Tobacco Documents Online

{ CC. .! wQ ~wt T-( THE TOBACCO INSTITUTE -~kt `, 1875 1 STREET, NORTHWEST SAMUEL D. CHILCOTE, JR. WASHINGTON, DC 20006 President 202/457-4800 • 800l424-9876 December 5, 1990 MEMORANDIIM TO: The Members of the Executive Committee FROM: Samuel D. Chilcote, Today at the conclusion of the two-day meeting held to discuss two EPA draft documents the EPA's Science Advisory Board (SAB) Chairman Morton Lippmann announced that the board agreed with the risk assessment conclusion that ETS is a cause of lung cancer. Dr. Lippmann told the EPA staff responsible for the drafts that the board agrees with their conclusion that ETS is a Class A carcinogen and that with some revisions to the draft materials staff "can make that case." The Indoor Air Quality and Total Human Exposure Committee of the Environmenta3. Protection Agency's Science Advisory Board met December 4 and 5 to discuss the accuracy and completeness of the two EPA draft documents: 1) Health Effects of Passive Smoking: Assessment of Lung Cancer in Adults and Respiratory Disorders in Children ("Risk Assessment"), and 2) Environmental Tobacco Smoke: Guide to Workplace Smoking Policies ("Policy Guide").. Initial media interest was moderate to light. Press coverage included radio reporters from Associated Press and Mutual Radio. Print media included the Associated Press, the Washington Post, and the New York Daily News. The meeting was also covered by a producer for ABC's 20/20. However media coverage of Wednesday's SAB press conference has been extensive, and included the Washington Post, CNN and CBS. Television cameras, not allowed in the hearing room, were present at the press conference. Prior to the hearing TI media kits were sent to the science and 11ealth writers of the top 100 newspapers, journalists likely to cover the meeting, and Washington based press. Also, an advisory was sent to the Washington based media on Monday. The industry's academic scientists were available to the press prior to and on the site of the hearing. Consulting scientists participated in an industry sponsored press conference following the SAB announcement. 14_4L

The Members of the Executive Committee December 5, 1990 Page 2 In addition to agency presentations, Tuesday's meeting featured four public comment periods with 24 individuals making statements. Eight academic scientists offered oral presentations on behalf of the industry. Steven Parrish, Vice President, Scientific Affairs, Philip Morris, also madee a statement. Following an introduction of the Board members by Chairman Lippmann, Donald Barnes of the EPA gave a history of the SAB and reviewed its role with the agency. Next, A. Robert Flaak of the EPA reviewed the agenda, the administrative issues and the board process. Lippmann in a prepared statement discussed the "unfortunate -allegations of bias" in the selection of SAB members. Each panel member then made voluntary disclosures about their work, funding and correspondence relating to the issue before the Board. Also making presentations for the EPA were Todd Thorslund discussing his tentative work on dose response analysis, Aparna Koppikar presenting information on the childhood respiratory effects chapter of the draft document, and Ken Brown on the need to restudy the relative risk aspect of the draft. This restudy was prompted by comments to the risk assessment submitted by Peter Lee and Judson Wells. The first public comment period was reserved for tobacco industry presenters. Because of a time limitation set by the SAB during the day's meeting, only nine of the twelve scheduled presenters were able to speak to the Board. Steven Parrish of Philip Morris presented an introduction to the overall comments of the industry on the EPA Risk Assessment. Next, Dr. Donald deBethizy limited his comments to why cotinine should not be used as a marker for ETS testing. The next two presenters discussed the epidemiologic evidence cited in the EPA's draft documents. Dr. Maurice LeVois stated that the observed epidemiological association between ETS exposure and lung cancer is insufficient and inconsistent. He also said that the EPA drafts create the illusion that the studies cited support EPA's conclusions. Dr. Richard Tweedie pointed out the flaws in the epidemiological methodology employed in the EPA drafts. He stated that his research leads to the conclusion "that the human evidence is inadequate at this time to enable a conclusion [on the carcinogenicity of ETS] to be reached."

The Members of the Executive Committee December 5, 1990 Page 3 Dr. William Butler discussed confounding factors, the lifestyle characteristics that are common to both the agent and the disease under study, and which therefore could create an apparent association where none in fact exist. Drs. Joseph Fleiss, Paul Switzer and Peter Lee made presentations on the flaws in the meta analysis conducted in the ETS risk assessment. (Meta analysis is the statistical procedure in which a number of studies are combined to produce a single estimate of relative risk.) Dr. W. Gary Flamm summarized the industry's position, noting d~hat the causal relationship reported in the EPA drafts is not justified. The classification of ETS as a Class A carcinogen is inconsistent with EPA actions on other substances, he noted. Representatives of the Coalition on Smoking OR Health comprised the second session. Fran DuMelle spoke on behalf of the Coalition. She reported the Coalition's belief that the conclusions in the EPA's draft report "are supported by the overall scientific evidence." Drs. Lawrence Garfinkel, Douglas Dockery and Dimitrios Trichopoulos echoed the Coalition's remarks. Public Comment Period III included a presentation by Dr. Devra Lee Davis from the National Academy of Sciences. Her comments were limited to the issue of general respiratory disorders. Dr. Michael Cummings of the Roswell Park Cancer Institute discussed the use of cotinine as a marker for ETS. The final Public Comment Period of the day had ten speakers. These were generally emotional presentations that did not discuss the science of the reports before the SAB. In his summary, following the review of the risk assessment chapters, Dr. Lippmann stated that the chapter on childhood respiratory disorders needs to be strengthened to expand the conclusions to include ETS as a cause for respiratory disorders in all age groups. He also agreed with the conclusions of Chapters 3 and 4 that ETS is a cause of lung cancer but he urged the EPA to revise and strengthen their report to prove their case.

r r J The Members of the Executive Committee December 5, 1990 Page 4 With regard to the workplace policy guide, Dr. Lippmann told the EPA that the SAB could not endorse it as written because it includes non-respiratory disorders in its list of ETS caused diseases. He suggested that the guide be redrafted to reflect only the conclusions of the risk assessment. SDC:mlr Enclosures cc: TI Senior Staff