Document J3e2kkjmBRjyybR354JE7QpKK

FRIDAY, OCTOBER 4, 1974 WASHINGTON, D.C. Volume 35 h Number 194 PART II >F Occupationcs! Safety And Health Administration a EXPOSURE TO VINYL CHLORIDE Occupational Safety and Health Standards i ! i VVC 000004305 35800 RULES AND REGULATIONS Title 29--Labor CHAPTER XVII--OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DE PARTMENT OF LABOR PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS Standard for Exposure to Vinyl Chloride Pursuant to section-, C(h), G'c>. and 8(c) of the Occupational Safety e.r.-J Health Act of 1970 184 Slat, 1503, 1553. J50D; 29 U.S.C. G65, 657) Secretary of Labor's Order No, 12-73 <30 PR 8754. and 29 CFR Part 1911, 5 1910.03 of Part 1910 of Title 29, Code of Federal Rcrulations is hereby amended in the manner set foith below, In order io provide an Occupational Safely and Health stand ard dealing with the exposure of em ployees to vinyl chloride. 3. Background--(1) Vinyl chloride. Vinyl chloride (chloroethenci, Chemical . Abstracts Service Registry No. 76014, is a synthetic organic chemical made from ethylene or acetylene and chlorine by any of several processes. It ic the pare::: compound of a series of thermoplastic resin polymers and copolymers which arc widely used for containers, wrap:;-::; film, electrical insulation, pipe, conduit, and a variety of other industrial ar.-J consumer products. Vinyl chloride lias 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 three segments: monomer production, polymer production, and fabrication. Production of the nonompr is a 1?.:^^scnle continuous process, involving only a few firms. There arc comparatively few employees In this segment of the indus try, because the processes lend them selves to automation. . Vinyl chloride (VC) 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 on 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 n fin ished product that needs no further chemical handling. The vast majority of employees involved in the VC industry arc employed by fabrication firms. Such firms range in size from those with few employees and sijnjsle equipment to large plants Involving many employees r.r.d considerable capital. Vinyl chloride (VC), a gas at ambient temperature and pressure, is a chlori nated hydrocarbon, which heretofore has been regarded ns having moderate liter toxicity. The Initial standard, contained In Table G-l of 1910.93. established a ceiling value of 500 parts of VC per mil lion parts of air. (2) The emergency temporary sfnnrierd. On January 22. 1971. the Occupa tional Safety and Health Administra tion (OSHA) was informed by the Na tional Institute for Occupational Saiciv and Health tNlOsin that the 13. r. Goodrich Chemical Company had re ported that deaths of several of Us em ployees from a rare liver cancer (angio sarcoma) may have been occupationally related. As a result of this notification and after consultation with NIOSH. and :i joint inspection of the 13. P. Goodrich plant by OSHA, NiOGIl and the Ken tucky Department of Labor, a lact-hndjng hearing was announced on Janu ary- 30. 1974 130 FR 3874> and held on February 15, 1074. Information obtained from this hear ing. particularly the preliminary reports of experiments conducted by Professor CoWare Maltoni ol the Instituto ch Oneolo'-ia, Bologna, Italy, demonstrated that vinyl chloride induced angiosarcoma m rats at levels as low as 250 ppiu. and in ufher species at higher levels. Experi ments performed at lower levels of ex posure were r.ot completed at that tune. Other testimony from medical witnesses and NIOSH. arcl the results of autopsies, Ic-d 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 woe reported among workers who had been exposed to VC in plants operated by Union Carbide Corporation. Firestone Plasties Corpora tion and Goodyear Tire &: Rubber Com- On the basis of all information avail able at that time, and the fact that em ployees were being exposed at levels .'.round the experimentally observed ef fect level of 259 ppm. an emergency i.-rr.porary standard <ET3j was promul gated on April o. 1 y'l-i us) FK l.jii) pursuant to section 61c> of the Act, as 23 CFR 1910.53q. This standard reduced the permissible exposure level from a ceiling of 500 ppm to a 50 ppm ceiling, and established other requirements, including, for example, men;taring 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 v.-ould be considered more fully ir. the light of additional information, especially the results of experiments which were known to be underway at that time. On April 15,1D74. information and data were presented to representatives of OSKA. NIOSH. and the Environmental Protection Aeoncy by the Industrial BioTest Laboratories. Northbrook. Illinois, concerning results of animal exposure studies with VC. These studies were sponsored by the Manufacturing Chem ists Association. Although only pre liminary in nature at that time, these results revealed that 2 out of 203 mice exposed to VC concentrations of 50 ppm for 7 hours a day. five days a week, ler approximately 7 months, had developed angiosarcoma of the liver. i3' The proposed permanent stand ard. Based on the demonstrated evidence of VC's enremo remedy in three animal species \rats. nv.ee and hamsters', and the subctAJitial probability that VC had been the causal agent tn the cases of liver angiosarcoma found in workers both here and abroad, OS1IA proposed to revise 19i0.03q and published a comprehensive proposal (39 Ml 16890! on Mav 10. 1974. to protect emplovces from ha/imds of exposure to VC. The propa a! calhc) fr.r limitation of employee exposure to VC to "no detectable level," as measured by a sampling and analytical method sensitive to 1 ppm, with an accuracy of 3 ppm 50 percent. The proposal &S'-.o called for the establishment of regulated areas and limited access lo such areas 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 protection would liave been required while engineering and work practice controls were being implemented or where exposures exceeded ihe per missible limit even after fra.-;l:le en gineering controls were instituted. In addition, the proposed n.andard Included requirements for medical sur veillance, protective clothing, emergency procedures, training, specific projection during maintenance and decontamina tion operations, transportation loading and unloading operations and record- keeping. (4) Ucarintj on the proposal. The pro posal. as published on May 10. 1374, allowed 20 days fer interested r nines to submit written comments and to request an informal rulemaking hearing, in formal contacts with OSHA stall and early re.-;)0:tr-s irdierd'-d ''-at wh- joct was of great interest and importance to many persons. Because of the limned 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 held a hearing ns soon as possible. Accord ingly, on May 24,1974. a notice cf a hear ing was published <39 FR 18303'. setting a hearing data of June 23. 1574. The hearing was conducted from June 25 through June 22, and again from July 3. through July 11, before Administrative Law Judge Gordon J. Myntt. All partici pants were given ihe 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 postlieanng com ments. including various items of infor mation which acre requested during the examination of witnesses. (5) Economic end technical impact study. During the hearing. OSllA 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. EneU Corporation, to conduct studies or the feasibility of compliance at various ex posure levels, including those proposed by OSHA and others advanced by industi-y spokesmen. Snell was al.-o com missioned to collect information regard ing the economic costs of compliance. This.action was announced at the close of the hearing, and Judge Myatt further announced that the record would be kept FEDERAL REGISTER, VOL 99. NO. 194--FRIDAY, OCTOBER 4. 1974 VVC 000004306 RULES AND REGULATIONS 35S91 open for a period of time beyond August 23, to allow Interested persons lo com ment In writing on the study. On August 20, 1974. OSHA announced that the pre liminary study was available ami that comments were to be submitted tin later than September 6, 1974 <39 )'n. 30844). On September 13. 1974. OSH A invited comments on both the preliminary and thefinal study, which was to lie received on or before September 25, 1974 (39 FR 33009). (C) Envirotnncnla! impact statements. A notice of intent to Tile an environmen tal Impact statement assessing Thu im pact of a proposed standard on occu pational cxjxjsure to VC was published In the Felilkal Rvc-isteh on April 24. 1974 <33 Fit 14522). The notice invited any person having infoiTnr.tion or data on the environmental impact to submit It to OSHA by May 17. 1974. On Jime 12. 1974, a draft environmental impact statement was prepared and circulated to all interested persons. Ten copies were forwarded to hie Council of Environ mental Quality (CLQ), which published a notice of its filing and availability in the Fedfir.il Registlk on June 25, 1974 <S9 FR 22975). A 45 day period was al lowed for the submission of comments on the draft statement. On September 5. 1974, the filial environmental impact statement was prepared and a copy of It and til substantive comments were sent to appropriate governmental agencies, private organizations, and other inter ested persons. CEQ published a notice of uvailabi.'.ity ter the fir.?.! statement in September 6, 1974 <39 FR 32350). The Submission of comment was invited un til September 25, 1S74. The final state ment and all significant- comments have been carefully considered In arriving at the final standard on occupational expo sure to VC. (7) The record. The record in fhis proceeding is one of the most exhaustive ever relied upon by OSHA. It consists of pre and post-heaving 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 ali, over 000 written com ments have, been received, with more than 200 separate oral and written 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, tmd specialists in many fields have been Invited to submit imovniaiion and have made their views, knowledge and experience available to OSHA. The en tire record encompassing these submis sions tras thoroughly reviewed and evaluated in reaching the determina tions set forth below. II. Fj'wdhiys regarding carcinogenicity, exposure let'tfs and feasibility--il> Car- einopenicity of vinyl chloride. The car cinogenicity of vinyl chloride for three animal species (rat, mouse, hamster) has been documented on the record by the studies of Maltonl and Bio-Test Labora tories. Moreover. Maltom's investigations have demonstrated a dosc-di'pciulvnl re lationship lor induction of tumors 'i.e., more tumors occur at. higher exposure levels), including angiosarcoma of the liver, in rats. The investigations of In dustrial Bio-Test Laboratories have dem onstrated ;v similar relationship for both rats and mice. These investigators have induced angiosarcoma of the hver in raLs ami mice at exposure concentra tions of 50 ppm, and in hamsters at high 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 in excess of control animals, Tne incidence of tumors in mice in the Industrial Iiio-Test Laboratories investi gations i:> particularly pertinent. Of 200 nuce e100 males, 100 females) exposed to 50 ppm of vinyl chloride by inhalation for eleven months, 100 died. Sixty-four ani mals died without gross postmortem pathologic examination being performed. Of the 35 remaining animals for which a gross postmortem pathologic examina tion wps performed, 13 (3G percent) were found with liver tumors (including angiosarcomas). 21 <58 percent) with Jung 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 me Evaluation of Low Levels of En vironmental Chemical Carcinogens, the finding of cancer in two or more animal species miv oe extrapolated to indicate a carcinogenic hazard to humans. Here, such a finding was made in three species that were exposed lo VC by inhalation-- a route comparable to employee ex posure. Jn addition, mere 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. r.t the rulemaking hearing). The findings of angiosarcoma of the liver in both experimental animals and exposed employees is compelling evi dence that exposure of humans to vinyl chloride induces tliis tumor. Industry spokesmen, at Die hearing, conceded that VC is carcinogenic for humans le g. testimony of Dr. McBuniey, Rulemaking hearing, 1041). Accordingly, it is con* eluded that VC must be regarded as a human carcinogen, and the probable causal Rgcnt 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, kiemey, 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. (See testimony nmi results of studies by Bio-Test Labora tories. Tuber.shaw-Coopcr. Maitonl, NIOSH. and Sclikoft.) i2> t:.rposurc Uinils. Upon finding that exposure of employees to vinyl chloride may create a carcinogenic hazard, the amount ol exposure which is hazardous must be determined. The Surgeon Gen erals Ad Hue Committee rcicrrud to ubote concluded that side exposut c levels for carcinogenic .substances cannot he scientifically deti'i'miiiCd. This position is supported by the testimony of NIOSH at the hearing, its recommendations for a standard of no detectable level, and by the testimony of expert witnesses from tile 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 exposuie turai experi mental animals. Proponents of this posi tion have argued that if humans were as sensitive as rodents, an "epidemic1' of cancer resulting from VC exposures should have already been discovered among employees. They also avc.uc that the employees in whom tumors have been observed are those who have ron = ic c-rnble employment experience as ;>olymcnzation reactor deanc.s. Becauac it is gen erally agreed that reactor cleaning in volved high exposures to vinyl chloride in years past, n is arem-d that the lower levels currently found in the workplace have not induced cancer auci are there fore safe We reject this argument. The fact that approximately threequarters of those employers witn ike longest exposure to VC fiux-auT than 20 years since initial exposure) hove not yet be-, n located, makes it impo: able to H.eKjrm.pA *Po '.H"*' -ir-'U-- r employees. The cases of liver minor:. ob served to date have an average latency period, since initial exposure, of approxi mately 20 years. If it Li 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 sucli tumors would be observed earlier for this em ployee population. For tins reason, the significance of presumed lower doses cannot to accurately assessed until a longer period of time has passed, as a longer induction period would be expected. Initiation of exposure to chemical carcinogens and induction of cancer are not nceesasrily synchronous events. Be cause of Die physiologic complexities in volved with carcinogenesis, induction of tumors does not occur ui oil employees with similar exposure histories. For ex ample. Dr. Schneidenunn of the Na tional Cancer Institute emphasized dur ing his testimony that only about a fifth of longer-term heavy smokers develop hunt cancer. Accordingly, the industry contention that exposure levels have boon dramatically reduced since tne 1940`s is not reliable evidence that cur rent levels of exposuie arc sale. Some industry spokesmen nl;o sug gested that the apparent nonrandom distribution of observed earner 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 4, 1974 VVC 00000*307 35892 RULES AND REGULATIONS (testimony and questioning by Tenneeo Chemicals, Inc.). It has also been em phasized that in only 3 of ft polymeriza tion plants where employees have been exposed In VC for more than 20 years have any employees developed anr.ior.ar- conia of the liver. Thin an'iimoul m very fil^nilar to that raised eonrermnr; varinbility of past employee exposure. Al though geographic and ucikpi-uclicc dilfcrenccs may ultimately be ck monstralcd to be /actors in distribution oi ungiosur- corna. suhieient information is unavail able lo exclude from consideration of risk those employees In workplaces for Which cases oi angiosarcoma have not been observed. It lias also been suggested that the absence of cancer in a population of 335 Dow Chemical Company polymerization employees monitored over a period of 7 years, indicates that cynosure to vinyl chloride at conccntrat-.on., of leas than 200 ppm is sale. iSee study by Dr. Cook, SUbmilied at the hearing by Dow Chem ical Company.) However, the group sur veyed did r.ot include all v.orl.ois who had been exposed, and me missing em ployees included many who had the longer term (over 20 ycaist exposures. Moreover, the statistically insignificant size of the .sample population decreases the possibility that turners would be observed. Dow also presented preliminary data In testimony at the hearing on the pos sible metabolic pathways of VC. The hypothesis presented wax ihat VC may exui i its i.elli.,! b- ?. metab olite, and that tlie metabolite is pro duced only when VC is metabolized by a secondary metabolic pathway operating only when enzymes regulating the pri mal y pathway are salinated, as would 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 in excess of 220 ppm. However, the occurrence of angio sarcoma in both rats and mice at VC exposure concentrations of 60 ppm in dicates that if a mclaboliic cl 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 Lo the thorough understanding oi the carcinogenicity of VC, it appeam that it decs not yet oiler 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 cnflcer, either in employees or experimental animal.-., at exposure concentrations of VC less than 50 ppm. (Sec c.g., testimony of Firestone, Tenneco Chemicals.) The conclusion of these witnesses was that no decision can be made concerning risk oi exposure to VC At concentrations less than 53 ppm. On the other hand, the testimony of most expert witnesses, including some in dustry biomedical expert.:, stated that quantification of a safe exposure con centration is not possible with the pres ent state of scientific knowledge. (See e.g., testimony of Selikoff, Firestone, NCI, and NlOyil.) Jn our view, the demonstration of can cer induction iti hun;stn:> at a particular level is r.ot a pi erequi..ilc lo a determina tion that a .substance represents a can cer hazard lor humans at that level. H would be imprudent to assume man lo be Is v.; spiisltlve lo VC expos ure than ex perimental animal:; in the absence of ror,elusive evidence. It would also be un founded to assume that animals will not develop tumors when exposed at concen trations of VC of less than 60 ppm. Should a sulflcicntly lame number m ex perimental animals be exposed to VC at concentrations of less than 60 ppm, Schn-nderman said that it would lie ex pected thil sonic would develop VC in duced tumors. (Hi Fcauhililv. There is virtually no dispute that most, if not nil. fabricators me (.urn.htly capable of reaching ex posure levels of l ppm through engineer ing controls. Thosy err.uloyers employ well oicr 53 percent of all employees ex posed to VC. i.navcd. several fabricators fire already operating at this level (see P1 testimony). However, industry spokesmen have universally claimed that it is infeasible for the VC and the PVC industries to remain LiIjw I ppm con sistently, using cneinocring controls. In addition, the Snell study on technical feasibility concluded th't a 1 ppm ceil ing is not feasible for The VC and PVC Industries with present technology, but that the VC industry con:,; runenriy at tain ij'-.l tX'i-c..ul'C :Cii.h fl.U.'i rvc industry. Labor union spokesmen and the Health Research Group. Inc., however, hove suggested that such a level is at tainable. Since there Is no actual evidence that any of the VC or PVC manufacturers have already attained a 1 mm level or in fact instituted all available engineering and worx practice controls, any estimate ns Lo the lowest feasible level attainable must necessarily involve sub'ective judg ment. I ikewisc. tlie projections of indus try, labor, and others concerning fensi- blli'v are essentially conjectural. Indeed, as Fircrtone has suggested., it is not pos sible to accurately predict the degree of improvement to be obtained from en gineer:!)? changes until such changes are actually implemented. We agree that the PVC and VC estab lishments will not be able to attain a 1 ppm TWA level for all job classifications in the near future. We do believe, how ever. that they will, in time, be able to obtain levels of 1 ppm TWA for most job classifications most of the time. It is ap parent tiiat reaching such levels may re quire some new technologv and work practices. It may also be necessary to in ihre technology presently used in other industries. In any event, i he VC and PVC ioiduMnos have already made great strid.'s in reducing exposure levels. (See test imony of Dow Chemical Co.. TR 073 >. l or example. 15. F. Goodrich teal ificd ITR 1120) that it has reduced average exposure levels in several PVC plants from 35--10 ppm early tills year to 12-13 ppm at the time of the hearing. We arc confident, that Industry will continue to (lo so. <4J Conclusions, 'The conclusions be low arc based on a thorough review and evaluation of all Die evidence MibnuUtcl. Where decisions can l.e bared on record evidence, litis ii;n been done. Where, however, factual certainties me lackin': or micro the lads alone do r.ot. provide an answer, policy judgments have been made. There is little dispute that VC Is car- cinogenic to man and we so conclude. However, the proiisn level of expo: c.re winch poses a hazaicl and the question of whether a "sale'' exposure level exists, cannot be definitively answered on the record. Nor is u clear to what extent exposures can be feasibly reduced. We cannot watt until indisputable answers to these questions arc available, bceati e lives of employees are at make. Thercfo;e, we have had to exercise our best judgment on the basis ef Lite bv.-s avail able evidence. These judgments have re quired a balancing process, in winch the overriding consirieiatr'n has been the protection of employees, even those who may have rcsukir expesurts to VC throughout their working lives. Based cn the available evidence and In view of the above considerations, includ ing feasibility, we believe that employee exposures to VC imr '. be reduced to a I ppm tinrc-wcmitid avcr.:;tC .TV.'A'. We also believe that PVC and VC c-1 sblivhm?nls will, in nine, be able lo attain that level thretr:!'. engineering control:, and that fak:l;-.`.ors c..h do ir. the Tt mediate future. In addition to the TWA requirement, we have established a 5 ppm ceding taveraned over a Ic-mrune pericci in order to prevent exposure of emploveos lo unacceptable high excursions. From an operation standpoint, this ceiling level is realistic because miner excur sions up to the ceiling level are likely to occur on a regular basis. III. The final standard -- tl) Scope a;itl uppricaliou. Both the LT5 paid the pro posal would apply tire standard to the entire VC industry. Including manufac turers of VC and PVC and fabricator?, but excluding employers lv'.na'ing cr using fabricated products made from VC. Titers is no dispute that a standard is required for the monomer and polymer industries. However, tin: Seciety of Plas tics Industry (SPI> and various fabrica tors (sec testimony of Goodyear, Gen eral Cable, cic.) recommended th.it fabricators be cxchidrd from the stand ard. or that a rcp.'.v.uc requirement he c-labiishcd for them because many cf them were already at or below the pro posed ceiling level. The record evidence establishes tiiat at least some employees in the lubricat ing industry are cxp.i.cd in excess of Urpermissible reiilm! limit.: Seu NIOAII testimony. Tit tag; RobmtOi h Tit iil2>. In those circumstances, we behove that it is Imprudent to grant a blanket exemp tion for all fubriis.Unrs. Therefore, the final standard Is applicable to the fabri cation Industry, r.s well na the monomer FEDERAL REGISTER, VOL 99, NO. 19-1---- FRIDAY, OCTOBER 4, 1974 VVC 00000430B RULES AND REGULATIONS 338`i:j and polymer industries. Employers who, in fact, arc substantially below the ex posure limit will lie subjected to only minimal burdens by virtue of the "action level" to be cii.scUw.-cd below. Where employers in the fabricating Industry have exposures approaching the permissible limit, they will appropriately bs subject to tiic standard. Employers handling or using fabricated products made of PVC were not included m the E7TS. or the proposal and arc excluded from the final standard. This conclusion is based on the absence of adequate evidencc of exposure to VC in these opei-nlions. The final standard clarifies the ex emption by defining a fabricated prod uct as a product made wholly or partly from FVC which docs not require further processing at temperatures, and for times, sullicicnt to cause mass melting of the PVC. Sri and others tcf. TTl. 3441 requested that PVC rosins with loss than 0.1 percent residual monomer be ex empted from the regulation now. and that tire exemption level be reduced to 0.01 percent in three years. SPI suggested that the exemption of materials with less than 0.1 percent of H carcinogens from 29 CFR 1B10.93P (39 FR 37D6> was an appropriate precedent. The eases arc not comparable, because no attempt had been made to set r.ir 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 u'ot exempt airborne Uv.vtu of oarcinoeens. The administrative cutoff was pro vided to avoid regulation of materials about which there was-no health haz ard information, and which would have broadly extended the application of the regulation beyond the record. Herein, no information was presented to show 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 reduction, would seem to indicate tiiat SFI has doubts about the safely of 0.1 percent residue level. Diamond Shamrock (Exhibit 1431 testified that there i.s no direct relation. They indicate that the airborne concentration is more related to the physical form of the resin and the ventilation provided. Also, monitor ing data from industry tcf. Exhibits 131. 1D8. 170) and OSHA (Exhibit 15D 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 employers to discontinue many duties upon ft showing of no exposures above the action level, it docs 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 CGD>. SPI (TR 3-15). among others, asked that compounded PVC pellets be ex empted from the .standard on the grounds that tiic pellets had too low a residue to cause harmful or measurable emissions. While it appears that PVC pellets would have ft lower residue level than virgin PVC, the fact that the Pellets must be heated to a molten mass at the some temperature as PVC. for further pro cessing. indicates that a potential for re lease of the residue still cxi'f It ap pears that the exemption of fabricated products should be limited to just those items which will not undergo such turuis healing. Further, the opixmlimlty to demonstrate that exponents aie below the action level, and thus, discontinue many duties of the standard, provides a more positive control and an adequate relief. (2) Permissible. exposure limit. The standard sots an exposure limit of 1 ppm averaged over any 8 hour period, and a ceiling of 5 pum averaged over any per iod not exceeding 15 minutes. As more fully discussed above, this limit is based on an evaluation of the best available evidence and on a judgment that the health and safety of employees must be procccled to Ihc fuih." i extent feasible. In view of the fact that release of VC in the VC and PVC nnnnfacturinrr processes arc variable, the 1 ppm ceiling level provided in the proposal would require maintenance of an average level sienincanlly more difficult to attain through feasible engineering controls. Therefore, the exposure limit pi escribed in the proposal has been rejccu ri. (3) Action lei:cl. The final standard, unlike the ETS and the proposal, pro vides for an "action level" of O.j ppm TWA, one-half of the permissible ex posure limit. The purpose of the action level is to minimize the impact of the r,apc!a'-J cm the employers "bo attained exposure levels well below the permissible limit. Thus, whore the re sults of monitoring under paragraphs (cli (1 > or <d> (2) demonstrate that no employee is exjxjsecl in excess of 0.5 ppm TWA, employers may, m effect, ho exempted from some provisions cf the standard. For example, fabricators who are below the action level arc not re quired *o provide medical surveillance or to monitor again, unless the employer bait reason to suspect that any employee is exposed in excess of the action level. In our judgment, exposures below the action level do not present a sufficient hazard to warrant, application of the en tire standard to the many employers who are or will be below that level. (4) Monitoring. The final standard, like the proposal, requires that individual employee exposure levels be doicrmmed. This may be accomplished by personal or area monitoring. Some witnesses and persons who submitted comments did not understand the meaning of the term "95 percent confidence level" in the proposal. Essentially it mean? tiiat the employer is required to take a sullicient 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 narrow enou *h to ensure that a deter mination of compliance can be made, and broad enough to allow the application of u variety of technologies All covered employers me required to conduct Initial monitoring. Where moni toring and measuring results are at or below the fiction level, no further moni toring Is required unless the employer has reason to suspect tiiat any employee Is exposed in exress of the action level, or unless changes have been made in production, process, control, type of resin, etc, Whrrc Die exposure level, without re gard to respirators, exceeds the permis sible levels, monitoring must be conduc ted at least monthly. When* exposures arc less than the permissible Irveis, but greater than the action level, monitoring must occur at least quarterly. (5) Methods of compliance. 'Die stand ard. like the proposal, requires that em ployers immediately institute feasible engineering and work practice controls to reduce exposures to at or below the permissible exposure limit. Where feasible engineering and work practice controls will reduce exposures below the permissible levels, they must be instituted. Where such control! will not reduce exposures below the pennis- Eible level, they must nenr.k: h"? be im plemented to reduce exposures to the lowest practicable level, and be supple mented by the use of respirators ;o pro vide the necessary protection. There upon. a continuing program of cr.ameciing and work practice controls must be Inst it nted to reduce exposures to the low est practicable level. When exposures are at or below the permi-.-.ib'c exposure limits, the program may be ci..-continued. In addition, a plan for acivcuig ccn- f*<0 r" 'V methods must be drawn up tn.cl be made* available, upon request, p- represent atives of OSHA and NIOSII. We recognize that many employers covered by the standard can not cur rently achieve compliance with the permlssible exposure limit solely by the use of feasible engineering and work practice controls. The record also reflects broad generic distinctions between the compli ance capabilities of the VC and FVC industries. Some industry spokesmen, including SPI (Til. 353-302), recom mended that a schedule of different per- inixsile exposure limits and compliance dates be established for the VC and FVC segments of the industry. This view assumes that the ability and the time required to feasibly reach in creasingly lower control Jowls is similar within each industry, but differs mark edly between industries. While the record docs suggest that such duTvrenres do exist between industries, as noted above, it is clear that intra-industry diOcrences also exist. Thus, the ability and time re quired by each employer io attain lower control levels may depend upun such factors ns the climate in which the plant is loralcd. the age of couiimirnl. the size of reactors, or the t-vpe of rcxm mann- lacturecl or used. (Snell study. Firestone testimony, etc ' Mmiiloriiig data also tends to support such inlra-indur.try vanal tons. 'Sec, o r. Dow. Firestone, Tenmvo.i As noted above, the stantiard requires all employers to institute U.i.uule engincenni: controls to the iulic.- i extent and to continue to Improve and apply engi- FEDERAL REGISTER, VOL. 39, NO. 19-4--FRIDAY, OCTOBER 4, 1974 We 000043Q9 35891 RULES AND REGULATIONS necrine controls until full corr.ruiiir.cc !s if the cr.vi: mit rnl,-! level is not con trations. In discussions of these find::.ns achieved. tra,.''! to | '.:..iv mlc cxixir.un Ijinii, witli NJO.SJI. it has indicated that it is We have not established arr, .t.\.r'.r 1 mu h i ,, i - iillord d n pna- willing to consider on an expedited bu: is for full compliance throuyn tr.: met: ..-v icc y plot'.-' -..-ju. the approval of alr-purifyins respirators controls because we arc pre-enUy un.ioiq While exposures in exrccs of the per for ire w.nnst VC. Consequently, to determine when it will be loasiUe lor missible level do ear.sUtuic a hazard, we have in d three types of .ur-pu . most eslabHshimntr. to rechi',o exposure believe that it is necessary trj militate ing respirators in the hvl of accept.ib!'- levfcls to the. permissible level. ;.onic of the problems associated with units, subject to the approval of suvu Wc Klso believe that the requirement implementing a program of respiratory units by MiOSIT. The maximum cniiccu- that each employer reriuce airborne con protection while employees are being tiation for which each respirator may centrations to the permijMbie Jcvr.l. or fitted and trained in respirator use, and be used is based npan our evaluation to the lowest level feasible as seen as while other sdiusiments which may be of the dnla submitted by NIOSIf and practicable will prenide for inter-indus required are implemented. Therefore, Goodrich. Because air-purif;- ing ivspi- try and iutra-indu-ti y tcchnolcr.ical c..f- until January i, 1976, where exposures ral.ors do not indicate sorbent exhair `.a n fcrcncts which do dm.-1., and -fi: r.v'.iri are not in cxr.tss of a 25 ppm ceiling- or brcn'i'.hiou'ili of VC, and b'c' U'e VC the selling of separate inmi-try stand each empioyer must provide each em has no inherent warning prny! tic; a' ards on the basis of the ccncral situation ployee wuh ?n appropriate respirator. levels for which these device' arc used, and conditions in each industry, However, employees whose exposures do strict administrative controls v XI be re (6) Regulated areas. The proposed not exceed a 25 j.ptn ceiling, may decline quired for their use. Such rciitm!:-; in standard would have requited that regu to use the rerpiratcr, in which case the clude a program to assure timely re lated areas be established, i:t.it accois re employer r.'.t cbhyated to require its placement of canisters or cart: idqes and limited to authorized employees, and U:C. During tkti= odju-ument period, em an alum system la alert rir.plo; i\?s when that daily rosters or sunnnaric.-, cf these ployees wiil be trained in the uses, pur vinyl chloride concentrations exceed the entering be kept for at least fid years. In poses and limitations of respirators, and concentrations allowed for the paitir'j- objection to these rcquii'env.'r.'.?. :t was tire baz'itq : cf e:.;-,oiure to vmvl chloride. lar type ef rerpirator in use. asserted that such control of e-i - Moieov*r. sack employee will bs notified <8) liir.iirdour, operations. Tins i a not necessary from a healt.i .-.:.:td;:o.:'.t. m writing ;; he has been exposed in ex new secuen within the final standard. It Secondly, it was claimed that these con ecs? of ti.e pcrrm'sihle exposure limit. encompasses cr.ser.tir.lly the pre-;:a-ar-.i trols would interfere with opeiv.'.ioiis by Where exposures exceed a 25 ppm ceil requi'.eir.erts for maintenance ard preventing access of nc-cded cnmicve-v- or ing, respiratory protection is mandatory ctintair.ina'jon but has rertated '.hem in non-employees, such ccr.uv.cicr', in light of our judgment that much terms c; cerfermance langu.i'e to aliiw truck drivers, customers and ccmsuharrii. greater r::l:s are associated with such greater ficvbili'.y for emnlovars to deal The purpose of establishing rc-rulr-ied exposures. With such opevauons. The intent of the areas In the proposal was to limit the The provisions in the final standard new section is to protect cmplc.- ees en- risk of exposure to as few employees as possible. This concern is still p.arr.mour.t. and thus the limited access feature re regarding the selection and use of respi ratory protective devices differ from those in the prcpo-al. The descriptions of f.ageci in activities that present a risk cf exposure to vinyl chloride in excess cf tlw permissible level:. An example would be mains. The final standard amends the atmosphere-supplying respirators have the cleaning, of a filter where resin con proposal slightly to allow ''auUvorizcd been revUrd to indicate more clearly in'' taining high residual monomer is persons" to enter regulated areas. This tynf.i- r>f md the ronv'- tfanned. change, U is fell, will allow operation? to mum permissible concentration level for The p.jposal's recvv.romer.t for continue without undue ir.to: fere each de\:r.'. Moreover, the number of body, impervious clothing lias been re The final standard has r.i-o ir.ctemid the length of time daily rosters must be maintained from 20 to go years. This types of atmosphere-supplying devices has been increased. At tiie hzr.rmq Mr. Edwin C. Hyatt, an placed by the direction to i:*e imjicrv.cc? parmentx suited to the parlicti.ar situa tion and probable extent, of exposing change was based largely on epidemic- OSHA consultant. made suggestions re Thus, fu!i-b-_tiy clothing is not always logical considerations. (See NIOSH testi garding the u;:0 of particular respiratory necessara. and is therefore net required mony. tr, 119.) devices. Wo have concluded that his sug where le;? protection is adequate. Sun-e (7) Respiratory protection. The final gestions are meritorious. Therefore, the vessel entry falls within the thh'.i'uon standard, like the proposal, requires the provisions for selection of atmosphere- of a hazardous operation, the Vis'd entry use of respirators where employee expo supplying devices follow closely the rec section of the proposal lias bc.n drieicd sures exceed the permissible control level. ommendations contained in his testi from th.e final standard. Industry representatives mad.' a number mony of SPI and B. F. Goodrich* (TR (91 C'a. rccncv situations. Tiie defini of objections to proposed icqur.emer.u wiMi Hyatts jug'-cstiens. (See eg. terii* tion of emergency lias been recast in tor respiratory protection. They ; mted mony of SPI and B. K Goodrich' <TR terms of an unexpected in a .-'.'c ivleaw that the "no detectable level" would ef b !f' Wc had originally omtttcrl air- The jiutu objection to the section on fectively require continuous wearing of respirators in rvc and VC plants, and that this is not feasible because respira purifying respirators because none had been approved by NIOSH for use against VC, principally because they larked in emergency situations in tiie m'ono.-al was that, as the term wn ciofi'te.l. many ordinary leaks or operations losultlng in tors are cumbersome, present a safety dicators to signal the expiration of the a small release of vlnvl chicniue would be hazard, and employees would not use service life of the sorbent. Hyatt and considered emergencies. This w.is not them. other witnc'sc' discussed in detail the the intent of th.e proposal. The final We would agree that respirator* have desirability of being able to use canisters standard bias been Clarified to e.-rreci many drawbacks; the propose.] da! net contemplate them os a final solution. Tin* record shows that tire PVC nums'iy par ticularly may need several years before or cartridge air-purifying respirators, provided p. sorbent could be shown to effectively absorb vinyl chloride v.i(!i an adequate service life. Reeem.lv. OSHA this ambiguity. It should be noted that the written operational pl.ui required ay the standard nerd net be developed for minor excursions above the pernii'-iblc plant environmental levels can be re has received respiratory data from labo exposure luuit. and that such excursions duced so that respirators arc necessary ratories retarding the effectiveness of need not be reported. only occnssionatl.v. However, wc cannot commercially available canisters and (101 Signs artel labels. The thrust of tiie agree that respiratory protection should cartridges for vmvl chloride. These eval signs and labels section is to appi. e not be required eimply because it ;s in convenient. may require add:;:e! .,l per sonnel. interferes with production, or may require extensive retraining of em uations were conducted separately by NIOSH r.rd tp the C. F. Goodrich Com pany and submitted to OSIIA m posthearing comments. The results indicate employees of the cancer and lire haz ards. No objections have beeu.vaircd v. ah rccprrt to Inlorming employers n the fire hazard, ili.v.cver, a r.um'er of objecUor.s were raised at (ho he.unv. ar.d ployees and restructuring of work prac that certain presently available canis in written attbrntsuons to the require tices. Wc have carefully considered all ters and cartridges effectively absorb ment tint the word cancer" appear on the objections, and have concluded that vinyl chloride at relatively low concen all signs imd labels. The principal nrgu- FlDiRAl IEGISIE8, VOL 39. NO. 194--.FRIDAY, OCTOBfl 4. t974 yVC 000004310 RULES AND REGULATIONS 35895 mcnt advanced against its urc was that the term '`cancer'' or "cancer-suspect agent" scares employees and that in stead. the inissunu .should contain in structions on how to deal with (lie .sub stance (Tit. 347). Wc believe that a diluted form of warnin': will not Milfice. We appreciate the concern of employers with the reaction of their employees. But we consider it imperative that a worker be fully informed, and that he realize the possible risks involved jn his occupation. Coupled with the training icciuircincnt in the standard, we believe Dial the sign;; and labels required will adequately in form employees of the hazard. In addi tion, such signs will warn unauihorizcd personnel to keep out of regulated areas. Tile proper application of most protec tive measures requires an amount of training and indoctrination of employees that cannot easily be conveyed on a sign or label. Also, the variety of measures that could be prescribed would result in an umvieldly or excessively detailed leg end. Consequently, the required message on signs and labels will not include in formation on precautions, relevant symptoms, etc. The addition of suitable information by the employer would be permitted, providing it does not detract in any way from the required statement. The requirement in the proposal for labeling containers of vinyl chloride has been amended by deleting the reference to the possible hazard of violent polym erization. Very little information was developed on this hazard during the btfiiiuaj u-settn.}> j<,ocuv.uio. 1 v'11-- pear that this hazard is essentially under control and that the fire ar.d carcino 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 CFR Part 173, Subpart H) already warns of the fire hazard, only a state ment concerning the carcinogenic haz ard need be added to the Department of Transportation labels. (II) Medical surveillance. The princi pal questions that have been raised re garding medical surveillance are the necessity and efficacy of requiring cer tain specific serum enzyme determina tions (SMA-12 series) and the applica tion of medical examination require ments to the fabrication segments of the industry where employees are exposed to lower levels of VC. The objection has also been raised that the specification of tests and procedures interferes with the ap plication of advances in medical knowl edge. A particular difficulty in considering medical surveillance is that the most commonly discussed lesion, angiosar coma of the liver, currently cannot be diagnosed until the victim is terminal and, usually, within months of death. Precursor physiologic alterations, which might be reversible, have not yet been directly associated with the lesion. Con sequently, there arc no specific diagnos tic tests which can be prescribed which will determine presence or absence of this tumor at an early stage of develop ment. However, most medical witnesses Indicated that the medical tests proposed are currently the only ones available which are useful for medical surveillance I'm 121. Exh. ?I5. TR 5i;9-5ni). Conse quently, the specific, blood tests promised have been retained as a minimum re quirement to assist the examining physi cian in determining fitnnss of potential employees for assignment to workplaces involving VC exposure. In addition, al ternative medical examinations mav be used where the examining physician de termines that they arc at least as good as those specified by the standard. The Tabcrshiuv-Coopcr study and the various animal experiments suggest that VC may produce a wuce spectrum ul ma lignant and non-mahgnant disorders. Tile general scope of tnc required medical examination has. ihereiove, been broad ened to include kidneys, skm. connective tissue, spleen, and pulmonary system, as well a-s the liver. No additional specific procedures or tests are required, but rec ommendations have been included in the Appendix to assist tiia examining physi cian. Because of the nonspecific nature of the required medical tests, it is not appropriate to prescribe thrum:, or type of followup test.-, or to mandate with drawal from exposure based solely on re sults of the tests. Instead, the employer is required to obtain a statement tram the examining physician of the em ployee's suitability for continued expo sure. when Hie examining physician has completed such tests as he considers ap propriate. Tne employer is required to WLitidraw an ouipivjj.ee u.iij ti,;.j statement indicates that the employee may be at added risk from continued VC exposure. As with monitoring, there appears to be no basis for complete exemption of the fabrication industry from the require ment for medical examination. The rec ord docs show fabricating establishments with concentrations of VC monitored considerably above the action level. In these instances, medical surveillance of affected employees will provide baseline data for future evaluation of their health, even if both monitoring and medical sur veillance are discontinued because im proved controls reduce concentrations beJow the action level. Where exposures are below the action level, the medical surveillance requirements do not general ly apply. i J 2) Training. A separate provision for employee training has been added to the final standard rather than including It within the section on emergency situa tions as in the proposal. The new para graph provides for training of employees concerning the carcinogenic hazard of VC. emergency procedures, the need for monitoring and an animal reitrw of the standard. It al.-o provides lor naming of employees concerning the purpose tor, proper use of, and limitations connected with respiratory protection. 113) iireords find reports. The provi sions for recordkeeping contained in the final standard require the preparation and maintenance of essentially the same information required by the proposal, The major change from the original pro posal is the requirement for maintenance qf monitoring records and daily roster sheds of authorized persons for 30 years, instead ot tiu years. Additionally, the em ployer is requited to maintain medical records for llic duration of an employee's employment plus 20 years, or 30 years, whichever is longer. The original pro posal called for only 20 years. This change has been imiik-ineniod be cause the latency period for induction of angiosarcoma ranges tip to 30 years from initial exposure. Therefore, as a raini- mum. medical records must, l.e main tained for at least Unit long. It should be noted that spokesman for both I dler and induslry recommenced that this change be made. The reporting requirements rue net significantly different from those in the original proposal. However, instead of the requirement for tenon mg incidents which result in the release of VC into areas where employees mry be exposed, ihe final standard clarifies our original intent by staling that only envu vs ncies must be reponea. Abo the requirement for filing u detailed, written report within 15 days has been deleted. It has been concluded mat submission, within 24 hours, of an initial report- thru in cludes facts immediately avaiinb!'*. won id ordinarily be sufficient. However, if the OSHA Area. Director requests further in formation relevant to the emcra ncy. the employer will be required to furnish such information. (14) Deleted portion* of the proposal. The piu,fu.-,i lOiffuiii.d ijijv.:cquirmg that shower facilities and change rooms be provided, and that storage or consumption ul food be prohibited in regulated arcus. v.'e have deleted these provisions because it is our conclusion they are no longer necessary. Showering facilities are not required because pro tective clothing, where requited by the final standard, should protect employees from skin absorption by direct contact with VC and because there is no reiiabie evidence that VC vapor is absorbed through the skin. In addition, since we anticipate that most employee:' will not be wearing protective clothing and that employees who wear protective clothing will change such clothing infrequently, we arc not requiring that change rooms be provided. In addition, we 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 m regulated areas has been deleted. The proposal also contained provisions on mnimcnLance and decontamination, trun.'-poruilion loading and unloading, and polvmer handling operations. These requirements are not mentioned in the final standard because attention to these items is implicit in the requirement that each employer reach the pcrmis. ablc ex posure limit or attain llic lowest feasible level. t <I5) Effective date. In order to ensure that affected employers mid employees will be Informed of the existence of these FEDERAL UCISTER, VOL. 39, NO. 194--FRBdT, OCTOBER 4, 1974 WC 000004311 35896 RULES AND REGULATIONS provisions find that employers affected of the operation or because of an acci opportunity to observe the monitor are clvcn an opportunity to famillarlzo dent In tile operation, which would result ing nnd rnejiMiririK required by this themselves nnd their employees v.uh the In an employee csiKisure in excess of the paragraph. CxisLcncc of the new requirements, the permissible exposure limit. <c> ReriuPi'.rtl nrc'i. < I) A rcpulaied effective date of the niiienmnent to 18) "OSHA Aren Director" means the area shall be ei-tabli-ned where: 5 1910.93q will bo Jnimniy 1. IDVj. To pro Director for the Occupational Safety (i) Vinyl chloride or polwinyl chloride vide continued protection lor employees and Health Administration Area Office is manufactured, reacted, repackaged, until that dale. the provisions currenlly having jurisdiction over the geographic stored, handled or u rd: and contained in 6 1510.D3q are hereby area in whifh the'employcr's establish (11) Vinyl cliloride cnnrcntrntiims are promulgated, pursuniit to section 0(b). ment is located. in excess of the permissible exposure 6(c) and 8<c> of the Occupational Safety <9' "Polyvinyl chloride" means poly limit. and Health Act, as an occupational vinyl chloride iiomopolvmcr or copoly <2) Access to regulated areas 11n 11 be safety and health standard effective mer before such is converted to a fabri- limited lo iiiilhoi ized person?. A daily October 4. 1971, the amendment to calcd product. roster shall be made o( authorized per 1910.03c| set out below will supersede (10i "Vinvl chloride" means vinyl sons who enter, these provisions as of January 1, J?ii5. chloride monomer. (f) Method1) o/ compliance. Eiv'lnycc Accordingly, upon consideration of Ihc whole record of this pvoccdiv.g, Part 1910 of Title 29, Code of Federal Regulations is amended, effective January 1, 1975, by <c' Pcrmiy.ubr' exposure limit, ri) No employee may be exposed to vinyl chlo ride at concentrations greater than 1 ppm averaged over any 8-hour period, and exposures to vinvl cliloride shall be con trolled to at or be'o'.v the permWib'e ex posure limit provider! m paragraph ic> of this section by engineering, work prac revision of 191 O SMq to read as follows: (2) No emphv ce may be exposed to tice. and personal protective roniroji as 19J0/;3rr Viujl .-liloriJe. vinyl chloride at concentrations greater follows: than 5 ppm nvcvaeort over any period not, (1) Feasible engineering and work (ft) Scope and application. (1) This exceeding 15 minutes. practice controls shall Immediately be section includes requirements for tire control of employee exposure to vinyl chloride (cliloroethene), Chemical AbEtvacts Service Registry No. 750 5 5. (2) This sec I ion applies to the manu facture, reaction, packaging, repackag (3) No employee may be exposed to vinyl chloride by direct contact with liquid vinyl chloride. id) Moiulorina. (1) A program of initial monitoring and measurement shall be undertaken in each establish used to redu-c exoesurcs to at or below the permissible exposure limit. (2) Wherever feasible mmc-crine and work practice controls which can hr in stituted immedi-'U-'v are not suf:'.-:o reduce exposures to at or below Hie per ing, storage, handling or use of vinyl chloride or polyvinvl cliloride. but cioe.s not apply to the handling or use of fabri cated products made of polyvinyl chlo ride. (3) This section applies to the trans ment to determine if there is any em ployee exposed, without regard to tiie use of respirators, in excess of the action level. (2) Where a determination conducted under paragraph (d>m cf this section missible expo-lire limit they 11 none theless be used to reduce expouuvs *o the lowest practicable level, ami shall be supplemented bv respiratory protoeicn In accordance with paragraph !g > of thus section. A program shall be established portation of vinyl chloride or polyvinyl shows any employee exposures, without and implemented to reduce expyurcs to chloride except to the extent that Lhc retard to the iwe of respirator.---, in ex at or below the ecrrubsiblo omc.-ure Department of 'liansporuu-mn may cess of liiL aeuori ievci. a program jor de limit, or to the ere^c-it extent pwitle. regulate the hazards covered by this sec terminin';! exposures for each such em solely by means of engineering and v.-ori: tion. ployee shall be established. Such a pro practice controls, as soon as Jensible. (b) Definitions. (1) "Action level" gram : <3> Written plans for such n program means a concentration of vinyl chtnride U) Shall be repealed at least monthly shall be develop'd rue) furnisned upc:i of 0.5 ppm averaged over an 8-hour work where any employee is exposed, without request for examination and copy:::;; to day. regard to the ire cf respirators, in ex authorized representatives oi the Assis (2) "Assistant Secretary'' means the cess of the permissible exposure limit. tant Secretary and the Dlrertor. Such Assistant Secretary of Labor for Occupa tii) Shall be repealed not less than plans shall be updated at least every six tional Safety and Health, U.S. Depart ment of Labor, or his designee. (3) "Authorized person" means any person s)>ecifically authorized liy the em ployer whose duties require him to enter ft regulated area or any person entering such an area as a designated representa tive of employees for tire purpose of ex ercising an opportunity to observe moni toring and measuring procedures. (4) "Director" means t)>e Director, National Institute for Occupational Safety and Health, U.S. Department of Health, Education, and Welfare, or Ills designee. quarterly where any employee is exposed, without regard to tiie use of respirators, in excess oi the action level. (iii) May be discontinued for any em ployee only when at least two consecu tive monitoring determinations, made not less than 5 working days apart, show ex posures for that employee 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 oi vinyl cliloride. or the employer has any other reason to suspect that any em ployee may be exposed in excess of the months. <) Respirator'/ protection. Whore respiratory protection Is required under this section: <1) The employer shall provide a respirator which meets the requirements of this paragraph and shall assure that the cmplovee use- sin-h respirator. except that until December 31. 1975. wearing of respirators shall be at the discretion cf each crtmlnyce for exposures not in ex cess of 25 ppm. measured over any 15minutc period. Until December 31. 1975, each employee w ho choose.'.; not to wear an appropriate respirator shall be in (5) "Emergency'' means any occur action level, a determination of employee formed at least quarterly of the hazards rence such ns, but not limited to. equip exposure under paragraph (d> (1) of this of vinyl chloride and the purpose, proper ment failure, or optmilion of a relief de section shall be performed. use, and limitations of respiratory vice which Is likely to, or docs, result in 14) The method of monitoring and devices. massive release ot vinyl chloride. measurement shall have an accuracy (2) Respirators shall be selected from (6) "Fabricated product" means a (with a confidence level of 95 perccnti of among ihose jointly approved bv the product made wholly or partly from not less than phi or minus 50 percent Mining Enforcement and Safety Admin- polyvinyl cliloride, and which does not from 0.25 through 0.5 ppm. plus or minus istratmn. Department of tiie Interior, require further processing at tempera 35 percent from over 0.5 ppm through and the National institute for occupa 1 tures. and lor times, sufficient to cause 1.0 ppm, and plus or minus 25 percent tional Safely and Health under the pro mass melting of tlie polyvinyl chloride over 1.0 ppm. (Methods meeting these visions of 3(1 CFR Part 1!. resulting In the release of vinyl cliloride. accuracy requirements arc available in (3) A respiratory protection program (7> "Hazardous operation" means any operation, procedure, or activity v.-hcrc a release of either vinyl chloride liquid or gas might be expected ns ft consequence the "NIOSIl Manual of Analytical Methods"). <5) Employees or their designated rep resentatives shall be afforded reasonable meeting the requirements of $ 1910.131 shall be established and maintained. (4) Selection of respirators lor vinyl chloride shall be as follows: FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 VVC 000004312 RULES AND REGULATIONS 35807 atmospheric concentration of vinyl chloride Required apparatus (1) Unknown, or above 3,000 ppra__. Open-clrcu It, nclf-con lamed breathing apparatus, pres* sure demand typo, wllh full lacepleoc. (It) Mot over 3.000 ppm.____(A) Comblimlirm lyjx* c supplied air respirator, pres sure demand type, wilti full or lmtf facepiece, end auxiliary solt-containcd utr supply, or (B) Typo C. supplied nir respirator continuous now typo, with lull or Imlf facepiece. and auxiliary soil-contained air supply. (Ill) Mot over 100 ppm--(A) Combination typo C supplied air respirator de mand type. v.ill) full facepiece, and auxiliary scH-cont.iliied air supply; or (B) Open-circuit self-contained breathing apparatus with full facepiece. In demand mode; or (C) Type C supplied air respirator, demand type, with full facepiece. (vl) The purpose for. and a dosenp- .Uon of, the medical surveillance program: (vii) Emergency procedures; (vlil* Specific information to mil tlie employee in recognition of conditions which may result in the release uf vinyl chloride; and i (ix) A review of this standard at the employee's first training and indoctrina tion program, and annually thm-niier. (2) All materials relating to the pro gram shall fie provided upon rr.*qi:c:,t to the Assistant Bcoretarv and Die Jjiicctor. <k) "ft'circa! surm'danee. A pio"iarr of medical surveillance shall be insti 00 Hot over 25 ppih..........___ (A) A powered ulr-purtfytnir respirator with hood. tuted for each employee e.xga:.v!. with Jielinet. full or hair facepiece, and a canister out regard to trie use of rcsiniators. to which provides a service life of at least 4 vinyl chloride* in excess of I!::* action hours for concenrations of vinyl chloride tip level. The program shall provide each to 25 ppm. or such employee with an oppoi limitv for (v) Hot over 10 ppm...--......... (B) Oas mash. front-, or back-mounted canister which provides a service ufo of at least 4 hours for concentrations r,r vinyl chloride up to 25 ppm. (A) Combination type C supplled-nlr respirator, de mand type, with half facepiece, and auxiliary belf-contalned air supply; or (B) Type C suppaed-wii respirator, demand type, wn'n hall facepiece; or (C) Any chemical car: ridge respirator with an organic vapor cartridge which provides a service life ol at least l hour for concentrations of vinyl chloride up to hi ppm. examination:; and terts in f.croi dance with this paragraph. AU medical cxuminations and procedures shell be per formed by or under Lite supervision of a licensed physician, and shall be p rovided without cost to the employee. (1) At the time of initial aosijnment, or upon institution of medical surveil lance; (j) A general physical examination shall be performed, with specific atten tion to detecting enlargement c>f hver. (5X1) Entry into unkown concentra tions or concentrations greater than 36,000 ppm (lover explosive limit) may be made only for purposes of life rescue; end (ii) Entry into coijCc.nuwtio..s of 1c$j than 36,000 ppm. but greater than 3,COO ppm may be made only for purposes of life rescue, firefighting, or securing equipment so ns to prevent c greater hazard from release of vinyl chloride. (6) Where air-purifying respirators are used: (i) Air-purifying cannisters or car tridges shall be replaced prior to the expiration of their service life or the end of the shift in which they are first Used, whichever occurs first, and (ii) A continuous monitoring and alarm 6ysteni shall be provided where concentrations of vinyl chloride could reasonably exceed the allowable concen trations for the devices in use. such sys tem shall be used to alert employees when vinyl chloride concentrations exceed the allowable concentrations for the devices In use. (7) Apparatus prescribed for higher concentrations may be used for any lower concentration. <h> Hazardous operations. (1) Em ployees engaged in hazardous operations, including entry of vessels to clean poly vinyl chloride residue from vessel walls, shall be provided and required to wear and use; spleen or kidneys, or dysfunction in these (2) Protective garments shall be pro vided clean ami diy for each use. organs, and for abnonnaltic' m skin, connective tissues and the pulmonary ii) Emcracncy situations. A written system tSce Appendix A). operational plan for emergency situa (ii) A medical history shall bo taken, tions shall be developed for each facility including Die following topics: storing, har.-ifing, c.;* ct'-erv. i;-c nrit'.g vinyl cldoiide as c. liquid or compressed ww Akxun.'i (B) Past history of hepatitis: gas. Appropriate portions ol the plan (C) Work history and past exposure shall be implemented in the event of an to potential hepatotoxic agents, includ emergency. The plan shall specifically ing drugs and chemicals: provide that: <Di Past history of blood transfu (1) Employees engaged in hazardous sions: and operations or correcting situations of ex ' (E> Past history of hospitalizations. isting hazardous releases shall be (ini A serum specimen shall be ob equipped ns required in paragraph (h) of this section; tained and determinations made of: (A) Total bilirubin: (2) Other employees not so equipped (TJ) A! kr.lir.fi pliosphato.se: shall evacuate the area and not return 1C) Scrum glutamic oxalacctic trans until renditions are controlled by the aminase (SGOT); methods required In paragraph (f) of this section and the emergency is abated. tj) Trnhifjia. Each employee engaged in vinyl chloride or polyvinyl chloride operations shall be provided training in a program relating to the hazards of vinyl chloride and precautions for its safe use. (1) The program shall include: (D) Serum glutamic pyruvic transam inase (SGl'T): and iE) Gamma clustamyl irauspcptldnse. (2j Examinations provided in accord ance with this paragraph shall fie per formed at least: (i) Every 6 months for each employee who has been employed in vinyl chlo ride or polyvinyl chloride manufacturing (D The nature of the health hazard fTom chrome exposure to vinyl chloride including specifically the carcinogenic hazard; for 10 years or longer: and lii) Annually for all other employees. <3> Each employee exposed to an emergency shall be afforded appropriate (ii) The specific nature of operations medical surveillance. which could result in exposure to vinyl (4> A statement of each employee's chloride in excess of the permissible suitability for continued exposure to limit and necessary protective steps; vinyl chloride including use of protec (I) Respiratory protection In accord (ii) The purpose for, proper use, and tive equipment and respirators, shall be ance with paragraphs <c) and (g) of this section; and (il) Protective garments to prevent skin contact with liquid vinyl chloride ov with polyvinyl chloride residue from vessel walls. The protective garments shall be selected for the operation and limitations of respiratory protective devices: (iv> The fire hazard and acute toxic ity of vinyl eliloridc, and the necessary protective steps; (v) The purpose for and a description obtained from the examining physician promptly alter any examination. A ropy of the physician's statement .shall be pro vided each employee. <5> If any employee's health would be materially Impaired by continued ex Its possible exposure conditions. of the monitoring program; posure. such employee shall be wilh- FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4. 1974 wvC OOOOOA313 . "V 35898 RULES AND REGULATIONS drawn from possible contact with vinyl chloride. (C) Laboratory' analyses for all bio logical specimens Included In medical examinations shall be performed in labo ratories licensed under 42 CT'K Fart 74. (7) If the examining phy. icinn deter mines that alternative mcdiral examina tions to those required by paragraph (k)(l) of this section will provide at least equal assurance of detecting med ical conditions pertinent to the exposure to vinyl chloride, the employer may ac cept such alternative examinations as meeting the requirements of paragraph (k) (l) of this section, if the employer obtains a jlatenu'iil from the examining physician setting forth the alternative examinations and the rationale lor sub stitution. This statement shall be avail able upon request lor examination and copying to auihorizcd representatives of the Assistant Secretary and the Director, (3) Slims and labels. < 1) Entrances to regulated areas shall be posted with leg ible signs bearing the legend: Cancer-Suspect Acent Area AumoKizm Personnel ONLY <2) Areas containing hazardous oper ations or where an emergency currently exists shall be posted with legible signs bearing the legend: Cancer-Srspec? Acent in Tins Area Protec tive Equipment Required Authorized Personnel Only <3> Containers of polyvinyl chloride resin waste from readers or other waste contaminated with vinyl chiunue snail be legibly labeled: Contaminated with Vinyl Chloride Cancer-Suspect Agent (4) Containers of polyvinyl chloride shall be legibly labeled: Polyvinyl Chlcejde (on Trade Name) Contains Vinyl Chloride: Vinyl Chloride is a Cancer-Suspect Agent (5) Containers of vinyl chloride shall be legibly labeled cither: (l) Vinyl Chloride ExTHFMI.T,* FLAMMABLE GAS UNDER I'RLSSU1:E Cancer-Suspect Acent or (ii) Jn accordance with 49 CFR Fart 173. Subpart H, with the additional legends: Cancer-Suspect Acent applied near the labor or placard, (6) No statement shall appear on or near any required sign, label or Instruc tion which contradict? or detract? from the tflccl of, any required warning, information or instruction. <:r. > Aetortii. (1 > All record.? main- la:r.in accordance with tins r-ccuon shall :r.~h:dc the name and social sccu- r.:y r. rr.-.cr of each employee where rel:"' r.`. 12; P.'ccrd- of required monitoring ar.d medical record?, and au thor.:::! ptrionncl roster.?, shall be made ar.d rii.ih be available upon request for ex.tr..::.:.::on and copying to authorized rep:v::::`-'.i;ves of Lhc Assistant Secre tary am:. t.-.e- Director. : . n.torihg and measuring records sh:.l,: A' Stale the date of aueli monitor ing ar.d measuring and the concentra tions determined and identify the inslni- r.iu'.t' sr.a methods used; E' Include any additional informa tion n-ce.-Erry to determine individual empexposures where such cxix>- surcs rre determined by mean.? other than individual monitoring of employees: iC'1 * F* *c* 6maintained for r.ot less than :. .-'.ulhcrired personnel rosters shall be :;:r.:r.u'.:r.cd for not less Uian 30 years. i::i .f.fcdi;::! records shall be main tained for the duration of the employ ment c; each employee plus 20 years, or 2. year? whichever b lor.gc-r. (31 Ir. the event that the employer coasts to do business and there Is no s`,::c--.:.r;r to receive and rcir.in his rec ords shall be transmitted by registered mo.-! to th? Director, and cr.cli employee inc!:'ri dually notified in writing of this transfer. (4 F.-r.rlcyces or their designated represent.', hies shall be provided access to examine and copy records of required monitoring attd measuring. (5- Former employees shall be pro vided .-.ccers to examine r.nd copy re quired monitoring and measuring records rcrieetir-c thr-ir own exposures. <6> "Upon written request of any em ployee. a copy of the medical record of that employer shall be furnished to any piiyric;.'.:'. designated by tire employee. tn' u-spor'.s. (1) Not later than 1 r.trr.th after the establishment of a renul.-.ifi area, the following information shah be reported to the OSIIA Area Di rector. Any change? to such information shad be reported within 15 days. <P The address and location of each establishment which lias one or more regul-U'd areas; and (li) The number of employees In each regulated area during normal operation.?, including maintenance. (2> fcirnergeiicic.;. and the facts ob tainable at that lime, shall be reported within 21 hours to the OSIIA Area Di rector. Upon request al the Area Direc tor, the employer shall .submit additional information in wining relevant U> the nature and extent ol employee cxpoMiies and measure? taken to prevent future emergencies of .similar nature. <3i Within 10 working dal's following nny monitoring and mcastirni;; which discloses that any employee has been exposed, without regard to the use of respirators in excess of the permissible exposure limit, each such employee shall be notified in writing of tire results of the exposure measurement and the steps being taken to reduce the exposure to within tlie permissible exposure limit. (o) EUcciinc dales, 'll Until Janu ary 1, 1975. the provisions currently set forth in 3910.&3q of this Part shall apply. (2) Effective January 1, 1975. the pro visions set forth in f 1310.93-3 of this Part shall apply. Ari'ENDiX A--Sui-PLrMENTAr.T Medical Information When required lent.? under pararrauh (k)il) of this section show sbaormniun-v the vesta should he repeated a? soon as pme- tica'oic. preferably v.lvhln 3 10 4 v.eei:,-. J' testa .mi:..tin abucniL'.:. coi,::'h-r..t!vn .-iicv.ii be fcivuli .0 V. Itudi a: h.o contact with vinyl chloride, while a mere comprehensive evaminn'lcn !s made. Additional tests which may be usefulA. For kidney dysfunction-. urine ex.oiv.ha- tlon for albumin, red blood cells, anti e\- foliativc abr.crmr.l veils. D. f'ulmonruy sysicm: Foiced vital capac ity, Tc-rccd expiratory volume at 1 racoiuI. and chest roentgenogram (posterior-Rr.ierlcr, 14 x 17 inches], C-. Additional scrum tests: Lactic avid de li yd rocenai-.e, lactic r.cid dc l-.vdi eigenaf e Isoenzyme, protein determination, mid protein electrophoresis. P. Tor a more comprehensive esanunxiion on repeated abnormal ?m:!n tests: Hepatitis D niui.TiTii, ar.d liver scanning. (Secs. 6 nnd B. B1 Slat. 129B, :jfl9 (29 U.S.C. tiiS. C57): Secretary of Labors Order No 12-71, 3d FR 8734) Signed nt Washington. D.C.. this 1st day of October, 1974. John Str.NDr.r.. Assistant Secretory of Labor. (FR Doc.74-33176 Filed 10-1-74:3:54 pxn] t K0EEAI REGISTER. VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 VVC 00000431^