Document 2qeMd5XYRmx7jO1wnpJmrBp07

V 35890 RULES AND REGULATIONS TRIa 29--Labor ployees from a rare liver cancer (angio and abroad, OSHA proposed to revise CHAPTER XVII--OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DE PARTMENT OF LABOR PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS sarcoma) may have been occupationally related. As a result of this notification and after consultation with NIOSH. and a joint Inspection of the B. F. Goodrich plant by OSHA. NIOSH and the Ken tucky Department of Labor, a fact-find 1910.93q and published a comprehensive proposal (39 FR 16096) on May 10. 1974, to protect employees from hazards of exposure to VC. The proposal culled for limitation of employee exposure to VC to "no detectable level," os measured by a Standard for Exposure to Vinyl Chloride ing hearing was announced on Janu sampling and analytical method sensitive Pursuant to sections 6<b). 6<c), and (c) of the Occupational Safety and Health Act of 1070 (84 Stat. 1593. 1598. 1599; 29 U.S.C. 655. 657) Secretory of Labor's Order No. 12-71 (36 PR 8754) and 29 CFR Part 1911. 9 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 (PVC), a resin which Is produced through batch processing. The conversion of the VC monomer Into a polymer or copolymer Is an Incomplete process, l.e., not all of the monomer is reacted. PVC is fabricated by a variety* of tech niques. Including extrusion, injection molding and calendering, to form a fin ished product that needs no lurlher 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 ary 30. 1974 (30 FR 3874 > and held cm to 1 ppm. with an accuracy of 1 ppm February 15.1974. d=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 persona. A requirement for Cesare Maltonl of the Institute di On- monitoring of employee exposures was cologia, 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 ments performed at lower levels of exposure were not completed at that time. were measured. Respiratory protection would have been required while engineering and work Other testimony from medical witnesses practice controls Were being implemented 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. hi post hearing comments, additional angiosarcoma deaths were reported among workers who bad been exposed to VC in plants operated by Union Carbide Corporation, Firestone Plastics Corpora tion and Goodyear Tire A Rubber Com pany. On the basis of all information avail able at that time, and the fact that em ployees were being exposed at levels around the experimentally observed ef fect level of 250 ppm. an emergency temporary standard (ETS) was promul gated on April 5, 1974 (39 FR 12341) pursuant to section 6(c) of the Act, as 29 CFR 1010.93Q. This standard reduced the permissible exposure level from a ceiling of 500 ppm to a 50 ppm ceiling, and established other requirements, including, for example, monitoalng and respiratory protection. It was expressly recognized that this standard limiting exposures to a SO 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. 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 for Interested par-ties 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. All partici pants were given the opportunity to pre sent testimony and to cross-examine other witnesses. Persons participating in 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 employees end simple equipment to large Protection Agency by the Industrial Bio- mation which were requested during the plants involving many employees and Test Laboratories. Northbrook, Illinois,- examination of witnesses. considerable capital concerning results of animal exposure (5) Economic and technical impact Vinyl chloride (VC), a gas at ambient temperature and pressure, is a chlori nated hydrocarbon, which heretofore has been regarded as having moderate liver toxicity. The initial standard, contained in Table G-l of 1910.93, established a ceiling value of 500 parts of VC per mil studies with VC. There 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 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 lion parts of air. approximately 7 months, had developed feasibility of compliance at various ex <2> The emergency temporary stand angiosarcoma of the liver. ard. On January 22, 1074, the Occupa (3) 77ie proposed permanent stand posure levels. Including those proposed by OSHA and others advanced by in tional Salot.v iinrl Health Administra ard. Bar.otl on the demonstrated evidence dustry spokesmen. Snell was also com tion (OS11A) whs informed by the Na of VC's carcinogenicity In three animal missioned to collect information regard tional Institute for Occupational Safety Kliecics (rats, mice and hamsters), and ing the economic costs of compliance. and Health (NIOSH? that the 13. F, the substantial probability that VC had This action was announced at the close Goodrich Chemical Company hod re been the causal agent in the cases of liver of the hearing, and Judge Myatt further ported that deaths cl several of its em angiosarcoma found In workers both here announced that the record would be kept C 2D CO to ftbElAl IIOtSTtl, VOL 34, NO. 194--friDAt, OCFOMk 4. 1974 -% RULES AND REGULATIONS 35891 open Jar a period of time beyond August studies of M&ltonl and Bio-Test Labora may create a carcinogenic hazard, the 23. to allow Interested persons to com tories. Moreover. MnltonTs investigations amount of exposure wlUch is hazardous ment In writing on the study. On August have demonstrated a dose-dependent re must be determined. The Burgeon Gen 28.1974. OSHA announced that the pre lationship for Induction of tumors (l e.. eral's Ad Hoc Committee referred to liminary study was available and that more tumors occur at higher exposure above concluded that safe exposure levels comments were to be submitted no later levels). including angiosarcoma of the for carcinogenic substances cannot be than September 6. 1974 (39 FR 30844). liver. In rats. Hie 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 lor at the hearing, its recommendations lor the Anal 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). (6) Environmental impact statements. in rats and mice at exposure concentra tions of 50 ppm. and In hamsters at high the National Cancer Institute. 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 Ls 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 (39 FR 14522). The notice invited The incidence of tumors In mice In the tion have argued that If humans were as any person having Information or data Industrial Bio-Test Laboratories investi sensitive as rodents, an "epidemic** of on the environmental Impact to submit gations Is particularly pertinent Of 200 cancer resulting from VC exposures It to 03HA by May 17. 1974. On June 12, 1974, a draft environmental Impact statement was prepared and circulated to all Interested persons. Ten copies were forwarded to the Council of Environ (ioo males, 100 females) exposed to 60 ppm of vinyl chloride by inhalation for eleven months, 100 died. Sixty-four ani mals died without gross postmortem pathologic examination being performed. 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 mental Quality (CEQ), which published a notice of its flung and availability In the Federal Recxstxi 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 aD substantive comments were sent to appropriate governmental agencies, private organizations, and other inter ested persons. CEQ published a notice of .avafiabfUty for the final statement an September 8 1974 (39 FR 32350). The submission of comment was invited un til September 25, 1974. Hie 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 personnek the environmental Impact state ments, the economic and technical Impact studies, and all other relevant Information. In an, 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. II. Findings regarding carcinogenicity, exposure levels and feasibility--.(1) Car Of the 38 remaining animals for which a gross postmortem pathologic examina tion was performed, 13 (36 percent) were found with liver turnon (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-Hoe 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 carcinogenic hazard to humans. Here, such a finding was made in three species that were exposed to VC by inhalation-- a route comparable to employee ex posure. In addition, there were at least 13 confirmed cases of angiosarcoma of the liver among employees exposed to VC, a particularly significant number in view of the extreme rarity of this cancer in the U.S. adult male population (testi mony of Dr. Marcus Key, Director of NIOSH, at the rulemaking .hearing). The findings of angiosarcoma of the liver in both experimental animals and exposed employees is compelling evi dence that exposure of humans to vinyl chloride induces this tumor. Industry spokesmen, at the hearing, conceded that VC Is carcinogenic for hitmans (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 tion reactor cleaners. Because It ls gen erally agreed that reactor cleaning in volved high exposures to vinyl chloriJe In yean past, it ls 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 three- quarters 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 yean. If It ls 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 dcises of vinyl chloride, It would be expected that such tumors would be observed earlier for tfri 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 necesosrily 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. Bchneiderman 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 cinogen!city of vinyl chloride. The car tories, Tabershaw-Cooper, M&ltonl, ployees may Indicate an exposure thres cinogenicity of vinyl chloride for three NIOSH, and Selikoff.) hold for tumor Induction, based on varia animal species (rat, mouses 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 C 33 co CO co RURAL REGISTER, VOL 3V, NO. 194--FRIDAY, OCTOBER 4, >974 URL 17899 35892 ( RULES AND REGULATIONS (testimony and questioning by Tenneco e.g., testimony of Sellkoff, Firestone, NCI, confident that industry will continue to Chemicals, Inc,>. It has also been em and NIOSK.) 4o so. phasized Uiat in only 3 ol 8 polymeriza- In our view, the demonstration of can (4) Conclusions, The conclusions be tlon plants where employees have been cer induction in humans at a particular low are based on a thorough review and exposed to VC for more than 20 years level is not a prerequisite to a determina evaluation of all the evidence submitted. have any employees developed angiosar tion that a substance represents a can Where decisions can be based on record coma ot the liver. This argument is very cer hazard for humans at that leveL It evidence, this has been done. Where, similar to that raised concerning vari would be Imprudent to assume man to however, factual certainties are lacking ability of past employee exposure. Al be less sensitive to VC exposure than ex or where the facts alone do not provide though geographic and workpractice dif perimental animals in the absence of an answer, policy judgments have been ferences may ultimately be demonstrated conclusive evidence. It would also be un made. to be factors in distribution of angiosar founded to assume that animals will not There is little dispute that VC Is car coma, sufficient information Is unavail develop tumors when exposed at concen cinogenic to man and we so conclude. able to exclude from consideration of trations of VC of less than 50 ppm. However, the precise level of exposure risk those employees in workplaces for Should a sufficiently large number of ex which poses a hazard and the question which cases of angiosarcoma have not perimental animals be exposed to VC at of whether a "safe1' exposure level exists, been observed. concentrations of less than 50 ppm, cannot be definitively answered on the It has also been suggested that the Sclmeiricrman said that It would be ex record. Nor is it clear to what extent absence of cancer in a population of 335 pected that some would develop VC in exposures can be feasibly reduced. We Dow Chemical Company polymerization duced tumors. cannot wait until indisputable answers employees monitored over a period of 7 (3) Feasibility. There is virtually no to these questions are available, because years. Indicates that exposure to vinyl dispute that most, If not all, fabricators lives of employees are at stake. There chloride at concentrations of less than are currently capable of reaching ex fore, we have had to exercise our best 200 ppm Is safe. (See study by Dr. Cook, posure levels of 1 ppm through engineer Judgment on the basis of the best avail submitted at the hearing by Dow Chem ing controls. These employers employ able evidence. These judgments have re ical Company.) However, the group sur well over 95 percent of all employees ex quired a balancing process. In which the veyed did not Include all workers who posed to VC. Indeed, several fabricators overriding consideration has been the had been exposed, and the missing em are already operating at tnta level (see protection of employees, even those who ployees Included many who had the SFl testimony). However, industry may have regular exposures to VC longer term (over 20 yean) exposures. spokesmen have universally claimed that throughout their working lives. Moreover, the statistically insignificant it is infeasible for the VC and the PVC Based on the available evidence and in size of the sample population decreases industries to remain below 1 ppm con view of thfeabove considerations, Includ the possibility that tumors would be sistently, using engineering controls. In ing feasibility, we believe that employee observed. addition, the Snell study on technical exposures to VC must be reduced to a 1 Dow also presented preliminary data feasibility concluded that a 1 ppm cell ppm time-weighted average (TWA). We in testimony at the hearing on the pos ing Is not feasible for the VC and PVC also believe that PVC and VC establish sible metabolic pathways of VC. The Industries with present technology, but ments will. In time, be able to attain that hypothesis presented was that VC may that the VC industry could currently at level through engineering controls, and exert Its carcinogenic effect by a metab tain lower exposure levels than the PVC that fabricators can do so in the Im olite. and that the metabolite is pro industry. Labor union spokesmen and the mediate future. duced only when VC Is metabolized by a Health Research Group. Inc., however, In addition to the TWA requirement, secondary metabolic pathway operating have suggested that such a level is at we have established a 5 ppm celling only when enzymes regulating the pri* tainable. (averaged over a 15-mlnute period) in mary pathway are saturated, as would Since there Is no actual evidence that order to prevent exposure of employees be the result at higher exposures. The any of the VC or PVC manufacturers to unacceptable high excursions. From preliminary data indicated the possi have already attained a 1 ppm level or In an operation standpoint, this celling bility of an additional pathway for fact instituted all available engineering level is realistic because minor excur metabolism of VC in rats exposed to con and work practice controls, any estimate sions up to the celling level are likely to centrations of VC in excess of 220 ppm. as to the lowest feasible level attainable occur on a regular basis. However, the occurrence of angio must necessarily involve subjective Judg IU. The final standard--- (1) Scope and sarcoma In both rata and mice at VC ment. Likewise, the projections of indus application. Both the ETS and the pro exposure concentrations of 50 ppm in try, labor, and others concerning feasi posal would apply the standard to the dicates that if a metabolite of VC is the bility are essentially conjectural. Indeed, entire VC Industry, Including manufac ultimate carcinogen, then it must be as Firestone has suggested, It is not pos turers of VC and PVC and fabricators, generated at lower exposure concentra sible to accurately predict the degree of but excluding employers handling or tions In these species. Although this re Improvement to be obtained from en using fabricated products made from search may be helpful to the thorough gineering changes until such changes are VC. understanding of the carcinogenicity of actually implemented. There is no dispute that a standard is VC, it appears that It does not yet offer We agree that the PVC and VC estab required for the monomer and polymer evidence which can assist in determina lishments will not be able to attain a 1 Industries. However, the Society of Plas tion of safe exposure concentrations for 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 ol Firestone, Ten neco Chemicals.) The conclusion of these witnesses was that no decision can be ppm TWA level for nil Job classifications in the near future. We do believe, how ever, that they will. In 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 praciieca. It may also be necessary to utilize technology presently used In other Industries. In any event, the VC and PVC industries have already mode great tics Industry (SPI) and various fabrica tors (see testimony of Goodyear, Gen eral Cable, etc.) recommended that fabricators be excluded from the stand ard. or that a separate requirement be established for them because many of them were already at or below the pro posed celling level. The record evidence establishes that at least some employees in the fabricat ing industry are exposed In excess of the made concerning risk of exposure to VC strides In reducing exposure levels. (See permissible control limits (See NIOSH at concentrations less thnn 50 ppm. testimony of Dow Chemical Co., TR 973). testimony, TR 10G: Robintech TR 642). On tlie 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 )*ussible with the pres For example, B. F. Goodrich testified (TR 1120) that It has reduced average exposure levels in several PVC plants from 35-40 ppm early tills year to 12-13 In these circumstances, we believe that It Is Imprudent to gTant a blanket exemp tion for &U fabricators. Therefore, the flnnJ standard Is applicable to the fabri ent state ol scientific knowlcdrc. (See ppm at the time of the hearing. Wc are cation industry, as well as the monomer FE0CRAI REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 RULES AND REGULATIONS 35893 and polymer Industries. Employers who, temperature as PVC. for further pro below the action level, no further moni in fact, are substantially below the ex cessing, indicates that a potential for re toring Is required unless the employer posure limit will be subjected to only lease of the residue still exists. It ap has reason to suspect that any employee minimal burdens by virtue or the "action pears that the exemption of fabricated is exposed in excess of the action level, level" to be discussed below. products should be limited to just those or unless changes have been made in Where employers in the fabricating items which will not undergo such mass production, process, control, type of resin, industry have exposures approaching the heating. Further, the opportunity to etc, permissible limit, they will appropriately demonstrate that exposures are below Where the exposure level, without re be subject to the standard. Employers the action level, and thus, discontinue gard to respirators, exceeds the permis handling or using fabricated products many duties of the standard, provides a sible levels, monitoring must be conduc made of PVC were not Included In the more positive control and an adequate ted at least monthly. Where exposures ETS or the proposal and are excluded relief. are less than the permissible levels, but from the final standard. This conclusion (2) Permissible exposure limit. The greater than the action level, monitoring is based on the absence of ad-quate evi standard sets an exposure limit of 1 ppm must occur at least quarterly. dence of exposure to VC In these opera averaged over any 6 hour period, and a (5) Methods of compliance. The stand tions. The final standard clarifies the ex celling of S ppm averaged over any per ard, like the proposal, requires that em emption by defining a fabricated prod iod not exceeding IS minutes. ployers immediately Institute feasible uct as a product made wholly or partly As more fully discussed above, this engineering and work practice controls from PVC which does not require further limit is based on an evaluation of the best to reduce exposures to at or below the processing at temperatures, and for available evidence and on a judgment permissible exposure limit. times, sufficient to cause mass melting of that the health and safety of employees Where feasible engineering and work the PVC. 6PI and others (cf. TR. 344) must be protected to the fullest extent practice controls will reduce exposures requested that PVC resins with less than feasible. In view of the fact that release below the permissible levels, they must 0.1 percent residual monomer be ex of VC in the VC and PVC manufacturing be instituted. Where such controls will empted from the regulation now, and processes are variable, the 1 ppm ceiling not reduce exposures below the permis that the exemption level be reduced to level provided In the proposal would sible level, they must nonetheless be im 0.01 percent in three years. 6PI suggested require maintenance of an average level plemented to reduce exposures to the that the exemption of materials with less than 0.1 percent of 14 carcinogens from significantly more difficult to attain through feasible engineering controls. lowest practicable level, and be supple mented by the use of respirators to pro 29 CFR 1910.93P (39 FR 3736) was an Therefore, the exposure limit prescribed vide the necessary protection. There appropriate precedent. The cases are not in the proposal has been rejected. upon, a continuing program of engineer oomparable. because no attempt had been (3) Action level. The final standard, ing and work practice controls must be made to set air concentration limits for unlike the ETS and the proposal, pro Instituted to reduce exposures to the low the 14 carcinogens. The record did not vides tor an "action level" of 0.5 ppm est practicable level. When exposures are tnclude information that reliable moni TWA, one-half of the permissible ex at or below the permissible exposure toring and measuring techniques were posure limit. The purpose of the action limits, the program may be discontinued. available. Moreover, the exemption did level Is to minimize the impact of thw In addition, a plan for achieving con not exempt airborne traces of carcino standard on the employers who have trol by engineering and work practice gens. The administrative cutoff was pro attained exposure levels well below the methods must be drawn up and be made vided to avoid regulation of materials permissible limit. Thus, where the re available, upon request, to represent about which there was no health haz sults ol monitoring under paragraphs atives of OSHA and NIOSH. ard Information, and which would have (d)(1) or (d)(2) demonstrate that no We recognize that many employers broadly extended the application of the employee is exposed in excess of 0.6 covered by the standard can not cur regulation beyond the record. Herein, ppm TWA, employers may, In effect, be rently achieve compliance with the per no information was presented to show exempted from some provisions of the missible exposure limit solely by the use safe concentration results from the use standard. For example, fabricators who of feasible engineering and work practice of resins with specific levels. Indeed, the are below the action level are not re controls. The record also reflects broad proposal to change the level later, when quired *o provide medical surveillance or generic distinctions between the compli Improved technology would permit such to monitor again, unless the employer ance capabilities of the VC and FVC reduction, would seem to indicate that has reason to suspect that any employee industries. Some Industry spokesmen, BFX has doubts about the safety of 0.1 is exposed In excess of the action level. including SPI (TR. 3S8-362), recom percent residue level. Diamond Shamrock In our judgment, exposures below the mended that a schedule of different per- (Exhibit 142) testified that there Is no action level do not present a sufficient misslle exposure limits and compliance direct relation. They indicate that the hazard to warrant application of the en dates be established for the VC and PVC airborne concentration Is more related tire standard to the many employers who segments of the Industry. to the physical form of the resin and are or will be below that level. This view assumes that the ability and the ventilation provided. Also, monitor (4) Monitorina. The final standard, the time required to feasibly reach in ing data from Industry (cf. Exhibits 131, like the proposal, requires that Individual creasingly lower control levels Is similar 168, 170) and OSHA (Exhibit 131) Indi employee exposure levels be determined. within each industry, but differs mark cate that levels in excess of 1 ppm may This may be accomplished by personal edly between industries. While the record be found in fabrication operations. In or area monitoring. Some witnesses and does suggest that such differences do view of these facts and of the opportunity persons who submitted comments did exist between Industries, as noted above, for employers to discontinue many duties not understand the meaning of the term it is clear that intra-industry differences upon a showing of no exposures above the "95 percent confidence level" in the also exist. Thus, the ability and time re action level, I t does not appear that any proposal. Essentially It means that the quired by each employer to attain lower residue exemption is either justified or employer Is required to take a sufficient control levels may depend upon such necessary at this time. This course also number of measurements so that the re factors as the climate In which the plant agrees with a number of industry pro sults obtained are statistically valid. We is located, the age of equipment, the size posals (cf. TR 660). have modified the proposal to establish of reactors, or the type of resin manu SP1 (TR 345), among others, asked accuracy range requirements for various factured or used. (Snell study, Firestone that compounded PVC pellets be ex measurement levels. These ranges are testimony, etc.) empted from the standard on the grounds narrow enough to ensure that a deter Monitoring data also tends to support that the pellets had too low a residue to mination of compliance can be made, and such intra-industry variations. (See, cause harmful or measurable emissions. broad enough to allow the application e.g. Dow, Firestone, Tenneco.) While it appears that PVC pollt-ts would of a variety of technologies. As noted above, the standard requires have a lower residue level than virgin All covered employers are required to all employers to Institute feasible engi PVC. the fact that the pellets must be conduct Initial monitoring. Where moni neering controls to the fullest extent and heated to a molten mass at the some toring and measuring results are at or to continue to Improve and apply engl- URL 17900 FEDEKAL REC1S1ER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, )9M I 35894 RULES AND REGULATIONS neeling 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 afforded respira willing to consider on on expedited basis for full compliance through engineering tory protection. the approval of alr-purlfylng 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 alr-purify- most establishments to reduce exposure believe that it Is necessary to mitigate lng 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 alr-purlfylng 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 celling, 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 arc used, and conditions In each industry. However, employees whose exposures do> strict administrative controls will be re (6) Regulated areos. The proposed not exceed a 2$ 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 use. During this adjustment period, em an alarm system to alert employees when that dally rosters or summaries of those ployees will be trained in the uses, pur vinyl chloride concentrations exceed Die 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 the hazards of exposure to vinyl chloride. lar type of respirator In use. asserted that such control of access was Moreover, each employee will be notified (8) Hazardous operations. Tills Is a not necessary from a health standpoint. In writing if he has been exposed in ex new section within the final standard. It Secondly, It was claimed that these con cess of the permissible exposure limit. encompasses essentially the proposal's trols would interfere with operations by Where exposures exceed a 25 ppm cell requirements for maintenance and de preventing access of needed employees or ing, respiratory protection Is mandatory contamination but has restated them In non-employees, such as contractors, In light of our judgment that much terms of performance language to allow truck drivers, customers and consultants. greater risks are associated with such greater flexibility for employers to deal The purpose of establishing regulated exposures. 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 w'ould be mains. The final standard amends the atmosphere-supplying respirators have 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 tor The proposal's requirement tor full- continue without undue Interference. each devlca. 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 mi 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 (?) 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 ol 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 BPI and B. F. 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 end B. F. Goodrich) (TR terms of an unexpected massive release. that the "no detectable level" would ef 85 ff) We had originally omitted alr- The main objection to the section on fectively require continuous wearing of purifylng 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 dicators to signal the expiration 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 them. 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 alr-purlfylng 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 cliloride 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 exposure limit, and that such excursions duced so that respirators arc necessary ratories regarding the effectiveness of need not be reported. only occasslonally. However, wc 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 posthearing 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" appear on the objections, mul have ronclmli-d that vinyl chloride nt relatively low concen all signs and labels. The principal argu- C 33 CD O FfOEtAL REGISUI, VOl. 39, NO. 194--FRIDAY, OCTOBER 4. 1974 URL 17902 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 dally roster agent" scares employees and that in which ore useful lor 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, the specific blood tests proposed ployer is required to maintain medical stance (TR. 347). We believe that a have been retained as a minimum re records for the duration of an employee's diluted form of warning will not suffice. quirement to assist the examining physi employment plus 20 years, or 30 years, We appreciate the concern of employers cian In determining fitness of potential whichever is longer. The original pro with the reaction of their employees. But employees for assignment to workplaces posal called for only 20 years. we consider it Imperative that a worker Involving VC exposure. Zn addition, al Ibis change has been implemented be be fully informed, and that he realize the ternative medical examinations may be cause the latency period for induction of possible risks involved in his occupation. used where the examining physician de angiosarcoma ranges up to 30 years from Coupled with the training requirement termines that they are at least as good initial exposure. Therefore, as a mini in the standard, we believe that the signs as those specified by the standard. mum, medical records must be main and labels required will adequately In- The Tabershaw-Cooper study and the tained for at least that long. It should be form employees of the hazard. In addi various animal experiments suggest that noted that spokesmen for both labor and tion, such signs will warn unauthorized VC may produce a wide spectrum of ma industry recommended that this change personnel to keep out of regulated areas. lignant and non-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. Ho additional specific which result in the release of VC Ipto that could be prescribed would result In procedures or testa 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 Oh 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 testa, it is not for filing a detailed, written report symptoms, etc. The addition of suitable appropriate to prescribe timing, or type within is days has been deleted. It has Information by the employer would be of followup testa, 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 testa. Instead, the employer cludes facta Immediately available, would The requirement in the proposal for is required to obtain a statement from ordinarily be sufficient. However. If the labeling containers of vinyl chloride has the examining physician of the em OSHA Area Director requests further In been amended by deleting the reference ployee's suitability for continued expo formation relevant to the emergency, the to the possible hazard of violent polym sure, when the examining physician has employer will be required to furnish such erization. Very little information was completed such testa as he considers ap information. developed on this hazard during the propriate. The employer is required to (14) Deleted portions of the proposal. standard-setting procedure. It does ap withdraw an employee only when this The proposal contained provisions re pear that this hazard is essentially under statement Indicates that the employee quiring that shower facilities and change control and that the fire and carcino may be at added risk from continued VC rooms be provided, and that storage or genic hazards at present are the most exposure. consumption of food be prohibited in significant. Since labeling or placarding As with monitoring, there appears to regulated areas. We have deleted these that is in compliance with the U.8. De be no basis for complete exemption of the provisions because it Is our conclusion partment of Transportation regulations fabrication industry from the require they are no longer necessary. Showering (49 CFR Part 173. Subpart H> already ment for medical examination. The rec facilities are not required because pro warns of the fire hazard, only a state ord does show fabricating establishments tective clothing, where required by the ment concerning the carcinogenic -haz with concentrations of VC monitored final standard, should protect employees ard need be added to the Department of considerably above the action level. In from skin absorption by direct contact Transportation labels. these instances, medical surveillance of with VC and because there Is no reliable (ID Medical svrveiUanee. The princi affected employees will provide baseline evidence that VC vapor is absorbed pal questions that have been raised re data for future evaluation of their health, through the skin. Iq 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 concerning the carcinogenic hazard of The proposal also contained provisions commonly discussed lesion, angiosar VC, emergency procedures, the need for on maintentance and decontamination, coma of the liver, currently cannot be monitoring and an annual review of the transportation loading and unloading, diagnosed until the victim is terminal standard. It also provides for training of and polymer handling operations. These and. usually, within months of death. employees concerning the purpose for, requirements are not mentioned in the Precursor physiologic alterations, which proper use of, and limitations connected final standard because attention to these might be reversible, have not yet been with respiratory protection. items is implicit In the requirement that directly associated with the lesion. Con 03) Records and reports. The provi each employer reach the permlssable ex sequently. there are no specific diagnos sions for recordkeeping contained In the posure limit or attain the lowest feasible is 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) Effectiw 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 RDEItAl KfGISTEB, VOl. 39, NO. 194--FRIDAY, OCTORU 4, 1974 \ URL 17903 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 familiarise dent in the operation, which would result ing, and measuring required by this 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: 11910.93q will be January 1.1975. 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 #1910.93q are hereby area In which the employer's establish (11) Vinyl chloride concentrations are promulgated, pursuant to section 6(b), ment is located. tot 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 authorised persons. A daily October 4. 1974, the amendment to cated product. roster shall be made of authorized per 11910.93Q set out below will supersede (10) "Vinyl chloride" means vinyl sons who enter. these provisions as of January 1, 1975. chloride monomer. <f> Method* of compliance. Employee Accordingly, upon consideration of the (e> Permissible exposure limit. (1) No exposures to vinyl chloride shall be con whole reccrd 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 hi paragraph (c> is amended, effective January 1,1975, by averaged over any B-hour period, and of this section by engineering, work prac revision of i 1910.93q to read as follows: (3) No employee may be exposed to tice. and personal protective controls as 11910.9Sq Vinyl chloride. vinyl chloride at concentrations greater follows: than 5 ppm averaged over any period not (1) Feasible engineering and work (a) Scope and application. (1) This 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 st or below control of employee exposure to vinyl vinyl chloride' by direct contact with the permissible exposure limit. . chloride (chk>roethese), Chemical Ab liquid vinyl chloride. (2) Wherever feasible engineering and stracts Service Registry No. 75015. <d> Monitoring, (l) 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 ehlorlde, 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 (2) 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 hows any employee exposures, without and Implemented toreduce exposures to chloride except to Use 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. (b> Definition*. (I) "Action level1* gram: (3) Written plans for such a program means a concentration of vinyl chloride (1) Shah 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 tilt permissible exposure limit. tant Secretary and the Director. Such Assistant Secretary of Labor for Occupa (U) Shall be repeated not lees than plans shall be updated at least every six tional Safety and Health, TJ3. Depart quarterly where any employee Is exposed, months. ment of Labor, or his designee. without regard to the use of respirators, (g) Respiratory protection. Where (8) "Authorised person" means any in excess of the action leveL respiratory protection Is required under person specifically authorized by the em (111) 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 of <4> "Director" means the Director, duction. process or control change which each employee for exposures not in ex National Institute for Occupational Safety and Health, US. Department of may result In an Increase in the release of vinyl chloride, or the employer has cess of 25 ppm, measured over any 15mlnute 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 tt> "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 this 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 (8) "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 Mining 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 the "NIOSH Manual of Analytical meeting the requirements of 51910.134 operation, procedure, or activity where a Methods"). shall be established and maintained. release of either vinyl chloride liquid or (5) Employees or their designated rep (4) Selection of respirators for vinyl gas might be expected as a consequence resentatives shall be afforded reasonable chloride shall be as follows: FEDERAL MOIST!*, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 URL 17904 r RULES AND REGULATIONS 35897 Atmospheric concentration of vinyl chloride 41) Unknown, or above 8,600 ppm.. (11) Not orir 8,600 ppm__ _______ (IK) Not over iOOppm-------- Acquired apparatus Open-cIreuU. Mlf-oontaioed bnotblsf apparatus, pres sure dtmud typs, with full fievpiM. (A) Combination typo C supplied sir respirator, proa sure demand typo, with full or hell facepleca, end auxiliary eelf-contalced air supply; or (B) Typo O, supplied sir respirator continuous flow typo, wttb full or bolt fscepleoo. and auxiliary self-contained air supply (A) Oomblnatlon type C supplied air respirator de mand type, with fun facepiece, and auxiliary self-contained air supply; or (B) Open-circuit self-contained breathing apparatus wtthfuh laeeplece, In demand mode; or (O) Type 0 supplied air respirator, demand type, with full facepiece. (vi) The purpose for. and a descrip tion of, the medical surveillance program; (11) Emergency procedures; (rill) Specific information to aid the employee In recognition of conditions which may result In the release of vinyl chloride; and 3 (la) 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 fie) Not over 36 ppTM (A) A powered air-purifying respirator with hood, tuted for each employee exposed, with helmet, full or half facepiece, and a canister out regard to the use of respirators, to which provides a service ills of at least 4 vinyl chloride in excess of the action hours for eoneeorations of vinyl chloride up level. The program shall provide each to 26 ppm, or such employee with an opportunity for (v) Nfft TTtr ' < " .. - ------------- (B) Gas mask, front- or back-mounted canister which provides a service life of at least 4 hour* for concentrations of vinyl chloride up to 38 ppm. (A) Combination typo C tupplled-alr respirator, de mand type, with half facepiece, and auxiliary self-contained air supply; or (B) Type C supplled-air respirator, demand type, with hw facepiece; or (O) Any chemical cartridge respirator with an organlo vapor cartridge which provides a service life ' of at least 1 hour for concentrations of vinyl chloride up to 10 ppm. examinations and tests In accordance with this paragraph. All medical ex aminations and procedures shall be per formed by or under the supervision of a licensed physician, and shall be provided without cost to the employee. (l) At the time of initial assignment, or upon'Institution of medical surveil lance; (1) A general physical examination shall be performed, with specific atten tion to detecting enlargement of liver, . (5) (1) Entry into unkown concentra (3) Protective garments shall be pro spleen or kidneys, or dysfunction In these organs, and for abnormaltles in skin, tions or concentrations greater than 96,000 ppm (lower explosive limit) may be made only for purposes of life rescue; vided clean and dry for each use. (1) Emergency situations. A written operational plan for emergency situa connective tissues and the pulmonary system (See Appendix A). (U) A medical history shall be taken, and <U> Entry Into concentrations of less than 96,000 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 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 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; hazard from release of vinyl chloride. provide that: (D) Past history of blood transfu (6) Where air-purifying respirators are used: (1) Alr-purlfylng cannisters or car (1) Employees engaged In hazardous operations or correcting situations of ex isting hazardous releases shall be sions; and ' (E) Past history of hospitalizations. (Ill) A serum specimen shall be ob 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 equipped as required 1q paragraph (h) of this section; (2) Other employees not so equipped shall evacuate the area and not return tained and determinations made of: (A) Total bilirubin; <B) Alkaline phosphatase; (C) Senim glutamic oxalacetlc trans 01) 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. (T) Apparatus prescribed for higher concentrations may be used for any lower concentration. <h) Hazardous operations, (l) Em ployees engaged in hazardous operations, until conditions are controlled by the methods required in paragraph (f> of this section and the emergency is abated. (J) Training. Each employee engaged in vinyl chloride or polyvinyl chloride operations shall be provided training in a program relating to the hazards of vinyl chloride and precautions for Its safe use. (1) The program shall Include: (1) The nature of the health hazard from chronic exposure to vinyl chloride including specifically the carcinogenic hazard; aminase (SOOT); (D) Serum glutamic pyruvic transam inase (SOPT); and (E) Gamma glustamyl transpeptldase. (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 <U) Annually for all other employees. (3) Each employee exposed to an emergency shall be afforded appropriate including entry of vessels to clean poly (U) The specific nature of operations medical surveillance. vinyl chloride residue from vessel walls, shall be provided and required to wear and use: which could result In exposure to vinyl chloride In excess of the permissible limit and necessary protective steps; (4) A statement of each employee's suitability for continued exposure to vinyl chloride Including use of protec (1) Respiratory protection in accord (11) The purpose for, proper use, and tlve equipment and respirators, shall be ance with paragraphs (c) and (g) of limitations of respiratory protective obtained from the examining physician this section; and <U> 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- ted each employee. (5) If any employee's health would be hall be selected for the operation and (v) The purpose for and a description materially impaired by continued ex Its possible exposure conditions. of the monitoring program; posure, such employee shall be wlth- FIDEtAl REGISTER, VOL 36, NO. 144--FRIDAY, OCTOSEt 4, 1474 URL 17905 35898 RULES AND REGULATIONS 4rawn 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. (6) Laboratory analyses for all bio Information or Instruction. Including maintenance. logical specimens included In medical <m) Record*. (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> (1) of this section. If the employer (I) Monitoring and measuring records exposed, without regard to the.use of obtains a statement from the examining physician setting forth the alternative examinations and the rationale for sub stitution. This statement shall be avail hall: (A) State the date ol such monitor ing and measuring and the concentre-' tions determined and identify the Instru 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 (B> Include any additional Informa being token to reduce, the exposure to the Assistant Secretary and the Director. (1) Signs and labels. (1) Entrances to Tegrulated areas shall be posted with leg ible signs bearing the legend: Csw-aesracT Aenrr Aaa* Actkciub Pxasottwsfc Onv 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 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 wrists shall be posted with legible signs bearing the legend: CAven-SosracT Aonrr m This Aui Florae- 30 years. (II) Authorized personnel rosters shall be maintained for not less than 30 yean. till) Medical records shall be main tained for the duration of the employ ment of each employee plus 20 years, (2) Effective January 1, 1975, the pro visions set forth In 11910.93q of this Part shall apply. Amxoiz A OpmoctstAtT Medical JlfTQBMATUnr tt* ZonriosT Bsemass Atmoaaso PotaoMMu. On>v <3) Containers of polyvinyl chloride resin waste from reactors or other waste contaminated with vinyl chloride shall be legibly labeled: or SO years, whichever is longer. (3) In the event that the employer ceases to do business and there is no successor to receive and retain his rec ords lor the prescribed period, these rec ords shall be transmitted by registered When nqUM tacts under paragraph (k)(l) of this section show abnormalities, tbo tests should be repeated ae soon as prac ticable, preferably within S to 4 weeks. If tecta remain abnormal, eonatderatlon should be given to withdrawal of the employee from contact with vinyl chloride, while a more Contaminated with Tom Csunns CAHcm-Svener Ascwr mail to the Director, and each employee comprehensive examination la made, Individually notified in writing of this Additional tecta which may be useful: transfer. A. Fee kidney dysfunction: urine examina (4) Containers of polyvinyl chloride - shall be legibly labeled: FoLYvum. Csuun (oa Hues.Hams) Contains Warn. Cut-cams am. Chlcsxde is a Camc-8usp*ct Aoxjtt (4) Employees or their designated representatives shall be provided access to. examine and copy records of required monitoring and measuring. (6) Ftormer employees shall be pro vided access to examine and copy re tion for albumin, red blood cells, and ex foliative abnormal cells. B. Pulmonary system: Forced vital capac ity, Forced expiratory volume at 1 second, and cheat roentgenogram (posterior-anterior, ' 14 x 17 Inches). C. Additional serum tecta: lactic acid de (fi) Containers of vinyl chloride shall be legibly labeled either: tt) urn. OLoanta XrrasMSLY Plammabls Oas Ona Fasssoas CAKen-flosracr Aeotr or til) In accordance with 19 CFR Part 273, Subpart H, with the additional quired monitoring and measuring records reflecting their own exposures. (0) 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 hydrogenase, lactic acid dehydrogenase isoenzyme, protein determination, and protein electrophoresla D. For'a more comprehensive examination on repeated abnormal serum testa: Hepatitis B antigen, and liver scanning. (Sees. and 8, 84 Stat. 1888. 1688 (28 UH.C. 8S6, 867); Secretary of labor s Order No. 12-71,96 FB 9754) legends: shall be reported to the OSHA Area Di 81gned at Washington, D C., this 1st Gsifcza-StTsrtcT Aoekt * applied near the labor or placard. (g) No statement shall appear on or rector. Any changes to such Information shall be reported within 15 days. (1) The address and location of each establishment which has one or more (lay of October, 1974. John Stxndeh, 'AsfUtant Secretary of Labor. near any required sign, label or instruc regulated areas; and |FR DOC.74-23176 Filed 10-1-74:9:54 pm) KDUAl UGISTM, VOL 39, NO. 194--FIUDAY, 0CI08U 4, 1974