Document GmRnpkb4r2rRdM9Y6dMBXQ5aN

v ...... FRIDAY, OCTOBER 4, 1974 WASHINGTON, D.C. Volume 39 Number 194 RECfciVED fe.' *J -`4 VHIT' r`t> n PART U - ..rz-t-iSfau- ' - .: :--e;r " DEPARTMENT OF LABOR,, Occupational Safety; And . Health Administration .V- t . %* r--* ' -`J'- i ' ,1: v v.^v.yi.'-_ .. ; ,r. ; h, /* f - _* Ct , - V-! - EXPOSURE TO VINYL .v?. ; CHLORIDE Occupational Safety and Health Standards CORRECTED AS PER FEDERAL REGISTER, v VOLUME 39, PAGE 4184 5T DECEMBER 3 , 1976. I : ucc 060218 35890 *- RULES AND REGULATIONS - -rrii> - - --; TO* CHAPTER XVI(---OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DE PARTMENT OF LABOR PART 1910--OCCUPATIONAL SAFETY ' AND HEALTH STANDARDS ployees from a Tare liver cancer (angio sarcoma) may have been occupationally related. As a result of this notification after consultation with NIOSH. and a joint Inspection of the B. 7. Goodrich plant by OSHA, NIOSH and the Ken tucky Department of Labor, a fact-find and abroad. OSHA proposed to revise 191093q and published a comprehensive proposal (39 FR 18898) on May 10,1074. to protect employees from hazards of exposure to VC. The proposal called for hmitathm of employee exposure to Veto 'bio detectable level," as measured fay a Standard for Exposure to Vinyl Chloride ing hearing was announced on Janu sampling and analytical method sensitive Pursuant to sections #0)). 0(c), mud S.:> of the Occupational Safety mud E-alth Act of 1970 (84 Stmt 1593, 1596, 1599; 29 TLS.C. 855. 857) Secretary of Labor's Order No. 13-71 38 FB 8754) and 29 CFR Past 1911,1191893 of Part 1910 of Title 29. Code of Federal Regu lations is hereby mf**** in the maims set forth below, in order to provide an Occupational Safety and Health stand ard dealing with the exposure of emTtim BB* to iteyl chiorldL L Background--(I) Vbtyt chloride. Vinyl chloride (ckloroeiheae), Chemical Abstracts Service Registry No. 75014. is a aynthetie organic chemical made from ethylene or acetylene and chlorine by any of several processes. H Is the parent compound of a series of thermoplastic rain polymers and copolymers which are widely used for containers, snapping 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 is >TM of seven billion pounds per.year. The vinyl chloride industry divides into three segments: monomer production, polymer production, and fabrication. Production of the monomer Is a largescale continuous process, involving only a few firms. There ere 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 th* -production of polyvinyl chloride ' fPViJ'; * -sin which is produced through batch .c.-v-.casing. The conversion of the VC monomer into a polymer or copolymer is an incomplete process, Le, not all of the monomer is reacted. PTC 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 ary 30, 1974 (30 PR 3874) and held on to 1 ppm. ,with an accuracy of 1 ppm February 15,1974. *50 percent. The proposal also called' Information obtained from this hear for the establishment of regulated areas ing, particularly the preliminary reports and limited access to such areas to au-. of experiments conducted by Professor thorized persona A requirement for Create Maltani of the Institute dl On- monitoring of employee exposures was cologia, Bologna, Italy, demonstrated proposed, along with engineering and that vinyl chloride Induced angiosarcoma work practice control* to be implemented In rata at levels es low as 250 ppm, and in other species at higher levels Experi over the detectable limit ments performed-at lower levels of ex protection would have posure were not completed at that time. healrequired while engineering and work Other testimony from mwMeei witnesses practice controls were being implemented and NIOSH, and the results of autopsies, or where exposures exceeded the per- led to the conclusion that the Goodrich ushers had angiosarcoma of the liver mtesible limit even altar feasible en gineering controls were instituted. and VC probably was the causal agent In the angiosarcomas observed. . lh addition, the proposed standard memitais requirements for medical sur- ' In post hearing comments, additional angiosarcoma deaths were reported ,Tvtng workers who had been exposed to VC In plants operated by Union Carbide Corporation, Firestone Plastics Corpora tion and Goodyear Tire h Rubber Com veOlanoe. protective clothing, emergency pyooedurea training, specific protection during maintenance and decantamlna'tion operations, transportation i"Ai"g and unloading operations and record- 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 (HIS) was promul gated on April 5, 1974 (99 FR 12341) pursuant to section 6(c) of the Act, ss 29 CFB1910934.' This standard reduced the permissible exposure level from s celling of 500 ppm. to s 50 ppm ceiling, and established other requirements, including, for example, monitoring and respiratory protection. It was expressly recognised that this standard limiting exposures to a 50 ppm ceiling was a tentative, interim standard, tvi that the whole question of exposure to VC would be considered more fully In the light of additional information, the results of experiments which were known to be underway at that time. (4) Hearing on the proposal. The pro posal. as published on May 10, 1974, allowed 30 days for interested parties to submit written comments and to request an Informal rulemaking hearing. In formal contacts, with OSHA staff and early responses Indicated that the sub ject was of great interest and Importance to many persona Because of the limited time available before expiration ef the six month period provided in section. 0(c)(3) of the Act for promulgation of a find standard. It was decided to bold a hearing as soon as possible. Accord ingly. an May 24,1074, a notice of a bear ing was published (39 FR 18303), setting a hearing date of June 25, 1974. The hearing was conducted from June 25. through June 28, and again from July 8, through July ll, before Administrative law Judge Gordon J. Myatt. All. partici pants were given the opportunity to pre sent testimony and to cross-examine other witnesses. Persons participating in On April 15,1974, information and data the hearing were given until August 23, are employed by fabrication firms. Such were presented to representatives of 1974,-to file additional posthearing com firms range In size from those with few OSHA, NIOSH, and the Environmental ments, Including various items of infor employees and simple equipment to large Protection Agency by the Industrial Bio- mation which were requested during the plants involving many employees and Test Laboratories, Northbrook, Illinois, examination of witnesses. considerable capital concerning results of animal exposure (5) Economic and technical impact Vinyl chloride (VC), a gas at ambient temperature and pressure. Is-a chlori nated hydrocarbon, which heretofore has studies with VC. These studies were sponsored by the Manufacturing Chem ists Association. Although only pre study. During the hearing, OSHA deter mined that additional facta would be needed to determine the practicality cf been regarded as having moderate liver liminary in nature at that time, these certain aspects of the proposed stand toxicity. The initial standard, contained results revealed that 2 out of 200 mice ard. Accordingly, OSHA contacted an in in Table 0-1 of 192093, established a exposed to VC concentrations of 50 ppm dependent consultant, -Foster D. Snell ceiling value of 500 para of VC per mil for 7 hours a day, five days a week, for Corporation, to conduct studies of the lion parts of air. approximately 7 months, had developed feasibility of compliance at various ex (2) The emergency temporary stand angiosarcoma of the liver. posure levels, including those proposed ard. On January 22, 1974. the Occupa (3) The proposed permanent stand by OSHA and others advanced by in tional Safety and Health Administra ard. Based on the demonstrated evidence dustry spokesmen. Snail was also com tion i.OSHA i was informed by the Na of VC's carcinogenicity in three animal missioned to collect information regard tional Institute for Occupational Safety species (rats, mice and hamsters), and ing the economic costs of compliance. and Health (NIOSH) that the B. P. the substantial probability that VC had This action was announced at the close Goodrich Chemical Company had re been the causal agent in the casea of liver of the hearing, and Judge Myatt further ported that deaths of several of Its em angiosarcoma found In workers both here announced that the record would be kept FeDZKAL tEGISTM, VOL 39, N . 194--MIDAV, OCTOIEK 4, 1974 ucc 060219 ^_____ - , RULES AND REGULATIONS 35891 open for a period of time beyond August 23. to allow interested persons to com ment to writing on toe study. On Angnst 26.187*. OSHA amuswicsd that the pre liminary study ees sisibUs and tost Mwimwati were to be submitted no later studies of Maltonl and Bio-Test Labora tories. Moreover, Maltonl's investigations have demonstrated a dose-dependent re lationship lor induction of tumors (La, snore tumors occur at Wftiw exposure levels), angiosarcoma of the may create a carcinogenic hazard, toe mount of exposure which to hazardous must be determined. The Burgeon Gen eral's Ad Hoe Committee referred to above concluded that safe exposure levels for carcinogenic substances cannot be than September 0,1ST* (32 FK 30344). On Septetober 12. 187*. t)6HA invited comments on both toe preliminary end toe final study, which was to be received on or before September 23, 137* (39 FR 33008). (6) Environmental impact statements. A notice of intent to file an environmen tal -impact statement assessing toe im pact of a proposed standard on occu pational exposure to VC was.published 'to toe FnniL Remain an April 24. 197* (39 FR 1*322). Hie notice Invited any person havine information or data on the envtronmmtal impact to submit It to 03HAby May 17.1874. On June 12. 1974, a draft envirocjmmtal impact statement was prepared and circulated to all interested persons. Ten copies were forwarded to toe Council of Enxiron- mental Quality (CEQ). which published a notice of Its filing sad availability to toe Fxdxesl Kzcisxn on June 25. 197* (39 FR 32875). A *3 day period was al lowed for toe submission of comments on - the draft statonent. On September 5. 197*. toe Rnai mvironmcntal fcnpact statement was prepared and a copy of it and all substantive comments were sent to appropriate govemmmtal agendas, private organizations, and other Inter ested persons. CEQ published a notloe of availability for the final stotemsit on September 6, 197* (39 m 32330). The submission of comment was Invited un til September 23, 197*. The final state ment and all aanments have been carefully considered to arriving at toe final standard e:< i -cupational expo sure to VC. ., (7) The record. Th i record to tola proceeding Is one of too most exhaustive ever relied upon by OSHA- It consists aC pre and post-hearing comments and testimony received at both factfinding and rulemaking hearings, toe studies and inspections conducted by OSHA person nel, the environmental Impact state ments, the economic end 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 too 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 to many Adds 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 to reaching the determina tions set forth below. n. Findings regarding carcinogenicity, exposure levels and tearOrUity--(i> Car cinogenicity of vinyl chloride. The car Bra', to rats. The investigations of In scientifically determined. This petition dustrial Bio-Test Laboratories have dem to supported by the testimony at NIOSH onstrated a relationship for at toe bearing. Its TMTM""*"dt|nn for both rats and mice. These investigators a standard of no detectable level, and by have induced angiosarcoma of the liver toe testimony of expert witnesses from in rats and at exposure concentra the National Cancer Institute. tions of 30 ppm. and tohamsters at high Several witnesses and persons who sub er concentrations of exposure. Additional mitted comments have taken a contrary tumors involving other organa, including view and have suggested that man to less the kidneys, limes, and skin of exposed sensitive to biologic aberrations induced miImI*, were else observed to frequen by vinyl chloride exposure than experi cies TM*h to at control sntotsls mental animals. Proponents of this posi The *"*--* of tumors in mine in the tion have argued that if humans were as Industrial Bio-Test Laboratories Investi sensitive as rodents, an "epidemic'' of gations Is particularly pertinent. Of 200 cancer resulting from VC exposures --i" (100 males, 100 females) exposed to should have already been discovered 50 ppm of vinyl chloride by Inhalation for among employees. They also argue tost eleven months, 100 died. Blxty-four ani tbs employees In whom tumors have been' mals died without gross postmortem observed are those who hava considerable pathologic examination being performed. employment experience as polymeriza Of tow 36 remaining enwnsis for which tion reactor cleaners. Because it to gen a gross postmortem pathologic examina erally agreed tbat reactor cleaning in tion was performed, 13 (36 percent) volved high exposures to vinyl chloride were found with liver tumors (including to years past, it to argued that the lower angiosarcomas), 21 (38 percent) with levels currently found to the workplace lung tumors, 9 (23 percent) with skin have not Induced cancer and are there tumors, and one with a kidney tumor. fore safe. We reject this argument.' According to toe 1970 report by toe The fact that approximately three- Surgeon General's Ad-Hoc Committee quarters of those employees with the on the Evaluation of Low Levels of En longest exposure to VC (greater than vironmental Chemical Carcinogens, toe wwdimg of cancer to two or more 20 yean since initial exposure) have not yet been located, makes It Impossible to species may be extrapolated to Indicate determine the actual number of affected a carcinogenic hazard to humans. Here, such a finding was made to three species . employees. The cases of fiver tumors ob served to date hews.an average latency that were exposed to VC by Inhalation-- period, since initial exposure, of approxi a route comparable to employee ex mately 20 years. If It to assumed that In posure. In addition, there were at least' 13 confirmed oases of angiosarcoma of the liver among employees exposed to VC, a particularly significant number to view of the extreme rarity of this cancer to the UB. adult male population (testi mony of Dr. Marcus Hey. Director of NIOSH. at the rulemaking hearing). The findings of angiosarcoma of toe fiver to both experimental animals and exposed employees Is compelling evi dence that exposure of humans to vinyl chloride induces this tumor. Industry spokesmen, at the hearing, conceded that VC is carcinogenic for humans (eg. testimony of Dr. McBuroey, Rulemaking hearing. 1041). Accordingly, it is con- . eluded that VC must be regarded as a human carcinogen, and toe probable causal agent of angiosarcoma of toe fiver, and that exposure of employees to VC must be controlled. Additional evidence of tumor Induction to a variety of other organs. Including lung, kidney, brain and skin, as well as nan-malignant alterations, such as fi brosis and connective tissue deteriora tion, Indicates additional oncogenic and toxicologic properties of vinyl chloride, which must be considered to establishing control regulations. (See testimony and duction of angiosarcoma to a dose-re lated phenomenon, and If employees cn- . gaged to cleaning reactors did, to fact, receive larger doses of vinyl chloride. It would be expected that such tumors would be observed earlier for this em ployee population. For this reason. the _ significance of presumed lower doses, cannot be accurately assessed until a longer period of time has passed, as a longer induction period would be expected. Initiation of exposure to chemical carcinogens and Induction of cancer are not necessarily synchronous events. Be cause of the physiologic complexities In volved with carcinogenesis, induction of tumors does not occur to all employees with similar exposure histories. For ex ample, Dr. Behnriderman ot the Na tional Cancer Institute dur ing hi* 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'a to not reliable evidence that cur rent'levels of exposure are safe. Some Industry spokesmen also sug gested that the apparent nonrandom results of studies by Bio-Test Labora distribution of observed cancer to em tories, Taberthaw-Cooper, Maitmi ployees may indicate an expoeure. thres cinogenicity of vinyl chloride for three NIOSH. and Selikoff.) hold for.tumor induction, based on varia animal species (rat. mouse, hamster) has (2) Exposure limits. Upon finding that tions to the workplace derign or prac been documented on ih> record by exposure of employees to vinyl Chloride tice and resultant employee exposures RDEXAl aroism, V L 3, NO. 194--fSIDAY, OCTOIEI 4, 1*74 / ucc 060220 RULES AND REGULATIONS (testimony and questioning by Tenneco Chemicals, toe.). It has also been em phasized that In only 3 of S polymeriza tion plants where employees have been exposed to VC for more than 20 yean have any employees developed angiosar coma of the liver. This argument is very to that raised concerning vari ex-. testimony of Sclfkoff, Firestone. NO, confident that industry will continue to andNXOSH.) - do - to our view, the demonstration of can <41 Conclusions. The conclusions be- cer induction In humans at a particular . low are baaed on a thorough-review and -level is not a prerequisite to a determina evaluation of all the evidence aubmlUed. tion that a substance represents a can Where decisions can be baaed an record cer hazard for humans at that level, it evidence, this has been dona Where, would be imprudent to aaaume man to however, factual certainties are lacking ability of past employee exposure. Al though geographic and workpractiee dif ferences may ultimately be demonstrated to be factors In distribution of angiosar coma. sufficient information is unavail able to exclude from consideration of be lea sensitive to VC exposure than ex perimental animals In the absence of conclusive evidence. It would also be un founded to assume that will not develop tumors when exposed at eoocm- trstions of VC of lea thin 0 ppm. or where the facts alone do not provide an answer, policy Judgments haxe been DMMte. There is little dispute that VC Is car- dnogenlc to man and we so conclude. However, the precise level of exposure risk thorn employees in workplaces lor Should a sufficiently lazge number of ex wfalctrpoeee a hazard and the question which cases of angiosarcoma have not perimental anlmils be exposed to VC at of whether a "safe" exposure level exists, been observed: concentrations of leas than 0 ppm, cannot be definitively answered on the It has also been suggested that the Bchneidennan said that It would be ex record. Nor is It dear to what extent absence of cancer in a population of SSS pected that come would develop VC In- exposures can be feasibly reduoed. We Dow Chemical Company polymerisation 6uced tumors. - cannot wait unto indisputable answers employees monitored over a period of 7 (3) Feasibility. There is virtually no to these questions are available, because years, indicates that exposure to vinyl dispute that most. If not all. fabricators llyes of employees are at stake. There chloride at concentrations of less than am currently capable of teaching ex fore. we have had to exercise our best 230 ppm is safe. (See study by Dr, Cook, posure levels of 1 ppm through engineer Judgment on the basis of the best avail submitted at the hearing by Dow Chem ing controls. Them employers employ able evidence. These Judgments haveje- ical Company.) However, the group sur well over >5 percent of all employees ex . qulred a balancing process, in which the veyed did not include an workers who posed to VC. Indeed, several fabricators overriding consideration has been the had been exposed, and the missing em am 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 Infeasible for the VC and the PVC - Rased on the available evidence and In irf* of the sample copulation decreases Industries to remain below 1 ppm con view of the above considerations, includ- . the possibility that tumors. would. be sistently, using engineering controls. In tog feasibility, we believe that employee observed. addition, the Knell study on technical exposures to-VC must be reduced to a 1 Dow also presented preliminary data feasibility concluded tb?t 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 metabolised by a Health Research Group, toe, however, to addition to the TWA requirement, - secondary metabolic pathway operating have suggested that such a level is at . we have established a S ppm celling only when enzymes regulating the pri tainable. - (averaged over a 15-minute period) In mary pathway are saturated, as would Since there Is no actual evidence that order to prevent exposure of employees be the result at higher exposures. The any of the VC or PVC manufacturers 1 to unacceptable high excursions. Prom preliminary data indicated the persi- have already attained a 1 ppm level or In an operation standpoint, this celling billty of an additional pathway fc:* fart instituted all available engineering level is realistic because minor excur metabolism of VC in rats exposed to con and work practice control*. any estimate sions up to the ceiling level are likely to centrations of VC in excess of 220 ire as to the lowest feasible level attainable occur on a regular basis. However, the occurrence of angio must necessarily Involve subjective lodg m. The final standard--tl) Scope and sarcoma in both rats and mice at VC ment. Likewise, the projections of indus application. Both the ET8 and the pro exposure concentrations of 0 ppm in try. labor, and others concerning feasi posal would apply the standard to the dicates that if a metabolite of VC is the bility are essentially conjectural. Indeed, . entire VC Industry, Including manufac ultimate carcinogen, then it must be as Firestone has suggested, it is not pos- turers of VC and PVC and fabricators, generated at lower exposure concentre- -slble to accurately predict the degree of but excluding employers handling or tlons m 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 tion of safe exposure concentrations for employees, or even that such safe ex posures exist. A number of witnesses representing employers have stressed that there Is no evidence of cancer, either in employees or experimental animals, at exposure concentrations of VC less than SO ppm. (See e.g., testimony of Firestone, Tenneco Chemicals.) The conclusion of these witnesses was that no decision can be lishments win not be able to attain a 1' Industries. However, the Society of Plas ppm TWA level for all job classifications tics Industry (SPI) and various fabrica In the near future. We do believe, how tors (see testimony of Goodyear, Gen- ever, that they will. In time, be able to . erel Cable, etc.) recommended that. attain levels of 1 ppm TWA for most job classifications most of the time. It is ap . fabricators be excluded from the stand. art, or that a separate requirement be. parent that reaching such levels may re established for them because many of quire some new technology and work practices. It may also be necessary to utilize technology presently used in other Industries. In any event, the VC and PVC them were already at or below the pro posed celling level. The record evidence establishes that at least some employees In the fabricat industries have already made great 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 50 ppm. testimony of Dow Chemical Co, TR 973). testimony. TR 106; Robintech TR 642). On the other hand, the testimony of For example, B. F. Goodrich testified - to 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 . (TR 1120) that it has reduced average exposure levels in several PVC plants from 35-10 ppm early this year to 12-23 is imprudent to grant a blanket exemp tion for an fabricators. Therefore, the final standard is applicable to the fabri-- ent state of scientific knowledge. (See ppm at the time of the bearing. We are cation industry, as well as the monomer FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY,. OCTOBER 4. 1974 ucc 060221 V RULESAND REGULATIONS 35S93 and polymer industries. Employers who. - temperature' at' FVC. for' further pro- below the action level, no further moni in fact, an substantially below Hie ex - cessing, fpd1'-**--- that a potential for re- toring is required unless the employer posure liaatt Q be subjected to only - lease of the residue still exists, it ap has reason to suspect that any employee iwintTwri burdens by virtue of the ''action pears that the exemption of fabricated ' is exposed in excess of the action level, level" to be dbcumed below. -products Should be limited to just those or ntiiim changes have been made in Where employer! in the fabricating Items which will not undergo such mass production, process, control, type of resin, industry hayc exposure approaching the permissible limit, they will appropriately beating. Further, the opportunity to demonstrate that exposures are below etc. . Where the exposure level, without re be subject to the standard. Employer* the action level, and thus, discontinue gard to respirators, exceeds the permis handling or using fabricated products mini 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. ere less then the permissible levels, but from the final standard. This conclusion (3) 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, v . dence of exposure to VC in these opera averaged over any $ hour period, and a (5) Method* of compliance: The stand tions- The final standard clarifies the ex Mining of S'ppm averaged over any per ard, like the proposal, requires that em emption by defining a fabricated prod iod not exceeding IS minutes. ployers immediately institute feasible uct as a product made wholly or partly As more fully discussed above, this engineering end work practice controls from PVC which dose 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 lodgment ' permlMtble exposure limit... , . ' ' times, sufficient to cause mass melting of that the health and safety of employed Where feasible engineering and work the PVC. SPI and others (cf. TR. *44) must be protected to the fullest extent practice controls will reduce exposures requested that PVC resins with leas 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 FVC manufacturing be instituted. Where such controls will empted from the regulation now, and proceasee are variable, the 1 ppm celling not reduce exposures below the permis that the exemption level be-reduced to level provided in the proposal would sible level, they m'vt 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 ignto.ntiy more difficult to attain lowest practicable level, and be supple than 0.1 percent of 14 carcinogens from through feasible engineering centrals. mented by the use of respirators to pro 29 CFB l10.83p (39 FR 3756) was an Therefore, the exposure limit prescribed vide the necessary protection. There appropriate precedent. The cases are not in the proposal has been rejected. upon, a continuing program of engineer comparable, because no attempt had been (3) Action level. The final standard, ing and work practice controls must be made to set air concentration limits for TMnfca 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 minimise 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 end 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, he rently achieve compliance with the per no information was presented to show exempted from some provisions of the missible exposure limit solely by the use safe concentration results from the use standard. For example, fabricators who ' of feasible engineering and work practice of resins with specific levels, indeed, the are be'ow the action level are not re controls. The record also reflects broad proposal to change the level later, when quired *e provide medical surveillance or generic distinctions between the compli improved technology would permit such to monitor again, unless the employer ance capabilities at 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 aafety of 0.1 - is 'exposed in excess of the action level. including SPI (TR, 358-362), recom percent residue level. Diamond Shamrock Ip 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 mlsslle exposure Omits 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 Conn of the resin and are or will be below that level This view assumes that the ability and the ventilation provided. Also, monitor (4) Monitoring. The final standard, the time required to feasibly reach in ing data from industry (cf. Exhibits 131, like the proposal, requires that Individual creasingly lower control levels is similar 168. 170) and OSHA (Exhibit 151) indi employee exposure levels be determined. within each industry, but differs mark cate that levels in excess of 1 ppm may This may be accomplished by personal edly between industries. While the record be found In fabrication operations, in or area monitoring. Some witnesses and does suggest that such differences do view of these facts and of the opportunity persons who submitted comments did exist between industries, as noted above, for employers to discontinue many duties not understand the meaning of the term it is clear that intra-industry differences upon s 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 ere statistically valid. We is located, the age of equipment the size posals (cf. TR 650). have modified the proposal to establish . of reactors, or the type of resin manu SPI (TR 345), among others, asked accuracy range requirements for various factured or used. (Snell study. Firestone that compounded PVC pellets be ex measurement levels. Then ranges are testimony, etc.) ,. empted from the standard on the grounds narrow enough to ensure that a deter Monitoring date also tends to support that the pellets bad too low a residue to mination of compliance can be made, and such intra-industry variations. (See, cause harmful or measurable emissions. broad enough to allow the application ex Dow, Firestone, Tenneco.) While it appears that PVC pellets would of a variety of technologic* As noted above, the standard requires have a lower residue level than virgin AH-covered employers sure required to all employers to institute feasible engi PVC, the fact that the pellets must be conduct initial monitoring. Where moni neering controls to the fullest extent and heated to a molten mass at the same toring and measuring results are at or to continue to Improve and apply engl- FEDERAl REGISTER, VOL 39, NO. 14--FIIDAY, OCTOBER 4, 1V74 UCC 060222 35894 RULES AND REGULATIONS ' ~ neering control! until full compliance !! |f tho itftwififnawhtl toft1 || J)0t OQQ* tfitlOQS. TRi fhwMriiwiR fff tbflM - achieved. trolled to the permissible exposure Halt, with NIOSH, It baa Indicated that It Is We have not established any deadlines then employees must be afforded respira willing to ronslder on an expedited basis for full iwHTitiawf!* throusb milrxniuf tory protection. the approval of air-purifying respirators control* because are presently unable While exposures In excess of the per for uae against VC. Consequently, we to determine when it wOl be feasible for missible level do constitute a hazard, we bwve included three types of air-purify most establishments to reduce exposure believe that It la necessary to mitigate ing respirators in the list of acceptable levels to the permissible level. some of the problems associated with unit*, auhjeet to the approval at such We also believe that the requirement implementing a program of respiratory units by NIOSH. The maximum concen that each employer reduce airborne con protection while employees are being tration for which each- respirator may centrations to the permissible level, or fitted and trained In respirator use. and be used la based upon our evaluation to the lowest level feasible as soon aa while other adjustments which may be of the data submitted by NIOSH and practicable win provide for inter-indus required are Implemented. Therefore, Goodrich- Because air-purifying respi try and Intra-Industry technological dif untQ January 1, 1876, where exposures rators do not Indicate sorbent exhaustion ferences which do exist, and will avoid are not In excess of a 25 ppm celling, or breakthrough of VC, and because VC. the setting of separate Industry stand each employer must provide each em has no inherent warning properties at ards on the basis of the general situation ployee with an appropriate respirator. levels tor which these devices are used, and conditions In each Industry. However, employees whose exposures do strict administrative controls will be re ' (6) Regulated areas. The proposed not exceed a 25 ppm celling, may decline quired tor their nee. Such controls in standard wduld have requiredthat regu to use the respirator, in which case the clude a program to assure timely re- , lated areas be established, that access be employer la not obligated to require its placement of canisters or cartridges and' limited to authorized employees, and use. During this adjustment period, em an alarm system to alert employees when that dally rosters or summaries of those ployees will be trained In the uses, pur vinyl chloride concentrations exceed the entering be kept for at least 30 years, hi poses and limitation* of respirator*, and concentrations allowed for the particu objection to these requirements, It was the haaards of exposure to tlnyl chloride. lar toP* at respirator in uae. asserted that such control of access ns Moreover, each employee will be notified (A) Hazardous operations. This la a not necessary from a health standpoint. . la writing if he baa been emoted In ex new.section within the final standard, it Secondly, it was claimed that these con cess of the permissible exposure limit. encflimpaaMS essentially, the proposal's trols would Interfere with operations by Where exposures exceed a 25 ppm cefl- requirements for maintenance .and de preventing access of needed employees or son-employees, such as contractors, truck drivers, customer* and consultants. The purpose of establishing regulated areas In the proposal was to limit fee 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 amend* 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 dally rosters must be ins, respiratory protection la mandatory Is light of our judgment that much greater risks are associated with such exposures. The provisions In the final.standard regarding the selection and um of respi ratory protective devices differ from those in the proposal. The descriptions at atmosphere-supplying respirator* have been revised to Indicate more dearly the types of devices intended, ami the maxi mum permissible concentration level for each device. Moreover, the number of types of atmoephere-supplyln" devices has been increased- .* . contamination but baa 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 employee* en gaged in activities that present a risk of exposure to viny) 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 for full- body, Impervious clothing has been re placed by the direction to use impervious garments suited to the particular situa maintained from 20 to 3d years. This change was based largely on epidemio logical considerations. (See NIOSH testi mony, tr. 118.) (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 FVC and VC plants, and that this Is not feasible because respira tors are cumbersome, present a safety hazard, and employees would not use them. We would agree that respirators have At the hearing Mr. Edwin C. Hyatt, an OSHA consultant, mad'- suggestions re garding the use of par' 'll-- respiratory devices. We have conduced tnat his sug gestions are meritorious. Therefore, the provisions for selection of atmospheresupplying devices follow closely the rec ommendations contained in his testi mony of SIT and B. F. Goodrich) (TR with Hyatt's suggestions. (See eg. testi mony of SPI and B. F. Goodrich) (TR 85 ff> We had originally omitted air- purifying respirators because none bad been approved by NIOSH for use against VC, principally because (hey 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 uae canisters tion and probable extent of exposure. Thus, full-body dnthing fa' not always necessary, and is therefore hot required where less protection Is adequate. Since vessel entry tolls within the definition of a hazardous operation, the vessel entry section of the proposal has been deleted from the final standard. (8) 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. Tbs final standard has been clarified to^correct many drawbacks: the proposal did not contemplate them as a final solution. The record shows that the FVC Industry par ticularly may need several yean before plant environmental levels can be re or cartridge air-purifying respirator*, provided a sorbent could be shown to effectively absorb vinyl chloride with an adequate service life. Recently, OSHA has received respiratory data from labo 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 duced so that respirators are necessary ratories regarding the effectiveness of need not be reported. - - only occassionaUy. However, we cannot commercially available canister* *pd (10) Signs and labels. The thrust of the, agree that respiratory protection should cartridges for vinyl chloride. These eval signs and labels section is to apprise not be required simply because It Is in uations were conducted separately by employees of the cancer and fire haz convenient, may require additional per sonnel, interferes with production, or may require extensive retraining of em ployees and restructuring of work prac tices. We have carefully considered all NIOSH and by the B. F. Goodrich Com ards. No objections have been raised with pany and submitted to OSHA In poetbearing comments. The results Indicate tint certain presently available cards- . respect to informing employees of the fire hazard. However, a number of oblections were raised at the hearing and In written submissions to the require ten and cartridges effectively absorb ment that the word "cancer" appear on the objections, and have concluded that vinyl chloride at relatively low eoncen- all signs and labels. The principal argu- IWEAM. KEGlHEt, VOL **, NO 194--HWXAY, OCTOSES 4, 1974 UCc 060223 1 , ` v' ' v v- ' RULES AND IEGUIAT1 NS 'I * X' / 35S95 ment advanced against its use tns thst indicated that the medical tests proposed posal to the requirement for maintenance the term "cancer" or "cancer-suspect ere currently the only ones available of monitoring records and daily roster - agent", scares employees and that In stead, the message should contain in structions on how to deal with the sub stance CTO. *47). we believe that a which ate useful far medical surveillance (TO 131, Exh. 95, TO 589-591). Conse quently, the specific blood tests proposed have been retained as a minimum re Sheets of authorised persons for 30 years, tnit--ii of 30 years. Additionally, the em ployer to required to maintain medical records for the duration of an employee's diluted form of waning will not suffice. We appreciate the concern of employers with the reaction of their employees. But we consider It imperative that a worker quirement to assist the --tT,,T'lrlT physi cian in determining fitness of potential employees for assignment to workplaces involving VC exposure. In addition, al employment plus 20 years, or 30 years, whichever to longer. The original pro posal called for only 20 years. This change has been implemented be be fully informed, and that he realise the ternative medical examinations may be cause the latency period for Induct! n of possible risks Involved in bis 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 Tabenhaw-Cooper study and the tained for at least that long. It should be form employees of the haeard. In addle various aTMi experiments suggest that noted that spokesmen far both labor and tton, such eigne will warn unauthorised VC may produce a wide spectrum of ma industry recommended that this change personnel to keep out of regulated areas. lignant and nan-malignant disorders. be made. The proper application of most protec The general scope of the required medical The reporting requirements are not tive measures requires an amount of examination has, therefore, been broad Significantly different from those in the training and indoctrination of employees ened to include kidneys, skin, connective original proposal. However, instead of that cannot easily be conveyed on a sins tissue, spleen, and pulmonary system, as the requirement for reporting incidents or label. Also, the variety of measures wdl as tbs liver. No additions! 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 expoeed, an unwieldly or excessively detailed teg- ommendations have been included in the the final standard clarifies our original end. Consequently, the required menage Appendix to sestet the eamminlng physi intent by stating that only emergencies on signs ind labels will not include in cian. Because of the nonspecific nature must be reported. Also the requirement formation on precautions, relevant of the required medical , testa, it to not for filing a detailed, written report symptoms, etc. The addition of suitable appropriate to prescribe timing, or type within 15 days bas been deleted. It has information by the employer would be of followup testa, or to mandate with been concluded that submission, within permitted, providing It does not detract drawal from exposure based solely on re 24 hours, of an initial report that in In any way from the required statement sults of the tests. Instead, the employer cludes facts immediately available, would The requirement in tire proposal for to required to obtain a statement from ordinarily be sufficient. However, If the containers of vinyl chloride has the TMniwtr physician of the em OSHA Area Director requests furuter in been amended by deleting the reference. ployee's suitability far 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 as he considers ap information. . developed on this hazard during the propriate. The employer to required to (14) Deleted portions of the proposal standard-setting procedure. It does ap withdraw an employee only when this The proposal contained provisions re pear that this hazard is essentially under control and that the fire and carcino genic hazards at present are the most significant. Since labeling or placarding that 1$ in compliance with the UJ3. 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. statement indicates that the employee quiring that shower faculties and change may be at added risk teem continued VC rooms be provided, and that storage or exposure. consumption of food be prohibited in As with monitoring, there appears to regulated areas. We have deleted these be no basis for complete exemption of the' provisions because it to our conclusion fabrication industry from the require they are no longer.necessary. Showering ment for medical examination. The rec `'emties are not required because pro-' ord does show fabricating establishment? tet-Hve clothing, where required by the with concentrations of VC monitored final standard, should protect employees considerably above the action level. In from akin absorption by direct contact these Instances, medical surveillance of with VC and because there to no reliable (11) Medical surveillance. The princi affected employees will provide baseline evidence that VC vapor to 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 he wearing protective clothing and that tain specific serum enzyme determina proved controls reduce concentrations employees who wear protective clothing tions (SMA-12 series) end 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 lower levels of VC. The objection has also been raised thst the specification of tests and procedures interferes with the ap plication of advances in medical knowl edge. \ ly apply(12) Training. A separate provision for employee training has been added to the final standard rather than including it within the section on emergency situa tions as in the proposal The new para In addition, we feel that there to In adequate evidence showing that hazar dous amounts of VC can be absorbed through ingestion. Bor this reason, the requirement prohibiting the storage or consumption of food in regulated areas A particular difficulty in considering graph provides for training of employees bas been deleted. medical surveillance is that the meet concerning the carcinogenic hazard of The proposal also contained provisions commonly discussed lesion, angiosar VC, emergency procedures, the need for on maintentanoe and decontamination, coma of the liver, currently cannot be monitoring and an annual review of the transportation loading and unloading, diagnosed until the victim to terminal standard. It also provides for training of and polymer handling operations. These and, usually, within months of death. employees concerning the purpose for, requirements are not mentioned in the Precursor physiologic' alterations, which proper use of, and limitations connected final standard because attention to these might be reversible, have not yet been with respiratory protection. . items to implicit in the requirement that directly associated with the lesion. Con (13) Records and reports. The provi each employer reach the permtosable ex sequently, there are no specific diagnos sions for recordkeeping contained in the posure limit or attain the lowest feasible tic tests which can be prescribed which final standard require the preparation level. will determine presence or absence of Slid ot --tbc stmt (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 FEDEKAl gEOISTEI, VOL. J*. NO. 19--aiDAY, OCTOSEt 4. 1*74 ucc 060224 I `"S " I - 35896 'RULES AND REGULATIONS i- ': - t* w Vs* proTlsloas sad Ifra* employer* affected of the operation or bceause of an acd- opportunity to observe the monitor- ire given an <nnwwM'"*iy to familiarize dent in the operation, which would result ing and measuring required by this themselves and their employees with the in an onployee exposure In exces of the paragraph, j existence of the new requirements, the .permissible exposure limit. - ' te) Nepalated area, Q) A regulated effective at the to (8) "OSHA Area Director" means the area shall be established where: < 1810 93c win be January 1,1975. To pro- Director for the Occupational Bafety a) Vinyl chloride or polyvinyl chloride Tide continued protection to employees and Health Administration Area Office is manufactured, reacted, repackaged, instil that date, the prarhdons currently having Jurisdiction over the geographic stored, handled oruaed; and fW.n-wi in 11910-lSq are hereby urea in which the employer's establish* (til Vinyl chloride concentrations are promulgated, pursuant to section 8(b). ment is located. in excess of the permissible exposure 8(c) and 8(c) of the Occupational Safety <91 "Polyvinyl chloride" means poly- limit. and Health Act, as' an occupational vinyl chloride homopolymer or copoly* (3) Access to regulated areas shall be - safety and health standard effective mer before such is converted to a fabri- limited to authorized persons. A dxlly - , October 4, 1974. - the amendment to cated product: - - mater draff be made of authorized per- - f 19lO.P3q set out below win supersede <10) "Vinyl chloride" means vinyl sons who enter. ` these provlsfasB as of January 1, 197$. chloride monomer. (f) Methods at compliance. -Employee. Acco-dingly, upon consideration of the <c) Permissible exposure Kmtt. til Ho exposures to vinyl chloride shell be con- whole record of this preceding. Part 1810 employee may be exposed to vinyl chlo- trolled to at or below the permissible exof Title 29, Code of Federal Regulations ride at concentrations greater than l ppm porare Bmlt provided In paragraph (el Is amended, effective January 1, 1975, by averaged over any 8-hour period, and of this section by engineering, work prac- revltion of i 1910JOq to read as follows: (31 No employes may be expoeed to tice. snd personal protective controls as _ finyl t OODentlttlODI fflTUfflT foIlDVr " S ? 910 -101.7 .Vinyl Chloride mans ppm averaged over say period not fl). nosfbie engineering and work () Scope and application. (1) This exceeding 1$ minutes. practice controls bn immediately be section Includes requirements to the (3) Mb employee may be upland to used to reduce exposures to at or below control of employee exposure to vinyl vtnyl chloride by direct contact with .the permissible exposure limit. - chloride (chloroethene), Chemical 41k Squid vinyl chloride. - (3) Wherever feasible engineering and tracts Service Registry No. 7501S. (<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, packaging, repacks*- shall be undertaken in each establish- reduce exposures to at or "below the per- leg, storage, handling or use of vinyl ment to determine if there is any cm- mlsslble exposure Umlt, they shall none- chloride or polyvinyl chloride, but does ployee exposed, without regard to the use tbelms be used to reduce exposures to not apply to the handling or use of fxbri- of respirators, in excess of the action the lowest practicable level, and shall be _ cated products made of poly vinyl chlo- leveL --- - supplemented by respiratory protection* 1 ride. (31 Where a determination conducted in accordance with paragraph (g) of tbu - (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 exposure Department of Transportation may cess of the action level, a program to de- Umlt, or to the greatest extent feasible, regulate the hazards covered by this sec- tennlntag exposures to each such em- solely by means of engineering yriA work tion. - ployee shall he established. Such a pro- practice controls, as soon as feasible. 0 DefinLtitms. a) "Action lever gram: - C3) Written plans to such a program means a concentration of vinyl chloride (17 Shall be repeated at least monthly shall be developed and furnished upon ' of 0.5 ppm averaged over an 8-hour work where any employee Is exposed, without request for and copying to day. V regard to the use of respirators,'in ex- nntharlt&I reprgnltlp nfypn Ai. - <2> "Assistant Secretary" means the cess of the permissible exposure limit. tent Secretary md the Director. Such Assistant Secretary of Labor for Occupa- til) Shall be repeated not less than plans bn he unlisted at least every six tional Safety and Health, US. Depart- quarterly where any employee Is exposed, imU ment at labor, or his designee. without regard to the use Of respirators. <g) Respiratory protection. Where' (37 "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 to any em- this section: Player whose duties require him to enter ployee only when at least two eonsecu- (l) 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 asa designated represents- less than 5 working days apart, show ex- of this paragraph and shall assure that ttve of employees to the purpose of ex- posures for that employee et or below the employee uses such respirator except erclsinx an opportunity to observe monl- the action leveL that until December 31,1975 wearing of toning and measuring procedures. (3) Whenever there has been a pro- respirators shall be at the discretion of (4) "Director" means the Director, duetion, process or control change which each employee for exposures not In exNational Institute to Occupational may result in an increase in the release cess of 25 ppm, measured over any 15Eafety and Health, U.B. Department of of vinyl chloride, or the employer has minute period, until December 31 1975 Health. Education, and Welfare, or his any other reason to suspect that any em- each employee who chooses not to wear designee. ployee may be exposed in excess of the an appropriate respirator be hi ts) "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 0f yjnyl chloride and the purpose proper ment failure, or operation of a relief de- section shall be performed. use. and Ww.i**in, of Mnfratoiy vice which Is likely to, or does, result in (4) The method of monitoring and devices. masstre release of vinyl chloride. measurement shall have an accuracy (2) Respirator* shall be selected from () "Fabricated product* means a (with a confidence level of 95 percent) of among ihote Jointly approved by the product made wholly or partly from not less than plus or minus 50 percent Mining Enforcement and Safety Admin- polyrinyl chloride, and which does not from 0.25 through 0JS ppm. plus or minus tstratton, Department of the Interior, require further processing at tempera- 35 percent from over 0.5 ppm through and the National institute for Occupa- ' turns, and for times, sufficient to cause L0 ppm. and plus or minus 25 percent tlonal Sefety end Health under the pro mass melting of the polyvinyl chloride over 1.0 ppm. (Methods meeting these visions of 30 CFR Part 11. resulting' in the release of vinyl chloride, accuracy requirements are available in (3) a respiratory protection program - (7) "Hazardous operation" means any the "NIOSH Manual erf Analyticalmeeting the requirements of (1910.134 operation, procedure, or activity where a Methods"). , shall he established and maintained, release of either vinyl chloride liquid or Employees or their designated rep- (4> Selection of respirators for vinyl gas might be expected as a consequence resentatives shall be afforded reasonable chloride shall be aa follows: FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 ucc 060225 RULES AND REGULATIONS ir> 35897 (vl) The purpose for. and a descrip tion of, the medical surveillance program; (rli) Emergency procedures; ' (vili) Specific Information tp aid the, employee in recognition of conditions which may result m the release of vinyl chloride; *H|1 i (lx) A review of this standard at the employee's first training and indoctrina tion program, and annually thereafter. (2) All materials relating to the pro gram shall be provided upon request to the Assistant Secretary and the Director, r <k) licdical wurvemanea. 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 rlsveL The program Shan provide each such employee with an opportunity for examinations and lasts tn accordance with this paragraph. AH medical ex aminations and procedures shall be per formed by or under the supervision of a licensed physician, and shall be provided without coat to the employee. (I) At the time of Initial assignment, or upon institution of medical surveil lance; (1) A general physical examination shall be performed, with specific atten tion to detecting enlargement of liver, (5) (1) Entry Into unkovrn concentra " ?2)~Protective garments shall he'pro tions or concentrations greater than vided dean and dry for each use. . 36.000 ppm dower explosive limit) may ' (1> Emergency situations.' A written be made only lor purposes ol life rescue; operational plan for emergency sltua- . dons shall be developed for each facility til) Entry Into concentrations of less storing. wnsU"y or otherwise using than 36.000 ppm. but greater than 3,600 vinyl chloride as a liquid or compressed ppm may be made only for purposes of life rescue, firefighting, -or securing gas. Appropriate portions.of the plan shall be Implemented m the event of an equipment so as to prevent a greater emergency. The plan shall specifically hazard from release of vinyl chloride.. provide that: <6> Where air-purifying respirators .. (1) Employees engaged in hazardous Are used: U> Air-purifybv cranlsten or car- tridges shall be replaced prior to the expiration of their service life or the end of the shift M which they are first used, whichever occurs first, and (ii) A continuous monitoring and alarm system shall be provided where ancen(rations of vinyl chloride could reasonably exceed the allowable concen trations for the devices in use. Such sys tem shati bs used to alert employees when vinyl chloride concentrations exceed the allowable concentrations for the devices In use. (7) Apparatus prescribed for higher concentrations may be used for any lower concentration. (h) Hazardous operations. (1) Em ployees engaged In hazardous operations, including entry of vessels to clean poly vinyl chloride residue from vessel walls, shall be provided and required to wear and use; 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 dn& 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: (1) The nature Of the health hazard from chronic exposure to vinyl chloride including specifically the carcinogenic hazard; til) The specific nature of operations which could result in exposure to vinyl chloride in excess of the permissible limit and necessary protective steps; (1) Respiratory protection In accord til) The purpose for, proper use, and ance with paragraphs Cc) and (g) of limitations of respiratory protective spleen or kidneys, or dysfunction In these organa, and for abnormalties In skin, connective tissues and the pulmonary system (See Appendix A). (II) A medical history shall be taken. Including the fallowing topics: - (A) Alcohol intake: (B) Past history of hepatitis; (C) Work history and past exposure to potential hepstotoxic agents, includ ing drugs and chemicals; CD) Past history of blood .transfu sions; and .... (E) Fast history of hospAT'lzations. (III) A serum specimen eh.n be ob tained end determinations t vie of: (A) Total bilirubin; . (B) Alkaline phosphatase;' (C) Serum glutamic oxalacetic trans aminase (SOOT); (D) Serum glutamic pyruvic transam inase (SOFT); and ... () 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 chlo ride or polyvinyl Chloride manufacturing for 10 years or longer; and <H> 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; (11> Protective garments to prevent shin contact with liquid vinyl chloride or with polyvinyl chloride residue from Vessel walls. The protective garments (lv) The fire hazard and acute toxic ity of vinyl chloride, and the necessary protective steps; shall be selected for the operation and (v> The purpose for and a description promptly after any'examination. A copy of the physician's statement shah be pro vided each employee. (ft) If any employee'* health would be materially Impaired by continued ex Its possible exposure conditions. of the monitoring program; posure, such employee shall be with- FEDEtAl MCtSTet, VOL 39, NO. 194--TODAY, CTOIER 4, 1974 -' - ucc 060226 I * . 7 -j. i? tULES AND REGUtATIONSj " Iran possible contact iU itari <*) lAbomiczy assJ^es for all tdo> logical spacemens Hf|nifc|1 in wofla) aiiall he performed In btho- y*ii*4it licensed lll|l>f 43 CfR Fart 74. (7> ji the euidElDi phyfein deter- sins that alternative medical rwTntna- tions to those required by paragraph of this section will provide at least equal aasuiaace of detecting med- leal eaadiriana to the exposure to vinyl chloride, the employer may ac cept such alteruaLike eywmtnatfcms as meeting the requirements of paragraph ewi which contradicts or detracts fran the effect of, any Tequtrad warning, totamstkm or instruction. ..... Gal Accords. (11 All records mainigiiiM in inm<Miw> with this section *.n tv--the f-- and social secu rity number of each employee where relevant (3) -Records of required monitoring mi measuring, medics! records, and au- ,, thorized personnel rosters, shall be made and be available upon request for examination and qopying to authorized representatives at the Assistant Secre- UlTiiulUifiDlnctQL . (ii) The numbex at employees ia eech .regulated area during normal operations. irwlndlny maintenance , . (3) Emergencies, and the facts ob tainable at that time, shall bo reported within 24 hours to the OSHA Area Di rector. Upon request of the Ana 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., (3) Within 10 working days following any manitoiing and measuring which Atrinna that any employed, has been - CD til of this section, if the empjorer (1) Monitoring and measuring records exposed, without regard to the use of obtains a statement Iran the examining respirators In. excess of the permissible physician -- n*'if forth the alternative examinatioES ->* the rationale for snbfHettnen. This atatemeat shall be aval!-able upon request far exminattoh_and copying to authorized repi leiutstlvri of (A) State the date of such monitor ing and measuring and the concentre-, tfona determined and Identify the instru ments and methods used; - . CB) Include any additional informa exposure limit, each such employee shall be notified in . writing of the results of the exposure measurement and the steps being taken to reduce. the exposure to the Assistant Secretary and the Director. tion necessary to determine individual within the permissible exposure limit. ' employee exposures where such expo (o) Elective dates. (1) Until Janu sures are determined by means otherindividual monitoring of employees; and ary 1,1073, the provisions currently set forth In |1910B3q of this Fart shall (CD Be maintained for not less thaw apply. 30 years. -. (2) Effective January 1,1075, the pro (HI Authorized personnel roster* shall visions set forth in { 1910.93q of this Part be maintained for not less than 30 years. shall apply. (lit) Medical records shall be main- tained for the duration of the employ Amoans A--Suwlxmzhtsit Mdical ment of each employee plus 30 years, jar 30 years; whichever is longer. - - Whan required tests wader paregrmph (3) Ih the event that the employer ceases to do business and there is no successor to receive and retain his rec ords tor the prescribed period, these rec ords shall be transmitted by registered (X) (IT at this section, show abnormalities, tor tests Should be repeated es soon as prac ticable. preferably within I to 4 weaka. It tests remain abnormal, consideration should be given to. withdrawal of tbs employes from contact wtth vinyl chloride, while a more mall to the Director, and each employee eomprebenrfva- examination Is made ' individually notified fn writing of this Additional tests which may be useful; transfer. <4> Employees or their designated -representatives shall be provided access [to and copy records of required monitoring and measuring. 1 (3) Former employees shall be pro A_ tar kidney dysfunction: urine-examina tion tor albumin, red blood ceils, and ex foliative abnormal cells. B- Pulmonary system-. Forced vital capac ity. Farced expiratory volume at ] second end chest roentgenogram (poetertor-enterior, 14 X IT Inches). vided access to examine and copy re C. Additional serum teste; Lactic add de quired monitoring and measuring records hydrogenase. lactic add dehydrogenase i reflecting their own exposures. (g) 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, (l) Not later than 1 month after the establishment of a reg ulated area, the following information iaoensyme. protein determination, end protein electrophoresis. D. Tor e more comprehensive examination on repeated abnormal serum tests: Hepstitis B antigen, end liver scanning. - (Sees. 4 end 8. 84 Stmt. 1268; 1569 (38 SAC. 85S, 857); Secretary of Labor's Order No. 13-71,38 f* 8754) shall be reported to the OSHA Area Di Signed &t Washington, D.C., tills 1st rector. Any changes to such information day of October, 1974. shall be reported within 15 days. CD The address and location of each establishment which has one or more Johw Stxksu, Assistant Secretary o/ Labor. regulated areas; and [PR Doc.74-23176 Filed 10-1-14;3154 pm] -TV. FS>3AL REGISTER, VOL 39, N . 194--FRIDAY, OCTOREK 4, 1974 ucc 060227 (1) Signs and labels. (1) Entrances to regulated areas shall be posted with legible signs bearing the legend: Cancer-Suspect Agent Area Authorized Personnel Only (2) Areas containing hazardous operations where an emergency currently exists shall be posted with legible signs bearing the legend: Cancer-Suspect Agent in This Area Protective Equipment Required Authorized Personnel Only (3) Containers of polyvinyl chloride resin waste from reactors or other waste contaminated with vinyl chloride shall be legibly labeled: Contaminated With Vinyl Chloride Cancer-Suspect Agent (4) Containers of polyvinyl chloride shall be legibly labeled: Polyvinyl Chloride (or Trade Name) Contains Vinyl Chloride Vinyl Chloride is a Cancer-Suspect Agent (5) Containers of vinyl chloride shall be legibly labeled either: (i) Vinyl Chloride Extremely Flammable Gas Under Pressure Cancer-Suspect Agent or (ii) In accordance with 49 CFR Parts 170-189 with the additional legend: Cancer-Suspect Agent applied near the label or placard. (6) No statement shall appear on or near any required sign, label or instruction which contradicts or detracts from the effect of, any required warning, information or instruction. ucc 060228