Document wqb83O665p7vnzvr9Opp14V94

35890 RULES AND REGULATIONS Title 29--Libor 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 inspection of the B. P. Goodrich plant by OSHA, NIOSH and the Ken tucky Department of Labor, a fact-find 1910.93q and published a comprehensive proposal (39 FR 16896) on May 10, 1974, to protect employees .from hazards of exposure to VC. The proposal called for limitation of employee exposure to VC to. "no detectable level," as measured by a Standard for Exposure to yinyl Chloride ing hearing was announced on Janu sampling and analytical method sensitive Pursuant to sections 6('87, eic>, and 8(c) of thfe Occupational Safety and Health Act of 1970 (84 Stat. 1593. 1596, 1599: 29 U.S.C. 855, 657) Secretary of Labor's Order No. 12-71 (36 FR 8754) and 29 CFR Part 1911, S 1910.93 of Part 1910 of Title 29, 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 (chloroethene), Chemical Abstracts Service Registry No. 76014, 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 of the monomer is a largescale continuous process, involving only a few Arms. 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 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 Maitoni of the Instituto di oncoiogia. Bologna, Italy, demonstrated that vinyl chloride induced angiosarcoma in rats at levels as low 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 NIOSH. and the results of autopsies, led 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 reported among workers who had been exposed to VC in plants operated by Union Carbide Corporation, Firestone Plastics Corpora tion and Goodyear Tire ti 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 (ETS) was promul gated on April 5, 1974 (39 PR 12341) pursuant to section 6<c) of the Act, as 29 CFR 1910.93q, This standard reduced the permissible exposure level from a ceiling of 600 ppm to a 50 ppm ceiling, and established other requirements, including, for example, monitoring and respiratory protection. It was expressly recognized that this standard limiting exposures to a 50 ppm ^celling was a tentative, interim standard, "and teat the 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 data were presented to representatives of to 1 ppm. with an accuracy of 1 ppm 50 percent. The proposal also called for the establishment of regulated areas and limited access to such areas to au thorized persons. A requirement for monitoring of employee exposures was proposed, along with engineering and work practice controls to be implemented when exposures over the detectable limit were measured. Respiratory protection would have been required while engineering and work practice controls were being implemented or where exposures exceeded tee per missible limit even after feasible en gineering controls were Instituted. In addition, tee proposed standard Included requirements for medical sur veillance. protective clothing, emergency procedures, training, specific protection during maintenance and decontamina tion operations, transportation loading and unloading operations and record keeping. (4) Hearing on the proposal. The pro posal, as published on May 10* 1974, allowed 30 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) (3) of tee Act for promulgation of a final standard. It was decided to hold a hearing as soon as possible. Aecord* ingly, on May 24,1974, a notice of a hear ing was published (39 Fit 18303). setting a hearing date of June 25. 1974. The hearing was conducted from June 25 through June 28, and again from July 8, through July 11, before Administrative Law Judge Gordon J. Myatt. All particl- - j pants were given the opportunity to pre sent testimony and to cross-examine other witnesses. Persons participating in ' the hearing were given until August 23, -' 1974, to file additional posthearlng com- jf firms range in size from those with few employees and simple equipment to large OSHA, NIOSH, and the Environmental Protection Agency by tee Industrial Bio- ments, including various items of informatlon 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 impactj Vinyl chloride (Vfc>, a gas at ambient temperature and pressure, Is a chlori nated hydrocarbon, which heretofore has been regarded as having moderate liver toxicity. The Initial standard, contained in Table G-l of 1910.93, established a ceiling value of 500 parts of VC per mil lion parts of air. studies with VC. These studies were sponsored by the Manufacturing Chem ists Association. Although only pre liminary in nature at teat time, these results revealed teat 2 out of 206 mice exposed to VC concentrations of 50 ppm for 7 hours a day, five days a week, for approximately 7 months, had developed study. During the hearing, OSHA deter mined teat additional facts would bej needed to determine the practicality ofj certain aspects of the proposed stand* ard. Accordingly, OSHA contacted an ln-1 dependent consultant, Foster D. Sne Corporation, to conduct studies of feasibility of compliance at various ex^ (2) The emergency temporary standard. On January 22, 1974, the Occupa tional Safety and Health Administra tion (OSHA) was Informed by the Na tional Institute for Occupational Safety 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 posure levels, including those prop by OSHA and others advanced by inj dustry spokesmen. Snell was also coni' missioned to collect information regard^ ing tee economic costs of compliance)! and Health (NIOSH) that the B. P. the substantial probability that VC had This action was announced at the clo Goodrich Chemical Company had re been the cau&l agent in the cases of liver of tee hearing, and Judge Myatt fu ported that deaths of several of its em angiosarcoma found in workers bote here announced that tee record would be 1 FEDERAl REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER , 1974 SL 098226 v RULES AND REGULATIONS 35891 fof period of time beyond August studies of Maltoni and Bio-Test Labora may create a carcinogenic hazard, the 3, to ftllow Interested persons to cont tories. Moreover, Maltonl's Investigations amount of exposure which Is hazardous ent In writing on the study. On August have demonstrated a dose-dependent re must be determined. The Surgeon Gen 30,1874, OSHA announced that the pre lationship for induction of tumors (l.e., eral's Ad Hoc Committee referred to liminary study was available and that more tumors occur at higher exposure above concluded that safe exposure levels cmments were to be submitted no later levels), Including angiosarcoma of the for carcinogenic substances cannot be ban September 6, 1974 (39 PR 30844). liver, in rats. The Investigations of In 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, Its recommendations for the final study, which was to be received both rats and mice. These investigators a standard of no detectable level, and by n or before September 25, 1974 <39 FR have induced angiosarcoma of the liver the testimony of expert witnesses from 33009). In rats and mice at exposure concentra the National Cancer Institute. (6) Environmental impact statements. tions of 50 ppm, and In hamsters at high Several witnesses and persons who sub 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 ct of a proposed standard on occu the kidneys, lungs, and skin of exposed sensitive to biologic aberrations Induced pational exposure to VC was published animals, were also observed In frequen by vinyl chloride exposure than experi In the Federal Register on April 24. cies much In excess of control animals. mental animals. Proponents of this posi 1974 <39 FR 14522). The notice invited The incidence of tumors In mice in the tion have argued that If humans were as any person having information or data Industrial Bio-Test Laboratories investi sensitive as rodents, an "epidemic" of on the environmental Impact to submit gations is particularly pertinent. Of 200 cancer resulting from VC exposures It to 03HA by May 17, 1974. On June 12. mice (100 males, 100 females) exposed to should have already been discovered 1974, a draft environmental Impact 50 ppm of vinyl chloride by Inhalation for among, employees. They also argue that statement was prepared and circulated eleven months, 100 died. Sixty-four ani the employees in whom tumors have been to all Interested persons. Ten copies were mals died without gross postmortem observed are those who have considerable 'orwarded to the Council of Environ pathologic examination being performed. employment experience as polymeriza mental Quality (CEQ), which published Of the 36 remaining animals for which tion reactor cleaners. Because It Is gen a notice of Its filing and availability in a gross postmortem pathologic examina erally agreed that reactor cleaning In the Federal Register on June 25, 1974 tion was performed, 13 (36 percent) volved high exposures to vinyl chloride:. (39 FR 22975). A 45 day period was al were found with Uver tumors (including In years past, it Is argued that the lower , lowed for the submission of comments on angiosarcomas),. 21 (58 percent) with levels currently found In the workplace' the draft statement. On September 5. lung tumors, 9 (25 percent) with skin have not induced cancer and are there `1974, the final environmental Impact tumors, and one with a kidney tumor. fore safe. We reject this argument. statement was prepared and a copy of It According to the 1970 report by the The fact that approximately three- and all substantive comments were sent Surgeon General's Ad-Hoc Committee quarters of those employees with the to appropriate governmental agencies, on the Evaluation of Low Levels of En longest exposure to VC (greater than private organizations, and other Inter vironmental Chemical Carcinogens, the 20 years since initial exposure) have not ested persons. CEQ published a notice of finding of cancer In two or more animal yet been located, makes it impossible to availability for the final statement on September 6, 1974 (39 FR 32350). The submission of comment was invited un- species may he extrapolated to Indicate a carcinogenic hazard to humans. Here, such a finding was made In three species determine the actual number of affected employees. The cases of liver tumors ob served to date have an average latency .tfi 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 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 800 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, lndepend- v ent experts, physicians, research scien: tlsts, and specialists in many fields have been Invited to submit Information and have made their views, knowledge and experience available to CSHA. The en tire record encompassing these submis sions was thoroughly reviewed and .evaluated In reaching the determina tions set forth below. n. Findings regarding carcinogenicity, : exposure levels and feasibility--(1) Car 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 Uver among employees exposed to VC, a particularly significant number in view of the extreme rarity of this cancer In the U.S. adult male population (testi mony of Dr. Marcus Key, Director of NIOSH, at the rulemaking hearing). The findings of angiosarcoma of the Uver In both experimental animals and exposed employees la compelling evi dence that exposure of humans to vinyl chloride induces this tumor. Industry spokesmen, at the hearing, conceded that VC la 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 weU 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 of studies by Bio-Test Labora 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 11 employees en gaged In cleaning reactom did, In fact, receive larger doses of vinyl chloride, it would be expected that such tumors would be observed earlier for this em ployee population. For this reason, the significance of presumed lower doses cannot be accurately assessed until a longer period of time has passed, as a longer induction period would be expected. Initiation of exposure to chemical carcinogens and induction of cancer are not necesasrlly 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 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 cinogenicity of vinyl chloride. The car tories, Tabershaw-Cooper, Maltoni, 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 i 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, OCTORER 4, 1974 SL 098227  35892 RULES AND REGULATIONS (testimony and questioning by Tenneco e.g., testimony of Sellkoff, firestone, NCI, confident that Industry will continue to, *5 Chemicals, Inc.). It has also been em andNIOSH.) do so. phasized that in only 3 of > polymeriza In our view, the demonstration of can (4) Conclusions. The conclusions be tion plants where employees have been cer induction in humans at a particular low are based on a thorough review and exposed to VC for more than 20 years level is not a prerequisite to a determina evaluation of all the evidence submitted. have any employees developed angiosar tion that a. substance represents a can Where decisions can be based on record coma of the liver. This argument Is very cer hazard for humans at that level. It evidence, this has been done. Where, simil would be imprudent to assume man to however, factual certainties are lacking ability of past employee exposure. Al be less sensitive to VC exposure than ex or where the facts alone do not provide though geographic and workpractice 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 angiosar founded to assume that animals will not There is little dispute that VC is car- ' coma, sufficient information Is unavail develop tumors when exposed at concen- 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 of 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 on the It has also been suggested that the Schnelderman said that it would be ex record. Nor is It clear to what extent absence of cancer in a population of 335 pected that some wduld develop VC In exposures can be feasibly reduced. We Dow Chemical Company polymerization 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 years, indicates that exposure to vinyl dispute that most, if not sill, fabricators lives of employees are at stake. There chloride at concentrations of less than are currently capable of reaching ex fore, we have had to exercise our best 200 ppm is safe. (See study by Dr. Cook, posure levels of 1 ppm through engineer judgment on the basis of the best avail submitted at the hearing by Dow Chem ing controls. Hiese 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, in which the veyed did not include all workers who posed to VC. Indeed, several fabricators overriding consideration has been the had been exposed, and the missing em are already operating at this level (see protection of employees, even thoeo who ployees included many who had the SPI testimony). However, industry may have regular exposures . toVC 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 and the PVC Based on the available evidence and In size of the sample population decreases industries to remain below 1 ppm con view of the above considerations, lnclud- the possibility that tumors would bo sistently, using engineering controls. In lng feasibility, we believe that employee observed. addition, the Knell study on technical exposures to VC must be reduced to a 1 . Dow also presented preliminary data feasibility concluded that a 1 ppm ceil ppm time-weighted average (TWA}, We 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 that hypothesis presented was that VC may that the VC industry could currently at level through engineering controls, and exert its carcinogenic effect by a metab tain lower exposure levels than the PVC that fabricators can do so In the Im olite, and that the metabolite is pro Industry. Labor union spokesmen and the mediate future. duced only when VC is metabolized by a Health Research Group, Inc., however, In addition to the TWA requirement, secondary metabolic pathway operating have suggested that such a level is at we have established a 5 ppm celling. only when enzymes regulating the pri tainable. (averaged over a 15-minute period) in mary pathway are saturated, as would Since there is no actual evidence that order to prevent exposure of employees be the result at higher exposures. The any of the VC or PVC manufacturers to unacceptable high excursions. From. preliminary data indicated the possi have already attained a 1 ppm level or in an operation standpoint, this celling bility of an additional pathway for fact instituted all available engineering level is realistic because minor excur metabolism of VC in rats exposed to con and work practice controls, 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 III. The final standard--Cl) 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, 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 or tions in these species. Although this re improvement to be obtained from en using fabricated products made Stem 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 does not yet offer We agree that the PVC and VC estab required for the monomer and polymer 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 In the near future. We do believe, how tors (sec testimony of Goodyear, Gen posures exist, A number of witnesses representing employers have stressed that there Is no evidence of cancer, either In employees or experimental animals, at exposure concentrations of VC less than 50 ppm. (See e.g., testimony of Firestone, Ten neco Chemicals.) The conclusion of these witnesses was that no decision can be ever. that they will, In time, be able to attain levels of 1 ppm TWA for most Job classifications most of the time. It is ap parent that reaching 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 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 made concerning risk of exposure to VC strides in reducing exposure levels. (See permissible control limits (See NIOSH at concentrations less than 50 ppm. testimony of Dow Chemical Co., TR 973). testimony, TR 106; Robintech TR 642). . 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 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 are In these circumstances, we believe that it j 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 monomen FEDERAL REGISTER, VOL. 39, NO. 194--FRIDAY, OCTOBER 4, 1974 SL 098228 RULES AND REGULATIONS 35893 d polymer Industries. Employers who, temperature as' PVC, for further pro below the action level, no further 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 less than the permissible levels, but from the final standard. This conclusion (2) Permissible exposure limit. The greater than the action level, monitoring is based on the absence of adequate evi- standard sets an exposure limit of 1 ppm must occur at least quarterly. ` dence of exposure to VC in these opera averaged over any 8 hour period, and a (5) Methods of compliance. The stand tions. The 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 an evaluation of the best to reduce exposures to at or below the . processing at temperatures, and for available evidence'and on a judgment permissible exposure limit. times, sufficient to cause mass melting of that the health and safety of employees Where feasible engineering and work the PVC. SPI and others (cf. TR. 344) must be protected to the fullest extent practice controls will reduce exposures 'requested that PVC resins with less than feasible. In view of the fact that release below the permissible levels, they must 0.1 percent residual monomer be ex of VC in the VC and PVC manufacturing be instituted. Where such controls will empted from the regulation now, and processes are variable, the 1 ppm celling not reduce exposures below the permis 4 that the exemption level be reduced to . 0.01 percent In three years. SPI suggested that the exemption of materials with less than 0.1 percent of 14 carcinogens from 29 CFR 1910.93P (39 FR 3756) was an appropriate precedent. The cases are not comparable, because no attempt had been ;made to set air concentration limits for the 14 carcinogens. The record did not include Information that reliable monl-torlng and measuring techniques were `available. Moreover, the exemption did not exempt airborne traces of carcino gens. The administrative cutoff was pro vided to avoid regulation of materials about which there was no health haz: ard information, and which would have broadly extended the application of the regulation beyond the record. Herein, no Information was presented to show safe concentration results from the use level provided In the proposal would require maintenance of an average level significantly more difficult to attain through feasible engineering controls. Therefore, the exposure limit prescribed in the proposal has been rejected. (3) Action level. The final standard, unlike the ETS and the proposal, pro vides for an "action level" of 0.5 ppm TWA, one-half of the permissible ex posure limit. The purpose of the action level is to minimize the Impact of the standard on the employers who have attained exposure levels well below the permissible limit. Thus, where the re sults of monitoring under paragraphs (d)(1) or (d)(2) demonstrate that no employee is exposed In excess of 0.5 ppm TWA, employers may, in effect, be exempted from some provisions of the standard. For example, fabricators who sible level, they must nonetheless be im plemented to reduce exposures to the lowest practicable level, and be supple mented by the use of respirators to pro vide the necessary protection. There* upon, a continuing program of engineer ing and work practice controls must be instituted to reduce exposures to the low est practicable level. When exposures are at or below the permissible exposure limits, the program may be discontinued. In addition, a plan for achieving con trol by engineering and work practice methods must be drawn up and be made available, upon request, to represent atives of OSHA and NIOSH. We recognize that many employers covered by the standard can not cur rently achieve compliance with the per missible exposure limit solely by the use of feasible engineering and work practice of resins with specific levels. Indeed, the are below the action level are not re controls. The record also reflects broad proposal to change the level later, when quired *o provide 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 FVC reduction, would seem to indicate that has reason to suspect that any employee industries. Some Industry spokesmen, SPI has doubts about the safety of 0.1 1s 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 missiie exposure limits and compliance 1 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. 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 ;i68, 170) and OSHA (Exhibit 151) lndl- 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 facts 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 this time. This course also number of measurements so that the re factors as the climate 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 660). 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 k. that the pellets had too low a residue to . cause harmful or measurable emissions, i While 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 ,FVC, 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 engi- FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, CTORER 4, 1974 SL 098229 35894 RULES AND REGULATIONS neerlng controls until full compliance Is achieved. We have not established any deadlines for full compliance through engineering controls because we are presently unable to determine when it will be feasible for most establishments to reduce exposure levels to the permissible level. We also believe that the requirement that each employer reduce airborne con centrations to the permissible level, or to the lowest level feasible as soon as practicable will provide for inter-indus try and intra-industry technological dif ferences which do exist, and will avoid the setting of separate industry stand ards on the hasis of the general situation and conditions in each industry. (6) Regulated areas. The proposed standard would have required that regu lated areas be established, that access be limited to authorized employees, and that daily rosters or summaries of those entering be kept for at least 20 years. In objection to these requirements, it was asserted that such control of access was 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 the risk of exposure to as few employees as possible. This concern is still paramount, and thus the limited access feature re mains. The final standard amends the proposal slightly to allow "authorized persons'' to enter regulated areas. This change, it Is felt, will allow operations to continue without undue interference. The final standard has also increased the length of time dally rosters must be maintained from 20 to 30 years. This change was based largely on epidemio logical considerations. (See NIOSH testi mony, tr. T19.) (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 fcs. se&*~ " -v respirators in PVC and VC plants, and that this Is not feasible because respira tors are cumbersome, present a safety hazard, and employees would not use them. We would agree that respirators have many drawbacks; the proposal did not contemplate them as a final solution, The record shows that the PVC Industry par ticularly may need several years before plant environmental levels can be re duced so that respirators are necessary only occassionally. However, we cannot agree that respiratory protection should 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 la not con trolled to the permissible exposure limit, then employees must be afforded respira tory protection. While exposures in excess of the per missible level do constitute a hazard, 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 1. 1976, where exposures are not in excess of a 25 ppm celling, each employer must provide each em ployee with an appropriate respirator. However, employees whose exposures do not exceed a 25 ppm ceiling, may decline to use the respirator, in which case the employer is not obligated to require its use. During this adjustment period, em ployees will be trained in the uses, pur poses and limitations of respirators, and the hazards of exposure to vinyl chloride. Moreover, each employee will be notified in writing if he has been exposed in ex cess of the permissible exposure limit. Where exposures exceed a 25 ppm ceil ing, respiratory protection Is mandatory In light of our judgment that much greater risks are associated with such exposures. The provisions in the final standard regarding the 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 atmospheresupplying 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 service 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 alr-purlfying respirators for use against VC. Consequently, we have included three types of air-purify ing respirators in the list of acceptable units, subject to the approval of such units by NIOSH. The maximum concen tration for which each respirator may be used is based upon our evaluation of the data submitted by NIOSH and Goodrich. Because air-purifying respi rators do not Indicate sorbent exhaustion or breakthrough of VC, and because VC has no inherent warning properties at 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 of the new section Is to protect employees en gaged In activities that present a risk of exposure to vinyl chloride In excess of the permissible levels. An example would be the cleaning of a filter where resin con taining high residual monomer Is trapped. The proposal's requirement for full- body, impervious clothing has been re placed by the direction to use Impervious garments suited to the particular situa tion and probable extent of exposure. Thus, full-body clothing Is not always necessary, and Is therefore not required where less protection is adequate. Since vessel entry falls within the definition of a hazardous operation, the vessel entry section of the proposal has been deleted from the final standard. (9) Emergency situations. The defini tion of emergency has been recast in terms of an unexpected massive release. The main objection to the section on 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 number 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 argjn FEDERAL REGISTER, VOL 39, NO. 194--FRIOAr, OCTOBER 4, 1974 SL 098230 RULES AND REGULATIONS 35895 .Advanced against its itiFWM that term "cancer" or "canieer-suspect t" scares employees milt that ln- the message should contain lntions on how to deal with the sub- (TR. 347). We believe that a 1 form of warning will not suffice, i appreciate the concern of employers th the reaction of their employees. But consider It imperative that a worker fully informed, and that he realize the :ible risks involved In his occupation, 'upled with the training requirement the standard, we believe that the signs labels required will adequately in employees of the hazard. In addlsuch signs will warn unauthorized rsonnel to keep out of regulated areas. The proper application of most protec- measures requires an amount of eg and indoctrination of employees t cannot easily be conveyed on a sign .label. Also, the variety of measures t could be prescribed would result in unwleldly or excessively detailed leg- Consequently, the required message signs and labels will not Include in formation on precautions, relevant ptoms, etc. The addition of suitable ~ormatlon by the employer would be rmltted, providing ft does not detract any way from the required statement. The requirement In the proposal for cling containers of vinyl chloride has n amended by deleting the reference to the possible hazard of violent polym erization. Very little Information was `eveloped on .this hazard during the ndard-setting procedure. It does sp ar that this hazard is essentially under otrol and that the lire and carcinohazards at present are the most scant. Since labeling or placarding ; Is In compliance with the U.S. De partment of Transportation regulations 49 C7R Part 173, Subpart H) already of the Are hazard, only a state- nt concerning the carcinogenic haz- need be added to the Department of Transportation labels. (11) Medical surveillance. The prlncl- questions that have been raised re garding medical surveillance are the slty and efficacy of requiring cer- iln specific serum enzyme determina tions (SMA-12 series) and the applica tion of medical examination require ments to the fabrication segments of the Industry where employees an exposed to 'ower levels of VC. The objection has also been raised that the specification of tests and procedures Interferes with uie ap plication of advances In medical knowl edge. A particular difficulty In considering medical surveillance Is that the most commonly discussed lesion, angiosar coma of the liver, currently, cannot be diagnosed until the victim is terminal and, usually, within months of death. Precursor physiologic alterations, which might be reversible, have not yet been 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 this tumor at an early stage of develop ment. However, most medical witnesses Indicated that the medical tests proposed posal is the requirement for maintenance are currently the only ones available of monitoring records and dally roster which are useful for medical surveillance sheets of authorized persons for 30 years, (TR 121, Exh. 95, TR 589-591). Conse instead of 20 years. Additionally, the em quently, the specific blood tests proposed ployer is required to maintain medical have been retained as a minimum re records for the duration of an employee's quirement to assist the examining physi employment plus 20 years, or 30 years, cian in determining fitness of potential whichever is longer. The original pijo- employees for assignment to workplaces posal called for only 20 years. involving VC exposure. In addition, al This change has been implemented be ternative medical examinations may be cause the latency period for induction of used where the examining physician de angiosarcoma ranges up to 30 years from termines that they are at least as good initial exposure. Therefore, as a mini as those specified by the standard. mum, medical records must be main The Tabershaw-Cooper study and the tained for at least that long. It should be various animal experiments suggest that noted that spokesmen for both labor and VC may produce a wide spectrum of ma industry recommended that this change lignant and non-malignant disorders. be made. The general scope of the required medical The reporting requirements are not examination has, therefore, been broad significantly different from those in the ened to include kidneys, skin, connective original proposal. However, Instead of tissue, spleen, and pulmonary system, as the requirement for reporting incidents well as the liver. No additional specific which result In the release of VC Into procedures or tests are required, but rec areas where employees may be exposed, ommendations have been included in the the final standard clarifies our original Appendix to assist the examining physi intent by stating that only emergencies cian. Because of the nonspecific nature must be reported. Also the requirement of the required medical tests, it is not for filing a detailed, written report appropriate to prescribe timing, or type within 15 days has been, deleted. It has of followup tests, or to mandate with been concluded that submission, within drawal from exposure based solely on re 24 hours, of an Initial report that In sults of the tests. Instead, the employer cludes facts immediately available, would is required to obtain a statement from ordinarily be sufficient. However. If the the examining physician of the em OSHA Area Director requests further In ployee's suitability for continued expo formation relevant to the emergency, the sure, when the examining physician has employer will be required to furnish such completed such tests as he considers ap information. propriate. The employer is required to (14) Deleted portions of the proposal. withdraw an employee only when this The proposal contained provisions re statement indicates that the employee quiring that shower facilities and change may be at added risk from continued VC rooms be provided, and that storage or exposure. consumption of food be prohibited in As with monitoring, there appears to regulated areas. We have deleted these be no basis for complete exemption of the provisions because it is our conclusion fabrication industry from the require they are no longer necessary. Showering ment for medical examination. The rec facilities are not required because pro ord does show fabricating establishments tective clothing, where required by the with concentrations of VC monitored final standard, should protect employees considerably above the action level. In from skin absorption by direct contact these Instances, medical surveillance of with VC and because there is no reliable affected employees will provide baseline evidence that VC vapor is absorbed data for future evaluation of their health, through the skin. In addition, since we even if both monitoring and medical sur anticipate that most employees will not veillance are discontinued because im be wearing protective clothing and that proved controls reduce concentrations employees who wear protective clothing below the action level. Where exposures will change such clothing infrequently, are below the action level, the medical we are not requiring that change rooms surveillance requirements do not general be provided. ly apply. In addition, we feel that there Is in (12) Training. A separate provision for adequate evidence showing that hazar employee training has been added to the dous amounts of VC can be absorbed final Standard rather than including It through ingestion. For this reason, the within the section on emergency situa requirement prohibiting the storage or tions as in the proposal. The new para consumption of food In regulated areas graph provides for training of employees, has been deleted. concerning the carcinogenic hazard of The proposal also contained provisions VC, emergency procedures, the need for on maintentance and decontamination, monitoring and an annual review of the transportation loading and unloading, standard. It also provides for training of and polymer handling operations. These employees concerning the purpose for, requirements are not mentioned in the proper use of, and limitations connected final standard because attention to these with respiratory protection. Items is implicit In the requirement that (13) Records and reports. The provi each employer reach the permlssable ex sions tor recordkeeping contained in the posure limit or attain the lowest feasible final standard require the preparation level. and maintenance of essentially the same (15) Effective date. In order to ensure information required by the proposal. that affected employers and employees The major change from the original pro will be Informed of the existence of these FEDERAL REGISTER. VOL. 39, NO. 194--FRIDAY, OCTOBER 4, 1974 * SL 098231 358% RULES AND REGULATIONS provisions and that employers affected are given an opportunity to familiarise themselves and theit employees with the existence of the new requirements, the effective date of the amendment to i 1910.93q will be January 1,1975. To pro vide continued protection for employees until that date, the provisions currently contained in f 1910.93q are hereby promulgated, pursuant to section 6(b), 6(c) and Sic) of the Occupational Safety and 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 as of January 1, 1975, Accordingly, upon consideration of the whole record of this preceding, Part 1910 of Title 29, Code of Federal Regulations Is amended, effective January 1, 1975, by revision of f l910.93q to read as follows: 1910.93q Vinyl chloride. (a) Scope and application. (1) This section includes requirements for the control of employee exposure to vinyl chloride (chloroethene), Chemical Ab stracts 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, (b) Definitions. (l) "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, buVJjot limited to, equip ment failure, or (mention of a relief de vice which Is likely to, or does, result In massive release of vinyl chloride. (6) "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 either vinyl chloride liquid or gas might be expected as a consequence of the operation or bceause of an acci dent In the operation, which would result In an employee exposure In excess of the permissible exposure limit, (8) "OSHA Area Director" means the Director for the Occupational Safety and Health- Administration Area Office having Jurisdiction over the geographic area in which the employer's establish ment Is located. (9) "Polyvinyl chloride" means poly vinyl chloride honiopolymer or copoly mer before such Is converted to a fabri cated product. (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: (i) 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 be 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 or 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 "NIOSH Manual of Analytical Methods"). (5) Employees or their designated rep resentatives shall be afforded reasonable opportunity to observe the monitor- ? lng and measuring required by this J paragraph. j (e) Regulated area. (1) A regulated area shall be established where: (1) Vinyl chloride or polyvinyl chloride 1 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 dally 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 (gl 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 under4! this section: : (1) The employer shall provide a respirator which meets the requirements of this paragraph and shaU assure that the employee uses such respirator, excerpt' 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 15r minute period. Until December 31, 1975,S each employee who chooses not to wear* an appropriate respirator shall be in-1 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 Admirii' lstratlon, Department of the Interior, and the National Institute for Occupa tional Safety and Health under the pi visions of 30 CFR Part 11. (3) A respiratory protection program] meeting the requirements of 11910.17 shall be established and maintained.-' (4) Selection of respirators for vlnj chloride shall be as follows: > FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, T974 SL 098232 RULES AND REGULATIONS 35897 tvtotpheric concentration of vinyl chloride Required apparatus own, or above 3,600 ppm__ Open-circuit, self-contained breathing apparatus, pm*. urn demand typo, with lull facepleoe. ot over 3,600 ppm__ _______ (A) Combination typo C supplied sir respirator, pres sure demand type, wltb full or ball facepiece, and auxiliary self-contained air supply; or ; \j (B) Typo c, supplied air respirator continuous flow typo, wltb full or half facepiece, and auxiliary self-contained air supply. JHot over 100 ppm_...______ (A) combination type C supplied air respirator de mand type, wltb full facepiece, and auxiliary self-contained air supply; or (B) Open-circuit self-contained breathing apparatus wltb full facepiece, In demand mode; or (C) Type C supplied air respirator, demand type, wltb full facepiece. Not over 38 ppm. ______ _ (A) A powered atr-purlfytng respirator wltb hood, helmet, full or half facepiece, and a canister wblcb provides a service life of at least 4 hours for concenratlons of vinyl chloride up to 36 ppm, or . (B) Qas maslc, front- or back-mounted canister wblcb provides a service life of at least 4 hours for concentrations of vinyl chloride up to 36 ppm. Not over 10 ppm___ ___ _____ '` - (A) Combination type 0 suppiied-alr respirator, de mand type, wltb half facepiece, and auxiliary self-contained air supply; or (B) Type C supplled-air respirator, demand type, with it- 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 up to 10 ppm. (S) (1) Entry Into unkown concentraons or concentrations greater than 36,000 ppm (lower explosive limit) may be made only for purposes of life rescue; and jll) Entry Into concentrations of less an se.ooo ppm, but greater than 3,600 ppm may be made only for purposes of life rescue, firefighting, or securing equipment eo as to prevent a greater hazard from release of vinyl chloride. , (6) Where alr-purtfylng respirators used: (I) Air-purifying cannlstere or car tridges shall be replaced prior to the plratlon of their service life or the end of the shift In which they are first used, whichever occurs first, and (II) 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; (I) Respiratory protection in accord ance with paragraphs (c) and (g) of this section; and (II) Protective garments to prevent skin contact with -liquid vinyl chloride or with polyvinyl chloride residue from vessel walls. The protective garments shall be selected for the operation and Its possible exposure conditions. (2) Protective garments shall be pro vided clean and dry lor 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: (1) Employees engaged In hazardous operations or correcting situations of ex isting hazardous releases shall be equipped as 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; (11) The purpose for, proper use, and limitations of respiratory protective devices; (lv) The fire hazard and acute toxic ity of vinyl chloride, and the necessary protective steps; (v) The purpose for and a description of the monitoring program; (vi> The purpose for, and a descrip tion of. the medical surveillance program; (vii) Emergency procedures; (viil) Specific Information to aid the employee In recognition of conditions which may result in the release of vinyl chloride; and 1*(II) * 1 2 (lx) A review of this standard at the employee's first training and Indoctrina tion program, and annually thereafter. (2) AH materials relating to the pro gram shall be provided upon request to the Assistant Secretary and the Director. (k) Medical surveillance. A program of medical surveillance shall be insti tuted for each employee exposed, with out regard to the use of respirators, to vinyl chloride in excess of the action level. The program shall provide each such employee with an opportunity for examinations and tests In accordance with this paragraph. All 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. (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, spleen or kidneys, or dysfunction In these organs, and for abnormaltles In skin, connective tissues and the pulmonary system (See Appendix A). (11) 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 hepatotoxlc agents, Includ ing drugB 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 (SGOT); (D) Serum glutamic pyruvic transam inase (SGPT); and (E) Gamma 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- rUe 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 of each employee's suitability for continued exposure to vinyl chloride Including use of protec tive equipment and respirators, shall be 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 materially Impaired by continued ex posure, such employee shall be wlth- FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 SL 098233 35898 RULES AND REGULATIONS drawn from possible contact with vinyl tlon which contradicts or detracts from chloride. the effect of, any required warning, (6) Laboratory analyses for all bio information or instruction. logical specimens Included In medical (m) .Records. (1) All records main examinations shall be performed In labo tained In accordance with this section ratories licensed under 42 CFR Part 74. shall Include the name and social secu (7) If the examining physician deter rity number of each employee where mines that alternative medical examina relevant. tions to those required by paragraph (2) Records of required monitoring (k)(l) of this section will provide at and measuring, medical records, and au least equal assurance of detecting med thorized personnel rosters, shall be made ical conditions pertinent to the exposure and shall be available upon request for to vinyl chloride, the employer may ac examination and copying to authorized cept such alternative examinations as representatives of the Assistant Secre meeting the requirements of paragraph tary and the Director. (k) (l) of this section. If the employer (I) Monitoring and measuring records obtains a statement from the examining shall: physician setting forth the alternative (A) State the date of such monitor examinations and the rationale for sub ing and measuring and the concentra stitution. This statement shall be avail tions determined and Identify the Instru able upon request for examination and ments and methods used; copying to authorized representatives of (B) Include any additional Informa the Assistant Secretary and the Director. tion necessary to determine Individual (1) Signs and labels. (1) Entrances to employee exposures where such expo regulated areas shall be posted with leg sures are determined by means other ible signs bearing the legend: than Individual monitoring of employees; CANCER-SUSPECT Agent AREA AUTHORIZED Fnaomn, Only and (C) 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. (II) Authorized personnel rosters shall be maintained for not less than 30 years. Oil) Medical records shall be main tained for the duration of the employ Cancer-Suspect Agent in Tais Area Fhotec- ment of each employee plus 20 years, ttve Equipment PERSONNEL ONLT Required Authorized ' or 30 years, whichever is longer. (3) In the event that the employer (3) Containers of polyvinyl chloride ceases to do business and there is no resin waste from reactors or other waste successor to receive and retain his rec contaminated with vinyl chloride shall ords for the prescribed period, these rec be legibly labeled: ords shall be transmitted by registered Contaminated with Vinyl Chloride Cancee-Suspect Agent (4) Container of polyvinyl chloride hall be legibly labeled: mail to the Director, and each employee Individually notified in writing of this transfer. (4) Employees or their designated representatives shall be provided access Polyvinyl Chloride (or Tbade Name) to examine and copy records of required Contains monitoring and measuring. Vinyl Chloride (5) Former employees shall be pro Vinyl Chloride is a Cancsr-Suspect Agent vided access to examine and copy re (5) Containers of vinyl chloride shall quired monitoring and measuring records be legibly labeled either: reflecting their own exposures. (l) Vinyl Chloride Eetremely Flammable Gas Under Cancer-Suspect Agent pressure (6) Upon written request of any em- . ployee. a copy of the medical record of that employee shall be furnished to any physician designated by the employee. (n) Reports. (1) Not later than 1 or <il) In accordance with 49 CFR Part month after the establishment of a reg 173, Subpart H, with the additional ulated area, the following information legends: shall be reported to the OSHA Area Di Cancer-Suspect Agent applied near the labor or placard. rector. Any changes to such information shall be reported within 15 days. (1) The address and location of each (6) No statement shall appear on or establishment which has one or more near any required sign, label or instrue- regulated areas; and (U) The number of employee# In each regulated area during normal operations, Including maintenance. * (21 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 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 S 1910.93q of this Part shall apply. (2) Effective January 1,1975, the pro visions set forth In ! 1910.93q of this Part shall apply. Appendix A--Supplementary Medical Information 'When required teats under paragraph (k)(l) of this section show abnormalities, . the teste should be repeated as soon as prac ticable, preferably within 8 to 4 weeks. If tests remain abnormal, consideration should be given to withdrawal of the employee from contact with vinyl chloride, while a more comprehensive examination Is made. Additional teste which may be useful: A. For kidney dysfunction: urine examina tion for albumin, red blood cells, and ex foliative abnormal cells. B. Pulmonary system: Forced vital capac ity. Forced expiratory volume at 1 second, and chest roentgenogram (posterior-anterior, 141 17 inches), C. Additional serum tests; Lactic add de- bydrogenaae, 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, a and 8. 84 Stat. 1596. 1696 (29 U&C.jf 655, 657); Secretary of Labor's Order No. jf 12-71, 36 FR 8754) ySigned at Washington, D.C., this ut day of October, 1974. r. j tS John Stender, '*$6 Assistant Secretary oj Labor. (FR Doc.74-23176 Plied 10-1-74;3:64 plj liAf'd FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 SL 098234