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COPIED BY MCA 10/9/74 FMOftY, OCTOBER 4, 1974 l, D.C. VMwm 99 Number 194 PART II Occupational Satiety And Health Admim*lratiofl EXPOSURE TO VINYL CHLORIDE Occupational Safety and Health Standards i DTH 000087457 35890 RULES AND REGULATIONS Title 29--Labor ployees from a rare liver cancer (angio and abroad, OSHA proposed to revise 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 this notification and after consultation with NIOSH, and a joint imposition of the B. F. Goodrieh plant by OSHA, NIOSH and the Ken tucky Department of Labor, a fact-find 101O.93q and published a comprehensive proposal (38 FR 16886) on May 10,1974, to protect employees from hazards of enposure to VC. The proposal called for limitation of employee exposure to VC to "no detectable level," as measured by a Standard tar Exposure to Vinyl Chloride ing hearing was announced on Janu sampling and analytical method sensitive Pursuant to sections 6(b), 6(c), and 8(c) of the Occupational Safety and Health Act of 1870 (84 Stat. 1803, 1506, 1599; 39 U.8.C. 6S5, 657) Secretary of Labor's Order No. 12-71 (36 FR 8754) and 29 CFR Part 1011. 11010.03 of Part 1910 of Title 38, Code, of Federal Regu lations is hereby amended in the manner set forth below, in order to provide an Occupational Safety and Health stand ard dealing with the exposure of em ployees to vinyl chloride. I. Background--(1) Vinyl chloride. Vinyl chloride (chloroetbene), Chemical Abstracts Sendee Registry No. 76014, is a synthetic orgasle chemical made from ethylene or acetylene and ohlorine by any of several processes. It la the parent compound of a series of thermoplastic resin polymers and copolymers which are widely used for containers, wrapping mm, electrical Insulation, pipe, oondult, 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 of the monomer Is a largescale continuous process, involving only a few firms. There are comparatively few employees in this segment of the Indus try, -because the processes lend them selves to automation. Vinyl chloride (VC) Is used primarily in the production of polyvinyl chloride <PVC), a resin which is produced through batch processing. The conversion of the VC monomer into a polymer or copolymer is 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 of employees involved in the VC industry are employed by fabrication firms. Such firms range In slse from those with few employees and simple equipment to large plants involving many employees and ary 30, 1974 (30 FR 3874) and held on February 15,1974. Information obtained from this hear ing. particularly the preliminary reports of experiments conducted by Professor Cesare Maltonl of the Institute di Oncologia, Bologna, Italy, demonstrated that vinyl chloride Induced angiosarcoma In rats at levels as low as 250 ppm, and In other special at higher levels. Experi ments performed at lower levels of ex posure were not completed at that time. Other testimony from medical witnesses and NIOSF and the results of autopsies, led to the conclusion that the Goodrich workers had angiosarcoma of the Brer and that VC probably was this oansal agent in the angiosarcomas ubsemd. In post hearing comments, additional angiosarcoma deaths were reported among workers who had bash united to VC in plants operated by Uhlan Carbide Corporation, Firestone Plastics Corpora tion and Goodyear Tire It Rubber Com pany. On the basis of all information avail able at that time, and the fact that em ployees were bring exposed at levels around the experimentally observed ef fect level of 250 ppm, an emergency temporary standard (ET6) was promul gated on April 6, 1974 (38 FR 12341) pursuant to section 6(c) of the Act, os 29 CFR 1910J8qThis standard reduced the permissible exposure level from a celling of 600 ppm to a 50 ppm celling, and established other requirements including, for example, monitoring and respiratory protection. It was expressly recognised that this standard limiting expostures to a 50 ppm celling was a tentative, interim standard, and that the whole question of exposure to VC would be eonsldoied more fttBv in the tight of additional Information, especially the results of experiments which were known to be underway at that time. On April IS 1974, information and data were presented to representatives of OSHA, NIOSH, and the Environmental Protection Agency by the Industrial BioTest Laboratories, Northbrook, Illinois, to I ppm, With an accuracy of l ppm 50 percent. The proposal also called for the establishment of regulated areas and limited acorns to such areas to authoriasd parsons. A requiroment for monitoring of employee exposures was proposed, alone with engineering and work prectioe controls to be implemented when exposures over the detectable limit were measured. Respiratory protection would have boon required while engineering and work practice controls were being Implemented ee where exposures exceeded the per missible limit even after feasible en gineering controls were instituted. In addition, the proposed standard included requirements for medical sur- veillanoe, protective clothing, emergency procedures, training, specific protection during maintenance and decontamina tion operations, transportation loading and unloading operations and recordkeeping (4) Hearing on the proposal. The pro posal. as published on May 10, 1974, allowed SO days for interested parties to submit written comments and to request an informal rulemaking hearing. In formal contacts with OSHA staff and early responses Indicated that the sub ject was of great interest and Importance to many persons. Because of the limited time available before expiration of the six month period provided In section 6(c)(8) of the Act for promulgation of a final standard. It was decided to hold a hearing as boon as possible. Accord ingly. on Mfey 24,1974, a notice of a hear ing was published (38 FR 18303), setting a bearing date, of June 28, 1974. The hearing was conducted from June 25 through June 28, and again from July 8, through July 11, before Administrative X*w Judge Gordon J. Myatt. All partici pants won given the opportunity to pre sent testimony and to cross-examine other witnesses. Persons participating In the hearing were given until August 23, 1874, to file additional posthearing com ments, Including various Items of infor mation which were requested during the examination of witnesses. considerable capital. concerning results of animal exposure (6) Economic and technical impact Vinyl chloride (VC), a gar at ambient temperature and pressure, is a chlori nated hydrocarbon, which heretofore has been regarded as haring moderate liver toxicity. The Initial standard, contained in Table CM of 1910.83, established a studies with VC. These studies wore sponsored by the Manufacturing Chem ists Astoria i ton. Although only pre liminary in nature at that time, these results revet.led that 2 out of 200 mlee exposed to VC concentrations of 50 ppm study. During the hearing, OSHA deter mined that sddttfamal facts would be needed to determine the practicality of certain aqpsnta of the proposed stand ard. Accordingly, OSHA contacted an in dependent consultant, Foster D. Snell ceiling value of 600 parts of VC per mil for 7 hours tn. 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 angiosarcoma of the liver. posure levels, including those proposed ard. On January 22, 1074, the Occupa (3) The proposed permanent stand by OSHA and others advanced by in tional Safety and Health Administra ard. Baaed on the demonstrated evidence dustry spokesmen. Snell was also com- tion (08HA) was informed by the Na of VC's canrnogenlclty In three animal Uiisstoned to Collect information regard tional Institute for Occupational Safety aperies (rats, mice and hamsters), and ing the economic costs of compliance. and Health (NJOBH) that the B. F. the subetaatal probability that VC had This cotton was announced at the close Goodrich Chemical Company had re been the caunal agent In the cases of liver of the bearing, and Judge Myatt further ported that deaths of several of Its em angiosarcoma found in workers both here announced that the record would be kept KDHAl MOISTM, VOL J9, NO. 194--telDAY, OCTOOgg 4, 1974 DTH 000087458 RULES AND REGULATIONS 35891 open for it period of time beyond August 23, to allow interested persons to com ment in writing on the study. On August 20,1074, OSHA announced that the pre liminary study was available and that comments were to be submitted no later than September 0, 1074 (39 FR 30844). studies of Maltonl and Bio-Test Labora tories. Moreover, Maltoni's investigations have demonstrated a dose-dependent re lationship for Induction of tumors (i.e., more tumors occur at higher exposure levels), including angiosarcoma of the liver, in rats. The investigations of In may create a carcinogenic hazard, the amount of exposure which la hazardous must be determined. The Surgeon Gen eral's Ad Hoc Committee referred to above concluded that safe exposure levels for carcinogenic substances cannot be scientifically determined. This position On September 13, 1974, OSHA invited dustrial Bio-Test Laboratories have dem is supported by the testimony of NIOSH comments on both the preliminary and onstrated a similar relationship for at the hearing, ite recommendations for the final study, which was to be received both rats and mice. These investigators a standard of no detectable level, and by on or before September 26, 1974 (30 FR have induced angiosarcoma of the liver the testimony of expert witnesses from 33009). in rata and mice at exposure concentra the National Cancer Institute. (6) Environmental impact statements. tions of 50 ppm, and in hamsters at high Several witnesses and persons who sub A notice of intent to file an environmen er concentrations of exposure. Additional mitted comments have taken a contrary tal impact statement assessing the im tumors Involving other organs, including view and have suggested that man is less pact of a proposed standard cm occu the kidneys, lungs, and skin of exposed sensitive to biologic aberrations induced pational exposure to VC was published animals, were also observed in frequen by vinyl chloride exposure than experi in the Fhmhuu. Rxoibtxx on April 24, cies much in excess of control animals. mental animals. Proponents of this posi 1974 (39 FR 14522). The notice invited The uicidence of tumors In mice In the tion have argued that if humans were as any person having information or data Industrial Bio-Test Laboratories investi sensitive as rodents, an "epidemic" of on the environmental Impact to submit it to OSHA by May 17,1974. On June 12, gations is particularly pertinent. Of 200 mice (100 males, 100 females) exposed to cancer resulting from VC exposures should have already been discovered 1974, a draft environmental impact 50 ppm of vinyl chloride by inhalation for among employees. They also argue that statement was prepared and circulated to all interested persons. Ten copies were eleven months, 100 died. Sixty-four ani mals died without gross postmortem the employees In whom tumors have been observed are those who have considerable forwarded to the Council of Environ pathologic examination being performed. employment experience as polymeriza mental Quality (CEQ), which published a notice of its filing and availability in the Fxaxiua Rsaxsrat on June 25, 1974 (39 FR 22975). A 46 day period was al lowed for the submission of comments on the draft statement. On September 5, 1974, the final environmental impact statement was prepared and a copy of it and all substantive comments were sent to appropriate governmental agencies, private organizations, and other inter ested persons. CEQ published a notice of availability for the final statement on September 6, 1974 (39 FR 32350). The submission of comment was invited un til September 25, 1974. The final state ment and all significant comments have been carefully considered in arriving at the final standard on occupational expo sure to VC. (7) The record. The record In this proceeding Is one of the most exhaustive ever relied upon by OSHA. It consists of pre and post-hearing comments and testimony received at both factfinding and rulemaking hearings, the studies and Inspections conducted lay OSHA person nel, the environmental Impact state ments, the economic and technical impact studies, and all other relevant information. In all, over 000 Written com ments have been received, with more than 200 separate oral and written sub missions made with regard to the two hearings. The record Itself exceeds 4,000 pages. Employers, employees, labor unions, public health groups, Independ ent experts, physicians, research scien tists, and specialists in many fields have been invited to submit information and have made their views, knowledge and experience available to OSHA. The en tire record encompassing these submis sions was thoroughly reviewed and evaluated hi reaching the determina tions set forth below. II. Findings regarding carcinogenicity. exposure levels and feasibility--(1) Car- Of the 36 remaining animals for which a gross postmortem pathologic examina tion was performed, 13 (30 percent) were found with liver tumors (including angiosarcomas), 21 (58 percent) with lung 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 be extrapolated to indicate a carcinogenic hazard to humans. Here, such v finding was made in three species that were exposed to VC by inhalation-- a route comparable to employee ex posure. In addition, there were at least 13 confirmed cases of angiosarcoma of the liver among employees exposed to VC, a partictdarly significant number in view of the extreme, rarity of this cancer in the U.8. adult male population (testi mony of Dr. Marcus Key, Director of NIOSB. at the rulemaking hearing). The flndlngi 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 homing, conceded that VC is carcinogenic for humans (e.g. testimony of Dr. McBurney, 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-mallgnant 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 at studies by Bio-Test Labora tion reactor cleaners. Because it is gen erally agreed that reactor cleaning in volved high exposures to vinyl chloride in years past, It Is argued that the lower levels currently found in the workplace have not induced cancer 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 served to date have an average latency period, since Initial exposure, of approxi mately 20 years. If it is assumed that in duction of angiosarcoma is a dose-re lated phenomenon, and If employees en gaged In cleaning reactors did. In fact, receive larger doses at vinyl chloride, it would he 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 asecaecd 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 necessarily 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. Schnelderman 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 oi exposure are safe. Some Industry spokesmen also sug gested that the apparent nonrandom distribution of observed cancer In em cinogenicity of vinyl chloride. The car tories, Tabarshaw-Cooper, Maltonl, ployees may Indicate an exposure thres cinogenicity of vinyl chloride for three NIOSH, and Sellkoff.) hold for tumor Induction, based on varia animal species (rat, mouse, hamster) has (2) Exposure limits. Upon finding that tions in the workplace design or prac been 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 DTH 000087459 35892 RULES AND REGULATIONS (testimony and questioning by Tenneco Chemicals, Inc.). It has also been em phasized that In only 3 of 8 polymerisa tion plants where employees have been exposed to VC tor more than 20 years have any employees developed angiosar coma of the liver. This argument is very similar to that raised concerning vari ability of past employee exposure. Al though geographic and workpractice dif ferences mayultimately be demonstrated to be factors In distribution of angiosar coma, sufBetsnt information la unavail able to exclude .from consideration of risk those employees in workplaces for which cases of angiosarcoma have not been observed. It has also been suggested that the absence of cancer in a population of 335 Dow Chemical Company polymerization employees monitored over a period of 7 yearn. Indicates that exposure to vinyl chloride at concentrations of less than 200 ppm la safe. (Bee study by Dr. Cook, submitted at the hearing by Dow Chem ical Company.) However, the group sur veyed did not include all workers who had been exposed, and the missing em ployees Included many who had the longer teem (over 20 years) exposures. Moreover, the statistically insignificant size of the sample population decreases the possibility that tumors would be observed. Dow also presented preliminary data In testimony at the hearing on the pos sible metabolic pathways of VC. The hypothesis presented was that VC may exert its carcinogenic effect by a metab olite, and that, the metabolite is pro duced only when VC Is metabolized by a secondary metabolic pathway operating only when enzymes regulating the pri mary pathway are saturated, as would be the result at higher exposures. The preliminary data Indicated the possi bility of an additional pathway for metabolism of VC in rats exposed to con centrations of VC in excess of 220 ppm. However, the occurrence of angio sarcoma in both rats and mice at VC exposure concentrations of 50 ppm in dicates that It a metabolite of VC is the ultimate carcinogen, then it must be generated at lower exposure concentra tions in these species. Although this re search may be helpful to the thorough understanding of the oarcinogenicity of VC, It appears that it does not yet offer evidence which can assist in determina tion of safe exposure concentrations for employees, or even that such safe ex posures exist. A number of witnesses representing employers have stressed that there Is no evidence of eaacer, either in employees or experimental animals, at exposure concentrations of VC less than 50 ppm. (See e.g., testimony of Firestone, Ten neco Chemicals.) The conclusion of these witnesses was that no decision can be made concerning, risk of exposure to VC at concentrations less than 50 ppm. On the other hand, the testimony of most expert witnesses, including some in dustry biomedical experts, stated that quantification of a safe exposure con centration is not possible with the pres ent state of scientific knowledge. (See e g., testimony of Selikoff, Firestone, NCI, andNIOSH.) In our view, the demonstration of can cer induction in humans at a particular level Is not a prerequisite to a determina tion that a substance represents a can cer hazard for humans-at that level. It would be imprudent to assume man to be less sensitive to VC exposure than ex perimental animals In the absence of conclusive evidence. It would also be un founded to assume that animals will not develop tumors when exposed at concen trations of VC at less th<m 50 ppm. Should a sufficiently large number of ex perimental animals be exposed to VC at concentrations of less than 50 ppm, Schnelderman said that it would be ex pected that same would develop VC in duced tumors (3) Feasibility. There is virtually no dispute that most. If not all, fabricators are currently capable of reaching ex posure levels of 1 ppm through engineer ing controls. These employers employ well over 85 percent of all employees ex posed to VC. Indeed, several fabricators are already operating at this level (see SFI testimony). However, industry spokesmen have universally claimed that it is infeasible for the VC and the FVC Industries to remain below 1 ppm con sistently, using engineering controls. In addition, the Snell study on technical feasibility concluded th"t a 1 ppm cell ing is not feasible for the VC and PVC industries with present technology, but that the VC Industry could currently at tain lower exposure levels than the PVC industry. Labor union spokesmen and the Health Research Group. Inc., however, have suggested that such a level is at tainable. Since there is no actual evidence that any of the VC or PVC manufacturers have already attained a 1 ppm level or in fact instituted all available engineering and work practice controls, any estimate as to the lowest feasible level attainable must necessarily involve subjective judg ment. Likewise, the projections of indus try. labor, and others concerning feasi bility are essentially conjectural. Indeed, as Firestone has suggested, It is not pos sible to accurately predict the degree of Improvement to be obtained from en gineering changes until such changes are actually implemented. We agree (hat the PVC and VC estab lishments will not be able to attain a 1 ppm. TWA level for all job classifications in the near future. We do believe, how ever, that they will, in time, be able to attain levels of 1 ppm TWA tor most Job classifications most of the time. It is ap parent that leaching such levels may re quire some' new technology and work practices. It may also be necessary to utilize technology presently used in other industries. In any event, the VC and PVC industries have already made great strides in reducing exposure levels. (See testimony of Dow Chemical Co., TR 973), For example, B. F. Goodrich testified (TR 1120) that It has reduced average exposure levels in several PVC plants from 35-40 ppm early this year to 12-13 ppm at the time of the hearing. We ares confident that Industry will continue to do so. (4) Conehwtoiu. The conclusions be low are baaed an a thorough,review and evaluation of all the evidence submitted. Where decisions can be baaed on record evidence, this has been done. Where, however, factual certainties are lacking or where the facts alone do not provide an answer, policy judgments have been made. There is little dispute that VC is car cinogenic to man and we so conclude. However, the precise level of exposure which poaes a hazard and the question of whether a "Bale" exposure level exists, cannot be definitively answered on the record. Nor is It clear to what extent exposures can be feasibly reduced. We cannot wait until indisputable answers to these questions are available, because lives of employees are at stake. There fore. we have had to exercise our best judgment on the basis of the best avail able evidence. These Judgments have re quired a balancing process, in which the overriding consideration has been the protection of employees, even those who may have regular exposures to VC throughout their working lives. Based bn the available evidence and in view of the above considerations, includ ing feasibility, we believe that employee exposures to VC must be reduced to a 1 ppm time-weighted average (TWA). We also believe that PVC and VC establish ments will, in time, be able to attain that level through engineering controls, and that fabricators can do so in the im mediate future. ___ In addition to the TWA requirement, we have established a 5 ppm ceiling (averaged over a 15-minute period) in order to prevent exposure of employees to unacceptable high excursions. From an operation standpoint, this ceiling level Is realistic because minor excur sions up to the ceiling level are likely to occur on a regular basis. HI. The final standard--(1) Scope and application. Both the ETS and the pro posal v/ould apply the standard to the entire VC industry, including manufac turers of VC and PVC and fabricator: , but excluding employers handling or using fabricated products made from VC. There is no dispute that a standard Is required for the monomer and polymer industries. However, the Society of Plas tics Industry (SPI) and various fabrica tors (see testimony of Goodyear, Gen eral Cable, etc.) recommended that fabricators be excluded from the stand ard, or that a separate requirement be established for them because many of them were already at or below the pro posed ceiling level. The record evidence establishes that at least some employees in the fabricat ing industry are exposed in excess of the permissible control limits (See niosh testimony, TR 106; Roblntech TR 642). In these circumstances, we believe that it is imprudent to grant a blanket exemp tion for all fabricators. Therefore, the final standard is applicable to the fabri cation Industry, as well as the monomer FEDERAL REGISTER, VOL :I9, NO. )94--FRIDAY, OCTOBER 4, 1974 DTH 000087460 RULES AND REGULATIONS 35893 and polymer Industries. Emplbyers who, temperature as PVC, for further pro below tiie action level, no fiirther moni In fact, are substantially below the ex cessing, indicates that a potential for re toring Is required unless the employer posure limit will be subjected to only lease of the residue still exists. It ap has reason to suspect that any employee minimal burdens by virtue of the "action pears that the exemption of fabricated Is exposed in excess of the action level, level" to be discussed below. products should be limited to Just those or unless changes have been made in Where employers In the fabricating Items which will not undergo such mass production, process, control, type of resin, industry have exposures approaching the heating. Further, the 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 are excluded relief. are leas than the peraolsrtbie levels, but from the final standard. This conclusion (2) Permissible exposure limit. The greater than the action level, monitoring is based on the absence of adequate evi standard sets an exposure limit of 1 ppm must occur at least quarterly. dence of exposure to VC In these opera averaged over any 8 hour period, mid 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 discussed above, this engineering and work practice controls from PVC which does not require further limit Is based on ah evaluation of the best to . educe exposures to at or below the processing at temperatures, and for available evidence and on a judgment permissible exposure limit. times, sufficient to cause mass melting of that the health and safety of employees Where feasible engineering and work the PVC. SPI and others (cf. TR. 344) must be protected to the fullest extent practice oontrols 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 celling 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 level, and be supple than 0.1 percent of 14 carcinogens from through feasible engineering controls. mented by the use of respirators to pro 20 Cm 1910.03p (39 PR 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) Action level. The flntd standard, ing and work practice controls must 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 TWA, one-half of the permissible ex at Or below the permissible exposure toring and measuring techniques were posure limit. The purpose of the action limits, the program may be discontinued. available. Moreover, the exemption did level is to minimize the Impact of the In addition, a plan for. achieving con not exempt airborne traces of carcino standard on the employers who have trol by engineering and work practice gens. The administrative cutoff was pro attained exposure levels well below the methods must be drawn up and be made vided to avoid regulation of materials permissible limit. Thus, where the re available, upon request, to represent about which there was no health haz sults of monitoring under paragraphs atives of OSHA and NIOSH. ard information, and which would have (d)(1) or (d)(2) demonstrate that no We recognize that many employers broadly extended the application of the employee is exposed In excess of 0.5 covered by the standard can not cur regulation beyond the record. Herein, ppm TWA, employers may, In effect, be rently achieve compliance with the per no Information was presented to show exempted from some provisions of the missible exposure limit solely by the use safe concentration results from the use standard. For example, fabricators who of feasible engineering and work practice of resins with specific levels. Indeed, the are below the act!chi level are not re controls. The record also reflects broad proposal to change the level later, when quired to 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 mem to Indicate that has reason to suspect that any employee Industries. Some industry spokesmen, SPI has doubts about the safety of 0.1 Is exposed In excess of the action level. including SPI (TR. 358-362), recom percent residue level. Diamond Shamrock In our judgment, exposures below the mended that a schedule of different per- (Exhibit 142) testified that there Is no action level do not present a sufficient missile exposure limits and compliance direct relation. They Indicate that the hazard to warrant application of the en dates be established for the VC and PVC airborne concentration Is more related tire standard to the many employers who segments of the Industry. to the physical form of the resin and are or will be below that level. This view assumes that the ability and the ventilation provided. Also, monitor (4) Monitoring. Tire final standard, the time required to feasibly reach In ing data from industry (cf. Exhibits 131, like the proposal, requires that Individual creasingly lower control levels is similar 108,170) and OSHA (Exhibit 151) Indi employee exposure levels be determined. within each industry, but differs mark cate 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 view of these facte and of the opportunity persons who submitted comments did exist between industries, as noted above, for employers to discontinue many duties not understand the meaning of the term it is clear that intra-industry differences upon a showing of no exposures above the "95 percent confidence level" In the also exist. Thus, the ability and time re action level, It does 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 tills time. This course also number of measurements so that the re factors as the climat e In which the plant agrees with a number of Industry pro sults obtained are statistically valid. We Is located, the age of equipment, the size posals (cf. TR 680). have modified the proposal to establish of reactors, or the type of resin manu SPI (TR 345), among others, asked that compounded PVC pellets be ex empted from the standard on the grounds that the pellets had too low a residue to cause harmful or measurable emissions. White 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 Intra-Industry variations. (See, e.g. Dow, Firestone, Tenneco.) As noted above, the standard requires have a lower residue level than virgin All covered employers are required to all employers to institute feasible engi PVC, the fact that the pellets must be conduct initial monitoring. Where moni neering controls to the fullest extent and heated to a molten mass at the same toring and measuring results are at or to continue to Improve and apply engl- FEDERAL REGISTER, VO 39, NO. 194--FRIDAY, OCTOBER 4, 1974 DTH 000087461 35894 RULES AMO REGULATIONS neering controls until full compliance Is achieved. We have dot established any deadline?) for full rompllanro through >gfrMring controls because we we presently unable to determine whan it wUl be feasible for most establishments to reduce exposure levels to the permissible 1ml. We also believe that the requirement that each employer reduce airborne con centrations to the permissible level, or to the lowest level feasible as soon as practicable will provide for inter-indus try and Intra-Industry technological dif ferences which do exist, and will avoid the setting of separate Industry stand ards on the basis of the general situation and conditions'll: each industry. (6) Ululated areas. The proposed standard wotdd have required that regu lated areas be established, that access be limited to authorized employees, and that dally rosters or summaries of those entering be kept for at least 20 years. In objection to these requirements, it was asserted that such control of access was not necessary from a health standpoint. Secondly, it was claimed that these con trols would interfere with operations by preventing access of needed employees or non-employees, such as contractors, truck drivers, customers and consultants. The purpose of establishing regulated areas in the proposal was to limit tide risk of exposure to as few employees as possible. This concern is still paramount, and thus the limited access feature re mains. The final standard amends the proposal slightly to allow "authorized persons" to enter regulated areas. This change, it is felt, will allow operations to continue without undue Interference. The final standard has also increased the length of time dally rosters must be maintained from 20 to 30 years. This change was based largely on epidemio logical considerations. (See N30SH testi mony. tr. 110.) (7) -Respiratory protection. The final standard, like the proposal, requires the use of respirators where employee expo sures exceed the permissible control level. Industry representatives made a number of objections to proposed requirements for respiratory protection. They stated that the "no detectable level" would ef fectively require continuous wearing of respirators In PVC and VC plants, and that this is not feasible because respira tors are cumbersome, present a safety hazard, and employees would not use them. We would agree that respirators have many drawbacks; the proposal did not contemplate them as a final solution. The record shows that the PVC Industry par ticularly may need several years before plant environmental levels can be re duced so that respirators are necessary only occassionaQy. However, we cannot agree that respiratory protection should not be required simply because it is in convenient, may require additional per sonnel, interferes with production, or may require extensive retraining of em ployees and restructuring of work prac tices. We have carefully considered all the objections, and have concluded that if the environmental level ia not con trolled to the permissible exposure limit, then employee} must be afforded respira tory protection. While exposures in excess of the per missible level do constitute a hazard, we believe that it is necessary to mitigate some of the problems associated with Implementing a program of respiratory protection while employees are being fitted and trained in respirator use, and while other adjustments which may be required are implemented. Therefore, until January l, 1076, where exposures are not in excess of a 25 ppm ceiling, each employer must provide each em ployee with an appropriate respirator. However, employees whose exposures do not exceed a 2$ ppm celling, may decline to use the respirator, in which case the employer la not obligated to require its use. During this adjustment period, em ployees will be trained in the uses, pur poses and limitations of respirators, and the hazards at exposure to vinyl chloride. Moreover, each employee will be notified in writing if he has been exposed in ex cess of the permissible exposure limit. Where exposures exceed a 25 ppm ceil ing, respiratory protection is mandatory in light of our judgment that much greater risks are associated with such exposures. The provisions in the final standard regarding the selection and use of respi ratory protective devices differ from those in the proposal. The descriptions of atmosphere-supplying respirators have been revised to indicate more clearly the types of devices intended, and the maxi mum permissible concentration level for each device. Moreover, the number of types of atmosphere-supplying devices has been increased. At the hearing Mr. Edwin C. Hyatt, an OSHA consultant, made suggestions re garding the use of particular respiratory devices. We have concluded that his sug gestions are meritorious. Therefore, the provisions for selection of atmosphere- supplying devices follow closely the rec ommendations contained in his testi mony of SPI and B. F. Goodrich) (TR with Hyatt's suggestions. (See e g. testi mony of SPI and B. F. Goodrich) (TR 85 ff> We had originally omitted airpurifying respirators because none had been approved by NIOSH for use against VC, principally because they lacked in dicators to signal the expiration of the service life of the sorbent. Hyatt and other witnesses discussed in detail the desirability of being able to use canisters or cartridge air-purifying respirators, provided a sorbent could be shown to effectively absorb vinyl chloride with an adequate sendee life. Recently, OSHA has received respiratory data from labo ratories regarding the effectiveness of commercially available canisters and cartridges for vinyl chloride. These eval uations were conducted separately by NIOSH and by the B. F. Goodrich Com pany and submitted to OSHA in post hearing comments. The results indicate that certain presently available canis ters and cartridges effectively absorb vinyl chloride at relatively low concen trations. In discussions of these findings with NIOSH, It has indicated that it is willing to consider on an expedited basis the approval of air-purifying respirators for use against VC. Consequently, we have Included three types of air-purify ing respirators in the list of acceptable units, subject to the approval of such units by NIOSH. The maximum concen tration for which each respirator may be used ia based upon our evaluation of the data submitted by NIOSH and Goodrich. Because air-purifying respi rators do not lndicate sorbent exhaustion or breakthrough of VC, and because VC has no inherent warning properties at levels for which these devices are used, strict administrative controls will be re quired for their use. Such controls in clude a program to assure timely re placement of canisters or cartridges and an alarm system to alert employees when vinyl chloride concentrations exceed the concentrations allowed for the particu lar type of respirator In use. (8) Hazardous operations. This is a new section within the final standard. It encompasses essentially the proposal's requirements for maintenance and de contamination but has restated them in terms of performance language to allow greater flexibility for employers to deal with such operations. The intent at the new section is to protect employees en gaged in activities that present a risk of exposure to vinyl chloride in excess of the permissible levels. An example wotdd be the cleaning of a filter where resin con taining high residual monomer is trapped. The proposal's requirement for fullbody, impervious clothing has been re placed by the direction to use Impervious garments suited to the particular situa tion and probable extent of exposure. Thus, full-body clothing is not always necessary, and is therefore not required where less protection is adequate. Since vessel entry falls within the definition of a hazardous operation, the vessel entry section of the proposal has been deleted from the final standard. (0) Emergency situations. The defini tion of emergency has been recast in terms of an unexpected massive release. The main objection to the section on emergency situations in the proposal was that, as the term was defined, many ordinary leaks or operations resulting in a small release of vinyl chloride would be considered emergencies. This was not the intent of the proposal. The final standard has been clarified to correct this ambiguity. It should be noted that the written operational plan required by the standard need not be developed for minor excursions above the permissible exposure limit, and that such excursions need not be reported. (10) Signs and labels. The thrust of the signs and labels section is to apprise employees of the cancer and fire haz ards. No objections have been raised with respect to informing employees of the fire hazard. However, a numix, of ob jections were raised at the hearing and in written submissions to the require ment that the word "cancer" appear on all signs and labels. The principal argu- FEDERAl REGISTER, VOL 3 ), NO 194--FRIDAY, OCTOBER 4, 1974 DTH 000087462 RULES AND REGULATIONS 35C95 ment advanced against Its use was that indicated that the medical tests proposed posal is the requirement for maintenance the term "cancer" or "cancer-suspect are currently the only ones available of monitoring records and daily roster agent" scares employees and that In which are useful for medical surveillance sheets of authorized persons for 30 years, stead, the message should contain in (TR 121, Bxh. 96, TR 589-591). Conse-, instead of 20 years. Additionally, the em structions on how to deal with the sub quently, the specific blood tests proposed ployer is required to maintain medical stance (TR. 347). We believe that a have been retained as a minimum re records for the duration of an employee's diluted form of warning will not suffice. quirement to assist the examining physi employment plus 20 years, or 30 years, We appreciate the concern of employers cian in determining fitness of potential whichever is longer. The -original pro with the reaction of their employees. But employees for assignment to workplaces posal called for only 20 years. < we consider it imperative that a worker involving VC exposure. In addition, al This change has been implemented be be fully Informed, and that he realize the ternative medical examinations may be cause the latency period for induction of possible risks involved in his occupation. used where the examining physician de angiosarcoma ranges up to 30 years from Coupled with the training requirement termines that they are at least as good initial exposure. Therefore, as a mini in the standard, we believe that the signs as those specified by the standard. mum, medical records must be main and labels required will adequately in The Tabershaw-Cooper study and the tained for at least that long. It should be form employees of the hazard. In addi various animal experiments suggest that noted that spokesmen for both labor and tion, such signs will warn unauthorized VC may produce a wide spectrum of ma industry recommended that this change personnel to keep out of regulated areas. lignant and non-m&lignant disorders. be made. The proper application of most protec The general scope of the required medical The reporting requirements are not tive measures requires an amount of examination has, therefore, been broad si-Icantly different from those in the training and indoctrination of employees ened to include kidneys, skin, connective original proposal. However, instead of that cannot easily be conveyed on a sign tissue, spleen, and pulmonary system, as the requirement for reporting incidents or label. Also, the variety of measures well as the liver. Ho additional specific which result in the release of VC into that could be prescribed would result in procedural or tests are required, but rec areas where employees may be exposed, an unwieldly or excessively detailed leg ommendations have been Included in the the final standard clarifies our original end. Consequently, the required message Appendix to assist the examining physi intent by stating that only emergencies on signs and labels will not Include in cian. Because of the nonspecific nature must be reported. Also the requirement formation on precautions, relevant of the required medical tests, it is not for filing a detailed, written report symptoms, etc. The addition of suitable appropriate to prescribe timing, or type within 15 days has been deleted. It has information by the employer would be of followup tests, or to mandate with been concluded that submission, within permitted, providing it does not detract drawal from exposure based solely on re 24 hours, of an initial report that in in any way from the required statement. sults of the tests. Instead, the employer cludes facts immediately available, would The requirement in the proposal for is required to obtain a statement from ordinarily be sufficient. However, if the labeling containers of vinyl chloride has the examining physician of the em OSHA Area Director requests further in been amended by deleting the reference ployee's suitability for continued expo formation relevant to the emergency, the to the possible hazard of violent polym sure, when the examining physician has employer will be required to furnish such erization. Very little information was completed such tests as he considers ap information. developed on this hazard during the propriate. The employer is required to (14) Deleted portions of the proposal. standard-setting procedure. It does ap withdraw an employee only when this The proposal contained provisions re pear that this hazard is essentially under control and that the fire and carcino genic hazards at present are the most significant. Since labeling or placarding that is in compliance with the U.S. De partment of Transportation regulations (49 CFR Part 173, Subpart H) already warns of the fire hazard, only a state ment concerning the carcinogenic haz ard need be added to the Department of Transportation labels. statement indicates that the employee may be at added risk from continued VC exposure. As with monitoring, there appears to be no basis for complete exemption of the fabrication industry from the require ment for medical examination. The rec ord does show fabricating establishments with concentrations of VC monitored considerably above the action level. In these instances, medical surveillance of quiring that shower facilities and change rooms be provided, and that storage or consumption of food be prohibited in regulated areas. We have deleted these provisions because it is our conclusion they are no longer necessary. Showering facilities are not required because pro tective clothing, where required by the final standard, should protect employees from skin absorption by direct contact with VC and because there is no reliable (11) Medical surveillance. The princi affected employees will provide baseline evidence that VC vapor is absorbed pal questions that have been raised re data for future evaluation of their health, through the skin. In addition, since we garding medical surveillance are the even if both monitoring and medical sur anticipate that most employees will not necessity and efficacy of requiring cer veillance are discontinued because im be wearing protective clothing and that tain specific serum enzyme determina proved controls reduce concentrations employees who wear protective clothing tions (SMA-12 series) and the applica below the action level. Where exposures will change such clothing infrequently, tion of medical examination require are below the action level, the medical we are not requiring that change rooms ments to the fabrication segments of the surveillance requirements do not general be provided. industry where employees are exposed to ly apply. In addition, we feel that there is in lower levels of VC. Thf objection has also (12) Tmininp. A separate provision for 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 this 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 commonly discussed lesion, angiosar coma of the liver, currently cannot be graph provides for training of employees concerning the carcinogenic hazard of VC, emergency procedures, the need for monitoring and an annual review of the has been deleted. The proposal also contained provisions on malntentance and decontamination. transportation loading: and unloading, 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 be prescribed which will determine presence or absence of standard. It also provides for training of employees concerning the purpose for, proper use of, and limitations connected with respiratory protection. (13) Records and reports. The provi sions for recordkeeping contained in the final standard require the preparation and maintenance of essentially the same and polymer handling operations. These requirements are not mentioned In the final standard because attention to these items is implicit in the requirement that each employer reach the permlssable ex posure limit or attain the lowest feasible level. (15) Efective date. In order to ensure this tumor at an early stage of develop information required by the proposal. that affected employers and employees ment. However, most medical witnesses The major change from the original pro will be informed of the existence of these FEDERAL REGISTER, VC I 39, NO 194--FRIDAV, OCTOBER 4, 1974 DTH 000087463 358% RULES AND REGULATIONS provisions and that employers affected are given an opportunity to familiarize themselves and their employees with the existence of the new requirements, the effective date of the amendment to } 1910.93q will be January 1,1975. To pro vide continued protection for employees until that date, the provisions currently contained In ' 11910.93d ` are hereby promulgated, pursuant to section 6(b), 6(c) and 8(c) of the Occupational Safety and Health Act, aa an occupational safety and health standard' effective October 4, 1974, the amendment to 11919.93d set out below will supersede these provisions as of January 1, 1975. Accordingly, upon consideration of the whole record of this preceding i irt, 1910 of Title 29, Code of Federal Reg; latlons is amended, effective January i, 1975, by revision of i 1910.93d to read as follows: g 1910.9341 Vinyl chloride. (a) Scope and application. (1) This section Includes requirements for the control of employee exposure to vinyl chloride (chloroethene), Chemical Ab stracts Service Registry No. 75015. (2) this section applies to the manu facture, reaction, packaging, repackag ing, storage, handling or use of vinyl chloride or polyvinyl chloride, but does not apply to the handling or use of fabri cated products made of polyvinyl chlo ride. (3) this section applies to the trans portation of vinyl chloride or polyvinyl chloride except to the extent that the Department of Transportation may regulate the hazards covered by this sec tion. (to) Definitions. <1) "Action level" means a concentration of vinyl chloride of 0.5 ppm averaged over an 8-hour work day. (2) "Assistant Secretary" means the Assistant Secretary of Labor for Occupa tional Safety and Health, U.S. Depart ment of Labor, or his designee. (3) "Authorized person" means any person specifically authorized by the em ployer whose duties require him to enter a regulated area or any person entering such an area as a designated representa tive of employees for the purpose of ex ercising an opportunity to observe moni toring and measuring procedures. (4) "Director" means the Director, National Institute for Occupational Safety and Health, U.S. Department of Health. Education, and Welfare, or his designee. (5) "Emergency" means any occur rence such as, but not limited to, equip ment failure, or operation of a relief de vice which Is likely to, or does, result in massive release of vinyl chloride. (S) "Fabricated product" means a product made wholly or partly from polyvinyl chloride, and which does not require further processing at tempera tures, and for times, sufficient to cause mass melting of the polyvinyl chloride resulting In the release of vinyl chloride. (7) "Hazardous operation'' means any operation, procedure, or activity where a release of tether vinyl chloride liquid or gas might be expected as a consequence of the operation or because of an acci dent In the operation, which would result ta an employee exposure in excess of the permissible exposure limit. (8) "OSHA Area Director" means the Director for the Occupational Safety and Health Administration Area Office having jurisdiction over the geographic area in which the employer's establish ment is located. (9) "Polyvinyl chloride" means poly vinyl chloride homopolymer or copoly mer before such is converted to a fabri cated produce. (10) "Vinyl chloride" means vinyl chloride monomer. (c) Permissible exposure limit. (1) No employee may be exposed to vinyl chlo ride at concentrations greater than 1 ppm averaged over any 8-hour period, and (2) No employee may be exposed to vinyl chloride at concentrations greater than 5 ppm averaged over any period not exceeding 15 minutes. (3) No employee may be exposed to vinyl chloride by direct contact with liquid vinyl chloride. (d) Monitoring. (1) A program of initial monitoring and measurement shall be undertaken in each establish ment to determine If there is any em ployee exposed, without regard to the use of respirators, in excess of the action level. (2) Where a determination conducted under paragraph (d)(1) of this section shows any employee exposures, without regard to the use of respirators, in ex cess of the action level, a program for de termining exposures for each such em ployee shall be established. Such a pro gram: (1) Shall be repeated at least monthly where any employee is exposed, without regard to the use of respirators, in ex cess of the permissible exposure limit. (11) Shall be repeated not less than quarterly where any employee Is exposed, without regard to the use of respirators, in excess of the action level. (ill) May lie discontinued for any em ployee only when at least two consecu tive monitoring determinations, made not less than 5 working days apart, show ex posures for that employee at or below the action level. (3) Whenever there has been a pro duction, process or control change which may result in an Increase in the release of vinyl chloride, or the employer has any other reason to suspect that any em ployee may be exposed in excess of the action level, a determination of employee exposure under paragraph (d)(1) of this section shall be performed. (4) The method of monitoring and measurement shall have an accuracy (with a confidence level of 95 percent) of not less than plus or minus 50 percent from 0.25 through 0.5 ppm, plus qr minus 35 percent from over 0.5 ppm through 1.0 ppm, and plus or minus 25 percent over 1.0 ppm. (Methods meeting these accuracy requirements are available In the "NTOSH Manual of Analytical Methods"). (5) Employees or their designated rep resentatives shall be afforded reasonable opportunity to observe the monitor ing and measuring required by this paragraph. (e) Regulated area. (}> A regulated area shall be established where: (1) Vinyl chloride or polyvinyl chloride Is manufactured, reacted, repackaged,' stored, handled or used; and (11) Vinyl chloride concentrations are in excess of the permissible exposure limit. (2) Access to regulated areas shall be limited to authorized persons. A daily roster shall be made of authorized per sons who enter. (f) Methods of compliance. Employee exposures to vinyl chloride shall be con trolled to at or below the permissible ex posure limit provided In paragraph (c) of this section by engineering, work prac tice, and personal protective controls as follows: (1) Feasible engineering and work practice controls shall Immediately be used to reduce exposures to at or below the permissible exposure limit. (2) Wherever feasible engineering and work practice controls which can be in stituted immediately are not sufficient to reduce exposures to at or below the per missible exposure limit, they shall none theless be used to reduce exposures to the lowest practicable level, and shall be supplemented by respiratory protection in accordance with paragraph (g) of this section. A program shall be established and implemented to reduce exposures to at or below the permissible exposure limit, or to the greatest extent feasible, solely by means of engineering and work practice controls, as soon as feasible. (3) Written plans for such a program shall be developed and furnished upon request for examination and copying to authorized representatives of the Assis tant Secretary and the Director. Such plans shall be updated at least every six months. (g) Respiratory protection. Where respiratory protection Is required under this section: (1) The employer shall provide a respirator which meets the requirements of this paragraph and shall assure that the employee uses such respirator, except that until December 31,1975, wearing of respirators shall be at the discretion of each employee for exposures not In ex cess of 25 ppm, measured over any 15mlnute period. Until December 31, 1975, each employee who chooses not to wear an appropriate respirator shall be in formed at least quarterly of the hazards of vinyl chloride and the purpose, proper use. and limitations of respiratory devices. (2) Respirators shall be selected from among those jointly approved by the Mining Enforcement and Safety Admin istration, Department of the Interior, and the National Institute for Occupa tional Safety and Health under the pro visions of SO CFR Fart 11. (3) A respiratory protection program meeting the requlremente of S 1910.134 shall be established and maintained. (4) Selection of. respirators for vinyl chloride shall be as follows: FEDERAL REGISTER, VOL. 39, MO 194 --FRIDAY, OCTOBER 4, 1974 DTH 000087464 RULES AND REGULATIONS 35897 itmoepheric concentration of (vi) The purpose for, and a descrip vinyl chloride Required apparatus tion of, the medical surveillance (I) Unknown, or above 8,000 ppm__ Open-circuit, BeU-cootlne<l breathing apparatus, pres program; sure demand type, with full facepiece. (vil) Emergency procedures; (II) Not over 8,600 ppm__________ (A) Combination type O supplied air respirator, pres (viil) Specific information to aid the sure demand type, with full or half facepiece, and auxiliary self-contained air supply; or (B) Type C, supplied air respirator continuous flow type, with full or half facepiece, and auxiliary self-contained air supply. (ill) Not over 100 ppm...__ ...__ (A) Combination type C supplied air respirator de mand type, with full facepiece, and auxiliary self-contained air supply; or (B) Open-circuit self-contained 'breathing apparatus with full facepiece, in demand mode; or (C) Type C supplied air respirator, demand type, with full facepiece. (lv) Not over 88 ppm (A) A powered air-purifying respirator with hood, employee In recognition of conditions which may result In the release of vinyl chloride; and ` (ix) A review of this standard at the employee's first training and Indoctrina tion program, and annually thereafter. (2) All materials relating to the pro gram shall be provided upon request to the Assistant Secretary and the Director. (k) Medical surveillance. A program of medical surveillance shall be insti tuted for each employee exposed, with helmet, full or half facepiece, and a caniste- out regard to the use of respirators, to whlch provider) a service life of at least a ' Jnyl chloride In excess of the action hours for concenratlona of vinyl chloride up level. The program shall provide each to 25 ppm. or such employee with an opportunity for (B) Oas mask, front- or back-mounted canister which examinations and tests In accordance provides a service life of at least 4 hours for with this paragraph. All medical ex (v) Not over 10 ppm concentrations of vinyl chloride up to 25 ppm. (A) Combination type O supplled-alr respirator, de mand type, with half facepiece, and auxiliary self-contained air supply; or (B) Type C supplled-alr respirator, demand type, with half facepiece; or (C) Any chemical cai ridge respirator with an organic vapor cartridge which provides a service life of at least 1 hour for concentrations of vinyl chloride up to 10 ppm. 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. (l) 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, <5 (i) Entry Into unkown concentra tions or concentrations greater than 36,000 ppm (lower explosive limit) may be made only for purposes of life rescue; and (li) Entry into concentrations of less than 36,000 ppm, but greater than 3,600 ppm may be made only for purposes of life rescue, firefighting, or securing equipment so as to prevent a greater hazard from release of vinyl chloride. (6) Where air-purifying respirators are used: (i) Air-purifying cannisters or car tridges shall be replaced prior to the expiration of their service life or the end of the shift In which they are first used, whichever occurs first, and (11) A continuous monitoring and alarm system shall be provided where concentrations of vinyl chloride could reasonably exceed the allowable concen trations for the devices In use. Such sys tem shall be used to alert employees when vinyl chloride concentrations exceed the allowable concentrations for the devices in use. (7) Apparatus prescribed for higher concentrations may be used for any lower concentration. (h> Hazardous operations. (1) Em ployees engaged in hazardous operations, including entry of vessels to clean poly vinyl chloride residue from vessel walls, shall be provided and required to wear and use; (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 for each facility storing, handling, or otherwise using vinyl chloride as a liquid or compressed gas. Appropriate portions of the plan shall be implemented in the event of an emergency The plan shall specifically provide that: (in Employees engaged in hazardous operations or correcting situations of ex isting hasardous releases shall be equipped an required in paragraph (h) of this 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. (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; spleen or kidneys, or dysfunction in these organs, and for abnorinaltles in skin, connective tissues and the pulmonary system (See Appendix A). (ii) A medical history shall be taken, including the following topics: (A) Alcohol Intake; (B) Past history of hepatitis; (C) Work history and Past exposure to potential hepatotoxic agents, includ ing drugs and chemicals; (D) Past history of blood transfu sions; and (E) Past history of hospitalizations. (ill) A serum specimen shall be ob tained and determinations made of: (A) Total bilirubin; (B) Alkaline phosphatase; (C) Serum glutamic oxalacetlc trans aminase (SOOT); (D) Serum glutamic pyruvic transam inase (SOFT); and (E) Oamma glustamyl transpeptidase. (2) Examinations provided in accord ance with this paragraph shall be per formed at least: (i) Every 6 months for each employee who has been employed In vinyl chlo ride or polyvinyl chloride manufacturing for 10 years or longer; and (ii) Annually for all other employees. (3) Each employee exposed to an emergency shall be afforded appropriate medical surveillance. (4) A statement cf each employee's suitability for continued exposure to vinyl chloride including use of protec (1) Respiratory protection in accord (ii) The purpose for, proper use, and tive equipment and respirators, shall be ance with paragraphs (c) and (g) of this section; and (il) Protective garments to prevent skin contact with liquid vinyl chloride or with polyvinyl chloride residue from vessel walls. The protective garments limitations of respiratory protective devices; (iv! The Are hazard and acute toxic ity o; vinyl chloride, and the necessary protective steps; 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 be shall be selected for the operation and v > The purpose for and a description materially impaired by continued ex its possible exposure conditions. of the monit oring program; posure, such employee shall be with FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 DTH 00008746b 35898 tt/LES AND REGtAATlONS l drawn from passible contact with vinyl chloride. (6) Laboratory analyses tor all bio logical specimens Included In medical examinations shall be performed In labo ratories licensed under 42 CFR Part 74. (7) If the examining physician deter mines that alternative medical examina tions to those required by paragraph <k)<l) of this section will provide at least equal assurance of detecting med ical conditions pertinent to the exposure to vinyl chloride, the employer may ac cept such alternative examinations as meeting the requirements of paragraph 00(1) of this section, if the employer obtains a statement from the examining physician setting forth the ah- rnative examinations and the rationale lor sub stitution. This statement shall be avail able upon request tor examination and copying to authorized representatives of the Assistant Secretary and the Director . U) Sterns and labels. U> Entrances to regulated areas shall be posted with leg ible signs bearing the legend: Canceb-Subfect Agent Amu Authorized Personnel Only (2) Areas containing hazardous oper ations or where an emergency currently exists shall be posted with legible signs bearing the legend: CAMcsra-Brarecr Agent in This Area Protec tive Equipment Required Authorized Personnix Only (3) Containers of polyvinyl chloride resin waste from reactors or other waste contaminated with vinyl chloride shall be legibly labeled: Contaminated with Vinyl Chloride Cancer-Suspect Agent (4) Containers of polyvinyl chloride shall be legibly labeled: Polyvinyl Chloride (or Trade Name) Contains Vinyl Chloride Vinyl Chloride u a Cawcse-Suspect Agent (5) Containers of vinyl chloride shall be legibly labeled either: <i) Vinyl Chloride Extremely Flammable Oas Under Pressure Cancer-Suspect Agent or (li> In aooordance with 49 CFR Part 173, Subpui H, with the additional legends: Cancer-Suspect Agent applied near the labor or placard. (6) No statement shall appear on or near any required sign, label or Instruc tion which con radicts or detracts from the effect of, any required warning, information or instruction. (m Recorit. U> All records main tained in accordance with this section shall include the name and social secu rity number of each employee where relevant. (2) Records Of required monitoring and measuring medical records, and au thorized personnel rosters, shall be made and shall be available upon request for examination and copying to authorized representatives, of the Assistant Secre tary and the Director. <i) Monitoring and measuring records shall: (A) State tlie 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 exp*ures where such expo sures are determined by means other than lndivldua l monitoring of employees; and <C) Be mai stained for not less than 30 years. 'll) Authori sed personnel rosters shall be maintained for not less than 30 years. iiii) Medical records shall be main tained for the duration of the employ ment of each employee plus 20 years, or 33 years, whichever is longer. (3) In the event that the employer ceases to do business and there is no successor to receive and retain his rec ords for the prescribed period, these rer ords shall be transmitted by registi-tod mail to the Di rector, and each employee individually notified in writing of this transfer. (4) Employees or their designated representative ; shall be provided access to examine arid copy records of required monitoring and measuring. (5) Former employees shall be pro vided access to examine and copy re quired monitoring and measuring records reflecting the:; own exposures. (6) Upon written request of any em ployee, a copy oi the medical record of that employee shall be furnished to any physician designated by the employee. (n) Reports, a) Not later than 1 month after the establishment of a reg ulated area, the following information shall be reported to the OSHA Area Di rector. Any changes to such information shall be reported within IS days. (i) The address and location of each establishment which has one or more regulated areas; and (ii) The number of employees in each regulated area during normal operations, including maintenance, \ , (2) Emergencies, and the facts ob tainable at that time, shall 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. (3) 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 employee shall be notified in writing of the results oi 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 currency set fortjj-iir 1910.93q of th*. "art shall apply. (2) Effective Janua:;, 1, 1975. the tiro- visions set forth in lf*,-?.93q of this Part shall apply. Appevjix A-P.-'clementary Medical '' 'j.roRMATIQN Wh/n required testa under paragraph (k);') of this section show abnormalities, V/ tests should be repeated as soon as prac ..-able, preferably within 3 to 4 weeks, it tests remain abnormal, consideration should be given to withdrawal of the employee froir, contact with vinyl chloride, while a my'comprehensive examination Is made. Additional tests which may be./useful: A. For kidney dysfunction: ur.-he examina tion for albumin, red blood tells, and ex foliative abnormal cells. B. Pulmonary system: Forced vital capac ity, Forced_e*plratory volume at 1 second, and chest roentgenogram (posterior-anterior, 14 z 17 Inches). C. Additional serum tests: Lactic acid de hydrogenase, lactic acid dehydrogenase isoenzyme, protein determination, and protein electrophoresis. D. For a more comprehensive examination on repeated abnormal serum tests: Hepatitis B antigen, and liver scanning. (Secs. 6 and 8. 84 Stat. 1606, 1500 (20 UJ3.C 665, 667); Secretary of Labor's Order No. 12-71, 36 FR 8754) Signed at Washington, D.C, this 1st day of October, 1974. John Stemder, Assistant Secretary of Labor. [FR Doc.74-23178 Filed 10-l-74;3:54 pm] COPIED BY MCA 10/9/74 FEDERAL REGISTER. VOL. y, MO 194--FRIDAY, OCTOBER 4, 1974 DTH 0000R7466