Document qd13GdV7xMyj0wjNO3qyyVXmj

! i j i I FRIDAY, OCTOBER 4, 1974 WASHINGTON, D.C. Volume 39 8 Number 194 PART I! .S" C'T Occupational Safety And HeGith AdminisiTcman a EXPOSURE TO VINYL CHLORIDE Occupational Safety and Health Standards 1 DTH 000011787 35890 RULES AND REGULATIONS Titto 29--Labor CHAPTER XVII--OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION. DE PARTMENT OF LABOR PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS Standard for Exposure to Vinyl Chloride Pursuant to sections 0<b). O'er, and 8(c) of the Occupational Safety and Health Act of 1970 (84 Slat. 1593. lat-S. 1599; 29 U.S.C. 055, 657) Secretary ot Labor's Order No. 12-71 >30 Fit 8754' and 29 CFR Part 1911. S 1910.93 of Prat 1910 of Title 29, Code of Federal P.eyulations is hereby amended in the manner set forth below, in older to provide r.n Occupational Safety and Health stand ard dealing with the exposure of em ployees to vinyl chloride. I. Background--(1) Vinyl chloride. Vinyl chloride (chloroethene). Chemical Abstracts Service Registry No. 75014. is a synthetic organic chemical made from ethylene or acetylene and chlorine by any of several processes. It is the parent compound of a series of thermoplastic resin polymers and copolymers which are widely used for containers, wrapping film, electrical insulation, pipe, conduit. and a variety of other industrial and consumer products. Vinyl chloride has been made commercially in this country since 1939. and present production is in excess of seven billion pounds per year. The vinyl chloride industry divides into three segments: monomer production, polymer production, and fabrication. Production of the rionomV is a large, scale continuous process, involving only a few firms. There are comparatively few employees in this segment of the indus try. because the processes lend them selves to automation. Vinyl chloride (VC) is used primarily in the production of polyvinyl chloride (PVC), a resin which is produced through batch processing. The conversion of the VC monomer into a polymer or copolymer is an Incomplete process, i.c.. not ail of the monomer is reacted. PVCis 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 arc employed by fabrication firms. Such firms range in size from those with few employees and simple equipment to large plants involving many employees ar.d 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 liter toxicity. The Initial standard, contained Jn Table G-l of 1910.93, established a ceiling value of 500 parts of VC per mil lion parts of air. (2) The emergency temporary stand ard. On January 22. 1971. the Occupa tional Safety and Health AdminbUration (OSHA) was informed by the Na tional Institute for Occupational Safety and Health iNlOSin that the B. F. Goodrich Chemical Company had re ported that deaths of several of Its em ployees from a rare liver cancer (angio sarcoma) may have been occupationally related. As a result of tills notification ar.d after consultation with NIOSH, and a joint Inspection of the u. F. Goodrich plant by OSHA. N103H and the Ken tucky Department of Labor, a fact-find ing hearing was announced on Janu ary 30. 1974 <30 FR 3874) and held on February 15.1974. Information obtained from this hear ing. particularly the preliminary reports of experiments conducted by Protestor Cciarc Maltoni of the Iustituto di Oncoiocia. Eolorrna. Italy, demonstrated that vinyl chloride induced angiosarcoma in rats at Icvc-is as low as 250 ppm. and i:i 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 ar.d NIOSH. and the results of autopsies, led to the conclusion that the Goodrich workers had angiosarcoma of the liver raid that VC probably was the causal agent in the angiosarcomas observed. Ir. post hearing comments, additional angiosarcoma deaths were reported among workers who had been exposed to VC in giants operated by union Carbide Corporation. Firestone Plastics Corporavic'A and Goodyear Tire h Rubber Coni- On the basis of all information avail able at that time, and the (act that em ployees were being exposed at levels around the experimentally observed ef fect level of 250 ppm. an emergency tvrr.porary standard `ETC) was promul gated on April 6. 1x74 us FR l-u-ii) 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 ar.d 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. Oil April 13,1074. 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 animat 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 2U0 mire exposed to VC concentrations of 50 ppm for 7 hours a day. five days a week, for approximately 7 months, had developed angiosarcoma of the liver. i3' 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 a gent In the cases of liver angiosarcoma found in workers both here and abroad, OSHA proposed to revise 1910.93q and published a comprehensive proposal (39 FR lGBOfii on Mav Hi. 1974. to protect employees from hazards of exposure to VC. The propo nl culled for limitation of employee cximsurc to VC to "no detectable level." as measured by a sampling and analytical method sensitive to 1 ppm. with an accuracy of 1 ppm 50 percent. The proposal also called for the establishment of regulated areas and limited access to such areas to au thorized persons. A requirement lor 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 die per missible limit even after feasible en gineering controls were instituted. In addition, the proposed arndard Included requirements for medical sur veillance. protective clothing, emergency procedures, training, specific protection, during maintenance ar.d decontamina tion operations, transportation loading and unloading operations and recordkeeping. (4) Hearing on the proposal. The pro posal. as 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 ar.d early respora-s irdicr.t`id tl'at the (`uh- ject was of great interest and imperial,ca to many persons. Because of the l.mited time available before expiration of the six mouth period provided in section 6(c)(3) of the Act for promulgation of a final standard, it was decided to hold a hearing as soon as possible. Accord ingly, on May 24, 1974. a notice of a hear ing was published <39 FP. 18303'. setting a hearing date of June 25. 1974. The hearing was conducted from June 25 through Juno 20. and again from July 3, through July 11. before Administrative Law Judge Gordon J. Myatt. Ail partici pants were given tiie opportunity to pre sent testimony and to cross-examine other witnesses. Persons participating in the hearing were given until August 23, 1974, to file additional posthearing com ments. including various items of infor mation which were requested during the examination of witnesses. (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. Sncil Corporation, to conduct studies ot the feasibility of compliance at various ex posure levels, including those proposed by OSHA and others advanced by in dustry spokesmen. Snell was ai.o com missioned to collect information regard ing the economic costs of copi^h.inie. This action was announced at the close of the hearing, and Judge Myatt further announced that the record would be kept FEDERAL REGISTER, VOL 34, NO. 144--FRIDAT, OCTOSER 4. 1474 DTH 000011788 RULES AND REGULATIONS 35831 open for a period of time beyond August studios of Maltonl and Bio-Test Labora 23, lo allow Interested persons lo com tories. Moreover. Miilbim's investigations ment In writing on the study. On -August have demonstrated a dosc-dcpendcnt re 20, 1974. OSHA announced that the pre lationship lor induction of tumors (i.o.. liminary study was available ami that more tumors occur at higher exposure comments were to be submitted no later icvclsi, including angiosarcoma of the than September 6. 1974 (39 FR 30844). liver, in rats. The investigations of In On September 13. 1974, OS11A invited dustrial Iho-Tcst Laboratories have dem comments on both Die preliminary and onstrated a similar relationship for the final study, which was to lie received both rats and mice. Those investigators on or before September 25, 1974 (39 FR have induced angiosarcoma of Hie liver 33009). in rats and mice at exposure concentra (G) Environmental impact statements. tions oi 50 ppm, and in hamsters at high A notice of intent to file an environmen er concentrations of exposure. Additional tal impact statement assessing the im tumors involving other organs, including pact of a proposed standard on occu the kidneys, lungs, and skin of exposed pational exposure to VC was published animals, were also observed in frequen in the Federal Register on April 24. cies much ill excess of control animals. 1974 (33 FR 14522). Tile notice invited The incidence of tumors in mice in tile any person having information or data Industrial ISio-Test Laboratories investi on the environmental impact lo submit gations is particularly pertinent. Of 200 it to OoHA by May 17, 1974. On June 12, mice <100 males. 100 females) exposed to 1974. a draft environmental impact 50 ppm of vinyl chloride by inhalation for statement was prepared and circulated eleven months, 100 died. Sixty-four ani to all interested persons. Ten copies were mals died without gross postmortem forwarded to tfie Council of Environ pathologic examination being performed. mental Quality (CEQ), which published Of the 36 remaining animals for which a notice of its filing and availability in a gross postmortem pathologic examina the FEara.it Register on June 25. 1974 tion was performed. 13 (3G percent) (39 FR 22975). A 45 day period was al lowed for the submission of comments on were found with liver tumors (including angiosarcomas). 21 (58 percent) with the draft statement. On September 5. lung tumors. 9 (25 percent) with skin 1974, the final environmental Impact tumors, and one with a kidney tumor. statement was prepared and a copy of it According to the 1970 report by the and all substantive comments were sent to appropriate governmental agencies, Surgeon General's Ad-Hoc Committee on the Evaluation of Low Levels of En private organizations, and other inter ested persons. CEQ published a notice of iivpih.bT.ly for the final .To:r-r :u* an vironmental Chemical Carcinogens, the finding of cancer in two or more animal species mav be extrapolated to mdicate September G. 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 ttie 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 a carcinogenic hazard to humans. Here, such a finding was made in three species that were exposed lo VC by inhalation-- a route comparable to employee ex posure. In addition, there were at least 13 confirmed cases of angiosarcoma of the liver among employees exposed to VC, a particularly significant number in view of Die extreme rarity of this cancer in Die U.S. adult male population (testi mony of Dr. Marcus Key, Director of NIOSH. at the rulemaking hearing). The findings of angiosarcoma of the liver in both experimental animals and exposed employees is compelling evi dence that exposure of humans to vinyl cliioride induces tliis tumor. Industry Impact studies, and all other relevant information. In all, over GOO written com spokesmen, at the hearing, conceded that VC is carcinogenic for hunians le.g. ments have been received, with more testimony of Dr. McBunicy, Rulemaking than 200 separate oral and written sub hearing, 1041). Accordingly, it is con missions made with regard to the two cluded that VC must be regarded as a hearings. The record itself exceeds 4.000 human carcinogen, and the probable pages. Employers, employees, labor causal agent of angiosarcoma of the unions, public health groups, independ liver, and that exposure of employees to ent experts, physicians, research scien VC must be controlled. tists, and specialists in many fields have Additional evidence of tumor induction been invited to submit information and in a variety of other organs, including have made their views, knowledge and lung, kidney, brain and skin, as well as experience available to OSHA. The en noil-malignant alterations, such as fi tile record encompassing these submis brosis and connective tissue deteriora sions was thoroughly reviewed and tion. indicates additional oncogenic and evaluated in reaching the determina toxicologic properties of vinyl chloride, tions set fortii beiow. which must be considered 111 establishing II. Findings regarding carcinogenicity, control regulations. (Sec testimony and exposure levels and feasibility--111 Car results of studies by Bio-Test Labora cinogenicity oi vinyl chloride. The car tories, Taborshaw-Coopcr. Maltonl. cinogenicity of vinyl chloride for three NIOSH. and Sclikofi.) animal species (rat. mouse, hamster) lias i2) Exposure limits. Upon finding that been documented on the record by the exposure of employees lo vinyl chloride may create a carcinogenic hazard, the amount of exposure which Is hazardous must be determined. The Surgeon Gen eral's Ad Hoc Committee referred to above concluded Dial sale exixisui c levels for carcinogenic substances cannot be scientifically determined. This position is supiiortcd by the testimony nf NIOSIf at Die hearing. iLs recommendations ior a standard of no detectable level, and by the testimony of expert witnesses from the National Cancer Institute. Several witnesses and persons who sub mitted comments have taken a contrary view and have suggested Dial man is less sensitive to biologic aberrations induced by vinyl cliioride exposure than experi mental animals. Proponents of tin., posi tion have argued that if humans were as sensitive as rodents, an "epidemic" oi cancer resulting from VC exposures should have already been discovered among employees. They .also argue (hat the employees in whom tumors have been observed arc those who have considerable employment experience as polymeriza tion reactor cleaners. Because it is gen erally agreed that reactor denning in volved high exposures to vinyl chloride in years past, it is argued that the lower levels currently found in Die workplace have not induced cancer and are there fore safe. We reject this argument. The fact that approximately three- quarters of those employees wun the longest exposure to VC (greater than 20 years since initial exposure) have not yet been located, makes it impoTible t.o rtgsf A *. *'*'*FA employees. Tlio cases of liver minors 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 close- re lated phenomenon, and if employees en gaged in cleaning reactors did. in fact, receive larger doses of vinyl chloride, it would be expected that such tumors would bo observed, earlier for this em ployee population. For tills 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 nccesasrily synchronous events. Be cause of the physiologic complexities in volved with carcinogenesis, induction of tumors does not occur ill all employees with similar exposure histories. For ex ample, Dr. Schneidonnnn of Die Na tional Cancer Institute emphasized dur ing his testimony that only about a fifth of longer-term heavy smokers develop lung cancer. Accordingly. Die industry contention that exposure levels have been dramatically reduced since Die 1940's is hot reliable evidence that cur rent levels of exposure are sate. Some industry spokesmen nlro sug gested that the apparent nonrandom distribution of observed cancer in em ployees may indicate an cxijosyre thres hold for tumor Induction, based on varia tions in Die workplace design or prac tice and resultant employee exposures FEDERAL REGISTER, VOL 39, NO. 194--fRIDAY, OCTOSER 4, 19Z4 DTH 000011789 3581)2 RULES AND REGULATIONS (testimony and questioning by Tcnncco Chemicals, Inc.). It has a); o been cinphn.sixcct that in only 3 of H polymerisation plants v.heic employees have been exposed to VC for more than 30 years have any employees developed ansiorar- coina of the liver. This arrumenl i:\ very sljnffar to Unit raided concerning van- ability of past employee exposure. Al though geographic anct v.oi l:practice dif ferences may ultimately be demonstrated to be factors in distribution ol angiosar coma, sufficient information iu unavail able lo exclude from consideration of risk those employees in workplaces for which cases of angiosarcoma have not been observed. It has also been suggested that the absonre of cancer in a population of 335 Dow Chemical Company polymerization employees monitored over a period of 7 years, indicates that exposure to vinyl chloride at concentrations; of less than 200 ppm Is sale. 'See study by Dr. Cook, submitted at the hearing by Dow Chem ical Company.) Howev-.-r, the group sur veyed did not include nil workers who had been exposed, and the missing em ployees included many who had the longer term lover 20 years) exposures. Moreover, the statistically insignificant size of the sample population decreases the possibility that turners would be observed. Dow also presented preliminary data In testimony at the hearing on the pos sible metabolic pathways of VC. The hypothesis presented was that, VC may exerv it* (.ai\;uivgei^o euiwl a metab olite, and that the metabolite is pro duced only when VC is metabolized by a secondary metabolic pathway operating only when enzymes regulating the pri mary pathway are saturated, as would be the result at higher exposures. The preliminary data indicated the possi bility' of an additional pathway for metabolism of VC in rats exposed to con centrations of VC in excess of 220 ppm. However, the occurj-er.cc of angio sarcoma in both rats and mice at VC exposure concentrations of 50 ppm in dicates that if a metabolite of VC is the ultimate carcinogen, then it must be generated at lower exposure concentra tions in these species. Although this re search may be helpful to the thorough understanding of the carcinogenicity of VC. it appears that it docs 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 cnficcr, either in employees or experimental animnlr.. at exposure concentrations of VC less than 50 ppm. (See eg.. testimony of Firestone, Tennecu Chemicals.) The conclusion of these witnesses was that no decision can he made concerning rusk of exposure to VC at concentrations less linn f>u ppm. On the other hand, the testimony of most expert witnesses, including dome in dustry biomedical expert.;, stated that quantification of a safe exposure con centration is not possible with the pres ent state of scientific knowledge. (See e.ff.. testimony of Scltkolt, Firestone, NCI, ami NiOSIIJ In our view, the demonstration of can cer Induction in human;-, at a particular level is not a prerequisite lo a ticLermiuaticn that a substance represents a can cer hazard for humans at that level. It would be Imprudent to assume man to be lev; sensitive Lo VC exposure than ex perimental animals in the absence of conclusive evidence. It would also be un founded to assume that animals will not develop tumors when exposed at concen trations of VC of loss than 50 ppm. Should a sufficiently Large number of ex perimental animals be exposed to VC at concentrations of levs than 50 ppm, Selin* iuerman said that it would be ex pected that some would develop VC in duced tumors. <3/ FcaiiWIify. There Is virtually no dispute that most, if not nil, fabricators arc currently capable of reaching ex posure levels of 1 ppm through engineer ing controls. Tliosc employers employ well ever 35 percent of pH employees ex posed to VC. Indeed, several fabricators are already operating at this level (see SPI testimony). However, industry spokesmen have universally claimed that it is infeasible for the VC and the PVC industries to remain below 1 ppm con sistently. using engineering controls. In addition, the Snell .study on technical feasibility concluded th't a l ppm ceil ing is not feasible for the VC and PVC industries with present technology, but that the VC industry could currently at tain lover C'Xt-u.iui'C Ic vcIj iki- PVC industry. Labor union spokesmen and the Health Research Group. Inc., however, have suggested that such n level is at tainable. Since there Is no actual evidence that any of the VC or PVC manufacturers have alreedy attained a t rpm level or in fact instituted all available engineering and work practice controls, any estimate as to the lowest feasible level attainable must necessarily involve subjective judg ment. Likewise, the projections of indus try. labor, and others concerning feastbilhv are essentially conjectural. Indeed, as Firertor.e has suggested, it is not pos sible to accurately predict the degree of improvement to be obtained from en gineering changes until such changes are actuallv implemented. We agree that the PVC and VC estab lishments will not be able to attain a 1 ppm TWA level for all job classifications in the near 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 u!iliac technology presently used in other industries. Tn any event, the VC and PVC industries have already made great strides in reducing exposure levels. (See testimony of Dow Chemical Co.. TO 973). For example, H. V*. Goodrich testified <TR 1120) that It has reduced average exposure levels in several PVC plants from 35--40 ppm early thU year to 12-13 ppm at the Ume of the hearing. We are confident that Industry will continue to do so. (4) Conclusions. The conclusions be low are boned on a thorough review and evaluation of all the evidence subuuitcd. Where decisions can l.e based on record evidence, this has been done. Where, however, factual certainties are lurking or where the facts alone do not provide ail answer, policy judgments have been made. TOcrc is IlUlc dispute that VC Is car cinogenic to man and we io conclude. However, the precise level of expo: rre which {>oscs a haznid and the question of whether a "sale" exposure level exists, cannot be definitively answered on tho record. Nor is ic clear to v. hat extent exposures can be feasibly reduced. We cannot wait until indisputable answers to these questions are available, beenire live* of employees are at stake. There fore. we have lied to cxeiv.ve our be?t judgment on the basis cf the best avail able evidence. These judgments have re quired a balancing process, in which the overriding consideration has been the protection of employees, even thoe who may have regular exposures to VC throughout their working lives. Based on the available evidence and in view of the above considerations, includ ing feasibility, we believe that employee exposures to VC mu* t be reduced to a L ppm timc-wctehtccl average TV.*A>. We also believe that PVC and VC en..bli:hments will, in time, be able to attain that level through, engineering control*. f-.'.d mediate future. In addition to the TWA requirement, we have established a 5 ppm ceiling (averaged over a lS-mruito period) in order to prevent exposure of emplovcos to unacceptable high excursions. From art operation standpoint, this ceiling level is realistic because minor excur sions up to the ceiling level are likely to occur on a regular basis. III. The final fiinv.dc.rd--ill Scape a,id apjricafion. Both the ET5 and the pro posal would apply the standard to the entire VC industry, including manufac turers of VC and PVC and fabricators, but excluding employers handling cr using fabricated products made from VC. There is no dispute that a standard is required for the monomer and polymer industries. However, the Society of Plas tics Industry (SPIV and various fabrica tors (sec testimony of Goodyear, Gen eral Cable, etc.) recommended th.it fabricators be excluded from the stand ard. or that a separate requirement L: o.tablushcd for them because mmy cf them were already at or below the pro posed ceiling level. The record evidence oLiblk-iics that at least some employees in the i.ibrieatiV4 industry arc exposal in exceeds of Hip penni-vable control limit.? w5eu NlOoIl testimony. Tli luG: Kobiulerh TU <M2. In these circumstances, we believe that it is imprudent to grant a blanket exemp tion for all fabricators. Therefore, the final standard Is applicable to the rubri cation Industry, c* well ns the monomer FfOCtAl lEGISTEt, VOL 39, NO. 194--MIDAY, OCTOBER 4, 1974 DTH 000011790 4> RULES AND REGULATIONS :m<xi and polymer Industries. Employers who. In fact, are substantially below the ex- ixtfurc limit will lx? subjected to only minimal burden/; by virtue of the "action level" to be discussed below. Where employers in the fabricating Industry have exposures approaching the permissible limit, they will appropriately be .subject to the standard. Employer;; handling or using fabricated products made of PVC were not included in the ETS.or tlic proposal and are excluded from' the final .standard. This conclusion Is based on the absence of adequate evi dence of exposure to VC in thoe opera tions. The final standard clarifies the ex emption by defining a fabricated prod uct as a product made wholly or partly front PVC which docs not require further processing at temperatures, and for times, sufficient to cause mass melting of the PVC. SPI and others ref. TO. 344) requested that PVC resms with less than 0.1 percent residual monomer be ex empted from the regulation now, and that the exemption level be reduced to 0.01 percent in three years. SPI .suggested that the exemption of materials with lers than 0.1 percent of H carcinogens from 29 Cm 1910.93P <39 FR 3756) was an appropriate precedent. The cases are not comparable, because no attempt had been made to set air concentration limits for the 14 carcinogens. The record did not Include information that reliable moni toring and measuring techniques were available. Moreover, the exemption did not exempt airborne traces of oaiclaogens. The administrative cutoff was pro vided to avoid regulation of materials about which there was-no health haz ard information, and which would have broadly extended the application of the regulation beyond the record. Herein, no information was presented to show safe concentration results from the use of resin's with specific levels. Indeed, the proposal to change the level later, when improved technology would permit such reduction, would seem to indicate that SPI has doubts about the safely of 0.1 percent residue level. Diamond Shamrock (Exhibit 142> testified that there is no direct relation. They indicate that the airborne concentration is more related to the physical form of the resin and the ventilation provided. Also, monitor ing data from industry (cf. Exhibits 131, ICS, 170) and OSHA lExhlbit 151) indi cate that levels in excess of 1 ppm may be found in fabrication operations. In view of these facts and of the opportunity for employers to discontinue many duties upon a showing of no exposures above the potion level, it docs not appear that any residue exemption is either justified or necessary at this time. This course also agrees with n number of industry pro posals (cf. TU (ICO). SPI (TR 31S>, among others, asked that compounded PVC pellets be ex empted from the standard on Ihc grounds thnt the pellets had too low a residue to cause harmful or measurable emissions. While it appears that PVC pellets would have a lower residue level than virgin PVC, the fact that the pellets must be heated to a molten mass at the same temperature as PVC. for further pro cessing. indicates that a potential for re lease of the residue still exists. It ap pears that the exemption of fabricated products should be limited to just those items winch will not undergo such mass healing. Further, the opi>ortunity to demonstrate that exposures are below the action level, and thus, discontinue many duties of the standard, provides a more positive control and an adequate relief. <2i Permissible exposure limit. The standard sets an exposure limit of 1 ppm averaged over any 8 houT period, and a ceiling of 5 ppm averaged over any per iod not exceeding 15 minutes. Ar. more fully discussed above, this limit is based on an evaluation of the best available evidence and on a judgment that the health and safety of employees must be protected to the fullest extent feasible. In view of the fact that release of VC in the VC and PVC manufacturing processes arc variable, the 1 ppm ceiling level provided in the proposal would require maintenance of an average level significantly more difficult to attain through feasible engineering controls. Therefore, the exposure limit prescribed in the proposal has been rejected. i3j /iefio/r level. The final standard, unlike the ETS and the proposal, pro vides for an "action level" of 0.5 ppm T'.VA, one-half of the permissible ex posure limit. The purpose of the action level is to minimize the impact of the on rh** wpo attained exposure levels well below the permissible limit. Thus, where the re sults of monitoring under paragraphs (d)(1) or <dM2> demonstrate that no employee is exposed in excess of 0.5 ppm TWA. employers may, in effect, be exempted from some provisions of the standard. For example, fabricators who are below* the action level are not re quired `0 provide medical surveillance or to monitor again, unless the employer has reason to suspect that any employee is exposed in excess of the action level. In our judgment, exposures below the action level do not present a sufficient hazard to warrant application o: the en tire standard to the many employers who arc or will be below that level. (4> Monitoring. The final standard, like the proposal, requires that individual employee exposure levels be determined. This may bo accomplished by personal or area monitoring. Some witnesses and persons who submitted comments did not understand the meaning of the term "95 percent confidence level" in the proi>osnl. Essentially it means that the employer is required to take a sufficient number of measurements so that the re sults obtained are statistically valid. We have modified the proposal to establish accuracy range requirements for various measurement levels. These ranges are narrow enough to ensure that a deter mination of compliance can be made, and broad enough to allow the application of a variety of technologies AU covered employers Are required to conduct initial monitoring. Where moni tormt3 and measuring results are at or below the action level, no further moni toring Is required unless the employer has reason tn suspect that any employee is cxjHxscd in excess of the action level, or unless change* have been made in production, process, control, type of resin, etc. Where the exposure level, without re gard to respirators, exceeds the permis sible levels, monitoring must be conduc ted nt least monthly. Where exposures are less than the permissible levels, but greater than the action level, monitoring must occur at least quarterly. 5> Methods nf cowpftoncr. The stand ard. like the proposal, require-. Hint em ployers immediately in/.ntuie feasible engineering and work practice controls to reduce exposures to at or below the permissible exposure limit. Where feasible engineering and work practice controls will reduce exposures below the permissible levels. ih<\v must be instituted. Where such controls will not reduce exposures below the permis sible level, they must nonetheless be im plemented to reduce exposures to the lowest practicable level, and be supple mented by the use of respirators to pro vide the necessary protection. There upon. a continuing program of engineer ing and work practice controls must be instituted to reduce exposures to the low est practicable level. Wh.cn exposures are at or below the permissible exposure limit*, the program may be dUrontinuid. In addition, a plan fur aairc' hig ccnbv -*tv** 'ud v-vi* methods mail be drnwr. up and be made available, upon reauest, to represent atives of OSHA and NIOSII. We recognize that many employers covered by the standard can no: cur rently achieve compliance with the per- missible exposure limit solely by the use of feasible engineering and work ct acrce controls. The record also reflects broad generic distinctions between the compli ance capabilities of the VC and PVC industries. Some industry spokesmen, including SPI (TO. 333-362>, recom mended that a schedule of different permissilc exposure limits and compliance dates be established for the VC and PVC segments of the industry. This view assumes that the ability and the time required to feasibly reach in creasingly lower control levels is similar within each industry, but differs mark edly between industries. While the record docs suggest that such differences do exist between industries, as noted above, it is clear thnt intra-industry differences also exist. Thus, the ability and time re quired by each employer to attain lower control level* may depend upon such factor* as the climate in which the plant is located, the age of equipment, the size of reactors. or the type of resin manu factured or used. (Snell study. Firestone testimony, etc.) Monitoring data also tend* to support such intra-industry variations. `Sec. e.g. Dow. Firestone. Tennero.i As noted nbove. Die sliuumrd requires all employers to institute feasible engi neering controls to the fullest extent and to continue to Improve and apply engi- rcocui tCCISTCf, VOL 39, NO, 194--FRIDAY, OCTOttft 4. 1974 DTH 000011791 1l 35891 RULES AND REGULATIONS nccrJng controls until full compliance Is It the environmental level is not ron- tration-,. In dkcu.V'lon5 of there f.v.tl.r.cs achieved. X:r\ to .- iik: rypo:.t:iv limit, with NIOSH. it has indicated that n is We have not established anv r.(.* i < Mtont--5 i<-j.iru* willing to consider on an expedited by: ir. for full compliance throu;u er.: mcer .r. ' to: y pr*;" vm. the approval of air-purifying respirators controls because we are pre-MUly unuole While exposures in excess of the per for tr.e v'-.dnst VC. Consequent!'.*. *ve to determine when it wiil he feasible lor missible level do constitute a hazard, we have mfav.'ird three types of u:r-;-u: liv most establishment.*: to reduce exposure believe that it is necessary to mitigate ing respirators in the list of acceptable Jcvbls to the. permissible level. some of the problems associated with units, subject to the approval of su'-h We also believe that the requirement implementing a program of respiratory units by NCOSTT. 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 ica>ji:!e a5 socn as while other adjustments which may lie of the data submitted by NIOSH and practicable will provide lor mtor-mcius- required are implemented. Therefore, Goodrich. Because air-purifying respi try and Intra-industry technolorical ci.f- until January 1. 1976, where exposures rator.*; do not indicate rorbent c::h;u:; `.;on feronecs which do exu-t. and *:> rvnri are not in excess of a 25 ppm ceiling, or breakthrough of VC, and br<nu:c VC the setting of separate indti'iry each employer must provide each em has no iMisront warning proyei tie; a- ards on the basis of the t-.-ncral .'-itunnon ployee with an impropriate respirator. levels for which these devices rrc uxed. and conditions ir. each inchutry. However, employees whose exposures do strict administrative controls * ;'! bo re (G) Regulated areas. The proposed not exceed a 25 ppm ceiling, may decline quired for their use. Such ecu:in standard would have required that regu to u*;e the rerpirator, in which case the clude a program to assure timclv re lated areas be established, that ac:c;i to employer is net obligated to require its placement of canisters or cr.rt: idites ar.d limited to authorised employees. and use. During this adjustment period, em an alarm system to alert employees vr.cn that daily rosters or summaries 0: these ployees will be trained in the uses, pur vinyl chloride concentrations rxreod the entering be kept for at least -0 ycais. In poses and limitations of respirators, ar.d concentrations allowed for the particu objection to these requirements, it was the hazard 5 of exposure to vinvl chloride. lar type cf respirator in use. asserted that such control o: a: is.-1*- v :.s Moreover, each employee will be notified <8) Hazardous operations. This is a not necessary from a health in writing if he has been exposed in ex new section within the final standard. It Secondly, It was claimed that these con cess of the permissible exposure limit. encompasses essentially the prcyoral's trols would interfere with operation* by Where exposures exceed a 25 ppm ceil requirements for maintenance and de preventing access of needed om.p'.ovc-vs or non-employees, such as contractors, truck drivers, customers and consultants. The purpose of establishing retaliated ing. respiratory protection is mandatory' in light cf our judgment that much greater risks arc associated with such exposures. contamination but has restated them ::i terms 0; performance languari ro niHw greater flexibility for emnlovcrs to deal with such operations. The intent of the areas iu the proposal was to Him: the The provisions in the final standard new section is to protect employees en risk of exposure to as few employees as regarding the selection and use of respi gaged in activities that presen: a r::= k of possible. Tills concern is still paramount, ratory protective devices differ from exposure to vinyl chloride in excess cf :he and thus the limited access feature re mains. The final standard amends the proposal slightly to allow "authorized persons" to enter regulated areas. This those in the proposal. The description of atmosphere-supplying respirators have been revised to indicate more clearly the M den-inA-. intended, and the maxi permissible levels. An exampie would be the cleaning of a filter where resin con taining high residual monomer is change. It is felt, will allow operations 10 mum permissible concentration level for The proposal's requirement for fufi- continue without undue interference. each device. Moreover, the number of bodv. impervious clothing has been re The final standard has also increased the types of atmosphere-supplying devices placed by the direction to use impervious length of time daily routers must be has been increased. garments suited to the particular situa maintained from 20 to 20 years. This At the hearing Mr. Edwin C. Hyatt, an tion ar.d probable extent of export::?. change was based largely on epidemio OSHA consultant, made suggestions re Thus, full-body clothing is not always logical considerations. iSee NIOSH testi garding the use of particular respiratory necessary. and is therefore not required mony. tr. 119.) devices. We have concluded that his sug where less protection Is adequate. Since (7) Respiratory protection. The Anal gestions are meritorious. Therefore, the vessel entry fails within the uefirttion standard, like the proposal, requires the provisions for selection of atmosphere- of a hazardous opevation. the ves.-el entry use of respirators where employee expo supplying devices follow closely the rec section of the proposal has been d.fieied sures exceed the permissible control level. ommendations contained in his testi from the fatal standard. Industry representatives made a number mony of SPI and B. F. Goodrich) iTR (9) Ctnerpcncy situations. The clcfijii- of objections to proposed requirements with Hyatt's suggestions. (See e g. testi tiou of emergency has been recast in for respiratory protection. They stated mony of SPI and B. F. Goodrich> tTR terms of an unexpected ma>.<:ce release. that the "no detectable level" would ef S5 !T* We had originally omitted air- The main objection to the section on fectively require continuous wearing of purifying respirators because none had emergency situations in the proposal war, respirators in PVC and VC plants, and been approved by NIOSH for use against that, as the term wa defined, many that tills 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, arid employees would not use service life cf the sorbent. Hyatt and considered emergencies. This was no: them. other witr.c*?c 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 time contemplate them as a final solution, hao 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 net be developed for ticularly may need several years before adequate service life. Recently. OSIIA minor excursions above the pcrmtrrible 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 oceassionnlly. However, we cannot commercially available canisters and U0> Signs and labels. The thrust of the agree that respiratory protection should cartridges fur vinyl chloride. Those eval signs and labels section is to apprize not be required dimply because it is in uations were conducted separately by employee.; of the cancer and fire haz convenient. may require additional per sonnel, interferes with production, or may require extensive retraining of em ployees and restructuring of work prac NIOSH and by the B. F. Goodrich Com pany and submitted to OSHA iu posthearing comments. The results Indicate that certain presently available canis ards. No objections have brcn.raixcd with respect to Informing employees of the fire hazard. However, a number of ob jections wore raised at the luurnr: and in written rubmisaions to the require tices. Wo luvvc carefully considered oil ters and cartridges effectively absorb ment tint the word `cancer" appear on the objections, and have concluded that vinyl chloride at relatively low concen all signs and labels. The principal argu- FEOEftAl REGISTER, VOL 39. NO. 194~FZIOAY, OCTOSCR 4, 1974 DTH 000011792 RULES AND REGULATIONS 35805 ment'advanced analnat ILs use was that the term "cancer'' or "cnnccr-suspecL Agent" scares employers mid that In stead, the mcstfi/ic .should contain in structions on how to deal with the sub stance (Tit. 347k Wc believe that a diluted form of warning will not suffice. We appreciate the concern of employers with the reaction of their employees. Cut we consider il imperative that a worker he fully informed, and that he realize the possible risks involved in his occupation. Coupled with the tmininn requirement in the standard, wc believe (hat the sums and labels required wid adequately in form employees of Hie hazard. In addi tion. such sijms will warn unauthorized personnel to keep out of rouulalcd areas. Tlic proper application of most protec tive measures requires an amount of tralniuc and indoctrination of employees that cannot easily be conveyed on a sicn or label. Also, the variety of measures that could be prescribed would result in an umvicldly or excessively detailed leg end. Consequently, the required message on signs and labels will not include in formation on precautions, relevant symptoms, etc. The addition of suitable Information by the employer would be permitted, providing it does not detract in any way from the required statement. The requirement in the proposal for labeling containers of vinyl chloride has been amended by deleting the reference to the possible hazard of violent polym erization. Very little information was developed on this hazard during the sisiiuiuil ap pear that this hazard is essentially under control and that the fire and carcino genic hazards at present are the most significant. Since labeling or placarding that is in compliance with the U.S. De partment of Transportation regulations (49 CFR Part 173. Subpart H> already warns of the fire hazard, only a state ment concerning the carcinogenic haz ard need be added to the Department of Transportation labels. (11) Medical surveillance. The princi pal questions that have been raised re garding medical surveillance arc the necessity and efficacy of requiring cer tain specific scrum enzyme determina tions (SMA-22 series) and the applica tion of medical examination require ments to the fabrication segments of the industry' where employees are exposed to lower levels of VC. The objection has also been raised that the specification of tests and procedures interferes with the ap plication of advances in medical knowl edge. A particular difficulty in considering medical surveillance is that the most commonly discussed lesion, angiosar coma of Uie liver, currently cannot be diaguosed until the victim is terminal and. usually, within months of death. Precursor physiologic alterations, which might be reversible, have not yet been directly associated with the lesion. Con sequently. there are no specific diagnos tic tests which can be prescribed which will determine presence or absence of this tumor at an early stage of develop ment. However, most medical witnesses Indicated that the medical tests proposed arc currently the only ones available which are useful for medical surveillance <TFt 121. i:xh. 95. TR 5KJ-591). Conse quently. the specific blood tests pro;x>scd have been retained as a minimum re quirement to assist the examining physi cian in determining fitness of potential employees for assignment to workplaces involving VC exposure. In addition, al ternative medical examinations may be used where the examining physician de termines that they arc at least as good as those specified by the standard. The Tabershaw-Cooper study and the various animal experiments surest that VC may produce a wide spectrum of ma- litjnant and non-inalignant disorders. The general scope of the required medical examination has. therefore, been broad ened to include kidneys, skin, connective tissue, spleen, and pulmonary system, as well as the liver. No additional specific procedures or tests are required, but rec ommendations have been included in the Appendix to assist the examining physi cian. Because of the nonspecific nature of the required medical tests, it is not appropriate to prescribe timing, or type of followup tests, or to mandate with drawal from exposure based solely on re sults of the tests. Instead, the employer is required to obtain a statement irom the examining physician of the em ployee's suitability for continued expo sure. when the examining physician has completed such tests as he considers ap propriate. The employer is required to wiuitiraw an employee usiii tin.* statement indicates that the employee may be at added risk from continued VC exposure. As with monitoring, there appears to be no basis for complete exemption of the fabrication industry from the require ment for medical examination. The rec ord docs shotv fabricating establishments with concentrations of VC monitored considerably above the action level. In these instances, medical surveillance of affected employees will provide baseline data for future evaluation of their health, even if both monitoring and medical sur veillance are discontinued because im proved controls reduce concentrations below the action level. Where exposures are below the action level, the medical surveillance requirements do not general ly apply, il3> Training. A separate provision for employee training has been added to the final standard rather than including it within the section on emergeury situa tions as in the proposal. The new para graph provides for training of employees concerning the carcinogenic hazard of VC. emergency procedures, the need for monitoring and an annual review of the standard. It aho provides for training of employees concerning the purpose for, proper use of. and limitations connected with respiratory protection. (13) Uncords and reports. The provi sions for recordkeeping contained in the final standard require the preparation and maintenance of essentially the same information required by the proposal. The major change from the ortgiuai pro posal Is the requirement for maintenance qf monitoring records and daily rosLer sheets of authorized persons for jo years, instead of 2U years. Additionally, the* em ployer is required to maintain medical records for the duration of an emplovce's employment plus 20 years, or 3) 5 cars, whichever h longer. The original pro posal called for only 20 years. Tills change has been implemented be cause the latency period for induction of angiosarcoma ranges up to 30 years from initial exposure. Therefore, as a mini mum, medical records must ho main tained for at least that long. Jt si oul:i be noted that spokesmen for both I. = and indust ry recommended that ihu change be made. The reporting requirements arc not significantly different from those; in t.:ie original proposal. However, instead of the requirement for reporting iv.udcr.ts which result in the release 01 VC into areas where employees may be exposed, the final standard clarifies our original intent by stating that only erne:eoucies must be reported. Also the requirement for filing a detailed, written report within 15 days has been deleted. It has been concluded that submission, within 24 hours, of an initial report tnat in cludes facts immediately available, would ordinarily bo sufficient. However, if the OSHA Area Director requests fun her in formation relevant to the emergency, the employer will be required to ftirm.-h such information. (14) Deleted portions of the proposal. x tiO pl'upOjUi. l1;- quiring that shower facilities and change rooms be provided, and that storage or consumption of food be prohibited in regulated areas. We have deleted these provisions because it is our conclusion they arc no longer necessary. Showering facilities arc not required because pro tective clothing, where required by the final standard, should protect employees from skin absorption by direct contact with VC and because there is no reliable evidence that VC vapor is absorbed through the skin. In addition, since we anticipate that most employees will no; be wearing protective clothing and that employees who wear protective clothing will chance such clothing infrequently, we are not requiring that change rooms be provided. In addition, wc feel that there is In adequate evidence showing that hazar dous amounts of VC can be absorbed through ingestion. For this reason, the requirement prohibiting tire storage or consumption of food in regulated areas has been deleted. Tile proposal also contained provisions on mnintcnlance and decontamination, transporiation loading amt unloading, and polymer handling operations. These requirements arc not mentioned in the final standard because attention to these items is implicit in the requirement that each employer reach the pcrimssable ex posure limit or attain the lowest feasible level. t <15) Effective date. In order to ensure that affected employers and employees will be Informed of the existence of these reOCKAl MCWfl. VOL J, NO. 1*4--fMWtr, OCTOttt 4, 1*74 DTH 000011793 35896 RULES AND REGULATIONS provisions and that employers affected of the operation or because of an acci opportunity lo observe the monitor arc given an opportunity to familiarize dent in the operation, which would result ing and measuring required by this themselves and I heir employees with the in an employee exposure In excess of the paragraph. existence of the new requirements, the permissible exposure limit. (c> Rcrtul'tfed arm. d) A regulated effective date of the amendment to <8> "OSHA Area Director" means the area shall be established where: | 1910.93q will bo January 1, 1975. To pro Director for the Occupational Safety (I) Vinvl chloride or poKvmvl chloride vide continued protection for employees and Health Administration Area Office is manufactured, reacted, repackaged, until that date, the proviMons currently having jurisdiction over the geographic stored, handled or tred; and contained in 5 I9l0.93q arc hereby area In which the*cmpioycr's establish (li) Vinyl chloride concentrations arc promulgated, pursuant to section G(b>, ment is located. In excess of the permissible exposure 6(c) and 8<c) of the Occupational Safety <9> "Polwinyl chloride" means poly limit. and Health Act. as an occupational vinyl chloride homopolyincr or copoly <2) Access to regulated areas shall be safety and health standard effective mer before such is converted to a fabri limited lo authorized persons. A dally October 4, 197-1, the amendment to cated product. roster shall be made of authorized per g 1910,93(1 set out below will supersede <10) "Vinvl chloride" means vinyl sons who enter. these provisions as of January 1, 1915. chloride monomer. (f> Methods of compliance. K^vdoycc Accordingly, upon consideration of the (c> Permissible exposure limit. (1) No exposures lo vinvl chloride shall bo con whole record of this preceding. Part 1910 employe may be exposed to vinyl chlo trolled to at or below the permit- ib'e ex of Title 20, Code ol Federal Regulations ride at concentrations greater than l ppm posure limit provided in paragraph 'o is amended, effective January 1. 1975. by averaged over any 8-hour period, and of tills section by engineering, wot !-: prac revision of $ I910.93q to read as follows: (2) No emplovcc may be expored to tice, and personal protective control; is 1910.93(1 Vinyl ililnruJt*. vinyl chloride at concentrations greater follows: than 5 ppm avemced over any period not (1) Feasible engineering etui work (a) Scope and application. (1) This exceeding 15 minutes. practice controls shall immediately he section includes requirements for the (3) No employee may be exposed to used to reduce exposures to at c; below control of employee exposure to vinyl vinyl chloride by direct contact with the permissible exposure limit. chloride (chloroethene). Chemical Ab liquid vinyl chloride. (2) Wherever feasible engineering and stracts Service Registry' No. 75015. (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 rot sufficient :o facture. reaction, packaging, repackag shall be undertaken in each establish reduce exposures to at or below i per ing, storage, handling or use of vinyl ment to determine if there is any em missible exposure limit, they .-hull none chloride or polyvinyl chloride, but does ployee exposed, without regard to the use theless be used to reduce exposures "o not apply to the handling or use of fabri of respirators, in excess of the action the lowest practicable level, and -had! be cated products made of polyvinyl chlo level. supplemented bv respiratory protection ride. (2) Where a determination conducted in accordance with paragraph (g> o:' 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 ;o chloride except to the extent that, the regard to the use of respirators, in ex at or below the permissible omo-ure Department of Transportation may cess of tile action jevei. a propram lor de limit, or to the grersest extent. icar:b!e, regulate the hazards covered by this sec termining exposures for each suen em solely by means of engineering and work tion. ployee shall be established. Such a pro practice controls, as soon as teasiblc. (b) Definitions. (1) "Action level'' gram: (3) Written plans for such a program means a concentration of vinyl chloride (i) Shall be repeated at least monthly shall be developed and fur::i:sneci uyen of 0.5 ppm averaged over an 8-hour work where any employee is exposed, without request for examination and copying io day. regard to the use of respirators, in ex authorized representatives of the As*is- <2) "Assistant Secretary" means the cess of the permissible exposure limit. taftt Secretary and the Director. Such Assistant Secretary of Labor for Occupa lit) Shall be repeated not less than plans shall be updated at least every six tional Safety and Health. U.S. Depart quarterly where any employee is exposed, months. ment of Labor, or his designee. without regard to the use of respirators, fg) Respiratory protection. Where <3> "Authorized person" means any in excess ol the action level. respiratory protection Is required under person specifically authorized by the em (iii) May be discontinued for any em this section: ployer whose duties require him to enter ployee only when at least two consecu U) The employer shall provide a a regulated area or any person entering tive monitoring determinations, made not respirator which meets the requirements such an area as a designated representa less than 5 working days apart, show ex of this paragraph and shall assure that tive of employees for the purpose of ex posures for that employee at or below the employee use? such respirator, except ercising an opportunity to observe moni the action level. that until December 31. 1975. wca.:ng of toring and measuring procedures. (3) Whenever there has been a pro respirators shall be at the discretion of (4) "Director" means Uie Director, duction, process or control change which ` each employee for exposures not in ex National Institute for Occupational may result in an increase in the release cess of 25 ppm. measured over any 15- Safety and Health, U.S. Department of of vinyl chloride, or the employer lias minute period. Until December 31. 1975. Health, Education, and Welfare, or Ills any other reason to suspect that any em each employee who chooses not to wear designee. ployee may be exposed in excess of the an appropriate respirator shall be in (5) "Emergency" means any occur action level, a determination of employee formed at least quarterly of the hazards rence such as, but not limited to. equip exposure under paragraph <d) (1) of this of vinyl chloride and the purpose, proper ment failure, or operation of a relief de section shail be performed. use, and limitations of respiratory vice which Is likely to. or does, result in (4) The merited of monitoring and devices. massive release of vinyl chloride. measurement shall have an accuracy <2) Respirators shall be selected from (6) "Fabx*icatcd product" means a (with a confidence level of 95 percent! of among those jointly approved bv the product made wholly or partly from not less than plus or minus 50 percent Mining Enforcement and Safety Acjmin- polyvinyl chloride, and which docs not from 0.25 through 0.5 ppm. plus or minus ustraiinu. 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 enure 1.0 ppm, and plus or minus 25 percent tional Safely and Health under the pro mass melting of the polyvinyl chloride over 1.0 ppm. (Methods meeting these visions of 30 CFR Part 11. resulting in the release of vinyl chloride. accuracy requirements arc available in (3' A respiratory protection program (7) "Hazardous operation'* means any the "NIOSII Manual of Analytical meeting the requirements of H 1910.13-1 operation, procedure, or activity where tv Methods"). shall be established and maintained. release of either vinyl chloride liquid or (5) Employees or their designated rep (4) Selection of respirators for vinyl gas might be expected os a consequence resentatives shall be afforded reasonable chloride shall be as follows: FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOtt* 4, 1974 DTH 000011794 -4* RULES AND REGULATIONS 35807 AfmojpAerte concentration of vinyl chloride Required apparatus (vi) The purpose for. and a d'scnp.tion of. the medical surveillance (I) Unknown, or above 3,COO ppm__ Open-circuit. Mir-cooLatnrcl hrcnthlnt' apparatus, pres* program; (II) Not over 3.000 ppm sure demand type, with full fuceplcoc. (A) Combination tyjwv c supplied air respirator, pres (vii) Emergency procedures; (vtil> Specific information to aid the (111) Not over 100 ppm. (It) Not over 25 ppm. sure demand type, with lull or half facepiece, and auxiliary self-contained air supply: or (B) Typo C, supplied nir respirator continuous now type, wiUi full or half facepiece, and auxiliary self-contained sir supply. (A) Combination type C supplied air respirator de mand type, with full facepiece, and auxiliary scU-conlulmrd air supply; or (B) Open-circuit self-contained breathing apparatus with full faccplvce. In demand modo: or (C) Type C supplied air respirator, demand type, with full facepiece. (A) A powered nlr-purlfylnf* respirator with hood. helmet, full or half faccpicce, and a cnnLtcr employee in recognition of conditions which may result in the release o/ vinyl chloride; and i (lx) A review of this standard at the employee's first training and indoctrina tion program, and annually Ua-n aiter. (2) All materials relating to the pro gram shall be provided upon request to the Assistant Secretary and the Director. (k> .'.Tcclical surveillance. A program of medical surveillance ahall be insti tuted for each employee expo:.'*d. with out regard to the use of respirators, to Which provides a service life of at least 4 vinyl chloride m excess of thi* action hours for concenratlous of vinyl cUlorido up level. The program shall provide each to 25 ppm. or such employee with an opportunity for (B) Oas mask, fronts or back-mounted canister which examinations and tests in accordance provides a service life of at least 4 hours for with this paragraph. Ail medical ex (t) Not over 10 ppm. concentrations of vinyl chloride up to 25 ppm. (A) Combination typo C sopplied-air respirator, de mand type, with half facepiece, and auxiliary self-contained air supply: or (B) Type C supplicd-air respirator, demand type, with hall facepiece: or (C) Any chemical currkl^e respirator with r.n organic vapor cartridge vJticli provides a service life of at leAst 1 hour for concentrations of vinyl chloride up to 10 ppm. aminations and procedures shall bo per formed by or under the supervision of a licensed physician, and shall be provided without cost to the employee. (1) At the time of initial assignment, or upon institution of medical surveil lance: <i> A general physical examination shall be performed, with specific reten tion to delecting enlargement of liver, (5) (i) Entry Into unkown concentra tions or concentrations greater than 3$,000 ppm (lower explosive limit) may be made only for purposes of life rescue: and (ii) Entry into coiiCcntratiOiis of less than 36,000 ppm. but greater than 3.C00 ppm may be made only for purposes of life rescue, firefighting, or securing equipment so as to prevent a Greater hazard from release of vinyl chloride. (6) Where air-purifying respirators are used: (i) Air-purifying cannisters or car tridges* shall be replaced prior to the expiration of their service life or the end of the shift in which they are first used, whichever occurs first, and (ii) A continuous monitoring and alarm system shall be provided where concentrations of vinyl chloride could reasonably exceed the allowable concen trations for the devices in use. Such sys tem shall be used to alert employees when vinyl chloride concentrations exceed the allowable concentrations for the devices In use. (7) Apparatus prescribed for higher concentrations may be used for any lower concentration. <li> Hazardous operations. (1) Em ployees engaged iu hazardous operations, including entry of vessels to clean poly vinyl chloride residue from vessel walls, shall be provided and required to wear and use; (2) Protective Garments shall be pro vided clean mid diy for each use. ii) Emergency situations. A written operational plan for emergency situa tions shall be developed for each facility storing, handling, cr oil.cr.uac using vinyl chloride as a liquid or compressed gas. Appropriate portions of the plan shall be implemented in the event of an emergency. The plan shall specifically provide that: (1) Employees engaged in hazardous operations or correcting situations of ex isting hazardous releases shall be equipped as required in ParaGraph (h) of tliis 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. ij) 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; spleen or kidneys, or dysfuncuon in these organs, and for abnormaltics in skin, connective tissues and the pulmonary system (See Appendix A). (li> A medical history shall be taken, including the following topics: .A* Al>.:otioi uiLU'.o; (B) Past history of hepatitis: (C) Work history and pa.-l exposure to potential hcpatotoxic agents, includ ing drugs and chemicals; <D Past history of blood transfu sions: and <E> Past history of hospitalizations. (ill) A serum specimen rhall be ob tained and determinations made o:: (A) Total bilirubin; . (B) Alkaline phosphatase: (C) Serum glutamic oxalacctlc trans aminase (SCOT); (D> Senun glutamic pyruvic transam inase (SGPT> : and <E) Gamma plustamyl tvanspeptidase. (2> Examinations provided in accord ance with this paragraph shall be per formed at least: <i) Every 6 months for each employee who has been employed in vinyl chlo ride or polyvinyl chloride manufacturing for 10 years or longer; and (ii) Annually for all other employees. <3) Each employee exposed to an emergency shall be afforded appropriate medical surveillance. (4) A statement of each employee's suitability for continued exposure to vinyl chloride including use of protec (i) Respiratory protection in accord (U) The purpose for, proper use. and tive equipment and ropinuois. .snail be ance with paragraph (c) and (g) of limitations of respiratory protective obtained from the examining physician this section: and (ii) Protective garments to prevent skin contact with liquid vinyl chloride or With polyvinyl chloride residue front vessel walls. The protective garments devices: Uv> Tlic fire hazard and acute toxic ity of vinyl ciiloridc, and the necessary protective steps; promptly after any examination. A copy of the physician's .statement shall be pro vided each employee. (0> If any employee's health would be shall be selected for the operation and (v> The purpose for and a description materially impaired by continued ex Its possible exposure conditions. of the monitoring program; posure. such employee shall be with- FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 19/4 DTH 000011795 35898 RULES AND REGULATIONS drawn from possible contact with vinyl tion which contradicts or detracts from chloride. the effect of, any required warning, (G) Laboratory analyses for ail bio* informauon or instruction. logical specimens Included In medical 'rr. Accord:. <1> AH records moln- examinations shall be performed In labo tair.ed :n accordance with this rection ratories licensed under 42 CFR Part 74. shall :rrh:de the name and social sccu- (7) If the examining pliy. irian deter r::y r. r.r.cr of each employee where mines that alternative medical examina rei:v r.v tions to those required by paragraph *2: F.rrcrds of required monitoring (k)(l) of this section will provide at ar.d rr.::-*urmg, medical records, and au least equal assurance of detecting med thor-:i ;-:r. onr.el rosters, shall be made ical conditions pertinent to the exposure a:;U sl-.ai: be available upon request for to vinyl chloride, the employer may ac e>::ir...:.:.\:'..n and copying to authorized cept such alternative examinations as rcpr<:::r.u*vi;vc5 of the Assistant Sccre- meeting the requirements of paragraph tai-y a:... me Director. (k) (l) of tliis section, if the employer M: :..:-vnng and measuring records obtains a statement from the examining physician setting forth the .alternative <A State the date of such monitor examinations and the rationale for sub ing i.-.a measuring and the concentra stitution. This statement shall be avail tor c-.-:cr:a:::ed and identify the instru able upon request for examination and ment.* ar.d methods used: copying to authorized representatives of 'S1 include any additional informa the Assistant Secretary and the Director. tion necessary to determine individual <l) Sitnts and labels. U) Entrances to cnr'ryee exposures where such exit regulated areas shall be posted with leg s'.: res rre determined by means other ible signs bearing the legend: than individual monitoring of employees; Cancicr-Suspect Agent Area Authorized arc Personnel Onlt <C) Be maintained for not less than (2) Areas containing hazardous oper ations or where an emergency currently exists shall be posted with legible signs bearing the legend: 30 rears. ' i: Authorized personnel rosters shall be maintained for not less than 30 years. .Medical records shall be main tained for the duration of the employ Canct*-Srsneer Agent in This Area Prottc- ment c: each employee plus 20 years, rtvfi Equipment Required Authorized or 31 years, whichever is longer. Personnel Onlt (3> In the event that the employer (3) Containers of polyvinyl ehlorirte ceases to do business and there is no resin waste from reactors or other waste contaminated with vinyl chloride su:c-'^:r to receive and retain his rcc--5 .* ..- ..*.U : vn. , ^ Jiw* 1, . C_. f.' be legibly labeled: orris shall be transmitted by registered Contaminated with Vinyl Chloride Cancer-Suspect Agent (4) Containers of polyvinyl chloride shall be legibly labeled: ir.r.i! Id trie Director, and cr.cit employee ir.ri:-.-:.-:jai'.y notified in writing of this transfer. <4` Dn.p'.ryces or their designated represer.-..v.:ves sliall be provided access Polyvintl Chloride (or Trade Name) to examine ar.d copy records of required Contains monitoring and measuring. Vinyl Chloride Co' Former employees shall be pro Vinyl Chloride is a Cancer-Suspect Agent vide.: atcess to examine and copy re (5) Containers of vinyl chloride shall quired monitoring and measuring records be legibly labeled either: refiecieng their own exposures. (l) Vinyl Chloride Extremely Flammarle Gas Under rnrssur.E Cancer-Suspect Agent or (11) Tn accordance with 40 CFR Part 173, Subpart H, with the additional (6> Upon written request of any em ployee. a copy of the medical record of that employee shall be furnished to any phy,:cian designated by the employee. in' Deports. (1) Not later than 1 month after the establishment of a reg ulated area, the following information legends: shall le reported to Llic OSIIA Area Di Cancer-Suspect Acent applied near the labor or placard, rector. Any changes to such information shafi be reported within 15 days. ti> The address and location of each (6) No statement shall appear on or establishment which lias one or more near any required sign, label or Instruc regulated areas; and (li) The number of employees In each regulated area during normal operations, including maintenance. I21 Emergencies, and the facts ob tainable at that. time, shall be reported within 21 ]lours to the OSIIA Area Di rector. Upon request ol tile Area Direc tor. the employer shall submit additional information in writing relevant to the nature and extent of employee exposures and measures taken to prevent future emergencies of similar nature. c3l Witliiu 10 working days following any monitoring and measuring wlncli discloses that any employee lias been exposed, without regard to the use of respirators in excess of the permissible exposure limit, cacli such employee sliall be notified in writing of the results of tiie exposure measurement and tiic steps being taken to reduce the exposure to within tire permissible exposure limit. (o) ESeclive dales, 'll Until Janu ary 1. 1075, the provisions currenTy set forth in 1910.03q of this Part shall apply. (2) Effective January 1, 1075. the pro visions set forth in 5 1910.93q of this Part shall apply. Ari'Exout A--Sut'pecMr.svxF.T Mhoicm. Information When required lest* under pe.racrauh <k)<l) of this section show abnormalities the tests should be repeated is soon as prac ticable. preferably v.-r.hiu 3 to 4 viee*.s. i: test* remain abnormal. coi'U'k-r.stirm mould be giCeU i</ VvItjjdTuV,a 4* i..c t.i..:.u^it contact with vinyl chloride, while a move comprehensive examination 19 made. Additional tests which may be usefulA. For kidney dysfunction: urine examina tion for nibvimn, red blood ceils, aud ex foliative abnormal cell.-?. 13. Pulmonary system: Forced vital capac ity, *Forced expiratory volume at \ second, and chest roentgenogram (posterior-anterior. 14 x 17 Inches). C. Additional serum tests: Lactic arid dchydrogenase, lactic acid dehydrogenase isocazvme, protein determination, uml protein electrophoresis. D. For a more comprehensive examination on repeated abnormal serum tests: Hope, tit is D antigen, ar.d liver scanning. (Sees. 6 and 8. 81 Cut. 1596. 1599 \29 U.S.C. 655, 057); Secretory of Labor's Order No. 12-71, 36 FR 8754) Signed at Washington. D.C., this 1st day of October, 1974. John STCNoar., Assistant Secretary of Labor. |TO DOC.74-33176 Filed 10-1-74:3:54 pm) FEDERAL REGISTER, VOL. 3f. NO. 194--FRIDAY, OCTOttl 4, 1974 l DTH 000011796