Document dapwzgonXLYX4Qk7gZwvxRv55

TECHNICAL INFORMATION COMN0V1TY HEALTH EFFECTS 0F V I H Y L CHLORIDE Prepared By* The Vinyl Institute Healthp SAfety, & Environment Committee Issuedt August 1, 1966 The Vinyl institute, A Division of The Society of the Plastics industry, fnc Wayne Interchange Piaza M, 155 Route 46 West, Wayne. New Jersey 07470, (201) 690*9299 yAB.OQO1140558 I. SUMMARY This document tsvltwi the toxicity find human health ftfficti of ambient exposure to vinyl chlorido (VC), the raw material uaed In the production of polyvinyl chlorido (PVC). It eumnfirlaoB the extonfiivo and rigorous federal regulation of the VC/PVC industry, and comparefi quantitative risk assessments with actual health observations of individualfl 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. INTRODUCTION 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 ennuslly In the United States is converted into PVC used in thousands of products in the home and In industry -- products such as wallcoverings, upholstsry, flooring, house siding, water pipes, aewer pipes, luggage, clothing, automotive parts, medical devices, food wrap, windows, doors, wire insulation, garden hoaea, and phonograph records* PVC ia a polymer produced from VC through a chemical reaction called polymerisation. VC is converted into PVC by suspension, emulsion, bulk or solution polymerisation methods. PVC resins can be extruded, molded or calendared into diverse shapes, sites, and colors. Mechanical characteristics can be controlled to produce forma that are rigid, flexible, or in a liquid form such as latexes, pastes, and adhesives. Vinyl chloride became of Industrial importance approxiatately fifty years ago when 8emon (1933) discovered that the polymer could be converted into useful articles by plasticization with phthalate esters* Commercial development began first in Europe and then in the United States in the lata 19301 a. It was not until the early 1950fa that widespread coneumer applications developed. PVC Is now a mature product, and its growth rate falls in stsp with the Cross National Product. Ill* HEALTH HISTORY A Vinyl chloride Is a strong anasthatlc at 8-121 in animals and humans* Death follows rapidly after unconsciousness sets in if exposure Is not rtdttttd quickly (Petty et si, 1930). No major histological changes wars reported after 100 days at exposures of 50,000 ppm (Kuebler, 1964). Reversible liver effects at 100-500 ppm lad to a recommendation of a 50 ppm TWA exposure limit (Torkeleon, Oyen, and Rowe, 1961), but the American Conference of Governmental Industrial Hyganlste adopted instead a recommendation by Tala scientists of 500 ppm. This is the value later accepted by 08HA and it servad until 1974. Lehman and Flury (1943) termed vinyl chloride to be "one of the least dangerous of the chlorinated hydrocarbons11* VAB.0001140559 h J* 4 Comunlty Hulth Effects of Vinyl Chloride i Pa|i Tiro tW There ere no other known acute human physiological effects from vinyl chloride exposure. The odor threshold Is shout 1,000 ppm. The high heat of vsporisetion causes a substantial part of a large spill to liquify and presents the danger of frostbite. Vinyl chloride is flammable over the range of 3.6-33X In air, and extreme care must be taken to avoid spills and leaks for that reason. Host measurement and warning systems were designed to hold plant atmospheres below the flemmable limits. Retrospective esttaate* of typical time-weighted average personal exposuraa for polymerisation workers In England have been estimated (Barnea, 1980) as followsi 1945 to 1955 1955 to 1960 1960 to 1970 Mid 1973 1975 1,000 ppm (or abova) 400 to 500 300 to 400 150 5 In some jobs, particularly the cleaning of polymerisation reactors, exposuraa in the thousands of ppm range were experienced for short periods. (See Purchase, at al, 1985 and Barr, 1986 for reviews of the toxicity of VC). Chronic Health Effects The first cleer Indication of chronic health problems associated with VC caste in the 1960's In men who entered VC polymerisation reactore to reatove build-up of polymer from the walla. Some of these men developed a acro-oeteolyeii, a disease resulting in softening of bones in the fingers (Suciu, et al, 1963j Harris and Adams, 1967) Cook, et al, 1981). Modification of working practical has led to the elimination of this disease In workers * in PVC plants* In tha late 1960'e, Professor P.L, Viola of the Solvay Company tried to reproduce aero-osteolysia In rats by exposing them to high concentrations of VC for long periods. He felled 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 been suggested that VC was an animal carcinogen. (Viola, 1969, 1970} Viola, Blgotti and Caputo, 1971). As a direct result of tha Viola work, four West European VC/PVC manufacturing companies in Italy, France, Belgium, and England supported a comprehensive study of the animal toxicology of VC by Professor C. Ha itout, 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 (Haltoni et el, 1984). By the end of 1972, Maltoni had found a rare tumor* angiosarcoma of the liver (ASL)., in Borne of the exposed rats and confirmed that VC is Indeed an animal carcinogen. . These early findings were reported at an international symposium In 1973 (Msltoni, 1977). Haltoni rscosssended epidemiological investigations and medical controls of exposed workers and early in 1974, a U.S. company announced that they had found three A8L cases in employees at one of their PVC polymerisation plants. This finding ted 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. A j VAB.0001140560 mm 7 mm * + n --4 Coomunlty Health Effects of Vinyl Chloride Page Three A8L ie i very rare tumor* Leu than 20 caret per year from all these causes occur in this country. A review (Popper( et el, 1978) of all cases reported in the United States for the period 1964-1974 revealed 167 cases, of which 19 were ascribed et that time to occupational VC exposure} 26 to thorium dioxide given medically, and 9 to arsenic in Fowler*s solution, also used medically* Tha 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 most certainly have bean reported, and none have. For a time, NXOSH published a summary of VC-related cases (Falk, ec al, 1981), but this task was taken over first by John Stafford of XCI, England (Foreman, et al, 1985) and later by Brian Bannett also of IC1. The 1986 update of VC-related ASL cases shows a total of 38 cases In the United States and 120 worldwide. All of these cases Involve high occupational exposures to VC* The everege A8L 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 been somewhat shorter, approximately 19 years. All the U.S. occupational casts, end elmoet ail 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 polymerisation cycle. There is 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 cove rad g,364 men with at least one year of exposure before 1973 (Tabershaw and Gaffey, 1974). The expected excess otf aAsSiL* was found. There were also suggestions of an excess of cancers at other sites, This study was 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, most of ths lung cancer cases come from the same facility, with many plants having no cases A follow-up study of this expanded cohort to determine the status of the workers as of the end of I960 is underway. 8everal studies have been made of the general population using ASL as the rnsrker disease In en 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 Center For Disease Control (Popper et al, 1978; Falk, et 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 their matched controls, but could not establish a direct connection with the disease to exposure. Ten cates of ASL in Wisconsin were examined for possible connection with VC exposure, and none was found (Fiechtner st 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 at, 19B0) found one case where the person had lived the last six years of his life near a PVC plant and three cases whsre the men had worked In the plastics fabricating industry but for whom there were no records to Indicate exposure V to VC. VAB.0001140561 Commity Health Effect* of Vinyl Chloride Page Four The leek of reletionehip between residence near vinyl chloride operation* and the that eeees of unknown etiology was confirmed. death* during the years 1968-1971 In an had been in operation since 1949 and in 8eric et al, (1976) stu4led area surrounding a FVC plant which three worker* had died Of ASL. Ho relationship was found for liver or for lung or bronchial eancer and place of residence for the general population. A similar study for coanunltles near a Swedish plant that had operated since 1945 and had found four A81* case* showed (Elinder and Pershagen, 1978) no unexpected elevation of fetal mortality! deaths from all cancers, or cancer of the liver or lunge during the years 1961-1974. Pancreatic cancer in males was elavatad in the group over 60. All ASL cases in Holland slnca 1950 (27 casts) vara studiedt and none had any traceable contact with VC (Palderup et al, 1976)* Xturra _ PVC (1976) plant observed an exceaa of cancer deaths in compared to a similar nearby city a city in Canada with 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. Representatives of the Environmental Protection Agency have atated that It has been unable to establish a link between living near VC manufacturing and using plants and ASL. There are about 20 caaes of ASL per year in the United 8tates that oaitfiot be aacribed to one of the known cauaea of the disease. There are also about 5 in Europe each year. Accordingly* there will be one caae of A8L among the 5 million - 5 mile neighbors of VC/PVC facilities about every two year# by chance alone. This has been seen in the studies in Hew York by Brady, et al* (1970), and in Connecticut (Heath and Landrigan, 1974). These 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 his ASL (In re Crasso* Civil Action No. 78-1562, D.N.J.). A thorough study (Chiasse, et el, (1977), Chiaase, (1980)) of more than 15,000 employees of PVC fabricators found no evidence of VC-related health effects in that group, which was estimated to have been expoaued to at least 15 ppm VC for many years. The disease ASL is often difficult to diagnose (Block, 1974$ Heath, Flak end Creech, 1975), is almost invariably fatal within a short time, and presents e variety of symptoms, including portal fibrosis and hypertension with splenomegaly and varices, proliferation of the sinusoidal lining, megalocytosla, and thrombocytopenia (Thomas and Popper, 1975$ Cedlgk et cl, 1975). Metastasis is frequently involved. These symptoms are very similar to those seen in the mouse (Schaffner, 1978) and rat (Feron and Krees, 1979) end the pethology also Is similar (Gordon et al, 1975). Ho really adequate early warning testa have been devised (Whelan et al, 1976$ Langbeiti et el, 1983$ Tsmburro and Greenberg, 1981), although the gammaglutamyl tranepepsIdase test is promising, together with ICG cleerance and SCOT. Radiographic liver scans and tomography and sonography (Kolactivltg et al, 1981) are said to be useful confirmatory teata. VAB. Community Health Effect* of Vinyl Chloride ^ Paga Five In summary, VC i* a classical procarcinogen, and ia clearly a human carcinogen, causing A8L In a email percentage of highly expoaed worker*. There ia auggeatlve evidence that it may be a weak general carcinogen at high concentratlonai perhaps through an immunoauppreaalva mechanism, but nore data are required to confirm thle suspicion* Several atudiaa of large populations have not shown a connection between general ambient exposure and an increased Incidence of cancer. ^ A The primary federal agencies regulating the VC/PVC Industry are the Occupational Safety and Health Administration (OSHA), which is part of the U.S. Department of Labor, the U.S. Environmental Protection Agency (SPA)a and the Food and Drug Administration (FDA). OSHA regulation focusas on worker heelth while EPA addresses the control of chemicals out*14e the workpiece. 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 atanderda at 29 C.F.R. 1910.1017. This was adopted in 1974, after extensive public hearings, and became effective in April 1975. 08HA first sat an emergency temporary standard of 50 ppm and proposed a permansnt Halt of nondetec table exposure by a test sensitive to 1 ppm. OSHA then promulgated e final standard of an 8-hour TWA of 1 ppm, and a 15*mlnuta celling of 5 ppm. In brief, the regulation setai 1. A level of 0.5 ppm VC below which no action Is required. This generally exempts most PVC fabrication plants and laboratories and many monomer plants. 2* A regulated area where expoauree are above 0.5 ppm which restricts entry to authorised persona. 3. Medical examination requirements and exposure record retention for specified employees. H 4. A liet of acceptable respirators. 5. Monitoring and alarm systems for the workplace, and routine measurement of worker exposure. 6. Labeling end signs for regulated areas and containers of vinyl chloride and PVC. 7. Work procedures for hasardous operations. 8. Training programs for employees. VAB.0001140563 4 Commity Hulth Bffcts of Vinyl Chloride Page Six A 08HA also has a Hasard Communication Standard (HCS), 29 C.F.R* 1910.1200, which provide* labeling rtqulrMnti complementary to the OSHA Vinyl Chloride Standard. Article* made from PVC are exempt from labeling requirementa under the atandard. SPA regulatea the releaae of vinyl chloride under aeveral statutes, including the Clean Air Act, Clean Water Act, Safe Drinking Water Act, Resource Conservation and Recovery Act (RCRA), Comprehensive Environmental Response, Compensation and Liability Act (CERCLA or Superfund), and the Toxic Substances Control Act (TSCA). 1. Air Standard (40 CFR 61.60) The EPA atandard established in 1976 specified the folloving conditions! a. Fugitive emission* controls by leak patrols and design standards for pump and compressor seals, agitators, and loading devices. b. Work practices for vessel openings and sampling. c. Stripping requirements for residual monomer in resins and wastewater. d. Abatement of specified point source emissions to 10 ppm. e. Prohibition of relief valve discharges, except for esttrgencies. f. Extensive monitoring, reporting and recordkeeping requirements. g. Specific analytical procedures. EPA estimated that this 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 parts per billion (ppb) to less than 1 ppb. 2. Water Reaulations Vinyl chloride is listed as a priority pollutant under Section 307(a) of the Clean Water Act, and a Water Quality Criteria Document has been prepared. This subjects VC and PVC manufacturing plants to special considerations when waste water discharge permits are Issued pursuant to EPA regulations. As part of its regulation of carcinogens in drinking water, EPA has published a final ReconsMnded Maximum Contaminant Level (RMCL - a non-binding guideline) for VC in drinking water of aero (see 50FR 46SS0, Nov. 13, 19S5 for this amendment to 40 CFR 141.50.) VAB.0001140564 Community 1 Figs 8mo A However, SPA Indicated that a "Justifiable" way to determine the beence of vinyl chloride would be by setting defined, state-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 50 FR 46,902 - Hov. 13, 1985). 3. Waste and Spill Regulation The EPA issued a rule under which certain VC manufacturing distillation residues are listed as hazardous wastes when disposed (49 FR 5308)* This rule requires that all such wastes are to be dlspoaed of only by RCRA-approved procedures. When disposed of, commercial grade VC is classified as a hasardoua waste under the Resource Conservation and Recovery Act (RCRA), because of its toxic and ignltable characteristics. Any disposal La subject to regulation under RCRA. EPA haa proposed additional RCRA regulations (51 7R 21648, June 13, 1986) which apply to all wastes containing VC. These proposed regulations define wastes as hazardous when the VC level in the extract by a specified test method exceeds 50 ppb* Congress has specified an interim 1 pound reportable quantity for vinyl chloride. Releaaaa to the environment in excess of 1 pound are regulated under CERCLA. 4. Hew Product Ma**n**u* facture The EPA also administers the Toxic Substances Control Act (TSGA) which establishes health end environmental regulations for both new and existing substances. No one may manufacture or use a substance which is not on the Agency's official inventory, unless the Fremenufeeturing Notice procedures ere followed. C. Pood and Drug Administration PVC is widely used for food contact applications* In airly 1986, the Food and Drug Administration (FDA) confirmed the safety of PVC for all food-contact applications and withdrew an outstanding proposal to limit its use In food packaging. (See 51 FR 4173 - February 3, 1986). An accompanying new proposal would set various residual vinyl chloride levels for different food contact materials. Among other things, FDA found that "vastly Improved production technology (since 1975) haa made it possible for sunufacturers to succeed in reducing the level of residual vinyl chloride monomer in vinyl chloride polymer." The comawnt period on the February 3, 1986 FDA proposal closed on June 5, 1986 without any adverse comments on the health or safety of FVC. This FDA proceeding lends 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 caee-by-case basis* VAB.0001140565 Community Hulch Effects of Vinyl Chloride Pl|< Bight A V. COHHUttm HEALTH COMCEBH8 As was discussed in Section IV, VC is a very strictly regulated substance* The EPA estlasted that the 1976 standard would reduce the annual average exposure of the persons living within 5 miles of VC/PVC facilities by 951 (from 17 ppb to about 0.85 ppb.) An EPA report (1985) states that current' industry performance has resulted In actual emissions that are elgolficanlty leas than that predicted amount. Many authors have attempted to develop quantitative risk assesssMnts for low level exposures to VC. (See Barr, 1982 and Purchase, 1985 for reviews). Some have incorporated human data (Cehrlng, et at, 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 husuins 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 haa been harmed by exposure to vinyl chloride* That fact eats the upper limit oflifetime risk et leas than 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 95% estimated by EPA), the actual risk Is lsss than 0.1 case of cancer in the next 70 yeere 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) haa attempted to hslp people understand this method of stating the risks of every day occurrences. Each of the following activities for example, la predicted to result in one death per million people* smoking 1.4 cigarettes (due to cancer, heart disease)) drinking Jf liter of vine (due to cirrhosis of the liver)i traveling 6 minutes by csnoe, 10 miles by blcyle, 300 miles by car, or 1,000 miles by jet (due to an accident) i and having one chest X-ray taken in e good hospital (due to cancer caused by radiation). We conclude, therefore, that there ia no basis for concern by persona living near VC-utlng or producing facilities for any health effects from exposure to ambient concentrations of VC now being experienced. VAB.0001140566