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minutes sfi PVC SAFETY GROUP - HEALTH COMMITTEE New Orleans Marriott Hotel New Orleans, LOUISIANA Thursday, February 7, 1930 1:00 P. M. SUM MARY 1 - OSHA's request for information on health aspects of PVC and VCM has received a 90 day extension to May 9, 1980. 2 - A limited number of industry speakers will be included in the 0SHA symposium on March 20-21. 3 - The committee will include a critique of the OSHA conference in material prepared for inclusion in the May 9 comments. r s I ### ATTENDEES: T. R. Torkelson - CHAIRMAN - Dow Chemical U.S.A. 1603 Bldg. Midland, MI 48640 Ed J. Baier - Diamond Shamrock Corp. 1100 Superior Avenue, Cleveland, OH 44114 T. J. Benya - Ethyl Corp. 451 Florida Blvd. Baton Rouge, LA 70316 Robert S. Brookman - Pantasote Inc. 26 Jefferson Street, Passaic, NJ 07055 Robert B. Downey - B. F. Goodrich Chemical, 6100 Oak Tree Blvd. Cleveland, OH 44131 John E. Ertel - Pantasote Inc, P. 0. Box 1800, Greenwich, CT 06830 Joseph E. Hadley, Jr. Keller & Heckman, 1150 17th Street, NW. Washington, D.C. Joseph L. Hottshouser - Goodyear Tire & Rubber Co. 1144 E. Market St. Akron, OH Maurice N. Johnson - B. F. Goodrich Co. 500 South Main St. Akron, OH 44318 Robert W. Laundrie - General Tire & Rubber Co. One General St. Akron, OK 44329 John R. Lawrence - SPI, 355 Lexington Avenue, New York, NY 10017 Matthew M. Swetonic - Hill & Knowlton, Inc. 633 Third Avenue, New York, NY 10017 Jean-Claude Thomas - Rhone Poulenc, 25 Quai Paul Doumer, Courbevoie 92408, France. THE SOCIETY OF THE PLASTICS INDUSTRY, INC. 355 Lexington Avenue* New York, N.Y. 10017 (212) 573-9400 SPI-08952 Il j it i 2- 1 OSHA's request for information relating to health aspects of workers exposed to PVC and VCM has been given a 90 day extension from the original date of February 10. The submission date is now May 9, 1980. In reviewing the plans for OSHA's March 20-21 conference to "Reevaluate the Toxicity of Vinyl Chloride, Polyvinyl Chloride and Structural Analogues", Mr. Hadley indicated that he is working with Dr. Infante to include industry speakers on the program. At this time it appears that Dr. Infante is only willing to accept a speaker on the ICI dust study and Dr. Cooper on the USA VCV epidemiology follow-up study. Dr. Infante has invited the following industry members by direct invitation to participate: Dr. Maury N. Johnson - B. F. Goodrich Mr. R. N. Wheeler, Jr. - Union Carbide 3 - Mr. Jean-Claude Thomas discussed the work which has been done to evaluate Dr. Maltoni's animal studies with vinyl chloride by statistical procedures. This was presented at a meeting in Paris in November 1979 at the time Dr. Maltoni presented his data on animal studies. It would be desirable to have this material included in the OSHA conference but Dr. Infante has rejected this proposal. 4 - Mr. Jean-Claude Thomas reported that there have been two recent European VC feeding studies. The CIVO study was sent to FDA in the spring of 1979. There has not been any report on the BIBRA feeding study. 5 - After a lengthy discussion, it was suggested that further detailed critiques and data on PVC and VCM health matters could be submitted at the time of the May 9 comment deadline. 6 - In discussing the ICI dust study it was agreed that the Health Committee re commend that the PVC Steering Committee be certain that the industry has been adequately informed of the observations made. 7 - The meeting adjourned at 5:00 p.m. Respectfully submitted March 5, 1980 John R. Lawrence Technical Director SPI-08953 r, PVC SAFETY GROUP - HEALTH COMMITTEE New Orleans Marriott Hotel New Orleans, LOUISIANA Thursday, February 7, I960 1:00 P. M. In response to the OSHA request for information relative to health hazards from over exposure to vinyl chloride and polyvinyl chloride, there will be a meeting of the PVC Safety Group's Health Committee on Thursday, February 7, 1980 at the New Orleans Marriott Hotel, New Orleans, Louisiana, from 1:00 p.m. through 5:00 p.m. This meeting is being held in the Chartres Room of the hotel. This location and time has been set up to coordinate with the meeting of the PVC Safety Group's Steering Committee on February 8 and in conjunction with the Chlorine Institute Annual Meeting occurring in New Orleans earlier that week. The principle items on the agenda will be as follows: . Review and critique of the 12 documents cited in the December 18, 1979 Federal Register (copy attached). . Discussion on new industry studies. (Attendees should come prepared to present any new company data or data from other sources which should be considered for submission to OSHA). Recommendations for industry response to the OSHA request. rlease call Mrs. Gloria Pyne (212/573-9437) as soon as possible indicating your plans for attending this meeting. Very truly yours, John R. Lawrence Technical Director JRL:gp Attachment SPI-08954 74928 Federal Register / Vol. 44, No. 244 / Tuesday, Decenoer IS, 1979 / Notices Dated: December 10.1978. Frank H. Madden, AID Advisory Committee Representative. Joint Committee on Agricultural Development. BoardforInternationalFood and Agricultural Development [FR Doc 7V-JU&I nid 1Z-17-7V, a15 us) BLUHO CODE (Tla-U-M DEPARTMENT OF LABOR Occupational Safety and Health Administration Occupational Exposure to Vinyl Chloride and Polyvinyl Chloride J 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 to 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 1975, 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 notice should be submitted to the Docket Officer, Docket No. H-034. Room SB212, U.S. Department of Labor. OSHA, 200 Constitution Avenue. N.W,, WashingtojfcriS^- 20210, (202--523--7294). FOR FUKfHER INFORMATION CONTACT: . Dr. Pefer Infante. Office of Carcinogen Identification ancfClassification. DirectoiatejiLHealth Standards Programs, Room N3718, U.S. Department of Labor, OSHA. 200 Constitution Avenue, N.W., Washington, D.C. 20210, (202-357-0325). SUPPLEMENTARY INFORMATION: Background Vinyl chloride (C*HC1; CAS No. / o-- 01-4: chloroethene) is a colorless gas at room temperature and pressure. After synthesis from VC monomer, polyvinyl chloride ((CHaQ)" CAS No. 9002--65--St 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 resins. The vinyl chloride industry can be divided into three major components: VC synthesis, VC polymerization, and PVC fabrication. It has been estimated that in the UiL, 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 amaged 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/m* averaged over any 8-hour period (29 CFR 1919.1000). Laborstoiy Studies Experimental bioassays have demonstrated the induction of cancer by VC at levels of exposure lower than those prerireslv reported. In VC inhalation strdies of rats, Maltoni (1) has induced fiver angiosarcomas at 25 ppm and nummary carcinomas at one ppm. In adSioa. several different test systems hive provided evidence for the mutagenic potential of VC, i.e., K. celt S. typhimurizs. S-pombe. insects, plants, and cultured mammalian cells (2). VC also has been demonstrated to have a transplacental effect in rats. Inhalation exposure of pregnant rats to VC concentrations of 6.000 and 30.000 ppa have resulted in VC-dependent tumor* in their offspring (1). There is also evidence from animal studies that PVC may induce nonmalignant respiratory disease. It ha* been reported that after seven month* qJ exposure, rats and guinea pigs caged ia work areas where sacks were being filled with PVC powder developed pulmonary pathological changes and granulomatous lesions contammp foreign particles thought to be PVC dust (3). Epidemiologic Studies Several investigations of employee populations have indicated that VC/ PVC exposure is associated with an increased carcinogenic risk to several organ sites in addition In the liver 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,. lvmpho-hemalopoietic system, and 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 GreaFBritain. which included PVC fabricators, demonstrated a statistically significant excess of stomach cancer (5). Also, an excest of mortality from digestive system runrfy among PVC fabricators of both sexes was found by Chia7ze et. aL in the U.S. (6). Among white females in the study observed deaths from breast and urinary tract cancers were also greeter than expected. Waxwefler et. aL performed a detailed study of the excess lung cancer risk previously observed at a synthetic plastics and robber plant (7J. Analysis of lung cancer cases by cell type demonstrated a greater frequency of adenocarcinomas (Type 3) and large cell undifferented (Type 4) cancrr. Neither cell type is believed to be strongly assoicated with cigarette smoking. Of 12 chemicals analyzed. ccFr PVC dust exposure proved to be Statistically signmcant The author* suggested that the excess of Type 3 aad 4 lung cancer cases in this plant wm related to PVC dust exposure. A recent epidemiologic study migoes** that PVC maytJfrelaledto pneumoconiosis (8). Employees of polyvinyl chloride production fnclcry m Italy wereTsubmitted to chest X-ray examination. Twentysubjects were diagnosed as having pneumoconipt sAll of these cases hacFworked five cr more years in departments with __ demonstrated PVC dust pollution. No SPI-08955 Federal Reglstei , Vol. 44, No. 244 / Tuesday, December 10, 1979 / Notices 74929 pneumoconiosis was observed in Subjects who worked in areas free of pVC dust. These findings are consistent vnlh earlier case reports of pneumoconiosis among workers gvposed to PVC dust (9,10). The Institute 0f Oncology and Tumor Center in Bologna, Italy has demonstrated a higher frequency of cytolgoicaUy abnonnal 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 smokerB (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 the wives of men occupationally expcsgdlo VC detected a significant excess in fetaTmortalitv follov husbantPy exposureto 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 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 ppir (i.) Studies of transplacental carcinogenic and teratogenic effects in humans or animals at any level of exposure to vinyl chloride. (3) Experimental studies of carcinogenicity and other toxic zcanifestions 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 casecontrol). (5) Case reports and case series of brain, lympho-hematopoietic, lung,, and Liver cancers by facility and relevant 1. MaltonL C. Vinyl chloride 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. carcinogenicity: An experimental model for carcinogenesis studies. Origins ofHuman Cancer. Cold Spring Harbor Laboratory, 1977, pp. 119-14&. Z. Wagoner, J. K, and P. F. Infante. Vinyl chloride: A case for the use oflaboratory (6) Mutagenicity study results of vinyl bioassay in the regulatory control procedure. chloride or polyvinyl chloride as Origins ofHuman Cancer, Cold Spring measured by the analysis of human Herbor Laboratory, 1077, pp. 1707-1805. body fluids, e.q.. direct mutagenic testing with peripheral blood lymphocytes, non-disjunction in humans with YFF sperm test, and in vivo cytogenetics. 3. Frongis. N,, A. Spinazzole and A. Bucarelli Lesion! polmonari sperimentoli da Inalazione prolungata di polveri di PVC in ambiente di lavoro: (Expermental lung damage from prolonged inhalation of airborne PVC dust). La Medicina del Lavoro, (7) Body burden measurements of 65: 321-342.1974. vinyl chloride in humans. 4. Waxweiler, R. J, W. Stringer. J. K. (8) For operations involving polyvinyl Wagoner, J. Jones, H- Falk, and C. Carter. 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 11 Neoplastic risk among workers exposed to vinyl chloride. Annals of the New York Academy ofSciences, 271: 40-48,1978. 5. Baxter, P. J. and A.). Fox. Angiosarcoma of the liver in PVC fabricators. Lancet. 1: 245- Individuals are working. This H 246,1976. information should include estimates of 6. nhiTTP I_ W. E. Nichols, and . Wang. the particles sizes and concentrations of Mortality among employees of PVC particles that fall within the respirable range. (9) In PVC bagging and nulling operations, atmospheric levels of PVC and VC, monitoring devices used to r detect VC, and the type of respirator , fabricators. Journal of Occupational Medicine. 19:623-628,1977. \ 7. Waxweiler. R_ J,, A- H. Smith. H. 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 protection program for individuals ''Health. Dubrovnik Yugoslavia, 25-30 working in these operations. This should^-Septeihber 197B. include the sensitivity and validity of 8. Mastroangelo, G-, M. Manna, G. Marier, 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 artolucd C Gemignani, G. Saladino, L. Simonato, and B. Saia. Polyvinyl chloride pneumoconiosis: Epidemiological study of exposed workers. Journal of Occupational Medicine. 21:540-542,1979. 9- Szende, B, K. Lapis, ArNemes, and A. employees involved in each vinyl Pinter. Pneumoconiosis caused by the chloride and polyvinyl chloride inhalation of polyvinyl chloride dust La exposure situation, separated by sex and race. (11) Appropriate engineering controls, work practices, and personal protective equipment available to reduce levels of Medicina del Lavoro, 61:433- '36.1970. 10. Amand. A_ P. Pommier Ue Santi. L. Garbe, H. Payan, and J. Charpin. Polyvinyl chloride pneumoconiosis. Thorax. S3,19-25, 1978. 11. Maltoni, C. Precursor lesions in exposed exposure to VC or PVCTSelow trie populations as indicators of occupational current-standards, nr tn the lowest cancer risk. Annals of the New York levels feasible. SUBMITTALS OF INFORMATION REQUESTED Interested persons are invited to submit written data, views, and comments witiuespect to the issues described abve. Abxommunications /should be submitted In quadruplicate, Academy ofSciences, 271:444-447,1976, 12. Infante, P. F, J. K. Wagoner. A. J. McMichaeL R. J. Waxweiler, and H. Falk. Genetic risks of vinyl chloride. Lancet, 1: 734- 735.1976. -*1 * 3 4 5 Signed at Washington. D.C. this 22th day of December 1979. Fji1 Bingham, Assistant Secretary ofLabor. by February 10,1980,.'to the Docket pTt Doc- 79-3B6S0 Filed 12-17-7* *45 txnj Officer, Docket H-034, Room S6212. U-S, BfUJHS CODE 4510-2t-U ^Qgpartment oLLgbor. 200"Constitution Avenue, N.W,, Washington, D.C. 20210 (202-523-7894). Pension and Welfare Benefit Programs References ' The following documents, referred to in (Prohlbtted 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. SPI-08956