Tobacco Documents Online

ETS AND SMOKING RESTRICTIONS Messages and References 1

CONTENTS 1. Company postions on the science 2. What others are saying 3. What the public is saying 2

COMPANY POSITIONS ON THE SCIENCE On Lung Cancer 0 0 0 0 0 Scientific studies on the possible association between environmental tobacco smoke (ETS) and lung cancer in non-smokers are inconclusive. Of the 35 studies that have examined the potential relationship between ETS exposure and lung cancer, 28 reported no overall statistically significant association. ETS is not the same as the "mainstream" smoke inhaled by the smoker. It is highly diluted and chemically distinct. The assumption that all types of tobacco smoke, i.e., mainstream, side-stream and ETS, are the same is not supported by the available scientific data. It is inappropriate to use studies of reported spousal smoking in the home as a justification for banning smoking in the workplace and other public places. Not only are the environments different, but the levels of exposure are most likely different as well. According to the (U.K) Independent Scientific Committee on Smoking and Health, most scientific groups who have scrutinized the published studies on ETS and lung cancer conclude that none of the studies can, on its own, be accepted as unequivocal. On Cardiovascular Disease (CVD) 0 0 0 0 Most studies (8 out of 14) examining the potential relationship between ETS and cardiovascular disease (CVD) do not report an overall statistically significant association. There are over 300 different risk factors that have now been reported for heart disease. Many of the studies on ETS and cardiovascular disease have not controlled for different risk factors that may also be associated with living in a smoking household, such as dietary habits. For example, it has been reported that non-smokers living with smokers tend to have diets that are high in fat and low in fresh fruits and vegetables. 3

On ETS and Children • The scientific studies that have been published on parental smoking and childhood respiratory disease have not controlled adequately for potential confounding factors, and, therefore, they have not conclusively shown that ETS, as opposed to other factors, is responsible for respiratory diseases in children. • Other factors, such as socioeconomic status, exposure to infectious agents and indoor air pollutants have all been associated with respiratory illness in children. • A growing number of complaints of childhood respiratory problems are associated with poor indoor air quality in schools and day-care centers where ETS is not a possible factor because smoking usually is not permitted. • At least 25 studies done on ETS and respiratory disease in children report no statistically significant association. On the EPA • The risk assessment on environmental tobacco smoke published by the U.S. Environmental Protection Agency in 1993 is based on flawed science influenced by a political agenda. • Twenty-four of the 30 studies initially reviewed by the EPA reported no overall statistically significant association between marriage to a smoker and lung cancer in non-smokers. • Not one of the 11 U.S. studies selected by the EPA as a basis for its risk assessment reported an overall statistically significant increased risk of lung cancer for non-smoking women married to smokers. • The EPA lowered the confidence level on the 11 U.S. studies from 95 percent -- the standard used originally by the reports' authors -- to 90 percent, doubling the allowance for error, in what appears to be an attempt to justify a claim of statistically significant increased risk. • The EPA failed to include the data from one of the largest and most recent studies on ETS which was funded, in part, by the National Cancer Institute (NCI). This study reported no overall statistically significant increased risk from spousal smoking. Had the data from the NCI study been included in the EPA report, it is unlikely that the Agency would have been able to claim any overall statistically significant increased risk. 4

In conjunction with other members of the tobacco community, Philip Morris has filed suit against the EPA in federal court. The suit charges that the Agency did no original research of its own, used inappropriate techniques of statistical analysis and failed to include data from relevant studies in its risk assessment. The Court has denied the Agency's motion to dismiss the suit, and the case is proceeding. Practical alternatives and solutions 0 0 The preferences of smokers and non-smokers alike can be accommodated. Simple separation of smokers and non-smokers is most likely sufficient to minimize the exposure of non-smokers who claim to be annoyed by tobacco smoke. Studies have indicated that a non-smoker would have to spend hundreds of hours in the non-smoking section of a restaurant to be exposed to the nicotine equivalent of one cigarette. Poor indoor air quality can most often be traced to an inadequate or poorly maintained heating ventilating and air conditioning (HVAC) system. Banning smoking is often a cosmetic solution. It may remove tobacco smoke from the scene, but it does nothing to address the unseen pollutants that can be the actual cause of the problem. 5

WHAT OTHERS ARE SAYING On the EPA Risk Assessment: "In its report on ETS, the EPA did not comply with accepted principles of toxicology, chemistry and epidemiology, nor with its own guidelines for undertaking cancer risk assessment. In fact, the conclusions drawn by the EPA are not even supported by the EPA's own statements." Dr. Gary L. Huber, et. al. Professor of Medicine at University of Texas Health Center "Smoke and Mirrors: The EPA's Flawed Study of Environmental Tobacco Smoke and Lung Cancer" in Regulation. The Cato Review of Business & Government, 1993 Number 3, p. 45 "Our assessment of the existing evidence on passive smoking was made as a basis for drawing conclusions about the efficiency justifications for an increase in the cigarette tax. Based on that evidence, as indicated in this testimony, our evaluation was that the statistical evidence does not appear to support a conclusion that there are substantial health effects of passive smoking." Dr. Jane Gravelle, et. al. Senior specialist in Economic Policy, Congressional Research Services, in testimony before The Subcommittee on Clean Air and Nuclear Regulation Committee on Environment and Public Works United States Senate May 11, 1994 "[T]he totality of data on ETS and lung cancer does not support the claim made in the draft EPA report that ETS is responsible for an increased incidence of lung cancer in the United States... There is no scientifically valid basis for conducting a risk assessment on ETS or classifying ETS as a known carcinogen or even probable human carcinogen." Dr. W. Gary Flamm Science Regulatory Services International Former Director of the Office of Toxicological Sciences The U.S. Food and Drug Administration (FDA) 6 -~

"Since probable effects of bias and confounding have not been adequately accounted for in the spousal smoking-lung cancer epidemiologic studies, the EPA's conclusion that these studies support a causal inference is not justified. The aggregated workplace data indicate no ETS-lung cancer risk evaluation, further undermining both a causal inference based on spousal smoking studies and the EPA's conclusion that ETS is a Group A carcinogen. The ETS-lung cancer epidemologic data provide no scientific basis for government regulation of smoking in the workplace." LeVois, M.E. et al. Environmental Health Resources, Tiburon, California "Inconsistency between Workplace and Spousal Studies of Environmental Tobacco Smoke and Lung Cancer" Regulatory Toxicology and Pharmacology 19:309-316 (1994) "Among other unjustifiable gambits, this EPA report stands out for its unorthodox insistence on one-tailed statistics and 90% confidence intervals, for arbitrary and unproven adjustment procedures, and for its selective use of epidemiologic evidence." Gori, G.B. The Health Policy Center, Bathesda, MD "Science, Policy, and Ethics: The Case of Environmental Tobacco Smoke" Journal of Clinical Epidemiology 47 (4):325-334 (1994) "The reader of the EPA report gets the uneasy feeling that a certain selectivity cannot be excluded.... this is a dangerous development against which the scientific community must actively defend itself." Dr. F.A. de Wolff Faculty of Medicine, University of Amsterdam Nederlands Tijdschrift Voor Geneeskunde March 5, 1994 "Despite serious questions about the report's assertion that ETS causes lung cancer and the process by which the EPA reached that conclusion, leading U.S. newspapers have treated this assertion as scientific fact. In so doing, not only have they exaggerated what is known about the effects of ETS, but they have missed an important story about the corruption of science by the political crusade against smoking." Jacob Sullum Forbes MediaCritic Summer 1994 ~ G ~ ~ w ~ co ~ ~ 7 ~

"[A] closer look [at the EPA ETS risk assessment] shows that the EPA manipulated data and finessed important points to arrive at a predetermined conclusion. The agency compromised science to support the political crusade against smoking." National Review May 16, 1994 "Critics in science, medicine and the nonpartisan Congressional Research Service say the EPA ignored contrary studies, used unreliable methodology, failed to consider such 'confounding factors' as diet, health care, poverty, heredity and consumption of alcohol and caffeine and changed its statistical standards midstream to produce the politically desired result." David Shaw "Living Scared: Why Do the Media Make Life Seem So Risky?" Los Anaeles Times September 11, 1994 "The EPA is attempting to prove that serious medical risks are created by even casual exposure to secondhand smoke. In its effort to do so, the EPA has manipulated selected portions of the existing literature until it produced the desired result." Science. Economics and Environmental Policy: A Critical Examination A Research Report by the Alexis de Tocqueville Institution August 11, 1994 "I am adamantly opposed to smoking; I completely agree about the magnitude of this health threat for people who smoke. But I think that the EPA played very fast and loose with its own rules in order to come to the conclusion that (secondhand) smoke is a carcinogen." Michael Gough, Senior Associate Congressional Office of Technology Assessment, quoted in "Living Scared: Why Do the Media Make Life Seem So Risky?" Los Anaeles Times September 11, 1994 8 ,~. ~

On the EPA in General: "EPA has not clearly conveyed to those outside or even inside the Agency its desire and commitment to make high-quality science a priority." Saf.e ,ar ing the Future: Credible Science. Credible Decisions, The Report of the (internal) Expert Panel on the Role of Science at EPA March 1992 "The science advice function -- that is, the process of ensuring that policy decisions are informed by a clear understanding of the relevant science -- is not well defined or coherently organized within EPA." Safeguarding the Future: Credible Science Credible Decisions, The Report of the (internal) Expert Panel on the Role of Science at EPA March 1992 "In many cases, appropriate science advice and information is not considered early or often enough in the decisionmaking process." feauar in he Futur edible r ience-yr edible D i I n The Report of the (internal) Expert Panel on the Role of Science at EPA March 1992 On ETS : "[I]n general, there was no elevated lung cancer risk associated with passive smoke exposure in the workplace." Dr. Ross C. Brownson American Journal of Public Health "There is no good scientific evidence that passive inhalation is truly dangerous under normal circumstances." Dr. Frederick Seitz President Emeritus of Rockefeller University Past President of the National Academy of Sciences "Global Warming and Ozone Hole Controversies: A Challenge to Scientific Judgment" George C. Marshall Institute April 1994 9

On Weak Association: "Epidemiological studies in general are probably not able, realistically, to identify with any confidence any relative risks lower than 1.3 (that is a 30 percent increase in risk.) In that context, the 1.5 is modest elevation compared to some other risk factors that we know cause disease." Dr. Eugenia Calle Director of Analytic Epidemiology American Cancer Society Washinaton Post October 27, 1994 "A strong association between possible cause and effect, as measured by the size of the risk ratio, is more likely to be causal than is a weak association, which could be influenced by confounding or bias. Relative risks greater than 2 can be considered strong." Beaglehole, Bonita and Kjellstrom Basic Epidemiology World Health Organization Geneva, 1993 "Until the 1980s, epidemiologists were concerned mainly with relative risks that exceeded about 1.5 and were often much higher. Many controversies now centre on much lower risks, a notable example being the effect of 'passive smoking' on lung cancer risk. The pooled data show a statistically significant effect, and all studies are consistent with a relative risk of about 1.3 (US National Research Council, 1986). In view of the many difficulties discussed above, however, it can plausibly be argued that such small effects are beyond the limits of reliable epidemiological inference (particularly for lung cancer, in which the major cause produces large relative risks), as smoking habits may be inaccurately recorded and are correlated with many other social and occupational factors, including the smoking habits of spouses. A number of spurious associations with relative risks for lung cancer of this order might thus be found in a large enough sample." (emphasis added) Julian Peto, Institute of Cancer Research, U.K. "Meta-analysis of epidemiological studies of carcinogenesis," Mechanisms of Carcinogenesis in Risk Identification, IARC, 1992, p. 573. 10

"Weak associations, particularly those with relative risks less than 2 and especially those with relative risks less than 1.5, are, however, much more likely to arise as an artifact arising from confounding. This is of particular importance when considering associations with environmental tobacco smoke exposure." Thornton, A., Lee, P. and Fry, J. "Differences Between Smokers, Ex-smokers, Passive Smokers and Non-smokers" J. Clin. Epidemiol. 47 (10): 1143-1162 (1994) "....an epidemiological association does not necessarily provide firm evidence of a cause/effect relationship. Quantitative exposure information necessary for establishing exposure/effect relationships is always difficult to obtain. Public health administrators and decision makers have to be made aware of these problems." WHO Positions on Guidelines for Epidemioloav Guidelines on Studies in Environmental Epidemiology Environmental Health Criteria 27, 1983, p. 342 On risk and media reporting: "In an effort to educate the public and attract readers and viewers, the media often overplay risks of dubious legitimacy. Scientific studies show that many of the alleged hazards the media trumpet are either misstated, overstated, nonexistent or that there just is not enough scientific evidence yet to yield reliable guidance on the true risk for the average American." David Shaw "Living Scared: Why Do the Media Make Life Seem So Risky?" Los Angeles Times September 11, 1994 On Smoking Restrictions in Restaurants "Our central thesis is that the food service industry already suffers greatly from excessive governmental regulation, and that each new item of regulation makes it more difficult for restaurateurs to operate their businesses. We believe that the question of smoking in food service establishments is, like most other similar questions, best determined by the people immediately affected: owners, customers, and employees." The National Restaurant Association Comments on OSHA's Proposed Rule on Indoor Air Quality August 17, 1994 11

"...OSHA notes that a growing number of businesses are adopting smoking policies on a voluntary basis (p. 16007). This supports our thesis that the best method to deal with the question of ETS is to let the persons directly involved make the decision, without the intervention of government in private business decisions. We believe that customers, employers and workers should make the decision about smoking in restaurants based upon their own mutual best interest. Nor are we alone in this view; 'the irony of federal manipulation of the science on secondhand smoke is that survey data show the marketplace continuing to adjust to its customers' desires."' The National Restaurant Association, Comments on OSHA's Proposed Rule on Indoor Air Quality August 17, 1994 "Assuming that smokers actually respond the way they said they would if a ban on smoking in the workplace is imposed, the economic impact on the food service industry in 1994 totals $18.2 billion in lost sales, representing 6.5 percent of total food service sales in 1994. These sales losses consist of fewer prospective visits, and shorter stays, which result in fewer purchases of before dinner drinks, wine with meals, coffee and other dinner drinks, and desserts." The National Restaurant Association, Comments on OSHA's Proposed Rule on Indoor Air Quality August 17, 1994 IA "... it's our observation, and I'll show other people who seem to agree with us, that even if we were to totally eliminate tobacco smoke from the workplaces tomorrow, you would have very little effect on sick-building syndrome and building-related illnesses in those buildings." Gray Robertson Healthy Buildings International, Comments on OSHA's Proposed Rule on Indoor Air Quality October 14, 1994 12

WHAT THE PUBLIC IS SAYING On Smoking Restrictions in the Workplace Switzerland 7/94 LINK Institute sponsored by Central Union of Swiss Employer Associations • 79% felt that smokers and non-smokers can coexist in the workplace relying either general freedom to smoke (18.9%) or by assigning smoking areas and breaks (60.9%) during the work day. United States 3/94 Gallup sponsored by CNN • 63% felt that certain areas should be set aside to accommodate both smokers and non-smokers. An additional 4% opposed any restrictions. Finland 6/92 Iltasonomat • 76% feel that decisions about smoking restrictions in the workplace are best resolved by the employees or through union negotiation, not by the government. Sweden 3/93 IMU TESTOLOGEN for Swedish Association of Wholesalers, Swedish Commerce • 69% felt that the decision about smoking should be made by the employees at the place of work. On Smoking Restrictions in the Hos itality Sector France 10/93 BVA sponsored by the CDIT • 71 % of those polled felt that the relations beween smokers and non- smokers should be handled among themselves; only 28% favored government intervention. United States 7/94 Gallup sponsored by CNN • 79% felt that smokers and non-smokers should be accommodated in hotels and motels. 68% felt that certain areas should be set aside and 11 % that there should be no restrictions. • 57% felt that smokers and non-smokers should be accommodated in restaurants by setting aside smoking and non-smoking areas. 13

Hungary 5/94 Multidata sponsored by Philip Morris • 83% felt that smokers and non-smokers can be accommodated by either separate sections (43%) or improved ventilation (40%). Sweden 3/93 IMU TESTOLOGEN for Swedish Association of Wholesalers, Swedish Commerce • 74% felt smoking in public places including restaurants, hotels, and places of entertainment should be allowed but subject to certain restrictions: 25% replied that there should be no-smoking zones and 49% replied that smoking should only be permitted in designated areas. • 66% felt that either the restaurant/hotel owner (42%), the employees (10%) or customers (14%) should decide about smoking. nr Italy 5/94 (TK) for Tolerance Observatory • 79% indicate that "the smoking issue is not important and that it is sufficient that smokers are courteous and non-smokers tolerant. (47% totally agree; 32% partially agree.) 14