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JANUARY 8, 1980 MS, TINA KARY Subj ec t: OSHA-VC/PVC Data & Seminar Attached for your_information is a SPI (Keller and Heckman) letter concerning vinyl chloride/polyvinyl chloride and OSHA's call for a data updating and seminar. Attachment cc: Messrs. Stehr Bonin Mullineaux Ms/e,rY M. J. SLOAN 6,____Jl sec 1'1ZX2 * \ JOSEPH E. KELLER JEROME EL HECKMAN CHARLES K. MEEHAN WILLIAM H. BOSGHESAMI, JJC. ROBERT R. TXERNAN WAYNE V. BLACK DAVID L. RILL MARTIN W BERCOVICI JOHN S. ELDRED JOSEPH E. HADLEY. JR. CAROLE C. HARRIS MICHAEL T. MORRONE LARRY S. SOLOMON .............. JOHN B. DUBECK CHRISTINE A.MEAOHER SHIRLEY S. FUJIHOTO LAWRENCE R. HALFRIN DEBORAH SHUR THINKER C. DOUGLAS JARRETT LAW OFFICES Keller ajxd Heckman ^ 1130 17-B STREET, K W. SUITE lOOO WASHINGTON, D. C. 20036 January 4, 1979 TELEPHONE 202 437-1100 CABLE ADDBESS"mMAK'' WRITER'S DIRECT DIAL NUMBER (202) 457-1116 To: SPI-PVC Safety Group SPI-VCM/PVC Mailing List SPI Plastic Bottle Institute SPI Plastic Beverage Container Division SPI--AN Polymers Group SPI--PET Safety Group SPI Food, Drug and Cosmetic Packaging Materials Committee SPI Ad Hoc Packaging Risk Assessment Committee SPI Plastic Bottle Institute SPI Plastic Pipe Institute SPI Vinyl Dispersions Group SPI-PVC Meat Film Wrap Group SPI Rigid Plastic Container Group SPI Vinyl Film and Coated Fabrics Group SPI Vinyl Siding Group Re: OSHA Request for Information on Vinyl Chloride and Polyvinyl Chloride, 44 Fed- Reg. 74928 December 18, 1979 Ladies and Gentlemen: The Occupational Safety and Health Administration (OSHA) published the above-referenced Notice requesting information on vinyl chloride and on polyvinyl chlorideBecause of the probable interest of all segments of the industry that manufacture, use or-process PVC, we are cir culating this letter as widely as possible- According to the Notice, research which has oc curred since 1975 has provided more information concerning see 1-1313 January 4, 1980 Page Two Keixer and Heckman the carcinogenic and other toxic effects of both vinyl chloride and PVC. By February 10, 1980, OSHA wants to accumulate any outstanding information related to this further research. OSHA*s Notice says that experimental bioassays have demonstrated.the induction of cancer associated with vinyl chloride at levels of exposure lower than those pre viously reported. Mutagenic and transplacental effects': have also been reported. In addition, PVC has reportedly induced non-malignant respiratory disease in experimental animals exposed to PVC dust. The Notice reports .-that, in addition to liver cancer, the National Institute for Occupational Safety and Health has identified an excess number of deaths due to cancer of the lung, lympho-hematopoietic system and the central nervous system. "" Also of concern to OSHA is the fact that It has received reports that PVC processing may subject workers to a carcinogenic risk as well as a risk of pneumoconiosis from PVC dust. Finally, OSHA proports to have information which demon strates that vinyl chloride is both mutagenic and -fetotoxic in humans. Based on the foregoing, OSHA is starting a reassess? ment of the health effects of vinyl chloride and polyvinyl chloride and, to begin this process, has asked for the results of all experimental studies which have taken place since the original OSHA rule making was concluded in 1974 In following up on this matter with the OSHA staff, we were informed that this request for information should not;be regarded as an Advance Notice of ProposedRule Making but that it is merely an indepth survey about the health effects of both vinyl chloride and polyvinyl chloride es pecially with regard to cancer at sites other than the liver and.the possible carcinogenicity of PVC dust. Further, they are interested in any need for added regulatory con trols and the feasibility thereof. As one staffer put it, this is a reevaluation of the adequacy of the current stan dard. :~ " In addition, OSHA hopes to gather a considerable amount of data for use in a symposium it plans for March 20 and 21, 1980 in Washington, D. C.. That symposium, ded icatee exclusively to vinyl chloride and polyvinyl chloride, is presently slated to cover the following topics: SCC 1-1314 January 4, 1980 Page Three v. Keller axd Heckman 1. 2. 3. 4* 5. 6. 7. 8. 9* 10. 11. carcinogenesis bioassays of vinyl chloride morbidity studies of vinyl chloride workers mortality studies of vinyl chloride workers industrial hygiene measurements of pVC dust - characterization and control techniques toxicology of PVC mortality studies concerning PVC morbidity studies concerning PVC reproductive effects of exposure to vinyl chloride and PVC community exposures to vinyl chloride and PVC structural analogs of vinyl chloride further research needs. The symposium will feature speakers from OSHA, NIOSH, and the National Institute for Environmental Health Services (NIEHS), In addition, both the Chemical Manufacturers* Association (CMA) and SPI were asked whether they would wish to offer speakers for the symposium. In talking with OSHA, we have asked informally on behalf of both SPI and CMA about the possibility of an extension of the February 10, 1980 filing date. Al though we must follow up on this with a formal request for an extension of time for answering the OSHA inquiry, the initial indications are that the Agency would be re ceptive to such a request but no commitment as to the amount of time that would be granted was given. The date for the symposium will not be changed. Our contacts at OSHA also indicate that they have a number of additional references which were not cited in the Federal Register. Since those listed in the Notice were only meant to be examples, the Agency has committed to preparing a bibliography of those materials for us. As to the next step, we can report that both the PVC Safety Group Steering Committee and the Group's Health Committee will be meeting in the near future to discuss the possibility of.both an `SPI response to the request for information and participation in the symposium. In the meantime, after you review the information requested, we would appreciate being informed whether you have infor mation which would be responsive to the questions posed by OSHA, and whether you would be interested in such in formation being submitted to the Agency by The Society's see 1-1315 January 4, 1980 Page Four V i Keixer Heckman Polyvinyl Chloride Safety Group, As always, should you have any questions, comments, suggestions or need any further information, copies of documents or the like, please do not hesitate to let us know. Cordially yours. Enclosure see 1-1316 74928 Federal Register ^ VoL 44, No. 244 / Tuesday, December 18. 1979 / Notices Dated: December 10.1979. oate: The information requested in (his * transplacental effect in ratsTInhalation Frank H. Madden, notice must be submitted in _ exposure of pregnant rats to VC AIDAdvisory Committee Representative. quadruplicate on or before February 10, - J concentrations of 6.000 and 10.000 ppm Joint Committee on Agricultural '1980. : j *"-- ---------- have resulted in VC-dependent tumors Development. BoardforInternational Food and AgriculturalDevelopment tni Do*. T9-JSA&S FU4 12-U-J. bJ BILLING CODE 4710-02-W DEPARTMENT OF LABOR Occupational Safety and Health Administration Occupational Exposure to Vinyl Chloride and Polyvinyl Chloride aqoress: The information requested in this notice should b.e submitted 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. (202-523-7894). FOR FURTHER INFORMATION CONTACT: Dr. Peter Infante. Office of Carcinogen Identification and Classification, Directorate.of Health Standards Programs, Room N3718, U-S. Department of Labor, OSHA, 200 Constitution'' 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 of exposure, rats and guinea pigs caged in work areas where sacks were being filled with PVC powder developed pulmonary pathological changes and granulomatous lesions' containing foreign particles thought to be PVC dust (3). agency: Occupational Safety and health Avenue, N.W., Washington, D.C. 20210, Administration. Department of Labor. (202-357-0325). Epidemiologic Studies Several investigations of employee action: Request for information on vinyl chloride and polyvinyl chloride. SUMMARY: This notice requests information on vinyl chloride (CAS No. 75-01-41 and on polyvinyl chloride (CAS No. 9002-86-2). Vinyl chloride (VC), a synthetic chemical, was once synthesized by the addition of hydrogen SUPPLEMENTARY INFORMATION: Background Vinyl chloride (CiHjCl; CAS No. 7501-4; chloroetkene) is a colorless gas at -room temperature and pressure. After synthesis from VC monomer, polyvinyl chloride ((C.PbCl)B: CAS No. 900Z-8&-2; chloroethene homopolymer) is in the populations have indicated that VC/ PVC exposure is associated with an increased carcinogenic risk to several organ sites in addition to the liver. A NIOSHre(respective cohort study of workers from four VC pobnerization plant showed an excess number of deaths due to cancer of the liver, lung, lympho-hematopoietic system, and chloride to acetylene. Currently, the most common route of production is by the halogenation of ethylene. In this latter process, ethylene is reacted with form of white or colorless granules. Residual vinyl chloride monomer can become trapped in the PVC particles. However, recent processing methods central nervous system (4). Of further concern is die finding that the carcinogenic risk may extend to industries fabricating polyvinyl chloride. hydrogen chloride and oxygen to give can reduce considerably the amount of A proportionate mortality study of ethylene dichloride, which is residual VC trapped in the polymer plastic workers in Great Britain, which subsequently cracked thermally to resins. included PVC fabricators, demonstrated produce vinyl chloride and hydrogen The vinyl chloride industry can be a statistically significant excess of chloride. Vinyl chloride is used divided into three major components: stomach cancer (5). Also, an excess of primarily to produce polyvinyl chloride VC synthesis, VC polymerization, and mortality from digestive system cancer (PVC). a plastic resin, through PVC fabrication. It has been estimated among PVC fabricators of both sexes conversion of the VC monomer into a that in the U.S,, 15 plants manufacture was found by Chiazze eL al. in the U,S. polymer or copolymer form. Vinyl vinyl choride, 43 plants polymerize (6). Among white females in the study, chloride is also used in the production of polyvinyl chloride, and at least 7,500 observed deaths from breast and methyl chloroform and in the production plants are engaged in the fabrication of urinary tract cancers were also greater of resins as a comonomer with PVC During 1978, 3.47 million tons of than expected. Waxweiler eL aL vinylidene chloride. PVC is used in the VC and 2.94 million tons of PVC were performed a detailed study of the excess manufacture of a variety of industrial produced. lung cancer risk previously observed at and consumer products, such as The present permissible limit for a synthetic plastics and rubber plant (7). containers, wrapping Sim, electrical occupational exposure to vinyl chloride Analysis of lung cancer cases by cell insulation, and pipes. is 1.0 ppm averaged over any 5-hour type demonstrated a greater frequency In 1975, OSHA regulated vinyl period, and 5.0 ppm averaged over any of adenocarcinomas (Type 3) and large chloride as a carcinogen, based period not exceeding 15 minutes (29 CFR cell undifferenled (Type 4) cancer. primarily on evidence of excess liver 1910.1017). For polyvinyl chloride dust, Neither cell type is believed to be angiosarcoma incidence following VC the standard is 15 mg/m3, averaged over strongly assoicated with cigarette exposure (29 CFR 1910.1017). OSHA did any 8-hour period (29 CFR 1S19.1000). smoking. Of 12 chemicals analyzed, only not regulate exposure to PVC dust in the same standard. Therefore, it continues Laboratory Studies PVC dust exposure proved to be statistically significant The authors to be regulated as an inert or nuisance Experimental bioassays have suggested that the excess of Type 3 and air contaminant (29 CFR 1910.1000, demonstrated the induction of cancer by 4 lung cancer cases in this plant was Table Z-3). VC at levels of exposure lower than related to PVC dust exposure. Research since 1975 has provided those previously reported. In VC A recent epidemiologic study suggests considerably more information inhalation studies of rafs, Maltoni (1) that PVC maybe related to concerning the carcinogenic and other has induced liver angiosarcomas at 25' ,jmeumocqnicsjs (8). Employees of a toxic effects of VC and PVC exposure. ' ppm and mammary carcinomas at one* polyvinyl chloride production factory in OSHA is currently in the process of ppnL In addition, several different test Italy were submitted to chest X-ray evaluating the available evidence systems have provided evidence for the examination. Twenty subjects were pertaining to the potential occupational * mutagenic'potential of VC, i.e., E. coli. S. diagnosed as having pneumoconiosis. health hazards of VC and of PVC and, typhimurium, S.pombe. insects, plants, All of these cases had worked five or by this notice, is requesting information and cultured mammalian cells (2). VC more years in departments with related to several important issues. also has been demonstrated to have a demonstrated PVC dust pollution. No see 1-1317 * Federal Register / Vol. ^4. No. 244 / Tuesday, December 18. 1979 / Notices 74929 pneumoconiosis was observed in subjects who worked in areas free of *C dust. These findings are consistent .1 earlier case reports of pneumoconiosis among workers exposed to PVC dust (9.10). The Institute of Oncology and Tumor Center in Bologna, Italy has demonstrated a higher frequency of cytolgoically 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 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, a study of miscarriages among t' vives of men occupationally v - - ,sed to VC detected a significant excess in fetal mortality following the husband's exposure to VC (12). Information requested on-vinyl chloride and polyvinyl chloride . The date recently received by OSKA suggest that a reassessment of the known health effects ofvinyl chloride and polyvinyl chloride is appropriate at this time. Additional information in veral areas is needed before a .^assessment 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 inogenic and teratogenic effects in tinmans or animals at any level of exposure to vinyl chloride. (3) Experimental studies of carcinogenicity and other toxic manifestions for any level of polyvinyl 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 concerning the industrial source of the polyvinyl chloride, the size and ' characteristics of the particles, and exposure levels or concentrations of ^VC and residual VC should be included for each study. (4) Epidemiologic studies of either vinyl chloride or of polyvinyl chloride (i.e. cohort, cross-sectional, or case- control). (5) Case reports and case series of brain, lympho-hematopoietic. lung, and liver cancers by facility and relevant demographic variables, such as age. sex, race.'-date of diagnosis, date of death, date of first exposure, and length of exposure for either vinyl chloride or polyvinyl chloride. (6) Mutagenicity study results of vinyl chloride or polyvinyl chloride as measured by the analysis of human 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. (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 include 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 exposure to VC or PVC below the current standards, or to the lowest levels feasible. 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, by February 10,1980, to the Docket Officer. Docket H-034. Room S6212, U.S. Department of Labor. 200 Constitution , Avenue. N.W., Washington. D.C. 20210 - (202-523-7694). 1. Maltoni. C. Vinyl chloride carcinogenicity:'An experimental mode] for carcinogenesis studies. Origins ofHoman Concer. Cold Spring Harbor Laboratory, 1377. pp. 119-146. 2. Wagoner, J. 1C. and P. F. Infante. Vinyl chloride: A case for the use of laboratory bioassay in the regulatory control procedure! Origins ofHuman Concer. Cold Spring Harbor Laboratory, 1977. pp. 1797-1805. 3. Frongia. N.. A. Sptnazxola and A. Bucarelli. Lesioni polmonari sperimeotali da inalazione prolungata di polveri di PVC in ambiente di lavoro: [Expermental lung damage from prolonged inhalation of airborne PVC dust). La Medicina delLavoro, 65:321-342.1974. 4. Waxweiler, R. W. Stringer. J. K. Wagoner, J. Jones. H. Falk, and C. Carter. Neoplastic risk among workers exposed to vinyl chloride. Annals ofthe New York Academy ofSciences. 271:40-48,1976. 5. Baxter. P. J. and A.). Fox. Angiosarcoma of the liver in PVC fabricators. Lancet, 1:245246,1976. 6. Chiazze, L..W. E. Nichols, and O. Wang. Mortality among employees of PVC fabricators, foumoi of'Occupational Medicine. 19:623-628.1377. 7. Waxweiler. R. J, A.H. Smith, H. A Tyroler, and H. Falk. As epidemiologic investigation of an excess lung caocerrisk in a synthetic chemicals plant Presented at the XIX International Congress on Occupational Health, Dubrovnik Yugoslavia, 25-30 September 1978. a. Mastroangelo, G-, M. Manno, C. Marier, C. B. Bartolucci, C. Gemignani. G- Saladino,. L. Simonato, and B. Saia. Polyvinyl chloride pneumoconiosis: Epidemiological study of exposed workers, foumal of Occupational Medicine. 21:540-542.1979. 9. Szende. Bm K. Lapis. A Nemes, and A Pinter. Pneumoconiosis caused by the inhalation of polyvinyl chloride dust La Medicina del Lavoro. 61:433-436.1970. 10. Aroaud, A- P. Pommier de Sand, L. Garbe. H. Payan. and |. Charpin. Polyvinyl chloride pneumoconiosis. Thorax. 33,19-25. 1978. 11. Maltoni, CL Precursor lesions in exposed populations as indicators of occupational cancer risk. Annals of the New fork Academy ofSciences, 271; 444-447.1976. 12. Infante. P. F,, J. K. Wagoner, A J. McMichael. R. J. Waxweiler. end H. Falk. Genetic risks of vinyl chloride. Lancet, 2:734735.1976. Signed at Washington. D.C. this 12th day of December 1979. Eula Bingham, AssistantSecretary ofLabor. (FK Doc. 79-MBS* FU*412-17-;aS *a| BILLING COOC 4StOW-*4 Pension and Welfare Benefit Programs References The following documents, referred to in this notice, are available for inspection and copying at the OSHA Technical Data Center, Room S6212, ILS. Department of Labor. 200 Constitution Avenue. N.W., Washington. D.C. 20210. (Prohibited Transaction Exemption 79-79; Exemption Application No. 0-837) Exemption from the Prohibitions for Certain Transactions Involving College Retirement Equities Fund agency: Department of Labor. see 1-1318