Tobacco Documents Online

5t~ t t3Y : 11-17-92 : 1:26P1f ; JfSS- 912128782163: r 9; 11 .Ww.- ~.~ ......~ ~ Multinational Business Services, Inc. 11 oupont Circle Washington, 0. C. 20036 U. S. A. (202) 293---'E86 Regulatory and Trade Fax: (202) 939-fi969 Counseilors November 13, 1992 Dr. Erich Bretthauer Assistant Administrator for Research and Development U.S. Environmental Protection Agency 401 M St., S. W. Washington, D.C. 20460 Dear Dr. Bretthauer: I would like to express to EPA my appreciation for providing me the opportunity to address the Science Advisory Board Executive Committee at its October 27 - 28, 1992 meeting concerning the outstanding risk characterization issues of the environmental tobacco smoke ("ETS") risk assessment. The thrust of my presentation to the Fxer.utive Committee was not that EPA needed to collect more data on ETS, but merely that EPA needed to highlight certain information already contained in the ETS risk assessment. To reiterate the key message of my Executive Committee presentation, there is data in the ETS risk assessment which indicates that there may or may not be an increase 'in lung cancer risk from ETS exposure. Significantly, this position is further supported by the newly-published National Cancer Institute ("NCI") epidemiologic ,Ludy on ETS entitled Passive Smoking and Lung Cancer in Nonsmoking Women S which is in the November 1992 edition of the American Journal of Public Health. IKeeping in mind that a relative risk of 1.0 or below indicates no detected increase in risk. the key findings of the study include: • No increase in lung cancer risk from spousal exposure to ETS. The EPA ETS risk assessment is based on the risk of lung cancer in nonsmoking female spouses. However, the NCT study states that - In earlier studies, the most eommonly r j reported index of passive smoking exposure has been the presence or absence of a - Lri J ~ The Muitinational Companies (J`. m 0 Multinational Business Serv+ces Multinational Legal Services Hamburg (40) tt Dupont Circle 220-4277 Washington. D. C. .'202) c..:, 797-7124 Multinational Investment Services 11 Dupont Circle Washington, D. C. (202) 797-6353

5t\ l' t31c : 11-17-92 : 1:26PM : 1iBS- 9121287821 ti3: T 1 u: 11 Multinational Business Services, Inc. 2 smoking spouse. In our data set, no elevated risk was noted for this variable. Th.is conclusion is supported by a-relative risk of 1.0. This result directly contradicts EPA's ETS risk assessment. • No statistically significant increases in iung cancer risk even from "heavy" ETS exposure. Although the NCI study reports a relative risk of 1.3 for the most heavily-exposed study subjects -- i.e., those who reported 40 or more pack-years of exposure -- this increase is not statistically significant as the 95% confidence interval includes 1.0. [NOTE: A pack-year is defined to be # packs of cigarettes smoked by the husband per day x # years of smoking by the husband -- so 40 pack- years means the husband smoked 14,600 packs or 292,000 cigarettes.) • No increase in lung cancer risk from occupational exposure to ETS. The EPA ETS risk assessment assumes, without empirical evidence, that there is a risk of lung cancer from background ETS exposure. Background exposures include occupational exposure._ However, the NCI study states - In general, there was no elevated lung cancer risk associated with passive smoke exposure in the workplace. Although the NCI study states that the most heavily occupationally- exposed lifetime nonsmokers reported a slight increase in risk -- relative risk of 1.2 -- this relative risk is statistically insignificant given that the lower bound of the 95% confidence interval is 0.9. • No increase in lung cancer risk from childhood exposure to ETS. The NCI study concluded that childhood exposure to ETS was not associated with an increase in the risk of lung cancer. Accordingly, given: • The size (i.e., it is the largest study on ETS and lung cancer in existence), quality, source and results of the new study; ~.n O ~ 0 ~ m Cr. 0 .A. • The significant. but ignored, scientific deficiencies in the EPA ETS risk assessment, including that EPA's results are not readily reproducible or

~t~i rsY 11-17-92 : 1:27Ptii : IiBS- 912128782165:=11:11 Multinational Business Services. Inc. 3 verifiable by independent statisticians; and ~ Administrator Reilly's often-repeated commitment to good science in light of Safeguarding the Future: Credible Science, Credible Decisions, I believe that it is incumbent upon EPA to defer issuing the ETS risk assessment until it is made to reflect the known science rather than the emotion and politics of ETS. This could be accomplished by including in the ETS risk assessment a statement or words to the effect that: Based on the data from the epidemiologic studies for spousal exposure to ETS, there may or may not be an increase in the risk of lung cancer from ETS exposure. ln addition to fairly and accurately reflecting the known science of ETS, this statement helps ensure that EPA is an institution of science-based policy, rather than policy-based science. ~r -Jin~,J, Tozzi Director cc: Dr. Ross Brownson Dr. William Farland Dr. Steven Bayard rr t cn 0 0 ~ ~ m C.G Cft