Document 6bG290oJ7y4eQJKE31vbKE623

* FRIDAY, OCTOBER 4, 1974 WASHINGTON, D.C. Volume 39 Number 194 PART II > DEPARTMENT OF LABOR Occupational Safety And Health Administration a EXPOSURE TO VINYL CHLORIDE Occupational Safety and Health Standards AP00024632 35S90 RULES AND REGULATIONS Title 29--Labor CHAPTER XVII--OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DE PARTMENT OF LABOR PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS Standard for Exposure to Vinyl Chloride Pursuant to sections 6(b), 6(c), and 8(c) of the Occupational Safety and Health Act of 1970 (84 Stat. 1593, 1596, 1699: 29 U.S.C. 655, 657) Secretary of Labor's Order No. 12-71 (36 Fit 8754) and 29 CFR Part 1911, 3 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 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 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.c., 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. 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 in Table G-l of 1910.93, established a celling value of 500 parts of VC per mil lion parts of air. (2) The emergency temporary stand ard. On January 22, 1974, the occupa tional Safety and Health Administra tion (OSHA) was Informed by the Na tional Institute for Occupational Safety and Health (NIOSH) that the B. F. Goodrich Chemical Company had re ported that deaths of several of its em- ployccs from a rare liver cancer (angio sarcoma) may have been occupationally related. As a result of this notification and alter consultation with NIOSH, and a Joint inspection of the B. F. Goodrich plant by OSHA. NIOSH and the Ken tucky Department of Labor, a fact-find ing hearing was announced on Janu 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 Maltoni of the Instituto di On- cologia, 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 & 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 S, 1974 (39 FR 12341) pursuant to section 6(c) of the Act, as 29 CFR 1910.93(1. 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 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 exposed to VC concentrations of 50 ppm for 7 hours a day, five days a week, for approximately 7 months, had developed angiosarcoma of the liver. (3) The -proposed permanent stand ard. Based on the demonstrated evidence of VC's carcinogenicity In three animal species (rats, mice and hamsters), and the substantial probability that VC had been the causal agent In the cases of liver angiosarcoma found in workers both here and abroad, OSHA proposed to revise 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 sampling and analytical method sensitive 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, alonfe with engineering and work practice controls to be implemented when exposures over the detectable limit were measured. Respiratory protection would have been required while engineering and work practice controls were being implemented or where exposures exceeded the per missible limit even after feasible en gineering controls were instituted. In addition, the proposed 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 tor interested parties to submit written comments and to request an informal rulemaking hearing. In formal contacts with OSHA staff and emly 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 the 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. All 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. (5T Economic and technical impact 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 dependent consultant. Foster D. Snell Corporation, to conduct studies of the feasibility of compliance at various ex posure levels. Including those proposed by OSHA and others advanced by In dustry spokesmen. Snell was also com missioned to collect information regard ing the economic costs of compliance. This action was announced at the close of the hearing, and Judge Myatt further announced that the record would be kept FEDERAI REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 AP00024633 RULES AND REGULATIONS 35891 open for a period of 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 (i.e., eral's Ad Hoc Committee referred to liminary study was available and that more tumors occur at higher exposure above concluded that sale 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 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 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 of intent to file an environmen er concentrations of exposure. Additional mitted comments have taken a contrary tal Impact statement assessing the im tumors Involving other organs, including view and have suggested that man is less pact of a proposed standard 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 (33 ER 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 on the environmental impact to submit it to 03HA by May 17.1974. On June 12, 1974, a draft environmental impact statement was prepared and circulated to all Interested persons. Ten copies were forwarded to the Council of Environ mental Quality (CEQ), which published a notice of its filing and availability In the Federal Recister on June 25, 1974 (39 FR 22975). A 45 day period was al lowed for the submission of comments on the draft statement. On September 5, 1974, the final environmental impact statement was prepared and a copy of It and all substantive comments were sent to appropriate governmental agencies, private organizations, and other inter ested persons. CEQ published a notice of availability for the final statement on September 6. 1974 (39 FR 32350). The submission of comment was Invited un til September 25, 1974. The final state ment and all significant comments have been carefully considered in arriving at the final standard on occupational expo sure to VC. (7) The record. The record hi this proceeding is one of the most exhaustive ever relied upon by OSHA. It consists of pro and post-hearing comments and testimony received at both factfinding and rulemaking hearings, the studies and inspections conducted by OSHA person nel, the environmental Impact state ments, the economic and technical Impact studies, and all other relevant Information. In all. over 600 written com ments have been received, with, more 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 feasibility--(1) Car cinogenicity of vinyl chloride. The car Industrial Bio-Test Laboratories investi gations is particularly pertinent. Of 200 mice (100 males, 100 females) exposed to 50 ppm of vinyl chloride by inhalation for eleven months, 100 died. Sixty-four ani mals died without gross postmortem pathologic examination being performed. Of the 36 remaining animals for which a gross postmortem pathologic examina tion was performed, 13 (36 percent) were found with liver tumors (including angiosarcomas), 21 (58 percent) with lung tumors, 9 (25 percent) with skin tumors, and one with a kidney tumor. According to the 1970 report by the Surgeon General's Ad-Hoc Committee on the Evaluation of Low Levels of En vironmental Chemical Carcinogens, the finding of cancer in two or more animal species may be extrapolated to Indicate a carcinogenic hazard to humans. Here, such 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 UF. 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-malignant 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 tories, Tabershaw-Cooper, Maltoni, sensitive as rodents, an "epidemic" of cancer resulting from VC exposures ' should have already been discovered among employees. They also argue that the employees In whom tumors have been observed are those who have considerable employment experience as polymeriza tion reactor cleaners. Because it Is gen erally agreed that reactor cleaning In volved high exposures to vinyl chloride in years past, it Is argued that the lower levels currently found in the workplace have not Induced cancer and are there fore safe. We reject this argument. The fact that approximately threequarters of those employees with the longest exposure to VC (greater than 20 years since initial exposure) have not yet been located, makes it Impossible to determine the actual number of affected employees. The cases of liver tumors ob served to date have an average latency period, since initial exposure, of approxi mately 20 years. If it Is assumed that in duction of angiosarcoma is a dose-re lated phenomenon, and if employees en gaged In cleaning reactors did, in fact, receive larger doses 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 s ~ 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 ployees may indicate an exposure thres cinogenicity of vinyl chloride for threo NIOSH, and Scllkoff.) hold for tumor Induction, based on varia animal species (rat, mouse, hamster) has (2) Exposure limits. Upon finding that tions in the workplace design or prac been documented on the record by the exposure of employees to vinyl chloride tice and resultant employee exposures FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY. OCTOBER 4, 1974 AP00024634 35892 GULES AND REGULATIONS (testimony and questioning by Tcnncco Chemicals, Inc.). It has also been em phasized that in only 3 of 0 polymeriza tion plants where employees have been exposed to VC for more than 20 years have any employees developed angiosar coma of the liver. This argument is very similar to that raised concerning vari ability of past employee exposure. Al though geographic and workpractlce dif ferences may ultimately be demonstrated to be factors In distribution of angiosar coma, sufficient information is unavail able to exclude from consideration of risk those employees In workplaces for which cases of angiosarcoma have not been observed. It has also been suggested that the absence of cancer in a population of 33S Dow Chemical Company polymerization employees monitored over a period of 7 years, indicates that exposure to vinyl chloride at concentrations of less than 200 ppm Is safe. (See study by Dr. Cook, submitted at the hearing by Dow Chem ical Company.) However, the group sur veyed did not Include all workers who had been exposed, and the missing em ployees Included many who had the longer term (over 20 years) exposures. Moreover, the statistically insignificant size of the sample population decreases the possibility that tumors would be observed. Dow also presented preliminary data In testimony at the hearing on the pos sible metabolic pathways of VC. The hypothesis presented was that VC may exert its carcinogenic effect by a metab olite, and that the metabolite is pro duced only when VC Is metabolized by a secondary metabolic pathway operating only when enzymes regulating the pri mary pathway are saturated, as would be the result at higher exposures. The preliminary data Indicated the possi bility of an additional pathway lor metabolism of VC In rats exposed to con centrations of VC in excess of 220 ppm. However, the occurrence of angio sarcoma In both rats and mice at VC exposure concentrations of 50 ppm In dicates that If a metabolite of VC is the Ultimate carcinogen, then it must be generated at lower exposure concentra tions in these species. Although this re search may be helpful to the thorough understanding of the 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, Tenneco Chemicals.) The conclusion of these Witnesses was that no decision can be made concerning risk of exposure to VC at concentrations less than 50 ppm. On the other hand, the testimony of most expert witnesses, including some in dustry biomedical experts, slated that quantification of a safe exposure con centration is not possible with the pres ent state of scientific knowledge. (See e.g., testimony of Selikaff, Firestone, Nd, - confident that industry will continue to and NIOSH.) do so. In our view, the demonstration of can (4) Conclusions. The conclusions be cer Induction in humans at a particular low are based on a thorough review and level is not a prerequisite to a determina evaluation of all the evidence submitted. tion that a substance represents a can Where decisions can be based on record cer hazard for humans at that level. It evidence, this has been done. Where, would be Imprudent to assume man to however, factual certainties axe lacking be less sensitive to VC exposure than ex or where the facts alone do not provide perimental animals in the absence of an answer, policy Judgments have been conclusive evidence. It would also be un made. founded to assume that animals will not There Is little dispute that VC Is car develop tumors when exposed at concen cinogenic to man and we so conclude. trations of VC of less than 50 ppm. However, the precise level of exposure Should a sufficiently large number of ex which poses a hhzard and the question perimental animals be exposed to VC at of whether a "safe" exposure level exists, concentrations of less than 50 ppm, cannot be definitively answered on the Schneiderman said that it would be ex record. Nor Is it clear to what extent pected that some would develop VC In exposures can be feasibly reduced. We duced tumors. cannot wait until Indisputable answers (3) Feasibility. There is virtually no to these questions are available, because dispute that most, if not all, fabricators lives of employees are at stake. There are currently capable of reaching ex fore, we have .had to exercise our best posure levels of 1 ppm through engineer judgment on the basis of the best avail ing controls. These employers employ able evidence. These Judgments have re well over 95 percent of all employees ex quired a balancing process, in which the posed to VC. Indeed, several fabricators overriding consideration has been the are already operating at this level (see protection of employees, even those who SPI testimony). However, Industry may have regular exposures to VC spokesmen have universally claimed that throughout their working lives. it Is Infeasible for the VC and the PVC Based on the available evidence and in industries to remain below 1 ppm con view of the above considerations, includ sistently, using engineering controls. In ing feasibility, we believe that employee addition, the Snell study on technical exposures to VC must be reduced to a 1 feasibility concluded that a 1 ppm ceil ppm time-weighted average (TWA). We ing Is not feasible for the VC and PVC also believe that PVC and VC establish Industries with present technology, but ments will. In time, be able to attain that that the VC Industry could currently at level through engineering controls, and tain lower exposure levels than the PVC that fabricators can do so In the Im industry. Labor union spokesmen and the mediate future. Health Research Croup. Inc., however, In addition to the TWA requirement, have suggested that such a level Is at we have established a 5 ppm ceiling tainable. (averaged over a 15-minute period) In Since there Is no actual evidence that order to prevent exposure of employees any of the VC or PVC manufacturers to unacceptable high excursions. From have already attained a 1 ppm level or In an operation standpoint, this ceiling fact Instituted all available engineering level Is realistic because minor excur and work practice controls, any estimate sions up to the ceiling level are likely to as to the lowest feasible level attainable occur on a regular basis. must necessarily involve subjective Judg m. The final standard--(1) Scope and ment. Likewise, the projections of indus application. Both the ETS and the pro try, labor, and others concerning feasi posal would apply the standard to the bility are essentially conjectural. Indeed, entire VC Industry, including manufac as Firestone has suggested, it is not pos turers of VC and PVC and fabricators, sible to accurately predict the degree of but excluding employers handling or Improvement to be obtained from en using fabricated products made from gineering changes until such changes are VC. actually implemented. There is no dispute that a standard is We agree that the PVC and VC estab required for the monomer and polymer lishments will not be able to attain a 1 industries. However, the Society of Plas- ppm TWA level for all job classifications tics Industry (SPI) and various fabricsIn tiie near future. We do believe, how tors (see testimony of Goodyear. Gen- ever. that they will, to time, be able to attain levels of l 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 proposed celling level. The record evidence establishes that at least some employees in the fabrlcating industry are exposed in excess of the strides in reducing exposure levels. (See permissible control limits (See NIOSH testimony of Dow Chemical Co., TR 973). testimony. TR 106; Robintech TR 612). For example. B. F. Goodrich testified In these circumstances, we believe that It <TR 1120) that It has reduced average Is imprudent to grant a blanket exemp- exposure levels in several FVC plants tlon for all fabricators. Therefore, the from 35-40 ppm early this year to 12-13 final standard Is applicable to thefabri- ppm at the time of the hearing. We are cation Industry, as well as the monomer i ! j | , 1 I ' i ( } S , | | ; i ; i 1 . i ; jj FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 | AP00024635 RULES AND REGULATIONS 35893 and polymer industries. Employers who. In fact, are substantially below the exposure limit will be subjected, to only minimal burdens by virtue of the "action level" to be discussed below. Where employers In the fabricating Industry have exposures approaching the permissible limit, they will appropriately be subject to the standard. Employers handling or using fabricated products made of PVC were not included In the ETS or the proposal and are excluded from the final standard. This conclusion is based on the absence of adequate evi dence of exposure to VC in these opera tions. The final standard clarifies the ex emption by defining a fabricated prod uct as a product made wholly or partly from PVC which does not require further processing at temperatures, and for times, sufficient to cause mass melting of the PVC. SPI and others (cf. TR. 344) requested that PVC resins with less than 0.1 percent residual monomer be ex empted from the regulation now. and that the exemption level be reduced to 0.01 percent In three years. SPI suggested that the exemption of materials with less than o.l 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 moni toring 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 of resins with specific levels. Indeed, the proposal to change the level later, when improved technology would permit such reduction, would seem to indicate that SPI has doubts about the safety of 0.1 percent residue level. Diamond Shamrock. (Exhibit 142) testified that there is no direct relation. They indicate that the airborne concentration Is more related to the physical form of the resin and the ventilation provided. Also, monitor ing data from industry (cf. Exhibits 131, 168. 170) and OSHA (Exhibit 151) indi cate that levels in excess of 1 ppm may be found In fabrication operations. In view of these facts and of the opportunity for employers to discontinue many duties upon a showing of no exposures above the action level, it does not appear that any residue exemption is either justified or necessary at this time. This course also agrees with a number of industry pro posals (cf. TR 660). SPI (TR 345). among others, asked first 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 have a lower residue level than virgin PVC. the fact that the pellets must be heated to a molten mass at the same temperature as PVC, for further pro- below the action level, no further monl- cossing, indicates that a potential for re- toring Is required unless the employer lease of the residue stlil exists. It ap- has reason to suspect that any employee pears that the exemption of fabricated is exposed in excess of the action level, products should be limited to just those or unless changes have been made in items which will not undergo such mass production, process, control, type of resin, heating. Further, the opportunity to etc. demonstrate that exposures are below Where the exposure level, without re- the action level, and thus, discontinue gard to respirators, exceeds the pennis- many duties of the standard, provides a sible levels, monitoring must be conduc- more positive control and an adequate ted at least monthly. Where exposures relief. are less than the permissible levels, but (2) Permissible exposure limit. The greater than the action level, monitoring standard sets an exposure limit of 1 ppm must occur at least quarterly, averaged over any 8 hour period, and a (5) Methods of compliance. The stand- ceiling of 5 ppm averaged over any per- ard, like the proposal, requires that em- iod not exceeding 15 minutes. ployers immediately institute feasible As more fully discussed above, this engineering arid work practice controls limit Is based on an evaluation of the best to reduce exposures to at or below the available evidence and on a judgment permissible exposure limit, that the health and safety of employees where feasible engineering and work must be protected to the fullest extent practice controls will reduce exposures feasible. In view of the fact that release below the permissible levels, they must of VC in the VC and PVC manufacturing be instituted. Where such controls will processes are variable, the 1 ppm ceiling not reduce exposures below the permis- level provided in the proposal would sible level, they must nonetheless be im- require maintenance of an average level piemented to reduce exposures to the significantly more difficult to attain lowest practicable level, and be supplethrough feasible engineering controls, mented by the use of respirators to pro- Therefore, the exposure limit prescribed vide the necessary protection. There in the proposal has been rejected. upon, a continuing program of englneer- (3) Action level. The final standard, ing and work practice controis must be unlike the ETS and the proposal, pro- instituted to reduce exposures to the low- vides for an "action level" of 0.5 ppm e$t practicable level. When exposures are TWA, one-half of the permissible ex- at or below the permissible exposure posure limit. The purpose of the action limits, the program may be discontinued, level Is to minimize the impact of the in addition, a plan for achieving con- standard on the employers who have trol by engineering and work practice attained exposure levels well below the methods must be drawn up and be made permissible limit. Thus, where the re- available, upon request, to represent- sults' of monitoring under paragraphs atives of OSHA and NIOSH. (d)(1) or (d)(2) demonstrate that no We recognize that many employers employee is exposed in excess of 0.5 covered by the standard can not curppm TWA, employers may, in effect, be rently achieve compliance with the per- exempted from some provisions of the missible exposure limit solely by the use standard. For example, fabricators who of feasible engineering and work practice are below the action level are not re- controls. The record also reflect* broad quired `o provide medical surveillance or generic distinctions between the compli- to monitor again, unless the employer .ance capabilities of the VC and PVC has reason to suspect that any employee industries. Some industry spokesmen, Is exposed in excess of the action level, including SPI (TR. 358-362), recom- In our judgment, exposures below the mended that a schedule of different per- action level do not present a sufficient missile exposure limits and compliance hazard to warrant application of the'en- dates be established for the VC and PVC tire standard to the many employers who segments of the industry, are or will be below that level. This view assumes that the ability and (4) Monitoring. The final standard, the time required to feasibly reach in like the proposal, requires that individual, creasingly lower control levels Is similar employee exposure levels be determined." within each industry, but differs markThis may be accomplished by personal edly between industries. While the record or area monitoring. Some witnesses and does suggest that such differences do persons who submitted comments did exist between industries, as noted above, not understand the meaning of the term it is clear that intra-industry differences "95 percent confidence level" in the also exist. Thus, the ability and time re proposal. Essentially It means that the quired by each employer to attain lower employer is required to take a sufficient control levels may depend upon such number of measurements so that the re- factors as the climate in which the plant suits obtained are statistically valid. We is located, the age of equipment, the size have modified the proposal to establish of reactors, or the type of resin manu- accuracy range requirements for various factored or used. (Snell study, Firestone measurement levels. These ranges are testimony, etc.) narrow enough to ensure that a deter- Monitoring data also tends to support mination of compliance can be made, and such intra-industry variations. (See, broad enough to allow the application e.g. Dow, Firestone. Tenneco.) of a variety of technologies'. As noted above, the standard requires All covered employers are required to all employers to Institute feasible engi- conduct initial monitoring. Where monl- neering controls to the fullest extent and toring and measuring results are at or to continue to improve and apply engi- FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 19X4 AP00024636 35894 RULES AND REGULATIONS peering controls until full compliance Is if the environmental level is not con trations. In discussions of these findings achieved. trolled to the permissible exposure limit, with NIOSH, it has Indicated that it is we have not established any deadlines then employees must bo afforded respira willing to consider on an expedited basis for full compliance through engineering tory protection. the approval of air-purifying respirators controls because we are presently unable While exposures In excess of the per for use against VC. Consequently, wc to determine when it will be feasible for missible level do constitute a hazard, we have included three types of air-purify- most establishments to reduce exposure believe that It Is necessary to mitigate lng respirators in the list of acceptable levels to tire permissible level. some of the problems associated with units, subject to the approval of such We also believe that the requirement implementing a program of respiratory units by NIOSH. Tlie maximum concen that each employer reduce airborne con protection while employees are being tration for which each respirator may centrations to the permissible level, or fitted and trained in respirator use, and be used is based upon our evaluation to the lowest level feasible as soon as while other adjustments which may be of the data submitted by NIOSH and practicable will provide for inter-indus required are Implemented. Therefore, Goodrich. Because air-purifying respi try and intra-industry technological dif until January 1, 1976, where exposures rators do not indicate sorbent exhaustion ferences which do exist, and will avoid are not in excess of a 25 ppm ceiling, or breakthrough of VC, and because VC the setting of separate industry stand each employer must provide each em has no inherent warning properties at ards on the basis of the general situation ployee with an appropriate respirator. levels for which these devices are used, and conditions in each industry. However, employees whose exposures do strict administrative controls will bo re (6) Kegulated areas. The proposed not exceed a 25 ppm ceiling, may dceline quired for their use. Such controls in standard would have required that regu to use the respirator, In which case the clude a program to assure timely re lated areas be established, that access be employer Is not obligated to require Its placement of canisters or cartridges and limited to authorized employees, and use. During this adjustment period, em an alarm system to alert employees when that daily rosters or summaries of those ployees will be trained in the uses, pur vinyl chloride concentrations exceed the entering be kept for at least 20 years. In poses and limitations of respirators, and concentrations allowed for the particu objection to these requirements, it was asserted that such control of access was not necessary from a health standpoint. Secondly, It was claimed that these con 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. lar type of respirator In use. (8) Hazardous operations. This is a new section within the final standard. It encompasses essentially the proposal's 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 Where exposures exceed a 25 ppm cell ing, respiratory protection is mandatory in light of our judgment that much greater risks are associated with such exposures. 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 areas in the proposal was to limit the The provisions in the final standard new section is to protect employees en risk of exposure to as few employees as regarding the selection and use of respi gaged in activities that present a risk of possible. This concern is still paramount, ratory protective devices differ from exposure to vinyl chloride in excess of the and thus the limited access feature re those in the proposal. The descriptions of permissible levels. An example would be mains. The final standard amends the atmosphere-supplying respirators have the cleaning of a filter where resin con proposal slightly to allow "authorized persons" to enter regulated areas. This change, it Is felt, will allow operations to continue without undue Interference. 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 taining high residual monomer is trapped. The proposal's requirement for full- body, impervious clothing has been re The final standard has also increased the types of atmosphere-supplying devices placed by the direction to use impervious length of time daily rosters must be has been increased. garments suited to the particular situa maintained from 20 to 30 years. This At the hearing Mr. Edwin C. Hyatt, an tion and probable extent of exposure. change was based largely on epidemio OSHA consultant, made suggestions re Thus, full-body clothing is not always logical considerations. (See NIOSH testi garding the use of particular respiratory necessary, and is therefore not required mony, tr. 119.) devices. We have concluded that his sug where less protection is adequate. Since (7) Respiratory protection.The final gestions arc meritorious. Therefore, the vessel entry falls within the definition standard, like the proposal, requires the provisions for selection of atmosphere- of a hazardous operation, the vessel entry use of respirators where employee expo supplying devices follow closely the rec section of the proposal has been deleted sures exceed the permissible control level. ommendations contained in his testi from the final standard. Industry representatives made a number mony of SPI and B. P. Goodrich) (TR (9) Emergency situations. Tile defini of objections to proposed requirements with Hyatt's suggestions. (See e.g. testi tion of emergency has been recast In for respiratory protection. They stated mony of SPI and B. P. Goodrich). (TR terms of an unexpected massive release. that the "no detectable level" would ef B5 ff) We had originally omitted air- The main objection to the section on fectively require continuous wearing of purifying respirators because none had emergency situations in the proposal was respirators in. PVC and VC plants, and been approved by NIOSH for use against that, as the term was defined, many that this is not feasible because respira VC, principally because they lacked in ordinary leaks or operations resulting in tors are cumbersome, present a safety 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 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 a small release of vinyl chloride would bo 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. only occassionally. However, we cannot commercially available canisters and (10) Signs and labels. The thrust of the agree that respiratory protection should cartridges for vinyl chloride. These eval signs and labels section is to apprise not be required simply because it is in convenient, may require additional per sonnel, interferes with production, or may require extensive retraining of em ployees and restructuring of work prac uations were conducted separately by NIOSH and by tire B. F. Goodrich Com pany and submitted to OSHA in post hearing comments. The results indicate that certain presently available canis 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 tices. We have carefully considered all ters and cartridges effectively absorb ment that the word "cancer" appear on the objections, and have concluded that vinyl chloride at relatively low concen all signs and labels. The principal argu- FEDERAL REGISTER. VOt. 39, NO. 194--FRIDAY, OCTOBER 4, 1974 i7. AP00024637 RULES AND REGULATIONS 35895 ment advanced against Its use was that Indicated that the medical tests proposed posal is the requirement for maintenance the term "cancer" or "cancer-suspect are currently the only ones available of monitoring records and daily roster agent" scares employees and that in which are useful for medical surveillance sheets of authorized persons for 30 years, stead, the message should contain In (TR 121, Exh. 95. TR 589-591). Conse Instead of 20 years. Additionally, the em structions on how to deal with the sub quently, tile specific blood tests proposed ployer is required to maintain medical stance (TR. 347). We believe that a have been retained as a minimum re records for the duration of an employee's diluted form of warning will not suffice. quirement to assist the examining physi employment plus 20 years, or 30 years, We appreciate the concern of employers cian in determining fitness of potential whichever is longer. The original pro with the reaction of tlielr employees. But employees for assignment to workplaces posal called for only zo years. 1 we consider it imperative that a worker Involving VC exposure. In addition, al This change has been implemented be be fully informed, and that he realize the ternative medical examinations may be cause the latency period for induction of -- possible risks involved in his occupation. used where the examining physician de angiosarcoma ranges up to 30 years from Coupled with the training requirement termines that they are at least as good initial exposure. Therefore, as a mini in the standard, we believe that the signs as those specified by the standard. mum. medical records must be main and labels required will adequately In The Tabershaw-Cooper study and the tained for at leait that long. It should be form employees of the hazard. In addi various animal experiments suggest that noted that spokesmen for both labor and tion, such signs will warn unauthorized VC may produce a wide spectrum of ma industry recommended that tills change personnel to keep out of regulated areas. lignant and non-malignant disorders. be made. The proper application of most protec The general scope of the required medical The reporting requirements are not tive measures requires an amount of examination has, therefore, been broad significantly different from those In the training and indoctrination of employees ened to include kidneys, skin, connective original proposal. However, instead of that cannot easily be conveyed on a sign tissue, spleen, and pulmonary system, as the requirement for reporting incidents or label. Also, the variety of measures well as the liver. No additional specific which result in the release of VC into that could be prescribed would result in procedures or tests are required, but rec areas where employees may be exposed, an unwieldly or excessively detailed leg ommendations have been included In the the final standard clarifies our original end. Consequently, the required message Appendix to assist the examining physi intent by stating that only emergencies on signs and labels will not include In cian. Because of the nonspecific nature must be reported. Also the requirement formation on precautions, relevant of the required medical tests, it is not for filing a detailed, written report symptoms, etc. The addition of suitable appropriate to prescribe timing, or type within 15 days has been deleted. It has information by the employer would be of followup tests, or to mandate with been concluded that submission, within permitted, providing it does not detract drawal from exposure based solely on re 24 hours, of an initial report that in in any way from the required statement. sults of the tests. Instead, the employer cludes facts immediately available, would Tire requirement In the proposal for is required to obtain a statement from ordinarily be sufficient. However, if the labeling containers of vinyl chloride has the examining physician of the em OSIIA Area Director requests further in been amended by deleting the reference to the possible hazard of violent polym erization. Very little Information was developed on this hazard during the ployee's suitability for continued expo sure. when the examining physician has completed such, tests as he considers ap propriate. Tire employer is required to formation relevant to the emergency, the employer will be required to furnish such information. (14) Deleted portions of the proposal. 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 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 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 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. 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 they are no longer necessary. Showering facilities are not required because pro tective clothing, where required by the final standard, should protect employees from skin absorption by direct contact with VC and because there is no reliable (11) Medical surveillance. The princi affected employees will provide baseline evidence that VC vapor is absorbed pal questions that have been raised re data lor future evaluation of their health, through the skin. In addition, since we garding medical surveillance are the even if both monitoring and medical sur anticipate that most employees will not necessity and efficacy of requiring cer veillance are discontinued because im be wearing protective clothing and that tain specific serum enzyme determina proved controls reduce concentrations employees who wear protective clothing tions (SMA-12 series) and the applica below the action level. Where exposures will change such clothing infrequently, tion of medical examination require are below the action level, the medical we are not requiring that change rooms ments to the fabrication segments of the surveillance requirements do not general be provided. industry where employees are exposed to ly apply. In addition, we feel that there is in lower levels of VC. The objection has also (12) Training. A separate provision for adequate evidence showing that hazar been raised that the specification of tests employee training has been added to the dous amounts of VC can be absorbed and procedures interferes with the ap final standard rather than Including It through ingestion. For this reason, the plication of advances in medical knowl Within the section on emergency situa requirement prohibiting the storage or edge. tions as in the proposal. The new para consumption of food in regulated areas A particular difficulty in considering graph provides for training of employees has been deleted. 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 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 The proposal also contained provisions on maintentsmee 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 tic tests which can be prescribed which final standard require the preparation level. will determine presence or absence of and maintenance of essentially the same (15) Effective date. In order to ensure this tumor at an early stage of develop information required by the proposaL that affected employers and employees ment. However, most medical witnesses The major change from the original pro will be Informed of the existence of these FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 19M AP00024638 35896 RULES AND REGULATIONS provisions and that employers affected of the operation or bceause of an acci opportunity to observe the monitor are given an opportunity to familiarize dent In the operation, which would result ing and measuring required by tills themselves and their employees with the In an employee exposure In excess of the paragraph. existence of the new requirements, the permissible exposure limit. <e) Regulated area. (1) A regulated effective date of the amendment to (8) "OSHA Area Director" means the area shall be established where: { 1910.93q will be January 1, 1875. To pro Director for the Occupational Safety (1) Vinyl chloride or polyvinyl chloride vide continued protection for employees and Health Administration Area Office Is manufactured, reacted, repackaged, until that date, the provisions currently having jurisdiction over the geographic stored, handled or used; and contained in J I910.93q are hereby area in which the employer's establish (11) Vinyl chloride concentrations are promulgated, pursuant to section 6(b), ment is located. In excess of the permissible exposure 6<c) and 8(c) of the Occupational Safety (9) "Polyvinyl chloride" means poly limit. and Health Act, as an occupational vinyl chloride homopolymer or copoly (2) Access to regulated areas shall be safety and health standard effective mer before such is converted to a fabri limited to authorized persons. A dally October 4, 1974, the amendment to cated product roster shall be made of authorized per i 1910.93q set out below will supersede (10) "Vinyl chloride" means vinyl sons who enter. these provisions as of January l, 1975. chloride monomer. (f) Methods of compliance. Employee Accordingly, upon consideration of the (c) Permissible exposure limit. (1) No exposures to vinyl chloride shall be con whole record of this preceding. Part 1910 employee may be exposed to vinyl chlo trolled to at or below the permissible ex of Title 29, Code of Federal Regulations ride at concentrations greater than 1 ppm posure limit provided In paragraph (c) Is amended, effective January 1,1975, by averaged over any 8-hour period, and of this section by engineering, work prac revision of 51910.93q to read as follows: (2) No employee may be exposed to tice, and personal protective controls as 1910.93q Vinyl chloride. vinyl chloride at concentrations greater follows: than 5 ppm averaged over any period not (1) Feasible engineering and work (a) Scape and application. (1) Hils exceeding 15 minutes. practice controls shall Immediately be section Includes requirements for the (3) No employee may be exposed to used to reduce exposures to at or below control of employee exposure to vinyl vinyl chloride by direct contact with the permissible exposure limit. chloride (chloroethene). Chemical Ab liquid vinyl chloride. (2) Wherever feasible engineering and stracts Service Registry No. 76015. (d) Monitoring. (1) A program of work practice controls which can be In (2) This section applies to the manu initial monitoring and measurement stituted Immediately are not sufficient to facture. reaction, packaging, repackag shall be undertaken In each establish reduce exposures to at or below the per ing, storage, handling or use of vinyl ment to determine if there Is any em missible exposure limit, they shall none chloride or polyvinyl chloride, but does ployee exposed, without regard to the use theless be used to reduce exposures to not apply to the handling or use of fabri of respirators. In excess of the action the lowest practicable level, and shall be cated products made of polyvinyl chlo leveL supplemented by respiratory protection ride. (2) Where a determination conducted in accordance with paragraph (g) of this (3) This section applies to the trans under paragraph (d)(1) of this section section. A program shall be established portation of vinyl chloride or polyvinyl shows any employee exposures, without and implemented to reduce exposures to chloride except to the extent that the regard to the use of respirators. In ex at or below the permissible exposure Department of Transportation may cess of the action level, a program for de limit, or to the greatest extent feasible, regulate the hazards covered by this sec termining exposures for each such em solely by means of engineering and work tion. ployee shall be established. Such a pro practice controls, as soon as feasible. Definitions. (1) "Action level" gram: (3) Written plans for such a program means a concentration of vinyl chloride (1) Shall be repeated at least monthly shall be developed and furnished upon of 0.5 ppm averaged over an 8-hour work where any employee Is exposed, without request for examination and copying to day. regard to the use of respirators, in ex authorized representatives of the Assis (2) "Assistant Secretary" means the cess of the permissible exposure limit. tant Secretary and the Director. Such 'Assistant Secretary of Labor for Occupa (11) Shall be repeated not less than plans shall be updated at least every six tional Safety and Health, U.S. Depart quarterly where any employee Is exposed, months. ment of Labor, or his designee. without regard to the use of respirators. (g) Respiratorg protection. Where (3) "Authorized person" means any In excess of the action level. respiratory protection Is required under person specifically authorized by the em (ill) May be discontinued for any em this section: ployer whose duties require him to enter ployee only when at least two consecu (1) The employer shall provide a a regulated area or any person entering tive monitoring determinations, made not respirator which meets the requirements such an area as a designated representa less than 5 working days apart, show ex of this paragraph and shall assure that tive of employees for the purpose of ex posures for that employee at or below the employee uses such respirator, except ercising an opportunity to observe moni the action leveL that until December 31,1975, wearing of toring and measuring procedures. (3) Whenever there has been a pro respirators shall be at the discretion oi (4) "Director" means the Director, duction, process or control change which each employee for exposures not In ex National Institute for Occupational may result In an increase in the release cess of 25 ppm, measured over any 15- Safety and Health, UJS. Department of of vinyl chloride, or the employer has minute period. Until December 31, 1975, Health, Education, and Welfare, or his any other reason to suspect that any em each employee who chooses not to wear designee. ployee may be exposed In excess of the an appropriate respirator shall be In (5) "Emergency" means any occur action level, a determination of employee formed at least quarterly of the hazards rence such as, but not limited to, equip exposure under paragraph (d) (1) of Oils of vinyl chloride and the purpose, proper ment failure, or operation of a relief de section shall be performed. use, and limitations of respiratory vice which Is likely to, or does, result In (4) The method of monitoring and devices. massive release of vinyl chloride. measurement shall have an accuracy (2) Respirators shall be selected from (6) "Fabricated product" means a (with a confidence level of 95 percent) of among those Jointly approved by the product made wholly or partly from not less than plus or minus 50 percent Kilning Enforcement and Safety Admin polyvinyl chloride, and which does not from 0.25 through 0.5 ppm, plus or minus istration, Department of the Interior, require further processing at tempera 35 percent from over 0.5 ppm through and the National Institute for Occupa tures, and for times, sufficient to cause 1.0 ppm, and plus or minus 25 percent tional Safety and Health under the pro mass melting of the polyvinyl chloride over 1.0 ppm. (Methods meeting these visions of 30 CFR Part 11. resulting in the release of vinyl chloride. accuracy requirements are available In (3) A respiratory protection program (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 the "NIOSH Manual of Analytical Methods"). (5) Employees or their designated rep resentatives shall be afforded reasonable meeting the requirements of S 1910.134 shall be established and maintained. (4) Selection of respirators for vinyl chloride shall be as follows: FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1924 AP00024639 3 CifrY i i / f T ':vi i J`ft i su er. 31 - r-i- ii m 131 inyl RULES AND REGULATIONS 35897 Atmospheric concentration of vinyl chloride .Required apparatus (vi) The purpose for. and a descrip tion of, the medical surveillance (I) Unknown, or above 3.600 ppm__ Open-circuit, self-contained breathing apparatus, pres, program; sure demand type, with full facepiece. (II) Not over 3.000 ppm.--______ (A) Combination type C supplied atr respirator, pres <vii> Emergency procedures; (vlii) Specific Information to aid the sure demand type, with full or half facepiece, employee In recognition of conditions and auxiliary self-contained air supply; or which may result in the release of vinyl (B) Type O, supplied air respirator continuous flow chloride: and ` (111) Not over 100 ppm__ (It) Not over 35 ppm. typo, with full or half facepiece, and auxiliary self-contained air supply. (A) Combination type O supplied air respirator de mand type, with full facepiece, and auxiliary self-contained air supply; or (B) open-circuit scir-contalned breathing apparatus with full facepiece. In demand mode; or (C) Type O supplied air respirator, demand type, with full facepiece. (A) A powered alr-purifytng respirator with hood. helmet, full or half facepiece, and a canister which provides a service life of at least 4 (lx) A review of this standard at the employee's first training and Indoctrina tion program, and annually thereafter. (2) All materials relating to the pro gram shall be provided upon request to the Assistant Secretary and the Director. (k) Medical surveillance. A program of medical surveillance shall be Insti tuted for each employee exposed, with out regard to the use of respirators, to vinyl chloride in excess of the action hours for concenratlons of vinyl chloride up level. The program shall provide each to 25 ppm. or such employee with an opportunity for (B) Gas mask, front- or back-mounted canister which examinations and tests In accordance provides a service life of at least 4 hours for with this paragraph. All medical ex concentrations of vinyl chloride up to 25 ppm. aminations and procedures shall be per (v) Not over 10 ppm.. (A) Combination typo C supplied-alr respirator, de formed by or under the supervision of ft mand type, with half facepiece, and auxiliary self-contained air supply; or (B) Type C supplied-alr respirator, demand type, with half facepiece; or (C) Any chemical cartridge respirator with an organic vapor cartridge which provides a service life of at least 1 hour lor concentrations of vinyl chloride up to 10 ppm. . licensed physician, and shall be provided without cost to the employee. "'4^. (l) At the time of Initial assignment, x 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 (5) (1) Entry into unkown concentra (2) Protective garments shall be pro organs, and for abnormalties In skin, tions or concentrations greater than vided clean and dry for each use. connective tissues and the pulmonary 38,000 ppm (lower explosive limit) may (1) Emergency situations. A written system (See Appendix A). be made only for purposes of life rescue; operational plan for emergency situa (II) A medical history shall be taken, and tions shall be developed for each facility including the following topics: Ui) Entry into concentrations of less storing, handling, or otherwise using (A) Alcohol intake; than 38,000 ppm. but greater than 3,600 .vinyl chloride as a liquid or compressed (B) Past history of hepatitis: ppm may be made only for purposes of gas. Appropriate portions of the plan (C) Work history and past exposure life rescue, firefighting, or securing shall be Implemented In the event of an to potential hepatotoxlc agents, Includ equipment so as to prevent a greater emergency. The plan shall specifically ing drugs and chemicals; hazard from release of vinyl chloride. provide that: (D) Past history of blood transfu (6) Where air-purlfylng respirators (1) Employees engaged in hazardous sions; and are used: operations or correcting situations of ex (E) Past history of hospitalizations. (1) Air-purlfylng cannisters or car isting hazardous releases shall be (III) A serum specimen shall he ob tridges shall be replaced prior to the equipped as required in paragraph (h) tained and determinations made of; expiration of their service life or the of this section; (A) Total bilirubin; end of the shift in which they are first (2) Other employees not so equipped (B) Alkaline phosphatase; used, whichever occurs first, and (il) A continuous monitoring and alarm system shall be provided where concentrations of vinyl chloride could reasonably exceed the allowable concen trations lor 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 shall evacuate the area and cot return until conditions are controlled by the methods required in paragraph (f) of this section and the emergency is abated. 0) 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: (1) The nature of the health hazard from chronic exposure to vinyl chloride including specifically the carcinogenic hazard; (U) The specific nature of operations (C) Serum glutamic oxalacetlc trans aminase (SGOT); CD) Serum glutamic pyruvic transam inase (SGPT); and (E) Gamma elustamyl transpcptldase. (2) Examinations provided in accord ance with this paragraph shall be per formed at least: (1) Every 6 months for each employee who has been employed In vinyl chlo ride or polyvinyl chloride manufacturing for 10 years or longer; and (il) Annually for all other employees. (3) Each employee exposed to an emergency shall be afforded appropriate medical surveillance. vinyl chloride residue from vessel walls, which could result in exposure to vinyl (4) A statement of each employee's shall be provided and required to wear and use; chloride in excess of the permissible limit and necessary protective steps; suitability for continued exposure to vinyl chloride Including use of protec (I) Respiratory protection in accord (U) The purpose for, proper use, and tive equipment and respirators, shall be ance with paragraphs (c) and (g) of limitations- of respiratory protective obtained from the examining physician 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 devices: (lv) The fire hazard and acute toxic ity of vinyl chloride, and the necessary protective steps; promptly after any examination. A copy of the physician's statement shall be pro vided each employee. (5) If any employee's health would be shall be selected lor the operation and (r) The puipose for and a description materially Impaired by continued ex its possible exposure conditions. of the monitoring program; posure, such employee shall be wlth.- RDE3AL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 19X4 AP00024640 35898 RULES AND REGULATIONS drawn from possible contact with vinyl tion. which contradicts or detracts from til) The number of employees in each chloride. the effect of, any required warning, regulated area during normal operations. ($> Laboratory analyses for all bio information or instruction. Including maintenance. logical specimens Included in medical (m) Accords. (1) All records main (2) Emergencies, and the facts ob examinations shall be performed in labo tained in accordance with this section tainable at that time, shall be reported ratories licensed under 42 CFR Tart 74. shall Include the name and social secu within 24 hours to the OSHA Area Di (7) If the examining physician deter rity number of each employee where rector. Upon request of the Area Direc mines that alternative medical examina relevant. tor, the employer shall submit additional tions to those required by paragraph (2) Records of required monitoring information In writing relevant to the (kXl) of this section will provide at and measuring, medical records, and au nature and extent of employee exposures least equal assurance of detecting med thorized personnel rosters, shall be made and measures taken to prevent future ical conditions pertinent to the exposure and shall be available upon request for emergencies of similar nature. to vinyl chloride, the employer may ac examination and copying to authorized <3) Within 10 working days following cept such alternative examinations as representatives of the Assistant Secre any monitoring and measuring which meeting the requirements of paragraph tary and the Director. discloses that any employee has been (k)(l) of this section, if the employer Monitoring and measuring records exposed, without regard to the use of obtains a statement from the examining shall: respirators in excess of the permissible physician setting forth the alternative examinations and the rationale for sub stitution. This statement shall be avail able upon request for examination and (A) State the date of such monitor ing and measuring and the concentra tions determined and identify the instru ments and methods used; exposure limit, each such employee shall be notified in writing of the results of the exposure measurement and the steps copying to authorized representatives of (B) Include any additional informa being taken to reduce the exposure to the Assistant Secretary and the Director, tion necessary to determine Individual within the permissible exposure limit. (1) Signs and labels. (1) Entrances to regulated areas shall be posted with leg ible signs bearing the legend: Cancer-Suspect Agent Axes Authorized Personnel Onlt employee exposures where such expo sures are determined by means other than individual monitoring of employees; and (C) Be maintained for not less than (o) Effective dates. (1) Until Janu ary l, 1975, the provisions currently set forth, in { 1910.93q of this Part shall apply. (2) . Areas containing hazardous oper ations or where an emergency currently exists shall be posted with legible signs bearing the legend: 30 years. 01) 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 This Aria Pkotcc- ment of each employee plus 20 years, txvs Equipment Personnel only Requires Authorises 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 vrith vinyl chloride shall ords for the prescribed period, these rec be legibly labeled: ords shall be transmitted by registered (2) Effective January 1,1975, the pro visions set forth In { 1910.93q of this Part shall apply. Appendix A--Supplementa*t Medical iKTOaMAXXON When required teste under paragraph (le)(l) of this section Show abnormalities, the tests mould be repeated as soon aa prac ticable, preferably within 3 to 4 weeks. If tests remain abnormal, consideration should be given to withdrawal of the employee from contact with vinyl chloride, while a more Contaminated with Vinyl Chloride Cakceb-Suspsct Agent (4) Containers of polyvinyl chloride shall be legibly labeled: . FOLTVIHTL CHLORIDE (OS TRADE NaHX) mall to the Director, and each employee Individually notified in writing of this transfer. (4) Employees or their designated representatives shall be provided access to examine and copy records of required comprehensive examination is made. Additional tests which may be useful: ` A. For kidney dysfunction: urine examina tion for albumin, red blood cells, and ex- follatlie abnormal calls. B. Pulmonary system: Forced vital capac ity. Forced expiratory volume at 1 second, Contains Vinyl CKi.or.rcE monitoring and measuring. and chest roentgenogram (posterior-anterior, (8) Former employees shall be pro 14 x 17 Inches). Vinyl Chloride is a Cancer-Suspect Agent <5> Containers of vinyl chloride shall be legibly labeled either: (i) Vinyl Chloride Extremely Flammable Oas Under Pxessure Cancer-Suspdct Agent or (il) In accordance with 48 CFR Part 173, Subpart H. with the additional vided access to examine and copy re quired monitoring and measuring records reflecting their own exposures. (6) Upon written request of any em ployee, a copy of the medical record of that employee shall be furnished to any physician designated by the employee. (n) Reports. (1) Not later than 1 month after the establishment of a reg ulated area, the following information C. Additional serum tests: Lactic acid de hydrogenase, lactic arid dehydrogenase isoenzyme, protein determination, and protein electrophoresis. D. For a more comprehensive examination on repeated abnormal serum tuts: Hepatitis B antigen, and liver scanning. (Secs. 8 and 8, *4 Seat. 1598, 1539 (29 TJS.C. ess. 657); Secretary of Labor'a Order No. 12-71.38 FB 8754) legends: shall be reported to the OSHA Area Di Signed at Washington, D.C.. this 1st Cancer-Suspect Agent applied near the labor or placard. (6). No statement shall appear on or near any required sigh, label or lnstruc- rector. Any changes to such information shall be reported within IS days. (1) The address and location of each, establishment which has one or more regulated areas; and day of October, 1974. John Stender. Assistant Secretary of Labor. [FE Doc.74-23178 Filed 10-1-74,'3:64 pm] l1 f RDERAl 3EOISTE*. VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 - i. 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