Document zdO5V92nNE2LN0k5QmNEGV5R0

1 FRIDAY, OCTOBER 4, WASHINGTON, D.C. Volume 39 Number 194 PART II Occupational Safety And Health Administration EXPOSURE JO VINYL CHLORIDE Occupational Safety and Health Standards BOR 008402 3W30 RULES AND REGULATIONS w Title 29--Labor ployres from a rare liver rnnrrr (nnglo- CHAPTER XVII--OCCUPATIONAL SAFETY and HEALTH ADM INIS TH A I ION, DE PARTMENT or LALtOR saiicima) may havr been occupationally related As a result of litis notiln-ation nml alter consultation with NIOf.Il, and a Joint inspection of the II V. Coodilrli PART 1910--OCCUPATIONAL SAFETY plant hy OSIIA, NIOS1I and the Ken- AND HEALTH STANDARDS tuckv Department of Labor, a farl-lind- standard for Exposure to Vinyl Chloride ing hearing was aniiouneed on Janu Puisuant to sections Gib), G(c>, and 8<c) of the Occupational Safety and Health Act of 1970 l84 Slat, 1593. 1590. 1503; 29 U S C. U55. 057) Sren-lary of Labor's Order No. 12-71 <26 Fit 8754) and 29 Cl lt Tart 1911. t 1910.03 of Part 1910 of Title 29, Code of Federal Pecu lations is hereby amended In the manner set forth below, In order to provide nn Occupational Safety and Health stand ard dealing with the exposure of em ployees to vinyl chloride. I. Background--' 1) Vinyl chloride. Vinyl chloride (chloroethcne). Chemical Abstracts Service Registry No. 7D014, is a synthetic organic chemical made from ethylene or acetylene and chlorine by any of several processes. It is the parent compound or a scries 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 1939, and present production Is in excess of seven billion pounds per year. The vinyl chloride industry divides into IhrCC--SCcmCDtSL mpnnmyr nrn.liu-l.um. polymer production end fahrip.it inn Production of the penamer is a largescale continuous process, involving only a few firms. There arc comparatively few ary 30, 1971 <30 I'll 3074) anrl held on February 15.1974 Information obtained from this hear ing, particulatly the preliminary rcpoit.x of experiments conducted by Professor Ccsarc Maltoni of tire Instituto dl Oncologia, Bologna, Italy, demonstrated that vinyl chloride induced angiosarcoma In rats nt levels as low as 250 ppm, and in oilier .species at higher levels. Experi ments performed at lower levels of ex posure were not completed nt that time. Other testimony from medical witnesses and NIOS1I. and the results of autopsies, led to the conclusion that the Goodrich workers had angiosarcoma of the liver and that VC probably was the causal agent in the 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 L Rubber Com pany. On the basis of all information avail able at that Umc, 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 (ETS) was promul gated on April 5. 1974 (39 FR 12341) pursuant to section G(c) of the Act, ns employees in this segment of the indus try, because the processes lentf them 29CFR 1910.93q. This standard reduced tire permissible selves to automation. exposure level from a ceiling of 500 ppm Vinyl chloride (V-C) is used primarily to a 50 ppin ceikr.g, and established other In the production of polyvinyl chloride requirements, including, for example, (PVCJ. a resin whip); thrrm-u. monitoring and respiratory protection. lint.ch processing. The conversion of the It was expressly recognized that this VC monomer into a polymer or copolymer standard limiting exposures to a 50 ppm is an incomplete process, i.c,, not all of ceiling was a tentative, interim standard, the monomer Is reacted, and that the whole question of exposure PVC is fabricated bv a variety of tech to VC .would be considered more fully niques. including extrusion, injection iTiOUhlVJ a:m caifndg!`i:lu 10 lorm a~tTn- in the light of additional information^ especially the results of experiment^ isnen product mat needs no further which were known to be undenvay at cTieffirrd Munaiwt. ftiajoriry that Umc. ol employees involved in the VC industry On April 15.1974, information and data are employed by fabrication firms. Such were presented to representatives of firms range in size from those with few OSHA. NIOSH, and the Environmental employees and simple equipment to large Protection Agency by the Industrial Bio- plants involving many employees and . Test Laboratories. Northbrook, Illinois, considerable capital. concerning results of animal exposure Viijyl chloride (VC), a gas at ambient temperature and pressure, is a chlori nated hydrocarlxm, which heretofore has been regarded ns having moderate liver studies with VC. These studies were sponsored by the Manufacturing Chem ists Association. Although only pre liminary in naturf at that time, these toxicity. The initial standard, contained results revealed that 2 out of 200 mice in Table G-l of 1910.93, established a exposed to VC concentrations of 50 pptn ceiling value of 500 parts of VC per mil for 7 hours a day. five days a week, for lion parts of air. approximately 7 months, had developed 12) The emergency temporary stand angiosarcoma of the liver. ard. On January 22. 1974, the Occupa (3) The proposed permanent stand tional Safely and Health AdmiiV,tril ard. Based on the demonstrated evidence lion (OS1IA) was nifuimcd by the Na of VC's carcinogenicity in three animal tional Institute for Occupational Satetv species (rats, mice and hamsters), and and Health (NIOSII) that the 15. F, tiic substantial probability that VC had Goodrich Chemical Company had re boon the causal agent in the eases of liver ported that deaths of several of its cm- angiosarcoma found in workers both hero anfT abroad. OSHA proposed to revise 1910 93q anil published a comprehensive proposal (39 Fit 1G89G) on May 10. 1974, to protect employees from hazards of exposure to VC. The proposal railed for limitation of employee cxjm.suie to VC to "no drtcetnblc level," ns rrmasnrt-d by a sampling and analytical method sensitive to 1 ppin, with an accuracy of 1 ppm S0 percent. The proposal also called for the establishment of re-plated areas and limited access to stuh anas to au thorized persons, A requirement for monitoring of employee exposures was proposed, along with engineering and work practice controls to be implemented when exposures over the detectable limit were measured. Respiratory protect ten would have been required while engineering and work practice controls were being implemented or where exposures exceeded tDo 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. 1974, allowed 30 days 1or interested parties to submit written comments and to request nn Informal rulemaking hearing. In formal contacts with OSHA staff and early responses Indicated that the sub ject was of great interest and importance to many persons. Because of the limited time available before expiration of the six month period provided in section 6(c)(3) of the Act for promulgation of a final standard, it was decided to hold a hearing as soon as possible! Accord ingly, on May 24,1974, a notice of a hear ing was published (39 FR 1B303', setting a hearing date of June 25. 1974. The hearing was conducted from June 25 through June 28. and again from July 0, through July 11, before Administrative Law Judge Gordon J. Myatt. All partici pants were given the opportunity to pre sent testimony -and to cross-examine other witnesses. Persons participating in the hearing were given until August 23. 1974, to file additional posthcanng com ments, including various items of infor mation which were requested during the examination of witnesses. (5) Economic and technical impact study. During the hearing, OSHA deter mined that additional facts would be needed to determine the practicality of certain aspects of the proposed stand ard. Accordingly. OSHA contacted an in dependent consultant, Foster D. Snell Corporation, to conduct studies of the feasibility of compliance at various ex posure levels, including those proposed by OSHA and others advanced by in dustry spokesmen. Snell was also com missioned to collect information regard ing the economic costs of compliance. Tills action was announced at the close of the hearing, and Judge Myatt further announced that the record would be kept FEDERAL REGISTER, VOl. 39, NO. 194--ER1DAY. OCTOBER 4, 1974 BOR 008403 **.3 " **" > ' , x a , * ,, ` iiib RULES AND REGULATIONS 33S91 Open for a period of time beyond August 2.';, to allow mlcrr-ted persons Vo rein* nent in writing on tlie study. On August ,6. 1974, OS1IA announced that the prej miliary study was available and that comments were to be submitted no Inter tlum September C. 1074 (30 Fit 30B44). On September 13, 1071, OSHA invited comments on both the preliminary mid the linal study, which was to be received on or before September 23, 1074 (39 Fit 330001. (G)` Environmental impact, statements, A notice of intent to file an environmen tal Impact statement assessing the im pact of a proposed standard on occu pational exivosuie to VC was published in the Federal nr.cisTi.it on April 24, 1074 (33 Fit 11522). The notice invited any person having information or data on the environmental impact to submit U to 031 LA by May 17, 1071, On June 12. 1974, a draft environmental impact statement was prepared and circulated to all interested persons. Ten copies were forwarded to the Council of Environ mental Quality (CEQ), which published a notice of its feline and availability in the Federal Register on June 23. 1374 (39 TO 22373). A 45 day period was al lowed for the submission of comments on the draft statement. On September 5. 1074, the final environmental impact statement was prepared and a copy of it and all substantive comments were sent to appropriate governmental ancnc.cs, private organizations, and other inter ested persons. CEQ published a notice of avvv ailability for the final statement on eptember G, 1074 (33 TO 32350). The mbSmclspsteiomnbocrf comment was 25, 1974. Tile invited unfmal state ment and all significant comments have been carefully considered in arriving at the final standard on occupation.J expo sure to VC. (7) The record. The record in this proceeding is one of the most exhaustive ever relied upon by OSHA. It consists of pre and post-hearing comments and 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 COO written com ments have been received, with more than 200 separate oral and wnttcu sub missions made with regard to the two hearings. The record itself exceeds 4.000 pages. Employers, employees, labor unions, public health groups, independ ent experts, physicians, research scien tists, and specialists in many fields have been Invited to submit information and have made their views, knowledge and experience available to OSHA. The en tire record encompassing these subihis- sionx was thoroughly reviewed and evaluated in reaching the determina tions sctfon.ii below. II. Findings regarding carcinogenicity, exposure levels and feasibility--(1) Car m*c.inn ogenicity of vinyl chloride. The enrnogcnicity of vinyl chloride for three lmal species (rat, mouse, hamster) lias been documented on the record by the studies of Maltool and Dio-Test labora tories. Moreover, Mahoni's invest n ations have demonstrated a close-dependent re lationship for induction of tumors (i o., more tumors occur at higher cxposinc levels), including angiosarcoma of the liver, in rats. The mvcatlgauuiir. of In dustrial Bio-Test laboratories have dem onstrated a similar relationship for both r..ts and mice. These investigators have induced angiosarcoma of the liver In rats and mice at exposure concentra tions of 50 ppm, and m hamsters at limb er concentrations of exposure. Additional tumors involving other organs, including the kidneys, lungs, and skin of exposed animals, were also observed in frequen cies much m excess of control animals. The incidence of tumors- in mice in the Industrial Dio-Test Laboratories investi gations is particularly pertinent. Of 200 mice (100 males, 100 females) exposed to 50 ppm of vinyl chldridc by inhalation for eleven montlis. 100 died. Sixty-four ani mals died without gross postmortem pathologic examination being performed. Of the 3G remaining animals for which a gross postmortem pathologic examina tion was performed, 13 (30 percent) were found with liver tumors (including angiosarcomas), 21 (50 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 ..r more animal species may be extrapolated to indicate a carcinogenic hazard to humans. Here, such a rinding was made in tlirec species that were exposed to VC by inhalation-- a route comparable to employee ex posure, In addition, there were at least 13 confirmed cases of angiosarcoma of the liver among employees exposed to VC, a particularly significant number in view of the extreme rarity of this cancer in the U.S. adult male population (testi mony of Dr. Marcus Key, Director of NIOSH, at the rulemaking hearing). The findings of amriosarcowi-T-pf-the liver m Potil CXTJCrmn nfal .mlmals-jun* exposed employees IS cr>pmp1Hng i'lldeuce that exposure o/ ?u;|'pan<^tn-vinvi cUToI kij Iii(llU!i!:!"fiTr'Tumar- industry spokesmen,""at the hearing, conceded that VC is carcinogenic for humans (c.g. testimony of Dr. McBurncy. Rulemaking hearing, 1041). Accordingly, it is con cluded that VC must be regarded as a human carcinogen, and the probable causal agent of angiosarcoma of the 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, as well as non-malignant alterations, such as fi brosis and connective tissue deteriora tion, indicates additional oncogenic and toxicologic properties of vinyl chloride, which must bo considered in establishing control regulations. (Hoe testimony and results of studies by Eio-Tcst Labora tories, Tabersliaw-Cooper, Mallonl. NIOSH, and SclikolT.) (2) Exposure limits. Upon finding that exposure of employees to vinyl chloride iiiiiv create a carcinogenic hazard, the iiiiiiniiil of exposure which Is hazardous must be determined- The Surgeon Gen eral's Ad Hoc Committee referred to above i f.ncluUed that safe cxiiosuve levels for carcinogenic substances cannot bo scientifically determined. This position is supported by the testimony of NIOSH iit the hearing, its recommendations for a standard of no delectable level, and ' y the testimony of expert witnesses from the National Cancer Institute. .Several witnesses and persons who sub mitted comments have taken a contrary view and have suggested that man is less sensitive to biologic aberrations induced by vinyl chloride exposure than experi mental annuals. Proponents of this posi 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 arc those who have considerable employment experience as polymeriza tion reactor cleaners. Because it is gen erally agreed that reactor cleaning in volved lush exposures to vinyl chloride in years past, It is argued that the lower levels currently found in the workplace have not induced cancer and arc there fore safe. We reject this argument. The fact that approximately thren= mi aTffrnr. IfiMu ciWovL^rnlh-^lie longest "''"'VlT t1'"" 20 years sinec-lnit(a) cfposi'rM. i.uvr epe yet bCCIl Inrat.crt. makes. ..it. hnnamhln La dfj.ermnm the actual wimhim.f sgfAif-H employees. The cases of liver tumors 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 dosc-related 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 lnwcrZZifiisas dm inn l bu BE curatel'v assessed until a longer period of. time has nrssr.-i no. a loncer jn^iicLiari p\ncrl.cH nn--irH n-.-,nl,l ilvr. Initiation of exposure to chemical carcinogens and induction of cancer are not necesasrily synchronous events. Be cause of the physiologic complexities in volved with carcinogenesis, induction of tumors docs not occur in all employees with similar exposure histories. For ex ample, Dr. Schneulcrman of the Na tional Cancer Institute emphasized dur ing his testimony that only about a fifth of longer-term heavy smokers develop lung cancer. Accordingly, the industry contention that exixisurc levels lmvo been dramatically reduced since the 1940's is not reliable evidence that cur rent levels of exposure are safe. Some industry spokesmen also sug gested that the apparent nonrandom distribution of observed cancer in em ployees may Indicate an exposure thres hold for tumor Induction, based on varia tions in the workplace design or prac tice and resultant employee exposures FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER A, 1974 BOR 008404 35S92 .RULES AND REGULATIONS (ledlmony and que-.t inning by Tenneeo Chemicals. Inc.). It bar. also been einplvui/cd tb.1t In only 3 of H polvin.il/utmn plants where employee/; h.ive lurii cxixv-ed to VC tor mrc than 2i> years h.'.vc any employees developed angiosar e.G.. testimony of Selikofl. Flrrstonr, NCI, ami NTotill.) In our view, tlie demonstration of can cer uiilurUon In humans at a particular level ir. not a prerequisite to a determina tion that a substance l( presents a ran confident that Industry will continue to do so. ('ll cov'-fiix.'nns. The conclusions be low are bused on a thorough icview and (.'Valuation of all the evidence submitted. When* decisions can be bavd on record coma of the liver. This argument Is very cor hazard for hiirnam at that level. Jt evidence, this Jie-s been (Ione. Where, similar to Ui/U riled concerning v:ri- would he unprud U to assume man to however, factual certainties aie lacking ability Of past rmpinyeo exposure. Al be less r.rnsith c to VC exposme than ex or where the facts alone d*> net provide though geographic nnd workprarliec dif- perimental animals in the absence of an answer, policy judgments have been lercnccs nny nltnnnlely be demonstrated conclusive evidence. It would also he un made. to l>c f.ietorr. In distribution of anaioi-ar- founded to assume that animals will not Tnere Is little dispute that VC Is car conia. sulbelent information Li unavail develop tumors when exposed at concen cinogenic to man ar.d wo io conclude. able to exclude from consideration of trations of VC of less than 50 ppm. However, the precise level of expoxiue risk those employees In workplaces lor Should a sufficiently large number of cx-- which poses a hazard and the question which cases of angiosarcoma have not pcriment.il anunals be exposed to VC at of whether a ".safe" exposure level exists, been observed. concentrations of less than 50 ppm, cannot be definitively answered on the It has also been suggested that the Schncidcrman said that It would be ex record. Uor Is It clear to what extent obscure of cancer in a population of 335 pected that some would develop VC In exposures ran be feasibly reduced. Wc Dow Chemical Company polymerization duced tumors. cannot wait until Indisputable answers employees monitored over a period of 7 (3) Feasibility. There Is virtually no years, indicates that exposure to vinyl dispute that most, if not all. fabricators. chloride at concentrations of less than auT blll'H'lirFT'ldi.'iDl'j urU'llfliilnf.' exT 200 ppm Is safe. tEcc study by Dr. Cook, pOSiiie levels of 1 nnm Uirnueli rmnnrgxj submitted at the hearing by Dow Chem j'lH `ronirois. These employers employ ical Company.) However, the Group sur well over ui percent of all employees cx- veyed did not Include all work on; who - posed to VC. Indeed, several fabricators hod been exposed, and the missing em arc already operating at this level (sec ployees Included many who had the SPI testimony). However. Industry lonttcr term (over 20 years) exposures. spokesmen have universally claimed that Moreover, the statistically Insignificant It is Infeasible for the VC and the PVC size of the sample population decreases Industries to remain below 1 ppm con the possibility that tumors would be sistently. using engineering controls. In observed. addition, the Snell study on technical to these questions arc available, because lives of employees are at rtakc. There fore. we have had to cxcrcirr our best Judgment on the basis of the beat avail able evidence. These Judgments have re quired a balancing process, in which the overriding consideration has been the protection of employees, even those who may have regular exposures to VC throughout their working lives. Based 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 1 ppm ceil ppm tini I'M', t'll'l ill'll V.rr:. "c_iT\YA). v,'c in testimony at the hearing on the pos ing Is not feasible for the VC and PVC fill5 5thieve that l^Vc and VC establish sible metabolic pathways of VC. The Industries with present technology, but ments will, in time, be able to attain that hypoLhcsis presented was that VC may that the VC Industry could currently at level through engineering controls, and exert its carcinogenic effect by a metab tain lower exposure levels than the PVC Ui.it fabricators can do so In the lmolite.'and that the metabolite Is pro industry. Labor union spokesmen nnd the .mediate future. duced, only when VC Is metabolized by a Health Research Group, Inc., however, In addition to the TWA requirement, secondary metabolic pathway operating have suggested that such a level Is at wc have established a 5 ppm celling only when enzymes regulating the pri tainable. (averaged over a 15-minutc period > jn mary pathway arc saturated, as would Since there Is no actual evidence that oiffTi ia nrmvinj.'TiMi11!' ai piers,.-- be the result at higher exposures. The preliminary data indicated the possi bility of an additional pathway for metabolism of VC in rats exposed to con centrations of VC m excess of 220 ppm. However, the occurrence of angio sarcoma In both rats and mice at VC exposure concentrations of 50 ppm in dicates that If a metabolite of VC Is the 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 any of the VC or PVC manufacturers have already attained a 1 ppm level or in fact Instituted all available engineering and work practice controls, any estimate n.s to the lowest feasible level attainable must necessarily involve subjective judg ment, Likewise, the projections of Indus try, labor, and others concerning feasl* bility arc essentially conjectural. Indeed; as Firestone has suggested. It Is not pos sible to accurately predict the degree of improvement to be obtained from en gineering changes until such changes are to Ult.ICce'u.imc high eveursinns. From an operation standpoint, this ceiling level Is realistic because minor excur sions up to the ceiling level are likely to occur on a regular basis. III. The. fnial standard--(1) Scope and application. Both the RTS and the pro posal would apply Ihd s'.andart! io the entire VC industry (erh;fV"i miiviifn----- (uiTi-g nf VP and T>\rn 'I f > " but excluding employers handling or Ush'ii; launcalcd products inat'.r. '.'ma" understanding of the carcinogenicity of VC, it appears that it docs 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 of witnesses representing employers have stressed that there Is no evidence of cancer, cither in employees or experimental animals, at exposure concentrations of VC lc-s than 50 ppm. (See e g.. testimony of Firestone, Tcnncco Chemicals.) The conclusion of these witnesses was that no dcciMon can be made concerning risk or exposure to VC at concentrations less than 50 ppm. On the other hand, the testimony of most expert witnesses. Including some In dustry biomedical experts, stated that actually Implemented. There is no dispute that a standard Is We agree that the PVC nnd VC estab required for the monomer and jwdymer lishments will not be able to attain a 1 industries. However, the Society of Plas ppm TWA level for all job classifications tics Industry (SPI) and various fabrica In the near future. We do believe, how-, tors (sac testimony of Goodyear, Gen ever, that thov will, in time,'be able la eral Cable, etc.) recommended that attain levels orT*pprn rv.'A for miiaLdnti fabricators be excluded from the stand classiT'c/uloils most ot Hie time. It Is an- ard. or that a separate requirement bo parent that reaenmr such levels may re established for them because many of quire some new technology nnd work practices. It may also bo necessary to them were already at or below the pro posed ceiling level. utilize technology presently used In other Industries. In any event, the VC and PVC Industries have already made great The record cvidcnec establishes that at least some employees in tile fabricat ing industry arc exposed In excess of the strides In reducing exposure levels. (Ecc permissible control IhuiU (See NIOSII testimony of Dow Chemical Co., TR D73). testimony, TR 10G; Kobintcch TR GIT. For example, B. F. Goodrich testified In these circumstances, wc believe that It (TR 1120) that It has reduced average Is Imprudent to grant a blanket exemp quantification of a safe exposure con exposure levels in several PVC plants tion for all fabricators. Therefore. the centration Is not possible with the pres from 35-40 ppm early this year to 12-13 final standard Is applicable to the fahrU ent state of scientific knowledge. (See ppm at the time of the hearing. We are rallon industry, as well as the monomer FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 BOR 008405 RULES AND REGULATIONS 35S'J.. and polymer Industries, Employers who. temperature as PVC. for further pro below the action level no further monL- Mid. !IU1 LULMIlllirSTlv txlow the cx- cessing, indicates that a iKHential for re Tnnni!1 !, rrmirei! - f^e n.mir.-gr ^HL-airc limtl will be .subjected to only lease of the residue still exists it an- liar. 11 a..mi tn iiL-.iiect that any r!lllllr`-^e ^Hffintinnl burdens by virtue of I be "action pears that the svsrai ,t isn nf f.ihri, ir-rymci.T in ew,-.' i.r the. nThT/m i.-i-u level" to be discussed below. iTlLUllR IJ. .sll.uulu eg luimcJ tn m .t. ihn,.,. rn*~imii-.'. fiin.ii'r. have been "-y^ m-- Where employers in the fabricating Hems winch will not imdcian.xur.h mmlTTtnSTT nrrr-^ '~fv',rn' M"n ':n-- industry have exposures approaching tbc heating. Further, the op,>orLumly to etc, _ peinii.sj.ible limit, they will appropriately demonstrate that exposures are below ` Where tin' exposure level, without re- be subject to the standard. Employers the action level, and thus, discontinue narfriA rrpil'M'Bf!,. I'.U"'".!, l.lUTfim. - _ handlin': or usir.i: fabricated products many duties of the standard, provides a slbie levi'l,1..' monitoring :i~~l~uc co::r:::(._ m-ie HI 1U. Wl'd'^rilllijUIIJI! Ill TTie more positive control and an adequate tc(Tring5st mnnUr"J-d. KTS or 1 be nrouosal andaTr . "fluilfld relief. <U`c*Tc'.s"tn.in ilic nermi:.able lcvc'.s. but from tJie 11n 11 1 ' "'tSr'i Tins ronclur.ion (2) Permissible exposure limit. Xll greater man tne action lcvul_mon:uirin!n is based on the absence of actuate evi standard sets an exppsure limit of 1 ppm must occur at leastouui icrht. dence of exposure to VC in these opera avcrar.gfl M'gr".MW ii nnHT Tb-Hud anrl a" (0) Mviliotis u! compliance. The stand tions. The final standard clarifies the ex ccTni jl' U! 3 TH!-n av^biE-(i-(>yer-iuiv ucxZ. ard, like the proposal, requires that em emption by defining a fabricated prod ioa not exceeding 15 minutes. ployers immediately institute feasible uct an a product made wholly or partly as more luliy discussed above, this engineering and work practice controls from rvc which does not require further limit is based on an evaluation of the best to reduce exposures to at or below the processing at temperatures, and for available evidence and on a judgment permissible exposure limit. times. suffinent to cause mans melting of that the health and .safely of employees Where feasible engineering and work the PVC. SPI and others (cf. Til. 344 > must be protected to the fullest extent practice controls will reduce exposures requested that PVC resins with less than feasible. In view ofhhc fact that release below the permissible levels, they must 0.1 percent residual monomer be ex of VC in the VC and PVC manufacturing be instituted. Where such controls will empted from the regulation now, and processes are variable, the I ppm ceiling not reduce ryinsures below tile permis- that the exemption level be reduced to level provided in the proposal would sTlilo If'.'Pl, 'Ll it! v ill ilk i ;inni't;^'T2?rTTPTtrr' 0.01 percent in three years. SPI suggested require maintenance of an average level plemcnteci to reduce exp^spres t.n -tii.-. that the exemption of materials with less significantly more difficult to attain lowest Pl'flCIliilble level. n_'"< Pc cnn-ile -- than 0.1 percent of 14 carcinogens from through feasible engineering controls. men led by the use OLiesmr.itors tn urn- 20 Cnt 1310.03p (3D Fll 375G) was an Therefore, the exposure limit prescribed vide the necessary protection. There appropriate precedent. The cases arc not in the proposal has been rejected. untilru I'OMLHllUng program ol enginccr- comparable, because no attempt had been (3) Action level. The final standard, ing and work practice controls must be made to set air concentration limits for unlike the ETS and the proposal, pro instituted to reduce exposures to the low the 14 carcinogens. The record did not vides for an "action Jevci'1 of c.Lnum est practicable level. When exposures are include information that reliable moni T-WA, one-half of Die m'i-miTi.i.i at or below the permissible exposure toring and measuring technique: were PQ^tire limit. The purpose of the action limits, the program may be discontinued. available. Moreover, the exemption did level is to minimize the"impact of_Lha In addition, a plan for achieving con- not exempt airborne traces of carcino- Standard 011 thq i;;;pl-,lnycrv mlin Iiimh trrtrnv cpfniceime mm wo-j.- lnacLice cns. The administrative cutoff was pro attained exposure levels well below the meinour, must bc-drawn up. and be mask 4ved to avoid regulation of materials ptaminwble limit. Tims, wheu. the iu~ available, upon request, to re-nresentpbut wluch there was no health haz- suits of monitoring under paragraphs ativ7To7*OKfIATne! rd information, and which would have (d)(1) or (d)(2) demonstrate that no W recognize that many employers broadly extended the application of the employee is exposed in excess of 0.5 covered by the standard can not cur regulation beyond the record. Herein, ppm TWA, employers may, in effect, be rently achieve compliance with the per no information was presented to show exempted from some provisions of the missible exposure limit solely by the use safe concentration results from the use standard. For example, fabricators who of feasible engineering and work practice of resins with specific levels. Indeed, the are below the action level aw nnt. . controls. The record also reflects broad proposal to change the level later, when qQircd `o provide medical surveillance or generic distinctions between the compli improved technology would permit such eo-nibulLoii imumr-nulcus lilt1 eq^unvar ance capabilities of the VC and PVC reduction, would seem to indicate that has reason to stisneot that any emnlrrTM industries. Some industry spokesmen, SPI has doubts about the safety of 0.1 is exposed in exec"] nf lh" lnrnli- including SPI (TR. 358-3G2), recom percent residue level. Diamond Shamrock In our judgment, exposures below th<^ mended that a schedule of different p?r- (Exhibit 142) testified that there is no action level do not present a sufficienii missile exposure limits and compliance direct relation. They indicate that the 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 ing data from industry (cf. Exhibits 131, 166. 170) and OSIIA (Exhibit 151) indi cate that levels in excess of 1 ppm may be found in fabrication operations. In view of these facts and of the opportunity for employee to discontinue many duties upon a showing of no exposures above the f.ction level, it does not appear that any residue exemption is either justified or necessary at this time. This course also agrees with a number of industry pro posals (cf. Til CCO). SPI (TTt 345), among others, ashed that compounded PVC indicts be ex (4) Monitoring. Thefinalstandarxi, like the proposal, requires luiat individual cnlWBS'fit txpo.j,ur"Jele15T5HWWMMtcl. Tins may be RCTCTiTT'ICTgntr Pf^Tal or area monitoring./Some witnesses and persons who submitted comments did not understand the meaning of the term `'05 percent confidence level" in the proposal. Essentially it means that the employer is required to lake a sufficient number of measurements so that the re sults obtained are statistically valid. We have modified the proposal to establish accuracy range requirements for various measurement levels. These ranges are the time required to feasibly reach in creasingly lower control levels is similar within each industry, but differs mark edly between industries. While the record docs suggest that such differences do exist between industries, as noted above, it is clear that intra-industry differences also exist. Thus, the ability ar.d time re quired by each employer to attain lower control levels may depend upon such factors as the climate m which the plant is located, the age of equipment, the sice of reactors, or the type of resin manu factured or used. (Snell study, I-irestonc testimony, etc.) empted trom the standard on the grounds that the pellets had too low a residue to cause harmful or measurable emissions. ^MVhdc it appears that PVC pellets would ^Hkvc a lower residue level than virgin ^^vC, the fact that the pellets must be heated to a molten mass at the same narrow enough to ensure that a deter mination of compliance can be made, and broad enough to allow the application of a variety of technologies All covered employers arc required to conduct Initial monitoring. Where moni toring and measuring results arc at or Monitoring data also tends to support such inlra-industry variations. (Sec, e.g. Dow. Firestone. Tcnncco.) As noted above, the standard requires all employers to Institute feasible engi neering controls to the fullest extent and to continue to improve and apply engi- FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, J974 BOR 008406 35S91 RULES AND REGULATIONS nccring controls until Tull compliance Is If the environmental level Is not con tratlons. fn discussions of these findings achieved. trolled to the pcrniLv.Jblc exposure limit, with NlO.'fll, lt has indicated that it is We have not rsh-.hh.'ihcd anv deadlines then cmpluvees must lie afforded respira willing to consider on an expedited basis lot lllll CUT'" nee uuoui ii nirii.niint; tory protection. the approval of air-purifying respirator,, cMiflTW LI'C.TTT'T-V.'U MV rwCTIlHV Hh'bTe While' exposures in excess of tho-per- lor Use against VC. Consequent'as to ileUTiiU.'1 v. hen 1^ v :.' he Jl- 3SL miSMiilc level do constitute a hazard, we have inrluded three types of air-p.... * -- PKi~s[~.sinrill.l.hn-.eiil--. In rriluir rsilfrUII believe that it Is necessary to mitigate ini! fluf'ni-.-birs in -LLc-list of .''cecrit.ibaL lcvvfs"i.'o uic pcriim. .Pile level.. some of the problems associated with mlu-^ukiu-i. tn .I.;ir,.'ini'.r.a-.il c w "WFTTTsBTlTTCTrTTnittncreri ti i rcnicn t implementing a program of respiratory nmis he r..axis. The maximum concen that each cmplo;, lt reduce airborne con protection while employees arc ljcinr: tration foi winch each retpirator may centrations to the permissible level, or fitted and trained m rr -pnator use. ami be used is based upon our evaluation to the lowest level feasible ivs toon as while other adjustments which may be/ of the data submitted hy N10SH and practicable will provide for inlei-indus required arc implemented. Then-forp- Goodrich. Because air-purifymg respi- try and intra-industry tcchnolo.'.ieal dif uutil January 1, 1976. where exposure: _rators rln not indicate foment exhaustion ferences which do exist, and will avoid dre ItbMii" cltJ'J1! 01~~Tla ijum_jceilim:.or breakthrough of VC. and because VC the setting of separate industry stand each eiilpiovcr must m-m-idc car.li ciTL has no inherent warning properties ct ards oil the basis of the general situation nlovce wilh -i- for which these devices arc used. and conditions m each industry. However, einploycer, whose exposures do strict administrative controls will be rc- (G) Regulated areas. The proposed nofeilficen-ir JO [)pm ceiling. may decline quired for their use. Such controls in- standard would have required that regu to use tlidTUiirnnu..], in' ffhltlll 5?isc~tnft.'`Tlu<lc a program to assure timely re- lated areas be established, that access be cmniil't'r IS'lltllt dMl'kilca to renuirr its placement of canisLers or cartridges and limited to authorized employees, and use, Dmiuu Ullk'ohjtij.unenc period. cm- an alarm system to alert employees when that daily rosters or summaries of those ploytm-.Tl'i nnrn.'lUJ 111 me haes. nnr-~ vinvl chloride concentrations exceed the entering be kept for at least no years. In poses and limitations of re:,mraLors, and, concentrations allowed for the particu objection to these requirements, it was 11*c hazards ol exposure to vinvl chlm-irlp lar type of respirator in use. asserted that such control of access was Moreover, eacli employee will be notified <8) Hazardous operations. ThLs Is a not necessary lrom a health standpoint. in writing If he has been exposed In ex new section within the final standard. It Secondly, it was claimed that these con cess of the permissible exposure limit. encompasses essentially the proposal's trols would Interfere with operations by Where exposures exceed a 25 ppm ceil - requirements for maintenance and de- preventing access of needed employees or lng; ft1: juratory protection is'nianclalorv . contamination but has restated them in non-employees, such as contractors, in Jn:snt ot our judgment l.lmt mr.rh_ terms of performance language to allow truck drivers, customers and consultants. Greater risks nrr m,cnrjr.iwt cueb--I'rr-.lrr flexibility for employers to deal The purpose of establishing retaliated with such operations. The intent of the areas In the proposal was to limit the The provisions In the final standard new section is to protect employees en risk of exposure to as few employees as regarding the selection and use of respi gaged in activities that present a risk of possible. This concern Is still paramount, ratory protective devices differ from exposure to vinyl chloride r.i excess of the and thus the limit---1 ppr'Ti ['p-Minr -- those in the proposal. The descriptions of permissible levels. An example would be ITiniiTS. Tfig llnal standard amends the atmosphere-sup. lying respirators have the cleaning of a filter where resin con proposal slightly to allow '|auUiaiicd been revised to indicate more clearly the taining high residual monomer is persons" to enter rerulaird areas. This types of devices intended, and the maxi trapped. knange^ it is :e't. will allow operations to mum permissible concentration level for The proposal's requirement for full- PmUnuc without undue- interference. each device. Moreover, the number of body, impervious clothing has been re Tlic final standard has also increased the types of atmosphere-supplying devices placed by the direction to use impervious length of lime daily rosters must he has been increased. garments suited to Uic particular `i~.ua- maintained lron^ZaLisJi years. This At the hearing Mr. Edwin C. Hyatt, an tinn_anri nr.'.bnhlo r\>nr.t~o! ryposurc- change w as base's largely on epidemio OSHA cons__u_lt_a__nt, m__a__d_e s__u_g,g__e_s_t_io_n__s__r_c- Thus, full-body clothing is not always logical considerations. (See KIOSH testi garding the use of particular respiratory necessary", and is therefore not required mony, tr. 119.) devices. We have concluded that his sug wneroTess protection is adequate. Since (7) Respiratory protection. Tire final ^estlons arc meritorious. Therefore-, the vessel entry tails within the achmlfon standard, like the proposal, requires t'ne" jjj-ovisions for selection of atmosphere- of a hazardous operation, the vessel entry JsS-51' H-'muniLUJi.* WiniUmdlhm'ljf tiKIT mpplying devices follow closely the ree- section of the proposal has been deleted sTTTfS CTCt'CCl LHC pu.TriisMhlft7y.nl rnLiamJ-- "wnmendalions contained in his testi-^ from the final standard. Industry' representatives made a number mony of SIT and B. F. Goodrich) (TR\ (9) Emergency situations. The defini of objections to proposed requirements with Hyatt's suggestions. (Sec e.g. testi tion of emergency has been recast in for respiratory protection. They stated mony of PI and B. F. Goodrich) (TR terms of an unexpected massive release. that the "no detectable level" would ef 85 ff) Y/e had originally omitted air- The main nbiecUon to the section on fectively require continuous wearing of purifying respirators because none had emergency situations in the proposal was respirators In PVC and VC plants, and been approved by NIOSII for use against that, as the term was defined, many that this is not feasible because respira VC, principally because they lacked in ordinary leaks or operations resulting in tors are cumbersome, present a safety dicators to signal the expiration of the a small release of vinyl cldondc would be hazard, and employees would not use service life of the sorbent. Hyatt and considered emergencies. This was not them. other witnesses discussed In detail the the Intent of the proposal. The final tVe jy.-ould agree that respirators have desirability of being able to use canisters standard has been clarified to correct many drawbacks; the proposal did not or cartridge air-purifying respirators, this ambiguity. It should be noted that contemplate them as a final solution. The provided a sorbent could be shown to the written operational plan required by record shows that the PVC industry par effectively absorb vinyl chloride with an the standard need not be developed for ticularly may need several years before adequate service life. Recently, OSIIA minor excursions above the pcvnusiible plant environmental levels tan be re has received respiratory data from labo exposure limit, and that such excursions duced so that respirators arc necessary ratories regarding the effectiveness of need not be reported. only occasionally. However, we cannot commercially available canisters and GO) Signs and labels, mho tm-grt. of the_ agree that respiratory protection should cartridges for vinyl chloride. These eval slgns and labels section--:, m ''t1--- not be required simply because it Is In uations were conducted separately by CU1U!iJ'iL'L,S,iU1 111" 1_ ft" . r nvi gr.-, 1- convenient, may require additional per NIOSIf end by the B. F, Goodrich Com aids. No objections have been raised with sonnel, interferes with production, or ^aay require extensive retraining of cm- oyecs and restructuring of work prac tices. We have carefully considered all pany and submitted to OSIIA in posthearing comments. The results indicate that certain presently available canis ters and cartridges effectively absorb respect to informing employees of U'-c fire hazard. However, a number of ob jections were raised at the hearing and in written submissions to the require ment that the word "cancer" nppcnr on the objections, and have concluded that vinyl ehlorldc at relatively low conecn- all signs and labels. The principal argu- FEDERAL REGISTER, VOl, 37, NO. 194--FRIDAY, OCTOBER 4, 1974 BOR 008407 RULES AND REGULATIONS 35895 ment advanced ngalnst Jt.s use was tli.it the term "cancer" or "cancer-Mispcet cent" scares employe,! and that n>tcad. tlic message sliould contain In structions on liow to deal with the sub Indicated that the medical tests proposed are currently the only ones available which are useful for medical surveillance <TR 121, Kxh. Ofi, Tit SkO-anl). Conse quently. the specific, bloorl tests proposed posat Is the requirement for maintenance of monitoring records and daily roster sheets of authorized persons for 30 years, instead of 20 years. Additionally, tlie em ployer is renuired to main turn metiiraT stance <TR. 317). We believe that a lia'vo beMi ITT.VrWM ".V, it TniTIIIJUnTl W-" FrcoFJs'for the duration of an employees diluted form of warning will not suffice. ouil'l'ITTPIlt IA anflst the examining physic Xeimiiuulutti'mmaottLLJJJjhluiS^ HQ-ygars^JU'-jn years, We appreciate the concern of employers CUH in Orfqiiuillll!? illness ot imlent-TaT yhii.hev-T is longer. The original pro with the reaction of their employees. Hut cfTO'dl'k Ui .t.'.ll,llliu'i it posal called for only 20 years. we consider It imperative that a worker involving vc exposun*. In addition, al- Tins change has been implemented be be fully informed, ami that he realize the ternalive medical examinations may bo cause the latency i>cnod for induction of possible risks involved m lus occupation. used where the examining pliysician de angiosarcoma ranges up to 30 years from Coupled with the training requirement termines that they are at least as good initial exposure. Therefore, as a mini in tlie standard, wc believe that the signs as those specified by the standard. mum, medical records must be main and labels required will adequately in Tlie Tabcrshaw-Codpcr study and the tained for -it least Unit long. It should be form employees of the hazard. In addi various animal experiments suggest that noted that spokesmen for both labor and tion, such signs will warn unauthorized VC may produce a wide spectrum of ma industry recommended that this change persoiuicl to keep out of rcr.ulatcd areas. lignant and non-malignant disorders. be made. lire proper application of most protec The general scope of the required medical Tlie reporting requirements arc not tive measures requires an amount of examination inis, tnei eiorc' been UioaclT significantly different from those Jn the training and indoctrination of employees cned to include kuinc vs, slon" connective original proposal. However, Instead of that cannot easily be conveyed on a sign tTCMlP. TTHTiW. find lmlm6fiM~syslrm'~5g: 'the requirement for reporting incidents or label. Also, the variety of measures well ai flic livct^Ho additional specific which result in the release of VC into that could be prescribed would result in procedures or tests are required, but rec areas where employees may he exposed, an unwicldly or excessively detailed leg- ommendations have been included in the the final standard clarifies our original end. Consequently, the required message Appendix to assist the examining physi intent by stating that only emergencies on signs and labels will not include in cian. Because of the nonspecific nature must be reported. Also the requirement formation on precautions, relevant of the required medical tests, it is not for fillnrr a detailed, written report symptoms, etc. The addition of suitable appropriate to prescribe timing, or type within 15 days has been deleted" U has Information by the employer would be of followup tests, or to mandate with been concluded-that submission, within permitted, providing it does not detract drawal from exposure based solely on re 24 hours, of an lniiiaL_rcDort_that. in-, In any way from tbc required statement. sults of tlie tests. Instead, the employer eludes facts Immediately available, would, The requirement in the proposal for is required to obtain a statement lro_ip ordinarily be sufficient. However. If the labeling containers of vinyl chloride has tTie TrOTHHTTljT- niiVBieiilft"of" tlic" cm- OSIIA Area Director requests further in- been amended by deleting the reference nlnveo's .^li'RtuTTtv for ennTnMT^JT'nvpor. formation relevant to the eincrgeney, the to the possible hazard of violent polym sure, wiien the examining ph` ysician h1 as employer will be required to furnish such erization. Very little information was commoted such tests as ho considers7iP- Information. developed on this hazard during the prOPr^l.e ^ln* 'nuilfiMt-.jt r^uil-nfl -ta- (14) Deleted portions o1 the proposal. standard-setting procedure. It docs ap- uhrlmr mi nmrinrr- -n'r --1"*t* ,t*iF The projxosal contained provisions re ear that this hazard is essentially under statement indicates that the employee _ quiring that shower facilities and change ontrol and that the fire and carcino- may be at auacd risk lrom continued VC rooms be provided, and that storage or cnic hazards at present are Utc most Bw.inuna consumption of food be prohibited in significant. Since labeling or placarding As with monitoring, there appears to regulated areas. We have deleted these that is in compliance with the U.S. De be no basis for complete exemption of the provisions because it is our conclusion partment of Transportation regulations fabrication industry from the require they are no longer necessary. Showering <49 CITT Part 173, Subpart H) already ment for medical examination. The rec facilities arc not required because pro warns of the fire hazard, only a state ord docs show fabricating establishments tective clothing, where required by the ment concerning the carcinogenic haz with concentrations of VC monitored final standard, should protect employees ard need be added to the Department of considerably above the action level. In from skin absorption by direct contact Transportation labels. these instances, medical surveillance of with VC and because there is no reliable (11) Medical surveillance. The princi affected employees will provide baseline evidence that VC vapor is absorbed pal questions that have been raised re data for future evaluation of their health, through the skin. In addition, since we garding medical surveillance aye the even if both monitoring and medical surt anticipate that most employees will not necessity and efficacy of requiring cer vcillance are discontinued because im-) be wearing protective clothing and that tain specific scrum enzyme determina proved controls reduce concentrations employees who wear protective clothing tions (SMA-12 series) and the applica below the action level. Where exposures will change such clothing infrequently, tion of medical examination require arc below the action level, me lilcdltM 'wc are not requiring that change rooms ments to tlie fabrication segments of the surveillanceIcquflTflltillKUflTlUF'iTcncral- be provided. industry where employees are exposed to Iy apply. In addition, we feel that there Is in- lower levels of VC. The objection has also TIzj '/raining, A separate provision for adequate evidence showing that hazar been raised that the specification of tests employee training has been added to the dous amounts of VC can be absorbed and procedures interferes with the ap final standard rather than including It through ingestion. For this reason, the plication of advances in medical knowl within the section on emergency situa requirement prohibiting the storage or edge. tions as in tlie proposal. The new para- consumption of food in regulated areas A particular difficulty in considering graph provides for training of employees' has been deleted. medical surveillance is that the most cohccrniTVT'Tni ciMiirrafrerng TO-mT'di' Tlie proposal also contained provisions commonly discussed lesion, angiosar- VC, emergency procedures, the nciv. iol- on maintcntancc and decontamination, coma of the liver, currently cannot be JhifillOTlIlk' illKTan annual ViVlm" gl Ihe"" transportation loading and unloading, diagnosed until the victim is terminal SHr.fiTirn. It also ni'tliVldiV.Tnr trauinii' ni and iKilymcr handling operations. These and. usually, within months of death. employees concerning the purpose for, ^requirements arc not mentioned in the Precursor physiologic alterations, which proper use of, and limitations connccti'cl 'final standard because attention to these might be reversible, have not yet been witli i-csimalni-v nrotertm-i' "Items Is implicit in the requirement that directly associated with the lesion. C.nn- . (13 > Records and reports. Tlie provi each employer reach the pcrinixsable ex scqucntly, there are no specific diagnos sions for recordkeeping contained in the posure limit or attain the lowest feasible tic tests wbich can lie TtTTTrlur-tl which final standard require tlie preparation level. will dctvi-innie.. I'.;*'-' ore, nr.^.h- enreTf and maintenance of essentially the same (15) F.Bcctivc date. In order to ensure thistuinor at iin_ear!v..sl:igfl pf dcvelan. information required by the proposal. that affected employers and employees ment. However, most medical witnesses The major change from the original pro- will be informed of the existence of these FEDtSAl KEGISUR, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 BOR 008408 V 35S% RULES AND REGULATIONS Drovt'tons and that employers affected of the operation or tx-eause of an accl- nirrec gpiivv.en.. nn o,p.ivrUioltv to familiarize ippi^clvcs p*n'l ilirlr cnijjV'vrf*^ tl\c .dentin the operation, which would result In nn employee exposure In exce;s of the FxKtoncc M tho new rrquirnrtrin.s, the permissible expo- tire limit. ClIfCtlYC .iLHfi-aL-lb? to (8) "OEITA Area Director" nienns-tlie { < 1. 1 o). To pro 'Director for the Oeenpatlonal Safety vide continued proii'clloi) for emplovees and Health Administration Area Oflicc until that (1ate. tip* provi:.iit:w currently having jurisdiction over the geographic contained In | ID10 !*:fn "a hereby nrcu in which the employer's establish promulgated. pursuant to section f><b). ment is located. opporlnnll y to observe the monitor, ini: ami measuring required by this paragraph, <c) Regulated arm. (1) A regulated area shall he established where: M) Vinyl r hlorlde or nolwinyl chloride Ls mainifnrf.ur''d, reaeted. repackaged, stored, handled or u-cd; and (li) Vinyl chloride concentrations arc In excess of the permissible exposure C(c) and (del nr t!*c Occupational Safety (9) "Polyvinyl chloride" means poly limit. nnd Health Act, ns nn occupational vinyl chloride homopolymer or copoly (2) Access to regulated areas shall be sufotv and health standard effective mer before such is converted to a fabri limited to authorized per- ons. A daily October 4, 1071, the amendment to cated product. roster shall be made of authorized per 5 I910,r0q set out below will supersede (10) "Vinyl chloride" means vinyl sons who enter. these p'ortsions IIS of January 1, 1975. chloride monomer. (f) Methods of compliance. Employee Accordingly, )ipon consideration of the X (c) Pcnniniblc exposure limit. (1> No exposures to vinyl chl-ride shall be con whole record of this preceding, Tart 1910 employee may be exposed to vinyl chlo trolled to at or below the permissible ex of Title 29. Code of Federal Regulations ride at concentrations (treater than 1 pp:n posure limit provided in paragraph (c) is amended, e.Trctlve Januai-y 1, 1975, by averaged over any 8-hour period, and of this section by engineering, work prac revision of 5 19lO.D3q to read as follows: ' (2) No employee may be exposed to tice. and personal protective controls as 1910.9311 Vinyl chloride. vinyl chloride at concentrations crcatcr follows: than 5 ppm nvcrngtd over any period not (1) Feasible engineering and work (a) Scope mul application. (1) This exceeding 15 minutes. practice controls shall Immediately be section includes requirements for the (3) No employee may be exposed to used to reduce exposures to at or below control of employee exposure to vinyl vinyl chloride by direct contact with the permissible exposure limit. chloride (chloroethenc). Chemical Ab* liquid vinyl chloride. (2) Wherever feasible engineering and straits Service Registry No. 75015. ^/r <d) Monitoring, (l) A program of work practice controls which can be in / (2> This section applies to the manu- initial monitoring and measurement stituted immediately arc not sufficient to lacture. reaction, packaging, repackag ahnll be undertaken In each establish reduce exposures to at or below the per ing, storage, handling or use of vinyl ment to determine If there is any em missible exposure limit, they shall none chloride or polyvinyl chloride, but docs ployee exposed, without regard to the use theless be used to reduce exposures to not apply to the handling or use of fabri of respirators, in excess of the action the lowest practicable level, and shall be cated products made of polyvinyl chlo level. supplemented by respiratory protection ride. (2) Where a determination conducted In accordance with paragraph (g) of this (3) This section applies to the trans under paragraph (d)(1) of this section section. A program shall be established portation of vinyl chloride or polyvinyl shows any employee exposures, without and Implemented to reduce exposures to chloride except to the extent that the regard to the use of respirators, in ex at or below the permissible exposure Department of Transportation may cess of the action level, a program for de limit, or to the greatest extent feasible, :nul.'ftc the hazards covered by this see- termining exposures for each such em- solely by means of engineering and work on. ploycc shall be established. Such a pro practice controls, as soon as feasible. (b) Dermitions. (1) "Action level" gram: <3) Written plans for such a program means a concentration of vinyl chloride (i) Shall be repeated at least monthly shall be developed and furnished upon of 0.5 ppm nverar d over an 8-hour work where any employee is exposed, without request for examination and copying to day. regard to the use of respirators, in ex authorized representatives of the Assis (2) "Assistant Secretary" means the Assistant Secretary of Labor for Occupa tional Safety and Health, V.S. Depart ment of Labor, or his designee. cess of the permissible exposure limit. (U) Shall be repeated not less than quarterly where any employee Is exposed, without regard to the use of respirators. tant Secretary and the Director. Such plans shall be updated at least every six months. (g) Respiratory protection. Where (3) "Authorized person" means nny In excess of the action level. respiratory protection Is required under person specifically authorized 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 to observe moni toring and measuring procedures, (4) "Director" means the Director, National Institute for Occupational Safety and Health. U.S. Department of Health, Education,'and Welfare, or his' designee. (57 "Emergency" means nny occur (lii).May be discontinued for any em ployee only when at least two consecu tive monitoring determinations, made ndt less than 5 working days apart, shoe/ ex posures for that cmplpycc at or below the action level. (3) Whenever there has been a pro duction, process or control change which may result in an Increase in the release of vinyl chloride, or the employer has any other reason to suspect that any em ployee may be exposed In excess of the action level, a determination of employee this section: (1) The employer shall provide a respirator which meets the requirements of this paragraph and shall assure that the employee uses such Tcspirator, except that until December 31.1075. wearing or respirators shall be at the discretion of each employee for exposures not in ex cess of 25 ppm. measured over any 15mlnulo period. Until December 31, 1975, each employee who chooses not to wear an appropriate respirator shall be In formed at least quarterly of the hazards rence such as, but not limited to, equip ment failure, or operation of a relief de vice which Is likely to. or does, result in massive release of vinyl chloride. exposure under paragraph (d)(1) of this section shall be performed. (4) The mctlrod of monitoring and measurement1 'shall have an accuracy of vinyl chloride and the purpose, proper use, and limitations of respiratory devices. (2) Respirators shall be selected from (C) "Fabricated product" means a (with a confidence level of DO percent) of among those Jointly approved by the product made wholly or partly from not less than plus or minus 50 percent Mining Enforcement and Safety Admin polyvinyl chloride, and which does not from 0.25 through 0.5 ppm, plus or minus istration, Department of the Interior, require further processing at tempera 35 percent from over 0.5 ppm through rtnd the Nntlonal Institute for Occupa tures, and for tunes, snifictent to cause 1.0 ppuv, and plus or minus 25 percent tional Safety nnd Health under the pro mass melting of the polyvinyl chloride over 1.0 ppm. (Methods meeting those visions of 30 CFR Part 11. resulting in the release of vinyl chloride. accuracy requirements nrc available In (3) A respiratory protection program (7) "Hazardous operation" means any the "NIOSII Manual of Analytical meeting the requirements of S 1910.131 operation, procedure, or activity whcic a Methods"). shall be established and maintained. release of cither vinyl chloride liquid or (5) Employees or their designated rep (4) Selection of respirators for vinyl gas might be expected as a consequence resentatives shall be afforded reasonable chloride shall be ns follows: FEDERAL REGISTER. VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 BOR 008409 RULES AND REGULATIONS ' C:>R`I7 Atmospheric concentration Of vinyl chloride Uoknown, or above 3.C00 ppm... (II) Hot over 3,000 ppm. (Ill) Not over 100 ppm................. (It) Not over 25 ppm... (t) Not over 10 ppm. Required apparatus Open-circuit, arlf-couUiluod liri'aihlng nppurutur,, prev. uro demand typo, wtlli full fnceplrro. (A) Combination typo O nuppllc-rt Air respirator, j uro demand typo, with full or JmU iuccplucc, And auxiliary Eclf-rontuliud ntr supply; or (D) Typo C. supplied sir rcr.pImUjr enuttmmun flour type, with lull or half facepiece, ami auxiliary self-contained air supply. (A) Combination typo C supplied air respirator do* nrnnd type, with full facepiece, and auxiliary solf-roulnlucd nlr stij>]>1 y; or (B) Open-circuit self-contained DicutliUig apparatus with full fuccplcco, lu demand mode; or (C) Typo C supplied nlr respirator, demand typo, with full facepiece. (A) A powered air-purifying respirator with hood, helmet, full or half fuccpiccc, and a canister which provides q eervlco lira of at least 4 hours for eonconratlons of vinyl chlorldo up to 25 ppm. or > (B) Oas mask, front- or back-mounted canister which provides a service life it at least 4 hours for concentrations of vinyl elilorldo up to 25 ppm. (A) Combination type C supplled-air respirator, de mand type, with half facepiece, and auxiliary self-contained air supply; or (B) Typo C suppllcd-nlr respirator, demand type, with half faceplcco; or (C) Any chemical cartridge respirator with an organic vapor cartridge Which provides a ncrvlco life of at least 1 hour for concentrations of vinyl chloride up to 10 ppm. (5) (i) Entry Into unkown concentra (2) Protective garments shall be pro tions or concentrations greater than vided clean and dry for each use. 36.000 ppm (lower explosive limit) may / (1) Emergency situations. A written be made only for purposes of life rescue; ^ operational plan for emergency situa ^|nd . tions shall be developed mr each facility ^^ft(li) Entry' into concentrations of less storing, handling, or otherwise using ^BFaii 3C.0C:0 ppm, but greater than 3,COO vinyl chloride as a liquid or compressed ppm may be made only for purposes of gas. Appropriate portions of the plan llfo rescue, firefighting, 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: (6) Where air-purifying respirators (1) Employees engaged in hazardous arc used: operations or correcting situations of ex (I) Air-purifying cannistcrs or car isting hazardous releases shall be tridges shall be replaced prior to the equipped as required in paragraph (h) expiration of th.ir service life or the of tills section; end of the shift in which they are first (2) Other employees not so equipped used, whichever occurs first, and shall evacuate the area and not returp (II) A continuous monitoring and until conditions arc controlled by tht alarm system shall be provided where methods required in paragraph (f) of concentrations of vinyl chloride could this scctmn and the emergency is abated. reasonably exceed tbc allowable concen l/t)) Training. Each employee engaged trations for the devices in use. Such sys in vinyl chloride or polyvinyl cliloride tem shall be used to alert employees when operations shall be provided training in vinyl chloride concentrations exceed the a program relating to the hazards of allowable concentrations for the devices, vinyl chloride and precautions for its in use. safe use. (7J Apparatus proscribed for higher (1) The program shall Include: concentrations may be used for any lower <1) The nature of the health hazard concentration. from chronic exposure to vinyl cliloride / (h) Hazardous operations. (1) Em- Including specifically the carcinogenic ^ ployces engaged in hazardous operations, hazard: including entry of vessels to clean poly (ii) The specific nature of operations vinyl chloride residue from vessel walls, which could result m exposure to vinyl shall bo provided and required to wear chloride m excess of the permissible and use; limit and necessary protective steps; (i) Respiratory protection in accord (ii) The purpose for, proper use. and ance with paragraphs (c) and (g) of this section; and (11) Protective garments to prevent Skin contact with liquid vinyl chloride or vlth polyvinyl elilorldo residue from ^vessel walls. The protective garments limitations of respiratory protective devices: <iv) The fire hazard and acute toxic ity of vinyl cliloride, and the necessary protective steps; shall be selected for the operation and (v) The purpose for and a description its possible exposure conditions. of the monitoring program; (vi) The purpose for, and a descrip tion of, the medical suru-illan. e program. tvui I.'tnerrenrv pror' dmvs: (vin) Mprnlic luli.r:i.i.tli'P to aid the cmploy< c in rec'oand ion of conditio::'. wliK li may result in the uIlmo of vinyl chloride: and (ix) A icvlip,v of this standard at the cmplov e's lust trainur' and indoctrina tion program, and iuii,p dly thereat ter. (2) All material:. i'd .:m,7 to the pro gram shall 1: provided upon request lo the Assistant Secretary ami the Director. (k) Medical sitrtieiUnncc. A program of medical surveillance shall be insti tuted for each employee exposed, with out regard to the tu>c of respirators, to vinyl chloride in excess of the action level. The program shall provide each such employee with an opportunity 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, (l) At the time of initial assignment, or upon institution of medical surveil lance; (1) A general physical examination shall be performed, with specific atten tion to detecting enlargement of liver, spleen or kidneys, or dysfum tion in these organs, and for abnormalties In skm, connective tissues and tnc pulmonary system (See Appendix A). (ii) A medical history shall be taken, in'hiding the following topics: (A) Alcohol intake; (B) Bast history of hepatitis: (C) Work history and past exposure to potential hcpatotoxic agents, Includ ing drugs and chemicals; (D) Past history of blood transfu sions: and (E) Past history of hospitalizations. (iil) A serum specimen shall be ob tained and determinations made of: (A). Total bilirubin ; . (B) Alkaline phosphatase: (C) Scrum glutamic oxolacetlc trans aminase (SGOT) ; (D) Scrum glutamic pyruvic transam inase (SGPT); and (E) Gamma glustamyl transpeptidasc. (2) Examinations provided ::i accord ance with this paragi'aph-shall be per formed at least: (1) Every G months for each employee who has been employed in vinyl cldoride or polyvinyl chloride manufacturing for 10 years or longer; and (ii) Annually for all other employees. (3) Each employee exposed to an emergency shall be afforded appropriate medical surveillance. (4) A statement of each employee's suitability for continued exposure to vinyl chloride including use of protec tive equipment and rc.spiratois, shall be obtained from the examining physician promptly after any examination. A copy of the physician's statement shall be pro vided each employee. (5) If any employee's health would be materially Impaired by continued ex posure. such employee shall be with* FEDERAL REGISTER, VOL. 39, NO. 194--FRIDAY, OCTOBER 4. 1974 BOR 008410 3WT>S HULES AND REGULATIONS drawn from possible contort with vinyl chloride. ^ (C) Lnborntoiy niuilyrri. for nil blo^k;.ical r.ivcbnrns initialed in medical IRaniinnUoivi Mmll la- pcrlonnril in htbomtoiics lii'cmcd under 42 CT`J4 J'art 7-1. (7) Jt till' examining pliyxu uni deter mines that alien.alive mcdiral examina tions to tho.v required by pal a:1, nil ill (k)il) of this section will provide nt Jrai.t equal njiuiancc of detecting nicdiraj conditions pei Uncut to the exposure to vinyl ehlnndc, t!ic employer may ncrrpt Midi nlterniitive examinations ns nice tint; the requirements of paragraph (k)(i) of this section, if the employer obtains a statement from the examining physician settin;.' fortli the alternative examinations ami the rationale for .sub stitution. This stalenient shall be nvaiinblc upon request for examination and copying to authorized rcpiescntalives of the Assistant Secretary and the Director. (1) Siuns and labels. tli Knlranee.s to regulated areas shall be posted with leg ible signs bearing the legend: CANcra-SusiTCT AerNT Aiirx Ai'Tno;ti?.Fc PlCAbONHia, ONLY (2) Areas coiuninimi hazardous oper ations or where an emergency currently exists shall be posted with legible signs hearing the legend: CANCt-H-SOKrrCT AGLNT IN Tills AllKA rHOITCtiv* Kqcipmunt Rr.Qumr.n AUTiiomz.cn Flusonnxl Oust (3) Containers of polyvinyl chloride resin waste from reactors or other waste contaminated with vinyl chloride shall ^e legibly labeled: Contaminated ivllh ^^Ptinyl Chloride Cancl'r-Sl'Si'ect Agent (4) Containers of polyvinyl chloride shall be legibly labeled: Poltvintl Chloride (on Trade Name) Contains Vinyl CiiLomnr Vinyl Chloride is a CxNCLU-SusrEirT Agent (5) Containers of vinyl chloride shall be legibly labeled either: <i) Vinyl CiiLonrnE Extremely Fi.ammari.l Gas Under Pressure Cancek-Sostdct Acent or (ii) In accordance with 49 CFR Fart 173. Subpart H, with the additional legends: CANCER-SUSrECT Agent applied near the labor or placard. ($) No statement shall appear on or near any required sign, label or Instruc tion which contradicts or detracts from the cllcrl of. any required warning, information or ntstiai'.lioii. / (m) Nccmm/s. (1) All lecordr, main tained m a'Tordance with this see Hon shall ini hide the mime and social secu rity number of each employee where relevant. (2) Hceords of required monitoring and meaaiinni:, medical records, and niithon/,rd personnel rosters, shall be made and shall he available upon request for examination and copying to authorized representatives ^of the Assistant Secre tary and the Director. (i) Monitoring and measuring records shall: (A) State the date of.such monitor ing and measuring-and the cone.cnuations determined and identify the Instru ments and methods used; <I3) Jnchidc any additional informa tion necessary to determine Individual employee exposures where such expo sures are determined by means other than individual monitoring of employees; and tC) Be maintained lor not less than 30 years. Hi) Autherf'Cd personnel rosters shall bo maintained for not less than 20 years. (iii) Medical records shall be main tained for the duration of the employ ment of each employee plus 20 years, or 30 years, whichever is longer. (3) In the event that the employer ceases to do business and there is no successor to receive and retain Ills rec ords for the prescribed period, these rec ords shall be transmitted by registered mail to the Director, and each employee individually notified in writing of tins transfer. <4) Employees or their designated representatives shall be provided across to examine and copy records of required monitoring and measuring. (5) Former employees shall be pro vided access to examine and copy re quired monitoring and measuring records reflecting their own exposures. (6) Upon written request of any em ployee, a copy of the medical record of that employee shall be furnished to nny physician designated by the employee. (n) Reports. (1) Not later than 1 month after the establishment of a reg ulated area, the following information shall be reported to the OSIIA Area Di rector. Any rhanges to such information shall be reported within 15 days. (t) The address and location of each establishment which has one or more regulated areas; and Mi) The number of employees in each regulated area durum normal operations. Including maintenance. 12) Krm ri:t ui:n and the facts ob tainable at that tune, shall be reported within 24 hours to the OSIIA Area Di rector. Upon li.qui .l of the Area Direc tor, the employer / hall submit additional Information m wilting relevant to the nature and extent of employee exposures and measure, taken to prevent future emergencies of i.iunlar nature. (3) Within 10 woi king days following any monitoimg amt measuring which discloses that any employee has been exposed, without regard to the use of respirators in excess of the permissible exposure limit, cadi such employee shall be notified in writing of the results of the exposure measurement and the steps being taken to reduce the exposure to within the permissible exposure limit. (o) Effective dates. (1) Until Janu ary 1, 1D75, the provisions currently set forth in { 1010.03q of this Fart shall apply. (2) Effective January 1, 1975. the pro visions set forth in 5 1910.92q of tins Part shall apply. AretNoix A--Suitlementary Medical lMOalZATION When required vests under paragraph (k)(l) of this section show Abnormalities, the tests should be repeated as soon as prac ticable, preferably within 3 to 4 weeks. If tests remain Rbno.-iual. consideration should be given lo withdrawal of the employee from contact with vinyl rhiorlrie, while a more Comprehensive cxamim,i.on Is tnude. Additional tests which may be useful: A. For kidney dyifunctlon: urine examina tion for albumin, red blood cells, and ex foliative abnormal cells. B. Pulmonary system: Forced vital capac ity, Forced expiratory volume at 1 second, and chest roentgenogram (posterior-anterior, 14 x 17 Inches). C. Additional scrum tests: Lactic acid de hydrogenase, luetic acid dchydrogcr.cAO Isoenzyme, protein determination, and protein electrophoresis. > D. For a more comprehensive examination Ou repeated abnormal scrum tests: Hepatitis B antigen, aud liver scanning. (gees. C and S, Si Stat. IS.CC. 1539 (2!) C-S.C. G55, G57): Secretary of Labor's Order No. 12-71, 30 Fit 8754) Signed at Washington, D,C., this 1st day of October, 1974. John Stender, Assistant Secretary of Labor. I Fit Doc.74-23170 Filed 10-1-74:3:54 pm] FEDtRAl REGISTER, VOL 39, NO. 194--FRIDAY, OCTOLIR 4, 1974 BOR 008411