FIFRA SCIENTIFIC ADVISORY PANEL (SAP) OPEN MEETING JUNE 19, 2003 DAY 3 OF 3 Located at: Crown Plaza Hotel 1489 Jefferson Davis Highway Arlington, VA 22202 Reported by: Frances M. Freeman 2 1 C O N T E N T S 2 3 Proceedings...........................Page 3 3 1 DR. ROBERTS: Good morning. I want to take the opportunity 2 now to briefly reintroduce the panel. And let me as we have done in 3 days previously begin with Dr. LeBlanc and ask each member of the 4 panel going around the table to state their name, their affiliation and 5 their expertise. 6 Dr. LeBlanc. 7 DR. LEBLANC: Good morning. My name is Gerry LeBlanc. 8 And I'm a professor in the department of environmental and molecular 9 toxicology at North Carolina State University. And my area of 10 expertise is endocrine toxicology. 11 DR. KELLEY: I'm Darcy Kelley. I'm a professor of biological 12 sciences on the faculty for the center for environmental research and 13 conversation and a member of the Earth Institute at Columbia 14 University. 15 And my area of expertise is sexual differentiation of the 16 amphibian xenopus laevis. 17 DR. KLOAS: My name is Werner Kloas. I'm professor for 18 endocrinology at University of Berlin. 19 I'm also heading the department of inland fisheries at the 20 Leibniz Institute of Freshwater Ecology and Inland Fisheries. And 21 my expertise is endocrine disruptors acting on sexual differentiation 4 1 and thyroid system in amphibians. 2 DR. GREEN: My name is Sherril Green. I'm an associate 3 professor in the department of comparative medicine at Stanford 4 University. My special interest and expertise is in the care and 5 husbandry of laboratory amphibians, xenopus laevis and other 6 species. 7 DR. COATS: My name is Joel Coats. I'm in the department of 8 entomology, chair of the department, and professor of entomology and 9 toxicology at. 10 DR. ISOM: State University. 11 My expertise is environmental toxicology, environmental 12 chemistry of pesticides. 13 DR. DENVER: I'm Robert Denver. I'm from the department of 14 molecular cellular developmental biology of the University of 15 Michigan at Ann Arbor. And my expertise is developmental 16 neuroendocrinology of amphibians. 17 DR. GIBBS: My name is James Gibbs. I'm an associate 18 professor of conversation biology at the State University of New 19 York's College of Environmental Science and Forestry. And my area 20 of expertise is amphibian demography. 21 DR. RICHARDS: My name is Carl Richards. I'm a professor of 5 1 biology at the University of Minnesota Duluth, and I'm director of the 2 Minnesota Sea Grant College Program. My expertise is aquatic 3 ecologist and landscape ecology. 4 DR. DELORME: My name is Peter Delorme. I'm a senior 5 environmental risk assessor with the Canadian Government, Pest 6 Management Regulatory Agency. My area of expertise is aquatic 7 ecology and risk assessment methods. 8 DR. SKELLY: My name is David Skelly. I'm an associate 9 professor of ecology at Yale University. And my area of expertise is 10 population and community ecology of amphibians. 11 DR. MATSUMURA: My name is Fumio Matsumura. I'm a 12 professor of environmental toxicology. I also serve as the director of 13 our Center for Environmental Health Sciences. My area of expertise 14 are molecular toxicology. And I also study some neural effect of the 15 pesticides. 16 DR. THRALL: I'm Mary Anna Thrall. I am a professor of 17 veterinary pathology at Colorado State University. And my area of 18 expertise is veterinary clinical pathology. 19 DR. ISOM: I'm Gary Isom, professor of toxicology at Purdue 20 University. And my area of expertise is neurotoxicology. 21 DR. HEERINGA: I'm Steve Heeringa, senior research scientist 6 1 with the Institute for Social Research at the University of Michigan. 2 I'm a statistician. My specialization is in the design of research and 3 in specialist research relating to human and animal populations. 4 DR. ROBERTS: And I'm Steve Roberts. I'm a professor at 5 University of Florida with joint appointments in the College of 6 veterinary medicine in the College of Medicine, and serve also there 7 as director for the Center for Environmental and Human Toxicology. 8 My areas of expertise are toxicology and risk assessment. 9 Before we proceed with the public comments this morning, at 10 the close of yesterday, there was a little bit of confusion about the 11 status of some research reports that were -- from research performed 12 by Dr. Hayes while at Ecorisk. 13 Dr. Sielken has offered to perhaps clarify the situation on that. 14 I would like Dr. Sielken to do that at this point for the panel. 15 DR. SIELKEN: Thank you, Mr. Chairman, and good morning to 16 the panel. 17 Just to be as clear as possible, I did print out a copy of the 18 clarification statement that I would like to make. And this is a 19 clarification of the materials that I submitted yesterday to the record 20 and to you all. That's my Texan coming through, you all. 21 On the morning of Wednesday, yesterday, Dr. Hayes made 7 1 reference to his study number 99XLATZ2. At the beginning of the 2 afternoon session, I submitted four items to the EPA or SAP related to 3 my review of the statistics in Dr. Hayes' report for that study. 4 These four items were as follows: And they are numbered here. 5 I won't read the titles. But the first one was a document that was 6 prepared for a meeting with EPA in June of 2002. And that document 7 was briefly summarizing the comments that I had made in my 8 presentation to Dr. Hayes on September 19th of 2000 at Berkeley. 9 There is no change in that. I'm just clarifying that that was the 10 first thing that I gave you yesterday. 11 DR. HAYES: We didn't have a meeting in September -- 12 DR. SIELKEN: That is the date that was on the front page of 13 the presentation that I gave. It was at the meeting in Berkeley, 14 whatever date it was. 15 DR. HAYES: It was January or February. It wasn't September. 16 DR. SIELKEN: I have been corrected. It was January. Boy. 17 This is what happens when you go to bed at quarter to 4 in the 18 morning. 19 It was at the one and only meeting that I attended in Berkeley 20 with Dr. Hayes. 21 The second item was the overheads that I presented at that 8 1 meeting, whenever it was. It expressed my professional concerns as 2 a statistician about characteristics of the study, including what Dr. 3 Hayes described as "haphazardly selecting a sample to analyze for 4 laryngeal size" instead of taking a random sample, the need to 5 explicitly provide more of the numerical data and errors I found in a 6 spot-check of the numerical accuracy of the report. 7 These overheads also contain the results of what I believe to be 8 more appropriate statistical analyses of the data on laryngeal 9 cross-sectional area. And the details of my findings are written out 10 there for you. 11 Basically, what I found was that there was not a substantial 12 reduction in laryngeal size due to atrazine. This was the same 13 conclusion that Dr. Hayes had noted in the body of his report, but did 14 not note in his summary. 15 The third thing that I handed out, which was probably pretty 16 obscure to you, was the copies of the 24 transparencies that I prepared 17 to show examples of some of the errors and inconsistencies I found in 18 Dr. Hayes' Excel spreadsheets, worksheets, and which I had 19 presented to Dr. Hayes at that meeting in Berkeley. Correct the date. 20 I just listed there some idea of what those errors and 21 inconsistencies were. I had copied the transparencies that I used to 9 1 identify those things and had provided those to you yesterday. 2 Now, where the confusion really probably arises is with respect 3 to Number 4. And the version of the final report signed by Nigel 4 Noriega on June 23rd, '00, was the copy that I submitted to you. 5 The first three of the items that I briefly discussed above were 6 reproduced from original copies that I had prepared and brought with 7 me to this meeting. 8 I did not think that I needed to bring my copy of the final report 9 that I reviewed. I didn't think I needed to bring those here since I 10 assumed that there would be plenty of copies here and I didn't need to 11 carry it in my luggage. 12 Therefore, I asked Ecorisk staff to provide a copy of the final 13 report for me to submit. The Ecorisk staff provided the only final 14 report that was signed. And I assumed that that was the same report 15 that I had been looking at. 16 Unfortunately, the only version of the -- and unfortunately, the 17 only version that the final report that was on the CD that was 18 provided to the SAP members. 19 In other words, Syngenta provided to you the only signed final 20 report. 21 When I asked the Ecorisk staff to reproduce the final report for 10 1 me, then that's what they did.