Document 06nbZ8pwN5yenx8aXpgzggyJR

PCB DISCUSSIONS GOVERNMENTAL AGENCIES NOVEMBER 13 AND 14, 1975 Monsanto Representatives G. Roush W. B. Papageorge J. C. Weber K. W. Easley . J. Calandra--Industrial Bio Test Labs Purpose of Discussions 1. To show that positive action was taken by Monsanto in response to Dr. Kimbrough's report that Aroclor 1260 caused malignant tumors in the liver of the rat. 2. To report that the recent review by Industrial Bio Test and Eppley Institute Consultants confirmed that high levels of PCB's does cause liver damage in the rat, but the lesions are not hepatocellular carcinomas. NIOSH John Finklea - Director (Present for the introductions only) K. Bridbord - Assistant to the Director R. A. Rhoden - Criteria Documents R. Moore - Editor "Alert" Bulletin R. Stein - Criteria Documents D. P. Brown - Epidemiologist, NIOSH Cincinnati Laboratory E. J. "Bud" Fairchild - Director, Cincinnati Laboratory T. Kopp - EPA, Office of Toxic Substances R. Shapiro - FDA, Bureau of Foods, Office of Science Renate Kimbrough - Center for Disease Control DiBcusBion centered on the fact that we and Dr. Kimbrough agree that PCB's cause lesions in the liver of the rats but disagree with her interpretation that some of these are hepatocellular carcinomas. Our interpretation is that these lesions are the expected damage you would see in the liver caused.by chlorinated hydrocarbons. Dr. Kimbrough's work was done on female rats using only Aroclor 1260. The point was made that the production of Aroclor 1260 was stopped in 1971. There is a real problem in that the people concerned with PCB'b treat them as one chemical like "DDT" and do not recognize the difference between Aroclor 1260, 1242, etc. MONS 030567 Page 2 Dr. Brown and Dr. Fairchild of the Cincinnati office plan to conduct a mortality study at Westinghouse's Bloomington, Ind. capacitor plant covering the past 30 years. This study will take about two years to complete. Dr Roush discussed our review of causes of death of employees associated with the production of PCB's over the past 25 years. Dr. Fairchild offered to help us complete our study. NIOSH is concerned that there is poor control in containment and plant practices once the PCB leaves our plant. NIOSH men tioned a "use permit" as a control. It appears NIOSH will not recommend the banning of PCB's but very restrictive practices on using them. CEQ - (Council of Environmental Quality) Warren Muir - Assistant Director Peter Winkel - TNO - Netherlands David Walsh - OSHA Short discussion on our review with NIOSH covering the same ground. CEQ has no specific planr regarding PCB's. Dr. Muir did report the Administration is backing the McAllister bill in the House on toxic substances. Dominick Daniels (N.J.) House Subcommittee Manpower, Compensation, Health and Safety Daniel Krivit - Counsel Mrs. Susan Nelson - Staff Assistant These people are interested in PCB's because they are concerned that NIOSH and OSHA are not carrying out their responsibilities as directed by Congress and can use PCB's as a political tool. Also PCB's are important to them because Representative Daniels will be proposing a bill called "Hazardous SubBtances Dispersion Act" and will use PCB's to show the need for such legislation. We expect that this Subcommittee will conduct hearings on the PCB problems. Krivit's and Nelson's knowledge about PCB's is very limited, but they are eager to establish a working relation ship with the chemical industry and invite active discussion with Monsanto. ' Krivit was involved in drafting the current Occupational Health and Safety Act. HONS 030568 Page 3 NCI Dr. Jim Peters - Director, Division of Cancer, Cause and Effect Dr. Garry Flamm - Assistant Director Dr. Herman Kraybill - Toxicologist R. A. Rhoden - NIOSH R. Shapiro - FDA - Bureau of Foods Short discussion of our interpretation of Dr. Kimbrough's data . and Industrial Bio Test report. Dr. Peters readily recognized the problem that the pathologists need to resolve the differences Dr. Peters recommended that HEW's Toxicology Coordinating Committee take it under advisement. This committee is chaired by Dr. David Rail. NCI also reports that Aroclor 1254 is included in the Stanford Research Institute's multi chemical chronic feeding studies with rats. m Dr. A1 Kolbye - Ass. Director for Sciences, Bureau of Foods Ray Shapiro - Bureau of Foods Charles Jalinek - Bureau of Foods Jerry Burke - Bureau of Foods Larry Garthoff - Bureau of Foods A1 Pohland - Bureau of Foods A. R. Bennett - Office of the General Council S. M. Pape - Office of the General Counsil We reviewed the data we had presented to the other agencies. Kolbye's concern is body burden. The FDA is considering lowering the allowable level of PCB'b in fish. If this happens, it will have a serious impact on sport fishing as many lakes and streams will be out of bounds. Kolbye reports that Canada will soon announce a guideline of 2 ppm PCB's maximum allowed in edible fish. Kolbye is also disturbed about the lasting effect of the Japanese PCB incident that happened in 1968. BPA John Buckley - Consultant Leonard J. Guarraia Arthur J. Pallotta - Toxicologist Lawrence A. Plumbe - M.D. A. M. Kuamack David Garrett - Office of Toxic Substances R. M. Hutlif - Office of the General Council Blake Biles - Attorney, Enforcement Office R. E. Shapiro - FDA Bureau of Foods ' HONS 030569 Page 4 EPA is continuing their concern about the high chlorinated homologs of PCB's in the environment. In general this group of EPA was not receptive to our concept that PCB's are not cancer causing agents. EPA most probably will treat PCB's as such which appears to be consistent with their desire to have a Toxic Substances Act. 'In general, it appears that our visit to these agencies on an individual basis was beneficial to Monsanto and did cause them to recognize the bigger problem of defining a cancer causing agent. This definition is extremely important not only to the status of PCB's but any other chemical that may cause lesions in an animal. J. Coleman Weber 11/17/75 smt HONS 030570