Tobacco Documents Online

Mr. William Reilly May 9, 1991 Page Il In considering the epidemiological research, what was the level of relative risk identified for the substance? Was a formal meta-analysis performed? What was the makeup of these studies in terms of U.S. and foreign? How many of the substances were classified exclusively on the interpretation of weak association epidemiology studies? Was there animal research to support the hypothesis? What confounders were considered and ruled out? I think it appropriate at this point to consider Dr. Kabat's comments at the SAB review panel meeting in so far as they help illustrate the Agency's apparent inconsistency. I think classifying ETS as a Class A Carcinogen is maybe a little rash. In the slide that Steve Bayard showed yesterday it showed the 15 carcinogens that EPA has classed as Class A Carcinogens or known human carcinogens and that included BCME, coke oven emissions, asbestos, vinyl chloride and others and I think that that's not what we're dealing with when we're dealing with ETS. [Transcript, Volume II, page 15-16.] At the public and press session on April 18 following the SAB Executive Committee meeting, Dr. Lippmann was asked to quantify the risk posed by ETS. He indicated that most people had exposed themselves to greater risk driving to EPA to attend the SAB meeting. I believe this speaks volumes for the need to review the care or lack thereof that EPA takes in seeing that it adheres to its own guidelines. Finally, I would like to follow up on the document request contained in my letter dated November 1, 1990. In that letter I requested the following material: 1) Such documents as are significant to show all procedures established by EPA, since the 1978 inception of Science Advisory Boards, for identification, evaluation and appointment of members of SAB review panels, including all documents relating to compliance with the requirements of the Federal Advisory Committee Act and all other relevant statutes and regulations in relation to such panels; 2) All documents relating to the identification, evaluation, and appointment of any proposed W or actual members of the ETS review panel, including all documents reflecting the decision- N making process within EPA; O G1D ,-~ ~ CD

Mr. William Reilly May 9, 1991 Page 12 3) All documents containing or reflecting communications with any persons or entities inside or outside EPA regarding the actual or potential membership of any person on the ETS review panel; 4) Identification of all individuals within the EPA staff and the SAB who have played a role in the decision-making process with respect to appointments to the ETS review panel, and a description of their role. I appreciate the material supplied by Dr. Donald Barnes' office in response to this request. I must note that in following up with EPA Congressional Affairs staff as to why there were no documents from the "program office", my staff was informed that the office maintained it had no such documents. I find this particularly interesting since a review of the documents provided by Dr. Barnes indicates that the "program office" recommended a number of the individuals who served on the panel. Please explain how recommendations such as this could be made without documentation. How did the program office come up with the list of individuals that it apparently recommended to the SAB? What individuals in the program office participated in recommending individuals for such membership? As you know, my November 1, 1990 letter expressed interest in whether or not the Federal Advisory Committee Act was being fully complied with. Please detail any instances in which you have authorized the SAB Executive Committee to meet in non-public session during the past two years on this or any other matter. Please supply copies of any such authorizations. While the controversy over Dr. David Burns' membership on the panel has come and gone, I would note for the record that a review of the documents previously supplied by the Agency indicates that a decision not to include Dr. Burns may have been made as early as August of last year. At least, Dr. Burns' name does not appear on some early drafts of the panel membership list. The decision to include him came only after Mr. Axelrad attended an October meeting with Dr. Barnes and anti-smoking activists on the issue of Dr. Burns membership. Dr. Barnes' memo indicates that [t]he visitors and Mr. Axelrad, while acknowledging that they can see how the [information concerning Dr. Burns' views] could lead some people to reach a conclusion that Dr. Bums not be asked to serve on the Panel, argue that in the eyes of the public (and Dr. Bums), he was invited to serve via the August 10 memo. Therefore, to reassess the Panel membership at this stage [was] inappropriate and unacceptable. [For The Record Memo, dated October 22; memo attached] I believe that the referenced August 10 memorandum is within the parameters of my November 1, 1990 request. However, it was not included in the materials that I was provided. I assume this was merely an oversight. Please provide a copy of this memorandum.

Mr. William Reilly May 9, 1991 Page 13 Your assistance and repsonse to these questions is greatly appreciated. I recognize this letter is lengthy so I have identified those areas where a response is necessary by putting the question or request in italics. Please supply answers to the above questions and requests for documents and information no later than May 31. 1991. I recognize this request may seem extensive, but I believe the time frame provided should be sufficient in light of the fact that EPA would have had to address or consider most of the issues raised in the drafting of the risk assessment in order to even begin to comply with its own guidelines. If you have any questions or need any further information, please feel free to contact Mr. Jeff Schlagenhauf of my staff at 225-2815. With kind regards, I am, Sincerely, f jI ~•~_--- Thgmas J. Bliley, Jr. Ranking Minority Member, Subcommittee on Oversight and Investigations cc: The Honorable John D. Dingell Chairman, Subcommittee on Oversight and Investigations The Honorable F. Henry Habicht, II Deputy Administrator, Environmental Protection Agency The Honorable William G. Rosenberg Assistant Administrator for Air and Radiation Environmental Protection Agency Dr. Erich W. Bretthauer Assistant Administrator for Research and Development Environmental Protection Agency

Mr. William Reilly May 9, 1991 Page 14 cc: Dr. William H. Farland Director, Office of Health and Environmental Assessment Office of Research and Development Environmental Protection Agency Dr. Donald Barnes Executive Director, Science Advisory Board Environmental Protection Agency TJBj/jls