Document J3O0G7XkvyRe4JNg7QrxnzqQ6

3 68 69 ", ^Ts Dnpliciate in all cards:--$ year as-1961- O0Q&M9 Pile nunber [Right justify [Kuneric only] Au^^r(s), as Last Kane PS (Ho Punctuation) and ~coden for journal as JAKA proceeded -by. one blank space 1' ' 20'"21 40 41 ^^a.n<s., J- oj , I 77 ' I Oc^T Sub-Index Code 60 61 62 11 12 13 II tie of Report; end with space-hyphen-hyphen-space. Pollov with Index "eras, separated from each other with -coma-space. Avoid other punctuation; do'not abbreviate. L2 . * 61'62 R&S 106198 (Journal, Vol., Ktmber, Pages, Date ) O /<^n / q/Il Tf A ' 'lier //CC v7^o- ;7' /9^d~ 32 10 '21ARY: 61 62 61 62 63 64 HD 7261 : 7^ z&. 75-63 SP 0000049 VINYL CHLORIDE: AN OCCUPATIONAL HEALTH HAZARD TABLE OF CONTENTS Page I. Introduction............................................................................................................................................................ X II. Chemical Properties of Vinyl Chloride (VC)....................................................................................... 2 III. Amount of Industrial Production and Uses of Polyvinyl Chloride (PVC)............................. 3 IV. Industrial Production Methods..................................................................................................................... 5 V. History................................................................................................................................................................ 9 VI. The Discovery of the Carcogenicity of Vinyl ChlorideMonomer (VCM)....................................12 VII. Worker Exposure in the Vinyl Chloride Industries......................................................................... 16 VIII. Other Exposure to Vinyl Chloride Monomer............................................................................................ 19 IX. Epidemiology...........................................................................................................................................................24 X. Animal Data on the Health Effects of VinylChloride.................................................................29 XI. Human Health Effects of Vinyl Chloride...............................................................................................30 XII. The Occupational Safety and Health AdministrationStandard................................................... 34 XIII. Feasibility of the Occupational Safety and Health Administration Standard.................... 35 Appendix I: Chronology of Events............................................................................................................39 Appendix II: Federal Register 39, FR1 35890, The OSHA Standard for Exposure to Vinyl Chloride........................................................................................... 43 Appendix III: Sources of Emission and Concentrations in Ambient Air of VCM in the VC-PVC Industries...................................................................53 Appendix IV: Current Occupational Exposure Limits for VCM In Nine Countries........................................................................................................................ Bibliography.......................................................................................................................................................... 57 30 fio (/> O 0> to o o R&S 106201 I. INTRODUCTION Vinyl Chloride Monomer, a gas used Co produce the second most widely used plastic in the United States, has been shown to be carcinogenic. Thousands of workers in the United States and other countries have been exposed to levels of this gas that now are presumed to be dangerous. The general public has also been exposed to low levels of vinyl chloride. The effects of these low levels are unknown. The Occupational Safety and Health Administration (OSHA) formulated an occupational standard for exposure to this gas which is presently being disputed in the U.S. Circuit Court. The major area of dispute seems to be whether OSHA's standard can be put into effect without forcing the vinyl chloride industries and vinyl-chloride-using plastic makers to cease operations. Some regulations protecting the general public from vinyl chloride in aerosol cans have been enacted and others, concerning environmental vinyl chloride and vinyl chloride residues in food, are being planned. This report was prepared in response to inquiries from members of Congress concerning the various occupational and other health issues associated with vinyl chloride. R&S 106202 CRS - 2 II. CHEMICAL PROPERTIES OF VINYL CHLORIDE (VCM) Vinyl chloride monomer (VCM), Chemical Abstracts Service Registry No. 75014, has a molecular weight of 62.50 and a boiling point of -13.37"C. VCM is a colorless gas at room temperature and pressure with a pleasant sweetish smell that can be detected by humans in air at levels of 2000 parts per million (ppm). It is a synthetic organic chemical made from ethylene or acetylene and chlorine by any of several processes. VCM is explosive at levels between 1.2% and 52% by volume in air. Prolonged exposure to levels above 6000 ppm can produce symptoms of intoxication. Higher levels can produce unconsciousness. VCM is usually handled as a liquid under pressure. V 2/ 1/ American Industrial Hygiene Association. Hygiene Guide Series: Vinyl Chloride. -- Southfield, Michigan, American Industrial Hygiene Association, Aug., 1964: p.1-4 2/ U.S. Occupational Safety and Health Administration. Final Environmental Impact " Statement, Proposed Regulation: Vinyl Chloride. Washington, D.C., Sept. 5, 1974. p. 14-15. ' .jv CRS - 3 III. AMOUNT OF INDUSTRIAL PRODUCTION AND USES OF POLYVINYL CHLORIDE (PVC) Polyvinyl chloride (PVC) is now the number two plastic in the United States in terms of tonnage production. Over 5.4 billion pounds (2.43 million metric tonnes) of vinyl chloride and over 4.4 billion pounds (1.98 million metric tonnes) of polyvinyl chloride are consumed annually. 3/ Synthesis of vinyl chloride is conducted in 15 plants in the United States. Poly vinyl chloride resin is produced in 37 plants in the United States. Five new PVC resin plants are under construction and together with expansion of five others will yield an additional annual capacity of 1.378 billion pounds. B.F. Goodrich, Co. is the largest U.S. producer of PVC resins. PVC resins are compounded with additives in approximately 200 plants. About 7500 plants, employing 350,000 workers, are engaged in fabricating products from PVC. 4/ The VCM^FVC industry for the past five years has shown an annually compounded rowth rate of 14%. PVC output has risen 70% in the past five years. Limits to rowth, until 1974, seemed to be based upon the availability of the petroleum feed stock necessary for the production of VCM. 5/ An Arthur D. Little study for the Society of Plastics Industries (SPI) states chat about 2.2 million jobs in the U.S, depend on the PVC industry. The market value of the gas and the resin made from it is perhaps $1.5 billion. Wholesale values of all products made from PVC is about $3 billion. The Arthur D. Little study estimates that between $65 and $90 billion dollars in sales and production would be lost annually if the material were banned. 6/ R&S 106203 JJ Ibid. p. 42-43. J Ibid. _5_/ Putting VCM Emissions on Skids. Chemical Week, Sept. 18, 1974: p. 67. __/ What's Ahead for Vinyl Makers: Slowdown or End of the Road? Chemical Week, July 3, 1974. p. 7-8. CRS - 4 97% of all VCM is used for Che manufacture of homopolymer and copolymer resins. The remainder is utilized for the production of methyl chloroform, additives and special coatings and, until recently, aerosol propellants. FVC is used in flooring and piping, apparel, insulation for electrical wiring, packaging, upholstery, phonograph records, blood storage bags, medical devices, and in a multitude of other applications. Hie average General Motors car contains thirty to forty pounds of plastics manufactured from PVC. At 325 million pounds per year consumption, packaging is a major outlet of PVC resin produced. 79 million pounds were used for bottles in 1973. 1.3A billion pounds of PVC, 25% of total PVC consumption, went to make pipe and fittings for building industry. A64 million pounds went into flooring. Total construction markets for PVC were well over 2 billion pounds or close to 43% of consumption by all industries. Auto upholstery, seat covers, mats and deco rative tops accounted for 256 million pounds. More than 400 million pounds are used annually on wire and cable as insulation, or about 10% of total production. Film and sheet for packaging and coated fabrics account for 15% of all consumption. _jJ R&S 106204 11 Second Thoughts on Using PVC. Chemical Veek, July 31, 1974. p. 19-20/ 1" if y CRS - 5 IV. INDUSTRIAL PRODUCTION METHODS The vinyl chloride industry is composed of three segments: monomer producers, polymer producers and fabricators. Vinyl chloride monomer is produced and shipped as a compressed liquid to polymerizations plants where the monomer is processed into homopolymer (consisting of only vinyl chloride) or copolymer (consisting of vinyl chloride and some other monomer) resins. The PVC copolymer or homopolymer is compounded with additives. Compounding may occur in the same plant that produces the basic resins, in the fabricating plant, or in a separate facility. Approximately 200 companies supply these compounded resins. Then, in granular form, as PVC paste (a fine powder with the texture of processed flour), or PVC latex (a stable suspension of PVC in liquid), at the fabrication point the compounded resin is reheated or otherwise treated to form final products, components of other equipment, or materials used in various industries. Production of the vinyl chloride monomer is a large-scale continuous process. There are relatively few employees in this segment of the industry because the processes lend themselves to automation. The Manufacturing Chemists Association (MCA) 8/ estimates that 1,500 people work in monomer production. Vinyl chloride monomer is synthesized from chlorine and petrochemical feedstocks (usually ethylene) in a continuous closed process. The plants are open to the air and resemble oil refineries. In some cases they are attached to them. 8/ U.S. Occupational Health and Safety Administration. Informal Hearing. Informal Fact-Finding Hearings on Vinyl Chloride. February 15, 1974. Unpublished. R&S 106205 9 2 9 0 /. 37 So CO CRS - 6 The basic chemical reaction which forms the polyvinyl chloride from the vinyl chloride monomer can be stated simply as: nCH, = CHC1 heat \ catalyst / (CH -CHC1) n where n (or any particular number) of vinyl chloride molecules in the presence of heat and a catalyst join together to form a polymerized chain. 9/ Polymerization is a chain reaction. The polymer chains will average 2,000 monomer units with individual chains ranging from few to perhaps 10,000 units. The actual distribution of molecular weights of the polymer chains, upon which the properties of the plastic depends,is influenced by the polymerization method, the catalyst, the temperature, the fraction of monomer polymerized and the presence of impurities or additives which can terminate the growing chains. Comonomers such as vinyl acetate, vinylidene chloride and acrylates may be added in small amounts with the vinyl chloride to contribute some desirable property. Depending upon the polymerization process and the reactivity of the comonomers used the comonomer may enter the PVC chain randomly or in blocks. These VC homopolymers and copolymers are generically known as PVC resins. They are generally found in the form of powders. 10/ There are several methods of carrying out the polymerization of vinyl chloride; suspension, emulsion, solution, and bulk or mass methods. About 79% of U.S. PVC resin is produced by suspension polymerization, 13% by emulsion, 6% by bulk and 2% by solution polymerization. OSHA estimates that between five and ten thousand workers are engaged in the industries producing PVC resins. 11 / American Chemical Society. Chemistry in the Economy. Washington, D.C., American Chemical Society, Oct. 1973. p.67-68. ly U.S. Occupational Safety and Health Administration. Final Environmental Impact Statement, p. 31-64.IV IV Ibid. CRS - 7 Polymerization is a batch process. Vinyl chloride monomer, as a compressed liquid, is put into a pressurized vat (110 to 160 psi) with other substances and a catalyst. Water or organic solvents may be added, or (as in bulk polymerization) the process may take place without the addition of liquids. Heat is applied (120 to 150 F) and after several hours the vat is emptied, opened and cleaned for the next batch. The reactor kettle, or vat, is an autoclave where the reaction takes place. The usual capacity is 2,000 to 5,000 gallons but newer units hold as much as 35,000 gallons. Conversion of 85% to 90% of the monomer to polymer is considered high. Unreacted monomer is removed from the vat by vacuum for recycle to the process and the polymer is fed into a drying tower or storage tank. After the polymer is pumped out, some remains adhering to the sides of the vat. It hardens and when accumulated, lowers.the heat transfer ability in the reactor. When heat transfer becomes too low, the vat must be cleaned. Older reactors are often scraped manually. But the new cleaning method is composed of high-pressure water and water-detergent systems. The new larger kettles are more easily cleaned by water jet and can produce larger quantities of resin between cleanings. Solvents such as tetrahydro furan, dimethyl formamide or ethylene dichloride may be used to remove baked-on polymer and absorb unreacted monomer. But then the solvent must be recovered and recycled. The unreacted VCM is pumped out of the vat and recovered by a series of secondary tanks containing compressors and condensers. The polymerized resin or the "slurry" is removed to tertiary tanks, dewatered, in a centrifuge, and dried with a stream of hot air in a rotary dryer. \2/ 13/ 12/ Ibid. 13/ U.S. Occupational Safety and Health Administration. Hearing Before Administrative Law Judge Myatt. Engineering and Control Practices. Testimony of K.H. Oelfke of the DOW Chemical Co., Freeport, Texas, July 8-11, 1974. CRS - 8 After polymerization, PVC resins are compounded with additives by a variety of methods- Additives to PVC may include thermal stabilizers to prevent the loss of hydrogen chloride in processing, flow agents, colorants, solid fillers, rubbers to improve low-temperature properties and plasticizers, which are needed in quantities of 20% to 40% in flexible PVC films. Finally, the compounded resin undergoes a variecy of processes at fabricating plants. 14/ R&S 106208 CRS - 9 V. HISTORY The first vinyl chloride resin was discovered In 1872. Polyvinyl chloride and copolymer resins remained laboratory curiosities with no commercial applications until 1927 when E.W. Reid discovered the useful properties of copolymers made of vinyl ace tate and vinyl chloride. Chemists at B.F. Goodrich Co. first learned to plasticize polymerized vinyl chloride itself Into flexible forms in the mid 1930's. The first commercial vinyl plant was opened by Union Carbide in 1936. In 1940 Goodrich opened its own plant. Polyvinyl chloride (PVC) was hailed as a miracle material; cheap, stable, fire resistant and able to assume an extraordinary range of soft and hard forms. The ready availability of natural rubber, however, limited development of the PVC industry until the outbreak of World War II. During World War II interest focused on the polyvinyl chloride resins as flame proof substitutes for rubber and as corrosionresistant coatings for naval supplies. Polyvinyl chloride plastics, although they had poor electrical insulating properties compared to polyethylene, were tough and abrasion resistant and especially useful in low voltage applications.15/ 16/ During the 1940's vinyl chloride gas was tried as a medical anaesthetic in con junction with nitrous oxide. Doctors abandoned the attempt when it was found to pro duce heart arrhythmias. From the time of its discovery, vinyl chloride gas seemed virtually harmless. The only apparent dangers were of explosions at concentrations greater than 36,000 ppm, and intoxication and narcosis at levels above 6,000 ppm. Effects of chronic exposure were not suspected. No particular attention was paid to workplace ambient concentrations so long as they were below explosive levels. In 1949, a Russian group 17/ found a hepatitis-like condition in fifteen of a group of forty- R&S 106209 15/ Ibid. 16/ American Chemical Society, op. clt. 2JJ Tribuch et al. Hepatitis-Like Liver Changes in U.S. Congress. Senate. Sub committee on the Environment. Dangers of Vinyl Chloride. Hearings, 93rd Congress, 2nd Session, Washington, D.C., U.S. Government Printing Office, Aug. 21, 1974. p.13. CRS - 10 eight polyvinyl chloride polymerization workers. At this time, levels in these plants most likely reached several thousand ppm.18/ European researchers detailed other symptoms of what came to be called 'vinyl chloride worker's disease' including skin lesions, gastritis and circulation disorders. 19/ 20 / In 1961, Torkelson and others 21/ discovered slight reversible liver injury in rats exposed seven hours per day to 100 ppm VCM and recommended that the time-weighted average (TWA) for industrial exposure not exceed 50 ppm. At about this time DOW Chemical Co. voluntarily adopted an average exposure limit of 50 ppm for its workers but government standards remained unchanged. By the late 1960's acro-osteolysis, a disease involving reversible degeneration of the finger bones was identified among workers who cleaned the polymerization vats. The etiology seemed to involve high level exposure to vinyl chloride monomer and minor trauma to the hands. 22/ In 1968 Kramer and Mutchler 23 / found that repeated exposure to vinyl chloride at 300 ppm TWA for a working lifetime could cause impairment of liver function in humans. 18/ Weaver, P.H. On the Homs of the Vinyl Chloride Dilemma, Fortune, Oct. 1974. p. 150-151. 19/ Lee, F.I. and D.S. Harry. Angiosarcoma of the Liver in a Vinyl Chloride Worker. The Lancet, June 29, 1974. p. 1317. 20/ How Hazardous to Health is Vinyl Chloride? Journal of the American Medical Asso ciation. June 10, 1974. p. 1355. 21/ Torkelson, T.R., Oyen F. and V.K. Rowe. The Toxicity of Vinyl Chloride as Determined by Repeated Exposure of Laboratory Animals. American Industrial Hygiene Association Journal, v. 22, no. 5, 1961. p. 354-361. 22/ Cook, W.A. et al.. Occupational Acroosteolysis: II, An Industrial Hygiene Study. Archives of Environmental Health, v. 22, Jan. 1971. p. 74--82. Dinman, B.D. et al. Occupational Acroosteolysis: I, An Epidemiological Study. Archivers of Environemntal Health, v. 22, Jan. 1971. p. 83--91. Dodson, V.N. et al. Occupational Acroosteolysis: III. A Clinical Study. Archives of Environmental Health, v. 22, Jan. 1971 p. 83-91. 23/ Kramer, C.G. and J.E. Mutchler. The Correlation of Clinical and Environmental Measurements for Workers Exposed to Vinyl Chloride. American Industrial Hygiene Association Journal, v. 33, 1972. p. 19-30. R&S 106210 R&S 106211 CRS - 11 Finally, in experiments begun in 1967, Dr. Pierluigi Viola, attempting to produce an animal model for acro-osteolysis, exposed rats to 30,000 ppm vinyl chloride and found that many developed cancers of the skin, lungs and other ograns. He presented this data at the Tenth International Cancer Congress in Houston in 1970 but mentioned that he felt that this data did not necessarily apply to humans. 24 / Dr. Viola's study caused four European producers of polyvinyl chloride plastics, Montedison, Imperial Chemical Industries (ICI), Solvay and Rhone-Progil, to commission Dr. Cesare Maltoni of the Instituto di Oncologia, Bologna, Italy, to undertake a large scale animal study testing for cancer at levels approximating worker exposure. R&S 106212 CRS - 12 VI. THE DISCOVERY OF THE CARCOGENICITY OF VINYL CHLORIDE MONOMER About September 5, 1971 Dr. Maltoni, In response to Dr. Viola's results, began toxicity studies in rats. He observed his first angiosarcomas in August 1972. On January 17, 1973 technical delegates of the Manufacturing Chemists Association's (MCA) VC and PVC industries visited Dr. Maltoni's facilities and learned details of his ex perimental procedures and results. MCA and participating U.S. Firms had promised to hold Dr. Maltoni's work confidential and not release information outside of the task group without specific consent of the European group sponsoring the study. The pur poses of the restriction were "that preliminary indications not be released until they have been validated, thereby to minimize unwarrented speculation" and "that release remains subject to the control of the project's proprietors." 25/ On January 30, 1973 National Institute of Occupational Safety and Health (NIOSH) published in the Fed eral Register a request for information on the potential hazards associated with occupational exposure to a list of 23 chemical substances and physical agents. Among these was vinyl chloride. MCA apparently did not at this time mention Maltoni's preliminary results. The first public disclosure of these findings tooks place at the Second International Symposium on Cancer Detection and Prevention held at Bologna on April 9 to 12, 1973. At that time, during presentation of a general paper on occupational carcinogenesis. Dr. Maltoni 26/ showed a table of preliminary results with vinyl chloride which indicated cancer formation; angiosarcomas, zymbal gland (ear canal) carcinomas and nephroblastomas, at 250 ppm exposures. The impact of the paper seems to have been minimal. At the same time several epidemiological studies of vinyl chloride workers had been initiated, in response to Dr. Viola's study. In 1971 ICI had begun such a study 25/ Vinyl Chloride Controversy Continues. Chemical and Engineering News. June 10, 1974. p. 12. 26/ Maltoni, C. Preliminary Report on the Carcogenicity Bio-Assay of Vinyl Chloride, (presented at the Occupational Health and Safety Administration Vinyl Chloride Fact-Finding Hearing, Feb. 15, 1974.) R&S 106213 CRS - 13 which was completed up to the end of 1971 and then updated to the end of 1972. This study disclosed no increase in deaths attributable to cancer among vinyl chloride workers when compared to a control group of chemical workers never exposed to VCM. On July 17, 1973 Dr. Marcus Key of NIOSH met with MCA delegates and an ICI representative from the United Kingdom, in Washington to discuss vinyl chloride. According to Dr. Key, "They went into some detail on the findings of Professor Viola in production of tumors of the skin, the ceruminous gland of the ear canal, lung, and bones of rats which occurred from exposure to very high concentrations. As the result of this study, we were told that a second order toxicology study was being conducted in Italy and that an epidemiological investigation had been conducted at ICI in the United Kingdom. The ICI study had turned up no human evidence of any problem with vinyl chlo ride. The second level animal toxicity study in Italy was also presented to us. We did not get the specifics of the study except that the concentrations of vinyl chloride were much lower and that several species of rodents had been exposed and tumors had been produced. We interpreted what was being presented to us as con firmation of Viola's previous work, especially as regards the production of cancer in the ceruminous glands of the rat's ear canal. No mention was made to us about liver cancer and the new Italian investigator was not named." 27/ According to A.W. Barned, Director of ICI Plastics Division, the ICI physician present at the meeting reported the production of primary tumors at several sites at levels lower than those of Dr. Viola's study but said that he did not construe this to mean only zymbal gland tumors and their metastases were produced. In this initial presentation, the European delegation apparently presented the animal results in a generalized form, saying that vinyl chloride apparently proved carcinogenic to rats at several sites and at levels as low as 250 ppm. Angiosarcoma, though detected,.was not mentioned specifically since there was no human epidemiological evidence to in dicate that this particular cancer, very rare in humans, was more important than the other cancers detected. 28/ In Britain, the United Kingdom Employment Medical Advisory 2U U.S. Congress. Senate. Subcommittee on the Environment, op. cit. p. 57. 28y Barnard, A.W. ICI Encfc Its Silence on Vinly Chloride. Chemical and Engineering News, July 8, 1974. p. 21 and 37. CRS - 14 Service and the Factory Inspectorate say they had no information on the carcogenicity of VCM, apart from Dr. Viola's paper, until January 1974. As New Scientist put it: 29/ It is probably impossible to say whether the chemical industry deliberately and maliciously hid unfavourable research findings (in 1973). It Is, however, likely that, even If this were not the case, the results would not have caused much of a stir. For by this time, the epidemiological survey was showing negative results. ICI had found no deaths from angiosarcomas among ex-employees. Thus in January 1973 there was no human evidence of VCM's carcinogenic properties. Be cause extrapolating from animals about carcinogenicity is notoriously problematic, epidemiological evidence carries greater weight in the minds of industry and reg ulatory bodies. Thus it is unlikely that animal studies alone would have been convincing enough to force a reappraisal of industrial exposure standards. "Firm" evidence only arose after the Goodrich report, when other cases of deaths from angiosarcoma were unearthed. ICI updated its survey and found one ex-employee who died from liver cancer in 1973. According to Dr. Key, if he had known of the induction of liver cancers in July of 1973,NIOSH "would have taken an entirely different course of action in view of the widespread use of this material (vinyl chloride)".NIOSH "would have immediately gotten together with NCI and the Food and Drug Administration (FDA), and brought in some of the best toxicologists in the country to review the data and decide what actions to take." 30/ In the spring of 1973, Dr. John L. Creech, plant physician for the B.F. Goodrich plant in Louisville, Kentucky, noting an increase in liver ailments among plant em ployees, Initiated tests to detect liver abnormalities. In December 1973 he received a report that one of the workers had died of angiosarcoma of the liver. Remembering another death from the same cause three years earlier, he notified a superior. By January 16, 1974, B.F. Goodrich, running a systematic mortality study of workers, discovered reports of a third angiosarcoma death. On January 22, 1974, Goodrich no tified NIOSH that three workers at their PVC polymerization plant had died of angio sarcoma of the liver. On January 29, 1974, further review by Goodrich turned up a 29/ McGinty, L. Science Paused and 17 Died. New Scientist., June 15, 1974. p. 675-676. 30/ U.S. Congress. Senate. Subcommittee on the Environment, op. cit. p. 57. R&s 106214 R&S 106215 CRS - 15 fourth case in 1968. The rarity of the disease and the clustering of deaths at a single plant raised suspicions that an occupational disease related to exposure to vinyl chloride had been discovered. On January 30, 1974 an OSHA fact-finding hearing was announced. It was held on February 15, 1974. Dr. Maltoni's animal data, showing cancer in rats at levels of 250 ppm was released at the hearing. 31/ 32/ 33/ ^1/ Falk, H., Creech, J.L., Heath, C.W., Johnson, M.N., and M.N. Key. Hepatic Disease Among Workers at a Vinyl Chloride Polymerization Plant. Journal of the American Medical Association, v. 230, no. 1, Oct. 7, 1974. p. 59-63. L/ Saar> Vinyl Chloride and Cancer. Die Washington Post, May 5, 1974. p. C2. 33/ Maltoni, C. op. cit. CRS - 16 VII. WORKER EXPOSURE IN THE VINYL CHLORIDE INDUSTRIES Workers are exposed In all three segments of the PVC industry, monomer production, polymerization and fabrication. The greatest exposure probably takes place in poly merization plants. 34/ Monomer production takes place as a relatively closed, continuous process and, especially in warm climates, takes place in the open air. Plants generally are highly automated. The major sources of exposure for the one thousand to 1500 workers involved in monomer production are judged to be: 1) sampling and analysis of vinyl chloride for quality control. 2) loading of vinyl chloride for shipping. 3) maintenance and repair work which necessitates entry of vinyl chloride con taining vessels and 4) exposure to leaks of vinyl chloride in the processing area. Leakage possibly accounts for 40% of the total emaission from vinyl chloride and polyvinyl chloride plants. 35/ 36/ It is probable that higher levels of vinyl chloride gas are encountered by the approximately- five to ten thousand workers In the PVC resin industries than by those in monomer production of fabrication. The areas of greatest exposure in the PVC industry are: e 1) unloading of incoming vinyl chloride, 2) reactor cleaning. 3) entry into vinyl chloride containing vessels for maintenance and repair work. R&S 106216 34/ u.S. Occupational Safety and Health Administration. Final Environmental Impact Statement; Proposed Regulation, Vinyl Chloride. Washington, D.C., Sept. 5, 1974. p. 31-64. 2/ Ibid. 36/ u.S. Environmental Protection Agency. Report of the Activities and Findings of the Vinyl Chloride Task Force. Washington, D.C., Sept. 1974. p. 1-16. CRS - 17 4) entry into PVC storage silos. 5) shipping or packing PVC. 6) leaks of vinyl chloride in the process area. Thirty-two out of 38 cases of occupationally related angiosarcoma in ten countries occurred in PVC polymerization workers. In most of the early PVC resin polymerization plants the vinyl chloride gas could be smelled almost constantly. This means constant exposure to levels in excess of 2000 ppm. Workers occassionally got 'high' from the fumes. It is generally agreed that during the early period of the industry, into the 1950's, exposures of several thousand ppm were common. During the 60's the ambient levels most commonly were in the range of 100 to 200 ppm with occasional excursions as high as 500 ppm, the American Conference of Government Industrial Hygienists (ACGIH) voluntary ceiling. Dow Chemicals, acting on Torkelson's data, attempted to reduce its own plant levels to below 50 ppm and by the early 1970's had achieved average exposures of about 25 ppm in its copolymer plants.37/ PVC production is labor intensive and in the colder climates it is necessary to enclose the plants. It has been estimated that in the United States less than half are open. Of the workers, it is likely that reactor cleaners suffer the greatest ex posure. Most of the cases of angiosarcoma of the liver in polymerization workers occurred among those who had at one time been reactor cleaners. Polymer, hardened and accumulated on the walls of the reactor tank must be cleaned away to allow efficient heat transfer into the vat. High pressure water jets do the bulk of the cleaning, but in some older vats this method cannot be used. Until recently vats in most older plants were entered once or twice a day. Although the air within the reactors was replaced several times, a short burst of vinyl chloride would be released from the reactors immediately upon opening. In addition, the PVC that remained encrusted 37/ ibid. CRS - 18 within the reactor, because of its porous structure, could retain significant amounts of entrapped VCM which was released in the process of chipping and cleaning the vat. Now, the most modem equipment is entered and cleaned manually only once a month. The job is presumably less hazardous with the introduction of respirators and protective clothing. Also air is more efficiently evacuated from the vat. 38/ Approximately 350,000 workers may be exposed during the fabricating process to unreacted vinyl chloride monomer which remains trapped in the PVC resin. The levels of unreacted VCM in PVC resins are usually between 50 and 100 ppm though they may be occasionally as high as 8000 ppm. Most of this VCM is released during storage or processing, especially heat processing. The levels of VCM found in finished products are probably no higher than 5 to 20 ppm. The vast majority of workers employed in the VC-PVC industries are involved in PVC fabricating and manufacturing. Levels of ex posure in many plants are probably well below 1 ppm. Levels in fabricating plants however may be as high as 12 ppm. Past levels may have been higher. Angiosarcomas of the liver have been found in workers in fabrication plants. 39/ A summary of estimated current exposure levels in PVC fabricating facilities, and polymerization plants and a list of major emission sources in PVC polymerization plants and VCM production plants is found in Appendix III. 38/ Ibid. 39/ Ibid. CRS - 19 VIII. OTHER EXPOSURE TO VINYL CHLORIDE MONOMER Emission There is a material loss of vinyl chloride and polyvinyl chloride of 4 1/2% to 7 1/2% during the PVC polymerization process. Substantial amounts of vinyl chloride, probably more than 200 million pounds per year, and PVC, more than 50 million pounds per year, are being discharged into the environment during the PVC production process. Seventy-five percent of the losses are probably by vinyl chloride air emissions. The principal area of vinyl chloride leakage in PVC plants is probably associated with the operation of the polymerization kettles which are periodically opened for cleaning or for recharging or sampling. Other losses occur during transfer of vinyl chloride from tanks to storage, during the PVC drying process and at a variety of leaks in valves, flanges and pump seals. 40/ Preliminary monitoring by the Environmental Protection Agency (EFA) in the vicin ity of VC and PVC resin plants indicates that levels of VC in ambient air fluctuate sharply, apparently due to periodic openings of the reactor kettles in PVC plants, variations in production processes, and meteorologic conditions. Almost all of the air samples taken by EPA at 12 PVC and VC plants contained detectable levels of VC. The overwhelming majority of those samples contained less than one ppm but there were occasional higher excursions, one instantaneous reading was as high as 33 ppm. Vinyl chloride in air probably has a reaction rate of eight to ten percent per hour. The reaction products include ozone, nitrogen dioxide, carbon monoxide, formaldehyde, formic acid and formyl chloride. Human eye irritation symptoms from exposure to -vinyl chloride in air may be caused by these products. Although vinyl chloride will disap pear within a few miles downwind of a vinyl chloride air emission source, near the source it may be considered a stable pollutant. i^J 4<y Ibid. 41/ Ibid. CRS - 20 R&S 106220 Wq,ter effluents typically contained levels of two to three ppm, the highest le vel being 20 ppm. Levels seemed to be dependent on in-plant handling of waste. Le vels of vinyl chloride entrapped in solid wastes and sludge ranged from 100 ppm to, in one case, 300 ppm. The EPA Task Foils estimates that emissions from PVC resin plants could be cut 75% and from VCM plants, 90%, with a concomitant increase in the cost of PVC of about 4%. It is also estimated that available control technology could be im plemented within a few months to two years after promulgation of a standard. If emis sion were cut 75% or 90% the 24 hour average concentrations would be about 90ppb. 42/ Cases of angiosarcoma of the liver have occurred among persons not directly in volved with vinyl chloride occupationally but who did live in the vicinity of VC-PVC plants. Emissions from these plants may therefore pose a health hazard. 43 / There is a close relationship between the EPA standard for emission and the al lowable levels of vinyl chloride in the workplace. EPA and 0SHA are working closely together to assure compatibility of standards. EPA is supporting toxicological studies to determine the effects of vinyl chloride on the developing fetus and Its interaction with other carcinogens. EPA is also planning epidemiological studies of population living near a PVC plant. EPA will continue monitoring possible air emission sources and drinking water supplies possibly contaminated with vinyl chloride from emission sources or from vinyl chloride migration out of PVC pipe and storage tanks. EPA will also investigate solid waste disposal of PVC plants, especially leachates from land disposal and incineration of PVC products. 44 / aiso EPA concern itself with the effect of vinyl chloride monomer and tars from vinyl chloride plants on aquatic life and other wildlife. 4_2J Ibid., p. 31-32. 43 / u.S. Center for Disease Control. Cancer and Birth Defects Division. Bureau of Epidemiology. Internal Report on Cases of Angiosarcoma of the Liver In Connecticut. Oct. 9, 1974. 44 / U.S. Environmental Protection Agency, op. cit. p. 63-65. I CRS - 21 Aerosols In response to a petition by a consumer advocate organization, the Health Re search Group, EPA has banned indoor pesticides using VCM as a propellant; the Con sumer Product Safety Commission (CPSC) has banned its use in household products; and the Federal Drug Administration (FDA) has banned it from use as a propellant in cosmetics and has stated that its use in drugs requires a New Drug Application. Vinyl 45/ chloride was never used in aerosol foods. Preliminary tests at EPA research facilities shows that a 30 second release of an aerosol containing vinyl chloride could result in a concentration as high as 400 ppm in air. Related tests showed that in closed rooms vinyl chloride will persist for many hours and, even when diluted by ventilation will probably result in some vinyl chloride exposure for several hours. Cosmeticians and other groups who may have used large quantities of aerosols in en closed spaces may have received significant exposure to vinyl chloride. The effect of the low levels the general public has been exposed to is not known. Transport Accidents More than two-thirds of the vinyl chloride monomer produced is transported to PVC resin plants located at another site. 95% of the transport is done by rail. During the last three years there have been 16 reported rail accidents involving vinyl chlo ride tank cars. The amount of vinyl chloride that persons in the vicinity may have been exposed to at these times and the effects of single large doses of vinyl chloride are not known. Finished Products Finished PVC products probably contain levels of unreacted VCM of 5 to 20 ppm. The VCM may be released slowly upon storage presenting a possible hazard to warehouse per sonnel. It may be released when the finished products are disposed of and incinerated. 4_^_/ Ibid. p. 32. CRS - 22 PVC pipes and liners are used in many water supply systems. Little is known about the extent or effect of possible PVC migration from there into drinking water. PVC wrappings used for food may also allow migration of small amounts of VCM into food products. The extent of this and the possible effects on the population are being investigated by FDA. Meat wrappers who use a heat source to cut PVC wrapping may develop 'meat wrappers syndrome'. This is a respiratory problem. It might be caused by hydrochloric acid, VCM, or some other PVC degeneration product. OSHA and NIOSH are presently investigating this problem. PVC packaging for food and drugs was introduced in the 1940's and was in use before the enactment of the Food Additives Amendment of 1958. Therefore, It was not tested for toxicity as more recent additives have been. FDA will set up an Interim level of allowable VCM migrating into food from PVC wrapping under Code of Federal Regulation 121.4000 pending an investigation of the carcogenicity of VCM by the oral route. The final proposal for an interim standard may be based upon a particular al lowable level of VCM migration from the PVC packaging rather than upon VCM residual levels in the PVC. The Society of the Plastics Industry has suggested a level of 50 ppb. Methods have been developed to detect vinyl chloride in foods in that quan tity. One of the problems with a standard of migration of VCM Is the difficulty In measuring lower amounts of VCM in food. FDA studies have indicated that a reading of 50 ppb Is the lowest that can be reported with confidence. 46 / Use of PVC in cosmetic and drug containers will probably follow the same standards as those the Bureau of Foods sets for food wraps. 47 / The use of PVC In blood bags is one particular case where substitutes are held to be inadequate. The only possible substitute is to return to the use of glass. R&S 106222 _46/ JiU PVC Interim Regulation Based on UCM Extraction Previewed Food.Chemical News, Jan. 20, 1975. p. 33-35. Second Thoughts on Using PVC. Chemical Week, July 31, 1974. p. 19-20. R&S 106223 CRS - 23 This would require complete redesign of facilities. It has also been suggested that the increased safety of PVC may make its use advantageous even if small amounts of VCM are present. 48/ Food and Drug Administration, Bureau of Foods Personal Communication. CRS - 24 IX. EPIDEMIOLOGY As of January 16, 1975, 38 cases of angiosarcoma of the liver among workers exposed to vinyl chloride had been i(`ported from ten countries. The median age at diagnosis of angiosarcoma of the liver for all known occupational cases is 45 years with a range of from 36 to 71 years. The median interval from first exposure to vinyl chloride to detection and diagnosis of angiosarcoma is 18 years with a range of from 6 to 30 years. The shortest exposure time is 3 years. See Table I. Two other cases of angiosarcoma of the liver occurred in persons who had no occupational exposure to vinyl chloride but who had lived within 1/2 mile of a plastics factory for 35 years and within 2 miles of an electrical products plant for more than 50 years. One case of hepatoma, not angiosarcoma, was diagnosed in 1971 in the young daughter of a PVC worker. However, hepatoma is a common lesion and occurs in perhaps 16% of all childhood tumors. 49/ to any possible vinyl chloride exposure. Therefore it may well be unrelated There is some question whether exposure to vinyl chloride specifically induces only angiosarcoma of the liver or whether it increases the rate of incidence of other more common cancers as well, as is the case in animals. Tabershaw and Gaffey 50 /, in a study of 8383 men, including 352 death records, who had at least one year of occupational exposure to vinyl chloride, gave evidence that vinyl chloride may possibly be involved not only with angiosarcoma of the liver but also with cancers of other sites. Cancers of the respiratory system, brain and of unknown site and lymphomas occurred very slightly more often than expected in those members of the study population with the greatest estimated exposure. Criticisms of this study, and R&S 106224 49/ U.S. Center for Disease Control, op.cit. 50/ Tabershaw, I.R. and W.R. Gaffey. Mortality Study of Workers in the Manufacture of Vinyl Chloride and its Polymers. Journal of Occupational Medicine, v.16, no.8, Aug. 1974. p.509. I TABLE I - Reported Cases of Liver Angiosarcoma in Workers Exposed to Vinyl Chloride or Polyvinyl Chloride 51 / Country Canada Canada Canada Canada Czechoslovakia Czechoslovakia France Great Britain Great Britain Italy Norway Rumania Sweden United States United States United StateB United States United States United States United States United States United States United States United States United States United States United States United States Case No. Birth Date First VC or PVC Exposure Diagnosis of angiosarcoma 01 02 03 04 01 02 01 01* 03 02 01* 01 01* 01* 02* 03* 04* 05* 06* 07* 08* 09* 10* 11* 12* 13* 16* 17 Polymerization Workers Awaiting Details -- 00-00-01 00-00-46 06-00-37 02-00-66 11-13-29 00-00-57 12-23-15 03-00-50 Awaiting Details 06-23-27 08-14-51 10-17-23 12-09-48 08-19-33 11-15-55 05-25-15 11-28-45 01-15-24 07-06-52 01-25-12 06-19-44 00-00-29 01-17-62 05-03-22 08-00-44 05-06-20 10-07-46 00-00-31 05-28-45 08-16-13 06-12-51 05-27-09 10-14-46 11-17-18 09-13-49 12-01-21 08-19-44 11-04-27 05-08-50 05-06-31 06-23-55 - 12-00-72 - 12-12-72 12-20-71 02-00-70 03-03-73 05-00-70 12-19-73 08-19-67 04-09-64 02-00-74 00-00-68 08-00-61 03-01-74 05-00-68 03-00-70 05-02-69 05-00-74 00-00-69 10-11-74 Age at DIag. 43 71 38 43 56 43 49 36 58 43 52 45 45 41 43 55 61 50 53 41 43 Years Since First Exposure Total Years Exposure 19 19 26 20 84 15 6 22 21 19 18 22 16 14 13 28 28 15 15 20 18 12 12 24 18 15 15 29 17 17 17 23 23 20 15 30 30 17 4 19 19 Date of Death 00-00-67 12-00-72 12-00-72 01-04-72 10-20-70 03-03-73 09-28-71 12-19-73 01-07-68 04-09-64 Alive 03-23-68 08-29-61 Alive 05-10-68 03-16-70 05-02-69 07-04-74 03-27-69 Alive CRS 5V U.S. National Institute of Occupational Health and Safety. Dr. Heath, Personnel Communication. SZZBOl S3U 932901 SSH TABLE I - Reported Cases of Liver Angiosarcoma in Workers Exposed to Vinyl Chloride or Polyvinyl Chloride 51/ Country West Germany West Germany West Germany West Germany Case No. 01 02 04 05 Birth Date First VC or PVC Exposure Diagnosis of angio sarcoma Age at Diag. 07-26-31 06-04-30 - - Polymerization Workers, cont. 10-14-57 10-01-57 - - 00-00-71 00-00-69 - - 40 39 44 49 Years Since First Exposure 14 11 17 11 Total Years Exposure 14 11 - Date of Death 12-14-71 01-25-69 - Alive Great Britain Italy Sweden United States United States West Germany Compound ers, Fabricators, and V.C. iPolymerization Workers 02** 09-08-14 00-00-46 01 06-15-34 00-00-65 02* 11-27-11 00-00-45 14 00-00-13 08-18-38 15* 00-00-25 00-00-00 03 00-00-00 00-00-00 02-00-70 04-19-71 05-15-72 06-00-73 07-00-72 00-00-00 55 36 61 60 47 43 24 6 27 36 00 14 11 3 23 00 00 00 12-00-70 04-16-71 00-16-72 07-03-73 02-15-73 00-00-00 Note 1 Note 6 Note 7 Note 2 6 5 Note 3 Note 4 Note 1 Note 2 Note 3 Note 4 Note 5 Note 6 Note 7 Pouring PVC oil mixture onto fabric bases Machine operator covering electrical wire with PVC plastic insulation Accountant at several fabrication plants (work history under review) Loading pesticide cans with VC propellant Diagnosis: Sarcoma (possibly ''angiosarcoma1'), liver. Possibility of generalized neoplasm of the reticuloendothelial cell system cannot be ruled out. Worked for producer of PVC sacks. Had angiosarcoma of several sites. VCM worker * Indicates microscopically confirmed angiosarcoma of the liver. "OO" Indicates unknown data. CRS i roo\  i--:- V. 1 H&S 106227 CRS - 27 the relatively small increase in cancer mortality it shows, have been made on the basis of the fact that workers with long exposure and long latency periods since first exposure are inadequately represented in the study. Monson and others 52 /, in a study of 161 deceased workers, found a 50% excess of observed versus expected deaths due to all cancers with the greatest specific excesses including cancer of the liver, biliary tract, lung and brain. Epidemiological studies carried on at the Dow Chemical plant in Midland, Michigan indicate in a very preliminary way that the vinyl-chloride-induced increase in some cancers may be reduced in populations exposed to less than 200 ppm TWA. No data on angiosarcomas is available. 53 / NIOSH - Center for Disease Control ' (CDC), in a study of 930 workers, including 109 death records, who had achieved five or more years of employment and ten years aince onset of initial employment, found a 57Z increase in deaths due to cancer. This apparent increase is "not limited to any single organ system. An excess cancer mor tality was observed for the respiratory system, the blood forming tissues and the brain and central nervous system." The number of deaths from liver cancer in this population was almost twelve times the number expected. Strikingly, the majority of these excess cancer deaths did not occur until 15 or more years after first exposure to vinyl chlo- % This latent period is consistent with other observations on occupational can cer . 54/ Dr. Thomas Mancuso of the University of Pittsburgh, School of public Health, pointed out that vinyl chloride is a possible "index carcinogen" for a whole group 52_/ Monson, R.R., Peters, J.M. and M.N. Johnson. Proportional Mortality Among Vinyl Chloride Workers. The Lancet, Aug. 17, 1974. p. 397-398. 53j/ U.S. Occupational Safety and Health Administration. Hearing before Administrative Law Judge Mvatt. Testimony by B.B. Holder of the Dow Chemical Co., Midland, Michigan. ^4_/ U.S. Congress, Senate. Subcommittee on the Environment, op. cit. p.59. i' R&S 106228 CRS - 28 of similarly structured chemicals. The chance recognition of vinyl chloride brought about because it causes a rare form of cancer will, he hopes, lead to a comprehensive national study of industrial cancers. OSHA is investigating indica tions which came from chemical manufacturers of a possible link between vinylidene chloride, one of the PVC copolymers, and cancer. 55 / Studies by Dr. Viola show the development of abdominal tumors at 200 ppm of vinylidene chloride in animals. The effects of vinyl chloride appear to have had a long latent period. This means that the relatively low numbers of deaths to date may, as Anthony Mazzocchi of the Oil, Chemical and Atomic Workers put it, "be only the tip of the iceberg" as far as the future effects of past vinyl chloride exposure is concerned. 55/Vinylidene Chloride: New Cancer Threat? Job Safety and Tfealth, Dec. 1974. p.2. CRS - 29 X. ANIMAL DATA ON THE HEALTH EFFECTS OF VINYL CHLORIDE Dr. P.L. Viola reported at the Tenth International Cancer Congress his observa tions of malignant tumors in the ear canals (cymbal glands) of rats exposed to 30,000 ppm vinyl chloride for four hours per day, five days per week. He also reported tumors in the lungs and bones of the rats. In the United States on May 5 and 6, 1971, he gave a more detailed report to the MCA noting that he had observed tumors at levels of 5,000 ppm.56/ Dr. Maltonl's studies, by February of 1974, uncovered the formation of tumors in animals exposed to 250 ppm vinyl chloride. In May he reported tumors produced at 50 ppm. Bio-Test Laboratories in Decatur, Illinois, under a contract with the MCA began animal tests February 1, 1973.57/ Three species of animals, albino mouse, albino rat, and golden hamster, were used. Tumors were developed in all three species. As of August 14, 1974 the hamsters had developed tumors only upon exposure to 2,500 ppm. But both mice and rats had developed tumors at 50 ppm. Tumors were found in the liver, lung, kidney and mammary gland. Both Bio-Test Laboratories and Dr. Maltoni have demon strated that the tumors are to some extent dose-related. That is, more tumors occur at higher levels. Whether vinyl chloride would continue to cause tumors, though propor tionally fewer and fewer tumors per exposed population, as the level of exposure dropped or whether investigators could eventually designate some level of vinyl chloride as a "no effect" level, below which vinyl chloride is not carcinogenic in animals, remains to be seen. At the present, tests have not been completed at levels below 50 ppm so the carcinogenicity of these low levels has not been determined. Studies are presently un derway to determine the teratogenic (birth defect) effects of vinyl chloride, if any. 58/ 56_/ Viola, P.L., Bigotti, A., and A. Caputo. Oconogenic Response of Rat Skin. Lungs, and Bones to Vinyl Chloride. Cancer Research, v. 31. p. 516-581. 57 / Industrial Bio-Test Laboratories, Inc. Decatur Research, 1800 East Pershing Road, Decatur, Illinois, 62526. Communication to Dr. K.D. Johnson of MCA, August 16,1974. R&S 106229 R&S 106230 CRS - 30 XI. HUMAN HEALTH EFFECTS OF VINYL CHLORIDE Angiosarcoma of the Liver Primary cancer of the liver is uncommon in the United States, and primary carcinoma of mesodermal origin is extremely rare. About 25 instances of angiosarcoma of the liver are normally found in a year in the entire U.S. population. Because of this, angiosarcoma is a difficult diagnostic problem. Many are recognized only upon autopsy. Initial clinical symptoms vary widely and include weakness and tiredness, pronounced weight loss and enlargement of the liver. About two-thirds of all carcinomas of the liver have a clinical onset characterized by indefinite abdominal symptoms which are usually attributed to gastric disturbances, sometimes gastric ulcer. The liver symptoms are generally indicative of cirrhosis. Some patients, when detected, were asymptomatic. In adults, carcinoma of the liver, if untreated, is uniformly fatal within six months. Carcinoma of the liver can be cured only by surgical excision and this is possible only when the lesion is small and well localized. Chemotherapeutic agents and radiation therapy are of palliative value only. It may be that there is considerable variation in susceptibility to the hepatic effects of vinyl chloride. Heavy alcohol intake renders workers more susceptible to the effects of carbon tetrachloride, for instance. In some of the PVC angiosarcoma cases non-malignant hepatic lesions, sinusoidal dilation, and atypical sinusoidal lining cells coexisted with the cancer. Conceivably such lesions may represent a precursor stage in development of the angiosarcoma and might aid in early detection. Cases of angiosarcoma do not seem to be typically preceeded by acro-osteolvsis. CRS - 31 Angiosarcoma of the liver is also proved to be caused in humans by exposure to arsenic and to Thorotrast, a radioactive material in the form of colloidal thorium dioxide used in cerebral vessel visualization between 1930 and 1947. 59/ 60/ Acro-osteolysis As early as 1957 a new occupational disease among PVC polymerization kettle cleaners was beginning to be identified. In the 1960's this syndrome first came prominantly to notice. It was wide-spread among workers, occurring in approximately one to three percent of vessel cleaners. Symptoms included soreness and thickening of the skin of the finger tips, gradual dissolution of the calcium of the bones of the fingers and toes, skin sores and sometimes heightened sensitivity of the hands to cold, including blanching or cyanosis of the skin (Raynaud's phenomenon), and pain. The bone lesions in the distal phalanges of the fingers were associated with striking changes in the vascular system. Hepatomegaly (enlargement of the liver) was also observed. The condition was apparently self-limiting, there being consider able improvement in skin and vascular changes when the patient left the manufacturing complex. j/ 2/ Vinyl Chloride Worker's Disease Exposure to vinyl chloride, for long periods of time has been shown to produce in some workers one or more of a constellation of symptoms that have been designated 5d/ Lee, F.I. and D.S. Harry. Angiosarcoma of the Liver in a Vinyl Chloride Worker. The Lancet, June 29, 1974. p. 1317. 60/ Interagency Collaborative Group on Environmental Carcinogens. Meeting Held April 17, 1974. Transcript. 61/ Dinman, B.D. et al. op, cit. Dodson, V.N. et al. op. cit. Cook, W.A. et al. op. cit. J52/ Wilson, R.H. et al. Occupational Acroosteolysis: Report of 31 cases. Journal of the American Medical Association, v. 201, 1967. p. 577-581. R&S 106232 CRS - 32 "vinyl chloride worker's disease." Reported symptoms include: blood changes such as slight to moderate lessening in the number of circulating platelets, production of excessive numbers of immature red blood cells, and circulatory disturbances of the Raynaud type, enlargement of the spleen, pain in the upper abdomen, nervous system lesions, impotence and hormonal imbalances, pulmonary lesions and changes in liver anatomy and function. The lung changes may be caused by exposure to PVC dust rather than to vinyl chloride itself. Liver changes include enlargement and tenderness of the liver apparent upon palpation, abnormal liver function tests, fibrosis of the liver, detectable by biopsy or by peritoneoscopy, and portal hypertension. The surface of the liver, upon biopsy, may be seen to be covered with highly character istic rice-grain sized nodules of surface fibrosis. The liver changes seem to conform to some extent to Banti's syndrome, and may thus be related to portal hypertension, at least in part. The liver damage may persist for up to two and a half years after the vinyl chloride worker has been removed from exposure, but much of the damage seems to be reversible. Whether the changes in the liver in some cases are indicative of a pre-cancer state has not been determined. 63 / Selikoff and others 64 / found that splenomegaly was more common in workers with longer, more than five years, experience, but that a higher percentage of abnormal liver function tests were found in workers with current exposure. Mutagenesis and Teratogenesis Rannug and others in Sweden, in a standard salmonella biotransformation test system showed that vinyl chloride is mutagenic. 65 / Dr. Selikoff, examining chromosomes 63 / Falk, H., et al. cop. cit. 64 / U.S. Congress. Senate. Subcommittee on the Environment, op. cit. p. 9, 65 / Ibid. p. 32. R&S 106233 CRS - 33 of 11 vinyl chloride workers has shown chromosome changes Co be present considerably more often chan would be expected* fjJ Finally, Dr. Infante, In epidemiological studies, has shown that there is a possibility that persons who may be exposed to environmental vinyl chloride in the vicinity of VC-FVC plants may have a higher rate of birth defects. 67/ These data are very preliminary. Dr. Maltoni's experiments 68/ also show that pregnant rats exposed to vinyl chloride may have offspring which develop angiosarcomas. The mutagenic and teratogenic potential of vinyl chloride has not, of course, been proven, but preliminary tests have certainly indicated that this is an area that should be explored further. Such considerations also make exposure of pregnant women or women at risk of pregnancy to vinyl chloride a special concern. R&S 106234 CRS - 34 XII.THE OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION STANDARD The Occupational Safety and Health Administration (OSHA) standard sets an expo sure limit of 1 ppm averaged over any eight hour period and a ceiling of 5 ppm averaged over any period not exceeding 15 minutes. This standard applies to the entire vinyl chloride industry, VCM and PVC producers and fabricators but, where monitoring shows that no employee is exposed to levels over 0.5 ppm TWA, as is the case presently In many fabricating plants, the employer will be below the "action level" and exempted from many provisions of the standard such as medical surveillance and continual remonitoring. Where levels of VCM exceed the permissible level the use of respirators is required. 69/ 70/ 71/ Medical surveillance of employees, and re tention of records of exposure and medical examination for more than 30 years are required. The standard was ordered to go into effect January 1, 1975. Until January 1, 1976, however, though employers must provide respirators, If VCM remains below a 25 ppm ceiling, the employee may decline to wear them. 77/ For current occupational exposure limits for VCM In nine foreign countries see Appendix IV. 6%j 39 FR 45012 70 / U.S. National Institute of Occupational Safety and Health. An Evaluation of Organic Vapor Respirator Cartridges and Canisters Against Vinyl Chloride. Wash ington, D.C., 1974. 71 / For a general review of respiratory protection see Stellman, J.N. and S.M. Daum. Work is Dangerous to Your Health. New York, Vintage Books, 1973. p. 306-326. 72/ 39 Fed. Reg. 35890. (1974). R&S 106235 CRS - 35 XIH: FEASIBILITY OF THE OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION STANDARD There is little dispute by government and industrial experts that PVC fabricating plants can reach a level of 1 ppm in ambient workplace air with little difficulty or economic disruption. However, industry representatives have contended that the im position of a 1 ppm level standard for VCM producers and PVC resin industries is technically impossible. Enforcement of such a standard, they claim, would cause shut down of PVC plants in the United States, eliminate 1.7 to 2.2 million PVC related jobs, and result in a loss of production valued at $65 to $90 billion dollars per year. 73/ Foster D. Snell, Inc., an Independent consultant company, in their report to OSHA, concluded that "acheiving no detectable levels ... is judged not feasible, both in PVC and VCM sectors." The Snell study offers several reasons for concluding that the stan dard is infeasible: technology to eliminate VCM leaks and fugitive losses does not exist, existing plants have not been designed to operate at no detectable VCM level, lere is no operating experience in operating at very low VCM levels, there are no technology transfer opportunities to aid in design of new plants and, because PVC manufacture is a batch process, it could not be made emission-free. The Snell study estimated the cost, time needed for implementation and danger to the economic life of the industry as shown in Table II. 7V Both the Society of Plastics Industries and the Snell study are in agreement that control of emissions from VCM plants will be rela tively easier. 22/ Putting VCM Emissions on Skids. Chemical Week, Sept. 18, 1974. p. 67 and 71'. 22/ Showdown on Vinyl Plant Rule Presages Shutdown. Chemical Week, Sept. 25, 1974. p. 15. 0 CRS - 36 Table II Foster D. Snell, Inc. Report on OSHA'i vinyl itandard* impact: higher costs, fewer plants Propcad VCM nponn ttandard* (ppm.) T>ma- iwighMd Maximum awaga *nere#o in wriQO uni; costs (canti/lb.) Lot* of Direct productivity TottJ1 Tim# to eoreply (months) Proportion of industry ndoflftred1 50 15 25 15 10 2-S 'ho detattabla amount" Mymar ptapti 50 = 25-40 15-25 15-25 10-15 "No detectable amount" 0.04 0.09 0.17 - 0.19 (130 0.90 4.01* 0.03 0.03 0.15 - 0.35 0.49 0.70 3.07* 0.07 t 10% 0.12 * 40% 0.32 40% 0 24 30 Not faauUa 0% 0% 0% 100% 0.54 i 20% 0.85 35% 1.00 50% 7.08 t 75%' 0-0 30 30 30-48' Negligibl* 4% 26% 100% # Vinyl chloride monomer (VCM) content, enpretaed # pertv per million. In the sir to which employee* ere ixpood. 1 With evtlmeted rang* of verlence for Indtvkfu#! plentm, beaed on pertlel ttetlstlcel analytleol dete. 1 ^ercentepe of cepeclty that manegement would gerloualy consider thutting down, 1 Baud on Flre*tone'tetlmete;ectual compliance I* not considered feeaible. Source: Foster 0, Snell, Inc. In the control of VCM emission in PVC resin production, according to Walter Schlegal, the "major trouble spots are at four primary points in the manufacturing process, 1) slurry holding tanks, 2) dryer, 3) reactor (during routine cleaning between batches), 4) recovery systems for process vent gases."75/ The largest problem may well be cleaning the humid, VCM filled air that has been used in drying the resin. Large amounts of air must be used, 40,000 cu. ft. / minute, for example. This problem could be solved if the VCM were removed from the slurry before it reached the dryer. Alternatively, this air might be dehydrated and recycled. Equip ment to do this is available, but very expensive. Other techniques for controlling VCM emissions are presently under investigation. One possibility is'adsorption of VCM from vent gases by activated carbon with re generation of the monomer by steam or the final vent gas streams from emission sources 3) could be refrigerated to remove most of the remaining VCM. , Such methods could possibly (/) --i jJ 75_/ Putting VCM Emissions on Skids, op. cit. p. 66. ro CO 0) " achieve levels of 5 ppm according to Tenneco Chemicals. Another process developed by Robin-Tech (Ft. Worth) is called Rocor IKC (in-kettle compound). It is in the process of being patented. The process combines two commonly used steps, resin making and incorporation of additives. The company claims that PVC made by this process virtually eliminates exposure of workers to VCM in the fabrication process. Companies are also looking into the possibility that the polymerization process may be driven more nearly to completion, thus easing the problem of down-stream clean-up. Another possibility is the remote operation of plants. Separation of control areas from reactor areas, while decreasing the on-the-spot ability to deal with emergencies, would decrease worker exposure.76/ "Tenneco has licensed a new PVC process which, in theory, should allow no film deposits on reactor walls. Consequently it is hoped reactors will not need to be opened on a routine basis in the Tenneco plant now being built in Pasadena, Texas." Dow, in its three monomer plants in Texas has instituted a series of procedures in cluding magnetic leading gauges for tank cars rather than venting gas, reintroduction into the closed system of gases removed for sampling rather than release to the atmos phere and use of inert gases to purge any part of the system that must be opened.77 / There are readily available substitutes for PVC in some products, more expensive substitutes for others and no substitutes at all for still others.78 / Glass, poly ethylene, polyvinylidene chloride, and other substitute materials could be used for containers, food wraps and packaging, in some cases, in place of PVC. According to Ralph L. Harding, President of the Society of the Plastics Industry (SPI): 79/1 1^J Ibid; Glack, G. The Best Available Evidence. Job Safety and Health, v. 3, no. 1. Jan. 1975. p. 12. ^_/ U.S. Environmental Protection Agency, op. cit. p. 1-5. ^2-! U.S. Congress. Senate. Subcommittee on the Environment, op. cit. p. 95. R&S 106237 R&S 106238 CRS -`38 "It would take a minimum of three to five years to come up with a replace ment Insulating material" for wires and cables. "PVC is regarded as having no known equal as a sealant for bridges and airport construction..........The PVC belting -t industry has similarly stated there is no known substitute for conveyor belting made from PVC." OSHA's environmental impact statement suggests that "in the long run U.S. companies^ might find it profitable to build plants abroad." The OSHA final standard states "We agree that the PVC and VCM establishments will not be able to attain a 1 ppm TWA level for all job classifications in the near future. We do believe, however, that they will,;S in time, be able to attain levels of 1 ppm TWA for most job classifications most of the ;> -. .1^' time; - It*-is apparent" that rAachin^ vauch levels may ' require some new technology and ''''rjl 'Pj work practices. It may also be necessary to utilize technology presently used in other-ij Industries. 80/ According to the petition filed by the SPI before the United States $ "I Court of Appeals there is no evidence to support the technological feasibility of ever achieving the exposure limits set by OSHA's final standard and the real effect of adop-'j* ' i/ai `_-A tion of the standard will be to compel full-time use of respirators by the work force -'$ which, in itself, will be detrimental to employee health. 81/ On October 1, 1974 SPI ',|j asked for Judicial review of the OSHA standard before the U.S. Court of Appeals. ^On November 5, 1974 they asked OSHA to postpone the effective date of the standard and were refused. On December 3, 1974 SPI asked the U.S. Court of Appeals to stay the OSHA order pending the decision of the court, and on December 13, 1975 the Court of Appeals granted a stay of the OSHA order. 82/ M/ 39 Fed. Reg. 35890. (1974). 81/ u.S. Court of Appeals for the Second Circuit. Brief for the Petitioner: The Society of the Plastics Industry, Inc. versus the Occupational Safety and Health Administration. (Case no. 74--2284) Washington, D.C., Bryon S. Adams Printing, Inc., Nov. 12, 1974. Plastics Corner. Journal of Commerce, Dec. 5, 1974. p. 8. -'.i CRS - 39 R&S 106239 APPENDIX I: CHRONOLOGY OF EVENTS 1946 American Conference of Governmental Industrial Hygienists establishes occupational exposure limit of 500 ppm for vinyl chloride in workplace air. 1949 A Russian group finds 15 of a group of 48 PVC workers with a hepatitislike condition. 1961 Torkelson et al. discover slight reversible liver injury to rats exposed seven hours per day to 100 ppm.. He recommends that the TWA of VCM not exceed 50 ppm. 1968 Kramer and Mutchler suggest that repeated exposure to VCM at 300 ppm TWA for a working lifetime can cause impairment of liver function, but no overt clinical disease in humans. 1970 ACGIH proposes lowering VCM exposure limit to 200 ppm because of liver toxicity studies. This action affirmed in 1972. OSHA level under the Occupational Health and Safety Act remains 500 ppm. May 22-29, 1971 Dr. Viola, at the Tenth International Cancer Congress describes observations of malignant tumors in the zymbal glands, skin, and lungs of rats subjected to levels of 30,000 ppm VCM. Jan. 30, 1973 NI0SH publishes in the Federal Register a request for information on the hazards associated with vinyl chloride and other substances from its 1972 priority list. Spring, 1973 B.F. Goodrich initiates liver tests on its VC industry workers. May, 1973 Dow Chemical warns its monomer customers not to use VCM in aerosols. May 9, 1973 FDA proposes rulemaking prohibiting the packaging of alcoholic foods in PVC because of leached VCM. Publishes notice in the Federal Register May 17. Fall, 1973 B.F. Goodrich finds 55 out of 271 tested workers show apparent liver abnormalities. Jan. 22, 1974 NI0SH is notified by B.F, Goodrich of three angiosarcoma deaths in the Goodrich plant in Kentucky. Jan. 24, 1974 Jan. 30, 1974 Feb. 1, 1974 Feb. 15, 1974 Feb. 21, 1974 NI0SH - CDC conduct onsite inspection of the Kentucky Goodrich plant. OSHA fact-finding hearing is announced. NIOSH - CDC holds a briefing for Federal agencies concerned about VCM. The OSHA informal fact-finding hearing on the possible hazards of vinyl chloride manufacture and use was held. Health Research Group, a Washington-based consumer action organization, petitions Consumer Product Safety Commission (SPSC) to prohibit continued use of household products containing VCM as a propellant and to remove CRS - 40 VCM containing products from the market; FDA to ban and name cosmetics with VCM; and EPA to suspend the use of pesticides containing VCM. Mar. 11, 1974 NIOSH publishes a recommended occupational health standard for VCM at no detectable level. Mar. 28, 1974 EPA asks for a voluntary ban of VCM in pesticides. Apr. 3, 1974 Recall by FDA of cosmetics containing VCM. Apr. 5, 1974 OSHA sets an Emergency Temporary Standard for VCM in air at 50 ppm. At this time no angiosarcomas had been found in animals at levels below 250 ppm. (39 FR 12341). Apr. 15, 1974 Industrial Bio-Test Labs presents data showing animal cancer at 50 ppm. Apr. 17, 1974 EPA releases the names of some pesticides containing VCM. Apr. 22, 1974 FDA requests a list of all marketed drug products containing VCM as a propellant or packaged in PVC. (39 FR 14238). Apr. 22, 1974 FDA publishes a notice of proposed amendment to the Food, Drug and Cosmetic Act concerning the use of VCM as an ingredient of aerosol drugs and cosmetics. Drugs containing VCM or packaged in PVC will require a New Drug Application. (39 FR 14215). Apr. 24, 1974 OSHA publishes notice of an intent to file an environmental impact statement of the proposed occupational VCM standard. (39 FR 14522). Apr. 26, 1974 EPA gives notice of an emergency aispension of the sale of pesticides containing VCM and an intent to cancel registration of the use of VCM in indoor pesticide sprays. (39 FR 14753). April and May, EPA carries out initial monitoring of the emission of VCM by twelve 1974 VCM and PVC plants. May 7, 1974 CPSC requests information on which aerosol products contain VCM and on possible hazards of these products. (39 FR 16511). May 8, 1974 AFL-CIO Industrial Union Department petitions OSHA for amendment of the Emergency Temporary Standard to be lowered to no detectable concentration. May 10, 1974 OSHA prints notice of proposal to reduce the limit of occupational exposure to VCM to "no detectable level" or 1 ppm plus or minus 0.5 ppm. (39 FR 16896). May 10 and 11, 1974 New York Academy of Sciences with the American Cancer Society holds a symposium on VCM sponsored by NIOSH and NIEHS. Among others, Dr. C. Malto gives data. May 23, 1974 CPSC prints notice of proposal to ban household aerosols containing VCM. (39 FR 18115). R&S 106240 R&S 106241 CRS - 41 May 24, 1974 May 31, 1974 OSHA gives notice of a public hearing on VCM (39 FR 18303). EPA requests manufacturers of VCM and PVC resins to provide detailed technical and economic information concerning steps that have been and could be taken to reduce VCM emissions, under section 114 of the Clean Air Act. June, 1974 CDC establishes nationwide surveillance registry for angiosarcoma. June 11, 1974 The Administrator of EPA releases preliminary data from monitoring of 12 VCM and PVC plants indicating no imminent pollution hazard. June 12, 1974 OSHA announces availability of the draft copy of the environmental impact statement. Notice published in the Federal Register June 25. (39 FR 22975). June 24 and 25 , LARC/WHO Working Group on Vinyl Chloride meets in Lyons, France to 1974 consider procedures for coordination of future international activities. NCI and NIOSH-CDC participate. June 25 and 28 The OSHA hearing before Administrative Law Judge Myatt on the possible July 8 and 11, hazards of exposure to VCM. 1974 July 1, 1974 EPA releases additional names of pesticides containing VCM. July 29 and 31 1974 The National Institute of Environmental Health Sciences holds a meeting at Pinehurst, North Carolina to assess the public health aspects of the plastics industry. July, 1974 The Department of Transportation publishes proposals to amend the bulk dangerous cargoes regulations for carriage of VCM (39 FR 26752) and requirements for flamable protection for VCM and others (39 FR 27572). Aug. 21, 1974 CPSC bans VCM as a hazardous substance. (39 FR 30114). Aug. 26, 1974 FDA publishes regulations which ban the use of VCM in cosmetics and require a New Drug Application for marketing drug aerosols with VCM. (39 FR 30830). Sept., 1974 EPA issues preliminary assessment of environmental problems associated with VCM and PVC. Sept. 6, 1974 OSHA files final environmental impact statement. (39 FR 32350). Sept. 13, 1974 OSHA files notice of the availability of the final economic impact statement for compliance with the proposed standard. (39 FR 33009). Sept. 18, 1974 EPA releases a report on air and water monitoring around several VCM and PVC plants. Oct.l, 1974 OSHA announces new regulations concerning levels of VCM in workroom air. CRS - 42 R&S 106242 Oct.l, 1974 SPI asks for Judicial review of the OSHA standard before the U.S. Court of Appeals. (case no. 74-2284). Oct. 4, 1974 OSHA publishes the Occupational Safety and Health Standard for VCM (39 FR 35890). It is a time weighted average of 1 ppm with a ceiling of 5 ppm and is scheduled to go into effect on Jan. 1, 1975. Oct. 11, 1974 CPSC denies requests by manufacturers for a hearing on the classifica tion of VCM as a banned hazardous substance and more specifically of the order to repurchase VCM containing aerosols. (39 FR 36576). Nov. 5, 1974 SPI requests OSHA to postpone the effective date of the standard. Nov. 12, 1974 SPI files a brief in the U.S. Court of Appeals of the Ninth Circuit against OSHA for review of the OSHA standard. Dec. 3, 1974 SPI asks the U.S. Court of Appeals of the Second Circuit to stay the implementation of the OSHA order pending the decision of the court. Dec. 13, 1974 The U.S. Court of Appeals for the Ninth Circuit stays that portion of the order of the CPSC ban on VCM aerosols requiring manufacturers to repurchase their products. Dec. 13, 1974 The U.S. Court of Appeals of the Second Circuit grants SPI a stay of the OSHA order. Jan. 1, 1975 The OSHA standard did not go into effect because of the Court action. APPENDIX II; FEDERAL REGISTER 39, 35890, THE OSHA STANDARD FOR EXPOSURE TO VINYL CHLORIDE FRIDAY, OCTOBER 4, 1974 WASHINGTON, D.C. Volume 39 Number 194 PART II CRS - 43 R&S 106243 DEPARTMENT OF LABOR Occupational Safety And Health Administration EXPOSURE TO VINYL CHLORIDE Occupational Safety and Health Standards CRS - 44 RULES AND REGULATIONS Title 29--Labor ployees from a rare liver cancer (angio and abroad. Q8HA proposed to revise CHAPTER XVII--OCCUPATIONAL SAFETY ANO HEALTH ADMINISTRATION, DE PARTMENT OF LACOR PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS sarcoma) may have been occupationally related. As a result of this notification and alter consultation with NIOSH. and a Joint inspection of the B. F. Goodrich plant by OSHA, NIOSH and the Ken tucky Department of Labor, a fact-find 1910.93q and published a comprehensive proposal <39 FR 16896) on May 10, 1974. to protect employees from hazards of exposure to VC. The proposal called for limitation of employee exposure to VC to "no detectable level." as measured by a Standard (or Exposure to Vinyl Chloride ing hearing was announced on Janu sampling and analytical method sensitive Pursuant to sections 6<b). 6(c), and 8(c) of the Occupational Safety and Health Act of 1070 <84 Stat. 1593. 1538. 1509: 29 O.S.C. 055. 657) Secretary of Labor's Order No. 12-71 <36 FR 8754) nd 20 CFR Part 1911. } 1910.93 of Part 1910 of Title 29. Code of Federal Regu lations U 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 Background-->( 1 > Vinyl chloride. Vinyl chloride (chloroethene). Chemical Abstracts Service Registry No. 75014. la a synthetic organic chemical made from ethylene or acetylene and chlorine by any ot several processes. It Is the parent compound of a series of thermoplastic resin polymers and copolymers which are widely used lor 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 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 farm 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 ary 30, 1974 <30 FR 3874) and held on February !5. 1974. Informal io . obtained from this hear ing. particularly the preliminary reports of experiments conducted by Professor Cesare Maltonl ot the Institute dl Oncologla. Bologna. Italy, demonstrated that vinyl chloride induced Angiosarcoma In rats at levels as law as 250 ppm, and In other species at higher levels. Experi ments performed at lower levels of ex posure were not completed at that time. Other testimony from medical witnesses and NIOSH. and the results of autopsies, led to the conclusion that the Goodrich workers had angiosarcoma of the liver and that VC probably was the causal agent In the angiosarcomas observed. In post hearing comments, additional angiosarcoma deaths were reported among workers who had been exposed to. VC In plants operated by Union Carbide Corporation. Firestone Plastics Corpora tion and Goodyear Tire fi 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 5, 1974 <39 FR 12341) pursuant to section 6(c) of the Act, aa 29 CFR 1010.93q. This standard reduced the permissible exposure level from a celling 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 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. On April 15,1974, Information and data were presented to representatives of to l ppm. with an accuracy of 1 ppm =t50 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 of employee exposures was proposed, along with engineering and work practice controls to be Implemented when exposures over the detectable limit were measured. Respiratory protection would have been required while engineering and work practice controls were being implemented or where exposures exceeded 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. <41 Hearing on the proposal. The pro posal, as published on May 10, T974, 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) <3X of the Act for promulgation of a final standard, it was decided to hold a hearing as soon as possible. Accord ingly, on May 24.1674. a notice of a bear ing was published <30 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 the hearing were given until August 23, 1974, to file additional posthearing com firms range in size from those with few OSHA, NIOSH, and the Environmental ments, Including various items of Infor employees and simple equipment to large Protection Agency by the Industrial Bio- mation which were requested during the plants Involving many employees and Test Laboratories, Northbrook. Illinois, examination of witnesses. considerable capital.' concerning results of animal exposure <51 Economic and technical impact Vinyl chloride tVC). a gas at ambient temperature and pressure, la a chlori nated hydrocarbon, which heretofore has been regarded as having moderate liver toxicity. The Initial standard, contained in Table G-l of 1910.93. established a ceiling value of 500 parts of VC per mil lion parts of air. <21 The emergency temporary stand ard. On January 22. 1974. the Occupa tional Safety and Health Administra tion (OSHAI was informed by the Na tional Institute for Occupational Safety and Health iNIOSH) that the B, F. Goodrich Chemical Company had re ported Utat deaths of several of Its em studies with VC. These studies were sponsored by the Manufacturing Chem ists Association. Although only pre liminary In nature at that time, these results revealed that 2 out of 200 mice exposed to VC concentrations of 50 ppm for 7 hours a day. five days a week, for approximately 7 months, had developed angiosarcoma of the liver, (3) The proposed permanent stand ard. Based on the demonstrated evidence of VC's carcinogenicity In three animal species (rats, mice and hamsters), and the substantial probability that VC had been the causal agent In the cases of liver angiosarcoma found In workers both here study. During the hearing. OSHA deter mined that additional facts would be needed to determine the practicality of certain aspects of the proposed stand ard. Accordingly. OSHA contrcted an In dependent consultant, Foster D. Snell Corporation, to conduct studies of the feasibility of compliance at various ex posure levels, Including those proposed by OSHA *nd others advanced by In dustry spokesmen. Snell was also com missioned to collect Information regard ing the economic costs of compliance. This action was announced at the close of the bearing, and Judge Myatt further announced that the record would be kept R&S 106244 FEDERAL REGISTER, VOL 39, NO. lVWFRlOAT. OCTOBER 4. 1974 R&S 106245 CKS - 45 RULES AND REGULATIONS open for ft period of time beyond August studies of Maltoni and Bio-Test Labora may create a carcinogenic hazard, the 23, to allow Interested persons to com tories. Moreover. Maltom's investigations amount of exposure which Is hazardous ment In writing on the study. On August have demonstrated a dose-dependent re must be determined. The Surgeon Gen 26, 1974. OSHA announced that the pre lationship for Induction of tumors (I.e.. eral's Ad Hoc Committee referred to liminary study was available and that more tumors occur at higher exposure above concluded that safe exposure leveb comments were to be submitted no later levels), including angiosarcoma ol the for carcinogenic substances cannot be than September 6, 1974 (39 FR 30044). liver, in rats. The investigations of In scientifically determined. This position On September 13, 1974. OSHA Invited dustrial Bio-Test Laboratories have dem la supported by the testimony of NIOSH comments on both the preliminary and onstrated a similar relationship for at the hearing. Its recommendations for the Anal study, which was to be received both rats and mice. These investigators a standard of no detectable level, and by on or before September 2S, 1974 (39 FR have Induced angiosarcoma of the liver the testimony of expert witnesses from 33009). In rats and mice at exposure concentra the National Cancer Institute. (6) Environmental impact statements. tions of 50 ppm. and In hamsters at high Several witnesses and persons who sub A notice of Intent to file an environmen er concentrations of exposure. Additional mitted comments have taken a contrary tal Impact statement assessing the Im tumors Involving other organs. Including view and. have suggested that man Is less pact of a proposed standard on occu the kidneys, lungs, and skin of exposed sensitive to biologic aberrations Induced pational exposure to VC was published animals, were also observed In frequen by vinyl chloride exposure than experi In the Federal Register on April 24, cies much in excess of control animals. mental animals. Proponents of this posi 1974 (39 FR 14522). The notice Invited The Incidence of tumors in mice in the tion have argued that If humans were as any person having Information or data Industrial Bio-Test Laboratories Investi sensitive as rodents, an "epidemic" of on the environmental impact to submit gations is particularly pertinent. Of 200 cancer resulting from VC exposures It to OSHA by May-17. 1974. On June 12, mice (100 males. 100 females) exposed to should have already been discovered 1974, a draft environmental Impact 50 ppm of vinyl chloride by Inhalation for among employees. They also argue that statement was prepared and circulated eleven months. 100 died. Sixty-four ani the employees In whom tumors have been to all Interested persons. Ten copies were mals died without gross postmortem observed are those who have considerable forwarded to the Council of Environ pathologic examination being performed. employment experience as polymeriza mental Quality (CEQ), which published Of the 36 remaining animals for which tion reactor cleaners. Because It Is gen a notice of Its filing and availability in a gross postmortem pathologic examina erally agreed that reactor cleaning In the Federal Register on June 25, 1974 tion was performed, 13 (36 percent) volved high exposures to vinyl chloride (39 FR 22975). A 45 day period was al were found with liver tumors (Including In years past. It Is argued that the lower lowed for the submission of comments on angiosarcomas), 21 (56 percent) with levels currently found In the workplace the draft statement. On September 5, lung tumors, 9 (25 percent) with skin have not Induced cancer and are there 1974, the final environmental Impact tumors, and one with a kidney tumor. fore safe. We reject this argument. statement was prepared and a copy of It According to the 1970 report by the The fact that approximately three- and all substantive comments were sent Surgeon General's Ad-Hoe Committee quarters of those employees with the to appropriate governmental agencies, on the Evaluation of Low Levels of En longest exposure to VC (greater than private organizations, and other Inter ested persons. CEQ published a notice of vironmental Chemical Carcinogens, the finding of cancer In two or more animal 20 years since Initial exposure) have not yet been located, makes it Impossible to avaDability for the final statement on species may be extrapolated to Indicate determine the actual number of affected September 6. 1974 (39 FR 32350). The submission of comment was Invited un ft-carcinogenic hazard to.humans.-Here, such a finding was made In three species employees. The eases of liver tumors ob served to date have an average latency til September 25, 1974. The final state that were exposed to VC by Inhalation-- period, since Initial exposure, of approxi ment and all significant comments have a route comparable to employee ex mately 20 years. If It Is assumed that in 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 pre and post-hearing comments and testimony received at both factfinding and rulemaking hearings, the studies and Inspections conducted by OSHA person-i 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 news, know-ledge and experience available to OSHA. The en tire record encompassing these submis sions was thoroughly reviewed and evaluated In reaching the determina tions set forth below. H, Findings regarding carcinogenicity, exposure levels and feasibility--U) Car- dnogenicity of vinyl chloride. The car cinogenicity of vinyl chloride for three animal species (rat, mouse, hamster) has 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 UB. adult male population (testi mony of Dr. Marcus Key, Director of NIOSH, at the rulemaking hearing). The findings of angiosarcoma of the liver In both experimental animal, 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 human., (e.g. testimony of Dr. McBuroey, Rulemaking hearing. 1041). Accordingly, it Is con cluded that VC must be regarded as a human carcinogen, and the probable causal agent of angiosarcoma of the liver, and that exposure of employees to VC must be controlled. Additional evidence of tumor induction In a variety of other organs, including lung, kidney, brain and skin, as well as non-mallgnant alterations, such as fi brosis and connective tissue deteriora tion. Indicates additional oncogenic and toxicologic properties of 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 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 tlje 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 liave been dramatically reduced since the 194Q'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 cr prac been documented on the record by the exposure of employees to vinyl chloride tice and resultant employee exposures FEDERAL REGISTER, VOL 39. NO. 194--FRIDAY, OCTOBER 4, 1974 r &S 106246 cns - 46 BUIES AND REGULATIONS (testimony and questioning by Tenneco e.g,, testimony of Bcllkoff. Firestone, NCI, confident that Industry will continue to Chemicals. Inc.). It has also been em and NIOSH.) do so. phasized that In only 3 0/8 polymeriza tion plants where employees have been exposed to VC for more Loan 20 years have any employees developed angiosar coma of the liver. This ar-umcnt is very similar to that ratted concerning vari In our view, the demonstration of can cer Induction in humans at a particular level is not a prerequisite to a determina tion that a substance represents a can cer hazard for humans at that level. It would be Imprudent to assume man to (4)Conclusions. The conclusions be low ore based on a thorough review and evaluation of all the evidence submitted. Where decisions can be based on record evidence, this has been done. Where, however, factual certainties are lacking ability of part employee exposure. Al be leas 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 an answer, policy Judgments have been ferences may ultimately be demonstrated conclusive evidence. It would also be un made. to be factors in distribution of angiosar founded to assume that animals will not There Is little dispute that VC Is car coma. sufficient information is unavail develop tumors when exposed at concen cinogenic to man and we 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-. "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 Schnelderman 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 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 95 percent of all employees ex quired a balancing process. In which the veyed did not Include ail 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 SPI testimony). However. Industry may have regular exposures to VC lancer 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 on the available evidence and in size of the sample population decreases Industries to remain below 1 ppm con view of the above considerations, includ the possibility that tumors would be sistently, 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 that a I ppm ceil ppm time-weighted average (TWA). We In testimony at the hearing on the pos ing is not feasible for the VC and PVC also believe that PVC and VC establish sible metabolic pathways of VC. The Industries with present technology, but ments will. In time, be able to attain that hypothesis presented was that VC may that the VC Industry could currently at level through engineering controls, and exert Its carcinogenic effect by a metab tain lower exposure levels than the PVC that fabricators can do so In the Im olite, and that the metabolite Is pro industry. Labor union spokesmen and the mediate future. duced only when VC Is metabolized by a Health Research Group. Inc, however, In addition to the TWA 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 aver a 15-minute periods 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 celling 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 ttt 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 as Firestone has suggested, it Is not pos turers of VC and PVC and fabricators, generated at lower exposure concentra sible to accurately predict the degree of but excluding employers handling or tions In these species. Although this re Improvement to be obtained from en using fabricated products made from search may be helpful to the thorough gineering changes until such changes are VC. understanding of the carcinogenicity of actually Implemented. There is no dispute that a standard Is VC. It appears that it does not yet offer 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. Tenneeo Chemicals.) The conclusion of these witnesses was that no decision can be 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 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 made concerning risk of exposure to VC strides In reducing exposure levels. (See permissible control limits (See NTOSH at concentrations less than 50 ppm. testimony of Dow Chemical Co, TR 9731. testimony, TR 106; Robintech TR 642'. On the other hand, the testimony of For example. B. F. Goodrich testified In these circumstances, we believe that It most expert witnesses, including some In dustry bluniedlc.il experts, stated that quantification of a safe exposure con centration is not possible with the pres ent state of scientific knowledge. (See (TR 1120) 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 Is Imprudent to grant a blanket exemp tion for all fabricators. Therefore, the final standard is applicable to the fabri cation Industry, as well as the monomer FEDEXAl REGISTER, VOl. 39, NO. 194----FRID4T, OCTOSE* 4, 1V74 CRS - 47 RULES AND REGULATIONS *nd polymer Industries. Employers who. temi>erature as PVC. for further pro below the action level, no further moni In fact, are substantially below the ex cessing. Indicates that a potential for re toring Is required unless the employer posure limit will be subjected to only lease of the residue still exists. It ap has reason to suspect that any employee minimal burdens by virtue of the "action pears that the exemption of fabricated Ls exposed In excess of the action level, level" to be discussed below. products should be limited to Just those or unless changes have been made in Where employers in the fabricating items which will not undergo such mass production, process, control, type of resin, Industry have exposures approaching the heating. Further, . the opportunity to etc. permissible limiL. they will appropriately demonstrate that exposures are below Where the exposure level, without re be subject to the standard. Employers the action level, and thus, discontinue gard to respirators, exceeds the permis handling or using fabricated products many duties of the standard, provides a sible levels, monitoring must be conduc made of PVC were not Included in the more positive control and an adequate ted at least monthly. Where exposures ETS or the proposal and are excluded relief. are less than the permissible levels, but from the Anal standard. This conclusion (2) Permissible exposure limit. The greater than the action level, monitoring Is based on the absence of ad~quate 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 8 hour peridd, and a (5) Methods of compliance. The stand tions. The Anal standard clarifies the ex celling of 5 ppm averaged over any per ard. like the proposal, requires that em emption by defining a fabricated prod iod not exceeding 15 minutes. ployers Immediately Institute feasible uct as a product made wholly or partly As more fully discussed above, this engineering and work practice controls from PVC which does not require further limit is based on an evaluation of the best to reduce exposures to at or below the processing at temperatures, and for available evidence and on a judgment permissible exposure limit. times, sufficient to cause mass melting of that the health and safety of employees Where feasible engineering and work - the PVC. SPI and others (cf. TR. 344) must be protected to the fullest extent practice controls will reduce exposures requested that PVC resins with less than feasible. In view of the fact that release below the permissible levels, they must 0.1 percent residual monomer be ex of VC in the VC and PVC manufacturing be Instituted. Where such controls will empted from the regulation now, and processes are variable, the 1 ppm celling not reduce exposures below the permis that the exemption level be reduced to level provided In the proposal would sible level, they .must nonetheless be im 0.01 percent in three years. SPI suggested require maintenance of an average level plemented to reduce exposures to the that the exemption of materials with less significantly more difficult to attain lowest practicable level, and be supple than 0.1 percent of 14 carcinogens from through feasible engineering controls. mented by the use of respirators to pro 29 CFR 1910.93p (39 FR 3756) was an Therefore, the exposure limit prescribed vide the necessary protection. There appropriate precedent. The cases are not In the proposal has been rejected. upon. a continuing program of engineer comparable, because no attempt had been ' (3) Action level. The final standard, ing and work practice controls must be made to set air concentration limits for unlike the ETS and the proposal, pro Instituted to reduce exposures to the Low the 14 carcinogens. The record did not vides for an "action level" of 0.5 ppm est practicable level. When exposures are Include information that reliable moni TWA, one-half of the permissible ex at or below the permissible exposure toring and measuring techniques were posure limit. The purpose of the action limits, the program may be discontinued. available. Moreover, the exemption did level is to minimize the impact of the In addition, a plan for achieving con not exempt airborne traces of carcino standard on the employers who have trol by engineering and work practice gens. The administrative cutoff was pro attained exposure levels well below the methods must be drawn up and be made vided to avoid regulation of materials' permissible .limit. Thus, where the re available, upon request, to represent about which there was no health haz sults of monitoring under paragraphs atives ot OSHA and NIOSH. ard Information, and which would have (d)(1) or (d)(2) demonstrate that no We recognize that many employers broadly extended the application of the employee is exposed in excess of 0.5 covered by the standard can not cur regulation beyond the record. Herein, ppm TWA. employers may, In effect, be rently achieve compliance with the per no information was presented to show exempted from some provisions of the missible exposure limit solely by the use safe concentration results from the use standard. For example, fabricators who of feasible engineering and work practice of resins with specific levels. Indeed, the are 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 (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, 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 mended that a schedule of different permlsslle 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 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 ((^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 ection level, it docs not appear that any proposal. Essentially it means that the quired by each employer to attain lower residue exemption is either justified or employer is required to take a sufficient control levels may depend upon such necessary at this time. This course also number of measurements so that the re factors as the climate In t.hlch the plant agrees with a number of industry pro sults obtained are statistically valid. We Is located, the age of equipment, the size posals (cf, TR 660). have modified the proposal to establish of reactors, or the type of resin manu SPI (TR 345). among others, asked 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 tliat the pellets had too low a residue to mination of compliance can be made, and such intra-industry variations. (See, cause harmful or mensurable emissions. broad enough to allow the application e.g. Dow, 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 some toring and measuring results are at or to continue to Improve and apply engi- R&S 106247 FtDELM. ttCISTEl, VOL 39, NO. 194--FtIDAY, OCTOSEt 4, 1974 R&S 106248 CRS - 48 RULES AND REGULATIONS necrlng controls until full compliance la achieved. We have not established any deadlines for full compliance through engineering control.; bccau.cc we ore presently tumble to determine when It will be feasible for most establishment; to reduce exposure levels to the permissible level. If the environmental level Is not con trolled to the pcrmlsilblc 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 trations. In discussions of these findings with NIOSH, it has indicated that it l.i willing to consider on an expedited basis the approval of air-purifying respirators for use against VC. Consequently, we have included three types oi air-purify ing respirators in the list of acceptable units, subject to the approval of such We also believe that the requirement that cacli employer reduce airborne con centrations to the permissible level, or to the lowest level feasible as soon as implementing a program of respiratory prour'ion while employees are being fitted ~..j trained in respirator use, and while other, adjustments which may be units by NIOSH. The maximum concen tration for which each respirator may be used i3 based upon our evaluation of the data submitted by NIOSH and practicable will provide for Intcr-mdus- required are Implemented. Therefore, Goodrich. Because air-punfying respi try and Intra-Industry technological dif until January 1, 1876, where exposures rators do not Indicate sorbent exhaustion ferences which do exist, and will avoid are noc 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. However, employees whose exposures do strict administrative controls will be re (6) Regelated areal. The proposed not exceed a 25 ppm ceiling, may decline quired for their use. Such controls In standard would have required that regu to use the respirator, in which case the clude a program to assure timely re lated areas be established, that access be employer is not obligated to require its placement of canisters or cartridges and limited to authorised 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 the hazards of exposure to vinyl chloride. lar type of respirator in use. asserted that such control of access was Moreover, each employee will be notified (8) Hazardous operations. This is a not necessary from a health standpoint. in writing if he has been exposed in ex new section within the final standard. It Secondly, it was claimed that these con cess of the permissible exposure limit. encompasses essentially the proposal's trols would Interfere with operations by Where exposures exceed a 25 ppm cell requirements for maintenance and de preventing access of needed employees or ing. respiratory protection is mandatory contamination but has restated them in non-employees, such as contractors, In light of our Judgment that much terms of performance language to allow truck drivers, customers and consultants. greater risks are associated with such greater flexibility for employers to deal The purpose of establishing regulated exposures. with such operations. The Intent of the areas In the proposal was to limit the The provisions In the final standard new section is to protect employees en risk of exposure to as few employees as regarding the selection and use of respi gaged in activities that present a risk of possible. This concern Is still paramount, ratory protective devices differ from exposure to vinyl chloride in excess of the and thus the limited access feature re those in the proposal. The descriptions of permissible levels. An example would be mains. The final standard amends the atmosphere-supplying respirators have the cleaning of a filter where resin con proposal slightly to allow "authorized been revised to Indicate more clearly the taining high residual monomer is persons" to enter regulated areas. This types of devices Intended, and the. maxi trapped. change. It Is felt, will allow operations to mum permissible concentration level for The proposal's requirement for full- continue without undue interference. each devlcz. Moreover, the number of . body. Impervious clothing has been re The final standard has also Increased the types of atmosphere-supplying devices placed by the direction to use irttpervious length of time daily rosters must be has been increased. garments suited to the particular situa maintained from 20 to 30 years. This At the hearing Mr. Edwin C. Hyatt, an tion and probable extent of exposure. change was based largely on epidemio OSHA'consultant, made suggestions re Thus, full-body clothing is not always logical considerations. (See NIOSH testi garding the use of particular respiratory necessary, and Is therefore not required mony. tr. 119.) devices. We have concluded that his sug where less protection is adequate. Since <7) Respiratory protection. The final gestions are meritorious. Therefore, the vessel entry falls within the definition standard, like the proposal, requires the provisions for selection of atmosphere- of a hazardous operation, the vessel entry use of respirators where employee expo supplying devices follow closely the rec section of the proposal has been deleted sures exceed the permissible control level. ommendations contained in his testi from the final standard. Industry representatives made a number mony of SPI and B. F. Goodrich) (TR (9) Emergency situations. The defini of objections to proposed requirements with Hyatt's suggestions. (See e.g. testi tion of emergency has been recast in for respiratory protection. They stated mony of SPI and B. F. Goodrich) (TR terms of an unexpected massive release. that the "no detectable level" would ef 85 If). We had originally omitted air- The main objection to the section on fectively require continuous wearing of purifying respirators because none had emergency situations In the proposal was respirators in PVC and VC plants, and been approved by NIOSH for use against that, as the term was defined, many that this is not feasible because respira VC, principally because they lacked in ordinary leaks or operations resulting In tors are cumbersome, present a safety dicators to signal the expiration of the a small release of vinyl chloride would tc hazard, and employees would not use service life of the sorbent. Hyatt and considered emergencies. This was not 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 other witnesses discussed in detail the desirability of being able to use canisters or cartridge air-purifying respirators, provided a sorbent could be shown to effectively absorb vinyl chloride with an adequate service life. Recently, OSHA has received respiratory data from labo the Intent of the proposal. The final standard has been clarified to correct this ambiguity. It should be noted that the written operational plan required by the standard need not be developed for minor, excursions above the permissible exposure limit, and that such excursions duced so that respirators are necessary ratories regarding the effectiveness of need not be reported. only ocrassionally. However, we cannot commercially available canisters and (10) Signs and labels. Thethrust of the agree that respiratory protection should cartridges for vinyl chloride. These eval signs and labels section is to apprise not be required simply because it is in convenient. may require additional per sonnel. Interferes with production, or may require extensive retraining of em uations were conducted separately by NIOSH end by the B. F. Goodrich Com pany and submitted to OSHA In posthearing comments. The results Indicate 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 ployees and restructuring of work prac that certain presently available canis in written submissions to the require tices. We have carefully, considered all ters and cartridges effectively absorb 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- FlDCKAl REGISTER, VOL 39, MO. 194----FRIDAY, OCTOBE* 4, 19/4 CRS - 49 RULES AND REGULATIONS 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. 3471, We believe that a indicated that the medical tests proposed are currently the only ones available which are useful for medical surveillance (TR 121. Exh. 95. TK 589-591). Conse quently. the specific blood tests proposed have been retained as a minimum re posal is the requirement for maintenance of monitoring records and dally 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 diluted form of warning will not suffice. quirement to assist the examining physi employment plus 20 years, or 30 years, We appreciate the concern of employers cian in determirdng fitness of potential whichever Is longer. The original pro with the reaction of their employees. But employees for assignment to workplaces posal called for only 20 years. > we consider It Imperative that a worker Involving VC exposure. In addition, al This change has been Implemented be be fully Informed, and that he realize the ternative medical examinations may be cause the latency period for Induction of possible risks Involved In his occupation. used where the examining physician de angiosarcoma ranges up to 30 yearn from Coupled with the training requirement termines that they are at least as good initial exposure. Therefore, as a mini In the standard, we believe that the signs as those specified by the standard. mum. medical records must be main and labels required will adequately In The Tabershaw-Cooper study and the tained for at least that long. It should be form employees of the hazard. In addi various animal experiments suggest that noted that spokesmen for both labor and tion, such signs will warn unauthorized VC may produce a wide spectrum of ma industry recommended that this change personnel to keep out of regulated areas. lignant and non-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 significantly different from those In the training and indoctrination of employees ened to include kidneys, skin, connective original proposal. However, Instead of that cannot easily be conveyed on a sign tissue, spleen, and pulmonary system, as the requirement for reporting Incidents or label. Also, the variety of measures well as the liver. No additional specific which result in the release of VC into that could be prescribed would result in procedures or tests are required, but rec areas where employees may be exposed, an unwieldly or excessively detailed leg ommendations have been included in the the final standard clarifies our original end. Consequently, the required message Appendix to assist the examining physi Intent by stating that only emergencies on signs and labels will not include in cian. Because of the nonspecific nature must be reported. Also the requirement formation on precautions, relevant of the required medical tests, It Is not for filing a detailed, written report symptoms, etc. The addition of suitable appropriate to prescribe timing, or type within 15 days has been deleted. It has Information by the employer would be of followup tests, or to mandate with been concluded that submission, within permitted, providing it does not detract drawal from exposure based solely on re 24 hours, of an Initial report that In In any way from the required statement. sults 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 erization. Very little Information was completed such tests as he considers ap Information. 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 U.S. De partment of Transportation regulations (49 CFR Part 173, Subpart H) already warns of the fire hazard, only a state ment concerning the carcinogenic haz ard need be added to the Department of Transportation labels. propriate. The employer Is required to (14) Deleted portions of the proposal. withdraw an employee only when this The proposal contained provisions re statement Indicates that the employee quiring that shower facilities and change may be at added risk from continued VC rooms be provided, and that storage or exposure. consumption of food be prohibited in - As with monitoring, there appears to 'regulated areas. We have deleted these be no basis for complete exemption of the provisions because It Is our conclusion fabrication industry from the require they are no longer necessary. Showering ment for medical examination. The rec facilities are not required because pro ord does show fabricating establishments tective clothing, where required by the with concentrations of VC monitored final standard, should protect employees considerably above the action level. In from skin absorption by direct contact these Instances, medical surveillance of with VC and because there Is no reliable (11) Medical surveillance. The princi affected employees will provide baseline evidence that VC vapor Is absorbed pal questions that have been raised re garding medical surveillance are 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 art exposed to 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. through the skin. In addition, since we anticipate that most employees will not be 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 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. j'* (12) Training. A separate provision for employee training has been added to the final standard rather than Including it within tiie section on emergency situa tions as in the proposal. The new para 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 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 an,, 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) Effecttoe date. In order to ensure this tumor at an early stage of develop Information required by the proposal. that affected employers and employees ment. However, most medical witnesses The major change from the original pro will be Informed of the existence of these FEDERAL REGISTER, VOL 3*, NO, 194--FRIDAY, OCTOBER 4. 1974 R8tS 106249 \ CRS 50 RULES AND REGULATIONS previsions and that employers affected of the operation or bceause of an acci opportunity to observe the monitor are *lvcn an opportunity to Xamlllaiire dent In the operation, which would result ing and measuring required by this themselves and their employees with the In an employee exposure In excess of the paragraph. existence of the new requirements, the permissible exposure limit. <e) Regulated area. (1) A regulated effective date of the amendment to <8) "OSHA Area Director" means the area shall be established where: I 1910.93q will be January 1, 1375. To pro Director for the Occupational Safety (1) Vinyl chloride or polyvinyl chloride vide continued protection for employees and Health Administration Area Office Is manufactured, reacted, repackaged, until that date, the provisions currently having jurisdiction over the geographic stored, handled or used: and contained In 1 1910.93q are hereby area In which the employer's establish (11) Vinyl chloride concentrations are promulgated, pursuant to section 6<b>. ment Is located. in excess of the permissible exposure 6<c> and 8(c) of the Occupational Safety (9) "Polyvinyl chloride" means poly limit. and Health Act. as an occupational vinyl chloride homopolymer or copoly (2) Access to regulated areas shall be safety and health standard effective mer before such Is converted to a fabri limited to authorized persons. A dally October 4. 1974. the amendment to cated product. roster shall be made of authorized per I 1910.93q set out below will supersede f 10J "Vinyl chloride" means vinyl sons who enter. these provisions as of January 1. 1975. chloride monomer. (f) Methods of compliance. Employee Accordingly, upon consideration of the <c> Permissible exposure limit. (1) NO exposures to vinyl chloride shall be con whole record of this preceding. Part 1910 employee may be exposed to vinyl chlo trolled to at or below the permissible ex of Title 29. Code of Federal Regulations ride at concentrations greater than 1 ppm posure limit provided In paragraph (c> Is amended, effective January 1, 1975, by averaged over any 8-hour period, and of this section by engineering, work prac revision of f 19io.93q to read as follows: (2) No employee may be exposed to tice, and personal protective controls as g 1910.93q Vinyl chloride. vinyl chloride at concentrations greater follows: than 5 ppm averaged over any period not (1) Feasible engineering and wort (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 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 la 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 products made of polyvinyl chlo level. 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 or 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 ride. (2) Where a determination conducted In accordance with paragraph (g) of this (3) Tills section applies to the trans under paragraph id) (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 regulate the hazards covered by this sec tion. (b) Definitions. (1) "Action level* cess of the action level, a program for de termining exposures for each such em ployee shall be established, such a pro gram: 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 means a concentration at vinyl chloride (I) Shall be repeated at least monthly' shall be developed and furnished upon ,, of 0.5 ppm averaged over an 8-hour work where any employee Is exposed, without request for examination and copying to ' day. regard to the use of respirators. In ex authorized representatives of the Assis (2) "Assistant Secretary" means the cess of the permissible exposure limit. tant Secretary and the Director. Such Assistant Secretary of labor for Occupa (II) Shall be repeated not lees than plans shall be updated at least every six tional Safety and Health, UjS. Depart quarterly where any employee is exposed, months. ment of Labor, or his designee. without regard to the use of respirators. (g) Respirators protection. Where (3) "Authorized person*' means any In excess of the action level. .respiratory protection Is required under person specifically authorized by the em (III) May be discontinued for any em this section: ployer whose duties require him to enter a regulated area or any person entering such an area as a designated representa tive of employees for the purpose of ex ercising an opportunity to observe moni toring and measuring procedures. (4) "Director" means the Director. National Institute for Occupational Safety and Health. tLS. Department of ployee only when at least two consecu fl) The employer shall provide a tive monitoring determinations, made not respirator which meets the requirements less than 5 working days apart, show ex of this paragraph and shall assure that posures for that employee at or below the employee uses such respirator, except the action leveL that until December 31. 1975, wearing of (3) Whenever there has been a pro respirators shall be at the discretion of duction, process or control change which each employee for exposures not In ex may result In an Increase In the release cess of 25 ppm. measured over any 15- of vinyl chloride, or the employer has . minute period. Until December 31, 1975, Health. Education, and Welfare, or his any other reason to suspect that any em each employee who chooses not to wear designee. ployee may be exposed In excess of the an appropriate respirator 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 "NIOSK Manual of Analytical meeting the requirements of ( 1910.134 operation, procedure, or activity where a Methods"). shall be established and maintained. release of cither vinyl chloride liquid or (5) Employees or their designated rep (4) Selection of respirators for vinyl gas might be expected as a consequence resentatives shall be afforded reasonable chloride shall be as follows: R&S 106250 FTDEftAL ZECISTEt, VOL 3V, NO. 194--FtlOAT, OCTOfl 4. 1974 R&S 106251 CRS - 51 RULES AND REGULATIONS Atmospheric concentration of vinyl chloride Required apparatus (vl) The purpose for. and a descrip tion of, the medical surveillance (1) Unknown, or ibov* 3,000 ppm__ Open-circuit, **Lf-<ont*loe<l brvithlng ipp&r&tus, pres* program: sure demind type* with full fxcepteoe. (vll) Emergency procedures: (tl) Hot orr 3.000 ppm-.---.*- (A) Combination. typo C supplied *ir respirator, pres (vlil) Specific information to aid the sure detnmxul type, wlih full or btlf facepiece, employee In recognition of conditions (Ut) Hot ov*r J00 (It) Hot over 25 ppm-- end auxiliary elf-cont*lned sir supply: or (B) Type C, supplied air respiretor continuous flow type, with full or half facepiece, and auxiliary self-contained sir supply, (A) Combination type C supplied air respirator de mand type* witb full facepiece, and auxiliary Self-contained air supply; or (B) Open-circuit self-contained breathing apparatus with full facepiece, in demand mode; or (O) Type C supplied air respirator, demand type, with full facepleee. (A) A powered air-purifying. respirator with hood, helmet, full or half facepiece, and a canister which may result In the release of vinyl chloride; and i (lx) A review of this standard at the employee's first training and indoctrina tion program, and annually therealter. (2) All materials relating to the pro gram shall be provided upon request to the Assistant Secretary and the Director. (k> Medical turveiltance. A program of medical surveillance shall be insti tuted tor each employee exposed, with out regard to the use of respirators, to which prorldes a sendee life of at least 4 vinyl chloride In excess of the action hours for conceorations of vinyl chloride up leveL The program shall provide each to 35 ppm. or such employee with an opportunity for (B) Qas rawk. front- or back-mounted eanister which examinations and tests in accordance provide* a service life of at least 4 hours for with this paragraph. All medical ex (t) Hot over to ppca_ concentrations of vinyl chloride up to 25 ppm. aminations and procedures shall be per (A) Combination type C supplted-slr respirator, de formed by or under the supervision of a mand type, with half facepiece, and auxiliary self-contained air supply; or (B) Type C supplled-air respirator, demand type, with half facepiece; or (G) 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. licensed physician, and shall be provided without cost to the employee. (1) At the time of Initial assignment, or upon institution of medical surveil lance; (1) A general physical examination shall be performed, with specific atten tion to detecting enlargement of liver, spleen or kidneys, or dysfunction In these . (S) (1) Entry Into unkown concentra (2) Protective garments shall be pro organs, and for abnormalties In skin, tions or concentrations greater than 36,000 ppm (lower explosive limit) may vided clean and dry for each use. (1) Emergency fitvatlon*. A written connective tissues and the pulmonary system (See Appendix A). be made only for purposes of life rescue; operational plan for emergency situa (II) A medical histor# shall be taken. and tions shall be developed for each facility Including the following topics: (11) Entry into concentrations of less -storing, handling, or otherwise using (A) Alcohol Intake; than 36,000 ppm, but greater than 3,600 vinyl chloride as a liquid or compressed (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, firefighting, or securing shall be Implemented in the event of an to potential hepatotoxlc agents. Includ equipment so as to prevent a greater hazard from release of vinyl chloride. emergency. The plan shall specifically provide that: ing drugs and chemicals: (D) Fast history of blood transfu (6) Where air-purifying respirators (1) Employees engaged in hazardous- sions; and are used; operations or correcting situations of ex (I) Air-purifying cannlsters or car isting hazardous releases shall be (E) Past history Of hospitalizations. (III) A serum specimen shall be ob 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. ITt Apparatus prescribed for higher concentrations may be used for any lower concentration. -** (h) HazardotH operation*. (1) Em ployees engaged In hazardous operations, 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; tained and determinations made of: (A) Total bilirubin; (B) Alkaline phosphatase; (C) Serum glutamic oxalacetlc trans aminase (SCOT); (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 clilorlde 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 entry of vessels to clean poly (II) The specific nature of operations medical surveillance. vinyl chloride residue from vessel walls, which could result In exposure to vinyl (4) A statement of e'ch employees 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 (!) Respiratory protection In accord (11) The purpose for, proper use, and tive equipment and respirators, shall be ance with paragraphs (c> and (g) of this section; and (11) Protective garments to prevent skin contact with liquid vinyl chloride or with polyvinyl chloride residue from vessel vails. TTie protective garments limitations of respiratory protective devices; (lv) The fire hazard and acute toxic ity of v-lnyl chloride, and the necessaryprotective steps; 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 hall 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- KDEKAL REGISTER VOL 39, NO. 194--FKtOAV, OCTOSrit 4, 1974 l' CRS - 52 RULES AND REGULATIONS drawn from possible contact with vinyl chloride. (6) Laboratory analyses for all bio logical specimens Included In medical Ruminations shall be performed In labo ratories licensed under <2 CFlt Part 74. (7) If the examining physician deter mines that alternative medical examina tions to those required by paragraph (k)(l) of this section will provide at least equal assurance of detecting med ical conditions pertinent to the exposure Uon which contradicts or detracts from the effect of. any required warning. Information or instruction. (m) Records. < D All records main tained in accordance with this section shall Include the name and social secu rity number of each employee where relevant. 12) Records of required monitoring and measuring, medical records, and au thorized p..`sonne! rosters, shall be made and shall be available upon request for (II) The number of employees in each regulated area during normal operations. Including maintenance. (2) Emergencies, and the facts ob- * tainable at that time, shall be reported within 24 hours to the OSHA Area Di rector, Upon request of the Area Direc tor. the employer shall submit additional Information In wiping relevant to the nature and extent of employee exposures and measures taken to prevent future emergencies of similar nature, 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 avail examination and copying to authorized (3) 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 exposed, without regard to the use of shall: (A) State the date of such monitor ing and measuring and the concentra respirators In excess of the permissible exposure limit, each such employee shall tions determined and Identify the instru be notified In writing of the results of able upon request for examination and ments and methods used; the exposure measurement and the steps 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: CAlT^ftwSUEPTCT ActJfr Axu AOTftOUED pntoinnL OfflT (B) Include any additional Informa 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 being taken to reduce the exposure to within the permissible exposure limit. (o) 'Effective dates. (1) Until Janu ary 1, 1975, the provisions currently set forth In ( 1910.93q of this Part shall apply. (2) Areas containing hazardous operatioos or where an emergency currently exists shall be posted with legible signs bearing the legend: Cawcxs-aozRcr Asrarr nr Tms Aax* Pivttc- 30 years. (II) Authorized personnel rosters shall be maintained lor not less than 30 years. (III) Medical records *han be main tained for the duration of the employ ment of each employee plus 20 years, (2) Effective January 1, 1975, the provtslonsset forth In ( 1910i)3qof this Part shall apply. Amma A--SnrLDimur Mdico. iHTOaJUTtOX rm Eanvunn Bnnnm Amoun or 30 years', whichever Is longer. Whan required tests under pirsgrspii PxoooMn Onr (3) In the event that the employer (X) (1) of this section show abnormalities, (3) Containers of polyvinyl chloride v--in waste from reactors or other waste contaminated with vinyl chloride shall be legibly labeled: Contaminated with Vixtt. Cidotnr Cartesa-Somcr Mm ceases to do business and there Is no successor to receive end retain his rec ords for the prescribed period, these rec ords shall be transmitted by registered mail to the Director, and each employee Individually notified in writing of this transfer. ' the teste should be repeated as soon ss prac ticable. preferably within S to 4 weeks. If teeta remain abnormal, consideration ebouid be given to withdrawal of the employee rrom contact -with vinyl chloride, wbUe a more comprehensive examination (s made. Additional tests which may be useful: A. JCor kidney dysfunction: urine examina (4> Containers of polyvinyl chloride ahall be legibly labeled: PoLTTom. ciiboxmx (oa TXue Nxks) Contains Vnrn. CBLoatmc Vont Cmsun is a CuKB-fiRKCT Mar (4) Employees or their designated representatives shall be provided access to examine and copy records of required monitoring and measuring. (9) Former employees shall be pro vided access to examine and copy re tion for albumin, red blood cells, and ex foliative abnormal cello. B. pulmonary system: Forced vital capac ity, Forced expiratory volume at 1 second, and chest roentgenogram (posterior-anterior, 14 z 17 inches), C. Additional serum testa: Lactic acid de (9) Containers of vinyl chloride shall be legibly labeled either: U> Van Chukide . bRUHXLT VtlUXABtS OaS UHDB PECS&tJEZ Cmefx-ScxrncT Amur or til) In accordance with 49 CPR Part 173, Subpart H. with ' the additional quired monitoring and measuring records reflecting their own exposures. (9) Upon written request of any em ployee, a copy of the medical record of that employee shall be furnished to any physician designated by the employee. (n) Reports. (1) Not lAter than l month alter the establishment of a reg ulated area, the following information hydrogenase. lactic acid dehydrogenase Isoenzyme, protein determination, and protein electrophoresis. D. For a more comprehensive examination on repeated abnormal eerum tests: Hepatitis B antigen, and Uver seanniDg. (Sees, a and S. 84 Stat. 1598. 1599 ( 29 VB.C. 895. 997); Secretary of Labor's Order No. 13-71, 38 FB 8754) legends: hall be reported to the OSHA Area Di Signed at Washington, D.C., this 1st Csrrccit-SDSPECT Accra applied near the labor or placard. (8) No statement shall appear on or rector. Any changes to such Information shall be reported within 19 days. (i) The address and location of each establishment which has one or more day of October, 1974. _ Jobs Stender. 'Assistant Secretary o/ Labor. near any required sign, label or lnstruc- regulated areas; and [FB Doc.74-33178 Filed 10-I-74;3:54 pm| R&S 106252 FfOttAt IfCISTER, VOL 39, NO. 194--TODAY, OCTOtfl 4, 1974 R&S 106253 mWF- n, CRS - 53 APPENDIX III: SOURCES OF EMISSION AND CONCENTRATIONS IN AMBIENT AIR OF VCM IN THE VC-PVC INDUSTRIES _83/ SUMMART OF VCM CONCENTRATIONS IN FVC FABRICATION FACILITIES TrRRtl RlMt film and meM (7 rImi): Nwkit>: MImMmiw <mfi> t*w*"ii*um>ftmiHmmi mtrym*<2(p: larti): <<ef>>* AiMn*tttiuiiCmnplpliwM1--., mu Mifttmuin 12 t MO <10 as MO <.J <.3 O <.l <al <.l Vtu Fnctttt>l 3 2/5 1.2 MI U IVZl <1 t li/ M2 two JUMUAtY OF VC CXPOWMK LEVELS IN A FVC fOLYUEKIZATlON PLANT TWA Pm* CmIiM t FM 4ryr aparvlar. Wiptrai-- mm: Ct<* tmm,, CWploi Ofy*r MNIIMNmmiNimi; unity ****-< 1 AkHaMAMtMRMH la *M. A FRffwaiai rmwIhm awalaaMca cb*Nm. ...... NKttN.... ....... ST!:; ......***,,_. ____ST;; ...... SBE7" ...... Star?;: ........nkST':: <i7 <<<4112211t121 7?1I7l <71714411119 <i ........NW$N.,,. ___ mar!:: ...... SBBTT- ........853?:: ........mwT... ...... SST:: ...... SST:: r*a<iry.. 2177t 11430 aI 37* a7 27 mnaa11iz02 2J0aaa21V333 ....... JM03M____ ...... SST:: .22 24 ......star!::; *e 12 ......STSSTT::: ......Star!::: .....::: * ><211 2432 <a123 n4s43 _8y U.S. Senate. Subcommittee on the Environment, op. cit. p. 51-53. CRS - 54 Major Vixvl Chloride Emission Sources in I'oltvintl Chloride POLYMERIZATION A.TD CoPOLTUERtXATION PLANTS orhouries vinyl chloride emissions wore practices AND CONTROL PROCE DURES THAT CAN BE UTILIZED TO REDUCE AND/OR ELIMINATE THE EMISSIONS 1. Polymerization reactor denning____ : 1 (a) Red action la the frequency of cleaning. lb) Automate cleaning process. (cl Maximize purging of reactor be- fore ami during employee entry Into reactor. (if) Employee use of air supplied res pirators (type prescribed by OSIIA) when cleaning reactors. 2, Venting vinyl chloride from proces- Bepipe rented vinyl chloride emissions sing equipment internally within to a recovery system or completely the plsnt. remove vinyl chloride from veuted air prior to release. 3. Quality control sampling of process. () Redesign sampling points to ellinnate excess pipe downstream of sampling valve* in order to re duce the amount of vinyl chlo ride ioat after sampling. (k) Employee collecting sample should wear air supplied respirator os prescribed by OSIIA. 4. Process leaks from such things as pmn|w, valves, flanges, gaskets, etc. () Use direct reading vinyl chloride samtillng device on a routine basis for early detection of proc ess leaks. () Change pump seals, agitator pack ing, etc. to designs better sill till to prevent leaks. ii. Tank mr InaiUng and uulosdlng____ () Eliminate vinyl chloride that Is nItaunted while loading and un loading tank cars by pitting changes and venting to recovery system or completely removing vinyl chloride from vented air prior to release. () Employee use of air snpplled resprlutors (ty|ie prescribed by OSIIA) while connection mid disconnecting lines. (1. Vinyl chloride monomer inter chang () Reduce frequency of monomer fil ing. ter i-hnnglng. (A) Employee use of air supplied respi rator (type prescribed by OSHA) while changing or cleaning Alter. 7. polyvinyl chloride waste dhqmsal__ Properly cover all tiolyvlnyl chloride waste ItarrelK, drums, bins, etc. N Packaging (bagging ninl drumming (a) improve local exhaust ventilation of |ai|y vinyl chloride I. at liagging and drumming sis- tlona to reduce polyvinyl chlo ride duat and rlnyl chloride gas enilssloiiH. (1) Clean bughouses and other control devices frequently to Insure top efficiency of ventilation system. (c) Employee use of air supplied respi rators type prescribed by OSIIA) while cleaning baghouse. r &S 106254 R&S 106255 CRS - 55 JiAJOS VlNTL CriLO*It>e EMISSION BoCgCES IX VlXTL CiriOKIDE MONOMF.k PBObUCTXON PUKTB BOUNCES OF TIXTL CHLOEIDE EMISSION* TVOBE FEACTICES ACCO COKTROL CBOCE DUXES THAT CAN BE UTILIZED TO SEDUCE AXD/OB ELIMINATE TIIE EMISSIONS 1. Tauk car loading and unloading____ (a) Eliminate vinyl chloride that is ex hausted while loading and un loading tank cars by piping changes and renting to recovery system nr completely removing vinyl chloride from vented air prior to release. (b) Employee use of air supplied respi rator (type prescribed by OBHA) while connecting and disconnect ing lines. 2. Quality control sampling of process. (a) Redesign sampling points to elim inate excess pipe downstream of sampling valves in order to re does the amount of vinyl chlo ride lost after sampling. (b) Employee collecting sample ahonld wear air supplied respirator as prescribed by OBHA. 3. Process leaks from such things as pumps, raises, flanges, gaskets, etc. (a) Use direct reeding vinyl chloride basis for early detectluo of proc- sampilng device on a routine ess leaks. (b) Change pump seals, etc. to designs better suited to prevent leaks. CRS - 56 APPENDIX IV: CURRENT OCCUPATIONAL EXPOSURE LIMITS FOR VINYL CHLORIDF (VCM) IN NINE COUNTRIES Current Exposure Limits for VCM in Nine Countries Canada(Ontario) 10 ppm TWA, 25 ppm ceiling England 50 ppm ceiling, 25 ppm TWA France no official regulation Holland 50 ppm ceiling Italy 50 ppm ceiling Japan committee recommenda tion expected by end of 1974 Norway temporary ban on PVC production , Sweden 1 ppm TWA adopted on Oct. 14, 1974 West Germany 50 ppm ceiling with pro viso that exposures be kept as low as possible / R&S 106256 84/ Clack, G. The Best Available Evidence. Job Safety and Health, v. 3, no. 1, Jan. Jan. 1975. p. 10. CRS - 57 R&S 106257 BIBLIOGRAPHY Angiosarcoma, of the liver in vinyl chloride/polyvinyl chloride workers. Journal of occupational medicine, v. 16, no. 12, Dec. 1974: 809. Barnard, A.W. ICI ends its silence on vinyl chloride. Chemical and engineering news, July 8, 1974: 21, 37. Cook, W.A., et al., Occupational acroosteolysis: II. An industrial hygiene study. Archives of environmental health, v. 22, Jan. 1971: 74-82. Dinman, B.D. et al. Occupational acroosteolysis: I, An epidemiological study. Archives of environmental health, v. 22, Jan. 1971: 61-73. Dodson, V.N. et al. Occupational acroosteolysis: III. A clinical study. Archives of environmental health, v. 22, Jan. 1971: 83-91. Encyclopedia of polymer science and technology, v. 14. New York, Interscience Publ., John Wiley & Sons, Inc., 1971: 305-483. Falk, H., Creech, J.L., Heath, C.W., Johnson, M.N. and M.N. Key. Hepatic disease among workers at a vinyl chloride polymerization plant. Journal of the American Medical Association, v. 230, no. 1, Oct. 7, 1974: 59-63. Galluch, R.J. Polyvinyl chloride. Plastics World, Aug. 20, 1973: 66-77, 149-152. Harris, D.K. and W.G.F. Adams. Acro-osteolysis occurring in men engaged in the poly merization of vinyl chloride. British medical journal, v. 3, 1967: 712. Keane, D.P., Stobaugh, R.B. and P.L. Townsend. Vinyl chloride: How, where, who future. Hydrocarbon processing, Feb. 1973: 99-110. Key, M.M. NI0SH on vinyl chloride. Chemical and engineering news, June 10, 1974: 3. Kramer, C.G. and J.E. Mutchler. The correlation of clinical and environmental measure ments for workers exposed to vinyl chloride. American Industrial Hygiene Association journal, v. 33, 1972: 19-30. Makk, L., Creech, J.L., Whelan, J.G., and M.N. Johnson. Liver damage and angiosarcoma in vinyl chloride workers: A systematic dection program. Journal of the American Medical Association, v. 230, no. 1, Oct. 7, 1974: 64-68. Maltoni, C. and G. Lefemine. Carcogenicity bio-assay of vinyl chloride: Current results. Annals of the New York Academy of Sciences, v. 246, Jan. 31, 1975: 195-218. (in print). Maltoni, C. Cancer detection and prevention. Proceedings of the second international symposium on cancer detection and prevention, April 9-12, 1973. Maltoni, C. Preliminary report on the carcogenicity bio-assays of vinyl chloride. (Presented at the OSHA vinyl chloride fact finding hearing, Feb. 15, 1974). McGinty, L. Science paused and 17 died. New scientist, June 15, 1974: 675-676. :L t.-ri R&S 106258 CRS -58 Monson, R.R., Peters, J.M. and M.N. Johnson. Proportional mortality among vinyl chloride workers. The lancet, Aug. 17, 1974: 397-398. Mutchler, J.E., and C.G. Kramer. Report on relation of exposure to state of health of Dov Chemical workers. Tilton, New Hampshire, Gordon conference, Aug. 1968. Production processes for vinyl chloride. Hydrocarbon processing, Nov. 1971: 220-223. PVC. Plastics Engineering, Dec. 1973: 25-40. Purchase, I.F.H. and K.S. Williamson. Proportional mortality among vinyl-chloride workers [letter]. The lancet. Sept. 7, 1974: 591-592. Putting VCM emissions on skids. Chemical week, Sept. 18, 1974: 67, 71. Selikoff, I.J. and E.C. Hammond [eds.]. Toxicity of vinyl chloride - polyvinyl chloride. Annals of the New York Academy of Sciences, v. 246, Jan. 31, 1975. Tabershaw, I.R. and W.R. Gaffey. Mortality study of workers in the manufacture of vinyl chloride and its polymers. Journal of occupational medicine, v. 16, no. 8, Aug. 1974: 509-518. Torkelson, T.R., Oyen, F., and V.K. Rowe. The toxicity of vinyl chloride as determined by repeated exposure of laboratory animals. American Industrial Hygiene Association journal, v. 22, no. 5, 1961: 354-361. U.S. Congress. Senate. Subcommittee on Environment. Dangers of vinyl chloride. Hearing, 93rd Congress, 2nd session, Washington, D.C., U.S. Government Printing Office, August 21, 1974. 156 p. U.S. Court of Appeals for the Second Circuit. Brief for the petitioner: The Society of the Plastics Industry, Inc. versus the Occupational Safety and Health Administration. (Case no. 74-2284) Washington, D.C., Bryon S. Adams Printing, Inc., November 12, 1974. 81 p. U.S. Environmental Protection Agency. Report of the activities and findings of the vinyl chloride task force. Washington, D.C., Sept. 1974. 67 p. U.S. National Institute of Occupational Safety and Health. A bibliography on vinyl chloride. March 19, 1974. US. National Institute for Occupational Safety and Health. An evaluation of organic vapor respirator cartridges and canisters against vinyl chloride. HEW publication no. (NIOSH) 75-111, Oct. 1974. 23 p. U.S. Occupational Safety and Health Administration. Hearing before Administrative Law Judge Myatt. Testimony of representatives of the Dov Chemical Co. June 25 to 28 and July 8 to 11, 1974. U.S. Occupational Safety and Health Administration. Final environmental impact state ment; Proposed regulation, vinyl chloride. Washington,D.C., Sept. 5, 1974. 200 p. Vinyl Chloride cancer controversy continues, Chemical and engineering news, June 10, 1974: 12. CRS -59 Viola, P.Ii-. Cancerogenic effect of vinyl chloride. Abstract, Tenth International Cancer Congress, (Houston, Texas), 1970: 20. Viola, P.L., Bigotti, A., and A. Caputo. Oncogenic response of rat skin, lungs and bones to vinyl chloride. Cancer research, v. 31: 516-522. Wilson, R.H., et al. Occupational acroosteolysis: Report of 31 cases. Journal of the American Medical Association, v. 201, 1967: 577-581. Withholding of vinyl chloride data hinted. Chemical and engineering news, May 20, 1974: 16. World Health Organization. Working Group on Vinyl Chloride. Report of a working group on vinyl chloride. IARC Internal technical report no. 74/005. (held in Lyon, June 24-25, 1974) Albany, N.Y., Q Corp. (in print). SP 349 R&S 106259 R&S 106260 Ms. Joanna Bourne Analyst, Life Sciences Science Policy Research Division Congressional Research Service Library of Congress Washington, D.C. % Dear Ms. Bourne: I recently received a copy of HD7261 75-63SP "Vinyl Chloride: An Occupational Health Hazard" dated January 17, 1975. You should be complemented on reducing a tremendous volume of literature to a concise form. Although we have not reviewed this summary in detail, we have found a few minor changes that we would like to call to your attention if it is necessary to re-draft this summary. CRS-2. The explosive range of 1.2% to 52% given in this section does not agree with most published references. While all test methods do not give identical results, most methods give a range starting at about 3.6% and extending to 25-35%. The Manufacturing Chemists' Association Chemical Safety-Data Sheet SD-56 which is not currently available because the Toxicology and Medical Sections are being revised quotes 3.6% to 26.4%. A copy of page 5 of SD-56 is attached. Since past industrial practice appears to have been to control vapor concentrations to 1/10 or 1/5 of the lower explosive limit to reduce the likelihood of explosions, you have correctly concluded that worker exposures to these concentrations may have been common if not frequent ' (p. CRS-9610). CRS-9 The older literature has been misquoted by several reviewers who have stated that the hepato (liver)toxicity of vinyl Ms. Bourne 2-- - May 19, 1975 chloride was recognized in the 1940's. We call this to your attention because the review tends to support this misinterpretation. In 1949, Tribuhk et al (Arg Sanit, 10, 38-45, 1949) reported numerous effects in PVC workers in what by today's standards must be considered as primitive production facilities. These authors found a "considerable number of cases of hepatitis among workers" but were more concerned with other hepatotoxic chemicals such as chlorinated diphenyl and chlorinated naphthylene (Holowax (sic)) than they were with vinyl chloride. CRS-10. While it is true that as the result of the studies by The Dow Chemical Company we did establish a company goal of 50 ppm about 1960, there were, in fact, no government standards at that time. The closest to a standard at that time was the unofficially recommended Threshold Limit Value (TWA) of 500 ppm published by the American Conference of Governmental Industrial Hygienists (ACGIH). Although the organization has an official sounding name it is not an official government agency. We hope these comments are useful to you. If you revise or update this summary, we would like to get a copy. Sincerely yours. Theodore R. Torkelson, Sc.D. Corporate Medical Department kfm R&S 106261