Document J3nqnmGvMVQb00Earjwn451QK

[ RUBBER MANUFACTURERS ASSOCIATION 1901 PENNSYLVANIA AVE, N IN WASHINGTON. D C 20006 [2021 765-2602 October 4, 1974 VC - 6 OSCHX - 46 EC - 135 TO: SUBJECT: VC/PVC Manufacturers and/or Users RMA Occupational Safety and Health Committee RMA Environment Committee OSHA Standard for Exposure to Vinyl Chloride 29 CFR 1910.93q Gentlemen: Enclosed for your information is the subject standard to be published in today's Federal Register. The entire document must be carefully read but please note the following major points: 1. The current 50 ppm level will continue as the level of exposure until December 31, 1974. 2. On January 1, 1975, employers must reduce levels to 1 ppm averaged over any 8-hour period, and 5 ppm averaged over any period no longer than 15 minutes. 3. Beginning January 1, 1976, wearing qf respirators will be mandatory for workers exposed to levels greater than the 1 ppm and 5 ppm allowable limits. Until that date, wearing of respirators is discretionary for exposures no greater than 25 ppm. 4. The standard applies to the manufacture, reaction, packaging, repackaging, transportation, storage, handling or use of vinyl chloride or polyvinyl chloride. 5. Employers must set up "regulated areas" where concentrations of VCM exceed the "one and five ppm" limits, with access limited to "authorized" workers. GENC 007175 VC ,,6 ' OSCHX - 46 EC - 135 October 4, 1974 Page Two 6. Plans for reducing exposure to the permissible "one and five ppm" levels must be available on request of OSHA, 7. Direct contact by employees with liquid VCM is prohibited. 8. Monitoring and measuring programs must be initiated to learn whether exposure levels exceed 0.5 ppm. Depending on levels found, repeat measurements are required at least monthly or quarterly. They may be discontinued only when two consecu tive measurements, no fewer than five working days apart, show individual employee exposures to be less than 0.5 ppm. 9. Any change in processes that may alter exposure levels will require new measurements for all affected employees. 10. Monitoring and measuring methods must meet accuracy require ments ranging from not less than plus or minus 50 percent in concentrations from 0.25 through 0.5 ppm, to plus or minus 25 percent for levels greater than one ppm. 11. Where the regular monitoring program shows excursion levels may exceed 25 ppm, a continuous monitoring and alarm system must be used to alert employees to potential danger if they are using air filtering respirators (gas masks). At that level, they must switch to respirators with a clean air supply. 12. Employees and their representatives must be given "reasonable opportunity" to observe monitoring and measuring. 13. Protective garments as well as respiratory protection must be provided for employees in hazardous situations, such as cleaning operations in PVC vessels. 14. Written plans must be prepared for emergency situations (accidental release of massive levels) in facilities making or using VCM. 15. Employees in VCM or PVC operations must be trained fully on topics such as nature of the hazards, protective measures, and the contents of the OSHA rules, 16. Medical programs must include complete initial examinations. Subsequent ones will be required every six months for employees who have worked in VCM or PVC operations for 10 or more years, and annually for all other exposed workers. Alternative medi cal examinations will be acceptable if the examining physician states his procedures and reasons for substitution. All medi cal checks are at no cost to employees. GENC 007176 VC - 6 OSCHX - 46 EC - 135 October 4, 1974 Page Three 17. Specified signs or labels are required at entrances to "regulated areas," in hazardous operations or emergency areas, on containers of PVC resin waste, PVC containers and VCM containers. 18. Records of required monitoring and measuring, medical records, and rosters of "authorized" workers must be kept for varying specified times, or be sent to the Director, National Institute for Occupational Safety and Health, if an employer ceases to do business before the expiration of retention periods. 19. Reports must be made to the nearest OSHA Area Director no later than one month after establishing a "regulated area," and within 24 hours of any "emergency" exposure. Also, reports to affected employees must be made within 10 days after monitor ing and measuring shows exposure in excess of the "one and five ppm" limits, including the results of the measurements and steps being taken to reduce exposure to permissible levels. ** Enclosed also for your information, is a telegram opposing the standard sent by RMA President Malcolm R. Lovell, Jr., to Undersecretary of Labor, Richard F, Schubert. Any further RMA action on this matter will be subject to developments and decisions that are yet to evolve. Individual company response to OSHA is urged and it would be appreciated if copies of any such responses would be sent to me. Sincerely FTR/evm Enclosures Frank T. Ryan V/ Director of Environmental, Health and Safety Affairs GENC 007177 FRIDAY, OCTOBER 4, 1974 WASHINGTON, O.C. Volume 39 Number 194 \ PART II m -V' DEPARTMENT OF LABOR Occupational Safety And Health Administration EXPOSURE TO VINYL CHLORIDE Occupational Safety and Health Standards GENC 007178 35890 RULES AND REGULATIONS Title 29--Labor ' CHAPTER XVII--OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DE PARTMENT OF LABOR PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS Standard for Exposure to Vinyl Chloride . Pursuant to sections 6(b), 6(c), and 8(c) of the Occupational Safety and Health Act of, 1970 (84 Stat. 1593, 1596, 1599; 29 U.8.C. 655. 657) Secretary of Labor's Order No. 12-71 (36 FR 8754) and 29 CFR Part 1911, 1910.93 of Part 1910 of Title 29, Code of Federal Regu lations is hereby amended in the manner set forth below, in order to provide an Occupational Safety and Health stand ard dealing with the exposure of em ployees to vinyl chloride. L Backgrounded) Vinyl chloride. Vinyl chloride (chloroethene). Chemical Abstracts Service Registry No. 75014, is a synthetic organic chemical made from ethylene or acetylene and chlorine by any of several processes. It Is the parent . compound of a series of thermoplastic resin polymers and copolymers which are widely used for containers, wrapping - film, electrical insulation, pipe, conduit, and a variety of other industrial and . consumer -products. Vinyl chloride -has been made commercially in this country since. 1939, and present production is in , excess of seven billion pounds per year. ' The vinyl chloride industry divides into three segments: monomer production, polymer production, and fabrication. Production of the monomer is a largescale continuous process, involving only ft 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 mbnomer into a polymer or copolymer is an incomplete process, Le^ not all of the monomer Is reacted. PVC is fabricated by a variety of tech- niques, Including extrusion, injection ~ molding and calendering, to form a fin ished product that needs no further . chemical handling. The vast majority ' of employees involved in the VC industry , are employed by fabrication firms. Such >fiims range in size from those with few employees and Bimple equipment to large plants involving many employees and ^.'^considerable capital. '.. '.Vinyl chloride (VC), a gas at ambient ' temperature and pressure; is a chlori nated hydrocarbon, which heretofore has been regarded as having moderate liver .toxicity. The initial standard, contained *jln Table G-l of 1910.93, established a ceiling value of 500 parts of VC per mil lion parts of air. (2) The emergency temporary stand ard. On January 22, 1974, the Occupa tional Safety and Health Administra.tion (OSHA) was Informed by the Na tional Institute for Occupational Safety ^kand Health (NIOSH) that the B. F. ^Bdoodrlch Chemical Company had. reported that deaths of several of its era- ployees from a rare liver cancer (angio and abroad, OSHA proposed to revise sarcoma) may have been occupationally 19J0.93q and published a comprehensive related. As a result of this notification proposal (39 FR 1G39G) on May 10, 1974, and after consultation with NIOSH. and to protect employees from hazards of a joint inspection of the B. F. Goodrich exposure to VC. The proposal called for plant by OSHA, NIOSH and the Ken limits non of employee exposure to VC to tucky Department of Labor, a fact-find "no detectable level," as measured by a ing hearing was announced on Janu sampling and analytical method sensitive ary 30, 1974 (30 FR 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 persons. A requirement for Cesare Maltoni of the Instituto di On- monitoring of employee exposures was cologia. Bologna, Italy, demonstrated proposed, along with engineering and that vinyl chloride induced angiosarcoma work practice controls to be implemented in rats at levels as low as 250 ppm, and when exposures over the detectable limit in other species at higher level:;. Experi were measured. ments performed at lower levels of ex posure were not completed at that time.' Other testimony from medical witnesses and NIOSH, and the results of autopsies, led to the conclusion that the Goodrich workers had angiosarcoma of the liver and that VC probably was the causal agent in the angiosarcomas observed. In post hearing comments, additional angiosarcoma deaths were reported among workers who had been exposed to VC in plants operated by Union Carbide Corporation, Firestone Plastics Corpora tion and Goodyear Tire & Rubber Com Respiratory protection would have been required while engineering and work practice controls were being implemented or where exposures exxeeded 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, pany. On the basis of all Information avail able at that time, and the fact that em ployees were being exposed at levels around the experimentally observed ef fect level of 250 ppm, an emergency temporary standard (ETS) was promul gated on April 5, 1974 (39 FR 12341) pursuant to section 6(c) of the Act, as 29 CFR 1910.930, This standard reduced the permissible exposure level from a ceiling of 500 ppm to a 50 ppm ceiling, and established other requirements, including, for example, monitoring and respiratory protection. It was expressly recognized that this standard limiting exposures to a 50 ppm ceiling was a tentative, interim standard, and that the whole question of exposure to VC would be considered more fully in the light of additional Information, especially the results of experiments, which were known to be underway at1' that time. - v (4) Hearing on the proposal. The pro posal, as published on May 10, 1974, allowed 30 days for interested parties to submit written comments and to request an informal rulemaking hearing. In formal contacts with OSHA staff and early responses Indicated that the sub ject was of great interest and importance to many persons. Because of the limits time available before expiration of the six month period provided in section 6(c)(3) of the Act for promulgation of a final standard, it was decided to hold a hearing as soon as possible. Accord ingly, on May 24,1974, a notice of a hear ing was published (39 FR 18303)setting a hearing date of June 25. 1974. The hearing was conducted from June 25 through 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 witnesses. Persons participating .in On April 15,1974, information and data the hearing were given until August 23, were presented to representatives of 1974, to file additional posthearing com OSHA, NIOSH, and the Environmental ments, including various items of infor Protection Agency by the Industrial Bio- mation which were requested during the Test Laboratories, Northbrook, Illinois, examination of witnesses. concerning results of animal exposure (5) Economic and technical impact studies with VC. These studies were study. During the hearing, OSHA deter sponsored by the Manufacturing Chem mined that additional facts would be ists Association. Although only pre needed to determine the practicality *of- liminary in nature at that time, these certain aspects of the proposed stand results revealed that 2 out of 200 mice ard. Accordingly, OSHA contacted an in exposed to VC concentrations of 50 ppm dependent consultant, Foster D. Snell- for 7 hours a day, five days a week, for Corporation, to conduct studies of the approximately 7 months, had developed feasibility of compliance at various ex angiosarcoma of the liver. posure levels, including those proposed (3) The proposed permanent stand by OSHA and others advanced by in ard. Based on the demonstrated evidence dustry spokesmen. Snell was also com of VC's carcinogenicity in three animal missioned to collect information regard species (rats, mice and hamsters), and ing the economic costs of compliance. the substantial probability that VC had This action was announced at the close been the causal agent In the cases of liver of the hearing, and Judge Myatt further angiosarcoma found in workers both here announced that the record would be kept -- r.i* f ' 1 ' FEDERAL REGISTER, VOL 39, NO. (94--FRIBAY, OCTOBER 4, 1974' "" w''"' * GENC 00717? f* f-1 ` ^r:' li- * '$J'L$' r' - J VA, *) M.v ULM I l| Wl M m* open for a period of time beyond August 23, to allow Interested persons to com ment In writing on the study. On August .28, 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, 1974 (39 FR 33009). CO) 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, 1974 (39 FR 14522). The notice invited any person having Information or data on the environmental impact to submit It to 03HA by-May 17, 1974. On June 12. 1974, a draft environmental Impact statement was prepared and circulated to all Interested persons. Ten copies were forwarded to the Council of Environ mental Quality (CEQ), which published a notice of Its filing and availability In the Federal Register on June 25, 1974 (39 FR 22975). A 45 day period was al lowed tor the submission of comments on the draft statement. On September 5. 1974, the final environmental impact statement was prepared and a copy of It and all substantive comments were sent ' to appropriate governmental agencies, private organizations, and other inter ested persons. CEQ published a notice of availability for the final statement on September 6. 1974 (39 FR 32350). The. submission of comment was Invited un til September 25, 1974. The final state ment and all significant comments have been carefully considered in arriving at the final standard on occupational expo sure to VC. (7) The record. The record In this proceeding is one of the most exhaustive ever relied upon by OSHA. It consists of pro and post-hearing comments and testimony received at both factfinding and rulemaking hearings, the studies and Inspections conducted by OSHA person nel, the environmental Impact state ments. the economic and technical impact studies, and all other relevant Information. In all, over 600 written com ments have been received, with more than 200 separate oral and written sub missions made with regard to the two hearings. The record Itself exceeds 4,000 pages. Employers, employees, labor unions, public health groups, independ ent experts, physicians, research scien tists, and specialists in many fields have been invited to submit information and have made their views, knowledge and experience available to OSHA. The en tire record encompassing these submis sions was thoroughly reviewed and evaluated in reaching the determina tions set forth below. II. Findings regarding carcinogenicity, exposure levels and feasibility--(1) Carr cinogenicity of vinyl chloride. The car cinogenicity of vinyl chloride for three animal species (rat, mouse, hamster) ha? been documented on the record by the studies of Maitonl and 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 Uver in rats 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 incidence of tumors In mice In the Industrial Bio-Test Laboratories investi gations is particularly pertinent. Of 200 mice (100 males, 100 females) exposed to 50 ppm of vinyl chloride by inhalation far eleven months, 100 died. Sixty-four ani mals died without gross postmortem pathologic examination being performed. Of the 36 remaining animals for which a gross postmortem pathologic examina tion was performed, 13 (36 percent) were found with liver tumors (including angiosarcomas), 21 (58 percent) with lung , tumors, 9 (25 percent) with skin tumors, and one with a kidney tumor. Recording to the 1970 report by the Surgeon General's Ad-Hoc Committee on the Evaluation of Low Levels 0' En vironmental Chemical Carcinogens, the finding of cancer in two or more animal species may be extrapolated to incicate a carcinogenic hazard to humans. Here, such a finding was made In three sjiecies that were exposed to VC by inhalation-- a route comparable to employe! ex posure. In addition, there were at least 13 confirmed cases of angiosarcoma of the liver among employees exposed to VC. a particularly significant ntfmt er in view of the extreme rarity of this cancer in the U.S. adult male population (;estimony of Dr. Marcus Key, Director of NIOSH, at the rulemaking hearing). The findings of angiosarcoma of the liver in both experimental animals and exposed employees is compelling1^ evi dence that exposure of humans tp vinyl chloride induces this tumor. Industry spokesmen, at the hearing, conceded that VC is carcinogenic for humans (e.g. testimony of Dr. McBurney, Rulemaking hearing, 1041). Accordingly, it is con cluded that VC must be regarded as a human carcinogen, and the probable causal agent of angiosarcoma of the liver, and that exposure of employees to VC must be controlled. Additional evidence of tumor induction in a variety of other organs, including* lung, kidney, brain and skin, as well as non-malignant alterations, such as fi brosis and connective tissue deteriora tion, indicates additional oncogenic and toxicologic properties of vinyl chloride, which must be considered in establishing control regulations. (See testimony and results of studies by Bio-Test Labora tories. Tabershaw-Cooper, Maltoni, NIOSH. and Selikoff.) (2) Exposure limits. Upon finding that exposure of employees to vinyl chloride may create a carcinogenic hazard, the amount of exposure which Is hazardous must be determined. The Surgeon Gen eral's Ad Hoc Committee referred to above concluded that safe exposure levels for carcinogenic substances cannot be scientifically determined. This position is supported by the 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 should have already been discovered among employees. They also argue that the employees in whom tumors have been observed are those who have considerable employment experience as polymeriza tion reactor cleaners. Because it Is gen erally agreed that reactor cleaning in volved high exposures to vinyl chloride In years past, it is argued that the lower levels currently found in the workplace have not induced cancer and are there fore safe. We reject this argument. The fact that approximately threequarters of those employees with the longest exposure to VC (greater than 20 years since initial exposure) have not yet been located, makes it impossible to determine the actual number of affected employees. The cases of liver tumors ob served to date have an average latency period, since initial exposure, of approxi mately 20 years. If it is assumed that in duction of angiosarcoma is a dose-re lated phenomenon, and if employees en gaged In cleaning reactors did. 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 necesasrily 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. Schneiderman of the Na tional Cancer Institute emphasized dur ing liis testimony that only about a fifth of longer-term heavy smokers develop lung cancer. Accordingly, the industry contention that exposure levels have been dramatically reduced since the 1940's is not reliable evidence that cur rent levels of exposure are safe. Some industry spokesmen also sug gested that the apparent nonrandom distribution of observed cancer In em ployees may Indicate an exposure thres hold for tumor induction, based on varia tions in the workplace design or prac tice and resultant employee exposures FEDERAL REGISTER, VOL. 39, NO. 194--FRIDAY, OCTOBER 4, 1974 GENC 007180 35892 RULES AND REGULATIONS (testimony and questioning by Tenneco e.g., testimony of Selikoff, Firestone. NCI, confident that industry will continue to Chemicals, Inc.), It has also been em and NIOSH.) do so. phasized that in only 3 of 8 polymeriza In our view, the demonstration of can (4) Conclusions. The conclusions be tion plants where employees have been cer induction in humans at a particular low are based on a thorough 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 humans at that level. It .evidence, this has been done. Where, similar to that raised concerning vari would be imprudent to assume man to however, factual certainties are lacking ability of past employee exposure. Al be less sensitive to VC exposure than ex or where the facts alone do not provide though geographic and workpractice dif perimental animals in the absence of on answer, policy judgments have been ferences may ultimately be demonstrated conclusive evidence. It would also be un made. to be factors in distribution of angiosar founded to assume that animals will not There is little dispute that VC is car coma, sufficient information is unavail develop tumors when exposed at concen cinogenic to man and wc so conclude. able to exclude from consideration of trations of VC of less than 50 ppm. However, the precise level of exposure risk, those employees in workplaces for Should a sufficiently large number of ex which poses a hazard and the question which cases of angiosarcoma have not perimental animals be exposed to VC at of whether a ``safe'' exposure level exists, been observed. concentrations of less than 50 ppm, . cannot be definitively answered on the It has also been suggested that the 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 best 200 ppm is safe. (See study by Dr, Cook, posure levels of 1 ppm through engineer judgment on the basis cf the best avail submitted at the hearing by Dow Chem ing controls. These employers employ ical Company.) However, the group sur- . well over 95 percent of all employees ex veyed did not includp all workers who posed to VC. Indeed, several fabricators had been exposed, and the missing em- - are already operating at this level (see ployees included many who had the SPI testimony). However, industry longer term (over 20 years) exposures. spokesmen have universally claimed that Moreover, the statistically insignificant it is Infeasible for the VC and the PVC size of the sample population decreases industries to remain below 1 ppm con the possibility that tumors would be sistently, using engineering controls. In observed. . addition, the Snell study on technical able evidence. These judgments have re quired a balancing process, in which the overriding consideration has been the protection of employees, even those who may have regular exposures to VC throughout their working lives. Based on the available evidence and in. view of the above considerations, includ ing feasibility, we believe that employee exposures to VC must be reduced to a 1 Dow also presented preliminary data feasibility concluded tht 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 da so In the Im olite, and that the metabolite is pro industry. Labor union spokesmen and the mediate future. duced only when VC is metabolized by a Health Research Group, Inc., however, In addition to the TWA requirement, secondary metabolic pathway operating have suggested that such a level is at we have established a 5 ppm ceiling only when enzymes regulating the pri tainable. (averaged over a 15-minute period) in mary pathway are saturated, as would Since there is no actual evidence that order to prevent exposure of employees be the result at higher exposures. The any of the VC or PVC manufacturers to unacceptable high excursions. From preliminary data indicated the possi have already attained a 1 ppm level or in an operation standpoint, this ceiling bility of an additional pathway for fact:instituted all available engineering level is realistic because minor excur metabolism of VC In rats exposed to con and work practice controls, any estimate sions up to the ceiling level are likely -to centrations, of VC in excess of 220 ppm. as to the lowest feasible level attainable occur on a regular basis. However, the occurrence -of " 'angio must necessarily involve subjective Judg HI. The final standard--(1) Scope and sarcoma in both rats and mice at VC ment. Likewise, the projections of Indus- . application. Both the ETS and the pro .exposure concentrations of 50 ppm in try, labor, and others concerning feasi posal would apply the standard to the dicates that if a metabolite of VC is the bility are essentially conjectural. Indeed, entire VC industry, including manufac ultimate carcinogen, then it must be generated at lower exposure concentra tions in these species. Although this re search may be helpful to the thorough as Firestone has suggested, it is not pos sible to accurately predict the degree of improvement to be obtained from en gineering changes until such changes are turers of VC and PVC and fabricators, but excluding employers handling or using fabricated products made from 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 eg., testimony of Firestone, Ten neco Chemicals.) The conclusicnof 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- llshments 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 0731. There is no dispute that a standard is required for the monomer and polymer industries. However, the Society of Plas tics Industry (SPI) and various fabrica tors (see testimony of Goodyear, Gen eral Cable, etc.) recommended that fabricators be excluded from the stand ard, or that a separate requirement be established for them because many of them were already at or below the pro posed ceiling level. The record evidence establishes that at least some employees in the fabricat ing industry are exposed in excess of the permissible control limits (See NIOSH testimony, TR 108; RobJnteoh 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 ent state of scientific knowledge. (See For example, E. F. Goodrich testified (TR 1X20) that it has reduced average exposure levels in several PVC plants from 35-40 ppm early this year to 12-13 ppm at the time of the hearing. We are In these circumstances, we believe that it is imprudent to grant ft blanket exemp tion for all fabricators. Therefore, the final standard is applicable to the fabri cation industry, ES we" mntinmer GB-1C 007181 REGISTO, VOL. 39, NO. 194--FRIDAY, OCTOBER 4, UW 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 final standard. This conclusion Is based on the absence of adequate evi dence of exposure to VC In these opera tions. The final standard clarifies the ex emption by defining a fabricated prod uct as a product made wholly or partly from PVC which does not require further processing at temperatures, and for times, sufficient to cause mass melting of the PVC. SPI and others (cf. TR. 344) requested that PVC resins with less than 0.1 percent residual monomer be ex empted from the regulation now, and that the exemption level be reduced to 0.01 percent In three years. SPI suggested .that the exemption of materials with less than 0.1 percent of 14 carcinogens from 29 CFR 1910.93p (39 PR 3756) was an appropriate precedent. The cases are not - comparable, because no attempt had been made to set air concentration limits for the 14 carcinogens. The record did not include information that reliable moni toring and measuring techniques were available. Moreover, the* exemption did not exempt airborne traces of carcino gens. The administrative cutoff was pro vided to avoid regulation of materials about which there was no health haz ard Information, and which would have broadly extended the application of the regulation beyond the record. Herein, no Information was presented to show safe concentration results from the use of resins with specific levels. Indeed, the proposal to change the level later, when improved technology would permit such reduction, would seem to Indicate that SPI has doubts about the safety of 0.1 percent residue level. Diamond Shamrock (Exhibit 142) testified that there is no direct relation. They indicate that the airborne concentration is more related to the physical form of the resin and the ventilation provided. Also, monitor ing data from industry (cf. Exhibits 131, 163, 170) and OSHA (Exhibit 151) Indi cate that levels in excess of 1 ppm may be found in fabrication operations. In view of these facts and of the opportunity for employers to discontinue many duties upon a showing of no exposures above the action level. It does not appear that any residue exemption is either Justified or necessary at this time. This course also agrees with a number of industry pro posals (cf. TR 660). SPI (TR 345). among others, asked that compounded PVC pellets be ex empted from the standard on the grounds that the pellets had too low a residue to cause harmful or measurable emissions. While it appears that PVC pellets would have a lower residue level than virgin PVC, the fact that the pellets must be heated to a molten mass at the same 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 standard sets an exposure limit of 1 ppm averaged over any 8 hour period, and a ceiling of 5 ppm averaged over any per iod not exceeding 15 minutes. As more fully discussed above, this limit is based on an evaluation of the best available evidence and on a judgment that the health and safety of employees must be protected to the fullest extent feasible. In view of the fact that release of VC in the VC and PVC manufacturing processes are variable, the 1 ppm ceiling level provided in the proposal would require maintenance of an average level significantly more difficult to attain through feasible engineering controls. Therefore, the exposure limit prescribed in the proposal has been rejected. (3) Action level. The final standard, unlike the ETS and the proposal, pro vides for an "action level" of 0.5 ppm TWA, one-half of the permissible ex posure .limit. The purpose of the action level is to minimize the Impact of the standard on the employers who have attained exposure levels well below the permissible limit. Thus, where the re sults of monitoring under paragraphs (d) (1) or (d) (2) demonstrate that no employee is exposed in excess of 0.5 ppm TWA, employers may, in effect, be exempted from some provisions of the standard. For example, fabricators who are below the action level are* not re quired io provide medical surveillance or to monitor again, unless the employer has reason to suspect that any employee Is exposed in excess of the action level. In our judgment, exposures below the action level do not present a sufficient hazard to warrant application of the en tire standard to the many employers who are or will be below that level. (4) Monitoring. The final standard, like the proposal, requires that individual employee exposure levels be determined. This may be accomplished by personal or area monitoring. Some witnesses and persons who submitted comments did not understand the meaning of the term "95 percent confidence level" in the proposal. Essentially it means that the employer is required to take a sufficient number of measurements so that the re sults obtained are statistically valid. We have modified the proposal to establish accuracy range requirements for various measurement levels. These ranges are narrow enough to ensure that a deter mination of compliance can be made, and broad enough to allow the application of a variety of technologies All covered employers are required to conduct initial monitoring. Where moni toring and measuring results are at or below the action level, no further 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 inproduction. 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 must occur at least quarterly. (5) Methods of compliance. The stand ard. like the proposal, requires that em ployers immediately institute feasible engineering and work practice controls to reduce exposures to at or below the permissible exposure limit. Where feasible engineering and work practice controls will reduce exposures below the permissible levels, they must be instituted. Where such controls will not reduce exposures below the permis sible level, they must nonetheless be im plemented to reduce exposures to the lowest practicable level, and be supple mented by the use of respirators to pro vide the necessary protection. There upon, a continuing program of engineer ing and work practice controls must be instituted to reduce exposures to the low est practicable level. When exposures are at or below the permissible exposure limits, the program may be discontinued. In addition, a plan for achieving con trol by engineering and work practice methods must be drawn up and be made available, upon request, to represent atives of OSHA and NIOSH. We recognize that many employers covered by the standard can not cur rently achieve compliance with the per missible exposure limit solely by the use of feasible engineering and work practice controls. The record also reflects broad generic distinctions between the compli ance capabilities of the VC and FVC industries. Some industry spokesmen, including SPI (TR. 358-362), recom mended that a schedule of different permissile exposure limits and compliance dates be established for the VC and PVC segments of the industry. This view assumes that the ability and the time required to feasibly reach in creasingly lower control levels is similar within each industry, but differs mark edly between industries. While the record does suggest that such differences do exist between industries, as noted above, it is clear that intra-industry differences also exist. Thus, the ability and time re quired by each employer to attain lower control levels may depend upon such factors as the climate in which the plant is located, the age of equipment, the size of reactors, or the type of resin manu factured or used, (Snell study. Firestone testimony, etc.) Monitoring data also tends to support such . intra-industry variations. (See, e.g. Dow, Firestone, Tenneco.) As noted above, the standard requires ail employers to institute feasible engi neering controls to the fullest extent and to continue to improve and apply engi FEDERAl REGISTER, VOL. 39, NO. 19-1--FRIDAY, OCTOBER 4, 1974 GENC 007132 35894 RULES AND REGULATIONS / neering controls until full compliance Is achieved. We have not established any deadlines for full compliance through engineering controls because we are presently unable to determine when it will be feasible for most establishments to reduce exposure levels to the permissible level. We also believe that the requirement that each employer reduce airborne con centrations to the permissible level, or to the lowest level feasible as soon as practicable will provide for inter-indus try and intra-industry technological dif ferences which do exist, and will avoid the setting of separate industry stand ards on the basis of the general situation and conditions in each industry. (6) Regulated areas. The proposed standard would have required that regu lated areas be established, that access be limited to authorized employees, and that daily rosters or summaries of those entering be kept for at least 20 years. In objection to these requirements, it was asserted that such control of access was not necessary from a health standpoint. Secondly, It was claimed that these con trols would interfere with operations by preventing access of needed employees or non-employees, such as contractors, truck drivers, customers and consultants, ' The purpose of establishing regulated areas in the proposal was to limit the risk of exposure to as few employees as possible. This concern is still paramount, and-thus the limited access feature re mains. The final standard amends the proposal slightly to allow "authorized persons" to enter regulated areas. This change, it is felt, will allow operations to continue without undue interference. The final standard has also increased the length of time daily rosters must be maintained from 20 to 30 years. This change was based largely on epidemio logical considerations. (See NIOSH testi mony, tr. 119.) (7) Respiratory protection. The final standard, like the proposal, requires the use of respirators where employee expo sures exceed the permissible control level. Industry representatives made a number of objections to proposed requirements for respiratory protection. They stated that, the "no detectable level" would ef fectively require continuous wearing of respirators in FVC and VC plants, and that this'Is not feasible because respira tors'are cumbersome, present a safety hazard, and employees would not use ithent:'' ' ,, , . 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 occassionally. However, we cannot agree that respiratory protection should not be required simply because it is in convenient,-may require additional per sonnel, interferes with production, or may require extensive retraining of em ployees and restructuring of work prac tices. We have carefully considered all the objections, and have concluded that if the environmental level is not con trolled to the permissible exposure limit, then employees must be afforded respira tory protection. While exposures in excess of the per missible level do constitute a hazard, we believe that it is necessary to mitigate some of the problems associated with implementing a program of respiratory protection while employees are being fitted and trained in respirator use, and while other adjustments which may be required are implemented. Therefore, until January 1. 1976, where exposures are not In excess of a 25 ppm ceiling, each employer must provide each em ployee with an appropriate respirator. However, employees whose exposures do not exceed a 25 ppm ceiling, may decline to use the respirator, in which case the employer is not obligated to require its use. During this adjustment period, em ployees will be trained In the uses, pur poses and limitations of respirators, and the hazards of exposure to vinyl chloride. Moreover, each employee will be notified in writing if he has been exposed in ex cess of the permissible exposure limit. Where exposures exceed a 25 ppm ceil ing, respiratory protection is mandatory in light of our judgment that much greater risks are associated with such exposures. The provisions in the final standard regarding the selection and use of respi ratory protective devices differ from those in the proposal. The descriptions of atmosphere-supplying respirators have been revised to indicate more clearly the types of devices intended, and the maxi mum permissible concentration level for each device. Moreover, the number of types of atmosphere-supplying devices has been increased. At the hearing Mr. Edwin C. Hyatt, an OSHA consultant, made suggestions re garding the use of particular respiratory devices. We have concluded that his sug gestions are meritorious. Therefore, the provisions for selection of atmospheresupplying devices follow closely the rec ommendations contained in his testi mony of SPI and B. P, Goodrich) (^TR with Hyatt's suggestions. (See e.g. testi mony of SPI and B. F. Goodrich) ^TR 85 ff) We had originally omitted airpurifying respirators because none had been approved by NIOSH for use against VC, principally because they lacked in dicators to signal the expiration1 of the service life of the sorbent. Hyatt and other witnesses, discussed in detail the desirability of being able to use canisters or cartridge air-purifying respirators, provided a sorbent could be shown to effectively absorb vinyl chloride with an adequate servlet life. Recently, OSHA has received respiratory data from labo ratories regarding the effectiveness of commercially available canisters and cartridges for vinyl chloride. These eval uations were ' conducted separately by NIOSH and by the B. F. Goodrich Com pany and submitted to OSHA In post- hearing comments. The results indicate that certain presently available canis ters and cartridges effectively absorb vinyl chloride at relatively low concen trations. In discussions of these findings with NIOSH, it has indicated that it is willing to consider on an expedited basis the approval of air-purifying respirators for mo against VC. Consequently, we have Included three types of air-purify ing respirators in the list of acceptable units, subject to the approval of such units by NIOSH, The maximum concen tration for which each respirator may be used is based upon our evaluation of the data submitted by NIOSH and Goodrich. Because air-purifying respi rators do not indicate sorbent exhaustion or breakthrough of VC, and because VC has no inherent warning properties at levels for which these devices are used, strict administrative controls will be re quired for their use. Such controls in clude a program to assure timely re placement of canisters or cartridges and an alarm system to alert employees when vinyl chloride concentrations exceed the concentrations allowed for the particu lar type of respirator in use. (8) Hazardous operations. This is a new section within the final standard. It encompasses essentially the proposal's requirements for maintenance and de contamination but has restated them in terms of performance language to allow greater flexibility for employers to deal with such operations. The intent of the new section is to protect employees en gaged in activities that present a risk of exposure to vinyl chloride in excess of the permissible levels. An example would be the cleaning of a filter where resin con taining high residual. monomer is trapped. The proposal's requirement for full- body, impervious clothing has been re placed by the direction to use impervious garments suited to the particular situa tion and probable extent of exposure. Thus, full-body clothing is not always necessary, and is therefore not required where less protection is adequate. Since vessel entry falls within the definition of a hazardous operation, the vessel entry section of the proposal h3s been deleted from the final standard. (9) Emergency situations,'The defini tion of emergency has been recast in terms of an unexpected massive.release. The main objection to the section on emergency situations in the proposal was that, as the term was.defined, many ordinary leaks or operations resulting in a small release of vinyl chloride would be considered emergencies. This was not the intent of the proposal. The final standard has been clarified to correct this ambiguity. It should be noted that the written operational plan required by the standard need not be developed for minor excursions above the permissible exposure limit, end that such excursions need not be reported. GO) Signs and labels. The thrust of the signs and labels section is to apprise' employees of the cancer and fire haz ards. No objections have been raised with respect to informing employees of the fire hazard. However, a number of ob jections were raised at the hearing and In written submissions to the require ment that the word "cancer" appear on all signs and labels, " --1 reu- 6ENC 00 71 S3 federal REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1774 RULES AN% REGULATIONS 35893 ment advanced against Its use was that the term "cancer" or "cancer-suspect agent" 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 we consider it Imperative that a worker be fully Informed, and that he realize the possible risks Involved In his occupation. Coupled with the training requirement In the standard, we believe that the signs and labels required will adequately in form employees of the hazard. In addi tion, such signs will warn unauthorized personnel to keep out of regulated areas. Hie proper application of most protec tive measures requires an amount of training and Indoctrination of employees that cannot easily be conveyed on a sign nr. label. Also, the variety of measures that could be prescribed would result in an unwieldly or excessively detailed leg end. Consequently, the required message on signs and labels will not include in formation on precautions, relevant symptoms, etc. The addition of suitahle Information by the employer would be permitted, providing it does not detract In any way from the required statement. The requirement in the proposal for labeling containers of vinyl chloride has been amended by deleting the reference to the possible hazard of violent polym erization. Very little information was developed on this hazard during the standard-setting procedure. It does ap pear that this hazard is essentially under control and that the fire and carcino genic hazards at present are the most significant. Since labeling or placarding that is in compliance with the TJ.S. De partment of Transportation regulations (49 CFR Part 173. Subpart H) already warns of the fire hazard, only a state ment concerning the carcinogenic haz ard need be added to the Department of Transportation labels. (ID Medical surveillance. The princi pal questions that have been raised re garding medical surveillance axe the necessity and efficacy of requiring cer tain specific serum enzyme determina tions (SMA-12 series) and the applica tion of medical examination require ments to the fabrication segments.of the industry where employees are exposed to lower levels of VC. The objection has also been raised that the specification of tests and procedures interferes with the ap plication of advances in medical knowl edge. A particular difficulty in considering medical surveillance is that the most commonly discussed lesion, angiosar coma of the liver, currently cannot be diagnosed until the victim is terminal and, usually, within months of death. Precursor physiologic alterations, which .might be reversible, have not yet been directly associated with the lesion. Con sequently, there are no specific diagnos tic tests which can be prescribed which will determine presence or absence of this tumor at an early stage of develop ment. However, most medical witnesses indicated that the medical tests proposed are currently the only ones available which are useful for medical surveillance (TR 121, Exh. 95. TR 589-591). 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 Involving VC exposure. In addition, al ternative medical examinations may be used where the examining physician de termines that they are at least as good as those specified by the standard. The Tabershaw-Cooper study and the various animal experiments suggest that VC may produce a wide spectrum of ma lignant and non-malignant disorders. The general scope of the required piedical examination has, therefore, been broad ened to include kidneys, skin, connective tissue, spleen, and pulmonary system, as well as the liver. No additional specific procedures or tests are required, but rec ommendations have been included In the Appendix to assist the examining physi cian. Because of the nonspecific nature of the required medical tests, it is not appropriate to prescribe timing, or type of followup tests, or to mandate with drawal from exposure based solely on re sults of the tests. Instead, the employer is required to obtain a statement from the examining physician of the em ployee's suitability for continued expo sure, when the examining physician has completed such tests as he considers ap propriate. The employer is required to withdraw an employee only when this statement indicates that the employee .may be at added risk from continued VC exposure. As with monitoring, there appears to be no basis for complete exemption of the fabrication industry from the require ment for medical examination. The rec ord does show fabricating establishments with concentration^ of VC monitored considerably above the action level. In these instances, medical surveillance of affected employees will provide baseline data for future evaluation of their health, even if both monitoring and medical sur veillance are discontinued because im proved controls reduce concentrations below the action level. Where exposures are below the action level, the medical surveillance requirements do not general ly apply, (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 graph provides for training of employees concerning the carcinogenic hazard of VC, emergency procedures, the need for monitoring and an annual review of the standard. It also provides for training of employees concerning the purpose for, proper use of, and limitations connected with respiratory protection, (13) Records and reports. The provision^ f<jr recordkeeping contained in the final standard require the preparation and maintenance of essentially the same information required by the proposal. The major change from the original pro- 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 ah employee's employment plus 20 years, or 30 years, whichever is longer. The original pro posal called for only 20 years. This change has been Implemented be cause the latency period for induction of angiosarcoma ranges up to 30 years from initial exposure. Therefore, as a mini mum, medical records must be main tained for at least that long, it should be noted that spokesmen for both labor and industry recommended that this change be made. The reporting requirements are not significantly different from those in the original proposal. However, instead of the requirement for reporting incidents which result in the release of VC into areas where employees may be exposed, the final standard clarifies our original intent by stating that only emergencies must be reported. Also the requirement for filing a detailed, written report within 15 days ha3 been deleted. It has been concluded that submission, within 24 hours, of an initial report that in cludes facts immediately available, would ordinarily be sufficient. However, if the OSHA Area Director requests further in formation relevant to the emergency, the employer will be required to furnish such information.* (14) Deleted portions of the proposal. The proposal contained provisions re quiring that shower facilities and change rooms be provided, and that storage or consumption of food be prohibited in regulated areas. We have deleted these provisions because it is our conclusion they are no longer necessary. Showering 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 evidence that VC vapor is absorbed through the skin. In addition, since we anticipate that most employees will not he wearing protective clothing and that employees who wear protective clothing will change such clothing Infrequently, we are not requiring that change rooms be provided. In addition, we feel that there Is In adequate evidence showing that hazar dous amounts of VC can be absorbed through ingestion. For this reason, the requirement prohibiting the storage or consumption of food in regulated areas has been deleted. The proposal also contained provisions on maintentance and decontamination, transportation loading and unloading, and polymer handling operations. These requirements are not mentioned in the final standard because attention to these items is implicit in the requirement that each employer reach the pertnissable ex posure limit or attain the lowest feasible level. (15) Effective date. In order to ensure that affected employers, and employees will be Informed of the existence of these FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 GENC 007184 35896 RULES AND REGULATIONS provisions and that employers affected of the operation or bceause of an acci are given an opportunity to familiarize dent in the operation, which would result themselves and their employees with the in an employee exposure in excess of the existence of the new requirements, the effective date of the amendment to 5 1910.93q will be January 1,1975. To pro vide continued protection for employees until that date, the provisions currently contained in 51910.93q 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, 1974, the amendment to 1910.93q set out below will supersede these provisions as of January 1, 1975. Accordingly, upon consideration of the' whole record of this proceding. Part 1910 of Title 29, Code of Federal Regulations is amended, effective January 1, 1975, by revision of 1910.93q to read as follows: 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. (9) ``Polyvinyl chloride" means poly vinyl chloride homopolymer or copoly mer before such is converted to a fabri cated product. (10) "Vinyl chloride" means vinyl chloride monomer. (c) Permissible exposure limit. (1) No 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 1910.93q Vinyl chloride, vinyl chloride at concentrations greater than 5 ppm averaged over any period not () Scope and application. (1) This exceeding 15 minutes. section includes requirements lor the (3) No employee may be exposed to control of employee exposure to vinyl vinyl chloride by direct contact with chloride (chloroethene), Chemical Ab liquid vinyl chloride. stracts Service Registry No.. 75015, (d) Monitoring. (1) A program of (2) This section applies to the manu- Initial monitoring and measurement facture, reaction, packaging, repackag shall be undertaken in each establish ing, storage, handling or use of vinyl ment to determine if there is any em chloride or polyvinyl chloride, but does ployee exposed, without regard to the use not apply to the handling or use of fabri of respirators, in excess of the action cated 1 products made of polyvinyl chlo level. ride. (2) Where a determination conducted (3) This section applies to the trans under paragraph (d) (1) of this section portation of vinyl chloride or polyvinyl shows any employee exposures, without chloride except to the extent that the regard to the use of respirators, in ex Department of Transportation may cess of the action level, a program for de regulate the hazards covered by this sec termining exposures for each such em tion. ployee shall be established. Such a pro <b) Definitions. (1) "Action level" gram: means a concentration of vinyl chloride (i) Shall be repeated at least monthly of 0.5 ppm averaged over an 8-hour work where any employee is exposed, without day. regard to the use of respirators, in ex (2) "Assistant Secretary" means the cess of the permissible exposure limit. Assistant Secretary of Labor for Occupa (11) Shall be repeated not less than tional Safety and Health. U.S. Depart quarterly where any employee is exposed, ment of Labor, or his designee. without regard to the use of respirators, (3) "Authorized person'', means any in excess of the action level. person specifically authorized by the em <iil) May be discontinued for any em ployer whose duties require him to enter ployee only when at least two consecu a regulated, area or any person entering tive monitoring determinations, made not such an area as a designated representa less than 5 working days apart, show Ex tive of employees for the purpose of ex posures for that employee at or below ercising an opportunity to observe moni the action level. toring and measuring procedures. (3) Whenever there has been a pro (4) "Director" means the Director, duction, process or control change which National Institute for Occupational may result in an increase in the release Safety and Health, U.S. Department of of vinyl chloride, or the employer has Health, Education, and Welfare, or his any other reason to suspect that any em designee. ployee may be exposed in excess of the (5) "Emergency" means any occur action level, a determination of employee rence such as, but not limited to, equip exposure under paragraph (d) (1) of this ment failure, or operation of a relief de section shall be performed. vice which Is likely to, or does, result in (4) The method of monitoring and massive release of vinyl chloride. measurement shall have an accuracy () "Fabricated product" means . a (with a confidence level of 95 percent) of product made wholly or partly from not less than plus or minus 50 percent polyvinyl chloride, and which does not from 0.25 through 0.5 ppm, plus or minus require further processing at tempera 35 percent from over 0.5 ppm through tures, and for times, sufficient to cause vl.o ppjn, and plus or minus 25 percent mass melting of the polyvinyl chloride over 1.0 ppm. (Methods meeting these resulting in the release of vinyl chloride. accuracy requirements are available in (7) "Hazardous operation" means any the "NIOSH Manual of Analytical operation, procedure, or activity where a Methods"). release of either vinyl chloride liquid or (5) Employees or their designated rep gas might be expected as a consequence resentatives shall be afforded reasonable opportunity to observe the monitor ing and measuring required by this paragraph. (e) Regulated area. (1) A regulated area shall be established where: (1) Vinyl chloride or polyvinyl chloride is manufactured, reacted, repackaged, stored, handled or used; and (ii) Vinyl chloride concentrations are in excess of the permissible exposure limit. (2) Access to regulated areas shall be limited to authorized persons, A dally roster shall be made of authorized per sons who enter. (f) Methods of compliance. Employee exposures to vinyl chloride shall t-e con 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 follows: (1) Feasible engineering and work practice controls shall immediately be used to reduce exposures to at or below the permissible exposure limit. (2) Wherever feasible engineering and work practice controls which can be in stituted immediately are not sufficient to reduce exposures to at of below the per missible exposure limit, they shall none theless be used to reduce exposures to the lowest practicable level, and shall be supplemented by respiratory protection in accordance with paragraph (g) of this section. A program shall be established and implemented to reduce exposures to at or below the permissible exposure limit, or to the greatest extent feasible, solely by means of engineering and work practice controls, as soon as feasible. (3) Written plans for such a program shall be developed and furnished upon request for examination and copying to authorized representatives of the Assis tant Secretary and the Director. Such plans shall be updated at least every six months. (g) Respiratory protection. Where respiratory protection is required under this section: (1) The employer shall provide a respirator which meets the requirements of this paragraph and shall assure that the employee uses such respirator, except 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 15minute period. Until December 31, 1975, each employee who chooses not to wear an appropriate respirator shall be in formed at least quarterly of the hazards of vinyl chloride and the purpose, proper use, and limitations of respl/atory devices- (2) Respirators shall be selected from among those Jointly approved by the Mining Enforcement apd Safety Admin istration, Department of the Interior, and the National Institute for Occupa tional Safety and Health under the pro visions of 30 CFR Part 11. (3) A respiratory protection program meeting the requirements of 5 1910.134 shall be established and maintained. (4) Selection of respirators for vinyl chloride shall be as follows: FEDERAL REGISTER, VOL 39, NO. T94--FRIDAY, OCTOBER 4, 1974 GENC 00718! RULES AND REGULATIONS 35897 Atmospheric concentration of , vinyl chloride Sequired apparatus (1) Unknown, or above 3,600 ppm__ Open-circuit, self-contained breathing apparatus, pres sure demand type, with full facepiece. - (tt) Not over 3,600 ppm_______________ (A) Combination type C supplied air respirator, pres sure demand type, with full or half facepiece, and auxiliary self-contained air supply; or (B) Type C, supplied air respirator continuous flow -. type, with full or half facepiece, and auxiliary self-contained air supply. (1U) Not over 100 ppm_____-______(A) Combination type C supplied air respirator de mand type, with full facepiece, and auxiliary self-contained air supply; or (B) Open-circuit self-contained breathing apparatus with full facepiece, in demand mode; or (0) Type C supplied air respirator, demand type, with full facepiece. (It) Not over 25 ppm_________________ (A) A powered all--purifying respirator. with hood, helmet, full or half facepiece, and a canister which provides a service life of at least 4 hours for concenratlons of vinyl chloride up ., ' to 26 ppm. or - (B) Gas mask, front- or back-mounted, canister which ` , provides a service life of at least 4 hours' for concentrations of vinyl chloride up to 25 ppm. , (y) Not over 10 ppm (A) Combination type C supplied-alr respirator, de mand type, with half facepiece, and auxiliary self-contained air supply; or ____ (B) Type C supplled-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-iQ ppm. (5) (1) Entry Into unkown concentra tions or concentrations greater than 38,000 ppm (lower explosive limit) may be made only for purposes of life rescue; and (11) Entry Into concentrations of less than 36,000 ppm, but greater than 3,600 ' ppm may be made only for purposes of life rescue, firefighting, or securing equipment so as to prevent a greater hazard from release of vinyl chloride. . (6) Where air-purifying respirators are used; (1) Air-purifying cannisters or car tridges shall be replaced prior to the expiration of their service life or the end of the shift In which they are first used, whichever occurs first, and (ii) A continuous monitoring and alarm system shall be provided where concentrations of vinyl chloride could reasonably exceed the allowable concen trations for the devices in use. Such sys tem shall be used to alert employees when vinyl chloride concentrations exceed the allowable concentrations for the devices in use. (7) Apparatus prescribed for higher concentrations may be used for any lower concentration. (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; (1) Respiratory protection in accord ance with paragraphs (c) and (g) of this section; and (ii) ` Protective garments to prevent skin contact with liquid vinyl chloride or with polyvinyl chloride residue from vessel walls. The protective garments shall be selected for the operation and Its possible exposure conditions. (2) Protective garments shall be pro vided clean and dry for each use. (i) Emergency situations. A written operational plan for emergency situa tions shall be developed for each facility storing, handling, or otherwise using vinyl chloride as a liquid or compressed gas. Appropriate portions of the plan shall be Implemented in the event of an emergency. The plan shall specifically provide that: (1) Employees engaged in hazardous operations or correcting situations of ex isting hazardous releases shall be equipped as required in paragraph (h) of 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: (1) The nature of the health hazard from chronic exposure, to vinyl chloride including specifically the carcinogenic hazard; (ii) The specific nature of operations which could result in exposure to vinyl chloride in excess of the permissible limit and necessary protective steps; (ll> The purpose for, proper use, and limitations of respiratory protective devices; (iv) The fire hazard and acute toxic ity of vinyl chloride, and the necessary protective steps; (v) The purpose for and a description of the monitoring program; (vl) The purpose for, and a descrip tion of, the medical surveillance program; (vil) Emergency procedures; (vili) Specific information to aid the employee in recognition of conditions which may result in the release of vinyl chloride; and (lx) A review of this standard at the employee's first training and Indoctrina tion program, and annually thereafter. (2) Ail 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 Jtg each employee exposed, with out regard to the use of respirators, to vinyl chloride in excess of the action level. The program shall provide each such employee with an opportunity for examinations and tests in accordance with this paragraph- All medical ex aminations and procedures shall be per formed by or under the supervision of a licensed physician, and shall be provided without cost to the employee. (l) At the time of initial assignment, or uponinstitution of medical surveil lance; (1) A general physical examination shall be performed, with specific atten tion to detecting enlargement of liver, spleen or kidneys, or dysfunction in these organs, and for abnormalties in skin, connective tissues and the pulmonary system (S<fe Appendix A). (il> A medical history shall be taken, including the following topics: (A) Alcohol Intake; (B) Past history of hepatitis: (C> Work history and past exposure to potential hepatotoxic agents, includ ing drugs and chemicals; (D) Past history of blood transfu sions; and (E > Past history of hospitalizations. (ill) A serum specimen shall be ob tained and determinations made of; (A) Total bilirubin; (B) Alkaline phosphatase; (C) Serum glutamic oxalacetic trans aminase (SGOT); (D) Serum glutamic pyruvic transam inase (SGPT) ; and (E) Gamma glustamyl transpeptidase. (2) Examinations provided in accord ance with this paragraph shall be per formed at least: (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 (11) Annually for all other employees, (3) Each employee exposed to an emergency shall be afforded appropriate medical surveillance. (4) A statement of each employee's suitability for continued exposure to vinyl chloride Including use of protec tive equipthent and respirators, shall be obtained from the examining physician promptly after any examination. A copy of the physician's statement shall be pro vided each'employee. (5) If any employee's health would be materially impaired by continued ex posure, such employee shall be with- FEDERAL REGISTER, VOL 39, NO. 194--FRIDAY, OCTOBER 4, 1974 6ENC O0?iSi 35898 RULES AND REGULATIONS drawn from possible contact with vinyl chloride. (6) Laboratory analyses for all bio logical specimens included in medical examinations shall be performed In labo ratories licensed under 42 CFR Part 74. (7) If the examining physician deter mines that alternative medical examina tions to those required by paragraph (fe).(l) of this section will provide at least equal assurance of detecting med ical conditions pertinent to the exposure to vinyl chloride, the employer may ac cept such alternative examinations as meeting the requirements of paragraph (k)(l) of this section, if the employer obtains a statement from the examining physician setting forth the alternative examinations and the rationale for sub stitution. This statement shall be-available upon request for examination and copying to authorized representatives of the Assistant Secretary and the Director. (1) Signs and labels. (1) Entrances to regulated areas shall be posted with leg ible signs bearing the legend: Cancer-Suspect Agent Area Authorized Personnel Onlt (2) Areas containing hazardous oper ations or where an emergency currently exists shall be posted with legible signs bearing the legend: Cancer-Suspect Agent in This Area Protec tive 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 Vintl Chloride Cancer-Suspect Agent ' (4) Containers of polyvinyl chloride shall be legibly labeled: Poltvim il Chloride (or Trade Name) Contains Vintl Chloriue * Vintl Chloride is a Cancer-Suspect Agent '(5) Containers of vinyl chloride shall be legibly labeled either: U) ,, Vintl Chloride Extremely Flammable Gas Under Pressure Cancer-Suspect Agent or (11) In accordance with-49 CFR Part 173, Subpart H, with the additional legends: , Cancer-Suspect Agent applied near the labor or placard. (6) No statement shall appear on or near any required sign, label or Instruc tion which contradicts or detracts from (ill The number of employees In each the effect of, any required warning, regulated area during normal operations. Information or instruction. including maintenance. (m) Records. (l)-AU records main (2) Emergencies, and the facts ob tained in accordance with this section tainable at that time, shall be reported shall include the name and social secu within 24 hours to the OSHA Area Di rity number of each employee where rector. Upon request of the Area Direc relevant. tor, the employer shall submit additional (2) Records of required monitoring information in writing relevant to the and measuring, medical records, and au nature and extent of employee exposures thorized personnel rosters, shall be made and measures taken to prevent future and shall be available upon request for emergencies of similar nature. examination and copying to authorized <3l Within 10 working days following representatives of the Assistant Secre any monitoring and measuring which tary and the Director. discloses that any employee has been (i) Monitoring and measuring records shall: (A) State the date of such monitor ing and measuring and the concentra tions determined and identify the instru exposed, without regard to the use of respirators in excess of the permissible exposure limit, each such employee shall be notified In writing of the results of ments and methods used; the exposure measurement and the steps (B) Include any additional informa being taken to reduce the exposure to tion necessary to determine individual employee exposures where such expo sures are determined by means other than individual monitoring of employees; and within the permissible exposure limit. (o) Effective dates. (1) Until Janu ary l, 1975, the provisions currently set forth In 5 I9l0.93q of this Part shall (C) Be maintained for not less than apply. 30 years. (2) Effective January 1,1975, the pro (ii) Authorized personnel rosters shall visions set forth in 1910.93q of this Part be maintained for not less than 30 years. shall apply. (iii) Medical records shall be main tained for the duration of the employ ment of each employee plus 20 years, Appendix A--Supplementary Medical Information or 30 years, whichever is longer. When required tests under paragraph <3) In the event that the employer tk) (1) of this section show abnormalities, ceases to do business and there is no the testa should be repeated as soon as prac successor to receive and retain his rec ticable. preferably within 3 to 4 weeks. If ords for the prescribed period, these rec ords shall be transmitted by registered' tests remain abnormal, consideration should be given to withdrawal of the employee from contact with vinyl chloride, while a more mail to the Director, and each employee comprehensive examination Is made. Individually notified in writing of this Additional tests which may be useful: transfer. A. For kidney dysfunction: urine examina (4) Employees or their designated tion for albumin, red blood cells, and ex representatives shall be provided access to examine and copy records of required monitoring and measuring. , V (5) Former employees shall be pro vided access to examine and copy re quired monitoring and measuring records foliative abnormal cells. B. Pulmonary system: Forced vital capac ity, Forced expiratory Volume at 1 second, and chest roentgenogram (posterior-anterior, 14 x 17 Inches). C. Additional serum tests: Lactic acid de hydrogenase, lactic acid dehydrogenase reflecting their own exposures. Isoenzyme, protein determination, and (0) 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. protein electrophoresis. D. For a more comprehensive Examination on repeated abnormal serum tests: Hepatitis B antigen, and liver scanning. (n) Reports. (1) Not later than 1 (Secs. 0 and 8, 84 Stat. 1596, 1599 (29 UAC. month after the establishment of a reg ulated area, the following information 655, 657); Secretary of Labor's Order No. 12-71, 36 FR 6764) shall be reported to the OSHA Area Di Signed at Washington, D.C., this 1st rector. Any changes to such Information day of October, 1974. shall be reported within 15 days. (1) The address and location of each establishment which has one or more John Stender. Assistant Secretary of Labor. regulated areas; and [FR Doc.74-23176 Filed 10-1-74; 3:54 pmj * GENC 007187 [ } MQMWJHT MSB ` MJ2026E27S002 10/02/7fl res ipmmtzz csp uie5tern union 1 2027632602'MOM TOMT WASHINGTON OC 10*02 021 OP COT ZIP 20006 ******* RUBBCR MANUPACTURfRS ASSOC 1601 PENNSYLVANIA AVC NORTHWEST WASHINGTON DC 20006 THIS MAILGRAM'* IS A CONFIRMATION* COPY OP THE FOLLOWING MESSAGE! 2027SS2602 TOMT WASHINGTON OC 60 10*02 0210P EDT PM HONORABLE RICHARD P SCHUBERT* DLR UNDERSECRETARY OP LABOR US 'DEPT OP LABOR 1TH AND CONSTITUTION AVI WASHINTON DC 20210 * THE ANNOUNCEMENT ON OCTOBER 1 BY ASSISTANT SECRETARY OP LABOR JOHN H JTINOER CONCERNING THE LEVELS OP EXPOSURE TO VINYL CHLORIDE TO BE REMITTED ON ANO AFTER JANUARY 1 1675 APPEAR TO IGNORE THE MASSIVE WEIGHT OP TESTIMONY'PRESENTED DURING THE OSHA HEARINGS LAST JULY. THESE "LEVELS ARE NOT ACHIEVABLE'. SY ARY KNOWN OR-PR^POSED TECHNOLOGY ANO ENFORCEMENT OF SUCH LEVELS CAN ONLY LEAD TO MAJOR ECONOMIC DISRUPTIONS WITHIN THE UNITED .'-STATES WITHOUT SIGNIFICANTLY ADDING TO EMPLOYEE HEALTH AND SAFETY. THE RMA URGENTLY REGUESTS IMMEDIATE RECONSIDERATION OP THIS STANDARD. . MALCOLM R LOVELL JR PRESIDENT RUBBER MANUFACTURERS ASSOCIATION 16110 EOT MQMWSHT HSB liENC 0Q7183