Document g2geYozx2XG00J87GmXkzd3nN

Monsanto .-- Monsanto Company 800 N. Lindbargh Boulevard St. Louis. Missouri 63166 Ptiona: (314) 094-1000 D***TMCNr Of WUCMf V*vntOW*KHTAL MCAt.rW June 1, 1978 Dr. David Martin Litton Bionetics 5516 Nicholson Lane Kensington, Md. 20795 Dear David: I was glad to have the opportunity of discussing with you again the details of the primate reproduction study that you are conducting with PCB's. This letter gives formal approval for you to continue the feeding and breeding of the animals from April 1 to May 31, 1978, under the terms indicated in your letter of April 11, 1978, excluding the semen'evalua tion. It is understood that the cost will be $8000. I am also giving you tentative approval, at this time, to continue to maintain the animals for a further 6 months after June 1, 1978, but to discontinue feeding the PCB and attempting to breed the animals. Clini cal tests and biopsies will be performed at appropriate intervals as discussed in our telephone conversation of May 30, 1978. All aduLts will undergo necropsy on or about December 1, 1978. Infants will under go a necropsy 2 months after birth, unless signs of PCB toxicity are evident, in which case they will be weaned and removed from exposure to PCB's to determine if these effects are reversible. I understand that the costs will be as follows: Maintenance, etc. June 1- December 1, 1978 Tests performed December 1, 1978 Infant necropsy (assume 22 infants) $ 30,000 1,400 14,080 $ 45,480 Please provide a written protocol for continuing this study and provide us with the protocol sheets previously prepared for the earlier part of the study. MQNS 002687 Dr. David Martin June 1, 1978 Page -2- I do not expect any problems with receiving formal approval for continuing the study as outlined, and expect to write to confirm it shortly after X receive your written protocol. I plan to provide you with the results of the tissue and milk analyses a3 soon as they become available and I have had an opportunity to review them. With kind regards. Sincerely PEB:alw beer~T?.Cv weber Peter E. Berteau, PhD Senior Toxicology Specialist MONS 002688