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a I I I I I I I I I I I I ~ I I I I t &q yAR,0 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY NATIONAL CENTER FOR ENVIRONMENTAL ASSESSMENT WASHINGTON, DC 20460 SEP2°1995 David Gushes, Chairsan Environaental Natural Resources Division Conqressional Research Service Library of Conqress Washinqton, D. C. 20540 Dear Dr. Gushee: A7T,;cs,/,. ~T _f 5c2/A 0"" CW RESEA,CH„NODE„aon*w With this transaittal letter, the EPA is subaittinq coaaents to the CRS Workshop Draft "Environaental Tobacco Saoke and Lunq Cancer Risk" by C. Stephen Redhead and Richard E. Aowberq, June 5, 1995. This is a follow-up to the workshop held on June 5, 1995, in which two of NCEA's staff scientists, Steven Bayard and Jennifer Jinot, were invited as expert participants. These camaents represent their forsal submissions, which sy office endorses. In qenaral, these scientists felt that the Draft lacked adequate scientific analysis and was particularly deficient in its literature review. The ETS database is quite extensive and the reliance by the Draft's authors on just a few studies for their analyses no doubt contributed heavily to the Draft's several incorrect conclusions. This current Draft is, as we believe was stated at the workshop, a partial follow-up to the 1994 CRS report "Ciqarette Taxes to Fund Health Care Refora: An Bconoaic Analysis", by Jana Gravelle and Dannis Zissersan (94-214 E, Karch i, 1994). As part of that analysis, the 1994 CRS Report presented an analysis of the external costs (spillover effects) of saokinq on nonsaokars and concluded (pq. CRS-7) that, "The link between passive saokinq and disease is uncertain. The best available estimate of this link iaplies external costs of no iore than a few cents per pack, not enouqb to justify a 75-cent increase in the ciqarette tax". Not havinq been qivea the opportunity to comment on the 1994 Report before its release, the EPA provided extensive,coaents to Dr. Kulholla4`N4bseqpeAtly (See attached.lettar to D*n Kulhollan froa Gary ro1*gj., 1Uoonq the many criticisas,-we toox.,particular issue with the Cits conclusion about the "uncertain" 1'TS-disease link stataaent. The current Draft, by two different CilR authors, appears to be addressinq this issue, at least with respect to lunq cancer. on the other hand, we were puzzled by the inclusion of Appendix C on ETS and Heart Disease in a document with a title on lunq cancer risk. While there is no stated purpose of this Draft and no pendinq STS leqislation of which we are aware, the Draft's new m.ssaqe to . P,tiww ,w+ vaq.nor Of ewd rra a+ 100% a.cycba Pqpr (40% Pa.oonwnrA I

/ Congress appears to be that there is no ETS workplace risk and, therefore, no need (for the Occupational Safety and Health Administration) to regulate smoking in the workplace. This message is stated a bit convolutedly in the Overview (CRS-1): "The principal (sic) implication of these calculations is that risk of developing lung cancer from ETS appears to be negligible for nearly all non ..aaokers who are not exposed to ETS in the home environment." However, we believe that this message is based on both faulty analyses and a policy which completely disreqards the principles of'public health and safety. We believe that the Draft's uncritical embracing of a virtual ETS lung cancer threshold at average exposure levels one-third to one-half those which show consistently increased risks is totally unjustified and unsupportable, and that a proper analysis will negate this conclusion. We also believe that a proper analysis will reveal a significant risk from workplace ETS exposures, especially for specific occupations and for workplaces without smoking restrictions. We also.felt that the Draft, as well as the 1994 CRS Report, uncritically equated the extensive, well-reviswed assessments by scientists in the EPA and other government and scientific organizations with tobacco industry-orchestrated criticisms. Tha Draft treats each of these assessments, not as analyses of hundreds of original papers but as one solitary opinion, which the Draft than weighs equally against the criticisms of a few tobacco industry consultants and one or two other sources. We thought that our commsnts to your 1994 Report would have cleared up this apparent confusion. The 1992 EPA report on "T'he Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders• (RPA/600/6- 90/006F) concluded that "widespread exposure to ETS in the U.S. presents a serious and substantial public health impact". The report has received many internal reviews and was reviewed twice publicly by a panel of 18 independent experts in the field. The panel endorsed EPA's conclusion that ETS causes lung cancer in adult nonsmokers, and extensive childhood respiratory impairment as well (See attactment, ")Ln SAa Report: Review of draft passive smoking health effects documant"). Several other federal and local government aqencies, the prestigious National Research Council, and many public health groups have arrived at similar conclusions. The National Cancer Institute has republished the EPA Report as part of its monograph series under its own loqo. - We believe the EPA Report reflects -the weight of the evidence and of- scientific opinion. While some of the EPA's conclusions are substantially based on studies of hone exposures, we believe that similar IiTS exposure levels in the workplace will cause similar effects. In many instances of risk extrapolation, effects occurring from chemical exposures at high occupational levels are extrapolated to occur at lower environmental levels. With ETS, effects are already seen at typical environmental levels. We believe that where that exposure occurs is lsss important than the amount of exposure. lsost I I I I I I I I I I I I I I I

I I I I I I I I I I I i analyses have shown similar ETS levels in smoking homes and in workplaces where smoking is unrestricted. We believe that when you have completed the necessary revised analyses, your conclusions will be similar. Thank you for the opportunity to review the Draft. We hop. that thesa comments are helpful. Sincerely, Michael Callahan Director, Washington Office, National Center tor Environmental Assessment (NCEA-DC) Attachments: 1. EPA Comments on CRS Draft "Environmental tobacco smoke and lung cancer risk" (Jun. 5, 1995). 2. Letter to Dan Nulhollan, CRS, from Gary Foley, Acting Assistant Administrator for Research and DevelopAsat (June 23, 1994).- 3. "An SAB Report: Review of draft passive smoking health etlect.. document" (November 1992). 4. "Reterence Dose (RfD): Description and use in health risk assessments", Barnes and Dourson, 1988. 5. "Passive Smoking and Lung Cancer: The U.S. EPA's Weiqht-ot- Evidence Analysis, With Emphasis on the Epidemiology Studies", Bayard, Jinot, and Brown, 1994. cc: Dan Mulhollan William Farland I