Document r3EnYLgeRGvQVrRwOQN7ev2q

Monsanto LOCATION . July 13, 1977 Industrial Bio-Test - Audit and Revalidation of Toxicology Studies TO ;M. C. THRODAHL ( F)7cu tc ttX c-: P. 0. De Garmo R. W. Duesenberg R. Harris s^G, J. Levinskas P. S. Park F. A. Provorny N. L. Reding R. A. Stohr P. A. Wright The following sets forth (i) a summary of the meeting held on July 11 between representatives of Monsantoj e.g., M. C. Throdahl, G. Roush, G. J. Levinskas, P. A. Wright, P. 0. De Garmo, P. S. Park, F. A. Provorny and W. W. Withers, and Industrial Bio-Test ("IBT"); e.g.. Dr. Frisque (president of IBT), Dr. Barry Phillips (a toxicologist for IBT) and F. R. Current (counsel for IBT), to discuss the auditing and revalidating of toxicology studies performed by Industrial Bio-Test for Monsanto, and (ii) recommenda tions regarding the course of action Monsanto should pursue. (1) Summary The reason for the meeting was to determine IBT's position in light of recent actions by the FDA and the EPA (pesticides) in questioning the validity of toxicology studies performed by IBT. In the June 22, 1977, issue of "Pesticide Sc Toxic Chemical News" it was reported that all toxicology tests performed by IBT used to support pesticide registration would have to be audited and revalidated by the registrant. Previously, FDA approval of TCC was questioned by the FDA because of toxicology studies per formed by IBT. Dr. Frisque stated that in reviewing IBT* s operations it had been discovered that the major problems were concentrated in one department at IBT's Northbrook, Illinois, facility. This department conducts long-term rodent studies ("LTRS"). Dr. Frisque stated that between January 1, 1957, and January 1, 1977, approximately 62 studies were conducted in this department with 12 of the 62 studies being conducted for Monsanto. The 12 Monsanto studies are: 0734657 EX P-2533 Page 1 of 4 PCB-ARCH0705738 -2 - IBT Study No. Study B5063 B5100 B7829 B9555 B9558 B9575 622-0554 622-0569 622-05250 622-05251 B7298 B7898 Ramrod Santicizer 4-09 Metabolite Mix CP 41845 - Polaris CP 41845 - Polaris TCC (No response on this study is necessary.) CP 67573 - Roundup CP 67573 - Roundup Avadex Avadex BW Aroclors Rogue Metabolite Dr. Frisque stated that IBT is reasonably confident of the validity of studies conducted in other departments even though some errors might be found. You asked specifically whether "fraud" was involved in the LTRS. Dr. Frisaue replied that "extrapolation" and "faulty interpretations* were part of the problems found in the department and that he guesses this constitutes "fraud." This was a very damaging admission and was made in the presence of a lawyer who took no exception to the question or answer. Dr. Frisque explained that IBT's financial status is extremely unfavorable and that it must rely upon Nalco, its parent, for financial assistance. He then explained that the auditing and revalidating of the toxicology studies would have to be carried out by Monsanto since IBT had neither the personnel nor finances to undertake such a project. He stated that IBT's contribution to this effort would consist of making available a room and the raw data at IBT's facilities at Northbrook to Monsanto personnel reviewing such raw data. Therefore, Monsanto's task would be to review the raw data to insure its accuracy and consistency, to provide toxicological interpretation and to rewrite the final reports, if necessary. In response to a question as to vrho would pay for the work performed by Monsanto, Dr. Frisque stated that no client has yet raised this question with IBT and then he proceeded to avoid answering the question. Dr. Frisque stated that Monsanto has been over the years IBT's largest client and therefore Monsanto would be given first priority among all of IBT's clients. However, in light of what Dr. Frisque is offering on behalf of IBT, this distinction is a rather dubious one. 0734658 EX P-2533 Page 2 of 4 PCB-ARCH0705739 3- (ii) Recommendations After IBT's personnel departed Monsanto representatives discussed the results of the meeting and a proposed course of action. The following are the recommendations made as to the course of action Monsanto should follow at this time: 1. In order to determine the parameters of the task involved in auditing and revalidating the studies, Monsanto should send representatives from the Department of Medicine & Environmental Health to IBT next week (July 18) to review the data relating to three specific studies: Avadex (No. 622-05250), Lasso (No. P1180) and Roundup (No. 622-0564). Selection of these was based on the following considerations. The Avadex study was conducted in the suspect department, and EFA has issued an RPAR against the product. The Lasso study was conducted at Decatur, Illinois. Thus, auditing of this study should indicate whether IBT's problems were confined to the suspect department at Northbrook, Illinois. The study on Roundup was conducted in the suspect department and it was audited by IBT. Monsanto's review of it will indicate how comprehensive IBT's internal audits are. After this review has been completed, it is anticipated that Monsanto will have a better idea of the task involved in auditing and revalidating additional studies. Thereafter, it is anticipated that Monsanto will audit and revalidate studies based upon the following priorities: (a) Long-term rodent feeding studies. (b) Reproduction studies. (c) Teratology studies. (d) Ninety-day rodent feeding studies on products if they have not had completed previously audited long term rodent studies. Audits of the following studies will be deferred unless a specific need arises since they are relatively short-term (and could be repeated readily, if necessary) or could be audited relatively easily: (a) Short-term tests (less than thirty days). (b) Long-term non-rodent studies. (c) Inhalation studies. 07**659 (d) Tissue residue studies. EX P-2533 Page 3 of 4 PCB-ARCH0705740 2. Since the possibility exists that IBT may become insolvent and go into bankruptcy and/or incriminating documents might possibly be intentionally destroyed. Monsanto snould request the original raw data (or microfilm) along with the slides and specimens relating to studies conducted by IBT for Monsanto. However, it should be noted that IBT during the discussion stated that they would not release to clients original data. 3. Consideration should be given to Monsanto's officers; e.g., Mr. Hanley or you, contacting the president of Nalco to explain that IBT's proposal regarding auditing and revalidating is unacceptable and that Monsanto expects Nalco to undertake the responsibility to instruct IBT to proceed with IBT personnel to audit and revalidate toxicology studies performed by IBT for Monsanto. Monsanto's position in this regard would be strengthened if item 4. below establishes Nalco's liability for IBT's actions. It should be noted that Monsanto's sales to Nalco in 1976 totaled $1,405,000; e.g., MIC - $896,000; ME&R - $100,000; MCI - $374,000; and MCP - $35,000. 4. Action has already been initiated to ascertain the legal relationship between Nalco and IBT in order to determine whether or not Nalco might be held liable for IBT's conduct. 5. Finally, it is recommended that consideration be given to the possibility of instituting suit against IBT (Nalco) at some point in time. Needless to say, many factors must enter into this consideration, such as Monsanto's desire to have IBT remain a viable testing laboratory (IBT is presently conducting 60 long-term feeding studies for Monsanto along with a number of short-term studies), the degree of cooperation Monsanto desires from IBT, and finally MOnsanto's ability to collect a Judgment if a verdict is rendered in Monsanto's favor. It is obvious that IBT's position as stated at the meeting is unsatisfactory to Monsanto. For Monsanto to undertake this effort, substantial time and money will be involved, not to mention the potential disruption to our own internal needs which require the time and devotion of the individuals who will be necessary participants in the auditing and revalidating. However, it should be noted that until the review is completed on the initial products mentioned in item 1. above, the magnitude of the task facing Monsanto cannot adequately b.e ascertained. EX P-2533 Page 4 of 4 PCB-ARCH0705741