PCBs fed to the combustion system, as provided in Annex 1. (5761.40(a)(3)). o Stack emission products including 02 C02, and CD, as provided in Annex I. (S761.40 (a)(7)). (ii) Wien PCBs are being incin erated, data and records resulting from the monitoring of stack emissions as required in Annex I - ($761.40(d)(8)), shall be collected and main- tained for 5 years. 963500 W3V Ul ro vJ DOCUMENTATION I i Note discrepancies in field book. Obtain copies of any data or records available over the interval in ques tion. -A9- REGULATORY REQUIREMENTS INSPECTION PROCEDURES Hater srtttten eh all neat any performance requirement* specified by the Regional Adminis trator* (|761.40(a)(9)) (1) Combustion efficiency shall be at least 99 per cent cosputed as followst Obtain concentration data from step 1* Calculate the combustlon Cpabustlon eff CcQf- Cco x 100 Ccoj Hhere Cco2* Cone, of carbon dioxide Cco Cone* of carbon Monoxide Section 761.40(a)(2) (j) Additional requlraaent* that the Check the approval document for Regional Administrator finds additional requirements. - necessary must be net. (761.40(d)(4)). > o (5) Particular Record Keeping Requirementa for Incineration Facilities (a) Failure to prepare and maintain all documents required by Annex VI. (4761.45(b)). Request opportunity to inspect PCB records, DOCUMENTATION of the water scrubber, .inspector must obtain copies of records showing non-compliance with scrub ber requirements. If not possible, note the euapected violation in field book. Combustion efficiency less than 99 per cent. Inspec tor must obtain a copy of appropriate records show combustion products concen trations. Show calcu lations in field book. Note failure to produce, or production of Inade quate records In field book o REGULATORT REQUIREMENTS________________ (76i.40U) (exiii)). Failure to maintain at least this dwell time causes auto matic suspension of incinerator operations* (9) The flow of PCBs into the incin erator must stop automatically if the combustion temperature drops below the value In the selected combustion criteria* (h) Water scrubbers shall be used for HCI. control during PCD Incineration. UJ *69003 WOV o INSPECTION PROCEDURES Material in the combustion chamber daring PCB incineration Calculate the naximum flow rate possible that would stay within the liaiti ai the dwell time- HaVd the operator show the tempera ture limit detection mechanism and the linkage to the automatic shut-off valve controlling PCB input. If possible, have tha operator test the unit using off line testing mechanisms Incorporated in the devices. Review records of flow rate and combustion tempera tures and locate any periods in which the temperature fell below the specified limit. Check the approval letter for the performance requirements for the water scrubber, and verify compliance requirements, menta. DOCUMEHTRTION FOR VIOLATION tain copies of the records showing the times when the, flow rates or the chamber velocity exceeded the rates that correspond(to minimum dwell time. The inspector should also show the appro priate dwell time calcula tion#. If not possible note suspected violation field book. No shut-off mechanism . exists or no actuation of the shut-off mechanism occured during a period in which the time fell below the specified limit. In spector must obtain copies of records showing the temp erature drop and no-cor responding cessation of flow. If no mechanism exists the Inspector should taka photographs of the feed mechanism that attests to the absence o f 1such a shut-off mechanism and record na ture of component parts and model numbers. If not pos sible, note the suspected violation in field book. No water srlibber is being used. The Inspector must take photographs of the emission control syatan that attest to the absence -117- OO REGULATORY REQUIREMENTS INSPECTION PROCEDURE (b) PCd feed rate and quantity of pCBs fed into combustion systems must be measured and recorded at least every 15 minutes.($761. 40(a)(3)). Failure to comply re sults In Immediate suspension of inclnator operations. (f761.40(a)(11)) Check the PCB feed rate and quantity records. Look for differences In the recording Intervals of greater than 15 minutes during PCB Incineration* Hold data on rate and quantity for use in dwell time determination. (c) The tooperature of the incinera- Check the PCB incineration and tion process shall be continuously temperature records making sure recorded. (761.40(a)(8)(H))* that the tonperature was continuously monitored throughout the PCB incin eration process. (d) Depending on the selected com-* bustion criteria, the tempera ture must be maintained at 1200s (+ 100*C) or 1600* (+100*C) (7fel.40(a)(lMl)t(iiT). Failure to comply results In immediate suspension of incinr ation operations. Check the temperature records against the selected combustion criteria tem perature. Make sure that the tempera ture is maintained within the 100* range throughout the PCB incineration process. (e) Depending on the selected com Check the combustion products, bustion criteria, the oxygen monitoring results. Make sure concentration must be maintained that oxygen concentration was ** at 2% or 3% excess oxygen* maintained at the appropriate ($761.40(a)(1)) Failure to main level during PCB incineration. tain excess oxygen at the level Verify automatic cut-off. specified cauaesc automatic sus pension of incinerator operations. ($761.40(a)(8)(iil)). (f) Depending on the selected com bustion criteria, the dwell time must be maintained for at least 1- 1/2 or 2 seconds. Obtain feed rate data from step 2. Have the operator provide the calculations he used to determine dwell time of the DOCUMENTATION Monitoring intervals greater than IS minutes dvxlng PCB incineration Inspector must note thii in field book. No tanperature recorded for periods of PCB incin eration. Inspector must note this in his field book. Temperature falls below above the specified limits Inspector must n o t e ,this in.his field book. Oxygen concentration fall below specified excess oxygen level. Inspector must obtain a copy of the monitoring records that show this violaton. If not possible, note the sus pected violation in field book. Dwell time Is less than time specified in the elected combustion cri teri a. Inspector must ob tain record of dwell time. -A 6 - \ REGULATORY HEQUIREMEWTS (c) Unless decontsslnatsd In accordance with Annex XV, failure to dispose of PCB containers In an Incinerator that coaplies with Annex I or In a chemical waste landfill that coaplles with Annex II* ($761.10(d)(1)). (d) Failure to drain the PCB con tainer of liquid and flush i If necessary so that reimlnlng PCB chemical sub stances are raooved. (3) Sec. 761.20 Marking of PCBs (a) Failure to mark as specified with Hark as described In Annex V each of the following items In existence on or after July 1, 1978i (I) PCB Contalnera (II) PCB article contalnera (III) Such storage area used to store PCBs (4) Sec. 761.40 Incineration (a) Continuously monitor and record the combustion products whenever PCBs are being Incinerated. At a minimum 0 2 C02 and CO are mon itored. (761.40(a)(7)). Failure to monitor results In t utornatic suspension of inclneraoc operations. (761.40(a)(9)(D) INSPECTION PROCEDURES Determine procedure for dlapoeltion of of used PCS containers articles* and equipment* Look for containers tAilch have residues. Look for marked and or dated containers rfildi have not been disposed but are contaminated* DOCUMENTATION Note In field book source of statement on Improper procedures. Photograph 1 marked containers Wtlch are Improperly disposed* 8 as above Saie as above* I Check FCB containers* article con tainers and storage araaa for appropriate marking. Photograph itans that are unmarked. Obtain sample from unmarked containers. Note discrepancies In field book* Check the incinerator records and the cembustion products monitoring records. Make sure that O 2* COj, and CO were moni tored at all times during the FCB incineration period. Hold data on C02f CO.for use in can bustlon efficiency determination. No combustion products monitoring records are available for periods'of PCB Incineration. Inspector must note this in field book. -A5- O REGULATORY RBQUIPfmiTS__________________ _____ (c) For anyperson who disposes of PCBs under an exemption fran incineration, failure to give at least 30 days prior written notice of such disposal to the State and local governments, within vhose jurisdiction the dis- posal is to take place. (5761.10(g)(2)). (d) For any person \ho is required to incinerate any PCD and who con tends that there is available a means of destroying PCBs tfiich is as efficient as the inclnera' tion procedure provided in Annex I, failure to obtain written approval of the Regional Adninlstrator. before onploying any method of disposal of any PCB other than incineration with Annex I. (5761.10(f)). (2) Sec. 761,10 Disposal Of Non-liquid PCBs (a) Failure to properly dispose of non-liquid PCBs in the form of contaminated soil, rags, or other debris (761.10(b)(2)), soiled or contaminated with PCBs as a result of a spill or as a result of placement of PCSs in a disposal site prior to February 17, 197B (761.10 (b)(3)). ACM C C 8 t 9 1 (b) -Failure to properly dispose of PCB articles. (761.10(c)). INSPECTION PROCEDURE Determine whether exemption is required, i.e. Aether disposal other than by incineration takes place. Verify notice. DCOJMHiTOTICN Obtain copies of notice letters. Verify by phone or letter that letters were sent or received by agencies. , i Ask to see approval docindentation determine whether disposal methods require approval beyond customary site approval. Inspector should note in field book that PCBs are being handled in a manner such that all PCBs are not incinerated. Verify by examining approval document. In areas tiiere PCB items are used, processed, transported, stored or decontaminated, or otherwise handled, dfteck for likelihood of PCB contamination. Observe for oily residues, discoloration etc. Sample, if necessary. Investigate source of contamination. Note observations in field book. Photograph obvious contamination and sources of contamin ation. Assess Uiether facility procedures Photograph PCB items assure incineration of all PCBs tiiich are not incineror sending them to proper disposal, ated or sent to disposal. -A4- A. Incineration REGULATORY REQUIREMENTS_________________ (1) (761.10 Disposal of Liquid PCBs (a) Failure to comply with any con ditions and/or liaitations stated in the written approval document. (b) For each operation of an incin erator or alternative to incin erator, failure to give the following written notices to the Etate and local governments within whose jurisdiction the disposal facility is located. (i) Notice at least 30 days before facility is first used for in cineration of PCBs. in an approved incinerator. (11) At the request of any State or local government# annual notice during the tine the facility is used for disposal of PCBs or disposed of during the year# not more than 30 days after the end of the year covered. (761-10(g)(!)(!)#(li)) 11 ACM C C 6 6 9 C INSPECTION PROCEDURES Compare operation to conditions and/or liaitations specified in the approval documents. DOCUMENTATION Obtain copies of record and charts that shob that that operation exceeds specific Un i t s Photograph if pos sible. Document in field boolu Check records of PCB disposal operation. Aak to see copies of notices. Obtain copies of records written notices Note discrepancies 'p. ) V.P i r A-2 also provide for sending the PCS iterns to incinerators which are' approved to incinerate them. An assessment of the facilities general* procedures for receiving and disposing of the PCBs received can often provide significant clues as to whether the facility is careful in disposing of items in accordance with its approval document. A portion of the inspection should consider whether the facility is fastidious in disposing of all its PCBs. Many items such as rags old containers and w e n sweepings from floors may be disregarded as insignificant trash or waste. The inspector should' explore the , facilities diligence in PCB housecleaning and assure that such con tamination is not left unaddressed. J A third but not necessarily final area of concern is the information in the facilities PCB records, The list of parties transporting PCBs to the a disposal facility should be copied. This may provide new information concerning PCB users. The inspector should also assess whether the facility is keeping all of th$ data which is required under Annex. VI and their approval or waiver douanents. In addition, the monitoring records for the facility should be reviewed to determine whether the facility is operating within its prescribed limits and whether these limits have been properly monitored. Sane of the monitoring requirements in the regulations require continous monitoring. Some require intermittent monitoring. Ihese monitoring methods should be reflected in the monitoring records whidi have been retained by the facility. The data should conform.to the requiremnts of annexes I or 11 and VI as wrell as any requirements imposed by approval waiver documents. UNAPPRCVED SITES The above discussion conerned only approved PQ3 disposal facilities, Inspections of suspected illegal or unapproved disposal facilities pre sent two problems: First of all the inspector must establish the presence of PCBs at the facility. Second it must be established that the act of disposal occurred after April 18, 1978. Establishing the presence of PCBs may be accomplished by locating PCB labels or PCS* items by sampling or by other methods such as comp aring serial numbers to manufacturers records. Determining that disposal occured after April 18, 1978 presents a more difficult problem. This may require direct observation of acts of disposal; unless other approaches are available. In the instance of PCBs which have at one tine been in a proper storage facility, the itans should be dated. Many other PCB items may be dated for one purpose or another. Where the operation of an unapproved site is suspected the inspector should make every effort to gather all relevant evidence to ensure comp lete enforcement against the facility. \, t ' ACM CG 6fc6S s. Introduction to Disposal Site Inspections A-l When inspecting PCB disposal facilities there are at least three investigations vhich should be pursued. l)'are the PCB disposal processess functioning properly. ' 2) are all of the PCBs sent to an approved disposal process, and 3).are the PCB records properly kept. Hie first concern in inspecting a disposal facility, is whether the facility effectively disposes of PCBs in a manner which is per mitted in the site's approval document. For incinerators and chemical waste landfill facilities there are specific minimal performance criteria thich are--incorporated as part of their facility approval documents (see requirements detailed below). Additionally the site approval document may apply further restrictions, require ments or waivers to the operation of the facility. Vhenever an alternative method of disposal is. authorized under the regulations the authorization will usually also specify performance standards for the alternative method to meet. The inspector should collect the performance standards fran the various approval and authorization documents and use them for comparison with the facility's operating data. Many of the performance requiranents in the regulation are , supported by requirements for related monitoring equipment. A neces sary first part of the inspection process is to determine vhether all of the required monitoring equipment for the facility is in .place and is operating properly. In addition to determining whether all of the equipment is measuring their required parameters properly, earns equipment, measuring vital criteria, may be required to incorporate automatic shut off mechanisns, The inspector should establish that these mechanisns work as required. Another priority during an inspection is to determine if the facility properly receives and sends all of the PG3s that it receives to an approved disposal process; The basic issues are vhether the facility is diligent in identifying the types of PCBs being received, and whether the facility is sending these PCBs to a disposal process thich is in accordance with its approval document. A simple example of this would occur when liquid PCBs are received at a chemical waste landfill transformers or cont ainers and the landfill fails to remove the liquid PCBs front the items before disposal. The liquids would then have to be either properly stored or directed to an approved incinerator. This situation will occur there transformers, containers, or equips ment are sent to landfills by users who have failed to drain the PCBs. Another example would occur there incinerators receive PCB equipment or articles for disposal and their approval document does not permit them to dispose of those particular items. Landfills receiving liquid PCTs should have observable procedures for recog nizing liquid PCBs then they are received and for sending them * on to an appropriate disposal facility. Incinerators should have * similar procedures* for identifying PCB items thich may not be disposed of under their approval document. The procedures must ACP `CCtccc INSPECTION PROCEDURES FOR INCINERATION FACILITIES 9 \ ACH 0 0 6 6 6 7 Appendix VI Environmental Protection Agency Toadc Substances Control Act PCS Harking and Disposal Regulation CHAIN OF CUSTODY RECORD Name of Person Talcing Sample: Inspector's Numberi Siglature: Type of Sample Date Taken Time Taken 9 Place Taken Required Analysis. Relinquished by: Received by: Date: Time: Relinquished by: Received by: Date: Time: Relinquished by: Received by: Date: Time: Dispatched byi Date: Time: Received for Laboratory by: Datei Time: Method of Shipmenti Distribution: Original to Accompany Shipment (Inside locked shipment con tainer)* One copy iron laboratory to Regional FCB Violation Coordinator upon completion of analysis* A CM CG&bOfc A ppendix V U,S. Environmental Protection Agency Receipt for Samples Regional Address; Sample Numbers: Name of Plant Manager or Similar Officiali Firm Name; Firm Address; p Samples Collected: (Describe fully the time, place, date and type of sanple, number of containers for each type of sanple) Acknowledgement of Plant Manager or Similar Official The undersigned acknowledges that the samples described above have been collected: Signature: Title: Duplicate Samples for each Type of Sample Taken: Sample Requested and provided Not requested Name of person who collected samples: Title of Collector: Signature of Collector: Distribution: one copy toVFacility Plant Manager original to PCB Violation Coordinator one copy for Inspector's Records ACM CC665  .) Appendix IV SRHPEE TAG USEPAt TSCA PCB Marking end Disposai Regulation field Sample Inspector1 Naas Type of Sample Date Taken O Time Taken Place Taken Q Kane of Person Taking Sample (written fi signed) Analysis Required*. (Determination of PCS Content) Sample Number: O \ a c k CCfcfco'. Acpendix III TSCA INSPECTION OQNFICSNTIALIIY NOTICE United State? Environmental Protection Agency Regional Address: Facility Inspected: Cate Inspected: tdress of Facility; Name of person at the facility to whan this -notice given; TITLE Name of chief officer of business: Cate mailed to chief officer": Name of EPA Inspector: Address: * It Is possible that EPA will receive public requests for release of the information obtained by inspectors during inspection of the facility indicated above. Such requests will be handled by EPA in accordance with provisions of the Freedaa of Information Act (FOIA), 5 U.S.C. 552, EPA regulations issued thereunder, 40 CFR Part 2, and the Toxic Substances Control Act Section 14. EPA is required to make inspection data available in response bo FOIA requests unless the Administrator of the agency deter mines that the data contains information entitled to -confidential treatment. In order to facilitate the Agency's timely response to any public inquiries, while giving due consideration to your canpany's right to request confidentiality, please provide us with a statement specifying any informa tion which our inspection of the above indicated facility may reveal which you believe should be entitled to confidential treatment. Your statement should be addressed to _________ (RESPONSIBLE EPA OFFICIAL) and should reach this address no later than 30 days after your receipt of this notice. Failure by your firm to sufcnit, within the 30 day time period, a written request that information be . characterized as confidential or privileged will be treated by EPk as a waiver by your company of any claims for confidentiality regarding the inspection data and the data will be made available to the public without , further notice to you.V* date received by owr.er/operator signature o"pTant Manager Distribution: one copy Plant Manager one copy Chief Officer of Business one copy PCS Violation Coordinator one copy Inspector's Files V ACM CCSfc3 .j L/ Reverse Side- Notice of Inspection TSCA Notice of Inspection Authority to Conduct Inspections By authority of Section 11 of the Toxic Substances Control Act (15 DSC 2601) an authorized representative of the Mministrator of the United States Environmental Protection Agency may enter and in spect, at reasonable times, any establishment facility, or other premises in vhich chemical substances or mixtures are manufactured, `processed, stored, or held before or after their distribution in commerce and any conveyance used to transport chemical substances, mixtures, or sudi articles in connection with distribution in commerce. Scope of Inspections 9 Inspections conducted under Section 11 of the Toxic Substances Control Act (15 USC 2601) extend to all things within the premises or conveyance inspected (including records, files, papers, processes, controls, and facilities) bearing upon whether the requirements of the Toxic Substances Control Act applicable to the chemical substances or mixtures within the premises or conveyance have been complied with. However,-inspections shall not extend to the following types of data unless the nature and extent of sudi data are described with reasonable specificity in the written notice presented to the owner, operator, or agent in charge of the pranises or conveyance: 1 . financial data 2 . sales data (other than shipment data) 3. pricing data 4. research data (other than research data required by the provisions of the Tbxic Substances Gontrol Act or under a rule promulgated thereunder) 5. personnel data. Penalties for Failure to Allow Inspection Section 15 of the Toxic Substances Control Act makes it unlawful for any person to fail or refuse to permit entry or ^inspection as required by Section 11 or to fail or refuse to permit access to or copying of records. Section 16 provides for both civil and criminal penalties for violations cr Sectier. 15. Section 17 authorizes specif; enforcement, including the obtaining of an injunction to restrain tv/ violations of Section 15. \ ACP CC8662 __ Name of Firm: Firm Address: Appendix II U.S. Environmental Protection Agency NOTICE OF INSPECTION UNDER THE TOXIC SUBSTANCES CONTROL ACT Date Inspection Commenced: Hour: EPA Itegional Office Address: (type) Reason for Inspection: For the purpose of inspecting (including taking samples, photographs and other inspection activities) an establishment, facility, or other premises in which chemical substances or mixtures or articles containing same are manufactured, processed or stored, or held before or after their distribution in commerce (including recordsc files, papers, processes, controls, and facilities) bearing on whether the requirements of the Act applicable to the chemical substances, mixtures or articles within or associated with such premises h a w been ccn^lied with. For the purpose of inspecting (including taking samples, photographs and other inspection activities) a conveyance being used to transport chemical substances, mixtures, or articles containing same in connec tion with their distribution in commerce (including records, files, papers, processes, controls and facilities) bearing on whether the requirements of the Act applicable to the chemical substances, mixtures or articles within or associated with the conveyance have been complied with. CJ In addition, this inspection extends to (circle appropriate letters): A) Financial data 'B) Sales data C) Pricing data D) Personnel data E) Research data The nature and extent of inspection of such data specified in A through E above is as follows: Name of Person to ttiom Notice of Inspection Was Given: Signature of EPA Employee: DATE TITLE TITLE Distribution: one copy Plant Manager one copy PCB violation Coordinator one copy Inspector's Files ACM C C 8 6 1 *_ Appendix I TSCA Inspection Credentials UNITED STATES Ct AMERICA ENVIRONMENTAL PROTECTION AGENCY This is to certify that whose signature'and photo appear below is an authorized representative of the Administrator of the U.S. Environmental Protection Agency. . Cate issued: Expiration Date: Name: ? Title: Inspector (Photo) This Inspector is authorized under the Tbxic Substances Control Act to conduct inspections (including taking samples, photographs and other inspection activi ties) of establishments, facilities, or other pranises in thidi chemical substances or mixtures or any articles containing saine are manufactured, processed, stored or held before or after their distribution in cannerce, and any con veyance being used to transport chemical substances, mixtures or such arti cles in connection with distribution in cannerce. Signature of inspector Signature of the fimmistrator No. AD* CCfcttC 11 Couriers picking up samples at the airport* post office* etc. shall sign jointly with the laboratory custodian. If samples are cfelivered to the laboratory then appropriate personnel arc not there to receive them, the saftples must be locked, in- a designated area within the laboratory in a manner so that no one can tamper with them. The same person must then return to the laboratory and unlock the sanples and deliver custody to the appropriate custodian. d. Immediately upon receipt* the custodian will place the sample in the sample roan* 'which will be locked at all times except Wien samples are roaoved or replaced by the custodian. To the maximum extent possible* only the custodian should be permitted in the sample roan. e. The custodian shall ensure that heat-sensitive or lightsensitive samples, or other sample materials having unusual physical characteristics* or requiring special handling* are properly stored and maintained. f. Only the custodian will distribute samples 4n personnel who are to perform tests. g. The sssple analyst will record* in his laboratory notebook or analytical worksheet* Identifying information describing the sample* the procedures performed and the results of the testing. The notes shall be dated and indicate who performed the tests and they should note any abnormalities which occured during the testing procedure. In the c e n t that the person who performed the tests is not available as a witness at time of trial* the government may be able to intro duce the notes in evidence under the Federal Business Records Act. h. Standard methods of laboratory analyses shall be used as described in the "Guidelines Establishing Test Procedures for Analysis of Pollutants"* 38 F.R. 287SB, October 16* 1973. If laboratory per sonnel deviate from standard procedures* they should prepare the justification for the deviation in the laboratory notebook. i. Once the sample testing is completed* the unused portion of the sample* together with all identifying tags and laboratory records* should be returned to the custodian. The returned tagged sample will be retained in the sample roan until it is required for trial. Strip charts and other documentation of work will also be turned over to the custodian. j* Upon completion of laboratory PCB sample analysis* the cus todian shall send a copy of sll laboratory records and a copy cf the appropriate chain cf custody record to the Regional PCB Violation Coordinator. The laboratoxy should retain the originals as permanent records. k. Alterations in or^deviation from this chain of custody procedure must be approved* by the Regional Office of General Counsel and/or the Headquarters Enforconent Office* prior to implementation. t ACh- C C 8 t 7 5 10- * "in yoiff physical possession or b* In your view after being in your physical possession or e. After being in your physical possession was locked by you in .manner, so that no one could tamper with it The following procedures should be followed: (1) Samples will be accompanied by a Chain of Custody Record (Appendix VI) %*iich includes the name of person taking the sample: inspector's number; type of sample taken; analysis required If the person who takes the sample is required to transfer possession of the sample prior to dispatching it to the appropriate laboratory for analysis# the transferor and transferee will sign date and tirs the sheet (2) The inspector taking the sample or the person who right fully receives possession of the sample directly or through a dialn originating with the inspector who took the sample has the respon sibility of properly packaging and dispatching samples to the proper laboratory for analysis As a matter of policy the inspector taking the sample should not relinquish possession of the sample prior to dispatch to the appropriate laboratory except in circum stances there to do so would be highly impractical In any event the person who dispatches the ssaple to the appropriate laboratory for analysis should fill in the "Dispatch" portion of th Chain of Custody Record (3) Samples vd.ll be properly packed in shipment containers such as ice chests to avoid breakage The shipping containers will be padlocked for transfer to the receiving laboratory (41 All packages will be accompanied by the Chain of Custody Record showing identification of the contents The original will accompany the shipment (inside the locked s h l p m n t container) and will remain on record in the laboratory performing the analysis (5) If sent by mail the person who dispatches the sample to the Laboratory must send the package certified mail with return receipt requested If sent by common carrier a government bill of lading should be obtained Receipts from post offices and bills of lading will be retained as part of the permanent Chain of Custody documentation 2 Laboratory Custody Procedures a The laboratory shall designate a "Sample Custodian" An alternate will be designated in his absence. In addition, the labora tory shall set aside a "sample storage security area" This should be a clean, dry, isolated roan which can be securely locked fraa the outside. b All samples should be handled by the minimum possible number of persons. c. All incaning samples shall be received only by the custodian who will indicate receipt by' signing the Chain of Custody Record Sheet accanpanying the samples and retaining the ahect as permanent records* AC* CC076 -9 is a "Duplicate Sample" Of course# the fact of having prepared a duplicate sample should be reflected in the Inspector's Field Notes, If you provide`"a duplicate sample, .mate the appropriate notation on the diain of custody record, described below. C. Special Category of Samples - Photographs During an inspection, you may went to photograph various parts of the facility, certain'operations in the facility or locations where a aample was taken. In all cases where you take a photograph during an inspection, write the following in your Field Notes for eech photograph taken,. 1. Nature of object or process photographed 2. The sequential number of that photograph for the inspection. 3. Inspector's Number 4. Inspector's Name p 5. Time, date end place of taking photograph. When the photographs are developed, transpose the inforrotion recorded in your fields notes onto the hack of the photograph . at your first opportunity. 4. Post-- Sampling Procedure A. Identification of Samples Each unit of the sample is to be tagged in the Inspector's hand* writing in ballpoint (waterproof) ink. The teg (See Attachment IV) shall contain, at a minimum, the following information: Inspector's Name# type of sample# sample number# name of person taking sample# and the type of analysis required* This tag should be canpletely filled out by the Inspector end attached to the sample container* B* Receipt of Samples After taking a sample prepare a Receipt for Samples Form in triplicate (See Appendix V)* Give one copy to the Plant Manager or similar official at the facility# include one copy in your Inspec tion Report and retain one copy for your own records* You may record all the samples taken during the inspection of a facility on one Receipt for Samples Form* Chain of Custody Procedures 1, Inspector to Laboratory The inspector who collects samples is responsible for the care > and custody of tha couples until properly dispatched to the receiving' laboratory or turned over to an assigned custodian. You must assure that each container ia: * k A O CC b 6 7 7 ^ Vv ,-** V.' -8- unless the situation ic such that it is impossible for ycu to do B or to force the issue, would provoke a scene creating en barrassment to or bring discredit on the government. B. Hake no private prcoises of any kind which may be construed as binding upon the Agency since a Government employee by his private word cannot bind the Government. C* N e w ; use any information, coming to you confidentially in the performance of governmental duties as a means for making private profit* 0* During an inspection do not speak of any product, process, facility or person in a derogatory nanner. Taking Samples 1* Responaibi11ty " Samples should be collected and prepared in accordance with procedures outlined in this Manual. Keep in mind that you may have to testify in court regarding a sample you have taken* You may be required to identify the sample collected and to explain that you followed the sampling proce dures provided in this Manual* Mistakes or deficiencies in procedures may damage the Government's case in this regard. However, if you mate a mistake in sampling, do not, under any circumstances, attempt to cover up the mistake. Record the mistake in your Field Motes and re-tate the sample as appropriate* 2* When to Sample Take a sample only wider the circumstances indicated in this Manual and only during the course of an inspection of a facility covered by this Manual* 3* How to Sample A* Taking Samples then taking a sample during an inspection of aiy facility covered by this Inspector's Manual you should follow the specific sampling techniques appropriate for each type of facility ycu inspect. Deviation from the Standard Methods and procedures for a sample might cause problems in introducing your sample into evidence during an enforcement proceeding. If there is any deviation from established procedures, explain the deviation in your Field Notes* B. Duplicate Samples Iff a responsible agent of .the facility being inspected requests a duplicate sample, it should be collected and marked in the same manner the official samples, with an indication on the extreme left hand corner of the Sample Tag to be attached thereto that the sample ACM C C t f c 7 c -7 the allowable scope cf your inspection, remind the person that such prohibition is vmlawful but do not argue with the person who prohibits yoix inspection. Simply ask the person * why' you are not being allowed to inspect the particular thing or process and note all the particulars in your Inspection Diary, along with the name of the person who refused to let you inspect- Then, continue the remainder of you: inspection of the facility. Following the inspection, contact the desig nated TSCA Enforcement Attorney for the regions for instruc tions concerning the area where you were not allowed to inspect* D. If an authorized representative of the facility being inspected wishes to accompany you during the inspection allow him to do so. E. Be alert for any statements made by employees of the facility being inspected which may be construed to be admissions of sets of violation of the regulation* Prohibited Activities The following activities may not be engaged in by sn ITA inspector before, during or after an inspection cf a facility under the FCB Harking and Disposal Regulation These prohibitions are based upon and derived from material in the EFA Pesticides Inspections Manual* A* Never discriminate by the dispensing of special favors or privileges to anyone, A e t h e r for reaineration or not; and never accept, for yourself or anyone else, favors or benefits under circumstances which might be construed by reasonable persons as influencing the performance of your goverment. duties* The EPA handbook entitled "Responsibilities and Conduct for EFA QnployeeaM specifies that an snployee shall not accept anything of value from the trade, public or consumers for or because of any official act he has perfoxmed or will perform* Each inspector should refer to the above referenced handbook for amplification of this policy* In this regard one area of concern to inspection personnel which generates more questions than any other is the matter of handling a situation here, during a facility inspection, you have lynch with plant officials and/or personnel and find your lunch paid for by them, or there is no way you can pay for your portion of the luncheon* EPA regulations cover this by providing an exemption whereby you can accept food and refresh ments of naninal value on infrequent occasions in the ordinary course of an luncheon or dinner meeting or other meeting or on sn inspection tour where you may be properly in attendance, v Under n circumstances shall you interpret this to allow acceptance of meals or refreshments when It is proper and fea sible for you to pay for your own. You must avoid such situa tions when possible and must make every effort to pay your part, ACK CCtit7 5 -6 reportsi they must contain only facts and observations. Language should be objective factual.and free from personal feelings or terminology which might p r o w inappropriate. The Field Notes are part of CPA's files and should not be considered the inspector's personal property. The goverrment's case in a formal hearing or criminal'prosecu tion hinges on the evidence gathered by the inspector. It is likely that inspectors will be called to testify in enforesnent hearings. Tharefore# it is imperatiw that each inspector keep detailed records of inspections in his Field Notes. This data will serve ss an aid in giving testimony# in determining the conduct of the prosecution cf the alleged violator# and in helping the inspector prepare his Inspection Report. Personal Demeanor During Inspection An inspector must conduct an inspection with the highest degree of honesty and is eepected to perform his duties in a^prof essional and responsible manner. At the very least# the inspector must conduct himBeIf at all times in accordance with the regulations prescribing Environmental Protection Agency Employee Responsibilities and conduct which were published in the Federal Register (Vol. 38# No. 73) on April 17# 1973# codified at 40 CFR Part 3, and reissued in the EPA handbook "Responsibilities and Conduct for EPA Bnployees". In addi tion, the.inspector must: A. Develop and report facts of inspections completely, accurately and objectively. B. Inspectors should at all times wear such safety equipment as is customary in the facility being inspected. Inspectors should wear a hard hat# safety glasses or gloves if the owner or his agent so advises. C. Know the limits of your inspection authority. If you have presented the appropriate credentials and written notice of inspection, your inspection of the facility may extend to all things within the premises being inspected (including records# files# papers, processes# controls and facilities) bearing on A e t h e r the requirements of the PCS Narking and Disposal Regulation have been conplied with. Although you may not on your own authority take anything belonging to the facility other than a sample out of the facility# you may copy any relevant records and tate the copies with you as part of your inspection report. You should remember that if you want to inspect financial data# sales data (other than shipment data), or most research data you need to describe the nature and extent of such data you wish to inspect in the written notice of inspection* If at^ any time during the inspection you are prohibited from inspecting particular things or processes which you believe are within ACN CC6o7<* 9 5- for such conclusions* Also note such observations bout the appearance of the facility as are possible, if there is a belief that an immediate inspection of the facility is imperative, call the Head quarters Regional Coordination Unit at 202-755-1212, Where inurediate Inspection is desired, a search warrant may be required by lav. The Regional "Coordination Unit will-aid the Inspector in obtaining a errant there appropriate, D, Inspection Procedures 1 Conduct During Inspection Inspector's Instructions, Violation Worksheet and Maintenance of Diaries and Field Notes The Inspection Manual for the PCB Marking and Disposal Regulation Is divided into a e w r a l sections. In addition to the sections dealing With Legal Requirements for Inspections and the Enforcement Proceedings Manual, the Inspection Manual contains instructions on how to conduct inspections at the variois categories of facilities subject to the regu lations, For each category of facilities, there are separate instructions. Thus, for example, if you are inspecting an electric utility company facility, turn to the Electric Utility Company portion of the Inspector's Manual and follow the instructions provided there. While conducting an inspection, of a particular facility, the inspector should closely follow the instructions in the Inspection Manual for Inspecting facilities of that type to the extent that they apply to the circumstances of the particular facility. Each inspector must maintain legible and detailed Field Notes providing an accurate and inclusive documentation of inspection activity. Entries in an Inspector's Field Notes should should include, but not be limited to, the following: (1) (ii) (ill) (iv). Name and location of facility inspected Explanation of what parts of the facility were inspected Summary of inspection related conversations with facility employees, along with names of employees with whom the conversations occured Place in the facility here samples were taken, along with explanation of the sampling tech nique employed, Including, but not limited toi (1) Number of samples collected (2} Description of origin of sample (transformer, PCB container, etc*) (3) Detailed analysis of method of obtaining the samples. Including description of sample container, (v) Nature of suspected violation, including place and tire of discovery, and including explanation of why you think your discovery is a violation. ACM CC6673 4- Ir.spection Confidentiality Notice, shown in Appendix III. You will have four copies of the T5CA Inspection Confidentiality Notice. At the tine you present a copy of this Notice to the facility official,* place a copy in an envelope addressed to the Chief Officer of the business whose facility you are inspecting. Yen should determine the name of such Chief Officer before your arrival at the inspection site. Mail the envelope at yo\s: earliest opportunity via certified mail. The envelope should be mailed no later than two days after your inspection cf the facility. As.indicated in the Enforcment Proceedings Manual, trfien you submit your Inspection Report to the person indicated in the Enforce ment Proceedings Manual, also submit one copy of the TSCA Inspection Confidentiality Notice* Retain one copy for your oui records. 6 . Opportunity to Accompany Inspector During Inspection At the time you present the appropriate facility official with the Notice of Inspection, tell him that company representatives may accompany the inspector during the inspection for th^purpose of: (a) indicating to the inspector which processes, facilities, operations, records, etc. of the facility should be treated as confidential, and (b) any other reasonable purpose* 7. Opportunity to Obtain Duplicate Samples At the time you present the appropriate facility official with the Notice of Inspection tell him that you may be taking samples during your inspection and inform the official that he has the right to request and receive duplicate samples. C. What To Do If You Are Denied Entry 1. If you are denied entry, first make sure that you have provided the appropriate facility official with all ctf the material which must be presented prior to inspection. If you have not pre sented this official tdth such material, do so. 2. If you have followed all the appropriate procedural steps prescribed a b o w and you are still denied entry, ask the person who denied you entry his or her reason for denying you entry into the facility. If the response indicates that you Called to adequately show your credentials show the person your credentials again. 3. If the person adamantly refuses to admit an inspector, mate no further attempt to enter. Upon leaving the premises make appropriate notes concerning any relevant observations wh^ichc may h a w been noted concerning the refusal. If there are any reasonable bases for suspecting that refusal was based upon a desire to cover up regulatory violations note the bases ADK CC fcc7 ~\ , t, . ' " '' 3. Written Notice of Inspection -3- You must present the appropriate' person at the facility to be inspected (preferably the Plant Manager or other similar official) with written notice of your intent to inspect the facility. Present th written notice at the time ycu appear at the facility to conduct the inspection. As a general rule advance notice of an inspection should not be given. However# a general notice to a company or an industry that it may be subject to inspection in the next several nonths is permissible. There may euan be instances where specific advance notice of inspection would be warranted. The giving of any such specific advance should first be cleared through the haedquarters Regional Coordination Unit. Presentation of this notice will allow you to inspect meat things in operation in the facilities. However, if you wish to inspect any of the following: (1) Financial datai (2) Sales data (other than shipment data); (3) Pricing data; (4) Personnel data# or (5) Koet research data ? The written notice of inspection which you present to the appropriate official at the facility to be inspected nust also contain a description of the nature and extent of the data in the above categories which is to be inspected. As a general rule# you will taiow in advance if you are going to inspect such data at the facility, in which case you should ensure that the notice of Inspection describes the nature and extent of that data. An example of a written notice of inspection is shown in Appendix IX. 4. Credentials You must bring with you and present to the appropriate person at the inspection site (Plant Manager or similar official having responsibility for operations at plant) credentials which indicate that you aro a lawful representative of the Administrator of the Environmental Protection Agency and that you are authorized to perform the inspection which you ere to undertake. Sample creden tials for making inspections of facilities under TSCA are shown in Appendix I. t 5. Confidentiality During the inspection of a facility# you may come across infor mation which should be treated as confidential by the Environmental Protection Agency. To help protect bona fide business trade secrets from public disclosure# you must adiero to the following jrocedure at the time you present yaus. credentials and notice of inspection to the approdiate official at the facility ycu are about to inspect. At the time you present the facility official with the Notice of Inspection# also present such official with one copy of the TSCA^ ADM C C 6 t 7 i . -2- B Fre Inspection Considerations 1. General Preparation for Inspections Certain Do currents and data should be obtained and reviewed prior to performing on site inspections Whenever practicable the inspectors should obtain relevant Federal State and Local permits and author izations which have been obtained by the facility for the purpose of operating the facility* These permits should be reviewed to determine whether FCBs hove been at issue with other regulatory programs* In addition vhere possible the record for compliance with other relevant regulatory programs should)be investigated by obtaining pertinent data* The Inspector should at all times obtain all PCB related approval documents authorizations, exemption documents prior to arriving at an inspection site Where these documents contain operating conditions and requirenents these conditions and requireants should be noted and serve as the basis for specific inquiries during the inspection The inspector should then verify that the facility is complying with these conditions and requiranents. After review of the above documents and any available FCB records the inspector should prepare the Notice of Inspection The scope of the Notice vhould, at a minimum, cover the specific areas that the office review indicated may be potential problems 2 Records Review Prior to conducting a physical inspection the FCB records for the subject facility should be examined In i o n instances the records inspection may be conducted prior to the physical Inspection by requesting the facility to send the r e c o r d to the Regional Office Conducting the records inspsctions early might make the conduct of the physical inspection less difficult The arithmetic related to records inspections is fairly simple: FCBs removed from service should equal the FCBs stored plus the FCBs disposed* In addition to striking an appropriate balance, the records should adequately describe the disposition of all of the PCB items connected with the particular facility* The inspector should be able co determine the nans and location of all storage and disposal facilities used, including the final disposal sits* The value off the r e c o r d inspection lies in forcing the PCb faci lity to account for their PCB i t m a in a fairly accurate manner. An inspector, by using the recorded information, should be better able to conduct physical inspections. Where reccrdc are kept properly, the inspector's observations of\facility processes cnouid serve co \r.covar sources of imbalance in the PCS equation* In addition to forming tne basis of a violation in itself, inadequate or inaccurate record keep ing serves as a flag to areas of concern in inspecting facilities ACP CC8t>7C A. INTRODUCTION 1 GENERAL AUTHORITY TO CONDUCT INSPECTIONS Section 11 ctf the Toxic Substancea Control Act (15 U.S.C. 2601) provides the basic authority for inspection of establishments and con veyances It authorises an inspector to enter , at reasonable tines any establishment, facility, or other premises in which chemical substances or mixtures are manufactured, processed, stored, or held before or after their'distribution in canmerce end ary conveyance used to transport chemical substances, mixtures, or such articles in connection with distribution in commerce* Inspections may be made only upon the presentation of appropriate credentials and written notice to the owner, operator, or agent in charge cf the premises or conveyance to be inspected* Section 11 provides that a separate notice shall be given for each such inspection, but a notice shall not be required for each entry made during tha period covered by the inspection* 9 2* SCOPE OF TSCA SECTION 11 INSPECTIONS Inspections conducted under Section 11 extend to all things within the premises or conveyance inspected (including records, files, papers, processes, controls, and facilities) bearing upon whether the require ments of TSCA applicable to the chemical substances or mixtures within the premises or conveyance have been complied with However, inspections shall not extend to the following types of data unless the nature and extent of such data are described with reasonable specificity in the written notice presented to the ovner, operator, or agent in charge of the premises or conveyance: a financial data b* sales data (other than shipment date) c* pricing data d research data (other than research data required by the provisions of TSCA or under a rule promulgated thereunder) e." personnel data 3* PENALTIES FOR FAILURE TO ALLOW INSPECTION Section 15 of TSCA makes it unlawful for ary person to fail or refuse to permit entry or inspection as required by Section 11 or to fail or refuse to permit access to or copying of records Section 16 provides for both civil and criminal penalties for violations of Section 15 Section 17 authorizes specific enforcenent, Including the obtaining of an injunction to restrain any violations of Section 15, or to compel taking of any action required under TSCA CCfct 1. LEGAL REQUIREMENTS OF INSPECTOR'S PROCEDURES Ah CCfcttb I . Legal A uthority to Conduct a n s s e c t i o n s A, Introductory Materials................................. General Autnority to Conduct TSC-. Inspections, cote of cli Inspections, Penalties for Failure to Allow inspection 5. Pre-Inspection Considerations.......................... General Precar ition for Inspections record Inspections, Written Notices of Inspection, Credentials, Confidentiality, Opportunity to Accompany Inspector, Ccccrfj.ity to Obtain Dedicate Sardes C. What to do if Denied O t r y .......... ................... D. Inspection Procedures......................................... -...,5 Conduct, Personal Demeanor, Pronicitsc Activities, Taxing-Sarcles E, Chain of Custody Procedures...................................... II F. Sarple TSCA Fonts TSCA Credentials........................................ Appendix : TSCA Notice of Inspection............................... Appendix II Notice of Inspection (Reverse Side) TSCA Inspection Confidentiality Notice.................. .Accencix I" .Sample Tag.................. .*.......................... Append ix I*. Faceipt ror Sarcles.......... ............................ cpend :x Chain of Custody Feccrd.................................. Appendix 73 II. Inspection Procedures A . I n c i n e r a t i o n ............... ..................................................... A1.-A 3 . C h e m ic a l W aste L a n d f i l l ............................................. C . h a r k in g Recu i r e t e n t s ................... ...... ............... .. D. E l e c t r i c U t i l i t i e s ..................................................... " i _r S. T ra n sfo rm e r M ain tenan ce and F e p a ir F a c i l i t i e s P a i l S y s te m s .................................................................... F. ?C3 T r a n s fe r r e r and C a p a c ito r M a n u fa c tu re rs .. G. S to r a g e R e q u ir e m e n t s ................................................. . H. D e c o n t a m in a t io n ................... .......................................... I . P e c o r i s and - i o n it e r in g ............................................... III. E n fo rc e m e n t P r o c e e d in g s M a n u a l..................................... Exam ples o f G r a v it v L e v e ls Sample P le a d in g s Aonen. X ccenoix . ACh C 0 tt7 V V TOXIC SUBSTANCES CONTROL ACT PCB MARKING AND DISPOSAL REGULATION * INTERIM INSPECTION GUIDANCE P ACM C C 6 b 6 b ! ri * -\ -J6 - a waterway could very well make the violation attain a higher level- of gravity. Upon making the level of gravity determination, the indicated penalty should be used as a base from which adjustments should be made according to the following additional statutory criteria: 1. Violator's ability to pay. This factor may b e 'difficult to consider at the time of penalty assessment, since the inspector ordinarily will not examine violators1 financial records (See Section 11(b)(2)(A)). Thus, the inability of a violator to pay probably would not be fully considered vmtil raised by the violator after issuance of the complaint. However, several factors can be evaluated at the initial stages of penalty ' determination. The inspector should inquire of the person-in-charge the size of the business being inspected. Gross annual revenue is probably the best indication. In addition, the inspector or violation coordinator can consult Dun Bradstreat, even prior to the inspection, to detenaine gross annual revenue. In determining a violator's ability to pay, the fact that a caitpany is a subsidiary of a parent corporation should be considered, i.e., it is'appropriate to look at the Resources of the parent. A reduction of penalty amount of up to 20% may be allowed where gross annual revenues are below $250,000 and up to 10% teiere gross annual revenues are between $250,000 and $1,000,000. No reduction will be allowed for larger companies* 2. Inability of a violator to continue in business* This cate gory is intertwined with "ability to pay". A substantiated claim of inability to continue in business if a large penalty is sustained may require ;negotiation of the penalty to an amount lower than would other wise be assessed under these guidelines. Since such a claim will not normally be raised until after the Initial penalty essessitunt, it is discussed below* 3* History of prior such violations. Where a violator has no prior history of violation of EFA regulations or statutes, penalties may be reduced up to 20%. A violator with a prior history of EPA viola tions, but with no prior violations of T5CA receives no penalty adjustment* If a violator has any previous TSCA violations his penalty should be in creased 10%, for each prior TSCA violation. If a violator has violated the same standard previously, the repeated nature of this violation requires that the penalty be raised 25% for Levels I and II: and 50% for Levels. Ill and IV (up to $25,000 total) - these figures should be doubled in cases *4iere the same standard is violated for the third time. For the purpose of this "repeat" policy, a company with more than one facility can be assessed for a repeat violation if the second violation takes place at a different facility than did the initial violation. 4 * Degree of culpability. The degree of culpability of a vio- res & & :ontributed to by personsvoutsidc the violator' canpany, or he violator has made a good faith effort to comply with the regulation, ACM CCb7ct -J7- Conversely# a person who negligently and/or willfully violates the Act suffers an upward penalty adjusenent. Thus,- a negligent violator can be assessed up to an additional* 20% penalty, depending on his degree of negligence. A willful violator.should be assessed an additional 25% penalty. The maximum adjustments for culpability are down 20% or up 25% - i.e., if a violator is willful and negligent the willful 25% upward adjustment only is assessed. Of course, such a violator may be the subject of criminal proceedings. Computation of' Penalties - In calculating the adjusted initial penalty, the adjustments should be added together prior to being applied to the ini tial level of gravity figure. For example, with a level II violation the penalty based on that level alone is $5000 if the violation was for one day. If the company's revenues are between $250,000 and $1,000,000 it is entitled a 10% reduction; if the company has a previous TSCA violation 10% is added on and if the violation occurred in spite of some good faith efforts by the company it may be entitled to a reduction of, say, 10%. The adjustment factors are, -10, +10, and -10, for a net reduction of 10%, which when applied to the $5000 initial penalty, results in a $4500 proposed penalty assessment sent to the violator. Do not compute the penalty piecemeal, i.e., do not deduct 10% of $5000 Cor size, then add 10% of the remainder for history, and than subtract 10% of the remainder for culpability. In computing duration of a violation generally only coint the days on which the violation was actually observed. Thus if a violation is observed during an inspection, and the complaint is not served for a month, compute the penalty as if the violation lasted one day, not a full month. However, if reliable evidence exists that the violation was pre sent before the inspection, an assessment for multiple days of violation may be appropriate. D. Disclosure of Information - Confidentiality TSCA Section 14 addresses the protection of trade secrets and confi dential information. Section 14 provides that any information reported to or otherwise obtained by EPA under this Act, which is exempt fran disclosure pursuant to subsection (a) of Section 552 of Title'5, United States Code, by reason of subsection (b)(4) shall not be disclosed by the Administrator or by any officer or employee of the United States. Exceptions from this prohibition are also provided. Disclosure of information described in Section 552(b)(4) of Title 5 may be made in the following situations; 1. to officers or employees of the United States in connection with their official duties to protect health or the environment, and for specific law enforcement purposes. 2. to contractors with the United States when the Administrator determines it'to be necessary for the satisfactory per formance of their dut.es in connection with this Act and under such conditions as may be necessary to preserve confiden tiality as the Administrator may specify. t ccei*9 Aiil* J9- 3* if the Administrator determines it necessary to protect health or the environment against !an unreasonable risk of injury to health or the environment. 4. $hen relevant under a proceeding under TSCA, except that disclosure under such proceeding under this Act shall be made in such a manner as to preserve confidentiality to the extent practicable without impairing the proceeding. Disclosure of any health or safety study, or- any information obtained from such study, o'h any substance or mixture which is already being distri buted, or for which testing is required under Section 4, or for which noti fication is required under Section 5, is not prohibited. Data in such a study, however, which discloses manufacturing processes or the propor tions of a mixture may not be disclosed if such processes or proportions would otherwise be entitled to protection from disclosure. Section 14(c) of TSCA provides that a manufacturer, processor or distributor in caimerce of a toxic substance may: A. designate the data which such person believes is entitled to confidential treatment under subsection (a) of the same section, and B. submit such designated data separately from other & t a submitted undar this Act. Designation by a manufacturer, processor, or distributor that certain information is entitled to confidential treatment must be made in writing. Section 14(c)(2)(A) states that where the Administrator proposes to release for Inspection data tfoich has been designated by the manufacturer, processor, or distributor as being entitled to confidential treatment, the Administrator shall notify in writing and by certified mail, the manufacturer, processor, or distributor who submitted such data, of the intent to release such data and that if release of such data is to be made pursuant to a request made under the Freedom of Informa tion Act, such notice shall be given immediately upon approval of such request by the Administrator. The Administrator may not release the data before the expiration of 30 days after the manufacturer, processor, or distributor submitting such data has received the notice of the Adminis trator's intent to release such data. Section 14(c)(2)(B) states an additional requirement that where disclosure of data is warranted by a determination by the Administrator that such disclosure is necessary to protect the health or the environment against an mreasonable risk of injury to health, or the environment, the Administrator must notify each manufacturer, processor, and distributor who submitted such data of such release. Such notice shall be made in writing by certified mail at least 15 days before the release of ouch data, except that if the Administrator determines t v i tha release of(such data is necessary to protect .gainsi an imminent, u-.r-aicr.ibie risk o: injury to health or the environment, such notice may be meda by such -re as the Administrator determines will provide notice at least 24 hours before such release is mads.i i AC* CC677C 1 -J9 - EPA regulations dealing with confidentiality of business informa tion appear in 40 CFR Part 2, Subpart a. Handling Inspection Data For the purposes ofj (1) assuring Agency compliance with Section 14 of the Toxic Substances Control Act,* (2) limiting the likelihood of inadvertent disclosure of confidential business information/ (3 affording businesses a fair opportunity both to assert a confiden tiality claim and to substantiate the claim prior to an E?A ruling on the claim; (4 protecting the interests of members of the public . who request disclosure of business information under the Freedom of Information Act 5 U.S.C. 552; and (5) furnishing assistance to those ZPA officers and employees who must deal with confidentiality claims requests for information obtained by the Agency p u r s m n t to its inspection authority, the following procedures will be employed in handling inspection data; A. At the time an inspector presents the TSCA Notice of Inspec tion (see Appendix II) to the appropriate official at a facility which is about to be inspected, he shall also present one copy of the TSCA Inspection Confidentiality Notice (See Appendix III). At the time the inspector presents a copy of said TSCA Inspec tion Confidentiality Notice to the facility official, he shall place a second copy in an envelope addressed to the chief officer of the business whose facility he is inspecting. The inspector, should determine the name and address of such chief officer before his arrival at the inspection site. The inspector shall mail the envelope at his earliest opportunity, via certified mail return receipt requested. In any event, the envelope should be mailed no later than 2 days after canpletion of the inspection of the facility. B. When an inspector submits his Inspection Report, via Regional procedures, to the PCB Violation Coordinator, the inspector shall include a third copy of the TSCA Inspection Confidential ity Notice along with his Inspection Report and shall keep a ' fourth copy for his own records. C. The business concern which receives the TSCA Inspection Confi dentiality Notice must make its confidentiality claim within )Q days after the chief officer receives the Notice. When a business concern asserts a timely claim of confidential ity for inspection data, the inspection data for which confi dentiality was claimed shall be removed, in accordance w^th Regional procedures, from the main file of the Inspection Report. Such data shall be placed in a locked file cabinet and shall be . , f p a emoloyees and contractors m the excr- ciseS o?t1iei.r1fficial duties anct responsibilities. If such a . claim is received before the PCB Violation Coordinator receives the Inspection Rcpqrt on the facility for whic.n the claim is made, the appropriate Inspector shall remove ouch dita and keep it in a ioexta file. u. ----1 turn t'-rn '-tea (/.airi.ua as "Claimed TSCA Inspection Confidential rftau) to the PC3 Viola tion Coordinator with his Inspection Report. If the confidential- P ACH. C C 6 7 7 1 137 \J " ^, Jto- E. 7. ity claim is received after t h e -PCB Violation Coordinator has possession of the Inspection Report he shall be responsible for separating such data, for maintaining it in a locked file, and for marking it "Claimed TSCA Inspection Confidential Data"* If a formal or informal request for data claimed as confiden tial is made by any person other than an EPA employee or contractor the person in possssion of the data claimed as confidential shall forward such data, in accordance with Regional procedures, to the person designated in the Region to handle such requests. Such person shall follow established procedures for granting or denying the request for informa tion. If a person other than an EPA employee or contractor requests data obtained during an inspection and no claim of confiden tiality has been asserted with respect to ouch data, the following procedures shall be followed: .4 1. If the request for information is received by EPA before the expiration of 30 days from the date when the chief officer of the business concern whose facility was inspected received the TSCA Inspection Confidentiality Notice, it shall be presumed that a claim of confiden tiality will be made within the thirty day period. The informtipn request shall be initially denied and the chief officer of the business whose data m s requested shall `be notified and required to substantiate any claims of confidentiality which he may make, in accor(fence with procedures stated in 40 CFR Section 2.204 2. If the request for information is received by EPA after expiration of such 30 day period, the requested data shall be treated, in accordance with procedures stated in 40 CPR Part II, Subpart B, like any data for which no claim of business confidentiality has been made* AC* CC677c t 109 SAMPLE PLEADINGS 1 Sample letter for Civil Penalty Action 2 Complaint for Civil Penalty Action 3* Default Order for failure to request hearing Consent Agreement-Final Order 5* Condemnation and seizure pleading 6 . Complaint for Injunction 7. Motion for Temporary Restraining Order 8 . Preliminary Injunction Order * 7 " ACM C C S 7 7 3 109 } 1 Complaints# Pleadings and Related Documents This section gives examples of the complaints, affidavits, verifi cations, pleadings and other documents that may be used to initiate actions under TSCA Sections 16 and 17 for violations of the PCB Marking and Dis posal Regulation* 1. Section 16 provides for the assessment cf civil penalties for TSCA violations# As indicated in Section III of this Enforcement Proceedings Manual* It is anticipated that most TSCA enforcement actions will be prosecuted under Section 16 and that an administrative civil penalty will be assessed. Such an action is initiated under Section 16(a)(2) by the issuance of a Complaint and Notice of Opportunity for Hearing* The following is a sample cf such a document, with cover letter* Please note that the question of who issues Default Judgements has not been finally determined pending development off the Consolidated Rules of Practice* ^ 'i \ f' l ACM CC677<* CERTIFIED MAIL R ETO K P g t n T T REQUESTED Mr. X . Chief Corporate O ffic e r twnen not lf T R e g io r T - Registered Agent) 25 R iv e r D rive A lto n , Michigan R E : TSCA Com plaint and N o tic e o f Opportunity for Hearing Docket No. B .G . Power"lnaustnes, Inc. A lto n , Michigan Dear Mr. X: ^ En c lo s e d p le a s e f i n d a C om p la in t and N o tic e o f O p p o r t u n i ty f o r Hearing concerning vio la tio n s of the Toxic Substances Control A c t , 15 U .S .C . 2601, discovered by EPA in spectors at the above-captioned f a c i l i t y . *i I t is recommended t h a t th e enclosed Compliant and Rules o f P r a c t i c e , AO C . F . R . , be c a r e f u l l y read and a n a lyze d t o determ ine th e a l t e r natives a va ila b le in responding to the alleged v io la tio n s , proposed penal t i e s , and o p p o r tu n ity f o r a h e a rin g . Please note t h a t each day the v i o l a t i o n s c i t e d h e r e in c o n tin u e c o n s t i t u t e s a new v i o l a t i o n f o r which a d d itio n a l p e n a lt ie s may be imposed. R eg ard less of vrtieth'er you choose to request a hearing w it h in th e pre scribed time lim it of f i ft e e n (15 ) days follow ing service of th is Complaint, you are extended an o p p o r t u n it y t o request an in form al s e ttle m e n t conference To request a conference, please w rite to Mr. A tto rn e y , Enforcement D ivisio n U n ited S ta te s Environm ental P r o te c tio n Agency, e t c .., o r telephone him at F a i l u r e t o respond t o t h i s Com plaint and N o tic e of O p p o r tu n ity to Hearing by s p e c ific answer w ith in 15 days of your re c e ip t of t h i s Complaint c o n s t i t u t e s y o u r adm ission of th e a l le g a t i o n s made in th e C o m p la in t. Such f a ilu r e shall re s u lt In the issuance of a D efau lt Order imposing the penal tie s proposed herein without fu rth e r proceedings. Very Truly Yours, Enforcement D ivision Director \ \ ACM CC6775 'A )t UNITED STATES ENVIRONMENTAL- PROTECTION AGENCY IN RE ) ) ) TSCA - V - 001 B / G '/D lO T S EftS /Ih C ., J C O M PLAH u AND > OF OPPORTUNITY FOR Respondent HEARING ) ) 1. COMPLAINT This 1s a c iv il adm inistrative action in stitu te d pursuant to Section 16(a) f *N o f th e T o x ic Substances C o n tro l A c t ( T S C A ) , 15 U . S . C . 2 6 1 5 ( a j . The com ,w plainant is the D ire c to r, Enforcement D iv is io n , Region United States Environmental Protection Agency (U .S . EP A ). The Respondent is B .G . Disposers, I n c . , vrfiich i s and a t a l l tim es h e r e i n a f t e r r e f e r r e d t o was a c o r p o r a tio n in c o r porated under the laws of the S ta te o f M ichigan , and has a place o f business ' at 100 North Nowhere, A lto n , Michigan, T h is Complaint serves as n otice of the D ir e c to r 's prelim inary determina t io n t h a t Respondent has v io la te d Se ctio n 6 and Section 15 o f TSCA, 15 U .S .C . 2605 and 2 6 1 4 , as f o llo w s : Count 1 1 . The a b o v e -r e fe r r e d f a c i l i t y o f B . G . D is p o s e r s , I n c . , operates an in c in e ra to r (as defined at 40 C .F .R 7 6 1 ,2 { j ) ) intended to des t r o y and dispose o f l i q u i d PCB. 2 . 40 C .F .R . 76 1.4 0 ( a ) (1) o f Annex I , in c in e ra tio n , ream'res th at l i q u i d PCB in tr o d u c e d i n t o an i n c i n e r a t o r f o r a 2 - second dwell time a t th re e percent excess oxygen in the stack gas be main tained at 1200 degree C (+ 100 degrees C) f o r d e s tru c tio n . 3 . On March 3 1 , 1 9 8 1 , a tem p erature o f 950 degrees C was being main tained in the incinerator at 8 . G. Disposers, In c ., during the attempted disposal of Liquid PCB, in violation o f Section 6 of TSCA and re g u la tio n s promulgated th ereu n aer. 15 U .S .C . 2605; 40 C .F .R . 761.4 0 ( a ) ( 1 ) ( i ) . CCfc77t Count 2 1 . 40 C .F .R . 7 6 1 .4 0 (a )(5) o f Annex I , In c in e ra tio n , requires t h a t th e i n t r o d u c t i o n of PCB i n t o an i n c i n e r a t o r must stop autom aticall'y whenever combustion temperatures fa ll-b e lo w 1200 degrees C ( + 1 0 0 degree C) when a two-second dwell tim e is employed. 2 . On March 3 1 , . 1 9 8 1 , th i n c i n e r a t o r a t the a b o v e -c ite d f a c i l i t y f a i l e d t o shut o f f a u t o m a t i c a l ly when th e combustion temperature c o n siste n tly f e l l below 1200 degrees C , in v io la t i o n o f S e c tio n 6 o f TSCA and re g u la tio n s promulgated th e re under. 15 U .S .C . 2605, 40 C .F .R . 7 6 1 .4 0 ( a ) ( 5 ) . Count 3 1 . 40 C .F .R . 76 1.4 0 (a )(3 ) o f Annex I , In c in e ra tio n , requires t h a t , fo r every in c in e ra to r used to dispose o f^ liq u id PCB, th e r a te and q u a n t it y o f PCB fed t o 1 the combustion system must be measured, and recorded r e g u la r ly a t i n t e r v a l s o f no more than 15 m inutes. 2 . 40 C . F . R . 7 6 1 .4 5 ( c ) ( 1 ) (A) also requires th a t the owner o r o p e ra to r o f PCB in c in e r a t o r s compile records on th e r a t e and q u a n t i t y o f PCB s u p p lie d t o th e combustion system, under the terms sp e clfie o at 40 C .F .R . 7 6 1 .4 0 ( a )( 3 ) . 3 . On March 3 1 , 1 9 8 1 , records m aintained at th e above-captioned f a c i l i t y n o tin g the ra te s and q u a n t it ie s o f PCB Introduced In to the combustion system re fle c te d a re co rdin g .a t ir r e g u la r in te r v a ls (va ry in g in length from ten t o 28 m in u te s ) o f th e ra te s and q u a n t i t i e s o f PCB in tro d u c e d i n t o th e combustion system , in v io la t io n o f Se ctio n 6 o f TSCA and reg ulatio ns promulgated thereunder. 15 U .S .C . 2605; 40 C .F .R . 7 6 1.4 0 (a )( 3 ) , 7 6 1 .4 5 ( c ) ( 1 ) ( A ) . u II PROPOSED C IV IL.PEN A LTY S e c tio n 16 o f TSCA, 15 U . S . C . 2615 and the re g u la tio ns promulgated thereunder, 40 C .F .R . [ f o r th e Section 16 c i v i l p e n a lty reg ula t io n s when pro m ulgated] a u t h o r iz e a c i v i l p e n a lty o f up to $25,000 per dqy f o r each v i o l a t i o n o f th e A c t . Based on th e f a c t s given in I above, and on th e n a tu r e , circu m stance s, e x te n t and g r a v i t y o f the above -cited v i o l a t i o n s , as well as th e Respondent's a b i l i t y to p a y , e f f e c t on a b i l i t y t o c o n tin u e t o do b u s in e s s , h i s t o r y o f p r i o r v i o l a t i o n s and degree o f c u l p a b il i t y , the follow in g proposed penalties are hereby proposed fo r the subject vio la tio n s: ACH CC617T I Count 1 1*5 U . S . C . 2 6 1 4 ( 1 ) 40 C .F .R . 76 1.4 0 (a )(1 ) Failu re to maintain proper incineration temperature $15,000 Count 2 15 U .S .C . 2614(1) 40 C . F . R . 76 1*4 5 ( a ) (5 ). Failure to automatically cease operation $15,000 Count 3 15 U .S .C . 2 6 1 4 (1 ),(3 ) 40 C .F .R . Failu re to record regularly r a te and q u a n tity o f PCB $15,000 S FO C IO TOTAL Payment o f t h i s p e n a lty may be made by c e r t i f i e d or c a s h i e r 's ch eck, payable to the United S ta te s o f Am erica, and rem itted t o : Regional Hearing Clerk R egion e t c . Il Ill OPPORTUNITY TO REQUEST A HEARING As p ro vid e d a t TSCA S e c tio n 1 6 ( a ) , and in accordance w it h S e c tio n 554 o f T i t l e 5 , United S ta te s Code, you have the rig h t to request a hearing regarding th e proposed Order to contest any m aterial fa c t contained in th is C o m p la in ti o r t o c o n te s t th e a p p ro p ria te n e ss o f th e amount of th e proposed p e n a lty. I f you wish to avoid being found in d e fa u lt, you must request a hearing of the Region Hearing C le rk , EPA Region e tc ., within fifte e n (15 ) days o f t h i s Com pTaint. A r e c e ip t o f w r i t t e n answer must be made, irtilch answer s h a ll c l e a r l y and d i r e c t l y a d m it, deny or e xp la in each o f the factual allegations contained in the Comolaint w ith respect to which Respondent has aqy knew!edge; o r which s r .jll c l e a r l y s ta ts tn a t respondent has no knowledge as to p a r t i c u l a r fa c tu a l a lle g a t io n s in th e C o m p la in t. The answer shall also s ta te : * ACM CC6776 114 1 , The circumstances or arguments which are alleged to c o n s titu te the grounds o f defense; 2 . The facts which Respondent intends to place at issue, The den ial o f any m a te ria l f a c t o r the r a i s i n g o f any a f f i r m a t i v e de fense sh a ll be construed as a request f o r a h ea rin g . F a i l u r e to deny any of the factual allegations in th is Complaint c o n s titu te s ' admission o f the undenied allegations* Any hearing th a t you request w i l l be held in the c o u n ty , p a r is h , o r incorporated c i t y of your residence. Hearings held in the assessment of these c i v i l p e n a ltie s w i l l bo conducted in accordance w ith th e p ro visio n s o f th e A d m i n i s t r a t i v e Procedure A c t (5 U . S . C . 552 ec s e q .) and th e "Consolidated Rules of Pra ctice Governing A dm in istrative Assessment of C iv il Penalties or the Revocation or Suspension of Permits" (40 C .F .R . ) , a copy o f which accompanies th is complaint. I f you f a i l to f i l e a w ritte n answer and request f o r a hearing w ith in f i f t e e n (15 ) days o f service of th is Com plaint, such f a i l u r e c o n stitu te s a b in d in g admission o f a l l a l l e g a t i o n s made in th e C om plaint and a w a ive r o f y o u r r i g h t to a h ea rin g under TSCA. A D e f a u l t O r d e r may t h e r e a f t e r be issued by the Regional A d m in is tra to r [A d m i n i s t r a t o r ] , and the c i v i l penalty proposed h e r e in s h a ll become due and p ayable w ith o u t f u r t h e r pro ceeding s. Such D e fa u lt Order is not subject to review in any c o u rt. V SETTLEMENT CONFERENCE W hether o r not you requ est a h e a r i n g , an in form a l conference may be requested in o rder to discuss the fa c ts o f th is case and to a r r iv e at settlem ent. To request a settlement conference, please w rite to Mr. A tto rn e y , Region , e t c ., or telephone him at Please note th a t a request f o r an informal settlem ent conference does not extend the f i f t e e n (15 ) day period during which a w ritte n answer and request f o r a hearing must be su bm itte d. The inform al conference procedure may be pursued as an a l t e r n a t i v e to and s im u lta n e o u s ly w ith th e adjudicatory hearing procedure. U . S . EP A encourages a l l p a r t i e s a g a in s t whem a c i v i l p e n a l ty is proposed t o pursue th e p o s s i b i l i t i e s o f s e ttle m e n t as a r e s u l t o f informal c o n fe re n c e . How ever, no p e n a lty re d u c tio n w i l l be made sim ply because such a con fere nce is h e l d . Any s e ttle m e n t which may be reached as a r e s u l t of such conference s h a ll be embodied in a w r i t t e n Consent Agree ment and F i n a l O rd e r by th e R egional A d m in i s t r a t o r [ A d m i n i s t r a t o r ] , U . S . EPA Region . The issuance of such Consent Agreement shall c o n s titu te a w aiver of~your r ig h t to request a hearing on any m atter s tip u la te d to therein. ACM GG677S 115 I f you have neither effected a settlement by informal conference nor requested a hearing w ith in the 15-day tim e-period allowed by th is N o tic e , th e above pen alties w ill be assessed w ithout fu r th e r proceedings, and you w i l l be n o t i f i e d t h a t th e p e n a ltie s have become due and p a y a b le . To explore the p o s s ib ility o f settlement in th is m atter by in fo r mal c o n f e r e n c e , c o n ta c t M r. , at telephone Sincerely yours, Enforcement D ivision Director 9 \ ACM CC7eC r 116 2 . Fa ilu re to request a hearing shall result in issuance of a d e fa u lt ord er by th e Regional A d m in is tra to r (depending on the f in a l form of the Consolidated Rules of Procedure). A sample D efau lt Order follow s. \ ACH OC0761 117 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY REGION IN THE MATTER OF B . G . POWER I N D U S T R I E S , I N C . , Respondent. ) ) ) j TSCA-V-OOl DEFAULT ORDER PRELIMINARY STATEMENT 1 . T h is c i v i l proceeding f o r th e assessment o f a p e n a lty was I n i tia te d pursusant to Section 16(a) o f the Toxic Substances Control Act ( T S C A ) , 15 U . S . C * 2601 e t s e q . The a c t io n was i n s t i t u t e d by th e issuance o f a Com plaint and N o tic e of O p p o r tu n ity f o r Hearing t o th e Respondent, charging v i o l a t i o n s o f 15 U . S . C . 2605 and 26 14 . I t is hereby determined t h a t an a p p ro p ria te D e f a u lt O rder s h a ll be issued based on th e F in d in g o f F a c t and Con clu sion s o f Law as se t out below . FINDINGS OF FACT 1 . B . G . Power In d u s tr ie s , I n c . , is a corporation organized pur suant to the laws Of the S ta te o f Michigan, 2 . Respondent operates a f a c i l i t y at A lt o n , M ichigan, which houses 86 la rg e h ig h -v o lta g e c a p a c ito r s , each c o n tain in g PCB d i e l e c t r i c f l u i d . 3 . On o r about March 3 1 , 1 9 8 1 , Respondent was unable t o produce the records of m onitoring data required under Section 6 of TSCA, 15 U .S .C . 2605, and 40 CFR 7 6 1 .4 5 , o r produce the id e n t i t y o f the central records location. 4 . On o r about March 3 1 , 1 9 8 1 , th e re were stored 1n Respondent's above c ite d f a c i l i t y PCB's th a t were c le a r ly marked fo r d is p o s a l. 5 . On o r about March 3 1 , 1 9 8 1 , Respondent f a i l e d t o p ro vid e th e f lo o r in g requ ire d by TSCA and re g u la tio n s promulgated thereunder in th a t no curbing has been i n s ta lle d in th e area of the above-referenced f a c i l i t y wherein PCB's marked fo r disposal were sto re d . 6 . On o r about March 3 1 , 1 9 8 1 , Respondent f a i l e d t o p ro vid e the f l o o r in g re qu ire d by TSCA and re g u la tio n s promulgated thereunder in th a t the flo o r in s ta lle d in the above-referenced f a c i l i t y wherein PCB's marked fo r disposal were stored consisted o f linoleum t i l e s . 7 . On Ju ne 1 , 1 9 8 1 , th e Enforcement D i v i s i o n , E P A , Region _ ( " th e C om plainant") issued a Complaint and N o tic e o f O p p o rtu n ity to Respondent p ursuant t o 15 U . S . C . 2 6 15 (a ) and th e then a p p lic a b le v ACM C06762 118 R u le s o f P r a c t i c e , a l l e g i n g t h a t Respondent has' v i o l a t e d TSCA by f a i l i n g to m ain tain records on th d is p o s it io n o f PCB's and by f a i l i n g to ccmply w ith *c e rta in construction sp e cifica tio n s fo r a f a c i l i t y that stores PC8s designated fo r disposal by not in s t a l l i n g a curb o f a minimum h e ig h t o f s ix inches and by not i n s t a l l i n g a f l o o r composed o f smooth and impervious m a te r ia ls . 8 . In th e i n s t a n t C o m p la in t, a c i v i l p e n a l t y o f $ 2 4 ,5 0 0 .0 0 was proposed a g a in s t th e R e sp on dent. S a id p e n a lty was proposed based on th e n a tu r e , circu m stances, e x te n t and g r a v i t y o f the v i o l a t i o n s , and, w ith respect to th e Respondent, a b i l i t y t o p a y , e f f e c t on Respondent' s a b i l i t y to continue to do business. Respondent's h is to ry o f p rio r such v i o l a t i o n s , and th e Respondent's degree o f c u l p a b i l i t y . F o r purposes o f assessing th e said p e n a lty , Respondent's gross annual revenues were determined to be 1n excess o f $5,0 00,000.00 during the previous y e a r . Based on a comparison of Respondent's gross annual revenues w ith th e amount o f th e proposed p e n a l t y , i t was determined t h a t said p e n a lty would have no s u b s ta n tia l e f f e c t on Respondent's a b i l i t y to continue in business. - 9 . The Complaint in the in s ta n t case set fo r th Respondent's rig h t to request a hearing w ithin f i f t e e n (15) days of receipt o f the Com plaint, the requirement of a w ritte n Answer to the Complaint w ith in f i f t e e n (15 ) days of receipt of the Complaint i f said hearing was d e s i r e d , and th e consequences o f f a i l u r e t o do e i t h e r . F u r th e rm o re , a copy o f th e I n t e r i m R ules o f P r a c t i c e was en closed w ith th e C o m p la in t. 1 0 . Said Complaint was m ailed t o Respondent on June 1 , 1 9 8 1 , by c e r t i f i e d m a i l . R e c e ip t N o . 202684 was re tu rn e d t o Complainant stamped June 5 , 19 8 1, and bearing the signature "B e tty Wilson" as signor fo r the addressee. (A copy of c e r tifie d mail receipt No. 202684 i s a tta c h e d t o and made a p a r t o f t h i s O r d e r .) 1 1 . * As of t h i s date Respondent has fa ile d to e ith e r request a formal h e a r in g , o r f i l e an Answer to the Complaint pursuant to the Rules of Practice. CONCLUSIONS OF LAW 1 . By reason of th e fa c ts as set out in th e Fin d in g s o f F a c t , Respondent has v i o l a t e d TSCA by f a i l i n g t o develop and m aintain records on the d is p o s itio n o f PCB's in v io la tio n o f 15 U .S .C . 2614(3) and 40 CFR 7 6 1 ,4 5 and by f a i l i n g t o comply w ith c e r ta in c o n s tru c tio n s p e c ific a tio n s in v i o l a t i o n o f 15 U . S . C . 2614(1.) (c) and 40 CFR 7 6 1 .4 2 ( b ) . 2 . By f a i l i n g t o f i l e a tim e ly Answer to the Complaint and/or to request a formal h e a rin g . Respondent has admitted the fa c ts alleged in the Com plaint and has waived i t s r ig h t to a h e a rin g . A c c o rd in g ly , Respondent is in d e fa u lt and the proposed c i v i l penalty is th e re fo re due end p a y a b le . 3 . I t is fu rth e r concluded th at by reason of the fa cts set out in ( F i n d i n g 8) tn e F i r c i . * ; : : c f F a c t cr.a of t/.a penalty is appropriate pursuant to i5 U .S .C . 5 ( c ) ( i) ^ J ;, * A CP. CC 87 63 119 ORDER Respondents shall immediately upon-receipt of th is Order pay by c a s h ie r 's o r c e r t i f i e d check a c i v i l p e n a lty in *th e amount o f TwentyFour Thousand F iv e Hundred D ollars ($24,500.00} payable to the T r e a s u r e r o f the U n ite d S ta te s o f A m e ric a . Such rem itta n c e s h a ll be delivered to the Regional Hearing C le rk , United States Environmental P r o t e c t i o n A ge ncy, Region V , 230 South Dearborn S t r e e t , C h ica g o, 1 1 1 . S0604. In th e event o f * f a i l u r e o f Respondent t o make such payment th e m a tte r s h a ll be r e fe rr e d t o th e A t to r n e y General pursuant t o 15 U . S . C . 2 6 1 5 ( a ) ( 4 ) f o r c o l l e c t i o n o f s a id amount by an a p p r o p r ia te action in United States D is tric t Court. AND NOW, TH IS DAY OF J u l y 1 0 , 1 9 8 1 , the fo re g o in g Order i s hereby issued under the authority o f the Toxic Substances Control Act and-the Rules o f P ra c tic e adopted pursuant t h e r e t o , 15 U .S .C . 2601 et seq. Regional Adm inistrator United States Environmental Protection Agency, Region V 230 South Dearborn S tre e t C h ic a g o , I l l i n o i s 60604 Date: ) \ ACH CCfc7e* 120 3 . Se ttle m e n t w i l l o fte n be reached p r i o r t o hearing on a c i v i l p e n a lty assessment. A sample Consent Agreement and Final Order follows ( i t is not necessary fo r the D ire c to r of the Enforcement D iv is io n to sign the agreement, as long as one of his attorneys s ig n s ). 121 UNITED STATES ENVIRONMENTAL. PROTECTION AGENCY REGION V IN THE MATTER OF B . G. DISPOSERS, IN C ., Respondent. - ) TSCA-V-002 CONSENT AGREEMENT AND FINAL ORDER PRELIMINARY STATEMENT 1 . This d v 1 1 proceeding fo r the assessment of a c i v i l penalty was I n i t i a t e d pu rsu an t t o S e c tio n 1 6 ( a ) o f th e T o x i c Substances C o n tr o l A c t ( T S C A ) , 15 U . S . C . 2 6 1 5 . The a c t i o n was I n s t i t u t e d by th e Issuance o f a Com plaint and N o tic e of O p p o r tu n ity f o r Hearing served upon the Respondent, charging v io la t io n s o f IS U . S . C . 2605 and 2 6 f t . 2 . Respondent admits the factual a lle ga tion s contained 1n the Complaint. 3 . Respondent has agreed to cooperate f u l l y v r fti the Environmen ta l Protection Agency to co n cilia te th is matter without the necessity of a formal hearing and, th e re fo re , consents to the Issuance of the Order h e r e in a fte r r e c ite d with th e Findings o f Fact and Conclusions o f Law . Respondent consents to the payment o f th e p e n a lty In th e amount h e r e in a fte r s tip u la te d as f u l l settlem e nt of any and a ll c i v i l p e n altie s o r l i a b i l i t i e s which m gith have a ttach e d as a r e s u l t o f t h i s p ro ceeding. 4 . Respondent waives I t s r ig h t to request a hearing on any issue consented to herein. STIPULATIONS OF FACTS 1 . B . G . Disposers, In c . 1s a corporation organized pursuant to th e laws of the S ta te o f Michigan. 2 . Respondent operates an I n c in e r a to r f o r the purposes o f des t r o y i n g and. d is p o s in g o f l i q u i d PCB m ix tu re s at I t s f a c i l i t y lo c a te d in A lto n , Michigan. 3 . On o r about March 3 1 , 1 9 8 1 , Respondent In c in e ra te d l i q u i d PC8 m ix tu re s a t i t s a b o ve -re fe re n c e d f a c i l i t y w ith an I n c in e r a t o r tem p e ratu re o f 950 degrees C . 4 . On or about March 3 1 , 1 9 8 1 , the above referenced In c in e ra t o r f a i l e d t o sh u t o f f a u t o m a t i c a l l y when th e combustion tem perature dropped below 1200 degrees C during the Incineration of PCB's. 5 . On or about March 3 1 , 19 8 1 , Respondent maintained re c o rd s , n o tin g t h e r a te and q u a n t i t i e s o f l i q u i d PCB m ixtures Introduced In to the combustion system recorded at irre g u la r in te rv a ls varying 1n length from ten to tw enty-eight minutes. v ACM CC678fc 122 CONCLUSIONS OF LAW 1 . By reason of the facts set out In the stipulations o f F a c t, above, i t is concluded th a t Respondent has V io la te d 15 U .S .C . 2614 ( 1 ) , ind 40 CFR 7 6 1 .4 0 ( a ) ( 1 ) by f a i l i n g to m aintain an in c in e r a to r tempera ture of 1200 degrees C . w ith a two-second dwell time at three percent excess oxygen in th e sta c k gas during the in c in e r a tio n and d e s tru c tio n of liq u id FCB m ixtures. 2 . By reason of the fa c ts set out in th e s tip u la tio n s o f F a c t , above, i t is concluded th a t Respondent has vio la te d 15 U .S .C . 2 6 1 4 (1 ), and 40 CFR 7 6 1 .4 0 ( a ) ( 5 ) by o p e ra tin g an in c i n e r a t o r f o r th e in c in e r a tio n and d e s t r u c t i o n o f l i q u i d PCB m ix tu re s where th e I n c i n e r a t o r does not shut o f f a u to m a tic a lly when the combustion tem perature drops below 1200 degrees C. 3 By reason of the fa c ts set out in the Findings of F a c t , above, i t is concluded th a t Respondent has v io la te d 15 U . S . C . 2 6 1 4 (1 ) ( 3 ) , and 40 CFR 7 6 1 .4 0 ( a ) ( 3 ), 7 6 1 .4 5 ( c ) ( 1 ) ( A ) , by fa ilin g to maintain records t h a t measure and re c o rd th e r a t e and q u a n t i t y o f PC B 's which a^re fe d in t o th e in c in e r a t o r combustion system a t i n t e r v a ls o f no more than fifte e n minutes. ORDER Respondent shall w ithin twenty days of receipt of th is Consent Agreement and F i n a l O r d e r pay by c a s h i e r 's check o r c e r t i f i e d check th e amount o f T h i r t y - F i v e Thousand D o lla r s ($ 3 5 ,0 0 0 .0 0 ) payable t o th e U n ite d S ta te s o f A m eric a . Such rem ittance s h a ll be d e liv e re d to the United States Environmental Protection Agency, Regional Hearing C le r k , 230 South Dearborn S t r e e t , Chicago, I l l i n o i s 60604. Respondent: _____ Date: JamesO^McOohaTd D ire c to r, Enforcement D ivisio n United States Environmental Protection Agency, Region V 230 South Dearborn S tre e t C h ic a g o , I l l i n o i s 60604 \Date: \' CCb76l AtK 123 I t is so o r d e r e d . T h i s O rd e r s h a ll become e f f e c t i v e im m e d ia te ly. Regional Adm inistrator United States Environmental Protection Agency, Region V 230 South Dearborn S tre e t C h ic a g o , I l l i n o i s 60604 Date: ^ V ( c c t i b AC* 124 4 . The fo llo w in g 1s a model p le a d in g in rem f o r s e iz u r e and condemnation o f PCBs sto re d o r d is p o s e tT in v i o l a t i o n o f th e .P C B Marking and Disposal R e g u la tio n . H ollow ing th e pleadings are the V e r if ic a t io n and Warrant fo r A rre s t o f Property, 0 v v GO*16* >0* 125 U n i t e d States Attorney Attorney for the P la in tiff IN THE UNITED STATES DISTRICT COURT FOR THE UNITED STATES OF AM ERICA, ) P l a i n t i f f , 1 C I V I L rtb. VS. ------------------------- . Defendant. J ) ) ) ) ) .j COHPLA.'.NT IN REM The United States o f America alleges th a t: I T h i s is an a c t io n in ren i n s t i t u t e d pursu an t t o S e c tio n 1 7 { b ) o f th e T o x i c Substances C o n tro l A c t ( 1 5 U .5 * C * 2 6 1 6 ( b ) ) , f o r th e s e iz u re and condemnation of chenical substances or mixtures manufactured, processed, or d i s t r i b u t e d in commerce which are _ and in v io la tio n of Section of the Toxic Substances'Control'Act, I V u .S .C . A u t h o r it y t o ' b rin g t h i s a c tio n i s vested in th e U n ite d S ta te s A tto r n e y by 28 U . S . C . 5 4 7 ( a ) . II T h is Court has j u r i s d i c t i o n of the subject m atter of th is action pursuant to 15 U.$C* 2616(b) III The p ro p e rty to be s e ize d is lo ca te d a t , irfnch i s vw ith in t h i s D i s t r i c t , a n a 'i s oh ia n d .~ "ih e lo c a tio n 'Is'7 \ ACM CC67SC 126 IV is a chemical' substance or mixture manufactured,' processed, o r " d is tr i- buted in commerce by J - ____ ____________ . V WHEREFORE, p l a i n t i f f , United States o f America, prays: ( 1 ) T h a t th e chemical substance o r m ix tu r e be S e iz e d and condemned * and t h a t t h e y be disposed o f as th e c o u r t may d i r e c t in accor dance w ith the provisions of Section 17(b ) o f the Toxic Substances Control A c t (15 U . S . C . 2 6 1 6 ( b ) ) and in c o n fo rm ity with th e p ra c tic e o f t h i s C o u r t. (2 ) T h a t th e p a r ty s p e c i f i e d in Paragraph _ _ o f t h i s Com p la in t and any and a ll other persons h a v in g , or pretencing to h a v e , any r i g h t , t i t l e or in t e r e s t in and to the chemical substarces or m ixtures be n o t i f i e d t o appear in o r d e r t h a t th e y may answer th e a l l e g a t i o n s set fo rth in th is Complaint. . (3 ) That the Court e n te r a l l such o rd e rs , decrees, and judgments as may be n ecessary in o r d e r t o g ra n t f u r t h e r r e l i e f t o th e p l a i n t i f f f o r the costs of th is proceeding. ( 4 ) F o r such o th e r and f u r t h e r r e l i e f as th e C o u r t may deem ju s t and pro pe r. Dated: United"States^Attorney Attorney for the P la in tiff \ AC* C08791 127 f' Attorney' Attorney for the P la in tiff IN THE UNITED STATES DISTRIC T COURT FOR THE UNITED STATES OF AMERICA, ` Plain tiff, ) C IVIL NO. vs. VERIFICATION Defendant. I. state th at: 1 . I am , being f i r s t duly sworn, 1 r e I T a & Ty"Tn fo rmed O f th e f a c t s set f o r t h in th e f o r e going Com plaint i n Rem which I have prepared a c c o r d i n g l y ; and 3. A ll of the facts set fo rth in the foregoing Complaint in Rem are t r u e to th e b e s t o f ny know ledge, in fo r m a tio n and b e l i e f . SUBSCRIBED AND SWORN TO BETORE t THIS DAY OF :v -> Rotary"? CdT ic AGf CCtVii 129 1 Melvin D. Close Nevada Bar #1694 2 JONES, JONES, CLOSE & BROWN, CHARTERED 3 700 Valley Bank Plaza 300 South Fourth Street 4 Las Vegas, NV 89101-6026 Telephone: (702) 385-4202 5 ATTORNEYS FOR JUI FA LIN, DEBTOR 6 7 UNITED STATES BANKRUPTCY COURT 8 DISTRICT OF NEVADA 9 In re: 10 JUI FA LIN, 11 Debtor. 12 13 BK-S-- 86-S634--LBR Chapter 11 Proceedings ORDER DISMISSING CHAPTER 11 CASE AND DISMISSING FEDERAL DISTRICT COURT CASE ( DATE: September 10, 1992 TIME: 10:00 a.m. 14 15 Debtor's Motion to Dismiss Chapter 11 Case and to Dismiss 16 Federal District Court Case having come on regularly for hearing this 17 10th day of September, 1992, the debtor appearing by and through his 18 attorney, Melvin D. Close, Esq., of Jones, Jones, Close & Brown; no 19 opposition having been filed, and good cause appearing therefore; it 20 is hereby 21 22 23 24 V 25 26 27 28 Attorney for the P la in t if f IN THE UNITED STATES D ISTRICT COURT FOR TH E_______________________________ UNITED STATES OF AMERICA, ) P la in tiff, C IVIL NO. vs. & WARRANT FOR ARREST OR PROPERTY "Defendants TO : UNITED STATES MARSHAL V0Q` Ai?E~ftRBY~C0.ROTJDED" t6 ~ arre s "an 3 ~ take in t o custody under fu rth e r order of the Court the fo llo w in g described p ro p e rty: Claims. ot p e r s o n s * e n t if T e 3 6*possessTon o f"th e *fo re g o in g property s h a ll be f i l e d w i t h th e C le r k o f th e C o u r t and a copy served upon th e Un ited States Attorney, ' , within ten (10) days a fte r date o f"p u b lic a tio n o v *n o f7c e *o f-,a r fe s t1o f ' tfie foregoing property o r w i t h i n such a d d it i o n a l tim e as may be allowed by th e C o u r t , and answers t o th e com p la in t s h a ll be f i l e d and served w i t h i n tw enty (20) days a fte r date o f p ub lication of notice of a rr e s t. Dated: \ ACfc OC t i 7 S 3 b 5 . The f o llo w in g is a model Complaint f o r I n j u n c t i o n , follow ed by a M otion f o r Temporary. R e s tr a in in g Order and a Proposed Preliminary Injunction. $ \\ i 130 . UNITED STATES D ISTRICT COURT FOR THE CENTRAL DISTRICT OF CALIFORNIA UNITED STATES OF A U R IC A Pla in tiff, V. BAD POI L U T E R , T S C A , Defendant ) ) > N o *_________________ 1 ' COMPLAINT FOR INJUNCTION } Section 17(a) of the Toxic ) Substances Control A c t, ) 15 USC 2617 The United States of America, by its undersigned attorneys, by a u t h o r i t y of th e A t to r n e y General o f th e United S t a t e s , $nd a c tin g on th e request of the United States Environmental Protection Agency, alleges that; I 1 . T h i s i s a c i v i l i n j u n c t i o n t o e n jo in th e above named defen dants from the continued storage of transforners contain*ng the chemical substance polychlorinated biphenyls (PCB's) in vio la tio n of regulations promulgated by th e A d m in is tra to r o f th e Environm ental P ro te c tio n Agency ( E P A ) , a t T i t l e 40 P a r ts 7 6 1 . 1 0 , - 7 6 1 . 4 2 , V o l . 4 3 , 34 FR 7150 e t seq on February 1 7 , 1 9 7 8 , as provided by Se ctio n 6 ( e ) ( 1 ) of the To xic Substances Control A c t , 15 USC 2605. 2 . Th is C ourt has j u r i s d i c t io n o f the subject m atter o f th is a c tio n pursuant to 15 USC 2616. 3. Defendant is a corporation doing business in Los Angeles, C a lif o r n ia and such act has occurred and is c o n tin u in g to occur at i t s fa c ility located at S tre e t, Los Angeles, C a lifo rn ia , with in the Central D is tric t o r L a lifo r n ia . 4 . The continued storage o f such transform ers c o n tra ry to the above c it e d r e g u la tio n s th re a te n s t o cause an immediate and ir r e p a r a b le i n j u r y to th e employees working a t said f a c i l i t y and th e general p u b lic l i v i n g nearby un less defendants are im m ediately r e s tr a in e d as p ra y e d , as more f u l l y appears in the a f f i d a v i t s submitted w ith p l a i n t i f f ' s motion fo r P re lim in a ry In ju n c tio n f i l e d h e re w ith . P l a i n t i f f has attempted to give oral notice of th is motion to defendants attorney. ( Defendants w i l l not be unduly prejudiced by issuance o f a tem po rary r e s t r a i n in g o rd e r pending hearin g and d e te rm in a tio n o f p l a i n t i f f ' s motion fo r Prelim inary Inju nction . v There is a s u b stan tial lik e lih o o d th a t p l a i n t i f f w i ll suceed on the m erits of t h is case. ACM CC67S5 131 I j ' _ Wherefore, p la in tiff prays: " 1, ' That the defendants, th e ir o ffic e rs , directors, agents, ` s e r v a n t s , employees, successors and assigns and each o f i then cease the storage of transformers containing ; PCB's c o n tra ry to the requirements o f T i t l e 40 P a rt 7 6 1 .1 0 C FR , and be immediately req u ire d to comply w ith i such re g u la tio n s . j 2 . Th a t cost's and disbursements o f t h i s a c tio n be awarded ; to the p la in tiff. ; 3 . T h a t t h i s c o u rt g ra n t such o th e r and f u r t h e r r e l i e f as j i t may deem j u s t and p ro p e r. i i t 1 f'` * ;/ > ! *< i i AO* CCt7St J 132 UNITED STATES DISTRICT COURT;FOR THE CENTRAL DISTRICT.OF CALIFORNIA UNITED STATES OF AMERICA Plain tiff, ) ) ) N o ._____________ ____ ) V . > MOTION FOR TEMPORARY ) R ESTRAINING ORDER AND ) ORDER TO SHOW CAUSE BAD P O L L U T E R , TSCA i " Defendant. i Upon th e Com plaint h e re in and upon th e papers subm itted in s u p p o rt o f t h i s m o tio n , p l a i n t i f f , by i t s a t t o r n e y s , r e s p e c t f u l l y moves th e C ourt f o r a temporary r e s t r a i n in g ord er r e s tr a in in g defendants as set fo r t h b e lo w , and f o r an ord e r th a t defendatns appear and show cause, as fo llo w s : 1 . That defendants th e ir o ffic e r , agent::, servants, employees, and a l l persons in a c tiv e concert w ith them or any of them be re s tra in e d and enjoined from th e continued storage o f tran sfon ne rs containing the chemical substance polychlorinated biphenyls (PCB's) in v io la tio n of regulations promulgated by the A dm in istration of the Environmental Protec t i o n Agency (EP A ) a t T i t l e 4 0 , P a r t 7 6 1 . 1 0 , 7 6 1 .4 2 C F R , V o l . 4 3 , 34 FR 7150 e t . seq . on February 1 7 , 19 78 . 2 . Immediate and i r r e p a r a b le i n j u r y t o th e employees working at sa id f a c i l i t y and to the general p u b lic w ill occur unless defendants a re im m ediately r e s t r a in e d as p ra y e d , as more f u l l y appears in th e complaint herein and the a f f i d a v i t s subm itted with p l a i n t i f f ' s Motion f o r Prelim inary In ju n c tio n f i l e d h e re w ith . P l a i n t i f f has attan pted to give oral n otice o f t h i s motion to d efe n d an ts' a tto r n e y s . N o tice should not be requ ired h e re in as a temporary r e s tr a in in g order is necessary to preserve the status quo in th is a c tio n * pending the determ ination o f p l a i n t i f f ' s motion f o r a prelim inary in ju n c tio n . P l a i n t i f f 's remedies at law are inadequate. Defendants w i l l not be unduly p re judiced by issuance o f a tem porary re s t r a in in g o rd e r pending hearing and de te rm in a tio n o f p l a i n t i f f ' s Motion for Preliminary Injunction. There is a s u b s ta n tia l lik e lih o o d th a t p l a i n t i f f w ill suceed on the m erits of th is case. WHEREFORE: P l a i n t i f f asks th a t th is Court Issue a Temporary R e s tr a in in g Order and Order t o Show Cause, as prayed. Dated: v Respectfully Submitted, i 133 UNITED STATES D ISTRICT COURT FOR THE . CENTRAL DISTRICT- OF CALIFORNIA Un i t e d s t a t e s - o f a r i c a Plain tiff, ) |j No. V. BAD POLL.UTER, TSCA, PRELIMINARY INJUNCTION ) i Defendant. i T h i s m a t t e r came on t o be heard on th e day of 19 7 8 , f o r p re lim in a ry i n j u n c t i o n . Upon c o n s id e ra tio n of $ie evidence'adduced a t th e h e a r i n g , th e p leadin gs and papers on f i l e h e r e i n , and th e arguments o f counsel : I t appears to the court th a t the defendants, personally or through t h e i r a g e n ts, are engaged in the continued storage o f transform ers containing the chemical substances polychlorinated biphenyls (PCB's) in v io la tio n of regulations promulgated by th e Adm inistrator of the Environmental Protection Agency ( E P A ) , a t T i t l e 4 0 , P a r t 7 6 1 . 1 0 , 7 6 1 .4 2 C F R , V o l . 4 3 , 34 FR 7150 e t . seq. on February 1 7 , 1 9 7 8 ,. as provided by Section 6 ( e ) ( 1 ) of the Toxic Sub stances Control A c t , 15 USC 2605, I t fu rth e r appears to the Court that the defendants w i l l , i f not enjoined by order of t h i s C o u r t, continue to store such transform ers contrary t o the above c ite d r e g u l a t io n s , and th e re b y cause an immediate and irr e p a ra b le i n j u r y to th e employees working at s a id f a c i l i t y and the general p u b lic and th at p l a i n t i f f 's remedies at law are inadequate. I t f u r t h e r appears t h a t defendants w i l l not be unduly p re judiced, by Issuance of a p re lim in a ry in ju n c tio n pending hearing and determ ination of the m erits. I t fu rth e r appears to the Court that there e xists a substantial lik e lih o o d th a t p l a i n t i f f w i l l suceed on the merits of i t s case. NOW T H E R E F O R E , I T IS OROERED, ADJUDGED AND DECREED t h a t d e fe n d a n ts , t h e i r - o f f i c e r s , a g e n ts , s e r v a n t s , em ployers, and a ll persons in a c tiv e con c e rt w ith them, o r any o f th a n , be enjoined fro m : : The continued storage of transformers containing the chemical substance polychlorinated biphenyls (PCB's) in vio la tio n of regulations pro mulgated by the A d m in is tra to r of th e Environmental P ro te c tio n Agency (CPA) at T i t l e 40 CFR P a rts 7 6 1 .1 0 , 7 ^ 1 .4 2 ., k ACM CG796 IT IS FURTHER ORDERED that th is injunction shall remain in 1ii'Ct f thf until fin a Court. l determination of the m erits, or until further order Dated: O u 3 g e a t e s District"Court Central D is tric t of C alifornia \ k ACK GQ8?SS i CORRECTIONS TO - EPA's FINAL,PCB BAN RULE; OVER 100 QUESTIONS AND ANSWERS TO HELP YOU MEET THESE REQUIREMENTS Page 4, Question 9: Line 22 should read "...July 2, 1979.H Page 7, Question 18: Line 22 should read **Use in Pigments...". Line 26 should read "Use in Small Quantities for Research and Development (Sec. 761.31 (j));". Line 28 should read "Use as a Microscopy Mounting Medium.". Page 10, Question 25: Line 7, the last sentence in this paragraph should read "Special restrictions^re dependent upon the concentration of PCBs in the transformer and whether PCBs are sold during the servicing activities." Page 11/12, Question 28: Line 19, the last sentence in this paragraph should read "If they sold only un contaminated mineral oil (less than 50 ppm PCB), then no exemption would be needed.". Page 15, Question 40: Line 5 add the sentence "No exemp tion from EPA is required for such sales.". Page 16, Question 45: Line 3, add to the end of the sentence "...and again between 12 and 24 months after such servicing." Page 18, Question 57: Line 2, disregard the current ' answer and substitute the following response "Repair restrictions apply only to the PCB motors, not the rest of the machine. While the machines are in use in mines or mining areas, PCBs can be added' to these motors until January 1, 1962. When PCB motors in loader-type equipment are returned to a service shop for servicing they must be rebuilt . as a i r c o o l e d or other non-PCB containing motors or be replaced with non-PCB motors. Because PCB motors in continuous miner equipment cannot be successfully converted to non-PCB motors, these motors are allowed to be rebuilt as PCB motors until January 1, 1980 in order to ease the impacts of phasing out this equipment. Any servicing or repair that involves th sale of PCBs can be performed only by persons who are granted an exemption by EFA." *t i ve INDUSTRY ASSISTANCE OFFICE U.S. E N V IR O N M FN T A L^ M O T C C T IO N AG EN C Y O F F IC E O F ASSISTANT AOMIN1STH*TO* FOft TO XIC SU BSTAN CES ITS-7SS) mW A S H I N G T O N , O . C . 4 * 0 10 424T e V L > M l |l< l -tOSS 114 148 I M I A C T O N . O . C . I - Errata: On page 35 of the Q s A's on PCB's the answer to question 120 should read: *Yes, there are OSHA regulations governing PCB's in the workplace". \ a c h C C 6 8 *-2 United S tifM Environment*! Protection Agerwy Offiav of" Toxic Sobftencn TS-799 Wahington DC 20460 June 1979 Toxic SoDtttncn V o EP A "*r\2+C-- EPA's Final PCB Ban Rule: ^ - 7 " Q v e r 100.l i ,1 - , Questions 8- Answers To Help You Meet ' 1; i These Reqirements EPA's Final PCB Ban Rule: Over7 100 Questions & Answers To Help You Meet These Requirements $ Prepared by: Industry Assistance Office Office of Toxic Substances U.S. Environmental Protection Agency \ \ I AC* CCttCs INTRODUCTION On Hay 31, 1979 in the Federal Register (44 FR 31514) the U.S. Environmental Protection Agency published the Final Rule for Polychlorinated Biphenyls (PCBs) Manufacturing, Processing, Distribution in Commerce, and Use Prohibitions. This Booklet* in a non-technical manner, deals with the Rule's coverage and requirements. Its question-and-answer format is categorized into the following 18 areas. y Q&A Category Questions Introductory Information ............... 1-8 General Rule Provisions................. 9-21 Import/Export .......................... T r a n s f o r m e r s ....................... .$. 22-23 24-40 Railroad Transformers .................. 41-49 C a p a c i t o r s .............................. 50-54 Mining Equipment ....................... 55-60 Hydraulic Systems ..................... 61-65 Heat Transfer Systems .................. 66-67 Other PCB U s e s ......................... 68-75 L a b e l i n g ................................ 76-83 T e s t i n g ................................. 84-86 Storage . . . . . . . .................. 87-95 S p i l l s .................................. 96-99 Recordkeeping .......................... 100-104 Disposal ................................ 105-119 PCBs in the W o r k p l a c e .................... 120-125 Contacts for Information . . . . . . . . 126-127 v This Booklet has been prepared by the Industry Assistance Office within EPA's Office of Toxic Substances. It is an informal document, and persons are directed to the PCB Fipal Rule for specific legal requirements. -1- CCcC5 INTRODUCTORY INFORMATION (1) WHAT ARE PCBs? The term PCBs is short for polychlorinated biphenyls. PCBs belong to a broad family of organic chemicals known as chlorinated hydrocarbons. PCBs' are produced by attaching chlorine molecules to a biphenyl molecule. Although PCBs may be produced naturally in the environment, almost all PCBs in existence today have been synthetically manufactured. (2) WHO MANUFACTURED PCBs? Monsanto Corporation was the principal manufacturer of PCBs in the United States. They began production of PCBs in 1929; in 1977 they voluntarily terminated production because of the wide spread environmental concerns about PCBs. (3) WHAT TRADE NAMES WERE PCBs SOLD UNDER? The tradename Monsanto Corporation sold PCBs .under was "Askarel". However, companies who used PCBs in the manufacture of transformers and capacitors, and for other uses, often used other tradenames. The following list is representative of PCB Tradenames: Aroclor, Pydraul, Therminol, Pyroclor, Santotherm, Pyralene, Pyranol, Inerteen, Asbestol, Chlorextol, Diachlor, Dykanol, Elemex, Hyvol, No-Flamol, Saf-T-Kuhl, Aroclor B, Clorinol, Clorphen, Eucarel. (4) WHAT ARE THE PHYSICAL AND CHEMICAL PROPERTIES OF PCBs? PCBs have a heavy liquid, oil-like consistency, and weigh 10-12 pounds per gallon. The properties which made them com mercially attractive include: a high degree of chemical stability, low solubility in water, low vapor pressure, low flammability, high heat capacity, low electrical conductivity, and a favorable dielectric constant. (5) HOW ARE PCBS USED? The primary use of PCBs has been in "closed" or "semiclosed" systems in electrical transformers, capacitors, heat transfer systems, and hydraulic systems. PCBs have also been used in paints, adhesives, caulking compounds, plasticizers, k -2ACM C Cc oCf c 'J inks, lubricants, carbonless copy paper, and sealants, coatings, and dust control agents. Host of the PCBs marketed rn the United States are still in service, primarily in electrical equipment. (6 ) WHY ARE PCBs HARMFUL TO HUMAN HEALTH AND THE ENVIRONMENT? v PCBs are harmful because once released into the environment they do not break apart into new chemical arrangements,*instead they bioaccumulate in organisms throughout the environment. In addition, PCBs biomagnify in the food chain -- that is, they ac cumulate in the tissues of living organisms and as they move up the food chain towards man their concentration increases. These facts are significant because PCBs have been shown to cause chronic (long-term) toxic effects in many specie^ even when the exposured to very low concentrations. (7) WHAT ARE THE KNOWN HEALTH EFFECTS OF PCBs? There are well documented tests which show PCBs cause, among other things, reproductive failures, gastric disorders, skin lesions, and tumors in laboratory animals. Studies of workers exposed to PCBs have shown a number of symptoms and adverse effects including, but not limited to, chloracne and other epidermal disorders, digestive disturbances, jaundice, impotence, throat and respiratory irritations, and severe headaches. (8 ) WHAT ACTION HAS EPA TAKEN AGAINST PCBs? In 1976, Congress enacted the Toxic Substances Control Act (TSCA) Section 6 (e) of this law requires EPA to establish rules to: (1) govern the disposal and marking of PCBs? and (2) pro hibit, with certain exceptions, the manufacture, processing, distribution in commerce, and non-totally enclosed use of PCBs. Final Marking and Disposal Rules appeared in the Federal Register on February 17, 1978 (clarifying amendments to this Rule appeared in the August 2, 1978 Federal Register). On June 7, 1978, the Proposed PCB Ban Rule was published in the Federal Register. ThevFinal PCB Ban Rule appeared in the Federal Register on May 31,' 1979; this Rule supersedes the February 17, 1978 PCB regulation and takes effect on July 2, 1979. -3- ALK CC6 tC 7 GENERAL RULE PROVISIONS (9) WHAT DOES THE HAY 31/ 1979 PCB BAN RULE DO? Specifically, the rule: (1 ) prohibits the manufacturing, processing, distribution in commerce, and the use of PCBs except in a totally enclosed manner after July 2, 1979; (2 ) provides authorizations for certain processing, dis tribution in commerce, and use of PCBs in a non-totally enclosed manner; (3) prohibits, unless exempted by EPA, all manufacturing of PCBs after July 2, 1979; $ (4) prohibits, unless exempted by EPA, all processing and distribution in commerce of PCBs after July 1, 1979. Also, the February 17, 1978 PCB Disposal and Marking Rule requirements are- integrated into this PCB Ban Rule. Therefore, with the total scope of the PCB regulation -- from labeling to production ban to disposal -- now appearing in the May 31, 1979 Federal Register, this publication supersedes all earlier PCB regulations upon its July 2, 1979 effective date. EPA has also published in the May 31, 1979 Federal Register a notice which explains how to file for an exemption from the July 1, 1979 bans on processing and distribution in commerce of PCBs. Petitions for exemptions must be filed by July 1, 1979. EPA earlier published procedures for filing petitions for exemp tion from the January 1, 1979 prohibition on manufacturing of PCBs. These procedures can be found in the November 1, 1978 Federal Register (43 FR 50905). (10) DOES THIS RULE APPLY TO ALL PCBs OR IS THERE A CUT-OFF POINT BASED ON THE CONCENTRATION OF PCBs? In order to practically implement this rule (i.e., excep tions, disposal and marking requirements), EPA had to adopt a PCB concentration cut-off point for regulation. Therefore, the final rule applies to any substance, mixture, or item with 50 ppm or greater PCB; wherever the term "PCB" or "PCBs" is used in the rule, it means PCBs at a concentration of 50 ppm or greater, unless otherwise specified. s This 50 ppm is a change from the February 17, 1978 Disposal and Marking Rule which set a 500 ppm cut-off. By lowering the PCB cut-off point from 500 ppm to 50 ppm, it will substantially increase health and environmental protection -- approximately, -4- A C f * C C c c C one million additional pounds of existing PCBs will be con- ' trolled, as well as 100,000 to 500,000 .pounds per year of new PCBs, (11) IS THERE ANYTHING WHICH CONTAINS LESS THAN 50 PPM PCBs WHICH IS BANNED FROM BEING USED UNDER THIS RULE? Yes, waste oil containing any detectable concentration of PCBs is forbidden ffrom being used as a sealant, coating, or dust control agent. To permit the use of waste oil with any PCBcontamination to be used in road oiling, pipe coating, or vege tation spraying would cause PCBs to directly enter the air and waterways, which could introduce them into the food chain. (12) WHAT IS THE DIFFERENCE BETWEEN "MANUFACTURING OF PCBs" AND "PROCESSING OF PCBs"? The actual creation of the chemical substance PCB, or a substance contaminated with PCBs (e.g., PCBs as an impurity), is the "manufacturing of PCBs". The production of PCB Articles and PCB Equipment is con sidered "processing of PCBs", and involves th use of existing PCBs. Processing PCBs includes such activities as placing man ufactured PCBs into capacitors or transformers. ( (13) WHAT IS CONSIDERED A PCB ARTICLE? PCB EQUIPMENT? PCB ITEM? An article whose surface is directly contacted by PCBs is considered a "PCB Article". Examples include capacitors, trans formers, electric motors, pumps, and pipes. Equipment whose surface is not directly contacted by PCBs, but contains a PCB article, is considered "PCB Equipment". Ex amples include televisions, air conditioners, microwave ovens, electronic equipment, and fluorescent light ballasts and fix tures. "PCB Item" is a collective term used throughout the Rule to refer to PCB Equipment/Articles/Containers/Article Containers. (14) WHAT EFFECT DOES THE^PCB BAN RULE HAVE ON PCB ARTICLES? PCB EQUIPMENT? After July 2, 1979, PCB Articles can no longer be produced because the production is not totally enclosed. However, s^nce - 5 - ACH CCcetS - -- the production of PCB Equipment is considered totally enclosed processing, this can continue until July 1, 1979 under the Rule; in order to continue PCB Equipment production after that date, an exemption must be obained from EPA. . I .1. I' '! (15) THE FINAL RULE SAYS THAT EPA CAN GRANT EXEMPTIONS FROM THE PCB MANUFACTURING/IMPORTATION BAN EFFECTIVE JULY 2, 1979 -- OR FROM THE PCB PROCESSING/DISTRIBUTION IN COMMERCE PRO HIBITION EFFECTIVE JULY 1, 1979. HOW CAN I GET AN EXEMP TION? HAS EPA ALREADY GRANTED SOME? In general, anyone wanting an exemption must petition EPA for it. An exemption, valid for only one year, must be granted annually through a formal rulemaking. In some instances, indi viduals may not have to seek separate exemptions when the Agency grants "class" exemptions for some processing and distribution in commerce bans. In the November 1, 1978 Federal Register, EPA published in terim rules for submitting exemption petitions from the July 2, 1979 PCB manufacturing/importation prohibition? over 70 petitions have been received. EPA announced, in the January 2, 1978 Federal Register, that it would not enforce the ban against those who had submitted petitions until action had been taken on them. Sub sequently, in the May 31, 1979 Federal Register notice, EPA published a Notice of Proposed Rulemaking which identifies each exemption petition received, and the action EPA proposed to take on most of them. Also, in the May 31, 1979 Federal Register, EPA has pub lished procedure rules for submitting exemption petitions from the July 1, 1979 processing/distribution in commerce prohib itions. These procedures include the categories eligible for class exemptions. (16) WHERE CAN I DETERMINE WHAT CATEGORIES ARE ELIGIBLE FOR CLASS EXEMPTIONS? You should make a careful review of Section 750.31(a) of the Interim Procedural Rules for the processing and distribution in commerce exemptions. These rules are published in the May 31, 1979 Federal Register. Section 750.31(a) lists and describes the categories that may file class exemption petitions. If your ac tivity is not listed in Section 750.31(a), you must*file a peti tion on an individual basis. \ -6- ACM C C 6 8 1 C ( 1 7 ) THE BAN RULE PROHIBITS THE USE OF PCBs EXCEPT IN A "TOTALLY ENCLOSED MANNER". WHAT IS MEANT BY "TOTALLY ENCLOSED MANNER? "Totally enclosed manner" is a term which Congress wrote into TSCA's Section 6(e) and refers to PCBs contained in a way that does not permit any detectable exposure to PCBs. Examples of totally enclosed PCB uses, allowed to continue after July 2, 1979, are found in television sets, air condi tioners, and micjrowave ovens. These items contain PCB components (such as PCB capacitors) but their normal continued use will not result in any exposure to human beings or their surroundings. (18) THE BAN RULE SAYS THAT EPA CAN GRANT EXCEPTIONS, KNOWN AS AUTHORIZATIONS, TO ENABLE THE CONTINUED#MANUFACTURING, PROCESSING, DISTRIBUTION IN COMMERCE, OR USE OF PCBs IN A NON-TOTALLY ENCLOSED MANNER AFTER JULY 2, 1979, HOW CAN I GET AN AUTHORIZATION? HAS EPA ALREADY GRANTED SOME? EPA may propose and grant an authorization without a spe cific request from those who will benefit from the authori zation. Also, the authorization can be valid for any time period that EPA finds appropriate. The following, non-totally enclosed PCB activities have al ready been authorized by EPA (beside each is the Rule section to refer to for details): o servicing PCB Transformers and PCB-Contaminated Transformers (Sec. 761.31(a)); o use in and servicing of Railroad Transformers (Sec. 761.31(b)); o use in and servicing of Mining Equipment (Sec. 761.31(c)); o use in Heat Transfer Systems (Sec. 761.31(d)); o use in Hydraulic Systems (Sec. 761.31(e)); o use in Carbonless Copy Paper (Sec. 761.31(f)); o Pigments (Sec. 761.31(g)); o servicing Electromagnets (Sec. 761.31(h)); o use in Natural Sas Pipeline Compressors (Sec. 761.31(i)); -7- ACM C C d c 1 1 o Small Quantities for Research & Development Sec. 761.31(j)); o Microscopy Mounting Medium.(Sec. 761.31(k)). EPA authorized the above PCB activities in a non-totally enclosed manner after evaluating: the likelihood, magnitude, and nature of exposure to human beings or the environment; the avail ability and characteristics of substitutes; and the economic sig nificance of the activity, including its importance to the nation al economy, small business, technological innovation, the envi ronment, and public health. (19) WHAT IS THE DIFFERENCE BETWEEN A PCB AUTHORIZATION AND A PCB EXEMPTION? Authorizations are for certain uses of PCBs to extend beyond July 2, 1979. However, exemptions for manufacturing are needed in order to manufacture PCB-contaminated substances after January 1, 1979. Also, exemptions for processing and distribution in commerce of PCBs are needed in order to continue these activities after July 1, 1979. Exemptions are only valid for a maximum of one year, while authorizations may be granted for longer periods of time. Other differences between authorizations and exemptions are described in detail in the Preamble to the Final Rule. (20) WHAT DOES THE RULE PROVIDE FOR LEASED PCB EQUIPMENT? PCB Equipment can be leased for any period of time as long as the lease begins before July 1, 1979; if you want to lease equipment after this date you will have to first get an exemption from EPA. To import or export leased PCB equipment after July 1, 1979 will also require an exemption from EPA. (21) IS THERE AN ECONOMIC IMPACT STATEMENT AVAILABLE? Yes, there is an economic impact statement available on the PCB Ban Rule. It is called "PCB Manufacturing, Processing, Dis tribution in Commerce and Use Ban Regulation: Economic Impact Analysis", also commonly referred to as the "Versar Report". For a copy of this document call the Industry Assistance Office (see the "Contacts for Information" section of this Booklet). I 8 CCtcii IMFORT/EXPORT (22) CAN PCBs (THE CHEMICAL ITSELF) BE IMPORTED OR EXPORTED AFTER THE BAN RULE'S JULY 2, 1979 EFFECTIVE DATE? WHAT ABOUT PCB EQUIPMENT (TELEVISION SETS, MICROWAVE OVENS, ETC.) WHICH CAN CONTINUE TO BE DOMESTICALLY PRODUCED UNTIL JULY 1, 1979, HOW LONG CAN THEY CONTINUE TO BE IMPORTED AND EXPORTED? v Because TSCA considers the term "import" to be synonomous with "manufacture", no PCBs (except waste) can be imported or exported after July 2, 1979, unless an exemption is obtained from EPA. Furthermore, it was the intent of Congress to have this Rule treat domestic and foreign PCB production equally. Therefore, PCB Equipment can be imported and exported until July 1, 1979. After July 1, 1979, an exemption must be obtained from EPA in order to continue this activity. (23) EPA HAS DECIDED TO ADOPT AN OPEN BORDER POLICY WITH RESPECT TO THE DISPOSAL OF PCBs. WHAT DOES THAT MEAN? The PCB Ban Rule allows for PCB wastes to be either imported or exported for disposal for one year -- until May 1, 1980. All imported PCB wastes must be disposed of in accordance with Subpart B of the Final Rule. Persons exporting PCB wastes for dis posal are to notify EPA at least 30 days before the first export shipment; quarterly reports of actual shipments are also required. EPA believes that the adoption of this open border policy for PCB waste disposal will be advantageous to both the U.S. and foreign countries, especially Canada. Generators of PCB wastes will be able to select the PCB disposal site that offers the most reasonable transportation and disposal costs. The open border policy will be in effect for almost one year, at which time EPA will examine the progress made by other nations in establishing and operating safe PCB disposal sites. The Agency will also at this time determine if extension of the open border policy is appropriate. \ -9- AuM CCfcel2 TRANSFORMERS ** (24) UNDER THE FINAL BAN RULE, -THE.USE OF PCBs IN TRANSFORMERS IS CONSIDERED USE IN A-TOTALLY ENCLOSED MANNER. DOES THIS MEAN I CAN CONTINUE TO USE* MY TRANSFORMERS CONTAINING PCBs? IF SO, FOR HOW LONG? Transformers containing PCBs can be used as long as they perform their intended function and do not leak PCBs into the environment. (25) IN ORDER TO GET THE FULL USEFUL LIFE OUT OF LIQUID FILLED TRANSFORMERS, THEY MUST BE SERVICED OR REPAIRED PERIOD ICALLY. ARE THESE ACTIVITIES PERMITTED UNDER THE RULE? ARE THERE ANY RESTRICTIONS? $ Servicing of these transformers is authorized until July 1, 1984. EPA will consider the necessity of extending the author ized period prior to the 1984 termination date. Special re strictions are related to the extent of the repairs or servic ing activities, and whether PCBs are sold during the servicing activities. There are four categories of transformers considered in this regulation and the restrictions and special conditions are easier to understand in the context of these categories. (26) WHAT ARE THE 4 TRANSFORMER CATEGORIES? WHAT IS THE SIGNIFICANCE OF EACH? The four categories of transformers established by the PCB Rule are: (1) PCB Transformers containing PCBs at a concentration of `500 ppm or greater; (2) PCB-Contaminated Transformers containing between 50 ppm and 500 ppm PCB; (3) Non-PCB Transformers containing less than. 50 ppm PCB; (4) Railroad Transformers used in electric railroad locomotives and self-powered cars that contain PCB fluid. The transformer categories are significant, because under the Rule each is subject to different disposal, servicing (including rebuilding), and storage requirements. (Note: The Rule, as do these Q & A's, address Railroad Transformer -10 - ACM C C t t l 4 requirements separately; the other 3 categories are discussed simultaneously.) (27) HOW DO I DETERMINE WHICH. OF THE FOUR TRANSFORMER CATEGORIES I HAVE? A transformer must be assumed to be a PCB Transformer if: (1) the nameplate indicates that the transformer contains PCB dielectric fluid; (2 ) the owner or operator has any reason to believe that the transformer contains PCB dielectric fluid; or (3) the transformer's dielectric fluid has been tested and found to contain 500 ppm or greater PCB. If a transformer does not have a nameplate or there isn't any information to indicate the type of dielectric fluid in it, the transformer must be assumed to be a PCB Transformer. $ If a transformer is tested and found to contain less than 500 ppm PCB, it will then fall into one of the other appropriate categories. A transformer can be reclassified as a Non-PCB Transformer if its dielectric fluid has been tested or otherwise verified to contain less than 50 ppm PCB. Testing Transformers in order to classify them as Non-PCB Transformers does not significantly change the actions required by the Rule. If your transformers are proven Non-PCB.Transformers you should take precautions to see that they aren't later contaminated during servicing with PCB fluid over 50 ppm. (28) WHY SHOULD I ASSUME THAT MY MINERAL OIL TRANSFORMER IS A PCB-CONTAMINATED TRANSFORMER? IF I GO TO THE EXTRA TROUBLE AND EXPENSE TO TEST MY TRANSFORMER IN ORDER TO CLASSIFY IT AS A NON-PCB TRANSFORMER, WHY WON'T MY REQUIREMENTS UNDER THE RULE BECOME SIGNIFICANTLY SIMPLER? Current data shows that 25-40% of the existing mineral oil transformers are contaminated with 50 ppm or more of PCBs. No clear pattern exists to explain why one transformer is contaminated and another one is significantly less contami nated. This means that testing all transformers would be necessary in. order to be certain about the appropriate cate gory. This would be extremely expensive. Therefore, the requirements in the Rule for servicing, disposal, labeling, and use have been designed to make this testing step largely unnec essary. \ The only servicing restriction on PCB'-Contaminated Trans formers is that companies servicing transformers owned by others and who sell PCB-contaminated minral oil to their customers must -11- AUM CCfifclS receive' an exemption from EPA. If they sold only uncontaminated' mineral oil (less than 50 ppm PCBs), then.an exemption would be needed. The disposal requirement's for FCB-contaminated fluids are specific thigh efficiency boilers, incineration or chemical waste landfills). However, the disposal options for fluids from NonPCB Transformers are not much greater, because of the broad pro hibition on using waste containing PCBs for'dust control, seal ant or coating purposes. v There are no labeling requirements for either transformer categories (PCB-Contaminated or Non-PCB Transformers), and no use restriction differences. (29) HOW WOULD TRANSFORMERS WHICH USE PCB-FREE MINERAL OIL DIELECTRIC FLUID BE CATEGORIZED? Because of the widespread contamination of mineral oil dielectric fluid transformers, they must be assumed to be PCBContaminated Transformers. Even if PCB-free dielectric fluid was added to an existing transformer, you couldn't be certain that PCB contamination in the transformer would not contaminate the new fluid to a level above 50 ppm PCB. You, of course, have the option of testing the new aggregate dielectric fluid in the transformer to determine if the PCB conr centration is below 50 ppm, in which case it could be consid ered a Non-PCB Transformer. (30) CAN I RECLASSIFY MY PCB TRANSFORMER IF I REDUCE ITS PCB CONCENTRATION? PCB Transformers can be reclassified to PCB-Contaminated Transformers by draining and refilling them with non-PCB di electric fluid. Before they .can be reclassified the trans formers must be tested and found to contain less than 500 ppm PCB after at least 3 months of in-service use. If the PCB concentration was successfully reduced below 50 ppm, then the transformer can be reclassified to a Non-PCB Transformer. (31) WHAT TYPE OF SERVICING CAN I DO ON MY TRANSFORMER? Routine servicing of ^transformers (i.e., testing the di electric fluid, filtering the fluid, removal of some fluid and then returning or replacing it, replacing gaskets) in any of the categories will result in minimal exposures to PCBs and allow the -12 use of most existing transformers throughout their lifetime, e p a has decided that this activity doesn't present an unreasonable risk to human health and the environment. However, any servicing -(including rebuilding) of PCB Trans formers that involves removing the coils from the casing is prohibited by the Ban Rule. Removing the coils substantially increases PCB exposure, therefore, EPA concludes this servicing to be an unreasonable risk. EPA believes the cost of this pro hibition (about $14 million the first year and steadily less each year after) is justified by the increased risks which would other wise occur to human health and the environment. (32) CAN I REBUILD MY TRANSFORMERS? Rebuilding a transformer would involve oqe or more of the following: draining the transformer, removing' and disassembling the core, reworking the coil or rewinding a new coil, reassem bling the core, and refilling the transformer with new fluid. EPA permits the rebuilding only of PCB-Contaminated Trans formers (containing between 50 ppm and 500 ppm PCB), and, of course, Non-PCB Transformers. If your transformer is classified as a PCB Transformer (containing 500 ppm or greater PCB), it cannot be rebuilt unless it is first reclassified to a PCBContaminated Transformer. EPA decided to permit rebuilding of PCB-Contaminated Trans formers, because the exposure to PCB is relatively low and the economic impact of not permitting this activity would be very high. (33) CAN I SERVICE MY OWN TRANSFORMERS? EPA has decided to authorize this activity, which is con sidered use, for persons who service their own transformers until July 1, 1984. (34) CAN I HAVE A SERVICE SHOP WORK ON MY TRANSFORMER? Yes, you can have work done on your transformer without receiving an exemption from EPA provided the shop does not add any PCB fluid. If PCB fluid (50 ppm PCB or greater) needs to be added, the shop can add your fluid without obtaining an exemp tion. However, if the service shop adds their PCB fluid to your transformer, they muit get an exemption to do so after July 1, 1979. \. 13 A O CCeel7 (35) CAN I REUSE MY DIELECTRIC FLUID? . Dielectric fluid can be reused as long as it is used in either the transformer that it.came from or in a transformer which had a higher concentration of PCBs than the replacement fluid. .' (36) WHAT FLUIDS^CAN I USE WHEN I RETROFILL MY TRANSFORMER? Dielectric fluids containing less than 500 ppm PCBs can be used to refill transformers. However, dielectric fluids containing less than 500 ppm PCB under no circumstances can be mixed with fluids containing 500 ppm or greater PCBs. In other words, the deliberate dilution of PCB Transformers is prohibited. A PCB Transformer must be drained, refilled, and tested after it was retrofilled before it can be reclassified as a PCB-Contaminated Transformer. It should be noted that PCB Transformers are usually retrofilled with fluids that have fire resistant properties similar to PCBs. (37) ARE THERE ANY RESTRICTIONS ON WHO CAN SELL ME DIELECTRIC FLUID? After July 1, 1979, only those persons who have obtained exemptions from EPA can distribute (and sell) PCB dielectric fluid. (38) CAN I SELL MY DIELECTRIC FLUID TO A WASTE OIL DEALER? Dielectric fluid containing greater than 50 ppm PCB cannot be sold to a waste oil dealer unless the dealer is to dispose of it in accordance with the regulation. Dielectric fluid with concentrations of less than 50 ppm can be sold to a waste oil dealer as long as it will not be used as a sealant, coating, or dust control agent. (39) CAN I SCRAP MY TRANSFORMER OR SELL IT TO SOMEONE TO SCRAP? If your transformer is a PCB Transformer, you cannot scrap or sell your transformer to someone else to scrap. You must dispose of it in an approved chemical waste landfill. On the* other hand, if the transformer is a PCB-Contaminated or Non-PCB Transformer, once the flui<^ is drained, the transformer can be scrapped or sold for scrap.* k -14- ACM CCfel (40) CAN.USABLE TRANSFORMERS -BE SOLD BY PRESENT OWNERS? Yes, provided the seller had originally obtained the transformer for use and not resale --- and the buyer does not purchase the usable PCB transformers for .resale,.but rather uses them himself. RAILROAD TRANSFORMERS (41) HOW DO I KNOW IF MY RAILROAD TRANSFORMERS ARE COVERED BY THE REGULATION? Unless a nameplate (or a test) indicates that the trans former on an electric locomotive contains dielectric fluid having either no PCBs or a concentration of less than 50 ppm PCBs, your railroad transformer is covered by the PCB regulation. (42) WHY ARE RAILROAD TRANSFORMERS DIFFERENT FROM OTHER TRANSFORMERS?' ARE THEY SUBJECT TO DIFFERENT REQUIREMENTS UNDER THE REGULATION? Railroad transformers are the transformers used on electric locomotives and some commuter cars. These transformers are subject to occasional leakage due to damage caused by objects thrown up from the tracks and by damage caused from overloads these heavy service units are subjected to. Because of the greater environmental and health risks from these transformers, the PCB Ban Rule requires that the PCBs be removed from these transformers on a phased reduction schedule. (43) WHAT IS THE SCHEDULE FOR REDUCTION OF PCBs IN RAILROAD TRANSFORMERS? By January 1, 1982 all Railroad Transformers must contain PCB concentrations of 60,000 ppm (6 %) or less. The next dead line is January 1, 1984, at which time all Railroad Transformers must have a PCB concentration of no more than 1,000 ppm. (44) HOW LONG CAN I USE MY PCB RAILROAD TRANSFORMERS? You can use your Railroad Transformer until January 1, 1982 if the PCB concentration^ exceeds 60,000 ppm, after that date it is possible to use the Transformer until January 1, 1984 if the PCB concentration does not exceed 60,000 ppm. You will not be,, -15- A O CC S S I S able to- use a Railroad Transformer containing greater than 1,000 ppm PCB after July 1/ 1984. (45) DO I HAVE TO TEST MY RAILROAD TRANSFORMER? i You will have to test your Railroad Transformers immediately after any PCB concentration reduction related servicing. (46) HOW OFTEN DO I HAVE TO TEST MY RAILROAD TRANSFORMER? It is necessary to test your Railroad Transformer immed iately after it has been serviced to reduce the PCB concentra tions in order to verify the new PCB concentration, j In addition, between 12 and 24 months after such servicing fche transformer is to be tested again to gauge the PCB concentration level. (47) ARE THERE RESTRICTIONS ON WHAT I PUT IN MY RAILROAD TRANSFORMER? Yes, there are restrictions. If you rebuild (remove the coil) the Transformer after January 1, 1982 it cannot be refilled with dielectric fluid containing a PCB concentration' greater than 50 ppm. After January 1, 1982, Railroad Transformers may only be serviced with dielectric fluid containing less than 0,000 ppm ' PCB. Finally, after January 1, 1984, Railroad Transformers may only be serviced with dielectric fluid containing less than 1000 ppm. (48) WHAT KIND OF SERVICING CAN BE DONE ON RAILROAD TRANSFORMERS? 1 Any kind of servicing can be done on Railroad Transformers until January 1, 1982. After that time, the transformer can be rebuilt only if it is to be refilled with dielectric fluid containing less than 50 ppm PCB. Starting on January 1, 1982 transformers may only be serviced with dielectric fluid contain ing less than 60,000 ppm PCB (except when it has been rebuilt). After January 1, 1984, Railroad Transformers may only be serviced with dielectric fluid containing less than 1000 ppm PCB (except when it has been rebuilt). After July 1, 1979, processing and distribution Fin commerce of PCBs in order to service Railroad Transformers can be con ducted only by those persoiis granted an exemption. it -16 ALh CCcc (49) CAN I REBUILD MY RAILROAD TRANSFORMER? Before January i, 1982*you can rebuild your Railroad Transformer with PCB dielectric fluid. After January 1, 1982, any rebuilt Railroad Transformers must not contain dielectric fluid with a PCB concentration greater than 50 ppm CAPACITORS (50) HOW DO THESE RULES AFFECT CAPACITORS? CAN I CONTINUE TO USE MY PCB CAPACITORS? Yes, you can continue to use your PCB capacitors for their useful life. The primary effect of the new prohibition rules is to terminate the manufacture of any new PCB capacitors. $ (51) WHAT ABOUT THE DISPOSAL OF PCB CAPACITORS? These rules continue the provisions of the PCB Disposal and Marking Rule published in the February 17, 1978 Federal Register. Large PCB capacitors must be disposed of in an EPA approved chem ical waste landfill or incinerator. After January 1, 1980 all large PCB capacitors will have to be incinerated in special EPA approved incinerators. Special disposal is not required for small capacitors --except those waste capacitors owned by PCB capacitor or PCB equipment producers. (52) WHAT IS THE DIFFERENCE BETWEEN LARGE AND SMALL CAPACITORS? Small capacitors have less than 3 pounds of contained dielectric fluid; large capacitors have 3 pounds or more of dielectric fluid. (53) I HAVE PCB CAPACITORS THAT ARE TEMPORARILY OUT OF SERVICE; CAN THEY BE PUT BACK INTO SERVICE? Yes, but they will be subject to disposal requirements at a later date. / -17- \ fict* c c b e ^ i MW (54) I NEED SPECIAL PCB CAPACITORS TO SERVICE MY PCB EQUIPMENT. WILL I BE ABLE TO BUY REPLACEMENT PCB CAPACITORS? If suppliers receive an-exemption from EPA, they can sell existing stocks of PCB capacitors to service existing PCB equipment. MINING EQUIPMENT (55) WHAT TYPE OF MINING MACHINES ARE LIKELY TO HAVE PCBs? PCBs are found in the electric motors in continuous miners and loader-type equipment that were manufactured up through the early 1970's. (56) CAN I CONTINUE TO. USE THESE MACHINES? In general, these machines can be used until January 1, 1982. The new rules set up a schedule whereby the motors in the equipment can be converted to non-PCB types. It appears that the continuous miner motors cannot be converted, which means the older models with PCB motors will probably have to be scrapped. (57) CAN I REPAIR THESE MACHINES? Servicing or repair of PCB mining equipment is permitted only for persons who are granted an exemption by EPA. PCB motors in continuous miner-type equipment may be rebuilt until December 31, 1979. PCB motors in loader-type equipment must be rebuilt as air-cooled or other non-PCB containing motors whenever they are returned to a service shop for servicing. After January 1, 1982 PCBs may not be added to mining equipment. (.58) CAN I REBUILD THESE MACHINES? Yes you can. In fact, when you have the loader serviced the motor must be rebuilt as a non-PCB motor. Rebuilding of the PCB motors in continuous miners is permitted only until December 31, 1979. -18- ACH C C 6822 (59) CAN I SCRAP THESE MACHINES? Yes, .but first the PCB motors must be removed and properly disposed. PCB motors can either be incinerated or, after drain ing the PCBs, placed in a chemical waste landfill. (60) HOW LONG CAN I USE THESE MACHINES? PCBs cannot'be used in mining equipment after January 1, 1982. HYDRAULIC SYSTEMS (61) DO ALL HYDRAULIC SYSTEMS HAVE PCBs IN T&EM? Probably not. PCB hydraulic fluid was developed for use in machines that were subject to high temperatures, such as aluminum die casting machines and hydraulic machines in steel mills. Be cause of their low flammability, PCBs provide an extra measure of fire protection. The use of these high concentration fluids was discontinued several years ago by most users, because of serious water pollution problems. However, residues of the original fluid remain in sufficient quantities to be of continuing envi ronmental concern.* In addition, it is possible that hydraulic systems on other machines that did not pose any special fire risk also had these PCB fluids added to them. These may be sufficiently contaminated to require action under these regulations. (62) CAN THESE PCB CONTAMINATED HYDRAULIC SYSTEMS'CONTINUE TO BE USED? IS ANY CORRECTIVE ACTION NECESSARY? These PCB contaminated systems can be used until July 1, 1984, provided that a corrective program of testing, draining, refilling, and/or topping-off is undertaken. (63) HOW OFTEN MUST I TEST MY HYDRAULIC SYSTEM? Any hydraulic system that ever contained PCB hydraulic fluid must be tested by November 1, 1979, and, at least annually there after, until the system reaches 50 ppm PCB. -19- AC* CC (64) DO I HAVE TO DRAIN AND THEN REPLACE ALL OF THE HYDRAULIC FLUID IN MY MACHINES WHENEVER THEY EXCEED 50 PPM PCBs? The regulations provide a flexible approach for reducing pcb concentrations. Highly contaminated systems will have to be drained and probably flushed and wiped clean in order to effec tively reduce the PCB levels.' Other systems may be effectively decontaminated by a drain and refill approach. Systems with low level contamination or borderline levels may be effectively con-* trolled by simply topping-off -ith non-PCB fluid. (65) ARE THERE ANY RESTRICTIONS ON THE FLUIDS THAT CAN BE ADDED TO THESE SYSTEMS? No fluids containing more than 50 ppm PCBs can be added. This means that fluids collected from leaking seals, fittings, etc. cannot be returned to the systems if the fluid exceeds 50 ppm PCBs. 4' HEAT TRANSFER SYSTEMS (6 6 ) DO HEAT TRANSFER SYSTEMS CONTAIN PCBs? WHAT ARE THE REQUIREMENTS FOR USE/OR REMOVAL? PCBs have been used in heat transfer systems-because of their high .heat retention capacity. These systems do leak at times, and, therefore, are controlled by this rule. The re quirements for testing, refilling, and topping-off are very similar to hydraulic systems. (67) ARE THERE DIFFERENT REQUIREMENTS FOR HEAT TRANSFER SYSTEMS USED IN THE MANUFACTURE OF FOODS, DRUGS, AND COSMETICS? Yes, after November 1, 1979 all heat transfer systems must contain fluid with 50 ppm PCB or less if they are to be used in the manufacture or production of foods, drugs, and cosmetics.. OTHER PCB USES (6 8 ) CAN PCBs BE USED AS A MOUNTING MEDIUM FOR MICROSCOPIC SLIDES? Yes, until July 1, 1984. EPA will decide later whether to extend the authorized time for this PCB use. -20- h i* CC te c h (69) CAN PCBs CONTINUE TO BE USED IN SMALL QUANTITIES FOR * RESEARCH AND DEVELOPMENT? . Yes, until July 1, 1984, As with microscopic slides, EPA will decide later whether to.extend the authorized time for use. (70) IN THE EARLY 1970's CARBONLESS COPY PAPER WAS MADE WITH INK CONTAINING PCBs. WHAT PROVISIONS DOES THE PCB BAN RULE MAKE FOR THIS PAPER? Although carbonless copy paper is no longer made with PCBs, supplies of this paperstock still exists; most are in files. Because the amount of PCB on each sheet is extremely small and no inexpensive method of separating PCB from non-PCB carbonless pa per has been developed, EPA has authorized the use of existing PCB carbonless copy paper indefinitely. (71) SOME PIGMENTS CONTAIN PCBs, CAN THEY CONTINUE TO BE USED? EPA's PCB Ban Rule authorizes the use of diarylide and pthalocyanine pigments, containing PCBs as an impurity in con centrations ranging from several thousand parts per million to 50 ppm, until January 1, 1982. However, after July 2, 1979, these pigments, containing greater than 50 ppm PCB, cannot be manufactured, and they cannot be processed or distributed in commerce after July 1, 1979, unless EPA grants exemptions for these activities. (72) OTHER CHEMICALS ALSO CONTAIN PCBs IN LOW CONCENTRATIONS, CAN THEY CONTINUE TO BE USED? At this time, EPA's Ban Rule does not authorize the use of any other chemicals containing PCBs. Several manufacturers have requested exemptions to manufacture chemicals with low concen trations of PCBs, and, if these exemptions are granted, EPA will consider appropriate authorizations to permit the use of the chemicals. (73) IF SOMEONE MANUFACTURERS PCB CONTAMINATED CHEMICALS BUT DID NOT APPLY TO EPA FOR AN EXEMPTION CAN THEY STILL REQUEST ONE? Anyone in that situation should apply to EPA for an exemption using the procedures EPA published in the Federal Register on November 1, 1978. (See the "Contacts for Infor- k 2 1 - ACM C C c e 2 5 mat ion"'Section of this Booklet to find o,ut how to obtain a copy of this Federal Register Notice.) (74) CAN ELECTROMAGNETS CONTAINING ECBs STILL BE USED? EPA considers the use of electromagnets (similar to trans formers in construction) containing PCBs to be used in a totally enclosed manner, therefore, these PCB elecromagnets may continue to be used and serviced. Persons may service their own PCB electromagnets. However, if someone else adds PCBs, not owned by the electromagnet owner, during the servicing, they must obtain an exemption from EPA after July 1, 1979. (75) CAN PCBs CONTINUE TO BE USED IN NATURAL GAS^ PIPELINE COMPRESSORS? Yes, until May 1, 1980. in general, these systems were drained of high concentration PCB fluid several years ago, thus removing most of the PCBs. EPA has authorized these compressors to be used until May 1, 1980 -- so that they can be drained and refilled with non-PCB fluid to further reduce the PCB concentration until it is below 50 ppm. LABELING (76) WHAT NEEDS A LABEL? Most PCB Items (including PCB Containers, PCB Article Containers, PCB Articles, PCB Equipment, and PCB Transport Vehicles) that contain 50 ppm or greater PCBs must be labeled. This labeling requirement is a modification from the February 17, 1978 Disposal and Marking Regulation which applied to PCB Items that contain 500 ppm or greater PCBs. To provide sufficient time to identify and mark these additional items containing between 50 and 500 ppm PCB, the final May 1979 Rule allows until October 1, 1979 for labeling requirements to be met. (77) DO ALL TRANSFORMERS CONTAINING PCBs HAVE TO BE LABELED? PCB Transformers, containing 500 ppm or greater PCB, are required to be labeled. PCB-Contaminated Transformers, con taining between 50 and 500 pph* PCB, are not required to be labeled. The cost of marking a very large number of PCBContaminated Transformers while they are in service would be -22- ACM C C c i t 1 ' -C ^ extremely high (approximately $10 for each of the 35 million transformers). An unmarked transformer is automatically assumed to be a PCB-Contaminated Transformer. However, if a transformer has no nameplate information but there'is a reasonable suspicion that PCBs may be present above 500 ppm --- the transformer should be labeled as a PCB Transformer until the PCB content can be verified. (78) WHERE DO I HAVE TO PUT THE LABELS? All labels (or marks) are to be put on the exterior of PCB Items and transport vehicles in a place that they can be easily seen and read by anyone inspecting or servicing them. 9 (79) THERE ARE A LOT OF PCB CAPACITORS AND EQUIPMENT CONTAINING THESE CAPACITORS IN USE. DO THEY ALL HAVE TO BE LABELED? The requirements for labeling capacitors are primarily related to disposal; the labels serve as a positive reminder regarding disposal. All large, high voltage PCB capacitors have to be labeled, including those in service. Large, low voltage capacitors have to be labeled when they are taken out of service, for disposal Small capacitors do not have to be labeled. Equipment con taining PCB capacitors does not have to be labeled unless the capacitor is a large, high voltage type or if the equipment was produced after January 1, 1979 and contains a small PCB capacitor. (80) DO I HAVE TO LABEL A PCB CAPACITOR THAT IS ON A POLE OR IN A SIMILAR INACCESSIBLE LOCATION? If a PCB capacitor is installed in a "protected" area (e.g., on a power pole, or structure, or behind a fence) the pole, structure, or fence is to be labeled, in a place easily seen by interested persons, such as servicemen. (81)' I SUBMITTED A PETITION TO EPA TO BE GRANTED AN EXEMPTION FROM THE JULY 2, 1979 MANUFACTURING BAN. IF I AM GRANTED AN EXEMPTION, WHAT WILL THE LABELING REQUIREMENTS BE FOR THE PCBs I MANUFACTUR? Any labeling requirements for chemical substances or mix tures containing 50 to 500 ppm PCBs manufactured after July 2, -23- ACM CC 7 1979, including PCBs that are byproducts or impurities, will be included in the exemption response EPA might grant to permit such manufacture.' If you have already submitted a petition to EPA for a manufacturing exemption and your-chemical contains less than 500 ppm PCBs, you do not have to apply a label until EPA acts on your petition. However, any container or any products that contain 500 ppm or greater PCB must be labeled -- even before EPA acts on the petition for your chemical. (82) IF RENTED OR LEASED EQUIPMENT CONTAINS PCBs, WHO IS RESPONSIBLE FOR LABELING? Both the owner and the operator could be held responsible for the labeling of rented PCB equipment. $ (83) DOES EPA SUPPLY LABELS FOR PCB CONTAINERS OR PCB ARTICLES. AND EQUIPMENT? DOES EPA PROVIDE NAMES OF SOURCES FOR SUCH PCB LABELS? EPA does not supply any PCB labels. However, the Agency knows of two sources from which you can obtain the required labels: LABELMASTER,-7525 North Wolcott Ave., Chicago, Illinois 60626, phone: 312-973-5100 -- to place only orders call toll free 800-621-5808 (except in Illinois); W.H. BRADY CO., Faci lities, Identification, Products Division, 727 W. Glendale Ave., Milwaukee, Wisconsin, phone: 414-332-8100 (X624). Printing shops who produce labels would also be potential sources for these labels. The label format and sizes are included in the regulation. TESTING (84) IS THERE AN EPA APPROVED TESTING AND SAMPLING PROCEDURE FOR PCB DETECTION? A variety of procedures exist for determining PCB con centrations in various media such as water/ air, soil, mineral oil, pigments, etc. EPA has already made available through its Regional offices copies of test procedures for PCBs in air, soil, water, and sediments. EPA is also preparing additional infor mation on test procedures for PCBs in oils; this information will also be available from EPA Regional Offices. In addition, copies of these procedures can be obtained from EPA's Office of Industry Assistance. (See the "Contacts for Information" Section of this Booklet on how to obtain this information.) -24- ALP- C C c c i (85) WHAT EQUIPMENT IS AVAILABLE TO DETECT PCBs? There is no simple field test for detecting PCBs. it is usually done using gas chromatography/electron capture. The best solution would be to contact an experienced chemical laboratory in your area that could perform* such tests. (8 6 ) ARE THERE EPA APPROVED LABS TO ANALYZED SAMPLES OF PCBs? No, EPA does not have a program for recommending or approving analytical laboratories. STORAGE (87) WHAT KINDS OF CONTAINERS ARE APPROPRIATE FOR STORAGE? The May 31, 1979 Final Rule permits 5 container types (5, 5B, 6D, 17C and 17E) which comply with Department of Trans portation (DOT) specifications set out in 49 CFR 173.346, to be used to store liquid PCBs. Most of industry already is using these containers for PCB storage and handling. (8 8 ) CAN LARGE CONTAINERS, SUCH AS STORAGE TANKS, BE USED FOR THE STORAGE OF PCB LIQUIDS? EPA decided in the Final Rule to permit large containers, such as storage tanks, to be used to store bulk PCB liquids. This is to allow safe transfer and storage of large PCB liquid quantities; in addition, reduce storage costs. In other words, the transfer of stored bulk PCBs from tanks to other tanks or tank trucks will lessen the spill risks as opposed to having to .transfer these large quantities from a number of smaller storage drums into transfer tanks. These storage tanks must meet design and construction standards adopted by OSHA (29 CFR 1910.106). Also the storage facilities must have a spill prevention control and counter measure plan similar to the plans required for oil spill prevention. Owners and operators of bulk storage facilities will have to keep records of the amounts added to and removed from bulk containers. These records will be important in tracing waste shipments and enforcing the\disposal and storage requirements. -25- A > CCteZS (89) CAN PCB CONTAINERS OF CONTAMINATED SOIL BE TEMPORARILY STORED? Yes, non-liquid PCB wastes, such as contaminated soil, can be temporarily stored for up to 30 days. (90) CAN PCB LIQUIDS OF LCW CONCENTRATION BE TEMPORARILY STORED? OE HIGH CONCENTRATION? Low concentration PCB liquids (50 to 500 ppm) can be temporarily stored for up to 30 days. All temporary storage areas must have a spill prevention control and counter measure plan. However, the final rule does not allow temporary storage for high concentration PCB liquids (above 500 ppm) because of the potential harm from a spill. (91) I HAVE A SMALL QUANTITY OF PCBs (I.E., A FEW SOAKED RAGS AND 1 GALLON OF PCBs IN AN APPROVED CONTAINER), AND I DON'T WANT TO SEND THEM A LONG DISTANCE FOR DISPOSAL. CAN I STORE THEM UNTIL A PCB DISPOSAL SITE CLOSE TO ME IS APPROVED? The mentioned items may be stored until the last day of 1983. (92) ONCE PCB ARTICLES ARE TAKEN OUT OF SERVICE, HOW LONG CAN THEY BE KEPT BEFORE BEING PLACED IN AN APPROPRIATE STORAGE AREA? WHAT ABOUT PCB EQUIPMENT CONTAINING LEAKING PCB ARTICLES? Non-leaking PCB articles and PCB containers containing leaking articles can be temporarily stored for up to 30 days. (93) WHEN PCB CAPACITORS OR CONTAINERS ARE STORED IN AN APPROPRIATE STORAGE AREA, WHAT HAPPENS WHEN ONE OF THESE ITEMS STARTS TO LEAK? A leaking PCB capacitor should be immediately placed in a non-leaking Department of Transportation approved drum and any spillage cleaned up using sorbent or suitable solvents. It is a good practice to add sorbent material, such as saw dust, to the container to soak up any liquid that continues to leak out of the capacitor. t -26- ALf* C C 6 c 3 C When a container develops a leak, the contents should immediately be transferred to another, non-leaking container or to special "overpack" containers, such as those used in the chemical industry for leaking-containers (94) MUST THE EPA INSPECT A PCB STORAGE AREA ONCE IT IS BUILT BEFORE IT CAN BE USED? No, it is the .responsibility of the organization storing the PCBs to insure that the storage area meets the specifications. (95) DO PCB STORAGE AREAS HAVE TO BE PERIODICALLY CHECKED FOR LEAKS OR OTHER PROBLEMS? WHAT ABOUT PCB ARTICLES, SUCH AS TRANSFORMERS, THAT ARE IN SERVICE? PCB storage areas must be checked by the owner or operators at least every 30 days. Articles in service are not required to be checked by the regulations, but periodic checks would be a wise practice. SPILLS (96) DO PCB SPILLS HAVE TO BE REPORTED Under the authority of TSCA, PCB spills have to be reported whenever the incident poses a substantial risk to human health or the environment. Since "substantial risk" cannot be precisely defined, however, any spill should be reported when people come into direct and uncontrolled contact with PCBs, or the extent of the spill is large engugh to expose significant numbers of ani mals. In addition, a spill should also be reported when the volume or the extent of the spill is unknown -- such as spills that enter drainage systems. PCB spills into water, onto shorelines, or those that threaten water-courses should always be immediately reported. EPA is currently completing regulations under the Clean Air Act that will require reporting for water-related hazardous chemical spills (including (PCBs). These regulations will have criminal penalties for failing to report such spills. As a general rule, skills involving a single capacitor do not have to be reported unless PCBs threaten or enter a water course. Because of the greater threat to health and the envi ronment, transformer spills should be reported -- unless oply -27- ACfc CC6 63 1 minor leaks, such as bushing leaks, are involved. Any spilling or leaking should be stopped and repaired as soon as possible. (97) HOW DO I REPORT PCB SPILLS? PCB spills can be reported to the National Response Center operated by the U.S. Coast Guard at 800-424-8802 (in the District of Columbia, caLl 426-2675). (98) WHAT HAPPENS WHEN I REPORT A PCB SPILL? CAN I GET INFORMATION OR ADVICE ON WHAT TO DO ABOUT THE SPILL? The National Response Center will direct the report to the appropriate EPA environmental emergency office, based on the location of the spill. Experts from these offices (or related state and local experts) will contact persons responsible for the spills, in order to evaluate the potential environmental threat and to determine the appropriate spill control and cleanup measures. I (99) IF I HAVE A SPILL, WHAT SHOULD I DO TO CONTROL OR CLEAN UP THE SPILL? - The first priority is to control the spread of the spill by damming or diking the leak. Also, any threats to water should be given top priority. Once a spill is contained clean up measures can begin. Clean up can be simply the removal of contaminated soil or debris. In some cases, more complex techniques may be required, such as special PCB sorbents or special filtration/carbon absorption removal of PCBs from water. Large and complicated spills should be cleaned up by trained and experienced personnel. Organizations, who frequently handle PCBs, should develop contingency plans and conduct training for dealing with spills. Commerical firms are also available on a contract basis to clean up spills. Government spill experts can provide information on such firms. RECORDKEEPING (100) MUST COMPANIES KEEP, RECORDS OF THE DI5POSITON OF PCBs IN SERVICE? IN STORAGE? IF SO, FOR HOW LONG? If you own or operate a facility which uses PCBs or PCB Items, or have either stored, you are to keep records of their -28- AO. CCtcdi disposition. Specifically, this applies to facilities using or storing at least 99.4 pounds.(45 kilograms) of, PCBs in PCB Container(s)? one or more PCB Transformers? or 50 or more PCB High or Low Voltage Large Capacitors. These records shall be maintained for at least 5 years after the facility ceases Using or storing PCBs or PCB Items in prescribed quantities. (101) DO PCB INCINERATOR FACILTIES HAVE TO KEEP RECORDS? CHEMICAL WASTE LANDFILL FACILITIES? HIGH EFFICIENCY BOILER FACILITIES? IF SO, FOR HOW LONG? Owners or operators of all three types of PCB Disposal Facilities have to keep records. Incinerator and high efficiency boiler facilities must keep their records fo$ 5 years; chemical waste landfill facilities must keep their records for at least 20 years after PCBs have stopped being disposed there. (102) WHEN MUST I BEGIN KEEPING RECORDS OF MY PCB FACILITIES? PCB recordkeeping, if applicable, was to have begun on July 2, 1978. These records form the basis of an annual document prepared for each .facility by July 1; the first annual reports should be compiled by July 2, 1979, (103) MUST COMPANIES SEND THEIR ANNUAL REPORTS CONCERNING PCBs TO EPA OR KEEP THEM FOR THEIR OWN RECORDS? Companies should keep their PCB records and annual reports at their facility for inspection by EPA personnel. Do not send the records or reports to EPA unless it is specifically requested by the Agency. (104) I HAVE PCB FACILITIES IN SEVERAL LOCATIONS. DO RECORDS HAVE TO BE KEPT AT EACH SITE? Owners or operators of more than one facility having PCBs may choose to keep all of the records at a single facility, but the identify of that single facility must be available at each location. The record location must be manned at least 8 hours a day. -29- C C cfcii DISPOSAL (105) HOW DO I DISPOSE OF TRANSFORMERS CONTAINING PCBs? There are two ways to dispose of a PCB Transformer, which contains PCB concentrations in excess of 500 ppm. The trans former and the dielectric fluid can be burned together in a high temperature incinerator approved by EPA, or the liquid can be drained out of the transformer first. If the liquid is drained, the transformer must be flushed with solvent for 18 hours; the solvent and the dielectric fluid must then be disposed of in an EPA approved high temperature incinerator. The drained trans former after it is resealed must be disposed of in a chemical landfill which has been approved by EPA. If the transformer is a PCB-Contaminated Transformer, containing more than 50 ppm PCB and less than $00 ppm PCB, the transformer and the liquid can also be incinerated or the di electric liquid can first be drained. If the liquid is drained it can be disposed of in a high temperature incinerator, a chem ical landfill which has been approved by EPA, or in a high effi ciency boiler. The drained transformer can be disposed of as scrap or in a disposal facility equivalent to good municipal solid waste disposal practices. (106) HOW DO I DISPOSE OF LARGE PCB CAPACITORS? Until January 1, 1980, large PCB capacitors can be disposed of in EPA approved chemical waste landfills or high temperature incinerators. After January 1, 1960, they must be disposed of by high temperature incinerators. It is expected that hammermilltype crushers will be used at the incinerators to improve the de struction efficiency. These large capacitors account for approx imately one-third of the PCBs currently in service. (107) WHERE CAN PCB ARTICLES (OTHER THAN PCB TRANSFORMERS AND CAPACITORS) BE DISPOSED? PCB articles can be disposed of in a chemical waste land fill, as well as, in high temperature incinerators, provided they are EPA approved. Examples of these articles, which account for less than 1% of the PCBs currently in use in the U.S., are pipes, hoses, parts of heat transfer systems, electromagnets, and electric motors. When these articles aVe disposed of in chemical waste landfills, they must be drained of free flowing liquid, and therefore, will contain only small amounts of PCBs. h -30- ACfc C C d d 3 *t (108) ARE THERE SPECIAL DISPOSAL REQUIREMENTS FOR SMALL PCB CAPACITORS CONTAINED PRIMARILY IN SMALL APPLIANCES AND FLUORESCENT LIGHT BALLASTS? No, small capacitors can be disposed of as municipal waste. EPA has determined that the random disposal of small capacitors in municipal solid waste sites by householders and other infrequent disposers does not present an environmental hazard. However, the disposal of large quantities of small PCB capacitors by commercial and industrial activities poses a larger environmental risk. Therefore, EPA encourages these persons to establish voluntarily a collection and disposal program that would result in the waste capacitors going to chemical waste landfills or high temperature incinerators. (109) HOW ARE HYDRAULIC MACHINES CONTAMINATED WITH PCBs TO BE DISPOSED? In general, only a relatively small portion of these ma chines are contaminated with PCBs, in particular those used in die-casting and forging operations. Therefore, instead of re quiring disposal in a chemical waste landfill, the final rule permits disposal of hydraulic systems as municipal solid waste and salvaging of these machines after draining. First, the ma chines must be drained of all free-flowing liquid. If the fluid contains more than 1000 ppm PCBs, the machine must be flushed with a solvent and thoroughly drained before disposal. The liquid must be disposed of by high temperature incinerators or, if the PCB concentration is 50 to 500 ppm, by high efficiency boilers or in chemical waste landfills. (110) HOW CAN I DISPOSE OF THE DIELECTRIC FLUID IN MY TRANSFORMER? Fluids from PCB Transformers (concentrations of 500 ppm greater) must be disposed of only by high temperature incin eration. Fluids from PCB-Conta.-inated Transformers (with 50 ppm to 500 ppm PCBs) must be disposed of in high efficiency boilers, in approved chemical waste landfills, or in high temperature incinerators. Fluids from Non-PCB Transformers (with less than 50 ppm PCBs) have one disposal restriction: they cannot be used as a sealant, coating, or dust control agent if they contain any detectable PCB. \ h -31- . ACM CC6 fc35 (Ill) WHERE CAN OTHER LIQUID WASTES WITH OVER 500 PPM PCB BE DISPOSED? BETWEEN 50 and 500 PPM PCBs? LESS THAN 50 PPM PCBS? The same disposal options apply as for transformer dielectric fluid, (refer to Question #110). (112) WHERE CAN NOti-LIQUID PCBs BE DISPOSED? Non-liquid PCBs at any concentration (e.g., contaminated rags and absorbent materials, and contaminated soils and other solids recovered from spills or removed from old disposal sites) can be disposed in Annex II chemical waste landfills* (113) CAN DECONTAMINATED PCB CONTAINERS BE DISPOSED OF IN AN ORDINARY LANDFILL SITE? Yes, decontaminated PCB containers may be disposed of in ordinary landfill sites, rather than in EPA approved chemical waste landfills. (114) CAN DECONTAMINATED PCB CONTAINERS BE REUSED? Containers decontaminated in accordance with Annex IV can be reused for general use. (115) HOW CAN PCB CONTAINERS USED ONLY TO HOLD LOW PCB CONCEN TRATIONS BE DISPOSED? PCB Containers used only to contain materials or fluids with PCB concentrations between 50 and 500 ppm can be disposed of as municipal waste. (116) WHAT ARE THE REQUIREMENTS FOR DISPOSAL SITES? Incinerators used to dispose PCBs must be approved by the appropriate EPA Regional Administrator. The approved incin erators must meet the requirements set out in Annex I of the May 31, 1979 Rule. Likewise, the chemical waste landfills used for the disposl of PCBs and PCB Items must be approved by the appropriate EPA Re gional Administrator, which must meet the requirements estabished in Annex II of the Final Rule. k / -32- ACf* C C c i f c (117) H&VE ANY DISPOSAL SITES BEEN APPROVED FOR PCBs? WHERE ARE THEY? Yes, eight chemical waste landfill sites have been ap proved. No incinerator sites .have yet been approved, but three sites are currently being considered. The landfill locations are as follows: 1. Facility; General Electric Co., Silicone Products Division. Facility Address: 260 Hudson River Rd., Waterford, N'v.v York 12189. Facility Telephone Number (518) 237-3330. Type of facility Approved: Incinerator. Type of PCB Waste Handled: Approval allows G.E. to incinerate only those PCB wastes which are generated on site, i.e., G. E. can not accept PCBs. for incineration from any other company or any other G.E. facility. Expiration Date of Approval: September 1, 1981. EPA Regional Office Contact: Wayne Pierre. EPA Telephone Number: (212) 264- 0505. 2. Facility: Newco Chemical Waste Systems, Inc, Facility Address: 4526 Royal Avenue, Niagara Falls, New York 14330. Facility Telephone Number: (716) 285-6944. Type of Facility Approved: Chemical Waste Landfill. Type of PCB Waste Handled: Capacitors (small and large); Properly drained transformers: Contaminated soil, dirt, rags, and other debris; Dredge spoils; Municipal sludges; and Properly drained containers (drums). Expirationd Date of Approval: August 18, 1981. EPA Regional Office Contact: Wayne Pierre. EPA Telephone Number: (212) 2640505. 3. Facility: SCA Chemical Services, Inc. Facility Address: 1550 Balmer Rd., Model City, New York 14107. Facility Telephone Number: (716) 754-8231. Type of Facility Approved: Chemical Waste Landfill. Type of PCB Waste Handled: Capacitors (small and large); Properly drained transformers; Contaminated soil, dirt, rags, and other debris; Dredge spoils; Municipal sludges; and Properly drained containers (drums). Expiration Date of Approval: October 2, 1981. 4. Facility; Waste Management of Alabama, Inc. Facility Address: P.O. Box 1200 Livingston, Alabama 35470. Facility Telephone Number: (205) 652-9529. Type of Facility Approved: Chemical Waste Landfill. Type of PCB Waste Handled: Capacitors (small and large): Properly drained transformers; Contaminated soils, dirt, rags, and other debris; Dredge spoils; Municipal sludges; and Properly drained containers (drums). Expiration Date of Approval: Open-ended. EPA Regional Office Contact: Mr. James Scarbrough. EPA Telephone Number (404) 881-3016. 5. Facility; Casmalia Disposal. Facility Address: 539 Ysidro Rd., p7o . Box 5275, Santa, Barbara, California 93108-main office (site located near Casmalia in Santa Barbara County). Facility Telephone Number: (805) 969-4703. Type of Facility Approved: -33- ADM CC 36 3 7 iMfia Chemical Waste Landfill, Type of PCB Waste Handled: Capacitors (small and large): Properly drained transformers; Contaminated soil, dirt, rags and other debris; Dredge spoils; Muncipal sludges; and Properly drained containers (drums). Expiration Date of Approval: Open-ended, ' EPA Regional Office Contact: Raymond Seid, EPA Telephone Number: (414) 556-3450, 6 , Facility: Nuclear Engineering Co,, Inc, Facility Address: 9200 Shelbyville Rd., Suite 526, P.O. Box 7246, Louis ville, Kentucky 40207, main office (site located near Beatty, Nev. in Nye County), Facility Telephone Number: (502) 4267160. Type of Facility Approved: Chemical Waste Landfill. Type of PCB Waste Handled: Capacitors (small and large); Properly drained transformers; Contaminated soil, dirt, rags and other debris; Dredge spoils; Municipal sludges; and Properly drained containers (drums). Expiration Date of Approval: Open-ended. EPA Regional Office Contact: Raymond Seid. EPA Telephone Number: (415) 556-3450, jS 7, Facility: Chem-Nuclear Systems. Inc, Facility Address: P.O. Box 1269, Portland, Oregon 47205 main office (Site located in Arlington, Oregon). Facility Telephone Number: (503) 2231912. Type of facility Approved: Chemical Waste Landfill. Type of PCB Waste Handled: Capacitors (small and large): Properly drained transformers; Contaminated soil, dirt, rags, asphalt, and other debris; and Properly drained containers (drums). Expira-- ation Date of Approval: January 1, 1980, EPA Regional Office Contact: Mr, Roger Fuentes. EPA Telephone Number: (206) 4421260. 8 , Facility: Wes-Con,, Inc. Facility Address: P. O. Box 564. Twin Falls, Idaho 83301. main office (Site located in Grand View, Idaho). Facility Telephone Number: (208) 7347711. Type of Facility Approved: Disposal in Missile Silos. Type of PCB Waste Handled: Capacitors (small and large); Properly drained transformers; Contaminated soil, dirt, rags, asphalt, and other debris; and Properly drained containers (drums). Expiration Date of Approval: January 1, 1980. EPA Regional Office Contact: Mr. Rogers Fuentes. EPA Telephone Number: (206) 442-1260. (118) CAN A COMMON CARRIER (E.G., TRUCK LINE) TRANSPORT PCBs FOR A COMPANY TO A DISPOSAL FACILITY IF THE TRANSPORT IS NOT WITHIN THE INDUSTRY? If the common carrier complies with the Hazardous Materials requirements set by the Department of Transportation, and the vehicle is properly and visibly labeled on its exterior with a PCB label it can be used o transport PCBs to a disposal site. -34- t A CC6S3 a (119) CAN PCBS OR PCB ITEMS BE EXPORTED FOR DISPOSAL? BE IMPORTED FOR DISPOSAL? Yes, refer to Question #23 in the "Import/Export" section of this Booklet. PCBS IN THE WORKPLACE (120) \RE THERE ANY OSHA RULES GOVERNING PCBs IN THE WORKPLACE? No, not at the present time? however, in 1977 the National Institute of Occupational Safety and Health (NIOSH) -- the HEW organization responsible for researching workplace safety -- published "Criteria for a Recommended Standard ... Occupational Exposure to Polychlorinated Biphenyls (PCBs)T, OSHA, associated with the Department of Labor, will use this document to develop mandatory standards regarding PCBs. (121) WHAT IS A RECOMMENDED STANDARD FOR OCCUPATIONAL EXPOSURE? WHAT IS THE STANDARD RECOMMENDED BY NIOSH FOR OCCUPATIONAL EXPOSURE TO PCBs? A recommended standard is a determination of the level of exposure that will substantially reduce any risks of reproductive or tumorigenic effects of PCBs and prevent other adverse effects of exposure in the workplace. It is based on a 10-hour workday, 40-hour workweek, over a normal working lifetime. NIOSH has recommended in their Criteria Document for PCBs that occupational exposure to PCBs be controlled so that no worker is exposed at a concentration greater than 1.0 microgram total PCBs per cubic meter of air (1.0 Mg/cu m ) , determination as time-weighted average (TWA) concentration, for up to a 10-hour workday, 40 hour workweek. This is only a recommended standard and it has not been adopted to date, by either OSHA or EPA. At the present time, however, OSHA is reviewing this recommended standard. (122) DID NIOSH RECOMMEND ANYTHING ELSE TO REDUCE EXPOSURE TO PCBs IN THE WORKPLACE? Yes, NIOSH made recommendations about work practices, per sonal protective equipment and clothing, medical surveillance, personal clean up and sanitation practices, and employee information programs. -35- ACM CC663S (123) HOW DO OSHA STANDARDS AND NIOSH RECOMMENDATIONS RELATE TO EPA13 PCB REGULATION? EPA's PCB Rules do not directly regulate workers, but the Rules do restrict or prohibit certain- PCB activities which reduce the number of workers exposed.' The-EPA Rules prohibit PCB trans former and capacitor manufacture, as well as PCB transformer re building (except for railroad transformers); these activities were the major long-term occupational exposures to high concentration PCBs. The rebuilding of PCB railroad transformers and mining ma chine PCB motors will result in long-term worker exposure that will warrant special worker protection, but these activities will be phased out over the next several years. Worker exposure can also occur as a result of PCB spills and authorized servicing operations for PCB transformers. (124) WHAT KIND OF PROTECTIVE CLOTHING SHOULD BE WORN WHEN WORKING WITH PCBs? The type of protective clothing which should be worn when working with PCBs is dependent on the individual circumstances. Worker protective clothing and equipment is intended to prevent skin and eye contact, and control respiratory exposure. Respiratory exposure control (whether individual protection or workplace control) Is most relevant for long-term production operations or major spills. PCB Transformer spills pose respir atory problems because of solvents, such as trichlorobenzene, that are mixed with the PCBs. Small spills, such as capacitor failures, seldom pose, respiratory problems, but protection should be provided for incidents in confined areas. Skin protection can usually be achieved by wearing nonporous gloves and boots and heavy overalls. For major spill clean up activities, a full suit of non-porous clothing may be appropriate. Also, non-porous aprons can be effective in re ducing contamination of worker clothing. Non-porous protective gear can usually be decontaminated with solvents. Work clothing can usually be laundered and reused, unless the.garment is heavily contaminated. It is wise to launder work clothes separately from other garments. Eye protection should be worn when it is possible for PCBs to be splashed in the eyes. Removing contaminated soil does not usually pose such a threat. \ -36 A O CCec<tC (125) It I'GET PCB LIQUID ON MY SKIN,; HOW,CAN I REMOVE IT? If liquid or solid PCBs are splashed or spilled on an employee, contaminated clothing should be removed promptly and the skin washed thoroughly with soap and water for at least 15 minutes. Eyes should be irrigated for at least 15 minutes if liquid or solid PCBs get into them. A drop of vegetable oil may be put into the eye to relieve the irritating effect of PCBs. CONTACTS FOR INFORMATION (126) IF I HAVE OTHER QUESTIONS ABOUT THE PCB BAN RULE'S PROVISIONS, IS THERE SOMEONE I CAN CONTACT? If you have more questions call the Industry Assistance Office on their nationwide toll free number: 800-424-9065; persons in the Washington, D.C. area can reach this Office by calling 554-1404. (127) HOW DO I GET A COPY OF THE RULE? SUPPORT DOCUMENT/ VOLUNTARY ENVIRONMENTAL IMPACT STATEMENT (REFERRED TO IN THE RULES AS THE VERSAR REPORT)? Copies of both can be obtained by calling the phone numbers mentioned in the answer to Question 126, or by writing to: John B. Ritch, Jr., Director Industry Assistance office Office of Toxic Substances (TS-799) U.S. Environmental Protection Agency 401 "M" Street, S.W. Washington, D.C. 20460 \ U .S . G OV U N M tN T HINTING o w a W O -- W T -O V U M -37 i , ' t ) I'M iii `Jj' :IC*JOn ,<nc( SC 3J '*-r.a jt-.ft ,--n ----" -' iJDO ' ~- -'*' -- * -- '- -- --- -- '"-f3C-*s . _ ____ r_--. __ ; ; yt. :'.f> 3. O C IL V c Governor -- n \\ W illiam L. D la seh J STATE OF ILLINOIS D i RCCTOiI AGEPKE N T aH O o T S ' ' X X i v j 1 j j ' O -V .L \ k / l i November 9 , 1971 Monsanto Company *' S a u g e t, I l l i n o i s 62201 Re: Your l e t t e r o f rSeptember 24, 1971 i <^ A tte n tio n : Mr. M. R . Foresaan Dear S ir : , In r e p ly to your req u e st to d isc o n tin u e p e rp e tu a l g o n ito r in g o f HCL and fr e e ch lo rin e g a s , em itted from the chem ical waste in c in e r a to r , the Agency f e e l s , t h a t b e fo re a d e c is io n can be made to d isc o n tin u e the m o n ito rin g , a r e p r e s e n ta tiv e o f th e Agency mast in s p e c t th e m o nito ring o f KCL and c h lo r in e during actu al operation of the in cin erato r. 1 Based on the subm itted w aste a n a ly s is , In c in e r a tio n o f d i- c h lo r o a n ilin e w a ste , may be perm itted under the fo llo w in g c o n d itio n s : Condition 1: D i-c h lo r o a n ilin e waste should be burned in the therm al o x id iz e r a t r a te s not g r e a te r than 800 pounds per hour ~ Condition 2: The operator has the r e s p o n s ib ility to d isp o se o f any a i r contam inants removed or c o lle c t e d by the c o n tr o l equipment in such a manner as to not cause a i r , w ater, or land p o llu tio n . C o n d itio n 3: S ta ck e ff lu e n t should not co n tain more than 5 .0 pounds per hour of hydrogen c h lo r id e , .05 grain o f p a r t ic u la t e s per standard cu b ic fo o t o f a i r , 50 p a r ts per m illio n o f fr e e c h lo r in e and co n ta in no c h lo rin a te d d e r iv a tiv e s o f a n ilin e . The a c tu a l concentra tio n s of these m aterials s h a ll be con tin ou sly determined and recorded acco rd in g to such procedures as are a cce p ta b le to th is Agency. Very tru ly yours, HDilp V* J K eith J .'T o n k lin , Manager x Permit Section D ivision of A ir P ollution Control In the \ew Illinois, wc aciyniiiuduiel ::i>' ..k ;,.;:`.ill jlu AT wvsr Il:FFcni>ON S ? F liv in '." 7; ILLINOIS ( > ' " * * a .-.c a g ,? : * zr.izs.j'-;: ACH CC6 b43 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ,, PCB In s p e c tio n , Monsanto Krunrnrlch P la n t C o rre c tio n JCT: to Calculated Storage Tank Em issions. DATE: HAY 2 0 1576 TMnu. FROM: C h ie f, A ir S u rve illa n ce Branch K a rl Brem er, Member, Lake M ichigan T o x ic Substances Coirmitte e An e r r o r was d isc o ve re d 1n th e c a lc u la tio n o f s to ra g e tank em issions a t the Krunrnrlch P la n t. The vapor pressure o f A ro c lo r 1242 a t 100 C 1s 0 .3 m Hg in ste ad o f 3 m as used 1n the c a lc u la tio n s (see fig u r e 2 .2 from the D ra ft M itre - copy a ttach e d ). A corre cte d re p o rt cover sheet and the se c tio n o f the re p o rt showing the calculations 1s attached. Please provide the corrections to a ll the p a rtie s th a t received the original report. tM h. i s m nw*. ACM C C C ^ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY SUBJECT: FROH: C a lc u la tio n o f PCS A i r Em issions from Storage and Dispensing Operations a t the Kruim rlch P la n t o f Monsanto. Technical A d v is o r, Special Projects Section A 1r S u rve illa n c e Branch TO: G e ra ld F . Regan, C h i e f , A i r S u rv e illa n c e Branch DATE: MAY 2 0 1976 P o te n tia l a i r em issions from th e s to ra g e and dispendin g o f PCB were c a lc u late d based on Inform ation supplied by Monsanto. The re s u lts o f these calculations are: Storage tanks fo r v irg in products Product loading Storage and h andling waste a ro c lo rs $ - 5 9 .7 kg/year - 0.0164 kg/year - 0.00066 kg/year Attachment (C a lcu la tio n s) CORRECTED COPY UNITED STATES ENVIRONMENTAL PROTECTION AGENCY SUBJECT: PCB in s p e c tio n , Monsanto Krunrnrlch P l a n t , Sauget, Illin o is _ .T_ o n 1578 D A T E: *** FROM: II TO: I C h ie f, A i r S u rv e illa n c e B rauch, S u rv e illa n c e and A n a ly s is D iv is io n Ka rl Brem er, Member, Lake M ichigan T o x ic Substances Coirmitte e A p re lim in a ry su rve y was made o f th e above I n s t a l l a t i o n to I d e n t if y and sample p o in t sources o f p o te n tia l PCB em issions to the atmosphere. The sam pling and a n a ly s is were c a rrie d o u t a t th is source to fu rn is h In fo rm a tio n to a r r i v e a t a f u r t h e r d e c is io n th a t may r e q u ire and in te n s iv e te s tin g program to q u a n tify th e PCB e m iss io n s. The sample a n a ly s is revealed the fo llo w in g : SAMPLING LOCATION______________ NO . OF SAMPLES PCB CONCENTRATION uq/M3 Steam E je c to r - Ground L e v e l, S i t e #1 2 * 3A - 2 7.5 38 - 3 3 .9 Steam E je c to r - Top L e v e l S i t e #2 2 3A - N .A . 38 - N .A . Calculated Storage Tank Emissions V irg in Product Product Loading and Waste Storage 5 9 .7 kg/year 0.02 kg/year Monsanto has performed a stack te s t a t the Sauget lo c a tio n q u a n tifyin g th e PCB em issions to th e atm osphere. S ta ck-sam p lin g and o th e r re p o rts d e s c rib in g process and sampling methodology used a t th is s it e are a ttac h e d . * 3A - R ig h t S id e o f sam pling, t r a i n - 3B - L e f t S id e CORRECTED COPY IF* fc* 13304 (%. *.73) 'P L A IN T IF F 'S * ^ EXH IB IT^ I ACM ccefe^fc 2 Emissions: Kg/yr. <60,000 x .0283 x 1.61 x 1 kg "ToSog" ^ Kg/yr. 0.0186 Emissions from handling of waste aroclors: Total waste ittte r la l received Into p]ant~as. reported by Monsanto f o r ST*o*. of 1375 r t,, 6 3 l,000 lbs Assume that aVI this a te r la T ls received and stored at 70*F and that I t displaced an equal volune of tank headspace gas at 70*F. Vol i r a of pwdoct 1,631,000 lbs. x 1 g al. T T T jlb T . x 3.785 lite r gal. X]Q* lljgr A7i,,n3. The concentration would be the same as In the loading operation that Is 1.61 mg/M3, Emissions: Kg/yr. 6 7 1 m3 x 1.6 mg/M3 x 1 kg 10*>- mg Kg/yr. .00066 ti i i i ACM CCe8<t7 Clarence Buckley o f Monsanto estim ated th a t storage and loading o p e ra tio n s a t the p la n t would d isp lace the fo llo w in g volume o f 1 . Storage tanks 635,000 f t 3 2 . Loading 460,000 f t 3 C alcu lation o f em issions: From F i g . 2 .2 'from the D ra ft M itre re p o rt the vapor pressure o f A r o c lo r 1242 Is 0 .3 m Hg a t 100 *C and 10 -4 a t 2 1 * C . The a ro c lo rs are s to re d a t 1 0 0 *C . I t may be assumed th a t th e tem p. In the tanks being loaded would be ap proxim ately 70 "F (2 1 * C ) . From D o lto n 's law o f p a r tia l pressure: Bx Px____ where Bx p ro p o rtio n by v o lu n e .o f a gas component P" m1x. 9 Px p a r tia l pressure o f gas component and P m ix . absolute pressure o f gas m ix tu re . Bx 0 .3 .039 o r 390 ppm 760 r To change ppm to mg/M3 use th e fo llo w in g fo rm u la : mg/M3 ppm x m ol, w t. m olecular volume m o le c u la r volume 3 0 .6 2 l l t e r s / m o l . a t 100#C mg/M3 - 390 x 261 - 3324' Emissions from sto rage . tanks : Em issions kg/year * V o l. o f gas dlsplaced/year x concentration o f PCB K g /y r - 635000 f t 3 x .0283 H3 x 3324 x 1 kg T t3 fo mg Kg/year 5 9 .7 Emissions from loading operations: Bx Px 1 0 " * 1 .3 x 10" 7 o r .1 3 ppm FmT3T. "7SS g/M3 - .13 x 26 1 - 1 .4 1 ng/M3 2 4 .6 4' Aor. ccto^ A ilOOO/T '(K) 'Source: l!ucxinj*cr O * , S. Safe and V Zitko, "The Chem istry of TCHs, CRC Press. Cleveland, O h io , 1974. FICURE 2.2 . VAPOR PRESSURES OP DIFFERENT AKOCLOR PREPARATIONS 3 CM 00 6649 / . / a 'v j K .l s s ; UNITED STATES ENVIRONMENTAL PROTECTION AGENCY W A S H I N G T O N , D.C. 204*0 DEC 3 I S8I orvtci op AMO TOXIC SU M T A M C O MEMORANDUM SUBJECT: Review of Studies oa the Health Effects of PCB FROM: Irwin Baumel Director Health and Environmental Review Division (TS-796) i TO: Margaret J. Stasikowski Acting Director Chemical Control Division (TS-794) As per your request, HERD staff have reviewed the documents on the various health effects of PCB toxicity. Our review is based on the six review documents and the Sumsary of the Health Effects of PCB (susmary of the findings reported in the above six review documents) submitted by CUA. The original articles cited in these documents were not secured and evaluated. Thus, the validity of the conclusions as to the original experimentation and findings cannot be assessed without substantial efforts. Our comments are sunanarized in the attached paper. Contributors for the review are C. C. Lee, J. Springer, C. Jason, J. Toth, C. Nadolney, P. Hurley and D. Kram.. Attachment I \ ACP CC665C G e n e ra l Comments These documents ars somewhat unobjectively written with unscientific discussions such aat On page 3-23 the author statest However, the overzealous use of aatheaatlcal models and the assuaptions made by the EPA without comparing these results to reality are easily demonstrated. * --- The report by the Hew England Gas Association begins "The' discovery of small amounts of FCBs the use of which has been banned by the EPA in natural gas transmission lines is neither unexpected nor cause for public alarm.* Later In discussing acute PCB toxicity the report states: Short term effects of moderate doses in animals are minimal. The toxicity is comparable to that expected from such substances considered relatively safe s u A as table salt alcohol or cafftlne." In discussing chronic effects the report states: "...PCBs produce minimal changes in new b o m s . In fact they are no more toxic to the fetus than aost diemicals, and less toxic with regard to birth defects than soma qommon vitamins and hormones." Summary of the Health Effects of PCBe The "Summary of the Health Effects of PCBa" tends to misguide the reader as to what the actual articles present. The overall tone of the Summary is a refutation of the technical presentation or an exaggeration of the "negative" arguments presented in the six review articles. On pp. 1, 2-1 and 2-2 of the Summary the authors cite and discuss Weisburgsp's and William's concept of promoters and initiators and epigenetie id genotoxlc mechanisms. However, they do not point out that the concept and the classification of carcinogens by Welsburger and Will aim are not shared by many. On pp. 1 2 and 1-5 the authors discuss the large number o negative carcinogenicity studies for PCBs and present the Inadequacies of the positive studies. They do not mention the inadequacies of ths negative studies. Por example the reference papers show that only a few of the negative studies are of sufficient duration to adequately characterise them as negative studies. Most of the studies quoted in the six articles are of one year or less duration (e.g.v sse article by Crump p. 24). For the positive etudies\ they criticise that the length of exposure was too short Cot an adequate study design (p. 2-3). This is not a relevant concern for a positive study. 1 ACM CCfcttSi "genetic," and ytt neither the sequence of bases-nor the number of chromosomes la affected* Because of such difficulties It is better perhaps not to stereotype chemicals. ^ Been if we accept the contractors reasoning It Is important to note that not all mjtagenleity tests on PCBs were negative. In the Monsanto document entitled."A review and evaluation of carcinogenicity la mice and rats and mitagenlclty studies with PCS* several positive mutagenicity tests were cited along with -the negative resultss Aroclor 1221 and 4-chlorobiphenyl were positive in the Ames test. TCB and the 3 4 epoxide of TCB Induced single strand brsaks in DMA of b-929 calls. Kanechlor 300 was found to Induce chroaosoaal aberrations ^ln, vitro while Kanechlor 500 was positive in vivo. Continuous exposure of C3H 10T cells to Aroclor 1254 cauieT cell transformation to type III foci* These cells formed a sarcoma when implanted into irradiated nice. Aroclor 1260 and 2452a,4'5* hexachlorobiphenyl also caused morphological -transformation of C3H lorr rz cells 4-Chlorobiphenyl caused m Increase in unscheduled ORA synthesis in CTO cells while Aroclor 1254 induced chromosome damage in ring doves fsd a 10 ppm diet. Clearly, based on these data one can argue that PCBa may have Initiator activity. Finally, in calculating the risk estimate for Increased human cancer cases caused by exposure to PCBs the contractor made (but did not state) an enormous assumption Zt was assumed that because hepatomas were induced In rodents this was the only tumor type for which humans were at risk. Although the . correlation between carcinogenicity in animals and man is good, the issue of site concordance is not elsar. Therefore, humans i&jy be at risk for other types of tumors as well. Since the incidence of hepatomas in the human population is low, the risk estimate produces a vary low number of PCT induced cancer. However, if these chemicals were also assoclattd with lung carelnoma, for example, risk estimates would be much higher. The latter pajrt of .the Summary consists mostly of a complete refutation of the risk 'assessment done by Crump and Kaateraan, the last' document on the "Assessment of Carcinogenic Risks from PCBs In Food," with very little documentation of the reasons for not accepting Or. Crump1s assessment In his assessment, certain models are used to derive virtually safe doses of PCBs at specified risks Be includes the probit model, the one-hit model, and the multi-stage model Be also uses the one-hit and multi-hit models to derive estimates of Ilfs time extra risks to humans for certain subpopulations at risk Although the "Summary" is interesting reading. In most cases it is not of sufficient scientific validity to warrant a response. In any case, the Summary conclusions for risk assessment v i not supported by tbs technical review documents. In fact, unlike the other section such as epidemiology, the risk assessment section 3 AL: p CCec r -* , 5) The author* of the summary document makes no attempt to estimate any risk* according to their proposed model of cancer. This may be because the probit model, also used by Crump, gives tthe lowest risks of almost any model available at low levels. 1The safe levels shown on page 34 of Grump's report using this model are below the exposure of average capacitor workers, even for risks as high am 10"* - The Epidemiology of PCBs The Epidemiology of PCBs by Gaffey was reviewed In great detail. Our comments are directed to answer, the question of whether his conclusions and generalizations are justified based on our cursery review of the cited studies. We chose to begin with the review of the carcinogenicity section since this is of most Concern. Carcinogenicity Xn general, Gaffey's conclusions concerning the strength of epidemiologic evidence necessary to support a causal association between PCB exposure and carcinogenicity are reasonable in light of the criteria established in Richard Doll's paper. However, several of the studies reviewed by Gaffey (Bertazzi et al. Sack and Musch) suggest an overall Increase in risk from death due to cancer id all studies reviewed by Gaf fey do in fact reveal excesses for specific sites; although most of these excesses were not statistically significant or site concordant with one another. It should be stated at the outset, that the presence of consistency strongly supports causality, but its absence does not rule it out. Gaffey deliberately emitted the preliminary mortality findings of the Tusho incident from this section because this study was not an epidemiologic salysii directed at cancer. Urabe et al reported 11 deaths from malignant neoplasms among 35 confirmed deaths of Tusho victims. The authors state that "this rate (11/3S) is substantially higher than the 21.1% that is the mortality rate from neoplasms In the i m t prefecture" for that year (1977) but tne authors also state that "it would be premature to conclude that this high mortality bears association with PCB poisoning. Nevertheless, three of these deaths were due to liver cancer id two from lung cancer, which suggests some concordance with reports from previous studies (Zack and Musch, Brown and Jonas). Several of the studies reviewed by Gaffey (Bahn et al, Zack and Musch) are based on so few deaths, especially among those workers with ten or more years of exposure or IS years since first exposure, that it would be premature to conclude that PCBs are definitely nan-carcinogenic. For instance, in the one study (Brown and Jones) with the greatest number of person-years observed, there were 1S3 deaths and it is not clear how many of these deaths were among workers with five or more years of exposure or 15 years latency since first exposure to PCBs. 5 ACM CC6fc55 Accidental Heavy Exposure i Gaffey reviews two incidents in this section (Meigs et al, Tusho reports) but Heigs is mors appropriately revieifed in the next section... The numerous studies which '^ave been published in conjunction with the TUsho Incident represent s sizeable Traction of the total health effect literature concerning PCBs. Gaffey, and the authors of the General Electric health effect report, attempt to minimise the relevance of these findings for two main reasons:' (1) samples of the Eastenl Rice Oil were found to be contaainated with dibenxofurans, and (2) v i c t i m of this Incident ingested* large doses of PCBs which e irrelevant to assessing the health effects froa lower occupational exposures found in the United States. Proper evaluation and interpretation of these objections are crucial to the assessment of health effects related to PCB exposure. Tusho disease Is a Japanese term which refers specifically to acute and sub-acute poisoning due to ingestion of Kaaeni Rice Oil which was contaminated with PCBs. There seems to be a general consensus that tha average amount of Kanechlor ingested was estimated to be about 2 gm while the minimum m o u n t ingested by a patient was about 0.5 ga. As of 1977 there were 1,665 victims of TUsho, who exhibitsd a variety of scuts symptoms ranging from severe chloracne and hyperpigmentation to less specific effects such as vomiting and diarrhea. The most notable finding from this incident seems to be that patients seen three and six years after first coming down with Tusho disease still exhibited symptoms of Tusho, biochemical abnormalities and persistent blood levels of PCBs. Unless these effects can all reasonably be attributable to the dibenzofuran contamination, then I would say that tha savarlty, incidence and persistence of these effects 1 warrant serious concern for PCB exposure. Both the specific toxic effects (as determined from animal and human .studies) of PCDFs id PCBs imist be compared, as well as the quantitative,evidence supporting the extent of PCD? contamination. t ... With respect to the preliminary mortality reports, Gaffsy /justifiably calls attention to the problem that the populationat-risk, or denominator of the relative risk rates, cannot be determined, and therefore presents a problem for determining the actual "attack rata" as wsll as ths relevance of elevated cancer deatha among Tuaho victims. This problem is mitigated somewhat by ths finding that among a group of 146 known users of oil, 80 consiDM d less that 720 ml, and 8t percent of these users were affected. Among those who used more than 720 ml, 100 percent were affected. .This would suggest that Tusho victims, as defined by various clinical criteria, do in fact represent tbs total number of people exposed t o .contamlnsted oil. This, of course, is conjecture and is subject to much criticism. But until this problem is resolved, epidemiologic analyses utllyzing the cohort approach may be.inappropriate and unacceptable. 7 AC* CC6657 "Moat studies, including one non-^ccupational study have associated inertased trlpycerides with PCS exposure. Tht <3It* on cholesterol art not consistent? 1 inert*#, * decrease *nd no change war* found (on# study each) RDL cholesterol either decreased or w*# unchanged (on# study each). Even if FOB exposure ha# son* effect on fat metabolism, it appear# to be without any ^ p a r e n t clinical signlficance, Symptoms, Illness and Other Condition! All of the studies reviewed in this section should be aor# thoroughly evaluated, Gaffey quotes Saith et al. as saying "that no studies to date have shown that occupational exposure to FCBs is associated with any adverse health outcome, to be distinguished from demonstrable subclinical biochemical alterations.* It is possible that these biochemical abnormalities have not yet revealed any clinical manifestations, and it is not clear whether-the subclinical alterations present serious health effect concerns. In general, most of these studies are cross-sectional, and therefore make no effort to ascertain the true population-atrisk. In other words, the Investigators did not identify their study populations from historical employment records - thereby ensuring that all workers bad sons minimal duration of exposure and furthermore, these studies made no effort to Identify workers who may have left employmment for occupational health reasons. In most cases, the study population represented those workers currently employed and healthy. I \ 9 ccaas* At* Adiara# Reproductive Puteo-- PIcuta ion w (Health sctecta of Citetrieai Grada P O U ) T.*.! ^^T*`1 1 %m general problems with document ^ l - - ..... '*-?-c ... ^ ; A* " T E l * Impossible to dispute'PCB related p r o b l e m in ~ ladlatlocu -Varlooa amount* of PCDP are always found with p c b . Many Isomers of PCI are found la any mixture of p c b , " acme of which are extremely toxic* .` o . >w *. * ->";jw ~t . . ' " . ~I " ' ' '* * 7: " t. The fate of PCB la adture beside bioaccumulation is not . clear*' For example, photooxldatlon of PCB to PCDP doee occur (Hutslngec 1974) but the probability of such occurrence la nature la not known 0 Heating of PCBa as would 'occur with PCB uae in heat exchangere results in Increaaed convert ion to PCDP. It la not clear how they addreaa thia laaue and Ita Inherent risk. Bow hot do capacitors and "closed* ayatema get la their life time. Vhat convert Ion oecura? 8 Given the limits of our attempts.to eliminate the remaining PCBa In the environment its transport through the food chela uncertain chemical transformations'd worrlease persistence in the animal world as the type of chlorination changes and the degree Increases It appears extremely unwlae to change any position without much further work at the health and basic dienlcal level* II. Deficiencies in consideration of reproductive effects A* Increaaed estrogen effect nay be seen via two different mechaniama. 1* Bstrogen like activity which would add to or compete with endogenous estrogens (uterotrophic activity in rats, Gellett 1971) l 2. Increaaed metabolism of endogenous estrogens throug P effect on hepatic.UFO system. These types of effects could easily account for menstrual Irregularities seen as well as impair the ability to maintain the fetus. Animal atudles Pingar 1972 Lindar 1974, Vllleneune 1971 show pronounced frtility probleas depending upon .PCB type and animal apeclea at lesa than 50 ppm PCB. ' v<* \ ' 10 ACfc C C f c e t C V 'W V- August 10, 1973 .x Dr. Barbara C. Levin National Institute of Health Room 3C25, Building 36 Bethesda, Maryland 20014 * Dear Dr. Levin: In response to your request for samples of Aroclor 1016, Aroclor 1242 and Aroclor 1254 I have enclosed a Request for Sample Quantity of Product Containing PCBa. If you will re turn the completed form to me I Mill make arrangements to have these samples forwarded to you. Kaneclor 400, of which you also requested a sample, is a PCB mixture that at one time was manufactured in Japan but is no longer available. If I can be of further service, please let me know. W. B. Papageorge Manager Product Acceptability W BF/bt Enclosure P L A IN T IF F 'S : ; EX H IB IT - CCt fe d - DEPARTM ENT O F HEALTH. EDUCATION, AND W ELFARE PUBLIC HEALTH SERVICE C tN T C R FOR DISEASE CONTROL August 30, 1976 ** FIlX. N A T IO N A L IN S T IT U T ! FO R O C C U P A T IO N A L S A FE T Y AND HEALTH , ' R O B ER T A. TA FT LA BO R A TO R IES 4 ST S C O LU M B IA PA R KW A Y. CIN CIN N ATI. OHIO 432 26 Paul E. Heisler Monsanto Route 3 Sauget, Illinois 62201 UJ ^ Dear Mr. Heisler: i Enclosed Is a paper describing the method NIOSH Is using to analyze the samples collected at your facility on July 21 and 22, 1976. I apologize for the delay in sending you the Information but the paper Is currently under review and hopefully will be published In the future. I will forward the results of the sample analysis to you as soon as I receive them. Thank you for your cooperation and If you have any questions, call me at (513) 684-3255. Sincerely yours, s enclosures cc: B. Hill TTiflrt-feLOCjfrnfia Mark W. Jones Industrial Hygienist Industrial Hygiene Section ACM CC6663 Polychlorinated Biphenyls.(PCB) in Air Measurements Research Branch Analytical Method DRAFT Analyte: Polychlorinated biphenyls (PCB) Matrix: Air Procedure: Adsorption on Florlsll? desorption with hexane, gas chromatography with electron capture detection Date Issued: Date Revised t l + * / n Method No.: P&CAM 244 Range: 0.001 to 1.5 mg/mPrecision: 4.4Z Relative Standard * Deviation Classification: D (Operational) 1. Principle of the Method A known volume of air is drawn through a small sorbent tube containing FlorisilP* which adsorbs the FCB's present in the air sample. The collected PCB's are desorbed with hexane, and the resulting solutions are analyzed using a gas chromatograph with an electron capture detector. The concentration of FCB's relative to the standard (ArodorR) most resembling the sample is read from a standard curve. 2. Range and Sensitivity The minimum detectable amount of FOB (Aroclor 1016) was found to be 32 plcograms per injection (4 pi injection). If the total desorption volume were'5 ml, this would represent a total sample of 40 ng. The recommended sample volume is 50 liters and thus the lower range of the method is approximately 0.001 mg/m . The upper range is apparently limitless depending only upon the degree of dilution needed to maintain the concentration of the sample within the linear range of the electron capture detector (33 plcograms up to 3 nanograms per injection). Field samples have been found to range as high as 1.5 mg/m 3. Interferences \ 3.1 Strict measures to avoid contamination are required with the electron capture detector. Foremost the syringe must be thoroughly cleaned after each injection. Hexane to be used for desorption and back flush should be injected periodically for a purity check. It should show no peaks later than forty-five seconds providing that not more than 5 pi have been injected. S p L A l N T i F F 'Si 1 , 244-1 ^|pEXH |BIT ACP C C b c t H DRAFT 3.2 Any compound vhlch has nearly the same retention time on the GC column as one of the PCB's Is an interferent. This type of interference can often*be overcome by changing the GC operating conditions or by selecting another column. Retention time data on a single column or even on a number of columns, cannot be considered as conclusive- proof of chemical ident-y. It is important, therefore, that a sample of the bulk mixture of PCB's be submitted at the same time as the sample tubes so that chemical identification of possible interierents can be made. (The bulk sample must not .be shipped In the same shipping container as the sample tubes.) 4. Accuracy and Precision 4.1 The volume of air sample can be measured to within 12 if a pump with a calibrated volume indicator is used. Volumes calculated from Initially set flow rates may be less accurate (52) because of changes in flow rates during sampling. & 4.2 The collection efficiency for PCB's is essentially 1002 as demonstrated by the negligible amount of PCB's collected in the backup section of the sorbent tube. 4.3 No loss of PCB has been observed in sealed tubes or desorbed samples stored for two months. 4.4 The precision of the analysis is dependent upon the precision and sensitivity of the technique used to quantitate the gas chromato graph peaks of samples and standards. 4.5 Known concentrations of PCB's which were spiked on Florisil and allowed to sit overnight were quantitatively (1002) recovered. The precision of twenty-seven spiked samples was reflected by a relative standard deviation of 4.42. 5. Advantages and Disadvantages of the Method 5.1 The sampling device is small, portable, and Involves no liquids. Interferences are minimal, and most of those which do occur can be eliminated by alternlng chromatographic conditions. The tubes are analyzed by means of a quick Instrumental method. 5.2 One disadvantage of the method is that the amount of sample which can be taken is.limited by the number of milligrams that the tube will hold before overloading. When the sample value obtained for the backup section of the Florisil* trap exceeds 252 of that found on the front section, the possibility of sampl * loss exists. During sample storage the more volatile compounds ma> migrate throughout the tube until equilibrium is reached (332 of the sample on the backup section). 244-2 ACK CC6bfc5 1 X7 l < | DRAFT 5.3 The precision of the method is limited by the reproducibility of the pressure drop across the tubes. This drop will affect the flow rate and cause the volume to be imprecise because the pump is usually calibrated for one tube only. 5.4 A substantial difference in air sample composition and the com mercial FCB mixture being used may result in a large error in accuracy since the standardization of this method is based on comparison with the PCB mixture being used. If this is the case an alternate method of standardization (Ref. 4) or determination (Ref. 2)--bay be used. 6. Apparatus 6.1 An approved and calibrated personal-sampling pump with a flow volume meter which operates in the range of 50-200 cc/min is preferred. These pumps should be calibrated with a representative sorbent tube in the sampling line. A wet or dry test meter or a glass rotameter capable of measuring a flow rate of 200 cc/min within +5% may be used in the calibration. 6.2 Sorbent Tubes. Each glass tube is at least 7 cm long with 4 mm l.d. Each contains two sections of 30-48 mesh deactivated FlorisilR , the front, which is preceded by glass wool, contains 100 mg and the backup section contains 50 mg. Urethane foam is placed between the sections and after the backup section. The ends of the tube are flame sealed to prevent contamination before use. 6.3 Gas chromatograph equipped with an electron capture detector (6-Hii foil). 6.4 Glass column (6 ft x 2 mm l.d.) packed with 1.5% OV-17/1.95% QF-1 on 80/100 mesh Supelcoport. 6.5 Vials (20 ml) with aluminum lined caps. 6.6 Mlcrollter syringe (10 Ul). 6.7 Volumetric flasks (10 ml for standards) with glass stoppers. *'6.8 A mechanical or-electronic integrator or a recorder and some method for determining peak area. \ 244-3 AC* C. C 6 6 7. Reagents DRAFT w 7.1 Hexane* Pesticide Quality 7.2 FlorisilR , (Registered trademark of the Floridin Co.) 30-48 _ mesh chromatographic adsorbent, deactivated. Florisil^ 30-60 mesh is sieved to the proper mesh size. Deactivation of Florlsil? Prior to packing tubes, dry a weighted amount of FlorisilK at 105*C for 45 minutes. After cooling to room temperature, the FlorlsilR is added to a round bottom flask which can be attached to a rotary evaporator. Three mis of water per 100 gms of FlorlsilR (i.e., 32 W/W water) are added and the mixture is turned in the rotary evaporator for one hour or until It is uniformly mixed (free flowing). 7.3 Nitrogen, prepurified g p 7.4 Arodor 1016 or a sample of the specific PCB compound under study. This procedure has been field tested only for AroclorR 1016 (Registered Trademark of the Monsanto Co.) Aroclor 1016 is a PCB mixture whose chlorine content is approximately 422. 8. Procedure 8.1 Cleaning of Equipment. All glassware used for the laboratory analysis should be detergent washed and thoroughly rinsed with tap water and.distilled water and dried. 6.2 Collection and Shipping of Samples 8.2.1 Immediately before sampling, break each end of the sorbent tube so as to provide an opening at least one-half the Internal diameter of the tube (2 mm). 8.2.2 The smaller section of Florlsll* is used as a back-up and should be positioned nearest the sampling pump. 8.2.3 The sorbent tube should be vertical during sampling. 8.2.4 Air being sampled should not be passed through any hose or tubing before entering the sorbent tube. t 8.2.5 The flow, time, and/or volume must be measured as accurately as possible. The sample shot d be taken at a flow rate of 200 cc/mln or less to attain the total sample volume required. The recommended sample volume is 50 liters. \ 244-4 CC66fcl , At** draft 8.2.6 The sorbent tubes should be dapped vith the supplied plastic caps immediately after sampling. Under no & circumstances should rubber caps be used. 8.2.7 One tube should be.handled In the same manner as the sample tubes (break, seal, and ship) except that no air la pumped through It. Label this tube as a blank. 8.2.8 8.2.9 Pack the tubes tightly before shipping to minimize breakage in transit. y After the sample Is collected, the tubes should not be subjected to extremes of high temperature or low pressure. 8.2.10 Samples of the FCB whose presence In the environment Is suspected should be submitted to the laboratory performing the analyses. These bulk materials should not be transported In the same container as the samples or blank tubes. If possible, a bulk air sample should be shipped for qualitative Identification purposes. 8.4 Analysis of Samples 8.4.1 Preparation of Samples. Each tube is scored with a file and the glass wool and front section are placed In a clean, dry vial. The separating urethane foam plug, the back section of the sorbent, and the retaining urethane foam plug are placed In a second clean dry vial. 8.4.2 Desorption of samples. Prior to analysis, 5.0 ml of hexane is pipetted into each vial. ?lorlsllR particles should not be allowed to cling to the glass above the solvent. A minimum of 10 minutes desorption time is required before analysis. Further dilutions may be necessary to bring the concentration of the sample solution Into the linear range of the electron capture detector. 8.4.3 Gas Chromatographic conditions: 1. Nitrogen carrier gas flow, 60 mls/mln 2. Injector temperature, 300*C ' 3. Interface and detector temperatures Loth 325*C 4. Column temperature, 180*C 244-5 ACM CCfifcfce w s v 8j4.4 draft Injection, The solvent flush injection technique is recommended. The volume of hack flush plus the volume of standard or sample solution should equal 5 yl, since larger volumes may give a solvent peak which interferes with sample components. For example, in order to inject 2 yl of sample;, the following procedure would be followed. Three yl of solvent' (hexane) would be drawn into the syringe, followed by 1 yl of air, followed by 2 yl of sample solution. (The plunger now rests at the 6 yl mark). After the needle is removed from the sample solution one additional yl of air is drawn into the solution to minimize evaporation at the tip of the needle. Not less than 1 yl of back flush should be used. The syringe must be cleaned with hexane after each injection. 8.4.5 Interpretation of the Chromatogram. The peak heights or areas of the prominent peaks in the sample chromato gram are selected and compared with fhoee of the standard which most nearly resembleethe sample composition. 8.5 Determination of Desorption Efficiency. Experiments have demontrated quantitative (1002) recovery of FCB's spiked on FlorisilR . Thus results need not be corrected by desorption efficiencies. 9. Calibration and Standards The particular PCB mixture being used in the work area In which air samples were taken is used as the standard. If, however, the air sample compositldn is different from that of the PCB mixture, then a different method determination (Ref. 2) or standardization (Ref. 4) must be used. Standards are prepared in hexane at concentrations ranging from 8 to 500 p g / y l (within the linear range of the electron capture detection -- upper limit is approximately 2 ng per injection). Cali bration curves should be established dally since the sensitivity of the electron capture detector may change from day to day. 10. Calculation 10.1 The height or area of several selected prominent peaks in the chromatogram are added and compared to the total height or area of those same peaks in the standard and the weight, in pg , of sample is calculated. 10.2 The weight found is divided by the number of microliters Injected and this concentration is multiplied by the total volume, in yl, of solution in sample to obtain the weight of PCB in theksample in pg. 244-6 AC* CCoBfcS wJ * I l -- m-- P8S " wl' x DRAFT vii pi of sample Injected Into GC - m ts total sample volume In pi P8i " weight of PCB injected PB* " weight of PCB in sample 10.3 Corrections for the blank should be made, If necessary, and the weight of PCB In the front and backup sections Is added .to obtain the total weight of PCB In the air sample. This weight Is conveniently expressed in ng. & ngtfl " " P*b3 + [P6S " P*bl front_____________ backup 1000 pg/ng ngt5 " total sample weight In ng pg^ PCB weight In pg found In blank 10.4 The concentration of PCB In the air sampled In pg/m3 , which is numerically equal to ng/1, Is calculated by dividing ngs by the volume, V, of air sampled In liters. pg/m3 - ngts V 11. References 11.1 C.S. Gian, H.S. Chan, and C.S. Neff, Anal. Chem., 47, 2319(1975). 11.2 J.A. Armour, Assoc. Offic. Anal. Chem.. 56, 987(1973). 11.3 R.H. Hill, Jr., J.A. Arnold and W.J. Woodfin, "Determination of Polychlorinated Biphenyls In Workplace Air," in preparation. 11.4 P.L. Beezhold and V.F. Stout, Bull. Env. Contam. Tox., 10, 10(1973). \ r 244-7 ACh cCfc7Q DEPARTM ENT O F HEALTH, ED U C A TIO N , AND W ELFARE P U B L IC H E A L T H S E R V IC E C E N T E R FO R D lfC A S C C O N IflO t. JflH 2 1 IS-/7 N A TIO N A L IN S T IT U T E TOR O C C U PATIO N AL S A FE T Y AND H EA l T * H O O E R T A . T A T T L A B O N A T O K <CS 4 S 7 S CO LUM CIIA PA R K W A Y . C IN C IN N A T I. CM IO 4 0 12 (j January 17, 1977 . : "> i W.B. Papageorge, Manager Produce Acceptability Monsanto Chemical Intermediates Company 800 N. Lindbcrg Boulevard St. Louis, Missouri 63166 Dear Mr. Papageorge: Thank you for your letter of December 20, 1976 In which you question the role of PCB's as human carcinogens. I assure you that NIOSH is carefully studying all the PCB data in our possession. Conclusions drawn from that data and recommendations based thereon will be made after we have consulted with representa tives of both the public and private sectors. However, conclusions and*recommendations made in the criteria document will be those of NIOSH and will not necessarily be those of any of the reviewers. Sincerely yours cc: Dr. J. May Cherry M. Johnson, Ph.D. Chief, Criteria Documentation Section 1 ACM 006311 December 20, 1976 Dr. Jerry M. Johnson Acting Chief, Criteria Documentation, HIQSH, DCD6D, KM 142 4676 Columbia Parkway Cincinnati, Ohio 45226 Section 1 Dear Dr. Johnsoni At ths review eeeting held on November 30 on the draft criteria docuaent for polychlorinated biphenyls I was left with the lopresslon that future drafts of the docuaent would continue to contain allegations that PCBs are huaan carcinogens and that they should be labeled as "cancer suspect agents". In previous opportunities to coeeant Z have aophaelxed the lack of persuasive evidence to provide a sound basis for designating PCBs as carcinogens. At the review seating Dr. Paul I. Brubaker reported that the cohort in the ongoing Mobil Bpideeiologlcal Study has been reideatified and changed and that the results ere now expected to differ free these initially reported. The reports, frae Industrial Blotsst Labor stories end the Ippley Institute, which I gave to Mr. John Fajen, contain conclusions which differ free those reached by Dr. Senate Kimbrough in her studies with fseals rats. It is our considarad opinion that this Informstion further aephaeiaes the uncertainty of sons of the available data and we strongly rerneean1 that your office reconsider its decision to continue to designate PCBs ee cancer suspect agents. ft.3.PAPtfcOSGE w. B. PapagsM rgs Product Acceptability bcc: R. A. Stohr/J. C. Weber AUK C C t clc M ONSANTO INDUSTRIAL CHEM ICALS CO. 8 0 0 N. U ndbsrgh B o u lavird S t. Louis. M isso u ri 63)66 f h o n a : (314) 6 9 4 - 1 0 0 0 November 20, 1976 Dr. Jerry M. Johnson Acting Chief, Criteria Documentation, Section 1 NIOSH, DCDSD, CDB, RM 142 4676 Columbia Parkway Cincinnati, Ohio 45226 Dear Dr. Johnson: Attached are answers to the questions on the draft criteria .document concerning occupational exposure to polychlorinated biphenyls. We hope our comments are helpful and appreciate the opportunity to participate in the preparation of a responsible criteria document. Sincerely WBP/ken attachment V W. B. Papageorge Mgr., Product Acceptability AC* CC6S73 POLYCHLORINATED BIPHENYL -EXTERNAL REVIEW QUESTIONS 1. The document inadequately documents industrial exposure related effects of PCB. It also inadequately defines clinical tests which could be used to monitor for potential adverse effects of PC3 exposure among the industrial population. The document dwells at great length upon the effects observed in a population of Japanese citizens who were accidentally exposed to an acute dose of PCB in a cooking oil. No relation is established between this accidental acute oral exposure to a relatively high concentration of PCB and industrial type exposures. No relationship is established defining relative body burdens resulting from acute oral exposure versus other routes of exposure, dermal absorption and respiratory, that are more likely to occur in an industrial environment. Another study given seemingly unwarranted consideration, involved an unpublished report of an epidemiological study conducted among a group of researc workers with some unknown previous exposure to PCB. No sound basis has been established to support the contention that PCBs are human carcinogens. It is suggested that efforts be extended to accurately assess the clinical health of U.S. workers exposed to PCB. 2'. In studies with rodents and subhuman primates the most sensitive target organ was usually found to be the liver. In these studies the dietary level which did not produce an effect on the liver was between 1 and 10 ppm. Based upon these studies the most probable toxic effect of excessive PCB exposure would be chronic hepatic injur 3. From the manner in which the document is put together it is impossitl to tell if the recommended standard is based upon a logical scientifi extrapolation of the information cited. Specifically, no attempt is made to relate the body burdens which would result from an industrial inhalation or dermal exposure to those obtained from animal experi mentation or the usual data following oral administration. Chapter V consists of a series of data relating the toxic effects observed after many different types or routes of exposure. It then states that on the basis of all this data the environmental limit should be 0.05 mg/M3 of PCBs in air. There is no logical support for the stated limit as based on the industrial usage this document is intended to relate. There has been no evidence shown to indicate that, as i n f e r r e d on lines 4071-4072, "teratogenicity, fetotoxicity ar carcinogenicity has^ occurred to man and to laboratory animals when they have been subjected to air-borne PCB levels below the current standard of 1.0 mg/M3 (42% chlorine}." \ 4a. To be supportable a standard' must be based on the application of a safety factor to experimental animal data and/or upon the utilizatior of previous work history exposure concentration and clinical worker monitoring data. Which of these was used in establishing this stand; is not clear. Specifically, the limit of 0.05 mg/M^ has not been supported by any data relating industrial worker exposure to clinica! effects. In fact, the arrival of 0.05 mg/M^ as a "safe" level has not been explained at all. b. The document on line 3929 states that the current PGB standard is based on an 8-hour dermal exposure. This is not entirely correct. 2. The current standard does include a "skin notation" which-refers to the potential contribution to the overall exposure by cutaneous route or particularly by direct skin contact. An environmental limit for air-borne material cannot totally prevent direct skin contact with material and the resulting dermal exposure. This concern has been aptly addressed by the ACGIH TLV committee on line 3925 by their reference to the fact that the current standard may not guarantee protection against dermal effects. The recommended environmental limit cannot guarantee such also since workers can still put unprotected hands in .the material if they wish. c. Inadequate information exists to properly evaluate the need for and type of protection for the pregnant worker. d. Until better scientific evidence is brought forth supporting a necessary change in the current OSHA standard on PCBs, no justificati exists for modifying the existing environment limit. 5. We recommend that the current users of PCBs, capacitor and transforme manufacturers, be consulted regarding feasibility of compliance. 6. To exclude biological monitoring in a standard for a material known to accumulate in fatty tissues would not appear advisable. Biologic testing is an acceptable monitoring device if it. is shown that a reasonable correlation exists between body burden, detrimental health effects, and degree of worker exposure. Biological monitoring may well give an indication of dermal exposure and degree of skin absorption that might not be evident through the use of air monitorin 7. We assume that if the composition of PCBs is unknown, the sample chrc togram does not match the chromatogram of any commercial PCB standard mixture. In this case, measurement by electron capture gas chroma tography is inadequate for two' reasons. First, interferences may be present which may account for the differences in the chromatograms. Secondly, -as pointed out in Table I of the draft, electron capture detector response varies by orders of magnitude for different PCB . isomers. Hence, the analyst would not know what response factor to apply, even using the weight factor technique of Webb & McCall (see attached comments for line 5354). Therefore, when the PCB composition is unknown, a more specific and accurate technique must be used. We recommend using GC/MS in the* selected ion monitoring mode as the detector device. The parent ion and a characteristic fragment ion are monitored for each PCB homolog. This technique is, much less subject to interferences and is more accurate because MS response factors are nearly constant. GC/MS detection can be used with samples collected on Florisil if sensitivi is adequate. If sensitivity'is inadequate, samples should be collect on a porous polymer sorbent such as Tenax GC. Collected components are then thermally desorbed directly into the GC/MS for analysis. 8. In those cases where the sample chromatogram matches a standard PCB chromatogram, the sampling procedure is adequate. However, as mentioned in 7., we recommend sampling with Tenax GC as a more genera method. Collected components can be thermally or solvent desorbed from Tenax GC. For further details, see pp 147-160.of the transcript of the Second N10SH Solid Sorbents Roundtable in December, 1973. 3. 9. No, several deficiencies should be corrected. See attached comments relative to lines 5252, 5253, 5258, 5273, 5291, 5292, 5303, 5310, anc 5320 of the draft. 10a. We recommend collection on.T'enax GC adsorbent, thermal desorption anc measurement by GC/MS. See 7., 8., and attached notes. b. See attached comments, especially the notes relevant to lines 5354, 5381, 5396, 5410, 5460, 5533, and 5590 of the draft. 11a. Annual compreherisive medical examinations are considered appropriate. b. The medical requirements listed in the document under Section 2 are patterned after the criteria document on Tetrachloroethylene. It would seem that the medical tests for PCB exposured workers could be more specific for that particular material.* Pulmanary function tests should be included as a check on capability of wearing respir atory protective devices. Contrary to lines 202-203, medical surveillance should be made available to all workers occupationally "exposured" to PCBs who contact the material and yet not be "exposed" on the basis of the NIOSH definition given on lines 176-177. 12. There is no persuasive evidence supporting the "cancer suspect agent" labelling all PCBs, therefore such labelling is inappropriate Warning signs should be posted in those areas in which workers are exposed above some specified limit or where potential skin contact is possible. To be functional a warning sign must inform the reader of specific effects of a material. PCBs have relatively mild irritant properties and has not been associated with acutely toxic effects. However, tissue accumulation and target organ effects may occur following prolonged exposures above the establishe permissible limits. A meaningful sign would warn of potential tissue PCB accumulation and indicate avoidance of skin and eye contact. 13. Considering that the concentration limits as listed in Table 1-1 represent the protection factors as shown below, the limits are considered to be appropriate and consistent with the respirator decision logic used in the Standards Completion Project. Along with the protection factor limits are listed various additiona respirator types which should provide adequate protection when used in areas of respective air contaminant concentrations. v Concentrations of ' . Respirator Type Polychlorinated Biphenyls (Modifications to Table) 0.5 mg/M3 or Less (lOx) 3. Chemical cartridge respirato with replaceable cartridges approved for organic vapors and mists and half-mask facepiece. 4. Gas mask, chin-stvle or fror or bacJr mounted organic vape and mist cannister. 4. Concentrations of Poly- chlorinated Biphenyls cont'd. 2.5 mg/M3 or Less (50x) Respirator Type (Modifications to Table) cont'd.______________ 3. A gas mask with a full facepi and front or back mounted vac cannister with high efficient filter. 5.0 mg/M3 or Less (lOOx) (Mo modification) Greater than 5.0 mg / M 3 (lOOx) (No modification) 14. Line 292: Detectable level is mentioned. Since the detectable limit of PCBs has not been addressed, this level is meaningless. It would make more sense to reduce air-borne concentration of PCBs to below the (TWA) environmental limit or permissible exposure limit. Lines 379 through 382 should be deleted since it seems unnecessary tchave escape type devices available in all areas of "potential" exposure where the exposures might be brief at low or moderate levels Escape type devices are generally made available in defined high risk areas containing potentially hazardous operations involving extremely toxic substances. The document does not provide data which supports PCBs as being considered extremely toxic. Earlier comments addressed the modifications in Table 1-1 on respirator types vs. concentration limits. 15. Line 405: Do hazards imply only health related hazards or environmen hazards also? In general, Section 5 provides adequate avenues for communicating work hazards to workers. 16. The work practices and control procedures are considered adequate for the protection of workers. 17. The recommended record retention period appears to be appropriate. 18. Additional research is needed in the following areas: a. Comparative data on the PCB body burden resulting from oral, dermal and inhalation exposures. b. Comparative metabolism studies of an homologous series in humans, non-human primates and rodents. These studies should include both a characterization xof the metabolites formed and kinetic studies to determine t h e `rates of mobilization and excretion. c. Clinical evaluation including liver function tests on industrial populations with previously documented PCB exposure. d. Epidemiological studies on major populations of PCB-exposed worke 19. Attached is a report compiled by Monsanto and distributed in November 1975 to representatives of concerned governmental- agencies, (NIOSH, OSHA, EPA, FDA, NCI, NIH) relating to histopathological evaluation of livers from rats treated with PCBs. COMMENTS ON SAM PLING AND A N A L Y T IC A L METHODS M in o r comments are on th e o r i g i n a l NIOSH d r a f t . General comments: In u s in g tr a d e names % th e document s h o u ld be c o n s is t e n t . A ny sh o rth a n d such as d ro p p in g r e g is t r a t io n - n o t a t io n sh o u ld be documented a t th e e a r lie s t o p p o rtu n ity and then a sta n d a rd form at adopted th e re a fte r e .g . ^ro c i or R Florisil R Environm ental Sampling and A n a ly tic a l Methods 3714 ....e v a lu a t e d under la b o ra to ry c o n d itio n s using aenfeol generation te c h n iq u e s . F ie ld s tu d ie s were a ls o p erfo rm e d in a PCB e n viro n m e n t c o n ta in in g aerosol and vapor components. The statem ent as i t stands leaves open the q u e stio n o f aerosol o r vapor s tu d ie s . The document should be com pleted by in c lu s io n o f th is in fo rm a tio n in a manner s im ila r to th e above amended s ta te m e n t, and e xp re s s in g the tru e nature o f the e x e rc is e ; Both aerosol and vapor co n ce n tra tio ns must be in c lu d e d . 3724 -3726 E a r lie r in the t e x t , 2 so lve n ts are m entioned along w ith the use o f s in g le and m u ltip le im p in g e rs. / Which s o lv e n t was used sh o u ld be c l a r i f i e d (to lu e n e o r e th y le n e g ly c o l) and the number o f im p in g e rs. The con clu sion s reached im p ly a s tu d y usin g an ae ro so l o f PCBs o r an e q u ilib ra te d vapor environm ent. Is th is true? 3737 t o use when p e rso n al sam p ling f o r P C B s. Th is circum vents o th e r techniques such as area m onitoring fo r c a lc u la tin g e ffe c tive exposures. 3738 NIOSH has n o t te s te d a ll a v a ila b le s o lid sorb en ts ( e .g . porous p o ly m e rs ). Hence, th is lin e sh ou ld be rew orded to r e f le c t o n ly those methods te s te d . 3752 E le c tro n capture gas chrom atography is the most w id e ly used m ethod, but not n e c e ssa rily the "p re fe rre d " m ethod. Fo r exam ple, the wide varian ce An response f a c t o r s r e f e r r e d t o in T a b le I is a d i s t i n c t d is a d v a n ta g e . 3801 -3803 In th is d a y , i t is n o t p o s s ib le t o e lim in a te a method based on th e la c k o r expense o f a com puter. In many sm all com panies, th e OSHA requ ire m en ts w ill r a p id ly fo rc e th e purchase o f such a u n it f o r many a p p lic a tio n s . 3809 -3810 One m ight p r e fe r NBS as a r e p o s ito r y f o r "s ta n d a rd " sam ples. 3824 P e r c h lo r in a t io n s h o u ld d e f i n i t e l y n o t be used t o q u a n t i t a t e P C B s. We have confirm ed th a t n o t o n ly b ip h e n y l, but a lso s u b s titu te d b ip h e n y ls , cause la rg e p o s itiv e e r r o r s . A t le a s t one o f the' repTacem ent flu id s f o r PCBs in c a p a c ito rs is a s u b s titu te d b ip h e n yl (Chem ical and E n q in e e rin p News, p . 25 , Nov. 1 5 , 19 7 6 ). Hence th is - in te rfe re n c e is a lre a d y present ACM 008876 -2- 3834 -3835 3843 -3845 See comments on a lt e r n a t e s t a n d a r d iz a t io n p ro c e d u re , l i n e 5354. See above comments on p e r c ,h lo r in a tio n . APPENDIX I 5248 5252 -5253 5258 -5260 5266 -5268 5273 5291 5292 -5293 5303 5304 5308 5310 5320 Samples c o lle c te d must be re p re s e n ta tiv e o f th e personal exposure o f individu al w orkers. R e co rd s s h o u ld i n c l u d e : Pump model & S e r i a l n o . Sam pling Tube type and n o . i . e . sam pling equipm ent d e ta ils 0 C a lib ra tio n data should a ls o be recorde d. The aim o f sam pling is to p e rm it d e te rm in a tio n o f th e personal exposure le ve l p r im a r ily . T h is leads to a d e c isio n on com pliance/ non-com pliance s itu a tio n s . I t cannot lead to the "low est fe a s ib le le v e l" w ith o u t o th e r m ajor in p u t beyond the scope o f sam pling and a n a ly s is . A i r f l o w th ro u g h th e pump s h a ll be c o n t r o l l a b l e w i t h i n 5% o f th e d e s ir e d ra te during the e n tir e sample p e rio d . A more fr e q u e n t r e q u ire m e n t f o r pump c a l i b r a t i o n i s r e q u i r e d . A t l e a s t m onthly and p re fe ra b ly in the method f o r a d a ily setup c a tib r a tio n . S p o t-c h e c ke d is an open s ta te m e n t and means n o th in g . F o r d i g i t a l re a d o u t pumps s p e c ify p a r i t y check between e xp e cte d s tr o k e count versus a c tu a l. F o r pump, w it h ro ta m e te r s s p e c i f y b e fo r e and a f t e r r e a d in g s . We w o u ld p r e f e r a c a l i b r a t i o n a f t e r f l o w s t a b i l i z a t i o n and a g a in b e fo r e pump i s turned o f f , fo r each sam ple. The sorben t tube should n ot be v e r t i c a l. P o in tin g down - lo s e s g la s s w ool and F l o r i s i l P o in tin g up - d u s t from o ve rh e a d , hard h a t , e t c . e n te rs . Suggest a close to h o rizo n ta l lo c a tio n , attached to the c o lla r o f the w orker. A ir being sampled shou ld pass d ir e c t ly in to the open i n l e t o f th e s o rb e n t t L T h is precludes f i l t e r s . . ' The reconmended sam ple volum e f o r t h is m ethod i s 50 l i t e r s ( U .S . s p e llin g ) The sorbent tubes should be la b e lle d . A t th is p o in t i t should r e ite r a te checking labe l and I .D . Number. A b u lk a i r sample is o f no v a lu e un less th e r e s tr a in ts re q u ire d to o b ta in a good and re c o ve ra b le sample are f u l l y docum ented." 5324 5346 5354 -3- Throughout Appendix I I nom enclature f o r PCB and PCBs is c o n fu se d . In g e n e ra l, PCBs should be used as a noun d e s c rib in g a PCB m ix tu r e , w h ile PCB is an a d je c tiv e . Th is reads more sm oothly i f w r it t e n , "T h is w ould correspond to a d e te c tio n l i m i t o f 40 ng o f 5 ml o f d e s o r b e n t" . This a lte rn a te sta n d a rd iza tio n procedure is o f h ig h ly questionable u t i l i t y . As pointed o u t"in lin e 5358, i t has n o t been-evaluated in NIOSH la b o ra to r ie s . As c o rre c tly sta te d in the d r a f t , th e reason an a lte rn a te procedure is needed a re t w o - f o l d . F i r s t , m ost o f th e GC peaks in a chrom atogram o f a PCB p ro d u c t c o n ta in more th a n one com ponent. S e c o n d ly , e le c tr o n c a p tu re d e te c to r response d i f f e r s s i g n i f i c a n t l y f o r d i f f e r e n t PCB isom ers (See Table I o f the d r a f t ) . These two fa c to rs in d ic a te th a t the a b solu te q u a n tity o f PCB re p re s e n te d by a g ive n peak c o n ta in in g un re so lve d components v a rie s depending on th e r e l a t i v e amounts o f th e com ponents. The r e la tiv e com position o f a g iven peak can va ry fo r the fo llo w in g rea son s: 1 . PCBs w ith a g ive n degree o f c h lo rin a tio n ( i . e . 42%) from d if fe r e n t m anufacturers con tain d iffe r e n t isom er r a tio s . 2 . Component ra tio s va ry fo r products w ith d iffe r e n t degrees o f c h lo rin a tio n . Fo r exam ple, from Table X I I - 6 , the r a tio o f d ic h lo ro - to tric h lo ro b ip h e n y ls f o r th e peak w ith RRT 28 in A r o c l o r 12 2 1 i s 8 5 :1 5 . From T a b le X I I - 8 , th e same peak in A ro c lo r 1242 has a r a tio o f 2 5 :7 5 . S im ila r ly , fo r peak RRT 70 in A ro c lo r 1242 and 12 5 4 , the te tra c h lo ro -to pentachlorobiphenyl ra tio s are 9 0 :10 and 2 5 :7 5 . 3 . Vapor pressure d iffe re n c e s a lte r the com position o f va p o rize d PCBs r e la t iv e to the l i q u i d . (See a tta c h e d fig u r e showing chromatograms o f liq u id and vapors from A ro c lo r 1 0 1 6 ). 4 . I n te r fe r in g components may be p re s e n t w hich d i s t o r t th e sample chromatogram. T h is is l i k e l y to be a m ajor problem in c a p a c ito r and tra n s fo rm e r m anufacturing f a c i l i t i e s because se ve ral o f the PCB replacem ent p ro d u c ts ( i . e . p h th a la te e s te rs and c h lo r o b u ty ld ip h e n y l e t h e r ) have s i m i l a r GC r e t e n t io n tim es t o PCBs and g ive an e le c tro n capture response. The w e ig h t f a c t o r te c h n iq u e o f Webb and M c C a ll does n o t adequately account fo r these d iffic u lt ie s . v F o r those s itu a tio n s where th e sample chromatogram c lo s e ly matches the chromatogram o f a re fe re n c e PCB m ix tu r e , th e Standard A n a lys is described in 5554 f f should be fo llo w e d . How ever, i f the chrom atogram s do n o t m a tc h , we b e lie v e th e o n l y - s a t i s f a c t o r y a n a ly tic a l method which w i l l y ie ld a ccurate re s u lts is gas chromatography/mass sp ectrom etry (GC/MS) using se le c te d ion m onitoring (S IM ). The d etection lim it o f th is technique fo r A ro c lo r 1016 is about one nanogram o f PCB in je c te d in to th e ^ in s tru m e n t. C o n s id e rin g th e e n viro nm e nta l l i m i t o f 0 .0 5 mg/nr recommended in t h is docum ent, i t m ig h t be* p o s s ib le ' to reach t h is low er d e te c tio n l i m i t f o r th e t o t a l procedure by sam pling as nn+iinprt in the d r a f t , p van n ratin o the hexane desorbent and a n a ly zin g ADM cceaac 5381 5396 5410 5460 5515 5533 5590 6118 -4 - A lte r n a tiv e ly , therm al deso rp tio n from a s u ita b le s o lid sorbent d i r e c t l y in t o th e GC/MS can be used. T h is w e ll documented technique analyses th e e n tir e c o lle c te d sample a t once, ra th e r than o n ly an a liq u o t a t a tim e . Response fa c to rs va ry o n ly s lig h t ly fo r d iffe r e n t PCB isom ers and most in te rfe re n c e s are elim inated. The b u lk sample m ust n o t be s h ip p e d in th e same c o n ta in e r as th e sam ple tu b e s . The volume o f a i r sampled can be measured to w ith in a t le a s t 5%. Delete next sentence. D e le te 100% and con clu d e se n te n c e w ith recovered w ith a re la tiv e sta nda rd d e v ia tio n o f 4.4% f o r 27 sp ike d s a m p l e s D e l e t e n e xt sentence. Type o f e le ctro n capture d e te cto r is not im p ortan t. rin s in g w ith p e s tic id e grade acetone and hexane should fo llo w the w ater rin s e s . Argon/m ethane is a ls o a s u ita b le GC c a r r i e r g a s . The flo w r a te f o r e i t h e r c a r r i e r gas s h o u ld be o n ly a b o u t 30 m l/m in f o r a 2 nsn i d c o lu m n . A ctu al re te n tio n tim es should be used in c a lc u la tio n s i f a v a ila b le . I f n o t a v a ila b le , then th e measurements describe d here can be used. The vapor pressures in Ta b le X I I I - 5 appear to be to o h ig h . What is the source o f these d a ta , and has th e ir accuracy been v e rifie d ? v 00&&e* / DEPARTM ENT OF HEALTH, EDUCATIO N, AND W ELFARE P U B L IC H E A L T H S E R V IC E C E N T E R FO R D ISE A SE C O N T R O L October 20, 1974 N A T IO N A L IN S T IT U T E FO B O C C U P A T IO N A L SAFETY AND HEALTH U .S. P O S T O F F IC E A N D C O U R T H O U S E C IN C IN N A T I. O H IO 45202 Dr. Eirmett Kelly Medical Director Monsanto Chemical Carp. 800 N. Lindberg St. Louis, Mo. 3166 Dear Dr. Kelly: This letter will serve to Introduce to you the personnel from the National Institute for Occupational Safety and Health (KIOSK) who will he attending the meeting concerning polychlorinated biphenyls we have tentatively scheduled for Friday, November 22, 1974. From this office in addition to myself the following persons will attend: Mr. Richard lenten, Chief, Biometry Branch, Division of Field Studies and Clinical Investigations; Mr Jay Jones, Industrial Hygienist, Environmental Investigations Branch, DFSd; Mr. Benjamin Braucker, Regional Program Director, NIOSH, Region VI. The following individuals possibly may attend: Dr. Joseph Wagoner, Director, Division of Field Studies and Clinical Investigations; Dr. Clark Heath, Director of Cancer and Birth Defects Division, CDC. Mr. Richard Lenten, Dr. Joseph Wagoner, Dr. ClarJt Heath and myself are .epidemiologists. Mr. Jay Jones indicated a desire to do a quick "walk-through1' survey of the facility where the PCB's are manufactured. Could this be arranged? Sincerely yours, -- David L. BaylissJ Assistant Chief, Biometry Branch Division of Field Studies and CP CC69C1 October 22, 1974 01 Dr. Joseph X. Wagoner Director, Division of Field Studies and Clinical Investigations Dept, of health, education & Welfare Public Health Service National Institute for Occupational Safety A health U. s . Post Office k Courteous* Cincinnati, Ohio 45202 Dear Dr. Wagoner: With reference- to b y letter to you yesterday, regardin a a e e t i m wit!-, nenbers of .Monsanto and :-.IC3H to discus affects cf rCl> on hur:ans, I was in error in giving you the naise of or. Oliver i>eharac. Ihe a an you should contact if you want a seeting before I return fxen my trip is :ir. Vtillia-r d . Fapagecrge, who can be reached at the above adcruss. Sincerely, R. T^sact belly, n. 0. Medical Director RK/ln cc: Hr. w. p. rapaaoorge Dr. Oliver De C a m s .. ,, - Ollie, will you please send the correspondence I sent you on this on to Bill Papageorge. x  /. October 21, 1974 Or, Joseph K. Wagoner Director, Division of Field Studies end Clinical Investigations Dept, of health, Education ft Welfare Public health Service National Institute for occupational Safety & Health Uy S. Post Office ft Courthouse Cincinnati, Ohio 45202 g Dear Dr. wagoner! Monsanto will be happy to attend a meeting similar to the one you proposed in your letter of ^etcher 15 concerning whether any of cur workers would constitute a suitable occupational group for the study of the affects of PCD on humans. We have a slight logistic prchlcn. I leave St. Louis on October 2b fer a tour of our far eastern plants and will return the early part of the week of November 17. Jr. 3oush, our Associate Medical Director v/ill be here hut I don't think ha is as familiar with the FCTl situation as I am. If you want a meeting before then, I would suggest you centsct Dr. Oliver D e G a m o , of our !ionnanto Industrial Chemicals Company at this same address. Dr. DeGanao is in charge of environmental matters for the MICC group. Hr. Elmer iiheelcr, of our own department, who is in charge of our environmental health services, is also familiar with tae PC? matter. Neither of tnesc arc eciical individuals and it may be that you will want to wait until I return. Please let mu know before the 25th if I can be of any nelp. Sincerely, V REK/ln cc: Dr. Oliver b o G a m o Mr. Elmer P. wheeler Mr. Gerry Eratsch R. I.'ixnet Telly, M. D Medical Director ACh 0C69C3 - DEPARTMENT OF HEALTH. EDUCATION, AND WELFARE P U B L IC H E A L T H S E R V IC E C EN T ER FO R D ISE A SE C O N T R O L N A T IO N A L IN S T IT U T E F O P O C C U P A T IO N A L SAFETY ANQ HEALTH U 3. POST O FFICE A N D C O U RTH O U SE C IN C IN N A T I. O HIO 45202 Pooa 523 October 15, 1974 Bimett Kelly, M,D, Medical Director Monsanto Chemical Corp. BOO H, Litdberg St, Louis, -Missouri 63166 Lear Dr, Kelly: As you are aware, the Occupational Safety and Health Act gives the national Institute for Occupational Safety and Health (NIOSB) legislated authority and responsibility for the conduct of industry wide studies of the effect of long-term, low-level exposure to indus trial materials, processes, and stresses on the potential for illness, disease or loss of functional capacity in occupationally exposed adults. This epidemiological research is aimed at defining the relationship of disease incidence to possible causative factors in the vorJfc environment. The primary responsibility for conducting such research in NIOSH belongs to the Division of Field Studies and Clinical Investigations (DFSCI), A tremendous quantity of research has demonstrated that environmental exposure to polychlorinated-biphenyls (PCB's) causes serious impair ment of the functions of the liver. This impairment subsequently affects a variety of enzyme systems as is indicated in several articles in the literature A recent article by Hobuyuki, Hagoeki, et al. entitled "Histopathologic Studies on Liver Tumorigenisis Induced in Mice by Technical Polychlorinated Biphenyls and Jts Promoting Effect on Liver Tumors Induced by Benzone Hexochloride" suggests PCBrs are carcinogenic in animals. However, results that evaluate long-term health effects in htmans from either acute or chronic exposure to PCS'# are not available. \ \ AC* CCeSC<' Dr. Emmett Kelly Peg* 2 For the purpose of assessing the potential for chronic effects, DFSCI is attempting to identify a suitable occupational group for study. To this end, I would like to arrange a meeting with representatives of Monsanto Chemical and NIOSS to discuss the inclusion of PC3-exposed active and inactive workers at Monsanto in a planned retrospective cohort study. The possibility of including other manufacturers and users of PCBfs in this study is being considered X may be contacted by writing to the address above or calling 513-684-3255. Your cooperation in this matter is appreciated. Sincerely yours, End: OSB Act of 1970 Joseph K. Wagoner, S.D. Hyg. ' ' Director/ Division of Field Studies and Clinical Investigations \ coescs '[(I DEPARTMENT OF HEALTH, EDUCATION. A ND WELFARE PU D LIC H E A L T H S E R V IC E a CEN T ER FO R DISEASE CO N TR O L A n a t i o n a l INSTITUTE FOR O CCU PATIO N AL s a f e t y AND h e a lt h A ugust 20, 1976 3600 FISHERS L A N E R o c k v i l l e , w a r y l a n o : : s 52 Dear Colleague: In a Ju n e 24, 1976 l e t t e r , M o b il O i l C o rp o ra tio n a d v is e d th e N a tio n a l I n s t i t u t e fo r O c c u p a tio n a l S a fe t y and H e a lth (MIOSH) o f a p o s s ib le a s s o c ia tio n between o ccu p a tio n a l exposure to p o ly ch lo rin a te d biphenyls (PCBs) and cancer in humans. M obil O il rep orted p re lim in a ry r e s u lts o f an e p id e m io lo g ic a n a ly s is based on m edical reco rd s o f employees exposed to PCSs a t t h e ir P a u ls b o r o , New Je r s e y p l a n t . T h is stu d y was conducted by P ro fe ss o r A n ita K. Bahn (Sch ool o f M e d icin e, U n iv e r s ity o f P en nsylvania) and i s b ein g rep orted by D r. 3alm in a le t t e r to the e d it o r o f the New England Jo u r n a l o f M e d ic in e , A ugust 19, 1976. The stu d y in c lu d e d two co h o r ts o f M o b il em ployees who were re p o rte d to have had v a r y in g exposure to A r o c lo r 1254 (a m ix tu re o f P C B s). The coh ort o f rese arch and developm ent em ployees was exposed to PCBs be tween 1949 and 1957 and the co h o rt o f r e f in e r y p la n t em ployees between 1953 and 1953. The e x t e n t o f exposure o f th e se w orkers to o th e r chem i c a l s .i s not known. The c a n c e r in c id e r c e among th e se w orkers fo r the p e r io d 1957 through 1975 was determ ined u s in g M ob il m e d ica l r e c o r d s . Because m e d ic a l reco rd s f o r 37 em ployees were in c o m p le te , th ese workers were excluded from th is a n a ly s is . Among the 92 w orkers in th e se two c o h o rts fo r whom adeq uate m e d ic a l records were a v a ila b le , e ig h t can cers (in seven w orkers) wore observed between 1957 and 1975. Of th e se e ig h t c a n c e r s , th r e e were m a lig n a n t melanoma and two were ca n ce r o f the p a n c re a s . T h is i s s i g n i f i c a n t l y more s k in ca n ce r (melanoma) and p a n c re a tic c a n c e r ,th a n would be e x p e cted in a p o p u la tio n o f t h i s s i z e (based on the T h ird N a tio n a l Cancer S u rv e y ). The rem aining cancers were found a t 't h r e e oth er s it e s i n two em ployees; sarcoma o f the r ig h t th ig h and m u lt ip le myeloma in one employee, and recto -sig m o id cancer in the o th e r. a ck ccesct Page 2 - Dear Colleague NTOSH i s unaware o f any o th e r p u b lis h e d a n t r a l or human d a ta w hich su g g e st a c o r r e la tio n between exposure to ?C3s and s k in (melanoma) or p a n c r e a tic c a n c e r . However, hepator.as ( n ic e , A r o c lo r . 1254) and h e p a to c e llu la r carcin o r.as ( n ic e , Kar-echlov 500: v a t s , A ro c lo r 1260) have been rep o rte d i n PC3 fe e d in g s t u d ie s o f la b o r a to r y a n im a ls . Background in fo r m a tio n on PCBs has been summarized in the NIOSll C u rren t I n t e lli g e n c e B u l l e t i n on P o ly c h lo r in a t e d 3 ip h e n y ls is su e d to the o ccupa t io n a l h e a lth community on November 3, 1975 , and su b s e q u e n tly p u b lish e d in the Jo u r n a l o f Q c r.u o a tio n .il HaHi c i n e , Volume 18, pages 109-13 3, February 1976. S in c e the NI03H B u lle t i n was f i r s t is s u e d , a number o f large firm s have introduced products ( e .g ., b u tv latcd nor.ochlorodiphanyi o x id e and d im eth}'! s ilo x a n e polym er) c liiin c U to be f i r e r e s i s t a n t d ie le c t r ic s which can serv e as a lt e r n a t iv e s to PCBs. In a d d itio n , one o f the la rg e dom estic transform er m anufacturers announced that i t w ill cease u sin g PCBs as f i r e r e s is t a n t tran sform er f lu id s a t the end o f t h i s y e a r . NIOSH would l i k e to s t r e s s th a t a l t e r n a t i v e s fo r PCBs sh ou ld be th o ro u g h ly s tu d ie d to a s s e s s th e consequences th ey may pose to human h e a lth . To a id in e v a lu a t in g PCBs as a p o t e n t ia l o c c u p a tio n a l h e a lt h problem , NIOSH would welcome r e c e iv in g r e p o r ts o f s t u d ie s r e g a r d in g the p o s s ib le a s s o c ia t io n between exposure to PCBs and human c a n c e r . Your cooperation in th is n a tte r is appreciated. Sin cerely yours. `Joh n F . F in k le a , M .D. D irector / ADM CC6SC7 / J U . S . Department o f H e a lth Ed u c a tio n and W elfare Public Health Service Center for Disease control N a tio n a l i n s t i t u t e f r O c c u pa tio n a l S a fe ty and H e a lth \ D i v i s i o n o f S u r v e illa n c e H azard E v a l u a t i o n s and F i e l d S tu d ie s C i n c i n n a t i , Ohio 45226 ADK C C6 9C `T ABSTRACT Due to the dem onstrated t o x i c e f f e c t s from p o l y c h l o r i n a t e d b ip h e n y ls ( P C B 's ) on exposed a n im a ls , the N a t i o n a l I n s t i t u t e fo r Occupational S a fe ty and H e a lth (NIOSH) conducted a series o f industryw ide studies to determine whether or not there are ajw l o n ^ tern^ e a l t h e f f e c t s among w orke rs o c c u p a t i o n a l l y exposed to P C B 's . As p a r t o f the.se in d u s try w id e s t u d i e s , NIOSH c o n d u c t e d a r e t r o s p e c t i v e c o h o r t s t u d y o f m o r t a l i t y --------------------------------------------------- ----- ------- among two w orke r p o p u l a t i o n s em ployed i n th e m a n u f a c t u r in g m e l e c t r i c a l c a p a c ito r s . The two study cohorts included 979 of w o r k e r s from p l a n t ' 1 and 15 8 1 fro m p l a n t 2 who were employed f o r a t l e a s t t h r e e m o n t h s i n a r e a s o f t h e p l a n t w h e r e P C B ' s "3 were used. * * The v i t a l s t a t u s o f o v e r 97% o f the two c o h o r t s was d e te rm in e d as o f Jan uary 1 , 1976 and 45,620 p e rso n -ye a rs were ac c u m u late d. There were 1 7 2 death c e r t i f i c a t e s c o l l e c t e d and coded by a n o s o l o g i s t . A p e r s o n - y e a r s l i f e t a b l e a n a l y s i s was c a rr ie d out to o b ta in the number o f cause s p e c ific deaths expected f o r each c o h o r t .a d j u s t e d fo r. age, r a c e , s e x , and c a l e n d a r t i m e p e r i o d . A l l - c a u s e m o r t a l i t y was l o w e r th a n 'a expected .(17 2 obs. v s . 19 0 .2 e x p .) as w e ll as a l l cancer m o r t a l i t y (39 obs* v s . 4 3 .6 e x p . ) . Among th e s p e c i f i c cancer c a u s e s , r e c t u m ( 4 o b s . ' v s . \.15 e x p . ) a n d l i v e r ( 3 o b s . v s . , ach ccescs 0 .9 3 e x p . ) were s i e v a t e d . The obse rved m o r t a l i t y due to cirrhosis o f t h s _ l i v e r was a l s o ' i n e x c e s s . N o n e o f t h e s e d if fe r e n c e s were s t a t i s t i c a l l y s i g n i f i c a n t at p < 0 .0 5 . A summary o f the d e t a i le d i n d u s t r i a l hygiene su rveys conducted in each p la n t to c h a r a c te r iz e the o c c u p a tio n a l exposures is p re s e n te d . The s ig n i f i c a n c e o f the m o r t a l i t y and i n d u s t r i a l hygiene results are discussed. $ \ { C O B "10 fkC* T INTRODUCTION P c 1'/c h lo rin a te d b ip h e n y ls ( P C B 's ) are a c la s s o f compounds composed o f b ip h e n y l m olecules w ith a v a r y in g number o f substituted chlorine atoms. In commercially prepared PCB's, the w e ig h t-p e rc e n t o f c h lo r in e has v a rie d between 21 and 6 8 *. i n some p r e p a r a t i o n s , t h e r e has a l s o been some degree; o f contam ination by c h lo r o d ib e n z o fu r a n s .(1) $ The prim ary use o f PC B 's has been as a l i q u i d In s u la tin g m a te ria l in e l e c t r i c a l c a p a c ito rs and tra n s fo rm e rs , and the g re a te s t p o te n tia l for occu pation al exposure has been in the m anufacturing and r e p a ir o f these components. PCB's have also been used in heat exchange u n i t s , h y d r a u lic system s, vacuum pumps, gas tra n s m is s io n -tu r b in e s , p l a s t i c i z e r s , a d h e s ive s , p e s t i c i d e e x te n d e rs , p a i n t s , and c a rb o n le ss copying pape rs. As o f 1 9 7 1 , PCB's were sold on ly fo r use in closed systems. According to the Toxic Substances Control Act of 1976, s p e c ific ru les and re g u la tio n s were promulgated to l i m i t the manufacture and. use o f P C B 's . T h is A c t s t i p u l a t e d th a t a l l U -S . production o f PC B 's end January 1 , 1979 and th a t a l l u .S . s a le and d i s t r i b u t i o n o f P C B 's end J u l y 1 , 1 9 7 9 . However, c o n t i n u a l e x p o s u r e t o P C B ' s w i l l o c c u r among w o r k e r s who CCA92 m ain tain tr a n s fo r m e r s and c a p a c i t o r s , and among the general population mainly through contaminated food. During the past few y e a r s , there has been a g re a t deal o f . i n t e r e s t i n s t u d y i n g the h e a l t h e f f e c t s among i n d i v i d u a l s exposed to P C B 's .' This in te r e s t has been s tim u la te d by: (1) the tendency fo r PC B 's to accumulate in tis s u e s and in c e r ta in organ s, ( 2 , 3) (2) the s t a b i l i t y o f PC B 's and t h e i r p e rs is te n c e in the e n viro n m e n t, ( 4 , 5) and (3)& the demonstrated long term e ffe c ts in exposed laboratory animals (6 -13 ) - in c lu d in g l i v e r tumors and other l i v e r diseases. Much o f t h i s i n t e r e s t was ex pre ssed at the N a t i o n a l Con feren ce on P o l y c h l o r i n a t e d B ip h e n y ls in November, 1975 ( 1 4 ) and the t o x i c i t y o f PCB's has been e x te n s iv e ly reviewed in the NIOSH * 1 C r i t e r i a Document on P C B ' s . (15) In order to determine whether or not past occupational .. exposure to comm ercially produced PCB's has caused any long term h e a l t h e f f e c t s , NIOSH i n i t i a t e d an e p id e m io lo g ic stu dy among w o rke rs i n two c a p a c i t o r m a n u f a c t u r i n g p l a n t s . I n conjunction with th is s tu d y, detailed in d u s tria l hygiene surveys were also conducted by NIOSH. ACH CC6S1< 2 DESCRIPTION O F-FA C ILITIES The two f a c i l i t i e s chosen f o r the study were s e le c te d a f t e r p re lim in a ry w alk-through surveys were conducted at numerous types o f p la n ts where PCB's were used. Both o f the p la n ts m anufacture e l e c t r i c a l c a p a c it o r s . These p la n ts were se le c te d because o f th e ir large w orkforce, the e a rly dates (1938 & 1946) at which PC B 's were f i r s t used at these p la n ts , the p o te n tial for exposure to PCB's with l i t t l e p o te n tial for exposure to o th e r known t o x i c c o n tam in a n ts , and the * a v a ila b ility of records necessary to id e n tify individuals to be in c lu d e d in th e *s t u d y p o p u l a t i o n . A t the tim e the study was i n i t i a t e d b o th p l a n t s were s t i l l u s in g P C B 's . P l a n t 1 is l o c a t e d i n New Y o r k S t a t e and i s d i v i d e d i n t o two m anufacturing f a c i l i t i e s w ith in close p r o x i m i t y . One f a c i l i t y # produced small i n d u s t r i a l ca p a c ito rs using PCB's since 1946 and the other produced la rg e PCB f i l l e d power c a p a c ito rs since 195 1. The type o f PC B 's used has va rie d over the years from " A r o c l o r " ( A r o c l o r i s a M o n s a n t o t r a d e n a m e ) 1 2 5 4 (54*$ c h lo rin e ) -to 1242 (42X c h lo rin e ) to 1016 (41X c h lo r i n e ) . S e ve ra l other kinds o f o i l s were used, but in a small number o f capacitors. These o ils included castor o i l , d ib u tyl m sebaceate., d i o t y l t h a l a t e and m ineral o i l . 3 4CH C 0 A 9 1 3 P lc n ; 2 is .located in Masachusetts where the use of PCB's to "a-iufacture capacitors started in 1938. This plant also chirked the type o f PCB's used from "A ro c lo r" 1254 .to 1242 to 1016. u n t il 1972, other types o f capacitors which did not c o n t a i n P C B ' s were made a t t h i s p l a n t i n c l u d i n g m i c a , e l e c t r o l y t i c and t u b u l a r . C a s t o r o i l was used i n l i e u o f PCB's to produce the la rg e power c a p acitors at th is p la n t. Both p la n ts assemble the c a p a c ito rs using the s|me general te c h n iq u e s , whether they are the small or la rg e ty p e s . The follow ing is a b r ie f d escription o f the assembly process: A . Winding and P re -a s s e m b ly - The in n e r components o f the c a p a c i t o r a re made o f paper., f o i l and som etim es p l a s t i c f i l m , wound to g e th e r', which are su b se q u e n tly loaded i n t o metal c a s in g s . T h is Job i s done in an enclosed d u s t - f r e e ' room where there i s minimal exposure to P C B 's . B. Impregnation - The pre-assembled capacitors are f i l l e d or impregnated with the P C B 's. W ithin 'this area there is potential for exposure to PCB's. C. F in a l Assembly- - The tops o f the ca p a c ito rs are closed using va rio u s techniques - crimpping (rubber stoppers) or \ s o l d e r i n g , which i n v o l v e * some e x p o s u re t o P C B ' s . The 4 008" ^ c a p a c ito rs are washed to remove excess P C 3 's by running them th ro ug h a d e te r g e n t wash or a degre aser such as tr ic h lo r o e th y le n e . F in a lly ., they are sent through the f i n a l o p e ra tio n s in v o lv in g d r y in g , t e s t i n g , and p a in tin g . Other areas of importance where there Is p o te n tia l exposure to PCB's in the p la n ts , in c lu d e the la b o ra to ry and the area where 4 r e je c t e d c a p a c ito r s are r e b u i l t . A p p r o x i m a t e ly ` 10% o f the two w orkforces have been employed .in jobs where th ere has been p o te n tial exposure to PCB's. H i s t o r i c a l l y , the w orkforce at P la n t 1 has been approxim ately 50% w h i t e males and 50% w h i t e f e m a l e s . P l a n t 2 has had a l e s s homogeneous w o rk fo rc e w ith t w o - t h i r d s being female and % r e fle c ts the general r a c ia l make-up o f the area, which is la r g e ly Cape Verdean and Portu gu ese. METHODS A r e t r o s p e c t i v e c o h o r t s t u d y o f m o r t a l i t y was c o n d u c te d to determine whether or not individuals- occupationally exposed to PCB's have experienced any Increase in c a u s e -s p e c ific m o r t a l i t y . The s t u d y c o h o r t s w er e d e f i n e d a s a l l w o r k e r s who accumulated at le a s t three months o f employment any time \ between January 1 , 19 4 6 -and Jan uary I , 1976 fo r P la n t 1 and January 1 , 1938 and January 1 , 1976 for P la n t 2 , in areas o f' th e p l a n t s where t h e r e was a p o t e n t i a l f o r e x p o s u r e t o P C B ' s . These exposed jobs were d esignated by the companies and v e r i f i e d by the la b o r u n io n s , and through the i n d u s t r i a l hygiene surveys. An e f f o r t was made t o d e t e r m i n e t h e v i t a l s t a t u s ( a l i v e o r deceased) o f each I n d iv id u a l in the cohorts as o f January 1 , 1 9 7 6 . V i t a l s t a t u s was d e te r m in e d th r o u g h r e c o r d s m a in t a in e d by Fe d e ra l and S ta te a g e n c ie s , in c lu d in g the S o c ia l S e c u r ity A d m in is t r a t io n , s t a t e motor v e h ic le r e g i s t r a t i o n , and s ta te v i t a l s t a t i s t i c s o f f i c e s . F o r t h o s e i n d i v i d u a l s who c o u l d n o t be located through these sou rces, U .S . P o s ta l Mail C o rre c tio n Se rvice s and o th e r fo llo w -u p searches were used. Fo r a l l t h 0o s e who w e r e k n o w n t o b e d e c e a s e d , d e a t h c e r t i fi c a t e s w e r e requested and causes o f death were in t e r p r e t e d by a q u a l i f i e d nosologist according to the In tern ation a l C la s s ific a tio n o f Diseases (ICDA) in e f f e c t a t the time o f death and then c o n v e r t e d t o t h e 7 t h R e v i s i o n o f t h e I C D A . Th o s e who had an unknown v i t a l s ta tu s were assumed to be a l i v e as o f Ja n u a ry 1 , 1 9 7 6 s o t h a t t h e t r u e r i s k o f m o r t a l i t y , w.as n o t o v e r e s t i m a t e d . Those who d i e d a f t e r J a n u a r y 1 , 19 7 6 were considered alive for purposes o f analysis. 6 i P e r s o n - y e a r s ' w er e a c c u m u l a t e d f o r e a c h w b r k 'e r s t a r t i n g a t t h e p o i n t in tim e 'when t h r e e months, o f employment in exposed jo b s was c o m p l e t e d a n d e n d i n g a t t h e - d a t e o f d e a t h o r t h e s t u d y end ' i ; i 1 date (1 / 1 / 7 6 ), whichever occurred f i r s t , using a modified l i f e ta b le computer program s i m i l a r to th a t d e sc ribe d by C u t l e r , (16 ) the p e rs o n -y e a rs fo r each cohort were combined . i n t o f i v e - y e a r c a le n d a r and f i v e - y e a r age time p e rio d s and m u l t i p l i e d by the corre sp ond in g U . S . w h ite male ( f o r male c o h o rt members) and U .S . w h ite female ( f o r female co h o rt members) c a u s e -s p e c ific m o r t a l i t y ra te s to y i e l d the expected number o f d e a th s. P e rs o n -y e a rs were a d d i t i o n a l l y d i s t r i b u t e d by f i v e - y e a r e x p o s u r e a n d f i v e - y e a r l a t e n c y . ( n u m b e r o f y e a r s from date f i r s t employed in exposed Jobs to date of death or stu dy end date)- c a t e g o r i e s . Observed and expected c a u s e -s p e c if i c deaths were compared and d i f f e r e n c e s were # te s te d based on the Po isson d i s t r i b u t i o n . The d e ta ile d i n d u s t r i a l hygiene surveys in clu de d personal time-weighted a ir samples o f employees from selected job t i t l e s , a s .w e ll as are a a i r sam ples. In both p l a n t s , samples were taken for PCB's (A r o c lo r 1 0 1 6 ) , tr ic h lo r o e th y le n e , le a d , t i n , and z i n c , in a d d itio n , samples for to lu e n e , methyl is o b u ty l ketone (MXBK), aluminum and iro n were taken a t P la n t 1 . These surveys were designed to c h a r a c te r ize the exposures v o c c u r r i n g a t t h e t i m e o f t h e s u r v e y and may n o t r e p r e s e n t coasn i exposures o f previous y e a rs , e s p e c ia lly those o f P la n t 1 where e x p o s u r e s may h a v e been r e d u c e d b e c a u s e o f new p r o d u c t i o n techniques which had re c e n tly , been i n i t i a t e d . RESULTS T h e r e # were a t o t a l o f 2 , 5 6 0 w o r k e rs who met th e d e f i n i t i o n o f the study cohort. Table 1 gives a breakdown o f v i t a l status ascertainm ent and the number o f p erson-years w ith in each s u b - c o h o r t . The v i t a l s t a t u s a s c e r t a i n m e n t was more th a n 97% com plete and o n l y 3 dea th c e r t i f i c a t e s c o u ld n ot be l o c a t e d . i A p p r o x i m a t e l y 55% (560 w o r k e r s ) o f th e c o h o r t members from P la n t 1 began employment p r io r to 1965 whereas, approxim ately 75% ( 1 ,1 8 0 workers) o f those from P la n t 2 began employment prior to 1965. A p p r o x i m a t e ly .37% o f the s t u d y c o h o r t from P l a n t 1 was e m p l o y e d i n nP C B e x p o s u r e " J o b e f o r l e s s t h a n 1 y e a r ( b u t g r e a t e r t h a n 3 m o n t h s ) , 55% were em p lo ye d i n t h e s e j o b s f o r 1 t o 1 0 y e a r s a n d 6% f o x g r e a t e r t h a n 1 0 y e a r s . I n P l a n t 2 , a p p r o x i m a t e l y 4 4 % o f t h e s t u d y c o h o r t wa s e m p l o y e d i n MP C B a exposure".Jobs for less than 1 year (but greater than 3 p C O 0 9 10 agh months), 47% for 1 to 10 years, and yesrs. f o r greater than io Tables 2 and 3 summarize the number of deaths observed from the study cohorts and the number of deaths expected. The all-cause mortality is lower than expected in each cohort, with an SMR (SMR = observed deaths/expected deaths x 100) of 90 (74 obs. vs. 82.3 exp.) for Plant 1 and an SMR of 91 (98 obs. vs. 107.91 exp.) for Plant 2. These low Im R' s reflect the "healthy worker effect".(17) There was no increase in observed mortali-ty for the major causes of death listed in Table 2. Table 3 lists the observed and expected number of deaths by % specific cancer cause. When both cohorts were combined, the. observed number of deaths were more than those expected for cancer of the rectum (4 obs. vs. 1.2 exp.) and liver cancer ICD=155, 156A (3 obs. vs. 0.9 exp.). The only statistically significant difference (at p < 0 . 0 5 ) in observed versus expected deaths occurred in females from Plant 2 for cancer of the rectum (3 obs. vs. 0.5 exp.; p < 0 . 0 5 ) . For both cohorts combined, there were 6 deaths due to cirrhosis of the liver, while 3.9. were expected. Five of these cases were from the Plant 2 cohort while 3.3 we^e expected. According to hospital reports, at least three of the six persons who died of 9 ACK 00691* c i r r h o s i s 0/ l i v e r e r e k n o w n t o h a v e - c o n s u m e d a l c o h o l -or. a regular basis. The r e l a t i o n s h i p between la t e n c y and the m o r t a l i t y from a l l cancer, cancer of the rectum , l i v e r cancer, and c i r r h o s i s of the l i v e r i s shown i n T a b l e 4 . F o r " a l l c a n c e r " t h e r e i s no apparent p atte rn in e ith e r c o h o rt. However, for cancer o f th rectum , a l l fo u r deaths o c c u rre d in the g r e a te r than 20 years la te n c y period where there were 0 .5 deaths expected (p < 0 .0 5 ). There i s no c le a r a s s o c ia t io n between la te n c y and m o r t a l i t y from l i v e r cancer, however, the three l i v e r cancers occurred between the 10-19 years latency period whereas 0.33 deaths were expected (p < 0 .0 5 ) . The r i s k o f m o r t a l i t y due to c i r r h o s i s o f the l i v e r as observed in p la n t 2 in c re a se s w ith an in c r e a s e in the l a t e n c y p e r i o d s . 0 The r e l a t i o n s h i p between th e s e same causes o f m o r t a l i t y and length o f employment In PCB exposed areas o f the p la n ts is given in Ta b le 5. F o r a ll- c a n c e r as w e ll as fo r ,l l v e r cancer there is no increase in observed m o r t a l it y w ith in c re a s in g lengths o f exposure. Fo r r e c ta l cancer and c ir r h o s is o f the l i v e r , t h e r e i s an I n c r e a s e i n th e r i s k o f m o r t a l i t y w it h an increase in lengths o f exposure. 10 ADh Th.s i n d u s t r i a l h y g i e n e s u r v e y r e s u l t s o f a r e a and p e r s o n a l sampling for PCE's (Aroclor 1015) are summarized .in Tables 6 ana 7 . Due to d i f f e r e n c e s in the p r o d u c t i o n p r o c e s s e s , the r e s u l t s by s p e c i f i c jobs or work areas are not comparable between the two p l a n t s . H o w e v e r , r e l a t i v e c o m p a r is o n s can be madfe a n d t h e r a n g e o f c o n c e n t r a t i o n s o b s e r v e d i n P l a n t 1 w e r e lower than those in Plant 2. in t h e t i m e velghtecV average (TIAKpersonalaixsaftpl*# r a n g e d fro m *yg/m3 to a n d t h e z*Jt rea. *ir s t a p l e ' r a n g e d / r o e -9 vg/e^ t o 47 4 g / m . i n P l a n t 2 , t h e TV'personal-air s a m p l e s t__ 7 r a n g e d f r o n r ' :1 7 D ' * i g / n r t o .- f g / n r and t h e TWA a r e a a i r sa m p le s ran g e d fro m 50 pg/m3 t o 810 pg/m3 . The c u r r e n t OSHA s t a n d a r d and M&CXtt'TL? for c h l o r o d i p h e n y l (42% c h l o r i n e ) i s lQ O Q ^ lip / a ^ There i s no c u r r e n t OSHA sta n d a rd o f ACGIH TLV for Aroclor 1016- . ' 0 T r i c h l o r o e t h y l e n e was measured n e ar th e d e g r e a s e r s i n b oth p l a n t s . Out o f eleven area a i r samples from P l a n t 1 , a l l were b e lo w 35 ppm e x c e p t f o r two which measured 195 ppm and 321 ppm. At P la n t 2 , three area a i r samples were taken which r a n g e d fro m 5 3 .4 ppm t o 7 7 . 5 ppm. The OSHA s t a n d a r d f o r t r i c h l o r o e t h y l e n e i s 10 0 ppm based on a 8 h o u r t i m e w e i g h t e d average. 11 GO 8** 1 Area a i r samples were measured fo r t i n , lead and z i n c near the s o l a e r i n g o p e r a t i o n s . There were no d e t e c t a b l e l e v e l s fo r t i n at e i t h e r p l a n t . Out o f fo u r samples c o l l e c t e d fo r lead and z i n c a t P l a n t 1 , l e a d was d e t e c t e d in one sample a t a l e v e l o f 12 pg/m5 , z i n c w a s .d e te c te d on two samples a t l e v e l s o f 8 and 24 pg/m5 . A t P la n t 2 , f i f t e e n samples were c o lle c t e d f o r le a d and z i n c . A l l bu t one o f these samples showed no d e t e c t a b l e l e v e l s f o r l e a d , th e Qne d e t e c t a b l e sample was 3* 4 1 . 2 pg/m . S i x o f the f i f t e e n samples found c o n c e n tr a tio n s o f zinc ranging from 2.3 to 9 4 .1 sta n d a rd fo r lead and z in c o xid e 3 p g / m . The c u rre n t OSHA m (re p o rte d as z i n c ) are Z O O p g / m 5 a n d 5 mg'/m5 r e s p e c t i v e l y . Both p e rso n al and area- samples were taken around the w elding * o p e r a tio n s for measuring aluminum and i r o n a t P la n t 1 . The aluminum samples ranged from n o n - d e t e c t a b le to 233 pg/m5 and 33 the i r o n samples from 47 pg/m to 123 p g / m . The ACGIH T L V f o r aluminum ( A l j O ^ ) i s 10 mg/m5 and th e c u r r e n t 3 O S H A s t a n d a r d f o r i r o n o x i d e ( m e a s u r e d as i r o n ) i s 1 0 mg/m . Tw elve pe rso n al samples were c o l l e c t e d f o r to lu e n e and MIBK during painting operations at Plant 1. Toluene concentrations r a n g e d fro m 0 . 4 8 t o 22 ppm and MIBK r a n g e d from 2 t o 5 ppm. The c u r r e n t OSHA s t a n d a r d f o k t o l u e n e i s 200 ppm and 100 ppm for MIBK. \7 AC* C G B 9 2 * I I :- DISCUSSION There are few previous epidem iolog ic s tu d ie s th a t have e x a m i n e d t h e l o n g t e r m h e a l t h e f f e c t s o f h u m a n s e x p o s e d t o < * P C B 's . i n d i v i d u a l s poisoned by r ic e o i l h e a v ily contam inated with PCB's (Yusho Disease) have been studied e x te n s iv e ly years a fte r the incident took place in japan in 19 6 8 .(18 , 19) However, the rice o i l contaminant also contained . pe 1y c h l o r i o a i d e n z o f u r a n v , a n d ^ a r t i^ M ^ o y le in higher^ ,, concentrations than that found In commercially prepared v P C B 's . A high p r e v a l e n c e .o f s k in and eye c o n d itio n s were noted in the Yusho p a t ie n t s . In a d d itio n , there were c l i n i c a l and la b o ra to ry fin d in g s th a t included changes in the microanatomy o f l i v e r c e l l s and a decreased c o n c e n tra tio n of b i l i r u b i n i n th e serum o'f th e s e i n d i v i d u a l s . ( 2 0 , 2 1 ) E a rly reports regarding the health e ffe c ts from occupational* exposure to PCB's include chloracne (2 2 ), digestive d is tu r b a n c e s ,'e y e i r r i t a t i o n , l i v e r in ju r y and im p o te n c e .(23, 24) Most o f these fin d in g s have been reported as case histories. In a recent study o f vo lu n te e rs conducted by the Mount S in a i S c h o o l o f M e d i c i n e ( 2 5 ) , 326 w o r k e r s who were e m p l o y e d a t P la n t 1 were examined. The most p re v a le n t symptoms noted were 13 ACM CC8S23 Z 2z - z t c l z z L z } l j .and these of the c e n t r a l n e r v o u s system. T h e r e was a' l o w p r e v a l e n c e o f a b n o r m a l l i v e r f i n d i n g s on physical exam ination. However, a subgroup exposed to PCB's were found to have l i v e r enzyme changes d i f f e r e n t from th a t of a n o rm al, non-exposed g ro u p , in a d d i t i o n , abnormal SGOT l e v e l s were a s s o c i a t e d w i t h p la s m a l e v e l s o f P C B ' s . T h e r e was a r e l a t i v e l y h i g h - p r e v a l e n c e o f d e c r e a s e d lu n g c a p a c i t y among a subgroup o f 243 workers te s te d . (2 6 ). In a p r e lim in a r y r e p o r t , Bahn (2 7 ) r e p o rte d an ^ncrease in deaths due to m a lig n a n t melanoma (2 obs. v s . 0 .0 4 e x p . ) and / cancer o f the pancreas among 51 r e s e a r c h and developm ent employees and 41 r e f i n e r y p l a n t employees a t a N e w 'Je rs e y petrochem ical f a c i l i t y . These in d iv id u a ls were considered to have had some e x p o su re t o A r o c l o r 1254 d u r i n g v a r i o u s p e r i o d s between 1949 and 19 5 7, along w ith exposure to oth e r t o x i c and p o te n tia lly carcinogenic compounds. VL In a summary o f case h i s t o r i e s ( 2 7 ) among a p p r o x i m a t e l y 300 workers employed in the m a n u fa c tu rin g o f P C B 's , no m alignant melanomas o r p a n c r e a t i c c a n c e r s were o b s e r v e d . H o w e v e r , among the de a th c e r t i f i c a t e s o f 50 fo rm e r w o rke rs a t t h i s manufacturing f a c i l i t y , seven cases o f lung cancer wereobserved whereas 2 * 7 cases were e xp e c te d . The fin d in g s were * i p re lim in a ry and were n ot a d ju s te d fo r age or smoking. 14 ACM C C o 5 i < i (written communication to MCSh from Roush, c. September, 1976.) The previously reported findings of an increased risk for mortality due.to malignant melanoma, cancer of the pancreas, and'lung cancer among workers exposed to RGB's were not corroborated in the present study. There were no observed deaths due to malignant melanoma and only 1 observed death from pancreatic cancer while 1.85 were expectec^ There were 7 observed deaths from repspiratory system cancer, whereas 8.2 were expected. The only categories of cancer in which the number of observed deaths were greater than expected were for cancer of the rectum and cancer of the liver. When both cohorts and sex groups were combined these excesses were not statistically significant at an alpha level of 0.05. However, the excess in liver cancer is noteworthy because it is consistent with the toxicology data observed in laboratory animals exposed to PCB's, where effects have been noted in the liver(6 -li). The increase in deaths due to cirrhosis of the liver in the Plant 2 cohort is also consistent with the notion that PCB's have a toxic effect on the liver. The exposures tp PCB's at the time o f the surveys (p la n t 1 - April, 1977; Plant 2 - March, 1977), were relatively higher in \ Plant 2. However, historic 'levels of exposure may have been 15 CM CO 6925 more e q u i v a l e n t and i t i s t h e s e e x p o s u r e s t h a t o c c u r r e d 2 0 to. 30 y e a r s ago t h a t are more r e l e v a n t when c o n s i d e r i n g the o c c u p a t i o n a l cancer r i s k among the s tu d y c o h o r t s . The PCB m ix tu r e s used d u r in g these tim e p e r io d s were A r o c l o r 1254 and 1 2 4 2 , w h e r e a s , A r o c l o r 1 0 1 6 was f i r s t used i n 1 9 7 1 . I n a d d itio n , several d i f f e r e n t s t a b i l i z e r s have been added to the P C B 's ( 1 %or le ss by w e ig h t) used a t P l a n t 1 sin ce the e a r ly 19 6 0 's. These Include p o te n tia l carcinogens such.as d i g l y c e r i d e e t h e r - d i s p h e n o l - a and more r e c e n t l y , v i n y l 9 cyclohexene d i o x id e . I t i s n ot known which s t a b i l i z e r s have been used at P la n t 2. The only s ig n ific a n t exposure other than PCB's at e ith er plant was t r i c h l o r o e t h y l e n e and th e s e e x p o s u re s were u s u a l l y below the T L V . However, due to t h i s p o t e n t i a l confounding exposure, workers employed around the tr ic h lo r o e th y le n e degreasers were not included in the cohorts. In most occupational h e a lth stu die s where cancer m o r ta lity is being asswssed, la te n c y is an Im p o rta n t v a r i a b l e ; the h y p o th e s is bein g t h a t th e re is an in cre a se d r i s k o f m o r t a l i t y once a c e r ta in time period a f t e r i n i t i a l exposure has elapsed. In th is study, examine due to the. sm all cancer causes. For "a ll this hypothesis is d iffic u lt to m number o f d e a th s among s p e c i f i c \ cancers" there does not appear to be 16 AC* 006926 a r e la tiv e increase in ris k a fte r any latency time perio d. A l l deaths due to cancer o f the r e c tu m .o c c u rr e d a f t e r at le a s t 20 years and a l l deaths due to l i v e r cancer occurred a f t e r at l e a s t 10 y e a r s . T h i s same p a t t e r n i s a p p a r e n t f o r ' d e a t h s due to c irrh o s is of the liv e r that occurred in Plant 2. Even though these are small numbers, the re s u lts in d ic a te that there is a p o te n tia l re la tio n s h ip between these causes o f death' and occu pation al exposure to PC B *s. The r is k o f m o r t a l it y from r e c ta l cancer and c i f r h o s l s o f the l i v e r , at l e a s t in P la n t 2 , a ls o in p re a s e s as the le n g th o f exposure in c re a s e s . Th is would be the expected o b s e rv a tio n f o r a response t h a t i s dependent on the m agnitude o f e xp o s u re . There are several va riab le s th a t could p o te n tia lly bias the r e s u l t s o f t h i s s tu d y ; and should be c o n s i d e r e d .* F i r s t , the p o s s ib ility of missing records from the personnel f i l e s t h a t were used t o assem ble t h e P l a n t 1 c o h o r t was questioned at the i n i t i a t i o n o f the stu dy. This is c u rre n tly b e in g I n v e s t i g a t e d by th e New Y o rk S t a t e D e p artm e n t o f H e a l t h . ( P e r s o n a l c o m m u n i c a t i o n f r o m P h i l T a y l o r , NYSDH, October, 19 79 .) in order to check the completeness o f the m icrofilm ed personnel f i l e s , they are being compared with the ** Social Security Adm inistration (SSA) quarterly earning 17 ACM 006917 statements from 19 4 5 -19 6 5 .(2 8 ) At the present tim e, the p e rso n ne l re c o rd s have been checked w ith the S5A q u a r t e r l y e a m i n g s records from 1945 to 1955, and a p p ro xim a te ly 179 a d d i t i o n a l names o u t o f a group numbering around 3 ,000 have been i d e n t i f i e d from the SSA r e c o r o s . The v i t a l s ta tu s o f th e s e 1 7 9 a d d i t i o n a l w o rk e rs was a s c e r t a i n e d and A4 were known to be deceased, 35X o f which were due to c a n c e r. T h e r e f o r e , based on t h i s check o f the rec ord s the P l a n t 1 s t u d y c o h o r t may b e m i s s i n g u p t o 6% o f t h e a c t u a l p o p u l a t i o n a at r i s k , in a d d itio n , th is missing group has a higher p ro p o rtio n o f deaths due to cancer than the study cohort id e n tifie d only from personnel records (35X for the missing group compared to 18X fo r the i d e n t i f i e d P la n t 1 study cohort: X2 = 3 .3 0 ; p < 0 .l0 ). Thus, the Plant 1 cohort c o u l d be m i s s i n g i n d i v i d u a l s who s h o u l d h ave been p a r t o f th e study, p o te n tia lly biasing the results o f the Plant 1 cohort. C o n s id e rin g thse f i n d i n g s , more emphasis should be d ire c te d , t o the m o r t a l i t y r e s u l t s o f the P l a n t 2 c o h o r t , which when examined alone shows an Increase in l i v e r and r e c t a l cancer, as w e ll as, c ir r h o s is o f the l i v e r . According to p la n t o f f i c i a l s , there vas no reason to b e lie v e th a t the personnel f i l e s y s te m a t P l a n t 2 was m i s s i n g r e c o r d s , and i t appeared \1 1o AU* CCi**6 from our in s p e c tio n th a t the person nel f i l e system had been maintained in ta c t. Another p o te n tia l confounding va ria b le is the possible e ffe c t o f a lc o h o l i n g e s t i o n on the ob se rved in c re a s e (a t P l a n t 2) in m o rta lity from c irrh o s is o f the l i v e r . However, th is cannot be p r o p e r l y assessed in the p re s e n t stu dy sin ce n o t enough is known a b o u t the i n g e s t i o n o f a l c o h o l among th e e n t i r e s tu d y cohort. CONCLUSIONS Due to a r e l a t i v e l y sm all number o f d e a t h s , c o n c lu s io n s drawn from the r e s u l t s o f t h i s s t u d y a re t e n t a t i v e , i n a d d i t i o n , up % t o ' 6% o f t h e a c t u a l p o p u l a t i o n a t r i s k may b e m i s s i n g f r o m t h e Plant 1 cohort. Despite these study lim ita tio n s , the observed excesses in l i v e r cancer and c ir r h o s is o f the l i v e r are c o n siste n t with p reviously reported findings o f experim ental animals exposed t o P C B ' s , and s u g g e s t t h a t t h e r e may be an a s s o c i a t i o n between these causes o f death and o ccu p a tio n a l exposure to PCB's (A ro c lo r 1254 and 1242) The observed excess in cancer o f th e. rectum r e l a t e d t o FC B exposu re was u n e xp e cte d and needs 10 AC* 0 0 8 5 2 * if her investigation. Additionally, the possible role ofalcohol ingestion together with exposure to RGB's is unknown and needs further examination. $ 20 ACK CC6930 REFERENCES 1 . Hutzi'n-er, 0 . , S a f e , S . , Z i t k o , V . 1 9 7 4 . T h e C h e m i s t r y o f P C B ' s . C le v e la n d , The Chemical Rubber Co. P re s s . 2. Yobs, fl.R. 19 72. Levels o f polychorinated biphenyls in adipose tissue o f the general population o f the n a tio n . -Environ. Health P e rs p e c t., Experimental issue No. 1: * 79-81. $ 3. P r ic e , H . A . , Welch, R . L . 1972. Occurrence of p o lyc h o rin a te d biphenyls in humans. E n v ir o n . Health P ro sp e c t., Experimental issue No. 1: 73 -78 . ` 4 . J e n s e n , S . , j o h n e l s , A . G . , O l s s o n , M. and O t t e r l i n d , G . 1969. DDT and PCB in marine animals from Swedish waters. Nature, 224:247-250. 5. Je n se n , $ . 19 72 . The PCB s t o r y , Ambio, 1 : 1 2 3 - 1 3 1 . 6 . Von vedfrlt H . , H o l l a , W . A . , Denton, J . 1943. O b s e rv a tio n s on the t o x i c e f f e c t s r e s u l t i n g from exposures to c h lo rin a te d naphthalene and c h lo rin a te d phenyls w ith suggestions for p re v e n tio n . Rubber Age 54:419-26. v ACM CC8531 Mi H e r ; - J . w . 1 9 4 4 . P a t h o l o g i c changes i'n a n i m a l s exposed to a commercial, chlorinated diphenyl. PublicHealth Rep. 59:1085-93. B ru ck n e r, J . V . , Khanna, K . L . , C o r n is h , h .h . 19 76 . Polychlorinated biphenyl-induced alteration of biologic parameters in the r a t . T o x ic o l. Appl. Pharmacol. .28:189-99. K i m b r o u g h , R . D . , L i n d e r , R . E . , G a i n e s , T .if. 1 9 7 2 . Morphological changes in liv e r s o f ra ts fed polychlorinated biphenyls. ,Arch. En viro n. Health 25:354-66. Kimbrough, R . O . , Lin d e r, R . E . , Burse, V.W ., Jennings, R V. 1973. Ade no fibrosis in the rat l i v e r - - With persistence of polychlorinated biphenyls in adipose tissu e . Arch. Environ. Health 27:390-95. I Kimbrough, R . O . , Lin d e r, R .E . 1974.- induction o f a d e n o f i b r o s i s and h e p a t o m a s o f t h e l i v e r i n BALB/cJ mice by p o lych lorina ted biphenyls (Aroclor 1256). j . N a tl. Cancer I n s t . 5 3 : 5 4 7 - 5 2 12. A lle n , J . R , , Abrahamson, L . J . , Norback, D.H. 1973. * B i o l o g i c a l e f f e c t s o f p o l y c h l o r i n a t e d b ip h e n y ls and t r i p h e n y l s on the subhuman p r i m a t e . E n v i r o n . R es. 6:344-54. 13 .' Vos, J . G . , Motenboom-Ram, E. 1972. Comparative to x ic ity study o f 2 , 4 , 5 , 2 , , 4 , , 5 , -h e xach lo ro b i'p he n yl and a polychlorinated biphenyl mixture in rabbits. Toxicol. Appl. Pharmacol. 23:563-76. ^ 1 4 . Procee d in g s o f the N a t i o n a l C onference on Polychlorinated Biphenyls. EPA, Office of Toxic Substances, Washington, D . C . , March, 1976. 1*5. N IO S H , CDC, P H S , DHEW. 1 9 7 7 . C r i t e r i a f o r a recommended sta n d a rd .. .Occupational Exposure to polychlorinated biphenyls (PCB's). 1 6 . C u t l e r , S . J . , E d e r e r , F . 19 5 8 . Maximum U t i l i z a t i o n o f the l i f e ta b le methods in a n a lyzin g s u r v iv a l. 0. Chron. D ls .| 8:699-709. i 1 7 . McMichael, A . J . , Haynes, S . G . , T y ro le r, H.A. 1975. O b se rva tio n s on the e v a lu a tio n o f o c c u p a tio n a l m o r t a l it y v d a ta . J . Occup. Med.' 1 7 : 1 2 8 - 1 3 1 . . 23 CM G0B933 13. K u r a t s n e , M . , M i s u d a , Y , , N a g a y a m a , * J . 1 9 7 6 . Some of t h e R e c e n t F i n d i n g s C o n c e r n i n g Y u s h o , i n P r o c e e d i n g s of the N a t i o n a l C o n fe re n c e on P o l y c h l o r i n a t e d B i p h e n y l s , November 1 9 - 2 1 , 1 9 7 5 , C h i c a g o , E P A - 5 6 0 / 6 - 7 5 - 0 0 4 . u . S , Environmental Protection Agency, O ffice of Toxic Substances, 1976, pp. 14-29. 19 . * Urabe, H. 19 7 4 . [Fo re w a rd , The fo u rth re p o rts o f the study o f "Yusho" and P C B .] Fukuoka Acta Med. 6 5 :1 - 4 , (Jap). * 20. Hirayama, C . , i r i s a , T . , Yamamoto, T. 1969. [Fin e s tru c tu ra l changes o f the l i v e r in a p a tie n t with c h lo ro b ip h e n y ls i n t o x i c a t i o n . ] Fukuoka Acta Med. 60:455-56 (Ja p ). ' * # 2 1. Hirayama, C . , Okumura, M ., Nagai, J . , Masuda, Y. 1974. Hypobillrubln in patients with polychlorinated biphenyls poisoning. C lin . Chim. A cta . 5 5 :9 7-10 0 . 22. Meigs, J . V . , Albom, J . J . , K a r tin , B .L . 1954. Cloracne f r o n an unusual exposure t o A r o c l o r . JAMA 1 5 4 : 1 4 1 7 - 1 8 . 2 3 . S c h w a rtz, L . 1936. D e r m a t it is from s y n t h e t ic re s in s and waxes. Am. J . P u b l i c h e a l t h 2 6 :5 8 6 -9 2 . 24 008934 ?a . D r in k e r ," G . K . , W arren, m . f . , Dennett,* G . A , 19 3 7. The problem o f possible systemic e ffe c ts from certain chlorinated hydrocarbons. 3. Ind. Hyg. Toxicol. 19:283-99. 25. Fischbein, A ., W olff, M .S ., L i l i s , R ., Thornton, 0 ., S e lik o ff, 1.3. 1979. C l i n i c a l f i n d i n g s . among P C B -e xp o s e d c a p a c i t o r m a n u f a c t u r in g w o r k e r s . New Y o rk Academcy o f Scien ces. 3 2 0 :70 3 -715 ,. 26. Warshaw, R . , Fis c h b e in , A . , Thornto n, 3 . , K i l l e r , A . , S e lik o ff, 1 .3 . 19 79 .' Decrease in V ita l Capacity in PCB-Exposed Workers in a C apacitor Manufacturing , F a c i l i t y . New Y o r k Academy o f S c i e n c e s . 3 2 0 : 2 7 7 - 2 8 4 . 2 t . Bahn, A . K . , Rosenwaike, I . , Herrmann, N ., Grover, p ., S te llm a n , 3 . , O 'L e a r y , K . : Melanoma a f t e r exposure to P C B 's . N. E n g l. 3. Med. 29 5:45 0, 19 7$ . 28. Marsh, G . M . , E n t e r lin e , P . E . , 1979. A Method fo r V e rify in g the completeness o f cohorts used in occupational m o rta lity stu d ie s. JOM, in Press. 25 ACH 006935 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY BEFORE THE ADMINISTRATOR In re: ) Proposed Toxic Pollutant Effluent ) FWPCA (307) Standards for Polychlorinated ) Docket No. 4 Biphenyls ) AFFIDAVIT OF ROSCOE M. MOORE, JR. Roscoe Mo Moore, Jr., being duly sworn, deposes and, says: 1. I am currently employed as an epidemiologist by the National Institute for Occupational Safety and Health (NIOSH) , at 5600 Fishers Lane, Rockville, Maryland. My biography is attached to this affidavit as exhibit 1. 2. As part of my duties at NIOSH I was'involved in the preparation of a "Dear Colleague" letter" which was sent out on August 20, 1976, by Dr. John F. Finklea,'Director of NIOSH. A copy of that letter is attached to this affidavit as exhibit 2. 3. In this letter NIOSH reviewed the preliminary results of an epidemiologic analysis based on medical records of Mobil Oil Company employees exposed to PCBs at Mobil's Paulsboro, New Jersey plant. \ 4. Among the 92 workers studied, for whom adequate medical records were available, eight cancers (in seven workers) were [ l observed between 1957 and 1975. Of these eight cancers, three were malignant melanomas and two were cancers of the pancreas. This is significantly more skin cancer (melanoma) and pancreatic cancer than would be expected in a population of this size (based on the Third National Cancer Survey). 5. Based on these findings and those reported earlier on the carcinogenicity of PCBs in tost animals, it is my conclu sion that when the results of further studies op occupationallyexposed individuals are completed, there is strong likelihood that PCBs will be shown to be carcinogenic to humans. / 6. NIOSH is currently conducting such follow-up studies on workers occupationally exposed to PCBs. Roscoe M. Moore Sworn to and subscribed before me November, 1976 Notary Public At* ' DR. RQSCOE MICHAEL MOORE, JR. ADDRESS: 1^315 A r c t i c Avenue R o c k v i l l e , Maryland 20353 TELEFrIONE: 301-871-3578 (Home) 301-443-380 (O ffice) I * BORN: December 2, 1944 - Richmond, V i r g i n i a FAMILY: W ife : P a t r i c i a Hayvood, E . S . in N u rs in g , Tuskegee I n s t i t u t e , 19C5; C .R .N .A ., School o f A n e s th e s ia , U n iv e r s ity o f M ich igan , 1969. Son : Roscoe M ic h a e l Moore, I I I , born May 16, 1971 Son: Jo h n Hayvood Moore, born A p r i l 6 , 1973 EDUCATION Tuskegee I n s t i t u t e , T u sk cg e e , Alabam a, 1962-1965, B . S . - 1968 T uskcgee I n s t i t u t e , T u sk e g e e , Alabam a, 1965-1969, D .V .M . f Chairman of the Honor Code, School o f V eterin ary M edicine, 1967-1968 President of Student Chapter of the American Veterinary Medical A s s o c ia tio n , Tuskegee I n s t i t u t e , 1968-1969 Congressman to the Student Government A s s o c ia tio n , 'Tuskegee I n s t i t u t e , 196S-1969 Who's Who i n American C o l l e g e s and U n i v e r s i t i e s , 1968-1969 U n iv e r s it y o f M ich igan , Ann A rb or, 1969-1970, M .P .H . in Epidem iology U n i v e r s i t y o f M ary lan d , C o l l e g e P a r k , Fe b ru ary 1971 - 'May 1971, e v e n in g course in Spanish CONTINUING EDUCATION PROGRAMS F o r t r a n T r a i n i n g Course a t th e C e n te r f o r D is e a s e C o n t r o l , November S - 1 2 , 197 P e s t i c i d e s and P u b l ic H e a lth T r a in i n g C o u r s e , sponsored by the Envi ro:;:r.c;*.Lni P ro te ctio n Agency (EPA), February 1 -4 , 1972, A tla n t a , Georgia Advanced Course - P e s t ic i d e s and P u b lic H e a lth , sponsored by FTA, May 1 6 -1 9 , 1972, A t l a n t a , G e o r g ia continu: "-z ducations phocams fcoN'7 .) Critl Management C ourse, sponsored by S c i e n t i f i c Methods, I n c . , O cto b e r 2 1 -2 6 , 1973, M o r r isto w n , New J e r s e y t Neurology Course, sponsored by D .C . Academy o f V e te r in a r y M e d icin e , A p r il 4 -5 , 1974, F a ir fa x , V ir g in ia , * Pharm acology C o u rse , sponsored by the Food and Drug A d m i n i s t r a t i o n , May-June, 1974, R o c k v ille , Maryland Immunology Course, presented by Johns Hopkins U n iv e r s it y , O cto b e r 25 - December 11, 1974, R o c k v i l l e , Maryland Comparative Pathology Course, sponsored by the Department of Defense, Armed F o rce s I n s t i t u t e o f P a t h o l o g y , Kay 10-12, 1976, W a sh in g to n , D .C . WORK EXPERIENCE Ja n u a r y 1976 - P re s e n t A Veterinary Medical O ffic e r in the U .S . Public Health Service, s t a t i o n e d a t the* N a t i o n a l I n s t i t u t e f o r O c c u p a t io n a l S a f e t y and Health (NIOSH), R o c k v ille , Maryland. C h ie f , T e ch n ica l E v a lu a tio n and Review Branch, O f f i c e o f ExLramural C o o r d in a tio n and S p e c i a l P r o j e c t s (OECSP), NIOSH, w ith prim ary r e s p o n s i b i l i t y i n co n d u ctin g and c o o r d in a tin g s h o r t-te r m t e c h n i c a l studies including evaluation of toxicologic information transmitted to the I n s t i t u t e fo r review . A ls o , m a in ta in in g and s u p e r v is in g the NIOSH C u rren t I n t e l l i g e n c e System . T h is system prepared b a c k ground in fo rm a tio n on p o t e n t i a l l y hazardous su b stan ces in the o c c u p a t io n a l environm ent i n c l u d i n g t o x i c i t y to man and a n i m a l s , p ro d u c tio n and u s e s , and the p o t e n t i a l p o p u la tio n a t r i s k . T h is system informs the occup ation al h e a lth community, other government ' a g e n c i e s , management, la b o r and p u b l i c i n t e r e s t groups o f new in f o r m a t io n on p o t e n t i a l o c c u p a t io n a l h e a l t h h a z a r d s . In addition, as Epidem iologist' for the O ffice of Extramural C o o rd in atio n and S p e c ia l P r o j e c t s , p ro v id e s the n ece ssary s t a t i s t i c a l and- e p i d e m i o l o g i c a l in f o r m a t i o n to q u a n t i t a t e the r e l a t i v e r i s k o f human exposure to c h e m ic a l s u b s ta n c e s i n the work e n v iro n m e n t. ACh GCtS^1* December 197A - Ja n u a r y 1976' A Veterinary Medical O ffic e r in the U .S . Public Health Service, s ta tio n e d a t the N a tio n a l I n s t i t u t e fo r O ccu p a tio n a l SafeLy and Health (NIOSH), R o c k v ille , Maryland. , > C h ief, P r io r itie s Evaluation Branch, O ffice of Occupational Health S u r v e il l a n c e and B io m e tric s (OOHSB), N10SH, w ith primary r e s p o n s i b i l i t y in directions the developm ent, im plem entation, and maintenance o f the P r i o r i t i e s E v a lu a tio n System which provides guidance ro the I n s t i t u t e D i r e c t o r and the NIOSH s c i e n t i f i c s t a f f fo r the a l l o c a t i o n o f r e s o u r c e s to a s s u r e maximum e f f o r t in combaLing h e a l t h h a za rd s i n the work environment. In a d d i t i o n , as S e n io r M e d ic a l E p id e m io l o g is t f o r the OOHSB, p ro v id e the necessary s t a t i s t i c a l and e p id e m io lo g ica l inform ation to quan t i t a t e the r e l a t i v e r i s k o f human e xp o su re to c h e m ic a l s u b s ta n c e s in the work environment. J u l y 1973 - December 197A A Veterinary Medical O ffic e r in the U .S . Public Health Service, sta tio n e d a t the Food and Drug A dm inistration (FDA), R o c k v ille , Maryland. A S u r v e il la n c e O f f i c e r , Bureau o f V e t e r in a r y M e d ic in e , Food and Drug A dm inistration with major r e s p o n s ib ility in evaluating the s a fe L y , r e l i a b i l i t y , and e f f i c a c y o f v e t e r in a r y drugs fo r the t a r g e t s p e c i e s as w e l l as human s a f e t y w it h r e s p e c t to t i s s u e residues in food anim als. A lso , have been a c tiv e in drug residue m o n ito r in g i n e d i b l e t i s s u e w h i le s e r v i n g as FDA c o n s u l t a n t to th e S t a t e s o f W is c o n s in and New Y o r k . In a d d i t i o n , a member o f th e P r o j e c t A d v is o r y Croup on FDA c o n t r a c t s f o r Heavy M e ta ls Research. Prim arily functioning- as a to x ico lo g ic epidem iologist for the Bureau. J u l y 1971 - Ju n e 1973 A Veterinary Medical O ffic e r in the U .S . Public Health Service, stationed a t the Center for Disease Control (CDC), A tlan ta, Georgia. An E p i d e m io l o g is t w ith the Epidem ic I n t e l l i g e n c e S e r v i c e (E IS) with primary re s p o n s ib ility for n ation al p sitta co s: s, t li s t c r i o s i s , v i r a l pox, Venezuelan equine e n c e p h a lit is , and animal b it e sur v e i l l a n c e . A c o n s u l t a n t to F a m ily P la n n in g A c t i v i t i e s a t CDC to develop anim al models fo r rep rod u ction and p o p u latio n s t u d i e s . A l s o , CDC L i a i s o n , R a b ie s C o n t r o l Program , Dade C o u n ty , F l o r i d a . In a d d it io n , c o n s u lta n t to the Alabama and F lo r id a S t a te H ealth Departments on Lead T o x i c o s e s . vonK r.x. h (co::'T.) September~1970 - Ju n e 1071 L Senior A ssistan t Veterinary O ffic e r in the U .S . Public Health S e r v i c e , s t a t i o n e d a t Lhe N a t i o n a l I n s t i t u t e s o f H e a lth (HIM), Bethesda, M aryland.. * t A member o f the Animal D is e a s e I n v e s t i g a t i o n S e r v i c e w ith major r e s p o n s ib ility fo r prevention nd co n iro l of d iseases w ithin the g e r m -fr e e arid s p e c i f i c p a t h o g e n - f r c c a n im a l c o l o n i c s a t NIH. In a d d i t i o n , a s s i s t i n g NIH I n v e s t i g a t o r s w ith r e s e a r ch problems related to animal d isease. Summer 19GS Worked as a V e t e r i n a r y T r a in e e w ith th e U . S . Department o f A gricu ltu re , Animal Health D iv isio n in the State 6f Georgia. Summers o f 1965 'and 1967 A t u t o r i n th e Tuskegee I n s t i t u t e summer e d u c a t io n program, a poverty program operating in the "Black B e lt" counties o f Alabama. Taught b io lo g y in s p e c ia l scie n ce centers to high school aged ch ildren in th is program. While in School at Tuskeree I fin a n c e d my e d u c a r io n through Work Study Program, F e d e r a l l o a n s , and sch o la rs h ip s . PERSONAL Pro fession al A ff ilia t io n s Member: American P u blic Health A sso ciation A c t i o n Board .Member (1974-1976) J o i n t P o l i c y Committee Member (1975) . American A s s o c ia tio n of Food Hygiene V e te rin a ria n s American A ssociation for Laboratory Animal Science American So ciety of Laboratory Animal P ra ctitio n e rs American Veterinary Medical A ssociation Conference of Public Health Veterinarians Drug Inform ation A sso cia tio n Society for Epidemiologic ftsearch ci* c o e s ^ i P r o f ps-.] on.-i 1 Af f i 11 a t ion s ( c o n ' i . ) Member by E l e c t i o n : American College of Veterinary T o x ico lo g ists (A ssociate Fellow) S o c ie ty fo r O ccu p atio n a l and Environm ental H e a lth Veterinary Cancer Society Appointments: An A d v is o r y Committee member on c u r r i c u l u m f o r the S c h o o l o f A g r i c u l t u r e ` and N atu ral R e so u rce s, Washington T e c h n ic a l I n s t i t u t e , W ashington, D .C . (1974 - P re sen t) External Reviewer for the N ation al Cancer I n s t it u t e ' s Bioassay Program ( T r ic h lo r o e th y le n e , Chloroform ) (1975 - P resent) NIOSH O c c u p a tio n a l C a r c in o g e n e s is Task Force - Working Croup on M u ta g e n ic ity T e s tin g (1975 - P re sen t) * Awards U nited S t a t e s P u b lic H e a lth S e r v ic e (U5PHS) Commendation Medal Award, A p r il 2, 1976, 'fo r outstanding performance in the develop ment o f a C u rren t I n t e l l i g e n c e System fo r the N a tio n a l I n s t i t u t e fo r O c c u p a tio n a l S a fe t y and H e a lth , and d e d ica te d s e r v ic e to the occupational health mission of the organization. Licensure L ice n se d to p r a c t i c e V e te r in a r y M edicine i n Alabama, G e o rg ia , and V irg in ia . Non-Professional A ffilia tio n s A lternate delegate representing the D ivision of Research Services (DRS) a t Nili i n the R e c r e a t io n and W e lfa r e A s s o c i a t i o n (1970-1971) A member o f the D i r e c t o r ' s A d v is o r y Committee o f DRS. T h is com m i t t e e i s concerned w ith e q u a l employment o p p o r t u n i t i e s v i i h DRS a t NIH (1970-1971) A-member o f the N a tio n a l W i l d l i f e F e d e r a tio n (1970 - F.rcsent) An A s s o c i a t e Member o f th e I n t c r r c l i g i o u s Fo u n da tio n f o r Community O r g a n iz a tio n s , I n c . (1974 - P re sen t) An A s s o c i a t e Member o f the Am erican Committee on A f r i c a (1974 - Pr Hobbies A p h i l a t e l i s t and ten n is e n t h u s ia s t pusuc.vrr Moore, ftv M: ,* Zehmer, R . B . ` L i n t e r i o s i s i n the U n ite d S t a t e s . 1971.- J . I n f e c t . D i s ., V o l. 127:610-611, 1973. Moore, R . M. Human O r f i n th e U n ite d S t a t e s . D i s ., V o l. 127:731-732, 1973. * 1972. J . I n f e c t . Moore, R. M ., Zchmer, R. B . , Moulthrop, J . I . , Parker, R. L. Su rv e illa n ce of Aninal B ite Cases in the United S ta te s. 1971-72. Arch. Environ. H lth . (In Tress) Moulthrop, J . I . , Moore, R.` M ., Parker, R. L. Venezuelan Equine E n c e p h a litis S u rv e illa n c e in the United S t a t e s . 1972. J . I n f e c t . D i s ., V o l. 127:572-573, October 1973. D u r f e e , P . T . , Moore, R. M. Human P s i t t a c o s i s i n the U n it e d S t a te s . 1971-1973. J . I n f e c t . D i s ., V o l. 131:193-194, 1975. L l o y d , J . W ., >D e c o u f l e , P . , Moore, R. M. Background I n f o r m a t io n on C h lo r o p r e n c . J . O ccu. M e d ., V o l. 17:263-265, 1975. Lloyd, J . W., Moore, R. M ., B r e s lin , P. P. Background Inform ation on T r i c h l o r o e t h y l e n e . J . O ccu . M e d ., V o l . 1 7 :6 0 3 -6 0 5 , 1975'. K a u fn a n n , A. F . , M o u lth r o p , J . I . , M oore, R . M. A 'p e r s p e c tiv e o f Sim ian T u b e rc u lo sis in th e U nited S t a t e s . 1972. J . Med. Frim atology, V o l. 4:278-266, 1975. L l o y d , J . W ,, Moore, P.. M . , W o o lf, E . 3 . , S t e i n , H. ? . P o ly ch lorin ated Biphenyls. J . Occu. K e d ., V o l .. I S :109-113, 1976. L e v i n e , R . J . , Moore, R. M . , M cLaren, C . ; B a r t h e l , W. F . , L a n d rig a n , P . J . O ccu p a tio n a l P o is o n in g , Animal D eaths, and Environmental Contamination a t a Lead Scrap Sm elter. June Issu e , AJPH, 1976. Moore, R. M ., Moulthrop, J . I . , Sather, C .,.H o lm e s, C. L . , Parker, R. L. Venezuelan Equine E n cep h a litis Vaccination Survey in A r iz o n a and Hew M e x ic o . 1972. P u b l i c H e a lth R e p o rts ( S u b m it t e d ) . Moore, R. H. . The Epidemiology of Animal B ite Cases in the United S t a t e s . P roceedings o f the 11th (1976) Annual V e te rin a ry Symposium, School o f V eterin ary M edicine, Tuskegce I n s t it u t e (In P r e s s ) . PUBLICATION EXPERIENCE Prepared monthly su rv e illa n ce reports for the Center for Disease C o n tr o l co n ce rn in g l i s t e r i o s i s , p s i t t a c o s i s , and Venezuela!! equine e n c e p h a l i t i s from 1971 to 1973. AC* CC6943 i' UULIC r,;*EA''.7!:C C h a i r e d s e s s l o n a t the 102nd Annual M e e tin g o f the AI'IIA in nu O rlea n s on October 22, 1974, e n t i t l e d "Zoonoses and the Non-White and Poo'r , " " P u b l i c H e a lt h and L e g a l S i g n i f i c a n c e (o f Drug R e s id u e s i n Pood Anim als" presented a t the Ninth Annual Symposium, School of V eterin ary M edicine, Tuskegee I n s t i t u t e , Alabama, A p r il 9 , 1974. "Environm ental Lead Contam ination - E f f e c t o f Humans, A nim als, S o i l and P la n t s " presented a t the Annual Epidem ic I n t e l l i g e n c e S e r v i c e (E IS ) C o n fere n ce a t the C e n te r f o r D is e a s e C o n t r o l (CDC) i n A t l a n t a , Georgia on A p r il 9 , 1973. "E q u in e VEE V a c c in a t i o n S u rv e y , 1972" p re se n te d a t th'c Annual EIS C o n fe r e n c e a t CDC i n A t l a n t a , G e o r g i a , A p r i l 13, 1973. "The Epidemiology of Animal B ite Cases in the United S tates" presented at the Eleventh Annual Symposium, School^ of V eterin a ry M edicine, Tuskegee I n s t it u t e , Alabama, A p r il 12, 1976. AGI". CCfcS^ DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PU B LIC H E A LT H 5 C R V IC E CEN TER FOR DISEASE CO N TR O L A ugust 20, 1976 * N A T IO N A L INSTITUTE FOR O CCU PATIO N AL SAFETY AND HEALTH s*oo f i s h e r s l a n e R O C K V IL L E , M A R Y L A N O 20852 Dear Colleague: I n a Ju n e 24, 1976 l e t t e r , M o b il O i l C o r p o r a tio n a d v is e d the N a t i o n a l I n s t i t u t e fo r O ccu p atio n a l S a fe t y and H ealth (NIOSH) o f a p o s s ib le a s s o c ia tio n between occupa tio n a l exposure to po ly ch lo rin ated hiphenyls (PCBs) and cancer.ItT humans. M o b il O i l reported" p r e lim in a r y r e s u l t s o f an e p id e m io lo g ic a n a ly s is based on m edical records o f employees exposed to PCBs a t t h e i r P a u ls b o r o , New J e r s e y p l a n t . T h is s tu d y was conducted by P r o fe ss o r A n ita K. Bahn (School o f M e d icin e, U n iv e r s it y o f P en nsylvania) and i s b e in g rep orted by Dr. Bahn in a l e t t e r to the e d i t o r o f th e New England J o u r n a l o f M e d ic i n e , A ugust 19, 1976. The stu d y in c lu d e d two c o h o r ts o f M o b il employees who were r e p o rte d to have had v a r y in g exposure to A r o c lo r 1254 (a m ixtu re o f PCB s). The .co h o rt o f r e s e a r c h and development employees was exposed to PCBs be tween 1949 and 1957 and th e c o h o r t o f r e f i n e r y p l a n t employees between 1953 and 1958. The e x t e n t o f exposure o f th e se workers to o t h e r chem i c a l s i s n o t known. The c a n c e r i n c i d e n c e among th e s e workers f o r the p e r io d 1957 through 1975 was determ ined u s in g M o b il m e d ic a l r e c o r d s . Because m e d ic a l r e c o r d s f o r 37 employees were i n c o m p le t e , th e s e workers were excluded from th is a n a ly s is . Among th e 92 workers i n th e s e two c o h o r t s f o r whom adeq uate m e d ic a l records were a v a ila b le , e ig h t cancers (in seven workers) were observed between 1957- and 1975. Of th e se e i g h t c a n c e r s , th r e e were m a lig n a n t melanoma and two were c a n c e r o f the p a n c r e a s . T h is i s s i g n i f i c a n t l y more s k in cancer (melanoma) and p a n c r e a tic cancer than would be ex p e c te d i n a p o p u la t io n o f t h i s s i z e (based on the T h ird N a t i o n a l Cancer Survey) The remaining cancers were found a t three other s it e s i n two em ployees; sarcoma o f bhe r i g h t t h ig h and m u l t i p l e myeloma i n one employee, and r e c to -s ig m o id can cer i n the o t h e r . Page 2 - Dear Colleague NIOSH is unaware of any other published animal or._human_data which sug gest a correlation between exposure to PCBs and skin"(melanoma) or panrTgcftiC~^ahce~r~r~~Howeve~r7`he^ralomas~Cmice, Aroclor 1254) and hepato cellular carcinomas (mice, Kanechlor 50lD; rats, Aroclor 1260) have been reported In FCB feeding studies of laboratory animals. % Background information on PCBs has been summarized in the NIOSH Current Intelligence Bulletin on Polychlorinated Biphenyls issued to the occupa tional health community on November 3, 1975, and subsequently published in the Journal of Occupational Medicine. Volume 18, pages 109-113, February 1976. Since the NIOSH Bulletin was first issued, a number of large firms have introduced products (e.g., butylated monochlorodiphenyl oxide and dimethyl siloxane polymer) claimed to be fire resistant dielectrics which can serve as alternatives to PCBs. In addition, one of the large domestic transformer manufacturers announced that it w i l l cease using PCBs as fire resistant transformer fluids at the end of this year. NIOSH would like to stress that alternatives for PCBs should be thoroughly studied to assess the consequences they may pose to human health. m t To aid in evaluating PCBs as a potential occupational health problem, NIOSH would welcome receiving reports of studies regarding the possible association between exposure to PCBs and human cancer. Your cooperation in this matter is appreciated. Sincerely- yours, H> 'John F. Finklea, M.D. I Director v \ Coes** AC*  f i? % \ L, 9 H DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE CENTER POR OISEASE CONTROL August 20, 1976 Dr. V. B. Papageorge Manager, Product Acceptability Specialty & Process Chemicals Monsanto Industrial Chemicals Co. 800 N. Lindbergh Boulevard St. Louis, M0 63166 Dear Colleague: ^7 J N A T IO N A L INSTITUTE FO R OCCUPATIONAL SAFETY AND HEALTH 5600 FISH ERS L A N E R O C K V IL L E . M A R Y L A N D 20652 $ In a June 24, 1976 letter, Mobil Oil Corporation advised the National Institute for Occupational Safety and Health (NIOSH) of a possible association between occupational exposure to polychlorinated biphenyls (PCBs) and cancer in humans. Mobil Oil reported preliminary results of an epidemiologic analysis based on medical records of employees exposed to PCBs at their Paulsboro, New Jersey plant. This study was conducted by Professor Anita K. Bahn (School of Medicine, University . of Pennsylvania) and is being reported by Dr. Bahn in a letter to the editor of the New England Journal of Medicine. August 19, 1976. The study included two cohorts of Mobil employees who were reported to have had varying exposure to Aroclor 1254 (a mixture of PCBs). The cohort of research and development employees was .exposed to PCBs be tween 1949 and 1957 and the cohort of refinery plant employees between 1953 and 1958. The extent of exposure of these workers to other chem icals is not known. The cancer incidence among these workers for the period 1957 through 1975 was determined using Mobil medical records. Because medical records for 37 employees were incomplete, these workers were excluded from this analysis. Among the 92 workers in these two cohorts for whom adequate medical records were available, eight cancers (in seven workers) were observed between 1957 and 1975. Of these eight cancers, three were malignant melanoma and two were cancer of the pancreas. This is significantly more skin cancer (melanoma) and pancreatic cancer than would be ex pected in a population of this size (based on the Third National Cancer Survey). The remaining cancers were found at three other sites In two employees; sarcoma the right thigh and multiple myeloma in one employee, and recto-sigmoid cancer in the other. ACM CGSSitI Page 2 - Dear Colleague NIOSH is unaware of any other'published animal or human data which sug gest a correlation between exposure to PCBs and skin (melanoma) or pancreatic cancer. However, hepatomas (mice, Aroclor 1254) and hepato cellular carcinomas (mice, Kanechlor 500; rats Aroclor 1260) have been reported in PCB feeding studies of laboratory animals. Background information on PCBs has been summarized in the NIOSH Current Intelligence Bulletin on Polychlorinated Biphenyls Issued to the occupa tional health community on November 3, 1975v and subsequently published In the Journal of Occupational Medicine. Volume 18, pages 109-113, February 1976. Since the NIOSH Bulletin was first Issued, a number of large firms have introduced products (e.g., butylated monochlorodiphenyl oxide and dimethyl siloxane polymer) claimed to be fire resistant dielectrics which can serve as alternatives to P(&s. In addition, or.e of the large domestic transformer manufacturers announced that it will cease using PCBs as fire resistant transformer fluids at the end of this year. NIOSH would like to stress that alternatives for PCBs should be thoroughly studied to assess the consequences they may pose to human health. To aid in evaluating PCBs as a potential occupational health problem, NIOSH would welcome receiving reports of studies regarding the possible association between exposure to PCBs and human cancer. Your cooperation in this matter is appreciated. Sincerely yours 'Joohhn F. Finklea, M.D Director v S ACh Ci' I Mobil Oil Corporation June 25, 1976 George Roush, J r . , M.D. Medical D ire c to r Monsanto Company 800 N o rth Lindbergh B l v d . S t . Louis, M issouri 63166 Dear George: As o f t h i s d a te I have Inform ed NIO S H o f o u r f i n d i n g s a t Mob I P s P a u l s boro R efinery En c lo s e d Is a cop y o f my l e t t e r t o D r . F l n k l e a p l u s a copy o f th e PCB Research Study done by D r. A n i t a Bahn a t th e U n i v e r s i t y o f Pennsylvania. May I r e p e a t my a p p r e c ia tio n o f y o u r s h a rin g y o u r d a ta w i t h rre. Cordial Iy you rs, * a / xa Harry A. Slnclalre, M.D. Medical D ire c to r H A S :b h E n c lo s u re s \ ooe<, < OFFICIAL FILE COPY netuM, O Tt .U U U. O It*cni( a iA Dr. John F. Finklea, Director National Institute of Occupational Safety fi Health Parklawn Bldg. 5600 Fisher lane Bocfcville, flaxyland 20014 24 June 1976 Dear Dr. Finkleas Enclosed you will find Information froa one of our enployee health surveillance programs that suggests a possible association of exposure to polychlorinated biphenyls (PGB's) during a period from 1949-58 and cancer (specifically swlttfioma and pancreatic cancer). We are aware that at least one of these chlorinated hydrocarbons (Arochlor 1254) has been shewn to be carcinogenic by oral administration in two species of experimental animals (nice, rats) To the best of our knowledge, there have been no prior reports implicating human cancer during the ^ manufacture or industrial use of PCT's. A preliminary evaluation of our small cohort suggests the overall, cancer - incidence observed is higher than for the population at large, but does not exceed the expected death rate for chemists. However, because of the possible occupational health significance of these preliminary findings, we call this to your attention in connection with your investigation of sore extensive and longer term industrial PCSexposure. Yours truly HAS :jd Enclosure Harry A. Sinclair, M.D. Medical Director \ S\'* pl.eaxinh tiff's ibit . I1 ACM C0655C KTOSH/GSHA PHAJ.T 'TECHHICAt STAHDAB9S POB SET I (PAST 1 of 2) AS 0? 17 SB? (i) Pleasure the exposure monthly of the employee so exposed; and (iir Institute control measures as required by paragraph (D) of this section; and (iii) Individually notify, in writing, within five days, every eaployee who is found to be exposed to chlorodiphenyl (59 percent chlorine) above the permissible exposure* The employee shall also be notified of the corrective action being taken to reduce the exposure to at or below *t.he permissible exposure. (7) Hi two consecutive employee exposure measurements taken at least one week apart reveal that the employee is exposed to chlorodiphenyl (54 percent chlorine) below the action level, the employer nay terminate measurement for the employee* (8) Por purposes of this paragraph, employee exposure is that which would occur if the employee were not using a respirator. (c) Methods of measurement. (1) An employee's exposure shall be obtained by an| combination of long tern or short term samples which represents the employee's actual exposure averaged over an eight-hour work shift (See Appendix B (iv) of this section) (2) The method of measurement shall have an accuracy, to a confidence level of 95%, of not less than that given in Table 1* Table 1 Concentration Required Accuracy Above permissible exposure 25% At or below permissible exposure and above the action level 35% At or below the action level * 50% (d) Compliance* (1) Ho employee shall be exposed to chlorodiphenyl (54 percent chlorine) above the permissible exposure as defined in paragraph (a) (1) of this section. (2) Employee exposures to airborne concentrations of chlorodiphenyl (54 percent chlorine) shall be controlled to at or below the permissible exposure by engineering and work practice controls : (i) Engineering and work practice controls shall be instituted to reduce exposures to at or below the permissible exposure, except to-th extent that such controls are not technically feasible. (ii) Wherever engineering and Work practice controls are not sufficient to reduce exposures to at or below the permissible exposure, they shall nonetheless be used to reduce exposure to 57 ACf HTOSH/OSHA DRAFT TECHNICAL STANDARDS POB SET I (PART 1 of 2) IS. OP 17 SEP 7 the lovest level feasible and shall be supplemented by respirators in accordance vith paragraph (d) (4) of this section. (3) Engineering controls. (i) .When mechanical ventilation is used to coctroi exposure# measurements which demonstrate system effectiveness#*for example, air velocity# static pressure# or air volume# shall be made at least every three months. Measurements of system effectiveness shall also be made within five days of any chanqe in production# process# or control which sight result in an increase in airborne concentrations of chlorodiphenyl (54 percent chlorine) (ii) Spray finishing operations shall be performed in accordance with S 1910.94(c). (4) Compliance with the permissible exposure shall not be achieved by the use of respiratorsexcept: (i) During the time period necessary to install or implement engineering or wort practice controls; or (ii) In work situation^ in which engineering and work, practice controls are technically not feasible; or (iii) To supplement engineering and work practice controls when such controls fail to reduce airborne concentrations of chlorodiphenyl (54 percent chlorine) to at or below the permissible exposure; or (iv) For operations which reauire enty into tanks or closed vessels; or (v) * In emergencies. (5) Where respirators are needed and uermitted under this paragraph to reduce employee exposure# the employer shall select and provide the appropriate respirator from Table 2 and shall ensure that the employee uses the respirator provided. TABLE 2 RESPIRATORY' PROTECTION FOB CHLORODIPHENYL (54 PERCENT CHLORINE) CONDITION PERMISSIBLE RESPIRATORY PPOTECTTON Vapor Concentration 5 ng/H3 or less Any supplied-air respirator with a full facepiece# helmet or hood. Any self-contained breathing apparatus vith a full facepiece. Greater than 5 mg/B3 or entry and escape from unknown concen trations Self-contained breathing apparatus vith a full facepiece operated in pressure-demand or other positive pressure mode. - - - - - - -y- - - - - - - - - - - - - A combination respirator which includes a Type C supplied-air respirator vith a fuil facepiece operated in pressure demand or other positive pressure or 58 CCBS53 AC* O /s FIOSH/OSHA DRAFT TECHNICAL STANDARDS FOR SET I *(PAST 1 Of 2) AS OF 17 SEP 7f continuous-flov code and an auxiliary self-contained breathing apparatus operated in pressure-deirand or other positive pressure mode.(Supplied-air suits may be necessary) Fire Fighting Self-contained breathing apparatus with a full facepiece operated in pressure-demand or other positive pressure mode. Escape Any gas mask providing protection against pesticides. Any escape self-contained breathing apparatus. $ (6) Respirators shall 'be approved by the Hining Enforcement and Safety Administration (formerly Bureau of Bines) or by the National Institute for Occupational Safety and Health under the provisions of 30 CFB Part 11. (7) The employer shall institute a respiratory protection program in accordance with $ 1910.13(b), (d), (e), and (f). (e) Fire and safety. (1) The eiployer shall familiarize himself with the information contained in the Substance Technical Guidelines (Appendix B of this section) for chlorodiphenyl (5 percent chlorine). (2) For the parpose of compliance with S 1910.157, chlorodiphenyl (5 percent chlorine) is classified as a Class B fire hazard. (3) For the purpose of compliance with S 1910.106, liquid chlorodiphenyl (5 percent chlorine) is classified as a class IIIB combustible liquid. () Sources of ignition such as smoking or open flames are prohibited where chlorodiphenyl (5 percent chlorine) presents a fire or explosion hazard. (5) Chlorodiphenyl (5 percent chlorine) shall be stored so as not to come in contact with strong oxidizers. (f) Personal protective equipment. (1) Employers shall provide and ensure that employees use impervious clothing, qloves, face shields (eight-inch minimum) and other appropriate protective dothisq necessary to prevent any possibility of skin contact with liquid chlorodiphenyl (5 percent chlorine). Face shields shall comply with S 1910.133(a) (2) , (a) () , (a) (5) , and (a) (6). (2) Employers shall ensure that clothing contaminated with liguid chlorodiphenyl (5 percent chlorine) is placed in closed containers for storage until it dan be discarded or until the employer provides for the removal of chlorodiphenyl (5 percent chlorine) f r o m `the clothing. If the clothing is to be laundered or otherwise cleaned to remove the chlorodiphenyl (5 percent 59 `1 -V AC* CC95* JTTOSH/OSHA DRAFT TECHNICAL STANDARDS FOR SET I (PART 1 of 2 ) AS OF 17 SEP 7 chlorine), the employer shall i n f o the person performing the operation of the hazardous properties of chlorodiphenyl (54 percent chlorine) (3) Employers shall ensure that *non-impervious clothing which becomes contaminated with liouid chlorodiohenyl (54 percent chlorine) be removed promptly and not reworn until the chlorodiphenyl (54 percent chlorine) is removed iron the clothing. (4) Employers shall provide and ensure that employees use splash-proof Safety toggles (cup-cover type dust and splash safety googles) which comply with S 1910.133 (a) (2) - (a) (6) where liouid. chlorodiphenyl (54 percent chlorine) may contact the eyes. (g) Spills and disposal. In the event that liguid chlorodiphenyl (54 percent chlorine) is spilled the employer shall immediately provide available ventilation and then clean up the spill. $ (h) Sanitation. (1) Employers shall ensure that employees whose skin becomes contaminated with liguid chlorodiphenyl (54 percent chlorine) immediately wash or shower with soap or mild detercent and water to remove any chlorodiphenyl (54 percent chlorine) from the skin* (2) Employers shall ensure that employees do not eat or smoke in areas where liguid chlorodiphenyl (54 percent chlorine) is handled, processed or stored. (3) Employers shall ensure that employees who handle liguid chlorodiphenyl (54 percent chlorine) wash their hands thoroughly with soap or mild detergent and water before eating, smoking or using toilet facilities. (i) Training and information. (1) Each employer who has a workplace in which chlorodiphenyl (54 percent chlorine) is present shall keep a copy of this regulation with Appendixes A, B and C at the workplace. This material shall be made readily available to affected employees. (2) Each employer who has employees exposed to chlorodiphenyl (54 percent chlorine) above the action level or employees who may have skin or eye contact with.liguid chlorodiphenyl (54 percent chlorine), or employees who work where an accidental spill of chlorodiphenyl (54 percent chlorine) may occur, shall annually: (i) Inform affected employees of the information contained in the Substance Safety Data Sheet for chlorodiphenyl (54 percent chlorine) (Appendix' A of this section); (ii) Advise affected employees as to the signs and symptoms of exposure to chlorodiphenyl (54 percent chlorine) (iii) Instruct affected employees to advise the employer of the development of signs and symptoms of exposure to chlorodiphenyl (54 percent chlorine) which are listed in Appendix A of the section; and v (iv) Provide training to ensure' that employees understand the precautions of safe use, emergency procedures, and the correct use of protective equipment relative, to chlorodiphenyl (54 percent chlorine) / 60 ACK CC8555 \_ J NIOSH/OSHA DHAFf' TECHNICAL STANDABDS FOB SFT X (PAST 1 of 2) AS OF 17 SIP (j) Medical surveillance. (1) The employer shall provide medical procedures as recuired by this paragraph. All Bedleal procedures shall be performed by or under the supervision of a physician at no cost to the employee, (2) The enployer shall rake available to each enployee who is to be exposed to liquid chlorodipheny.l' (5ft percent chlorine) or airborne concentrations of chlorodiphenyl (5ft percent chlorine) at or above the action level, vithout regard to the use of respirators, a medical examination which shall include the following: (i) A medical history and physical examination with emphasis on the liver and skin. (ii) A profile of liver function. (3) The employer shall obtain from the physician, as a record of the examination, the following information: (i) A written opinion which conforms with paragraph (j) (7) of this section. g (ii) A record of results of liver function tests. (ft) The employer shall make available to each employee, exposed to chlorodiphenyl (5ft percent chlorine) in excess of the action level at 12 months from the date of the employee's first exposure, and at every 12 months of exposure in excess of the action level thereafter, a medical exasination which must include the following: (i) A medical history and physical exasination (see paragraph (J) (2) (i) of this section) . . (ii) Tests of liver function (see paragraph (j) (2)(ii) of this section) . (5) The employer shall obtain from the physician, as a record of the periodic examination, the following information: (i) A written opinion which conforms with paragraph (j) (7) of this section. (ii) A record of results of liver function tests. (6) The employer shall provide to the examining physician the following information: (i) A copy of this regulation with its Appendixes A, B, and C for chlorodiphenyl (5ft percent chlorine): (ii) A description of the employee's duties as they relate to his exposure to chlorodiphenyl (5ft percent chlorine); (iii) A description of any personal protective equipment and respirators required to be used; (iv) The results of any measurement which may Indicate the affected employee's exposure; (v) The affected employee's anticipated exposure; and (vi) Opon reguest of the physician, any available information from previous medical examination of the affected employee. (7) (i) "The physician's written opinion shall be a signed statement by the examining physician specifically stating: (A) Whether the employee has any detected medical conditions which would place the enployee at increased risk of material impairment of the employee's health from exposure to chlorodiphenyl (5ft 61 Cci5e NIOSF/OSHA DRAFT'TECHNICAL STANDARDS FOR SET I (PART 1 of 2) AS OF 17 SEP 7 percent chlorine) or would directly.or indirectly aggravate any detected medical condition; (5) Any recoomended limitatons upon the employee's exposure to chlorodipheryl (54 percent chlorine), including limitations upon the use of personal protective equipment and respirators;* (C) That the employee has been informed by the physician of any detected medical conditions which require further medical examination or treatment. (ii> The physician's written opinion shall not reveal specific medical findings or diagnoses unrelated to exposure to chlorodipheryl (54 percent chlorine) (iii) The emoloyer shall provide the employee with a copy of the ohysician's written opinion. (6) No employee shall be exposed to liquid chlorodiphenyl (54 percent chlorine) or airborne concentrations of chlorodiphenyl (54 percent chlorine) in such a way as would put the employee at increased risk of material impairment of his health from such eXDOsure. This determination may be based on the physician's written opinion. (9) The employer shall provide emergency and follow up medical examinations and treatment for any employee injured through exposure to chlorodiphenyl (54 percent chlorine) (10) If the examining physician chooses to use alternative medical examinations to those specified in paragraphs (j)(2) and (4) of this section, the employer may accept such alternative medical surveillance examinations as meeting the requirements of this part provided that the employer: (i) Obtains a statement from the examining physician setting forth the alternative medical examinations and the rationale for substitution and evidence that they will be equally effective. (11) Informs each exposed employee of the fact that alternative medical examinations to those required in paragraphs (j)(2) or (4) of this section are to be made available. (11) If an employee refuses any required medical examination, the employer shall inform the employee of the possible health consequences of such refusal and obtain a signed statement from the employee indicating that the employee understands the risks involved by refusing to be examined. (12) No medical procedure which would be performed pursuant to this section need be performed if records of a previous such procedure performed within the past six souths are acceptable to the examining physician. (k) Recordkeeping. (1) Exposure determination. (i) The employer shall keep an accurate record of all deterainations required to be made pursuant to paragraph (b) (1) of this section. (ii) The record shall include the written deteraination required in paragraph (b) (2) of this section. (iii) This record shall be maintained until replaced by a more tecent record. 62 ACK C G 8 S 5 7 HIOSH/OSHA DRAFT TECHNICAL STANDARDS FOR SET I (PART 1 of 2) AS OF 17 SrP 7 (2) Exposure Measurements, (i) The employer shall keen an accurate record of all measurements taken to determine employee exposure to chlorodiDhenyl (54 percent chloride) (ii) This record shall include: (A) The date of measurement; (B) Operations involving exposure to chlorodiphenyl (54 percent chloride) vhich are being monitored; (C) Sawolina and analytical methods used and evidence of their accuracy, including the method, results and date of calibration of sampling equipment (D) Number, duration, and results of samples taken; and (E) Name, social security number and exposure of the eaployee monitored. (iii) This record shall be maintained until replaced by a more recent record but in no event for less than one year. (3) Mechanical ventilation. (i) When mechanical ventilation is used as an engineering control, the employer shall? maintain an accurate record of the measurements demonstrating the effectiveness of such ventilation required by paragraph (d)(3) of this section. (ii) This record shall include: (A) Date of measurement; (B) Type of measurement taken; (C) Result of aeasureaent. (iii) These records shall be maintained for at least one year. (4) Employee training and information. (i) The employer shall /I keep an accurate record of all eaployee training and information required by paragraph (i)- of this section. (ii) This record shall include: (A) Date of training; (B) Name and social security number of employee trained; (C) Content or scope of training provided. (iii) This record shall be maintained until replaced by a more recent record (5) Medical surveillance. (i) The employer shall keep an accurate record of employee medical surveillance required by paragraph (1) of this section. (ii) The record shall include: (A) Results of tests reguired by paragraph (j) (2) and (j) (5) of this section; (B) Any employee medical complaints relative to exposure to chlorodiphenyl (54 percent chloride); (C) A copy of information provided to the physician pursuant to paragraph (3) (6) (ii), (iii) , (iv) , (v) , and (vi) of this section. (D) Physicianvs written opinion; and (E) 1 signed statement of any refusal to be examined. (iii) This record shall be maintained for the duration of the . employment of the affected employee. (6) Access to records. (i) All records reguired to be maintained by this section shall be wade available upon request to authorized representatives of the Assistant Secretary of Labor J- 63 ACM CQ6S 5B NI0SH/0S5A DFAFT_ TECHNICAL STANDARDS FOR SET I (PART 1 of 2) AS 0 ? 17 SEP 7 for Occupational Safety and Health and the Director of the National'institute for Occupational Safety and Health. (ii) Employee exposure determination and exposure measurement records required to be maintained by this section shall be oade available to employees and former employees and their designated representatives. (iii) Employee medical records reguired to be maintained by this section shall be made available upon written reguest to a physician designated by the employee or former employee. (1) Employee observation of measurement. (1) The employer shall give affected employees or their representatives an opportunity to observe any measurement of employee exposure to chiorodiphenyl (54 percent chloride) which is conducted pursuant to this section. (2) When observation of measurement of employee exposure to chiorodiphenyl (54 percent chloride) reguires entry into an area where the use of personal protective devices, including respirators, is reguired, the observer shall be provided with and reguired to use such eguioment and comply with all other applicable safety procedures. (3) Without interfering with the measurement, observers shall ' be entitled to: (1) Receive an explanation of the measurement procedure. (ii) Visually observe all steps related to the measurement of the airborne concentration of chiorodiphenyl (54 percent , chloride) that are being performed at the place of exposure; and (iii) Record the results obtained. VOTE: The information contained in the following appendixes is advisory in nature and is not intended, by itself, to create any additional obligations not otherwise imposed or detract from any existing obligation. 64 ACM CC959 NIOSE/OSKA^ DRAFT TECHNICAL STANDARDS POE SET I (PART 1 of 2) -AS OP 17 SEP APPENDIX A V. / 1 I. II. . :il. SnBSTAVCE SAFETY DATA SHEET FOB CHLORODIPHENYL <5ft percent chlorine) SUBSTANCE IDENTIFICATION A* Substance: Chlorodiphenyl (5ft percent chlorine) B. Pernissible Exposure: 0.5 nilligran of chlorodiphenyl (5ft percent chlorine) per cubic neter of air (ng/cu ) averaged over an eight-hour work shift. C. Appearance and Odor: Pale yellow viscous liauid with rild hydrocarbon odor. $ HEALTH HAZARD DATA A . Ways in Which the Cheaical Affects Tour Body: Chlorodiphenyl (5ft percent chlorine) can affect your body if you inhale it or if it cones in contact with your eyes and skin or if you swallow it. It nay be absorbed through the skin. Every effort should be made to prevent skin, eye, oral or inhalation contact with this aaterial. B. Effects of Overexposure: 1. Chlorodiphenyl (5ft percent chlorine) nay cause irritation the eyes, nose and throat, and an acne-like skin rash. It nay also injure your liver resulting in such effects as fatigue, dark urine and yellow jaundice. Repeated skin contact with the liquid nay cause skin irritation. 2. Reporting Signs and Synptons: You should inforn your enployer if you develop any signs or sysptons and suspect they are caused by exposure to chlorodiphenyl (5ft percent chlorine). EHSEGENCY PIRST AID PROCEDURES A. Eye Exposure: If chlorodiphenyl (5ft percent chlorine) gets into your eyes, wash your eyes innediately with large anounts of water, lifting the lower and upper lids occasionally. Get nedical attention innediately. Contact lenses should not be worn when working with this chesical. B. Skin Exposure: If chlorodiphenyl (5ft percent chlorine) gets on your skin, innediately wash the contaninated skin vusing soap or nild detergent and water. If chlorodiphenyl (5ft percent chlorine) soaks through your clothing, renove the clothing innediately and wash the skin using soap or nild 65 ADS CCtStC ' NI0SR/05HI DRAPT TECHNICAL STANDARDS .FOR SET I (PART 1 of 2) AS OP 17 S?P 75 1 detergent and water. Tf. irritation persists after C. . washing, get medical attention. Breathing: If you or apy other person breathes in large amounts of chlorodiphenyl (54 percent chlorine), move the exposed person to fresh air at once. If breathing has stopped, perform artificial respiration. Keep the affected person warn and at rest. Get medical attention as soon as possible. D. Swallowing: When fchlorodiohenyl (54 percent chlorine) has been swallowed get medical attention immediately. If medical attention is not immediately available get the affected person to vomit by having him touch the back of the throat with his finger or by giving him large amounts (one pint or more) of warm salt water (two tablespoons of salt per mint of water) Do not make an unconscious person vomit. $ IV. i E. Rescue: Hove .affected person from the hazardous exposure. If the exposed person has been overcome, notify someone else and put into effect the established emergency rescue procedures. Do not become a casualty yourself. Understand your emergency rescue procedures and know the locations of the equipment before the need arises. RESPIRATORS AND PROTECTIVE CLOTHING A. Respirators: Respirators are not the best way to control exposure to chlorodiphenyl (54 percent - chlorine). You can only be reunited to wear them for routine use if vour employer is in the process of installing controls or control measures prove inadequate. You.may be required to wear respirators for non-routine activities or in emergencies. If respirators, are worn, they must have a Hining Enforcement and Safety Administration (BESA) or National Institute for Occupational Safety and Health (HIOSH) approval label. (Older respirators nay have a Bureau of Hines approval label.) For effective protection, respirators must fit your face and head snugly. Respirators should not be loosened or removed in work situations where there use is required. If you can smell chlorodiphenyl (54 percent chlorine) while wearing a respirator, the respirator is not working correctly; go immediately to fresh air. If yon experience difficulty breathing while wearing a _ respirator, tell your employer. B. Supplied-air suits: in some work situations the wearing of supplied-air suits nay be required. Tour employer should instruct you in their proper use and operation.V V f^4*( 66 ACt* r ''v, ) HT0SH/0S3# DRAFT*TECHNICAL STANDARDS FOR SET I (PART 1 of 21 AS OF 17 SHF C. . Protective Clothing: Ton oast wear impervious clothing# gloves# face shield or other appropriate protectiveclothina to prevent any possibility of skin contact with licnid. chlorodiphenyl (54 percent chlorine). Replace or repair impervious clothing that has developed leaks. D~ ?ye Protection: Ton oust wear splash-proof safety gogqles (cup-cover type dust and spiash safety goggles) vhere eye contact to liguid chlorodiphenyl say occur. 7 PRECAUTIONS FOR.SAFE U5F, HANDLING AND STORAGE A. Chlorodiphenyl (54 percent chlorine) is a combustible liguid and its vapors can form explosive mixtures with air at elevated temperatures. B. Chlorodiphenyl (54 percent chlorine) must be stored in tightly closed containers in a cool# veil ventilated area avay from heat# sparks# flames and strong oxidizers. C. Sources of ignition such as smoking and open flames \ are prohibited wherever chlorodiphenyl .(54 percent chlorine) is handled# used or stored in a manner that could create a potential fire or explosion hazard. D. If your skin becomes contaminated with licnid chlorodiphenyl you must immediately wash or shower using soap or mild detergent and water to remove any chlorodiphenyl (54 percent chlorine) from the skin. You must promptly remove any non-impervious clothing that becomes contaminated with liguid chlorodiphenyl (54 percent chlorine) and this clothing must not be revorn .until the chlorodiphenyl (54 percent chlorine) is removed from the clothing. F. You must -not eat or smoke in areas vhere liquid chlorodiphenyl (54 percent chlorine) is bandied# processed or stored. G. If you handle liguid chlorodiphenyl (54 percent chlorine)# you must wash your hands thoroughly with soap or mild detergent and water before eating# smoking or using toilet facilities. H. Fire extinguishers# vhere provided# must be readily available and you shQuld know where they are and how to operate them. I. Ask your supervisor vhere chlorodiphenyl (54 percent chlorine) is used in your work area and for any additional plant safety and health rules. TI ACCESS TO XNFOHHATION A. Each year your employer is required to inform you of the information contained in this Substance 67 A&* STOSF/OSHA DRAFT TECHNICAL STANDARDS FOR SET I (PART 1 of 2) AS OF 17 SEP 7 Safety Data Sheet for chlorodiphenyl (54 percent chlorine) In addition, your employer must instruct you in the safe use of chlorodiphenyl (54 percent chlorine), emergency procedures, and the correct use of protective'equipment. B. Tour employer is required to determine vhether you are being exposed to chlorodiphenyl (54 percent chlorine). You or your representative have the right to observe employee exposure measurements and 'to record the results obtained. If your employer determines that you are being overexposed, he is required to inform you of the exposure and of the actions which are being taken to reduce your exposure. C. Tour employer is required to keep records of exposure determinations, exposure measurements, and medical surveillance. Tour employer is required to make records of exposure determinations and your exposure measurements available to you or your representative upon your request. Tour employer is required to release your medical records to your physician upon your written request. \ 68 i ccfi*63 NXOSH/OSHA BRAFT TECHNICAL STANDARDS POP SET T (PART 1 of 2) AS OP 17 STP 75 APPFNDIX S SOBSTANCT TECHNICAL GUIDELINES POR CHLORODIPHENYL (54 percent CHLORINE) I. PHYSICAL AND CHEMICAL tTATA A* Substance 'Identification 1. Synonycs: Polychlorinated biphenyl; PCB 2* Poraula: C12H5C15 (approximately) 3. Molecular weight: 326 (approziaately) B. Physical Bata 1. Boiling point (760 trm Hg) : 365 - 390 C (689 - 734 F) 2. Specific gravity (Hater 1) : 1.5 3. Vaoor density (air = 1 at boiling ifoint of chlorodiphenyl (54 percent chlorine): 11.2 4. Melting point: 10 C (50 P) (Pour ooint) 5. Vapor pressure at 20 C (68 P ) : 0.00006 an Hg 6. Solubility in water, % by weight at 20 C (68 F ) : insoluble 7. Evaporation rate (butyl acetate = 1 ) : such less than 1 8. lppearance and odor: pale yellow viscous liauid with nild hydrocarbon odor. II. PISE, EXPLOSION AND REACTIVITY HAZARD BATA A Pire 1. Plash point: 222 C (432 P) 2. Autoignition temperature: none to boiling point 3. Flanaable liaits in air, % by voluae: not available 4. Extinguishing aedia: Foam, dry che&ical, carbon dioxide 5. Special fire-fighting procedures: Do not use a solid stream of water since a streaa will scatter and spread t&e fire. Use water spray to cool containers exposed to a a fire. 6. Unusual fire and explosion hazards: Liquid chlorodiphenyl (54 percent chlorine) is a ' i combustible liquid. At elevated temperatures its vapors can fora explosive mixtures with air. All ignition sources must be controlled when chlorodiphenyl (54 percent chlorine) is used, handled stored in a aanner that aay create a potential fire or explosion hazard. 7.. For purposes of coaplying with the requirements of 29 CPR 1910.106, liquid chiorodiohenyl (54 uercent chlorine) is - classified as a Class IIIB coabustible liquid. B. Reactivity 1. Conditions contributing to instability: Beat 2. Incompatibilities: Contact with strong oxidizers aay cause fires and explosions. WIOSH/OSEA DB APT TECHNICAL STANDARDS POR SET I (PART 1 of 2) AS 0? 17 SIP 75 III. IV. 3. -Hazardous decomposition products: Toxic gases and vapors (such as hydrogen chloride and carbon aoooxide) say be released in a fire involving chlorodiphenvl (54 percent chlorine). 4. Special precautions: Chlorodiphenyl (54 percent chlorine) will attack some fores of plastics, rubber and coatings* SPILL, LEAK, AED DISPOSAL PROCEDURES A. If chlorodiphenvl (54 percent chlorine) is spilled or leaked, .the following steps should be taken: 1. Remove all ignition sources. 2. Ventilate area of spill or leak. 3. Collect for reclamation or absorb in vermiculite, dry sand, earth or a similar material. B. Persons not wearing protective equipment should be restricted from areas of spills or leaks intil cleanup has been conpleted. C. Waste disposal methods: Chlorodiphenyl (54 percent chlorine) nay be disposed of by absorbing in vermiculite, dry sand, earth or a similar material and disposing in a secured sanitary landfill. HOHITORIWG AHD MEASUREENT PROCEDURES A. Exposure above the action level: Measurements . taken for the purpose of deternining employee exposure under this section are best taken such that the average 8-hour exposure aay be deterained from a single eight-hour savple or two (2) 4-hour saaples.' Several short tiae interval samples (up to 36 minutes) aay also be used to determine the average exposure level. Air samples should be taken in the e m p l o y e e ^ breathing zone (air that would aOst nearly represent that inhaled by the eaployee) Sampling and analyses aay be performed by instruments such as detector tabes certified by VIOSB under 42 CPR part 84. Portable directreading instruments, dosineters, or gas and vapor adsorption tubes with subsequent cheaical analyses. The aethod of aeasureaent aust determine the concentration of chlorodiphenyl (54 percent chlorine) to plus or sinus 35%. B. Exposure above the peraissible exposure: The onitoring and aeasureaents under this section should be essentially the saae as described under paragraph (IV) (A) Laboratories perforaing _ cheaical analyses should be accredited in Industrial Hygiene Chemistry by the American Industrial Hygiene Association. The aethod of aeasureaent must determine the concentration of CCfc56 5 NI0SE/0S3A DRAFT TECHNIC*! STANDARDS FOR SET J (PART 1 of 2) AS OF 17 SEP 75 O chlorodiuhenyl (54 oercent chlorine) to plus or ilnas 25*. C.` Hethods: Hethods aeeting the above accuracy requirements are available from NIOSH. D. Qualified Persons: Since aany of the duties relating to eaployee protection are dependent on the results of monitorina*and measuring procedures, employers should assure that the evaluation of eaployee exposures is performed by competent industrial hygienist or other technically qualified person 7. BISCELLANEOUS PRECAUTIONS A. Store chlorodiphenyl (54 percent chlorine) in tightly closed containers in a veil ventilated area avay from heat* B. Employers should advise employees of all areas and operations here exposure to chlorodiphenyl (54 percent chlorine) could occur. 71. COBHOW OPERATIONS Common operations in which exposures to chlorodiphenyl (54 percent chlorine) is likely to occur are: during its use as a transformer fluid;for impregnating papers, cloths, etc* for heat, moisture and chemical resistance properties; as a heat transfer fluid, lubricant, and wax extender; in the compounding of sealing compounds and printing inks; as a plasticizer: in the manufacture of insecticides, pesticides and fungicides; in cutting oils; and during its production. - n 71 AC* OCSSfee NIOSH/OSHA DRAFT TECHNICAL STANDARDS FOP SET I (PART 1 of 2) AS OF 17 SEP 7 APPENDIX C - HEDICAL SURVEILLANCE GUIDELINES I. ROUTE OF 2NTHT Inhalation; skin absorption. II. TOXICOLOGY Chlorodiphenyl (5ft percent chlorine) vapor is toxic to the liver. Pats exposed to 5.ft ag/a3 for 7 hoars daily for ft nonths shoved increased liver veiaht and injury to liver cells; 1.5 ag/ft3 for 7 aonths also produced histopathologic evidence of liver damage which was considered to be'of a reversible character. The vapor and the liguid are aoderately irritating to the eye; contact with skin leads to reaoval of natural fats and oils with subsequent.drying and cracking of the Skin. A single case of an acne-fora dersatitis (chloracne) due to exposure to chlorodiphenyl of unspecified chlorine content has been reported but the period of exposure vas not indicated. III. SIGFS AND STHPTOHS '' Eye and skin irritation; acne-fora dernatitls; based on animal data it aay cause liver injury. IV. SPECIAL TESTS None in cocnon usage. V. .TREATMENT "S Remove froa exposure. Flush eyes vith water and vash skin with soap and water. If swallowed and the person is conscious, induce voaiting. Give artificial resuscitation if indicated. Recovery is usually rapid and complete. VI. SURVEILLANCE AND PREVENTIVE CONSIDERATIOIS A. GENERAL Host reported effects of chlorodiphenyl (5ft percent chlorine) are caused by its capacity to affect the liver and produce an acne-fora deraatitis. Skin absorption occurs. It is irportant that the physician becomes familiar vith plant operating conditions in which exposure to chlorodiphenyl (5ft percent chlorine) occurs. Those with skin disease aay not tolerate the wearing of* *CK C 0 8 9 tl HIOSH/OSSA DRAFT TECHNICAL STANDARDS FOP SET I (PAST .1 of 2) AS OP 17 s^P 1 '- " protective clothing and those with chronic resniratory disease *av not tolerate the veering of1 negative pressure r respirators, . . B. jPSBPLACSHENT The following medical procedures must be nade available to each employee who is exposed to chlorodiphecyl (5U percent chlorine): chlorine: * . 1. I, A complete history and physical examination -- The purpose is to detect preexisting conditions that night place the exposed employee at increased risk, and to establish a baseline for future health nonitoring. Examination of liver and skin should be stressed. ;2. Liver function tests -- Chlorodiphenyl ^54 percent chlorine) spy cause liver damage.' A profile of liver function shall be obtained by utilizing a medically acceptable array of biochemical tests. C. ` PERIODIC EIAHIPATIONS ,* 'The above medical examinations are to be repeated on an j annual basis. References i. 1. American Conference of Governmental Industrial Hygienistis: "Chlorodiphenyl, 54 percent Chlorine," Documentation of the Threshold Limit Values for Substances in Workroom Air (3d ed., 2d Printing), Cincinnati, 1974, p. 52. 2. Hygienic Guide Series: "Chlorodiphenyls," American Industrial Hygiene Association Journal, 26:92*94, 1965. 3. Olivier, H.:"Chloracne," Archives of Dermatology, 99: 127128, 1969. 73 cc.fc'' 6 ^