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ENVIRONMENTAL TOBACCO SMOKE: A GUIDE TO WORKPLACE SMOKING POLICIES U.S. E.P.A. PUBLIC REVIEW DRAFT COMMENTS OF PHILIP MORRIS INC. SEPTEMBER 28, 1990 't

TABLE OF CONTENTS The Workplace Smoking Policy Guide . . . . . . . . . . . . . 1 Overview . . . . . . . . . . . . . . . . . . . . . . . 1 C1 a ims/Responses . . . . . . . . . . . . . . . . . . . 1 Policy Regulations Before Science? . . . . . . . . . . . . . 6 References . . . . . . . . . . . . . . . . . . . . . . 9 (i)

Commentary: "Environmental Tobacco Smoke: A Guide to Workplace Smoking Policies," Public Review Draft EPA/400/6- 90/004 Overview: In his transmittal letter for the Review Draft to the Science Advisory Board, Assistant Administrator William G. Rosenberg asks for the "SAB's views concerning the accuracy and manner in which the scientific information on passive smoking is presented." Pages 1-20 of the Review Draft present arguments regarding the claimed health effects of ETS exposures on nonsmokers. We find the arguments fraught with errors, misapplications of scientific data, and generalizations which are not supported by the scientific literature. We also note at the outset that this Review Draft was prepared for the EPA by associates of the Smokina Policy Institute, a firm which consults with industry and government for the development of policies on smoking restrictions. We are unaware of any specific credentials of the staff regarding the scientific evaluation of ETS. The authors of this Draft, consistent with the strategy of the anti-smoking movement, present a health argument in order to justify recommendations on smoking restrictions and prohibitions. The argument, however, is without conclusive scientific support; indeed, the entire discussion on pages 1-20 begs the fundamental question, namely, whether or not ETS is associated with chronic disease in nonsmokers. To support our contention, we examine, in the following, a number of examples of misstatement and error found in the Review Draft. Claim: "[F]ield studies, controlled experiments and mathematical models have shown that Environmental Tobacco Smoke (ETS) is one of the most widespread and harmful indoor air pollutants and is a major contribution to particulate indoor air pollution." (p. 1) Response: No references are cited for this claim in the v w Draft. Recent published articles on ETS indicate

; that nonsmoker exposure to ETS is minimal and often below levels of detection. We know of only one author who makes the above claim (Repace), but his sampling protocol has been challenged and his results have never been verified or duplicated. Indeed, his exposure estimates are from 2 to 20 times higher than the results reported elsewhere in the literature on ETS. Claim: "The smoke emitted by cigarettes, cigars and pipes contains over 4,000 chemicals . . ." (p. 1) Response: This is misleading. While 4,000 chemicals have been identified in mainstream smoke, less than 100 of those have been identified in ETS. Given the quantitative and qualitative differences among mainstream smoke, sidestream smoke and ETS, inferences from one species to another are not applicable. Claim: "ETS exposure . . . aggravates the conditions of people with heart disease." (p. 1) Response: We challenge the authors to identify these passages in either the 1986 Surgeon General's Report or the 1986 NAS Report on ETS. Indeed, both reports conclude that few data support that claim. Claim: "In 1990, EPA completed a risk assessment of the health effects of ETS. The report examined the 24 epidemiological studies . . ." (p. 1) Response: The risk assessment,alluded to above is currently undergoing public review. It was written by an outside consultant for the EPA. The risk assessment examined 2.} studies. It omitted the largest case-control study to date (Varela, 1987) which reported no significant increases in risk for lung cancer among nonsmokers from spousal smoking or from exposure to ETS in the workplace and in social settings. Claim: "The evidence linking ETS exposure to increased lung cancer incidences cannot be attributed to chance." (p. 2) Response: The reference here is to the Draft Risk Assessment, now undergoing public review. The remark is incredible, since 18 of the 23 studies report nQ - 2 -

statistically significant risks for lung cancer for nonsmokers exposed to ETS! That means that the data in those studies do not refute the null hypothesis, i.e. there is no association between ETS and lung cancer. "Chance" is thereby not excluded. Even more dubious is the analysis offered in the Draft Risk Assessment itself, which addressed only one form of possible bias in the studies, and nQ potential confounders which, incidentally, have been identified in the published literature as responsible for the claimed association between ETS and lung cancer. Claim: "What is ETS? . . . It contains over 4,000 chemicals, at least 43 of which are known human or animal carcinogens." (p. 3) Response: This claim is unreferenced and misleading. 4,000 chemicals have not been identified in ETS, nor have 43 carcinogens. The claim is not supported by scientific data. Two animal inhalation studies on sidestream smoke have been published to date; both concluded that there are no significant differences in pulmonary tumors among exposed versus unexposed animals. Short-term tests of body fluids in humans reveal no significant differences among exposed nonsmokers versus nonexposed nonsmokers. Claim: "According to the EPA classification of carcinogens, ETS is classified as a Group A carcinogen." (p. 3) Response: This is misleading. The reference is to the Draft Risk Assessment, now undergoing public review. While the EPA administration claims that the Draft Risk Assessment and the Draft Workclace Smokina Policy Guide are independent documents, it is clear that the latter depends upon the former. They are = independent. We also question the scientific integrity of referencing a public review draft as "fact." Claim: "The number of ETS-attributed lung cancer deaths in U.S. never-smoking adults is approximately 2,500 annually." (p. 3) Response: No reference is cited, but an allusion is once again made to the Draft Risk Assessment. Calculation of' ETS-attributed deaths presupposes the argument of - 3 -

causality, which has not been established by the Assessment. Claim: "Many of the chemicals in ETS are known carcinogens, mutagens, toxins or irritants." (p. 8) Response: No reference. Animal inhalation studies and short term tests on humans do not support this claim. Inferences from mainstream and sidestream smoke to ETS are not applicable. Response: Claim: "Sidestream smoke is known to have significantly higher concentrations of carcinogens and mutagens than mainstream smoke." (p. 9) This is irrelevant because it says nothing about ETS. Sidestream smoke constituents are diluted from 100 to 1000 times in ETS. "ETS diffuses rapidly through buildings, persists for long periods after smoking ends, and represents one of the major sources of indoor particle pollution." (p. 12) No reference cited. On the contrary, a number of recent studies show this claim to be false. (cf Sterling 1987, 1988) "[S]tudies show that where smoking is permitted, ETS is the major contributor to RSP in indoor air." (P• 12) Response: Only one reference cited. Other studies indicate that the RSP contributed by smoking in smoking areas is less than 50 percent. Claim: "Personal air monitor studies found similar results." (p. 12) Response: No reference. We know of no published personal air monitor studies for RSP (all use area samplers). Claim: "Cotinine is the most commonly used biomarker." (p. 13) Response: Cotinine cannot be used to determine Quantitative exposures to ETS. Claim: "ETS may also cause respiratory disease in adults." (p. 16) 4

Response: Most studies on the association between ETS exposure and respiratory disease in adults do not support this claim. Claim: "Respiratory disease has also been linked to ETS exposure in children." (p. 16) Response: The studies reporting such "links" rarely control for confounding factors, e.g. diet, cross-infections, housing conditions, etc. Other studies report no significant increase in respiratory disease among children whose parents smoke. Conclusion: Many of the claims in this Review Draft are unsupported by actual data or are in error. While "causation" regarding ETS was suggested by the Surgeon General•s Report (1986) and the KaS Report (1986), most independent, nongoverramental scientific reviews do not support the claims made by those bodies. 5

POLICY REGUTATIONS BEFORE SCIENCE? The EPA has recently issued two draft reports on ETS for public review. One report is a policy manual which recommends that smoking be severely restricted or prohibited in the workplace on the basis that ETS causes disease in nonsmokers. This draft has been issued j& Jhg same time that a draft risk assessment, ostensibly the policy guide's scientific justification, has been offered to the public for review. The recent decision to ban smoking on commercial airlines in the U.S. provides an instructive example of establishing public policy regulations prior to the resolution of a scientific issue. By way of background, in 1984, the U.S. Civil Aeronautics Board (CAB), the federal agency responsible at that time for regulating smoking aboard aircraft, considered a petition calling for a ban on smoking on flights lasting two hours or less. The CAB assessed the health claims advanced by many anti-smoking organizations, but denied the petition, arguing that there was little scientific basis to the claims.1 In 1987, the U.S. Department of Transportation rejected a recommendation from the National Academy of Sciences to prohibit smoking aboard commercial airliners2 because it was not supported by data associating health effects and ETS exposures aboard 6

aircraft.3 Nonetheless, the U.S. Congress voted in 1987 to ban smoking aboard domestic flights of two hours or less until 1990, when the law would expire. The Department of Transportation subsequently issued a request for proposals for in-flight monitoring of ETS and other indoor air constituents,4 intending that the results would be presented to Congress for its deliberations in 1990. Congress did not wait for the Report from the DOT and voted in 1989 to institute a permanent smoking ban aboard commercial airliners. When the DOT Report was issued in 1990, the data indicated that nonsmoker exposure to ETS in nonsmoking sections aboard commercial aircraft was negligible and that risks from cosmic radiation, poor ventilation (C02) and viable airborne organisms were greater than previously believed.5 In a recent presentation on the DOT study, one of the principal scientists responsible for the study recommended that "the first question I would ask is whether or not Congress knew that the ETS results were not strongly compelling prior to the study's release and as a result preempted the use of the results in the deliberations on whether or not to make the ban permanent."6 Thus, while rhetoric regarding the claimed health effects of ETS was advanced by the sponsors of smoking ban in Congress, the - 7 -

claims were not convincingly supported by actual scientific evidence. The EPA is responsible for providing the best possible interpretation of science for the public. In this instance, the EPA has abandoned its charge and is pursuing policy without scientific justification.