Document zd9YBV5Y2w42K76oBq5BoXyo3

A TECHNICAL INFORMATION COMMUNITY HEALTH EFFECTS 0F VINYL CHLORIDE Prepared Byt The Vinyl Institute Health, Safety, A Environment Coassittee Issued* August 1, 1986 The Vinyl Institute, A Division of The Society of the Plastics Industry, inc VAB.0001165713 A I. SUMMARY This document reviews the toxicity and human health effects of ambient exposure to vinyl chloride (VC), the raw material used in the production of polyvinyl chloride (PVC). It summarises the extensive and rigorous federal regulation of the VC/PVC industry, and compares quantitative risk assessment# with actual health observations of Individuals In non-occupattonal settings. A review of the world scientific literature shows no community health impacts associated with exposure to VC emissions from VC/PVC manufacturing facilities. II. IMTRODUCTION Vinyl chloride is the basic building block for producing the most versatile plastic yet developed -- polyvinyl chloride and its copolymers with other monomers. Most of the seven billion pounds of VC produced annually in the United States is converted into PVC used In thousands of products In the home and in Industry -- products such as wallcoverings, upholstery, flooring, house siding, water pipes, sewer pipes, luggage, clothing, automotive parts, medical devices, food wrap, windows, doorB, wire insulation, garden hoses, and phonograph records. PVC Is a polymer produced from VC through a chemical reaction called polymerization. VC Is converted Into PVC by suspension, emulsion, bulk or solution polymerisation methods. PVC resins can be extruded, molded or calendared into diverse shapes, sizes, and colors. Mschanical characteristics can be controlled to produce forms that are rigid, flexible, or in a liquid form such as latexes, pastes, and adhesives. Vinyl chloride became of industrial Importance approximately fifty year# ago when Semon (1933) discovered that the polymer could be converted into useful articles by plasticization with phthalate asters. Comswreial development began first in Europe and then in the United Statee in the late 1930's. It was not until the early 1950'a that widespread consumer applications developed. PVC is now a mature product, and its growth rate fall# In step with the Gross National Product. Ill. HEALTH HISTORY e Vinyl chloride is a strong anesthetic at B-lZZ in animals and humans. Death follows rapidly after unconsciousness sets in if exposure is not reduced quickly (Petty et al, 1930). No major histological changes were reported after 100 days at exposures of 50,000 ppm (Kuebler, 1964). Reversible llwer affects at 100-500 ppm led to a recommendation of a 50 ppm TWA axposura limit (Torkslson, Oyen, and Rowe, 1961), but the American Conference of Governmental Industrial Hygenlsts adopted instead a recommendation by Y#le scientists of 500 ppm. This is the value later accepted by 0SHA and It served until 1974. Lehman and Flury (1943) termed vinyl chloride to be "one of the least dangerous of the chlorinated hydrocarbons". P4l -l#--! DM' - ^ ^ ! ` VAB.0001165714 * -- ^ I Conaunlty Hulth Effect* of Vinyl Chloride P| Two There ere no other known ecute human physiological effects from vinyl chloride exposure. The odor threshold is about 1,000 ppm. The high heat of vaporisation causes a substantial part of a large spill to liquify and presents the danger of frostbite. Vinyl chloride is flammable over the range of 3.6*331 In air, and extreme care must be taken to avoid spills and leaks for that reason. Most measurement and warning systems were designed to hold plant atmospheres below the flammable limits. Retrospective estimates of typical clme*velghted average personal exposures for polymerlestion workers In England have been estimated (Barnes, I960) as followsi 1945 to 1955 1955 to 1960 1960 to 1970 Mid 1973 1975 1,000 ppm (or above) 400 to 500 300 to 400 150 5 In some jobs, particularly the cleaning of polymerization reactors, exposures in the thousands of ppm range were experienced for short periods. (See Purchase, et al, 1985 and Barr, 1986 for reviews of the toxicity of VC). Chronic Health Effects The first clear Indication of chronic health problems associatsd with VC came in the 1960's In men who entered VC polymerization reactors to ramova build-up of polymer from the walls. Some of these men developed aero-osteolysis, a disease resulting in softening of bones In the fingers (Suciu, et el, 1963\ Harris and Adams, 1967*, Cook, et al, 1981). Modification of working practices has led to the elimination of this disease in workers in PVC plants. In the late 1960's, Professor P.L. Viola of the 8olvey Company tried to reproduce acro-osteolysls in rats by exposing them to high concentrations of VC for long periods. He failed to produce acro-osteolysls, but he reported an increase in incidence of a variety of tumors at various sites. For the first time, it had bean suggested that VC was an animal carcinogen. (Viola, 1969, 1970$ Viola, Blgotti and Caputo, 1971). As a direct reeult of the Viola work, four West European VC/PVC manufacturing companies in Italy, France, Belgium, and England eupportad a comprehensive study of the animal toxicology of VC by Professor C. Mai tool, Director of the Institute of Oncology at Bologna. Maltoni's work which extended over eight years has proved to be the most comprehensive study of VC toxicology (Miltooi et el, 1984). By the end of 1972, Maltoni had found a rara tumor, angiosarcoma of the liver (ASL)., in some of the exposed rets end confirmed that VC is indaed an animal carclnogan. These early findings were reported at an international symposium in 1973 (Maltoni, 1977). Maltoni racommanded epidemiological Investigations and Radical controls of exposed workers end early in 1974, a U.S. company announced that they had found three A8L cases in employees at one of their PVC polymerization plants. This finding led to the conclusion that VC was a human carcinogen because it gave rise to a rare tumor whose only other known etiological agents in man were thorium dioxide, arsenic and possibly anabolic steroids. I VAB.0001165715 IL + J I| '_i i____ i _i X mOUI rtlj Community Health Effects of Vinyl Chloride Page Three ' '.I,'.' . . .I-TI-. 9 ASL Is s very rare tumor* Less than 20 cases per year from all these causes occur in this country* A review (Popper, t al, 1978) of all cases reported in the United States for the period 1964-1974 revealed 167 cases, of which 19 were ascribed at that time to occupational VC exposure, 26 to thorium dioxide given medically, and 9 to arsenic in Fowler's solution, also uaed medically. The remainder were of unknown etiology, with no connection to VC. The high level of Interest In this specific tumor is such that any^ subsequent cases associated with environmental exposure to VC would aioat certainly have been reported, and none have. For a time, NIOSH published a sumary of VC-related caaee (Falk, et al, 1981), but this task was taken over flrat by John Stafford of ICI, England (Foreman, et al, 1985) and later by Brian Bennett also of ICI. The 1986 update of VC-related ASL cases shows a total of 38 caaet In the United States and 120 worldwide. All of theta cases Involve high occupational exposures to VC. The average ASL latency period (years from first exposure to diagnosis) in the United States has been 25 years, but with a median of about 22 years. The latency period In Europe, particularly in Germany, has bean somwhet shorter, approximately 19 years. All the U.S. occupational cases, and almoet all such cases In the rest of the world are closely associated with the Job of reactor cleaning, which was once done manually at the end of the polymerization cycle. There la clustering of cases In relatively few plants and the majority of plants have had no cases. Differing work programs and Job progressions may have had some effect on reducing rates at various plants. An Industry*sponsored epidemiological survey of workers In the VC/PVC industry covered 8,384 men with at least one year of exposure before 1973 (Taberahaw and Gaffey, 1974). The expected excess of ASL was found. There were also suggestions of an excess of cancera at other sites. This study wee expanded to 10,173 workers (Cooper, 1981), where suggested excess of brain and respiratory cancers continued to be seen without, however, an association between the brain cancer and exposure. In addition, moat of the lung cancer cases coma from the same facility, with many plants having no caeee. A follow-up study of thia expanded cohort to determine the status of the workers aa of the and of 1980 is underway. Several studies have been made of the general population using ASL aa the marker disease in an effort to detect an association with possible environmental exposure to VC. There was no association with living near a plant manufacturing or using VC In the general U.S. survey conducted by the Canter For Diaeaaa Control (Popper et al, 1978i Falk, at al, 1981). Brady et al, (1977) surveyed 26 ASL deaths in New York State between 1970 and 1975, and found five who lived nearer plants handling VC than did chair matched controls, but could not establish a direct connection with the diaeaaa to exposure. Tan cases of ASL in Wisconsin were examined for possible connection with VC exposure, and none was found (Fiechtner et al, 1976). Baxter et al, (1977) found no relationship between distance of residence from VC emitters and the 47 cases of ASL in the general population of Great Britain reported in 1963-1973. A later update (Baxter et el, 1980) found one case where the person had lived the last six years of his life near a PVC plant and three cases where the men had worked in the plastics fabricating industry but for whom there were no records to indicate epa0tM165716 to VC. - -- ,i-i- , - Ilk'T rtfft I Ij4-rt+' Community Health Effects of Vinyl Chloride Pago Pour A The leek of reletlonehlp between residence near vinyl chloride operations and caaea of unknown etiology was confirmed. 8arlc at al, (1976) studied the deaths during the years 1968>1971 in an area surrounding a PVC plant that had been in operation since 1949 and in which three workers had died of ASL. No relationship was found for liver or for lung or bronchial cancer and place of residence for the general population. A similar study for consunitles near a Swedish plant that had operated since 1945 and had foun^ four ASL cases showed (Blinder and Pershagen 1978) no unexpected elevation of fetal mortality! deaths from all cancers, or cancer of the liver or lunge during the yeers 1961-1974. Pancreatic cancer In males waa elevated In the age group over 60. All ASL caaea in Holland since 1950 (27 cases) ware studied, and none had any traceable contact with VC (Dalderup et al, 1976)* Iturra (1976) observed en excess of cancer deaths in a city in Canada with a PVC plant compared to a similar nearby city. This difference waa principally found In males aged 20 to 64, which is not Indicative of a general pollution effect. The author drew no conclusion as to why the condition existed. Representstives of the Environmental Protection Agency have stated that It has been unable to establish a link between living near VC manufacturing and using plenta and ASL. There are about 20 caaea of ASL per year In the United 8tatea that cannot be escribed to one of the known causes of the disease. There are also about 5 in Europe each year. Accordingly, there will be one case of ASL among the 5 million - 5 mile neighbors of VC/PVC facilities about every two years by chance alone. This has been seen in the studies in New York by Brady, et el, (1970), and in Connecticut (Heath and Landrigan, 1974). Theta states have cancer registries, which are of great value. In one case, a jury award was made to the estate of an individual who died of ASL, and who had lived the last four years of his life near a PVC plant. Inasmuch as that parson also had occupational exposure to VC and exposure to other ASL causative agents, it cannot be concluded that ambient VC exposure caused hit ASL (In re Craeao, Civil Action No. 78-1562, D.N.J.). A thorough study (Chiasce, et al, (1977), Chiasae, (1980)) of more than 15,000 employees of PVC fabricators found no evidence of VC~related health effects in that group, which waa estimated to have been expoaued to at least 15 ppm VC for many years. The disease ASL is often difficult to diagnose (Block, 19741 Heath, Flak and Creech, 1975), la almost invariably fatal within e abort time, and prtaents a variety of symptoms, including portal fibrosis and hypertension with splenomegaly and varices, proliferation of the sinusoidal lining, magalocytoala, and thrombocytopenia (Thomas and Popper, 1975) Cedigk et al, 1975). Metastasis is frequently involved. These symptoms ara very similar to those seen in the mouse (Schaffner, 1978) end rat (Faron and Krees, 1979) and the pathology also is similar (Gordon et al, 1975). No really adequate early warning tests have been devised (Whelan et al, 19761 Langbein et al, 1983t Tamburro and Greenberg, 1981), although the gammaglutamyl transpepaldeae teat is promising, together with IGG clearance and SGOT. Radiographic liver scene and tomography end sonography (Knlscbwlts et al, 1981) are said to be useful confirmatory teats. vaB.uuUTi55717 -I M'.MWMI la.k Community Hulch Effects of Vinyl Chloride Page rive A In summary, VC Is a classical procarcinogen, and la clearly a human carcinogen, causing ASL In a small percentage of highly exposed workers* There Is suggestive evidence that It may be a weak general carcinogen at high concentrations, perhaps through an immunosuppressive mechanism* but more data are required to confirm this suspicion. Several studies of Large populations have not shown a connection between general ambient exposure and an Increased Incidence of cancer. ^ IV. FEDERAL REGULATION OF VC/PVC INDUSTRY The primary federal agencies regulating the VC/PVC Industry ere the Occupational Safety and Health Administration (OSKA), which la part of the U.S. Department of Labor, the U.S. Environmental Protection Agency (SPA), end the Food and Drug Administration (FDA). OSHA regulation focuees on worker health while EPA addresses the control of chemicals outside the workplace* FDA oversees uses of PVC that Involve foods, drugs, cosmetics* and medical devices. A. The Occupational Safety and Health Administration The allowable occupational exposure for vinyl chloride of 1 ppm on an 8*hour time weighted average (TWA) is set by the OSHA workplace standarda at 29 C.F.R. 1910.1017. This was adopted In 1974, after extensive public hearings, and became effective in April 1975. 08HA first set an emergency temporary standard of 50 ppm and proposed a permanent limit of nondetectable exposure by a test sensitive to 1 ppm* OSHA than promulgated e final standard of an 8-hour TWA of 1 ppm, and a 15-nlnuta ceiling of 5 ppm* In brief, the regulation setei 1. A level of 0*5 ppm VC below which no action la required* Thie generally exempts most PVC fabrication plants and laboratories and many monomer plants. 2* A regulated area where exposures ere above 0.5 ppm which restricts entry to authorised persons. 3. Hedies1 examination raquirements and exposure record retention for specified employees. 4. A list of acceptable respirators. 5. Monitoring and alarm systems for the workplace, end routine measurement of worker exposure. 6. Labeling and signs for regulsted areas and containers of vinyl chloride end PVC. 7. Work procedures for hasardous operations. 8. Training programs for employees. VAB.0001165718 Community Health Effects of Vinyl Chloride Page Six 08HA also has a Hasard Communication Standard (HC3), 29 C.F.R. 1910.1200, which provide# labeling requirement# complainantary to the OSHA Vinyl Chloride Standard. Articles made from PVC are exempt from labeling requirements under the standard. B. Environmental Protection Agency EPA regulates the release of vinyl chloride under several statutes, including the Clean Air Act, Clean Water Act, Safe Drinking Water Act, Resource Conservation end Recovery Act (RCRA)# Comprehensive Environmental Response, Compensation and Liability Act (CERCLA or Superfund), and the Toxic Subatancaa Control Act (TSCA). 1. Air Standard (40 CFR 61.60) The EPA standard established in 1976 specified the following conditional a. Fugitive emissions controls by leek patrols end design standards for pump and compressor seals, agitators, and loading devices. b. Work practlcaa for vassal openings and sampling. c. Stripping requirements for residual monomer in resins and vastavatar. d. Abatement of specified point source emissions to 10 ppm. e. Prohibition of relief valve dischargee, except for emergencies f. Extantiva monitoring, reporting and recordkeeping requirements. g. Specific analytical procedures. EPA estimated that thia standard would result in a 95% reduction of VC emissions to the atmosphere from VC/PVC manufacturing plants and reduce the 5 mile annual average VC ambient air concentration from 17 parta par billion (ppb) to leas than 1 ppb. 2. Water Regulations Vinyl chloride is Hated as a priority pollutant under Section 307(a) of the Clean Water Act, and a Water Quality Criteria Document has bean prepared. Thia subjects VC and PVC manufacturing plants to special considerations when waste water discharge permits are leaned pursuant to EPA regulations, At part of its regulation of carcinogens in drinking water, EPA haa published a final Raconssandad Maximum Contaminant Laval (IMCL - a non-binding guideline) for VC in drinking water of aero (see 50PR 468S0, Mov. 13, 1983 for this amendment to 40 CFR 1WEMWL165719  Community Health Effect# of Vinyl chloride Pig* Seven * I However, EPA indicated that "Justifiable" way to determine the absence of vinyl chloride would be by setting a defined, tate-of-the-art detection limit sensitive to approximately l ppb. (49FR 24,330 24,347 - June 12, 1984). EPA has also proposed a maximum contaminant level of 1 ppb for vinyl chloride in drinking water. (See SO FR 46,902 - Nov. 13, 1985). 3. Waste and Spill Regulation H. 0 The EPA issued a rule under which certain VCmanufacturing distillation residues are listed aa hazardous wastes when diipossd (49 FR 5308). This rule requires that all such wastes are to be disposed of only by RCRA-approved procedures. When disposed of, commercial grade VC Is classified as e haserdous waste under the Resource Conservation and Recovery Act (RCRA), because of its toxic and lgnltable characteristics. Any disposal la subjact to regulation under RCRA. EPA has proposed additional RCRA regulations (51 FR 21648, June 13, 1986) which apply to all wastes containing VC. Thesa proposed regulations define wastes as hazardous when the VC level in the extract by a specified test method exceeds 50 ppb. Congraaa has specified an Interim 1 pound reportable quantity for vinyl chlorlds. Relssses to the environment in excess of 1 pound are regulated under CERCLA. I 4. New Product Manufacture The EPA also administers the Toxic Substances Control Act (T6CA) which establishes health and environmental regulations for both nav and existing substances. No one may manufacture or use a substance which la not on tha Agency's official inventory, unless the Premanulecturing Notice procedures are followed. C. Pood and Drug Administration PVC is widely used for food contact applications. Zn early I986v tha Food and Drug Administration (FDA) confirmed the safety of PVC for all food-contact applications and withdraw an outstanding proposal to limit Its use In food packaging. (See 51 FR 4173 - February 3, 1988). An accompanying new proposal would set various residual vinyl chloride levels for different food contact materials. Among ocher thlnge9 FDA found that "vastly Improved production technology (since 1975) has made It possible for manufacturers to succeed in reducing tha level of residual vinyl chloride monomer in vinyl chloride polymer." The constant period on the February 3, 1986 FDA proposal cloaed on June 5, 1986 without any adverse comments on ths health or safety of PVC. This FDA proceeding lands further support to the Inherent safety of human exposure to PVC. FDA regulates the use of PVC in medical devices and drug packaging on a case-by-case basis. VAB.0001165720 4 - M * V* Community Health Effects of Vinyl Chloride Pege Eight V. COMMUNITY HEALTH CONCERN8 Ae wee diecueeed in Section IV, VC ie a very strictly regulated substance* The EPA estimated that the 1976 standard would reduce the annual average exposure of the persons living within 5 miles of VC/PVC facilities by 95% (from 17 ppb to about 0.85 ppb.) An EPA report (1985) states that current* Industry performance has resulted in actual emissions that art significantly lees then that predicted amount. Many authors have attempted to develop quantitative risk assessments for low level exposures to VC. (See Barr, 1982 and Purchase, 1985 for reviews). Some have Incorporated human data (Cehring, et al, 1979, Anderson* at al, 1980, Purchase, et al, 1985) and only these predict reaulta which are compatible with the absence of any observed effects on humans from ambient exposures. The remaining estimates all used variations of the EPA upper limit model (Anderson, 1983) and overstate the probability of risk by several orders of magnitude. There la no confirmed case on record in which a member of the general population has been harmed by exposure to vinyl chloride. That feet sate the upper limit of lifetime risk at leas then 0.3 predicted cases of cancer per 1 million for exposure to 1 ppm of VC. Because the date show that industry emissions have been reduced by 99.99% (rather than the 95X estimated by EPA), Che actual risk is lass than 0.1 case of cancer in the neat 70 years among the 5 million presumed to be exposed to VC from living within 5 miles of a VC/PVC facility. Dr. Richard Wilson of Harvard (1979) has attempted to help people underatand this method of stating the risks of every day occurrences. Each of tho following activities for example, Is predicted co result in one death per million people* smoking 1.4 cigarettes (due to cancer, heart disease)) drinking h liter of wine (due co cirrhosis of the liver)) traveling 6 minutes by canoe, 10 miles by bieyle, 300 miles by car, or 1,000 mllea by Jet (due to an accident)) and having one chest X-rey taken in e good hospital (due to cancer ceueed by radiation). Wo conclude, therefore, that there is no basis for concern by persona living near VC-ualng or producing facilities for any health effects from oxpoaure to ambient concentrations of VC now being experienced. PH,E .IK- n M-ii- .ft-1- niv. . . v > mm iiih VAB.0001165721 T