Document wgYZDr9X4rr61nr02x3L75zVE

R&S 110571 BIO-MEDICAL RESEARCH DOCUMENT DESCRIPTION FORM Duplicate in all cards:--^ _______________ year as-1961- 69 J6 T7T ^ i File number [Right justify [Numeric only] Author(s), as Last Name FS (No Punctuation) and coden for journal as JAMA preceeded by one blank space 1 r--------- - 20 21 <T 40 41 ______ xJ. ar/r/t 77 78 Sub-Index Code 60 61 62 11 12 13 Title of Report; end with space-hyphen-hyphen-space. Follow with Index Terms, separated from each other with comma-space. Avoid other punctuation; do not abbreviate. ,, 21 22 - 23 24 Source (Journal, Vol., Number, Pages, Date ) 12 61 62 31 32 Brief Summary 12 10 SUMMARY: 61 62 61 62 63 64 J FRIDAY, OCTODSR 4, 1974 WASHINGTON, D.C. Volume 39 a Number 194 i `, PART II 0s-~X9l Occupational Safety anc! HealtK Standards 33S90 ' RULES AND REGULATIONS R&S 110573 Title 29--Labor ployecs from a rare liver cancer (angio and abroad, OSHA proposed to revi - CHAPTER XVII--OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DE PARTMENT OF LABOR PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS sarcoma) may have been occupationally related. As a result of tills notification and after consultation with NJOSII. and a joint inspection of the 13. F. Goodrich plant by OSHA, NlOSH and the Ken tucky Department of Labor, a fact-find 1010.93d and published a comprehcn;.;-. proposal (30 FR 1G390) on May 10. log: to protect cmplovces from hazards o; exposure to VC. The proposal called r-j limitation of employee exposure to VC v, "no delectable level." as measured by ;l . Standard for Exposure to Vinyl Chloride ing hearing was announced on Janu sampling and analytical method sensitive Pursuant to sections Gtb), G(c). and 8(c) of the Occupational Safety and. Health Act ol 1070 (St Stat. 1503. 150G. 1509; 20 U.S.C. G55. G57) Secretary of Labor's Older No. 12-71 <20 FR 875-1) and 29 CPU Part 1911. 5 1910.03 cf Part 1910 of Title 29. Code of Federal Regulatlons 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 chloride. I. Background--(1) Vinyl chloride. Vinyl chloride (chloroether.c). 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 series of thermoplastic resin polymers and copolymers which Are widely used for containers, wrapping film, electrical Insulation, pipe, conduit, and a variety of other industrial and consumer products. Vinyl chloride has been made commercially in this country since 1939, and present production is in excess of seven billion pounds per year. The vinyl chloride industry divides into three segments; monomer production, polymer production, and fabrication. Production cf the monomer is a Ir.rgescale 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 iVC) is used primarily In the production of polyvinyl chloride (PVC), a resin which is produced through batch processing. The conversion of the VC monomer into a polymer or copolymer is an incomplete process. J.c., not all of the monomer is reacted. PVC is fabricated by a varisty of tech niques, including extrusion, injection molding and calendering, to form a fin ished product that needs i;o further chemical handling. The vast majority ary 30, 1074 (30 FR 3874) and held on February 15.1074. Information obtained from this hear ing. particularly the preliminary reports of experiments conducted by Professor Ccsarc Maltoni of tire Inscituto di Oncolosia. Bologna. Italy, demonstrated that vinyl chloride induced angiosarcoma in rats at levels as lew as 250 ppm. and in other species at higher levels. Experi ments performed at lower levels of ex posure were not completed at that time. Other testimony from medical witnesses and NlOSH, and the results of autopsies, lad to the conclusion that the Goodrich workers had angiosarcoma of the liver and that VC probably was the causal agent In the angiosarcomas observed. In post hearing comments, additional angiosarcoma deaths were reportedamong workers who had been exposed to VC in plants operated bv Union Carbide Corporation. Firestone Plastics Corpora tion and Goodyear Tire L Rubber Com pany. On the basis of all information avail able at that time, and the fact that em ployees were being exposed at levels around the experimentally observed ef fect level of 250 ppm. an emergency temporary standard (ETC) was promuiLUied on April 5. 107-i- (39 Fit 12341) pursuant to section G(c> of the Act. as 2DCFR 1010.3q. - This standard reduced the permissible exposure level from a cv.'img of 50u ppm to a 50 ppm ceiling, and established other requirements, including, for example, monitoring and respiratory protection. It was cxorcssly recognized that this standard limiting exposures to a 50 ppm ceiling was a tentative, interim standard, and that the whole question of exposure to VC would be considered more tully In the light of additional information, especially the results of experiments which were known to be underway at that time. to 1 ppin, with an accuracy of 1 ppm *50 percent. The proposal also caiir-u for the establishment of reguiatzd areas and limited access to such areas to a:;, thorised persons. A requirement fc: moniioring of employee exposures was proposed, along with engineering and work practice controls to be implements when exposures over the detectable limn were measured. Respiratory protection would have been required while engineering and work practice controls were being implemented or wiieie exposures exceeded uio per missible limit even after feasible en gineering controls were instituted. In addition, the pronossd standard Included requirements for medical sur veillance, protective clothing, emergency procedures, training, specific protection during maintenance ar.d decontamina tion operations, transportation loading and unloading operations and record- keeping. (4) Hearing on the proposal. The pro posal, as published on May 10, 1574. allowed 30 days for interested parties to submit written comments and to request an Informal rulemaking hearing. In formal contacts with OSHA start and early responses indicated that the sub ject was of creat interest and iiu-icrtance to many persons. Because oi me limit:.: time available before expiration of the six month period provided in cec:i 0-i. 2) of tits'Ac: for promulgation cf a final standard, it was decided n> held a hearing as soon as, possible. Accord ingly, on May 24.1074. a notice of a hear ing was published (39 FR 1C303>, setting a hearing date of June 25. 1974. The hearing was conducted from June 25 through June 23. and again from July S. through July lh before Administrative Law Judge Gordon J. Myatt. All partici pants were given the opportunity to pre sent testimony and to cross-examine other witnesses. Persons participating in of employees involved in the VC industry On April 15. 1974. information and data the hearing were given until August 23. are employed by fabrication firms. Such were presented to representatives of 1074, to 51e additional posthearing com firms range in size from those with few OSHA, NlOSH, and the Environmental ments. including various items of infor employees and simple equipment to large Protection Agency by the Industrial Sio- mation which were requested during the plants involving many employees and Test Laboratories, Northbrook, Illinois, examination of witnesses. considerable capital. concerning results of animal exposure (5) Economic and technical imped Vinyl chloride (VC), a gas at ambient temperature and pressure, is a chlori nated hydrocarbon, which heretofore has studies with VC. These studies were sponsored by the Manufacturing Chem ists Association. Although only pre study. During the hearing. OSHA deter mined that additional facts woula be needed to determine the practicality of been regarded as haring moderate liver liminary in nature at that time, these certain aspects of the proposed stand toxicity. The initial standard, contained results revealed that 2 out of 200 mice ard. Accordingly. OSHA contacted an Lnin Table G-l of 1910.03, established a exposed to-VC concentrations of 50 ppm dependent consultant, Foster D. Snell ceiling value of 500 parts of VC per mil for 7 hours a day, five days a week, for Corporation, to conduct studies of the lion parts of air. approximately 7 months, had developed, feasibility of compliance at various ex (2) The emergency temporary stand ard, On January 22, 1S74, the Occupa tional Safety and Health Administra tion (OSHA) was informed by the Na tional Institute for Occupational Safety and Health (NlOSH) that the B. F. angiosarcoma of the liver. (3) The proposed permanent stand ard. Based on the demonstrated evidence of VC's carcinogenicity in three animal species (rats, mice and hamsters), and the substantial probability that VC had posure levels, including those proposed by OSHA and others advanced by in dustry spokesmen. Sneil was also com missioned to collect information regard ing the economic costs of compliance. This action was announced at the close Goodrich Chemical Company had re ported that deaths of several of its cm- been the causal agent i:i tuc cases ot iner ar.gicearccma found sn werki-re both here of hearing, ami Judge tint... r announced that the record would be kept FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 * -- * \ 'N R8tS \1057A RULES AND REGULATIONS * . 35891 .icrt'for a period of time beyond August studies of Moltont and Bio-Test Labora may create a carcinogenic hazard,, the ; \o allow interested persons to com- tories. Moreover. Maltoni's inve.stications amount of exposure which is hazardous "f In writing on the study. On August have demonstrated a dose-dependent re must be determined. The Surgeon Gen y 974, OSHA announced that tire pre- lation.'hip for induction of tumors 'i.e.. eral's Ad Hoc Committee referred to .ary study was available and that more tumors occur at higher exposure above concluded that sae exposure levels '-.nunents were to be submitted no later levels), including angiosarcoma of the for carcinogenic substances cannot be -.tit September G. 1974 (29 FR 30344). liver, in rats. The investigations of In scientifically determined. This position Cvi September 13, 1974, OSSA invited dustrial Bio-Test Laboratories have dem is supported by the testimony of NTOSH aliments on both the preliminary and onstrated a similar relationship for at the hearing, its recommendations for :.:rfinal study, which was to be received both rats and mice. These investigators a standard of no detectable level, and by or before September 25, 1974 (39 FR have Induced angiosarcoma of the liver the testimony of expert witnesses from ;:'oo3). i6> Environmental impact statements. in rats and mice at exposure concentra tions of 50 ppm. and in hamsters at high the National Cancer Institute. Several witnesses and persons who sub * notice of intent to (lie 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 -act of a proposed standard on occu the kidneys, luncs, 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 the Feoeral Recister 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 :. person having information or data rn the environmental impact to submit Industrial Bio-Test Laboratories investi gations is particularly pertinent. Of 2C0 sensitive as- rodents, an "epidemic" of cancer resulting from VC exposures :: to OSSA by May 17, 1974. On June 12. mice (100 males. 100 females) exposed to should have already been discovered ;*74. a draft environmental impact 50 ppm of vinyl chloride by inhalation for among employees. They also argue that -latement was prepared and circulated eleven months. 100 died. Sixty-four ani the employees in whom tumors have been ro all interested persons. Ten copies were mals died without gross postmortem observed are those who have considerable forwarded to tiie Council of Environcental Quality (CEQ). which published a notice of Us filing and availability in pathologic examination being performed. Of the 36 remaining animals for which a gross postmortem pathologic examina employment experience as polymeriza tion reactor cleaners..Because It is gen erally agreed that reactor cleaning in the Federal Register on Jung 25, 1974 (39 FR 22975). A 45 day period was al lowed for the submission of comments on the draft statement. On September 5. 974. the final environmental impact statement was prepared and a copy of it rnci all substantive comments were sent to appropriate governmental agencies, ;rivate organisations, and other inter ested persons. CEQ published a notice of readability for the final statement on ^ .ember C. 1974 (29 FR 32350). Tlie .. air-Mon of comment tvas invited un fit September 25. 1974. The final state ment and all significant comments have beer, carefully considered in arriving at the final standard on occupational expe erre to VC. (7) The record. The record in this proceeding is one of the most exhaustive ever relied upon by OSHA. It consists of pro and post-hearing comments and testimony received at both factfinding and rulemaking hearings, the studies and inspections conducted by OSHA person nel, the environmental impact state ments. the economic and technical impact studies, and all other relevant information. In all. over 600 written com ments have been received, with more ihan 203 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 hcaltfi groups, independ ent experts, physicians, research scien tists, and specialists in many fields have |>een invited to submit information and have made their news, knowledge and experience available to 03HA. The en tire record encompassing these submis sions was thoroughly reviewed and evaluated in reaching the determina tions set forth below. II. Findings regarding carcinogenicity, exposure levels and feasibility--<T) Car- tion was performed, 13 (36 percent) were found with liver tumors i including angiosarcomas), 21 (58 percent) with long tumors, 9 (25 percent) with skin tumors, and one with a kidney tumor. According to the 1970 report by the Surgeon General's Ad-Hoc Committee on the Evaluation of Low Levels of En vironmental Chemical Carcinogens, the finding of cancer in two or more animal species may bo extrapolated to indicate a carcinogenic hazard to humans. Here, such a finding was made in three soeeies that were exposed to VC by mkmniiun-- a route comparable to employee ex posure. In addition, there were at least 13 confirmed cases of annosarcoma 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 KIOSK, 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 chloride induces this tumor. Industry spokesmen, at the hearing, conceded that VC is carcinogenic for humans (e.g. testimony of Dr. McBumey, Rulemaking hearing. 1041). Accordingly, it is con cluded that VC must be regarded as a human carcinogen, and the probable causal agent of angiosarcoma of the liver, and that exposure of employees to VC must be controlled. Additional evidence of tumor induction In a variety of other organs, including lung, kidney, brain and skin, as well as non-malitmant alterations, such as fi brosis and connective tissue deteriora tion, indicates additional oncogenic and toxicologic properties of vinyl chloride, which must be considered in establishing control regulations. (See testimony and results of studies by Bio-Test Labora 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 affected employees. The cases of liver tumors ob serve') to date have an average latency period, >.nce initial exposure, of approxi mately 20 years. If it is assumed that in duction of angiosarcoma is a dose-re lated phenomenon, and if employees en gaged in cleaning reactors did, in fact, receive larger do't-s 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 nccesasrily 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. Schncidermaii 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 1940`s is not reliable evidence that cur rent levels of exposure are safe. Some industry spokesmen also sug gested that the apparent nonrandom distribution of observed cancer in em 'inoggnicity of vimil chloride. The car- tories. Tabersimw-Coopcr, Maltoni, ployees may indicate an exposure thres TOgeuicity of vinyl clUoride for three NIOSH. and SeiikoiT.) hold for tumor induction, based on varia inal species (rat, mouse, hamster) has (2) Exposure limits. Upon finding that tions in the workplace design or prac ueen documented on the record by the exposure of employees to vinyl chloride tice and resultant employee exposures FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 # I ' 35S92 ' RULES AND REGULATIONS R&S 110575 (testimony nnd questlonim; by Tcnneco e.g., testimony of Scllkcfl, Firestone, NCI, confident that Industry will continue to Chemicals, Inc.). It has also been em and NIOSH.) do so. phasized that In only 3 of 3 poK-mcriza- In our view, the demonstration of can (4) Conclusions. The conclusions be tion plants v.-Jicrc employees have been cer Induction in humans at a particular low arc based on a thoro-m review as-! exposed to VC for more than 20 years level is net a prerequisite to a determina evaluation of all the evidence submrp-d. have any employees developed nngiosar- tion that a substance represents a can Where decisions can be b.i.-cd cn rr-.-er-i coma of the liver. This argument is very cer hazard for humans at that level. U evidence, tins has been done. Y/Uc-:-\ similar to that raised concerning vari would be Imprudent to assume man to however, factual certainties are las'.::-.'. ; ability of past employee exposure. Al be less sensitive to VC exposure than ex or where the facts alone do not prov;-:* though Geographic and wcvknrnctice dif perimental animals In the absence of an answer, policy judgments have been ferences may ultimately be demonstrated conclusive evidence. It would also be un made. to be factors in distribution of anqiscnr- 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 cinogenic to man and veo so ccneiv.de. able to exclude'from consideration of trations of VC of less tli'ii 50 ppm. However, the precise level of expzn-.re Tisfc those employees in workplaces for Should a sufficiently larre number of ex which poses a hazard and the ouenti.-n which eases of angiosarcoma have not perimental animals be exposed to VC at of whether a "safe" exposure lcvci c-mms. been observed. concentrations of less than 50 ppm. cannot be definitively answered cn It has also been suggested that the Schr.clderman said that it would,be ex record. Kor is it clear to what eftte--. absence of cancer in a population of 335 pected that some would develop VC In exposures can be feasibly reduced, ".V- Dow Chemical Company polymerization duced tumors. cannot wait until indisputable answer- employees monitored over a period of 7 12) Feasibility. There Is virtually no to these questions arc available, ceeru-e years, indicates that exposure to vinyl dispute that most, it not all. fabricators lives of empievees are at Mike. Ti'.:; :- chloride at concentrations of less than are currently capable of reaching ex fore. v.-e have had to exercise cur Us: 200 ppm is safe. iSee study by Dr. Cook. posure levels of I ppm thrau^h engineer judgment on the oasis cf 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 quired a balancing process.un which the veyed did r.ct inriude all workers who posed to VC. Indeed, several fabricators overriding consideration has c:e:i tk-i had been exposed, ar.ci the missing em are already operating at this level (see protection ot employees, even those v.-'us ployees included many who had the SPI testimony. However, industry may have regular exposures to VC longer term (over 20 years) exposures. spokesmen have universally claimed that throughout their working lives. Moreover, the statistically insignificant It Is Infeasible for the VC ar.d the PVC Based on the available evidence and i.i size of tlie sample population decreases industries to remain below 1 ppm con view of the above considerations, ii.e'. id- the possibility that tumors would be sistently. using engineering-controls. In Ing feasibility, we believe that employ.:* observed. addition, the Snell study on technical exposures to VC must be reduced :o a 1 Dow also presented preliminary data feasibility concluded tlm a l ppm ceil ppm time-weighted averred >TV.'A >. V.`> In 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 present technology, but ments will. In time, be able to attain th" hypothesis presented was that VC may that the VC industry could currently at level through engineering controls, mid exert Us carcinogenic effect by a metab tain lower exposure levels than the PVC that fabricators can do so in the im C olite, nnd that the metabolite is pro indu -try. Labor tinier, spokesmen and the mediate future. duced oniv when VC is metaboliz'd bv a Hcahh Research Group. Inc., however, In audition to the TV/A rrgulr'mev.:. secondary metabolic pathway operating have suggested that sue;) a level is at we have established a 5 yp;n cc..k.z only When enzymes regulating the pri tainable. (avera-ed over a 15-rni-u`e peri'v.' it: mary pathway" are saturated, as would Since there is no actual evidence that order to n re vent exposure of cr.::.; " be th.e result at higher exposures. The any cf the VC cr PVC manufacturers to unacceptable ln -.h excursions. -: nr. preliminary data indicated the possi have already attained a 1 ppm level or in an operation standpoint, this c-cii;:.,; 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, any 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 must necessarily involve subjective judg HI. The Anal standard--(1) Scope r.::d sarcoma In both rats and mice at VC ment. Likewise, the projections of indus application. Beth the ET3 and the pro : exposure concentrations of 50 ppm in try. labor, and others concerning feasi posal-would apply the standard to the dicates that if a metabolite of VC is the bility are essentially conjectural. Indeed, entire VC Industry, including manufac Ultimate carcinogen, then it must be as Firestone has suggested, it is not pos turers of VC and PVC and fabricators, generated at lower exposure concentra sible to accurately predict the degree of but excluding employers handling cr tions in these species. Although this re improvement to be obtained frem en using fabricated products made from search may be helpful to the thorough gineering changes until such changes are VC. understanding of the carcinogenicity of actually implemented. There is no dispute that a standard is VC, it appears that it dees not yet oiler We agree that the PVC and VC estab required for the monomer ar.d poiyiuzr evidence which-can assist In determina lishments will not be able to attain a 1 industries. However, the Society of Plas tion of safe exposure concentrations for ppm TWA level for all job classifications tics Industry (SPI) and various .fabrica employees, or even that such safe ex posures exist, in the near future. We do believe, how ever; that they will, in time, be able to tors (see testimony of Goodyear. Gen eral Cable, etc.) recommended that A number of witnesses representing attain levels of 1 ppm TWA for most job fabricators be excluded from the stand employers have stressed that there is no classifications most cf the time. It is ap ard. or that a separate requirement be evidence of cancer, cither in employees parent that reaching such levels may re established for them because many of ' or. experimental animals, at exposure quire some new technology and work them were already at or below the pro concentrations of VC less than 50 pom. practices. It mav also be necessary to posed ceiling level. (See e.g... testimony of Firestone, Tcn utilize technology presently used in other The record cvtcience establishes that neco Chemicals.) The conclusion of these industries. In any event, the VC and PVC at least seme employees ui the fabric-.^ witnesses was that no decision can be uidustries have already made great Ing industry are expoicci m excess o: made concerning risk of exposure to VC strides In reducing exposure levels. (See permissible control limits (See NlO.-'i! at concentrations less than 50 ppm. testimony of Dow Chemical Co.. TR 973). testimony, TR 106; Robmtezii TR til- On the other hand, the testimony of most expert witnesses, including some in dustry' biomedical experts, stated that Quantification of a ;r.:o exposure con centration is not possible with the pres For example, B. F, Goodrich testified (TR 1120) that It has reduced average exposure levels in several PVC plants from 35--10 ppm early this year to 12-13 In these circumstances, we believe that ' Is imprudent to grant a blanket exem-** tion tor all fabric.-torn. Thw~:'r- ' ' final standard Is applicable to the " ent state ot scientific knowledge. iSee ppm at the time of the hearing. Wc are cation industry, as wed as me meiu.iw-' RDERAl REGISTER VOL 39, NO. 194--fRIDAV, OCTOBER 4. 1974 .1 * ' - R&S 110576 a ;< RULES AND REGULATIONS 33S93 and polymer Industries. Employers who. temperature as PVC. for further pro below the action level, no further moni In fact, arc substantially below the ex- cessing. indicates that a potential for re toring is required unless the employer c 'osttre limit will be subjected to only lease of the residue still exists. It ap has reason to suspect that any employee lnimal burdens by virtue of the "action pears that the exemption of fabricated Is exposed in excess of the action level, ,evd" 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 wall not undergo such mass production, process, control, type of resin, Industry have exposures approaching the heating. Further, the opportunity to etc. , , permissible limit, they will appropriately demonstrate that exposures are below Where the exposure level, without re be subject 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 arc excluded relief. are less than the permissible levels, but from the final standard. This conclusion. Permissible exposure limit. The greater than the action level, monitoring Is based on the absence of ad-quate evi standard sets an exposure limit of I ppm must occur at least quarterly. dence of exposure to VC in these opera averaged over any S hour period, and a (5) Methods of compliance. The stand tions. The final 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 dlscuyscd above, this engineering and work practice controls from PVC which docs 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. SIT and others tcf. 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 processes are 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 require maintenance of an average level plemented, to reduce exposures to the that the exemption of materials with less significantly more difficult to attain lowest practicable live!, and be supple than 0.1 percent of 14 carcinogens from through feasible engineering controls. mented by the use cf respirators to pro 29 CEIL 1010.03p (39 FR 3750) was an Therefore, the exposure limit prescribed vide the necessary protection. There appropriate precedent. The cases are not in the proposal has been rejected. upon. a continuing program of engineer comparable, because no attempt had been (3) Actio71 level. The final standard, ing and work practice controls m'ist be made to set air concentration limits for unlike the ETS and the proposal, pro Instituted to reduce exposures to the low the 14 carcinogens. The record did not vides for an "action level" of 0.5 ppm est practicable level. When exposures are include information that reliable moni T'-VA, otto-ha!:' of the permissible ex at or below the permissible exposure toring ard measuring techniques were posure limit. The purpose of the action limits, the program may be discontinued. available. Moreover, -the exemption did level is to minimize the impact of the In addition, a plan for achieving con not exempt airborne traces of carcino- standard on the employers who have' trol by engineering and work practice cens. Tiie administrative cutotl was pro- attained exposure levels well belcw the methods must be drawn up and be made idccl to avoid regulation of materials permissible limit, Thu*, where the re available, uron recucst. to represent about which there was no health haz sults of monitoring unuer paragraphs atives of OSKA and .VIOSil. ard Information, and which would have (dm) or (d)'.Si demonstrate that no We recognize that many employers broadly extended the application of the employee is exposed in excess of 0.5 covered by the standard can not cur- regulation beyond the record. Herein, ppm TVA. employers may. in effect, be- rcntlv achieve compliance with t'nc per no information was presented to show exempted from some previsions of the missible exposure limit solely by the use safe concentration results from the use standard. For example, fabricators who -of feasible engineering and work practice of resins with specific levels. Indeed, the arc below the action level are r.ot re controls. The record also reflects broad proposal to change the level later, when quired `o provide medical 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 suspect that any employee Industries. Some industry spokesmen, SPi has doubts about the safety of o.l is exposed in excess of the action level. including SPI (TR. 35S-3C3), recom- percent residue level. Diamond Shamrock In our judgment, exposures below the : mended that a schedule of different per- 'Exhibit 142) testified that there Is no action level do not prerent a sufficient missile exposure limits and compliance direct relation. They indicate that the hazard to warrant application of the en dates bo established for the VC and PVC airborne concentration is more related tire standard to the many employers who segments of the industry. to the physical form of the resin and are or will be below that level. This view assumes that the ability and the ventilation provided. Also, monitor (+> Monitoring. The final standard, the time required to feasibly reach in ing data from industry <cf. Exhibits 131. like the proposal, requires that Individual creasingly lower control levels is similar 1G3. no) and OSKA (Exhibit 151) indi employee exposure levels be determined. within each industry, but diilers mark rate that levels in excess of 1 ppm may This may be accomplished by' personal edly between industries. While the record be found in fabrication operations. In or area monitoring. Some witnesses and does suggest that such differences do new of these facts ar.d of the opportunity persons who submitted comments did exist between industries, as noted above, far employers to discontinue many duties not understand the meaning of the term it is clear that intra-industry dijTercnccs a;>on a showing of no exposures above the "95 percent confidence level" in the also exist. Thus, the ability ar.d time re tetian level. it doe5 not appear that any proposal. Essentially -it means that the quired by each employer to attain lower residue exemption is either justified or employer is required to take a sufficient control levels may depend upon such necessary at this time. This course also number of measurements so that the re factors as the climate in which the plant 'r.rces with a number of industry pro suits obtained are statistically valid. We Is located, the age of equipment, the size fits (cf. TP. 660). have modified the proposal to establish of reactors, or the type of resin manu Sl'i <TR 345). among others, asked ~>Li compounded PVC pellets be exni.ptod from the standard on the grounds `'at the pellets had too low a residue to n>u ,e harmful or measurable emtssions. accuracy range requirements for various measurement levels. These ranges are narrow enough to ensure that a deter mination of compliance can be made, and broad enough to allow the application factured or used, <Snell study. Firestone testimony, etc.) Monitoring data also tends to support such intra-industry variations. (See. e.g. Dow. Firestone. Tenncco.) it appears that PVC pellets would of a variety of technologies As noted above, the standard requires V a lower residue level than virgin -j>w\ll covered employers arc required to "C. the fact that the pellets muust be conduct initial monitoring. Where moni all employers to institute feasible engi neering controls to the fullest extent an ' Seated to a molten mass at the same toring and measuring results arc at or to continue to improve and apply engi-' FEDEltAl REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 . 35S01 RULES AND REGULATIONS R&S 110577 iiccrlng controls until full compliance Is If the environmental level la not con trations. In discussions of these finding* achieved. trolled to t!:e permissible exposure limit, with NIOSH. it has indicated that it h We have not cstah!ij.hcd any deadlines then employees must be afforded respira willing to consider on an expedited be*:-, for full compliance through enrinccrins tory protection. the approval of air-purifying ve.-piraters controls because we me presently unable While exposures in excess of the per for use r.gains! VC. Consequently. *vo to detcnninc when it will be feasible for missible level do constitute a hazarci. we have included three types ot air-pun';.-, most establishments to reduce exposure believe that it is necessary to mitigate ing respirators in the list of acceptable Icvfcls to the permi'.'tbie level. some of the problems associated with units, subject to the aporovel of such We also believe,that the requirement Implementing a program of respiratory units by NIOSH. The maximum concen that each employer i educe airborne con- protection while employees are being tration for which each respirator may . cenlrations to the permissible level, or fitted and trained in respirator use, and be used is based upon our evaluation to the lowest level feasible as soon as while other adjustments which may be of the data submitted by NIOSH ar.o practicable will provide for lntor-ir.dus- required are implemented. Therefore, Goodrich. Because air-purifying respi . try and intra-industry technological dif until January 1, 197G, where exposures rators do not indicate sorbent exhaustion ferences which do exist, and will avoid are not in excess of a 23 ppm ceiling, or breakthrough of VC, and because vc the setting of separate industry stand each employer must provide each em has no inherent warning properties ards on the basis of tire general situation ployee with an appropriate respirator. levels for which these devices are used, and conditions in each industry. However, employees whose exposures do strict administrative cor.trois will be re .(G) Regulated areas. The proposed not exceed a 23 ppm ceiling, may decline quired for their use. Such controls in standard would have required that regu to use the respirator, in winch case the clude a program to assure timely re lated areas be established, that access bo employer is not obligated to require its placement of cani-.tcrs or cartrtbces and limited to authorised employees, and use. During this adjustment period, em an alarm system to alert employees when that daily rosters or summaries of those ployees will be trained in the uses, pur vinyl chloride concentrations exceed the entering be kept for at least 20 years. In poses and limitations of respirators, and concentrations allowed for the particu objection to these requirements, it was the hazards of exposure to vinyl chloride. lar type Gf respirator in use. asserted that siteii control of access was Moreover, each employee will be notified (3) Hazardous operations. This is a not necessary from a health standpoint. in writing it he has been exposed in ex new section within the final standard, l: Secondly. It was claimed that these con cess of the permissible exposure limit. encompasses essentially the prcr*o-:aiv. 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 thcpropocal slightly to- allow "autheriaed persons" to enter regulated areas. This change. It is felt, will allow opera-ions to Where exposures exceed a 25 ppm ceil requirements for maintenance ana de ing, respiratory protection is mandatory contamination but has restated them m In light of our Judgment that much terms of performance language to allow greater risks-are associated with such greater flexibility for employers to deal exposures. with such operations. The Intent of the The previsions in the final standard new section is to protect employees en regarding the selection and use of respi gaged in activities that present a risk m ratory protective devices differ from exposure to vinyl chloride In excess of the those in the proposal. The descriptions of permissible levels-An example would be atmosphere-surplying respirators have the cleaning of a filter where resin con been revised tv indicate mors clearly the. taining high residual monaster :s tvpos of devices intended. and the maxi trapped. mum permissible concentration levci for The proposals requirement for full- continue without undue interference. c-.teh device. Moreover, the number of body. impervious clothing has been re The final standard h *.: also ir.crccreci the typer, of . ;t1;rre-s*.i;)plying devices placed by the dircciriii to u*e .mi.-.rvnv: - length of time chhy rosters inu.'t be has teen increased. Garments suited to the particul.-.r : maintained from 2*J to CO years. This At the hearing Mr. Edwin C. Kvatt. an ticn and probable extent o: exyssme. change was based largely on epidemio OSHA consultant, made suggestions re Thus, full-bcdy clothing is not always logical considerations. (See NIOSH testi garding the use of particular respiratory necessary, and is therefore not required mony, tr. 119.) devices. We have concluded that his sug where less protection is adequate. Since (7) Respiratory protection. The final gestions are meritorious. Therefore, the vessel entry fails within the definition standard, like the proposal, requires the provisions for selection of fttmosphere- of a hazardous operation, the vessel entry use of respirators where employee expo supplyimt devices follow closely the rec section of the proposal has been deleted sures exceed the permissible'control level. ommendations contained in his testi from the final standard. Industry representatives made a number mony of SFf and B. F. Goodrich) tTR (9) Emergency situations. The defini of objections to proposed requirements with Hyatt's suggestions. 'See e.g. testi tion of emergency has been recast in for respiratory protection. They stated mony of SPI and B. F. Goodrich) (TR terms of an unexpected massive release. that the "no detectable level" would ef 85 ff) We had originally omitted nir- The main objection to the section on fectively require continuous wearing of purifyir.g respirators because none had emergency situations in the proposal was respirators In FVC and VC plants, and been approved by NIOSH for use against that, as the term was defined, many that this Is not feasible because respira VC. principally because they lacked in ordinary leaks or operations resulting in tors are cumbersome, present a safety dicators to signal the expiration of the a small release of vinyl chloride would be hazard, and employees would not use service life of the sorbent. Hyatt and considered emergencies. This was no; them. other witnesses discussed in detail the the intent of the proposal. The final We would agree that Respirators have many drawbacks: the proposal did not contemplate them as a final solution. The record shows that the FVC industry par ticularly may need, several years before -plant environmental levels can be re desirability of beifig able to use canisters or cartridge air-purifying respirators, provided a sorbent could be shown to euectiveiy absorb vinyl chloride with an adequate service life. Recently. OSHA has received respiratory data from labo standard has beer, clarified to correct this ambiguity. It should be noted that the written operational plan required by Hie standard need not be developed for minor excursions above the permissible exposure limit, and that such excursions duced so that respirators are necessary ratories regarding the elfectivenoss of need not be repot ted. only occassionally. However, we cannot commercially available canisters and (10) Signs and Icbcls.Tr.t thrust of the agree that respiratory protection should cartridges for vinyl chloride. These eval signs and labels section is to apprise not be required simply because it is In uations were conducted separately by employees of the cancer and fire hn;- convenient, may require additional per sonnel, interferes with production, or may require extensive retraining of em NIOSH and by the B. F. Goodrich Com pany and submitted to OSHA in posthearing comments. The results indicate ards. No objections have been raised wit.r respect to Informing employees of the fire hazard. However,, a number of ooJcctions were raised at the hearing and ployees and restructuring of work prac that certain presently available canis in written submissions to me r-.auire- tices. We have carefully considered all ters and cartridges eifectively absorb mcr.t that the word "cancer*' r it ear o:i the objections, and have concluded that vinyl chloride at relatively low concen all signs and labels. The principal argti* tEOERAL CcCISTER, VOL 39. HO. 194--FRIPAT, OCTOBER 4, 1974 -v RULES AND REGULATIONS - 35S95' nl advanced ngninst Its use was that Indicated that the medical tests proposed posal is the requirement for maintenance term "cancer" or "cancer-suspect are currently the only ones available of monitoring records and daily roster *eares employees and that m- which are useful for medical surveillance sheets of authorized persons for 30 years, !(* the message should contain ln- (TR.121, Exh. So. TU 5E0-531). Conse instead of 20 years. Additionally, the em "ions on how to deal with the sub- quently. the spzclfic blood tests pressed ployer is required to maintain medical f <TR. 347). We believe that a have been retained as a minimum re records tor the duration of an employee's V. - ted form of warning will not suffice, quirement to assist the examining physi employment plus 20 years, or 30 years? prsfdojte the concern of employers cian in determining fitness of potential whichever is longer. The original pro ".qthc reaction of their employees. But employees for assignment to workplaces posal called for only 20 years. ."/Vensidcr it imperative that a worker involving VC exposure. In addition, al This chance has been implemented be u;;v informed, and that he realize the ternative medical examinations may bo cause die latency period for induction of . v'.ihie risks involved in his occupation, used where tne examining physician de angiosarcoma ranees up to 30 years from .-.ivied with the training requirement termines that they are at least as good initial exposure. Therefore, as a mini - the standard, we believe that the signs as those specified by the standard. mum, medical records must be main iTj labels required will adequately in The Tabershaw-Cooper study and the tained for at least that long. It should be i'.,,, employees of the hazard. In addi- various animal experiments suggest that noted that spokesmen for both labor and J'ii. such signs will warn unauthorized VC may produce a wide spectrum of ma industry' recommended that this change "rVonncl to keep out of regulated areas. lignant and non-malignant disorders. be made. ' The proper application of most protec- The general scope of the required medical The reporting requirements are not > . ,e measures requires an amount of examination has. therefore, been broad significantly different from those in the '-..iainc and indoctrination of employees ened to include kidneys, skin, connective original proposal. However, Instead of -lit cannot easily be conveyed on a sign tissue, spleen, and pulmonary- system, as the requirement for reporting incidents label. Also, the variety of measures well as the liver. No additional specific which result in the release of VC Into ir-t could be prescribed would result in procedures or tests are required, but rec areas where employees may be exposed, i uawieldly or excessively detailed les- ommendations have been included in the the final standard clarifies our original ,-d. Consequently, the required message Appendix to assist the examining physi intent by stating that only emergencies -a signs and labels will not include in- cian. Because of the nonspecific nature must be reported/ Also the requirement r/nnation on precautions, relevant of the required medical tests, it is not for filing a detailed, written report imptoms, etc. The addition of suitable appropriate to prescribe timing, or type within 15 days has been deleted. It has formation by the employer would be of followup tests, or to mandate with been concluded tiiat submission, within -Knitted, providing it does not detract drawal from exposure-based solely on re 24 hours, of an inirial report that in .-.any way from the required statement, sults of the tests. Instead, the employer cludes facts Immediately available, would Tne requirement in the proposal for is required to obtain a statement from ordinarily be sufficient. However, if tne : fading containers of vinyl chloride has the examining physician of the em OSHA Area Director requests further in amended by deleting the reference ployee's suitability for continued expo formation relevant to the emergency, the : the possible hazard of violent polym- , sure. when the examining physician has employer will be required to furnish such nation. Very little information was completed such tests a3 he considers ap information, /eloped on this hazard during the propriate. The employer is reouired to (14) Deleted portions o! the proposal. ' ...ndard-fotemg procedure. It does ap- withdraw an employee only when this The proposal contained provisions re :-ar that this hazard is essentially under statement indicates that the employee quiring that shower facilities and change rural and that the fire and carcino- may be at added risk from continued VC rooms be provided, and that storage or C:.!c hazards at present are the most exposure. consumption of food be prohibited in r.ificaut. Since labeling or placarding As with monitoring, there appears to regulated areas. We have deleted there :.,c: Is in compliance with the U.3. De- be no basis for complete exemption of the provisions because it is our conclusion ;;tment of Transportation regulationfasbrication industry from the require they are no longer neeessaiy. Showering 10 CFFt Part 173. Subpart Hi already ment for medical examination. The rec facilities are not required because pro ./.ms of the fire hazard, only a state- ord does show fabricating establishments tective clothing, where required by the ... at concerning tire carcinogenic haz- with concentrations of VC monitored final standard, should protect employees ; ird need be added to the Department of considerably above the action level. In from skin absorption by direct contact 'I ransporiation labels. these instances, medical surveillance of with VC and because there is no reliable . til) Medical surveillance. The princl- affected employees will provide baseline evidence that VC vapor is absorbed i til questions that have been raised re- data for future evaluation of their health, through the skin. In addition, since we ; nrding medical surveillance are the even if both monitoring and medical sur anticipate that most employees will not treessity and efficacy of requiring cer- veillance are discontinued because im be wearing protective clothing and that . '..mi specific scrum enzyme determina- proved controls reduce concentrations employees who wear protective clothing boas lSMA-12 series) and the applica- below the action level. Where exposures will change such clothing infrequently, i of medical examination require- are below the action level, the medical we are not requiring that change rooms l z.ents to the fabrication segments of the surveillance requirements do not general be provided. 1 w.dustry where employees are exposed to ly apply. In addition: we feel that there Is in 1 cr levels of VC. The objection has also (12) Trainino. A separate provision for adequate evidence showing that hazar 1 i'.'tn raised that the specification of tests employee training has been added to the dous amounts o' VC can be absorbed i ;d procedures interferes with the ap- final standard rather than including it through ingestion. For this reason, the f location of advances in medical knowl- within the section on emergency situa requirement prohibiting the storage or ; ifsc. tions as in the proposal. The new para consumption of food in regulated areas .* A particular difficulty in considering graph provides fer training of employees has been deleted. i a.tdical surveillance is that the most concerning the carcinogenic hazard of The proposal also contained provisions j twr.monly discussed lesion, angiosar- VC, emergency procedures, the need for on niair.tentance and decontamination, 1 ijaia of the liver, currently cannot be monitoring and an annual review of the transportation loadimt and unloading, { ! ^-'gnosed until the victim is terminal *:-d. usually, within months of death. standard. It also provides for training of employees concerning the purpose for. ar.d polymer handling operations. These requirements are not mentioned in the : brc-cursor physiologic alterations, which proper use of. and limitations connected final standard because attention to these t < i;-cht be reversible, have not yet been '"itetly associated with the lesion. Con- with respiratory protection. <13> Records and. reports. The provi Items is implicit in the requirement that eacii employer reach the potmissable ex i :,quQatly. there arc no specific diagnos- sions for recordkeeping contained in the posure limit or attain the lowest feasible tests which can be prescribed which final standard require the preparation level. v.il determine presence or absence of and maintenance of essentially the same (15) Effective date. In order to ensure . tumor at an early stage of develop- information required by the proposal. that affected employers and employees r i-enl. However, most medical witnesses The ma;cr change from the original pro will be informed of the existence of these i>. FEDERAt REGISTER, VOt. 39, MO. 19*--FRIDAY, OCTOBER 4, 1974 R&S 110578 R&S 110579 35S06 RULES AND REGULATIONS provisions and that employers affected of the ojicrntlon or because of an acci opportunity to observe the monitor arc given an opportunity to familiarise dent in the operation. which would result ing and measuring required by (hi., themselves and their employees with the in an employee exposure In excess of the- paragraph. existence of the new requirements, the permissible exposure limit. (c) Rcyulatcd area. <1) A regulated effective elate of the amendment to (SI "OSilA Area Director" means the area shall be established where: j 1910.93q will he January 1.1375. To pro Director for the Occupational Safety (1) Vinvl chloride or polwinyl chlorir:- vide continued protection for employees ancl Health Administration Area Office is manufactured, reacted, repackaged, until that date, the provisions currently havin'; jurisdiction over the ceoernphie stored, handled or used: and contained in 5 1010.92q are hereby area m which the employer's establish (ii) Vinyl chloride concentrations are promulcated. pursuant to section 6fb), ment is located, In excess of the permissible exposure 6(c) and 8fc) of the Occupational Safety (9> "Polyvinyl chloride" means poly limit. and Health Act. as an occupational vinyl chloride hemopolymer or copoly (2) Access to regulated areas shall he 'safety and health standard effective mer bcforc such is converted to a fabri limited to authorized persons. A daily October 4, 1974, the amendment to cated product. roster shall be made of authorised per S 1910.93q set out below will supersede (10) "Vinyl chloride" means vinyl sons who enter. these provisions as of January 1, 1975. chloride monomer. (f) Methods of compUanc1'. Employee Accordingly, upon consideration of the-?* *c) Pcrmicsiole exposure limit. (1) No exposures to vinyl chloride shall he con whole record of tills preceding. Part 1510 employee may be exposed to vinyl chlo trolled to at or below the permissible ex of Title 29. Code of Federal Regulations ride at concentrations greater than 1 ppm posure limit provided in paragraph >c> Is amended, effective January 1. 1575. by averaged ever any C-hci'.ir period, and of this section by engineering, work nrae- revision of 5 1310.Mq to rend ns follows: (2) No employee may be exposed to tiee. ar.d personal protective controls as 1910.93q Vin) l chloride. vinyl chloride at concentrations greater follows: than 5 ppm averaged over any period not (1) Feasible engineering ar.d work (a) Scops and application. (1) This exceeding 15 minutes. practice controls shall immediate!" be section includes requirements for tiie (3) No employee may be exposed to used to reduce exposures to at or below control of cmnlovec exposure to vinyl vinyl chloride by direct contact with the permissible exposure knit. chloride (chloroctiicne). Chemical Ab liquid vinyl chloride. (2) Wherever feasible engineering ar.d stracts Service Registry No. 75015. (d) Monitoriny. (1) A program of work practice controls which can be in (2) This section applies to the manu initial monitoring and measurement stituted immediately are r.o; sufficient m facture, reaction. packaging, repackaq- shall be undertaken in each establish reduce exposures to at or bciow the per Jng, 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 does ployee exposed, without regard to the use theless bo used to reduce exposures to not apply to the handling or use of fabri of respirators, in excess of the action the lowest nracticahle leva!, r nd she .i cated products made of polyvinyl chlo level. supplemented bv respiratory protect:::: ride'. (2) Where a determination conducted in accordance with paragraph <g> of this (3) This section applies to the trans under paragraph (d)(1) of this section section. A program shall bo establish.:-.! 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 permis'iVe exyc-.r- Department of Transpoi tation may cess the action `.eve!, a program for de limit, or to the greatest cx.wns k:. regulate the hazards covered by this 'ac termining exposures for each such em fclely by means of engine":-:.".g rad v.c:`: tion. ployee siiail be established. Such a pro practice controls, as scon as ter sibic. (b) Definitions. (1) "Action level" gram: (2) Written plans far a ".c -- .r : means r. concentration of vinyl eiticr.de ti> Shall he repeated at least monthly shall be developed ar.d :u.m::l.ed v .. of 0.5 ppm averaged over an 3-hcur work where any employee is exposed, without request for examination and copymy :: day. regard to the use of respirators, in ex authorized representatives of the A;si-i- (2) "Assistant Secretary" means the cess of the permissible exposure limit. tar.t Secretary and the Director. Such Assistant Secretary of Labor for Occupa til) Shall be repeated not lees than plans shall be updated at least every six tional Safety and Health. LT.S. Depart quarterly where any employee is exposed, months. ment of Labor, or his designee. without regard 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 (fit) 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 requirement; such an area as a designated representa less than 5 working days apart, show ex of this paragraph and shall assure ihn: 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. 1973. wdaring m 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 15- Safety and Health, U.S. Department of of vinyl chloride, or the employer has minute period. Until December 31, 1575. Health, Education, and Welfare, or his any other reason to suspect that any em each employee who chooses not to wear designee. ployee may be exposed In excess of the on appropriate" respirator shall be in .(5)-"Emergency" means any occur action level, a determination of employee formed at least quarterly of the hazard.; rence such as. but not limited to, equip exposure under paragraph (d) (1) of this of vinyl chloride and the purpose, proper ment failure, or operation of a relief de section shall be periormed. use. and limitations of respiratory vice which is likely to. or dees, result in ~*"U> The method of monitoring and devices. massive release of vinyl chloride. measurement shall have an accuracy (2) Respirators shall be selected frrm (G) "Fabricated product" means a (with a confidence level of 95 percent) of among those jointly approved by the product made wholly or partly from not less than plus or minus 50 percent Mining Enforcement and Safety Admin polyvinyl chloride, and which does not from 0.25 through 0.5 ppm. plus or minus istration. Department of the Interior, require further processing at tempera 35 percent from over 0.5 ppm through and tiie National Institute for Occupa tures, and for times, suificient to cause 1.0 ppm, and plus or minus 25 percent tional Safety and Health under the pro mass melting of the polyvinyl chloride over l.O ppm.' (Methods meeting these visions of 30 CTR Part 11. resulting In the release of vinyl chloride; accuracy requirements are available In (3) A respiratory protection program (7) "Hazardous operation" means any the "NIOSH Manual of Analytical meeting the requirements of } lOia.'.D operation, procedure, or activity where a Motiious"). shall be established and n-.'unuuucii. release of either vinyl chloride liquid or (5) Employees or their designated rep (4) Selectien of respirators for vm--l eas might be expected os a consequence resentatives shall be aflorded reasonable chloride shall be as follows: FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 R&S 110580 RULES AND REGULATIONS 35S97 atmospheric concentration of vinyl chloride ; -- Required apparatus c gaiwowi!. f bove 3,600 ppm__ Open-circuit, self-contained breaihlng apparatus, presaure demand type, with lull facepiece, .. Sot over 3,600 ppm________ ... (A) Combination typo C supplied air respirator, pres- 1 sure demand type, with lull or ball facepiece, . . and auxiliary sell-contained air supply; or (B) Typo C, supplied air respirator continuous flow * type, with full or half facepiece, and auxiliary self-contained air supply. I-U) Hot over 100 ppm..___....... (A) Combination type C supplied air respirator de- *' - mand type, with full facepiece, and, auxiliary seU-contalned air supply; or `. , (B) Open-circuit self-contained breathing apparatus with full facepiece, la demand mode: or . (C) Type C supplied air respirator, demand type, with full facepiece, tti) Hot over 25 ppm...._._______ (A) A powered alr-purlfying respirator with hood. 1 helmet, full or half facepiece, and a canister which provides a service life of at least 4 hours for conccnratlons of vinyl chloride up to 25 ppm, or (B) Oas masi:, front- or back-mounted canister which ' provides a service life of at least 4 hours for concentrations of vinyl chloride up to 25 ppm. (t) Not over 10 ppm.....--------- (A) Combination type C supplicd-alr respirator, de mand type, with half facepiece, and auxiliary self-contained air supply; or (B) Type C supplled-alr respirator, demand typerwith half facepiece; or (C) Any chemical cartridge respirator with an organic vapor cartridge which provides a service life of at least 1 hour for concentrations of vinyl chloride tip to 10 ppm. <5) (I) Entry Into uniform concentrams or concentrations greater than ..000 ppm (lower exilicjive limit) may e made only for purposes of life rescue; c . <ii) Entry Into concentrations of less . _;n 3G,Gt;G pynt. but greater than 3.C0C sir. may be made only for purposes of Lie rescue, firefighting, or securing fquipment so ns to prevent a greater :...2ard from release of vinyl chloride. *6) Where air-purifying respirators are used: <1> Air-purifying cannistcrs or car tridges shall be replaced prior to the ftpiration of their service life or the tad of the shift in which they are first in-d, whichever occurs first, and tii) A continuous monitoring and sisnn system shall be provided where . mcentrations of vinyl chloride could reasonably exceed the allowable concen trations for the devices in use. Such sysfv.m shall be used to alert employees when -nyl chlorine concentrations exceed the tilovrable concentrations for the devices sa use, <7> Apparatus prescribed for higher i-jr.cpntrations may be used for any lower Oncentration. <h) Hazardous operations. (1) Em ployees engaged in hazardous operations, secluding entry of vessels to clean poly';nyl chloride residue from vessel walls, `;saU be provided and required to wear nd use: (1> Respiratory protection In accord ance with paragraphs tc) and (g) of ''its section: and . -b) Protective garments to prevent tf-in contact with liquid vinyl chloride or th polyvinyl chloride residue from t'Sel walls. The protective garments `mil be selected for the operation and *-s possible exposure conditions. '2> Protective garments shall be pro vided clean and dry for each use, ti) Emergency situations. A written operational plan for emergency situa tions shall be developed for each facility storms, handling, or otherwise using vinyl chloride r.; a iiquid or compres.ed gas. Appropriate portions ef the plan shall be implemented in the even: of an emergency. The plan shall specifically provide that; (1) Employees engaged in hazardous operations or correcting situations of ex isting hazardous releases shall be equipped as required in paragraph th) of tills section: (2) other employees net so equipped shall evacuate the area and not return until conditions are controlled by the methods required in paragraph <f) of this section and the emergency is abated. (j) Training. Each employee engaged in vinyl chloride or polyvinyl chloride operations shall be provided training in a program relating to the hazards of vinyl chloride and precautions for its safe use. (1) The program shall Include: (i) The nature of the health hazard from chronic exposure to vinyl chloride including specifically the carcinogenic hazard: (ii) The specific nature of operations which could result In exposure to vinyl chloride in excess of the permissible limit and necessary protective steps; (li) The purpose for, proper use, and limitations of respiratory protective devices: (iv) The fire hazard and acute toxic ity of vinyl cliloride, and the necessary protective steps; (v) Tile purpose for and a description of the monitoring program; (vi) The purpose for, and a descrip tion of. the medical surveillance program: (vli) Emergency procedures; (viii) Specific Information to aid the employee in recognition of conditions which may result in the release of vinyl chloride: and r (ix) A review of this standard at the employee's first treimng and indoctrina tion program, and annually thereafter. (2) AH materials relating to the pro gram shall be provided upon request to the Assistant Secretary and the Director. (k> Medical surveillance. A program of medical surveillance shall be insti tuted for each employes exposed, with out regard to the use of respirators, to vinyl cliloride In excess of the action level. The program shall provide each such employee with an opportunity for examinations and tests in accordance with this paragraph. Ail medical ex aminations and procedures shall be per formed by or under the supervision of a licensed physician, and shall be provided without cost to the employee. U) At the time of Initial assignment, or upon Institution of medical surveil lance: (1) A general physical examination shall be performed, with specific atten tion to detecting enlargement of liver, spleen or kidneys, or dysfunction In these organs, and for abnormalties In skin.' connective tissues and the pulmonary system iSee Appendix A). Ui> A medical history shall be taken, including the following topics: (A) Alcohol intake: 03) Past history of hepatitis: <C> Work history ana past exposure to potential hepatotoxic agents, ir.clud- . ing drugs and chemicals: <D) Past history of- blood transfu sions; and (E> Past history of hospitalizations. (iii) A scrum specimen shall be ob tained and determinations made of: (A) Total bilirubin: (B) Alkaline phosphatase: (C) Serum glutamic oxalacetic trans aminase (SGOT); (D) Serum glutamic pyruvic transam inase <SG?T>: and (E) Gamma gluslatnyl transpeptidase. (2) Examinations provided in accord ance with tiiis paragraph shall be per formed at least: (1) Every G months for each employee who has been employed in vinyl chlo ride or polyvinyl chloride manufacturing for 10 years or longer: and (iii Annually for all other employees. (3) Each employee exposed to an emergency shall be aiforded appropriate medical surveillance. K> A statement of each employee's suitability for continued exposure to vinyl chloride including use of protec tive equipment anu respirators, shall bo obtained from the examining physician promptly after any examination. A copy of the physician's statement shall be pro vided each employee. (5) If any employee's health would bo materially Impaired by continued ex posure, such employee shall be with- TEDERAL REGISTER, VOL 39, HO. 194--FRIDAY, OCT03ER 4, 1974 33S98 RULES AND REGULATIONS drawn from possible contact with vinyl tion which contradicts or detracts from (ID The number of employees In each, chloride. the effect of, arty required warning, regulated area during normal operatm.-.v <G) Laboratory analyses for all bio Information or Instruction. including maintenance. logical specimens included In medical (m> Records, tl) All records main (2) Emergencies, ar.d the facts <),- examinations shall be performed in labo tained in accordance with this section tainablc at that time, shall be reperv-! ratories licensed unticr 'I- CFil I'art 74. shall include the name ar.d social secu within 24 hours to lire OSIIA Area D.. (1) If the examining physician deter rity number of each employee where rector. Upon request of the Area Dine- mines that alternative medical examina relevant. tor. the employer shall submit addit:.`.::. i tions to those required by paragraph (2) Records of required monitoring information in writing relevant to <fc)(l) of this section will provide at and measuring, medical records, and au nature and extent of employee o.xnov.irr-. least equal assurance of detecting med thorized personnel rosters, shall be made and measures taken to prevent iini;.-- 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 i3) Within 10 working days follow.';;-- cept such alternative examinations as representatives of the Assistant Secre any monitoring and measuring v.h:,;-, meeting the requirements of paragraph tary and the Director. discloses that any employee has bet.-, (fc)(l> of this section, if the employer <i> Monitoring and measuring records exposed, without regard to the use r* obtains a statement from the examining physician setting forta the alternative examinations and the rationale l'or sub stitution. This statement shall be avail able upon request far examination and shall: tA) State the date of such monitor ing and measuring and the concentra tions determined and identify the instru ments and methods used: respirators in excess of the perma-s::;;.* exposure limit, each such employee sii..-:; be netihed In writing of the results a the exposure measurement and the sic-.- copying to authorised representatives of (B) Include any additional informa being taken to reduce the experuro the Assistant Secretary and the Director. tion necessary to determine individual (1) Signs end labels. (1) Entrances to employee exposures where such expo regulated areas shall be posted with leg sures are determined by means other ible slams bearing the legend: than individual monitoring of employees; CANCER-SusrECT AGENT AREA AUTHORIZED Personnel Onlt and CC) Be maintained for not less than (2) Areas containing hazardous oper ations or where an emergency currently exists shall be posted with legible signs bearing the legend: 30 years. Ui) Authorized personnel rosters shall bo maintained for not less than 30 years. (Hi) Medical records shall be main tained for the duration of the employ ' Cancer-Suspect Agent in This Area Protec ment of each employee pi'as 20 years, tive Equipment Required Authorized or 33 years, whichever is longer. Personnel Onlt ' (3) In the event that the employer (3) Containers of polyvinyl chloride ceases to do business and there is no reslrv waste from reactors or other waste successor to receive and retain his rec contaminated with vinyl.chloride shall ords for the proscribed period, these rec be legibly labeled: ords shall be transmitted by regirtcrvii Contaminated with Vinyl Chloride Cancer-Suspect agent ' (4) Containers of polyvinyl chloride shall be legibly labeled: mail to the Dire.ter. and each employes individually notified in writing of tins trr.n-fcr. 14) Employees or their designated representatives shall be provided access Polyvinyl Chloride (or Trade Name)' to examine and copy records ot required Contains monitoring and measuring. * Vinyl Chloride (5) Former employees shall be pro VlNTL CHLORIDE is A CANCE-SUSPECT AGENT vided access to examine and copy re within the permissible exposure h:u.:. (o) Effective dates. (1) Until Janu ary 1. 1975, the provisions cunentlv ; forth in 5 1910.$2q of this Fart she.:: apply. (2) Effective January 1, 1975, the pro visions set forth In 3 1910.93q of this Far. shall apply. . Appendix a--Supplementary Medical . INTOZMATION When required teits ur.de.- psr.-.i-r.v . (fc)(l) of nils section chow abnorr.-.Uii.i. the tests should be repeated ns soon a-, p.-w- ilcable, preferably within 3 to 4 ttveki. i. tests remain abnormal, consideration *;.ou : be riven to withdraws! of the ente.ii-.-c contact with vinyl chitridc. a :. comprei.ci.iive exaav.na-.tcR is r...-.dv. Ad'i-.t.or.al tostj v.hmu may bi- t . A. Fct itldr.ey dyilttncttoa: utt.-.v mw:... : tlo.l for aiatinttn. r.-.i L-tood o. to:`.stive r.sr.o.-tsal cvl.j. B. rul.-aoxtary itut.-m: Fcrccu ,it:.; ; ity, Forced expiratory volume a: 1 and chest roentgenogram (poitcrtcr-at-tst.:- 14 x 17 Inches). C. Aduitional serum tests: Lactic r.cld :> (5) Containers of vinyl chloride shall be legibly labeled either: 0) ' Vinyl Chloride Rxtremelt Flammable Cas Under Pressure Cancer-Suspect Agent or (II) In accordance with 49 CFR Part 173, Subpart U. 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, tl) Not later than 1 month after the establishment of a reg ulated area, the following Information shall be reported to the OSHA Area Di hyurosciiise, lactic acid dshydre.-er.- Isoenzyme. protein determination, protein electrophoresis. D. For a more comprehensive exitr.'.iuai: s on repeated abnormal scrum t3ts: Hegatn-t B antigen, and liver scanning. (Sees. 0 ond 8, 84 Stat. 1596. 1599 (29 Ust C55. G37): Secretary of Labor's Order :13--71, 38 Fit 8734) Signed at Washington. D.C., this b*. .' Cancer-Suspect Agent applied near the labor or placard. (6) No statement shall appear on or near any required sign, label or instruc rector. Any changes to such information shall be reported within 15 days. (1) The address and location of each establishment _ which has one or more regulated areas; and day of October, 1974. John Stencer. 'Assistant Secretary of Lc'jer. [FR Doc.74--23176 Filed 10-1-74:3:54 ?=i {t l f FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 t 30 f f. co 07 CD *r V: ,7 .``XM RULES ANO REGULATIONS f Ti Title 29--Labor chapter xvii--occupational safety ANO HEALTH ADMINISTRATION, DE- PAfiwJKNT Oi- LASCn l-AiY;' IS 10--OCCUPATIONAL SAFETY AND HEALTH STANDARDS Y Standard (or Exposure to Vinyl Chloride Pursuant to sections 61!>'*. Gic), and il<ci of the Occupational Safety and Health Act of i973 <84 Stat. 1533. 159G. 1590; 20 U.S.C. 655, 657) Secretary of Labor's Order No. 12-71 (36 PH 8734) and 25 CFR Part 19U, J 1010.93 of Part 1910 of Title 20, Code of Federal Regu lations is hereby amended in the manner sec ;ovt)i below. in order to provide an Occupational -Safety and Health stand ard dealing with the exposure of em ployees to vinyl chloride. I. Bavkgrovnd--(11 Vinyl chloride. Vinyl chloride (chlc-reethene). Chemical Abstracts Service Registry No. 75014, b a synthetic organic chemical made from cthvlc-ne er acetylene and chlorine by any of several processes. It is the parent compound of a series of thermoplastic resin polymers and copolymers which are rudely used for containers, wrapping Him. electrical insulation, pipe, conduit, and a variety of other industrial and consumer products. Vinyl chloride has been made commercially in this country riiv.-a 1033, and present production is in excess cf saver- billion bounds per year. The vinyl chloride industry divides into throe segments: monomer production, polymer production, and fabrication, "i-owcnon oc me monomer is a scaio cor.tinuoos process, involving only a tow firms. There are comparatively few eu.pics`c:s.fn this segment of the industrv, because the processes lend them selves to automation. vinyl chloride (VC) Is used primarily in the production of polyvinyl chloride (PVO. a resin which is produced through batch, processing. The conversion of the VC monomer into a polymer or copolymer 4s an incomplete process, l.e.. not all of the monomer Is reacted. PVC is fabricated by a variety, of tech niques. Including extrusion, injection molding and calendering, to form a fin ished product that needs no further chemical handling. The vast majority or employees Involved in the VC industry arc employed by fabrication firms. Such firms range in sice from these with few employees and simple equipment to large p'-ants involving many employees and considerable cu'pftrl. Vinyl chloride ` VO, a gas at ambient tempt:; atuve and pressure is a chlori nated hydrocarbon, wnich heretofore has been regarded us having moderate liver tc.xicUv. The initial standard, contained in Tabic G-l ct 1310.93, established a ceilin'* Value of 503 paiti of VC per mil lion parts of air. ;2 The emcrgenet temporary standam. On January 22. 1574, the Occupa tions.! Safety and Health Administra tion 1 OSH*\i was informed by the Na il institute for Occupational Safety am: iY.' `KIOSK) that, the ii, IA Gor-inch C.'.cmieal Company had rsp ortori that ri-r.th:; of sever;',.' of its em ployees from a rare ltver cancer (angio sarcoma) may have boon occupationally related. As a result of this notification and alter consultation .vith Nicr;u. and a joint inspection of the 13. F. Goodrich plant by Oh HA. t-.TOSU ai.d tire Ken tucky Department of Labor, a fact-find ing hearing was announced oil Janu ary 30. 1974 (30 FR 3874) and held on February 15.1974. Information obtained from this near ing, particularly the preliminary reporis of experiments conduct ed by Professor Cesare Maltoni of the Instituto di Oucolor-ia, Eolojna, Italy, demonstrated that vtnj 1 chloride Induced angiosarcoma in rats at levels as low as 250 ppm, and in other species at hisfcey levels. Experi ments performed at lower levels of ex posure were not completed at that time. Other testimony from medical witnesses and NIOSI-t. and Cue results of autopsies, led to the conclusion that tne Goodrich workers had onyiosarccma cf the liver and that VC probably was the causal agent Jn the angiosarcomas observed. In post hearing comments, additional angiosarcoma deaths were reported among workers who had been exposed to VC in plants operated by Union Carbide Corporation, Firestone Plastics Corpora tion and Goodyear Tire L Rubber Com pany. On the basis of all information avail able at that time, and the fact time em ployees were being exposed ct levels around the experimentally observed ef fect level of 25') ppm. an emergency tpnin.iraiw- tsta4n1da1 rd2 fr)i*i'4TO/"iOwa"FsT1prlOomT-utMi- pursuant to section G(o) of the Act, as 29 CFR 1010.93(1. Tins standard reduced the permissible exposure level from a ceiling ct 500 ppm to a 50 npm coiling, and ostaolished other requirements, including, for examme, monitoring and rcsphv.tory protection. It was expresslv recognixett that this standard limiting exposures to a 50 ppm ceiling wa-'i a tentative, interim standard, and that tire whole question of exposure to VC would be considered more fully in the light of additional information, especially the results of experiments which were known to be underway at that time. On .April 15,1974, information and daft, wore presented to representatives of OSHA, NlOSII. and the Environmental Protection Agrury by the Industrial BioTest Laboratories. Northbrook, Illinois, concerning results of animal exposure studies w'.rh VC. These studies were sponsored by the Manufacturing Chem ists Association. Although only pre limYew in nature at that time, these resv.Y reveried that 2 out of 200 mice exposed iu VC concentrations oi 50 ppm tor 7 hours ~ cl. , five clays a week, for uppr--;imp.tciy 7 na/n.hs. had developed a.U'.'ia:.r.vco:u-. of the kvor, <31 '1'hr urcyes:-.! carin-.incut stand- era. Rased on U'.c avid-man. of Vi's catctf'enicvy m three s nine cl rocrivs t'Y. re and human.r:>). and tin- subrisniw.l yrtcukirity Neat VC h"ri been the crij-.'.l ivc.tc in the casts m liver amriix-arco.e.i found in workers rc'.n here and abroad. CSITA proposed to revise lOlO.'.riq end pubushori a comprehensive prcpo.-'l '39 I-7I IGuSu) on May 13, 197-1, to protect employees :rom hazards of exposure to VC. The proposal called for limitation of employee c.-n't-suie to VC to "no detectable level." as measured by a sampiih""and analytical method sensitive to 1 ppm, with an accuracy of 1 ppm ri59 percent. The proposal also called for the establishment of regulated areas and limited acoe:;.- to such areas to au thorized persons, a requirement for monitoring of employee exposures was proposed, a.iong with engineering and work practice controls to be implemented i when exposures over the detectable limit were measured. Respiratory protection would have been required while engineering and work practice centre's were bring implemented or where exposure's exceeded rite per missible limit even alter feasible en gineering controls were instituted. In addition, the proposed standard Ineluded requirements for medical sur- vsil'ar.ce, protective clothing, emergency procedures, training, specific protection during maintenance and decontamina tion operations, transportation loading paid unlc&uing operations and recordkeeping. (4) IIcar:.-ia on the proposal. The pro posal, as published an May 1974, Hllr.-.ved :;0 day, for interest'd parties to submit written comments and to request an inforc.a.1 rulemaking bearing. In formal contacts with OSKA stall and ft***!** pevts,*seni. i rsf* W'A t art 11>_ -it# t * .,. s . , to many pf.-rscr.s. Because of fit : limited time available before cxpiralir.;: of the six month period provided in section S(c''i3.` of the \ct .`or promulgation of a final standora, ;t was decided to hold a hearinu ns soon as possible. Accordir.g'y, on May 2i. 1974, n notice of a hear ing was pub'.Uhcd (30 FR 183031, .-ettmsf a hearing date of June 25. 1974. The hearing wan conducted from Juno 25 through June 23, and again from Juiy .3, through July II. before Administrative Law' Judge Gordon J. Myatt. Ail partici pants were given the- opportunity to pre sent te-iiirtny and to cross-examine ether witnegse-s. Persons participating in the her.rr.vj " or? given until August 23, 1374, :o file m'dit-ional posthearm.g com- ; i 1 a 0 If 1 st Ift n. a th U iu rh i9 at. ar. to Pi. ns.' tm tdz; Slit til ; mi'! I N; v j the I sur C Prcever pro tos`i and ihsp ! no!, ; rwm 1 hUp, ; :r.-,0, ru'.uv.s. rr.cl'jdms various iiomr. of infor- ' 'uau Riatinu which were requested during the examination of witnesses. 5) Ecohonrc and technical imped study. During the hearing, CCHA deter mined that r.riiiitlbr.al facts would l't' I J 1 ; S', is s: `.Air; `rifft- 'nt f needed to determine rite practicality of certain asncct? cf the proposed stand , , '~,u, :--;n ard. Accordingly, OSHA contacted an hr : .`'.I, dependent consultant. Foster D. Sr.c'.l Carp -arion. to conduct studies of tm ; ; 0; frasiUbty of c''aiplian-:i: r.c various r.x- y.ra-y.v ic.cb;. i".d,.,d!ug ti;o.-.' proper by Own A anti others advanced by fir nu.:.V rpo'tcvrucr.. Si'.cil v.as ai-o co" nrwUii'O id col'..;: .n-.ormaf'.oi' rcs:'!-- r.::: cc.'m.i.rij ccr-'a of . w..pb'.::" T'lus avy u vas avnoui.w.-' ' cf 'hr bev:.w, and .furgo Mya*;t b.'ri-" M.r.c,r.-...' i fh.-.t if.a record wouid b - 'i,` R&S 110582 FDRAt ilsCUUT:, VCt. S'). N'J. ) 71--FriOAY, CfTOOfS 4, 19V4 iti . RUIES Am) REGULATIONS 35S91 tvehe-. y 10. if: ' ,.;1 for k period of time beyond August lu i-1`0'./ interested persons to ,;o:n.'nt in vrttjr.o on the study. On Ausust : iOSHA. announced that the pro- study was available and that ued t-. spn.sif;, junents were to be submitted no hi'cr n September-6. 1974 (39 FR 30P44> September 13, 197-i. OSHA mvi red -uidier, of Maiton1 and Bio-Test Labcra- may create a carcinogenic hazard. _th ,w Moreover. Maltoni's investigations amount of exposure wliicii is hazardous h,-..'^nr.i-onr.n-ateri n. dese-denendent re.-. 'must bT'aeterminecT The Surgeon Gcnfor Induction of tumors (i.e.. eral's Ad Hoc Committee referred to iiio-e tumors occur at higher exposure above concluded Hint safe exposure levels i,,vrN> including angiosarcoma of the for carcinogenic substances cannot be I'v.-r i'n rats. The investigations of In- scientifically determined. This position i j>-nal Bio-Test Laboratories have dem- is supported by the testimony of NIGSH * 7 !-V,, SO C^JJa cd ai-,: -S to ..aments on both the preliminary ami final study, which was to be received or before September 23, 1974 t3S FR m009>. or , p-med a similar relationship. .for bjliCrats and inico. These investigators I,'\c induced angiosarcoma of the liver in'raw and mice at exposure concentra- at the hearing, its recommendations for a standard of no delectable level, aucl by the testimony of expert witnesses from the National Cancer Institute, ;ent /c nea Wf i-iff an; 6) Environmental impact statements. notice of intent to file an enviroumc-n',u impact statement assessing use tm- tions of 50 ppm, and in hamsters at higher concentrations of exposure. Additional Illinois involving other organs, including Several witnesses and persons who submlttcd comments have taken a contrary view' and have suggested that man is less iiee nJ'iru;'|' ,,~a~cylonoafl a FrcPosed standard exposure to VC was on occupublished the kidneys, lungs, and skin of exposed animals, were also observed in freemen- sensitive to biologic aberrations induced by vinyl chloride exposure than experi- 1 . ! ;n the Federal Register on April 24, c.-s much in excess of control animals, mental animals. Proponents of this posi- Vsi1dm l374 133 14522). The notice invited 'reen"Pteerd- i Je en- < say person having information or darn on the environmental impact to' submit it tc OSHA by May 17. 1074. On Jure 12. Is74, a draft environmental impact ndai-d -1 sur-: scacy : action : t-hiaadlng > cord- 1 statement was prepared and circulated to all interested persons. Ten copies were forwarded to the Council of Environ mental Quality (C2Q), which published & notice of its filing and availability ir. the Feseras Register on June 25. 1971 139 FR 22975). A 45 da7 period was al lowed for the submission of comments on pro- the draft statement. On September 5. 1974, the final environmental impact 1974, es to .'/Moment was prepared and a cc:>y of it cad all substantive comments were sent fiiest In o appropriate governmental agencies, private organisations, and other inter dia ub* ested persons. CEQ published a notice of availability for the final statement on nee _ September C. 1974 (39 FR 32350;. The led ^4 A|Swiian* ti'oe 3 iic incidence 0/ tumors in mice hi the tion have argued that if humans were as Industrial Bio-Test Laboratories invest!- sensitive as rodents, an "epidemic' of gallons is particularly pertinent. Of 200 cancer resulting from VC exposures mice 1100 males, 100 females) exposed to should have already been discovered HO ppm of vinyl cliloride by inhalation for among employees. They also argue that civ-. en months. ICO died. Sixty-four ani-*7 the employees In whom tumors have been mais died without gross postmortem observed are those who have considerable -p.unolo-nc examination being Performed. * employment experience as polymeriza Of the 3G remaining animals for which tion reactor cleaners. Because It Is gen a gross postmortem pathologic examina erally agreed that reactor cie?.ning in tion was performed, 13 (36 percent) volved high exposures to vinyl chloride v.vrc found with liver tumors (Including in years past, it is argued that the lower angiosarcomas), 21 <58 percent) with levels currently found In the workplace lung tumors, 9 (25 percent) with skin have not induced cancer and are there tumors, and one with a kidney tumor. fore safe. We reject tills argument. According to the 1970 report_byjthe The. fatfiL-jih&ik appfdxlmutoly three-: Surgeon General's Ad-Hoc Committee quarters..of those employees with the on the Evaluation of Low Levels of En longest .exposure to VC (greater than vironmental Chemical Carcinogens, tne 20 years sines initial exposure) nave not finding of cancer in two or more animal yet been located, makes it Impossible to. suedes may be extrapolated to indicate determine the actual.number of aifectod a ran-.iuogenic hazard to humans. Rare, eniglpyees. Tho cases of liver tumors ob such a finding was made In three species served to date have an average latency JO.'l Of 3ld : . d'.r** : ug he 23 [ ; e. !, re { I- } | 0 j ni 1 1 | ! I i fttrylemun -3, Ta*v r.4*wl meat and all significant comments have been carefuny* CdllSluereti m ainvimi at ihe'ffruil syjndard 0:1 occupational expo- sure to VCl ' (7) The record. The record In this proceeding is one of tne most exhaustive ever relied upon by OSHA. it consults oi pic and post-hearing comm-nts and testimony received at both factfinding and rulemaking hearings, the stuuies and inspections conducted by OSHA persun- liel. the environmental impact str.te- mentis. tlio economic and technical Impact studies, and all other relevant Information. In all. over GOO written com ments have been, received, with more than 200 separate oral and written sub missions made with regard to the two hearings. Tiic record itself exceeds,4POO Dazes. Employers, employees. labor unions, public health groups, independ ent exports, physicians, research scien tists, ana 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 evaluated in reaching the detcrmina- lions sot forth below, H. Findings regarding carrAvoncnimiy, exposure levels and Jeo.'Aidily--' !> fi'ur- mat were exuosea to Yw oy inhaiatijii-- r. route comparable to employee ex:v.'-tt:-e. In addition, there were at least 13 confirmed cases of angiosarcoma of the l;vcr among employees exposed to Va particularly significant number m view 0/ the extreme rarity of this cancer mu U.S. adult male population (testi mony of Dr. Marcus Key, Director of I.TOSH. at tiic rulemaking hearing). Tiic findings of angiosarcoma of the liver in both experimental animals and exposed employees is compelling evi dence that exposure of humans to vinyl ch'oridc induces this tumor. Industry rpekesmen, at the hearing, conceded ! hut VC is carcinogenic for humans <e.g. :wMmony of Dr. McEuruey, Rulemaking hearing. 1041). Accordingly, it is coneiuded that vC must be regarded as a human carcinogen, and the probable r'v.'iti agent or angiosarcoma of the l.vv, arid that exposure of employees to VC must be controlled. Addition:'.: evidence of tumor induction in a variety of other organs, including ',un,f, indney, brain and skin, as well as r."ii -iitahenant alterations, such as flb.iisi.' and connective tissue deterlora1:^;:. indicates additional oncogenic and pAii-ologic ',vopei'ties of vinyl chloride, wiiicli nui'-t be considered in establishing control rvulations, iSee testimony and rc.-alu of Mutiic-s by Bio-Test Labora- nerind. since initial exposure. 01 auoroximateiy 20 years. If it is assumed that in duction of angiosarcoma is a dose-re lated phenomenon and If employees en gaged in cleaning reactors did. in fact, receive larger doses of vinyl chloride, it would be expected that such tumors would l>e 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 bo expected. Initiation of exposure to chemical carcinogens and Induction of cancer are not nccesasriiy 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 ing his testimony that only about a fifth of longer-term heavy smokers develop lung cancer. Accordingly, the industry contention that exposure leveis have been dramatically reduced since tho 1940's is net reliable evidence that cur rent levels of exposure are safe. Sonic Industry spokesmen also sug gested that tiie apparent nonrandom distribution cf observed cancer in em J cmogcniciig or vinyl chlorine. The ear- toic.i. Taller:,iiaw-Cooper, Maltoni. ployees may indicate an exposure tsires- i cinogcnieity of vinyl chloride for three ' iotill, and oclikoff.) liold for tumor induction, based on varia R&S 110583 nimai species (vat, mouse, hamster/ ha- Fj-jn-fure limits. Upon finding that tions in the workplace design or prac eon documented on the record by the i '.pesure of employees to vinyl chloride tice and resultant employee exposures f fEDEIV.i r.fC:lT", vot. ?9, ho. 194--FRIDAY, OCTOBER -1, 1974 35892 P.UI2S AND PECULATIONS (testimony and questioning by Teimeco e.g . testimony of ScliltolT, Firestone, NCI, confident that industry will continue to, Chemicals, Tnc.). It has also been cm- and NJCOSH.) do so. pl'ia.'dzod that in only 2 ol 8 polymerUa- In our view, the demonstration of can (4) Conclusions, 'the cor.el^ftkts be tion plants where employees have been cer induction in humans at a particular low arc 'oared pn a thorough aivc exposed to VC for more than 20 years level is not a prerequisite to a" determina evaluation .of all the ewdenee stBrnitter have any employees developed angiosar tion thar a sucstaticc represents a can Where decisions can be based o:t reeor.: coma of the liver. This argument is very cer hazard for humans at that level. It evidence, this has b:-cn done. Where, similar to that raised concerning vari .would be imprudent to assume man to however, factual certainties are iackir.y ability of past employee exposure. Al be less sensitive to VC exposure than ex- or where the facts alone do not provid- though geographic and wnrkpractiee dif Pcrimcr.tal animals in the absence of an .'.newer, policy judgments have been ferences may ultimately be demonstrated conclusive evidence. It would also be un- made. to be factors in distribution of angiosar lounded to assume that animals will not There is little dispute that VC Is car coma, sufficient information is unavail develop tumors when exposed ac concen cinogenic to man and we so conclude. able to exclude from consideration of trations of VC of less than 50 ppm. However, the precise level or exposure risk those employees in workplaces for Should a sufficiently large number of ex which poses a hazard and the question which cases of angiosarcoma have not perimental animals be exposed to VC at of whether a "safe" exposure level exists, been observed. concentrations of less than 50 ppm, cannot be definitively answered an the It -has- filtp heen snppestert that the Schneidermau said that it would be ex record. Nor is It clear to what extent pected that some would develop VC in exposures can be feasibly reduced. We Dcw_ Chcmiori-Company polymerizalien duced tumors. cannot wait until indisputable answers employees monitored over a period of 7 (3) Feasibility. There is virtually no to these questions are available, because 33 years, indicates that exposure to vinyl dispute chat must, if net ell, fabricators lives of employees are at stake. There chlerid^.al;-concentrations of less than are currently capable of reaching ex fore, 'vc have had to exercise our best (/> 200.pp.m iS-Safe. (See study by Dr. Cook, posure levels of I ppm through engineer judgment on the basis of -he best avail submitted at the hearing by Dow Chcm- ing controls. There employers employ able evidence. These judgments have re 110584 icai Company.) However, the group sur well over 95 percent of all employees ex quired a balancing process, in which the veyed did not include all workers who posed to VC. Indeed, several fabricators overriding consideration has fceeiithe had been exposed, and the missing em are already operating a: this lcvc-1 tree protection or "employees, even tlicse who ployees included many who had tiie 5PI testimony). However. Industry 'may have regular exposures to VC longer term lover 20 years) exposures. spokesmen have universally claimed that throughout their working lives. Moreover, the statistically insignificant .it :s infeasible.for tlm VC and the PVC Eased on the available evidence and in sire of the sample population decreases industries to remain below l ppm con view ot the above considerations. Includ the possibility that tumors would be sistently, using engineering controls. In ing feasibility, we believe that employee observed. rdriition, the Snell study on technical exposures to VC must be reduced to a l Dow also presented preliminary data feasibility concluded that a 1 ppm ceil ppm tune-weighted average (TWA). We in testimony at the hearing on the pos ing Is net feasible for the VC* and PVC also believe that PVC ar.d VC establish sible metabolic pathways of VC. The Industries w:tn present technology, but ments will, in time, be able to attain that hypothesis presented was that VC may that the VC Industry conld currently at level throde'.i engineering controls, and exert its carcinogenic effect by a metab tain lower exposure levels than the PVC that fabric.: tors cun do so In the lm- olite, and dial the metabolite is pro t,ahwif' ***"*c ,*ccT-iin duced omv wnen vc is mpr.-boUr''-' by Iler.'.fk Itcs-.vrC.. Inc., nowever, in aac-tion fo the TWA rcql^Hhcni, secondary metabolic pathway operating liavc suggested that .such a level is at we have established a 5 ppm."ceiling only when enzymes regulating the pri tainable.- (averaged over o 15-n:ir.ute period) in mary oathway 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 excursions. Front preliminary data indicated the possi have, already attained a 1 pure level or in an operation standpoint, this ceiling bility of an additional pathway for fact instituted all at a liable omtir.ecifing level is teaks"!'; because minor excur metabolism of VC in rats exposed to con and work practice controls, any estimate sions up to the crilin:; level are likely to centrations of VC in excess of 220 ppm. os to the lowest feasible level attainable occur on a regular basis. However, the occurrence of, angio mart necessarily invol ve subjective judg HI. The Huai standard--(t) Scope and sarcoma in both rats and mice at VC ment. Likewise, the projections of indus application. Both the-ETS and the pro exposure concentrations of 50 ppm in try, labor, ar.d others concerning feasi posal mould apply the standard to the dicates that if a metabolite cf VC is the bility ait* essentially conjectural. Indeed, entire VC indmury. including manufac ultimate carcinogen, then it must be as Firestone has suggested, it is not pos turers of VC end PVC ar.d fabricators, generated at lower exposure concentic- sible to accurately predict the degree of but excluding employers handling or tions in these species. Although this re Improvement to be obtained from en using fabricated products made from search may be helpful to the thorough gineering chanyec iiuLil ouch changes are VC. understanding of the carcinogenicity of actually imp! m.er.teJ. There is no dispute that a standard Is VC, it appears that it does not yet offer Vv'c agree that the PVC e.r.d VC estab required for the monomer ar.d polymer evidence which can assist in determina lishments will not be able to attain a 1 iR.vJstnss. Ho--- ever, the Gamely of Plas tion of^safe exposure concentrations.for ppm TWA level for a" job clustiticatiuns tics industry 'SPD and various fabrica employees, or even that such safe ex ui the near future. '.Vc do behove, how- tors (arc testimony of C soot car. Gen posures exist. evpr. that thev wifi. in time, be able to eral Cable, etc.) recommended that A number of witnesses representing attain levels of 1 y.-r.n T'.v.\ : .r most Job fabricators be excluded fre.n the stand employers have stressed that there is no cla^UTmalioru; most qf the tirne. It. in ap ard. or that a separate r-.-q-.uremont be evidence of cancer, either In employees parent that reachiiv: such levels may re established for them because many of or experimental* animals, at exposure quire seme new urcar.clvsy and work them were a!ready at or bylaw the pro concentrations of VC less than 50 ppm. i See e.g.. testimony of Firestone. Tcnr.eco Chemicals.) The conclusion of these witnesses was that no decision can bn practices. It may nk.u be r.eecsrary to Utilise technology pre-rantiy v-ed :n other indu-tri-.s. In any iy.>nr, hie VC and PVC iriduVi its have ai-ciry made great posed ceiling level. The record evidence establishes that n>; least some employees the fahrlraih.ig ir.d i.tr-y arc ex;;-'".--. ;; -eeers ,:f the mad.: concerning risk of exposure Lo VC stiffie?. in reducing c.'.'.-o.-ure Ic-'e'-. fyjr'0 por:;i;sMbi-; 'ciitre-i ik.Jos -See MLCicif at concentrations less chan 50 ppm. teslimony ol Dow Chcr'.U-'i Co.. T? 97Ji. Ustimony. TV, 155; F.obirxech Z'tl n-.'l'. On me other hand, the testimony of I-or exauu ie, E. F. O...-drier, fo:! ified I.u these circumstances. we bciir/u that it most expert r, iineti.s, including some influ.-.try biomedical experts, stated that quantification of a .'-.aft! exposure con centration is not possible wl-ii the pres (in. 1 lico > that It hue reduced "v.v-.ro exposure levels in {`"'C p'.iv, front M-'U ppm earl:-- tills y,. 12-1J is imprudent 'o grant a blanket exemp tion lor all fabricators. There; ti'.c final standard Is applicable to tl ri- ent state of scientific knowledge. (Hoe ppm 't the time of tl a norrir.y. We arc cr.tion industry, as '.veil as the monomer fed:?.ac sec; st.!, L'Ot. 39, NO. '.c-l--r*\0i\r, OL'CS'-I 4, 1771 R&S 110585 RULES AND REGULATIONS 35S93 U polymer industries. Employers who, temperature as PVC. for further pro- below the action level, no further moni ! irtet. are substantially below the ex- . cessing, indicates that a potential far re toring is required unless the employer onc-u ,-'-"'!:<ure limit will be subjected to only lease of the residue still exists. It ap has reason to suspect that any employee ' ih'.imsl burdens by virtue of the "action pears that the exemption of fabricated is exposed in excess of the action level, ` to be discussed below. products should be limited .taTusl those or unless changes have been made in items which will not undergo such mass production, process, control, type of icsm. heating. Further, the opportunity to etc. demonstrate that exposures are below Where the exposure level, without re the action level, and thus, discontinue gard to respirators, exceeds the permis many duties of the standard, provides a sible levels, monitoring must be conducjade of r*VC wore not Included In the more positive control and an adequate * ted', at least monthly. Where exposures ' <f,,C ,VTS or the proiio.-'al and'are'excluded relief. arc less than the permissible levels, but "jf' COnc `in the final standard. Tills conclusion (2) Permissible exposure limits.The. greater than the action level, monitoring 1 tb exp > based on tluf absence of adequate evi standard sets an exposure limit of 1 ppm must occur at least quarterly. tae_quesunce 0f exposure to VC In these opera- averaged' over any 3 hour period, and a -- (5) Methods o/ compliance. The stand ` : ,,el eJi;ons. The final standard clarifies the ex- ceiling'of 3 ppm averaged over ,any_i?er- ard. like the proposal, requires that em '^, onmption by defining a faDncatec Drec- ioa'nrw eweedirm jninutes. ployers .immediately institute feasible. * v xSct as a product made wholly or parity as more fuliy discussed above, this ehlneeuii-flad-Vccu`k-PmcUce. controls ahi CCa` roin P^C dc=3 not require further limit Is based on an evaluation of the best to reduce exposures to at or below the ->hiA ^^'ocessing &t temperatures, and for available evidence and on a Judgment permissible exposure limit. fTf. ' , suftlcicnt to cause mass melting of Ste pvc. sn unci others (cf. TR. 244) that the health and safety of employees must be protected to the fullest extent Where feasible engineering and work practice controls will leduce exposures e -`lr Inquest:cd that FVC resins with less than feasible. In view of the fact that release below the permissible levels, they must " av,.l percent residual monomer be ex- of VC in the VC and PVC manufacturing bo instituted. Where such controls will ^ i j empteri from the regulation now. and processes are variable, the 1 ppm ceiling not reduce exposures below the permis is h1, fiat the exemption level be reduced to level provided In the proposal would sible level, they must nonetheless be im n ti -01 Percent In three years. SPI suggested require maintenance of an average level plemented to reduce exposures to the it-.tilc5e 'hat the exemption of materials with less significantly more difficult to attain lowest practicable level, and be supple nr W han 0.1 percent of 14 carcinogens from ;, Jl cm. 1910.930 (39 FR 3750) was an through feasible engineering controls. Therefore, the exposure limit prescribed mented by the use of respirators to pro vide the necessary protection. There ence al".ppropriate precedent. The cases are not in the proposal has been rejected. upon, a continuing program of engineer , ,`wnparabie. because no attempt had been (3) Action level. The fin?.! .i-uvlarr;. ing, and.work practice controls must be i!-!!? nr`de to set air concentration limits for unlike the ETS mid_thc_jjisiiasah, ura- ^instituted to reduce exposures to the low- .---hV `f V.s 14 carcinogens. The record did not vides for an "action level1* of 0.5 ppm jesi practicable level. When exposures are v. . , I'clude Information that reliable moni* TWA, one-half of the permissible ex at or below the permissible exposure T. ??,!'?. ,^'Jlng and measuring techniques were posure" limit. The purpose of the action limits, the program may be discontinued. ntrni * '^Liable. Moreover, the exemption did levells to minimize the impact of the In addition, a tihin fn- apiu^-inc rr-r- iut,s' ift exempt airborne traces of carcino- standard on the employers who have trol br engineering and work practice n me 4enS- The administrative cutoff was pro- attained exposure levels well below the wbaMcay/mup 4nd.be mace _,_^_dded to avoid regulation of materials u*Wirh t.hpvr* nre* n*\ h^lrh permissible limit. Thus, where the re sults of monitoring unner tiara axa,iuiR available, uuon request, to reoresent- "`".(I^R'd information, and which would have r.T,V.c^r h-uadly extended the implication of the ans rri,"'!':t!5n beyond tire record. Herein, d~ V iir ihfoimation was presented to show lot pf. ,i- te concentration, results, from. the.use e lilt? resins with specific levels. Indeed, the 1 Keiy Proposal to'change the level later, when inproved technology would permit such j n,,,. .`eduction, would seem to indicate that ac^5PI has doubts about tHcPsafety oiTTf ,^^"'^rfextuinrT427" testified that- there Is no (dHl) or (d)(2) demonstrate that no employee is exposed _ in excess of 0.5 p;n TWA.' employers may, in effect, be exempted from some provisions of the standard. For example, fabricators who are below the action level are not re quired *o provide medical surveillance or to monitor again, unless the employer has reason to suspect that any employee is exposed In excess of the action level. In our judgment, exposure* helnw the action level .do not.present a sufficient ' We "recogirize^lliat many employers covered by the standard can not cur rently achieve compliance with the per missible exposure limit solely by ihe use of feasible engineering and work practice controls. The record also reflects broad generic distinctions between the compli ance capabilities of the VC and PVC industries. Some industry spokesmen, including SPI (TR. 353-362), recom mended that a schedule of different permissile .exposure limits and compliance ntiMri t "*rcct rc^Ucn. They indicate that the hazard to warrant application of the en dates be established for the VC and PVC -ii, r. airborne concentration is more related tire standard to the many employers who segments of the industry'. "ji, lrc^ tlle physical form of the resin and are or will be below that level. Tills view assumes that the ability and ,, ^the ventilation provided, Also, monltor- (4) Monitoring. The final standard, the time required to feasib'y reach in i ,Ing data from industry (cf. Exhibits 131, like the proposal, requires that Individual creasingly lower control levels is similar . no.ym26S. 170) a.K; osha (Exhibit 151) Indi- employee exposure levels be determined. within each industry, but differs mark - jVi .oSV310 that levels in excess of 1 ppm may Tins may ue accompusnea py personal edly between industries. While the record * jaur.Cho found in fabrication operations. In . or area monitoring. Some witnesses and does suggest that such differences do ^'^Vlcw of these fact.", and of the opportunity persons who submitted comments did exist between industries, fts noted above, jfor employers to discontinue many duties not understand the meaning of the term it is clear that intra-industry differences ,, s:va(noon a showing of no exposures above the "95 percent confidence level" in the also exist. Thus, the ability and time re inent Vction level, it does not appear that any proposal. Essentially it means that the quired by each employer to attain lower ,,nny Vesidue exemption. is either justified or employer is required to take a sufficient control levels may depend upon such lae "`necessary' af*this time'.'This course* also number of measurements so that the re factors ns the climate in which the plant , .. agrees with d number of industry pro- sults obtained are statistically valid. We is located, the age of equipment, the size :'*' J^Wsals (cf. TR C60). have modified the proposal to establish of reactors, or the type of resin manu s of tb (TR 345), among others, asked h-TQ-jthst compounded PVC pellets be ex- 41* g-ptitiiKed from the standard on the grounds . i| ,,V.r-hat the pellets had too low a residue to "1 1" 'cause harmful or measurable emissions, exciniiwhj'e it appears that PVC pellets would accuracy range requirements for various measurement levels. These ranges are narrow enough to ensure that a deter mination of compliance can be made, and broad enough to allow the application of a variety of technologies. factured or used. (Snell study. Firestone testimony, etc.) Monitoring data also tends to support such imra-industry variations. tSec, c.g. Dow, Firestone, Tenneco.) As noted above, the standard requires ire, tbhave a lower residue level than virgin Ail covered employers are required to all empIo;,ers to institute feasible engi fab^^C. the fact that the pellets must be conduct initial monitoring. Where moni neering controls to the fullest extent and ononl tiled to a molten mass at the same toring and measuring results are at or to continue to improve and apply engi- FEDCRAt REGISTER, VOt. 39, NO. 194--FRIDAY, OCTOBER 4, 1974 i R&S 110586 :soS9 t RUI.ES 4Mn BFGtILATIOMC nearing controls until full compliance la If the environmental level Is not con trations. In discussions of these findings achic'ed. trolled to the permissible exposure limit, with NIOSII, it iias indicated that It is We have not established any deadlines then employees must be afforded respira willing to consider on an expedited for-full compliance through engineering tory pro'-action. the approval of air-purity inr; respi controls because we are presently unable Whfie exposures in excess of the per for u:o against VC. roiifequentlyj toilet ermine when it will be feasible for missible level do constitute a hazard, we have included three types of air-purify most establishments to reduce exposure believe that it is necessary to mitigate ing respirators in the list of acceptable levels to the permissible level. some of the problems associated with units, subject to the approval of such We also believe that the requirement implementing a program of respiratory units by MtOSH. The maximum concen that each employer reduce airborne con protection while employees are being tration fer which each respirator may centrations to the persni.-sible level, or fitted and trained in respirator use, and bo used is based upon our evaluation to the lowest level feasible as soon as while other adjustments which may be of the data submitted by NIOSH and practicable will provide for inter-indus required are implemented. Therefore, Goodrich. Because air-purifjing respi try ancl Intra-industry technological dif until January 1, 1976, whefelkfJfiSares rators do not Indicate sorbent exhaustion ferences which do exist, and will avoid are morirrexcess of 'a-2b ppnv celling, or breakthrough of VC, and because VC the setting of separate industry stand each employe?-musr~pfdvifle each em has no inherent warning properties at ards on the basis of the general situation ployee with an 'Appropriate respirator. levels for which these devices are used, and conditions ir. each industry. However, employees whose exposures do strict administrative controls will be re-. '5t Regulated areas. The proposed not exceed a 25 ppm ceiling, may decline b'-hi-prl fn- T.hrir lire Ffiirh controls in standatd would have required that regu lo use tile respirator, in which case the clude a program to assure timely, re lated areas bo established, tint access be employer is not obligated to require its placement of canisters er cartridges and limited to authorized employees, and use. During this adjustment period, em an alarin system to alert employees when that daily rosters or summaries of those ployees will be trained in the uses, pur vinyl chicnee concentrations exceed the entering 'be TcepITor at least'20 years. In objection to' these' requirements. It" was poses and limitations of respirators, and the hazards of exposure to vinyl chloride. concentrations allowed for the particu lar type of respirator in use. asserted that such control of access was Moreover, each employee will be notified (8) Hazardous operations. This is a not necessary from a health standpoint. in v. siting if he has been exposed in ex new section within the final standard. It Secondly, it was claimed that these con cess of the permissible exposure limit. encompasses essentially the proposal's trols would Interfere with operations by Where exposures exceed a 25 ppm ceil requirements for maintenance and de preventing access of needed employees or ing, respiratory protection is mandatory contamination but has restated them in ncn-emplcyecs. such as contractors, in light of our Judgment that mucii terms of performance ianraage to allow truck drivers, customers and consultants. greater risks are associated with such greater flexibility for employers to deal The purpose of establishing regulated exposures. with such cporations. The Intent, of the areas in the proposal was to limit tne The provisions in the final standard new section is to protect employees un risk of exposure to as few employees as regarding tile selection and use of respi paged In activities that present a risk of possible. This concern Is still paramount, ratory protective devices differ from exposure to vinyl chloride in excess of the and thus tne limited access feature re those in the proposal. The descriptions of permissible levels. An example would be mains, The final standard atnenas the atmosphere-supplying respiraters have tha cleaning cl r, filter where resin con proposal slightly- to allow "authorized nrpfl* `Vim* been revised to indicate more dearly the nm'f fhp mnvt- taining high tranneo. residual monomer Is cnan^rit L> felt, will allow operations to mum permissible concentration level for The proposal's requirement conrinue without undue interference. each device. Moreover, the number of body, impervious clothing has ocapre- The final standard has also increased the types of atmosphere-supplying devices placed by the direction to use impervious length of time daily rosters must be has been increased. garmems suited to the paiiicuiar situa maintained from'20 to 30 years. This At the hearing Mr. Edwin C. Hyatt, an tion and probable extent of exposure. cHruigc was bused largely on epidemio ORHA consultant, made suggestions re Thufull-body clothing is not always logical considerations. (See NIOSH testi garding the use of particular respiratory necessary., and L therefore not required mony, tr, 113.) devices. We have concluded that his sug where less prelection is adequate. Since C7) Respiratory protection. The final gestions are meritorious. Therefore, the vessel .entry falls within the definition standard, like the proposal, requires the provisions for selection of atmosphere- of a hazardous operation, the vessel entry Use of respirators where employee expo supplying devices follow closely the rec section , of .the proposal has been deleted sures exceed the permissible control level. ommendations contained in his testi- from the final standard. Industry representative; made a number iTMWri. of. SOT and-B..EV Goodrich j (TR (0) Emergency situations. The defini of objections to proposed requirements with Hyatt's suggestions. 'See e.g, tcstl- tion of emergency has been recast in for respiratory' protec'lon. They stated ir.onv of SPf and B. F. Goodrich) (TR terms of an unexpected massive release. that the "no detectable level" would et- 85 ff) We had originally omitted air- The main objection to the section on factively require continuous wearing of purii'ylng reapiratccs because none had * emergency situations in the proposal was respirators In PVC and VC plants, and been approved by NIOSH for use against that, as the term v. as defined, many that this is not feasible because respira VC. principally because they lacked in ordinary leaks or operations resulting in tors arc cumbersome, present a safety dicators to signal the expiration of the a small release cf vinyl chloride would be hazard, and employees would not use service life of the sorbent, li-.-att and considered emergencies. This was act tiv.-in. other witnesses discussed lu detail the the intent of the proposal. The fine! We would agree rhat respirators have desirability of being able to use canisters standard has been clarified to comm many drawbacks: the proposal did not or carlriJio air-purifying respirators, this ambiguity. It should be noted tii.it contemplate them as a final solution. The provided a sorbent could be shown to the written operational plan required by record shows mat the PVC industiy paruculaiiv may need several years before plant environmental levels can be re duced so that respirators are necessary effectively absorb vinyl chimide with an the standard need not be developed Is: adequate service life. Recenily, OSHA minor excursions above the permissible lies received respiratory data, uom labo efifihstire'irmrrrf.nd that such excursion' ratories regarding the effectiveness of _ner.-' uot be ranorted. only occ.'issionaV.y. However, we cannot cottmiciciai!" available canisters and (10) S:y;:i and labels. The thrust of (Ik agree that respiratory protection should cart ridges for viuyi chloride. These eval signs and labels section v; to appru'.- not be required simply because it is in uations were conducted separately by ciui.lccc-j of the cancer and fire lie.';' convenient. may require additional per_ronncl, interferes with production, or raa.v require extensive retraining of cm- tiTOc'.H and by the 3, F. Goodrich Com pany and submitted to OSHA in postheoHng ') i* writs. Tlie result.-; indicate arils. Mo cbicottons have been raised wi'respect to informing employees of t!i- firo hazard. However, a number of o'J' jections were raised at the hearing ah- p'r/ee-j nr.d resuuc.urins of worh pr.ic- t'.i.-t certain pverenUy available canis ui written s-ibrahsioin tc the tiea.i. V-'e have carefully considered all ters r.nd cartridges cffecti'-vly absorb meat tiiat the word "cancer" as the objections, and have concluded chat vinyl chloride at relatively iow concen all signs and labels. The priticinJ FCSfSat r.CdSTY.r.. VOt. 37, CIO. 194--FRIDAY, CCiOtSfR 4, 1974 R&S 110587 RULES AND REGULATIONS 35S95 -,i advanced c.gainst its use was that indicated that the medical tests proposed '. ., term "cancer"' or "cancer-suspect are currently the only ones available out" scares employees and that in- which are useful for medical surveillance the message should contain iu- fTR 121. 3::h. 1-5, TR 5S9-531). Conse J unions on how to deal with the sub- quently. the specific blood tests propo.ud .ucf. 'TP.. 347). We believe ilia1- a have beer, returned as a minimum re red form of warning will not solace. quirement to assist the examining physi V.'e appreciate the concern of employers cian in determining fitness of potential 7,-ith the reaction of llieir employees. But employees for assignment to workplaces we consider it imperative that a worker involving VC exposure. Ir. addition, al b fully informed, and that he realize the ternative medical examinations mey Co i possible risks involved in his occupation, useed where ttie examining ohysicl3.ll UCCoupled with the training requirement Tterm:ines that they are at least as good in the standard, we believe that the signs as those specified by the standard. and labels required will adequately in The Tpbershaw-Cnoper study c.nd the form employees of the hazard. In addi various animal experiments suggest that tion, such signs will warn unauthorized VC may produce a wide spectrum of ma personnel to keep out of repeated areas. lignant and non-malignant disorders. Hie proper application of most protec The general scope of the required medical tive measures requires an amount of' examination has. therefore, been broad training and indoctrination of employees ened to include kidneys, skin, connective that cannot easily be conveyed on a sign tissue, spice::, and pulmonary system, as or label. Also, the variety of measures well as the liver. No additional specific that could be prescribed would result in procedures or tests arc required, but rec an imwieldly or excessively detailed leg ommendations have been included in the end. Consequently, the required message Appendix to assist the examining physi on signs and labels will not include, ln- cian. Because of the nonxi>ccific nature Tonr.ation on precautions, relevant of the required medical tests, it is not symptoms, etc. The addition of suitable appropriate to prescribe timing, of type information by the employer would be o'f followup Tests. prto mandate with permitted, providing it does not detract drawal from exposure based solely on re In any way from the required statement. sults of the tests. Instead, the employer The requirement in the proposal for ^required to obtain^ r. statement from labeling containers of vinyl chloride has the examining physician cf the em be n amended by deleting the reference ployee's suitability foz.contiiified expo to the possible hazard of violent poiym- sure, when the examining physician has eri-ration. Very little information was completed such tests as he considers ap tit -eloped on this hazard during the propriate. The employer is required to stunilard-setiing procedure. It does ap withdraw an employee only when this ppeeaarr that this hazard is essentially under gkUirol and that the fire and carcino- statement indicates that tire employee tTlfi V Ha n f nqlr frvrm wnfiriijoH TfP posul is the requirement for maintenance cf mon'tevmg records and cia'.iy raster sheets of authorized persons for 37 years. instead of 20 years. Additionally, the e;nployev is required to maintain medical records for the duration cf an employee's employment plus 20 years, or 30 years, whichever is longer. The original pro posal called for only TO years. This change has been implemented be cause the latency period for induction of angiosarcoma ranges 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 rioted that spokesmen for both labor and 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 exp ^c-a. 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 be sufficient. Hcwevez, if the OSHA Area Director requests (uniter in formation relevant'to the emergency, tr.e employer will be required to furnish such information. <14) Oeleted portions of the r.-epora.7. The proposal contained provisions re quiring that shower facilities and chance Hoa nx <4aJ '* rdficant. Since labeling or placarding ` As with monitoring, there appears to that Is in compliance with tho U-S. De be no basis for templet.: exemption cf the partment cf Transportation regulations fabrication industry from the require .49 CFR Part 173. Subpart H) already ment for medical examination. The rec warns of the Are hazard, only r state ord does show fabricating establishments ment concerning the carcinogenic haz with concentrations of VC monitored ard need be added to the Department of considerably above the action level. In Transportation labels. these instances, medical surveillance of (11) Medicc.lsvrveiil.mee. The princi- effected employees will provide baseline pal questions that have been raised re data for future evaluation of their health, garding medical su:veiilar.ce are the even if both monitoring and medical sur necessity and efficacy of requiring cer veillance are discontinued because im tain specific serum enzyme determina proved controls reduce concentrations tions vSIvIA-12 scries) and the apolica- below the action level. Where exposures tion of medical examination require are below the action level, the medical ments to the fabrication segments of the surveillance requirements do not general industry where employees are exposed to ly apply. lower levels of VC. The objection has also (12) Training. A separate provision for vumtuupuu/i ui vtf l*i`uiiiuiw* in regulated areas. Wc have deleted those provisions because it is our cor.c!u*>on they are no longer necessary. Showering facilities are not required because pro tective clothing, where required by the final standard, should protect enu. icyscs from skin absorption by direct con. act 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 win not bo wearing protective clothing and that employees who wear protective clothing will change such clothing infrequently, we are not requiring tnat change rooms be provided. In addition, we feci that there is in adequate evidence showing that hazar been raised that the specification of tests employee training has been added to the dous amounts of VC can be absorbed and procedures Interferes with the ap final standard rather than including it through ingestion. For tins reason, the plication of advances in medical knowl within the section on emergency situa requirement prohibiting the storage or edge. tions as in the proposal. The new para- consumption of food in regulated areas A particular difficulty in considering medical surveillance is that the most common!*/ discussed lesion, angiosar coma of the liver, currently cannot be diagnosed until the victim Is terminal and. usually, within months of death. Precursor physiologic alterations, which might be reversible, have not yet been directly associated with the lesion. Con sequently. there are no specific diagnos tic tests which can bo proseriuccT\vnTch will determine presence^or" absence" of tumor at an early stage or developul. However, most medical witnesses graph provides for training of employees concerning the carcinogenic hazard cf VC. emergency procedures, the need for monitoring and an annual review of the standard. It also provides for training of eir.uioyees concerning liic purpose lor, proper use of. and limitations connected with respiratory protection. >13/ Records and reports. The provi sions tor recordkeeping contained in the final standard require the preparation and maintenance of essentially the same information required by the proposal. The major change from the originai pro- has been deleted. The proposal also contained provisions on maintentance and decontamination, transportation loading and unloading, and polymer handling operations, iliese requirements are not mentioned in die final standard because attention to there items is Implicit in the requirement that each employer roach the. permissablc ex posure limit or attain the lowest feasible level. (15) Effective date. In order to ensure that affected employers and employees will be informed of the existence of these FEDERAL REGISTER, VOL. 3b, NO. 194--FRIS OCTOF.FR 4, 1974 U5G95 RULES AND REGULATIONS provisions nr.d that employers affected are riven an opportunity to familiarize ihemstlvr", and their employees with the existence ot ttv new requirements, the effective dote ot the amendment to 5 1210.93q will be January 1. l'JTa. To pro vide continued protection iur "employees until tnat date, the provisions currently contained in 5 1910.93q are hereby prnmulir.tted. pursuant to section ti(b), Ott'l anti 8<c' of the Occupational Safety met Health Act, as an occupational safety and health standard effective October 4, 1974, the amendment to 5 1910.93q set out below will supersede these provisions os of January 1, 1975. Accordingly, upon consideration of the whole reco. d of this proccditvr. Fart 1910 of Tide 20. Code of Federal Regulations is amended, effective Januaiy 1, 1975, by revision of s 1910.93a to read as follows: S l-.H0.93q Vinyl chloride. (a) Scope and application. (1) This section Includes requirements for the control of employee exposure to vinyl chloride (chloroethene), Chemical Ab stracts Sendee Registry No. 75015. (2) This section applies to Cue manu facture. reaction, packaging, repackag ing. storage, handling nr use of vinyl chloride or polyvinyl chloride, but does not apply to the handling or u.-e of fabri cated products made of polyvinyl chlo ride. Z) This section applies to the trans portation of vinyl chloride or polyvinyl chloride except to the exit ,it that the rioM-n-fr'ie-t cif TrnnspnrmMon m?.v tion. <b) Definitions. (1) "Action level" means a concent ration Of vnyi chloride of O.fi ppm averaged over an il-hour work day. (2> "Assistant Secretary" means th.c Asslsia*'! See rotary of I.afcov for Occupa tional Safety and Health. U.fJ.. Dc-partnient of Ac.1.' >r or hi3 designee. (3i "Authorized person" means any person spcriiicailv audiorirod by ths ^mplovc.r uhose duties require him to enter a regulated area orjiny cor''n cmeri.*.':: such an area as p d?siyr.at.;d r5i>rc-s6r.ta tire of employees for the purpose of ex ercising r.n opportunity to obseive moni toring rr.d rnt.-.surma procedures. (it `E-hector'' moans the DT.-cior. Kationnl Institute for Tvcuphuonai G-'.f.y.y and Health, TJ.G. Do:.artmeat of Health, Education, and Welhv.'o. or his designee. ill.* "EmcTsenoy" incars any occur rence such as. but net limited to. equip ment failure, or operation of a relief device which, is I'iceiy to. or doer-, resui: in massive release of vinyl chloride. '.sf"^F-.\bvicr.tt'd product" means a product made who*!'/ or pertly from p.'O.ax-.-ri ciiicrkle. and whit.: docs net require lurlh.f r preces: :.vt *t f-;oi;:;rr.- iuri-s. and <"r times, su.T-cvn' to cause ina-.j m.of the .m l ch'cricie res'dt.'.'V! :n 'he rc-ist..;3 oi '.my: chlcri:'.". <7i "fl \ rune'; C.-Ci1.".!''' ;aor,m.. any t.:;.;i,aiicn. 'ic-iut'e, or i.a.risy where a r* ir1* cf r'icer vmyl erha'"- i'quid c" gas mlg-n, be expected as t: const'qui-nco of the opcrationjjj bceause of an acci dent in the operation, which would result in an employee exposure in excess of tne permissible expc.sure limit. 18' "OSiiA Area Director" means die Director for the Occupational .'.*: ty and Health Administration Ave.i OP:, o having jurisdiction over the geographi', area in which the employer's establishnieitt is located. (91 "Polyvinyl chloride" means poly vinyl chloride homopelynicr or copoly mer beiore such is converter! to a fabri cated product. (l'J) 'Vinyl chloride'' means vinyl chloride monomer. -- (c) Permissible exposure limit, tl) No employee may he exposed to vinyl chlo ride at concentrations greater than 1 ppm averaged over any 8-1;iur period, a.hi (2) No employee may 'oe exposed la vinyl chloride at concentrations srer ter than 3 ppm averaged over r ru. pe.-iad ,w~ txceedine 15 minutes. ' "* (3) No "Employes may he exposed to vinyl chloride by direct contact with liquid vinyl chloride. (d) iUmitoriv.'j. (1) A program of initial . monitoring u:td measurement s'.an De unaertaken in' eacF establish.- nicr.t to determine it taere is~oy em ployee exposed, without regard to the use of iaspirators, in excess of tne ..rricr. level. (2) Where n determination conducted under paragraph <d.*U> of this se-r.b.p shows any employee exposures, without reg.-rd to the use ot respirators. ex cess of the action level, a program for tic- ftvnmitfw 'it1 csif'l'; ployee shall oe csce.bliched. Such a pro gram: (i) Shall be repeated at least monthly where ary employee Ls exposed, without regard to the use of respirators, in ex- .!:)""Shaii"be rcncTtednct lest than quarter!." wnsre ar.y utwicyco Is exposed, without regard to the use cf respirators, in excess of the action levyI. fill) Ntay be discbntinuc'd fer any emp'oyee only when at least two consecu tive monitoring determinariors. mods not less than 5 working u.-.ys apart, show ex posures for that employee at or below the action level. (3> Whenever there nr.s been a cro- ductioti. prordhs ur ccnfrcl cliaryj which ru.,y in an .-laresse in r.-l.-as.o of vinyl chloride, ev the cm Joycr has any oihc wnso.* to suspect h..itr.y cra- o'oyee may ba exposed in cl cite ievet, a da! rmi netion cf Cn-.:tl'\> f-C exposur" v.-ulcr paragraph <d - (i; cf this section siintl be peri^r/ned. (4V The .'neli.-.f. of mcrJtoring and n.easurcment "slmiT have r.n accuracy (v, ith a connu-use ievei cf :7j pcrcei,:.* of rot 10.-5 Jv-r, or minus 30 percent fron 0..'-` t.-iroi'ch *.' - ,','r.i. o: : ii;i-..s :|3 r.c-rscnt from over 0.5 <>;. *r. t'.'v..',ql'. 1.0 nr,;;:, r.nci o!uo or myy ;-;ut ij-rr I.n torn. <Metlicd.! msi'iin' ilvsse rrrurac-' rcc.;:-'-?'!;*ms arc ;/. .ti'.r,1:1,.' in the "MrO'fH M--::ual of Anah'itni ecus'1. to * r.T.'.'loyc.- bli.--.it drsignafe J .-cp- rcj::d:.,:' es siiiill h; .'.fforct'd re: .toueiilo opportunity to obserT )h-i miiiuoinuictorJi;j~air{!"nve.aritig required tbyyJ^jris porasvaph. (e) Rrvulut'-d ;t`ca. (D A reg area shall im str.bii'hvJ where: (i) Vinyl chlrricle or uoivvijiy! chloride is manufactured, rur * ..J. re-ackaged, stored, hanclieii or v -c-.: (ii) Vlnj-i chloride conecrn'rAtiens are La excess c.i tha i-cimivnblc exposure limit. ' (2) Access to regulated areas shall be limited to authorized persons. A daily roster shall he made- of authorized per sona who enter. Cf) Methods of coinpUaKd. Employee exposures to vinyl caioride shall be con trolled to at or beloa the permissible ex posure limit provided in paragraph (c) of this section by enginonrutg, work prac tice. and personal protective controls as follows: <1) -Feasible engineering and work practice controls rhai! Immediately be used to reduce exposures to at or below the permissible exposure limit. (2) Wherever feasible engineering and work practice; controls which con be in stituted immediately are not sufficient to reduce exposures to at or below the permi.-siblc exposure limit, they shall none theless be used to reduec exposures to the lowest rraiv.icab'.e level, and shdH'he supplemented hv respiratory protection Ir. accordance will; pnri.cr.'ipn *s> oi r.nis section. A program shall b-e established and implemented to reduce exposures to at cr below die permissible exposure limit, or to tl.c m.-oatesS c.'.i.mt izmjjrtx. practice coni, els, vs soon as feac:ihbl'lWr (5) Written rh-ms fu- such, a program hail he dvvri--ivi mv1 fn-r.:r,hcd_jncn- request lor examhiation and copying to authorized repre.-entt.fives of the A sis- Ient. Eecrerat'- ar.d tne Di.cctor. Gucii plans shall be m.-'etad ;lr. i--ist tnrtv six months ((g) JRespUatory protection. V/lwre resuirato:y protection i; required under this section: (1) The employer 'sh.all provide a respirator wir-h meet- ii.c rrquiremcr.ts of this paragraph and shall assure that the employee uses sum rercliaiwr, except that until December 31, i?'3. wearing cl resr-irotors shall bs at the discretion ' c-arii amp' oyee fer e.\,vc.-.;rs.i not In ex cess ot 2' p-'T.. met^tur^n over any if- minute p-tted. thiti! Occcmb-'.T 31, J97t each, eir.vhr'e- who choc.as not to v e:-.-` an appr.ririatv rsr.pira>cr 'hall bo i*.' formed ac least auartc.Iy cf the hozu<- of vinyl chloride and th> purpose, p'.op'" use, and limitations of respin- ;o. devices. ;2,' R'"ipirrton' shall bu .'ciccstd Ivc -' [ rnouc <hosi joiinly ap; :u.ed by h-' Mii.uva L7uf<:. c:merit r-nd Gaiety Adrah ' Lssr'-tiun. r.` icui si r'oo .in|..,,,," r.u:i the N.;:l insiff for Oc< at' ti.hiai f-iafety a:;:! cftaP.u under the !" vi.'ii'V.ia of 25 CFA Varl ft. <5' A i ts- iratory pro'action pro'll' n'e-uiiie ti;c r'C'iirenu:::!- '-f 5 ll)i('-; si'.al: be r.r..1 iraamu 1) Salcci.'n of rc.-pi' a:a-rs ! chloride si-.a'i bo as fci!,a-.c: R&S 110588 fsOE-'At KM.o7.-:<, VCL 2 ?, Mb*, i s'.'.--iT-iC At, C2TCSE3 -1, 1974 R&S 110589 i' RULES AND REGULATIONS 35S37 I i st b; a? -T- cc tc) c- !$ ik bo id to re* i i to uo >n is d o i } i * ii f :i 0 j , : ii 1 -x { ! e1 T & 5 ,fc (, X ! j f >, r i i x X'vioso'oerfc concentration of (vl) The purpose for, and a descrip 'Anyl rhlotide Required, apparatus tion of, the medical surveillance l(i) Unknown, or absvo 3,600 ppm__ Open-circuit, self-contained breathing Apparatus, pres program: sure demand type, wltts full facepiece, ivii? Emergency procedures: (li) Not over 3,600 ppm------------------ (A) Combination typo C supplied air respirator, pres (viii) Specific information to aid the sure demand type, with full or half facepiece, employee in recognition of conditions (1U) Not over 100 r.pm. (It) Not over 25 ppm.. and auxiliary self-contained air supply; or (B) Typo C. supplied air respirator continuous flew typo, with full or hall laceplece, and auxiliary self-contained air supply. (A) Combination type C supplied air respirator de mand type, with full facepiece, and auxiliary self-contained* air supply; or (B) Open-ctrcvUt self-contained breathing apparatus with full facepiece. In demand mode; or (C) Type C supplied air respirator, demand type, with full facepiece, (A) A powered alr-purlfylng respirator with hood, helmet, full or half fnccploce. and a canister which may result in the release of vinyl chloride: and (ix) A review of this standard atthc_ employe(!*s_Crst training and indcc:riua-_" tion. progranir and' annually fiiere~after. (2) Ail materials relating to the pro gram shall be provided upon request to the Assistant Secretary and the Director. (k) Medical surveillance. A program of medical surveillance shall be insti tuted for each employee exposed, with out regard to the use oi respirators, to which provides a service life of at least 4 vinyl chloride In excess of the action hours for concenrations of vinyl chloride up level. The program shall provide each* to 25 ppm, cr suen employee with an opportunity ior (B) Gas mash, front- or bach-mounted canister which examinations and tests hi" accordance provides a service life of at least 4 hours for with this paragraph. Ail medical ex concentrations of vinyl chloride up to 25 ppra. aminations and procedures shall be per (r) Not over 10 pp (A) Combination type C supplled-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 (B) Type C supplled-alr respirator, demand type, with half facepiece; or (C) Any chemical cartridge respirator with an organic vapor cartridge which provides a :rvice life of at least 1 hour for couceii'mrlonr. r.f vinyl chloride up to 10 ppm. without cost to the employee. (l) At the time of initial assignment, or upon institution of medical surveil lance: U) A general physical examination shall be performed, with specific atten tion to detecting enlaigement of liver, (5) (i> Entry Into unkown conccntrailorts or concentrations greater than 35,000 ppm (lower explosive limit) may be made only for purposes oi life rescue; pmd Hit I _ t its fcnp.n 3cm;vu ppm, out greater man ppm may be made only for purposes of life rescue, firefighting, cr securing equipment so as to prevent a greater hazard from release of vinyl chloride. (6) \v*honT_'ciir:plTrifying respirators are used: (1) Air-purifying car.nlsters or car- tridges shall be replaced prior to the expiration of their service life or the end of the shift in which they are first used, whichever occurs first, and (il) A continuous monitoring and .alarm system shall bo provided where concentrations of vinyl chloride could : reasonably exceed the aiiowaole concen tratiors for the devices in use. Such sys- j tenLshall_be uscdjto alert. employees when j vinyl chloride concentrations exceed tne `iallowable concentrations for the devices i i(Luse; (7) Apparatus prescribed for higher concentrations may be used for any lower concentration. (h> Ilar.'irdous operations. (1) Em ployees engaged in hazardous operations, including entry of vessels to clean poly vinyl chloride residue from vessel walls, shall be provided and required to wear and use; (2) Protective garments shall be pro vided clean and dry for each use. (1) Emergency situations, A written operational plan for emergency situa tions shall be developed lor each facility ci -- i.i-.--.. :vw- vinyl cinoiiue itn u liquid or cumpresiaa gas. Appropriate portions of the plan shall be implemented in the event of an emergency. The plan shall specifically provide that: (1) Employees engaged In hazardous operations or correcting situations of ex isting hazardous releases shall be equipped as required hi paragraph (h) of tins section:. (2) Other employees not so equipped shall evacuate the area and not. return until conditions are controlled by the methods required in paragraph (f) of this section and the emergency is abated. CJ) Training. Each employee engaged in vinyl chloride or polyvinyl elileririe operatlons shall be provided training in a program relating to the hazards of vinyl chioride and precautions for its safe use. (1) The program shall Include: (i)_T1ie nature of the health hazard from chronic exposure to vinyl chloride including specifically the carcinogenic hazard: fiil The specific nature of oweiations which could result urcxnoiiure to vmyT chloride in excess of the permissible limit and necessary protective steps: spleen or kidneys, or dysfunction in these organs, and for abnormalties in skin, connective tissues and the pulmonary system (See Appendix A;. Mi) A medical history shall be taken, including the following topics: iai Aiconoi incase: (B) Pest history of hepatitis: (C) Work history and past exposure to potential liepatotoxic agents, includ ing drugs and chemicals; (D) Past history of blood transfu sions; and (E) Past history of hospitalizations. (iil) A serum specimen shall be ob tained and determinations made of: (A) Total bilirubin: (B> Alkaline phosphatase: (C) Set urn glutamic oxalacetlc trans aminase (SGOT); (D) Scrum glutamic pyruvic transam inase iSGPT): and -- (E) Gamma glustamyl transpcptidasc. (2) "Examinations prSVTdcaTfiKCCSfdance with this paragrapn shall bo per formed at least: (i) .Every 6 months for each employee who lias* been employed in vinyl chlo ride or polyvinyl chloride manufacturing for 10 yearn or longer: ana Tii) Anr.uaUy lor all other employees. (3) Each employee exposed to Tin emergency shall be afforded appropriate medical surveillance. (4) A statement^ oi each emplovce's suitability for" 'continued exposure to vinyl chloride including use of protec (1) Respirator:,' protection hr accord (il) The purpose for, proper use. and tive equipment and rcs.uirators, snail bo ance with paragraphs (c) and (g) of limitations of respiratory protective obtained from the examining physician this section: and (ii) Protective garments to prevent j;!:in contact with liquid vinyl chloride or " rith polyvinyl chloride residue from Vessel walls. The protective garments "shah be ."Seated for the operation and devices; <iv> The fire hazard and acute toxic ity of vinyl chloride, and the necessary protective steps; v) The purpose for and a description promptly after any examination. A copy of the physician's statement sh3H_h_iiijO- vided each employee. (5) If any employee's health would be materially impaired hy continued ex Its possible exposure conditions. of the monitoring program; posure, such employee shall be wPh- t FEDERAt liECISI:*, VOl. 30, UO. 194--FKI0AY, OCIOSER 4, 1974 nr.SB3 RULES AND 3GGUIATIONS drawn fiora possible contact with vinyl chloride. (O' laboratory analyses for all bloicyicai specimens Included in medical examine.'.ions shall be performed in labo ratories hocused under 42 CEP. Part 74. i 7' If the examining phvsirian deter* mines that altemnUv.vmeriioal examina tions to these required by paragraph i!OU) of this section will provide at least, equal assurance of detecting med ical conditions pertinent to the exposure to vinyl chloride, tlic employer may ac cept such alternative examinations as meeting the requirements of paragraph <fc> (1) of this section, if.the employer obtains a statement from thV cxnrhining physician setting forth the alternative examinations and the rationale for sub stitution. This statement shall be avaiiable' upon request "for examination and ccpylnir to authorized representatives of the. Assistant Secretary and the Director. f!i Siptss and labels. (1) Entrances to regulated areas shall be posted with leg ible signs bearing the legend: Can'ces-Svsi'ect Atwr Asm AirntoRKED Personnel Onlt (2) Areas containing hazardous oper ations or where an emergency currently exhts.3h:iH bo' posted .with, legible signs bearing the'legehti:" CaNCER-SUSPECT ACENT IN TlIIS AREA PgOfEC- nvr Eoutriteirr Required Authorizv-d PERSONNEL OSLT <Si Containers of polyvinyl chloride -resin waste from reactors or other waste c3n^anT!r7T?'i with vum chloride -hall be legibly labeled: Contaminated with Vatn Chloride Cancer-Suspect Agent f4* Containers af-roiwlnvl chloride shall bo legibly labeled: POLTVIWTL CllLORIDS {OR TRADE NAME) Contains .. ;Vom CMtoaro* Vintl Chloride ts a Cances-Scspect Agent <S) Containers of vinyl chloride shall be legibly labeled either: Cl) Vmn chloride Extremelt Ft-ammaslz Gas Unoet, pressure Cancer-Suspect Age.it or (ID In accordance with 49 CFTt Part 173, Subpart H, with the additional legends: Cancer-Suspect Agent applied near the labor or placard. (6) No statement shall appear or or near any required slim, label or Instruc tion wlUch contradicts or detracts from the effect of, any required warning, information or instruction, <m) Records, (l' AH records main tained in accordance with this section shall include the name .and,social sccu- rit.y number of each employee where relevant. (2) Records of required monitoring and measuring, medical records, and au thorized personnel rosters, shall be mode aha- shairff^rarrmlatd(f~upori request for examination and copying to authorized representatives of the Assistant Secre tary and the Director. (I) Monitoring and measuring records shall: (A) State the date of such monitor ing and measuring and the concentra tions determined and identify the instru ments and methods used: !B) Include any additional Informa tion necessary to determine, individual employee exposures where such expo sures are determined by means other than individual monitoring of employees: and (Cj_ Be maintained for not less than 30 years. ~ (II) Authorized personnel rosters shall be maintained for not less than 30 years. (ill) Medical records shall be main tained for tiie duration of the employ ment of each employee plus 20 years, or 30 yaars. whichever Is longer. (3) In the event that the employer ceases to do business and there is no successor to rereive and retain his ree- v*H- ter ran nrescribod period, these yec- o.dc thaU b. f.--------i!*-i-rri dv registered mail to the Director, and each employe - individually notified in writing of this transfer, (4) Employees or their designated representatives shall be provided acres. to examine and copy records or required monitoring and measuring. (5) Former employees shall- be pro vided access to examine and copy re- reflecting their own exposures, " (ffrUpeh writteii request of any em ployee, a copy of the medical record of that employee shall be furnished to an? Physician designated bv the employee. (m Reports. U) Not later than l month after the establishment of a reg ulated area, the following information shall be reported to the OGXTA Area Di rector. Any changes to such information shall be reported within 15 days. (i) The address and location of each establishment wnich has one or more regulated areas; and (li) The number of employees in each regulated area during normal operations, including maintenance. t2> Emergencies, and the facts ob tainable at that time, shell be reported within 24 hours to the OSHA Area Di rector. Upon request of the Area Direc tor. the employer shall submit additional Information in writing relevant to the nature and extent of employee exposures and measures taken to prevent future emergencies of similar nature. f3> Within 10 working days following any monitoring and measuring which discloses that any employee has been exposed, without regard to the use of respirators in excess of the permissible exposure limit, each such empioyee'shall be notified In writing of the results of the exposure measurement and the steps being taken to reduce the exposure to within the permissible exposure limit. (o) Effective dates. (1) Until Janu ary 1, 1975. the provisions currently set forth in 319l0.93q of this Part shall apply. (2) Effective January 1,1975. the pro visions set forth In 3 I910.93q of this Part shall apply. AAppendix --Suppeementart IIedical . Information V/i'.ett required tests under paragraph (fcl'i) o' this eectlon show Abnormalities, the tests should be repeated as soon as prac ticable. preferably wltblr. 4 to 4 weeks. If teats remain abnormal, consideration should be given rv withdrawal of the eotplsyre from contact -ill, lEIrtlle. * more corr.ptor.rnstve v'niin.la made Additional tests which may bo useful; A. For kidney dysfunction: urine examina tion fer albumin, red blood cells, and ex foliative abnormal colls. T3. Pulmonary system: Forced vital capr.c- jtv. Forced expiratory volume at l second, and chest rocntgeuOgratn (posterior-anterior, 14 x 17 Inches). C. Additional scrum tests: Lactic acid de hydrogenase; lactic acid dehydrogenase isoenzyme, protein determination, uinl protein electrophoresis. D. For a mote comprehensive examination on repeated abnormal serum tests: Hepatitis D antigen, and liver scanning. (Sees, u and 8. 84 Stat. 1693. 1539 (29 U.S.C. 055. S57); Secretary of Labor's Order No. 12-71. 38 FR 8754) Signed at Washington, D.C., this 1st day of October, 1974. * John 3tendsr, Assistant Secretary of Labor. [FR Doc.74-23176 Hied 10-1-74:3:64 pm) 23 Qo O) cn <o ,FEDERAL 3EGi;:CR, VOL 39, NP. 194--FRIDAY, OCfOBEft 4 1974