Document MG0oKk1ExnDOLjY6q91Gd4z9j

,0 r Jj . 1 j ,A J/'-'' COPIED BY MCA 10/9/74 FRIDAY, OCTOBER 4, 1974 WASHINGTON, D.C. .Volume 39 8 Number 194 PART 15 DEPARTMENT OF LABOR Occupational Safety And Health Administration S3 EXPOSURE TO VINYL CHLORIDE Occupational Sdfety and Health Standards OCC 020012 35890 RULES AND REGULATIONS Title 29--labor ployees from a rare liver cancer (angio end abroad, OSHA proposed to revise CHAPTER XVII--OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DE PARTMENT OF LABOR sarcoma) may have been occupationally related. As a result of this notification and after consultation with NIOSH, and a joint Inspection of the B. P. Goodrich 13lQ.33q and published a comprehensive proposal (38 FR 16896) on May 10, 1074, to protect employees from hazards of exposure to VC, The proposal called for PART 3.910---OCCUPATIONAL SAFETY plant by OSHA, NIOSH and the Ken limitation of employee exposure to VC to AMD HEALTH STANDARDS tucky Department of Labor, a fact-find "no detectable level," as measured by a Standard for Exposure to Vinyl Chloride ing hearing was announced on Janu sampling and analytical method sensitive Pursuant to sections 60s), 6(c), and 8(c) of the Occupational Safety and Health Act of 1570 (84 Stat. 1553, 1556, 1599; 2S U.S.C. 55, 557) Secretary of Labor's Order No. 12-71 (33 PR 8754) and 20 CFR Part 1811, ? 1910.83 of Part 1910 of Title 29, Code of Federal Regu lations is hereby amended in the manner set forth below, In order to provide an Occupational Safety and Health stand ard dealing with the exposure of em ployees to vinyl chloride. I, Background--(1) Vinyl chloride, Vinyl chloride (chloroethsne), Chemical Abstracts Service Registry No. 75014, is a synthetic organic chemical made from ethylene or acetylene and chlorine by any of several processes. It la 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 1839, and present production Is in excess of Eeven billion pounds per year. The vinyl chloride Industry divides Into three segments: monomer production, polymer production, and fabrication. Production of the monomer Is a largescale continuous process, involving only a few firms. There are comparatively few employees in this segment of the indus try, -because the processes lend them selves to automation. Vinyl chloride (VC) Is used primarily In the production of polyvinyl chloride (PVC), a resin which is produced through batch processing. The conversion of the VC monomer into a polymer or copolymer is an Incomplete process, l.e., not all of the monomer Is reacted. PVC Is fabricated by a variety of tech niques, Including extrusion, injection molding and calendering, to lorm a fin ished product 'that needs no further chemical handling. The vast majority ary 30, 1874 (30 FR 3874) and held on February 15,1974. Information obtained from this hear ing, particularly the preliminary reports of experiments conducted by Professor Cesare Maltoni of the Institute dl Oncologia, Bologna, Italy, demonstrated that vinyl chloride induced angiosarcoma In rats at levels as low as 250 ppm, and In other species at higher levels. Experi ments performed at lower levels of ex posure wero not completed at that time. Other testimony from medical witnesses and NIOSF. and the results of autopsies, led to the conclusion that the Goodrich workers had angiosarcoma of the liver and that VC probably was the causal agent in the angiosarcomas observed. In post hearing comments, additional angiosarcoma deaths were reported among workers who had been exposed to VC In plants operated by Union Carbide Corporation, Firestone Plastics Corpora tion and Goodyear Tire & Rubber Com pany, on the basis of all information avail able at that time, and the fact that em ployees were being exposed at levels around the experimentally observed ef fect level of 250 ppm, an emergency temporary standard (ETS) was promul gated on April 6, 1874 <39 FR 12341) pursuant to section 6(c) of the Act, as 29 CFR 1010.93q, This standard reduced the permissible exposure level from a ceiling of 500 ppm to a 50 ppm celling, and established other requirements, including, for example, monitoring and respiratory protection. It was expressly recognized that this standard limiting exposures to a 50 ppm celling was a tentative, interim standard, and that the whole question of exposure to VC would be considered more fully in the light of additional information, especially the results of experiments which were known to be underway at that time. to 1 ppm, With an accuracy of 1 ppm 50 percent. The proposal also called for the establishment of regulated areas and limited access to such areas to au thorized persons. A requirement for monitoring off employee exposures was prepared, along with engineering and work practice controls to be Implemented when exposures over the detectable limit were measured. Respiratory protection would have been required while engineering and work practice controls were being implemented or where exposures exceeded the per missible limit even after feasible en gineering controls were Instituted. In addition, the proposed standard included requirements for medical sur veillance, protective clothing, emergency procedures, training, specific protection during maintenance and decontamina tion operations, transportation loading and unloading operations and record keeping. (4) Hearing on the proposal. The pro posal, as published on May 10, 1974, allowed 30 days for Interested parties to submit written comments and to request an Informal rulemaking hearing. In formal contacts with OSHA stall and early responses indicated that the sub ject was of great Interest and Importance to many persons. Because of the limited time available before expiration of the six month period provided in section 6(c)(3) of the Act for promulgation of a final standard, It was decided to hold a hearing as boon as possible. Accord ingly, on May 24,1874, a notice of a hear ing was published (39 FR 18303), setting a hearing date, of June 25, 1974. The hearing was conducted from June. 25 through June 28, and again from July 8, through July 11, before Administrative Law Judge Gordon J. Myatt. All partici pants were given the opportunity to pre sent testimony and to cross-examine other wltnessesrPersons participating in of employees Involved In the VC Industry 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 insize from those with few OBHA. 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' studies with VC. These studies were temperature and pressure, la a chlori sponsored by the Manufacturing Chem nated hydrocarbon, which heretofore has ists Association. Although only pre been regarded as having moderate liver liminary in nature at that time, these study. During the hearing, OSHA deter mined that additional facts would be needed to determine the practicality of certain aspects of the proposed stand toxicity. The initial standard, contained results revelled that 2 out of 200 mice ard. Accordingly, OSHA contacted an in in Table G-l of 1910.83, established a exposed to VC concentrations of 50 ppm dependent consultant, Foster D. Snell celling value of 500 parts 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. 1874, the Occupa (3) The proposed permanent stand by OSHA and others advanced by in tional Safety and Health Administra ard. Based on the demonstrated evidence dustry spokesmen. Snell was also com tion (OSHA) was Informed b'y the Na of VC's carc'nogenlclty In three animal missioned to Collect Information regard tional Institute lor Occupational Safety species (raw, 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 cases of liver of the hearing, and Judge Myatt further ported that deaths of several of Its em angiosarcoma found In workers both here announced that the record Would be kept FEDERAL REGISTER, VOL 39, NO. 194--FStDAY, OCTOBER 4, 1974 OCC 020013 sz RULES AND REGULATIONS 35891 open for fa period of time beyond August 23, to allow interested persons to com ment in writing on the study. On August 26, 1974, OSHA announced that the pre liminary study was available and that comments were to be submitted no later than September 6, 1974 (39 FR 30844). On September 13, 1974, OSHA invited comments on both the preliminary and the final study, which was to be received, on or before September 25, 1074 (38 HR 33009). (6) Environmental impact statements, A notice of intent to file an environmen tal impact statement assessing the im pact of a proposed standard on occu pational exposure to VC was published in the Federal Register on April 24, 1074 (30 FR 14522). The notice invited any person having information or data on the environmental impact to submit studies of Maltoni aiid Bio-Test Labora tories. Moreover, Maltoni's investigations have demonstrated a dose-dependent re lationship for Induction of tumors (i.e., more tumors occur at higher exposure levels), including angiosarcoma of the liver, in rats. The investigations of In dustrial Bio-Test Laboratories have dem onstrated a similar relationship for both rats and mice. These investigators have induced angiosarcoma of the liver in rata and mice at exposure concentra tions of 50 ppm, and in hamsters at high er concentrations of exposure. Additional tumors involving other organs, including the kidneys, lungs, and skin of exposed animals, were also observed in frequen cies much in excess of control animals. The mddenee of tumors in mice in the Industrial Bio-Test Laboratories investi gations is particularly pertinent. Of 200 may create a carcinogenic hazard, the amount of exposure which is hazardous must be determined. The Burgeon Gen eral's Ad Hoc Committee referred to above concluded that safe exposure levels for carcinogenic substances cannot be scientifically determined. This position is supported fay tire testimony of NIOSH at the hearing, its recommendations for 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 that man is less sensitive to biologic aberrations induced by vinyl chloride exposure than experi mental animals. Proponents of this posi tion have argued that if humans were as sensitive as rodents, an "epidemic" of cancer resulting from VC exposures it to OSHA by May 17, 1074. On June 12, 1974, a draft environmental impact mice (100 males, 100 females) exposed to 50 ppm of vinyl chloride by inhalation for should have already been discovered among employees, They also argue that statement was prepared and circulated to all interested persons. Ten copies were eleven months, 100 died. Sixty-four ani mals died without gross postmortem the employees in whom tumors have been observed are those who have considerable forwarded to the Council cf Environ mental Quality (CEQ), which published a notice of its filing and availability in pathologic examination being performed. employment experience as polymeriza Of the 36 remaining animals for which tion reactor cleaners. Because it is gena gross postmortem pathologic examina erally agreed that reactor cleaning in the Federal Register on June 25, 1974 (39 FR 22975). A 46 day period was al lowed for the submission of comments on tion was performed, 13 (36 percent) were fuund with liver tumors (including angiosarcomas), 21 (58 percent) with volved high exposures to vinyl chlorUe in years past, it is argued that the lower levels currently found in the workplace the draft statement. On September 5, 1974, the final environmental impact statement was prepared and a copy of it end ail substantive comments were sent to appropriate governmental agencies, private organizations, and other inter ested persons. CEQ published a notice of availability for the final statement on September 6. 1974 <39 FR 32350). The submission of comment was invited un til September 25, 1974. The final state ment and all significant comments have been carefully-considered in arriving at the final standard on occupational exporare to VC. (7) The record, The record in this proceeding is one of the most exhaustive ever relied upon by OSHA. It consists of pre and post-hearing comments and testimony received at both factfinding and rulemaking hearings, the studies and inspections 'conducted by OSHA person nel, the environmental impact state ments, the economic and technical impact studies, and ell other relevant information. In all, over 600 written com ments have been received, with more than 200 separate oral and written sub missions made with regard to the two hearings. The record itself exceeds 4,000 pages. Employers, employees, labor unions, public health groups, independ ent experts, physicians, research scien tists, and specialists in many fields have been invited to submit information and lung tumors, 9 (25 percent) with skin tumors, and one with a kidney tumor. According to the 1870 report by the . Burgeon General's Ad-Hoc Committee on the Evaluation of Low Levels of En vironmental Chemical Carcinogens, the finding of cancer in two or more animal species may be extrapolated to Indicate a carcinogenic hazard to humans. Here, such v finding was made in three species that were exposed to VC by inhalation-- a route comparable to employee ex posure. In addition, there were at least 13 confirmed cases of angiosarcoma of the liver among employees exposed to VC, a particularly significant number in view of the extreme, rarity of this cancer in the U.S. adult male population (testi mony of Dr. Marcus Key, Director of NIOSB, at the rulemaking hearing). The findings of angiosarcoma of the liver in both experimental animals and exposed employees is compelling evi dence that exposure of humans to vinyl chloride induces this tumor. Industry spokesmen, at the hearing, conceded that VC is carcinogenic for humans (e.g. testimony of Dr. McBiuney. Rulemaking hearing, 1041). Accordingly, it is con cluded that VC must be regarded as a human carcinogen, and the probable causal agent of angiosarcoma of the liver, and that exposure of employees to VC must be controlled. Additional evidence of tumor Induction in a variety of other organs, including have made their views, knowledge and lung, kidney, brain and skin, as well as experience available to OSHA. The en non-malignant alterations, such as fi tire record encompassing these submis sions was thoroughly reviewed and brosis and connective tissue deteriora tion, indicates additional oncogenic and evaluated in reaching the determina tions set forth below. II. Findings regarding carcinogenicity, toxicologic properties of vinyl chloride, which must be considered in establishing control regulations. (See testimony and have not induced cancer and are there fore safe. We reject this argument. The fact that approximately three-"' quarters of those employees with the longest exposure to VC (greater than 20 years since initial exposure) have not yet been located, makes it impossible to determine the actual number of affected employees. The cases of liver tumors ob served to date have an average latency period, since initial exposure, ot approxi mately 20 years. If It Is assumed that in duction of angiosarcoma is a dose-re lated phenomenon, and if employees en gaged in cleaning reactors did, in 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 in all employees with similar exposure histories. For ex ample, Dr. Schneidennan of the Na tional Cancer Institute emphasized dur ing his testimony that only about a fifth of longer-term heavy smokers develop lung cancer. Accordingly, the industry contention that exposure levels have been dramatically reduced since the 1940's is not reliable evidence that cur rent levels of exposure are safe. Some industry spokesmen also sug gested that the apparent nonrandom exposure levels and feasibility-ill Car cinogenicity of vinyl chloride. The car cinogenicity of vinyl chloride for three results of studies by Bio-Test Labora tories, Tabershaw-Coooer, Maltoni, NIOSH. and Selikoff.) distribution of observed cancer in em ployees may indicate an exposure thres hold for tumor Induction, based on varia animal epecies (rat, mouse, hamster) has (2) Exposure limits. Upon finding that tions in the workplace design or prac been documented on the record by the exposure of employees to vinyl chloride tice and resultant employee exposures FEDERAL REGISTER, VOl. 34, NO. 144--FRIDAY, OCTOBER 4, 1974 OCC 020014 35892 RULES AND REGULATIONS - O' / (testimony taal questioning by Tenueco e.g., testimony of Sellfcoff, Firestone, NCI, confident that industry will continue to Chemicals, Inc.). It has also been em phasized that to only 3 of 8 polymeriza and NIOSH.) In our view, the demonstration, of can do so. (4)Conclusions. The conclusions be tion plants where employees have been cer induction to humans at a particular low are based on a thoroi^b review and exposed to VC for more than 20 years level is not a prerequisite to a determina evaluation of all the evidence submitted. have any employees developed angiosar tion that a substance represents a can Where decisions can be based on record coma of the liver. This argument is very cer hazard for bumans-at that level. It evidence, this has been done. Where, similar to that raised concerning vari would be imprudent to atoume man to however, factual certainties are lacking ability of past employee exposure. Al be less sensitive to VC exposure than ex or where the facts alone do not provide though geographic and workpractiee dif perimental animals to the absence of an answer, policy judgments have been ferences mayultimately be demonstrated conclusive evidence. It would also be un made. to be factors to distribution of angiosar founded to assume that animals will not There is little dispute that VC Js car coma, sufficient information is unavail develop tumors when exposed at concen cinogenic to man and we so conclude. able to exclude-from consideration of trations of VC of less thsn 50 ppm. However, the precise level of exposure risk those employees in workplaces for Should a sufficiently large number of ex which poses a hazard and the question which cases cl angiosarcoma have not perimental animals be exposed to VC at of whether a "safe" exposure level exists, been observed. concentrations of less than 50 ppm, cannot be definitively answered on the It has also been suggested that the Schneiderman said that it would be ex record. Nor is it clear to what extent absence of cancer in a population of 335 pected that some would develop VC in exposures can be feasibly reduced. We Dow Chemical Company polymerization duced tumors. cannot wait until indisputable answers employees monitored over a period of 7 (3) Feasibility, There is virtually no to these questions are available, because years, indicates that exposure to vinyl dispute that most, if not all, fabricators lives of employees are at stake. There chloride at concentrations of less than are currently capable of reaching ex fore. we have had to exercise our beet 200 ppm is safe. (Bee study by Dr. Cook, posure levels of 1 ppm.through engineer judgment, on the basis of the best avail submitted at the hearing by Dow Chem ing controls. These employers employ able evidence. These Judgments have re ical Company.) However, the group sur well over 05 percent of all employees ex quired a balancing process, in which the veyed did not include all workers who posed to VC. Indeed, several fabricators overriding consideration has been the had been exposed, and the missing em are already operating at this level (see protection of employees, even those who ployees included many who had the SKI testimony). However, industry may have regular exposures to VC longer term (over 20 years) exposures. spokesmen have universally claimed that throughout their working lives. Moreover, the statistically Insignificant it is infeasible for the VC and the PVC Based bn the available evidence and in size of the sample population decreases industries to remain below 1 ppm con view of the above considerations, includ the possibility that tumors would be sistently, using engineering controls. In ing feasibility, we believe that employee observed. addition, the Knell study on technical exposures to VC must be reduced to a 1 Dow also presented preliminary data feasibility concluded thH a 1 ppm ceil ppm. time-weighted average (TV7A), 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 to the im olite, and that, the metabolite is pro industry. Labor union spokesmen and the mediate future. duced only when VC is metabolized by a Health Research Group, Inc,, however, In addition to the TWA.requirement, secondary metabolic pathway operating have suggested that such a level is at we have established a 5 ppm celling only when enzymes regulating the pri tainable. (averaged over a 15-minute period) in mary pathway are saturated, as would Since there is no actual evidence that order to prevent exposure of empiiyees be the result at higher exposures. The any of the VC or PVC manufacturers , to unacceptable high excursions. From preliminary data indicated the possi have already attained a J ppm level or in an operation standpoint, this ceiling bility of an additional pathway for fact Instituted all available engineering level is realistic because minor excur metabolism of VC in rats exposed to con and work practice controls, any estimate sions up to the ceiling level are likely to centrations of VC in excess of 220 ppm. as to the lowest feasible level attainable occur on a regular basis. However, the occurrence , of angio must necessarily involve subjective judg IIL The final standard--(1) Scope and sarcoma to both rats and mice at VC ment. Likewise, the projections of indus application. Both the ETS and the pro exposure concentrations of 50 ppm in try, labor, and others concerning feasi- posal would apply the standard to the dicates that If a metabolite of VC is the bility are essentially conjectural, indeed, entire VC industry, including manufac ultimate carcinogen, then It must be as Firestone has suggested, it is not pos turers of VC and PVC and fabricators, generated at lower exposure concentra sible to accurately predict the degree of but excluding employers handling or tions in these species. Although this re Improvement to be obtained from en using fabricated products made from search may be helpful to the thorough gineering changes untiil such changes are VC. understanding of the carcinogenicity of VC, It appears that- it does not yet offer evidence which can assist in determina tion of safe exposure concentrations for employees, or even that such safe ex posures exist. A number of witnesses representing employers have stressed that there is no evidence of cancer, either in employees or experimental animals, at exposure concentrations of VC less than 50 ppm, (See e.g., testimony of Firestone, Tenneco Chemicals.) The conclusion of these witnesses was that no decision can be made concerning, risk of exposure to VC at concentrations less than 50 ppm. actually 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 utilize technology presently used in other Industries. In any event, the VC and PVC Industries have already made great strides in reducing exposure levels, (See testimony of Dow Chemical Co., TR 973). There Is no dispute that a standard Is required for the monomer and polymer industries. However, the Society of Plas tics Industry (SPI) and various fabrica tors (see testimony of Goodyear, Gen eral Cable, etc.) recommended that fabricators be excluded from the stand ard, or that a separate requirement be established for them because many of them were already at or below the pro posed ceiling level. The record evidence establishes that, at least some employees to the fabricat ing industry are exposed in excess of the permissible control limits (See NIOSH testimony. TR 106; Robintech TR 642). On the other hand, the testimony of most expert witnesses, including some in dustry biomedical experts, stated that quantification of a safe exposure con centration is not possible with the pres For example. B. F. Goodrich testified (TR 1120) that it has reduced average exposure levels In several PVC plants from 35-40 ppm early this year to 12-13 In these circumstances, we believe that it 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 hearing. We are cation industry, as well as the monomer FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 OCC 020015 s RULES AND REGULATIONS 35893 and polymer Industries. Employers who, in fact, are substantially below the ex posure limit will be subjected to only minimal burdens 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. Employers handling or using fabricated products made of PVC were not included in the ETS or the proposal and are excluded from the flnalstandard. This conclusion 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 which will not undergo such mass heating. Further, the opportunity 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. (2) Permissible exposure limit. The below the action level, no fiirther moni toring is required unless the employer has reason to suspect that any employee is exposed In excess of the action level, or unless changes 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 at least monthly. Where exposures are less, than the permissible levels, but greater than the action level, monitoring is based on the absence of adequate evi standard sets an exposure limit of 1 ppm must occur at least quarterly, dence of exposure to VC in these opera averaged over any B hour period, and a (5) Methods o/ compliance. The stand tions. The final standard clarifies the ex ceiling of 5 ppm averaged over any per ard, like the proposal, requires that em emption by defining a fabricated prod iod not exceeding 15 minutes. ployers immediately institute feasible uct as a product made wholly or partly As more fully discussed above, this engineering and work practice controls from PVC which does not require further limit Is based on an evaluation of the best to . educe exposures to at or below the processing at temperatures, and for available evidence and on a judgment permissible exposure limit. times, sufficient to cause mass melting of that the health and safety' of employees Where feasible engineering and work .the PVC. SPI and others (cf. TR. 344) must be protected to the fullest extent practice controls will reduce exposures requested that PVC resins with less than feasible. In view of the fact that release below the permissible levels, they must 0.1 percent residual monomer be ex of VC in the VC and PVC manufacturing be instituted. Where such controls will empted from the regulation now, and processes are variable, the 1 ppm ceiling not reduce exposures below the permis that the exemption level be reduced to level provided in the proposal would sible level, they must nonetheless be im 0.01 percent in three years. SPI suggested require maintenance of an average level plemented to reduce exposures to the that the exemption of materials with less significantly more difficult to attain lowest practicable level, and be supple than 0,1 percent of 14 carcinogens from through feasible engineering controls. mented by the use of respirators to p:o- 20 CFR 1910.63p (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 finitl standard, ing and work practice controls must be made to set 6lr concentration limits for unlike the ETS and the proposal, pro instituted to reduce exposures to the low the 14 carcinogens. The record did net vides for an "action level" of 0.5 ppm est practicable level. When exposures are include information that reliable moni TWA, one-half of the permissible ex at or below the permissible exposure toring and measuring techniques were posure limit. The purpose of the action limits, the program may be discontinued. available. Moreover, the exemption did level Is to minimize the impact of the In addition, a plan for achieving con not exempt airborne traces of carcino standard on the employers who have trol by engineering and work practice gens. The administrative cutoff was pro attained exposure levels well below the methods must be drawn up and be made vided to ovoid regulation of materials permissible limit. Thus, where the re available, upon request, to represent about which there was no health haz sults of monitoring under paragraphs atives of OSHA and NIOSB. ard information, and which would have (d) (1) or (d) (2) demonstrate that no We recognize that many employers broadly extended the application of the employee is exposed in excess of 0.5 covered by the standard can not cur regulation beyond the record. Herein, ppm TWA, employers may. in effect, be. rently achieve compliance with the per no information was presented to show exempted from some provisions of the missible exposure limit solely by the use safe concentration results from the use standard. For exampJe, fabricators who of feasible engineering and work practice of resins with specific levels. Indeed, the are below the action level are not re controls. The record also reflects broad proposal to change the level later, when quired `o provide medical surveillance or generic distinctions between the compli improved technology would permit such to monitor again, unless the employer ance capabilities of the VC and PVC reduction, would seem to Indicate that has reason to suspect that any employee industries. Some industry, spokesmen. SPI has doubts about the safety of 0,1 is exposed in excess of the action level. Including SPI (TR. 358-362), recom percent residue level. Diamond Shamrock In our judgment, exposures below the mended that a schedule of different per- (Exhibit 142) testified that there is no action level do not present a sufficient roissile exposure limits and compliance direct relation. They indicate that the hazard to warrant application of the en dates be established for the VC and PVC airborne concentration Is more related tire standard to the many employers who segments of the industry. . . to the physical form of the resin and are or will be below that level. This view assumes that the ability and the ventilation provided. Also, monitor (4) Monitoring. The final standard, the time required to feasibly reach in ing data from industry (cf. Exhibits 131, like the proposal, requires that individual creasingly lower control levels is similar 168, 170) and OSHA (Exhibit 151) indi employee exposure levels be determined. within each industry, but differs mark cate that levels in excess of 1 ppm may This may be accomplished by personal edly between industries. While the record be found in fabrication operations. In or area monitoring. Some witnesses and does suggest that such differences do View of these facts and of the opportunity persons who submitted comments did exist between industries, as noted above, for employers to discontinue many duties not understand the meaning of the term it is clear that intra-industry differences upon a showing of no exposures above the "95 percent confidence level" in the also exist. Thus, the ability and time re action level, 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 cllmat: in which the plsnt agrees with a number of industry pro sults obtained are statistically valid. We is located, the age of equipment, the size posals (cf. TR 660). have modified the proposal to establish of reactors, or the type of resin manu SPI (TR 315), among others, asked accuracy range requirements for various factured or used. (Snell study. Firestone that compounded PVC pellets be ex measurement levels. These ranges are testimony, etc.) empted from the standard on the grounds narrow enough to ensure that a deter Monitoring data also tends to support that the pellets had too low a residue to mination of compliance can be made, and such intra-industry variations. (See, cause harmful or measurable emissions. broad enough to allow the application e.g. Dqw, Firestone, Tenneco.) While it appears that PVC pellets would of a variety of technologies As noted above, the standard requires have a lower residue level than virgin All covered employers are required to all employers to Institute feasible engi PVC, the fact that the pellets must be conduct initial monitoring. Where moni neering controls to the fullest extent and heated to a molten mass at the same toring and measuring results are at or to continue to improve and apply engi- FEDERAl REGISTER, VOL. 39, NO. 194--FRIDAY, OCTOBER 4, 1974 OCC 020016 35894 mRULES A REGULATIONS fleering control* until full compliance Is if the environmental level in Slot con (rations. In discussions of these findings achieved. . trolled to the permissible exposure limit, with NIOSH, it has indicated that it is We have not established any deadlines then employees must be afforded respira willing to consider on an expedited basis for full compliance through engineering tory protection. the approval of alr-purifyiag respirators controls because we are presently unable While exposures in excess of the per for use against VC. Consequently, we to determine when it will be feasible for missible level do constitute ft hazard, we have included three types of air-purify most establishments to reduce exposure believe that it Is necessary to mitigate ing respirators in the list of acceptable levels to the permissible level. some of the problems associated with units, subject to the approval of such We also believe that the requirement implementing a program,of respiratory units by NIOSH. The maximum concen that each employer reduce airborne con protection while employees are being tration for which each respirator may centrations to the permissible level, or fitted and trained in respirator use, and be used is based upon wi evaluation to the lowest level feasihle ns soon as while other adjustments which may be of the data submitted by NIOSH and practicable will provide for inter-indus required are implemented. Therefore, Goodrich, Because air-purifying respi try and Intra-industry technological dif until January 1. 1076, where exposures rators do not tndicate sorbent exhaustion ferences which do exist, and will avoid are not in excess of a 25 ppm ceiling, or breakthrough of VC, and because VC the setting of separate Industry stand- each employer must provide each em has no inherent warning properties at , ards on the basis of the general situation ployee with an appropriate respirator. levels for which these devices are used, and conditions'In each industry. Howevci-, employees whose exposures do strict administrative controls will be re (6) Regulated areas, The proposed not exceed a 25 ppm celling, may decline quired for their use. Such controls in standard would have required that regu to use the respirator, in which cp.ee the clude a program to assure timely re lated areea be established, that access be employer Is not obligated to require its placement of canisters or cartridges and limited to authorized employees, and use. During this adjustment period, em an alarm system to alert employees when that dally rosters or summaries of those ployees will be trained In the uses, pur vinyl chloride concentrations exceed the entering be kept for at least 20 years. In poses and limitations of respirators, and concentrations allowed for the particu objection to these requirements, it was asserted that such control of access was notnecessary from a health standpoint. Secondly, it was claimed that these con trols would interfere with operations by preventing access of needed employees or non-employees, such as contractors, truck drivers, customers and consultants. The purpose of establishing regulated areas in the proposal was to limit the risk of exposure to as few employees as possible. This concern is still paramount, and thus the limited access feature re mains. The final standard amends the proposal slightly to allow "authorized persons" to enter regulated areas. This change, it Is felt, will allow operations to continue' without undue interference. The final standard has also increased the length of time daily rosters must be maintained from 20 to SO years. This change was based largely on epidemio logical considerations. (Sea NIOSH testi mony, tr, 112.) tTI 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 many drawbacks: the proposal did not contemplate them as a final solution. The record shows that the PVC industry par ticularly may need several years before plant environmental levels can be re duced so that respirators are necessary only occasionally. However, we' cannot agree that respiratory protection should the hazards of exposure to vinyl chloride. lar type of respirator In use. Moreover, each employee will be notified (8) Hazardous operations. This is a in writing if he has been exposed in ex new section within the final standard. It cess of the permissible exposure limit. encompasses essentially the proposal's Where exposures exceed a 25 ppm ceil requirements for maintenance send de ing, respiratory protection is mandatory contamination but has restated them in in light of our Judgment' that much terms of performance language to allow greater risks are associated with such greater flexibility for employers to deal exposures. with such operations. The intent ol the The provisions in the final standard new section is to protect employees en regarding the selection and use of respi gaged In activities that present a risk of ratory protective devices differ from exposure to vinyl chloride in excess of the those in the proposal. The descriptions of permissible levels. An example would be atmosphere-supplying respirators have the cleaning of a filter where resin con been revised to Indicate more clearly the' taining high residual monomer is types of devices intended, and the maxi trapped. mum permissible concentration level for The proposal's requirement for lull- each device. Moreover, the number of body, impervious clothing has been re types of atmosphere-supplying devices placed by the direction to use impervious has been increased. garments suited to the particular situa At the hearing Mr. Edwin O. Hyatt, an tion and probable extent of exposure. OSHA consultant, made suggestions re Thus, full-body clothing is not always garding the use of particular respiratory necessary, and is therefore not required devices. We have concluded that his sug where less protection is adequate. Since gestions ftre meritorious. Therefore, the vessel entry falls within the definition provisions for selection of atmosphere- of a hazardous operation, the vessel entry supplying devices follow closely the rec section of the proposal has been deleted ommendations contained in his testi from the final standard. mony of EPI and B. P. Goodrich) <TK (9) Emergency situations. The defini with Hyatt's suggestions. (See e.g, testi tion of emergency has been recast in mony of 6PI and B, P. Goodrich) (TR terms of an unexpected massive release. 85 ft) We had originally omitted air- The main objection to the section on purifying respirators because none had emergency situations in the proposal was been approved by NIOSH for use against that, as the term was defined, many VC, principally because they lacked in ordinary leaks nr operations resulting in dicators to signal the expiration of the a small release of vinyl chloride would be service life of the sorbent. Hyatt and considered emergencies. This was not other witnesses discussed in detail the the Intent of the proposal. The final desirability of being able to use canisters standard has been clarified to correct or cartridge air-purifying respirators, this ambiguity. It should be noted that provided a sorbent could be shown to the written operational plan required by effectively absorb vinyl chloride with an the standard need not be developed for adequate service life. Recently, OSHA minor excursions above the permissible has received respiratory data from labo exposure limit, and that such excursions ratories regarding the effectiveness of need not he reported. commercially available canisters and (10) Signs and labels. The thrust of the cartridges for vinyl chloride. These eval signs and labels section is to apprise not be required simply because it is in uations were cohducted separately by employees of the cancer and fire haz convenient, may require additional per NIOSH and by the B. P. Goodrich Com ards. No objections have been raised with sonnel, interferes with production, or may require extensive retraining of em ployees and restructuring of work prac tices. We have carefully considered all pany- and submitted to OSHA in posthearing comments. The results indicate that certain presently available canis ters and cartridges effectively absorb respect to informing employees of the fire hazard. However, a numbe, of ob jections were raised at the hearing and In written submissions to the require ment that the word "cancer" appear on the objections, and have concluded that vinyl chloride at relatively low concen- all signs and labels. The principal argu- FEPERAI. REGISTER, VQb 39, NO. I!4~FRIDAY, OCTOBER 4, 1914 OCC 020017 7 RULES AND REGULATIONS 35C35 raent advanced against Its use wds that the term "cancer" or "cancer-suspect agent1' scares employees and that- In stead, the message should contain in structions on how to deal with the sub stance (TR.. 347), We believe that a diluted form of warning will not suffice. We appreciate the concern of employers with the reaction of their employees. But Indicated that the medical tests proposed are currently the only ones available which are useful for medical surveillance (TR 121, Exh. 95, TR 583-531). Conse-, quently, the specific blood tests proposed have been retained as a minimum re quirement to assist the examining physi cian in determining fitness of potential employees for assignment to workplaces posal is the requirement for maintenance of monitoring records and daily roster sheets of authorized persons for 30 years, instead of 20 years. Additionally, the em ployer is required to maintain medical records for the duration of an employee's employment plus 20 years, or 30 years, whichever Is longer. The original pro posal called for only 20 years. i we consider it imperative that a worker involving VC exposure. In addition, al This change has been implemented be be fully informed, and that he realize the ternative medical examinations may be cause the latency period for induction of possible risks Involved in his occupation. used where the examining physician de angiosarcoma ranges up to 30 years from Coupled with the training requirement termines that they are at least as good initial exposure. Therefore, as a mini In the standard, wc believe that the signs as those specified by the standard. mum. medical records must be main and labels required will adequately in The Tabershaw-Cooper study and the tained for at least that long. It should be form employees of the hazard. In addi various animal experiments suggest that noted that spokesmen for both labor and tion, such signs will warn unauthorized VC may produce a wide spectrum of ma industry recommended that this change personnel to keep out of regulated areas. lignant and non-maiignant 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 si' ffificantly different from those In the training and indoctrination of employees ened to include kidneys, skin, connective original proposal. However, instead of that cannot easily be conveyed on a sign tissue, spleen, and pulmonary system, as the requirement for reporting incidents or label. Also, the variety of measures well as the liver. No additional specific which result in the release of VC into that could be prescribed would result in procedures or tests are required, but rec areas where employees may be exposed, an unwieldly or excessively detailed leg ommendations have been included in the the final standard clarifies our original end. Consequently, the required message Appendix to assist the examining physi Intent by stating that only emergencies on signs and labels will not Include in cian. Because of the nonspecific nature must be reported. Also the requirement formation on precautions, relevant of the required medical tests, It is not for filing a detailed, written report symptoms, etc. The addition of suitable appropriate to prescribe timing, or type within 15 days has been deleted. It has Information by the employer would he of followup tests, or to mandate with been concluded that submission, within permitted, providing it does not detract drawal from exposure based solely on re 24 hours, of an initial report that in In any way from the required statement. sults of the tests. Instead, the employer cludes facts Immediately available, would The requirement in the proposal for is required to obtain a statement from ordinarily be sufficient. However, if the labeling containers of vinyl chloride has the examining physician of the em OSHA Area Director requests further in been amended by deleting the reference ployee's suitability for continued expo formation relevant to the emergency, the to the possible hazard of violent polym sure, when the examining physician has employer will be required to furnish such erisation. Very little information was completed such tests as he considers ap information. developed on this hazard during the propriate. The employer is required to (14) Deleted portions of the proposal. standard-setting procedure. It does ap withdraw an employee only when this The proposal contained provisions re pear that this hazard is essential]}- under statement indicates that the employee quiring that shower facilities ond change control and that the fire and carcino may be at added risk from continued VC rooms be provided, and that storage or genic hazards at present are the most exposure. consumption of food be prohibited in significant. Since labeling or placarding As with monitoring, there appears to regulated areas. We have deleted these that is in compliance with the U.3. De be no basis for complete exemption of the provisions because it is our conclusion partment of Transportation regulations fabrication industry from the require they are no longer necessary. Showering (49 CFR Part 173, Subpart H) already warns of'the fire hazard, only a state ment concerning the carcinogenic haz ard need be added to the Department of Transportation labels. ment for medical examination. The rec ord does show fabricating establishments with concentrations of VC monitored considerably above the action level. In these instances, medical surveillance of facilities are 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 (11) Medical surveillance. The princi affected employees will provide baseline evidence that VC vapor is absorbed pal questions that have been raised re data for future evaluation of their health, through the skin. In addition, since we garding' medical surveillance are the even if both monitoring and medical sur anticipate that most employees wifi not necessity and efficacy of requiring cer veillance are discontinued because im be wearing protective clothing and that tain specific serum enzyme determina proved controls reduce concentrations employees who wear protective clothing tions (S3MA-12 series) and the applica below the action level. Where exposures will change such clothing infrequently, tion of medical examination require are below the action level, the medical we are not requiring that change rooms ments to the fabrication segments of the surveillance requirements do not general be provided. Industry where employees are exposed to ly apply. In addition, we feel that there is In lower levels of VC. The objection has also (12) Training. A separate provision for adequate evidence showing that hazar been raised that the specification of tests employee training has been added to the dous amounts of VC can be absorbed and procedures interferes with the ap final standard rather than Including it through ingestion. For this reason, the plication of advances in medical knowl within the section on emergency situa requirement prohibiting the storage or edge. tions as in the proposal. The new para consumption of food in regulated areas A particular difficulty in considering graph provides for training of employees has been deleted. medical surveillance is that the most concerning the carcinogenic hazard of The proposal also contained provisions commonly discussed lesion, angiosar VC, emergency procedures, the need for on maintentance and decontamination, coma of the liver, currently cannot be monitoring and an annual review of the transportation loading and unloading, diagnosed until the victim is terminal standard. It also provides for training of and polymer handling operations. These and, usually, within months of death. employees concerning the purpose for, requirements are not mentioned in the Precursor physiologic alterations, which proper use of, and limitations connected final standard because attention to these might be reversible, have not yet been with respiratory protection. Items is implicit in the requirement that directly associated with the lesion. Con (13) Records and reports. The provi each employer reach the permlssable ex sequently, there are no specific diagnos sions for recordkeeping contained in the posure limit or attain the lowest feasible tic tests which can be prescribed which final standard require the preparation level. will determine presence or absence of and maintenance of essentially the same (15) Effective dale. 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 FEDERAL REGISTER, VOL 39, NO. 194---FRIDAY, OCTOBER 4, 1974 { OCC 020018 # 35896 RULES AMD REGULATIONS provisions and that employers affected are Given an opportunity to familiarize themselves and their employees with the existence of the new requirements, the effective date of the amendment to 1910.D3q wfll be January 1,1975. To pro vide continued protection for employees until that date, the provisions currently contained In ' 5 1910.93q " are hereby promulgated, pursuant to section 6(b), 6(c) and 8(c) of the Occupational Safety and Health Act, as an occupational safety and health standard' effective October 4, 1S74, the amendment to of the operation or bceause of an acci dent in the operation, which would result In an employee exposure in excess of the permissible exposure limit. (8) "OSHA Area Director" means the Director for the Occupational Safety and Health Administration Area Office having jurisdiction over the geographic area in which the employer's establish ment is located. (S) "Polyvinyl chloride" means poly vinyl chloride hotnopolymer or copoly mer before such is converted to a fabri cated product. opportunity to observe the monitor ing and measuring required by this paragraph. (e) Regulated area. (I> A regulated area shall be established where: (1) Vinyl chloride or polyvinyl chloride is manufactured, reacted, repackaged,' stored, handled or used; and (11) Vinyl chloride concentrations are in excess of the permissible exposure limit. (2) Access to regulated areas shall be limited to authorized persons. A daily roster shall he made of authorized per 51910.93q set out below will supersede (10) "Vinyl chloride" means vinyl sons who enter. these provisions as of January 1, 1975. chloride monomer. (f) Methods o1 compliance. Employee Accordingly, upon consideration of the (c) Permissible exposure limit. (1) No exposures to vinyl chloride shall be con whole record of this preceding i vrt 1910 of Title 20, Code of Federal Reg; lotions is amended, effective January 1, 1975, by revision of 8 lS10.93q to read as follows: employee may be exposed to vinyl chlo ride at concentrations greater than 1 ppm averaged over any 8-hour period, and (2) No employee may be exposed to trolled to at or below the permissible ex posure limit provided in paragraph (c) of this section by engineering, work prac tice, and personal protective controls as 1910.93q Vinyl chloride. vinyl chloride at concentrations greater follows: than 5 ppm averaged over any period not (1) Feasible engineering and wofk (a) Scope and application. (1) This exceeding 15 minutes. practice controls shall immediately be section includes requirements for the (3) No employee may be exposed to used to reduce exposures to at or 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 not sufficient to facture, reaction, packaging, repackag shall be undertaken in each establish reduce exposures to at or below the per ing, storage, handling or use of vinyl ment to determine if there Is any em missible exposure limit, they shall none chloride or polyvinyl chloride, but does ployee exposed, without regard to the use theless be used to reduce exposures to not apply to the handling or use of fabri of respirators, in excess of the action the lowest practicable level, and shall be cated products made of polyvinyl chlo level. supplemented by respiratory protection ride. (2) Where a determination conducted in accordance with paragraph (g) of this (3) This section applies to the trans under paragraph (d)(1) of this section section. A program shall be established portation of vinyl chloride or polyvinyl shows any employee exposures, without and Implemented to reduce exposures to chloride except to the extent that the regard to the use of respirators, in ex at or below the permissible exposure Department of Transportation may cess of the action level, a program for de limit, or to the greatest extent feasible, regulate the hazards covered by this sec termining exposures for each such em solely by means of engineering and work tion. ployee shall be established. Such a pro practice controls, as soon as feasible. (b) Definitions. (1) "Action level" gram: (3) Written plans for such a program means a concentration of vinyl chloride (1) Shall be repeated at least monthly shall be developed and furnished upon of 0.5 ppm averaged over an 8-houi work where any employee Is exposed, without request for examination and copying to day. regard to the use of respirators, in ex authorized representatives of the Assis (2) "Assistant Secretary" means tile cess of the permissible exposure limit. tant Secretary and the Director. Such Assistant Secretary of labor for Occupa (11) 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, (g) Respiratory protection. Where <33 "'Authorized person" means any in excess of the action level. respiratory protection Is required under person specifically authorized by the em (ill) May be discontinued for any em this section:' ployer whose duties require him to enter ployee only when at least two consecu (1) The employer Bhall provide a a regulated area or any person entering tive monitoring determinations, made not respirator which meets the requirements such an area as a designated representa less than 5 working days apart, show ex of this paragraph and shall assure that tive of employees for the purpose of ex posures for that employee at or below the employee uses such respirator, except ercising an opportunity to observe moni toring and measuring procedures. (4) "Director" means the Director, National Institute for Occupational Safety and Health, U.S. Department of Health, Education, and Welfare, or his designee. ` the action level. (3) Whenever there has been a pro duction, process or control change which may result in an increase in the release of vinyl chloride, or the employer has any other reason to suspect that any em ployee may be exposed In excess of the that until December 31, 1975, wearing of respirators shall- be at the discretion of each employee for exposures not In ex cess of 25 ppm, measured over any 15mlnute period. Until December 31, 1975, each employee who chooses not to wear an appropriate respirator shall be In (5) "Emergency" means any occur action level, a determination of employee formed at least quarterly of the hazards rence such as, but not limited to, equip exposure under paragraph (d)(1) of this of vinyl chloride and the purpose, proper ment failure, or operation of a relief de section shall be performed. use, and limitations of respiratory vice which is likely to, or does, result In (4) The method of monitoring and devices. massive release of vinyl chloride. measurement shall have an accuracy (2) Respirators shall be selected from (6> "Fabricated product" means a (with a confidence level of 95 percent) of among those Jointly approved by the product made wholly or partly from not less than plus or minus 50 percent Mining Enforcement and Safety Admin polyvinyl chloride, and which does not from 0.25 through 0.5 ppm, plus or minus istration, Department of the Interior, require further processing at tempera 35 percent from over 0.5 ppm through and the National Institute for Occupa tures, and for times, sufficient to cause 1.0 ppm, and plus or minus 25 percent tional Safety and Health under the pro mass melting of the polyvinyl chloride over 1.0 ppm. (Methods meeting these visions of 30 CFR Part 11. resulting in the release of vinyl chloride, accuracy requirements are available in <3) A respiratory protection program (7) "Hazardous operation" means any the "NIOSH Manual of Analytical meeting the requirements of 1910.134 operation, procedure, or activity where a Methods"). shall be established and maintained. release of either vinyl chloride liquid or (5) Employees or their designated rep (4) Selection of, respirators tor vinyl gas might be expected as a consequence resentatives shall be afforded reasonable chloride shall be as follows: -`z7' FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 OCC 020019 RULES AND REGULATIONS 35S97 Atmospheric cemccntration of (vi)The purpose for, and a descrip vinyl chloride Required apparatus tion of, the medical surveillance (l) Unknown, or above 3,600 ppm__ Ojwn-c!rcuit, self-contained breathing apparatus, preS" program; Luro demand type, v4th full facepiece. Cvil) Emergency procedures: (U) Not over 3,600 ppm____________ (A) Combination typo G supplied air respirator, pres (viii) Specific information to aid the sure demand type, with full or half facepiece, employee in recognition of conditions and auxiliary self-contained air supply; or which may result in the release of vinyl (E) Type C. supplied ah respirator continuous flow chloride; and ` type, with full or half facepiece, and auxiliary (ix) A review of this standard at the (III) Not over 100 ppm-....-TM-., (IV) Not OVW 26 ppm____ --...____ _ self-contained, air supply, (A) Combination type C enpplled air respirator de mand type, with full facepiece, end auxiliary self-contained air supply; or (B) Open-circuit self-contained "breathing apparatus with full facepiece, in demand mode; or (C) Type C supplied elr respirator, demand type, with full facepiece. (A) A powered alr-purifylng respirator with hood, helmet, full or half facepiece, and a canlste" which provides a service life of at least a hours for concenratlons of vinyl chloride up employee's first training and indoctrina tion program, and annually thereafter, (2) All materials relating to the pro gram shall be provided upon request to the Assistant Secretary and the Director. (k) Medical surveillance. A program of medical surveillance shall be insti tuted for each employee exposed, with out regard to the use of respirators, to 'inyl chloride in excess of the action level. The program shall provide each to 28 ppm, or such employee with an opportunity for (B) Gas mass, front- or back-mounted canister which examinations and tests In accordance provides a service life of at least A hours for with this paragraph. All medical ex concentrations of vinyl chloride up to 25 ppm, aminations and procedures shall be per <v) Not over 10 ppm.________ _____ (A) Combination type O supplled-air respirator, de formed by or under the supervision of a, mand type, with half facepiece, and auxiliary licensed physician, and shall be provided self-contained air supply; or without cost to the employee. (B) Type C supplied-air respirator, demand type, with half facepiece; or (C) Any chemical cartridge respirator with an organic vapor cartridge which provides a service life of at least 1 hour for concentrations of vinyl chloride up to 10 ppm. (l) At the time of Initial assignment, or upon institution of medical surveil lance; (il A geheral physical examination shall be performed, with specific atten tion to detecting enlargement of liver, spleen or kidneys, or dysfunction in these (5) (i) Entry Into nnkown concentra (2) Protective garments shall be pro organs, and for abnormalties in skin, tions or concentrations greater than vided clean and dry for each use, connective tissues and the pulmonary 36,000 ppm Gower explosive limit) may (i) Emergency situations. A written system (See Appendix A). be made only for purposes of life rescue; operational plan for emergency situa (ii) A medical history shall be taken, and tions shall be developed for each facility including the following topics: <ii> Entry into concentrations of less storing, handling, or otherwise using than 36,000 ppm, but greater than 3,600 vinyl chloride as a liquid or compressed (A) Alcohol intake; (B) Past history of hepatitis ; ppm may be made only for purposes of gas. Appropriate portions of the plan (C) Work history and past exposure life rescue, flreflghtinp, or securing shall be implemented in the event of an to potential hepatotoxic agents, includ equipment so as to prevent a greater emergency. The plan shall specifically ing drugs and chemicals; hazard from release of vinyl chloride. provide that: (D) Past history of blood transfu (6) Where air-purifying respirators are used: (i) Air-purifying caimisters 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 ;coneentratlons for the devices in use, Buch sys tem shall be used to alert employees when vinyl chloride concentrations exceed the allowable concentrations for the devices in use, (7) Apparatus prescribed for higher concentrations may be used for any lower concentration, (h) Hazardous operations. (1) Em ployees engaged in hazardous operations, (1) Employees engaged in hazardous operations or correcting situations of ex isting hazardous releases shall be equipped as required in paragraph (h) of this section; (2> Other employees .not so equipped shall evacuate the area and not return until conditions are controlled, by the methods required in paragraph (f) of this section and the emergency is abated. (j) Training. Each employee engaged in vinyl chloride or polyvinyl chloride operations shall be provided training in a program relating to the hazards of vinyl chloride and precautions for its safe use. (1) The program shall Include: (i) The nature of the health hazard from chronic exposure to vinyl chloride including specifically the carcinogenic hazard; sions; and (E) Past history of hospitalizations. (ill) A serum specimen shall be ob tained and determinations made of; (A) Total bilirubin; (B) Alkaline phosphatase; (C) Serum glutamic oxalacetic trans aminase (SGOT); (D) Serum glutamic pyruvic transam inase (SGFT); and (E) Gamma glustamyl transpeptidase. (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 including entiy of vessels to clean poly vinyl chloride residue from vessel walls, Cii) The specific nature of operations' which could result In exposure to vinyl medical surveillance. (4) A statement cf each employee's shall be provided and required to wear chloride in excess of the permissible suitability for continued exposure to and use; limit and necessary protective steps; vinyl chloride including use of protec (i) Respiratory protection in accord (ii) The purpose for, proper use. and tive equipment and respirators, shall be ance with paragraphs (c) and (g) of limitations of respiratory protective obtained from the examining physician this section; and devices; promptly after any examination. A copy (il) Protective garments to prevent skin contact with liquid vinyl chloride or with polyvinyl chloride residue from (iv) The fire hazard and acute toxic ity of vinyl chloride, and the necessary of the physician's statement shall be pro vided each employee, vessel walls. The protective garments protective steps; (5) 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, 1974 OCC 020020 8Ul.es AMO REGUUTIOMS //- ^,-^j 'rt)tn passlbis contact with vlryl tion which contradicts or detracts from (ii) The number of employees in each the effect of, any required warning, regulated area during normal operations, ` /laboratory analyses for all falo-r information or instruction. including maintenance. . ";,1 n>cclme3 included In medical (ml Records. 11) All records main (2) Emergencies, and the facts ob f \ jtiiiuitiora shall be performed In labo- tained in accordance with tide section tainable at that time, shall be reported riiiiVfn's licensed under 42 CFR Part 74, shall include the name and social secu within 24 hours to the OSHA Area Di i 7 j If the examining physician deter- rity number of each employee where rector. Upon request of the Area Direc ir ncs that alternative medical examina relevant. tor, the employer shall submit additional tions to those required by paragraph (2) Records of required monitoring information in writing relevant to the i V. h 1) of this section will provide at and measuring, medical records, and au nature and extent of employee exposures least equal assurance of detecting med thorized personnel rosters, shall be made and measures taken to prevent future ical conditions pertinent to the exposure and shall be available upon request for emergencies of similar nature. to vinyl chloride, the employer may ac examination and copying to authorized (3) Within 10 working days following cept such alternative examinations as representatives of the Assistant Secre any monitoring and measuring which meeting the requirements of paragraph tary and the Director. discloses that any employee has been (k)(D of this section, if the employer (i) Monitoring and measuring records exposed, without regard to the use of obtains a statement from the examining physician setting forth the al'-rnative examinations and the rationale lor sub stitution. This statement shall be avail able upon request for examination and shall: (A) State the data of such monitor ing and measuring and the concentra tions determined and identify the instru ments and methods used; respirators in excess of the permissible exposure limit, each such employee shall be notified in writing of the results of the exposure measurement and the steps copying to authorised representatives of (B) Include any additional informa being taken to reduce the exposure to the Assistant Secretary and the Director, <11 Signs and labels. (1) Entrances to regulated areas shall be posted with leg ible signs hearing the legend: Cancer-Suspect Agent Area Authorized PERSONNEL Ohlt tion necessary to determine individual employee exposures where such expo sures are determined by means other than individual monitoring of employees; and (C) Be maintained for not less than within the permissible exposure limit. (o) Effective dates. Cl) Until Janu- ary 1, 1975, the provisions currently set, forth in $ 1910.93q of th's-fiart shah apply, (2) Areas containing hazardous oper ations or where an emergency currently exists shah be posted with legible signs bearing the legend: Canceh-Scstect Agent in Tins Area Protec tive Equh-meht Required Authorized Personnel Only (3) Containers of polyvinyl chloride resin waste from reactors or other waste contaminated with vinyl chloride shall be legibly labeled: Ccirtmnlnsitctl with Vinyl Chloride Cancer-Suspect AceNt (4) Containers of polyvinyl chloride shall be legibly labeled: Polyvinyl Chloride (or Trade Name) Contains Vrm Cbloribe Vinyl Ciiloruik ts A Cancer-Suspect Agent 30 years. (2) Effective Janua:> 1, 1975, the pro (ID Authorized personnel rosters shall visions set forth in lP;o.33q of this Part be maintained for not less than 30 years. (iil) Medical records shall be main tained for the duration of the employ ment of each employee plus 20 years, or 30 yearn, whichever is longer, shall apply. APPENDIX a--- ?,''ELEMENTARY MEDICAL ' .--^FORMATION / Wl'/*n required tests under paragraph /" (3) In the event that the employer (ix)i') of this erection stow Abnormalities, '' ceases to do business and there is no successor to receive and retain his rec ords for the prescribed period, these rec,, tv/"tests should be repeated as soon as prac^ /.table, preferably within 3 to 4 weeks. If ,, tests remain abnormal, consideration should / be given to withdrawal of the employee frony * ords shall be transmitted by registr-fed contact with vinyl chloride, while a nr/1 mail to the Director, and each employee comprehensive examination is mad*/ individually notified in writing of this Additional tests which may bf/urcful; transfer. A. For kidney dysfunction: ur,Zie examina (4) Employees or their designated representatives shall be provided access to examine and copy records of required monitoring and measuring, (5) Former employees shall be pro vided access to examine and copy re tion for albumin, red blood '.ells, and ex foliative abnormal cells, B. Pulmou&ry system: Forcod vital capac ity, Forced,jexplratory volume at 1 second, and chest roentgenogram (posterior-anterior, 14 x 17 inches), C. Additional serum tests: tactic acid de (5) Containers of vinyl chloride shall quired monitoring and measuring records hydrogenase, lactic acid dehydrogenase be legibly labeled either: U> Vinti. CuLoaiDE Extrcuelt Flammable Gas TJvr&tB Pressure Cancer-Suspect Agent or til) In accordance with 49 CFR Part 173, fiubpait H, with the additional legends: reflecting their own exposures. (6) Upon written request of any em ployee, a copy of the medical record of that employee shall be furnished to any physician designated by the employee. (n> Reports. (1) Not later than. 1 month after the establishment of a reg ulated area, the following information shall be reported to the OSHA Area Di isoenzyme, protein determination, and protein electrophoresis. D. For a more comprehensive examination on repeated abnormal serum tests: Hepatitis B antigen, and liver scanning. (Secs. C and 8, 64 Stat. 1566, 1560 (20 U.S-C, 655, 657); Secretary of Labor's Order No, 12-71. 30 FR 8754) Signed at Washington, P.C., this 1st Cancer-Suspect Agent Applied near the labor or placard. <6) No statement shall appear on or rector. Any changes to such information shall be reported within 15 days. (D The address and location of each establishment which has one or more day of October, 1974. John Stender, Assistant Secretary a] tabor. near any required sign, label or instruc regulated areas; and [FR Doc.74-23176 Filed 10-1-74;3:64 pm] . COPIED BY MCA 10/9/74 FEDERAL REGISTER, VOL. 39, NO. 194--FRIDAY, OCTOBER 4, 1974 OCC 020021