Document vyYn8rGZ42v0YXevvJpkQGv6Y

,1 R'JLES AND lEGULATIONS Title 29--Labor ployees from i. rare liver rnnrer (nnnln- nnd abroad. OSHA i>ror*osed to revise API Lit XVII--OCCUPATIONAL SAFETY AND HEALTH AO'.itNlSl KA (TON, DEPAHIMENT OF LABOR FART 1010-----OCCUPATIONAL SAFETY AND HEALTH STANDARDS sareomai mat have hern ocr upaTTonally rcJate.T~As a rc.ailt of that notification nnd niter consultation with NlOSlI.nnd a joint inspection nl the 13. P. Goodrich plant by OSH A. NT OSH and Die Ken tucky Department of Labor, a tact-llnd- 1910.92q nnd published ji comprehensive proposal f39 I'R )Gli9d) on May JO, 1974. to .protect employees from hazards of exposure to VC. The proixv-al called for hnutation of employee-exposure to VC to "no detectable level." ns measured by a Standard for Exposure to Vinyl Chloride ing her,run: was announced on Janu sampling and analytical-method sensitive Pursuant to sections G(b'. G<cl, nnd 8(c) ol the Occupational Safety and Health Act of 1970 (f,4 Slat. 1993, 1S9G. 1599; 29 U.K.C. G55. G57> See: clan' of Labor's Order No. 12-71 <"G PH S754) nnd 29 CPU Part 1911. 4 1910.93 of Part 1910 of Title 29. Cede of Federal Regu lations is hereby amended in the manner set forth bcio'.v. in order to provide an Occupational Safety and Health stand ard dealing with the exposure of em. ployces to vinyl cldoridc. I. Background--<1* Vinyl chloride. Vinyl chloride (ehloroc-thenc). Chemical Abstracts Service Registry No. 75014. Is a synthetic orr.anic. chemical made from ethylene or acetylene and chlorine by any of several processes. It is the parent compound of a series of thermoplastic resin polymers and copolymers which arc widely used for containers, wrapping film, electrical insulation, pipe, conduit, end a variety cf other industrial nnd consumer products. Vinyl chloride has be.cn made commercially in this country since 1939. nnd present production is in exedss of seven biiiiun pounds per year. Tiie vinvj chloride industry divides into three segments: monomer pror.uctioR. polymer production, and fabrication. Production of (he monomer is e. largescale continuous process, involving only a few firms. There are 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 resir. which is piociuceri tin ouch batch processing. The conversion, of the VC monomer into a polymer or copolymer Is an Incomplete process, i.c.. not all of the monomer is reacted. PVS IT faTinrated by a variety of tech niques. including extrusion, injection molding and calendering, to form a fin ished product that needs no further chemical handling. The vast majority ary 30. 1974 <30 PR 3374) and held on to 1 pnm. with itn. accumry of 1 ppm February 15. 1974. r*r50 iK'reent. The proposal also called Information obtained from this hear for the establishment of regulated areas ing. particularly the preliminary reports and limited access to such areas to au of experiments conducted by Professor thorized persons. A requirement for Cesare Maitoni of the lnstituto til On- monitoring of employee exposures was cologia. Bologna. Italy, demonstrated that vinyl chloride induced angiosarcoma ill rats at levels as low ns 250 ppm. nnd proposed, along with engineering and work practice controls to be implemented wiicn exposures over the detectable limit in other species at higher levels. Kxperi- were measured. mehts performed at lower levels of ex Respiratory protection -would have posure were not completed at that time. . been required while engineering and work Other testimony from medical witnesses practice controls were being implemented and NIOSH. and the results of autopsies, or where exposures exceeded tlic per led to the conclusion that the Goodrich missible limit even after feasible en workers, had angiosarcoma of the iiver end that VC probably was the causal gineering controls were instituted. In addition, the pro]>oscd stahdard agent in thc 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 ITa.stirs Corpora tion and Goodyear Tire U Rubber Com pany. On the basis of all information avail able at that time, a.nd the fact that em ployees were being exposed at levels around the experiment-ally observed ef fect level of 230 ppm. an emergency temporary standard (NTS) was promul gated on April 5. 1574 (39 F'R 12341) pursuant to section Gtc) of the Act, as 29 CFP. 1910.93q. This standard reduced the permissible exposure ievel from a ceiling of 509 ppm to a 50 ppm ceiling, ana established other requirements, including, for example, monitoring and resjnrr.icry protection. It was' expressly recognized that this standard limiting exposures to a 50 ppm ceiling was-a tentative, interim standard, and that the whole question of exposure to VC would be considered more fv.liy in the light of additional information, especially the results of -experiments which were known to be underway at that time. 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 record keeping. (4) Hearing on the proposal. The pro posal, os published on May 10. 1974, allowed 20 days for interested parties to submit written comments.and to request an informal rulemaking hearing. In formal contacts with OS1IA r.tafT and early responses indicated that the sub ject wfibof great interest and importance to many persons. Because of the hii'dlcd time available before expiration of the six month period provided in section G(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 21, 1974, a notice of a hear ing was published (39 F'R 1F3'.I3), setting a hearing date of June 2 5, 1974. The hearing was conducted .from June 25 through Jimc 28. and again Horn July 8. through ; Jui? 13, before Administrative Law Judge Gordon J. Myall. All partici pants were given the opportunity to pre sent testimony and to crcss-examine other witnesses. Personsijjjarticipating in of employees involved in the VC industry On April 15. 1974, information and data the hearing were given"'Ol:til August 23, are employed by Fabrication firms. Such were presented to representatives of 1974, to file additional pc:',then ring com firms range ir, size from those with tew OSHA, NiCSH, and the .Piivironmental ments, including various items of infor employees nnd simple equipment to large Protection Agency by the Industrial IJio- mal ion which were requested'during the plants involving many employees ana Test Laboratories. North-brook, minors, examination cf witnesses. considerable capital. concerning results of animal exposure (5) Becuoiiuc and technical impact Vinyl chloride iVC', a gas at ambient studies with VC. The.-.c studies were stmiv. During the hearing. OSHA deter temperature and pressure, is a chlori sponsored by the Manufacturing Chem mined that additional facts would be nated hydrocarbon, which heretofore has ists .Association. Ahhour.h only pre needed to determine the practicality of been regarded as Inning moderate liver liminary in nature- at that time, tiwoo certain aspects of thq proposed .stand toxicity. The initial standard, contained results revealed that 2 out of 200 mice ard. Accordingly, OSIfA'contactci! an in in Table G-l of 1910.93. established a expored to VC concentrations of 50 ppm dependent consultant. Poster D. Snell ceiling value oi SCO parts of VC per mil for 7 hours a day, five days a week, for Corporation, to conduct studies of the lion parts of air. approximately 7 months, had developed' feasibility of compliance at various ex (2) The emergency temporary j'end- angiosarcoma of the Liver. posure levels. Including those proposed nrd. On Jan,nary 2.7. 1974. the Occupa (3) The proposed i:ern:tincni stend- liy OSIJA and others advanced by in tional Safely and Health .Viminwtra- ard. Based on the ilcir.on.str.ucd evidence dustry spoXosrycn. Snell was also cem- tion tOSHA) v.v. . informed by the Na of VC's careinogcn'.'. ity in throe animal niissi-nnert to collect information regard tional Institute ter O.cup.aiionn! Safety species (rats, mice and hamsters), and ing tiie economic costs of compliance. and Health (NT'VJ-I) that il.c 11. P. the substantial probability that VC had ThLs actum was announced at the close Goodrich Cl.emu nl Company had re been the causal agent in the cases of liver of the hearing, ami Judge Myall fur:hex ported that deaths of several of Hs em angiosarcoma found hi workers both here announced that the record would be kept 4, 1974rrO*M fcCCISTF.*, VOl. 37, NO. 174--FRIDAY, OCTOUFIt ' "" DTH 000066924 RULES AND REGULATIONS 33S91 :od of llr.ir beyond August studied of M,allonl nnd Bio-Test labora may create' n carcinogenic hazard, the i>ov.' :: ilcrcstcd persons Io coidv. riling on the mik.v. On August Ob'; A announced that the pre liminary stu.-iy was available and tlmt common!* wcre to bo submitted no inter than tk'nlcmber C, 1974 (39 i`R 33344). Oit September 13. 1974. O.-IIA Invited tom.'ncnL' on both top preliminary and tories. Moreover. Miilumis investigations havd uinnr,nuctT571 or.o-deiiencitni rcri,rttorrstTrrrfo:--tncmcllon of tumors' file., men--tumor*-occur at higher exiwr.iirc levels), including anaiomrcoma of the liver, in rats. The investigations of In dustrial Bio-Tc.xt Laboratories have dem onstrated a similar relationship for nmtiuni of cx'posure which Is hazardous mad be determined. Tire Surgeon Gen eral's Ad Hoc Committee referred to nbave concluded that safe exposure levels for carcinogenic substances cannot be scientifically determined. This position Is snpixn tcd by the testimony of NIOSH nt t)ic hearing, its recommendations for the fma! study, which was to be received on or before September do, 1974 <39 FR 330091. (C) Znriro:i:ncntcl ir.ipc.ci ric/cmcnfs, A notice of intent to file an environmen tal imp.act statement r.r.sc.'ruig the im pact of a proposed standard on occu pational exposure to VC was published in the FEDERAI. li L'G J STlIit Oil A ill'll If4. both rats and mice. These investigators n standard of no detectable level, and by have induced angiosarcoma of the fiver the testimony of expert witnesses from in.rats nnd mire nt exposure concentra - the National Cancer Institute. tions of 50 ppm. nr.d in hamsters at high Several witnesses and persons who sub er concentrations of exposure. Additional mitted comments have taken a contrary tumors involving other organs, including view and have suggested that man Is less uic kidneys, lungs, and skin ol exposed sensitive to biologic aberrations induced animals, were also observed in frequen by vinyl chloride exposure than experi cies much in excess of control .animals. mental animals. Proponents of this jvosl- 1974 (39 FR 14532). The notice invited any person having information or data on tire environmental Impact to submit it lo 031IA by May 17. 1974. On June 12, 1974. a draft environmental impact statement was prepared and circulated lo all interested persons. Ten copies were forwarded to the Council of Environ mental Qualify (CEQ). which ppb)i.s)ied a notice of its Aline rend availability. In the Fedvrai. Register on June 25. 1971 (39 FR 23975). A 45 day period was al lowed for the submission of comments on the draff statement. On September 5. 1974. the Anal environmental impact statement was prepared and a copy of it and all substantive comments were sent to appropriate governmental agencies, private organizations, and other inter ested persons. CEQ published a notice of availability for the Anal stniomcnt on September C-. 1971 (29 FR 22359). Tire submission of comment was invited un til September 25. 157 f. "Fee filial state ment and all rirmificant comments have been carefully considered in arriving at the Anal standard on occupational expo sure to \'C. (7) The record. The record In this proceeding is one of the most exhaustive ever relied upon by OSIIA. It consists of pre and post-hearing comments and testimony received at both factfinding and rulemaking hearings, the studies and inspections conducted by 0311A person nel, the environmental in'.;',act state ments, the economic and technical impact studies, and all other relevant information. In all, over GOO un it ten com ments have boon received, with more than 200 separate oral and written sub missions made with regard to the two hearings. The record it.-tlf exceeds 4.000 pages. Employers, employees, labor unions. public health groups, independ ent experts, physicians, research scien tists. and .specialist* in many Acids havo been invited to subr.-Jt Information and have made their slews, hr. owl calve nr.d experience available lo 031 L-\. The en tire record encompassing these submis sions was thoroughly reviewed and evaluated in reaching the determina tions set forth below. JT. Findings reearc:::o cr.rr'.'\orcr.:c:tlf, r.rjiosL're levels and fcr.r--< 1 > Carciimecvlc-itv of r:::y! c?:!onde. Toe carcii'.ogemeity of vinyl chloride for three The incidence of tumors in mice in the Industrial Bio-Test Laboratories investi gations is particularly pertinent. Of 200 mice (100 males. 100 females) exposed to 50 ppm of vinyl rlJoricie by inhalation for eleven months. 100 died. Sixty-four ani mals died without gross postmortem pathologic examination being performed. Of Uie- 30 remaining animals for which a gross post-mortem pathologic examina tion was penormccL 13 (30 percent) were found v.dth liver tumors (including angiosarcomas). 21 (53 percent.) with lung turners. 9 (25 percent) with skin tumors, and one v.dth 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 Carcinogcn3v.UiC Ending o: cancer in ..two, or more animal species may be extrapolated. lo_ iiidicaic ~a~carcinogenic, hazard to hunurns. Here, such a iinanir wnsTnade in three 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 m view of the extreme rarity of this cancer In the U.S. adult male population (testi mony of Dr. Marcus Key, Director of XIGSK. at the rulemaking hearing). Hie 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 tins tumor. Industry spokesmen, at the hearing, conceded that VC is carcinogenic for humans (e.g. testimony ol Dr. McBumcy, Rulemaking lira ring. llSl). Accordingly, it is con cluded that VC must be regarded as a human carcinogen, and the probable causal agent of angiosarcoma of tile liver, and that exposure of employees to VC must be controlled. Additional evidence of tumor induction in a variety of ether organs, including lung, kidney, brain and skin, as well as iion-inabgr.anf alterations, such ns fi brosis and connective tissue deteriora tion. Indicates additional onccgrnlc and toxicologic properties ol vinyl chloride, which must be considered in cstablislung control regulations, (Fee testimony and results of studies by lho-Tesi Labora tories. Tnuorsha-.v-Cooper, Mahon!, NJOGII. and Lellkoll.) 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 bc-en observed are those who have considerable employment experience ns polvnicrication reactor cleaners. Because it Is gen erally agreed that reactor cleaning in volved high exposures to vinyl chloride in years past, it is argued that the lower levels currently found In the workplace have not induced cancer arid arc there fore safe. We reject this argument. The fact- that approximately threequarters of those employees with the longest exixisure to VC (greater than 20 years since initial exposiu-c) have not yet been located, makes it impossible to determine the actual number of afTected employees. The cases ox 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 dose-re lated, phenomenon. nnd If employees en gaged In cleaning reactors did, in tact, receive larger dor.es of vinyl chloride, it would be expeood that such tumors would be observed earlier for this em ployee population. For this reason, the significance of presumed lower doses cannot be accurately assessed until a longer period of time has passed, as a longer indue) ion period would be expected. Initiation of exposure to chemical carcinogens and induction of cancer are not ncccsasrily synchronous events. Be cause of the physiologic complexities in volved with carcinogenesis, induction of tumors does not occur in all employees with similar exposure histories. For ex ample, Dr. Pchnciricrmnn 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 exposure levels have been dramatically reduced since the lO'iO's Is no; reliable evidence that cur rent levels of exposure arc safe. Pome intiusiry 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 animal species (rat. moure. hamster) ha.'. (2) AV/,p.i;;rc limils. Ujxm finding that tions lti the workplace design or prac been documented on the record by the exposure of employees to vinyl chloride tice and rcxulLant employee oxjxiomes riblRAt REGimfc, VOL 39, NO. 194--DUDAY, OCT03ER 4, 1974 DTH 000066925 S32 ' RULES AND REGULATIONS (tc.Mlrr. ny and questioning by Tenncco Chcnm ds. Inc.). It. ha-s rJso been cmphaxizi c! that In only 3 of S polymeriza tion j.f.'iiitr, where employees have been exposed to VC for more laan 30 years have any employees developed angiosar coma of the liver. Tins argument is very rim:!ar to that raiser! conccmms vari ability cf past employee exposure. Al' though geographic and workpraqticc dif ferences may ultimately he demonstrated to be factors in disirinuti'in cf angior-arcomi. sufficient lnfcrmaficn :s unavail able to exclude from con.sideiation of risk those employees in workplaces lor which cases of angiosarcoma have not been observed. It has 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 exposure to vinyl chloride at concentrations of icss than 200 ppm is sale. (See study hy Dr. Cook, submitted at the hearing by Dow Chem ical Company.) However, the p-roup sur veyed did not Include all workers who had been exposed, and the missing em ployees included many who had the longer term (over 20 years) exposures. Moreover, the statistically insignificant size of the sample population decreases the possibility that tumors would be observed. Dow also presented preliminary data In testimony at the hearing on tire pos sible metabolic pathways of VC. The hypothesis presented was-that VC may exert Its carcinogenic effect by a metab olite. and that the mo:'.-.'.mine is pro duced only when VC is metav-olized by a secondary metabolic pathway operating only when enzymes regulating the pri mary pathway are saturated, as would be the result at higher exposures. Tne preliminary data indicated the possi bility o: 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 o; 50 ppm in dicates that if a metabolite cf VC is the ultimate carcinogen, tnen it must be generated at lower exposure concentra tions In these species. All hough this re search. may be helpful to the thorough under;-!ar.ciing of the carcinogenicity of VC, it app-:.-ars that It (ices not yet offer evidence which can assist in determina tion of safe exposure concentrations for employers, or even that such safe ex posures exist. A number of witnesses representing employers hare stressed that lucre is no evidence of cancer, either in employees or experimental animals, at exposure concentre!ions of VC less than 50 ppm. (Sec c.ra. testimony cf 1-1 rest one. Ten- ncco Chemicals.) The conclusion of these witnesses was t'n.at no di ci.uon can be made concerning Task of exposure to VC at coneenfralions less than go pp:n. On the other hand, the testimony of most exp.'i t " nne.v.i-5. m.cludm;; some in dustry ti..medical ex; crlx. stated that quantifies!i.-n of a safe exposure con centration Is not j-ossmle with the pres ent state cf cclcnthic knowledge. (See e.g.. testimony of SellkofT, Firestone. NCI, and NIOSII.) In our view. tIre demonstration of can cer Induction m humans at a particular* level is not a prerequisite to a civLermiimtion that a substance represents a can cer hazard lor humans at Umt level. It would be imprudent to assume man to be less sensitive to VC exposure than ex perimental animals in the absence, of conclusive evidence. It would also be'unfounrica to assume that animals will not develop tumors when exposed at concen trations of VC cf less than 50 ppm. Should a. sufficiently large number of ex perimental animals be exooreJ to VC at concentrations of less Lhan 50 ppm, Schnciderman raid that it would be ex pected that some would develop. VC in duced tumors. - (3! Feasibility. There is virtually no dispute that most, if not all. fabricators are currently capable of reaching ex posure levels of 1 ppm through engineer ing controls. These employers employ well over 95 percent of ail employees ex posed to VC. Indeed, several fabricators arc already operating .at this level (sec SPI testimony). However. Industry spokesmen have universally claimed that it is infeasible for the VC and the PVC industries to remain below. 1 ppm con sistently. using engineering controls. In addition, the Snell study on technical feasibility concluded Lhat a 1 pprn ceil ing is not feasible for the VC and PVC industries with present technology, but that tiie VC industry could currently at tain lower exposure levels than the PVC industry. Daozr union sportsmen ano uic Health Research Group, Inc., however, have 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 ppm level or in fact instituted all .available engineering and work practice controls, my estimate as to the lowest feasible level attainable must necessarily involve subjective judg ment. Likewise..tiie projections of indus.trv. labor, and others concerning feasi bility .arc essen'i:'.!];.' conjectural, indeed, as Firestone has suggested, it is not pos sible to accurately predict the degree of improvement to be obtained from en gineering chances until such changes are actually implcmrutec!. We agree that tiie PVC ar.d 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, m time, he able to attain levels of 1 ppm TWA for most job classifications most of the time. If Is ap parent that reaching r-ueli levels may re quire some new technology and work practices. It may also be necessary to utilize technology presently used in other, industries. In any event, the VC and PVC industries have already made [Trent strides In reducing exposure levels. tC.ee testimony of Dow Chemical Co.. Tit 973). For example. D. F. Goodrich tea-titled <TH 1120) that If has reduced awcago cxjxwtire levels in several PVC plants from 25--iU ppm early this year to 12-13 ppm r.t the time of the hearing. We tvve confident that Industry wlU continue to do so. (t) Conclusions. The conclusions be low ure based on a thorough review and evaluation of nil the evidence submilied. Where decisions can be based on record evidence, this has been done. Where, however, factual certainties are lacking or where the facts alone do not provide an answer, policy judgments have been made. There is little dispute that VC is car-' einogenic to man and we so conclude. However, the precise level pf exposure which poses n hazard and the question of whether n "safe'' exposure level exists, cannot bo definitively answered on the record. Nor is It clear to what, extent exiwsurcs can be feasibly reduced. We cannot wait until tiidirputnble answers to these questions ere available, because lives of employees arc at stake. There fore. we have had to exercise our best judgment on the basis cf the best avail able evidence. These judgments have re quired a balancing pi occss, in which tiie 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 i.itu in view of the above considerations, includ ing feasibility, we believe that employee exposures to VC must be reduced to r. 1 ppm time-weighted average (TWA). We also believe that PVC and VC establish ments Mill, in time, be able to attain that level through engineering controls, mid that fabricators can do so'ln the im mediate future. In addition to the TWA requirement, we have established a 5 ppm ceiling (averaged over a 15-minute period) lit Older to prevent exposure of employees to unacceptable high excursions. Freni tin operation standpoint, this ceiling level is realistic because minor excur sions up to the ceding level are likely to occur on a regular basis. HI. The final standard--(1) Scope and appiicaUun. Both the LTS and the pro posal would apply the standard to ilia entire VC industry, including manufac turers cf VC and PVC and fabricators, but excluding employers handling or using fabricated products made from VC. Yhcre'L? no dispute that a standard Is required for the monomer and polymer Industries. However, the Society of Pies-' tics Industry (SPI) and various fabrica tors (see testimony of Goodyear. Gen eral Cable, etc.) recommended that fabricators be excluded from the stand ard. or Lhat a separate requirement kc established for them because many cf them were already at or below the pro posed ceding level. The record evidence cslr.biishcs that at least some employees in the fabricat ing industry are exposed In excess of the permissible control limns ii.Vc NIOI5II testimony, 'tii 105; Robintr.-h TP- 042'. In there cSirr.m.si.anccs. we lx lievc that ft is Imprudent to grant a blanket exemp tion for all fabricators. Therefore, the final standard Is applicable to tire fabri cation Industry, as well as the monomer FEDERAL REGISTER, VOL 39, NO. 194--FLIC AY, OCTOBER 4, 1974 DTH 000066926 RULES AND REGULATIONS 35S93 industries. Employers who. temperature ns PVC. for further pro below the nctlon level, no further moni .uhsianUally below the cx- cessing. indicates that n potential for re toring Is required unless the employer t will be subjected to only lease of the residue still exists. It np- has reason to suspect that any employee x r-s by virtue of the action __ pears that the exemption of fabricated is exposed Tn excess of the action level, cussed below. products should be limited to just those or unless changes have been made in loyers in the fabricating items which will not undergo such mass production, process, control, type of resin, iustry hove exposures approaching the heating. Further, the opportunity to etc. "permissible limit, they will appropriately demonstrate that exposures are below Where the exposure level, without re be subject t-o the standard. Employers the action level, and thus, discontinue gard to respirators, exceeds the permis handling or using fabricated products many duties of the standard, provides o sible levels, monitoring must be conduc made ol PVC were not included in the more positive control and an adequate ted at least monthly. Where exposures ETS cr the proposal and are excluded relief. are less than the permissible levels, but from the final standard. This conclusion (2) Permissible cxj>osure limit. The greater than the action level, monitoring is-based on the absence of adequate evi standard sets an exposure limit of 1 ppm must occur at least quarterly. dence of exposure to VC in these opera averaged over any 8 hour period, and a (5) Methods of compliance. The stand tions. The final standard clarifies the ex ceiling cf 5 ppm nveraged over any per ard. like the proposal, requires that em emption by denning a fabricated prod iod not exceeding 15 minutes. ployers immediately institute feasible uct as a product made wholly or partly As more fully discussed above, this engineering and work practice controls from PVC which coos 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, sufficient to cause mass melting of that the health and safety of employees Where feasible engineering and work the PVC. SPI and otiiers (cf. TR. 3440 must be protected to the. fullest extent practice controls will reduce exposures requested that PVC resins with less than feasible. In view of the 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 1 ppm ceiling not reduce exposures below the permis that the exemption level be reduced to level provided In tire proposal would sible level, they must nonetheless be im 0.01 percent in three years. SPI suggested require maintenance of an average level plemented to reduce exposures to the that the exemption of materials with less significantly more 'difficult to attain lowest practicable level, and be supple than 0.1 percent of 14 carcinogens from through feasible engineering controls. mented by the use of respirators to pro 29 cm 1910.93U (3D FR 375G) was an Therefore, the exposure limit prescribed vide the necessary protection. There appropriate precedent. The cases are not in the proposal has been rejected. upon. a continuing'program of engineer comparable, became no attempt had been (3) Action level. The final standard, ing and work practice controls must be made to ret 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 level'1 of 0.5 ppm est practicable level. When exposures are include information that reliable moni TWA. one-half of the permissible ex at or below the permissible exposure toring and measuring techniques were posure limit. The purpose of the action limits, the program may be discontinued. available. Moreover, the exemption did level is to minimize the impact of the In addition, a plan for achieving con not exempt airborne traces of carcino standard on the employers who have trol by engineering and work practice gens. The administrative cutoff was pro attained e>:;>osure levels well below the methods must be drawn up and he made vided to avoid regulation of materials permissible limit. Thus, where the re available, upon request, to represent about which there was no health haz sults of monitoring under paragraphs atives of OSHA and I,'JOSH. ard information, and which would hate (d)(1) or (d)(2) demonstrate that no We 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 are not re controls. The record also reflects broad proposal to change the level later, wnen quired 'o provide medical surveillance or generic distinctions between the compli improved technology would permit such to monitor again, unless tire employer ance capabilities of the VC and PVC reduction, would seem t-o indicate that has reason to suspect that any employee industries. Some industry- spokesmen, SPI has doubts about tiie safety of 0.1 is exposed in excess of the action level. including SPI (TR. 358-3G2), recom percent residue level. Diamond Shamrock In. our judgment, exposures below the mended that a schedule of different per- (Exhibit 142) testified that there is no action level do not present a sufficient 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 (4) Monitoring. Tire final standard, the time reo.uired to feasibly reach in ing data lroni industry (cf. Exhibits 131, like the proposal, requires that individual creasingly lower control levels is similar 163, 170) and OSKA (Exhibit 151) indi employee exposure levels be dcforntTfrcdr within each industry, but differs mark cate that levels in excess of 1 ppm may This'taartCT aecotnpTTshcdlbyTrc rs 6h a.1 edly between industries..While the record be found in fabrication operations. In 6r~afefrTnbifftoriirg. "Svmeffivitnesses bind does suggest that such differences do view of these facts and of the opportunity persons-wlid-submitted comments did- exist between industries, as noted above, for employers to discontinue many duties not understand the meaning of the term it is clear that, intra-industry differences upon a showing of no exposures above Uie "D5 percent confidence level" in the also exist. Thus, the ability and time re action level, it does not appear mat any proposal. Essentially it means that the quired by each employer to attain lower residue exemption is either justified or employer is required to take ft sufficient control levels may depend upon such necessary at this time. This course also number of measurements ro that the re factors ns the climate in which the plant agrees with p. number of Industry pro sults obtained are statistically valid. We Is located, the age of equipment, the size posals (cf. TR CG0). have modified the proposal t-o establish of reactors, or the type of resin manu SPI (TP. 345). among others, asked accuracy range requirements for various factured or used. (Snell study. Firestone that comjxiundcd PVC pellets be ex measurement levels. Thc-.-e ranges are testimony, ei-c.) s empted from the standard on the grounds narrow enough to ensure that a deter Monitoring data also tends to support that the pellets had too low a residue to mination of compliance can be made, and tech intra-industry variations. (See, cause harmful or measurable emissions. broad enough to allow the application c.g. Dow. Firestone, Tcnncco.) While It appears that PVC pellets would of a vnrieLy of technologies As noted above, the standard requires have a lower residue level than virgin All covered employers arc required to tdl employers to institute feasible engi PVC, the'fact that the pellets must be conduct initial monitoring. Where moni neering controls to the fullest extent and heated to a molten mass at the same toring and measuring results are at or to continue to improve and apply engl- ftbiRAl REGlSTtR. VOL 09, NO. 194--WDAY, OCTODt: 4, IS74 DTH 000066927 RULES AND REGULATIONS _c!-inr c nlrols until full compliance Is iicnic-'cJ. -- Wc lKnc not established any deadlines for full c rnpllancc through engineering controls i .cause we arc presently unable to detenu.sic when It will be icasibic for most establishments to rcnuce exposure levels to the permissible level. We also believe that the requirement that each employer reduce airborne con centrations to the permissible.level, or to the lowest level feasible as soon ns practicable will provide lor inter-indus try and intra-industry technological dif ferences which do exist, ami will avoid the setting of separate industry stand ards on the basis of the general situation and conditions in each industry. (C) Regulated areas. The proposed standard would have required that regu lated areas be established, ihat access be ' limited t-o authorized employees, and that daily rosters or summaries of those entering be Kept for at least 20 years. In objection to these requirements, it was asserted that such control of access was not necessary from a health standpoint. Secondly, it was claimed that these con trols would Interfere with operations by preventing access of needed employees or non-employees, sueh as contractors, trucb drivers, customers and consultants. The purpose of establishing regulated areas in the proposal was to limit the risk af exposure to as Sew employees as possible. This concern is still paramount, and thus the limited access feature re mains. The final standard amends the proposal slightly to allow "authorized persons" to enter regulated areas. This change, It is felt, will allow operations to continue without undue Interference. The final standard has also increased the length of time daily rosters must be maintained from 20 to 30 years. Tills change was based largely on epidemio logical considerations. (See NIOSH testi mony, tr. 119.) (7) Respiratory protection. The final standard, like the proposal, requires the use of respirators where employee expo sures exceed the permissible control level. Industry representatives marie a number .of objections to proposed requirements for respiratory protection. They stated that the "no detectable level" would ef fectively require continuous wearing of respirators In PVC and VC plants, and that this is not feasible because respira tors are cumbersome, present a safety hazard, raid employees would not use them. ' We would agree that respirators have many drawbacks; the proposal did not contemplate them as a final solution. The record shows that the PVC Industry par ticularly may need several years before plant environmental levels can be re duced so that respirators arc necessary only occasionally. However, we cannot agree that respiratory protection should not be required simply because It Is in convenient. may require additional per sonnel, Interferes with production, or may require extensive retraining of em ployees and restructuring of woi Y. prac tices.' We have carefully considered all the objections, and have concluded that If the environmental level la not con trolled to the permissible exposure limit, then employees must be aflordcd respira tory protection. While exposures In excess of the per missible level do constitute a hazard, we believe that it is necessary to mitigate some of the problems associated with implementing a program of respiratory protection while employees are being fitted and trained in respirator use, and while other adjustments which may be required are implemented. Therefore, until January I, 1976, where exposures are not in excess of a 25 ppm ceiling, each employer must provide each em ployee with an appropriate respirator. However, employees whose exposures do not exceed a 25 ppm ceiling, may decline to use the respirator, in which case the employer Is not obligated to require Its use. During this adjustment period, em ployees will be trained In the uses, pur poses and limitations of respirators, and the hazards of exposure to vinyl cidoridc. Moreover, each employee will be notified trations. In discussions of these findings with NIOSII. It has Indicated that It Is willing to consider on an expedited basis the approval of air-purifying respirators for use'" against VC. Consequently, we have included three types of air-purify ing respirators in the list of acceptable units, subject to the approval of such units by NiOSH. The maximum concen tration for which each respirator may -be used is based upon our evaluation of the data submitted by NIOSH and Goodrich. Because air-purifying respi rators do not Indicate sorbent exhaustion or breakthrough of VC, and because VC has no inherent warning properties at levcLs for which these devices are used, strict administrative controls will be re quired for their use. Such controls in clude a program to assure timely re placement of canisters or cartridges and an alarm system to alert employees when vinyl chloride concentrations exceed the concentrations allowed for the particu lar type of respirator in use. (8) Hazardous, operations. This is a Ticnt a .he tc: agent" dead. Urucfi. stance dilutee We a: with f. v.-c roi be full pcssie' Coup:, in the and 1. form tion. : persov The tive : train: that i cr la that an u: end. in writing If he lias been exposed in ex cess of the permissible exposure limit. Where exposures exceed a 25 ppm ceil ing, respiratory protection Is mandatory in light of our judgment that much greater risks are associated with such new section within the final standard. It encompasses essentially the proposal's requirements for maintenance and de contamination but has restated them in terms ox performance language to allow greater flexibility for employers to deai on f forr. cynv. info: perr. in a- *T" exposures. Tile provisions In the final standard regarding the selection and use of respi ratory protective devices differ from with such operations. The Intent of the new section is to protect employees en gaged in activities that present a risk of exposure to vinyl chloride in excess of the ' labs . bee; to i. those in the proposal. The descriptions of permissible levels. An example would be atmosphere-supplying respirators have the cleaning of a filter where resin con been revised to indicate more clearly the taining high residual monomer l; fc ru de v star types of devices intended, and the maxi trapped. , pee- mum permissible concentration level for The proposal's requirement for full- coi- each device. Moreover, the number of body, impervious clothing has been re ecr types of atmosphere-supplying devices placed by the direction to use impervious si-.- has been increased. garments suited ter the particular situa At the hearing Mr. Edwin C. Hyatt, an tion and probable extent of exposure. t th:. pa: OSHA consultant, made suggestions re Thus, full-body clothing is not always garding the use of particular respiratory necessary, and is there-(ore not required devices. We have concluded that his sug where less protection is adequate. Since vs nr gestions are meritorious. Therefore, the vessel entry falls within the definition provisions for selection of atmosphere- of a hazardous operation, the vessel entry- supplying devices follow closely tire rec section of the proposal has been deleted ommendations contained in his testi from the final standard. p: mony of SPI and B. F. Goodrich) (TR (9) Emergency situations. The defini EE with Hyatt's suggestions. (See e.g. testi tion of emergency has been recast In mony of SPI and B. F. Goodrich) (TR terms of an unexpected massive release. nt ta. 5 fi) We had originally omitted airpurifying respirators because none had been approved by NIOSH for use against VC, principally because they lacked in The main objection to the section on emergency situations in the proposal was that, as the term was defined, manyordinary leaks or operations resulting in tii tit ir. ir dicators to signal the c-xpiration of the a small release of vinyl chloride would be l'c service life of the sorbent. Ilyatt and considered emergencies. Tibs was not other witnesses discussed in detail the the intent of the proposal. The final desirability of being able to use canisters standard has been clarified to correct or cartridge ail-purifying respirators, this ambiguity. It should be noted that provided a sorber.t ccuid be shown to the written operational plan required by ch'eclively absorb vinyl chloride with an the standard need not be developed for adequate service life. Recently. OSHA minor excursions above the permissible has received respiratory data from labo exposure limit, and that such excursions ratories regarding the cGectivencss of need not be reported. commercially available canisters and (10) Signs and labcis. The thrust of the cartridges for vinyl chloride. These eval signs and labcis section is to apprise uations were conducted separately by employees of the eancer and fire haz NIOS1I and by Die B. F. Goodrich Com ards. No objections have been raised with pany and submitted to OSHA in postbearing comments. The results indicate Hint certain presently available canis respect to informing employees of the fire hazard. However, a number of ob jections were raised at the heaving and in written submissions to the require ters and cartridges effectively absorb ment tii.vt the word "cancer" appear oil vinyl chloride at relatively low concen all signs and labcis. The principal nrgu- fEDERAl REGISTER, VOL 39, NO. 194--Tf.lDAY, OCTOBER 4, 1974 DTH 000066928 RULES AND REGULATIONS / 35S95 'vnncc. against Its use was that indicated that the medical tests proposed *rm "career" or "canccr-suspcct arc currently the only ones available 1 ..cares employee.', and that .in- which arc uv-iul lor medical surveillance the me sage should contain in- Cm 121, Exh. to. Tit 58fi-D31). Conse (ions on how to deal with the sub- quently, the specific blood tests, proposed re <TR. 317'. We believe that a have been retained as a minimum re 'diluted form o: v.nniin; will not suffice. quirement to assist, the examining physi \Ve appreciate the eonrern of employers cian m determining fitness of potential with the reaction of their employees. But employees for assignment to workplaces we consider it imperative that a worker Invoking VC exposure. In addition, al be fub.v informed, and that he realise the ternative medical examinations may be possible risks involved in his occupation. used where the examining physician de CoupU-d with the training requirement termines that they are at least as good In the standard, we- believe that the signs as those specified by the standard. and labels required will adequately in The Tabcrshaw-Cooper study and the form employees of the hazard. In addi various animal experiments suggest that tion, such signs will warn unauthorised VC may produce a wide spectrum of ma personnel to-keep out cf regulated areas. lignant and noil-malignant disorders. The proper application of most protec The general scope of the rce,uircd medical tive measures requires an amount of examination has, therefore, been broad train!)!?-.' End indoctrination of employees ened to include kidneys, skin, connective that cannot easily be conveyed on a si,ail tissue, spleen, and pulmonary system, as or label. Also, the variety of measures well as the liver. No additional specific that could be prescribed would result in procedures or tests arc required, but rec an umvleluly or excessively detailed leg- ommendations have been included in the end. Consequently, the required message Appendix to assist the examining physi on sign:; and labels will not include in- cian. Because of the nonspecific nature formal: on on precautions, relevant of the required medical tests, it is not symptoms, etc. The addition of suitable appropriate to prescribe timing, or type information by the employer would be of followup tests, or to mandate with permitted, providing it does not detract drawal from exposure based solely on re ill any way from, the required statement. sults of the tests. Instead, the employer The requirement in the proposal for is required to obtain a statement from labeling containers of vir.yl chloride has the examining physician of the em been amended by deleting the reference ployee's suitability for continued expo to the possible hazard of violent polym sure, when the examining physician has erization. Very little information was completed such tests as he considers ap developed on this hazard during the propriate. The employer Is required to slandard-r-cUiDK procedure. Is does ap withdraw an employee only when this pear that this hazard is essentially under statement indicates that the employee control and that the f;rc and carcino may be at added risk from continued VC genic hazards at present arc the most significant. Since labeling or placarding that is in compliance with the US. De partment of Transportation regulations exposure. As with monitoring, there appears to be no basis for complete exemption ol the fabrication industry from the require (4f) CFJT Part 173, Subpart H) already ment for medical examination. The rec warns of the fire hazard, only a state ord does show fabricating establishments ment concerning the c.arcinortonic haz with concentrations of VC monitored ard need be added to the Department of considerably above the action level. In Transportation labels. these instances, medical surveillance of X1D Medical surveillance. Tire princi Effected employees will provide bac.ehne pal questions that have been raised re data for future evaluation of their health, gardin':-. medical surveillance are the even if both monitoring and medical sur necessity and efficacy of requiring cer veillance are discord blued because im tain specific serum enzyme determina proved controls reduce concentrations tions (SlvfA-12 series) and the applica below the action level. Where exposures tion o! medical examination require are below the action level, the medical ments to the fabrication segments of the surveillance requirements do not general industry whc-re employees arc exposed to ly apply. lower levels of VC. The objection has also (12; Training. A separate provision for been raised that the specification of tests employee training has been added to the and procedures interferes with the ap final standard rather than including it plication of advances in medical knowl within the section on emergency situa edge. 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 tions as in the proposal. The new para graph piovidcs for training of employees concerning the carcinogenic hazard of VC, emergency procedures, the need for monitoring and an annual review of the standard. It also provides for training of and, usually, within months of death. employees concerning the purpose for. Precursor physiologic nilcratkiv., which might be reversible, have not yet been directly associated with the hwicn. Con sequently. there are no specific diagnos tic tests which can be prescribed which will determine presence or absence of proper use of, and limitations connected with respiratory protection. U3i Aero re's r.::d reports. The previ sions for recordkeeping contained in I he finc.l standard require the preparation raid maintenance of essentially the : ime this tumor at nn early stave of develop information requited by the pioporal. ment. However, most mc-uical witnesses , The major change Item the original j ro- posul is the requirement for maintenance of monitoring records and daily roster sheets of authorized persons for 30 years. Instead of 20 years. Additionally, the cmploycr'is required to maintain medical records for the 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 implemented be cause the latency period for induction of angiosarcoma ranees up to 30 years from initial exposure. Therefore, as a miniintun. medical records must be main tained for at least that long. It should be noted that spokesmen for both labor and industry recommenced that this change be made. The reporting requirements are not significantly different from these in the original proposal. However, instead of the requirement for reporting incidents which result In the release of VC into areas where employees may be exposed, the final standard clarifies our original intent, by stating that only emergencies must be reported. Also the requirement for filing a detailed, written report within 15 days has been deleted. It has been concluded that submission, within 24 hours, of En initial report that in cludes facts immediately available, would ordinarily be sufficient. However, if the OSHA Area Director requests further In formation relevant to the emergency, the employer will be required to furnish such Information. (14) Deleted portions cf the proposal. The proposal contained provisions re quiring that shower facilities and change rooms be provided, and that storage or consumption of food be prohibited in regulated areas. We have deleted fiic.sc provisions because it is our conclusion they are no longer necessary. Showering facilities are not required because pro tective clothing, where required by tire final standard, should protect employees from skin absorption by direct contact with VC and because there is no reliable evidence that VC vapor is absorbed through the skin. In addition, sinre we anticipate that most employees will not be weaving protective clothing and that employees who wear protective clothing will change such clothing infrequently, we are not requiring that change rooms be provided. In addition, we feel that there is in adequate evidence showing that hazar dous amounts of VC car. be absorbed through ingestion. For this reason, the requirement prohibiting tire storage cr consumption of food in regulated areas lias been deleted. The proposal also eontalncd provisions on maintentance and decontamination, transportation loading and unloading, and polymer handling operations. These requi) eiv.ents are not, mentioned in the final standard because attention to these items. Is. Implicit in the yrguirement that each on mover rearh the pc-nnUT.able ex posure limit or cl.tain the lowest feasible level. (15) Cfcclivc date. In order to ensure that Effected employers and employees will be informed of the existence of these ,FPRAL fcCGUfilP., VOL. 39, NO. K(----- FRIDAY. OCTOELR A. 1V74 DTH 000066929 RULES AND REGULATIONS Mu -gl N \ .vision- find that employers affected krc r'vcr an opiwrtunily to f.nmSiuirizc Iherrmeiv; ; and their employees vviUj the existence cf tiie new requirement::.. the effective date of the amendment,' to S JP10.93q will be January 1.1370. To pro of the operation or because of an acc-i-' dent in tiie operation, which would result In nil employee exposure In excess of tiie permissible exposure limit. (3) "OGHA Area Diiector" means the Director for the Occupational Safety opportunity to observe the monitor ing and measuring required by this i paragraph. (c) jlcauiatcd area. (1) A regulated area shall be established where: (1) Vinyl chloride or polyvinyl chlcridc i (i; (u vide continued protection lor employees and Health Administration Area Office Is manufacturer;, reacted, repackaged, j until that date, the provisions currently having jurisdiction over the geographic storcQ. hTTTTTncn or uTTTT r.nd *" ~T contained In 5 IfllO.S.Iq sire hereby area in winds the employer's establish-/ --mi VITiTT ch'ioriucTtonccntrations arc j j promulgated, pursuant to section (jib), ment is located. . d in excess Of the riprrnl-.-ii-a p r.-rs-'W I / 6(c) ana 0(c) of tie Occupational Safety (5) "Polyvinyl chloride" means poly-^ limit. - 'f and Health Act. as an occupational vinyl chloride homopoiymer or copoly (2) Access to regulated areas shall be |- safety and health standard effective mer before such is converted to a fabri limited to authorized persons. A crib' I October 4, 1374.- the amendment to cated product. roster shall be made of authorized per- j 5 1019.331] set out below will supersede (10) "Vinyl chloride" means vinyl sons who enter. |* these provisions a;.: of January 1, 1375. chloride monomer. (f) Methods of compliance. Employee j Accordingly, upon consideration of the Permissible exposure limit. (1) No exposures to vinyl chloride she ll be con- i ^ whole record of this preceding. Part 1910 employee may be exposed to vinyl chlo trolled to at or below the permissible ex- ; of Tide C9, Code of Ferie-ra! Rc-rrularions ride at concentrations greater than 1 ppm pnsure limit provided In paragraph (c) j Is amended, effective January 1, 1575, by averaged over any 8-hour period, and of this section by engineering, work prac- I revision of l lSlO.CJq to read as follows: (2) No employee may be exposed to tice, and personal protective controls as I910.93q Yin.] chloride. vinyl chloride at concentrations greater follows: than 5 ppm averaged over any period not (1) Feasible engineering and work (a) Scops end application. (1) This exceeding 15 minutes. practice centre!? shall immediately be section includes requirements for the (3) No employee may be exposed to used to reduce exposures to at or fc-riow control of employee exposure to vinyl vinyl Usloride by direct contact with thc permissible exposure limit. ch'oridc (chlorocthcne), Chemical Ab liquid vinyl chloride. (2) Wherever feasible epidncerinq ar.d stracts Service Deyrictry No. 75015. - r Cel) fifonuorinp. (1) A" program of vrerk practice controls which can be in (2) This section applies to the mama-' initial monitoring and measurement stituted immediately are not su.'l.cier.*. to facture, reaction, pacha sing, rcpackag-' sha/l be undertaken in each establish reduce ex:->osures to at or below the- per ins, stora.se, handling or use of myl ment to determine if there is any em missible exposure limit, they snail r.cr.e- chloride or polyvinyl chloride,-but does ployee exposed, without regard to the use theless be used to reduce cxpcvur&s tc not apply to the handling or use of fabri of respirators, in excess of the action the lowest practicable levei, and shall be cated products made of polyvinyl chlo level. ' ga== - - supplemented by respiratory protection, ride.- (2) Y/here a determination conducted, in ritcordrm.ee with paragraph (g) rf trills (3) Tills section applies to the trans under paragraph (d)(1) of this section section. A program shall be criahlisicd portation of vinyl cliioririe or polyvinyl shows any employee exposures, without and impDm.cntrJ to reduce exposures to i chloride except to the extent that tiie regard to the use of res pi rn tors, in ex at or below trie permissible exp mure i Department of Transportation may cess of the action level, a T.-romam for de limit, or to the greatest extent fc.rgible, I regulate tiie hazards covered by this sec termining exposures lor each such em solely by mean? of engineering me work -, tion. ployee ebali be established. Euch &~prp- practice controls, as soon as feasible. (b) 'Definitions. (1) "Action level" kt am: ' -- (3) V/r it ten plans for such a program- | means a concentration of vinyl clricride (I) Shall be repeated at least monthly shah be developed and furnished upon i of 0.5 ppm averaged over an a-hour work where any employee is exposed, without request for examination and ropyir.j to | day. ' regard to the use of respirators, in ex authorized representative-; of '.lie Arsis- (2) "Assistant Secretary" means the cess of the permissible exposure limit. tant Secretary and the Diiector. Sucn j `Assistant Secretary o: Labor for Occupa (11) Shall be repeated not less (hail Plans shall be updated at least every fix | tional Safety and Health, U.S. Depart quarterly where any employee fa exposed, months. ment of Labor, or his designee. without regard to the use of respirators, (g) respiratory protection. VTr.rre (3) "Authorized person" means any in excess of the action ierei. respiratory protection is required under | person specifically authorized by the em (jii) May be discontinued for any em tills sc-ction: ployer y:hose duties require him to enter ployee only when at least two consecu (1) The employer shall proride a n regulated area or any perron entering tive monitoring hetormini-lidns, made not respirator which meets the requirements such an area ns r. designated rc-prmcnla- less than 5 working days apart, show ex of this paragraph and shall assure -ms: tive of employees for tire purpose of ex posures for that employee at or below the employee uses such respirator, cxec-pt ercising an opportunity to observe moni the action leveL that until December 31, 1575, wearing o' toring and measuring procedures. (3) Whenever there has been a pro respirators Ehrui be at the di'crchen cf (4) "Director" means tiie Director, National Institute for Occupational Safety r.nd Health, U.S. Department of Health, Education, and 'vvehare, or his designee. - (5) "Emergency" means any occur rence such as, but not limited to. equip ment failure, or operation cf a relief de duction, process or ccu-.rcl change which may result in an increase in the release of vinyl chloride, or the employer has any other reason to su-or-ct that any em ployee may be exposed in excess of the action level, a uc-icrmine.iic*n of employee exposure under paragraph id) (1) of this section shall be perform'd. each employee for exposures r.ot in ex cess o: 25 ppm. measured over r.xy 13nrir.uic period. Until December 31. 1375, each cmp'.oy-ee_v.-hq c-hcoses not to wear ::t eppropflr.te_rcf.pin-!tor riveril t? in,- Toffhed at Dnst quin leriy of 'theltr.r.-.ros `of vinj i`cb!cr:de and the purpose. proper use aria limitations" JsH-iir tory vice which is likely to, or oops, result fa (4) The method o: m.cr.iicrins and cc-VTce massive release of vinyl chloride. measurement shall 'nave an acruincy R~csoive.tors shall be selected from ' <C) "Fabricated product" means a product made wholly or partly from (with a confidence levei of CTi.percent) of list less than j-i-.is or minim 50 percent- ' .m.linai.n-n-e-g---~E(rh--nof---so-erc1 ej1 or-i,netnlyt nnnroved ana Sr.ieiy tv----i-h--e--- polyvinyl chloride, and which docs not from 0.25 throu.j:: CZ pr:::" pitis or m'ir.l-a ion. 1)03X1 i.-nent cT Tnc la.s rr. require further processing at tempera _o5"percent"from ever 0 5 m:m. through and the National Institute- for (vcv. 3tures, and for times, sufficient to enure J'.0"ppmrani? Thus crhr'uus 25 percent iicnai g.aiciy iynu Hualtii under trie pro mass melting of cite polyvm;. 1 chloride over 1.0 pom. C.t:thu ri trie thug thcsc- visions of 30 CPN Par: 11. resulting in the reiea.-.c of vinyl chloride. 1Ccc'Jrt:cy''u-q\:iretT>e:us me available in (3) A ri rr .ir:'ogy`paxi'crri.-.n pe'crcn; <7> "Harm-clous operation" menus any the "NIOSH Manual of Analytical morting the rc-nircme-n.Ls of i 1-712.134 operation, procedure, or activity where a Methods"). F,!mll be rr.tr.b.'isiiccl and rnaint.-.ir.ed. release, of either \in.yl chloride liquid or (5) Employ ?cs or th.r ir herignr.tad rep- <4) o,qrct:cn. ot rceipiralnis for vlny: 'ls might be expected as a corea-quer-ca - iesc::talives shall be nLordcu reasonable chlcridc- shnli be r.s follows: VDLfCDZRAl PtGlSTEP, 39, NO. 194--ftlDAY, OCTCSrg A, 1J74 t' DTH 000066930 Kt .' r . 14M RULES AND REGULATIONS . ; 35897 Ktnocphcric concentration of vinyl chloride Required apparatus (vl) Tlie purpose for. and a descrip tion of. tlie medical surveillance " Unknown, or above 3,000 ppm-- OpMi-circult, sclf-ronl-ftlntvi bmvthlns: npparntua, pre5- program: Hoi over 3,COO ppm----- fiuro demand type, with full facepiece. (A) Combination typo C r.uppltcd nlr respirator, pre5- (vii) Jbner-fTrncy procedures; (vill) Specific information to aid the ,,. BX1T9 demand typo, with lull or half Xuccplecc, \ . * had auxiliary self-contained air supply; or ' 0-5) 3'ypo C, cuppHcd r.lr respirator continuous flow type, with fvill or half facepiece, r.ud auxiliary - ` toU-contalned r.lr: ijpply. - (1H) ITot over 100 ppm-- (A) Combination type C supplied air respirator de- - ' izumd type, with full facepiece, nod auxiliary fcclf-conLalncd air puppir; or (E) Opc-n-circuit relf-containcd breathing apparatus with, full facepiece, in demand mode: or <C) Type C supplied air respirator, demmui type, vlth lull facepiece. (lv) Not over 25 ppm______________ (A) A powered tlr-purifying respirator with hood* helmet, full or half facepiece, r.nd a canister , ' * vhlch provides n. rerfice lilo ol at least 4 employee in recognition of conditions which may result in the release of vinyl chloride; and r (ix) A review of this standard at the employee's first training and Indoctrina tion-program, and annually thereafter! (2) Ah materials relating to the pro gram shall be provided upon request to the Assistant Secretary and tiie Director. / (k) / Medical surveillance. A program o medical surveillance shall be insti tuted for each employee exposed, with out regard to the use of respirators, to vinyl cliloride in excess of .the action hours for conconrations of vinyl chloride up level.- The program shall provide cach- *\ to 25 ppm. cr -Btam"employee with an opportunity for (B) Gas maah, front- or bach-mount cd canister which examinations and tests in accordance - provides n. service life of at least -1 hour? for with this paragraph. All medical ex concentrations of vJnvl chloride uo to 25 ppm, aminations and procedures shall be per (v) Not over 10.ppm_. (A) Combination type C supplied-air respirator, de formed by or under the supervision of a mand type, with half facepiece, and auxiliary Belf-contalned air r.upply; or (B) Typo C Buppllcd-E.ir respirator, demand type, with half facepiece; or (C) Any chemical carlrldpe respirator with an organic vapor cavlrklgo which provides a service life * ,v : -of at least 1 hour for concentrations cf vinyl chloride up to 10 ppm. licensed physician, and shall be provided without cost to the employee. (1) At the time of initial assignment. or upon institution of medical surveil lance; (ii A general physical examination shall be performed, with specific atten tion to detecting enlargement of liver, (5)(i) Entry Into untosm concentra tions or concentrations greater limn 36,000 ppm (lower explosive limit) may be made only tor purposes ol lire rescue; and (Ji) Entry into concentrations of less than 35,000 ppm, but profiler than 3,COO ppm mav be made only tor purposes of llfo rescue, firefighting, or securing equipment so ns to prevent n greater hazard from release of vinyl chloride. CG) Where air-purifying respirators are used: s _ (1) Air-purifying cnr.rdstcrs--or--c?.r. Irfdpcs shall be repiaced_j5rior to^the ) Sphr. fieri" of'"their service life or'.the 'end of the shift in'which they are first / used, whichever occurs first, and Cii) A continuous 'monitoring and alarm system shall be provided where conccntiT.tions of vinyl ch.loride could reasonably exceed the allowable concen_ trations for the (fences in use. Such sys tem shall be used to alert employees when vinv] 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. <11 Em- engaged in hazardous operations. Including entry of vessels to clean poiyvinyl cliloride rasidue f;I'em vers cl walls. shall l>c jirov! ded and ;required io wear and use; (i) Tter-p'ra'lory prole ction in Ct c cord- spleen or kicneys, or dysfunction in those (2) Protective garments sl'.al! be pro organs, and for abnormnities in s.)::n, vided clean and dry for each use. connective tissues and the pulmonary <i) Emergency sUvaUm:.-., A written. system (See Appendix A). o'b'*Tntional plan lor emergency fitua- (ii) A medical history shall be taken, TrofiuTshn 11 be Uiyclopcd 1pr.caeh fucih iy including the following-topics: sibling. handling,__or__cjfihew.vi.ie--using. (A) Alcohol intake; .yir.yl chlormc as a liquid or compressed <B) Fast history of hepatitis; - gas. Appropriate portions of the plan (C) Woik his Lory and past exposure shall be implemented in the event cf an to potential licpatotoxic agents, includ emergency. The plan shall specifically ing drugs and chemicals; provide that; <D) Fast Ids,lory of blood transfu (1) Employees engaged in hazardous sions; and operations cr correcting situations of ex (E) Past history of hospitalizations. isting hazardous releases shall be (ill) A serum specimen shall be ob- equipped as required in paragrapn (li> 'tallied and determinations made of: of this section; (A) Total bilirubin: (2) Other employees not so equipped (B) Alkaline phosphatase; shall evacuate the area and not return until conditions arc controlled by the methods required in paragraph (f) of this f.ccticn and the emergency is abated. f (j) \Training, Ezrh employee engaged is. I'-jiyl chloride or polyvinyl cliloride operations ahull be provided iraining in a program relating to the hazards of vinyl chloride and precautions for its safe use. O.) Tiic program shall include: (I) The nature of the health hazard from chronic exposure to vinyl cliloride including specifically the carcinogenic hazard; (C) Serum glutamic oxaiacetic trans aminase (3GOT); (D) Serum glutamic pyruvic transam inase (SC-PT) ; and (E) Gamma giusiamyl transpeptidnse. (2) Examinations provided in accord ance with this paragraph shall be per formed acleiLi.t: U) Every 0 months for each employe? who lias been employed in vinyl chlo ride 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 efterded appropriate (II) The specific nature of operations medical f urveillanee. which could result in exposure 1o vinyl (4) A statement of each employee's chloride in excess of the permissible suitability for continued exposure to limit and necessary protective slvys: vinyl chloride including use of protec (il) Tlie purpose for, proper use. and tive equipment and jetpirators, shail be nnee with pa raar.n pi is (c.) and u') of limivalions of resDirntory protective obtained from tlie examining physician this .s cclion: i iv.d (U> Frotrct i VC ra;Tnier.'s to pr event r.hin c or.tact v. ilh ' iquid vinyl r.b.i ori be c-r Wi hi poly vir.j;] c::ilorK! a reside!C f rem vessel. V.TillS. Ti ic pro* cellvc r a t: aen: a cfiir.U be sdcpLed i or V: c opera lion; fmd devices; (tv) The fire hazard and acute toxic ity- of vinyl cliloride, and the necessary protective steps; (v) The purpose for and r. description picmptly after any examination. A copy of the physician's statement shall bcTpre-\Tdcd cach cmj)!(ivec. --(5) If any employee's health would fir materially linpciicd by continued ex Its possible exposure conditions. of Ui-z monitoring program; posure. sucii employee shall be with- f[DtD.Al r.EOISUR, VOL 39, NO. 19<----FRIDAY, OCTGiiR A, 1974 DTH 000066931 -> I "7 RULES AND REGULATIONS r ois possible contact with vinyl tion which contradicts or detracts from (11) The number of employees In each the effect oi, any required warning, regulated area during normal operations. borntory armlvscs for all blo- information or Instruction. Including maintenance. pccimcr.r, Included in medical (mi Jlccords. (1) .All records.main (2) Emergencies, and the facts ob- ion.; shall be performed In labo tained in accordairce'--with this section taluablC'-nt that time, shall be .reported ratories licensed under 42 Clu Part 74. sivall--fn^ndc-t!i"_ns.me and -social secti- within 2! hours tu the OSIJA Area Di the examining p! ririan deter rify--number of each ^employee where rector. Upon request of the Area Direc mines that alternative medical examina ~ relevant,_ tor, the employer shall submit additional tions to those required by paragraph ' (2) Records of required monitoring information in writing relevant to the <k)(l) of this section will provide at and measuring, medical records, and au nature and extent of employee exposures . least equal assurance cl detecting med thorized personnel rosters, snail be made Hnd measures taken to prevent future ical conditions pertinent to the exposure and shall be available u;x>n request for emergencies of similar nature. to vinyl eliicrlcle. the employer may ac examination and copying to authorized (3). Within 10 working days following cept such alternative examinations as representatives of the Assistant Secre any nioITitoriHg-arid measuring which meeting tire requirements of paragraph tary and the Director. TlEcloscs- that any' employee 'has~becn (1c) (11 cf tills section, if the employer obtains a statement frem the examinin'? physician setting forth the alternative examinations and the rationale for sub stitution. This statement shall be avail (i) Monitoring and measuring records shall: (A) State the date of such monitor ing and measuring and the concentra tions determined and identify the Instni- exposed,_wIthout_rcgard' to the usc of respirators" in exccss of the~penms.slbic exposure- limit, each such employee shall lia'iiotificd in writing of the results of able upon request for examination and ments and methods used; the exposure measurement and the steps copying to authorized representatives of .tmhe Assistratmn-t dSueec:rceutaairyv ratnuud tuhiue uDmirector. ? (DJAipus end labels. (li^ontrancces to reg_u_l_a__te__d__ areas shall be pos_t_ed wiiitihxJcg- lbie signs bearing me it'ire hi f" CANCEK-SUKrr.CT Agent Area Autkokizqi (ID Include any additional informa tion necessary to determine individual employee exposures where such expo sures are determined by means other tiian individual monitoring of employees; and being taken to reduce the exposure to within_the permissible exposure limit. (o) Effective dales. (1) Until Janu ary 1, 1075, the provisions currently set forth In $ 1910.93q of this Part shall I PERSONNEL O.N-LT (C) Be maintained for not less than apply. (2) Areas containing hazardous oper ations'or where an emergency currently Exists shall be posted with legible signs Bearing the legend: Cancep.-Susi-lct Acen r in Tins Area PhotecTTVX EQUIPMENT lUlGOIKEH ACT! IOP.LLED Personnel Only (3) Containers of polyvinyl chloride resin waste from reactors or other waste contaminated v.iih vinyl chloride shall be legibly labeled: _" Contaminated with Vinyl Chloride CArcr?.-S'j.n:ixT Acent (4) Containers of polyvinyl chloride shah be legibly labeled: Poltvikyl Chloride (or Tkade Name) Contains Vjmvl Chloride VnrrL Chloride is a Can cm-Suspect Agent 30 years. (2) Effective January 1, 1975, the pro (11) Authorized personnel rcslcrs shall visions set forth In 1010.93q of this Part be maintained for not less than 30 years. (iii) Medical records shall be main shall apply. tained for the duraiicn of the employ ment of each employee phis 23 years, A.T'endix A--Supplementary Medical Information .. or 30 yea:-, whichever Is longer. When required tests under paragraph (3) In the event that the employer (k)(l) cl this cectloh chow abnormalities, cc-ascs to do business and there is no successor to receive and retain his rec ords for the prescribed period, there rec ords shall be transmitted by registered mail to the Director, and each cmrlc.ee the torts rhouid be repeated as r-uon as prac ticable, preferably within 3 to 4 weeks. If tests remain abnormal, consideration should be given to withdrawal of the cranluyce Iron, contact with vinyl chloride, while a more comprehensive examination Is maae. Individually notified in writing of this Additional tests which may be useful: transfer. A. For klduev dysfunction: urine nomina (4) Employees or their designated representatives shall be provided access to examine and copy records of required monitoring and measuring. (5) Former employees shall be pro tion for albumin, red biood cells, and ex foliative abnormal cells. B. Pulmonary system: Forced vital capac ity. Forced expiratory volume at 1 second, and chest rocntgcDogranr (porterlcr-anterlor, * H x 17 Indies). vided access to examine and copy re G. Additional serum tests: Lactic p.cld dc- (5) Containers of vinyl chloride shall be legibly labeled either: (I) Vinyl Chloride ErTixurLT Flammable Gas Cnduf. Cancer-Scsieict Agent . PinsideI or (11) In accordance with <9 CPR Part 173, Subpart H, with the additional quired monitoring and measuring records reflecting their ow n exposures:. (6) Upon written request of any em ployee, ft copy of the medical record of that employee shall he furnished to airy physician designated by the employee. <n) I'.cporis. (1) Not later than I month after the establishment of a reg ulated area, the following information hydre,genr.se, lactic acid dehydrogenase Isoenuyme, protein determination, and protein electrophoresis. D. For r. more comprehensive examination on repeated abnormal scrum tests: Hepatitis B antigen, and liver scanning. (Secs. C and 3, 84 Stat. 159G, J5D9 (29 U.S.C. C55, Gb7): Secretary of Labor's Order No. 12-71, 30 FR C754) legends: .1 shall be reported to the GSIIA Area Di Signed at Washington, D.C., this 1st CAMcnn-SusPECT Agskt applied near the labor or placard. (C) No statement shall appear on or rector. Any changes to such information shall he reported witliin 15 days. (i) The address and location of each cr-tsblir.hmcnt which hn.s one or more day of October, 3 974. John Stumper. 'Assistant Secretary of Lcbor. near any required sign, lr.be! or inslruc- regulated areas; and [FR Doc.74-33170 Filed 10-1-74:3:54 pm] l )I A' \ KDIRAl RIGriUR, VOL 39, NO. 194--III CAY, OCIOrES 4, 1774 DTH 000066932