Document oYa4v57YkQJmqN7ODy3nk6nX

\ ` f- \ -a. * JOSENH . KELLER <JBOMZ H. HECKMAN CHAJSZ.ES X- MEEHAN TIU.IAM H. BORGHESANT, JB. ROBERT N. TIERNAN WAYNE V. BZACK David i_ niu MARTIN W. BERCOVICI JOHN S. ELDRED JOSEPH E. HADIXY, JR. CAROLE C. HARRIS MICHAEL r. NOBROME LARRY S. SOLOMON ................ JOHN B. DUBECK CHRISTINE A. MEAGHER SHIRLEY S. FUJ1MOTO LAWRENCE P. HALPRIN DEBORAH SgtlR THINKER C. DOUGLAS JARRETT LAW OFT1CES Keller ani> Heckman USO ITt* STREET, N. W. SUITE lOOO WASHINGTON; >. C. 2003 January 4, 1979 OC/ i/O ouvclPVC-C^H TELEPHONE 202 437-UOO CABLE ADDRESS"!ELMAN" WRITER'S DIRECT DIAL NUMBER (202) 457-1116 \ {*& To: SPI-PVC Safety Group j 1 SPX-VCM/PVC Mailing List - \ >, SPI Plastic Bottle Institute V 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 chloride. Because 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 3-0886 January 4', 1980 Page Two Kelxer amd 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 al$o been reported. In addition, PVC has reportedly induced1'non-malignant respiratory disease in experimental aninjals exposed to PVC dust. The Notice reports that, injaddition to liver cancer, the National Institute for Occupational Safety and Health has identified an excess number of ddaths due to cancer of the lung, lympho-heraa-- topoietic system and the central nervous system^ Also of concern o"0SHA 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 Proposed Rule 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 standard- 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 icated -exclusively to vinyl chloride and polyvinyl chloride, is presently slated to cover the following topics: see 3-0887 January 4, 1980 Page Three Keller and Heckman 1. carcinogenesis bioassays of vinyl chloride 2. morbidity studies of.vinyl chloride workers 3. mortality studies of vinyl chloride workers 4. industrial hygiene measurements of PVC dust - characterization and control techniques 5. toxicology of PVC 6. mortality studies concerning PVC 7. morbidity studies concerning PVC 8. reproductive effects of exposure to vinyl ' chloride and PVC 9* community exposures to vinyl chloride and PVC 10.' structural analogs of vinyl chloride I >* 11. 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 0888 January 4, 1980 Page Pour Keuler a2td 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. see 3-0889 74938 ** Federal Register / VoL 44, No. 244 / Tuesday. December 18. 1979 / Notices Dated: December 10.1479. Freak H. Madden. date; The information requested in this notice must be submitted in transplacental effect in rats. Inhalation exposure of pregnant rats to VC AWAdvisory Committee Representative. quadruplicate on or before February 10, concentrations of 6.000 and 10,000 ppm Joint Committee on Agricultural Development BoardforInternationa/Food andAgricu/toralDevelopment |FR Dm.7S-US8S fa4u-ir-fe MUiNO COOE 4710-02-*! ! DEPARTMENT OF LABOR Occupational Safety and Health Administration Occupational Exposure to Vinyl Chloride and Polyvinyl Chloride I960. ----------------- address: The information requested in this notice should be 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" have resulted in VC-dependent tumors 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 m- 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 iftioride. ______ * summary: This notice requests Information onprinyl chloride (CAS No. 75-01-4] and on polyvinyl chloride (CAS No. 9002-86-2].^Vinyl chloride (yC), a -synthetic chemical, was once * synthesized by the addition of hydrogen chloride to acetylene. Currently, the most common route of production is by the halogenation of ethylene. In this Utter process, ethylene is reacted with hydrogen chloride and oxygen to give ethylene dichloride, which is SUPPLEMENTARY INFORMATION: Background Vinyl chloride (C,R,C1; CAS No. 7501-4: chloroethene) is a colorless gas at room temperature and pressure. After synthesis from VC monomer, polyvinyl chloride ((CJiCl)n: CAS No. 9002-86-2: chloroethene homopolymer) is in the form of white or 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 populations have indicated that VC/ PVC exposure is associated with an increased carcinogenic risk to several organ sites inaddition to the fiver. A NIOSH retrospective cohort study of workers from four VC polmerization plant showed an excess number of deaths due to cancer of the liver, lung, lympho-hemalopoietic system, and . central nervous system (4). Of further concern is the finding that the carcinogenic risk may extend to industries fabricating polyvinyl chloride. A proportionate mortality study of plastic workers in Great Britain, which subsequently cracked thermally to produce vinyl chloride and hydrogen chloride. Vinyl chloride is used ' primarily to produce polyvinyl chloride (PVC). a plastic resin, through resins. The vinyl chloride industry can be' divided into three major components: VC synthesis, VC polymerization, and PVC fabrication. It has been estimated included PVC fabricators, demonstrated a statistically significant excess of stomach cancer (5). Also, an excess of mortality from digestive system cancer 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 et -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 et ai 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 Elm, electrical occupational exposure to vinyl chloride Analysis of lung cancer cases by cell insulation, and pipes. is 1.0 ppm averaged over any 8-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 undifferented (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 assoicaled with cigarette exposure (29 CFR 1910.1017). OSHA did any 8-hour period (29 CFR 1919.1000}. 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 2-3]. 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 rats, Maltoni (1) that PVC may be related to concerning the carcinogenic and other has induced liver angiosarcomas at 25 . .pneumoconiosis (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 ppm. 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. Le., E. coii. S. diagnosed as having pneumoconiosis. health hazards of VC and of PVC and, typhimvrium, 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 3-0890 > * Federal Register / Vol. 44. No. 244 / Tuesday. December 18. 1979 j Notices 74929 pneumoconiosis was observed in subjects who worked in areas free of PVC dust. These findings are consistent '' earlier case reports of 4 omoconiosis among workers exposed to PVC dust (9,10]. The Institute of Oncology and Tumor Center in Bologna. Italy has demonstrated a higher frequency of cytoigoically 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 . vives of men occupationally el^osed to VC detectpa a significant excess in. fetal mortality following the husband's exposure t5 VC (12]. Information requested on-vinyl chloride and polyvinyl chloride The date recently received by OSHA 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 ;sessmenl can be completed. The i..quested 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 jcinogenic .and teratogenic effects in humans 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 PVC 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- itrol). t5) 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. 1. Maltoni. C. Vinyl chloride carcinogenicity: An experimental model for carcinogenesis studies. Origins ofHuman Cancer. Cold Spring Harbor Laboratory. 1977. pp. 119-146. 2. Wagoner. ]. K_ and P. F. Infante. Vinyl chloride: A case for the use of laboratory (6) Mutagenicity study results of vinyl bioassay in the regulatory control procedure! 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. Origins ofHuman Cancer. Cold Spring Harbor Laboratory. 1977, pp. 1797-1S05. 3. Frongia. N_ A. Spinazzola and A. Bucarelli. Lesioni polmonari sperimentali da . inalaziooe prollingsta di polveri di PVC in ambiente di lavoro: (Expenoealal lung damage from prolonged inhalation of airborne PVC dust). La Medidna delLavoro. (7) Body burden measurements of 65: 321-342.1974. 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 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 Hew York Academy ofSciences. 271'. 40-48,1978. v 5. Baxter. P. J. and A. J. Fox. Angiosarcoma of the liver is PVC fabricators. Lancet. X* 24S- 248,1976. 6. rtitnyTM, L, ,W. E. Nichols, and O. Wang. the particles sizes and concentrations of particles that fail 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 Mortality among employees ofPVC fabricators. Journal of'Occupatioaal Medicine. 19: 623-628.1977. 7. Waxweiler. R.I.A.H, Smith, H. A Tyroler, and H. Falk. An epidemiologic investigation of an excess hmg cancer risk In a synthetic chemicals plant. Presented at the XDC International Congress on Occupational protection program for individuals Health. Dubrovnik Yugoslavia. 2S-30 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 September 1978. 8. Mastroangelo, C,, M. Manno, C. Marier. C. B. Bartolucci, C. Gemignani, G. Saladino,. L. Simonato. and B. Saia. Polyvinyl chloride pneumoconiosis: Epidemiological study of exposed workers.Journal ofOccupational Medicine. 21:540-842,1979. 9. Szende, B_ JC Lapis. A. Netnes. and A. 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 Pinter. Pneumoconiosis caused by the inhalation of polyvinyl chloride dust La Medicina del Lavoro, 61:433--436.1970. 10. Amaud. A. P. Ponunier de Sand, L. Garbe. H. Payao. and J. Charpin. Polyvinyl chloride pneumoconiosis. Thorax, 33,19-25, 1978. 11. Maltoni. C Precursor lesions in exposed populations as indicators ofoccupational current standards, or to the lowest cancer risk. Annals of the New York levels feasible. SUBMITTALS OF INFORMATION REQUESTED Academy ofSciences. 271:444-447.1976. 12. Infante. P. F- j. JC Wagoner. A. J. McMichaeL R. J. Waxweiler, and H. Falk. Genetic risks of vinyl chloride. Lancet 1:734- 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 735.1976. Signed at Washington, D.C. this 12th day or December 1979. Eula Bingham, Assistant Secretory ofLabor. pH Doc. 7S-3MSB Filed 12-17-99. SMS ts] Officer. Docket H--034. Room S6212, U.S. BILLING COOt <S10-7S-M Department of Labor, 200 Constitution . Avenue. N.W., Washington, D.C. 20210 - (202-523-7894). Pension and Welfare Benefit Programs References The following documents, referred to In {Prohibited Transaction Exemption 79-79; Exemption Application No. D-837) this notice, are available for inspection and copying at the OSHA Technical Data Center. Room S6212. US. Department of Labor, 200 Constitution Avenue. N.W.. Washington. D.C. Exemption from the Prohibitions for Certain Transactions Involving College Retirement Equities Fund 20210. agency: Department of Labor. SCC 3-0891