Document N272ap37a7BXZ4Ky2mkGybVEE

- RULES AND REGULATIONS Title 29--Labor ployees from a rare liver rnnerr (nneln- and Abroad. OSHA proposed to revise ! T XVII--OCCUPATIONAL SAFETY Af HEALTH AilMiNIST RA TION, DEPA I MENT OF LABOR KA I 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS sarroma may have been occ up.aTionally related. As a result oi this not dil ation and alter consultation with NlOSll.nnd u joint inspeolion of l!ie D. K. Goodrich plant by OSHA, NIOSIT and L'ic Kcnluclty De larlnieni of Labor, a fact-find l'J10.92n and published a eomprchenMve 'proposal (39 FIT IGllMt on May 10. 1974. to .protect nnployccs from hazards of exposure to VC. The. proposal callrd for limitation of employee exposure to VC to "no detectable level," ns measured by a Standard for Exposure to Vinyl Chloride ing hearmr: was announced on Janu sampling iuid analytical method sensitive Pursuant to sections G(b>. 6<ct, nnd 8(c) of the Occupational Safety and Health Act of 1970 (El Slat. 1593, 159G. 1599: 29 U.SC G55. G57) Secretary of Labor's Order No. 12-71 (30 Pit 8754) and 29 CPU Part 1911, 5 1910.93 of Part 1910 of Title 29, Cede of Federal Regu lations is hereby amended in the manner set forth below. in order to provide an Occupational Safety and Health stand ard dealing with the exposure of em. ployees to vinyl cltloridc. I. Background--*1) Vinyl chloride. V;nyl chloride (chloroethenc). Chemical Abstracts Service Registry No. 75014. Is a synthetic organic chemical made from ethylene or acetylene and chlorine by any of several processes. It is the parent compound of a scries of thermoplastic resin polymers and copolymers which arc widely used for containers, wrapping film, electrical insulation, pipe, conduit, ar.d a variety cf other industrial and consumer products. Vinyl chloride has been marie ronimereialiy in this country since 1939, and present production is in exetfss of seven billion pounds per year. The vinyl chloride industry divides into three segments: monomer production, polymer production, and fabrication. Production of (he monomer is a largescale continuous process, involving only a few firms. There are ccrr.pnrat.iveiy few cinpiovccs hr 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 (P VC), a resin which is pi oduceri through batch processing. Toe conversion of the VC monomer mto a polymer or copolymer is an incomplete process, i.c.. not all of the monomer is reacted. pV! is fabricated by a variety of tech-. nic;ucs. Including extrusion, injection molding and calendering, to form a fin ished product that needs no further chemical handling. The vast mr.iority c>f employees involved in the VC industry arc employed by fabrication firms. Such firms i an;:c in size from those with lew employees and simple equipment to largeplants involving many employees and ary 30. 1974 <30 KK 3374) and held on February 15, 1974. Information obiainrd from this hear ing, particularly the preliminary reports of experiments conducted by Proiessor Cesare Maitoni of the Institute di CUicologia. Bologna. Italy, demonstrated that vinyi chloride induced angiosarcoma id rats nf levels as tow as 255 ppm. and in other .pceies at higher levels. Kxpcrimchts performed at lower levels of ex posure were not completed at that time. Other testimony from medical witnesses and NlOt il, and the results of autopsies, led to th- conclusion that the Goodrich workers nad angiosarcoma of the liver end that VC prnoably was the causal agent in die angiosarcoma*-observed. In post nearing' comments, additional angiosarcoma deaths were reported among w< ikers who had been exposed to VC in plants operated by Union Caibidc Corporation, Firestone Plastics Corpora tion and Goodyear Tire E- Rubber Com pany. On the basis of all Information Avail able at tbit time, a-nd the fact that em ployees were being exposed at levels around the experimentally observed ef fect level of 250 ppm. an emergency lemporan standard UJTS) was promul gated on April 5. 1974 <39 FR 12341) pursuant i-o section Gic) of the Act, as 29 CFR li)i0.93q. Tiiis standard reduced the permissible exposure level from a ceiling of 500 ppm to a 50 ppm ceiling, and established other requireme -Is, including, for example, monitorin' and respiratory protection. It was c: pressiy recognized that this standard .uniting exposures to a 50 ppm ceiling wa. a tentative, interim standard, and that me whole question of exposure to VC wo lid be considered more fuliy in the light of'additional information, especially the results of -experiments which weie known to be underway at that time. On April 15, 1974, Information end data were presented to representatives of OSHA, KlOSH, and the .Environmental Prelection Agency by the Industrial BioTcsL Labo-atones, Northbrook, Itlirois, to 1 pnm. with im accuracy of 1 ppm ri:50 percent, The proposal also called for the establishment of regulated areas and limited access to such areas to au thorized persons; A requirement for monitoring of employee exposures was proposed, along with engineering and work practice controls to be, implemented when exposures over the detectable limit were measured. Respiratory protection would, have been required while engineering and work practice controls were being implemented or where exposures exceeded the per missible limit even after feasible en gineering controls were instituted. In addition, the proposed - stahdard 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, ns 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 D$UA staff and early responses indicated that the sub ject wfii of great interest and importance to many persons. Because of the limited time available before expiration of tho six month period provided in section 0(c)(3) of the Act for promulgation of r. final standard, it was decided to hold a hearing ns soon as possible. Accord ingly, cn Msy 24, 1974, a notice or a hear ing was published (39 FR If303), setting a hearing date of June 25, 1974. Tiie heanng wn.s conducted .from June 25 through June 28, and-again irom July 8, through July 11, before Administrative Law JurfiYc Gordon J. Myall. AH partici pants were riven the opportunity to pre sent testimony and to crcss-examine other witnesses. Persons marticipa ling in the hearing were civeitHniUl. August 23, 1974, to file additions'! pcsUicaring com ments, includins various items of infor mation which were requested during the examination cf witnesses. considerable capital. Vinyl chloride tVC), a gas at ambient temperature and pressure, is a chlori nated hydrocarbon, which heretofore has been regarded as having moderate liver toxicity. The initial standard, contained in Table G-l of 1910.93. established a cei'.mg value oi 5C0 parts of VC per mil lion parts of air. (2) The emergency temporary stand concerning rcsull-s of animal exposure studies w lit VC. Tiie.'.c studies were sponsored by the V.anufectnring Chem ists Association. Ah hough only pre liminary l.i nature- at that time, these results ret aaled that 2 out of 200 mice expored to VC concentrations of 50 ppm for 7 hour, a dav, five days a week, for approximately 7 months, had developed' arydosareo na of the bver. (5) Economic and technical impact study. During tiie hearing. OSHA deter mined t'nat additional facts would be needed to determine the practicality of certain aspects of the proposed stand ard. Accordingly. OSWA-conlactcd an in 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 23. 1974. die Occupa (5) The proposed permanent stand by OSHA and others advanced by in tional Saiely and Health Admim-tra- ard. Based on the ilen.on.str.itcd evidence dustry spokesmen. Snell was also com tibn iOSllA) was informed bv the Na ot VC's ca iiiiiogcnl. i:y in three anlntai missioned to collect information regard tional '.nsiilutr for Occupational Safety species Ira is. mice and hamsters), and ing the economic costs of compliance. and Health (NIOGII) that the H. F. the rubrta uiial probe.bitity Uiat VC luul This action was announced at the e'.oso Goodrich Chemical Company had re been the c: usal agent in Hie eases of liver of the hearing, and Judge Myivlt further ported that deaths of several of its em angnvsarco na found In workers both here announced that the record would be kept rrCtlAl RtCiSTE?, VOt. 39, WO- 194--fSIDAY, OCTOBS8 4, TJ74 DTH 000088295 RULES AND REGULATIONS 35S91 lod of line beyond August studios of Malfonl and Bio-Test labora may create' a cnrcinoncnic hazard, the i i,f teresti persons to cciid- tories. Moreover, MuKonTs investigations amount of exposure which Is hazardous I . 'r. on the mik.v. On Angus; have ii' Uiriir,tr.i;ctra'71or.e-det:eiKieni re- must be determined. The Surgeon Gen : v . ' \ r.niHui'.'riT, thnt the pre- '4>PrHjfystTTTr-fi-ir-hicuction of tumors' (fie., eral's Ad Hoc Committee referred to I wm available and llmt mwr-iamots-occur at higher exi>or.urc nbve concluded that safe exposure levels w.ro to be submitted no Inter levels), including angiosarcoma of the for carcinogenic substances cannot be : dumber 6. 107-1 (39 FR 30S44). liver, in rats, Tnc investigations of In scientifically determined. This position mitu'-r 13. 1071. OHIIA Invited dustrial Bio-Test Laboratories have dem Is sup;x>rted by the testimony of NIOSH :, k:;uv on both the preliminary and iC final study. which was to be received ii r,r b- Tore September 25, 1074 (39 l'R 730031. onstrated a similar relationship for at the hearing, its recommendations for both rats and mice. These investigators a standard of no detcclablc level, and by have induced angiosarcoma c>f tiie fiver the testimony of expert witnesses from In.rats nnd mice at exposure concentra ' the National Cancer Institute. (0) Environmental iripr:ct statements. tions of 50 pom, and In hamsters at high Several witnesses and persons who sub A notice of Intent to file an envn-omnenta! Impact statement arxw'smg the im pact ol a proponed standard on occu pational exposure to VC was published in the lYnur/n- HfCisn-.n on April 04. er concentrations o; exposure. Additional tumors invowing other orjrnns. including uic kidneys, lungs, nnd skin ol exposed animals, we e nbo observed In frequen cies much in excess of control animals. mitted comments have taken a contrary view and have suggested that man is less sensitive to biologic aberrations induced by vinyl chloride exposure than experi mental animals. Proponents of this jiosl- 1974 (39 ER 14522). 17*e notice invited any perron having information or data on the (miror-mcnlal impact t-o submit It lo OSHA by May 17. 1374. On June 12. 1974, a droit environmental impact statement was prepared and circulated to all Jmercst-cd persons. Ton copies were forwarded to the Council of Environ mental Quality (Ci:Q). which published a notice of Its filing and availability. In the FruvRAi. Kecistf.k on June 25, 1974 (39 FR 22975). A 45 day period was al lowed for the submission of comments on tite draft statement. On September 5. 1974, the final environmental impact statement was prepared and a copy of it nnd nil substantive comments were sent to appropriate governmental agencies, private o: ganiaations, am! other uncr eated persons. CEO published a notice of aval,ability for the final statement on Eeptemt: er C. 1974 (39 FR 32350). Tire submission of comment was invited un til Ceptembor 25. 197 1. 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) Tnc record. The record in this proceeding is one of the most exhaustive ever reli'-ci upon by OSHA. It consists of pre anc post-hearing comments mid testimony received at both factfinding and rulemaking hearings, tiie studies and inspections conducted by 05HA person nel, the environmental impact state ments, the economic and technical Impact studies, and r-1) other relevant informat-ion. In all. over GOO written com ments l ave been received, with more than 200 separut e oral and written sub missions made with regard to the two hearings. The record ifiuif exceeds 4.000 pages. Employers, employees, labor unions, public health croups, 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 OSiLA. The en tire record encompassing these submis sions v-as thoroughly reviewed and rvahuiicJ in reaching tiie determina tions set forth hclovv. JI. Fii TCn.ard:.r.a carrinoccnicify, r.ippserr levels and lee.sil'ilitv--<1> Ccr- ciiaiccu: ".tv ol r.i.'fl chloride. Tiie car- cuioteirchy of vinyl chloride for ll.ree The incidence of tumors in mice in tiie Industrial Bio-Test laboratories investi gations is p .rticularly pertinent. Of 200 mice (100 miles. 100 females) cxrosed to 50 pp:n of v; tyi ctforme by inhalation for eleven months. 100 died. Sixty-four anfmals died without gross postmortem pathologic camimuion being performed. Of the 3G remaining animals for which a gross postmortem pathologic examina tion was penonned, 13 (3G percent) were found r.itii liver tumors (including angiosarcomas), 21 (58 percent) with lur.." tumor:. 9 (25 percent) with skin tumors, tint one v.-itb a kidney tumor. According fo-thc 1970 report by the Surgeon G-neral's Ad-Hoc Committee on the Evaluation of Low Levels of En vironmental Clir-mical Carcinogens^ Uig finding o: c:.peer in tvro or ioi~c nntuia1 species may be extrapolated, to! indicate a carrii02!dc hazard to humans. Here, such n Tihdf:ifTwas Triade in three species tint were exposed to VO by inhalation-- a route co. parable to employee ex posure. In addition, there were at least 13 confirmed eases of angiosarcoma of the livc.r n; tong employees exposed to VC, a particularly significant number in view of Die extreme ranly of this c'anccr in Die U.S. : emit male population (testi mony of Bi. Marcus Hey, Director of NTOSK. nt the rulemaking hearing). The find! :gs of angiosarcoma of tile liver in both experimental animals and exposed employees is compelling evi dence that \posurc of humans to vinyl chloride In: arcs tins tumor. Industry spokesmen, at the hearing, conceded that VC is c ireinogenic lor jnimnns (e.g. testimony o: Dr. McLurncy, Rulemaking hearing, 10 1). Accordingly, it is con cluded that VC must be regarded ns a human car mogrn. and the probable causal agei-t of angiosarcoma of the liver, and that exposure of employees to VC must be controlled. Ariditionn' evidence of tumor induction in a variety of ot.'icr organs, including Jung. kidne>, brain end skin, as well as non-malig.nr nt alterations, such ns fi brosis nnd connective tissue deteriora tion, indicates nddiiionnl oncogenic and toxicologic |iropcrties of vinyl rhionde. ' which must .is considered in csinblislting control rug; Lilians. i?;>c testimony and results of s '.aims by Bio-Test Labor:!- ! nries. Tr. ocrshaw-Coopcr. Maltonl, NIOC-II. ant; tiehkoS..' tion have argued that if humans were ns sensitive as rodents, an "epidemic'' of cancer resulting from VC exposures should have already been discovered among employees. They also argue that tiie employees in whom tumors have been observed are those who have considerable employment experience ns poh-mcrication rcnctor cleaners. Because it Is gen erally agreed that reactor cleaning in volved high exposures to vinyl chloride in years past, it is argued that the lower levels currently found in the workplace have not induced cancer and are there fore safe. We reject this argument. The fact that approximately threequarters 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 determine the actual number of alTccted 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 core-re lated. phenomenon, and If employees en gaged in cleaning reactors did, in fact, receive larger doses of vinyl chloride, it would be expc-cicd 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 n 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 ncccsasrily synchronous events. Be cause of tiie physiologic complexities in volved with carcinogenesis, induction of tumors does not occur in ail employees with similar exposure histories. For c.vnmplc. Dr. Schneiderman 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 IDip'.s is no; reliable evidence that cur rent levels of exposure arc safe. Some inciusiry spokesmen also sug gested that the apparent nonrandom distribution of observed cancer in em ployees may Indicate nn exposure'thres hold for tumor Induction, based on varia animal species (rat, mouse, hamster) has (2) Efr/av :.re limits. Uixm finding that tions In the workplace design or prac beer documented on Um record by the exposure of employees to vinyl chloride tice and resultant employee cxjwsurcs rtbtRAl r.CGISUS, VOL 3?, LO. JC4 -- FRIDAY, OClODtR 4. 1974 DTH 000088296 RULES AND REGULATIONS cny and questioning by Tcnneco .r a is. Inc.). K has nlso been cm* : d that In only 3 ol 8 polymrriza- ; lnr.tr. where employees have been ; jsfd to VC lor more limn 30 years c any employees developed anniosar> ciri a ol the liver. This argument is very rim .'nr to that raised conccmniK vari ability cl past employee exposure. Al though geographic and work practice differenres may ultimately he demonstrated to be factors in distribution cl angiosar coma. sufficient information is unavail able to exclude from consideration of risk those employees in workplaces lor which cases ol angiosarcoma have not been observed. It has nlso been suggested that the absence ol cancer in a population of 335 Dow Chemical Company polymerization employees monitored over a period ol 7 years, indicates that exposure to vinyl chloride at concentrations ol less than 200 ppm is .sale. (See study by Dr. Cook, submitted at the hearing by Dow Chem ical Company.) However, the group sur veyed did not include all workers who had been exposed, and the missing em ployees included many who had the longer term (over 20 years) exposures. Moreov'er, the statistically insicniScant size of the sample population decreases the possibility that tumors would be observed. Dow also presented preliminary data In testimony at the hearing on the pos sible metabolic pathways of VC. The hypothesis presented was that VC may exert Its carcinogenic effect by a metab olite, and that the mett-huliie is pro duced only when VC is metabolized by a secondary metabolic pathway operating only when enzymes regulating tire pri mary pathway are satura.teri, ns would be the result at higher exposures. Tne preliminary data indicated the possi bility of an additional pathway for metabolism of VC m rats exposed to con centrations of VC in excess ol 220 ppm. However, the occurrence, ol angio sarcoma in both rats and mice at VC exposure concentrations, of 50 ppm in dicates that il a metabolite cl VC is the ultimate carcinogen, then it must be generated at lower exposure concentra tions in these species. Although this re search may be helpful to the thorough understanding of the carcinogenicity cf VC, H appears that It dees net yet offer evidence which can assist in determina tion of sale exposure concentrations for employers, or even that such safe ex posures, exist. A number of witnesses representing employers have stressed that there Is no evidence oi cr.nrcr, either in employees or experimental animals, at exposure concentre.! ir us of VC less than 50 punt (See e.g.. testimony ol firestone, Tenmco Cnc'.mcals.) The conclusion ol these witnesses, was. that no di.-ision can be made concerning risk of exposure to YC at concentrations loss liiaa 5.1 ppm. On the other hand, the testimony ol most expert 'vhnesses, including mint- in dustry Li..medical experts, .stated that rjUantificMi.-h of a safe exposure con tent rnlicn is not iosole with the pres ent state of scientific knowledge. (See e.g.. testimony of Selikofl. Firestone. NCI, and N1GSII.) In our new. the demonstration of can cer induction in humans at a particular* level is not a prerequisite to a determina tion tint n substance represents a can cer hazard lor humans at that level. It would oe imprudent to assume man to he less sensitive to VC exposure than ex perimental animals in the absence, of conclusive evidence. It would nlso be'un founded to assume that animals will not develop1 tumors when exposed at concen trations of VC cf less than 50 ppm. Should a sufficient ly large number of ex perimental animals be exposed to VC at concentrations oi lens than 50 ppm, Schnciuermrn said that il would be ex pected that seme would develop VC in duced tumors. (3) j ccsibihtp. There i.s virtually no dispute that most, if not all. fabricators arc cu.rently capable of reaching ex posure 'eveis of 1 ppm through engineer ing controls. These employers employ well over 95 percent of all 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 lndustr es to remain below 1 ppm con sistently, tsn?r engineering controls. In additio i. the Knell study cm technical feasibility concluded that a 1 ppm ceil ing is rot feasible for the VC and PVC industries with present technology, but that tlie VC ini iustry could currently at tain Inner exposure levels than the PVC industr Lana: unicr. spokesmen and the Health Research Group. Inc., however, have si 'Tested that such a level Is attainnbl r .Sinn there Is no actual evidence that any of the VC or PVC manufacturers have ali early attained a 1 p;i:n level or in fact in 'diluted all .available engineering and work practice controls, my estimate as to the low esc feasible level attainable must necessarily involve subjective judg ment. likewise.,Uie projections of iudus.trv. labor, ancj others concerning feasi bility .are css crU: ally conjectural. Indeed, as Firestone has suggested. H is not pos sible to accurately predict the degree of improvement to be obtained from en gineering changes until such changes are actual! ' implemented. IVc i rree that lire PVC and VC cslabhshmei.ts will not be able to attain a 1 ppm T1VA level for ail 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 rim silk alums most of the time. It Is ap parent fiat reaching such levels may re quire .`Sine new technology rend work Pivclic r. It riav nl-.o be ncees-ai-y to utilize ` cnnolr r y presently used in other. nniustr es. In any event, the VC and lVC Jndustr.es have already made great strides m reducing exposure lewis. (Gee testimery of Dow Chemical Co.. Til 973). 1 or ex implc. 15. F. Goodrich UvLiHed mt 11 :3) that It lies reduced nverago cMpoun: e level;, in several PVC plants from 3: --40 ppm c.'.ilv this year to 12-13 ppm a: the time of the hearing. We are confident that Industry will continue to do so. (4.) Conclusions. The conclusions be low ure based on a thorour.il review nr.d evaluation of nil the evidence submitted. Where decisions can be based on record evidence, tilts has been done. Where, however, factual certainties arc lacking or where the facts alone do not provide an answer, policy judgments have been made. There Is little dispute that VC Is car cinogenic to man and we so conclude. However, the precise level pi exposure which poses a hazard and the question of whether a "safe" exposure level exists, cannot be definitively answered on the record. Nor is it clear to what extent exiwssires can be feasibly reduced. We cannot wait until indisputable 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 of the best avail able evidence. These judgments have re quired a balancing piucess, in which the overriding consideration has been Lhc protection of employees, even those who may have regular exposures to VC throughout their working lives. Based on the available evidence ;.rd 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). Wo also believe that PVC and VC establish ments will, in time, be able to attain that level through encUiecrinj controls, end that fabricators can do so in the im mediate future. In addition to the TWA requirement, we have established a 5 ppm ceiling (averaged over a 15-minute period) lit order to prevent exposure of employees to unacceptable high excursions. From an operation standpoint, this ceiling level is realistic because minor excur sions up to the ceiling level are likely to occur on a regular basis. HI. The final standard---(1) Scope car? application. Both the HI'S and the pro posal would apply the standard to the entire VC Industry. Including manufac turers cf VC and PVC nncl 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. Ho.vevcr. the Society of Plas 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 that a separate requirement be established for them because many of them were already at or below the pro posed celling level. The record evidence establishes that at least some employees hr the fabricat ing industry are exposed In excess cf the permissible control limns tSec NIOGII testimony. Tit 105; KobiihrcJi Tit 0421. In there circumstances, wc hehcvc that It is Imprudent to grant a blanket exemp tion for all fabricators. Therefore', the final standard Is applicable to the fabri cation Industry, ns well as (iic monomer FEDERAL fCISTER. VOL 39, NO. 194--EklPAV. OCTOBER < 1974 dTh 000088297 RULES AND REGULATIONS . /s t 35S93 > K=#r ndustrles. Employers who, temperature as PVC. for further pro below the action level, no further moni ;; # ubs.tantlaHy below the cx- cessing, indicates that a )>ctcntial for re toring is required unless the employer 1' will be subjected to only lease of the residue still exists. It ap- has reason to suspect that any employee |f cons by virtue of the "action _ pears that the exemption of fabricated is exposed Tn excess of the action level, f' : '..ACtuwrd below. "products should be limited to just those or unless changes have been made in . employers in the fabricating items which will not undergo such mass production, process, control, type of resin, r\ Ti c exposures approaching the heating. Further, the opjrortunity to etc. nriolr Strait, they will appropriately demonstrate that exposures are below Where the exposure level, without re i > li-ject to the standard. Employers the action level1, and thus, discontinue gard to respirators, exceeds tire permis ir idling or using fabricated products many duties of the standard, provides a sible levels, monitoring must be conduc tn. n;: oi PVC were not included in the more positive control and an adequate ted at least monthly. Where exposures E7E cr the proposal and are excluded relief. are less than the permissible levels, but from the final standard. This conclusion (2) Permissible exposure limit. Tire greater than the action level, monitoring :s based or. the absence of nd-qtinte 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 o1 compliance. The stand tions. The final standard clarifies the ex ceiling cf 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 full;, discussed above, this engineering arrd work practice controls from PVC which coos not require further limit is based on rn 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 end safety of employees Where feasible engineering and work the PVC. SP2 and others (cf. TR. 344-1 must be protect-d 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 tile regulation now, and processes arc variable, the 1 ppm ceiling not reduce exposures below the permis that the exemption level be reduced to level provided in the proposal would sible level, they must nonetheless be im 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 (33 I-'R 375G1 was an appropriate precedent. The cases are not comparable, because no attempt had been require maint-enr nee of an average level significantly mere `difficult to attain through feasible engineering controls. Therefore, the exposure limit prescribed in tire proposal h is been rejected. (3) Action lev .1. The final standard, plemented to reduce exposures to the lowest practicable level, and be supple mented by tlie use of respirators to pro vide the necessary protection. There upon, a continuing-program of engineer ing and work practice controls must be mac c to ret air concentration limits for unlike the ETS and the proposal, pro instituted to reduce exposures to the low the 14 carcinogens. Tire record did not vides for an "action level'' of 0.5 ppm est practicable level. When exposures are Include information that reliable moni TWA. onc-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 practicegens. The administrative cutoff was pro attained exposure levels veil below the methods must be drawn up and be 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 monitor .ng under paragraphs atives of OSHA and EIOSH. ard information, and which would have (d)(1) or (d)(2) demonstrate that no We recognize that many employers broadly extended the application of the regulation beyond the record. Herein, no information was presented to show employee is exp >sed in excess of 0.5 covered by the standard can not cur ppm TWA, cmpl< vers may, in effect, be rently achieve compliance with the per exempted from some provisions of the missible exposure limit solely by the use cafe concentration results from the use standard. For cx tuple, 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, when quired `o provide nedical surveillance or generic distinctions between the compli improved technology' would permit such to monitor again unless the employer ance capabilities of the VC and PVC reduction, would seem to indicate that has reason to sus; ect that any employee industries. Some industry spokesmen, SPI has doubts about the safety of 0.1 is exjxjscd 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 n :>t 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 tl e many employers who segments of the industry. to the physical form of the resin and are or will be belov that level. This view assumes that the ability and the ventilation provided. Also, mordtor- (4) Monitoring The final standard, the time required to feasibly reach in ing data from industry (cf. Exhibits 131, like the proposal, i equires that individual creasingly lower control levels is similar 162, 1705 and OSH A (Exhibit 151) indi employee exposure levels be derermThcdl within eacli industry, but differs mark cate that levels in excess of 1 ppm may Thi5ju_nu.y~b(f acc: in pH sEcdlby person sd edly between industries..While the record be found in fabrication operations. In orareaTMhfltorin ;. 'Sofne~w)lncs~seTand aces suggest that such differences do view of these facts and of the opportunity 'persons-\vho'~sub pitted comments did- exist between industries, as noted above, for employers to discontinue many duties not understand th meaning of the term it is clear that intra-industry differences upon a showing of no exposures above the "35 percent con idcnce level" in the also exist. Thus, the ability and time re action level, it does not appear that any proposal. Essentia ly it means that the quired by each employer to attain lower residue exemption is either justified or employer is requu d to take a sufficient control levels may depend upon such necessary at this time. This course also number of ine.asui -mcnis so that the re factors as the climate in which the plant agrees with r number of industry pro sults oblaincd are statistically valid. We is located, the age of equipment, the size posal:; (cf. TR C00). have modified the proposal to establish of reactors, or the type of resin manu SPI (TR 345). among others, asked that compounded PVC pellets be ex empted iron the standard on the grounds that llie pellets had too low a residue to cause harmful or measurable emissions. accuracy range rec-idrements for various measurement levc s. These ranges are narrow enough to ensure that a determlnabon of enmph mce can be made, and broad enough to Plow the application factured or used. (Snell study. Firestone wslimony, etc.) Monitoring data also tends to support such Intra-industry' variations. (See, c.g. Dow, Firestone, Tcnncco.) While 1! appears that PVC pellets would of a variety of te< imologies As noted above, the standard requires have a lower residue level than virgin All covered crop oyer:; arc required to employers to institute- feasible engi PVC, the'fact that the pellets must be conduct initial rno.'.iiorlng. Where moni neering controls to the fullest extent and heated to a molten mass at the same toring and measuring results nrc at or to continue to improve and apply cngl- \ '` EEDIRAl EEGISTtK. VOL 39, WC. 194 -- rEIPAY, OCTOEt: 4, 1974 DTH 000088298 RULES AND REGULATIONS : jnlrols until full compliance Is c not established any deadlines : , ' amplJuncc through engineering i i . otcausc we arc presently unable ;k i. - r.nnc when It will be Icasiblc for uiosl establishments to reduce exposure ev jis u> the permissible level. We a iso 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 lor inter-indus try and intra-industry technological dif ference;. which do exist, and will avoid the setting cf separate industry stand ards on the basis cf the general situation and conditions in each Industry'. (C) Herniated areas. The proposed standard would have required that regu lated areas be established, that 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 riot necessary from a health standpoint. Secondly, It was claimed that these con trol: would interfere with operations by preventing access of needed employees or non-employees, such as contractors, truck drivers, customers and consultants. Tire purpose of establishing regulated areas in. the proposal was to limit the risk of exposure to ns few employees as possible. T his 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 filial 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.) 17) 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 are necessary only occassionally. However, we cannot agree that, respiratory protection should cot be required simply because it Is In convenient, may require additional per son]'el, interferes with production, or may require extensive retraining of cm-, ployees and restructuring of work prac tices.' We have card ally considered all the objections, and have concluded that If the environmental level le not con trolled to the permissible exposure limit, then employ ccs must be aflordcd respira tory protection. 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 ment a .he tci agent" >lcad. While exposures in excess of the per missible levcl 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 fof usf 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 struct:; stance dilutee We a: with t. v.e cor be Ink po. required are implemented. Therefore, until January 1, 1076, 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 t. 25 ppm ceiling, may decline to use the lespirator, 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 li mi tat ions of respirators, and the hazards of exposure to vinyl cliloricle. 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 he 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. COUP':. l:i the and form tion. : person The tiVC : train: that - or la that an U- Moreover, each employee will be notified in writing h 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 (8) Hazardous operations. This is a new section within the final standard. It encompasses essentially the proposal's requirements for maintenance and de contamination but has restated them tn terms of performance language to allow greater flexibility for employers to deal cnd. on s; form eym; info: perr. in a- exposures. - with such operations. The Intent of the , t: The provisions in the final standard new section is to protect employees en lab;. regarding tl e selection and use of respi gaged in activities that present a risk of . bee: ratory proiective devices differ from exposure to vinyl chloride in excess of the 1-0 v. those in the 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 hei ring Mr. Edwin C. Hyatt, an OSHA consultant, made suggestions re garding the use of particular respiratory devices. We cave concluded that his sug gestions are meritorious. Therefore, the permissible levels. An example would be the cleaning of a filter where resin con taining high residual monomer is trapped. The proposal's requirement for lull body, impervious clothing has been re placed by the direction to use impervious garments suited to-the particular situa tion and probable extent of exposure. Thus, full-body clothing is not always necessary, and is therefore not required where less protection is adequate. Since vessel entry falls within the definition dev stay per COI-' gc-y siv f th:. pai <4; Y'Z nv. ar. provisions for selection of atmosphere- of a hazardous operation, the vessel entry supplying di-vices follow closely the rec section of the proposal has been deleted ommendations contained in his testi from the final standard. p: mony of SFI and B. F. Goodrich) (TR with Hyatt';- suggestions. (See c.g. testi mony of SFI and B. F. Goodrich) (TR 85 ff> We lad originally omitted air- (9) Emergency situations. The defini tion of emergency has been recast in terms of an unexpected massive release. The main objection to the section on e: m to. tu purifying respirators because none had emergency situations in the proposal was tit been approved by KIOSK for use against that, as the term was defined, many VC, principally because they lacked In ordinary leaks or operations resulting in dicators to vignal the expiration of the a small release of vinyl chloride would be XT. ir Vc service life of the sorbent. Ilyalt and considered emergencies. Tills was not other witnesses discussed In detail the the intent of the proposal. The final desirability if 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 sorbent could be shown to the written operational plan required by effectively a >sorb vinyl chloride with an the standard need not he developed for 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. commercial!.' available canisters and' (10) Signs and labels. The thrust of the cartridges f; r vinyl chloride. These eval signs and labels section is to apprise uations wcie conducted separately by employees of the cancer and fire haz NIOS1I and by the R. F. Goodrich Com ards. No objections have been raised with pany and submitted to OSH\ in posthearing con ments. The results indicate that ccrtair presently available canis respect to informing employers of the fire hazard. However, a numbtr 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 FEDERAL REGISTER, VOL 39, NO. 1 94--FRIDAY, OCTOBER 4, 1974 DTH 000088299 I RULES AND REGULATIONS if' i against its use was that Indicated that the medical tests proposed nccr" or "canccr-suspcct arc current iy die only ones available ,;t' employees and that ,in- which arc us-lui tor medical surveillance i i . -sr.agc should contain In (TO 121, E.v.h, :0. Tit 5RP-591). Conse is* >-. now to deal with the sub- quently, the specific blood tests proposed 317>. We believe that a have been rctamed as a minimum re or- : of v.amine will not suffice. quirement to assist the examining physi J ;:;c r::itc the concent of employers cian in determining fitness of potential ic reaction of their employees. But employees for a v igmnent to workplaces > : : ;>ns;der it imperative that a worker involving VC c: posure. In addition, al -x ' ,`hv informed, and tiiat lie realize the ternative medic.d examinations may be ,>o: : iblc risks involved in his occupation, used .where the examining physician de ijo.riicd with the training rcciuiremcnt termines that Iney are at least as good !i. i he standard, we believe that the signs as those speeifird by the standard. anti labels required will adequately in The Tnbcrsha -Cooper study and the form employccs of the hazard. In addi various animal c xperhnents suggest that tion, such signs will warn unauthorized VC may produce a wide spectrum of ma personnel to keep out cf regulated areas. lignant and nosi-malignant disorders. 11k proper application of most, protec The general scojw of the rer,uircd medical tive measures requires an amount of examination lias therefore, been broad trainin': and indoctrination of employees ened to induce I uineys, skin, connective that cannot easily be conveyed on a sign tissue, spieen, 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 ter is arc required, but rec an umvieluly or excessively detailed left- ommendations have been included in the end. Consequently, the required mesnage Appendix to assi t the examining physi on sic nr. and labels will not include in- cian. Because of the nonspecific nature . fori no lion on precautions, relevant of the required ncdical tests, it is not symptoms, etc. The addition of suitable appropriate to p-escribe timing, or type Information by the employer would be of followup test:, or to mandate vrith- permitted. providing it does not detract drav.-nl from c-xpof.n e based solely on re 111 any way from the required statement. sults of the texts Instead, the employer I Tire requirement in the proposal for is required to o'.fin a statement from labeling ter. (kin err. of vinyl chloride has the examining physician of the em been amended by deleting the reference ployee's suitability for continued expo to the possible hazard of violent polym sure, when the c: ainining physician has erization. Very' little information was completed such t- :.ts as he considers ap developed on this hazard during the propriate. `Die c nploycr is required to stands:d-setting procedure. It does ap withdraw an err; fioyee only when this pear lint this hazard is es sentially under slateniciit indicr: us that the employee control and that the fire and carcino may be at added ; isk from continued VC genic Hazard? at present are the most exposure. sign fie ant. Since labeling or placarding As with monittiing. there appears to that is in compliance with the U.S. De be no basis for eo; iplcie exempt ion of the partment of Transportation regulations fabrication indu.irv from the require (49 Chit Pari 173, Subpart H) already ment for medical examination. The rec i wan is of the fire hazard, only a stale- ord does show fab xcatir.g establishments men". concerning the carcinogenic haz with concentrations of VC monitored I ard need be raided to the Department of Trm:spoi-f aticn labels. considerably aboi t the action level. In these instances, i icdicitl surveillance of tl'f) J.fttfk-c! surveillance. The princi affected employee; will provide bc-seline pal (.next) ins that have been raised re data for future ev; luation of their health, garding medical surveillance are the even if both moni' wing and medical sur necessity and efficacy of requiring cer veillance are disc entinued because im tain specific serum enzyme determina plored controls (dure concentrations t tions (tMf.-K! series) and the applica below the action level. Where exposures I tion of medical examination require ments to t he fabrication segments of the arc below the action level, the medical surveillance requii merits do not general industry v. hero employees ore exposed to ly ripply. .. lower Jr \els of VC. The obiection has also (12) Training. A separate provision for been rr.scd that the specification of tests employee training has been added i.o the and procedures interferes with the ap final standard rariicr 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 and, usually, within months of death. Precursor physiologic alterations, which might be reversible, have not yet been d. redly ns.sorit.ted with the le.,icn. Conlequently, th-re are no specific diagnos tic tc;!'. which (an be pi escribed which will I'cterr'.inc presence or absence of l this tumor at in early stare of develop ment. However, most medical witnesses tions as in tlie pr.--jio.sal. The new para graph provides for ;raining of employees concerning the c. ifinogcnic hazard of VC, emergency j:r.-< edures, the need for monitoring and a; annual review of the standard. It also p iv.ddes for training of employees concert mg the. purpose for, proper use of, and limitations connected with respiratory p .lection. (13) accords ar.-J icp-orts. Tiic provi sions for reeordkei i.-ir.g contained in the final standard re. wire the preparation raid maintenance ( f ei-'cntlallv the ; nine Ir.fnni.ation requ! cd by the pioporal. The ii.ujoi ciiangc nern tire original pro 35S95 posal Is the requirement for maintenance of monitoring records nnd 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 go 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 mini mum, medical records must be main tained for at least that long. It should be noted that spokesmen for both labor nnd industry recommended that this change be made. The reporting requirements are not ' significantly different from those 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 an initial report that in cludes facts immediately available, would ordinarily l>e 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 c/ the proposal. The proposal contained provisions re quiring that shower facilities and change rooms be provided, and that storage or consumption of iood be prohibited in regulated areas. We have deleted these provisions because it is our conclusion they are no longer necessary. Showering facilities are not required because pro tective clothing, where required by the final standard, should protect employees from skin absorption by direct contact with VC and because there is no reliable evidence that VC vapor is absorbed through the skin. In addition, since we anticipate that most employees will not be wearing protective clothing and that employees who wear protective clothing will change such clothing infrequently, we are not requiring that ciiangc rooms be provided. In addition, we feel that there is in adequate evidence showing that hazar dous amounts of VC can be absorbed through ingestion. For this reason, the requirement prohibiting the storage cr consumption of food in regulated areas has been deleted. The p; o;>osal also contained provisions on mnintentance and decom amlnation. ' transportation loading and unloading, arid polymer handling operations. These requirements are not mentioned in the final standard because attention to these Hems is implicit in the requirement that each (imiinvcr reach the ] ermicsable ex posure limit or attain the lowest feasible level. (15) Effective dale. In order to ensure that atTecled employers mid employees will be informed of tiic cxk-.lc-nce of these 'FEDERAl REGISUP., VOL 39, NO ISA--HtlDAY, OCTOBER A, 1974 - DTH 000088300 RULES AND REGULATIONS /*u *AI s. t/ \ and that employers affected of the operation or because of an acci opportunity to observe the monitor-' : an opixmlunity to f.-uniiawizc dent in the Deration, which would result ing ar.tf measuring required by tills i i s and their employees with the in an employee exposure in excess of Uie paragraph. I (1) tem-c- cf the new requirements, Uie permissible exposure limit. <c) ifryiilclrif area. (1) A regulated i filer'ivi.: date of the amendment* to <!i) "OSKA Area Dnc-ctor" means the area shall be established where: | <l i 3 5 lO.SSq will be January 1.1375. To pro Director for the Occupational Safety (1) Vinyl chloride or polyvinyl chloride I s'de continued protection for employees and Healtli Administration Area Otlice Is manufactured reacted, repackaged, i until that date, the provisions cunx-nily having jurisdiction over the geographicc stoorrcec37 hAnOicn or ugRH and " *i contained In 5 1310.S3q are hereby area in which the employer's establish-/ _Tn) V lhl'I elder:dc 'Ct>a c c r, t ra11 ons arc | promulgated, pursuant to section 6(b), 6(c) ai d 3(e) of the Occupational Safety ment is lor ,ited. (3) "Pol .'vinyl chloride" means poly-tfkfcess of Uie pcnnlssjlilg_cffiaam.' <u and Health Act. as an occupational vinyl chloride bomopoiynier or copoly (2) Access to regulated areas shall be j- safety and health standard effective mer before such is converted to a fabri limilcd to authorized perrons. A dally i October 4, 1974. the amendment to cated product. roster shah be made of authorized per- j $ 1919.03q set out below will supersede (10) "Vinyl chloride" means vinyl sons who enter. j- these provisions as of January 1. 1373. chloride m ..:iomer. (f) Methods of compliance. Employee Accordingly, upon consideration of the Permissible exposure limit. (1) No to vinyl chloride shall be con- i (1 whole record of this procedinp. Part 1910 employee nay be exposed to vinyl chlo trolled to at or below the permissible ex- ; of Tiile 23, Cede of Federal Regain'ions ride at concentrations greater than 1 ppm pnsurc limit provided In paragraph (c) i Is amended, effective January 1, 1375, by averaged ever any 8-hour period, and of this section by engineering, work prac- I revision cf 5 1910.C3q to read as follows: (2) No employee may be exposed to tice. and personal protective controls as 1910.93q Vinyl chloride. vinyl chloride at concentrations greater follows: than-5 ppm averaged over any period not (1) Feasible engineering and work fa) Scope end 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 fc-How control of employee exposure to vinyl vinyl Odoride by direct contact with tne permissible exposure limit. cldoride (chlorocthene). Chemical Ab liquid vinyl chloride. (2) Wherever feasible engineering ar.d stracts Service Registry Ho. 75015. - , i) Monitoring. (1) A program of work practice controls which can be in (2) This section applies to the mami-1 ial monitoring and measurement stituted immediately are not sufficient to facture, reaction, packs sing, repackag shaJl be undertaken in each establish reduce exposures to at or below the per ing, storage, handling or use of vinyl ment to ci.'tcrmine if there Is any em missible exposure limit, they shall r.cr.e- chlorlc.e or polyvinyl chloride,-but docs ployee exposed, without regard to the use theiess be used to reduce exposures to not apply to the handling or use of fabri of respirators, in excess oi the action the lowest practicable level, and shah be cated products made of polyvinyl chlo level, ' - supplemented by respiratory protection ride. -' (2) V.Ti-:re a determination conducted, in atcordar.ee with paragraph (g) cl this C3) Tills section applies to the trans under paragraph (d)(1) of this section seel ion. A pnnrram shall be established portation of vinyl cluoririe or polyvinyl shows arp employee exposures, without anc implemented to reduce exposures to i cliloridc except to the extent that the regard to the use of respirators, in ex at or below the permissible c::g::-uro i Department of Transportation may cess of the action level, a r.-merrim tor de limit, or to the grcaic-st extent- feasible, i re.julate Uie hazards covered by tills sec termining exposures ior each such em solely by means of engineering r.r.c work i tion. ployee (S: TTT-c established. t5\Icn tTprp- practice controls, as soon as feasible. ; Cb) Definitions. (1) "Action level" giam: (3) Written pirns for such a program- ; means a concentration of vinyl cliioride TI)" Sim.:3 be repealed at least monthly shah be developed and furnished upon i of 0.5 ppm averaged over an 8-hour work where any employee Is exposed, without request for examination and copying to day. regard to the use of respirators, in ex authorized representatives of the Arsis- i <2) "Assistant Secretary" means the cess of Ik : permissible exposure limit. tant Secretary and the Director. Sue.n i Assistant Secretary o: Labor for Occupa (11) Eh hi he repeated not less (nan plans shall be updated at least- every six j tional Safety and Health, U.S. Depart quarterly ( here any employee L". exposed, months. ment of Labor, or his designee. without r yard to the use of respirators, (g) respiratory protection. Where <3) "Authorized person" means any in excess of the action level. respiratory protection is required under person specifically authorized by the em (iii) May be discontinued for any em this section: ployer whose duties require him to enter ployee oiily when at least two consecu (I) The employer shall provide a r. regulated area or any person entering tive monj. orir.f: determinations, made not respirator which meets tl'.e requirements such ;:n area as a designated representa less than 5 working days apart, show ex of this paragraph and shall assure that tive of employees fer 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. 1575, wears: g cf toring and measuring procedures. (3) Whenever there has been a pro respirators shall be at the dinereiisn cf (4) "Director" men ns the Director, duction, process or control change which each employer for exposures not ip ex national Institute for Occupational may rest;:', in nn increase in the release cess of 25 ppm. measured over any 15- Safety r.nd Health, U.S. Department of Health. Education, and Well are, or his designee. - <51 "Emergency" means any occur rence such as, but not limited to, equip ment failure, or operation of r. relief de of vinyl chloride, or the employer lias any othe: reason to suspect (net any em ployee my be exposed in excess oi tfcs action Ic-xl. a ucterminaiUm of employes exposure under paragraph (d)(1) of this section shall be performed. minute period. Until December 31. 1375, each employee who chcoscs not to wear rn eppropflate respiretor shall t? i.\-' TorSicdjitlenst quarterly of theTu.r'.rds joT vinyl chloride and the purpose, groper use! ana lini tatlons_ " oT~_j e lory vice which is likely to, or ooes, result in (4) Tlx method of monitoring and Sovlces. massive release of vinyl chloride. measurement shall have nn accuracy EfTWRcsph-riors shall be selected from (G) "Fabricated product" means a (with a e unf:driK-c level of 35 percent* of among those jointly approved by the product made wholly or partly from not less tia.h plus or mint:- 50 percent-, Mining Enforcement and ftafety Aarr.in- polyvinyl chloride, and which cioc-s not from 0.2:. ihroug:: C.5 pf::;, plus or mimes Isimtion, Department cT trie in.erirr." require further processing at tempera _35~rleftc at" fimm over 0.5 nnm through ._gnd_the National Institute for CVciipa- tures, and for times, sufficient to ecu e anil phis nr' s.-.bim 25 percent tionnl Snieiy and Health ur-.ccr the pro- mass melting of Uie polyvinyl chloride _ovc"r 1.0 py.m. (f T; tl:o h iru rtlr.n these vbion.s of "0 Ci-'R Par: 11. resulting in the release oi Vinyl chloride. iu.'c'Dmc:. icuv.ir.'meiiis are available la (3) A respiratory pro-taectlilon pwcrani (7* "Hazardous operation'' mea vs any c-pc ration. procedure. or activity -..here a tue ^ -> Method.-. OL;I ). Mmiu.ll of Analytical meeting the requirements o: ivM.lf-i film 11 be established and niaint,',.'r.-:-d. release of either vinyl chloride liquid or (5) Employees or thr-Ir dcslgnnled rca- (4) Selrction of res pi re.tors Ivr vinyl f-LS might be expected as a con.,cquLT.ce ' rcsc-r.taf w. sh.ali be n-iordvd reascnable chloride shall be as follows: HDEJLAt StC.ISTtR, CL 39. HO. 194--FRIDAY, OCTCSrK 4, 1974 ^ Q0008830l MM / RULES AND REGULATIONS . - . . 358D7 :ir J # r '; Ic concentration of riyt chloride :-r above 3.C00 ppm__ , Required appiraivji Open-circuit. nclf-contalncd breathing apparntm, pres sure derrmnd type. with full facepiece. (vl) The purpose for, and a descrip tion of, the medical surveillance program: (vii) Emergency procedures; N : over 3,600 ppm (A) Comfcfm.llon typo C supplied nlr icsptrotor, pres (vlli) Specific information to aid the sure demand wilt Tull or bait facepiece, employee in recognition of conditions ,, . - and ouxinary seir-toDlulned air supply; or fB) Typo C. supplied clr re p'.rator continuous flow . j. Mrr . . type, wltb lull or ball facepiece, i-utl auxiliary . - Bcll-contalnecl r.lr r.upp y. til) Hot over 100ppm. (A) Combination type C supplied air respirator de mand t3T>e. with full facepiece, and auxiliary self-coDUilnrti air supply; or . .. ; CB) Open -circuit rr-lf-contained breathing apparatus .' '. " .I ' "witi! full laccptcrc. in c jn-.and mode: or ' *- ' ; ' (O) Type C supplied nlr respi-ator, demand type, with full facepiece. (lv) Kot over 25 ppm- __ (A) A powered clr-purifyir: j respirator with hood, helmet, full or halt Incepicce, and a canister , . -~V- _ .. * ' which provides a r.ei Vice life of at least 4 which may result in the release of vinyl chloride; and r (!x) A review of this standard nt the employee's first training and indoctrina tion-program, and annually thereafter; (2) All materials relating to tire pro gram shall be provided upon request to the Assistant Secretary and tiie Director. / ik) {Medical surveillance. A program oi medical surveillance shall be insti tuted for each employee exposed, with out regard to the use of respirators, to vinyl chloride in excess of .the nction. ' `J " hours for concenratio is of vinyl chloride up levclr The program shall provide each \ ' to 25 ppm. cr tCELTemployee with an oppor^iniiv for - r. ' : --. -- (B) Gas snash, front- or bad -mounted canister which examinations and tests In ac^TJfdance . . : : ` provides a service life of at least 4 hours for with this paragraph. All medical ex concentrations of viny: chloride up to 25 ppm. aminations and procedures shall be per (Y) Not over 10.ppm1. (A) Combination typo C an piled-air respirator, de formed by or under the supervision of a -, -z' mand type, with 2:vi; facepiece, and auxiliary self-contained air r.'.'.nplv; or (B) Type C suppUcd-air rcr.j irator. demand type, with - half facepiece; or (C) Any chem.cal cartridge respirator with an orpar.lc vapor cartridge whlcl. provides a service lifo . - d -of at least 1 hour fo concentrations of vinyl chloride up to 10 pp;~_ 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 ; (1) A general physical examination shall be performed, with specific atten tion to detecting enlargement of liver, spleen or kicneys, or dysfunction in these (5) 0) Entry into uni.own concentra (2) Protective carmen is shall be pro organs, and for abnormnlties in skin, tions or concentrations greater than vided clean and dry for each use. connective tissues and the pulmonary 3C.0DD ppm (iotver explosive limit) may (i) Emergency situations. A written. system (See Appendix A). be made only for purposes of life rescue; cwTht;ignal plan for cmergetrey, ritya- (ii) A medical history shall be taken, and "ttOffs shall be tier elppcd.t(>r_caciy facility including the following-topics: (11) Entry Into concentrations of less ,3.torin7cTZ3miluh'v u-..or._othiir,vir,e-u;;lng- (A) Alcohol intake; than 35,COO ppm, but greater than 3,600 \viiry l_chlor'ue as a liquid or compressed (B) Past history of hepatitis; ppm may be made only for purposes of gas. Approprir.tf portions of the plan (C) Work history and past exposure life 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 (S) Where air-purifying respirators (1) Employees engaged in hazardous sions; and are used: operations or coi ecting situations of ex (E) Past history of hospitalizations. f <l) AixaPJirifylns cannSsiea.jf.-jar- isting hazardous releases shall be Ciil) A seinim specimen shall be ob- \ IricTges shall be replacedj^ioc...to_the equipped as required In paragraph (h) 'tallied and determinations made of: > eipirr.f'oiTof'Trielr'servlce ,llle,.or_jthe of tills section; (A) Total bilirubin; end of ihe shift in'whicfTThcy p.re first (2) Other employees not so equipped (B) Alkaline phosphatase: / used, whichever occurs first, and shall evacuate the area and not return (C) Serum glutamic oxalacelic trans (ii) A continuous'monitoring and until conditions are c out roiled by the aminase iSGOT); tilanu system shall be provided where methods required in paragraph (f) of (D) Serum glutamic pyruvic transam concentrations of vinyl cb.loride could this section and he emergency is abated. inase (SGPT) ; and reesonnbly exceed the allowable concen,, tralions for I be derices in use. Such sys tem shall be sed to alert employees when viny) cliloricie concentrations exceed the nUovf.l.'lt: concentrations for the devices ' in use. (7) Apparatus prescribed for higher concentrations may be used for any lower concentration. (h) Hazardous operations. (1) EmJ578yt!R engaged in hazardous operations. f (j)\rrnf;;t>i.7. loch employee engaged is .!}iyl eljlo: id ; or polyvinyl chloride operations shall he provided training in a program refring to the hazards of vinyl chloride i i.d precautions for its safe use. O.) The proa ran shall include: (i) Tlic nature of the health hazard from chronic ox >osure to vinyl c)deride Including spccii .c.ally the carcinogenic hazard; (E) Gamma pluslamyl transpeptidase. (2) Examinations provided in accord ance with this paragraph shall be per formed arleiLst: (1) Every G 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 ofher employees. (3) Each employee cxposc-d to an emergency shall be afferded appropriate Including entry of vessels to clean poly (ii) Tire specific nature of operations medical surveillance. vinyl chloride residue from vessel walls, which could res lit in exposure to vinyl (f) A statement of each employee's f.haU be j provided and required to wear chloride in ext as of the permissible suitability for continued exposure to and use; limit and necesv ry protective stops; vinyl chloride Including use of protec (i) Respiratory protection in accord (it) The puri.se for, proper use, and tive equipment and icspirators, sin'll be ance with paragrapiis ic.) and (g) of limitations of respiratory protective obtained from the examining physician this section; and devices; promptly after any examination. A copy (ID Protective garments to prevent rlJn ton-: net with liquid vinyl chloride or with polyvinyl chloride residue from vet'el Wills. The projective garments shall be ecii-clcd lor the operation and (iv) The fire nazard and acute toxic ity of vinyl cl'.! ride, and the necessary protective steps; (v) Tlic jmrp i e far and a description Of the physician's statement shall bcpTro- 'Vised cach'emjikiycc. - - (D) If any employee's health would be materially impahed -by continued ex its pcrolbie exposure conditions. of the monitor'll; progir.ru; posure, such employee shall be with- flDlSAt rtGISUR, VOL 39, NO. 194---- FRIDAY, OCT03iK 4, 1974 DTH 000088302 RULES AND REGULATIONS 1 om possible contact with vinyl tion which ctnlmdlets or detracts from (ill Tlie number of employees in each :|i! , tlie cllcct of, any required warning, regulated area during normal operations. . borntoo' nnalyscs for all blont'clmrn.'-, included In medical : i! n: lion.; shall be performed In Inborici licensed under 42 Cl'Tt Part 74. ,U I.* the examining pb-yiician dctcrr cls Uiet alternative medical examinn- 11eras to those required by paragraph Cl) oi this section will provide at least equal assurance cf detecting med ical conditions pertinent to the exposure 10 vinyl chloride, the employer may ac cept such alternative examinations as meeting tire requirements oi paragraph iniormation cr instruction. (nil Accords. (D All records main tained In accordance with tins section shHH-4ncJudc Uie muuc and -social sccuri'y--number of each "employee where ~ relevant.^ ' (2) Records of required monitoring and measuring, medical records, and .au thorized personnel rosters, shall be made and shall be available upon request lor examination and copying to authorized representatives of Uic Assistant Secre tory and the Director. Including maintenance. <2) Emergencies. and the facts ob- taiuablc'-at that lime, shall be .reported within 24 hours tu the OSHA Area Di rector. Upon request of the Area Direc tor, the employer shall submit additional information in writing relevant to thn nature and extent of employee exposures and measures taken to prevent future emergencies of similar nature. (3). Within 10 working days following any rrioniLoiThfTTnd measuring which TlECloses" that any employee'has-been (k) (R ci tliis 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 the Assistant Secretary and the Director. ? ClnSipis and labels. <1; VIr.trances to regulated areas shall be posted vrilh leg ible signs bearing tne leacriHr C^KercK-flusrF.cT Acikt A hea Authorized Personnel ONX.T __[ C2) Areas containing hazardous operations^f T-flutfc an emergency currently f3ffits shall be posted with legible signs SETTIng the legend: Cancer-Sesi'lct AcrNT in This Area Protec tive Eouifment rtEquiRrD Authorized iTJi.-.CKj: ee Oh et (3) Containers of polyvinyl chloride resin waste from reactors or other waste contaminated with vinyl chloride shall be legibly labeled: Contaminated vlth Vintl Chloh::>u CaTv*ci:r*Slt:*i^t Agent C4) Containers of polyvinyl chloride ehall be legibly labeled: Poi.tvinyl Chloride (or Trade Name) Contains Vinyl Chloride Vinte Chloride is a Cancer-Suspect Acint (5) Containers of vinyl chloride shall be legibly labeled either: > Ventl Chloride Extremely Flammable Gas Under Cancer-Suspect Agent Pressure or.(ill In accordance with 4D CFR Part 173, Subpart H, with the additional legends: (i) Morale ing and measuring records exposed," without" regard to the use of shall: (A) State :ho date of such monitor ing and roes :unng and the concentra tions dot arm: red and identify the instmjnents and methods used: fesplralors" lnTexccss of thc~pcnnisf.)bic exposure limit, each such employee shall 'be notified-!)! writing of the results of the exposure measurement and the steps (B) Induce any additional Informa being taken to reduce the exposure to tion necussa:v to determine individual employee exuosures where such expo sures are determined by means ether tiian individv. -3 monitoring of employees; and within_lhc permissible exposure limit, (o) Effective dates. (1) Until Janu ary 1, 1075, the provisions currently set forth In 1910.93q of this Part shall (C) Be mrintained for not less than apply. 30 years. (2) Effective January 1, 1975, the pro fit) Authorized personnel rosters shall be maintaine-.i for not less than 30 years. (iii) Medical revokes shall be main tained for the duration of the employ ment of each employee plus 20 years, visions set forth In 1910.93q of this Part shall apply. Aitendix A--Supplementary Medical Information or 30 years, whichever is longer. <3) In the event that the employer ceases to do business and there is no successor to receive and retain his rec ords for the prescribed period, ther e rec ords shall be transmitted by registered mail to the Director, end each employee When required tests under paragraph (k) (1) cl this ccctloh chow abnormalities, the teats chouid he repealed os coon 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 chloride, while n more comprehensive examination Is made. Individually notified in writing of this Additional tests which may be useful: transfer. (4) Emplojees or their designated representatives shall be provided access to examine a: id copy records of required monitoring and measuring. (5) Forme: employees shall be pro 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 1 second, and chest roentgenogram (posterior-anterior, -14 X 17 Inches). vided access to examine and copy re C. Additional serum tests: Lactic acid de quired monitcring and measuring records hydrogenase, lactic acid dehydrogenase reflecting the r own exposures. (6) Upon written request of any em ployee, n cops of the medical record of that employe shall be furnished to any physician ce: ;prated by the employee. (n) Report(11 Not later (nan I month, after lie establishment of a reg ulated area, the following information Isoenzyme, protein determination, and protein electrophoresis. D. For a more comprehensive examination on repeated abnormal serum tests: Hepatitis 3 antigen, and liver scanning. (Secs. C and 3. 84 Stat. 1G9G, 1399 (29 U.6.C. G55, C67); Secretary of Labor's Order No. 12-71, 3G Fit G754) shall be reported to the OSHA Area Di Signed nt Washington, D.C., this 1st OaNCEH-SCSPECT Agent applied near the labor or placard. <6) No statement shall appear on or near any required sign, label or inslruc- rector. Any Changes to such information day of October, 1974. shall be rcjxu .oti v. it him 15 days. (i) Tlie ac: Irccs and location of each ' rssoblir.hmcnt which lias one cr more John Sxender. 'Assistant Secretary of Labor. regulated are is; and 1FR Doc.74-23176 Filed 10-1-74; 3:64 pm] ; .DTH 000088303 \ FEDERAL REGISTER, VOL 39, NO. 194--ItlDAY, OCTCfER 4, 1974