Document vVj7vR5QXx23K7q5DGEy7yR49

center for regulatory services April 27, 1979 Hr. J.W, Anderson Manager, Material Safety Corporate Environmental Services Allied Chemical Corporation P. 0. Box 1057-R Morristown, NJ 07960 Dear Jim: SUBJECT: Vinyl Chloride Enclosed are the newspaper stories following the disclosure by the Consumer Product Safety Commission that short-term high level inhalation exposure of mice to vinyl chloride resulted in tumor development. Apparently, they did not observe the same effect in rats. 1 have requested copies of the reports of the rat and mouse experiment. The final regulations for environmental exposure to vinyl chloride monomer, as proposed by EPA, have not yet been completed and there does not seem to be much acitivity related to completion of the air quality standards. The FDA likewise has not been active in completing the final regulation for polyvinyl chloride in food contact. Sincerely, William A. Olson, Ph.D. Consultant WAO:chm Enclosures: "Study Says One Exposure Can Cause Cancer," The Washington Post, Friday, April 27, 1979 "1 Exposure to Chemical Said to Give Mice Cancer," The Washington Star, Thursday, April 26, 1979 2347 Paddock Lane Reston, Virginia 22091 703-620-9175 ASX 000011678 703-860-0078 ) center for regulatory services the WASHINGTON POST J) 3 Friday, April 27,1979_________ ___________ Study Says One Exposure Can Cause Caneer By Larry Kramer Wiishlnrton Po*t Staff Writer 4 A new federal study for tbe first time, that inhaling only a single high dose of a known- carcinogen cSfise3ITllRgT~~ft^animals,' fhe~bn- sumer Product Safety Commission im ported yesterday. The S700.000 study, four years in the making, centered on vinyl chloride; a proven carcinogen once widely used in a variety of products from aerosal spray paints to pesticides. It foudd that tumors were common in mice which had been subjected to single high level doses of a vinyl chloride gas. ' A CPSC spokesman said yesterday that the findings of the study suggest that similar studies should be done for other known carcinogens. * `Previous cancer research," the CPSC found, "had focused almost ex clusively on the effects of repeated low-level and high-level exposures to carcinogens over lengthy time peri ods." But the latest study, performed 6y Chemical Systems Laboratory (ftjrmerjy the Edgewood Arsenal at the Aberdeen Proving Grounds in Mary land) found that after only a one-hour exposure to high doses of vinyl chlo ride monomer (VCM) gas, many labo ratory mice were found to have tu mors. Vinyl chloride monomer has been banned by the CPSC as a propellant or an ingredient, by the Food & Drug Administration as an ingredient in hairsprays and cosmetics, and by the EI'A from use in pesticides. The new study suggests that a one time exposure, resulting, for example, from an accidental spillage of VCM ' on the nation's highways, railways or waterways, could threaten workers at the spillage site, or perhaps even nearby residents. The study will be reviewed by sev eral government agencies and re searchers to assess the impact of the findings, and is expected to stimulate \ further research in the area. A-12 The Washington Star two,, April 26,1979 1 Exposure to Chemical Said to Give Mice Cancer By Merrill Brown Washington Star Stall Writer The federal government for the first time said today that inhalation of a hazardous chemical, in this case vinyl chloride, can cause cancer in laboratory animals after just a single dosage. The S700.000, four-year study, pre pared for the Consumer Product Safety Commission by the govern ment's Chemical Systems Laboratory at the Aberdeen Proving Grounds in Maryland, is the first investigation of the effects of a known carcinogen when inhaled in a large, single-dose quantity by laboratory mice. Vinyl chloride is widely used to make polyvinyl chloride, a plastic that is found in consumer gooes such as food wrappings and in other prod ucts that are commerically called vinyl. Furthermore, CPSC spokesman John Bell said that the study raises questions about chemical spills and the short-term hazards they pose to people living in the vicinity of a chemical accident. Bell said the study suggests that other carcinogenic .'chemicals should be studied under Sifllilar circumstances to determine their dangers. i '. . '"THE STUDY SUGGESTS that you don't have to be exposed over and over again to something to produce cancers if you have big enough doses," said Dr. Bernard McNamara, who headed the study team. The results of the study are prelimi nary and will be reviewed by other federal cancer experts, Bell said. Although vinyl chloride was once a widely used ingredient in home aerosal spray products, its sale in con sumer goods has been banned by the1 CPSC and the Food and Drug'Adminis tration because it is a known carcino gen. In addition, the Environmental Protection Agency has banned its use in the production of pesticides and the Occupational Safety and Health Administration has set limits for workplace exposure to vinyl chloride. MCNAMARA, THE CHIEF of the toxicology branch of the laboratory, said in an interview last night that many scientists already had under stood the possibility that single, in haled dosages of a cancinogen could cause the development of cancers, but that "inhalation experiments hadn't been done to prove it." McNamara said mice exposed to a large, hour-long dose of vinyl chlo ride showed tumors eight months after the exposure, although he pointed out that the tumors could have developed sooner since the scientists did not check the animals at an earlier date. In these tests, vinyl chloride was in haled by the laboratory rats and mice over a one-hour period at levels of 50,000 and 5,000 parts per million. Pulmc> nary tumors, Bbth" Benign and malignant, were found to be common in the mice when autopsies were per formed. Nearly a third of the mice tested showed a typeof tumor alter thelnF gle exposucgg^altliough ihfTaTr Qfd~ ASI 000011679 2347 Paddock Lane Reston, Virginia 22091 703-620-9175 703-860-0078 center for regulatory services April 27, 1979 Consumer Product Safety Commission 1111 18th Street, N.W. Washington, D.C. 20207 Gentlemen: SUBJECT: Request for Information Report of Vinyl Chloride Carcinogenicity This letter is a request for one copy of the final report, or if not available, any preliminary report following the study sponsored by the Consumer Product Safety Commission at the Chemical Systems Laboratory, to determine the carcinogenicity of vinyl chloride monomer following short-term high concentration exposure of mice and rats. We are interested in the reports of the studies both in mice and in rats. Sincerely WAO:chm 19A, 41, 8L William A. Olson, Ph.D. Consultant 2347 Paddock Lane Reston, Virginia 22091 703-620-9175 ASI 000011680 703-860-0078