Document zzw6q4qmJqkwyR5G92MwDKo1R

Prepared by the Safety Department - B-101 Thc attached document was published in the (Federal Register) %) dated: 10-4-74 ________, and concerns: Cc: OSHA - Occupational Safety and Health Act ( ) NIOSII - National Institute for Occupational Safety and Health () Jid_Baln.wrd.ei^, H. H. McClUr'e P. L. Daniel __ J. R. Vcnab 1e,__ ;. Safety Director, Safety Dent. Notice of: (j^K^hanye ( ) Addition ( ) Interpretation ( ) Effective date: See below. ( ) Proposed Change ( ) Request for Information ( ) Your written comments are requested and are due in Safety Dent. , by: Reference: 1910.95g - Vinyl Chloride - Permanent Standard. 37 C/7 o CT> cn cn C omment s /Summary: Attached is the Permanent Standard for Exposure to Vinyl Chloride which was issued by OSHA and published in the Federal Register on 10-4-74, together with discussion on the background for the standard by the Department of Labor. This new standard will reduce the 50.parts per million in air exposure to Vinyl Chloride now permitted to as low as one part per million averages over any eight-hour period and five parts per million averaged over any period no longer than 15 minutes. In order to ensure that employers and employees will be informed on these new provisions and'hhat employers are given an opportunity to familiarize themselves and their employees with the new requirements, the effective date will be January 1, 19?5. To provide continued protection, the provisions currently contained in the existing temporary standard will continue in effect from October 4, 1974, and will be superseded by these new provisions on January 1, 1975. Safety Directors should reproduce and distribute copies of this new standard to those in their areas having need. The standard should be inserted in your copy of the OSHA Standards at the following pages, depending on wThich copy of the Federal Register you possess: Holders of the Federal Register reprint of 6-27-74 - page 23582 Holders of the Federal Register issued 10-18-72 - page 22144 G. P. Jackson Safety - B-101 10-9-7^ KtCElVEQ 10 1974 J**. Daniel R&S 140656 V.oS'M RULES AND REGULATIONS Title -Labor ployees from a rare liver cancer faiv.lo- raid abroad, 0(11 tA proposed h> H'wfi'i #IAP7EF! XVII--OCCUPATIONAL SAFETY !::> I'F.'.i.T!: / D':;r;:sT.TATiON, OEAurr.u'::r of laeoh PART TriO--CCCUi'ATiUNAL SAFETY AND LEnLi ;! tnANDARiyj surcuma) may have been occupationally related. As a lv.mlt of tins notification and alter consult,hum v, itii MiOolI, and a joint inr,prelum of the H. 3fi Goodrich plant by OSHA, NiOoH and the Ken tucky Department, of Labor, a fact-find IJ.m.f.'.'lq end pubis bed a compi < !u n, n e proposal (33 I'll IGt'-jj) on Ma;, in. 137-r, to [rated employees Irom htvmrd". of c.'.po.mre to VC. The proposal call'd for iimtiaiion of employee exposure to VC to "no detectable "level," as measured by a Standard far Exposure In Vinyl Chloride ing hearing was announced on Janu sampling and analytical method xcnsiiive- Pursuant to scriious C(b>. 6(c), and 8(c) of the Orcmx'tional Safely and Health Act of IS70 (Of Slat. 1503, I50G, 1539; 23 U.S.C. r.55, C37) Secretary of Labor's Order No. J 2--71 (36 HR 273-1) and 23 CFR Part 1011, 5 1310.33 of Part 1010 of Title 20. Cede of Federal Pecu lations is hereby amended in the manner set forth bc'lrnv, in order to provide an Occupational Saic-ty and Health stand ard dealing with the exposure of em ployees to vinyl chloride. I. Backcrcnml--il) Vinyl chloride. Vinyl chloride tchloroelhene), Chemical Abstracts Service nejnstry No. 72QM, is a synthetic organic chemical made from ethylene or acetylene and chlorine by any Of several processes. It is the parent compound of a scrir-s of thermoplastic resin polymers and copolymers which are widely used for containers, wrapping film, electrical insulation, pipe, conduit, and a variety of other industrial and consumer products. Vinyl chloride has been made commercially in this country since 3 339, and present production is in excess of seven billion pounds per year. The vinyl cldoricle inducin' divides into three segments: monomer production, polymer production, and fabrication.' ^fcpduction of the monomer is a largc- continuous process, involving only ^afew firms. There are comparatively few employees in this segment of the indus try'. because the processes lend them selves to automation. Vinyl cliloridc tVC) is used primarily In the production of polyvinyl chloride (PVC), a resin which is produced through batch processing. The conversion of the VC monomer into a polymer or copolymer is an incomplete process, i.e., not all of the monomer is reacted. PVC is fabricated by a variety of tech niques, including extrusion, injection molding and calendering, to form a fin ished product that neeos no further chemical handling. The vast majority ary 30, 127-1 <30 PR 2674) and held on February 15, 197-i. - Information obtained from this hear ing, particularly the preliminary reports of c:\])ii,mi!.,i1.,'i conducted by Professor Ccsave Maltoni of the Instituio di Oneologia, Bologna, Italy, demonstrated that vinyl r.hloiide induced angiosarcoma in rats at level; as low as 25u ppm, and in other species at higher levels. Kxperimcnis performed at lower levels of ex posure were not completed at that time. Other testimony from medical witnesses and Niosn. and the ; exults of autopsies, led to the conclusion that the Goodrich workers had angiosarcoma of the liver and that VC probably was the causal agent in (he angiosarcomas observed. In post hearing comments, additional angiosarcoma deaths were reported among workers who had been exposed to VC in plants operated by Union Carbide Corporation, Firestone Plastics Corpora tion and Goodyear Tire & Rubber Com pany. On the basis of all information avail able at that time, and the fact that em ployees were being exposed at levels around the experimentally observed ef fect level of 250 ppm. an emergency temporary standard (FTS) was promul gated on April 5, 137-1 (39 FR 12311) pursuant to section G(c) of the Act, as 29 Cm 1910.03Q. This standard reduced the permissible exposure level from a ceiling of 500 ppm to a 50 ppm c.eilir.g, and established other requirements, including, for example, monitoring and respiratory protection. It was expressly recognized that this standard limiting exposures to a 50 ppm ceiling was a tentative, interim standard, and that the whole question of exposure to VC would be considered more fully in the light of additional information, especially the results of experiments which were known t-o be underway at that time. to 3 ppm, will) an accuracy of 1 man 50 percent. The proposal also called for the establishment of regulated r.rcr>s and Jimitcd access t-o such areas to nt-ithoriccvl persons. A requirement. for monitoring of c-mploycc exposures was proposed, along with engineering and v, or;: practice controls to be implemented when exposures over (he detectable limit were measured. Respiratory protection would have been required while engineering and work practice controls were being implemented or v.isere exposures exceeded the per missible limit even after feasible en gineering controls were instituted. In addition, the proposed standard included requirements for medical sur veillance. protective clothing, emergency procedures, training, specific protection during maintenance and decontamina tion operations, transportation loading and unloading operations and recordkeeping. (4) Hearing on the proposal. The pro posal, as published on May. 10, 197-3, allowed 30 days for interested parties to submit written comments and to request an informal rulemaking hearing. In formal contacts with OSHA staif and early responses indicated that the sub ject was of great interest- and importance* to many persons. Because of the Jimitcd ,imo available before expiration of the six month period provided in section G(cH3) of the Act for promulgation of a final standard, it was decided to hold a hearing as soon as possible. Accord ingly, on May 24,1374, a notice of a hear ing was published (39 FR JC303), setting a hearing date of June 25, 1274. The hearing was conducted from Juno 25 through June 23, and again from July 3, through July 13, before AdminirdratheLaw Judge Gordon J. Afyatt-, Ail partici pants were given the opportunity to pre sent testimony and to cross-examine other witnesses. Persons participating in of employers involved in the VC industry are employed by fabrication firms. Such firms range in size from those with few employees and simple equipment to large On April 15,1974, information and data were presented to representatives of OSKA, NIOSH, and the Environmental Protection Agency by the Industrial Bin- the hearing were given until August; 23. 1374, to flic additional posthcaring com ment including various items of infor mation which were requested during tire plants Involving many employees and Test Laboratories, Northbrook, Illinois, examination of witnesses. considerable capital, concerning results of animal exposure if,) Economic and technical_ impact Vmyl chloride <VO), a gas at ambient, temperature and pressure, is a chlori nated hydrocarbon., which heretofore has studios with VC. There studies were sponsored by the Manufacturing Chem ists Association. Although oniy pre slndi/. During the hearing, OSHA deter mined that additional inct.c would be needed to determine the practicality of been regarded r-.s having moderate liver liminary in nature at that time, these certain aspects of "the^prepa-ted i-L'.uTT-' toxicity. The initial standard, contained results revealed that 2 out of 293 mice ard. Accordingly, OSHA contacted an in in Table 0--1 of 1910.93, established a exposed to VC concentration.'; of 50 ppm dependent consultant, Foster J9. Snell c.cilin:; value of 500 parts of VC per mil for 7 hours a day, five days a wed:, for Corporation, to conduct rtucties of the lion parts of air. approximately 7 months, had det doped feasibility of compliance at various ex (2) The c mcrgeiwy Inn porn ry standaid. On January 22, 137-1. the Occupa tional f-J.-'fctv and Health Admimsirn- was inuwmed by the Na- angiosarcoma of the liver. (3) The pioposcd permanent- stand ard. Hast'd on the demonstrated evidence of VCs carcinogenicity in throe animal posure levels, including' those proposed by OSHA ami others advanced by indu dry spokesmen. >S:iclI was also roi.imirt-ionccl to collect uiformuLon regard ^Phi.-iI lii-ihti'c for Oivtipulional Safely species (rats, mice and hamsters), and in'' the economic costs of compliance. ^Jhd Health iNi.0till) that Die 13. P. the substantial probability final VC had VlI.':; action war. announced at the close Goodrich Chemical Company had re been the cau-ril agent in the oases of liver of the hearing, and Judge Myatt- fiumer ported that deaths of several of its em angiosarcoma found in weaker.-; botn here announced that the record would be kept rtDCRAL RGGISTCtf, VOL 39, NO. 19-1--IHIOAY, OCTCUUR 4,' 1974 RUI.C5 AND !'. oGULA'l IONS open for a !>erUv.l r,f time, beyond August sl.udi'v, of 7!riltcnt put! Elo-Tost T,"bora may create a carcinogenic hn/.ard, the 23, to allow interested person'; to oom- te,ric.;. ? iot.-ov'T. Malloni's in res! ovations omi.nnil oi exposure winch i, dons incut in writing on the study. On Au ;u'.t lie,vc (bunon-,;rated a clo.x'-dcpriidrnt re must be determined. The f.tmycon (;on- 26. 1974, O.'JiA announced met i 1;o pm- lation.'inn lor induction of turnon; tie., cial's Ad line Committee 'be;e: i a io liminnry study v;,.s ^vriilnb!o and iunt more lumms occur at higher cspO'.ure above concluded (hat safe expo, m e levels comment'; v.'iic to tin submit tod no Inter levels), including amdosarcoma of the for carcinogenic substances cannot be them Genie ml cr C. 1974 (7!) I-Tl HOiM-l). liver, in vats. The invoatignUuns of In scientifically determined. Ting pwition On September 12, 1974, OGHA invited du'd rial liio-T'csl f alior.'iioi ie.s have dem is supported by Hie testimony of MCTJli comments on both 1 lie preliminary rind onstrated a similar rclalioivJnp for at the hearing, its rceommendations-uov the final study, which was to be received both rats and mice. These investigators: a Mundard of no detectable Icvc-J, auciby on or before September 25, 1974 (39 Flit have induced angiosarcoma of the liver tire testimony of expert witnesses fi'om 33009). in rats and mice at exposure concentra the; National Cancer Institute. (G> Environmental impact statements. tions of 53 ppm, and in hamsters at high Several witnesses and persons who sub A notice of intent to file an enviionmcn- er conccn!muons of exposure. Additional mitted comments have taken a contrary tal impact .da (cm cut ;>.< sensing the im Uiriors involving other organs, including view and have suggested that man is less pact of a proposed standard on occu tire kidneys, lungs, and skm of exposed sensitive to biologic aberration.-, inuuced pational exposure to VC was published animals, were al.,o obi cawed in frcciucn- by vinyl chloride exposure than experi lit the PrruitM, ih.c.nvrr.ii on Ap:j] 74, cim, much in excess ot control annuals, mental animals. Proponents of tilts posi 1974 (39 nt 1 --,">1:21. Inc notice.- invited any person bavin;; information or data on the environmental impact to submit it to OSHA by I'd ay 17, 1374. On Juno 12, 1974, a draft environmental impact statement was prepared and circulated, to all interested persons. Ten copies v/ero forwarded to the Council of Environ mental Quality (CEQ), which published a notice of its filing and availability in tire Fxiu.t.al RtuisTcn on June- 25, 1974 (39 Fit 22975). A 45 day period was al lowed for the submi.uion of comments on the draft statement. On September 5, 1974, tire final environmental impact statement was prepared and a copy of ft and all substantive comments were sent to appropriate governmental agencies, private, organizations, and other interested persons. CEQ published a notice of availabiht" for the final statement cn September C. 1974 (39 FR 32350). The submission of comment was invited un til September 25, 1974. Tire final state ment and all significant comments have been carefully considered in driving at the final standard on occupational expo sure to VC. (7) The record. The record In this proceeding is one of the most exhaustive ever relied upon by OS17A. It consists of pre and post-hearing comments end testimony received at both factfinding and rulemaking hearings, the- studies and inspections conducted by OSHA person nel, the environmental impact state ments, the economic and technical impact studies, and all other relevant information. In all, over 600 written com ments have bean received, with more than MOO separate oral and written sub missions made with regard to the two hearings. Tire, record itself exceeds 4.000 pages. Employers, employees, labor unions, public health groups, independ ent experts, physicians, research scien tists, and specials,U in many fields have been invited to submit information mul have- made their vie,a;, knowledge and experience mailable to OSJIA. The en tire record encompr.'aing these submis sions was thoroughly reviewed end cvaluaicd in reaching the deteuninalion.r .-el-forth below. II. Fiml.r,[is rctutruina cnrcinottenicilit, e.ruruvre lee els and Jeasibihlv--(1) Cutcino[' ~nk'l:!/ oj r lml chloride. The car cinogenicity of \injl ciiloride for iluec 'idle incidence of tumors in mice m- the Industrial Eio-TosL Laboratories investi gations is particularly pertinent. Of 200 mice (100 males. 100 females) exposed to 50 ppm ot \ myl chloride by inhalation for eleven months, 100 died. Sixty-four ani mals died without grows postmortem pathologic examination being performed. Of the 36 remaining animals for which a gross postmortem pathologic examina tion was .performed, 13 (36 percent) were found with liver tumors (including angiosarcomas), 21 (53 percent) with lung tumors, 9 (25 percent) with skin tumors, and one with a kidney tumor. According to the 1970 report by the Surgeon General's Ad-Hoc Committee on the Evaluation of Low Levels of En vironmental Chemical Carcinogens, the finding of cancer in two or move animal species may be extrapolated to indicate a carcinogenic hazard to humans. Here, such a finding was made In Uirce species that were exposed to VC by inhalaiioima route comparable to employee ex posure. In addition, there were at least 13 confirmed eases of angiosarcoma of the liver among employees exposed to VC, a particularly significant number in view of the extreme rarity of tlii.s cancer in the U.S. adult male population (testi mony of Dr. Marcus Key, Director of NIOSH, at the rulemaking hearing). The findings of angiosarcoma, of the liver in both experimental animals and exposed employees is compelling evi dence Unit exposure of humans to vinyl chloride induces tins tumor. Industry spokesmen, at the hearing, conceded that VC is carcinogenic for humans (e.g. testimony of Dr. I.iclluniey, Rulemaking hearing, 1011), Accordingly, it Is con cluded that VC must bo regarded as a human carcinogen, and the probable causal agent oi angiosarcoma of tire liver, and that exposure of employees to VC must be controlled. Additional evidence of tumor induction in a variety of other organs, including lung, kidney, brain and skin, ns well as non-malr-.nr.nt ultciutions, such as fi brosis and connective tissue deteriora tion, indicates additional oncogenic, and toxicologic properties of vinyl chloride, which must be considered in establishing control regulations. (Lee testimony ami rc-uhs of sindics by Bio-Test Labora tories. Tabor;,have-Cooper, Mailoni, JNIOfill, andCelihoff.) tion have argued that if humans were as sensitive as rodents, an "epidemic" of cancer resulting from VC exposures should have already been discovered among employees. They also argue that the employees in whom tumors have been observed are those who have considerable employment experience as polymeriza tion reactor cleaners. Because It is gen erally agreed that reactor cleaning in volved high exposures to vinyl chloride in years past, it is argued that the lower levels currently found in the workplace have .not induced cancer and are there fore safe. V/e reject this argument. The fact that approximately tiueequarters of those employees with tile longest exposure to VC (greater than 20 years since initial exposure) have not yet been located, makes it impossible to determine the actual number o( affected employees. Tiic eases of liver turners ob served to date have an average latency period, since initial exposure, of approxi mately 20 years. If It Is assumed that in duction of angiosarcoma is a dose-re lated phenomenon, and If employees en gaged in cleaning reactors did, in fact, receive larger doses of vinyl chloride, it would be expected that such tumors would be, observed earlier for this em ployee population. For this reason, the significance of presumed lower closes cannot be accurately assessed until a longer period of time lias passed, ns a longer induction period would be expected. Initiation of exposure to chemical carcinogens and induction of cancer arc not ncccsasrily synchronous events. Be cause of the physiologic complexities in volved with carcinogenesis, induction of tumors does not occur in nil employees wiili similar exposure histories. For ex ample, l')r. Schncidcrman of the Na tional Cancer Instilutc emphasised dur ing his testimony il^rvt.only about ofijlh. of longer-term heavy smokers develop lung cancer. Accordingly, the industry contention that exposure levels have been dramatically reduced since the 1 tii'J'.s is not reliable evidence that cur rent levels of exposure arc safe. Feme industry spokesmen also sug gested Uist the apparent nonrandom dishibuiion of observed cancer in em ployees may indicate an exposure thres hold for tumor induction, based on Ymiu- animal ,'pceics (rat, mouse, hem.-,up-) has (2) Ex;y);,urc limits. Upon finding' that tion.s in the wmkplaec design or prac been documented, on thr record by the exposure of employees to vinyl chloride tice and rcsulln.nl employee exposures R&S 140657 rroERAt iitomtg, vol 37, no. 794--today, ocroita: 4, 1774 pul;:5 /.:! nee'iiAiiOHS (I.--.tiwony and tmnuv,: by T'nneco r g , !o ! ii.'.ony of Meliko.'I, Kir;: inuc, NCI, confident that Indus; ry vdl conl.nue io c;ii<-;-f:r.iI:;, )nC.). .It her, also bear, f:;i- am! Nr'.;. '! 1.) do so. 'i! ihat in, orlv 5' of .1 pol/iueiixa- In cur \ (ho dcrioustra'i-'U of can (I) CojiclU'-inns. 'the conclu.'.iv.: be t.iun pkniR where i mpki.vee.'; have been cer inu'iCiion m humans id. ; particular low arc based on e. thorough l'c;;::.: and ev.-o.-iJ lo VC i-n- 1: u.v ihan HI) yen: , level r. i.o;. a p: tvuiui: i.o tj a d. termina e.'.ab.i'.t fan c;I all the ovid x'.oti Hub.: e.-.d. have any employee.'. t.isJvi:3opccl n.>.'.ir,:,a; - tion that a nice reprereuis a can Where decision.', can be bared cm iveecd coma of the Jiwr. Vina argument is very cer ha: aid for humans at that level. It evidence, this has been done. Where, similar to that iv.ised concerning vari would be imprudent to a:-.-'r>ne man to however', factual cei tain tic,:; are hukmg ability of past orpine re c-jpcnir.', Al- lac lass sen.'jin,e to VC exposure than ex or where the facts alone do not j-mnjde thouyh geographic ami worl-praLlice dif- perimental animals in the absence of an answer, policy judgments have been fcieneir. may niim,;.lie demoirRaled conclu-.ive evidence. It would also oc un made. to be facial's ill C.i .1:ibuiinn of anr.io.'ar- founded to assume that animal; will not There Is little dir,pule that VC car ccima, suttieient iniormr,! ion is unavail- develop tumors '.''hen exposed at concen cinogenic to man and we so conclude. nble to exclude from consideruikin of trations of VC of less !:i.'in 53 ppm. However, the pre.ci.-e level of c.w'bM'.re rid; thorn employees i:i workplace? for Should a MiPleicntly large number of ex which pewes a liaxaul one! lire question which cases of angiosarcoma have not perimental animals be exposed to VC at of whether a "safe" exposure level ex: Is, boon oh; caved. concentration., of less than 50 ppm, cannot be definitively answered on the It has also been f.iif'gcr.lcd that the Sehncid'PMgin said that it would be; ex record. Nor is it clear to wind extent absence of cancer in a p-apulktion of ri pected I hut some would deuiep VC In cxpoMires can lie feasibly rcdu'-cd. Wo Dow Chemical Coi'o;;nny polymerization duced tumors. cannot, wait until indisputable an awe rx employees monitored over a period of 7 (3) Fec;<ii)/. There is \htunHy no to these questions are available, berauee years, indicates that exposure to vinyl dispute that meat, if not. all, lubiicators lives of employees are nt stake. There chloride at concern ration.; of less than are currently capable of reaching ex fore, wo have had to exercise our beet 200 pn;n is safe. (See finely by Dr. Cock, submitted at the hearing by Dow Chem ical Company.) However, the Group sur veyed did not include all workers who had been exposed, and the missing em ployees included many who had the longer term Cover 20 years) exposures. Moreover, the statistically insignificant slue of the sample population decreases the possibility that tumors would be observed. posure levels of 1 ppm tin or.eh engineer ing controls. These employers employ well over 55 portent of all employees ex posed to VC. Indeed, several fabricators are already operating at tliis level (see SPI testimony). However, industry spokesmen have universally claimed that it is infeasible for the VC and the PVC industries to remain below 1 ppm con sistently, using engineering conuols. In addition, the Knell study on technical judgment on tile basis of the test avail able evidence. These judgments have re quired a balancing process, in winch the overriding consideration li3s been Ibc protection of employees, even these who may have regular exposures to VC throughout their working lives. Eased on the available evidence and in view of the above considerations, includ ing feasibility, we believe that employee exposures to VC must be reduced to a 1 Dow also presented preliminary data feasibility concluded that a I ppin ceil ppm time-weighted average (TWA). We in testimony at the hearing on the pos ing is not feasible for the VC and PVC also believe that PVC and VC establish sible metabolic pathways of VC. The industries with present technology', but ments will, in time, be able to attain that hypothesis presented was that VC may that the VC industry could currently at level through engineering controls, and exert its carcinogenic eifect. by a metab tain lower exposure levels than the PVC that fabricators can do so In the Im olite, and that the metabolite is pro industry. l>bor union spokesmen and the mediate future. duced only when VC is metabolized by a. Health Research Croup, Inc., however, In addition to the T'VA requirement, secondary meLabolie pathway operating have suggested that such a level is at we have established a 5 ppm ceiling only when enzymes regulating the pri tainable. (averaged over a 15-minute period) in mary path.way arc saturated, as. would Since there Is no actual evidence thar order to prevent exposure of employees be the result at higher exposures. The any of the VC or PVC manufacturers to unacceptable high excursions. Fiom preliminary data indicated the possi have already attained a 1 ppm level or in an operation standpoint, this ceiling bility of an additional pathway for fact instituted all available engineering level is realistic because minor excur metabolism of VC in rats exposed to con and work practice controls, eny estimate sions up to the' ceiling level arc likely to centrations of VC in excess of 220 ppm. fuy to the lowest feasible level attainable occur on a regular basis. However, the occurrence of angio must necessarily involve subjective judg III. The final standard--(1) Scope and sarcoma in both rats and mice at VC ment. Likewise, the projections of indus application. Both the ETS and the pro exposure concentrations of SO ppm in try'. labor, and others concerning feasi posal would apply the standard to'the dicates that if a metabolite of VC is (he ultimate carcinogen, then it must be generated at lower exposure concentra tions in these species. Although this re search may be helpful to the thorough understanding of the carcinogenicity cf VC, it appears that it does not yet offer evidence which can assist in determina tion of safe exposure concentrations for employees, or even that such safe ex posures exist, A number ef witnesses representing employers have stressed lhat iiiere is 1.0 evident c of cancer, cither in employee;; Or rxperuuc'ni.r.l animals^ at exposure concentrations of VC less than 50 pm a. (Fee e.g., testimony of firestone. Tcnneco Cnemicals.) The Lunelusion of (her-e v.'ilne.. e, v.as lhat no decision cam bo made oonrorumg nsk oi exposure to VC at cc-ncenlral ions lets i ban 50 ppm. On the other hand, the testimony of most i Xpert wit nesses, including some uidu'.liy biomedical experts. Mated lhat 1'iu.inti,leatain of a . ate exposure eonci ntralit-n is not. pe.-..,:b!e with the pres bility arc essentially conjectural. Indeed, as Firestone lias suggested, it is not pos sible to accurately predict the degree of improvement, to be obtained from en gineering changes until such changes are actually implemented. V/e agree (hat the PVC and VC estab lishments will not be able to attain a 1 ppm TWA level for all job c3a' mirations in the near future. We do believe, how ever, that they will, in time, be able to attain levels of 1 ppm TWA for most job classifications most of the time. It is ap parent lhat reaching such levels may re quire some new " feclmolbgv and" woVlr practices. H may also be rvewsary to Utilize ir-ohnoh-gy presently r.M\l in other industries. In my evert, the VC and PVC industries hat-.; alu-ady made great strides in reducing exposure levels, (See testimony of Dow Chemical Co., TR 573). For example, B. F, Goodrich testified (TR 1120) that it has rcdiu-.d average exposure level.; in .several l'VC plants from 55--10 ppm early tills year to 15-13 entire VC industi-y, including manufac turers of VC and PVC and fabricators, but excluding employers handling or using fabricated products made from VC. There is no dispute that a standard is required for the monomer and polymer industries. However, the Society of Plas tics Industry (SPI) and various fabrica tors (cat; testimony of Goodyear, Gen eral Cable, etc.) recommended that fabricators be excluded from the st.-ndard, or that a separate requirement bo established for them because many of them were already af'or^below the pro posed ceiling level. The record evidence establishes that at least some employers in the fabric. 1ing industry arc. exposed m excess of the pcrii)w able control limits (pci; .'\TOSlI testimonv, TR 105: Eobmtcch 'PR In these encumstauces, we believe that it is imprudent to grant a blanket oemp- lion for nil fabrk'uk'rs. Therefore, the final Mandard is applicable to tile f:'hri- ent slate of seienliiic knowledge. (See ppm at the time of the hearing. Wo are calion Industry, as well a;; the luone-imr R&S 140658 rcDt "At necisTn:, vot. :w, uo. pm lUhAY, octocr; a, ham RULES AND REGULATION. and pnljmer Imlu: ' rif':-. Euii iIovcit; who, lempcrafure as PVC, for furlhcr pro- below the aclion level, no further moni m are suhVantudh' h-h-w 1 lie ex re.-Mirr, indicator, that a polon!i.d foe re- toring is required unless the employer posure limit, v.ill be stlbiccl.'-d In only le.v:<- of Ihe residue Mill cmMs Tt ap lins reason to .suspect that any cnrdoyeo minimal burden.; by viriuo of (he "action pears. that the exempt ion of fr-bt baited is exposed in excess of the action bn cl, level" to bo dire us;.yd below. products should be hmiicd to just those or unless changes have been made in Where employer:; in the f.dnioaling ilems which will not undeigo .such mass production, process, control, type o! re .an, industry ha-.." exposures approaching the heal ir.lt. Further, the opportunity lo etc. permi.vdbie limit, they will appropriately demonstrate that expo.-iues arc ia-low Where the exposure level, without re 1)0 subject t.o the Monel.ml Employers the u'-t.inn level, and Urns, discontinue gard to respirators, exceeds the pernus- handling or using fabricated products many duties of the standard, provides a sible levels, monitoring must be conduc made of PVC we not. included in the more positive conlioi and an adequate ted at. least monthly. Where expooures ETC or tho proposal and ore excluded relief. are less than the permissible levels, but from the final .standard. This conclusion (2j Permissible exposure limit. The greater than the action level, monitoring i$ based on the absence of nd-qiie.te evi .standnid sets an exposure limit of 1 ppin must occur at least quarterly. dence of exposure to VC in the,so opera averaged over anv 8 hour period, and a (5) T.Tcthous of compliance. Tile stand tions. Tito final standard clan be;; flic ex ceiling of 5 ppm averaged over any per ard, like the proposal, requires Unit em emption by defining a fabriratod prod- iod not exceeding 15 minukis. ployers immediately institute feasible uc.t as a product made wholly or partly As more fully rtixeu ;cd above, this engineering and work practice controls from PVC which docs not requ-re further limit is based on a.n evaluation oi (he best to reduce exposures to at or below the processing at temperature:;, and for available evidence and on a judgment permissible exposure limit. tunes, sufficient l-o cause mass melting of that (lie health and safety of empire.cos "Where feasible engineering and work the PVC. SPJ and others (of. Tft. 344) mud be protected to the fullest extent practice controls will reduce exposmes requested that PVC resins with less than feasible, in view of the fact lb,at release below the permissible levels, they must 0.1 percent residual monomer be ex of VC in the VC and PVC manufacturing be instituted. Wit ere such controls will empted from the regulation now, and processes are variable, the 1 ppm ceiling not reduce exposures below the pcrrmm that- the exemption level be reduced to 0.01 percent m three years. SP1 suggested that the exemption of materials with less than 0.1 percent of 14 carcinogens from 20 cm 1910.93p (39 PR 373G) was an appropriate precedent. The cases are not comparable, because no attempt had been made to set air concentration limits for the 14 carcinogens. The record did not include information that reliable moni toring and measuring techniques were available. Moreover, the exemption did not exempt airborne traces of carcino gens. The administrative c-utoil was pro vided to avoid regulation of materials level provided in the proposal would require maintenance of an average level significantly more difficult lo attain through, feasible engineering controls. Therefore, the exposure limit prescribed in tlio proposal lias been rejected. (3) Action torch Tne final standard, unlike the ET3 and the proposal, pro vides for an "action level" of 0.5 ppm TWA, one-half of the permissible ex posure limit. The purpose of the action level is to minimize the impact of the standard on the employers who have attained exposure levels vrcll be'ow the permissible limit. Thus, where the re sible level, they must nonetheless be im plemented to reduce exposures to the lowest practicable level, and be supple mented by the use oi respirators to pro vide the necessary protection. There upon, a continuing program cf engineer ing and work practice controls must he instituted to reduce exposures to the low est practicable level. When1 exposures arc at or below the permissible exposure luniks, the program may be discontinued. In addition, a plan for achieving con trol by engineering and work practice methods must be drawn up and be made available, upon request, to represent about which there was no health haz sults of monitoring under paragraphs' atives of OSHA and NIOSH. ard information, and which would have broadly extended the application of the regulation beyond the record. Herein, no information was presented to show- (d)(1) or (d)(2) demonstrate that employee is exposed in excess of 0.5 ppm TWA. employers may, in effect, be exempted from some provisions of the We recognize that many employers covered by the standard can not cur rently achieve compliance with the per missible exposure limit solely by the use safe concentration results from the use of resins with specific levels. Indeed, the proposal to change the level later, when improved technology would permit such standard. For example, fabricators who are bcloiv the action level ru-e not re quired `o provide medical surveillance ot to monitor again, unless the employer of feasible engineering and work practice controls. The record also reflects broad generic distinctions between the compli ance capabilities of the VC and PVC reduction, would seem to indicate that has reason to suspect that any employee industries. Some industry spokesmen, SPI has doubts about the safety of 0.1 is exposed in excess of the action level. including SPI (TR. 358-3G2), recom percent residue level. Diamond Shamrock In our judgment, exposures below the mended that a schedule of different per- (Exhibit 142} testified that there is no action level do not present a sufficient missilc exposure limits and compliance direct relation. They indicate that Ihe hazard to warrant application of the en dates be established for the VC and PVC - airborne, concentration is more related tire standard to the many employers who segments of the industry. to the physical form of the resin and are or will be below that level. This view assumes that the ability and the ventilation provided. Also, monitor- (4) Monitor'nut. The final standard, the time required lo feasibly reach in inf; data from industry (cf. Exhibits 131, like the proposal, requires that individual creasingly lower control levels is similar 108, 170) and OMHA (Exhibit J51) indi employee exposure levels be determined. within each industry, but differs mark cate that, levels in excess of 1 ppm may This may be accomplished by personal edly between industries. While the record be found in fabrication operations. In or area monitoring. .Some witnesses and does suggest that such differences do view of these fads and of (lie opportunity persons who submit! eri comments did exist between industries, as noted above, for employers to discord inue many duties not understand the meaning of Ihe term it is clear that inti a-iiidustry differences upon a shoving of no exposures above the "35 percent confidence level" in the, also exist. Tin;;:, the ability and time re action let el. i: does not appear that any proposal.(Essentially it meant-, that the_ quired by eiiclt c,n;ploi,,nr,l,o attain.loiror-- residue exemption is eitheT justified or employer is required to take a .sufficient, control level', may depend upon such necessary at this time. This course also number of measurements so that the re- factors as the climate in which, the plant agrees with a number of industry pro Milla obtained are siati.VJeaUy valldMVc ia located, the age of equipment, the- size posals (cf, TR Offfn. have modified Uni proposal to establish oT reactors, or the type of re tin manu SPI (TR 343), among others, asked that compounded PVC pellets bo ex empted from the .standard on the mounds that the pelh-l.j had too low a residue to cause, harmful or measurable emissions. kVi'iilo it appears that- PVC pellets would accuracy range requirements for various measurement, levels. These langes are narrow enough to cnr,tiro that a doterminaiion of f omplianee can be made, and broad enough to allow the application of a \ariety of technologies factured or used, (Snell study, Firestone testimony, etc.) Monitoring data also tends to support such intra-industry variations, tCce, c.g. Dow, Fm-stone, Tenncco.) As noted above, the standard requires lave a lower ivxiV.ue level than virgin Ail covered employer;! are required to all employer.: to hi .Unite feanble eii -i- "l`\'C, lire fa.c.t that the pellets must be. conduct initial monitoring. Where moni iiec.nng controls to the fullest, extent and heated to a molten mass at (he same toring and measuring results are at or to continue to improve and apply cugi- R&S 140659 ITDri'At ntcisi LR, VOL 39, NO. 194--nil DAY, oaOlffR 4, 1974 R&S 140660 n:>wi i P.UI.I'S AND :;;:CUfAT!QN5 lwoii:;,, coniioh unfii full coiiipbam C i.s B V/c bale uni t .-!i hed any C'd!,'','o *r Dili coiup'.i.inei: Ibrouxii cilg.iU'erm,'; coui'uU lx-onuso we i.ie present!,,' unzbie to determine when ii will be fcasihia fur mn-t rslnbli-.hmenu, lo reduce (.xposuie lei els to the perm:,-.able level, Yve also belie, e Dun. tiie requirement th.-it each empM; cr r.dt:cc airborne concent rations to the permissible level, or to the lowest level feasible as soon as practicable v.ill provide for ioter-indu.';(ry and inlra-ir.riurlry technologic,tl <l'fferences which do exk!, and v,dl avoid the setting of sepm ale industry stand ards on the basis of the genorat At nation and condition;; in each indnr-try. (0) Hcyulrtcd arccr:. The proposed standard would have iCLpiircd that regu lated areas be estai fished, that nccess ha limited to nut hr,:: ic'd employees, and that daily rosters or summaries of those entering be kept for at least 20 years. In objection to these i eouireinenis, it was essence! that shell control of access was not necessary from a. health standpoint. Secondly, it was claimed that these con trols would Interfere with operations by preventing access of reeded emplcjces or non-employccs, such as contractors, truck, drivers, customers and consultants. The. pur-pose of establish inti retaliated areas in the proposal was to limit the risk cf exposure to es few employees as possible. This concern is still paramount, and thus the limited access feature re mains. The final standard amends the proposal slightly to allow "authorized persons" to enter regulated areas. This chance, it is felt, will allow operations to continue without undue interference. The final standard has also increased the lcniith .of time daily rosters must be maintained from 20 to 30 years. This change was based largely on epidemio logical considerations. iScc fiHOSH testi mony, tr. 119.) (7) Respiratory protection. The final standard, like the proposal, requires the use of respirators where employee expo sures exceed the permissible conti ol level. Industry representatives made a number of objections to proposed requirements for respiratory protection. They stated that the "no detectable level" would ef fectively require continuous wearing of respirators in PYC and VC plants, and that this is no1, feasible because respira tors are cumbersome, present a safety hazard, and employees would not use them. We would aero;: that respirators have many drawbar':.'; the proposal did not contemplate tkc.n as a finirt solution. The record chow.1; that the PVC industry par ticularly may need several years buore plant environmental levels can bo re duced so that re.-pir: Icr.-i arc necessary only oeca.wirmnhy. However, we cannot agree that respiratory protection should not be required .simply because it. is in convenient, nicy require additional per sonnel. iiueiieies with product ion, or may require extensive retraining of em ployee,:; and i cstructuring of work prac tice.';. VYo have carefully contiidtred nil the objection..,, and have eonc'iuiUd that If the environmental level is not con 1 rations. In discussion;; Of these findings trolled to the pined . idle t xinsure mail, Vvilfi NTOBJf. it ha..- Indicated (i? T it. i; then cun'h" . es nut; t he attended respira vilim:; to cou.'jdcr on an expedited )>:.r,r, tory pi o'.1, el ton. lie: approval ol e.U- purifying rci'kidor;; While eeqa/ in-ec in ewe'a uf the per- for use against VO. ConsequcuUy, we mitiMidc ).'\vl do cnnxlfiulc a hazard, we, hr.vc included.three, types of air-purify- believe tiled, it is necessary to militate ing respirators in the last of areeptaide come of the problem'; as noouloci with imils, subject to the approval oi i,ucfi implement!:-!; a pngr, m ot respiratory v.nlis by NiOfilf, Th? maximum <owcn- -I pro* eel am wi'.ilc cmpl-nt ct; are being nation for which each respirator may , ' fitted and trained in re. piralor use, and be iiscd is based upon our evaluation while other adjustments which may be of the chita submitted by NTo;-;n and. , required are mipk nn-nteu. Therefore, Goodrich. Because air-purifying respi until January 1, )D';<j, where exposures rators do not indicate sorbent exiiau:,! ion are not. in excess of a 2j ppm ceiling, or breakthrough of VC, and because VC each employer must provide each em Jur; no inherent warning progenies at ployee with n:i a;'prop; i,-he respirator. levels for which there devices are mod, However, employees vhn-e exposures do strict administrative controls will be re not exceed a mi ppm ceilmj, may decline quired for their use. Such controls in to rr.c the respirator, m v.huh carc lfie clude a program to assure timely re employer r; not obligated to require its placement of ce.nisfci'.s or cartvidgcs and use. Dump; ihi,3 ad.iu'tmjm period, em an alarm system to alert employees when ployees will be trained in Die uses, pur vinyl chloride concentrations exceed fi.c poses and limitations of respirators, and concentrations allowed for the particu the hazards of exposure to vinyl chloride. lar type of respirator in use. Moreover, each employee will be notified (3) Hazardous operations. Tins i.s a in writing if he has been exposed in ex new .section within the final standard. It cess of the permissible c'.'POoiire limit. encompasses essentially the proposal's Where exposures, exceed a 25 ppm ceil requirements for maintenance and de ing, respiratory protection is mandatory contamination but has restated them in in light of our judgment that much terms of performance language to allow Greater risks are associated with such greater flexibility for employers to deal exposures. with such operations. The intent of the The provisions in the final standard new section is to protect employees en regarding the selection and use of respi gaged in activities that present a risk of ratory protective devices differ from exposure to vinyl chloride in excess of the those in the proposal. The descriptions of permissible levels. An example would be atmosphere-supplying respirators have the cleaning of a filter where retin con been revised to indicate more clearly the taining high residual monomer is types of devices intended, and Ihc maxi trapped. mum permissible concentration level for The proposal's requirement for full- each device. Moreover, the number ofi- body, impervious clothing has been re types of atmosphere-supplying devices placed by the direction to use impervious has been increased. garments suited to tile particular situa At Uie hearing Mr, Edwin C. Hyatt, an OSHA consultant, made suggestions re garding the use of particular respiratory devices. We have concluded that his sug gest ion.--; are meritorious. Therefore, the tion and probable c-xtent of exposure. Thus, full-body clothing is not always necessary, and Is therefore not required where less protection is adequate. Since vessel entry falls within the definition provisions for selection of utmosphevc- of a hazardous operation, the vessel entry supplying devices follow closely the rec section of ilie pioeosal lias been deleted ommendations contained in his testi from the final standard. mony of SPI and B. I-, Goodrich) (TR (3) Emergency situations. The defini with Hyatt's suggestions*. (See e.g. testi tion of emergency has been recast in mony of SPI and B, F. Goodrich) (TR terms of an unexpected massive release. 85 ft) Wc had originally emitted air- The main objection to the section on purifying respirators because none had emergency situations in the propose.! was been approved by KTOS11 for use against Unit, as the term was defined, many VC, pi menially because they lacked in dicators to signal the expiration of the service )e of the sorbent, Hyatt and other witnesses discussed in detail the dcMr.ibibi.v of being able to use canisters or car;ridge air-punfying respirators, provided n sorbent could be shown-to. el'Lciively absorb vinyl chloiide wiih an adequaic serwee life. l-hivatly, G.S'TI.Y lias received respiratory dam from labo ratories regarding flic cil'ectiveners of ordinary leaks or operations resulting in a small release of vinyl chloride would be considered emergencies. This was not the intent of the proposal. The final rdanda.nl has been clarified to correct finis ambiguity, it should be noted that the written operational plan required by the standard need ntft` he developed-fro^- minor excursions above the pcmus.uble exposure limit, and that such excursions need not be. reported. comm u'cmliy available canisters and (10) Sii/nr. and h:br!s. The thrust of the cartridge', lor vinyl chlorine. These eval signs and l.ibfls section is to uppn-e uation;, were conducted separately by employees of the cancer and lire her NJ.GGB and by the B. R Goodrich Com pany and submitted to OxJUA in poslhvarin;: comment.';. The reruns indicate Hint certain presently available milk alds. No objections have been raked with respect to informing employees oi the Jh'o liaM.'ird. However, a nvmiv-r of ob jections were raised at tile lit arm;; and in will ten siibini.'Sion:; to fine icquue- ier;; and ca: tncb.'es ofireuvoiy absorb meni. that (fie word "cancer" rippear on Vinyl chloride at relatively low eoneeii- all sum:; and fitbrJ.;. The pihinpal aiyu- rr-rur.AL r.imsriK, vol. a?, no. mi--iiiiday, ociotta a, p)7i RU1XS Ann RCCULATiOI'iS men l advanced awdnst ils use wn;. Hint indicated dial, the mod'cal tests propo .ed the term "cum cr" or "ca.neer-'usprcl me curieidJy the only oiks available agent" scare.; O'!::j;''jfc.s and that in vlia-h an: uv,usd fur medical .'.urveiliancu stead, tiit* me. age should contain in (VD i:ii, ;:.-;h. *jt;. iu-a-Din. Conse structions. on hoy to deal wjlii the sub quently, Ibe .specific blood teals proposed stance (TR. 3-17). V/o behove. that a have been retailed as a minimum ic- diluted form (if warning will not suffice. qum. me id, to assist the examining physi We appreciate 11:c concern of employers cian in determining illness of potential with the reaction of their employee.!. Hut employees ior assignment to workplaces we consider it imperative that a worker involving VC exposure. In addition, al be fully informed, rnd Mint lie realize t,he ternative medical examinations may be possible risks involved in his occupation. used where the examining physician de Coupled v.ith t.he training requirement termines that they arc-at iensl as good in the standard, \vc. believe that the signs as those specified by the standard. and labels required will adequately in The Tnbcrshaw-Cooper study and the. form employees o' the haz.'iid. In addi various animal experiments suggest that tion, sueli signs will v.am unauthorised VC may produce a wide s pectrum of ma personnel to beep out ol regulated areas. lignant and lion-malignant disorders. Tlie proper applk at am of met protec Tim general scope of the required medical tive measures 11 cmirc:; an amount of examination has, therefore, been broad training and indoctrination of employees ened to include kidneys, skin, connective that cannot easily be conveyed on a sign tissue, spleen, and pulmonary system, as or label. Also,'toe variety of measures well as the liver. Ko additional specific that could be prescribed would result in procedures or (eels are required, but rec an unwicldly or excessively detailed leg- ommendations have been included in tire end. Consequently, the required message Appendix to assist the examining physi on signs and labels v, ill not include in cian. Because of the nonspecific nature formation on precautions, relevant of the required medical tests, it is not symptoms, etc. The addition of suitable appropriate to prescribe liming, or type information by the employer would be of followup tests, or to mandate with permitted, providing it does not detract drawal fiom exposure based solely on re in any way from the required statement, sults of the tests. Instead, the employer Tiie requirement in the proposal for is required to obtain a statement from labeling containers of vinyl chloride has the examining physician of the em been amended by deleting the reference ployee's suitability for continued expo to the possible hazard of violent polym sure, when the examining physician has erization. Very little information was developed on this hazard during the standard-setting procedure. J.L does ap pear that this hazard U essentially under completed such tests as lie considers ap propriate. The employer is required to withdraw an employee only when this statement indicates that the employee control and that the fire and carcino may be at added risk from continued VC genic hazards at present are the most significant. Since labeling or placarding that is in compliance with the U.S. De partment of Transportation regulations (49 CPft Part 173, Subpart ID already warns of the fire hazard, only a state ment concerning the carcinogenic haz ard need be added t.o the Department of exposure. As with monitoring, there appears to be no basis for complete exemption of the fabrication industry front the require ment for medical examination. The rec ord does show fabricating establishments with concentrations of VC monitored considerably above the aci.ion level. In Transportation labels. these instances, medical surveillance of (11) Medical surveillance. The princi affected employees will provide baseline pal questions that have been nosed re data for iuturc evaluation of tlieir health, garding medic:. 1 surveillance are the even if both monitoring and medical sur necessity and efficacy of requiring cer veillance are discontinued because im tain .specific scrum enzyme determina proved controls reduce concentrations tions (SMA-12 scries) and the applica below the action level. Where exposures tion of medical examination require are below the action level, the medical ments to the fabrication segments of the surveillance requirements do not general industry where employees arc exposed to ly apply. lower levels of VC. 'Ih.c objection has also (12) Training. A separate provision for been raised that Die specification of tests employee training has been added to the and procedures interferes with the ap final standard rather than including it plication of advances in medical knowl within the section on emergency situa edge. tions as in tlie proposal. The new para A particular difficulty in considering graph provides for training of employees medical surveillance is ttiat the most concerning tho carcinogenic hazard "of commonly discussed lesion, angiosar VC, emergency procedures, the need for coma of the liver, currently cannot bo monitoring and an annual review of the diagnosed until the victim is terminal standard. It also provides for training of and, usually, within moiuhs of death. employees concerning the purpose for, Precursor physiologic alterations, which proper use of, and limitations connected might be reversible, have not yet been with respiratory protection. divccUy associated with the lesion. Con (13) Decot ds and reports. Tlie provi sequently, there are no specific diagnos sions for i vcordkcrping contained in the tic tesla which can ba proscribed which final standard require the. preparation will determine pie.-cncc or aLseiuc of and iiininu-uancc of essentially the same tills tumor at an early stage of develop information required by the propo :ai. ment. However, mo..t medical witnesses The major change from the original pro posal is the remiiremonl for maintenance of monitoring records and daily roster sheets of authorized persons for 20 years, instead ol 20 jcm-... Additionally, tlie em ployer is required to maintain in'thcal records for the dumlion of an employee's omplojmenl plus 20 years, or 30 ycaia, whichever is longer. The original pro posal calk'd for only 20 years. " ' ; This change lias been implemented be cause the latency period for induclionYit angiosarcoma ranger, up to 30 years from initial exposure. Thcrclorc, as a mini mum, medical records must be main tained for at least that long- It should be noted that spokesmen for both labor and industry recommended that this change lie made. The reporting requirements are not significantly ditleronl, from these in the original proposal. However, instead of tlie requirement, for reporting incidents which result in the release of VC into areas where employees may be e:-,PO;ed, (he final standard clarifies our original intent by stating that only emergencies must be reported. Also the requirement for filing a detailed, written report within 15 days has been deleted. It has been concluded that submission, within 24 hours, of an initial report that in cludes facts immediately available, would ordinarily be sullicient. However, if the OSHA Area Director requests further in formation relevant to the emergency, the employer will be required to furnish such information. (14) Deleted portions ol the proposal. The proposal contained provisions re quiring that shower facilities and change rooms be provided, and that storage or consumption of food be prohibited in regulated areas. We have deleted these provisions because it is our conclusion they are no longer necessary. Showering facilities arc not required because pro tective clothing, where required by the final standard, should protect-employees from skin absorption by direct contact with VC and because there is no reliable evidence that VO vapor is absorbed through the skin. In addition, since we anticipate that most employees will not be wearing protective clothing and that employees who wear protective cleaning' will change swell clothing infrequently, we are not requiring that change rooms be provided. In addition, wc feel that there is in adequate evidence showing that hazar dous amounts of VC can be absorbed through ingestion. For this reason, the requirement prohibiting the storage or consumption of food in regulated areas has been deleted. The. proposal also contained provirrornr on mamientanco and decontamination, transportation leading and unloading, and polymer handling operations. Tnexe leqmremcnt.s are not mentioned in tlie final standard because attention to these items is implicit in the requirement that cavil employer reach the. permissuble ex posure limit or attain the lowest Jeasibie level. (15) Epeativc date. In order to ensure that affected employers and en.iplo.Vces will be intormed of the existence ot these 3D </) CT> Cl not SAL KIGISTia:, VOL. 39, NO. 194--FRIOAY, OC10tjl.lt 4, 1974 R&S 140662 1 ;5r>y..f KULtS f.'.WJ "r.0Li!AVi.';;3 provisions and that employers aii'ccbd are fiver. an expo.'; urn.to A-m;.1. e tlH'in.'.c'i'.v.- and their t-1:';11 iyco-i vUn the L'Xi'.i.uec of the lie ;, ir y.nomeMs. (he riicei'.vo <1 ile of 111rj ow.civil.'.ont lo 5 1310.`.`A kill be J, 1575. Vo pro vide co!!1,biiv:u Piotecq-uii for employee:; 'Until Fiat dale, the JV,-jvi HIPS CUITf.!itiy contained in 5 idle ! 3 j nee hereby promulynied, pursuam io section 0(h), G(c) andD'c) of the Occupational Hafeby and Health Act, sis an occupational safely and hc-iiUh *,t-a-lard effective October 4, 1P7-1, the amendment to 5 lDlOJDq ret out below will supcr.-.cde these provisions us of J, I'-qary ?, 1375. Accordingly, upon con.',:V-.;raiion ot the whole lcoord of this pjctadiiifi, Fart 1030 of Title IT, Code of F'-'.'iercl Jicm'iniions is amended, effective January 1, 1375, by revision of 5 1910.!;3q to read as follows: ]91ff.9.')q Vinj 1 Oilori J;-. (a) Scope and application. f^S^Thir, section includes requirements for the control of employee c..pcs'.ire to vinyl chloride (chloroefhene), Chemical Ab stracts tdervice Henistry lio, V5015. sfftyTiiir- section applies to the manu facture, reaction, packaging, repackag ing, siorage, handling e.r use of vinyl chloride or polyvinyl chloride, but docs not apply to the handling or use of fabri cated products made of polyvinyl chlo ride. is section applies to the trans ition of vinyl chloride or polyvinyl chloride except to the extent that the Department of Trampo) tation may regulate the hazards covered by this sec tion. (b) Definitions. "Action level'' means a concentration of vinyl chloride of 0.5 ppm averaged over an 3-hour work day. , t2J "Assistant Secretary" means the Assistant Secretary of Labor for Occupa tional Safety and Health, U.S. Depart S5Jment of Labor, or his d:f lance. "Authorised person" means any person specifically authorised by the em ployer whose duties require him to enter a regulated area or any person entering such an area as a designated representa tive of employees for the purpose of ex ercising an opportunity io observe moni toring unci measuring procedures. gjt)) "Director" means the Director, Nation;.] Institute lor Occupational Safety and Health, U.S, Department of Health, Education, and Welfare, or his designee. "Emergency" means any occur rence such ai, but r.ol Ladled to. equip ment failure, or oner.'.t: -a of a relief de vice which is likely lo, nr Tioes, result in massive release of viivi chloride. W'Fabricated product" means a. product made wholly or partly from pol.un.yl chloride, rod which cams i;,;f requne further prove .Ay; m, tempera tures, arid lor times, su.ament is enu-o maos nidling of the polyvinyl chloride result in/: in the release of vinyl cidonde. j7)J "Harariious epemtiiiii" means any operation, lu-i-eeduie, e.r activity where a release of Cither \iu.vl chloride iicjtiid or uns might be expected m, a consequence of the opiqv.tum or because el rn acci oppo.!,unity Io observe the mimil vdent in lb,'1 op.-! a; am, vhieli v.i '.id result inn and mrnsunng lequircd by this in ail empi y.-.j,, t --pn .m-e in exee- of the PUriV'.r:;;')]. ij.-imR-abh: c;;p> u;, limit. (c) Jlequlatal (irrn.fi 1] A Ecoilaied *V3y "OfJlA Area. Director" m-mr; the area shall lie cat.abb lied '.'here: JDirector for the Oecup.u.ors! Un'cty (U Vinyl chloride or poivvinvl chlordo r.'Sid Health Administration Aiw. Oflice is laaui'fi'ctured, ivivlcd, repackaged, having jurisdiction over the cioarnphic stored, bandied or ir erl; and : area in wliicii flic employer's establish (ii) Vinyl chloride cnncentralidhs me ment is, hvat/d. i'.i excess of the permissible expense rjLtm "Polyvinyl chloride" means poly limit. vinyl chloride. hamopolymer or copoly "(2j) Access to regulated areas shrill he mer before fuch is. converted to a fabri limited lo authorized persons. A daily cated prohuer roster shall be made of authorized per .OT. "Vinyl chloride" mean*: vinyl sons who enter. chlloride monoumr. (f) Methods of compliance. Employee (C) FamtssiOic exposure limit/ilf) No expo.viiies to viny 1 chloride shall be co.i- employee may he exposed to \inyl chlo trelJod to at or below (he pernu.v.ible ex ride acconcc-ulrsl ions grcaicr than 1 ppm posure lim:t provided i:i paragraph (c.> averaged over any C-jiour peuob, and of thu section by engineering, work prac '<2fl No employee may be exposed to tice. and personal proircLivc controls as vinyl chloride at concentration:! rreatcr follows: then 5 ppm avc raged over any period not XI)I Feasible cnr.incerlus and wo'.'h exceeding io minutes. practice controls Ehr.il immediately Lo 3<3J No cmph.vce may be exposed to used to reduce exposure:: to at or below vinyl chloride by direct contact with the peirniisiule exposure limit. liquid vinyl chloride. licrever feasible engineering and <d) Monitoring. JD> A program of work practice control.'; which can be in initial monitoring and measurement stituted immediately ai'e not sufficient to shall be undertaken in each establish reduce exposures to at cr below the per ment to determine If there is, any em missible exposure limit, they shall none ployee exposed, without regard to the use theless he used to reduce exposures to of respirators, in excess of tire action the lowest practicable level, and shall be level. supplemented by respiratory protection Tt2j Where a determination conducted lr. accordance with paragraph (g) of this under paragraph (d)(1) of this section section. A program shall be established chows any employee exposures, without and implemented to reduce exposures to regard to the use of respirators, in ex at or below the permissible exposure cess of the action level, a program for de limit, or to the Greatest extent feasible, termining exposures for each such em solely by means of eiunnceriiic and work ployee shnli be established. Such a pro piactice controls, ns soon as feasible. gram: *p)i Written plans for such a pro,'train (1) Shall be repeated at least month]?' slialrbc developed and furnished upon where any employee is exposed, without request, for examination and copying to regard to the use of respirators, in ex authorized representatives of the Assis cess of the permissible exposure limit. tant Secretary and the Director. Such (ii) Shall be repeated not less than Plans shall be updated at least every six quarterly where any employee is exposed, months. without regard to the use of respirators, <g) Respiratory prelection. Where in excess of the action level. respiratory protection' is required under (iii) May be discontinued for any em this section: ployee only when t,t least two consecu fXL)j The employer shall provide a tive monitoring determinations, made not less than 5 working days .apart, show ex posures for that employee at or below the action level. i$J Whenever there has been a pro duction, process or control clu nge which respirator which meets the requirements of this paragraph and shall assure that the employee uses such respirator, except that until December 31, 1075, wearing of rcKpi'xUoir, shall be at the discretion of each employee for exposures not in ex may result in an increase in tire- release of viryl chloride, or the employer has any other rc-ivon to suspect that any em ployee may be exposed in excess of the action level, a determination of cmplovee exposure under iv.rrxraph (d) (1) of this section shall be performed. cess of 25 ppm, measured over any 15minute period. Until December 31, 1075, caeii employee who chooses iut to wear an appropriate respirator shall be in formed at least quarterly of the hazarda of vinyl chloride and the purpose, proper use, and limitations ol respiratory m The method of monlioiin;; anil deview.. ' - measurement- shrill have an accuracy m Kcspirators shall be selected from (with a confidence level of (hi p-.-reenl) of among those jointly approved by the not. less than plus or minus do percent Minin1-: Enforcement and Safety Admin- from 0.:L" through 0.5 ppm, nit:-: or minus i.'.fsaiion. Department of the Interior, G.i percent Horn over 0,5 ppm through and the National .lnsHuLo for Oecura- 1.0 pimi, and plus or minus 115 percent, tional SaiVty and Health under the n;o- over 1.0 ppm. (Methods im-cim;: these visionr, of 30 CFH Fart 11. neenrnev mmirrments are available in J3i3Tl A respiratory promotion promom the "NIOSN Manual of Analytical meeting the requirements of S 3010.1 `J-1 hid hulls"). shall he esla.lilislud and maintained. Hmpl'ij cos or their designated rep ^f'S) Neleriion of respirators for vinyl resentatives shall he afforded reasonable chloride shall be as follows: | r Dt() AL HCGISTIiR, VOl. 39, NO, 1 9P-- I KID A V, OCTOrUT, -I, 19M RULES AND REGULATIONS .*?5K!)7 Atmospher'.r cwm-.ti'afion of vinyl ihl'evJc (1) Unknown, or above a.fiiiO ppm... (il) Not over 3.C00 ppm____________ (111) Not owr 100 ppm. (If) Not. over 20 ppm (v) Not over 10 ppaS-- Jlvquircd apparatus Oi>n-clrciiil, :;ft!r-co.it-".!nrU lirrotbin;; apparatus, prem ium; demand lypa, with ltd! (A) Combination typo C eipijllnrt ale loKpiralor, pres ume (unnrn'l type, wllli lull or ImU facepiece, and auxlliory .sclf-ec.iitalnnd air supply; or (13) Typo C, supplied (tlr respirator continuous Hot/ typo, with lull or half raeopiess, micl au.vUlr.ry f;elf-co:it.ii;ic.cl air supply. (A) Combination type C supplied sir respirator tie* mnnd type, with full facapiceo, ro)U auxiliary cclf-coislalMctl air supply: or (13) Open-circuit self-contained breathing apparatus with full Ir.ccpicee. in demr.url mode; or (C) Type C supplied air respirator, demand type, tvlth full facepiece. (A) A powered i.lr-purifying rcrplrator with hood, helmet, full or half facepiece, and a can Liter wliich provides a service life of at least 4 hours for cnucaiiraltous of vinyl chloride up to ?;i ppm. or (B) Gas mask, front- or hack-mounted canister which provides service life of nt least 4 hours for concentrations of vinyl chloride up to 25 ppm. (A) Combination type C euppllud-sur respirator, de mand type, with half -facepiece, and auxiliary self-contained air supply; or (33) Typo C supplkd-afr respirator, demand type, with half facepiece; or (C) Any chemical cartridge respirator with an organic vapor cartridge which provides a service life of nt least 1 hour for concentrations of vinyl chloride up to 10 ppm. mi(S)J(i) Entry Into unkown concentra Protective garments shall be pro tions or concentrations greater than vided clean and dry for each use. 30,000 ppm (Jorer explosive limit) may (i) Emergency situations. A written be made only fc; purposes of life rescue; operational plan for emergency situa and tions shall be developed for each facility (ii) Entry into concentrations of.less storing, handling, or otherwise using than 3G.C00 ppm, but greater than 3,G00 vinyl cliloride as a liquid or compressed ppm may be made only for purposes of gas. Appropriate portions of the phni life rescue, fire lighting', or securing shall be implemented in the event of an equipment so as to prevent a greater emergency. The plan shall specifically hazard from release of vinyl chloride. provide that: dg8|) Where air-punfying respirators $1? Employees engaged in hazardous are used: operations or correcting situations of ex (i) Air-purifying cannlsters or car isting hazardous releases shall be tridges shall be replaced prior to the equipped as required in paragraph (li) expiration of their service life or the oftlus section; end of the ihilt in which they are first $&)} Other employees not so equipped used, whichever occurs first, and shall evacuate the area and not return (il) A continuous monitoring and until conditions arc controlled by the alarm, system shall tic provided where methods required in paragraph (f) of concentrations of vinyl chloride could this section and the emergency is abated. reasonably exceed the allowable concen <j) Training. Each employee engaged trations for the dtraces in use. such sys in vinyl chloride or polyvinyl chloride tem shall be mod to alert employees when operations shall be provided training in vinyl chloride concentrations exceed tlse a program relating to tiie hazards of allowable concentrations for the devices vmyi chloride and precautions for its in use. sale use. m Apparatus prescribed for higher >--''17 The program shall include: conceal rations may bo used for any lover concentration. (i) The nature of the health hazard from chronic exposure (o vinyl cliloride (h> Hazardous operations. $CXJ Em ployees engaged in hazardous operations, including specifically -the carcinogenic hazard; including entry of vessels to clean poly (ii) The specific nature of operations vinyl chloik's residua from vessel walls, which could result in exposure to vinyl shall be provided and required to wear chloride in excess of the permissible and ire; limit end necessary protective steps; (1) 11expiratory prelection in accord (iiltYrhe purpose for, proper use, and ance with paragraphs (c) and 0;) of limitations of respiratory protective this section; ; ud devices; (li) Protect:', e garments to prevent akin contact \y;:n liquid vivo, I chloride or with polyunyl chloride Jidduo from vessel wain;, 'file protective garments (iv) The fire hazard and acute toxic ity of vinyl chloride, and the necessary protective steps: allr,11 be rvleclcu for the opi ration :md (v) 'Hie purpose for and a description IU posable c/p.isure condition.';. of the monitoring program; (vi) The purpose for, and a descrip tion of, the medical .mu vcillancc program; (vii) Emergency procedures; (viil) Specific information to aid the employee in recognition of conditions which may result in the release, (if vinyl cliloride; and *s (ix) A review of this standard at the employee's first training and indcctrirrnv tion program, and annually thereafter. (2)/All material:; relating to the pro gram shall be provided upon request to the Assistant Secretary and the Director. (k) Medical surveillance. A program of medical surveillance shall be insti tuted for each employee exposed, with out regard to the use of respirator.,, to vinyl chloride in excess of the action level. The program shall proud.- each such employee with, an oppoilunity for examinations and tests in accordance with this paragraph.. All medical ex aminations and procedures shall be per formed by or under the supervision of a licensed physician, and shall be provided without-cost- to the employee. 3tl# At the lime of initial assignment, or upon institution of medical surveil lance; (i) A general physical examination shall be performed, with .specific atten tion to detecting enlargement of liver, spleen or kidneys, or dysfunction in these organs, and for abnormaltics m skin, connective tissues and the pulmonary system (See Appendix A). (ii) A medical history shall be taken, including the following topics: (A) Alcohol intake; 03) Past history of hepatitis; (C) Work history and past exposure to potential hopatotoxic agents, includ ing drugs and chemicals; (D) Past history of blood transfu sions; and (E) Past history of hospitalizations. (iii) A scrum specimen shall be ob tained and determinations made of: (A) Total bilirubin: (B) Alkaline phosphatase; (C) Serum glutamic oxalacelic trans aminase (SGOT); (D) Serum glutamic pyruvic transam inase (SGPT); and (E) Gamma glu/tamyl transpeptidase. 88 Examinations provided in accord ance with this paragraph shall be per formed at least: (i) Every C months for each employee who has been employed in vinyl chlo ride or polyvinyl chloride manufacturing for 10 years or longer; and (ii) Annually for all oilier employees. SSI Each employee- exposed. -To__air. emergency shall be aiforded appropriate fifgxHcal surveillance. A statement of each employee's suitability for continued exposure to vinyl cliloride inclmbn; use of protec tive equipment and respiralm.s, shall be obtained from the examining physician promptly after any examination. A copy of the physician's statement .shall be pro vided ear h employee. If any employee's health would bo materially Impaired by continued ex posure, such employee shall be with- FCDEKAL RtCISlfH, VOf. 39, HO. 194--mnAY, OCrOOnH 4, 1974 i >T M'3 [;U!.T:- AMD IMlGh''.ATIOMS drawn. from po.-Mblt: donhiel with vinyj chl'Tide. 1G? Dabcir.itory atinh'.'jCA for pH hioijiioal xpivimcm: included in medical r mutnrio;;.; Mini; 1 . j m h;nc,vd in k.boaloric-l hceii'-cb 'O'; ,.r -:2 CFi!. Part 7-. If the exam in nr' physician deter mines ihat nhomnUu: medic.ri examina tions to tho.'o icqum-ii by p.ti'fiyTaph (k)(l) of tliis section will provide at least equal .a.'-.jiir.uia.: of tiulcolins med ical condi'uor.s peninmii, to the exposure to vinyl chloride, the employer may ac cept .such ei'.ern.ativc c;.aiihn:'.tion.,i as meeting the requirement:; of paragraph <k)(l) of this section, if tile employer obtains n flclenient from tile c::a:jur.;nf; physician retting foriii the iiReniativo examinations rr.d tie: rationale for subsliLuLion. This r,:ntemer,i .'hall he avail able upon, request for examination and copyinr: to autho:ized representatives of the Amisfanl t'ecivliiry and the Director. (1) Sicms and. labels. Xl)l Entrane.c.s to regulated areas .shall iie posted vvicii leg ible signs bearing the legend: Cancer-Suspect Am*.nt A*u:a Authorized Personnel Only wh Areas containing hazardous oper ations or v.'here an emergency currently exists shall be posted with legible signs bearing the legend: Cancer-Susi-ect Agent in Tins Anea Protectiye Kquipmtnt Required Authorized Personnel Only '(3)^ Containers of polyvinyl chloride resin waste from reactors or other waste contaminated with vinyl chloride shall legibly labeled: Contaminated with Vinyl Chloride CANcr.R-iSusrECT Acknt Containers of polyvinyl chloride shall be legibly labeled: Polyvinyl CiiLoarnn (on Trade Name) Contains Vinyl Chloetije Vinyl Chloride is a C.iNCEa-SusrEcrr Agent $G$$$SContainevs of vinyl chloride shall be legibly labeled cither: (i) Vinyl Citlomde Extremely Flam.maule Gas Ukdo: Pklssuhe Canceh-Sillvect Agent or (If) In accordance with 49 CFR Part 173, Subpart H, with the additional legends: Canccc-Suspect Agent applied near the labor or placard. No statement shell appear on or near any required sign., label or instruc- lion which eontradieh: or ('uiiacis from riii The number of employee., in mIi the cdci-t of, any rcr.idred warning, rr.Mil.dcd .area dm nr; normal open,I ion.-;, inform.ilmn or iBAirucliuit. including in.imU nance. (in) Jtccords. ir\Sj A)i ie/orfls main- i(2y J.'inftir.envie:,, ami the fact; ob- taii.cd in accordance t.u'i section shah include the name and .social rccu- l'Lfy number of euclt employee where relevant. M2)/ Records of required monitoring and measuring, medical record-;, and .au l; 'Inside at rir.d li'i.c. shall be reported will,m ;M horns to tin; ODHA Area. Diu.ct.or. Upon request of the Area Direc tor, the employer sliali submit additional information m weiring relevant to; the nature and extent of employee exposures thorized personnel rosier.':, .`.hail bo mode and shall be available upon la quest for examination and copying to authorized representatives of the Assistant {secre and measures taken to prevent future emevgencir:; of similar nature. ^J[3V'V/iUun 10 working days following any monitoring and measuring which tary and Die Director. discloses that any employee has been (i) Monitoring and measuring records exposed, without regard to the use of shah: (A) State Uic date of such monitor ing and measuring and tire concentra tions dckrmir.r-d and identify the instru ments and methods used; respirators i:i excess of the pc: miaaihie exposure limit, each .such employee shall be notified in writing oT the results of Die exposure measurement and the steps CC) Include any additional informa being taken to reduce the exposure to tion necc-s'iiiT to determine individual employee exposure;} where such expo sures are determined by means other than individual monitoring of employees; and (C) Be maintained for not less than within the permissible exposure limit. (o) Effective dates. Until Janu ary 1, 1375, the provisions currently set forth In 5 1310.93q of this Part sliali apply. 30 years. Effective January 1, 1975, the pro (ii) Authorized personnel rosters shall be maintained for not less than 30 years. (iii) Medical records shall be main tained for the duration of the employ ment of each employee phis 20 years, or 30 years, whichever is longer. In the event that the employer ceases to do business .and there is no successor to receive and retain liis rec ords for the prescribed period, these rec ords shall lie transmit Led by registered mail to the Director, and each employee visions set forth in 191Q,93q of this Part shall apply. Api'cndiS A--Supplementary Medical Information When required tests under paragraph (!;)(1) of this section show abnormalities, the te.;u, should be repealed as soon as prac ticable, preferably within 3 to 4 weeks. If tc:ls remain abnormal, consideration should be given to withdrawal of the employee lrnm contact with vinyl chloride, while a more comprehensive eve'nh'ation is made. individually notified in writing of this Anditlonal tcits which may be useful: transfer. A. For kidney dysfunction; urine o.anaar.- t4)y Employees or their designated -Aioii for albumin, red blood cells, and ex representatives shah be provided access foliative abnormal cells. B. Pulmonary system: Forced vital capac to examine and copy records of required ity, Forced expiratory volume at 1 second, mpijitoring and measuring. and chest roentgenogram (posterior-anterior, ^<517 Former employees shah be pro- ' 14 x 17 Inches). vftTecl access to examine and copy re C. Additional serum tests; Lactic acid de- quired monitoring and measuring records reflecting their own exposures. 3S5?7Upon written request of any em ployee, a copy of the medical record of that employee shah be furnished to any physician designated bv the employee, (n) Reports. Not later than f month after l-he establishment of a reg ulated area, the following information shah he reported to the OF.71A Area Di hydrogenasc, lactic cold dehydrogenase isoenzyme, protein determination, and protein electrophoresis. D. For a radio comprehensive examination oh lcpeali'd abnormal scrum tests: Hepatitis B antigen, and liver noaunlng. (Secs. C and 0. 84 Rtal. 1590, 1593 (29 U.S.C. 055, C57); hocrclary of Labor's Order No, 12-71, C8 Lit 6751) Ginned at tVafihiiiglon, D.C., this 1st rector. Any changes to such information day of Ovto'ccT, 1371. shall be rcjrorted within 3 0 days. . <i) 'Hie address and location of each establishment which has one or more regulated ureas; and Joiiir Sxexpl-r, 'Assistant Secretary oj Labor. [FR DO0.74-2317G Filed 10-1-74;.1:64 pm) R&S 140664 rrtiuva Riouiffi, vot. 39, uo. dm--idday, ocTcr.tn 4, ism