Document 8297DZLMDRq1EELMv762x5wY5

35890 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, 1599; 29 U.8.C. 655, 657) Secretary of Labor's Order No. 12-71 (36 FR 8754) and 29 CFR Part 1911, { 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. L 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 - <FVC), 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. ' * TVC Is fabricated by a variety of tech. rdques, including extension, 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 ;Vd9nns range in size from those with few j-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 ceiling 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 (OSBA) 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 ployees from a rare liver cancer (angio and abroad, OSHA proposed to revise sarcoma) may have been occupationally 1910.93q and published a comprehensive related. As a result of this notification proposal (39 FR 1G39G) on May 10, 1974, and after consultation with NIOSH. and to protect employees from hazards of a joint inspection of the B. F. Goodrich exposure to VC. The proposal called for plant by OSHA, NIOSH and the Ken limitation of employee exposure to VC to tucky Department of Labor, a fact-find "no detectable level," as measured by a ing hearing was announced on Janu sampling and analytical method sensitive ary 30. 1974 (30 FR 3874) and held on to 1 ppm, with en accuracy of 1 ppm February 15,1974. 50 percent. The proposal also called Information obtained from this hear for the establishment of regulated areas ing, particularly the preliminary reports and limited access to such areas to au of experiments conducted by Professor thorized persons. A requirement for Cesare Maltoni of the Instituto di On- monitoring of employee exposures was cologla, Bologna, Italy, demonstrated proposed, along with engineering and that vinyl chloride induced angiosarcoma work practice controls to be implemented In rats at levels as low as 250 ppm, and when exposures over the detectable limit in other species at higher levels. Experi were measured. ments performed at lower levels of ex Respiratory protection would have posure were not completed at that time. been required while engineering and work Other testimony from medical witnesses practice controls were being implemented and NIOSH. and the results of autopsies, or whore exposures exceeded the per led to the conclusion that the Goodrich missible limit even after feasible en workers had angiosarcoma of the liver gineering controls were instituted. 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 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. pany. On the basis of all information avail able at that time, and the fact that em ployees were bring exposed at levels around the experimentally observed ef fect level of 250 ppm, an emergency temporary standard (ETS) was promul gated on April 5, 1974 (39 FR 12341) pursuant to section 6(c) of the Act, as 29 CFR 1910.93q. "nils 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, (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 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. Ail partici pants were given the opportunity to pre which were known to be underway at ^ sent testimony and to cross-examine - that time. other witnesses. Persons participating_tn On April 15,1974, Information and data the hearing were given until August 23, were presented to representatives of 1974, to file additional posthearing com OSHA, NIOSH, and the Environmental ments, Including various items of infor Protection Agency by the Industrial Bio- mation which were requested during the Test Laboratories, Northbrook, Illinois, examination of witnesses. concerning results of animal exposure (5) Economic and technical impact studies with VC. These studies were study. During the hearing, OSHA deter sponsored by the Manufacturing Chem mined that additional facts would be ists Association. Although only pre needed to determine the practicality 'of- liminary in nature at that time, these certain aspects of the proposed stand results revealed that 2 out of 200 mice ard. Accordingly, OSHA contacted an In exposed to VC concentrations of 50 ppm dependent consultant, Foster D. Snell- for 7 hours a day, five days a week, for Corporation, to conduct studies of the approximately 7 months, had developed feasibility of compliance at various ex angiosarcoma of the liver. posure levels, including those proposed (3) The proposed permanent stand by OSHA and others advanced by In ard. Based on the demonstrated evidence dustry spokesmen. Snell was also com of VC'e carcinogenicity in three animal missioned to collect information regard species (rats, inice and hamsters), and ing the economic costs of compliance. the substantial probability that VC had This action was announced at the close been the causal agent in the cases of liver of the hearing, and Judge Myatt further angiosarcoma found in workers both here announced that the record would be kept FEDERAL RMISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 GENC 006711 open for a period of time beyond August 23, to allow interested persons to com ment In writing on the study. On August .26,1974, QSHA announced that the pre liminary study was available and that comments were to be submitted no later than September 6, 1974 (39 FR 30844). On September 13, 1974, OSHA invited comments on both the preliminary and the final study, which was to be received oh or before September 25, 1974 (39 FR 33009). (fl) Environmental impact statements. A notice of intent to file an environmen tal. impact statement assessing the im pact of a proposed standard on occu pational exposure to VC was published in ttie Federal Register on April 24, 1974 (39 FR 14522). The notice invited any person having information or data on the environmental impact to submit it to 63HA 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 Register on June 25, 1974 (39 FR 22975). A 45 day period was allowedfor the submission of comments on the draft statement. On September 5, 1974, the final environmental impact statement was prepared and a copy of it and all substantive comments were sent to appropriate governmental agencies, private organizations, and other inter ested persons. CEQ published a notice of availability for the final statement on September 6, 1974 (39 FR 32350), The. submission of 'comment was invited un til September 25, 1974. The final state ment and all significant comments have been carefully considered in arriving at the final standard on occupational expo sure to VC. (7) The record. The record in this proceeding is one of the most exhaustive ever relied upon by OSHA. It consists of pre and post-hearing comments and testimony received at both factfinding and rulemaking hearings, the studies and inspections conducted 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. It, Findings regarding carcinogenicity, exposure levels and feasibility--(1) Carr cinogenicity of vinyl chloride. The car cinogenicity of vinyl chloride for three animal species (rat, mouse, hamster) ha? been documented on the record by the studies of Maltonl and Bio-Test Labora tories. Moreover, Maitorsi's investigations have demonstrated a dose-dependent re lationship for induction of tumors (i.e., more tumors occur at higher exposure levels). Including angiosarcoma of the liver, in rats. The investigations of In dustrial Bio-Test Laboratories have dem onstrated a similar relationship for both rats and mice. These investigators have induced angiosarcoma of the liver in rats and mice at exposure concentra tions of 60 ppm, and in hamsters at high er concentrations of exposure. Additional tumors involving other organs, including the kidneys, lungs, and skin of exposed animals, were also observed in frequen cies much in excess of control animals. The incidence of tumors in mice in the Industrial Bto-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. Recording to the 1970 report by the Surgeon General's Ad-Hoc Committee on the Evaluation of Low Levels oEn 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 sr*ecies that were exposed to VC by tnhalat .on-- a route comparable to employe! ex posure. In addition, there were at least 13, confirmed cases of angiosarcoma of the liver among employees exposed to VC, a particularly significant numt er in view of the extreme rarity of this cancer in the TJ.S. adult male population (:estimony 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. Ihdustry 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, NIOSH. and Selikoff.) (2) Exposure limits. Upon finding that exposure of employees to vinyl chloride may create a carcinogenic hazard, the amount of exposure which Is hazardous must be determined. The Surgeon Gen eral's Ad Hoc Committee referred to above concluded that safe exposure levels for carctnogenfc substances cannot be scientifically determined. This position is supported by the testimony of NIOSH at the hearing, its recommendations for a standard of no detectable level, and by the testimony of expert witnesses from the National Cancer Institute. Several witnesses and persons who sub mitted comments have taken a contrary view and have suggested that man is less sensitive to biologic aberrations induced by vinyl chloride exposure than experi mental animals. Proponents of this posi tion have argued that if humans were as 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 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 ployees may indicate an exposure thres hold for tumor induction, based on varia tions in the workplace design or prac tice and resultant employee exposures FEDERAL REGISTER, VOL. 3V, NO. 194--FRIDAY, OCTOBER 4, 1974 GENC- 006712 35892 rules and regulations (testimony and questioning by Tenneco Chemicals, Inc.). It has also been em phasized that in only 3 ol 8 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 workpractice 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 335 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 (lid 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 to 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 many pathway are saturated, as would .be the result at higher exposures. The ,,, preliminary data indicated the possibillfcy of an additional pathway for - t&etobolism o VC to rate exposed to con; centraQons of VC to excess of 220 ppm. However, the occurrence of angioJ sarcoma to 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 to 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 to determtaa. tion of safe exposure concentrations for -' employees, or. even that such safe ex- .posures exist. '/-A. number cff witnesses representing employers have stressed that there is no evidence of cancer, either to employees or experimental animals, at exposure .concentrations of VC less than 50 ppm. ' (See eg,, testimony of Firestone, Tenneco Chemicals.) The canclusionof these witnesses was that no decision can be made concerning risk of exposure to VC at concentrations less than 50 ppm. On the other hand, the testimony of most expert witnesses, including some in dustry biomedical experts, stated that quantification of a safe exposure con centration, is not possible with the pres ent state of scientific knowledge. (See e.g., testimony of Selikoff, Firestone. NCI, and NIOSH.) In our view, the demonstration of can cer induction in humans at a particular level is not a prerequisite to a determina tion that a substance represents a can cer hazard for humans at that level. It would be imprudent to assume man to be less sensitive to VC exposure than ex perimental animals in the absence of conclusive evidence. It would also be un founded to assume that animals will not develop tumors when exposed at concen trations of VC of less th^n 50 ppm. Should a sufficiently large number of ex perimental animals be exposed to VC at concentrations of less than 50 ppm, Schneiderman said that it would be ex pected that some would develop VC in duced tumors. (3) Feasibility. There is virtually no dispute that most, if not all, fabricators are currently capable of reaching ex posure levels of 1 ppm through engineer ing controls. These employers employ well over 95 percent of all employees ex posed to VC. Indeed, several fabricators are already operating at this level (see SPI testimony). However, industry spokesmen have universally claimed that it is infeasible for the VC and the PVC Industries to remain below X ppm con sistently, using engineering controls. In addition, the Snell study on technical feasibility concluded tht a 1 ppm ceil ing is not feasible for the VC and PVC industries with present technology, but that the VC industry could currently at tain lower exposure levels than the PVC Industry. Labor union spokesmen and the Health Research Group, Inc., however, have suggested that such a level is at tainable. Since there Is no actual evidence that any of the VC or PVC manufacturers have already attained a I ppm level or to fact , instituted all available, engineering and work practice controls, any estimate as to the lowest feasible level attainable must necessarily involve subjective Judg ment. Likewise, the projections of indus try, labor, and others concerning feasi bility are essentially conjectural. Indeed, as Firestone has suggested, it is not pos sible to accurately predict the degree of improvement to be obtained from en gineering changes until such changes are actually implemented. We agree that the PVC and VC estab lishments will not be able to attain a 1 ppm TWA level for all job classifications to the near future. We do believe, how ever, that they will, to 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 to other industries. In any event, the VC and PVC industries have already made great strides to reducing exposure levels. (See testimony of Dow Chemical Co, TP. 973 /. For example. B. F. Goodrich testified (TR 1120) that it has reduced average exposure levels in several PVC plants from 35--40 ppm early this year to 12-13 ppm at the time of the hearing. We are confident that industry will continue to do so. (4) Conclusions. The conclusions be low are based on a thorough review and evaluation of all the evidence submitted. Where decisions can be based on record .evidence, this has been done. Where, however, factual certainties are lacking or where the facts alone do not provide an answer, policy judgments have been made. There is little dispute that VC is car cinogenic to man and we so conclude. However, the precise level of exposure which poses a hazard and the question of whether a "safe" exposure level exists, cannot be definitively answered on the record. Nor Is it clear to what extent exposures can be feasibly reduced. We cannot wait until indisputable answers to these questions are available, because lives of employees are at stake. There fore, we have had to exercise our best judgment on the basis of the best avail able evidence. These judgments have re quired a balancing process, in which the overriding consideration has been the protection of employees, even those who may have regular exposures to VC throughout their working lives. Based on the available evidence and to view of the above considerations, includ ing feasibility, we believe that employee exposures to VC must be reduced to a 1 ppm time-weighted average (TWA). We also believe that PVC and VC establish ments will, in time, be able to attain that level through engineering controls, and that fabricators can do so to the Im mediate future. In addition to the TWA requirement, we have established a 5 ppm ceiling (averaged over a 15-minute period) to order to prevent exposure of employees to unacceptable high excursions. From an operation standpoint, this ceiling level is realistic because minor excur sions up to the ceiling level are likely* to occur on a regular basis. m. The final standard--(1) Scope and application. Both the ETS and the pro posal would apply the standard to the entire VC industry, including manufac turers of VC and PVC and fabricators, but excluding employers handling or using fabricated products made from VC. There is no dispute that a standard is required for the monomer and polymer industries. However, the Society of Plas tics Industry (SPI) and various fabrica tors (sse testimony of Goodyear, Gen eral Cable, etc.) recommended Hint 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 celling level. The record evidence establishes that at least some employees in the fabricat ing industry are exposed in excess of the permissible control limits (See NIOSH testimony, TR 10G; Robintech TR 942), In these clrcumatan/ys, we believe ttiat It is imprudent to grant a blanket exemp tion for all fabricators. Therefore, the final standard Is applicable to the fabri cation industry, es well as the monomer -f. AAT?*> FEDERAL REGISTER, VOL 39, MO. 194--FRIDAY, OCTOBER 4, 1974 GENC 006713 RULES AND REGULATIONS 35893 and polymer Industries. Employers who. In fact, are substantially below the ex posure 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 0.1 percent of 14 carcinogens from 29 CFR 1910 93P (39 PR 3756) was an appropriate precedent. The cases are not '-^comparable, because no attempt had been made to set air concentration limits for the 14 carcinogens. The record did not Include Information that reliable monl- . taring 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 hroadly 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 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 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 cessing, indicates that a potential for re lease of the residue still exists. It ap pears that the exemption of fabricated products should be limited to Just those Items which will not undergo such mass heating. Further, the opportunity to demonstrate that exposures are below the action level, and, thus, discontinue many duties of the standard, provides a more positive control and an adequate relief.' (2) Permissible exposure limit. The standard sets an exposure limit of 1 ppm averaged over any 8 hour period, and a ceiling of 5 ppm averaged over any per iod not exceeding 15 minutes. As more fully discussed above, this limit is based on an evaluation of the best available evidence and on a judgment that the health and safety of employees must be protected to the fullest extent feasible. In view of the fact that release of VC in the VC and PVC manufacturing processes are variable, the 1 ppm ceiling level provided in the proposal would require maintenance of an average level significantly more difficult to attain through feasible engineering controls. Therefore, the exposure limit prescribed in the proposal has been rejected. (3) Action level. The final standard, unlike the ETS and the proposal, pro vides for an "action level" of 0.5 ppm TWA, one-half of the permissible ex posure limit. The purpose of the action level is to minimize the Impact of the standard on the employers who have attained exposure levels well below the permissible limit. Thus, where the re sults of monitoring under paragraphs (d) (1) or (d) (2) demonstrate that no employee is exposed in excess of 0.5 ppm TWA, employers may, in effect, be exempted from some provisions of the standard. For example, fabricators who are below the action level are- not re quired *o provide medical surveillance or to monitor again, unless the employer has reason to suspect that any employee is exposed in excess of the action level. In our Judgment, exposures below the action level do not present a sufficient hazard to warrant application of the, en tire standard to the many employer? Vho are or will be below that level. v (4) Monitoring. The final standard, like the proposal, requires that individual employee exposure levels be determined. This may be accomplished by personal or area monitoring. Some witnesses and persons who submitted comments did not understand the meaning of the term "95 percent confidence level" in the proposal. Essentially it means that the employer Is required to take a sufficient number of measurements so that the re sults obtained are statistically valid. We have modified the proposal to establish 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 All covered employers are required to conduct initial monitoring. Where moni toring and measuring results are at or below the action level, no further moni toring is required unless`*the employer has reason, to suspect that any employee is exposed in excess of the action, level, or unless changes have been made inproduction, process, control, type of resin, 6tc. Where the exposure level, withovft re gard to respirators, exceeds the permis sible levels, monitoring must be conduc ted at least monthly. Where exposures are less than the permissible levels, but greater than the action level, monitoring must occur at least quarterly. (5) Methods of compliance. The stand ard, like the proposal, requires that em ployers Immediately institute feasible engineering and work practice controls to reduce exposures to at or below the permissible exposure limit. Where feasible engineering and work practice controls will reduce exposures below the permissible levels, they must be instituted. Where such controls will not reduce exposures below the permis sible level, they must nonetheless be im plemented to reduce exposures to the lowest practicable level, and be supple mented by the use of respirators to pro vide the necessary protection. There upon, a continuing program of engineer ing and work practice controls must be instituted to reduce exposures to the low est practicable level. When exposures are at or below the permissible exposure limits, the program may be discontinued. In addition, a plan for achieving con trol by engineering and work practice methods must be drawn up and be made available, upon request, to represent atives of OSHA and NIOSH. We recognize that many employers covered by the standard can not cur rently achieve compliance with the per missible exposure limit solely by the use of feasible engineering and work practice controls. The record also reflects broad generic distinctions between the compli ance capabilities of the VC and PVC industries. Some industry spokesmen, including SPI (TR. 358-362), recom mended that a schedule of different permissile exposure limits and compliance dates be established for the VC and PVC segments of the industry. This view assumes that the ability and the time required to feasibly reach in creasingly lower control levels is similar within each Industry, but differs mark edly between industries. While the record does suggest that such differences do exist between industries, as noted above, it is clear that intra-industry differences also exist. Thus, the ability and time re quired by each employer to attain lower control levels may depend upon such factors as the climate in which the plant is located, the age of equipment, the size of reactors, or the type of resin manu 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 all employers to institute feasible engi neering controls to the fullest extent and to continue to improve and apply engi FEDERAl REGISTER, VOL. 39, NO. 194--FRIDAY, OCTOBER 4, 1974 GENC 006714 35894 RULES AND REGULATIONS 1 neering 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 be aflorded 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, we 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 ing respirators in the list of acceptable levels to the permissible level. some of the problems associated with units, subject to the approval of such We also believe that the requirement implementing a program of respiratory units by NIOSH, The 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 be re (6) Regulated areas. The proposed not exceed a 25 ppm ceiling, may decline 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 that daily rosters or summaries of those entering be kept for at least 20 years. In objection to these requirements, it was use. During this adjustment period, em ployees will be trained in the uses, pur poses and limitations of respirators, and the hazards of exposure to vinyl chloride. an alarm system to alert employees when vinyl chloride concentrations exceed the concentrations allowed for the particu lar type of respirator in use. asserted that such control of access was not necessary from a health standpoint. Secondly, It was claimed that these con trols would interfere with operations by preventing access of needed employees or non-employees, such as contractors, truck drivers, customers and consultants. " The purpose of establishing regulated areas in the proposal was to limit the Tisk of exposure to as few employees as possible. This concern is still paramount, and'thus the limited access feature re mains. The final standard amends the Moreover, each employee will be notified in writing If he has been exposed in ex cess of the permissible exposure limit. Where exposures exceed a 25 ppm ceil ing, respiratory protection is mandatory in light of our judgment that much greater risks are associated with such exposures. The provisions In the final standard regarding the selection and use of respi ratory protective devices differ from those in the proposal. The descriptions of atmosphere-supplying respirators have (8) Hazardous operations. This Is a new section within the final standard. It encompasses essentially the proposal's requirements for maintenance and de contamination but has restated them In terms of performance language to allow greater flexibility for employers to deal with such operations. The intent of the new section is to protect employees en gaged in activities that present a risk of exposure to vinyl chloride in excess of the permissible levels. An example would be the cleaning of a filter where resin con proposal slightly to allow "authorized been revised to indicate more clearly the taining high residual. monomer is persons" to enter regulated areas. This types of devices intended, and the maxi trapped. change. It is felt, will allow operations to mum permissible concentration level for The proposal's requirement for fullcontinue without undue interference. each device. Moreover, the number of 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 Ot) Respiratory protection. The final gestions are meritorious. Therefore, the vessel entry falls within the definition standard, like the proposal, requires the provisions for selection of atmosphere- of a hazardous operation, the vessel entry use of respirators where employee expo supplying devices follow closely the rec section of the proposal has been deleted sures exceed the permissible control level. ommendations contained In his testi from the final standard. Industry representatives made a number mony of SPI and B. P. Goodrich) (TR (9) Emergency situations.`The defini of objections to proposed requirements with Hyatt's suggestions. (See e.g. testi tion of emergency has been recast in for respiratory protection. They stated mony of SPI and B. F. Goodrich) <TR terms of an unexpected massive.release. that .the "no detectable level" would ef 85 ff) We had originally omitted 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 FVC and VC plants, and been approved by NIOSH for use against that, as the term was. defined, many that this is not feasible because respira- VC, principally because they lacked in ordinary leaks or operations resulting in tors are cumbersome, present a safety dicators to signal the expiration1 of the a small release of vinyl chloride would be hazard, and employees would not use service life of the sorbent. Hyatt and considered emergencies. This was not itbentr ' , : . other witnesses, discussed in detail the the intent of the proposal. The final We would agree that respirators have desirability of being able to use canisters standard has been clarified to correct many drawbacks; the proposal did not or cartridge air-purifying respirators, this ambiguity. It should be noted that - contemplate them as a final solution. The provided a sorbent could be shown to the written operational plan required by record shows that the PVC Industry par effectively absorb vinyl chloride with an the standard need not be developed for ticularly may need several years before adequate service, life. Recently. OSHA minor excursions above the permissible plant environmental levels can be re has received respiratory data from labo exppsure limit, and that such excursions duced so that respirators are necessary ratories regarding the effectiveness of need not be reported. only occasslonally. 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 uations were conducted separately by employees of the cancer and fire haz convenient,, may require additional per sonnel, interferes with production, or may require extensive retraining of em ployees and restructuring of work prac NIOSH and by the B. F. Goodrich Com pany and submitted to OSHA in post hearing comments. The results Indicate that certain presently available canis 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" appeax on the objections, wnrt have concluded that vinyl chloride at relatively low concen all signs and labels. The principal argu- FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 GENC 006715  i ' ,, '-.jf rules anU REGULATIONS 35895 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 unwleldly or excessively detailed leg end. Consequently, the required message on signs and labels will not include in formation on precautions, relevant symptoms, efcc. 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 o 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 lor medical surveillance (TR 121, Exh. 95, TR 589-591). 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-maltenant disorders. The general scope of the required (nedical 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 tests 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 sion? f(?r 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. t This change has been implemented be cause the latency period for induction of angiosarcoma ranges up to 30 years from initial exposure. Therefore, as a mini mum, medical records must be main tained for at least that long. It should be 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 15 days has been deleted. It has been concluded that submission, within 24 hours, of an initial report that In cludes facts immediately available, would ordinarily be sufficient. 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 maintentance 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 roach 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 GENIC 006716 35896 RULES AND REGULATIONS provisions and that employers affected are given, an opportunity to familiarize themselves and their employees with the existence of the new requirements, the effective date of the amendment to 1910.93q will be January 1,1975. To pro vide continued protection for employees until that date, the provisions currently contained in 1910.93q 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 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 Is located. (9) "Polyvinyl chloride" means poly vinyl chloride homopolymer or copoly mer before such is converted to a fabri October 4, 1974, the amendment. to 1910.93q set out below will supersede these provisions as of January 1, 1975, Accordingly, upon consideration of the whole record of this proceding. Part 1910 of Title 29, Code of Federal Regulations Is amended, effective January 1, 1975, by revision of 1910.93q to read as follows: 1910.93q Vinyl chloride. cated product. (10) "Vinyl chloride" means vinyl chloride monomer. (c) Permissible exposure limit. (1) No employee may be exposed to vinyl chlo ride at concentrations greater than 1 ppm averaged over any 8-hour period, and (2) No employee may be exposed to vinyl chloride at concentrations greater than 5 ppm averaged over any period not (a) Scope and application. (1) This exceeding 15 minutes. section includes requirements for the (3) No employee may be exposed to control of employee exposure to vinyl vinyl chloride by direct contact with chloride (chloroethene), Chemical Ab liquid vinyl chloride. stracts Service Registry No. 75015. (d) Monitoring. (1) A program of (2) This section applies to the manu initial monitoring and measurement facture, reaction, packaging, repackag shall be undertaken in each establish ing, storage, handling or use of vinyl ment to determine if there is any em chloride or polyvinyl chloride, but does ployee exposed, without regard to the use not apply to the handling or use of fabri of respirators, in excess of the action cated products made of polyvinyl chlo level. ride. (2) Where a determination conducted (3) This section applies to the trans under paragraph (d)(1) of this section portation of vinyl chloride or polyvinyl shows any employee exposures, without chloride except to the extent that the regard to the use of respirators, in ex Department of Transportation may cess of the action level, a program for de regulate the hazards covered by this sec termining exposures for each such em tion. ployee shall be established. Such a pro (b) Definitions. (1) "Action level" gram: means a concentration of vinyl chloride (1) Shall be repeated at least monthly of 0.5 ppm averaged over an 8-hour work where any employee is exposed, without day. regard to the use of respirators, in ex (2) "Assistant Secretary" means the cess of the permissible exposure limit. Assistant Secretary of Labor for Occupa (11) Shall be repeated not less than tional Safety and Health, U.S. Depart quarterly where any employee is exposed, ment of Labor, or his designee. without regard to the use of respirators, (3) "Authorized person", means any in excess of the action level. person specifically authorized by the em (iii) May be discontinued for any em ployer whose duties require him to enter ployee only when at least two consecu a regulated area or any person entering tive monitoring determinations, made,not such an area as a designated representat less than 5 working days apart, show ex ive'of employees for the purpose of ex posures for that employee at or below ercising an opportunity to observe moni the action level. toring and measuring procedures. (3) Whenever there has been a pro (4) "Director" means the Director, duction, process or control change which National Institute for Occupational may result in an increase in the release Safety and Health, U.S. Department of of vinyl chloride, or the employer has Health, Education, and Welfare, or his any other reason to suspect that any em designee. ployee may be exposed in excess of the (5) "Emergency" means any occur action level, a determination of employee rence such as, but not limited to, equip exposure under paragraph (d)(1) of this ment failure, or operation of a relief de- section shall be performed. vice which Is likely to, or does, result in (4) The method of monitoring and massive release of vinyl chloride. measurement shall have an accuracy (6) "Fabricated product" means . a (with a confidence level of 95 percent) of product made wholly or partly from not less than plus or minus 50 percent polyvinyl chloride, and which does not from 0.25 through 0.5 ppm, plus or minus require further processing at tempera 35 percent from over 0.5 ppm through tures, and for times, sufficient to cause vl.O ppjn, and Plus or minus 25 percent mass melting of the polyvinyl chloride over 1.0 ppm. (Methods meeting these 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 accuracy requirements are available in the "NIOSH Manual of Analytical Methods"). (5) Employees or their designated rep gas might be expected as a consequence resentatives shall be afforded reasonable opportunity to observe the monitor ing and measuring required by this paragraph. (e) Regulated area. (1) A regulated area shall be established where: (ri Vinyl chloride or polyvinyl chloride is manufactured, reacted, repackaged, stored, handled or used; and (ii) Vinyl chloride concentrations are in excess of the permissible exposure limit. (2) Access to regulated areas shall be limited to authorized persons. A dally roster shall be made of authorized per sons who enter, (f) Methods of compliance. Employee exposure's 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 of below the per missible exposure limit, they shall none theless be used to reduce exposures to the lowest practicable level, and shall be supplemented by respiratory protection in accordance with paragraph (g) of this section. A program shall be established and implemented to reduce exposures to at or below the permissible exposure limit, or to the greatest extent feasible, solely by means of engineering and work practice controls, as soon as feasible, (3) Written plans for such a program shall be developed and furnished upon request for examination and copying to authorized representatives of the Assis tant Secretary and the Director. Such plans shall be updated at least every six months. (g) Respiratory protection- Where respiratory protection is required under this section: (1) The employer shall provide a respirator which meets the requirements of this paragraph and shall assure that the employee uses such respirator, except that until December 31, 1975, wearing of respirators shall be at the discretion of each employee for exposures not in ex cess of 25 ppm, measured over any 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 respifatory devices. (2) Respirators shall be selected from among those jointly approved by the Mining Enforcement and Safety Admin istration, Department of the Interior, and the National Institute for Occupa tional Safety and Health under the pro visions of 30 CFR Part 11. (3) A respiratory protection program meeting the requirements of 1910.134 shall be established and maintained. (4) Selection of respirators for vinyl chloride shall be as follows: FEDERAL KEGiSTEt, VOL 34, NO. 194--FRIDAY, OCTOSES 4, 1974 bENC 006717 RULES AND REGULATIONS 35897 Atmospheric concentration of . vinyl chloride ' Rcqulrr.d apparatus (1) Unknown, or Above 3,600 ppm____ Open-circuit, self-contained breathing apparatus, proe- suro demand type, with full facepiece. - (it) Not over 3,600 ppm_______________ (A) Combination type C supplied air respirator, pres sure demand type, with lull or half facepiece, and auxiliary self-contained air supply; or (B) Type C, supplied air respirator continuous flow i . type, with full or half facepiece, and auxiliary self-contained air supply. (1U) Not over 100 ppm___________ (A) Combination type C supplied air respirator de mand type, with full facepiece, and auxiliary self-contained air supply; or (B) Open-circuit self-contained breathing apparatus with full facepiece, In demand mods; or (C) Type C supplied air respirator, demand type, with full facepiece. (tv) Not over 35 ppm--- (A) A powered . air-purifying respirator with hood. J helmet, full or half facepiece, and a canister which provides a service life of at least 6 hours for concenratlons of vinyl chloride up , .' to 38 ppm, or - (B) Gas mask, front- or back-mounted, canlster whlch , provides a service life of at least 4 hours" for concentrations of vinyl chloride up to 35 ppm. (V) Not over 10 ppm (A) Combination type C supplled-alr respirator, de mand type, with half facepiece, and auxiliary self-contained air supply; or - . (B) TypeC supplled-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 for concentrations of vinyl chloride up to-10 ppm. ____ (5) (i) Entry into unkown concentra tions or concentrations greater than 36,000 ppm (lower explosive limit) may be made only for purposes of life rescue; and (il) Entry into concentrations of less than 36,000 ppm, but greater than 3,600 ppm may be made only for purposes of life rescue, firefighting, or securing equipment so as to prevent a greater hazard from release of vinyl chloride. , (6) Where air-purifying respirators are used: (i) Air-purifying cannisters or car tridges shall be replaced prior to the expiration of their service life or the end of the shift in which they are first used, whichever occurs first, and (ii) A continuous monitoring and alarm system shall be provided where concentrations of vinyl chloride could reasonably exceed the allowable concen trations for the devices in use. Such sys tem shall be used to alert employees when vinyl chloride concentrations exceed the allowable concentrations for the devices in use. (7) Apparatus prescribed for higher concentrations may be used for any lower concentration, (h) Hazardous operations. (1) Em ployees engaged in hazardous operations, including entry of vessels to clean poly vinyl chloride residue from vessel walls, shall be provided and required to wear and use; (1) Respiratory protection in accord ance with paragraphs (c) and (g) of this section; and (ii) Protective garments to prevent skin contact with liquid vinyl chloride or With polyvinyl chloride residue from vessel walls. The protective garments shall be selected for the operation and its possible exposure conditions. (2) Protective garments shall be pro vided clean and dry for each use. (i) Emergency situations. A written operational plan for emergency situa tions shall be developed for each facility storing, handling, or otherwise using vinyl chloride as a liquid or compressed gas. Appropriate portions of the plan shall be Implemented in the event of an emergency. The plan shall specifically provide that: (1) Employees engaged In hazardous operations or correcting situations of ex isting hazardous releases shall be equipped as required In paragraph (h) of this section; (2) Other employees not so equipped shall evacuate the area and not return until conditions are controlled by the methods required in paragraph (f) of this section and the emergency is abated, (j) Training. Each employee engaged in vinyl chloride or polyvinyl chloride operations shall be provided training in a program relating to the hazards of vinyl chloride and precautions for its safe use. (I) The program shall Include: (i) The nature of the health hazard from chronic exposure to vinyl chloride including specifically the carcinogenic hazard; (II) The specific nature of operations which could result in exposure to vinyl chloride in excess of the permissible limit and necessary protectivesteps; (ii) The purpose for, proper use, and limitations of respiratory protective devices; (iv) The fire hazard and acute toxic ity of vinyl chloride, and the necessary protective steps; (v) The purpose for and a description of the monitoring program; <vi) The purpose for, and a descrip tion of, the medical surveillance program; (vil) Emergency procedures; (viii) Specific Information to aid the employee in recognition of conditions which may result In the release of vinyl chloride; and (lx) A review of this standard at the employee's first training and indoctrina tion program, and annually thereafter. (2) Ail materials relating to the pro gram shall be provided upon request to the Assistant Secretary and the Director. (k) Medical surveillance. A program of medical surveillance shall be insti tuted f9 each employee exposed, with out regard to the use of respirators, to vinyl chloride in excess of the action level. The program shall provide each such employee with an opportunity for examinations and tests in accordance with this paragraph. All medical ex aminations and procedures shall be per formed by or under the supervision of a licensed physician, and shall be provided without cost to the employee. <1) At the time of initial assignment, or upon^institution of medical surveil lance; (1) A general physical examination shall be performed, with specific atten tion to detecting enlargement of liver, spleen or kidneys, or dysfunction in these organs, and for abnormalties in skin, connective tissues and the pulmonary system (3<fe Appendix A). (ii) A medical history shall be taken, including the following topics; (A) Alcohol intake; (B) Past history of hepatitis; (C> Work history and past exposure to potential hepatotoxlc agents, includ ing drugs and chemicals; (D) Past history of blood transfu sions; and (E) Past history of hospitalizations. (ill) A serum specimen shall be ob tained and determinations made of; (A) Total bilirubin; (B) Alkaline phosphatase; (C) Serum glutamic oxalacetic trans aminase (SGOT); (D) Serum, glutamic pyruvic transam inase (SGPT); and (E) Gamma glustamyl transpeptidase. (2) Examinations provided in accord ance with this paragraph shall be per formed at least: (l) Every 6 months for each employee who has been employed in vinyl chlo ride or polyvinyl chloride manufacturing for 10 years or longer; and (ii) Annually for all other employees. (3) Each employee exposed to an emergency shall be afforded appropriate medical surveillance. (4) A statement of each employee's suitability for continued exposure to vinyl chloride including use of protec tive equiprhent and respirators, shall be obtained from the examining physician promptly after any examination. A copy of the physician's statement shall be pro vided each employee, (5) If any employee's health would be materially impaired by continued ex posure, such employee shall be with- FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 GENC 006718 35898 RULES AND REGULATIONS drawn from possible contact with vinyl tion which contradicts or detracts from (II) The number of employees In each chloride. the effect of, any required warning, regulated area during normal operations, (6) Laboratory analyses for all bio information or instruction. including maintenance. logical specimens included in medical (m) Records. (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 Fart 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 (k) (1) 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 obtains a statement from the examining physician setting forth the alternative examinations and the rationale for sub stitution. This statement shall be-avail- (i) Monitoring and measuring records shall: (A) State the date of such monitor ing and measuring and the concentra tions determined and identify the instru exposed, without regard to the use of respirators in excess of the permissible exposure limit, each such employee shall be notified in writing of the results of able upon request for examination and ments and methods used; the exposure measurement and the steps copying to authorized representatives of the Assistant Secretary and the Director. <1) Signs and labels. (1) Entrances to regulated areas shall be posted with leg ible signs bearing the legend: Cancer-Suspect Agent Area Authorized Personnel Only <B) Include any additional Informa tion necessary to determine Individual employee exposures where such expo sures are determined by means other than individual monitoring of employees; and (C) Be maintained for not less than being taken to reduce the exposure to within the permissible exposure limit. (o) Effective dates. (1) Until Janu ary 1, 1975, the provisions currently set forth in 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. (ii) Authorized personnel rosters shall be maintained for not less than 30 years. (ill) Medical records shall be main tained $or the duration of the employ (2) Effective January 1, 1975, the pro visions set forth In 19l0.93q of this Part shall apply. Appendix A--Supplementary Medical Cancer-Suspect Agent in This Area Protec ment of each employee plus 20 years, tive Equipment 'Requires Authorized or 30 years, whichever is longer. . Personnec Only (3) In the event that the employer Information 'When required tests under paragraph tic) (1) of this section show abnormalities, (3) Containers of polyvinyl chloride resin waste from reactors or other waste contaminated with vinyl chloride shall be legibly labeled: * Contaminated with Vmn. Chloride Cancer-Suspect Agent ` (4) Containers of polyvinyl chloride - shall be legibly labeled: Polyvinyl Chloride (or Trade Name) Contain* Vinyl Chlorhie Vinyl Chloride is a Cancer-Suspect Agent ceases to do business and there is no the tests should be repeated as soon as prac- successor to receive and retain his rec tlcable, preferably within 3 to 4 weeks. If ords ords for the prescribed period, shall be transmitted by these rec registered' tests remain abnormal, consideration should . be given to withdrawal of the employee from contact with vinyl chloride, while a more mail to the Director, and each employee comprehensive examination Is made. Individually notified In writing of this Additional tests which may be useful: transfer. A. For kidney dysfunction: urine examina (4) Employees or their designated tion for albumin, red blood cells, and ex representatives shall be provided access foliative abnormal cells. to examine and copy records Of required B, Pulmonary system: Forced vital capac monitoring and measuring. ^ ity, Forced expiratory Volume at 1 second, and chest roentgenogram (posterior-anterior, (5) Former employees shall be pro- 14 x 17 Inches). vided access to examine and copy in O. Additional serum tests: Lactic add de '(5) Containers of vinyl chloride shall quired monitoring and measuring records hydrogenase, lactic acid dehydrogenase be legibly labeled either: <i> Vinyl chloride Emmoii Flammable Gas Under Pressure Cancer-Suspect Agent or (ID In accordance with-49 CFR Part 173, Subpart H, with the additional legends: 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 shall be reported to the OSHA Area Di isoenzyme, protein determination, and protein electrophoresis. D. For a more comprehensive Examination on repeated abnormal serum tests: Hepatitis B antigen, and liver scanning. (Secs- 6 and 8, 84 Btat. 1SS8, 1598 (29 VAC. 655, 657): Secretary of Labor's Order No. 12-71, 38 Fit 8784) Signed at Washington, D.C., t.Hia lat , Cancer-Suspect Agent applied near the labor or placard. (6) No statement shall appear on or rector. Any changes to such information shall be reported within 15 days. (I) The address and location of each establishment which has one or more day of October, 1974, John 6tender, Assistant Secretary of Labor. near any required sign, label or Instruc regulated areas; and [FR Doc.74-23176 Filed 10-1-74;8:S4 pm] GENC 00671? * MGMWlWT MSB #** *0120291275002 l0/02/7 IPS IPMMTZZ CBP 1 20*7832*02;' MGM TOMT WASHINGTON DC 1002 021 OP COT ZIP 2000* RUBBER MANUFACTURERS ASSOC 1901 PENNSYLVANIA AVE NORTHWEST WASHINGTON DC 2000* THIS MAILGRAM-'IS A CONFIRMATION* COPY OF SHE FOLLOWING MESSAGEi .20*7832*02 TOMT WASHINGTON DC 90 10-02 0*iOF COT PMS HONORABLE RICHARD F SCHUBERTi OLR UNOIRSECRETARY OF LABOR US DEPT OF LABOR 1TH AND CONSTITUTION AVI . WABHINTON DC 20110 '* THE ANNOUNCEMENT ON OCTOBER 1 BY ASSISTANT SECRETARY OF LABOR . . JOHN H ITENOIR CONCERNING THE LEVELS OF EXPOSURE; TO VINYL CHLORIDE TO BE PERMITTED ON AND AFTER JANUARY l 197$ APPEAR TO IGNORE THE MASSIVE WEIGHT OF TESTIMONY PRESENTED DURING THE OSHA HEARINGS LAST JULY. THE$E*LtVELS ARE NOT ACHIEVABLE' BY ANY KNOWN 0R'PR(JPOSED TECHNOLOGY AND ENFORCEMENT OF SUCH LEVELS CAN ONLY LEAD TO MAJOR ECONOMIC DISRUPTIONS WITHIN THE UNITED 'STATES WITHOUT SIGNIFICANTLY ADDING TO EMPLOYEE HEALTH AND SAFETY, THE RMA URGENTLY REGUISTS IMMEDIATE RECONSIDERATION OF THIS STANDARD'. MALCOLM R LOVELL JR PRESIDENT RUBBER MANUFACTURER ASSOCIATION Ul 10 EOT MGMW9HT MSB GENIC 006720