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1. PUBLIC HEALTH STATEMENT 1.1 THAT IS ram CHLORIDE? \ Vinyl chloride is s colorless ges with a mild, sweet odor. Most of the vinyl chloride produced in the United States is used to aake 'polyvinyl chloride (PVC), a notarial used to Manufacture a variety of plastic and vinyl products including pipes, wire and cable coatings, packaging aaterials, furniture and autoaobile upholstery, wall coverings, housewares, and automotive parts. Much smaller amounts of vinyl chloride are used as a refrigerant gas and in the aanufacture of other chlorinated compounds. The aajor sources of release of vinyl chloride to the environment are atmospheric emissions and wastewater discharges from the plastics industries (primarily vinyl chloride and. PVC manufacturers). Most of the vinyl chloride released to the environment eventually ends up in air. 1.2 HOT MIGHT I BE EXPOSED TO VIHTL CHLORIDE? Humans are exposed to vinyl chloride from environmental and occupational sources. The low levels of vinyl chloride found in the environment (often called background levels) are usually more than a thousand times lower than levels found in occupational locations. Background levels in the environment are usually expressed in terms of parts of vinyl chloride present in a billion parts of air or water v, (ppb). Background levels found in the air we breathe result from the ^ discharge of exhaust gasses from factories that aanufacture or process i^ J vinyl chloride, or evaporation from areas where chemical wastes are ^ O'\ ^ stored. Highest background levels have been measured in air near vinyl r I ^t ^ ^ r_ chloride factories or over ehemicsl waste storage areas. Air inside new cars may contain levels of vinyl chloride higher than expected background levels, because vinyl chloride may seep ineo the air from the 6 new plastic parts. V/) Background levels in drinking water come from factories that release wastes into rivers and lakes, from seepage into water in areas where chemical wastes are stored, or from contact with polyvinyl chloride pipes. In the past, concentrations exceeding expected background levels ware present in foods packaged in plastic that contained vinyl chloride. A -v Jv.w-fS Occupational sources, such as what might be experienced in vinyl chloride manufacturing or processing factories, may result in exposure to levels in the sir much higher than those from environmental sources. Levels in the air in occupational locations are usually expressed in terms of parts of vinyl chloride per million parts of air (ppm). 1 CTL017541 18 found near vinyl chloride production planes (Gordon and Masks 1977, Pallizzari at al. 1979, IARC 1979, E?A 1983b), and lavals have ranged froa undetectable eo 23.4 pg/a^ (0.01 ppa) over landfills (Stephens at al. 1986, Baker and Maekay 1983). It is unlikely that levels in ambient air would result in significant exposure. Several epideaiologieal studies associated occupational exposure with adverse health effects, including cancer; however, these studies (see Sect. 4, Toxicological Data) did not quantify exposure. A NIOSH survey of three vinyl chloride aanufsecuring plants reported a time* weighted average concentration of 0.18 to 69 ag/m^ (0.07 to 27 ppm) in workplace air (Fishbein 1979). Concentrations in some plants were as high as 100 to 800 ag/a^ (39 to 313 ppa) (Fishbein 1979). There seems little doubt that occupational exposure reaains Che aosc important source of exposure to vinyl chloride. Levels in drinking water as high as 10 Mg/1* have been detected (Dyksen and Hess 1982, HSDB 1987), but aosc monitoring studies have reported no detectable vinyl chloride in drinking water (HSDB 1987, Coniglio ec al. 1980). Data were not located regarding the aonitoring of vinyl chloride in soil, but exposure froa contact with contaminated soil is likaly to be negligible because deraal absorption is not considered significant (Hefner ec al. 1973a). In the past, vinyl chloride had been detected in various foods, as a result of migration froa polyvinyl chloride food wrappings and containers (E?A 1983b). Currently, the FDA regulates Che use of vinylchloride-containing polymers to maintain levels of vinyl chloride in food at sS ppb. A recant report suggests chat migration of vinyl chloride into food froa polymers containing very low levels would be negligible, and that intake froa food is expected to be negligible (Kontoainas ec al. 1983). 2.2.3.2 Hnaan exposure potential Monitoring data indicate chat people living in the vicinity of vinyl chloride, PVC, or vinyl chloride copolymer aanufacturers, or hazardous waste sites chat contain vinyl chloride, would be exposed to this compound through inhalation of contaminated air, whereas people not living near these sources would be exposed to negligible levels. Locations of large industrial sources include, but are not Halted to: Plaqueaine, Louisiana; Houston, Texas; Lake Charles, Louisiana; Calvert City, Kentucky; Point Coafore, Texas; Oklahoma City, Oklahona; Baton Rouge, Louisiana; Delaware City, Delaware; Pensacola, Florida; and Aberdeen, Massachusetts (CMR 1986a,b). The greatest likelihood for human inhalation exposure to vinyl chloride is occupational. NIOSH estimated that 27,000 workers are definitely exposed to vinyl chloride, and workers probably exposed aay be as aany as 2.2 alllion (Sittig 1983). The level of vinyl chloride in drinking water is expected to be highest in areas where the raw water supplies axe contaainated with vinyl chloride. The aosc probable source of surface water contaalnati n is wastewater froa vinyl chloride, PVC, and vinyl chloride copolymer aanufacturers. The most probable sources of groundwater contamination are landfills. It has been shown that use of PVC pipes(aiff result in leaching of vinyl chloride aonoaer into drinking watersupolles; 24 animal* and humans. Further understanding of the ichanism of action on other systems, such as the CHS, could be gained. 2.3.3.2 Monitoring of buaan biological samples The most practical biological monitoring procedure appears to be quantification of urinary output of thiodiglyeolic acid, the predominant urinary metabolite of vinyl chloride (Heger et al. 1982). Individual variation, however, renders this method unreliable at exposure concentrations <3 ppm (Tarkovski 1984). 2.3.3.3 Environmental considerations Limited data are available regarding the vinyl chloride levels in foodstuffs. Monitoring data on levels of vinyl chloride in food contained in FVC packaging materials are needed. Intake of vinyl chloride by ingestion of contaminated food was assumed to be negligible, based on strict FDA regulations and one laboratory study (Kontominas et al. 1983) that simulated actual food packaging and food storage conditions. This assumption should be verified with monitoring data. uo, JY " >1 v' >V' * Data on the amount of leaching of vinyl chloride from rigid PVC water pipes into drinking water need to be obtained. Monitoring data alone cannot reveal the extent of the leaching problem, because monitoring data frequently reflect levels in drinking water supplies before transport through FVC distribution systems. Limited data are available on the persistence of vinyl chloride in the environment, particularly in surface waters, soil, and groundwater. Although a half-life for vinyl chloride In surface water has been estimated, significant uncertainty exists.- Due to lack of data, it was not possible to estimate a half-life for vinyl chloride in soil or groundwater. CTL017543 5. MANUFACTURE, IMPORT, USE AND DISPOSAL 5.1 OVERVIEW Vinyl chloride is produced ec 10 locaCions in Che United States. During 1986, an estiaated 8.S Co 8.6 billion lb o this cheaical was produced in the Uniced Seates. It is produced by thermal cracking of ethylene dichloride. Vinyl chloride is used alaosc exclusively in the United States for the production of polyvinyl chloride (PVC) and several copolymers. These compounds yield a wide range of end-use products which are used by industries and consumers. 5.2 PRODUCTION' Domestic production of vinyl chloride during 1986 was estiaated to range between 3.5 and 8.6 billion lb. This was -94 to 98% of available production capacity in 1986. In 1985, 7.8 billion lb of vinyl chloride was produced in the United States (C&EN 1987). Manufacturers and sices of production are as follows (CMR 1986a): Borden Cheaical in Geismar, Louisiana; Dow Cheaical in Oyster Creek, Texas, and Plaqueaine, Louisiana; Formosa Plastics in Bacon Rouge, Louisiana, and Point Comfort, Texas; BF Goodrich in Calvert City, Kentucky, and La Force, Texas; PPG Industries in Lake Charles, Louisiana; Shell Oil in Deer Park, Texas; and Vista Cheaical in Lake Charles, Louisiana. Vinyl chloride is produced commercially by thermal cracking of ethylene dlehloride (EDO). EDC used in this process is aade by either direct chlorination of ethylene using liquid chlorine, or oxychlorination of ethylene using dry hydrochloric acid and oxygen (Cowfer and Magistro 1985). Vinyl chloride is usually supplied as a liquid under pressure (IARC 1979). The technical grade product is available in 99.9% purity (Sex end Lewis 1987). 5.3 IMPORT Imports of vinyl chloride were -200 million lb in 1987 (C&EN 1987). 3.A USES The use pattern for vinyl chloride is as follows (CMR 1986a): polyvinyl chloride (PVC), 85%; exports, 13%; and ocher, mostly cop lymer use, 2%. This use pattern indicates that vinyl chloride monomer is used almost exclusively in the United States by the plastics industry. Very small amounts are used as a refrigerant gas and as an intermediate in the production of chlorinated compounds (Curry and Rich 1980, Gosselin et al. 1984, IARC 1979). Limited quantities of vinyl chloride were used in the United States as an aerosol propellant, and as an ingredient of 63 CTL017544 ft 64 drug and cosaetic producer; h wever, ehasa praccicaa hava ba n discontinued (EPA 1985b). Vinyl chlorida la industrially important bacauaa of ica inherent flaaa racardant proparcies, ica vida variacy of and-uaa produces, and tha low cose of producing polymars froa vinyl chlorida (Cowfer and Magiacro 1985). Principal and-uaa produces includa: PVC pipas, wira and cabla coatings, packaging aacarials, fumieura and aucoaobila upholstery, wall coverings, housewares, and aucoaocive pares and accessories; vinyl chlorida-vinyl acetate copolymer floor coverings, phonographic records, and flexible film; vinyl chloride-acrylonitrile battery cell separators; and vinyl chlorida-vlnylidina chlorida copolyaer food packaging fila (Curry and Rich 1980, Salklnd and Pearlman 1978, Farkas 1980). 5.5 DISPOSAL EPA requires that persona who generate, transport, treat, store, or dispose of this compound coaply with regulations of the Federal Resource Conservation and Recovery Act (RCRA). The recommended method of disposal, reported by Sittig (1985), involves the incineration of this cheaical after mixing it with another combustible fuel f~tsiren an ensure atwe'complete combustion has taken place, avoid -fuHatluU irf^pheegaoa.. An said scrubber is seMtfG^tt to remove HC1. In addition to this method, other /disposal techniques^have been developed for the recovery of vinyl chloride froa P'XC latexes (Sittig 1985). I sUAS Cu+Jj Hi CTL017545 EHVX&ONMEOTAL FATS 6.1 OVERVIEW Effluents and amissions from vinyl chlorida and PVC manufacturers are responsible for the majority of vinyl chlorida released'to the environment. When released to the atmosphere, vinyl chlorida is expected to be removed by reaction with photochemically generated hydroxyl radicals (half-life - 1.2 to 1.8 days). Reaction products Include HC1, formaldehyde, formyl chloride, acetylene, chloroacetaldahyde, chloroacetylchloranil, and chloroethylene. In photochemical smog situations, vinyl chloride has a half-life of 3 to 7 h. When released to water, volatilization is expected to be the primary fate process (halflife - 8.7 to 43.3 h). In waters containing photosensicizers, such as humic materials, sensitized photodegradation may also be important. When released to soil, vinyl chloride will either volatilize rapidly from soil surfaces, or leach readily through soil, ultimately entering groundwater. 6.2 RELEASES TO THE EHVIROHHEHT The major source of release o 1 chloride to the environment is believed to be emissions and efflu root plastic industries (primarily vinyl chloride and PVC cturers). Vinyl chloride released in wastewater is expected latilize fairly rapidly (on the order of hours to days) into the a ere. Ocher sources of release include disposal of vinyl chloride -------- s in landfills, incomplete combustion of PVC, tobacco smoke, spills, and biodegradation of trichloroethylene, tetrachloroethylene, and 1,1,1-crichloroethane in groundwater (XARC 1979, HSOB 1987, Wafcaaan and Johnson 1978, Wilson and Wilson 1983, Smith and Dragun 1984). EPA estimated that prior to 1973, 110 million kg/year of vinyl chloride escaped into the atmosphere from PVC production facilities in the United States (1ARC 1979). Worldwide emissions of vinyl chloride into the atmosphere during 1982 was -400 million lb (Hartmans et al. 1983). 6.3 OVUOHMEHTAI. FATE 6.3.1 Air Based on a vapor pressure of 2660 mm Hg. at 25*C, essentially all vinyl chlorida in the atmosphere la expected to exist in vapor form (Verscbuaren 1983, Eisenxelch at al. 1981). Consequently, removal from the atmosphere by dry deposition is not expected to be an important face process. Vinyl chloride has a relatively high partition coefficient between air and water (H - 50), which suggests that significant amounts of vinyl chloride would not be removed from the atmosphere by wet deposition (EPA 1983b). 65 C**S4 66 Reaction f vinyl chlorida vapor wish photochaaically generated hydroxyl radicals is pradlccad co ba cha primary dagradaclon mechanism for this compound in cha atmosphere. Tha half-Ufa for this raacclon In cha cypical atmosphere has baen -1.5 Co 1.8 days (E?A 1985b). Produces of chis raacclon ara HC1, formaldehyde, formyl chlorida, carbon aonoxida, carbon dloxida, chloroacacaldahyda, acacylana, chloroachylana, chloroacacylchloranll, and H20 (E?A 1985b). In phoeochaaical saog sicuacions, cha raacclon half-lifa of vinyl chlorida Is pradicced co ranga batvaan 3 and 7 h (HSDB 1987). Raacclon with ozone (half-life 4.2 Co 33 days), raacclon vich oxygen acorns [0(3P)] (half-lifa - 373 co 532 days), and dlracc phocolysis ara ralacivaly insignificant dagradaclon aachanisas in Cha acaosphara (EPA 1985b). 6.3.2 Water Tha primary loss procass for vinyl chlorida In natural water syseaas is volatilization into cha acaosphara. Tha half-lifa for vinyl chlorida volatilization froa a cypical pond, river, and laka has baan estimated co ba 43.3, 8.7, and 34.7 h, respectively. These values ara based on an experimentally determined raaeraeion race ratio of -2 and assumed oxygen reaeration raeas of 0.008, 0.04, and 0.01 hour'l for a cypical pond, rlvar, and laka, respectively (EPA 1985b). Pradlccad half-lives should ba considered rough estimates since cha presence of various sales in natural water syseaas aay efface cha volatility of vinyl chlorida significantly (EPA 1985b). In waters containing phoeosensielzars, such as huaic materials, photodagradation aay ba fairly rapid. This suggests chat in soaa wacars sensitized phocodagradatlon would also ba a significant reaoval mechanism (HSDB 1987, EPA 1985b). Cheaieal hydrolysis of vinyl chlorida does not appear co ba environmentally important. Tha hydrolytic half-lifa for vinyl chlorida has baan estimated to ba <10 years (EPA 1985b). Vinyl chloride is not axpactad to oxidize chemically by reaction with photochaaically generated hydroxyl radicals, aolecular oxygen, or alkyl peroxy radicals in natural water systeas. Halted available data on the biodegradation of vinyl chlorida indicate that this coapound is resistant to aicrobial degradation under aerobic conditions (EPA 1985b). Vinyl chloride is not axpactad to adsorb significantly to suspended solids and sediments in water or bioeccuaulata significantly in aquatic organisms (HSDB 1987). 6.3.3 SoU The relatively high vapor pressure of vinyl chloride (2660 an Hg at 25*C) indicates that chis coapound should volatilize quite rapidly froa dry soil surface. The effective half-life (due to volatilization) of vinyl chloride placed 10 cm deep in dry soil is predictad to ba 12 h (EPA 1985b). Evaporation froa moist soil surfaces is also axpactad to ba significant since this coapound does not adsorb strongly to soil and appears to volatilise fairly rapidly froa water. Experimental data regarding adsorption of vinyl chloride to soil were not located. Based on the regression aquations given by Lynan at al. (1982) and Sabljlc (1984), tha soil adsorption coefficient (Koc) for vinyl chloride has baan estimated to range between 17 and 131. These Koc CTL017547 67 values suggest chat this compound would be highly aobile In soil. Thus, vinyl chloride has the potential to leech into groundwater. Based on data in aquatic media, chemical reaction of vinyl chloride in soil does not appear to be a significant face process, and it appears that vinyl chloride would be resistant to biodegradation under aerobic conditions. ^017548 7. POTENTIAL POK HUMAN EXPOSURE 7.1 OVTOVgW^^^-------- r"A>^ y ^Anthropogenic sources are responsible for ell of the vinyl chloride foundlirrhe-environmenc. Most of che vinyl chloride released co che environment will eventually locate in che acaosphere while such smaller amounts will eventually locate in groundwater. Vinyl chloride has been detected in the ambient air in the vicinity of vinyl chloride and PVC manufacturing plants and hazardous waste sites. Vinyl chloride is expected to leach into groundwater from spills, landfills, and industrial sources. Segments of che general population living in che vicinity of 1 emission sources are exposed co vinyl chloride by inhalation of contaminated air. Average daily intake of vinyl chloride by inhalation for these people ranges from trace amounts to 2100 pg/day. The average daily intake of vinyl chloride by inhalation is expected co be essentially zero for the remainder of che population. However, short* term inhalation exposure co relatively high levels may occur during use of new cars. This is due co volatilization of vinyl chloride from vinyl polymers within the car interior. The majority'of che general population is not expected to-be > exposed to vinyl chloride through ingestion of drinking water. However, people who have PVC water pipes that have not been created adequately to remove' vinyl chloride monomer may ingest >0.06 co 2.8 pg/day of vinyl chloride from drinking water. The average daily intake of vinyl chloride through diet is predicted to be essentially zero. NIOSH estimated chat 27,000 workers are definitely exposed to vinyl chloride and. that workers probably exposed may be as many as 2.2 million. Intake is expected to occur primarily through inhalation and lees importantly by absorption through skin. Workplace air in some PVC earnlfar curing plants- wee found to contain 100 to 800 g/*3 (39 to 312 ppm) vinyl chloride with peak concentrations of up to S7\ 300 mg/m-3 (34,000 ppm). A NIOSH survey of three vinyl chloride manufacturers reported a time*weighed-average exposure of 0.18 to 69 mg/m3 (0.07 to 27 ppm) vinyl chloride in workplace air. 7.2- LEVELS MONITORED OR ESTIMATED H TEE ENVIRONMENT 7.2.1 Air Air in rural/remote and urben/suburben areas of che United States typically contain no detectable amount of vinyl chloride (Stephens ec al. 1986; Crimarud and Rasmussen 1975a,b; Harkov at al. 1984; Wallace ec al. 1984; EPA 1983b). Limited monitoring data indicate chat in areae naar vinyl chloride end polyvinyl chloride manufacturers, the 69 CTL017549 70 concentration of vinyl chloride in air typically rang** from trace lavala to -105 jig/m^ (Gordon and Meek* 1977, Pellizzari at al. 1979, IARC 1979, EPA 1985b), but nay axcead 2600 pg/m^ (1 ppa) (Fishbain 1979). Elevated lavals of vinyl chlorida aay also ba found in tha vicinity of hazardous waste landfills. Concentrations ranging from below detection liaits to 5 to 8 Mg/a^ (0.002 to 0.003 ppa) have bean aonitorad in tha air above soaa landfills (Stephans at al. 1986, Baker and Mackay 1985). Hoaas near a hazardous waste site in Southern California ware found to contain levels as high as 1040 ng/m} (0.4 ppm) (Stephens at al. 1986). Typical values for the average daily intake of vinyl chloride by Inhalation in urban/suburban and rural/remote areas have been estimated to be essentially zero. Assuming that the average intake of air is 20 m^/day, the average daily intake of vinyl chloride by people living in source-dominated areas has been estimated to range from trace amounts to 2100 pg/day. 7.2.2 Vater Vinyl chloride has been detected at varying concentrations in surface, ground, and drinking waters throughout the United States (EPA 1985b). Concentrations as high as 9.8 fig/L in surface water, 380 jigA in groundwater, and 10 pg/L in drinking water have been reported (Dyksen and Hess 1982, HSDB 1987). There was no report in the literature of vinyl chlorida being detected in sediment. The level of vinyl chloride id groundwater in the United States was determined during the 1982 EPA Groundwater Supply Survey, tfater' supplies from 945 sites geographically located throughout the United States were studied. Results indicate that vinyl chloride was positively identified in only 0.74% of groundwater supplies (detection limit 1 j*g/L) The maximum concentration detected was 8.4 pg/L (Vestrlck et al. 1984). Other studies have also reported the occurrence of vinyl chloride in groundwater throughout the United States at levels at or below 380 Mg/1 (Cotruvo 1985, Goodenkauf and Atkinson 1986, Page 1981, Coniglio et al. 1980, Stuart 1983). The concentration of vinyl chloride in finished drinking waters in the United States was studied during the 1976-1977 EPA National Organics Monitoring Survey (NQMS). Only 2 samples out of 113 contained detectable levels (>0.1 (tg/L), and-these averaged 0.14 ms/1 (HSDB 1987). Results of other studies also indicate that the majority of drinking water supplies in the United States contain no detectable levels of vinyl chloride (HSDB 19B7, Coniglio et al. 1980). Based on these studies, it is assumed that the average daily intake of vinyl chloride by ingestion of drinking water for meet persons in the United States would be essentially zero. Estimates provided in EPA (1985a) indicate that 0.9% of the United States population is exposed to levels of vinyl chloride in drinking water kl.O pg/Lt end 0.3% of the population is exposed to levels >5 jig/L- CTL017550 71 7.2.3 Sell Monitoring data for vinyl chlorida in soil vara not locatad in the available litaracura. 7.2.4 Other In the past, vinyl chlorida had bean detected in various foods as a result of aigraeion froa polyvinyl chloride food wrappings and containers (EPA 1983b). Vinyl chloride has been found in vinegar at levels up to 9.4 ppa, in edible oils at 0.13 to 14.8 ppm, and in butter at 0.03 ppa when these foods were packaged and stored in PVC containers (IARC 1979). Ac present, the Food and Drug Adainistration (FDA) regulates use of vinyl chloride polymers available for use in production of articles intended to contact food. These articles include foodpackaging materials, coatings, plastisols, gaskets, end parts for food processing (see Sect 9, Regulatory and Advisory Status). A recent study on the migration of vinyl chloride from PVC under conditions closely simulating actual food packaging and storage revealed that at very low concentrations of vinyl chloride in PVC packaging material, there was essentially zero migration of vinyl chloride (Koncominas et al. 1985). It is reported that migration of vinyl chloride from rigid PVC water pipes into drinking water occurs, and that it is directly proportional to the residual level of vinyl chloride in the pipe itself. Under certain conditions, reaction with chlorine in the water may result in the complete removal of vinyl chloride from drinking water (Fishbein 1979, Ando end Sayato 1984). During one study, it was found that drinking water which ran through recently installed PVC pipes contained vinyl chlorida at 1.4 Mg/1-, while water .which ran through a 9-year-old system contained 0.03 to 0.06 Mg/1* (HSDB 1987). This suggests chat use of PVC pipe in water distribution systems contributes to intake of vinyl chloride through ingestion of contaminated drinking water. Assuming thac the average daily intake of water is 2 L. the average intake .of vinyl chloride froa water contaminated with vinyl chloride froa PVC pipes is expected to range froa 0.06 to 2.8 Mg/day. ^ The Interior air of two new cars was analyzed and the level of vinyl chloride was found to range from 824 to 3120 n%/w? (0.3 to 1.2 ppm) (EPA 1983b). The source of vinyl chloride was believed to be 7 volatilization froa vinyl plastics found in the car interiors. Levels of vinyl chloride in the air in new cars may exceed esclmaces of minimal risk levels for acuta and intermediate expoaure. Vinyl chloride has been detected in tobacco smoke (EPA 1983b). Cigarettes and little cigars have been found to contain 5.6 to 28 ng vinyl chloride per cigarette (IARC 1979). 7.3 OCCUPATIONAL EXPOSURES 5I0SH estimates definite worker exposure to vinyl chloride to be 27.000 persons and probable worker exposure to be 2.2 million (Sittig 1983). This includes -3000 workers employed in vinyl chloride synthesis, 3000 workers involved with polymerization processes, and as many as 330.000 workers associated with fabrication plants. Exposure is believed to occur primarily through inhalation and less frequently by absorption CTL017551 72 through skin (Sitrig 1983). In the pssc, concentrations of vinyl chloride in workplace air in soma planes producing PVC havs been raportad to ranga from 100 co 800 mg/m^ (39 to 313 ppa) with paak concancrations up to 87,300 ag/a^ (34,000 ppa) (IaRC 1979). Currantly. tha Occupational Safaty and Health Adainistratlon (OSHA) sats standards for occupational exposure co vinyl chlorlda (saa Sact. 9, Ragulacory and Advisory Status). A recant N10SH survey of ehraa vinyl chloride plants indicated that tha time-weighted-average exposure to vinyl chloride varied between 0.2 to 70 ag/a^ (0.08 to 27 ppa) (IARC 1979). 7.4 POPULATIONS AT HIGH StISX Data ware not located specifically regarding subpopulations unusually sensitive to the effects of vinyl chloride. Individuals located near or downwind of production facilities, hazardous waste disposal sites, and landfills aay potentially be exposed to higher aabient ataospherlc levels. Workers involved in the production or polymerization of vinyl | chloride aay constitute a group at risk because of the potential for J occupational exposure. Since the aid 1970s, however, ataospherlc levels -jj in the workplace have often been reduced co si ppa (Fishbein 1979, j Kilian et al. 1973, Hansteen et al. 1978). Occupationally exposed aen i aay represent a sensitive subgroup because occupational exposure in aen i has been associated with an Increased incidence of fetal loss in their j wives (Infante et al. 1976, Waxweiler et al. 1977). (to threshold concentration has been detarained for this effect. Woaen (or couples) of child-bearing age aay constitute a group at risk, because data suggest j that aabient exposure to low (but not quantified) environaental levels ;j is associated with an increase in the Incidence of malformations at | birth (Infante 1976; Edaonds et al. 1973, 1978; Theriault et al. 1983). No threshold has been determined for this effect. Inhalation studies.in enlaals demonstrated that exposure early in life resulted in greater risk of developing cancer than did exposure later in life (Drew et al. 1983). Although huaan studies that address the effect of age on cancer risk were not located, the aniaal data suggest that exposure during the younger years aay result in increased cancer risk. Other animal studies suggest that prenatal exposure aay increase cancer risk (Maltoni et al. 1980, 1981). Although huaan data ! were not located, the animal data may suggest that the prenatal exposure | of humans to vinyl chloride aay Increase risk of cancer. Animal studies have demonstrated that pretreataent with xenobiotics or drugs that induce mixed-function oxidase (HFO) potentiates the hepatotoxlclcy of vinyl chloride (Jaeger at al. 1974, Reynolds et al. 1973, Conolly et al. 1978). Although huaan data were not located, the aniaal data suggest that huaan exposure to environaental pollutants r drugs that Induce NFO aay result in increased sensitivity to vinyl chloride. CTL017552 9. REGULATORY AND ADVISORY STATUS 9.1 INTERNATIONAL Advisory guidance issued by the World Health Organization (UHO) for vinyl chloride was noc locacad in eh available literature. 9.2 NATIONAL 9.2.1 Regulations 9.2.1.1 Air The Occupational Safety and Health Administration (OSHA 1983) regulations for vinyl chloride state chat a worker must noc be exposed to a concentration of >1 ppm over any 8-h period and that a worker oust noc be exposed to >5 ppm for any period of time exceeding IS minutes. Direct contact with liquid vinyl chloride is prohibited. E?A (1982c) has established emission standards for vinyl chloride released to the atmosphere by vinyl chloride and polyvinyl chloride plants. Emissions are noc to exceed 10 ppm. 9.2.1.2 Veter Pursuant to the Safe Drinking Vacer Act, EPA (1987c) promulgated a wax 1mm contaminant level (MCL) for vinyl chloride of 0.002 mg/L. equivalent to an estimated cancer risk of 10*3. This regulation is to become effective January 9, 1989 and is to apply to all community drinking water systems chat regularly serve the same 23 persons for at least 8 months/year. 9.2.1.3 Food The Food and Drug Administration (FDA 1988) recently proposed to mend its regulations regarding the vinyl chloride content of polymers used in packaging materials or processing equipment for foods. Depending on the nature of the polymer and its use, proposed vinyl chloride content may range from 3 to 50 ppm. 9.2.1.4 Other EPA (1982d) has designated vinyl chloride as a hazardous constituent of solid waste and requires that it be handled in accordance with the regulations governing the same. EPA (1987d) lists a reportable quantity (RQ) for vinyl chloride of 1 lb, but proposes chat the RQ be changed to 10 lb. The RQ is the quantity that, if released to the environment, must be reported iasiediacely to the National Response Center. 79 CTL017553 80 9.2.2 Advisory Guidance 9.2.2.1 Air Tho American Conference of Governmental Industrial Hygienists (ACGIH 1986b) recommends a Threshold LIalt Value (TLV)-TUA for vinyl chloride of 5 ppa and a Short-Terrs Exposure Limit (STEL) of 10 ppm wich the notation that the compound is a recognized human carcinogen. The National Institute of Occupational Safety and Health (NIOSH 1975) concluded that a TLV for vinyl chloride was inappropriate because of its carcinogenicity. NIOSH (1975) recommended that any workers exposed to vinyl chloride should wear an air-supplied respirator. -9.2.2.2 Veter DA (1980), based on a human of 1.74 x 10*2 (mg/kg/day)*^ calculated from the incidence of tumors in a preliminary report of an inhalation study in rats (Maltoni and Lafemlne 1975), estimated levels in ambient water of 20, 2, and 0.2 /ig/L associated with cancer risks of 10*3, 10*7t respectively, assuming daily consumption of 2 L water and 6.5 g fish and shellfish. For consumption of fish and shellfish alone, water concentrations of 5246, 525, and 52.5 pg/L correspond to cancer risk estimates of 10*3, io*6 and 10*7, respectively. More recently, EPA (1985a, 1987b) estimated that cancer risk levels of 10*^, 10*3, and 10*6 Would result from daily consumption of drinking water containing vinyl chloride at 1.5, 0.15, and 0.015 Mg/L, respectively. EPA (1985a, 1987a) promulgated health advisories for vinyl chloride in drinking water. A 10-day health advisory of 2.6 mg/L was based on-a KOAEL of 30 mg/kg/day in a 13-week gavage study by Feron et al. (1975). Because data were not sufficient for derivation of a 1-day health advisory, the 10-day health advisory was adopted as a conservative 1-day health advisory. Longer-term health advisories of 0.013 mg/L for a 10 kg child and 0.046 mg/L for an adult were estimated from the NOAEL of 0.13 mg/kg/day in a lifetime dietary study in rats (Dow Chemical Company 1984, Til et al. 1983). 9.2.3 Data analysis 9.2.3.X Severance doses (RfSe) Reference doses for vinyl chloride have not been estimated by EPA. 9.2.3.2' Carcinogenic potency DA (1985a) classified vinyl chloride in IARC Group 1, and more recently, DA (1987a) assigned the compound to Carcinogen Assessment Croup (CAG) Class A. By either classification scheme, the designations have the same meaning, that evidence for carcinogenicity to humans is so convincing as to be considered "sufficient. DA has derived several estimates of carcinogenic potency for vinyl'chloride for both oral and inhalation exposure. In an early estimate, DA (1980) derived a q^* for human oral exposure of 1.74 x 10*2 (mg/kg/day)*^ based on preliminary reports of the incidence of total tumors in rats of both saxes exposed to vinyl chloride by inhalation at concentrations up to 10,000 ppa CTL017554 81 (Maltoni and Lefemine 1975). A subsequent estiaate of potency for oral exposure is 2.3 (mg/Vg/day), which appears in EPA (1985a, 1987a) and represents the most recent analysis by CAG (EPA 1987a). This estimate was baaed on the incidence of lung and liver tuaors in both sexes of rats exposed for lifetime to discs Chat contained vinyl chloride (Feron at al. 1981). The first estiaate for carcinogenic potency by inhalation exposure, 2.5 x 10`2 (ag/lcg/day)derived in EPA (1984), was based on the same preliminary inhalation data (Maltoni and Lafeaine 1975) that was used as the basis of the EPA (1980) oral estimate. A more recent estimate of 2.95 x 10*^ (mg/kg/day)'^ (EPA 1985b) was based on the final report of the Incidence of liver angiosarcomas in male and female rats exposed for up to 1 year to concentrations up to 30,000 ppm (Maltoni ec al. 1980, 1981). 9.3 STATE (Regulations and advisory guidance from Che states were still being compiled at the time of printing.) wyn55 10. REFERENCES ACCIH (American Conference of Governmental Induetrial Hygienists). 1986a. Documentation of the Threshold Limit Values and Biological Exposure Indices, 5th ed. Cincinnati, OH: ACGIH; 623-626. ACCIH (American Conference of Governmental Industrial Hygienists). 1986b. 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