Document JvBEwp7wGmdLg9JExkRJK3rL2

March 20, 1980 To: Vinyl Chloride Project Panel 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 CMA 008061 BY MESSENGER -- 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 jforce and, because it was part of a larger audit (including-a review of compliance of IBT with good laboratory practice*^'was 'Hot 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. CMA 0080A2 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) 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 grotip- discovered that we had not made Dr. 3usey's audit report on the vinyl chloride study available to the Agency.. Accordingly, I am 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 retain d 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 0080&3 Chemical Manufacturers Association Record of Meeting VINYL CHLORIDE PROJECT PANEL March 18, 1980 Washington Hilton Hotel Washington, D. C. 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. Carrolli'--. r. t. Gottesman. - MEMBERS ABSENT; J. T. Carter w. Bittenbender F. Kennedy R. W. McBurney Air Products & Chemicals, Inc. CertainTeed Products Dow Chemical Company Ethyl Corporation Firestone Plastics Co. BFGoodrich Company PPG Industries, Inc. Union Carbide Corporation CMA Staff 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., Inc. Firestone Plastics Co. Tenneco Chemicals, Inc. BP Chemicals, Ltd. Borden Chemical Continental Oil Co. Diamond Shamrock CMA 008064 J. Lynch R. W. Laundr-ie 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 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 Edmund Frost, Esq., summarized the purpose of the meeting and briefly described the history of the Panel's research project with industrial Bio-Test and an audit of the study by the Experimental Pathology Laboratory (EPL). 2.0 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. 3.0 Following a discussion of the research project conducted by Industrial Bio-Test, a motion was made, duly seconded and passed to immediately conduct further pathologic analysis of all remaining brain tissue salvageable from the study. CMA 008065 3 4.0 Following discussion of CMA's efforts to terminate the Industrial 310-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 T. Seawall Project Administrator Vinyl Chloride CMA 008066 \ J. Lynch R. W. Laundrie j. Gabbett tiC. 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 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 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 Edmund Frost, Esq., summarized the purpose of the meeting and briefly described the history of the Panel's research project with Industrial BIO-Test and an audit of the study by the Experimental Pathology Laboratory (EPL). 2.0 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. 3.0 FollowJjatf-a. discussion of the research project conducted by Indu$tial BIO-Test, a motion was made, duly seconded and passed to immediately conduct further pathologic analysis of all remaining brain tissue salvageable from the study. CMA 0080A7 I -3 t 4.0 Following discussion of CMA's efforts to terminate the Industrial BIO-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. Seawall Project Administrator Vinyl Chloride CMA 008068