Document peReynQ0ppr4YZdxBydmOqdwd

Monsanto W. Easley - 1920 an December 13, 1977 uantr . ^ ^PCBsX < IMM( i TO : G. J. Levinskas - A2SG CC R. C. Isham - B1NB E. T. Mollica - B2SB A. M. Navarro - A3NB R. A. Stohr - B2SC D. Wood - B2SD G. Roush, Jr. - A2SA In your memo of November 9, you asked thaC I chase down Che Massachusetts Audobon Society letters which question the IBT data on PCBs and to seek confir mation of EPA's view that IBT's raw data is not being questioned. To get my hands on the letter, I had to go to the FDA Hearing Clerk's Office in Rockville. Attached is a rough transcription of my tape recording of the letter. The attachments referred to in the letter are not included, but should come along in a week or two and will include copies of the letters themselves. I requested them under the Freedom of Information Act, incidentally. The Audubon Society letter which was sent to EPA is identical to that which was sent to FDA. I do not plan to get a separate set from EPA. The EPA acknowledgment, like FDA's, doesn't really say anything, I'm told. I had a long talk with John Weasel of FDA's Office of Compliance. As you know, he has been Involved in this issue for some time. Incidentally, he is going to trans fer to some other part of FDA and this work will be Bicked up by Betty Campbell in the Office of Compliance. easel does not know how FDA is going to react to the letter. He says that the Bio Research Monitoring group is examining it. The '73 PCB tolerances wer'e established, according to John, primarily on the basis of Yusho data which, as he put it, is confirmed by the observations at IBT. If the IBT data turns out to be unreliable, they will still have the Yusho data to fall back on. He pointed out that it was after the 1973 tolerances were set that the cancer question arose. This got them into a box because no amount of PCBs in food could be considered safe, and they had to work toward getting the levels as low as possible considering analytical uncertainties, unavoidability of some contamination, and scientific Judgments as to the levels people would consume over time. They could not fall back on a formula relating intake and toxicity. It follows then that even if the IBT data is discredited after their reassessment, there would still be no change in the final standard. Also, he noted, if FDA were to lower the standards, there would not be much of a reduction in PCB intake from foods. For HONS 011184 tm 6. J. Levinakas - A2SC Page Two December 13, 1977 example, if they were to cut certain species of fish in the Great Lakes and the Hudson from S to 2, a change that looks significant on paper, it would, in practice, stake no big difference. Asked when there might be something costing out of FDA, he said that they would probably be slow and that nothing will appear until 1980. The suitter has a fairly low priority. The person at EPA who is most responsible for this issue is Dr. Eugene Wallen. I have not talked to him about PCBs in connection with your memo, although I can do so if Indicated. I have talked with George Wirth, Dave Downer, and Tost Kopp, all in the Office of Toxic Substances and all concerned with PCB. Kopp was the source of the report that EPA has no argument with the basic data that IBT developed, but probably does have some disagreement with IBT's conclusions. Kopp was giving us the opinion of others. He is not willing, of course, to put such an opinion in writing and it wouldn't mean anything if he did. I have no hesitancy about getting into a detailed conversation with Wallen on this, but before I do so, I would like for you to react to the material attached and the additional ma terial you will be getting. . KVE/pah Attachment K. Warren Easley mons 011185