Document LKqzL8bDrrJQ38vGwnaNv1k2X

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 Inspection of the B. F. Goodrich plant by 06HA. NI06H and the Ken tucky Department of Labor, a fact-find 1910.93d and published a comprehensive peopoeal (39 FR 16896) on May 10, 1974, to protect employees from hazards of expoeure to VC. The proposal called for limitation ot employee exposure to VC to "no detectable level,'' as measured by a Standard for 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 1970 (84 Stat. 1593, 1596, 1599 ; 29 U.S.C. 655, 657) Secretary of Labor's Order No. 12-71 (36 PR 8754) and 29 CPR Part 1911, i 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. 75014, is a synthetic organic chemical made from ethylene or acetylene and chlorine by any of several processes. It is the parent compound of a series of thermoplastic resin polymers and copolymers which are widely used for containers, wrapping Sim, 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 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, i.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 size from those with few employees and simple equipment to large plants involving many employees and considerable capital. 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 Oncologla. 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 Si Rubber Com pany. On the basis of all information avail able at that time, and the fact that em ployees were being exposed at levels around the experimentally observed ef fect level of 250 ppm, an emergency temporary standard (ETC) was promul gated on April 5, 1974 (39 FR 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 500 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 ceiling was a tentative, interim standard, and that 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 OSHA, NIOSH, and the Environmental Protection Agency by the Industrial BioTest Laboratories, Northbrook, Illinois, concerning results of animal exposure to 1 pptn, 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 thorised persons. A requirement for monitoring of employee exposures was proposed, along with engineering and work practice controls to be implemented when exposures over the detectable limit were measured. Respiratory protection would have been.required while engineering and work practice controls were being implemented or where exposures exceeded the per missible Mmlt even after feasible en gineering controls were Instituted. In addition, the 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 lire Act for promulgation of a final standard. It was decided to hold a hearing as soon as possible. Accord ingly, on May 24,1974, a notice of a hear ing was published (39 FR 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. AH partici 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 posthearing com ments, Including various items of infor mation which were requested during the examination of witnesses. (5) Economic and technical impact Vinyl chloride (VC), 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 studies with VC. These studies were sponsored by the Manufacturing Chem ists Association. Although only pre liminary in nature at that time, these results revealed that 2 out of 200 mice study. During the hearing, OSHA deter mined that additional facts would be needed to determine the practicality of certain aspects of the proposed stand ard. Accordingly, OSHA contacted an in in Table Q-l of 1910.93, established a exposed to VC concentrations of 50 ppm dependent consultant, Foster D. Snell ceiling value of 500 parts of VC per mil for 7 hours a day, five days a week, for Corporation, to conduct studies of the lion parts of air. approximately 7 months, had developed feasibility of compliance at various ex (2) The emergency temporary stand angiosarcoma of the liver. posure levels, including those proposed ard. On January 22, 1974, the Occupa (3) The proposed permanent stand by OSHA and others advanced by in tional Safety and Health Administra ard. Based on the demonstrated evidence dustry spokesmen. Snell was also com tion (OSHA) was informed by the Na of VC's carcinogenicity in three animal missioned to collect Information regard tional Institute for Occupational Safety species (rats, mice and hamsters), and ing the economic costs of compliance. and Health (NIOSH) that the B. F. the substantial probability that VC had This action was announced at the close Goodrich Chemical Company had re been the causal agent in the cases of liver Of the hearing, and Judge Myatt further ported that deaths of several of its em angiosarcoma found in workers both here announced that the record would be kept FEDERAL REGISTER, VOL. 39, NO, 194--FRIDAY, OCTOBER 4, 1974 UCC 093905 RULES AND REGULATIONS 35891 open lor a period ol time beyond August studies of Maltonl and Bio-Test labora may create a carcinogenic hazard, the 23, to allow Interested persons to com tories. Moreover, Maltoni's investigations amount of exposure which Is hazardous ment in writing on the study. On August have demonstrated a dose-dependent re must be determined. The Surgeon Gen 26,1974, 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 comments were to be submitted no later levels), including angiosarcoma of the for carcinogenic substances cannot be than September 6, 1974 (39 FR 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 oomments 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 on or before September 25, 1974 (39 FR have Induced angiosarcoma of the liver the testimony of expert witnesses from 33009). in rats and mice at exposure concentra the National Cancer Institute. (6) Environmental impact statements, tions of 50 ppm, and in'hamsters at high Several witnesses and persons who sub A notice ol intent to file an environmen er concentrations at 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 ol 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 freouen- 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 forwarded to the Council of Environ mals died, without gross postmortem pathologic examination being performed. observed are those who have considerable 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 (39 FR 22975). A 45 day period was al lowed for the submission of comments on the draft statement. On Beptember 5, 1974, the final environmental Impact tion was performed, 13 (36 percent) were found with liver tumors (including angiosarcomas), 21 (58 percent) with lung tumors, B (25 percent) with skin tumors, and one with a kidney tumor. 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. 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 fined 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 by OSHA person nel, the environmental impact state ments, the economic and technical impact studies, and all other relevant information. In all, over 600 written com ments have been received, with more than 200 separate oral and written sub missions made with regard to the two hearings. The record itself exceeds 4,000 pages. Employers, employees, labor unions, public health groups, independ ent experts, physicians, research scien tists, and specialists in many fields have been invited to submit Information and have made their views, knowledge and experience available to OSHA, The en tire record encompassing these submis sions was thoroughly reviewed and evaluated in reaching the determina tions set forth below. n. Findings regarding carcinogenicity, exposure levels and teasibility--lV Car 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 a 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 particularly significant number in view of the extreme rarity of this cancer in the U.S. adult male population (testi mony of Dr. Marcus Key, Director of NIOSH, at the rulemaking hearing). The findings of angiosarcoma of the liver in both experimental animals and exposed employees is compelling evi dence that exposure of humans to vinyl chloride induces this tumor. Industry spokesmen, at the hearing, conceded that VC is carcinogenic for humans (e.g. testimony of Dr. McBumey. Rulemaking hearing, 1041). Accordingly, it is con cluded that VC must be regarded as a human carcinogen, and the probable causal agent of angiosarcoma of the liver, and that exposure of employees to VC must be controlled. Additional evidence of tumor induction in a variety of other organs, including lung, kidney, brain and skin, as well as non-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 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 of vinyl chloride, it would be expected that such tumors would be observed earlier for this em ployee population. For this reason, the significance of presumed lower doses cannot be accurately assessed until a longer period of time has passed, as a longer induction period would be expected. Initiation of exposure to chemical carcinogens and induction of cancer are not necesasrily synchronous events. Be cause of the physiologic complexities in volved with carcinogenesis, induction of tumors does not occur in all employees with similar exposure histories. For ex ample, Dr. Schneiderman of the Na tional Cancer Institute emphasized dur 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 o/ vinyl chloride. The car cinogenicity of vinyl chloride for three tories, Tabershaw-Cooper, NIOSH, and Selikoff.) Maltoni, ployees may Indicate an exposure thres 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. 3V, NO. 194--FRIDAY, OCTOBER 4, 1974 UCC 093906 35892 RULES AND REGULATIONS (testimony and questioning by Tenneco e.g., testimony of Sellkoff. Firestone, NCI, confident that Industry will continue to Chemicals. Inc.). It has also been em andNIOSH.) do so. phasized that in only 3 ol S 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 lor more than 20 years level is not a prerequisite to a determina evaluation of all the evidence suomltted. have any employees developed angiosar tion that a substance represents a can Where decisions cun be bused on record coma ol the liver. This argument is very cer hazard for humans at that level. It evidence, this has liTMn done. whm.. niyiiiar to that raised concerning vari would be imprudent to assume man to however, factual certuinUrb mo lurkin ' ability ol past employee exposure. Al be lees sensitive to VC exposure than ex or where the facta nitmr i1*> nut prnvtiln though geographic and workpractice dif perimental animals In the absence of an answer, policy JudgmentR hHve been ferences may ultimately be demonstrated conducive 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 thin 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 he 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 would 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 all, fabricators lives of employees are at stake. There chloride st concentrations of lees 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. These employers employ able evidence. These judgments have re ical Company.) However, the group sur well over 95 percent of all employees ex quired a balancing process. 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 those who ployees included many who had the SPI testimony). However. Industry may have regular exposures to VC longer term (over 20 years) exposures. spokesmen have universally claimed that throughout their working lives. Moreover, the statistically insignificant it Is infeasible for the VC 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, includ the possibility that tumors would be sistently, using engineering controls. In ing feasibility, we believe that employee observed. addition, the Snell study on technical exposures to VC must be reduced to a 1 Dow also presented preliminary data feasibility concluded th"t 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 FVC 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 FVC 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 ceiling only when enzymes regulating the pri tainable. (averaged over a 15-mlnute 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 & regular basis. However, the occurrence of angio must necessarily involve subjective judg m. The final standard--(1) 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 v.puld 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 from search may be helpful to the thorough gineering changes until such changes are VC. understanding of the carcinogenicity 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 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 actually implemented. We agree that the PVC and VC estab lishments will not be able to attain a 1 ppm TWA level for all job classifications in the near future. We do believe, how ever. that they will, in time, be able to attain levels of 1 ppm TWA for most Job classifications most of the time. It 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 FVC Industries have already made great There is no dispute that a standard ts 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 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, TB 106; Roblntech TR 6421. On the other hand, the testimony of most expert witnesses, including some in dustry biomedical experts, stated that quantification of a 5ia exposure COP4 For example, B. F. Goodrich testified (TR 1120) that it has reduced overage exposure lcveis in several PVC plants In these circumstances, we believe that it Is imprudent to grant a blanket exemp tion for all fabricators. Therefore, the ccntration is not possible with the pres from 35-40 ppm early this year to 12-13 final standard is applicable to the fabri ent state of scientific knowledge (See ppm at the time of the hearing. We are cation industry, as well as the monomer ,FEDERAL REGISTER, VOL. 39, NO. 194--FRIDAY, OCTOBER 4 1974 UCC 093907 RULES AND REGULATIONS 35893 and 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 aotlon 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 mess 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 JETS or the proposal sold 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 celling 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 thatpvc reelns 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. 20 CFR 1910.93P (39 FR 3756) was an Therefore, the exposure limit prescribed appropriate precedent. The cases are not In the proposal has been rejected. comparable, because no attempt had been (3) Action level. The final standard, made to set air concentration limits for unlike the ET5 and the proposal, pro the 14 carcinogens. The record did not- vides for an "action level" of 0.5 ppm Include Information that reliable moni TWA, one-half of the permissible ex toring and measuring techniques were posure limit. The purpose of the action 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. 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 broadly extended the application of the regulation beyond the record. Herein, no Information was presented to show (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 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 safe concentration results from the use of resins with specific levels, indeed, the proposal to change the level later, when Improved technology would permit such standard. For example, fabricators who are below the action level sue not re quired lo provide medical surveillance or to monitor again, unless the employer of feasible engineering and work practice controls. The record also reflects broad generic distinctions between the compli ance capabilities of the VC and PVC reduction, would seem to indicate that has reason to suspect that any employee Industries. Some Industry spokesmen, SPI has doubts about the safety of 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 mlsslle 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. The final standard, the time required to feasibly reach In ing data from Industry (cf. Exhibits 131, like the proposal, requires that Individual creasingly lowef control levels is similar 168, 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 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 that the pellets had too low a residue to cause harmful or measurable emissions. 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 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- FSDERAl REGISTER VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 UCC 093908 35891 RUtCS AND REGULATIONS neerlng controls until lull compliance Is achieved. We have not established any deadlines lor lull compliance through engineering controls because we are presently unable to determine when it will be leaeible lor 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 leasible as soon as practicable will provide lor inter-indus try and intra-industry technological dif ferences which do exist, and will avoid the setting ol separate Industry stand ards on the basis ol the general situation and conditions In each Industry. (8) Regulated areas. The proposed standard would have required that regu lated areas be established, that access be limited to authorized employees, and that dally rosters or summaries ol those entering be kept lor at least 20 years. In objection to these requirements, it was asserted that such control ol access was not necessary from a health standpoint. Secondly, It was claimed that these con trols would Interfere with operations by preventing access ol needed1 employees or non-employees, such as contractors, truck drivers, customers and consultants. The purpose ol establishing regulated areas in the proposal was to limit the risk of exposure to as lew employees as possible. This concern is stDT 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. 119.) (7) Respiratory protection. The final standard, like the proposal, requires the use ol respirators where employee expo sures exceed the permissible control level. Industry representatives made a number ol abjections to proposed requirements for respiratory protection. They stated that the "no detectable level" would ef fectively require continuous wearing of respirators In FVC and VC Plants, and that this Is not leasible 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 FVC industry par ticularly may need several years before plant environmental levels can. be re duced so that respirators are necessary only occasionally. 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 ol em ployees and restructuring of work prac tices. We have carefully considered all the objections, and have concluded that if the environmental level is 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 e hazard, we believe that It is necessary to mitigate some of the problems associated with implementing a program ol 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 ol a 35 ppm ceiling, each employer must provide eaeh em ployee with an appropriate respirator. However, employees whose exposures do not exceed a 25 ppm celling, 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 ol respirators, and the hazards ol exposure to vinyl chloride. Moreover, each employee will be notified la writing 11 he has been exposed in ex cess ol the permissible exposure limit. Where exposures exceed a 25 ppm cell ing, respiratory protection is mandatory in light ol our judgment that much greater risks are associated with such exposures. The provisions In the final standard regarding the selection and use ol respi ratory protective devices differ from those in the proposal. The descriptions ol atmosphere-supplying respirators hove been revised to indicate more clearly the types of devices Intended, and the maxi mum permissible concentration level lor each devlcj. 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 lor selection ol atmospheresupplying devices follow closely the rec ommendations contained in his testi mony ol SFI and B. F. Goodrich) (TR with Hyatt's suggestions. (See e.g. testi mony ol 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 ol 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 poet 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-purlfytng respirators lor use against VC. Consequently, we have Included three types ol alr-purlfylng respirators in the list ol acceptable units, subject to the approval of such units by NIOSH. The maximum concen tration lor which each respirator may be used is based upon our evaluation ol the data submitted by NIOSH and Goodrich. Because air-purifying respi rators do not Indicate sorbent exhaustion or breakthrough ol 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 alssrm system to alert employees when vinyl chloride concentrations exceed the concentrations allowed lor the particu lar type ol respirator in use. (8) Hazardous operations. This is a new section within the final standard. It encompasses essentially the proposal's requirements lor maintenance and de contamination but has restated them in terms ol performance language to allow greater flexibility lor employers to deal with such operations. The intent ol the new section is to protect employees en gaged in activities that present a risk of exposure to vinyl chloride In excess ol 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 lor lullbody, impervious clothing has been re placed by the direction to use impervious garments suited to the particular situa tion and probable extent ol exposure. Thus, lull-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, andthat 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 argu- ,FEOERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4 1974 UCC 093909 RULES AND REGULATIONS 35S95 ment advanced against Its use was that the term "cancer" or "cancer-suspect agent" scares employees and that In stead. the message should contain In structions on how to deal with the sub stance (TR. 347). We believe that a diluted form of warning will not suffice. We appreciate the concern of employers with the reaction of their employees. But we consider it imperative that a worker be fully Informed, and that he realize the possible risks Involved In his occupation. Coupled with the training requirement In the standard, we believe that the signs and labels required will adequately in form employees of the hazard. In addi tion, such signs will warn unauthorized personnel to keep out of regulated areas. The proper application of most protec tive measures requires an amount of training and indoctrination of employees that cannot easily be conveyed on a sign or label. Also, the variety of measures that could be prescribed would result in an unwieldly or excessively detailed leg end. Consequently, the required message on signs and labels will not include in formation on precautions, relevant symptoms, etc. The addition of suitable Information by the employer would be permitted, providing it does not detract in any way from the required statement. The requirement In the proposal for labeling containers of vinyl chloride has been amended by deleting the reference to the possible hazard of violent polym erization. Very little information was developed on this hazard during the standard-setting procedure. It does ap pear that this hazard is essentially under control and that the fire and carcino genic hazards at present are the most significant. Since labeling or placarding that is in compliance with the U.S. De partment of Transportation regulations (49 CfR Part 173. Subpart H) already warns of the fire hazard, only a state ment concerning the carcinogenic haz ard need be added to the Department of Transportation labels. (11) Medical surveillance. The princi pal questions that have been raised re garding medical surveillance are the necessity and efficacy of requiring cer tain specific serum enzyme determina tions (SMA-12 series) and the applica tion of medical examination require ments to the fabrication segments of the Industry where employees are exposed to lower levels of VC. The objection has also been raised that the specification of tests and procedures interferes with the ap plication of advances in medical knowl edge. ' 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 are currently the only ones available which are useful for medical surveillance (TR 131. Exh. 96, TR 689-691). Conse quently, the specific blood tests proposed have been retained as a minimum re quirement to assist the examining physi cian in determining fitness of potential employees for assignment to workplaces Involving VC exposure. In addition, al ternative medical examinations may be used where the examining physician de termines that they are at least as good as those specified by the standard. The Tabershaw-Cooper study and the various animal experiments suggest that VC may produce a wide spectrum of ma lignant and non-mallgnant disorders. The general scope of the required medical examination has, therefore, been broad ened to include kidneys, skin, connective tissue, spleen, and pulmonary system, as well as the liver. No additional specific procedures or testa are required, but rec ommendations have been included in the Appendix to assist the examining physi cian. Because of the nonspecific nature of the required medical tests, it is not appropriate to prescribe timing, or type of followup tests, or to mandate with drawal from exposure based solely on re sults of the tests. Instead, the employer is required to obtain a statement from the examining physician of the em ployee's suitability for continued expo sure. when the examining physician has completed such tests as he considers ap propriate. The employer is required to withdraw an employee only when this 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 affected employees will provide baseline data for future evaluation of their health, even if both monitoring and medical sur veillance are discontinued because im proved controls reduce concentrations below the action level. Where exposures are below the action level, the medical surveillance requirements do not general ly apply. (12) Training. A separate provision for employee training has been added to the final standard rather than including it within the section on emergency situa tions as in the proposal. The new para graph provides for training of employees concerning the carcinogenic hazard of VC, emergency procedures, the need for monitoring and an annual review of the 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 Information required by the proposal. The major change from the original pro- posal is the requirement for maintenance of monitoring records and daily roster sheets of authorized persons for 30 years, instead of 20 years. Additionally, the em ployer is required to maintain medical records for the duration of an employee's employment plus 20 years, or 30 years, whichever is longer. The original pro posal called for only 20 years. i This change has been implemented be cause the latency period for Induction of angiosarcoma ranges up to 30 yean from initial exposure. Therefore, as a mini mum, medical records must be main tained for at least that long. It should be noted that spokesmen for both labor and industry recommended that this change be made. ' The reporting requirements are not significantly different from those in the original proposal. However, instead of the requirement for reporting incidents which result in the release of VC Into areas where employees may be exposed, the final standard clarifies our original intent by stating that only emergencies must be reported. Also the requirement for filing a detailed, written report within IS days has been deleted. It has been concluded that submission, within 24 hours, of an Initial report that in cludes facts immediately available, would ordinarily be sufficient. However, if the OSHA Area Director requests further in formation relevant to the emergency, the employer will be required to furnish such information. (14) Deleted portions of the proposal. The proposal contained provisions re 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 evidence that VC vapor is absorbed through the skin. In addition, since we anticipate that most employees will not be wearing protective clothing and that employees who wear protective clothing will change such clothing Infrequently, we are not requiring that change rooms be provided. In addition, we feel that there is in adequate evidence showing that hazar dous amounts of VC can be absorbed through ingestion. For this reason, the requirement prohibiting the storage or consumption of food in regulated areas has been deleted. The proposal also contained provisions on malntentance and decontamination, transportation loading and unloading, 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 permissable ex posure limit or attain the lowest feasible level. (15) Effective date. In order to ensure that affected employers and employees will be informed of the existence of these FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 ucc 093910 35896 MILES AND REGULATIONS provisions and that employers affected are given an opportunity to familiarise themselves and their employees with the existence of the new requirements, the effective date of the amendment to { 1910.B3q will be January 1,1975. To pro vide continued protection for employees until that date, the provisions currently contained In f 19l0.93q are hereby promulgated, pursuant to section 6(b), 6(c) and 8(c) of the Occupational Safety and Health Act, as an occupational safety and health standard effective October 4, 1974, the amendment to J i9io.93q set out below will supersede these provisions as of January 1, 1975. Accordingly, upon consideration of the whole record of this procedlng, Part 1910 of Title 29. Code of Federal Regulations Is amended, effective January 1, 1975, by revision of { 1910.93q to read as follows: 1910.1017 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 ehlorlde except to the extent that the Department of Transportation may regulate the hazards covered by this sec tion. (b) 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 net 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. (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 because of an acci dent In the operation, which would result In an employee exposure in excess of the permissible exposure limit. (8) "OSHA Area Director" means the Director for the Occupational Safety and Health Administration Area Office having jurisdiction over the geographic area in which the employer's establish ment to located. (9) "Polyvinyl ehlorlde" means poly vinyl chloride homopolymer or copoly mer before such to converted to a fabri cated product. (ID) "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 avenged over any period not exceeding 15 minutes. (3) No employee may be expoeed to vinyl chloride by direct contact with liquid vinyl chloride. (dl Monitoring. (1) A program of initial monitoring and measurement shall be undertaken In each establish ment to determine If there to 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 to exposed, without regard to the use of respirators, In ex cess of the permissible exposure limit. (II) Shall be repeated not less than quarterly where any employee to 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 36 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- tog and measuring required by this paragraph. (e) Regulated area. (1) A regulated area shall be established where: (1) Vinyl chloride or polvvlnyl chloride to 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 miter. (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 tn 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 15minute 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 elected 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 30 CFR Part 11. (3) A respiratory protection program meeting the requirements of 51910.134 shall be established and maintained. (4) Selection of respirators for vinyl chloride shall be as follows: ,FEDERAL REGISTER, VOL. 39, NO. )94--FRIDAY, OCTOBER 4 1974 UCC 093911