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CM CHEMICAL MANUFACTURERS ASSOCIATION CHEMICALS RESEARCH MAR 2 4 1380 March 20, 1980 To: Vinyl Chloride Project Panel WR3 LM Gentlemen: Enclosed is a copy of a communication to Mr. Frank D. Kover that serves as a letter of transmittal for the report from Experimental Pathology Laboratories, Inc. (EPL) entitled "Vinyl Chloride Pathology Report". Please note the last paragraph of the letter and the fact that CMA has not at tempted to evaluate the report as a Section 8(e) TSCA report because CMA does not have a reporting obligation under Section 8(e). Also enclosed is a record of the Panel meeting held on March 18, 1980. A copy of the EPL report is being sent to all Panel members who were unable to attend the March 18 meeting. Sincerely, J . T . Seawell Project Administrator Vinyl Chloride JTS: db Enclosures CCR 000011321 Formerly Manufacturing Chemists Association --Serving the Chemical Industry Since 1872. 1825 Connecticut Avenue, NW Washington, DC 20009 Telephone 202/328-4200 Telex 89617 (CMA WSH) CHEMICAL MANUFACTURERS ASSOCIATION March 19, 1980 Mr. Frank D. Kover - TS 792 Chief Chemical Hazards Identification Branch Assessment Division Environmental Protection Agency 401 M Street, S.W. 611 East Tower Washington, D.C. 20460 Dear Mr. Kover: On January 14, 1977, Mr. Albert Clark forwarded to Mr. Robert McGaughy of EPA, on behalf of the Manufacturing Chemists Association (now the Chemical Manufacturers Asso ciation) , a copy of the protocol and the 23-month status summary for the Association-sponsored research on vinyl chloride at Industrial Bio-Test Laboratories (IBT). Mr. Clark stated in that letter that the final report was expected to be submitted soon, and when available, would be forwarded to the Agency. As you know, all testing undertaken at IBT has come under a cloud. In particular, serious flaws were discovered in the vinyl chloride study, and no final report of the IBT study was ever issued. The Association undertook to deter mine whether the vinyl chloride study could be validated through an audit of the pathology by Experimental Pathology Laboratories (conducted by Dr. William Busey). Dr. Busey subsequently submitted a report of his audit to the Associa tion on January 9, 1979. It was reviewed by an Association task force and, because it was part of a larger audit (including a review of compliance of IBT with good laboratory practices), was not further distributed at that time. Unfor tunately, because of the interim change in the management of the Association and the extraordinary increase in the scien tific work of the Association caused by the Toxic Substances Control Act and related environmental legislation, we failed to send it to the Agency as a follow-up to Mr. Clark's letter of January 14, 1977. CCR 000011322 Formerly Manufacturing Chemists Association--Serving the Chemical Industry Since 1872. 1825 Connecticut Avenue. NW Washington. 0C 20009 Telephone 202/328-*200 Tefex 89617 (CMA WSH] Mr. Kover March 19, 1980 Page Two Recently, the Association has established a task force to oversee and coordinate all scientific testing projects. In the course of reviewing existing projects, this group discovered that we had not made Dr. Busey's audit report on the vinyl chloride study available to the Agency. Accordingly, I an enclosing a copy of the audit report as a follow-up to Mr. Clark's letter of January 14, 1977. As shown in the interim report sent to the Agency in January, 1977, three suspect brain tumors were noted in male rats at the high dose level. These brain tumors, plus one at the lower dose level, were confirmed by patho logy subsequently conducted by IBT and then by Dr. Busey. Unfortunately, not all of the brain specimens were retained by IBT and not all retained specimens were examined. The Association has therefore concluded to determine whether additional information can be obtained from whatever brain specimens remain at IBT from this highly-flawed study by conducting histopathological examination of all remaining brain tissues. We have not identified any other findings that would appear to warrant further attempts to salvage other information from this study. We apologize for failing to follow-up on Mr. Clark's earlier letter, and wish to assure you that we will, in the future, keep you apprised of any additional relevant infor mation as it becomes available to us. While CMA does not itself have a Section 8(e) reporting obligation, and while it appears that this information would not be reportable under Section 8(e) in any event, pursuant to our earlier commitment we are submitting it to the Agency. Sincerely yours, Hasmukh C. Shah, Ph.D. Director, Special Projects cc:. (with enclosure) - Mr. Robert McGaughy - Office of Research & Development Environmental Protection Agency CCR 000011323 Chemical Manufacturers Association Record of Meeting VINYL CHLORIDE PROJECT PANEL March 18, 1980 Washington Hilton Hotel Washington, D. C. T MEMBERS PRESENT: w. M. Smith H. w. Blakeslee T. R. Torkelson T . J . Benya R. Park M. N. Johnson Z. G. Bell R. N. Wheeler J. T. Seawell PRESENT BY INVITATION; C. R. Hopper J. P. Murphy R. M. Walter H. Shaw R. W. Hill G. K. Hatfield J. Hanson D. F. Zoll E. Frost W. Busey W. F. Carroll R, T. Gottesman MEMBERS ABSENT: J. T. Carter W. Bittenbender F. Kennedy R. W. McBurney Air Products & Chemicals, CertainTeed Products Dow Chemical Company Ethyl Corporation Firestone Plastics Co. BFGoodrich Company PPG Industries, Inc. Union Carbide Corporation CMA Staff i Gulf Oil Chemicals Co. Stauffer Chemical Co. Firestone Plastics Co. CMA Staff Diamond Shamrock Diamond Shamrock Dow Chemical Co. CMA Staff CMA Staff Experimental Pathology Labs., Firestone Plastics. Co. Tenneco Chemicals, Inc. Inc. BP Chemicals, Ltd. Borden Chemical Continental Oil Co. Diamond Shamrock CCR 000011324 J . Lynch R. W. Laundrie J. Gabbett C. A . Johnson R. B. Judge P. Cohen R. L. Gibson R. J. Abramowitz G. Roush A. G. Wheeler S. K. Law R. L. O'Connell R. Brookman V. L. Kirkland j. Stauffer P. M. Reed W. D. Harris 2- - -f Exxon Chemical Co. General Tire & Rubber Co. Georgia-Pacific Corp. Goodyear Tire & Rubber W. R. Grace & Company Great American Chemical Co. Gulf Oil Chemicals Co. Hooker Chemicals & Plastics Corp. Monsanto Company ICI Americas, Inc. Keysor-Century Corp. Olin Corporation Pantasote Company Shell Chemical Co. Stauffer Chemical Co. Tenneco Chemicals, Inc. Uniroyal, Inc. 1.0 2.0 3.0 Edmund Frost, Esq., summarized the purpose of the meeting and briefly described the history of the Panel's research project with Industrial BlO-Test and an audit of the study by the Experimental Pathology Laboratory (EPL). Following a discussion of EPL's January 9, 1979 "Vinyl Chloride Pathology Report" a motion was made, duly seconded and passed to submit the Report forthwith to the U. S. Environmental Protection Agency. Following a discussion of the research project conducted by Industrial BlO-Test, a motion was made, duly seconded and passed to immediately conduct further pathologic analysis of all remaining brain tissue salvageable from the study. CCR 000011325 3 4.0 Following discussion of CMA's efforts to terminate the Industrial BlO-Test contract and to seek reimbursement of funds, it was the consensus of the Panel that no additional efforts were required at this time and that the CMA Legal Department would handle the remaining aspects of the matter. JTS:md Record Subject to Approval March 20, 1980 J. T . Seawell Project Administrator Vinyl Chloride CCR 0000Xi326 EPL EXPERIMENTAL PATHOLOGY LABORATORIES, INC, Note to J. J. Hall C. L. Whetstone W. D. Broddle Virginia Moore This report was included in my earlier mailing to you. F. Kennedy VINYL CHLORIDE PATHOLOGY REPORT Submitted to Manufacturing Chemists Association Washington, D.C. 20009 January 9, 1979 CCR 000011327 1 1.................. ....... -....--______________ (CCR 000011328 CURRENT REPORT 1955 The planned system would be more efficient, the official explained, and would allow better use of agency personnel by allowing them to set aside quickly those notices which pre sent little concern. At one time, EPA treated all notices the same throughout the review period. The agency, however, quickly learned that such an approach would not work once the volume of notices being submitted increased. It then established the 40-day preliminary screening and discovered that one of every six or seven notices needs a more detailed review, the EPA official told Chemical Regulation Reporter March 17. While the new review system would establish a "slow track" and a "fast track" for different new chemicals, the EPA official stressed that the agency still will review every new chemical. A new chemical cannot be dismissed on the basis of its chemical structure alone, he said. Even though its structure may be similar to an existing chemical or the substance may be part of a group of chemicals considered to be innocuous, the agency cannot dismiss the chemical without considering its application and exposure, he noted. Even structurally related chemicals may vary in fat solubility, in ability to be broken down by light, or in other characteristics which alter their potential for creating hazards, he said. Continuing Lack of Data The agency is trying to find more ways to get data on in dividual notices. The EPA official noted that after many months of receiving notices, the amount and quality of data received on new chemicals has improved very little. There are two troubling trends, he said. The first, one which the agency has complained about on numerous oc casions. is the lack of test data on new substances. Many of the notices contain no test data and almost none have presented any subchronic or chronic studies, he noted. Industry is not keeping promises it made to submit infor mation on new chemicals, he said. Some of the submiters, many of them large firms with long-term experience in the chemical industry, have refused to provide use information, he said. He complained that some of the firms which promised a cooperative effort in submitting PMN information now are refusing to supply basic information. Industry is shirking responsibility for testing new chemicals, he said, adding that he sees no evidence of a trend indicating industry intends to assume such a respon sibility. Exemption Requests The second problem facing the agency in the review of the notices is an industry trend to submit a test marketing ex emption (TME) request with the premanufacture notice. Since the TME must be approved or disapproved within 45 days, the agency is forced to perform the review more quick ly, he explained. The trend could lead to instances where the agency lacks evidence at 45 days to disapprove the TME but decides later in the PMN review period to take some regulatory action on the new substance, he noted. If the trend continues, the agen cy will have to uncouple the two reviews, he said. In recent weeks EPA has taken several actions to rein force its position that PMNs and TMEs should include adequate information and test data. Such efforts include the rejection of some submissions as inadequate. Another is increasing interest in using sig nificant new use rules to require future reporting for sub stances which complete review without any regulatory ac tion being taken. Vinyl Chloride ALCOHOL INCREASES CANCER EFFECTS, UNIVERSITY RESEARCHER TELLS CONFERENCE Alcohol drinkers mvhave increased susceptibility to the carcinogeniceffects Wvinyl chlorideA'apors. a Governmentsponsored conference was told March 20. Martha Radike. of the University of Cincinnati, reported the results of a study in which laboratory rats were given water containing 5 percent ethanol and were exposed to vinyl chloride. The animals that received alcohol had a much higher in cidence of vinyl-chloride-induced malignant tumors than the rats exposed to vinyl chloride alone, she said. The test animals were exposed to a concentration of 600 part per million vinyl chloride vapor, four hours each day, five days a week for one year. Control groups exposed to vinyl chloride alone and to alcohol alone had elevated tumor rates in comparison with a control group not exposed to either substance, Radike reported. The tumors in the alcohol-only group tended to be benign, rather than malignant, she said. Radike compared the level of alcohol given to the test animals to a moderate drinking level, similar to a six-pack of beer or a few glasses of wine. She said the experiment was suggested by the fact that ethanol and vinyl chloride are known to share a step in the metabolic pathway. Radike suggested that epidemiological studies should be carried out on human populations exposed to vinyl chloride to determine whether chronic alcohol use is related to cancer incidence The two-day conference on vinyl chloride toxicity was sponsored by the National Institute of Environmental Health and Safety, the National Institute for Occupational Safety and Health, and the Occupational Safety and Health Ad ministration. The conferees heard reports from 37 researchers, in cluding Caesar Maltoni of the Institute of Oncology and Tumor Center in Bologna. Italy. Inhalation Studies Maltoni reported the results of extensive inhalation studies in rodents at various dose levels ranging from one to 30.000 ppm. In long-term studies, test rats developed increased in cidences of cancer at levels as low as 10 ppm. Maltoni said. The OSHA standard for worker exposure to vinyl chloride sets a maximum limit of one ppm. averaged over an eight-hour period. Maltoni's experiments involved exposure of test animals for four hours a day, five days a week, for varying periods. He reported that the test animals exposed to vinyl chloride suffered a variety of tumors, including cancer of the liver, lung, kidney, stomach, skin, brain, mammaries, and Zymbal's gland. May Affect Fetus Maltoni also reported a study suggesting that exposure of a pregnant animal to vinyl chloride can increase the in cidence of cancer in her offspring. He described experiments in which female rats were ex posed during pregnancy to vinyl chloride vapors at concen trations of 6.000 and 10.000 ppm. The offspring of the exposed rats later developed a higher incidence of liver cancer than the offspring of unexposed control rats, Maltoni said. 3-21-80 Copyright * 1980 by The Bureau of National Affairs. Inc 0148-7973/B0'SO0 SO CCR 000011329