Document Ev6RKz2adQ4yLLDvOLmZNaJ90

+* * l SI* * * i* * -v * 4v 4* i*4a Ip FRIDAY, OCTOSER 4, 1974 WASHINGTON, D.C. Volume 39 n Number 194 PART II * *. \* ** /t.Co. f i i p' * A .t *t \i \< .* *>3i*. i i 1 ii tr *f r. * \ t t* f ." tj j d Occu gfional Safety And Health Administration I '* r P i **-**> f* > f *" VV ** 4* * s-4 T 1 l TO VINYL CHLORIDE W* * t* Occupational Safety jand Health Standards ^ -* * *4 ^* r *4 *: * i4 n 4 .. * t* p. - .> it - ** #^ p * * 4* *P * i` * *> ; ii i.; il '!* * 4i * in Ii it t 1S tl 1L *1JT! I* f pI i 4I34 j t| l 3 .n < * :< 54 * * ih h t. !1 *j f 1> h pr iNJyl ? I s< !j 4. ri * - 1H+ ^ i' r#i - r > y *H * ' v .r* j* s i .i '1 VAB.0001041976 M i i-1 * * t- ** S5SD0 VH RULES AND REGULATIONS 1t f * A Title ployees from a rare liver cancer and abroad. OSHA proposed to revise CHAPTER XVII--OCCUPATIONAL SAFETY sarcoina< may have been oct upnltonally 1910.92q nnd published a comprehensive AND HEALTH ADMIN1S1 RATION, DE related. As a result of this notification proposal (39 FIT 1GH90) on May 10. .1974. PARTMENT OF LADOR and after consultation with NIOSII, nnd to protect employees from hazards of PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS n joint inspection of the 1). F. Goodrich exposure to VC. The proposal called for plant by OSHA. N10311 and the Ken limitation of employee exposure lo VC to tucky Department of Labor, a fact-find "no detectable level." ns measured by a Standard for Exposure to Vinyl Chloride ing hearing was announced on Janu sampling find analytical method sensitive Pursuant lo sections G(b>. 6<c>t nnd 8(c) of the Occupational Safety and Health Act of 1970 (84 Slat. 1593, 159G. 1599: 29 U.S.C. G55. G5?> Secretary of Labor's Order No. 12-71 <3G PIT 8754) and 29 CFH Part 1911, 1910.93 of Part 1910 of Title 29, Code of Federal Regu lations is hereby amended in the manner aet forth below, in order to provide an Occupational Safety and Health stand ard dealing with the exposure of em. ployecs to vinyl chloride. I. Background--11) Vinyl chloride. Vinyl chloride (chloroethene). Chemical Abstracts Service Registry No. 75014. Is & synthetic organic chcinical 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 ore widely used for containers, wrapping film, electrical insulation, pipe, conduit, and a- variety of other industrial and consumer products. Vinyl chloride has been made commercially in this country since 1939, and present production Is in exedss of seven billion pounds per year. The vinyl chloride industry divides into three segments: monomer production, polymer production, and fabrication. Production of the monomer is a 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 CPVC), a resin which is produced through batch processing. The conversion-of the VC monomer into a polymer or copolymer is an incomplete process, i.e., not all of the monomer is reacted, p'WTisiaDricated 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 of employees involved in the VC industry are employed by fabrication firms. Such firms range in size from those with few employees and simple equipment to large plants involving many employees and considerable capital. Vinyl chloride (VC), a gas at ambient temperature and pressure, is a chlori nated hydrocarbon, which heretofore has been regarded as haring moderate liver toxicity. The initial standard, contained ary 30. 1974 <30 Fit 3374> and held on to l ppm, with an accuracy of I ppm February 15,1974. rb50 percent. The proposal also called Information obtained from this hear-' for the establishment of regulated areas lng, particularly the preliminary reports and limited access to such areas to au of experiments conducted by Professor thorized persons. A requirement for Ccsare Maitonl of the Institute di On- monitoring of employee exposures was colosia. Bologna. Italy, demonstrated proposed, along with engineering and lssTirOPcwiIcewsattrme2pattifgpsaCaaeneaVtOawplimpotihpmteeoetoeeeitns9nxtilrSuhearubmhnsonganoOoaCofsoqomoaonocdpTpstiOderdItalruaigCilHynsdenhdnnereuVtennnrowttccioeutsnotrnhihnpleepuiktnynseeiddaF5itAoethCcnuttisnatantriNAsoeeetrgao.coahoAhvLtis0sslartetisurRpogea,dmserasshtprtrrsnntrieaIaaiormrypoh'ipsnrpwenwvtatraOlsnworsledpNdaiwblerilrwten1ticsneeeyaldptrwtnytiteraoehcgenaeheoo`.9siwtSiavtsyIiohlesgmlttotlllsxgorGcnnOeanih1rtethiehuprbnbeAerertaIAmophicnfi1maVt0levthsIktmceaatoaeelatooyedrnsSdhcs,dhrre5,pg.teeetoaecCntlsoefera9vi,otatkaeseeilo,tnaaeItemilaFwoirrintonoax13esdeoesImnisrerdhniasiVnnnorbnfd,nflnicdqi9pdrlst2lsyuphn*biocieerirpsnedueiycdnCtngen.lol7g5.eewedorelottuedyatwsdrgatyara5iiegarg0,4ch.fascoaserorolmersiteM,hnfeti.cedrntainse,h,tloerootsrbsaanbAmi*duaadoadioorooigcidutxvseaThmasaNnpeaynn1Tetqotudnltllnaaonpmleeaihtolpnrhti9dhncpbtdGt(dfucfosihpgtoiceormtrsti2r,osnnL7ewohdrialumluieohceeeei(corrloohtsyned4cettsggrTeibtadacxmhmedespPtfnosemunahw>o.humebefeahtnpy,eaoutSnitramosearle.le&teluebborgrwiewaeoai(IclsetaEideolfitaezdytrlan3)nhotneUdmtrarhassrsstsalsmenfterfdsneoR9tyuna2ugeedtef*iobeattsiiincrsaodwtoleahvimv5ononntndoroeueuucoanllorca,oibitefiito0pxeimlaFkofngpodsfbmsvndhebrtsfttftloeslpasefaohi,hietsntseRnrsi2meaagbtoooepaxeehahGrteweoeCetrr.denetelt50rlurphiemprsrmsphnxyasintIxvxweaart,Ce5r00viemddaoEoACltoearrtpiamvepnaedlo1r00menttipaoaiocrioalsagserocxctho2nltomtesCdppmdewh,ecoafedytimtrfdBpps3dettseppvseolioustnaioesbtoei,ovduiro*pmaeihaurr.iopnunaphemviibn1sceetrtiurimselimeemosloarnsrdeteancarcldnmta1meieierleteexaeaeyfllaeslses-oi,)hyfsse,dtrld,a.,sr.,ll^^',mnscasLpmeomtt1siahtai0afejtdpastptakbivpowgwmwannhhheenotioeiaer9axiteemuoaeuelr(ovnuiriexdngaeghrleerhwcnc7roo(rnfnciaanoIheseaRhibdrod(sonri5nmtm.drll4ltneeetec*rnel4t)aalmwcutiypneierseyymwwuu)athkn,ees(oAnmewrdii)esatl,Jaidiaia.3nnae,gnndgeairubnhgsoimndta,tcicurpwacnlnewerlEoraotgred)efsDgchlpeanhiHpuevcieedsonirneydaqatiinxdeesnn.ctswwritralnaesrahomucpgforegoansre3upteiooJtogrcd,tgpitMsJacrnwciimrpoaheuaelirr0hesaaooliulrsafaonmfedopciautriiptlige.enantdbuisnttsi,uadrmoennpteincnoeongaiicgGbddtirrniisqtnsotrdloueyyagieonderduxsssohciamphtnereivlantlaestyuagrrnvatinoeoeeportndbgie.ntceedteteyo2tsghsn*wae2eiicldrrtr,csyswnoaef1slccrtdnrys.sr4h.rloddei8gsonocoiesourssi1dscb,thm,Aeane,iopweoe,o.ldPotnton.u,oimfohnltseiiiornvOiinwae1itdorhtacnfvlnniiavtoderpenvwmIehtefBtgineof9hrdbcneewm(aotronteenttreSneruneagdeh3in7eeoetteJeisesimdnervrerrndehaertcdpcrafHJ9w4na,eeicieelro.hafcesatononsosraatecreo,uealstpqsktneaeAoMselraonatahFtgsubhrppottlarsnunrtiiuteiptspeesdxneionnppoveongeoifeseeirROotptsefptnecyrcnstconxpuodhiiodsnegfoagieecpe>dndreoaos.naeSasbdspoprirsincso.AMfirhptso1nraeeettcnognnercaet2rteesHotiloeiptadhttstrnif8Oldroicrddg5rdthtrnmihaetitcm.usimdaoifacebsiaetctlicwaA3eeuifif,mmm,mnddSieaaedyicrdenstlsAaoccicdcu0ncstteeoAiodmgelaaeieHtaheospipt1.optv3itinodnlw.tldtsmuepdnpuaigmurdle-sol9odylnla1i)csTnprAfttJieeientldao,biriaagn7ochhA0d.afptnsabtoeuhilrammxtgriarll4utassa,ugtsnoJtteeomeetidcflearoodtlanrieaiiee.merhifelmiotlgs.unhtangeeccdtqecneaaefmracpw1cylhtdtehnsepldgnonoppsotfTuisiitntytatn9ttmatinaoIinaeutioieiroaitiutr2irmrecehnennh7nvdbhonnoeocee2iddvcoacbnorr3ltrrr8rnsri4eeedegded5ndonoegiddokyft,f,tt, In Table G-l of 1910.93. established a ceiling value of 5C0 parts of VC per mil lion parts of air. (2) The emergency temporary stand exi>oscd to VC concentrations of 50 ppm for 7 hours a day. five days a week, for approximately 7 months, had developed' arcoma of the liver. dependent consultant, Foster D. Snell Corporation, to conduct studies of the feasibility of compliance at various ex posure levels. Including those proposed ard. On January 22. 1974. the Occupa (3) The proposed permanent stand by OSHA and others advanced by in tional Safety and Health Administra ard. Based on the demonstrated evidence dustry spokesmen. Snell was also com tion (OSHA) was informed by the Na of VC's carcinogenk ily in three animal missioned (o collect information regard tional Institute for Occupational Safety sjjccics (rats, mice and hamsters), and ing the economic costs of compliance. mu! Health (N'lOGlI) that the B. F. the substantial probability that VC had This action was announced at the close Goodrich Chemical Company had re been the causal agent in the cases of liver of the hearing, and Judge Myall further ported that deaths of several of its em angiosarcoma found in workers both here announced that the record would be kept J** * +* y n > rrOIXAl REGISTER, VOl. 39, NO. 194--fWDAY, OCTOBER 4, )974 VAB.0001041977 I J... T. mMh *% A t1 v * t m * I RULES AND REGULATIONS * 35S91 open lor a period of time beyond August studies of Maltonl-and Bio-Test labora may create* n carcinogenic hazard, the 23, to allow interested persons to corn- tories. Moreover, Mai tout's investigations amount of exposure which is hazardous incut In writing on the .siuuv. On Ai!uu;.t have demonstraletTa dbae-dopendetil re- must be deiermined. The Surgeon Gen 26, 137-1. OSH A announced thnt the pre * htlionshin for Induction of liur.orsrrRe., eral's Ad Hoc Committee referred to liminary study was available and that "mote tumors-occur at higher exposure above concluded that safe exposure levels comments were to be submitted no later levels), including angiosarcoma of the for carcinogenic substances cannot be than September 6, 1974 (09 FR 30S44). liver, in rats. The investigations of In scientifically determined. This position On September 13, 1974. OSIIA invited dustrial Bio-Test Laboratories have dem Is supported by the testimony of NIOSH comments on both the preliminary and onstrated & similar relationship for at the hearing, its recommendations for the final study, which was to be received both rats and mice. These investigators a standard of no detectable level, and by on or before September 25, 1974 (39 FR have induced angiosarcoma of the liver the testimony of expert witnesses from 33009). In.rats and mice at exposure concentra the National Cancer Institute. (G) m'iron7!2ctrfe! impact statements. tions of 50 ppm, ar.d in hamsters at high Several witnesses and persons who sub A notice of intent to file an environmen er concentrations of exposure. Additional mitted comments have taken a contrary tal Impact statement assessing the im tumors involving other organs, including view and have suggested that man is less pact of a proposed standard on occu the kidneys, lungs, and skin of exposed sensitive to biologic aberrations induced pational exposure to VC was published animals, were also observed in frequen by vinyl chloride exposure than experi In the Fedehal Register on April 24. cies much in excess of control animals. mental animals. Proponents of this posi 1974 (33 FR 14522). The notice invited The incidence of tumors in mice in the tion have argued that if humans were as any person having information or data Industrial Bio-Test Laboratories investi sensitive as rodents, an "epidemic'* of on tire environmental impact to submit gations is particularly pertinent. Of 200 cancer resulting from VC exposures It to 03HA by May 17, 1974. On June 12, mice (100 males, 100 females) exposed to should have already been discovered 1974, a draft environmental impact 50 ppm of vinyl cVJoride by inhalation for among employees. They also argue that statement was prepared and circulated eleven months, 100 died. Sixty-four ani the employees in whom tumors have been to all interested persons. Ten coiaies were mals died without gross postmortem observed are those who have considerable forwarded to the Council of Environ pathologic examination being performed. employment experience ns polymeriza mental Quality (CEQ), which published Of tile 36 remaining animals for which tion reactor cleaners. Because it is gen a notice of its filing and availability, in a gross postmortem pathologic examina erally ngreed that reactor cleaning in the Federal Register on June 25, 1974 tion was performed, 13 (36 percent) volved high exposures to vinyl chloride <39 FR 22975). A 45 day period was al were found with liver tumors (including in years past, it is argued that the lower lowed for the submission of comments on angiosarcomas), 21 (58 percent) with levels currently found in the workplace * the draft statement. On''September 5, lung turners, p (25 percent) with skin have not induced cancer and are thcre- 1974, the final environmental impact tumors, and one with a kidney tumor. fore safe. We reject this argument. statement was prepared and a copy of it and all substantive comments were sent to appropriate governmental agencies, private organisations, and other inter ested persons. CEQ published a notice of According to'the 1970 report by the Surgeon General's Ad-Hoc Committee on the Evaluation of Low Levels of En vironmental Chemical Carcinogens, tin* finding of cancer in two or more animal The fact- that approximately three- ` quarters of those employees with the longest exposure to VC (greater than 20 years since Initial exposure) have not yet been located, makes it impossible to availability for the final statement on 'September 6. 1974 <39 FR 32359). Tire submission of comment was invited un til September 25. 197 i. 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 this proceeding is one of the most exhaustive over relied upon by OSHA. It consists of pro and post-hearing comments and testimony received at both factfinding End rulemaking hearings, the studies and inspections conducted by OSHA person- nel, the environmental impact state ments, the economic and technical impact studies, and all other relevant information. In all, over 600 written com ments have 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, and specialists in many fields have been invited to submit information and have made their views, knowledge and experience available to OSHA. The en tire record encompassing these submis sions was thoroughly reviewed and . species may be extrapolatedJt&Jlvfic&Lo carcinogenic hazard to humans. Here, such a finding Was inatleTh 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 in view of the extreme rarity of this cancer In the U.S. adult male population (testi mony of Dr. Marcus Key, Director of NIOSH. at the rulemaking hearing). The findings of angiosarcoma of the liver in both experimental animals and exposed employees is compelling evi dence that exposure of humans to vinyl cliloritfe Induces tills tumor. Industry spokesmen, at the hearing, conceded that VC is carcinogenic for humans (e.g. testimony of Dr. McRumcy, Rulemaking hearing. 1941). Accordingly, it is con cluded that VC must be regarded as a human carcinogen, and the probable causal agent of angiosarcoma of the liver, and that exposure of employees to VC must be controlled. determine the actual number of affected employees. The cases of liver tumors ob served to date have an average latency period, since Initial exposure, of approxi mately 20 years. If it is assumed that in duction of angiosarcoma is a dose-relaled. phenomenon, and if employees en gaged in cleaning reactors did. in fact, receive larger doses of vinyl chloride. It would be expected that such tumors would be observed earlier for this em ployee population. For this reason, the significance of presumed lower doses cannot be 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 necesasrily 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. Schneiderman of the Na tional Cancer Institute emphasized dur Additional evidence of tumor induction ing his testimony that only about a fifth in a variety of other organs, including of longer-term heavy smokers develop lung, kidney, brain and skin, as well as lung cancer. Accordingly, the industry non-malignant alterations, such ns fi ' contention that exposure levels have brosis and connective tissue deteriora tion, indicates additional oncogenic and been dramatically reduced since the 191p\s is not reliable evidence that cur evaluated in reaching the determina tions sot forth below. II. Findings reyard lit a cnrcinoacnicity, exposure levels and feasibility--(1) Careinoycnlcity of vinyl chloride. The car cinogen" city of vinyl chloride for three animal species (rat, mouse, hamster) has been documented on Ilia record by the toxicolcgic properties of vinyl chloride.' which must be considered In establishing control regulations. (See testimony and rent levels of exposure are safe. Some industry spokesmen also sug gested that the apparent nonrandom results or studies by Bio-Test Labora distribution of observed cancer In em tories. Taborshaw-Coopcr, Maltoni, ployees may indicate an exposure thres NIOSH. and SclikolX.) hold for tumor Induction, based on varia (2) Exposure limits. Upon finding that tions hi the workplace design or prac exposure of employees to vinyl chloride tice and resultant employee exposures rtOttAl REGISTER, VOL 39, NO.' 194--FRIDAY, OCTOBER 4. 1974 * K VAB.0001041978 4* 44 35SD2 * 1 4 l iA 4 RULES AND REGULATIONS * * * * * trL * p t it i {testimony and questioning by Tonneco e.R., testimony of Sellkoff. Firestone. NCI, confident that industry will continue to Chemicals. Inc.). It has also been em and NXOSII.) do so. phasized that in only 3 of 8 polymeriza In our view, the demonstration of can (4) Cmic/usions. The conclusions be tion plants where employees have been cer Induction in humans at a particular low are based on a thorough review nud exposed to VC lor more than 30 years level is not a prerequisite to a determina evaluation of nil the evidence submitted. . have any employees developed angiosar tion that a substance represents a can Where decisions can be based on record coma of the liver. This argument is very cer hazard lor humans at that level. It evidence, this lias been done. Where, similar to that raised concerning vari would be imprudent to assume man to however, factual certainties arc Jacking ability cf past employee exposure. Al- be less sensitive to VC exposure than ex or where the facts alone do not provide ' though geographic and workprartice dif perimental animals in the absence of an answer, policy judgments have been ferences may ultimately he demonstrated conclusive evidence. It would also be un to be factors in distribution cf angiosar founded to assume that animals will not There Is little dispute that VC Is car-' coma. sufficient information is unavail develop tumors when exposed at concen dnofjwnic to man and wc so conclude. able to exclude from consideration of trations of VC of less than 50 ppm. However, the precise level of exposure risk those employees in workplaces for Should a sufficiently large number of ex which poses ft hazard and the question which eases of angiosarcoma have not perimental annuals be exposed to VC at of whether ft "safe" exposure level exists, been observed. concentrations of less than 50 ppm, cannot be definitively answered on the It has also been suggested that the Schncidermnn said that it would be ex record. Nor is it clear to what extent absence of cancer in a papulation of 335 pected that some would develop. VC in m exiJosures can be feasibly reduced. V/e Dow Chemical Company polymerization duced tumors. cannot wait until indirputable answers employees monitored over a period of 7 (3) Feasibility. There is virtually no to these questions are available, because years, indicates that exposure to vinyl .dispute that most, if not all. fabricators lives of employees ore at stake. There chloride at concentrations of less than arc currently capable of reaching ex fore. we have had to exercise our best 200 ppm is safe. (See study by Dr. Cook, posure levels of 1 ppm through engineer judgment on the basis of the best avail submitted at the hearing by Dow Chem ing controls. These employers employ able evidence. These judgments have re ical Company.) However, the group sur well over 95 percent of all employees ex veyed did not include all workers who posed to VC. Indeed, several fabricators had been exposed, and the missing em arc already operating .at this level (sec ployees included many who had the SPI testimony). However, industry longer term (over 20 years) exposures. spokesmen ha\'e universally claimed that Moreover, the statistically insignificant it is infeasible for the VC and the PVC size of the sample population decreases industries to remain below 1 ppm con tho possibility that tumors would be sistently, using engineering controls. In observed. addition, the Snell study on technical quired a balancing process, in which the overriding consideration has been the protection of employees, even those who may have regular exposures to VC throughout their working lives. Based on the available evidence and in view of tho above considerations. Includ ing feasibility, we believe that employee exposures to VC must be reduced to r. 1 Dow also presented preliminary data feasibility concluded that a 1 ppm ceil ppm time-weighted average (TWA). Wo tn testimony at the hearing on the pos ing is not feasible for the VC and PVC also believe that PVC and VC establish sible metabolic pathways of VC. The industries with prescut technology, but ments will. In time, bo able to attain that hypothesis presented was that VC may that the VC industry could currently at level through engineering coutroLs, and exert Its carcinogenic effect by a metab tain lower exposure levels than the PVC that fabricators can do so in the Im olite, and that the metabolite is pro industry. Labor union spokesmen and the mediate future. duced only when VC is metabolized by a Health Research Group, Inc., however, In addition to the TWA requirement, secondary metabolic pathway operating have suggested that such a level is at we have established a 5 ppm coiling only when enzymes regulating the pri tainable. (averaged over a 15-minute period) In mary pathway are saturated, as would Since there is no actual evidence that order to prevent exposure of employees be the result at higher exposures. The any of the VC or PVC manufacturers to unacceptable high exclusions. From preliminary data indicated the possi have already attained a 1 ppm level or In an operation standpoint, this celling bility of an additional pathway for fact instituted all .available engineering level Is realistic because minor excur metabolism of -VC in rats exposed to con and work practice controls, rny estimate sions up to the ceiling level are likely to centrations of VC in excess of 220 ppm. as to the lowest feasible level attainable occur on a regular basis. However, the occurrence of angio sarcoma in both rats and mice at VC exposure concentrations of 50 ppm in dicates that if a metabolite of VC is the ultimate carcinogen, then it must be generated at lower exposure concentra tions in these species. Although this re search may be helpful to the thorough understanding of the carcinogenicity of VC, It appears that It does not yet oiler evidence which can assist in determina. tlon of safe exposure concentrations for employees, or even that such safe ex posures exist. ' A number of witnesses representing employers have stressed that there is no evidence of cancer, either in employees or experimental animals, at exposure concentrations of VC less than 50 ppm. (See e.g.. testimony of Firestone, Tcnneco Chemicals.) The conclusion of these witnesses was that no decision can be made concerning risk of exposure to VC at concentrations less than 5o ppm. On the other hand, the testimony of most expert witnesses, including some in dustry biomedical experts, stated that quantification of a safe exposure con must necessarily involve subjective judg ment. Likewise,.tbe projections of indus try. labor, and others concerning feasi bility arc essentially conjectural. Indeed, as Firestone has suggested, it is not pos sible to accurately predict the degree of improvement to be obtained from en gineering changes until such changes are actually implemented. \Vc 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 attain levels of 1 ppm TWA for most Job classifications most .of the time. It fs ap parent that reaching such levels may re quire some new technology and work practices. It may nlso be nocessmy to utilize technology presently used in other industries. In any event, the VC and PVC industries have already made great strides in reducing exposure levels. (See testimony of Dow Chemical Co., Tit 973). For example. B. P. Goodrich testified (171 1120) that it has reduced aversgo exposure levels in several PVC plants III. The final standard--(1) Scope and application. Both the ETS and the pro posal would apply the standard to tho entire VC Industry, including manufac turers of VC and PVC and fabricators, but excluding employers handling or using fabricated products made from VC. There* Is no dispute that a standard Is required for the monomer and polymer industries. However, the Society of Plas tics Industry (SPI) and various fabrica tors (sec testimony of Goodyear, Gen eral Cable, etc.) recommended that fabricators be excluded from the stand ard. or that a separate requirement be established for them because many cf them were already at or below the 'pro posed ceiling level. Tho record evidence establishes that at least some employees In the fabricat ing Industry are exposed in excess cf the permissible control limits tSec NICSI I testimony, TR 106; Robintech TR 642). In tlicie circumstances, we believe that it is imprudent to r.rant a blanket exemp tion for all fabricators. Therefore, tho centration Is not possible with the pres from 35-40 ppm early tills year to 12--13 final standard is applicable to the fabri- . ent state of scientific knowledge. (See ppm at the time of the hearing. Wc are cation Industry, as well as the monomer - ROESAt REGISTER, VOL 39, NO. 194--fRIOAY, OCTOBER 4, 1974 I w VAB.0001041979 4 4 fIt t ;( i! s t -------- A-..-L 4 % 1t h * * *. t jr \ v * ** f ' i% * *i * a *r * *% #b- 1 t p 1. V - RULES AND REGULATIONS ^' 35893 +* a and polymer industries. Employers who, temperature as PVC. for further pro below the action level, no further moni \ to fact, are substantially below the ex cessing. indicates that n potential for re toring is required unless the employer posure limit will be subjected to only lease of the residue still exists. It ap has reason to suspect that any employee minimal burdens by virtue of the "action pears that the exemption of fabricated is exposed In excess of the action level, level-* to be discussed below. products should be limited to just those or unless changes have been made in Where employers in the fabricating items which will not undergo such mass production, process, control, type of resin, industry have exposures approaching the heating. Further, the opi>ortunity to etc. permissible limit, they will appropriately demonstrate that exposures are below Where the exposure level, without re be subject to 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 a sible levels, monitoring must be conduc made of PVC were not included in the more positive control and an adequate ted at least monthly. Where exposures ETS or the proposal and are excluded relief. are less than the permissible levels, but from the final standard. This conclusion (2> Permissible exposure 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 linal standard clarifies the ex- ceiling of 5 ppm averaged over any per ard, like the proposal, requires that em . emption by defining 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 does not require further limit is based on an evaluation of the best to reduce exposures to at or below the processing at temperatures, and for available evidence and on a judgment permissible exposure limit. times, sufficient to cause mass melting of that the health and safety of employees Where feasible engineering and work the PVC. SPI and others (cf. TR. 344) 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 that the 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 14 carcinogens from 29 CFR 1910.93p (S3 FR 375G) was an appropriate precedent. The cases are not comparable, because no attempt had been made to set air concentration limits for the 14 carcinogens. The record did not Include information that reliable moni toring and measuring techniques were available. Moreover, the exemption did not exempt airborne traces of carcino gens. The administrative 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 that SPI has doubts about the safety of 0.1 percent residue level. Diamond Shamrock (Exhibit 142) testified that there is no direct relation. They indicate that the airborne concentration is more related processes are variable, the 1 ppm ceiling not reduce exposures below the permis level provided in the proposal would sible level, they must nonetheless be im require maintenance of an average level plemented to reduce exposures to the significantly more 'difficult to attain lowest practicable level, and be supple through feasible engineering controls. Therefore, the exposure limit prescribed mented by the use of respirators to pro vide the necessary protection. There in the proposal has been rejected. upon, a continuing-program of engineer (3) Action level. The final standard, ing and w'ork practice controls must be unlike the ETS and the proposal, pro instituted to reduce exposures to the low vides for an "action level" of 0.5 ppm est practicable level. When exposures are TWA, one-half of the permissible ex at or below the permissible exposure posure limit. The purpose of the action limits, the program may be discontinued. level is to minimize the impact of the In addition, a plan for achieving con standard on the employers who have trol by engineering and work practice attained exposure levels well below the methods must be drawn up and be made permissible limit. Thus, where the re available, upon request, to represent sults of monitoring under paragraplis atives of OSHA and NIOSH. (d)(1) or <d) (2) demonstrate that no employee is exposed in excess of 0.5 We recognize that many employers eovered by the standard can not cur ppm TWA, employers may. In effect, be rently achieve compliance with the per exempted from some provisions of the missible exposure limit solely by the use standard. For example, fabricators who are below the action level are not re of feasible engineering and work practice controls. The record also reflects broad quired `o provide medical surveillance or generic distinctions between the compli to monitor again, unless the employer ance capabilities of the VC and PVC has reason to suspect that any employee industries. Some industry spokesmen, is exposed in excess of the action level. including SPI (TR. 358-362), recom In. our judgment, exposures below the mended that a schedule of different per- action level do not present a sufficient missiie exposure limits and compliance hazard to warrant application of the en dates be established for the VC and PVC tire standard to the many employers who segments of the industry. Jto the physical form of the resin and the ventilation provided. Also, monitor ing data from industry (cf. Exhibits 131, 168. 170J and OSHA (Exhibit 151) indi cate that levels in excess of 1 ppm may be found in fabrication operations. In view of these facts and of the opportunity for employers to discontinue many duties upon a showing of no exposures above the action level, it does not appear that any residue exemption is either justified or necessary at this time. This course also agrees with p, number of Industry pro posals (cf. TR 6G0). are or will be below that level. (4) Monitoring. Hie final standard, like the proposal, requires that individual employee exposure levels be determined. This view assumes that the ability and the time required to feasibly reach in creasingly lower control levels is similar within each industry, but differs mark edly between industries. While the record or rfffinlt"oringTBome wlthessesland does suggest that such differences do persons who" submitted comments did- exist between industries, as noted above, not understand the meaning of the term it is clear that intra-industry differences "95 percent confidence level" hi the also exist. Thus, the ability and time re proposal. Essentially it means that the quired by each employer to attain lower employer is required to take a sufficient control levels may depend upon such number of measurements so that the re factors as the climate in which the plant sults obtained are statistically valid. We fa located, the age of equipment, the size have modified the proposal to establish of reactors, or the type of resin manu SPI (TR 345), among others, asked accuracy range requirements for various factured or used. (Snell study. Firestone that compounded PVC pellets be ex measurement levels. These ranges are testimony, etc.) 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 swell intra-industry variations, (See, cause harmful or measurable emissions. broad enough to allow the application e.g. Dow, Firestone, Tcnneco.) While Jt appeals that PVC pellets would of a variety of technologies As noted above, the standard requires have a lower residue level than virgin All covered employers nre required to alt 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 moss at the same toring and measuring results are at or to continue to improve and apply engi- * 1 -' ' _ VAB.. oa FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOfilt 4,, 1974 *A 3S&A 4+ %* ** * 4 * i 'laccrlng controls until full compliance Is achieved. - - We have not established any deadlines for full compliance through engineering controls because we arc presently unable to determine when It will be feasible for most establishments to reduce 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 as practicable will provide for inter-indus try and intra-industry technological dif ferences which do exist, and will avoid the setting of separate industry stand ards on the basis of the general situation and conditions in each industry. ' <G) Regulated crcas. The proposed standard would have required that regu lated areas be established, tiiat access be limited to 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 Hot 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, such as contractors, truck drivers, customers and consultants. The purpose of establishing regulated areas in the proposal was to limit the risk of exposure to as few employees as possible. This concern is still paramount, and thus the limited access feature re mains. The final standard amends the proposal slightly to allow "authorized persons" to enter regulated areas. This 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. This change was based largely on epidemio logical considerations. (See NIOSH testi mony, tr. 119.1 (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 made a number of objections to. proposed requirements for respiratory protection. They stated that the "no detectable level" would ef fectively require continuous wearing of respirators in PVC and VC plants, and that this Is not feasible because respira tors are cumbersome, present a safety hazard, and 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 are necessary only occassionally. However, we cannot agree that respiratory protection should pot be required simply because it Is In convenient, may require additional per sonnel, interferes with production, or may require extensive retraining of cm* ployees and restructuring of work prac tices.' We have carefully considered all the objections, and have concluded that ft . , 4 4 r*. I ' * 0* 9-n RULES AND REGULATIONS ** * * -ta % 1, .1 \ "7 .* ^ if the environmental level Is not con trattons. In discussions of these findings trolled to the permissible exposure limit, then employees must be afforded respira tory protection. While exposures in excess of the per missible level do constitute a hazard, wc believe that it is necessary Tto 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 1, 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 chloride. Moreover, each employee will be notified in writing if he has 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 exposures. - The provisions In the final standard regarding the selec tion and use of respi ratory protective devices differ from those in tlie proposal. The descriptions of atmosphere-supplying respirators have been revised to indicate more clearly the types of devices intended, and the maxi mum permissible concentration level for each device. Moreover, the number of types of atmosphere-supplying devices has been increased. At the hearing Mr. Edwin O. Hyatt, an OSHA consultant, made suggestions re garding the use of particular respiratory devices; We have concluded that his sug gestions are meritorious. Therefore, the provisions for selection of atmosphere- with NIOSH, It has indicated that it is .M willing to consider on nn 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 >t_c_adj, jtructie stance diluted We a;with Lwc cor. be full of the data submitted by NIOSH am! Goodrich. Because air-purifying respi rators do not Indicate sorbent exhaustion or breakthrough of VC, and because VC has no inherent warning properties at levels for which these devices arc used, strict administrative controls will be re quired lor 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 new section witlffn the final standard. It encompasses essentially the proposal's requirements for maintenance and de contamination but has restated them in terms of performance language to allo>v greater flexibility for employers to deal possii.'; Coupl. in the and In form tion, l persor The tivo ; train* that f or la' that i an u: end. ` on si form sym; infoi perr. in a* 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 permissible levels. An example would be the cleaning of a filter where resin con i TJ labc.. . bee: to U triz ; dev taining high residual monomer Is ! star trapped. ! PCS: The proposal's requirement for fullbody. impervious clothing has been re placed by the direction to use Impervious \ con1 ger. si? garments suited ter the particular situa tion and probable extent of exposure. ; the. 5 pai Thus, full-body clothing is not always ; (4C necessary, and is therefore not required ; wa: where less protection is adequate. Since j me vessel entry falls within the definition ; an. of a hazardous operation, the vessel entry Tr: supplying devices follow closely the rec section of the proposal lias been deleted ommendations contained in his testi from the final standard. it P?i n mony of SPI .and B. P. Goodrich) (TR (9) Emergency situations. The defini g? with Hyatt's suggestions. (See e.g. testi tion of emergency has been recast in nt mony of SPI and B, P. Goodrich) (TR terms of an unexpected massive release. 85 ff) We had originally omitted air- The main objection' to the section on I ta: tk purifying respirators because none had emergency situations In the proposal was tk been approved by NIOSH for use against that, as the term was defined, many xn VC, principally because they lacked in ordinary leaks or operations resulting in in dicators to signal the expiration of the a small release of vinyl chloride would be lc service life of the sorbent. Hyatt and considered emergencies. Tiffs was not b other witnesses discussed in detail the the Intent of the proposal. The final a desirability of being able to use canisters standard has been clarified to correct P or cartridge air-purifying respirators, this ambiguity. It should be noted that e provided a sorbent could be shown to the written operational plan required by effectively absorb vinyl chloride with an the standard need not be developed for n adequate service life. Recently, OSHA minor exclusions above the permissible has received respiratory data from labo exposure limit, and that such excursions ratories regarding the effectiveness of need not be reported. commercially available canisters and' GO) Signs and labels. The thrust of the c c c cartridges for vinyl chloride. These eval signs and labels section Is to apprise' k. uations were conducted separately by employees of the cancer and fire haz NIOSII and by the B. F. Goodrich Com ards. No objections have been raised with pany and submitted to OSHA, in post- respect to informing employees of the hearing comments. The results indicate that certain presently available canis fire hazard. However, a number of ob jections were raised at the hearing and in written submissions to the require ters and cartridges effectively absorb ment that the word "cancer" appear on vinyl chloride at relatively low concen- all signs and labels. The principal argu- * *1 *4 # * FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 VAB.0001041931 14 I. * ' * 4 if &-- RULES AND REGULATIONS 35S95 \ taent advanced against Its use was that Indicated that the medical tests proposed posal Is the requirement for maintenance tine term "cancer** or "cancer-susi>cct arc currently the only ones available of monitoring records and daily roster agent* scares employees and that .In which arc useful for medical surveillance sheets of authorized persons for 30 years. stead, the message should contain in (TR 121, Exh. 95. TR 589-591). Conse Instead of 20 years. Additionally, the em structions on how to deal with the sub quently, the specific blood tests proposed ployer is required to maintain medical stance. (TR. 347'. Wc believe that a have been retained ns a minimum re records for the duration of an employee's diluted form of warning will not suffice. quirement to assist the examining physi employment plus 20 years, or 30 years, We appreciate the concern of employers cian in determining fitness of potential whichever is longer. The original pro With the reaction of their employees. But employees for assignment to workplaces posal called for onfr 20 years. WS consider it imperative that a worker invoking VC exposure. In addition, al This change has been implemented be be fully informed, and that he realize the ternative medical examinations may be cause the latency period for induction of possible risks involved in his occupation. used .where the examining physician de angiosarcoma ranges up to 30 years from * Coupled with the training requirement termines that they are at least as good initial exposure. Therefore; as a mini in the standard, we believe that the signs as those specified by the standard. mum, medical records must be main and labels required will adequately in- The Taborshav.-Cooper study and the tained for at least that long. It should be ' form employees of the hazard. In addi various animal experiments suggest that noted that spokesmen for both labor and tion, such signs will warn unauthorized VC may produce a wide spectrum of ma industry recommended that this change personnel to .keep out cf regulated areas. lignant and non-malignant disorders. be made. Hie proper application of most protec The general scope of the required medical The reporting requirements are not ` tive measures requires an amount of examination has, therefore, been broad significantly different from those in the training and indoctrination of employees ened to include kidneys, skin, connective original proposal. However, instead of that cannot easily be conveyed on a sign tissue, spleen, and pulmonary system, as the requirement for reporting incidents or label. Also, the variety of measures W'ell as the liver. No additional specific which result in the release of VC into that could be prescribed would result in procedures or tests are required, but rec areas where emplos'ces ma3T be exposed, an unwieldly or excessively detailed leg ommendations have been included in the the final standard clarifies our original end. Consequently, the required message Appendix to assist the examining physi intent by stating that only emergencies on signs and labels will not include in* formation on precautions, relevant cian. Because of the nonspecific nature of the required medical tests, it is not must be reported. Also the requirement for filing a detailed, written report symptoms, etc. The addition of suitable Information by the empioycr would be permitted, providing it docs not detract in any way from the required statement. The requirement in the proposal for appropriate to prescribe timing, or type of followup tests, or to mandate with drawal from exposure based solel3' on re sults of the tests. Instead, the employer is required to obtain a statement from within 15 days has been deleted. It has been concluded that submission, within 24 hours, of an initial report that in cludes facts immediately available, would ordinarily be sufficient. However, if the labeling containers of vinyl chloride has been amended by deleting the reference to the possible hazard of violent polym erisation. Very little information was developed on this hazard during the standard-setting procedure. It does ap pear that this hazard is essentially under control and that the fire and 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. till 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 (BMA-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. the examining physician of the em- OSHA Area Director requests further in ployee's suitability for continued expo formation relevant to the emergency, the sure, when the examining physician has employer will be required to furnish such completed such tests as he considers ap Information. , propriate. The employer is required to (14) Deleted portions of the proposal. withdraw an employee only when this The proposal contained provisions re statement indicates that the employee quiring that shower facilities and change may be at added risk from continued VC rooms be provided, and that storage or exposure. consumption of food be prohibited in As with monitoring, there appears to regulated areas. We have deleted these be no basis for complete exemption of the provisions because it is our conclusion fabrication industry from the require they are no longer necessary. Showering . ment for medical examination. The rec facilities are not required because pro ord docs show fabricating establishments tective clothing, where required by the with concentrations of VC monitored final standard, should protect employees considerably above the action level. In from skin absorption by direct contact these instances, medical surveillance of with VC and because there is no reliable alXected employees will provide baseline evidence that VC vapor is absorbed data for future evaluation of their health, through the skin. In addition, since we even if both monitoring and medical sur anticipate that most employees will not veillance are discontinued because im be wearing protective clothing and that proved controls reduce concentrations employees who wear protective clothing below the action, level. Where exposures will change such clothing Infrequently, are below the action level, the medical we are not requiring that change rooms surveillance requirements do not general be provided. ly apply. ' In addition, we feel that there is in (12) Training. A separate provision for adequate evidence showing that hazar employee training has been added to the dous amounts of VC can be absorbed final standard rather than including it through ingestion. For this reason, the within the section on emergency situa requirement prohibiting the storage cr tions as in the proposal. The new para consumption of food in regulated areas A particular difficulty in considering graph provides for training of employees has been deleted. medical surveillance is that the most commonly discussed lesion, angiosar coma of the liver, currently cannot be concerning the carcinogenic hazard of VC, emergency procedures, the need for monitoring and an annual review of the The proposal also contained provisions on maintentance and decontamination, transporta lion loading and unloading, ` diagnosed imtll the victim is terminal standard. It also provides for training of and polymer handling operations. These and, usually, within months of death. employees concerning the purpose for, requirements are not mentioned in the Precursor physiologic alterations, which might be reversible, have not yet been directly associated with the lesion. Con sequently, there are no specific diagnos tic tests which can be prescribed which proper use of, and limitations connected with respiratory protection. U3) Records and reports. The provi sions for recordkeeping contained In the final standard require the preparation final standard because attention to these Items Is implicit in the requirement that each employer reach the permissable ex posure limit or attain the lowest feasible level. will determine presence or absence of this tumor at an early stage of develop ment. However, most medical witnesses and maintenance of essentially the same information required by the proposal. The major change from the original pro (15) Effective date. In order to ensure that affected employel's and employees will be informed of the existence of these 4* rj*- T -4 mr * 4f Ipt + t%* 4 & *I1-. V i *- 1> * l . kfc * t-l J*1v fx at -v 4? d -f r < '1 y* 4 *V k r A3 l I f1i * * 4 41 * i .FEDERAL REGISTER, VOL 3V, NO. 154--FRIDAY, OCTOBER 4, 1974 * ** VAB.00Q1041982 i i* * 35896 RULES AND REGULATIONS A U ACj sc A \ proyfatoas and that employers affected K9 dven aii opportunity to familiarise Ives and their employees with the Lee of the new requirements, the effective date of the amendment to f39i0.93q will be January 1,1975. To pro vide continued protection for employees until tliat date, the provisions currently contained In $ 1910.93q are hereby promulgated, pursuant to section 6(b), 6Cc) and 3(c) of the Occupational Safety and Health Act, as an occupational safety and health standard effective October 4, 1074,- the amendment to 5 1910.93q set out below will supersede these provisions as of January 1, 1075. Accordingly, upon consideration of the whole record of this preceding. Part 1910 of Title 29. Code of Federal Regulations is amended, effective January 1, 1975, b7 revision of 1910.93a to read as follows: % I910.93q Vinyl chloride. of the operation or because of an acci dent in the operation, which would result in an employee exposure in excess of the permissible exposure limit. <8> "OSHA Area Director" means the Director for the Occupational Safety and Health Administration Area Olllce having jurisdiction over the geographic circa in which the employer's establish ment is located. . (9) "Polyvinyl chloride" means poly vinyl chloride liomopolymer or copoly mer before such is converted to a fabri cated product. (10) "Vinyl chloride" means vinyl chloride monomer. Permissible exposure limit. (1) No npioyee may be exposed to vinyl chlo ride at concentrations greater than 1 ppm averaged over any 8-hour period, and (2) No employee may be exposed to vinyl chloride at concentrations greater than*5 ppm averaged over any period not opportunity to observe the monltoring and measuring required by this paragraph. <c> Regulated area. (1) A regulated area shall be established where: (1) Vinyl chloride or polyvinyl chloride is manufactured, reacted, repackaged. stored, riiinc ted or uSBEH and "Tit) VfflJT chloride concentrations are i ---------0f the pcnni-~:"'" --~ -- (2) Access to regulated areas shall be limited to authorized persons. A daily roster shall be made of authorized per sons who enter. TVjf) Methods of compliance. Employee j .ires to vinyl chloride shall be con- \ trolled to at or below the permissible ex- ; pnsure limit provided in paragraph (c) i of this section by engineering, work prac- i tice, and personal protective controls as ( follows: (1) Feasible engineering and work .( (l) V v. <tt) (til) flv) <&) Scope and application. (1) This exceeding 15 minutes. practice controls shall immediately be section includes requirements for the (3) No employee may be exposed to used to reduce exposures to at or below (V) control of employee exposure to vinyl vinyl cliioride by direct contact with the permissible exposure limit. chloride (chlorocthene), Chemical Ab liquid vinyl chloride. (2) Wherever feasible engineering and stracts Service Registry No. 75015. - ) Monitoring. (1) 'program of work practice controls which can be in 2) This section applies to the manu-* monitoring and measurement stituted immediately arc not sullicient to facture. reaction, packaging, repaefcag-* snan be undertaken in each establish reduce exposures to at or below the per ins, storage, handling or use of vinyl ment to determine if there is any em missible exposure limit, they shall none chloride or polyvinyl chloride, but docs ployee exposed, without regard to the use theless be used to reduce exposures to not apply to the handling or use of fabri of respirators, in excess of the action the lowest practicable level, and shall be cated products made of polyvinyl chlo level supplemented by respiratory protection ride.* ) Where a determination conducted In accordance with paragraph (g) ci this C3> Tills section applies to the trans under paragraph (d)(1) of this section section. A program shall be established lb; portation of vinyl chloride or polyvinyl shows any employee exposures, without and Implemented to reduce exposures to chloride except to the extent that the regard to the use of respirators. In ex at or below the permissible exposure ! Department of Transportation may cess of the action level.ji program for de limit, or to the greatest extent feasible, I b fi regulate the hazards covered by tills sec tion. - <b) 'Definitions. (1) "Action level** means a concentration of vinyl cliioride of 0.5 ppm averaged over an 8-hour work day. * termining exposures for each such pioyee chan oe established, suefi pro- be repeated at least monthly where any employee is exposed, without regard to the use of respirators, in ex solely by means of engineering and work r I practice controls, as soon as feasible. i (3) Written plans for such a program- I shall be developed and furnished upon ! request for examination and copying to authorized representatives of the Assis I l: r / C2) "Assistant Secretary** means the cess of the permissible exposure limit. tant Secretary and the Director. Such /[Assistant Secretary of Labor for Occupa (11) Shall be repeated not less than plans shall be updated at least every six tional Safety and Health, U.S. Depart- quarterly where any employee is exposed, months. j ment of Labor, or his designee. without regard to the use of respirators, ialjx cspirctory protection. Where 4 Vi C3) "Authorized person" means any in excess of the action level. respiratory protection is required ur.dcr |>erson specifically authorized by the em (iii) May be discontinued for any em this section: ployer whose duties require him to enter ployee only when at least two consecu (1) The employer shall provide a a regulated area or any person entering tive monitoring determinations, made not respirator which meets the requirements such an area as a designated representa less than 5 working days apart, show ex of this paragraph and shall assure that tive of employees for the purpose of ex posures for that employee at or below the employee uses such respirator, except ercising an opportunity to observe moni the action leveL that until December 31, 1975, wearing of toring and measuring procedures. (3) Whenever there has been a pro respirators shall be at the discretion, of (4) "Director" means the Director, duction, process or control change which each employee for exposures not in ex National Institute for Occupational may result in an increase in the release cess of 25 ppm. measured over any Id- Safety and Health, U.S. Department of of vinyl cliioride, or the employer has minute period. Until December 31. 1975; HHealth. Education, and Weliare, or his designee. '- any other reason to suspect t hat any em ployee may be exposed in excess of the each employee who chcoses not an appropriate respirator shall to wear be In- S 1 -<5) "Emergency** means any occur action level, a determination of employee formed at least jguarteriy"of the hazards rence such as, but not limited to, equip exposure under paragraph <d) (1) of this pFvinyf chlpridejmd the purpose, proper ment failure, or operation of a relief de section shall be performed. use. and- limitations of- iespir:jji>ry vice which is likely to. or oocs, result in (4) The method of monitoring and * massive release of vinyl chloride, measurement shall have an accuracy (6) "Fabricated product" means a (witha confidence level of 95 percent) of product made wholly or partly from not less thnn_plus oi* minus 50 percent, polyvinyl chloride, and which does not from 0.25 throuciio.5 -pi5mTplus,or.minus require further processing at tempera [TeTceht^Jrom over 0.5 pjun_through tures, and for times, sufficient to cause ppm, and plus or minus 25 percent mass melting of the polyvhiyl cliioride over l.O ppm. (Methods meeting these resulting in the release of vinyl chloride. aUCTlvacy "requirements arc available la TTTK splratory protection program (7) "Hazardous operation" means any the "NIOSH Manual of Analytical meeting the requirements of & 1910.121 operation, procedure, or activity where a Methods"). shall be established and maintained, release of cither vinyl chloride liquid or (5) Employ ets or their designated rep <4) S lection of respirators for vinyl gas might be expected as a consequence resentatives shall be aLorded reasonable chloride shall be as follows: b t-4 # rCOEHAl REGISTER, VOL 39, NO. 194--FRIDAY, OCTC5TB 4, 1?74 VAB.000104198 { -I 4* h I!- -*-* -*1 HI jltlllfc _E_L __ _j, Jw 1 i *M * 0 % 4 * ^* , *r a * * a* f Aimosphprte concentration vinyt chloride Unknown, or above 3,600 ppi ' - . tULES AND REGULATIONS * ^ V ,, * *. ^ *, * fa M - , ,.' '* ** * V *** ' * * - ; Jlegvfrrtf apparatus Open-circuit, Klf*coaMnc4 breathing apparatus, pres* 35897 4 4' (vi) The purpose for, and a descrip tion of, the medical surveillance program: Hot ter 3.600 ppm........ sure demand type, with full facepiece. (A) Combination typo C supplied, nfr respirator, pres (vii) Emergency procedures; (vili) Specific Information to aid the fttl) Hot over 100 ppm... 1 1 * 25 ppm__ *t ^/ \ * *# *^ 4- sure demand type, with full err half facepiece, . * - smd auxiliary scl (-contained air supply; or (B) Typo C, supplied air respirator continuous flow type, with full or half facepiece, and auxiliary * self-contained air supply. (A) Combination type c supplied air respirator de mand type, with full facepiece, and auxiliary t \ self-contained air supply; or (B) Open-circuit rcif-containcd breathing apparatus *a with, full facepiece. In demand mode; or (O) Type C supplied nlr respirator, demand type, with lull facepiece. (A) A powdred air-purifying respirator with hood* helmet, full or half facepiece, and a canister * which provides a service life of at least 4 hours for concenrations of vinyl chloride up to 25 ppm. or <B) Gas mask, front- or back-mounted cantster which employee in recognition of conditions which may result in the release of vinyl chloride; and r (lx) A review of this standard at the employee's first training and indoctrina- ; tion program, and annually thereafter: (2) All materials relating to the pro gram shall be provided upon request to the Assistant Secretary and the Director. / (k) I Medical surveillance. A program e medical surveillance shall be insti tuted for each employee exposed, with out regard to the use of respirators, to vinyl chloride in excess of ,ilie action. ,evcl,- The program shall provide each employee with an for examinations and tests li^accmdance 4 * - * .. ' provides a service life of at least 4 hours for with this paragraph. All medical ex concentrations of vjnvl chloride up to 25 ppm. aminations and procedures shall be per lO.ppm. (A) Combination type C suppllcd-alr respirator, de formed by or under the supervision of a mand type, with half facepiece, and auxiliary licensed physician, and shall be provided self-contained air supply; or without cost to t he employee. (B) Type C supplied-air respirator, demand type, with (1) At the time of initial assignment, V" " f ** (O) half faccpiccc; or Any chemical cartridge respirator with an organic 4 vapor cartridge which provides a service life .v ; -of at least i hour for concentrations of vinyl or upon institution of medical surveil lance ; (1) A general physical examination . chloride up to 10 ppm. shall be performed, with specific atten tion to detecting enlargement of liver, spleen or kidneys, or dysfunction in these (5V(1) Entry Into unkown concentra (2)Protective garments shall be pro organs, and for abnormalties in skin, tions or concentrations greater than vided clean and dry for each use. connective tissues and the pulmonary 36,000 ppm (lower explosive limit) may It} Emergency situations. A written system (See Appendix A). be made only for purposes of life rescue; tH^Wttional plan for emergency situa- (ii) A medical history shall be taken, and - "ttPruTshall be developed for each facility including the following'topics: (11) Entry Into concentrations of less storing-, hand'lltic.__or athcrwise^-Ufdn^ (A) Alcohol intake; than 30,000 ppm, but greater than 3,600 ^vinyl'chloride as a liquid or compressed (B) Past history of hepatitis; ppm may be made only for purposes of gas. Appropriate portions of the plan (C) Work history and past exposure llfo rescue, firefighting, or securing shall be implemented in the event of an to potential hepatotoxic agents, includ equipment so as to prevent a greater emergency. The plan shall specifically ing drugs and chemicals; hazard from release of vinyl chloride. provide that: <D> Past history of blood transfu (6) Where air-purifying respirators (1) Employees engaged in hazardous sions; and r* are used: rifvlng y?TiiV*fa>1r* '****" shall be rcnlacca prior to the service life or ihe operations or correcting situations of ex isting hazardous releases shall be equipped as required in paragraph (h> of this section; (E) Past history of hospitalizations. (ill) A serum specimen shall be ob`tained and determinations made of: (A) Total bilirubin; the tmre Ufi which they are first iw.mTtmw^rdeeiifS'fTi^r^ ~ War*11 v6m7 *\i*m* wvr**momt&rng and alarm system shah be provided where concentrations of vinyl chloride could reasonably exceed the allowable concen,, tratlons 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. otts operations. <1) EmR engaged in hazardous operations. Including entry of vessels to. clean poly (2) Other employees not so equipped shall evacuate the area and not return until conditions arc controlled by the methods required in paragraph (f) of Oils section and the emergency is abated. J^jATraininp. Each employee engaged nff^Wyl chloride or polyvinyl oldoride operations shall be provided training in a program relating to the hazards of vinyl chloride and precautions for Its safe use. (I) The program shall include: (i) Tiie nature of the health hazard from chronic exposure to vinyl chloride including specifically the carcinogenic hazard; (ID The specific nature of operations (B) Alkaline phosphatase; (C) Serum glutamic oxalacetlc trans aminase (SGOT); (D) Serum glutamic pyruvic transam inase (SGPT); and (E) Gamma rlustamyl transpeptidase. (2) Examinations provided in accord ance with this paragraph shall be per formed at least: (1) Every 6 months for each employee who has been employed in vinyl chlo ride or polyvinyl chloride manufacturing for 10 years or longer; and (ii) Annually for all other employees. (3) Each employee exposed to an emergency shall be afforded appropriate medical surveillance. vinyl chloride residue from vessel walls, which could result in exposure to vinyl (4) A statement of each employee's shall be provided and required to wear chloride in excess of the permissible suitability for continued exposure to and use: 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 paragraplis (c> and <g> of limitations of respiratory protective obtained from the examining physician this section: and devices; promptly after any examination. A copy (II) Protective garments to prevent skin contact with liquid vinyl chloride or with polyvinyl chloride residue from (iv) The fire hazard and acute toxic ity of vinyl cliloridc, and the necessary of the physician's statement shall be pro- ' Vidcd carh crnnlcypc? " vessel walls. The protective garments protective steps; TS) If any employee's health would be shall be selected for the operation and (v) The purpose for and a description materially impaired by continued ex its possible exposure conditions. of the monitoring program; posure, such employee shall be with- L A ? F1 4* 4 -I f' V' J fc I i- i fa I lF* l * y it *V .I *' f: ti I, I I **p- I6i"-,1i V t* FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOSIA 4, 1974 YAB.0001041984 i I 6 ir *I 'l t iisss r RULES AND REGULATIONS t drawn from- possible contact with vinyl ; tion which contradicts or detracts from A 1, (ill The number of employees In each chloride. / the cflect of, any required warning, regulated area during normal operations, (6) Laboratory Rnalyscs for all bio information or Instruction. including maintenance. logical specimens included in medical (m)Records. (1) All records^nmiQ.- <2) Emergencies, and the facts ob examinations shall be performed In labo tnined in accordance with this section, tainable at that time, shall be .reported ratories licensed under 42 CPU Part 74. sltftH-include-the name and ^social secu- within 24 hours to the OSHA Area Di <7) If the examining physician deter-^ rity--number of each'employee where rector. Upon request of the Area Direc rriincs that alternative medical examina-V"'relevant,_ tor. the employer shall submit additional tions to those required by paragraph (2) Records of required monitoring Information In writing relevant to the (IcKl) of this section will provide at and measuring, medical records, and au nature and extent of employee exposures least equal assurance of detecting med thorized personnel rosters, shall be made and measures taken to prevent future ical conditions pertinent to the exposure and shall be available upon request for emergencies of similar nature. to vinyl chloride, 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 monitormgrrttid measuring which meeting the requirements of paragraph tary and the Director. Tttsclo.ses that any employee has "been <k) (1) of tiiis section, if the employer obtains a statement from, the examining physician setting forth the alternative examinations and the rationale for sub stitution. This statement shall be avail able upon request for examination and copying to authorized representatives of (i) Monitoring and measuring records shall: (A) State the date of such monitor ing and measuring and the concentra tions determined and identify the instru ments and methods used; (B) Include any additional informa exposed,' without regard to the use of fespI ra16in "exccss of the~permlssj.bic exposure limit, each such employee shall notified ^hi writing of the results of the exposure measurement and the steps +r ,, . a - being taken to reduce the exposure, to the Assistant Secretary and the Director. (In Signs and labels. <1> Entrances to ulated areas shall be pos Riixnnifig- CAKCER-Su$Fr.CT AGENT AttEA AUTHORIZED Personnel Oni/t tion necessary to determine individual employee exposures where such expo sures are determined by means other than individual monitoring of employees: and (C) Be maintained for not less than within the permissible exposure limit. (o) Effective dates. (1) Until Janu ary 1, 1975, the provisions currently set forth in 1910f)3q of this Fart shall apply. (2) Areas containing HSiS'lWTOJH BSflffllg the legend: Cancer-Strsrlct Agent ih This Area Protec tive Equipment Required Authorized PERSONNEL ONLT 30 years. <ii) Authorized personnel rosters shall be maintained for not less than 30 years. (iii) Medical records shall be main tained for the duration of the employ ment of each employee plus 20 years, or 30 years, whichever is longer. (3) In the event that the employer (2) Effective January 1, 1975, the pro visions set forth in 1910.93q of this Part shall apply. Appendix A--Supplementary Medical . Information ., When required tests under paragraph (k)(1) of this section show abnormalities, (3> Containers of polyvinyl chloride resin waste from reactors or other waste contaminated with vinyl chloride shall be legibly labeled:. - - * i. '* Contaminated with ` - ' Vintl Ckloridc Cancer-Sue:*ect Agent <4) Containers of polyvinyl chloride hall be legibly labeled: Pokttinvl Chloride (or Trade Name) Contains Vintl chloride Vam Chloride is a Cancer-Suspect Agent ceases to do business and there is no successor to receive and retain his rec ords for the prescribed period, these rec ords shall be transmitted by registered mail to the Director, and each employee individually notified in writing of this transfer. . <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 vided access to examine and copy re the tests should be repeated os soon as prac ticable, preferably within 3 to 4 weeks. If tests remain abnormal, consideration should be given to withdrawal of the employee from contact with vinyl chloric!?, while ft more comprehensive examination Is made. Additional tests which may be useful: A. For kidney dysfunction: urine examina tion for albumin, red blood cells, and ex foliative abnormal cells. B. Pulmonary system: Forced vital capac ity, Forced expiratory volume at l second, and chest roentgenogram (posterior-anterior, 14 x 17 Inches). C. Additional serum tests: Lactic acid de <5) Containers of vinyl chloride shall be legibly labeled either: Q> - Vintl Chloride XriREUELT Flammable Oas Under Pressure Cancer-Suspect Acekt or (ill In accordance with 49 CFR Part 173, Subpart H, with the additional legends: quired monitoring and measuring records reflecting their own exposures. (6) Upon written request of any em ployee, a copy of the medical record of that employee shall be furnished to any physician designated by the employee. (n) Reports. (1)^ Not later than 1 month after the establishment of a reg ulated area, the following information shall be reported to the OSHA Area Di hydrogenase, lactic acid dehydrogenase Isoenzyme, protein determination, and protein electrophoresis. D. For a moro comprehensive examination on repeated abnormal scrum tests: Hepatitis B antigen, and liver scanning. (Secs. 6 and 8, 84 Stat. 1590. 1509 (29 U.6.C. C55, C57); Secretary of Labor's Order No. 12-71. 30 FR 8754) Signed at Washington, D.C.,. this 1st Cancer-Suspect Agent applied near the labor or placard, ' <6) No statement shall appear on or rector. Any changes to such information shall be reported within 15 days. (i) The address and location of each, establishment which has one or more day of October, 1974. John Stender, Assistcmt Secretary of Labor. near any required sign, label or lnstruc- regulated areas; and _ |FR Doc.74-23176 Filed 10-1-74;3:54 pm] 1* v * m4 t ^ I* . I V* t .4 m4 I2I4 - v * - >* A- . L **P- * 4_ * * * 4 4 r`1 ** I Vt* * p . N f* *'* - * V *1 44 *A u- m * * ft 4+ .1 i* + . t.r * 4* * t i * 4* 4 * f t * ,,J/1 ** > *- i + ,+ s Ij ** I t4 * * * 4' -i. i * ** j m* * 4 -I 4 4* va ^ l' }: \ f4 * # 4\ -9 i ^4 4* * V* *t .n r t**. *K .* *4 4* * 'I V* 1+ ? * < ^ *> ^ 4 * i - I 4* 4 fEDERAL REGISTER, VOL 39, NO. 194--IftlOAY, OCT08EI 4, 1974 .VAB.0Q01041985 r b j* f I t t fI 4 *a v* *+ m- 4 * * . 4 - 4I :J