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f,t KO M iNAM! LOCATION SUBJCCT H f ERTNCL W. B. Papageorge - B3NJ December 3, 1976 Polychlorinated Biphenyls NIOSH Draft Criteria Document H. N. Brandstetter - B2SA E. W. Eley - A2SA J. T. Garrett -- A2SA G. J. Levinskas - A2SA J. P. Mieure - T2F R. A. Stohr - B2SA, J. C. Weber - B2SK P. L. Wright - A2SC The review panel consisting of the individuals on the attached list met at the Taft Laboratories on November 30, 1976. The discussion was chaired by Mr. John Fajen with strong technical support offered by Dr. Mason. The review con centrated on toxicology and human health effects with only passing reference to analytical methodology. Dr. Kimbrough made opening remarks in which she reported that the Bureau of Foods, FDA, had new information that the rice bran oil in the Yushu incident did not contain an average of about 2000 ppm of PCB as previously reported, but was recently determined to have about 1000 ppm PCBs, 5 ppm chlorinated dibenzo furans and about 1000 ppm of . unidentified chlorinated hydrocarbons. The question which remains unanswered is "What were the victims exposed to?" Dr. Kimbrough firmly stated that in her opinion there was inadequate evidence to arrive at an exposure standard for PCBs. Dr. Brubaker reported that the Mobil epidemiologic study was still active. The cohort has been reidentified and changed. He predicted that the results would be different from those originally reported. He was not too specific regarding the changes in cohort. Drs. Brubaker, Kotelchuck, Smith, and Meyer agreed with Dr. Kimbrough that inadequate information was available to establish a standard. Drs. Allen and Lawrence disagreed and pointed to the one Japanese paper in which workers exposed to 0.01 mg/M^ exhibited symptoms. They both went on record proposing a 0.01 mg/M^ standard instead of the proposed 0.05 mg/M^. DSW 308117 STLCOPCB4070019 2- - My stated position was the one we had discussed previously, i.e. not enough information to set a standard, no basis for using "cancer suspect" wording and the need for more studies. Dr. Kotelchuck strongly opposed any number and suggested that each plant using PCBs be considered on a case basis with every effort made to reduce PCB exposure to the practical minimum suitable to the site. Mr. Fajen repeatedly stated that NIOSH was under pressure to issue a criteria document and must do so quickly. He did not explain why it must be completed soon. Mr. Fajen requested copies of Monsanto's Askarel Maintenance Bulletin, ANSI PCB guidelines, the September, 1976 press release describing our employe study, and of a current PCB product label. This information has been mailed to him. Mr. Fajen and Dr. Hill again mentioned that they wanted to visit our laboratory and discuss PCB analytical methodology with Jim Mieure. I told them I couldn't commit Jim to a meeting now but they should write to Monsanto requesting a meeting and we would consider their request later. The lack of support from the review panel for the proposed standard, the new information relating to the Yusho incident and the predicted change in.the results of the Mobil employe study have placed Mr. Fajen and Dr. Mason in a very awkward position. I personally don't believe they can arrive at a supportable standard in the short time they apparently have available. . /kn W. B. Papageorge DSW 308118 STLCOPCB4070020 NIOSH REVIEW CONSULTANTS ON POLYCHLORINATED BIPHENYLS James R. Alleh, DVM, Ph.D. Department of Pathology University of Wisconsin Madison, Wisconsin 53706 Paul E. Brubaker, Ph.D. Senior Toxicologist, MRDC Mobil Oil Corporation Paulsboro, New Jersey 08066 Renate Kimbrough, M.D. Toxicology Branch Center for Disease Control Atlanta, Georgia 30333 Robert Hill, Ph.D. Research Chemist Org. Methods Devel. Branch 1014 Broadway Cincinnati, Ohio Tei. 513-684-262S Channing Meyer, M.D. . Acting Section Chief Medical Section DSHEFS Post Office Bldg. Cincinnati, Ohio Tel 513-684-273^ Dr. David Kotelchuck Consultant to United Electrical Radio and Machine Workers of America Health Policy Advisory Center 17 Murray Street New York, New York 10007 Charles Lawrence, Ph.D. Research Scientist Cancer Control Bureau New York State Department of Health Empire State Tower Albany, New York 12237 Mr. William P. Papageorge Mgr., Product Acceptability Process Chemicals Division Monsanto Industrial Chemicals St. Louis, Missouri 63166 Company Mr. John M. Fajen Criteria Manager for PCBs NIOSH Taft Laboratories Cincinnati, Ohio 45226 Tel. 513-684-8207 Robert Mason, Ph.D. Technical Reviewer NIOSH Taft Laboratories Cincinnati, Ohio 45226 Tel. 513-684-8207 A. Blair Smith, M.D. Medical Officer NIOSH Post Office Bldg. Cincinnati, Ohio Tel. 513-684-3594 SW 308119 STLCOPCB4070021