Document BRezB11yE67eOZO730qNQw2bm

FRIDAY, OCTOBER 4, 1974 WASHINGTON, D.C. Volume 39 = Number 194 PART II department of LABOR Occupational Safety And Health Administration exposure to vinyl CHLORIDE Occupational Safety and Health Standards ASI 0022715 33890 RULES AND REGULATIONS Title 29--Labor ployees from a rare liver cancer (angio and abroad, OSHA proposed to revise CHAPTER XVI!--OCCUPATIONAL SAFETY sarcoma) may have been occupationally 1910.93q and published a comprehensive AND HEALTH ADMINISTRATION, DE related. As -a result of this notification proposal (39 FR 16896) on May 10, 1974, PARTMENT OF LABOR and after consultation with NIOSH, and to protect employees from hazards of PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS 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 Standard for Exposure to Vinyl Chloride ing hearing was announced on Janu sampling and analytical method sensitive Pursuant to sections 6(b), G(c). and 8>c) of the Occupational Safety and Health Act of 1970 (84 Slat. 1593, 1596, 1599; 29 U.S.C. 655, 657) Secretary of I,abor's Order No. 12-71 (36 PR 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. I. Background--11) Vinyl chloride. Vinyl chloride (chloroethcne), Chemical Abstracts Service Registry No..75014, is a synthetic organic chemical made from ethylene or acetylene and chlorine by any of several processes. It is the parent compound of a series of thermoplastic resin .polymers and copolymers which are widely used for containers, wrapping film, electrical insulation, pipe, conduit, and a variety of other industrial and consumer products. Vinyl chloride has been made commercially In this country since 1939, and present production is in excess of seven billion- pounds per year. The vinyl chloride Industry divides- into three segments: monomer production, polymer production, and fabrication. Production of the monomer is a largescale continuous process, involving only a few firms. There are comparatively few employees in this segment of the indus try, because the processes lend them selves to automation. Vinyl chloride (VC) is used primarily in the production of polyvinyl chloride (PVC), a resin which is produced through batch processing. The conversion of the VC monomer into a polymer or copolymer is an incomplete process, i.e,, not all of the monomer is reacted. PVC is fabricated by a variety of tech niques, Including extrusion, injection molding and calendering, to form a fin ished product that needs no further chemical handling. The vast majority ary 30, 1974 (39} FR 3374) and held on February 15, .1974. Information obtained from this hear ing, particularly the preliminary reports of experiments conducted by Professor Ccsarc Maltoni of the Institute di Oncologia, Bologna, Italy, demonstrated that vinyl chloride induced angiosarcoma in rats at levels as low as 250 ppm, and in other species at higher levels. Experi ments performed at lower levels of ex posure were not completed at that time. Other testimony from medical witnesses and NIOSH, and the results of autopsies, led to the conclusion that the Goodrich workers had angiosarcoma of the liver and that VC probably vTas,the causal agent in the angiosarcomas observed. In post hearing comments, additional angiosarcoma deaths were reported among workers who had been exposed to VC in plants operated by Union Carbide Corporation, Firestone Plastics Corpora tion and Goodyear Tire & Rubber Com pany. On the basis of all information avail able at that time, and the fact that em ployees were being exposed at levels around the experimentally observed ef fect level of 250 ppm, an emergency temporary standard (ETS) was promul gated cxn April 5, 1974 (39 FR 12341) pursuant to section 6(c) of the Act, as 29 CFR 1910.93q. This standard reduced the permissible exposure level from a ceiling of 500 ppm to a 50 ppm ceiling, and established other requirements, including, for example, monitoring and respiratory protection. It was expressly recognized that this standard limiting exposures to a 50 ppm ceiling was a tentative, interim standard, and that the whole question of exposure to VC would be considered more fully in the light of additional information, especially the results of experiments which were known to be underway at that time. to 1 ppm, with an accuracy of 1 ppm 50 percent. The proposal also called for the establishment of regulated areas and limited access to such areas to au thorized persons. A requirement for monitoring of employee exposures was proposed, along with engineering and work practice controls to be implemented when exposures over the detectable limit were measured. Respiratory protection would have been required while engineering and work practice controls were being implemented or where exposures exceeded 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 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, omMay 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 Jime 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 of employees involved in the VC industry are employed by fabrication firms. Such 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 firms range in size from those with few employees and simple equipment to large plants involving many employees and OSKA, 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, Ulinols,. examination, of witnesses. 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. concerning results of animal exposure studies with VC. These studies were sponsored by the Manufacturing Chem ists Association. Although only pre liminary in nature at that time, these results revealed that 2 out of 200 mice exposed to VC concentrations of 50 ppm for 7 hours a day, five days a week, for approximately 7 months, had developed - (5) Economic and technical impact study..During the hearing, OSHA deter mined that), additional facts would be needed to determine the practicality of certain.aspects of the proposed stand ard. Accordingly, OSHA contacted an in dependent consultant, Foster D. Snell Corporation,, to conduct studies of the feasibility of compliance at various ex (2). The emergency temporary stand angiosarcoma of the liver. posure levels, including those proposed ard. On January 22, 1974, the Occupa (3) The proposed permanent stand by OSHA and'others advanced by in tional Safety and Health Administra ard. Based on the demonstrated evidence dustry spokesmen. Snell was also com tion (OSHA) was informed by the Na of VC's carcinogenicity in three, animal missioned to collect information regard tional Institute for Occupational Safety species (rats, mice and hamsters), and ing the economic costs of compliance. and Health (NIOSH) that the B. F. the substantial probability that VC had This action, was announced at the close Goodrich Chemical Company had re been the causal agent in the cases of liver of the hearing, and Judge Myatt further ported that deaths of several of its em angiosarcoma found in workers both here announced'that the record would be kept FEDERAL REGISTER, VOL, 39, NO. 194--FRIDAY, OCTOBER 4, 7974 ASI 000Z2716 RULES AND REGULATIONS 35891 open lor a period of time beyond August studies of Maltonl and Bio-Test Labora may create a carcinogenic hazard, the 23, to allow interested persons to com- tories. Moreover, Maltoni's investigations amount of exposure which is hazardous m'ent in writing on the study. On August have demonstrated a dose-dependent re must be determined. The Surgeon Gen 26, 1974, OSHA announced that the pre lationship for induction of tumors (i.e., eral's Ad Hoc Committee referred to liminary study was available and that more tumors occur at1 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 G, 1974 (39 PR 30844). liver, in rats. The investigations of In scientifically determined. This position On September 13, 1974, OSHA invited dustrial Bio-Test Laboratories have dem is supported by the testimony of NIOSH comments on both the preliminary and onstrated a similar relationship for at the hearing, its recommendations for the final study, which was to be received both rats and mice. These investigators a standard of no detectable level, and by-, on or before September 25, 1974 (39 FR have induced angiosarcoma, of the liver the testimony of expert witnesses from 33009). in rats and mice at exposure concentra the National Cancer Institute. (6) Environmental impact statements. tions of 50 ppm, and in hamsters at high Several witnesses and persons who sub A notice of intent to file an environmen er concentrations of exposure. Additional mitted comments have taken a contrary tal impact statement assessing the im tumors involving other organs, including view and have suggested that man is less pact of a proposed standard on occu the kidneys, lungs, and skin of exposed sensitive to biologic aberrations Induced pational exposure to VC was published animals, were also observed in frequen by vinyl chloride exposure than experi in the Federal Register on April 24, cies much in excess of control animals. mental animals. Proponents of this posi 1974 (33 FR 14522), The notice invited The incidence of tumors in mice in the tion have argued that if humans wehe as any person having information or data Industrial Bio-Test Laboratories investi sensitive as rodents, an "epidemic" of on the environmental impact to submit gations is particularly pertinent. Of 200 cancer resulting from VC exposures it to 03HA by May 17, 1974. On June 12, mice (100 males, 100 females) exposed to should have already been discovered 1974, a draft environmental impact 50 ppm of vinyl chloride by inhalation for among employees. They also argue that statement was prepared and circulated eleven months, 100 died. Sixty-four ani the employees in whom tumors have been to all Interested persons. Ten copies were mals died without gross postmortem observed are those who have considerable forwarded to the Council of Environ mental Quality (CEQ), which published pathologic examination being performed. Of the 36 remaining animals for which employment experience as polymeriza tion reactor cleaners. Because it is gen a notice of its filing and availability in the Federal Register on June 25, 1974 (39 FR 22975). A 45 day period was al lowed for the submission of comments on the draft statement. On September 5, 1974, the flnai 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 experJGjtfcavailable to OSHA. The en tire record encompassing these submis sions was thoroughly reviewed and evaluated in reaching the determina tions set forth below. n. Findinc/s regarding carcinogenicity, exposure levels and feasibility--(1) Car a gross postmortem pathologic examina erally agreed that reactor cleaning in tion was performed, 13 (36 percent) volved high exposures to vinyl chloride were found with liver tumors (including in'years past, it Is argued that the lower angiosarcomas), 21 (58 percent) with levels currently found in the workplace lung tumors, 9 (25 percent) with skin have not induced cancer and are there tumors, and one with a kidney tumor, fore safe. We reject this argument. According to the 1970 report by the The fact that approximately three- Surgeon General's Ad-Hoc Committee quarters of those employees with the on the Evaluation of Low Levels of En longest exposure to VC (greater than vironmental Chemical Carcinogens, the 20 years since Initial exposure) have not finding of cancer in two or more animal yet been located, makes it Impossible to species may be extrapolated to indicate determine the actual number of affected a carcinogenic hazard to humans. Here, employees. The cases of liver tumors ob such a finding was made in three species served to date have an average latency that were exposed to VC by inhalation-- period, since initial exposure, of approxi a route comparable to employee ex posure. In addition, there were at least mately 20 years. If It is assumed that in duction of angiosarcoma Is a dose-re 13 confirmed cases of angiosarcoma of lated phenomenon, and if employees en the liver among employees exposed to gaged in cleaning reactors did, in fact, VC, a particularly significant number in view of the extreme rarity of this cancer in the U.S. adult male population (testi receive larger doses of vinyl chloride, It would be expected that such tumors would be observed earlier for this em mony of Dr. Marcus Key, Director of NIOSH, at the rulemaking hearing). The findings of angiosarcoma of the liver in both experimental animals and exposed employees is compelling evi dence that exposure of humans to vinyl chloride induces this tumor. Industry spokesmen, at the hearing, conceded that VC is carcinogenic for humans (e.g. testimony of Dr. McBumey, Rulemaking hearing, 1041). Accordingly, it is con cluded that VC must be regarded as a human carcinogen, and the probable causal agent of angiosarcoma of the liver, and that exposure of employees to VC must be controlled. Additional evidence of tumor Induction in a variety of other organs, including lung, kidney, brain and skin, as well as non-malignant alterations, such as fi brosis and connective tissue deteriora tion, indicates additional oncogenic and toxicologic properties of vinyl chloride, which must be considered in establishing control regulations. (See testimony and results of studies by Bio-Test Labora 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 necessarily 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. Schnelderman of the Na tional Cancer Institute emphasized dur ing his testimony that only about a fifth of longer-term heavy smokers develop lung cancer. Accordingly, the industry contention that exposure levels have been dramatically reduced- since the 1940's is not reliable evidence that cur rent levels of exposure are safe. Some Industry spokesmen also sug gested that the apparent nonrandom distribution of observed cancer in em cinogenicity of vinyl chloride. The car tories, Tabershaw-Cooper, Maltonl, ployees may indicate an exposure thres cinogenicity of vinyl chloride for three NIOSH, and Sellkoff.) hold for tumor Induction, based on varia animal species (rat, mouse, hamster) has (2) Exposure limits. Upon finding that tions in the workplace design or prac been documented on the record by the exposure of employees to vinyl chloride tice and resultant employee exposures FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 AS I 00022717 :r>S92 RULES AND REGULATIONS (testimony and questioning by Tcnneco e.g., testimony of Selikoff, Firestone, NCI, confident that industry will continue to Chemicals, Inc.). It has also been em and NIOSH.) do so. phasized that in only 3 of 8 polvmeriza- In our view, the demonstration of can (4) Conclusions. The conclusions be ion plants where employees have been cer induction in humans at a particular low are based on a thorough review and Jxposed to VC for more than 20 years level is not a prerequisite to a determina evaluation of all the evidence submitted. have any employees developed angiosar tion that a substance represents a can Where decisions can be based on record coma of the liver. This argument is very cer hazard for humans at that level. It evidence, this has been done. Where, 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 vorkpractice 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 he factors in distribution of angiosar founded to assume that animals will not There is little dispute that VC is car coma, sufficient information is unavail develop tumors when exposed at concen cinogenic to man and we so conclude. able to exclude from consideration of trations of VC of less than 50 ppm. However, the precise level of exposure risk those employees in workplaces for Should a sufficiently large number of ex which poses a hazard and the question which cases of angiosarcoma have not perimental animals be exposed to VC at of whether a "safe" exposure level exists, been observed. concentrations of less than 50 ppm, cannot be definitively answered on the It has also been suggested that the Schneidcrman 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 05 percent of all employees ex quired a balancing process, in which the veyed did not include all workers who posed to VC. Indeed, several fabricators overriding consideration has been the had been exposed, and the missing em are already operating at this level (see protection of employees, even, those who ployees included many who had the SFI testimony). However, industry may have regular exposures to VC longer term (over 20 years) exposures. spokesmen have universally claimed that throughout their working lives. Moreover, the statistically insignificant it is infeasible for the VC and the PVC Based on the available evidence and in size of the sample population decreases industries to remain below 1 ppm con view of the above considerations, includ the possibility that tumors would be sistently, using engineering controls. In ing feasibility, we believe that employee observed. addition, the Knell study on technical exposures to VC must be reduced to a 1 Dow also presented preliminary data feasibility concluded that a 1 ppm ceil ppm time-weighted average (TWA). We in testimony at the hearing on the pos ing Is not feasible for the VC and PVC also believe that PVC and VC establish Js5iUbJ le metabolic pathways of VC. The industries with present technology, but ments will, in time, be able to attain that pothesls presented was that VC may that the VC Industry could currently at level through engineering controls, and ert its carcinogenic effect by a metab- tain lower exposure levels than the PVC that fabricators can do so in the im i'te, and that the metabolite is pro industry. Labor union spokesmen and the mediate future. ___ duced only when VC is metabolized by a Health Research Group, Inc., however, In addition to the TWA requirement, secondary metabolic pathway operating have suggested that such a level is at we have established a 5 ppm celling only when enzymes regulating the pri tainable. (averaged over a 15-minute period) In mary pathway are saturated, as would Since there is no actual evidence that order to prevent exposure of employees be the result at higher exposures. The any of the VC or PVC manufacturers to unacceptable high excursions. From preliminary data indicated the possi have already attained a 1 ppm level or In an operation standpoint, this ceiling bility of an additional pathway for fact instituted all available engineering level is realistic because minor excur metabolism of VC in rats exposed to con and work practice controls, any estimate sions up to the ceiling level are likely to centrations of VC in excess of 220 ppm. as to the lowest feasible level attainable occur on a regular basis. However, the occurrence of angio must necessarily involve subjective judg . HI. The final standard--Cl). Scope and sarcoma in both rats and mice at VC ment. Likewise, the projections of indus application. Both the ETS and the pro exposure concentrations of 50 ppm in try, labor, and others concerning feasi posal would apply, the standard to the dicates that if a metabolite of VC is the bility are essentially conjectural. Indeed, entire VC Industry, including manufac ultimate carcinogen, then it must be as Firestone has suggested, it Is not pos turers of VC and PVC and fabricators, generated at lower exposure concentra sible to accurately predict the degree of but excluding employers handling or tions in these species. Although this re improvement to be obtained from en using fabricated products mad from search may be helpful to the thorough gineering changes until such changes are (VC. understanding of the carcinogenicity of VC, It appears that it does not yet offer evidence which can assist in determina tion of safe exposure concentrations for employees, or even that such safe ex posures exist. A number of witnesses representing employers have stressed that there is no evidence of cancer, either In employees or experimental animals, at exposure concentrations of VC less than 50 ppm. (See e.g., testimony of Firestone, Tenneco Chemicals.) The conclusion of these witnesses was that no decision can be 1 actually implemented. We agree that the PVC and VC estab lishments will not be able to attain a I ppm TWA level for all job classifications in the neim future. We do believe, how ever, that they will, in time, be able to attain levels of 1 ppm TWA for most Job classifications most of the time. It is ap parent that reaching such levels may re quire some new technology and work practices. It may also be necessary to utilize technology presently used in other industries. In any event, the VC and PVC industries have already made great 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 (see testimony of Goodyear, Gen eral Cable, etc.) recommended that fabricators be excluded from the stand ard, or that a separate requirement be established for them because many of them were already at or below the pro posed ceiling level. The record evidence establishes that at least some employees in the fabricat ing Industry are exposed in excess of the made concerning risk of exposure to VC strides in reducing exposure levels. (See permissible control limits (See NIOSH ,t concentrations less than 50 ppm. testimony of Dow Chemical Co., TR 973). testimony, TR 106; Robintech TR 642). r On the other hand, the testimony of For example, B. F. Goodrich testified in these circumstances, we believe that it lost 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 (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 Is imprudent to grant a blanket exemp tion for all fabricators. Therefore, the final standard Is applicable to the fabri cation Industry, as well as the monomer FEDERAL REGISTER, VOL. 39, NO. 194--FRIDAY, OCTOBER 4, 1974 AS I 00022718 RULES AND REGULATIONS 35893 and polymer Industries. Employers who, temperature as PVC, for further pro below the action level, no further moni m fa-ct, are substantially below tire ex cessing, indicates that a potential for re toring is required unless the employer posure limit will be subjected to only lease of the residue still exists. It ap has reason to suspect that any employee minimal burdens by virtue of the "action pears that the exemption of fabricated is exposed in excess of the action level, level" to be discussed below. products should be limited to just those or unless changes have been made in Where employers in the fabricating items which will not undergo such mass production, process, control, type of resin, industry have exposures approaching the heating. Further, the opportunity to etc. permissible limit, they will appropriately demonstrate that exposures are below Where the exposure level, without re be subject to the standard. Employers the action level, and thus, discontinue gard to respirators, exceeds the permis handling or using fabricated products many duties of the standard, provides a sible levels, monitoring must be conduc made of PVC were not included in the more positive control and an adequate ted at least monthly, where exposures ETS or the proposal and are excluded relief, ^ ~ ~"\ are less than the permissible levels, but from the final standard. This conclusion /'""T27 PirrnfflisTble exposure limit. The] greater than the action level, monitoring is based on the absence of adequate evi ' standard sets an exposure limit of 1 ppm / must occur at least quarterly. dence of exposure to VC in these opera- : averaged over any 8 hour period, and a/ (5) Methods of compliance. The stand tions. The final standard clarifies the ex-/ ceiling of 5 ppm averaged over any per-/ ard, like the proposal, requires that em eruption by defining a fabricated prod-j iod not exceeding 15 minutes^,----------- ployers immediately institute feasible net as a product made wholly or partly "Tfiore fully--dlscOssed^abovc, this engineering and work practice controls from PVC which does not require further limit is based on an evaluation of the best to reduce exposures to at or below the processing at temperatures, and for available evidence and on a judgment permissible exposure limit. times, sufficient to cause mass melting of that the health and safety of employees Where feasible engineering and work the PVC. SPI and others (of. 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 releases below the permissible levels, they must 0.1 percent residual monomer be ex of VC in the VC and PVC manufacturing be Instituted. Where such controls will empted from the regulation now, and processes are variable, the 1 ppm celling not reduce exposures below the permis that the exemption level be reduced to level provided in the proposal would sible level, they must nonetheless be im 0.01 percent in three years. SPI suggested require maintenance of an average level plemented to reduce exposures to the that the exemption of materials with less significantly more difficult to attain lowest practicable level, and be supple than 0.1 percent of 14 carcinogens from through feasible engineering controls. mented by the use of respirators to pro 29 CFR 1910.93p (39 FR 3756) 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 comparable, 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 for an "action level" of 0.5 ppm est practicable level. When exposures are include 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 the In addition, a plan for achieving con not exempt airborne traces of carcino standard on the employers who have trol by engineering and work practice gens. The administrative cutoff was pro attained exposure levels well below the methods must be drawn up and be made vided to avoid regulation of materials permissible limit. Thus, where the re available, upon request, to represent about which there was no health haz sults of monitoring under paragraphs atives of-OSHA and NIOSH. ard information, and which would have (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 0.5 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 concent; ation 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 to 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 PVC reduction, would seem to indicate that has reason to suspect that any employee industries. Some industry spokesmen, SPI has doubts about the safety of 0.1 is exposed in excess of the action level. including SPI (TR. 358-362), recom percent residue level. Diamond Shamrock In our judgment, exposures below the mended fihat a schedule of different per- (Exhibit 142) testified that there is no action level do not present a sufficient missile exposure limits and compliance direct relation. They indicate that the hazard to warrant application of the en dates be established for the VC and PVC airborne concentration is more related tire standard to the many employers who segments of the industry. to the physical form of the resin and are or will be below that level. This view assumes that the ability and the ventilation provided. Also, monitor (4) Monitoring. The final standard, the time required to feasibly reach in ing data from industry (cf. Exhibits 131, like the proposal, requires that Individual creasingly lower control levels is similar 168, 170) and OSHA (Exhibit 151) indi employee exposure levels be determined. within each Industry, but differs mark cate that levels in excess of I ppm may This may be accomplished by personal edly between industries. While the record be found in fabrication operations. In or area monitoring. Some witnesses and does suggest that such differences do view of these facts and of the opportunity persons who submitted comments did exist between industries, as noted above, for employers to discontinue many duties not understand the meaning of the term it Is clear that Intra-Industry differences upon a showing of no exposures above the "95 percent confidence level" in the also exist. Thus, the ability and time re action, level, it does not appear that any proposal. Essentially it means that the quired by each employer to attain lower residue exemption Is either justified or employer is required to take a sufficient control levels. may depend upon such necessary at this time. This coux-se also number of measurements so that the re factors as the climate In which the plant agrees with a number of industry pro sults obtained are statistically valid. We is located, the age of equipment, the size posals (cf. TR 660). have modified the proposal to establish of reactors, or the type of resin manu-' SPI (TR 345), among others, asked that compounded PVC pellets be ex empted from the standard on the grounds that the pellets had too low a residue to cause harmful or measurable emissions. While it appears that PVC pellets would have a lower residue level than virgin PVC, the fact that the pellets must be heated to a molten mass at the same 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 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 ASI 00022719 >>$94 RULES AND REGULATIONS nocring controls until full compliance is achieved. We have not established any deadlines for full compliance through engineering controls because ae are presently unable to determine when it will be feasible for most establishments to reduce exposure levels to the permissible level. We also believe that the requirement if the environmental level Is not con trolled to the permissible exposure limit, then employees must be afforded respira tory protection. While exposures in excess of the per missible level do constitute a hazard, we believe that it is necessary to mitigate some of the problems associated with implementing a program of respiratory trations. In discussions of these findings with NIOSH, it has indicated that it is willing to consider on an expedited basis the approval of air-purifying respirators for use against VC. Consequently, we have included three types of air-purify ing respirators in the list of acceptable units, subject to the approval of such units by NIOSH. The maximum concen 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 whoso exposures do (6) Regulated areas. The proposed not exceed a 25 ppm ceiling, may decline standard would have required that regu to use the respirator, in which case the lated areas be established, that access be employer is not obligated to require its limited to authorized employees, and use. During this adjustment period, em that daily rosters or summaries of those ployees will be trained in the uses, pur entering be kept for at least 20 years. In poses and limitations of respirators, and objection to these requirements, it was the hazards of exposure to vinyl chloride. asserted that such control of access was Moreover, each employee will be notified not necessary from a health standpoint. in writing if he has been exposed in ex Secondly, it was claimed that these con cess of the permissible exposure limit. trols would interfere with operations by Where exposures exceed a 25 ppm cell- preventing access of needed employees orv*ng> respiratory protection is mandatory strict administrative controls will be re quired for their use. Such controls in clude a program to assure timely re placement of canisters or cartridges and an alarm system to alert employees when vinyl chloride concentrations exceed the concentrations allowed for the particu lar type of respirator in use. (8) Hazardous operations. This is a new section within the final standard. It encompasses essentially the proposal's requirements for maintenance and de contamination but has restated them in non-employees, such as contractors, Hght 0f our judgment that much terms of performance language to allow truck drivers, customers and consultants, ft 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 h. The provisions in the final standard new section is to protect employees en risk of exposure to as few employees asjpVegarding the selection and use of respi- gaged in activities that present a risk of possible. Tliis concern is still paramount, v ratory protective devices differ from exposure to vinyl chloride in excess of the and thus the limited access feature re- .those in the proposal. The descriptions of permissible levels. An example would be mains. The final standard amends the A atmosphere-supplying respirators have the cleaning of a filter where resin con proposal slightly to allow "authorized>n-heen revised to indicate more clearly the taining high residual monomer is persons" to enter regulated areas. This '-3types of devices intended, and the maxi trapped. change, it is felt, will allow operations to vinum permissible concentration level for The proposal's requirement for full- continue without undue interference, $each device. Moreover, the number of body, Impervious clothing has been re Tile final standard has also increased the jtypes 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 g 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-v^garding the use of particular respiratory necessary, and is therefore not required mony, tr. 119.) devices. We have concluded that his sug- where less protection Is adequate. Since (7) Respiratory protection. The flngl^ eestions are meritorious. Therefore, the vessel entry falls within the definition standard, like the proposal, requires the x provisions for selection of atmosphere- of a hazardous operation, the vessel entry use of respirators where employee expose supplying devices follow closely the rec- section of the proposal has been deleted sures exceed the permissible control level. J ommendations contained In his testi- from the final standard. Industry representatives made-a number^ rnonv of SPT^nd-W--ja-jinnrii-iehT^ (TR (9) Emergency situations. The defini of objections to proposed requirements^ with Hyatt's 'suggestions! (See elgTresti- tion of emergency has been recast In for respiratory protection. They stated Vfnony of SPI and B. F. Goodrich) (TR terms of an unexpected massive release. that the "no detectable level" would ef- S5 ff) We had originally omitted Ef The main objection to the section on fectively require continuous wearing of purifying respirators because none had emergency situations in the proposal was respirators in PVC and VC plants, and been approved by NIOSH for use against that, as the term was defined, many that this is not feasible because respira VC, principally because they lacked in ordinary leaks or operations resulting in tors are cumbersome, present a safety 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 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 exposure limit, and that such excursions duced so that respirators are necessary ratories regarding the effectiveness of need not be reported. only occassionally. However, we cannot commercially available canisters and (10) Signs and labels. The thrust of the agree that respiratory protection should cartridges for vinyl chloride. These eval signs and labels section is to apprise not be required simply because it Is in uations were conducted separately by employees of the cancer and fire haz convenient, may require additional per sonnel, interferes with production, or may req'iire extensive retraining of em ployees nd restructuring of work practi Ve have carefully considered all NIOSH and by the B. F. Goodrich Com pany and submitted to OSHA in post hearing comments. The results indicate that certain presently available canis ters and cartridges effectively absorb ards. No objections have been raised with respect to informing -employees of the fire hazard. However, a number of ob jections were raised at the hearing and in written submissions to the require ment that the word "cancer" appear on the .sections, and 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 ASI 00022720 RULES AND REGULATIONS 35395 mcnt advanced against its use was that indicated that the medical tests proposed posal is the requirement for maintenance tLhJ e term "cancer" or "cancer-suspect are currently the only ones available of monitoring records and daily roster gent" scares employees and that in ivhich are useful for medical surveillance sheets of authorized persons for 30 years, stead, the message should contain in (TR 121, Exh. 95, TR 589-591). Conse instead of 20 years. Additionally, the em structions on how to deal with the sub quently, 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. In addition, al This change has been implemented be be fully informed, and that he realize the ternative medical examinations may be cause the latency period for induction of possible risks involved in his occupation. used where the examining physician de angiosarcoma ranges up to 30 years from Coupled with the training requirement termines that they are at least as good initial exposure. Therefore, as a mini in lire standard, wc 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 a the liver. No additional specific which result in the release of VC into that could be prescribed would result in procedures or tests'are required, but rec areas where employees may be exposed, an unwieldfr or excessively detailed leg ommendations have been included in the the final standard clarifies our original end. Consequently, the required message Appendix to assist the examining physi intent by stating that only emergencies on signs and labels will not include in cian. Because of the nonspecific nature must be reported. Also the requirement formation on precautions, relevant of tlje required medical tests, it is not for filing a detailed, written report symptoms, etc. The addition of suitable appropriate to prescribe timing, or type within 15 days has been deleted. It has information by the employer would be of followup tests, or to mandate with been concluded that submission, within permitted, providing it does not detract drawal from exposure based solely on re 24 hours, of an initial report that in in any way from the required statement. sults of the tests. Instead, the employer cludes facts immediately available, would 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 A11_cerrization, Very little information was completed such tests as he considers ap information. eveloped on this hazard during the propriate. The employer Is required to (14) Deleted portions of the proposal. tandard-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.S. 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 C49 CPR 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 (11) Medical surveillance. The princi affected employees will provide baseline evidence that VC vapor ,1s .absorbed pal questions that have been raised re data for future evaluation of their health, through the skin. In addition, since we garding medical surveillance are the even if both monitoring and medical sur anticipate that most employees will not necessity and efficacy of requiring cer veillance are discontinued because im be wearing protective clothing and that tain specific serum enzyme determina proved controls reduce concentrations employees who wear protective clothing tions (SMA-12 series) and the applica below the action level. Where exposures will change such clothing infrequently, tion of medical examination require are below the action level, the medical we are not requiring that change rooms ments to the fabrication segments of the surveillance requirements do not general be provided. industry where employees are exposed to ly apply. . In addition, we feel that there is in lower levels of VC. The objection has also (12) Training. A separate provision for adequate evidence showing that hazar been raised that the specification of tests employee training has been added to the dous amounts of VC can be absorbed and procedures interferes with the ap final standard rather than including it through ingestion. For this reason, the plication of advances in medical knowl within the section on emergency situa requirement prohibiting the storage or edge. tions as in the proposal. The new para consumption of food in regulated areas A particular difficulty in considering graph provides for training of employees has been deleted. medical surveillance is that the most commonly discussed lesion, angiosar coma of the liver, currently cannot be diagnosed until the victim is terminal and, usually, within months of death, SpTrLecursor physiologic alterations, which m.light be reversible, have not yet been Iirectly associated with the lesion. Con sequently, there are no specific diagnos tic tests which can be prescribed which will determine presence or absence of concerning the carcinogenic hazard of VC, emergency procedures, the need for monitoring and an annual review of the standard. It also provides for training of employees concerning the purpose for, proper use of, and limitations connected with respiratory protection. (13) Records and reports. The provi sions for recordkeeping contained in the final standard require the preparation and maintenance of essentially the same 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 reach the permissable ex posure limit or attain the lowest feasible level. , (15) Effective date. In order to ensure this tumor at an early stage of develop information required by the proposal. that affected employers and employees ment. However, most medical witnesses The major change from the original pro wifi be Informed of the existence of these FEDERAL REGISTER, VOL. 39, NO. 194--FRIDAY, OCTOBER 4, 1974 AS I 00022721 35896 RULES AND REGULATIONS provisions and Unit employers affected of the operation or because of an acci opportunity to observe the mon arc given an opportunity to familiarize dent in the operation, which would result ing and measuring required by 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 regu] effective date of the amendment to (3) "OSHA Area Director" means the area shall be established where: 5 1910.93q will be January 1,1975. To pro Director for the Occupational Safety (1) Vinyl chloride or polyvinyl chli vide continued protection for employees and,Health Administration Area Office is manufactured, reacted, repack; until that date, the provisions currently having jurisdiction over the geographic stored, handled or used; and contained in 5 1910.93q are hereby area in which the employer's establish (ii) Vinyl chloride concenti*ation; promulgated, pursuant to section 6(b), ment is located. in excess of the permissible exp; (he) 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 she safety and health standard effective mer before such is converted to a fabri limited to authorized persons. A < October 4, 1974, the amendment to cated product. roster shall be made Qf authorized 5 ]910.93q set out below will supersede (10) "Vinyl chloride" means vinyl sons who enter. these provisions as of January 1, 1975. chloride monomer. (f) Methods of compliance. Emp] Accordingly, upon consideration of the (c) Permissible exposure limit. (1) No exposures to vinyl chloride shall be whole record of this proofing, Part 1910 employee may be exposed to vinyl chlo trolled to at or below the permissibli of Title 29, Code of Federal Regulations ride at concentrations greater than 1 ppm posuro limit provided in paragraph is amended, effective January 1, 1975, by averaged over any 8-hour period, and of this section by engineering, work j revision of 1910.93q to read as follows: (2J No employee may be exposed to lice, and personal protective contro g 1910.93q Vinyl chloride. vinyl chloride at concentrations greater follows: than 5 ppm averaged over any period not (1) Feasible engineering and (a) Scope and application. (1) Tills exceeding 15 minutes. practice controls shall immedlatel section includes requirements for the (3) No employee may be exposed to used to reduce exposures to at or t control of employee exposure to vinyl vinyl chloride by direct contact with the permissible exposure limit. chloride (chloroethene), Chemical Ab liquid vinyl chloride. (2) Wherever feasible engineering stracts Service Registry No. TSOIS'. Off (d) Monitoring. (1) A program of work practice controls which can b (2) This section applies to the manu Initial monitoring and measurement stituted Immediately are not sufflcle facture, reaction, packaging, repackag shall be undertaken In each establish reduce exposures to at or below the ing, storage, handling or use of vinyl ment to determine if there Is any em mlsslble exposure limit, they shall n chloride or polyvinyl chloride, but does ployee exposed, without regard to the use theless be used to reduce exposure not apply to the handling or use of fabri of respirators, in excess* of the action the lowest practicable level, and she cated products made of polyvinyl chlo level. ' supplemented by respiratory prote< ride. (2) Where a determination conducted in accordance with paragraph (g) of (3) This section applies to the trans under paragraph (d)(1) of this section section. A program shall be establl portation of vinyl chloride or polyvinyl shows any employee exposures, without and implemented to reduce exposur chloride except to the extent that the regard to the use of respirators, in ex at or below the permissible expc Department of Transportation may cess of the action level, a program for de limit, or to the greatest extent fea; regulate the hazards covered by this sec termining exposures for each such em solely by means of engineering and tion. ployee shall be established. Such a pro practice controls, as soon as feasible. (b) Definitions. (1) "Action level- gram: (3) Written plans for such a pro; means a concentration of vinyl chloride (i) Shall be repeated at least monthly'' shall be developed and .furnished ' of 0.5 ppm averaged over an 8-hour work where any employee Is exposed, without request for examination and copyfr day. regard to the use of respirators, in ex authorized representatives of the A (2) "Assistant Secretary" means the cess of the permissible exposure limit. tant Secretary and the Director. I Assistant Secretary of Labor for Occupa (11) Shall be repeated not less than plans shall be updated at least ever; tional Safety and Health, U.S. Depart quarterly where any employee Is exposed, months. ment of Labor, or his designee. without regard to the use of respirators, (g) Respiratory ' protection. W (3) "Authorized person" means any in excess of the action level. respiratory protection is required u person specifically authorized by the em (ill) May be discontinued for any em this section:" ployer whose duties require him to enter ployee only when at least two consecu (1) The employer shall provld a regulated area or any person entering tive monitoring determinations, made not respirator which meets the requirem such an area as a designated representa less than 5 working days apart, showW eCxA-- .. of this paragraph and shall assure tive of employees for the purpose of ex posures for that employee at or b#eelloow|_.the employee uses such respirator, ex ercising an opportunity to observe moni the action level. pMtoring and measuring procedures. (3) Whenever there has been a t. Vthat until December 31. 1975, wearir ; respirators7 shall be~aFth__e__d_is_c__retio (4) "Director" means the Director, duction, process or control change which/ each employee for exposures not to National. Institute for Occupational may result in an increase in the release (cess of 25 ppm,, measured over any Safety and Health, U.S. Department of of vinyl chloride, or the employer has minute period. Until December 31. ` Health, Education, and Welfare, or his any other reason to suspect that any em- each employee w' EETchoos--es--no1t to~i designee. ployee may be exposed In excess of the an appropriate respirator shall be (5) "Emergency" means any occur action level, a determination of employee formed at least quarterly of the haz; rence such as, but not limited to, equip exposure under paragraph (d) (1) of this of vinyl chloride and the purpose, pri ment failure, or operation of a relief de section shall be performed. use, and limitations of respira 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 f (6) "Fabricated product" means a (with a confidence level of 95 percent) of among those Jointly approved by product made wholly or partly from not less than plus or minus 50 percent Mining Enforcement and Safety Adr polyvinyl chloride, and which does not from 0.25 through 0.5 ppm, plus or minus istration, Department of the Inte, require further processing at tempera 35 percent from over 0.5 ppm through and the National Institute for Occi tures, and for times, sufficient to cause 1.0 ppm, and plus or minus 25 percent tional Safety and Health under the"; 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 prog (7) "Hazardous operation" means any the "NIOSH Manual of Analytical, meeting the requiremehts of 1910 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 v gas might be expected as a consequence resentatives shall be afforded reasonable chloride shall be as follows: FEDERAL REGISTER, VOL. 39, NO. 194--FRIDAY, OCTOBER 4, 1974 AS I 00022722  /icf /Ll A- MtpJr,JS< Si ) * RULES AND REGULATIONS 35897 Atmospheric concentration of vinyl chloride y Required apparatus (vi) The pin-pose for, and a descrip tion of, the medical surveillance (I) Unknown, or above 3,600 ppm.. ftlOpeii-clrcull, self-contained breathing npparatvis, pres program; sure demand type, with full facoploce. (II) Not over 3,600 ppm_____ .. , , A; Combination typo C supplied air respirator, pres sure demand type, with full or half facepiece, ^A ,/ \\r ,i Not over 100 ppm____________ and auxiliary self-contained air supply; or 4t&) Typo C, supplied air respirator continuous flow type, with full or half facepiece, and auxiliary self-contained air supply. ,V(A) Combination type C supplied air respirator de mand type, with full facepiece, and auxiliary self-contained air supply; or tfAy(vB,) Open-circuit self-contained breathing apparatus with full facepiece, In demand mode; or (C) Type C supplied air respirator, demand type, with $> Not over 25 ppm_ full facepiece. (A) A powered air-purifying respirator with hood, helmet, full or half facepiece, and a canister which provides a service life of at least 4 hours for concenrations of vinyl chloride up (vii) Emergency procedures; (vili) Specific information to aid. the employee In recognition of conditions which may result In the release of vinyl chloride; and (ix) A review of this standard at the employee's first training and indoctrina tion program, and annually thereafter. (2) All materials relating to the pro gram shall be provided upon request to the Assistant Secretary and the Director. (k) Medical surveillance. A program of medical surveillance shall be insti tuted for each employee exposed, with out regard to the use of respirators,, to vinyl chloride in excess of the action level. The program shall provide each to 25 ppm, or such employee with an opportunity for (B) Gas mask, front- or back-mounted canister which examinations and tests in accordance Vi , provides a service life of at least 4 hours for with this paragraph. All medical ex concentrations of vinyl chloride up to 25 ppm. aminations and procedures shall be per '}ijy Not over 10 ppm_ -''(A) Combination type C supplled-air respirator, de formed by or under the supervision of a mand typo, with half facepiece, and auxiliary /' self-contained air supply; or [B) Type C 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. 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) (i) Entry Into unkown concentra tions or concentrations greater than 35,000 ppm (lower explosive limit) may be made only for purposes of life rescue; and (11) 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: (1) Air-purifying cannlsters 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 ih use. (7) Apparatus prescribed for higher concentrations may be used for any lower concentration. ? (h) Hazardous operations. (1) Em ployees engaged in hazardous operations, including entry of vessels to clean poly vinyl chloride residue from vessel walls, shall be provided and required to wear and use; (i) Respiratory protection in accord ance with paragraphs (c) and (g) of (2) Protective garments shall be pro spleen or kidneys, or dysfunction in these organs, and for abnormaltles In skin, vided clean and dry for each use. connective tissues and the pulmonary (i) Emergency operational plan situations. A written for emergency situa system (See Appendix A). (Ii) A medical history shall be taken, tions shall be developed for each facility including the following topics: storing, handling, or otherwise using vinyl chloride as a liquid or compressed (A) Alcohol intake; (B) Past history of hepatitis; gas. Appropriate portions of the plan (C) Work history and past exposure shall be implemented in the event of an to potential hepatotoxic agents, Includ emergency. The plan shall specifically ing drugs and chemicals; provide that: (1) Employees engaged in hazardous operations or correcting situations of ex (D) Past history of blood transfu sions; and (E) Past history of hospitalizations. isting hazardous releases shall be (iii) A serum specimen shall be ob equipped as required in paragraph (h) of this section; tained and determinations made of: (A) Total bilirubin; (2) Other employees not so equipped (B) Alkaline phosphatase; shall evacuate the area and not return (C) Serum glutamic oxalacetlc trans until conditions are controlled by the methods required in paragraph (f) of aminase (SOOT); . (D) Serum glutamic pyruvic transam this section and the emergency is abated. (j) Training. Each employee engaged inase (SGPT); and (E) Gamma glustamyl transpeptidase. in vinyl chloride or polyvinyl chloride operations shall be provided training in a program relating to the hazards of vinyl clJoride 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; (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 (ii) Annually for all other employees. (3) Each employee exposed to an emergency shall be afforded appropriate (ii) The specific nature of operations medical surveillance. which could result in exposure to vinyl (4) A statement of each employee's chloride in excess of the permissible suitability for continued exposure to limit and necessary protective steps; vinyl chloride including use of protec CJll> The purpose for, proper use, and tive equipment and respirators, shall be limitations of respiratory protective obtained from, the examining physician this section; and (ii) Protective garments to prevent skin contact with liquid vinyl chloride or with polyvinyl chloride residue from vessel walls. The protective garments shall be selected for the operation and devices; (iv) The fire hazard and acute toxic ity of vinyl chloride, and the necessary protective steps; (v) The purpose for and a description 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 its possible exposure conditions. of the monitoring program; posure, such employee shall be with- 7 AS I 00022723 35S9S RULES AND REGULATIONS drawn from possible contact will', vinyl tion which contradicts or detracts from (li) Hie number of employees in eacl chloride. the effect of, any required warning, regulated area during normal operation' (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 reportc ratories licensed under 42 CFR Part 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 additions tions to those required by paragraph (2) Records of required monitoring information in writing relevant to th (k) (1) of this section will provide at and measuring, medical records, and au nature and extent of employee exposure least equal assurance of detecting med thorized personnel rosters, shall be made and measures taken to prevent futur 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 followin' cept such alternative examinations as representatives of the Assistant Secre any monitoring and measuring whici meeting the requirements of paragraph tary and the Director. discloses that any employee has bee: (k) (11 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 o resplrators^in excess of the permissibl exposure limit, each such employee shal be notified in writing of the results o able upon request for examination and ments and methods used; the exposure measurement and the step copying to authorized representatives of (B) Include any additional informa being taken to reduce the exposure t 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: Catjber-Suepxct Agent Area ,Atfuomma jointsson.nel Oust tion necessary to determine individual within the permissible exposure limit. employee exposures where such expo sures are determined by means othe: than individual monitoring of employees; and IEffective dates, (l) Until Janu 'ary 1, 1975, the provisions currently se forth in 1910.93q of .this /Fart shai (C) Be maintained for not less than apply. _ tfl/h' (2) Areas containing hazardous oper ations or where an emergency currently exists shall be posted with legible signs bearing the legend: ^Cancer-Suspect Agent in This Area FauuA.- 30 years. (il) Authorized personnel rosters shall be maintained for not less than 30 years. (ill) Medical records shall be main tained for the duration of the employ ment of each employee plus 20 years, (2) Effective January 1, 19T5, the pro visions set forth in 1910.93q of this Par shall apply. Appendix A--Supplementary Medical Information fjfinvz Equipment Required. AoihuuLIKB Personnel Only (3) Containers of polyvinyl chloride resin waste from reactors or other waste contaminated with vinyl chloride shall be legibly labeled: Contaminated with Vinyl Chloride ICancer-Suspect Agent j ^2--------' / (4) Containers of polyvinyl' chloride shall be legibly labeled: Polyvinyl Chloride (or Trade Name) Contains Vinyl Chloride Vinyl Chloride is a Cancer-Suspect Agent or 30 years, whichever is longer. When required tests under paragrapl (3) In the event that the employer (k)(i) of this section show abnormalities ceases to do business and there is no successor to receive and retain his rec ords for the prescribed period, these rec ords shall be transmitted by registered the tests should be repeated as soon as prac ticabie, preferably within 8 to 4 weeks, I tests remain abnormal, consideration shouit be. given to withdrawal of the employee fron contact with vinyl chloride, while a mor 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: urtne'examina (4) Employees or their designated representatives shall be provided access to examine and copy records of required monitoring and measuring. tlon for albumin, red blood cells, and ex follatlve, abnormal cells. J3.. Pulmonary system: Forced vital capac lty, Forced expiratory volume at. I second and chest roentgenogram, (posterior-anterior (5) Former employees shall be pro ' 14 x 17 inches) vided access to examine and copy re C. Additional serumtests: Lactic add de (5) Containers of vinyl chloride shall quired monitoring and measuring records hydrogenase, -lactic .acid ; dehydrogenase be legibly labeled either: reflecting their own exposures. (6) Upon written request of any em (i) Vinyl Chloride Extremely Flammable Gas Under Pressure __________ Cancer-Suspect Agent ployee, a copy of the medical record of that employee shall be furnished to any physician designated by the employee. ,, or (ii) In accordance with 49 CFR Partrv n) Reports. month after the (1) Not later than 1 establishment of a reg |.73 Subpart H, with the additional ulated area, the following information Isoenzyme, protein, idetermination, 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 Stftt. 1698, 1699 (29 U6.C. 666, 057); Secretary of Labor's Order No, 12-71, 36 FR 8764) V legendjf: hall be reported to the OSHA Area Dl- Signed at Washington, D.C., this 1st Cancer-Suspect Agent applied near the labrtfor placard. _ (6) No statemenfTShHITappear on or ector. Any changes to such Information ihall bo reported within 15 days. (I) The address and location of teach stablishment which has one or more day of October, 1974. John Stender, , Assistant Secretary of Labor. near any required sign, label or instruc egulated areas; and , . j [FR Doc.74-28176 Filed 10-l-74;3:54 pm] J FEDERAt REGISTER, VOL. 39, NO. 194--FRIDAY, OCTOBER 4, 1974 AS I 00022724