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I I I I I I I I I I I I I I I I I J~, tO 57.,F `~ S Z UNITED STATES ENVlRONMENTAI PROTECTION AGENCY ~ WASFIiNGTON, D.C. 20460 , yl~c e.ut4 JLIN 2 3 f994 OFFfCE OF RESEAnOH AND DEYELOPM[.yT Dr. Dan Mulhollan Director Congressional Research Service Library of Congress First and Independence, S.E. Was:Lington D. C. 20540-7000 Dear Dr. Mulhollan: I am writing to express misgivings about the discussion of environaental tobacco smoka (ETS) in the recent Congressional Research Service (CRS) report entitled "Cigarette Taxes to Fund Health Care Reform• An Economic Analysis" (94-214E). Speciifically, we disagree with GRS szatements that "[t]he link between passive sr,:oking and disease is uncertain" (CRS-7) and that "the apidemiology evidence for passive-smoking-related disease is weak" (CRS-13). The appraisal by CRS economi sts of the scientific evidence about the effects of ETS on non-smoking adults, and on infants and children, is being widely quoted as an authoritative scientific opinion of CIRS. This is unfortunate since the CRS has not taken a position on the health effects of passive smoking, and the economists were careful to state in a May 11, 1994 Senate hearing that this science is outside of their area of expertise. The 1986 ETS reports of the II.S. Surgeon General, and the National Academy of Sciences, as well as the. 1992 Environmental Protection Agency report, all concluded that ETS is a significant public health hazard and received extensive peer review before their issuance. Peer review of discussions of the science in the CRS report would have been helpful and iraportant since the report raises questions about methods and interpretations that have already been subjected to extensive peer review, some in the review of the EPA report, others in the reviews of all three reports. The attachment to this letter brings to your attention our views with respect to.the CRS statements about the EPA assessment and its results_ In addition the attachment notes alternative views about scientific (not economic) aspects of weighing health e=fects of ETS in the economic analysis. The following points are elaborated in the attachment: vrru.d on Aaeydee R:,ar

I Sincerely yours, f Tae epidemiology data on ETS and lung cancer show a remarkable consistency supporting a causal association between ETS and lung cance•r in nonsmoking adults. The observed increased risk estimates are not large, but are significant for an environmental exposure, especially considering the inherent difficulties of studying the effects of a mixture to which virtually everyone is exposed at some level. Such difficulties are very likely to hinder the ability to detect an effect if one exists. To observe consistent, though relatively small, increases supported by exposure-response trends, in a variety of countries •is highly.significant, particularly considering the difficulties involved in conducting these types of studies. For these reasons, it is erroneous to conclude that the overall evidence for an _effect is weak simply based on the size of observed increases between spousal smoking and lung cancer. Accepted epidemiology criteria for causality such as consistency, dose-response relationships, biological plausibility, specificity, and temporality, are clearly met by the ETS database. The EPA report assesses over loo original studies in reaching its finding that ETS causes several respiratory effects in children. It is difficult to understand the CRS report's summary statement, made without analysis, that "many of the statismical concerns with respect to lung cancer also apply to respiratory effects in children" (CRS-49), since the statistical aethods and scieritific issues are guita different in the analysis of cancer from those in the analysis of respiratory effects. Many other organizations also have concluded that the evidence that ETS causes significant health hazards is, in fact, quite strong. These organizations include the National Academy of Sciences (1986), the U.S. Surgeon General (1986), the National "C3nce_r Institute (1993), the National Znstitute of occupational Safety and Health (1991), and many public health organizations. We be~lieve the attached discussion can be helpful in your further consideration of this health issue. S I I I I I I I I I I I I . Attac.~.=ent 2 J. Foley Acting Assistant Administrator for Research and Development I

ATTACBMENT A. E?A's Scientific Apnroach A.l. Lung Cancer A.2. Noncancer Respiratory Disorders 8. Public and Scientific Reviews of the EPA Report C. Differences in Analysis, Process, and Documentation between the EPA and CRS Reports D. critique of CRS Criticisms of the EPA Report E. EPA Comments on the Health Effects Comnongnts Assessment of Costs due to Passive Smoking of the CR5 0 crx ~ tn 0 4