Tobacco Documents Online

THE TOBACCO INSTITUTE 11175 1 STlir l: i'. NDRTIiWES'I' SAMUEL D. CHILCOTE. IR. WASiIfNt7l'UN. DC 2iHH1tS Pretifdenl :U?1-i57•-1RiH1 • }liH1/324-987t3 January 16, 1991 The Honorable William Reilly Administrator U.S. Environmental Protection Agency Washington, D.C. 20460 Dear Mr. Reilly: On December 4, 1990, I wrote to you to outline a number of concerns in connection with the Environmental Protection Agency's review of its draft risk assessment and policy guide on environmental tobacco smoke (ETS). A copy of that letter is enclosed. To date, we have not received a reply to the letter. Now that the Science Advisory Board (SAB) panel has completed its initial review of the two draft documents, we are writing to reiterate and amplify our earlier concerns. No doubt because of the problems that we described in our earlier letter, the SAB panel meeting was conducted in a manner that prevented scientific viewpoints critical of the two draft ETS documents from being given a full and fair hearing. In fact, the conduct of the ETS hearing stands in remarkable contrast'to that of most other SAB deliberations, which generally permit and in fact encourage a free and open discussion of the issue under consideration. The most recent example of this more objective approach is the SAB hearing held just this week on the EPA's risk assessment of electromagnetic radiation. As a further example of the SAB panel's failure to conduct a fair hearing with regard to ETS, consider that two of the panel members who agreed to review the report did not even attend the first day of the meeting, which was the only time reserved for public comment. It was evident that other panel members had not reviewed the written submissions, even though they had been provided well in advance of the meeting. Moreover, a number of scientists with critical views concerning the two draft documents were not afforded any time to speak -- in contrast to the fact that twice as much time was allotted at the meeting for presentations by anti-smoking organizations. Clearly there was sufficient time for all who wished to speak, yet the opportunity to do so was denied to some.

The Honorable William Reilly January 15, 1991 Page 2 One of the oral presentations that was not heard pertained to Chapter 5 of the draft risk assessment, dealing with the respiratory health of children. As a consequence, no presentation raising questions about Chapter 5 was permitted, even though scientists desiring to do so were present, there was ample time on the schedule to permit such presentations to be made, and the SAB raised significant questions about this section. We believe that this presents serious questions as to whether the SAB panel's examination of the draft ETS documents was conducted in accordance with applicable statutory and regulatory provisions governing the activities of federal advisory committees, not to mention fundamental notions of due process. An equally troubling aspect of the SAB panel meeting, however, was the suggestion at the end, both in the chairman's summary remarks and in statements by him and others to the press after the panel adjourned, to the effect that the panel had reached a "consensus" on the classification of ETS as a human carcinogen. As reflected by the transcript of the meeting, there was no such "consensus." one panel member stated unequivocally that such a determination would be "rash." Several others voiced significant criticisms of the draft risk assessment that cannot be reconciled with the notion that there was anything approaching a "consensus." Furthermore, even if a majority of the SAB panel is currently of the view that the carcinogen classification issue is or can be resolved, the basis for such a conclusion is manifestly inadequate. Overall, the panel was very critical of the weight placed on the ETS epidemiologic studies in the draft risk assessment, and this criticism was certainly justified given the fact that the overwhelming majority of the epidemiologic studies do not support the classification of ETS as a human carcinogen. Several panel members suggested, however, that a finding of carcinogenicity could be based instead on the notion that ETS and mainstream tobacco smoke are sufficiently similar in composition and behavior that one can extrapolate from data concerning the latter to reach conclusions concerning the former. In fact, the available data do not allow for such a conclusion. We believe that the inappropriateness of such an extrapolation will become obvious as EPA staff proceed with the additional analyses called for by the SAB panel.

The Honorable William Reilly January 15, 1991 Page 3 The issue remaining, of course, is how the Agency now should proceed with the ETS documents. In that connection, we reiterate the four proposals contained in our December 4 letter: that (1) the risk assessment and policy guide should be submitted for further SAB review after they have been revised in light of SAB and other comments (as recommended repeatedly by the panel itself on December 5); (2) such review should be undertaken by an objective and independent panel, chosen in accordance with the criteria described in our letter of December 4; (3) the draft ETS technical compendium be submitted for review by an SAB panel before there is further Agency consideration of the risk assessment and policy guide; and (4) all of the Agency's draft ETS documents should receive careful senior level Agency review before a determination on whether to release them is made by your office. With regard to the last point, we would ask that the Agency take note of all of the public comments that have been provided to the Agency, including the many comments that were not considered by the SAB panel on December 4 and 5. We wish to make one additional point concerning the Agency's review process. As a number of eminent scientists have emphasized orally and in writing, the labeling of ETS as a Group A carcinogen cannot be reconciled with the Agency's own classification criteria, which demand the determinations that no identified bias can explain the apparent association, that potential confounders can be ruled out and that the association is unlikely to be due to chance. In addition, the proposed classification of ETS cannot be reconciled with the treatment of other substances that the Agency has examined, particularly with its manifestly different treatment of exposure to electromagnetic fields (EMF). As you know, the Agency recently issued a draft EMF report which concludes that the data do not warrant a determination that exposure to EMF causes cancer. And yet, as we have frequently pointed out, the epidemiologic data base is in fact considerably stronger for EMF than it is for ETS. The obvious care with which the Agency is approaching the EMF issue likewise contrasts sharply with the way in which the ETS issue has been handled. For example, EMF was the subject of a workshop by a panel of scientists from outside the Agency in June 1990. Nothing of the sort was undertaken with respect to ETS; in fact, a Philip Morris request that such an independent review be undertaken was expressly rejected (correspondence enclosed). Second, the SAB panel that will review the EMF issue has scheduled a full three days for its task; contrast this with the obvious rush to judgment in the SAB's consideration of ETS, where requests for additional time for review were rejected.

The Honorable William Reilly January 15, 1991 Page 4 Third, according to published statements by SAB Executive Director Donald Barnes, the SAB panel convened to review the EMF report was selected based on "objective expertise," with several candidates rejected for having "basically taken a public position" on the EMF issue. In contrast, most of the panel members selected to review the ETS risk assessment -- including Dr. David Burns, a widely quoted anti-smoking activist -- hold views on the alleged health effects of ETS that are well known to both the public and their peers. And finally, the Agency indicated in a December 18 Federal Recrister notice that a revised EMF report, based on reviews by the SAB and others, will be released for further public comment before it is finalized. Since the Agency is now contemplating very significant revisions of the draft ETS documents -- including the addition of entirely new chapters on topics that were not addressed at all in the initial drafts -- we urge that the public be afforded an opportunity to comment on the revised documents. We likewise urge that the senior Agency review discussed above take such comments carefully into account. We note that any premature release of the policy guide during this process would be a serious mistake that could serve only to mislead and confuse the public. Finally, we note that the President's science advisor, D. Allan Bromley, has set up a specia3l review group in the White House to review the EMF report, as a supplement to the Agency's own SAB review mechanism. of particular significance is Dr. Bromley's decision that reviewers for the group "cannot have had any previous experience with the Agency's EMF data so they can 'make a decision from a fresh view' after reviewing the literature." We believe this to be a prudent course, one that should have been followed from the outset with regard to the Agency's ETS documents. We trust that it is not too late to apply the same approach to ETS. We thank you once again for your attention to our concerns and would appreciate the favor of a prompt reply. If you or your staff would like to discuss these matters further, we would be happy to do so at your convenience. Sincerely, ~ Samuel D. Chilcote, Jr. Enclosures SDC: j 1w