Document JrM1Qm86KmYz7MeGQ5QJ2xnoO

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 R&S 100393 R&S 100394 .15500 RULES AND REGULATIONS Till* 29--Labor ployees from a rare liver cancer fangio and abroad, OSHA proposed to CHAPTER XVII--OCCUPATIONAL SAFETY ANO HEALTH ADMINISTRATION, DE PARTMENT OF LABOR PART 1910--OCCUPATIONAL SAFETY ANO HEALTH STANOARDS sarcoma) may have been occupationally related. Aa a result of this notification and alter consultation with NIOSH. and a joint inspection of the B. F. Goodrich plant by OSHA. NIOSH and the Ken tucky Department of Labor, a fact-find 1010,930 and published a eompronen.^^ proposal 33 FR 16896) on May 10. to protect employees from harords of exposure to VC. The proposal called for limitation of employee exposure to VC to "no detectable level," as measured by a Standard (or Exposure to Vinyl Chloride ing hearing was announced on Janu sampling and analytical method sensitive Pursuant to sections 8(b), S'c). and 8(c) of the Occupational Safety and Health Act Of 1970 (84 Stat. 1593. 1598. 1599; 29 U.S.C. 855. 857) Secretary of Labor's Order No. 12-71 (38 FR 8754) and 29 CTO Part 1911, 3 1310.93 of Part 1910 of Title 23. Code of Federal Regu lations Is hereby amended In the manner set forth below. In order to provide an Occupational Safety and Health stand ard dealing with 'the exposure of em ployees to vinyl chloride. I. Background--(1) Vinyl chloride. Vinyl chloride (chloroethenc). Chemical Abstracts Service RegL-arv 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 ts In excess of -seven billion pounds per year. The vinyl chloride Industry divides Into three segments: monomer production, polymer production, and fabrication. Production cf the monomer is s laryc- -caJe continuous process, involving only ;i few Arms. There arc comparatively few employees in this segment of the indus try, because the processes lend them selves to automation. Vinyl chloride tVC 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 further chemical handling. The vast majority of employees Involved In the VC Industry are employed by fabrication Arms. Such Arms range In size from those with few employees and simple equipment to large plants involving many employees and considerable capital. Vinyl chloride (VC). a gas at ambient temperature and pressure, ts a chlori nated hydrocarbon, which heretofore has been regarded as having moderate liver toxicity. The Initial standard, contained In Table G-l of 1310.93. established a ceiling value of 500 parts of VC per mil lion parts of'air. ary 30. 1374 (30 FR 3874) and held on February 15.1974. Information obtained from this hear ing. particularly the preliminary reports of experiments conducted by Professor Cesare Maltonl of the Instituto dl Oncologla, Bologna- Italy, demonstrated that vinyl chloride Induced angiosarcoma In rats at levels as low as 250 ppm. and In other species at higher levels. Experi ments performed at lower levels of ex posure were not completed at that time. Other testimony from medical witnesses and NIOSH. and the results of autopsies, led to the conclusion that the Goodrich workers had angiosarcoma of the liver and that VC probably was the- causal agent In the angiosarcomas observed. In post hearing comments, additional angiosarcoma " deaths were reported among workers who had been exposed to VC In plants operated by Union Carbide Corporation. Firestone Plastics Corpora tion and Goodyear Tire & Runoer 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, 1374 <39 FR 12341) pursuant to section 8(o of the Act, as 20 CFR 19l0.93q. This standard reduced the permissible exposure level from a ceiling of 530 ppm to a CO ppm ceiling, and established other requirements, including, for example, monitoring and respiratory protection. It was expressly recognized that this standard limiting exposures to a 50 ppm ceiling was a tentative. Interim standard, and that the whole question of exposure to VC would be considered more fully in the light of additional information, especially the results of experiments which were known to be underway at that time. On April 13,1974. information and data were presented to representatives of OSHA. NIOSH. and the Environmental Protection Agency by the Industrial BioTest Laboratories. Northbrook, Illinois, concerning results of animal exposure studies with VC. These studies were sponsored by the Manufacturing Chem ists Association. Although only pre liminary in nature at that time, these results revealed that 2 out of 200 mice exposed to VC concentrations of 50 ppm for 7 hours a day, five days a week, for approximately 7 months, had developed to 1 ppm, with an accuracy of 1 pom 2:50 percent. The proposal also called for the establishment of regulated arena 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. Respirator;' protection would - have been required while engineering and work practice controls were being implemented or where exposures exceeded (he permissiuie limit even after feasible en gineering controls were instituted. In addition, the proposed standard Included requirements for medical sur veillance. prcectlve clothing, e:r.aretncy 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. os published on May 10. 1374. allowed 30 days for interested parties to submit written comments and to request an informal rulemaking hearing. In formal contacts with OSHA stall and early responses Indicated that the sidg^ Jcct was of great interest and Importai^^P to many persons. Because of the limttw^ time available before expiration of the fix month period provided In s<*ction S'c'(3) of the Act for promulgation of a Anal standard. It was decided to hold a hearing as soon as possible. Accord ingly, on May 24, 1374, 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 3, through July 11, before Administrative Law Judge Gordon J, Myatt. All partici pants were given the opportunity to pre sent testimony and to cross-examine other witnesses. Persons participating In the heating were given until August 23. 1974, to file additional posthearmg com ments. Including various items of infor mation which were requested during the examination of witnesses. (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 standard. On January 22. 1074. the Occupa tional Safety and Health Administra tion (OSHA) was informed by the Na tional Institute for Occupational Safety :nd Health (NIOSH' that the B. F. Goodrich Chemical Company had re ported that hiLthji of several cf Its em angiosarcoma of the liver. (3) The proposed permanent stand ard. Based on the demonstrated evidence of VC's carcinogenicity in three animal species (rats, mice and hamsters), and the substantial probability that VC had been the causal agent in the cases of liver angiosarcoma found In workers both hero posure levels. Including those proposed by OSHA and others advanced by In dustry spokesmen. Snell was also com missioned to collect Information regard ing the economic costs of compliance. This action was announced at the close of the hearing, and Judge Myatt furtl^^k announced that ths record would be FfDItAi ucmit, VOL 37, NO. 174--FWQAY, OCTOSII 4, 1774 RULES AND REGULATIONS R&S 100395 35891 open for a period of Umo beyond August studies of Maltonl and Bio-Test Labors- may create a carcinogenic hazard, the 23. to allow Interested persons to com lories. Moreover. Maltonl's Investigations amount of exposure which Is hazardous ment In writing on tile study. On August have demonstrated a dose-dependent re- must be determined. The Surgeon Gen- 26, 1374. OSIIA announced tlmt the pre- lallonshlp for induction of tumors (l.e., oral's Ad Hoc Committee referred to mlnary 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. 1374 (39 FR 30844). liver. In rats. The investigations of In- scientifically determined. This position On September 13, 1074. 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 bo received both rats and mice. These investigators a standard of no detectable level, and by on or before September 23, 1974 (39 FR have Induced angiosarcoma of the liver the testimony of expert witnesses from 33009). in rats and mice at exposure concentra tho 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 on environmen er concentrations of exposure. Additional mitted comments have taken a contrary tal impact statement assessing the im tumors Involving other organs. Including Mew 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 were as any person having In forma'Ion 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 OSHA by May 17. 1974. On June 12. mice <100 moles, 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 'a notice of its filing and availability In the Federal Recxstex on June 25, 1974 (39 FR 22975). A 43 day period was al lowed for the submission of comments on the draft statement. On September 5, 1974, the final environmental impact statement was prepared and a copy of it and all substantive comments were sent to appropriate governmental agencies, private organizations, and other inter ested persons. CEQ published a notice of availability for the final statement on September 6, 1974 (39 FR 32330). 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 tn this proceeding is one of the most exhaustive ever relied upon by OSHA. It consists of pre and post-hearing comments and testimony received at both factfinding and rulemaking hearings, the studies and inspections conducted by OSHA person nel, the environmental Impact state ments, the economic and technical impact studies, and all other relevant Information. In all. over 600 written com ments have been received, with more than 200 separate oral and written sub missions made with regard to the two hearings. The record Itself exceeds 4,000 pages. Employers, employees, . labor unions, public health groups. Independ ent experts, physicians, research scien tists, and specialists In many fields have been invited to submit Information and have made their views, knowledge and experience available to OSHA. The en tire record encompassing these submis sions was thoroughly reviewed and evaluated In reaching the determina tions set forth below. H, Findings regarding carcinogenicity, exposure levels and feasibility--(1) Car- pathologic examination being performed. Of the 36 remaining animals for which a gross postmortem pathologic examina tion was performed. 13 (3u percent) were found with liver tumors (including angiosarcomas), 21 <58 percent) with lung tumors, 9 (25 percent) with skin tumors, and one- with a kidney tumor. According to the 1970 report by the Surgeon General's Ad-Hoc Committee on the Evaluation of Low Levels of En vironmental Chemical Carcinogens, the finding of cancer in two or more animal species may be extrapolated to indicate a carcinogenic hazard to humans. Here, such a finding was mode 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 Mew 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 bearing). The findings of angiosarcoma of the liver in both experimental animals and exposed employees is compelling evi dence tlmt exposure of humans to vinyl chloride Induces this tumor. Industry spokesmen, at the hearing, conceded that VC Is carcinogenic for humans (e.g. testimony of Dr. McBumey, Rulemaking hearing, 1041). Accordingly, it is con cluded that VC must be regarded as a human carcinogen, and the probable causal agent of angiosarcoma of the liver, and that exposure of employees to VC must be controlled. Additional evidence of tumor Induction In a variety of other organs, including lung, kidney, brain and skin, as well as non-mallgnant alterations, such as fi brosis and connective tissue deteriora tion. Indicates additional oncogenic and toxicologic properties of Mnyl chloride, which must be considered in establishing control regulations. (See testimony and results of studies by Bio-Test Labora employment experience as polymeriza tion reactor cleaners. Because it is gen erally agreed that reactor cleaning in volved high enrosures to vinjl chloride In years post, it is argued that the lower levels currently found in the workplace have not Induced cancer and are there fore safe. We reject this argument. The fact that approximately threequarters of those employees with the longest exposure to VC (greater than 20 years since Initial exposure) have not yet been located, makes it impossible to determine tire actual number of aCected employees. The cases of liver tumors ob served to date have an average latency period, since initial exposure, of approxi mately 20 years. If it Is assumed that in duction of angiosarcoma is a dose-re lated phenomenon, and if employees en gaged In cleaning reactors did. :n fact, receive larger doses of Mnyl chloride. It would be expected that such tumors would be observed earlier for this em ployee population. For this reason, the significance of presumed lower doses cannot be accurately assessed until a longer period of time has passed, as a longer induction period would be expected. Initiation of exposure to chemical carcinogens and induction of cancer are not necesasrily synchronous events. Be cause of the physiologic complexities in volved with carcinogenesis, induction of tumors does not occur in ail 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 dnogenicUy of vinyl chloride. The car tories. Taberehaw-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 FVDUAL UOISTII, VOL 3f, NO. 194--FRIDAY, OCTOItl 4, 1974 35892 RULES AND REGULATIONS (testimony and questioning by Tenneeo' ex. testimony of Seilkoff, 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 polymerisa In our view, the demonstration of can (4)Conclusions. TUe conciusi^^^e- tion plants where employees have been cer Induction In humans at a particular low are based on a thorough rcvj^^Kiq exposed to VC for more than 20 years level Is not a prerequisite to a determina evaluation of all the evidence tub^Rcd. 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 lcveL It evidence, this has brrn 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 workpractlce 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 roan and we so conclude. able to exclude from consideration of trations of VC of less than SO ppm. However, the precise level of exposure risk thofb employees In workplaces for Should a sufficiently large number of ex which poses a hazard and the question which ww of angiosarcoma have not perimental 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 Schneiderman said that-It would be ex record. Nor is It clear to what extent absence of cancer in a population of 333 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, it 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 or.r best 200 ppm is safe. (See study by Dr. Cook, posure levels of l ppm through engineer Judgment on the basis of the be^t 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 93 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 ore already operating at this level (see protection of employees, even those who ployees included many who had the SPI testimony). However, Industry may have regular exposures to VC longer term (over 20 years) exposures. spokesmen have universally claimed that throughout their working lives. Moreover, the statistically Insignificant it Is lnfeastblo 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, using1 engineering controls. In ing feasibility, we believe that employee observed. addition, the Snell study on technical exposures to VC must be reduced to a I 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 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 requlrcMUit. secondary metabolic pathway operating have suggested that such a level la at we have established a S ppm only when enzymes regulating the pri tainable. (averaged over a 13-minute peri^^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 anv of the VC or PVC manufacturers to unacceptable high excursions. Frcm preliminary data indicated the possi have already attained a 1 pum level or in an operation starnncint, 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. os to the lowest feasible level attainable occur on a regular basis. However, the occurrence .of angio must necessarily involve subjective Judgr m. The final standard--(l) Scope and sarcoma in both rats and mice at VC ment. Likewise, the projections of indus application. Both the ETS and the pro exposure concentratlonsv of SO ppm in try, labor, and others concerning feasi posal mould apply the standard to the dicates that if a metabolite of VC is (he 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 ppm TWA level for all Job classifications tics Industry (SPI) and various fabrica employees, or even that such safe ex in the near future. We do believe, how tors (see testimony of Goodyear. Gen posures exist. ever. that they will. In time, be able to eral Coble, etc.) recommended that A number of witnesses representing employers have stressed that there Is no evidence of cancer, either in employees or experimental animals, at exposure 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 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 concentrations of VC less than SO ppm. (See e.g.. testimony of Firestone. Tenneco Chemicals.) The conclusion of these witnesses was that no decision con be practices. 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 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 than SO ppm. testimony of Dow Chemical Ca,, TH 973). testimony, TH 106; Robintech TR 642). On the other hand, the testimony of For example. B. F. Goodrich testified In these circumstances, we believe that it most expert witnesses. Including some In dustry biomedical experts, stated' that quantification of a safe exposure con centration Is not possible with the pres ent state of scientific knowledge. (See 1TK 1120) that It has reduced average exposure levels In several PVC plants from 33--40 ppm early this year to 13-13 ppm at thu time of the healing. We ore Is imprudent to grant a blanket exemp tion for all fabricators. Therefore, the final standard Is applicable to the fabri cation industry, os well os the moatttcr R&S 100396 rtattAi ifoisnx, voc 3, no. im--nuoar, octomx 4. ms RULES AND REGULATIONS R&S 100397 35S93 and polymer Industries. Employers who, temperature as PVC. for further pro below the action level, no further monf- in fact, are substantially below the, a*" cessing, indicates that a potential for re toring Is required unless the employer posuro 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 (2) Permissible exposure limit. The greater than the action level, monitoring is based on the absence of adequate evi standard sets an exposure limit of 1 ppm must occur at least quarterly. dence of exposure to VC In these opera averaged over any S 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 emption by defining a fabricated prod iod not exceeding 15 minutes. ployers immediately Institute feasible uct as a product made wholly or partly As more fully discussed above, this engineering and work practice controls from PVC which does not require further limit Is based on an evaluation of the best to reduce exposures to at or below the processing at temperatures, and for available evidence and on a judgment permissible exposure limit. times, sufficient to cause mass melting of that the health and safety of employees Where feasible engineering and work the PVC. SPI and others (cf. TR. 344) must be protected to the fullest extent practice controls will reduce exposures requested 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 v.-fil 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. 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.Q3p (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 comparable, because no attempt had been (3) Action Jevet. 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 achieva 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 PVC reduction, would seem to Indicate that has reason to suspect that any employee Industries. Some Industry spokesmen. SPI has doubts about the safety of 0.1 Is exposed In excess of the action level. Including SPI (TR. 358-362), recom percent residue level. Diamond Shamrock In our judgment, exposures below the mended that a schedule of different per- (Exhibit 142) testified that there is no action level do not present a sufficient 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. ThlA 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 163, 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 thu opportunity persons who submitted comments did exist between Industries, as noted above. for employers to discontinue many duties not understand the meaning of the term It Is clear that intra-industry differences upon a showing of no exposures above the "95 percent confidence level" In the also exist. Thus, the ability and time re action level. It does not appear that any proposal. Essentially It means that the quired by each employer to attain lower residue exemption Is either justified or employer Is required to take a sufficient control levels may depend upon such necessary at this time. This course also number of measurements so that the re factors as the climate in which the plant agrees with a number of Industry pro sults obtained are statistically valid. We Is located, the age of equipment, the size posals (cf. TR 660). have modified the proposal to establish of reactors, or the type of resin manu SPI (TR 345). among others, asked that compounded PVC pellets be ex empted from the standard on the grounds that the pellets had too low a residue to cause harmful or measurable emissions. While It appears that PVC pellets would have a lower residue level than virgin 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 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 PVC, the fact that the pellets must be conduct initial monitoring. Where moni neering controls to the fullest extent and heated to a molten mass at the same toring and measuring results are at or to continue to Improve and apply engl- nOllAt UOISTU, VOL 3*. NO. 1f4--FHOAY, OCTOBU 4, 1V/4 R&S 100398 35894 RULES AND REGULATIONS nesting controls until lull compliance Is achieved. We have not established an? deadlines lor lull compliance through engineering controls because we 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 that each employer reduce airborne con centrations to the permissible level, or to the lowest level feasible as soon as practicable will provide for inter-indus try and intra-industry technological dif ferences which do exist, and will avoid the setting of separate industry stand ards on the hmt* of the general situation and conditions in each industry. (81 Regulated *areas. The proposed standard would have required that regu lated areas be established, that access be limited to authorized employees, and that daily rosters or summaries of those entering be kept for at least 20 years. In objection to these requirements, it was asserted that such control of access was not necessary from a health standpoint. Secondly. It was claimed that these con trols would Interfere with operations by preventing access of needed employees or non-employees, such as contractors, truck drivers, customers and consultants. The purpose of establishing regulated areas In the proposal was to limit the risk of exposure to as few employees as possible. This concern is still paramount, and thus the limited access feature re mains. The final standard amends the proposal slightly to allow "authorized persons" to enter regulated areas. This change, it is felt, will allow operations to continue without undue interference. The final standard has also increased the length of time daily rosters must be maintained from 20 to 30 years. This change was based largely on epidemio logical considerations. (See NIOSH testi mony. tr. 119.) (7) Respiratory protection. The final standard, like the proposal, requires the use of respirators where employee expo sures exceed the permissible control leveL Industry representatives made a number of objections to proposed requirements for respiratory protection. They stated that the "no detectable level" would ef fectively require continuous wearing of respirators in PVC and VC plants, and that this Is not feasible because respira tors are cumbersome, present a safety hazard, *nd employees woui'* not use them. We would agree that respirators have many drawbacks: the proposal did not contemplate them as a final solution. The record shows that the PVC Industry par ticularly may need several years before plant environmental levels can be re duced so that respirators are necessary only occasionally. However, we cannot agree that respiratory protection should not be required simply because it is in convenient;' may require additional per sonnel. Interferes with production, or may require extensive retraining of em ployees and restructuring of work prae- .Icf*, We have carefully considered all tha objections, and have concluded that If the environmental level is not con trolled to the permissible exposure limit, then employees must be afforded respira tory protection. While exposures in excess of the per missible level do constitute a hazard, we believe that it is necessary to mitigate some of the problems associated with implementing a program of respiratory protection while employees are being fitted and trained in respirator use. and while other adjustments which may be required are implemented. Therefore, until January 1, 1978, where exposures are not In excess of a 23 ppm celling, each employer must provide each em ployee with on appropriate respirator. However, employees whose exposures do not exceed a 23 ppm ceiling, may decline to use the respirator, in which case the employer is not obligated to require its use. During tliis adjustment period, em ployees will be trained in the uses, pur poses and limitations of respirators, and the hazards of exposure to vinyl chloride. Moreover, each employee will be notified in writing if he has been exposed In ex cess of the permissible exposure limit. Where exposures exceed a 23 ppm cell ing, respiratory protection Is mandatory in light of our Judgment that much greater risks are associated with such exposures. The provisions In the Anal standard regarding the selection and use of respi ratory protective devices differ from those In the proposal The descriptions of atmosphere-supplying respirators have been revised to indicate more clearly the types of devices Intended, and the maxi mum permissible concentration level for each device. Moreover, the number of types of atmosphere-supplying devices has been Increased. At the hearing Mr. Edwin C. Hyatt, an OSHA consultant, made suggestions re garding the use of particular respiratory devices. We have concluded that his sug gestions are meritorious. Therefore, the provisions for selection of atmospheresupplying devices follow closely the rec ommendations contained In his testi mony of SPI and B. F. Goodrich) (TR with Hyatt's suggestions. (See e.g. testi mony of SPI and B. P. Goodrich) (TR 83 ff) We had originally omitted airpuilfying respirators because none had been approved by NIOSH for use against VC. principally because they lacked In dicators to signal the expiration of the service- life of the sorbent. Hyatt and other witnesses discussed in detail the desirability of being able to use canisters or cartridge air-purifying respirators, provided a sorbent could be shown to effectively absorb vinyl chloride with an adequate service life. Recently. OSHA has received respiratory data from labo ratories regarding the effectiveness of commercially available canisters and cartridges for vinyl chloride. These eval uations were conducted separately by NIOSH and by the B. F. Goodrich Com pany and submitted to OSHA In post hearing comments. The results Indicate that certain presently available canis ters and cartridges effectively absorb vinyl chloride at relatively low concen trations. In discussions of there findings with NIOSH. It has Indicated that 4^ willing to. consider on an expedited the approval of air-purifying respir^^K 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 tration for which each respirator may be used Is based upon our evaluation of the data submitted by NIOSH and Goodrich. Because air-purifying respi rators do not Indicate sorbent exhaustion or breakthrough of VC. and because VC has no inherent warning properties at levels for which these devices are used, strict administrative controls will be re quired for their use. Such controls in clude a program to assure timely re placement of canisters or cartridges and an alarm system to alert employees when vinyl chloride concentrations exceed (he concentrations allowed for the particu lar type of respirator in uie. (8) Hazardous operations. This is a new section within the final standard. It encompasses essentially the proposal's requirements for maintenance and de contamination but has restated them in -terms of performance language to allow greater flexibility for employers to deal with such operations. The Intent of the new section is to protect employees en gaged in activities that present a risk of exposure to vinyl chloride in excess of the permissible levels. An example would be the cleaning of a filter where resin con taining high residual monomer is trapped. The proposal's requirement fpr body. Impervious clothing has bee placed by the direction to use impervious garments suited to the pnrticul.tr s:rus tic:! and probable extent of exposure. Thus, full-body clothing Is not always necessary, and Is therefore not required where less protection Is adequate. Since vessel entry- falls within the definition of a hazardous operation, the vessel entry section of the proposal has been deleted from the final standard. (9) Emergency situations. The defini tion of emergency has been recast, in terms of an unexpected massive release. The main objection to the section on emergency situations In the proposal was that, as the term was defined, many ordinary leaks or operations resulting in a small release of vinyl chloride would be considered emergencies. This was not the intent of the proposal. The final standard has been clarified to correct this ambiguity- It should be noted that the written operational plan required by the standard need not be developed for minor excursions above the permissible exposure limit, and that such excursions need not be reported. (10) Signs and labels. The thrust of the signs and labels section is to apprise employees of the cancer and fire haz ards. No objections have been raised with respect to Informing employees of the fire hazard. However, a number of ob jections were raised at the hearing and In written submissions to the require ment that the word "cancer" appe all signs and labels. The principal ffOflAi BOOTH. VOL 39, NO. 194--fttOAY, OCTOtn 4, 1974 R&S 100399 RULES AND REGULATIONS 35S93 ment advanced against Its use was that indicated that the medical tests proposed posal is the requirement for maintenance the term "cancer" or "cancer-suspect are currently the only ones available of monitoring records and daily roster agent" scares employees and that In which are useful for medical surveillance sheets of authorized persons for 30 years. stead, the message should contain In (TR 121. Exh, 95, TR 589-591). Conse Instead of 20 years. Additionally, the em structions on how to deal with the sub quently. the specific blood tests proposed ployer is required to maintain medical stance (TR. 347). Wc 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 29 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. 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-mallgnant disorders. be made. Hie proper application of most protec The general scope of the required medical The reporting requirements are not tive measures requires an amount of examination has, therefore, been broad significantly different from those in the training and indoctrination of employees ened to include kidneys, skin, connective original proposal. However. Instead of that cannot easily be conveyed on a sign tissue, spleen, and pulmonary system, as the requirement for reporting incidents or label. Also, the variety of measures well as the liver. No additional specific which result in the release of VC into that could be prescribed would result in procedures or tests are required, but rec areas where employees may be exposed, an unwieldly or excessively detailed leg ommendations have been included in the the final standard clarifies our original end, Consequently, the required message Appendix to assist the examining physi intent by stating that only emergencies on signs and labels will not include in cian. Because of the nonspecific nature must be reported. Also the requirement formation on precautions, relevant of the required medical tests, it is not for filing a detailed, written report symptoms, etc. The addition of suitable appropriate to prescribe timing, or type within 15 days has been deleted. It has Information by the employer would be of followup tests, or to mandate with been concluded that submission, within permitted, providing it does not detract drawal from exposure based solely on re 24 hours, of an initial report that in in any way from the required statement. sults at the tests. Instead, the employer cludes facts immediately available, would The requirement in the proposed 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 tests os he considers ap information. developed on this haznrd during the propriate. The employer Is required to (14) Deleted portions of the proposal. standard-setting procedure. It does ap withdraw on 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 there 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 (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 (11) Medical surveillance. 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. 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 separata provision for adequate evidence showing that hazar been raised that the specification of tests employee training has been added to the dous amounts of VC can be absorbed and procedures Interferes with the ap final standard rather than Including It through ingestion. For this reason, the plication of advances in medical knowl within the section on emergency situa requirement prohibiting the storage or edge. tions as in the proposal The new para consumption of food In regulated areas A particular difficulty In considering graph provides for training of employees has been deleted. medical surveillance is that the most commonly discussed lesion, angiosar coma of the liver, currently cannot be diagnosed until the victim is terminal and. usually, within months of death. Precursor physiologic alterations, which might be reversible, have not yet been directly associated with the lesion. Con sequently, there are no specific diagnos concerning the carcinogenic hazard of VC. emergency procedures, the need for monitoring and an annual review of the standard. It also provides for training of employees concerning the purpose for, proper use of. and limitations connected with respiratory protection. (13) Records and reports. The provi sions for recordkeeping contained in the The proposal also contained provisions on maintenance 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 permlssable ex posure limit or attain the lowest feasible tic tests which con be prescribed which final standard require the preparation leveL will determine presence or absence of and maintenance of essentially the same (15) Effective date. In order to ensure this tumor at an early stage of develop information required by the proposal. that affected employers and employees ment. However, most medical witnesses The major change from the original pro will be Informed of the existence of these (DUAL UOISTfl. VOC 39, NO. 1*4--FtlOAT. OCTOU* 4, 1974 R&s 100400 35896 RULES ANO REGULATIONS provisions and that employers affected of the operation or been.use of an acci opportunity to observe the me mA;are given an opportunity to familiarize dent In the operation, which would result tag and measuring required bW3themselves 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: i 1910.93q 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 I 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. In excess of the permissible exposure 6(e) and 8(c) of the Occupational Safety (9) "Polyvinyl chloride" means poly limit. and Health Act, os an occupational vinyl chloride homopolymer or copoly (2) Access to regulated areas shall be safety and health standard effective mer before such Is converted to a fabri limited to authorized persons. A dally October 4, 1974, the amendment to cated product. roster shall be made of authorized per I I910.93q set out below will supersede (10) "Vinyl chloride" ntmm. vinyl sons who enter. these provisions as of January 1. 1979. chloride monomer. (f) Methods of compliance. Employee Accordingly, upon consideration of the (c) Permissible exposure limit. (1) No exposures to vinyl chloride shall be con whole record of this preceding. Part 1910 employee may be exposed to vinyl chlo trolled to at or below the permissible ex of Title 29. Code of Federal Regulations ride at concentrations greater than 1 ppm posure limit provided In paragraph (c> is amended, effective January 1, 1975, by averaged over any 8-hour period, and of this section by engineering, work prac revision of J 1910.93q to read as follows: (2) No employee may be exposed to tice. and personal protective controls as 1910.!)3q Vui>I rliloride. vinyl chloride at concentrations greater follows: than 5 ppm averaged over any penod not (1) Feasible engineering and work (a) Scope- and application, '1) This exceeding 15 minutes. " - - practice controls shall immediately bo section includes requirements for the 733 fro employee may be exposed to used to reduce exposures to at or bclow control of employee exposure to vinyl vinyl chloride by direct contact with the permissible exposure limit. chloride (chloroethene). Chemical Ab liquid vinyl chloride. (2) Wherever feasible engineering and stracts Service Registry No. 79015. (d) Monitoring. (1) A program of work practice controls which can be In (2) This section applies to the manu Initial monitoring and measurement stituted immediately are not sufficient to facture, reaction, pactaging, repackag shall be undertaken In each establish reduce exposures to at or below the per ing. storage, handling at use .of vinyl ment to determine if there Is any em missible exposure limit, they shall none chloride or polyvinyl chloride, but does ployee exposed, without regard to the use theless be used to reduce exposures to not apply to the handling or use of fabri of respirators. In excess of' the action the lowest practicable leveL and shall be cated products made of polyvinyl chlo level. . supplemented by respiratory protection ride. (2) Where a determination conducted In accordance with paragraph (g> of this (3) This section applies to the trans under paragraph (d)(1) of this section section. A program shall be established portation of vinyl chloride or polyvinyl shows any employee exposures, without and implemented to reduce exposures to chloride except to the extent that the regard to the use of respirators, in ex at or below the permissible exxppoo3surve Department of Transportation may cess of the action level, a program for de limit, or to the greatest extent feq 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 feasib>l'ea.-' Cb) Definitions. (1) "Action level" gram: (3) Written plans for such a program means a concentration of vinyl chloride (1) Shall be repeated ct least monthly slum 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 ure of respirators, in ex authorized representatives of the Assis (2) "Assistant Secretary" means the cess of the permissible exposure limit. tant Secretary and the Director. Such Assistant Secretary of Labor for Occupa (11) Shall be repeated not less tmw plans shall be updated at least every six tional Safety and Health, XJJ3. Depart quarterly where any employee Is exposed, months. ment of Labor, or his designee. without regard to the use of respirators. (g) Resviratorg protection. Where (3) "Authorized 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 bn 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 employe* 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 may result In an Increase In the release cess of 25 ppm, measured over any 13" Safety and Health, UH. Department of of vinyl, chloride, or the employer has amiUdjiendi UmlTDecember" 3177373; Health. Education, and Welfare, or his any other reason to suspect that any em each employee who chooses not to wear designs ployee may be exposed In excess of the an appropriate respirator shall be In (5) "Emergency" means any occur action leveL a determination of employee formed at least quarterly of the hazards rence such as. but not limited to. equip exposure under paragraph (d) (1) of 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 docs 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 23 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. (7) "Hazardous operation" mean* any operation, procedure, or activity where a release of either vinyl chloride liquid or gas might be expected as a consequence accuracy requirements are available In the "NTOSH Manual at Analytical Methods"). (5) Employees or their designated rep resentatives shall be afforded reasonable (3) A respiratory protection program meeting the requirements of 5 1ly9i1u0..1u3*4 shall be established and maintn_llrne<L_ *9(4) Selection of respirators lor chloride shall be as follows: TOHAL Mina VOt- 34, NO. 144--HHOAT, QCTOMK 4, 1474 R&S 100401 RULES AND REGULATIONS 35807 Atmospheric concentration of vinyl chloride Acquired epporeius (vl) The purpose for, and a descrip tion of. the medical surveillance (I) Unknown, or above 3,000 ppm--. Open-circuit, eelf-eoatalned breathing apparatus, pree- program; . sure demand typo, wltn fall feeepieoe. (vll) Emergency procedures: (II) Not orer 3,000 ppm--------- (A) Combination typo C eupplled air respirator, pres (vill) Specific Information to aid the sor* demand typo, with fall or half facepiece, employee In recognition of conditions and auxiliary ulf-contained air supply; or which may result in the release of vinyl (S) Typo C, supplied air respirator continuous flow chloride: and > type, wttb full or half feeepieoe. and auxiliary (lx) A review of this standard at the self-contained air supply. employee's first training and Indoctrina (U!) W-t "mf,M pp"* (It) Not over 28 ppm .....m.i (A) Combination type C supplied air respirator de mand type, wltb full facepiece, and auxiliary self-contained air supply; or (B) Open-circuit self-contained breathing apparatus wtth full facepiece. In demand moder or (d Typo C supplied air respirator! demand type, with full facepiece. (A) A powered air-purifying respirator with hood. helmet, full or half facepiece, and a canister which prosIdes a serrtce life of at least 4 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. (1c) Medical surveillance. A program of medical surveillance shall be Insti tuted for each employee exposed, with out regard to the use of respirators, to vinyl chloride in excess of the action hours for concenratlons of vinyl ehlorldt up level. The program shall provide each to 39 ppm, or such employee with an opportunity for (B) Osa mask, front- or back-mounted canister which examinations and tests in accordance provides a service life of at .least 4 hours for with tills paragraph. All medical ex concentrations of vinyl chloride up to 39 ppm. aminations and procedures shall be per (v) Not over 10 ppm (A) Combination type C supplled-etr respirator, de formed by or under the supervision of a mand type, with belt facepiece, end auxiliary licensed physician, and shall be provided self-contained air supply; or without cost to the employee. (B) Type C supplied-air respirator, demand type, with (1) At the time of initial assignment, 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. or upon Institution of medical surveil lance; (1) A general physical examination shall be performed, with specific atten tion to detecting enlargement of liver, (9) (1) Entry Into unkown concentra tions or concentrations greater than 36t000 ppm (lower explosive limit) may be made only tot purposed ot life rescue; and (11) Entry Into concentrations of less than 3G.000 ppm. but greater than 3.600 ppm may be made only lor 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 (11) A continuous monitoring and alarm system shall be provided where concentrations of vinyl chloride could reasonably exceed the allowable concen trations for the devices In use. Such sys tem shall be used to alert employees when vinyl chloride concentrations exceed the allowable concentrations for the devices In use. (7) Apparatus prescribed for higher concentrations may be used for any lower concentration. (h> Hazardous operations. (1) Em ployees encaged In hazardous operations. Including entry ot vessels to clean poly vinyl chloride residue from vessel walls, shall be provided and required to wear and use; (1) Respiratory protection in accord ance *ith paragraphs (c) and (g) of (3) Protective garments shall be pro vided clean and dry for each use. (1) Emergency situations. A written operational plan for emergency situa tions shall be developed for each facility storing, handling, or otherwise using vinyl chloride ns a liquid or compressed gas. Appropriate portions of the plan shall be Implemented In the event of an emergency. The plan shall specifically provide that; (1) Employees engaged In hazardous operations or correcting situations of ex isting hazardous releases shall be equipped as required In paragraph (h) of this section; (2) Other employees not so equipped shall evacuate the area and not return until conditions are controlled by the methods required In paragraph (f) of this section and the emergency Is abated. (J) Training. Each employee engaged In vinyl chloride or polyvinyl chloride operations shall be provided training In a program relating to the hazards of vinyl chloride and precautions for Its safe use. (1) The program shall Include; (I) The nature of the health hazard from chronic exposure to vinyl chloride Including specifically the carcinogenic hazard; (II) The specific nature of operations which could result In exposure to vinyl chloride In excess of the permissible limit and necessary protective steps; (11) The purpose for, proper use, and limitations of respiratory protective spleen or kidneys, or dysfunction in these organs, and for abnormaltles in skin, connective tissues and the pulmonary system (See Appendix A). (11) A medical history shall be taken, including the following topics: (A) Alcohol Intake; (B) Past history of hepatitis: (C) Work history and past exposure to potential hepatotoxlc agents, includ ing drugs and chemicals; (D) Past history of blood transfu sions; and (E> Past history of hospitalizations, (ill) A serum specimen shall be ob tained and determinations made of: (A) Total bilirubin: (B) Alkaline phosphatase; (C) Serum glutamic oxalacetic trans aminase (SGOT); (D) Serum glutamic pyruvic transam inase (SGPT) ; and (E) Gamma glustamyl transpeptidase. (2) Examinations provided in accord ance with this paragraph shall be per formed at least: (1) Every 6 months for each employee who has been employed in vinyl chlorUe or polyvinyl chloride manufacturing for 10 years or longer: and (11? Annually for all other employees. (3> Each employee exposed to an emergency shall be afforded appropriate medical surveillance. (4) A statement of each employee's suitability for continued exposure to vinyl chloride including use of protec tive equipment and respirators, shall be obtained from the examining physician this section; and devices; promptly after any examination. A copy (U) Protective garments to prevent skjn contact with liquid vinyl chloride or with polyvinyl chloride residue from vessel walla. The protective garments shall be selected for the operation and (lv) The fire hazard and acute toxic ity of vinyl chloride, and the necessary protective steps; (v) The purpose tax and a description of the physician's statement shall be pro vided each employee. (9) 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- mOAi KMISTO. VOt. 39, NO. J94--flUOAT, OCTOtCI 4, 1V74 c,; 33898 RULES AND REGULATIONS R&S 100402 drawn from possible contact with vinyl tlon which contradicts or detracts from (il) The number of employees in^B chloride. the effect of, any required warning, regulated area during normal operaMg (6) Laboratory analyses lor all bio information or instruction. Including maintenance. logical specimens Included in medical fm) Records. (1) Ail 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 CKR Fart 74. shall include the uTM 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 Aya.minn.Hrtw 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 hns been (k) 1) 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 il) Monitoring and measuring records shall: (A) State the date of such monitor ing and measuring and the concentra tions determined and identify the Instru exposed, without regard to the use of respirators in excess of the permissible exposure limit, each such employee shall be notified in writing of the results of able upon request icr examination and ments and methods used: the exposure measurement and the steps copying to authorized representatives of (B) Include any additional informa being taken to reduce the exposure to the Assistant Secretary and the Director. (1) Signs and labels. (1) Entrances to regulated areas shall be posted with leg ible signs bearing the legend: CAMCxa-Susrrcr Men Ain Acthmob Fkbootma. Otter 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) EDecline dates. (I) Until Janu ary 1, 1973, the provisions currently set forth in {19i0J33q of tills Parr shall apply. (2) Areas containing hazardous oper ations or where an emergency currently exists shall be posted with legible signs besting the legend: -- CA*ci>-St7snirr Mart at Tsa Ajiica PaorscTiv* EqcimurT Bsqtnao Atrrnoarxxo pmaomrex, Otter 30 yean. (Ill 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, or 30 yean, whichever Is longer. (3) In the event that the employer <2) Effective January 1. 1273. the pro visions set forth In 1 i9i0D3q of tins Part shall apply. Awnwa A Burets irricraav IIcdicai, iMTOalAATIOW When required tests under paragraph (k)(l) at tat* oectloa show obnotmantlet, (3) Containers of polyvinyl chloride resin waste from reactors or ocher waste contaminated with vinyl chloride shall be legibly labeled: Contaminated with Vixtl Cneonmz cAuer*-Soared Mart (4) Containers of polyvinyl chloride shall be legibly labeled; Toltyimts CHLOtm* (oa Toads Ham*) Contains Vnm. Ckuuudc Yam. cwtoeme r* a CAjrera-Suwsd Aon 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 restnered mail to the Director, and each employee Individually notified In writing of this transfer. (4) Employees or their designated representatives shall be provided access to examine and copy records of required monitoring and measuring. (3) Former employees shall be pro vided access to examine and copy re me teste should be repeated os soon as prac ticable, preferably within 3 to 4 e-seas._jl tests remain abnormal, consideration Its ciren to withdrawal of the employee contact with vinyl chloride. a 39m comprehensive examination lx r..x,,e. Additional tests which may l-e v.acful: A. For kidney dysfunction: urine ,::.uuii.n- tto:i lor albumin, rid iMcod celix ,...d rt- folUtive abnormal cent. E. Pulmonary system: Forced ti:.u inp:..-. lty. Forced expiratory volume a; l second, and chest roentgenogram iposterior-anterior, 14 X 17 Inches). C. Additional serum tests: Lactic acid de (3) Containers of vinyl chloride shall quired monitoring and measuring records hydrogenase, lactic acid dehydrogenase be legibly labeled either: U) Varre Canoam* ImouiT Ft i mmin t aa* Unn Fusnu CAwaa-fiinrscr Man or (11) In accordance with 49 CFR Part 173, Subpart H. with the additional reflecting their own exposures. (9) 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 fallowing information Isoenzyme, protein determination, and protein electrophoresis. D. For a more comprehensive examination on repeated abnormal serum tests: Hepatitis B antigen, and Uver scanning, (Seca. 4 and 8. S4 SUL 1393. 1549 (29 U.3.C. 853, 537): Secretary of fjhor s Order Ho. 13-71, 38 PR 8734) legends: shall be reported to the OSHA Area Di , Signed at Washington. D.C.. this 1st Cjurcxa-StrSTECT Acnrr applied near the labor or placard. (5) No statement shall appear on or rector. Any changes to such information shall be reported within 13 days. (1) The address and location of each establishment which has one or more day of October. 1974. John SxxxDca. Assistant Secretary of Labor. near.any required sign, label or inscruc- regulated areas; and JFR Doc.74-23178 Filed 10-1-7413:34 pm] MOIlia, VOL 39, NO. 194--FUOAT. OOOta 4, 1974