Document omXaBnZR12g1gndxb4x7nD5w3

CHEMICAL MANUFACTURERS ASSOCIATION January 5, 1980 TO: Vinyl Chloride Project Panel Vinyl Chloride Research Coordinators SUBJECT: OSHA's Request for Information on VCM and PVC Gentlemen: Attached is an excerpt from the Federal Register, Volume 44, Number 244, Tuesday, December 18, 1979, pages 74928 and 74929. You are urged to give particular attention to bracketed items 1 through 11 on page 74929 listing areas in which OSHA wishes to have additional information for a reassessment of the known health effects of vinyl chloride. CMA plans to resubmit all research reports that were previously submitted to pertinent government agencies immediately after their acceptance by the Vinyl Chloride Research Coordinators, and finally, by the Vinyl Chloride Panel. Please observe that the information requested in this Federal Register notice must be submitted in quadruplicate on or before February 10, 1980. All information submitted should be addressed to the Docket Officer, Docket No. H-034, Room S6212, U. S. Department of Labor, OSHA, 200 Constitution Avenue, N.W., Washington, D. C. 20210. Sincerely, JTS:das Enclosure Project Administrator Vinyl Chloride Formerly Manufacturing Chemists Association --Serving the Chemical Industry Since 1872. CMA 100817 1825 Connecticut Avenue NW * Washington, DC 20009 * Telephone 202^328-4200 Telex 89617 [CMA WSH, 74928 Federal Register / Vol. 44, No. 244 / Tuesday, December 18, 1979 / Notice'', Dated: December 10,1979. Frank H. Madden, AID Advisory Committee Representative. Joint Committee on Agricultural Development, Board for International Food andAgricultural Development. [TTt Out. 7B-JSS&5 Tiled 12-17-7V: J45 *m] BILUHQ CODE 47,0-02-M DEPARTMENT OF LABOR Occupational Safety and Health Administration Occupational Exposure to Vinyl Chloride and Polyvinyl Chloride AGENCY: Occupational Safety and health Administration, Department of Labor. ACTION: Request for information on vinyl chloride and polyvinyl chloride. summary: This notice requests information on vinyl chloride (CAS No. 75-01-4) and on polyvinyl chloride (CAS No. 9002-86-2). Vinyl chloride (VC), a synthetic chemical, was once synthesized by the addition of hydrogen chloride lo acetylene. Currently, the most common route of production is by the halogenation of ethylene. In this latter process, ethylene is reacted with hydrogen chloride and oxygen to give ethylene dichloride, which is subsequently cracked thermally to produce vinyl chloride and hydrogen chloride. Vinyl chloride is used primarily to produce polyvinyl chloride (PVC), a plastic resin, through conversion of the VC monomer into a polymer or copolymer form. Vinyl chloride is also used in the production of methyl chloroform and in the production of resins as a comonomer with vinylidene chloride. PVC is used in the manufacture of a variety of industrial and consumer products, such as containers, wrapping film, electrical insulation, and pipes. In 1875, OSHA regulated vinyl chloride as a carcinogen, based primarily on evidence of excess liver angiosarcoma incidence following VC exposure (29 CFR 1910.1017). OSHA did not regulate exposure to PVC dust in the same standard. Therefore, it continues to be regulated as an inert or nuisance air contaminant (29 CFR 1910.1000, Table Z-3). Research since 1975 has provided Considerably more information concerning the carcinogenic and other toxic effects of VC and PVC exposure, OSHA is currently in the process of evaluating the available evidence pertaining to the potential occupational health hazards of VC and of PVC and, by this notice, is requesting information related to several important issues. DATE: The information requested in this notice must be submitted in quadruplicate on or before February 10, 1980. ADDRESS: The information requested in this nolice should be submitted to the Docket Officer, Docket No. H-034, Room SG212, U.S Department of Labor, OSHA, 200 Constitution Avenue, N.W,, Washington, D.C. 20210, (202-523-7894). FOR FURTHER INFORMATION CONTACT: Dr. Peter Infante, Office of Carcinogen Identification and Classification, Directorate of Health Standards Programs, Room N371B, U.S. Department of Labor, OSHA, 200 Constitution Avenue. N.W., Washington, D.C. 20210, (202-357-0325). SUPPLEMENTARY INFORMATION: Background Vinyl chloride (CiHjCI: CAS No. 7501-4; chloroelhcne) is a colorless gas at room temperature and pressure. After synthesis from VC monomer, polyvinyl chloride [(C,H>C1),,; CAS No. 9002-80-2; chloroethene homopolymer) is in the form of white dr colorless granules. Residual vinyl chloride monomer can become trapped in the PVC particles. However, recent processing methods can reduce considerably the amount of residual VC trapped in the polymer resins. The vinyl chloride industry can be divided into three major components: VC synthesis, VC polymerization, end PVC fabrication. It has been estimated that in the U.S., 15 plants manufacture vinyl choride, 43 plants polymerize polyvinyl chloride, and at least 7,500 plants are engaged in the fabrication of ' PVC, During 1978, 3.47 million tons of VC and 2,94 million tons of PVC were produced. The present permissible limit for occupational exposure to vinyl chloride is 1.0 ppm averaged over any 8-hour period, and 5.0 ppm averaged over any period not exceeding 15 minutes (29 CFR 1910.1017). For polyvinyl chloride dust, the standard is 15 mg/m5, averaged over any 8-hour period (29 CFR 1919,1000). Laboratory Studies Experimental bioassays have demonstrated the induction of cancer by VC at levels of exposure lower than those previously reported. In VC inhalation studies of rats, Maltonl (1) has induced liver angiosarcomas at 25 ppm and mammary carcinomas at one ppm. In addition, several different test systems have provided evidence for the mutagenic potential of VC, i.e., B, coli, S. typhimurium. S. pombe, insects, plants, and cultured mammalian cells (2). VC also has been demonstrated to have a transplacenta^effect in rats. Inhalati< exposure of pregnant rats to VC concentrations of 6.000 and 10,000 pp: have resulted in VC-depcndcnt tumoi in their offspring (1). There is also evidence from animal studies that PVC may induce nonmalignant respiratory disease. It has been reported that after seven months exposure, rats and guinea pigs caged r work areas where sacks were being filled with PVC powder developed pulmonary pathological changes and granulomatous lesions containing foreign particles thought to be PVC di far Epidemiologic Studies Several investigations of employer populations have indicated (hat VC/ PVC exposure is associated with an increased carcinogenic risk to sever,,; organ sites in addition to the liver. A NIOSH retrospective cohort study oT workers from four VC polmcrization plant showed an excess number of deaths due to cancer of the liver, lun.t lympho-hcmatopoietic system, and central nervous system (4). Of further concern is the finding ti the carcinogenic risk may extend to industries fabricating polyvinyl chloi. A proportionate mortality study of plastic workers in Great Britain, whi, included PVC fabricators, demonstr;.1 a statistically significant excess of stomach cancer (5). Also, an excess e mortality from digestive system cam . among PVC fabricators of both sexr , was found by Cliiazze et, nl. in the U (6). Among white females in the stud observed deaths from breast and urinary trfict cancers were also grea1 than expected. Waxweiler et. nl. performed a detailed study of the r\ lung cancer risk previously observed a synthetic plaslics and rubber plant ! Analysis of lung cancer cases by cell type demonstrated a greater frequem of adenocarcinomus (Type 3) and lnr cell undifferented (Type 4) cancer. Neither cell type is believed to be st'ongly assoicated with cigarette smoking. Of T2 chemicals analyzed, c PVC dust exposure proved to be statistically significant. The authors suggested that the excess of Type 3 a 4 lung cancer cases in this plant was related to PVC dust exposure. A recent epidemiologic study suge, that PVC may be related to pneumoconiosis (8). Employees of a polyvinyl chloride production faclon Italy were submitted to chest X-ray examination. Twenty subjects were diagnosed as having pneumoconiosi AH of these coses had worked five w more years in departments with demonstrated PVC dust pollution. Ni CMA 100818 t Federal Register / Vol. 44, No. 244 / Ttir`uJay, December IS, 1979 / Notices 74G29 pneumoconiosis was observed in liver cancers by facihiy end relevant 1. Mattoni. C. Vinyl chloride subjects who worked in areas free of demographic variables, surh as age. sex, carcinogenicity: An experimental mod, I for PVC dust. These findings are consistent race, date of diagnosis, date of death, cnrdnogrncsis studies. Origins af Human with earlier caSe reports of pneumoconiosis among workers date of first exposure, and length of exposure for either vinyl chloride or Cancer, Cold Spring Harbor Laboratory, 1977, pp. 119-140. 2. Wngoncr, J. K., and P. F. Infante. Vinyl exposed to PVC dust (9,10). The Institute polyvinyl chloride. chloride: A case for the use of laboratory { of Oncology and Tumor Center in (6) Mutagenicity study results of vinyl b'oissay in the regulatory control procedure. Bologna, Italy has demonstrated a chloride or polyvinyl chloride as Origins af Human Cancer, Cold Spring higher frequency of cytolgoically measured by the analysis of human Harbor Laboratory, 1977, pp, 1797-13U5. abnormal sputum cells among the workers employed in the VC/PVC industry in contrast either,to workers in the general chemical industry or to individuals who are heavy smokers (11). Epidemiologic studies also exist which demonstrate the mutagenicity of body fluids, e q., direct mutagenic testing with peripheral blood lymphocytes, non-disjunction in humans with.YFF sperm test, and in vivo cytogenetics. (7) Body burden measurements of vinyl chloride in humans. 3. Frongia. N- A. Sptnazzola and A. Bucarelli. Lesioni polmonan spcrinientnli da inalazione prolungata dl polveri di PVC In ambiente di lavoro: (Expernionie! lung damage from prolonged inhalation of airborne PVC dust). La Medic.ina del Lavoro. 65: 321-342, 1974. 4. Waxweiler, R. J- W. Stringer, J, K. VC in humans. Chromosomal aberrations in lymphocytes of male workers, in excess of the number observed in non-exposed workers, have been reported in several studies (2). Morever, e study of miscarriages among the wives of men occupationally exposed to VC detected a significant excess in fetal mortality following the husband's exposure to VC (12). Information requested on vinyl chloride ind polyvinyl chloride The date recently received by OSHA suggest that a reassessment of the known health effects of vinyl chloride and polyvinyl chloride is appropriate at this time. Additional information in several areas is needed before a reassessment can be completed. The requested information includes, but is not limited to, the following: (1) Experimental test results for carcinogenicity of vinyl chloride at atmospheric exposures of less than 50 ppm. (2) Studies of transplacental carcinogenic and teratogenic effects in humans or animals at any level of exposure to vinyl chloride. (8) For operations involving polyvinyl chloride, the types of resin in use, the Concentration of vinyl chloride trapped in the resin, and the concentration of VC and PVC dust in the atmosphere where individuals are working. This information should inc lude estimates of the particles sizes and concentrations of particles that fall within the respirable range. (9) In PVC bagging and milling operations, atmospheric levels of PVC and VC, monitoring devices used to detect VC, and the type of respirator protection program for individuals working in these operations. This should include the sensitivity and validity of analytic techniques in use. (10) Types of occupations, job classifications, and industries where exposure to either VC or PVC at any level may occur, and the numbers of employees involved in each vinyl chloride and polyvinyl chloride exposure situation, separated by sex and race. (11) Appropriate engineering controls, work practices, and personal protective equipment available to reduce levels of Wagoner,). Jones, H. Falk, ami C, Carter. Neoplastic risk among workers exposed to vinyl chloride. Annals of the New York Academy of Sciences, 271 40-48,1978. 5. Baxter, P. J. and A. J. Fox. Angioaorroma of the liver In PVC fabricators. Lancet, 1; 24524C. 1978. 8. Chlazze. L., W, E, Nichols, and 0, Wang. Mortality among employees of PVC fabricators. Journal of Occupational Medicine. 19-. 623-628, 1977, 7. Waxweiler, R ]., A 11, Smith. II. A, Tyroler, and H Falk. An epidemiologic investigation of an excess lung cancer risk in a synthetic chemicals plant. Presented at the XIX International Congress on Occupational Health. Dubrovnik Yugoslavia, 25-30 September 1978. 8. Mastroangelo, C, M Munno, 0. Moricr, G, B. Bartolucci, C. Ccmignuni, G. Snlndino, L, Simonato, and D. Snia. Polyvinyl chloride pneumoconiosis: Epidemiological study of exposed workers. Journal of Occupational Medicine, 21: 540-512,1979. 9. Szende, B,, K. Lapis. A. Nemos, and A. Pinter. Pneumoconiosis caused by the inhalation of polyvinyl chloride dust. La Medicina del Lavoro, 61: 433--436, 1970. 10. Amuud, A., P. Pommter de Sunti, L Garhe. II. Paynn, and J. Chilrpin. Polyvinyl chloride pneumoconiosis. Ikoru*. JJ, 19-25, 1978. 11. Maltoni. C. Precursor lesions In exposed (3) Experimental studies of exposure to VC or PVC below th populations as indicators of occupilional carcinogenicity and other toxic current standards, or to the lowest cancer risk. Annals of the New York manifestions for any level of polyvinyl levels feasible. Academy of Sciencrs, 271; 414-447, 1978. chloride exposure. These effects should include, but are not limited to, mutagenicity, teratogenicity, embryotoxicity, and other transplacental effects, as well as cytotoxic and cytogenetic effects on sperm cells. To the greatest extent possible, complete information SUBMITTALS OF INFORMATION REQUESTED Interested persons are invited to submit written data, views, and comments with respect to the issues described abve. All communications should be submitted in quadruplicate, 12. Infante. P. F.. |. K. Wagoner, A, |. McMichael, R, J. Waxweiler, and 11. Falk. Genetic risks of vinyl chloride. Lancet, 1, 734735, 1978. Signed at Washington, D.C. this 12lh day of December 1979. Euln Bingham, Assistant Secretary ofLabor. concerning the industrial source of the by February 10,1980, to the Docket {FR Dot TV-iaara litre 1J-17-7V, S 45 *m] polyvinyl chloride, the size and Officer, Docket H-034. Room S0212, U.S, aiLUNQ COOC 4510-H-M characteristics of the particles, and Department of Labor, 200 Constitution exposure levels or concentrations of PVC and residual VC should be Avenue, N.W., Washington, D.C, 20210 (202-523-7894), Pension and Welfare Benefit Programs included for each study. (4) Epidemiologic studies of either vinyl chloride or of polyvinyl chloride (i.e. cohort, cross-sectional, or casecontrol). (5) Case reports and case series of References The following documents, referred to in this notice, are available for inspection and copying at the OSIIA Technical Data Center, Room S0212, U.S. Department of Labor. 200 Constitution Avenue, N.W, Washington, D C (Prohibited Transaction Exemption 79-79; Exemption Application No. D-837) Exemption from the Prohibitions for Certain Transactions Involving College Retirement Equities Fund brain, lympho-hematopoietic, lung, and 20210. AGENCY; Department of Labor. 01^00819