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Lorillard

the Epa and the Science of Environmental Tobacco Smoke

Date: 1994 (est.)
Length: 19 pages
92756102-92756120
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Author
Jeffreys, K.
Singer, S.F.
Area
EXECUTIVE FILE ROOM
Alias
92756102/92756120
Type
SCRT, SCIENTIFIC REPORT
FOOT, FOOTNOTE
Site
N105
Named Person
Browner, C.M.
Conda, C.V.
Gravelle
Huber, G.L.
Pandora
Stockwell
Tollison, R.
Spears, A.W.
Named Organization
Center on Regulation + Economic Growth
Comm on Energy + Commerce
Comm on Environment + Public Works
Congress
Congressional Research Service
Epa, Environmental Protection Agency
Ftc, Federal Trade Commission
George Mason Univ
House
NCI, Natl Cancer Inst
Senate
Subcomm on Clean Air + Nuclear Regulatio
Subcomm on Health + the Environment
TI, Tobacco Inst
Alexis De Tocqueville Inst
Bureau of Economics
Date Loaded
05 Jun 1998
Document File
92756085/92756695/Tiec - Epa (Ets)
Request
R1-003
R1-004
Litigation
Stmn/Produced
Author (Organization)
Alexis De Tocqueville Inst
Univ of Va
Characteristic
DRFT, DRAFT
UCSF Legacy ID
phi70e00

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six of the 24 found a passive smoking effect opposite to the expected relationship.n16 Worse perhaps, the EPA goes further and rejects the possibility of any null hypothesis: that ETS has no effect on health. Thus, EPA refuses to accept any result which would refute its preexisting assumption: that ETS causes lung cancer in nonsmokers. Whatever one may think of this as a policy outcome, this is not valid science. Ordinarily, researchers utilize a standard mathematical procedure to determine the range of possibilities within which random error is extremely unlikely. By scientific convention, over decades of trial and error and careful review, studies must produce results which have no more than a 5 percent chance of being the result of the natural randomness of the studied population. 'I~is is normally referred to as a "95 percent confidence interval." In other woids, a15 `percent confidence interval means thut there is a 95 percent possibility that the resSA&M not`happen from chance, or a 5 percent possibility that it did. -®-- However, the EPA rejected this as the~t .§kor its.survey of the literature on ETS and lung cancer. Because the purported relative risk,for ETS was so close to perfectly random, the combined results of the studies examined by the EPA could not pass the 95 percent confidence interval test. In the scientific jargon, the results were not "statistically significant." It is at this point that EPA broke with the established procedure in such matters and declared that a 90 percent confidence interval would be used for this report's findings, thereby doubling the chance of being wrong. As a result, EPA could declare that its findings were "statistically significant" but -- only if one applies the less rigorous standard. Applying the standard test (a 95 percent confidence interval) would show that lung cancer rates for people exposed to ETS are indistinguishable from the lung cancer rates of unexposed populations. This is no mere academic debate, for there are numerous potential risk factors for 16 Jane G. Gravelle and Dennis Zimmerman, Congressional Research Service, Library of Congress, "Cigarette Taxes to Fund Health Care Reform: An Economic Analysis" March 8, 1994, at pages CRS-46, 47. Hereinafter cited as "Gravelle." 9
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lung cancer involving everything from diet to genetics to smoking tobacco. If the EPA's chosen procedures cannot distinguish among the possible risk factors, the report cannot provide useful or reliable guidance to policy makers. Perhaps the strongest criticism of this and other points in the EPA report has come from Gary L. Huber and his co-authors:' "EPA's risk assessment is built on the manipulation of data, ignores critical chemical analyses and key epidemiological data, violates time-honored statistical principles, fails to control adequately for important confounding influences (factors other than the one studied that may affect the result or a conclusion) that provide alternative explanations for its conclusions, and violates its own guidelines for assessing and establishing risk_tcz~a potential environmental toxin:r18 One of the particular points of d~eenient between Huber, et al., and the EPA report arises from a major study of ETS a~ung cancer in U.S. female nonsmokers by ~ough the EPA did not include this researchers at the National Cancer Institute.VA study's findings in its report's calculations,`Yt dic~bte irVm the report in an effort to \ demonstrate general consistency. The exact quotati'ow. 6ef ected by the EPA is that "long- term exposure to [ETS] increases the risk of lurig c.~ancer in women who have never smoked.n20 Huber, et al., quote a different, yet equally revealing passage. Stockwell and his co-authors report that "we found no statistically significant increase in risk associated with exposure to environmental tobacco smoke at work or during social activities n21(emphasis added) This is an important point because EPA suggests that workplace regulations are legitimized by studies of the wives of smokers. 17 See, for example, Gary L. Huber, et al., "Smoke and Mirrors" supra, note 8. Is lb" d. , at page 45. 19 H.G.Stockwell, et al., "Environmental tobacco smoke and lung cancer risk in nonsmoking women" Journal of the National Cancer Institute, September 16, 1992, Vol. 84:1417-1422. 20 21 U.S. EPA Report, Addendum, at page ADD-i. Huber, et al., "Smoke and Mirrors," at page 51. 10
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In a recent report for Congress from the Congressional Research Service22, another major study is cited which is not included in the EPA report.' This study, which covered a larger population sample than the Stockwell study, "found no overall increased risk of lung cancer among nonsmoking spouses of smokers."u Furthermore, if standard statistical procedures were applied to the Stockwell study, it too would fail to support EPA's final results. Bear in mind that Huber and his co-authors do not assert that ETS does not or cannot cause lung cancer in nonsmokers. They simply point out that, under well- established scientific standards, the question of ETS and lung cancer has not been answered. They further call attention to.the faot that even if one uncritically accepts • , ~ EPA's conclusions, the resulting increa,"se inikk fiom ETS is approximately the same as the lifetime risk of being killed on a bicycle. ~r$ ps 3nore compelling is this statement: "It is a risk that is less than that associa ' deyeloping colon cancer by drinking chlorinated water, which is in most U.S: cities4wate~pplies.` Chlorination of drinking water supplies has been one of the most nnportant weapons in the battle ~ against water-borne diseases, such as cholera. Were the EPA to apply a non-threshold standard to chlorination of drinking water, America might see an enormous increase in water borne diseases. Because the relative increase in the risk of contracting lung cancer fc,und by the EPA is so slight (even after carefully tweaking the confidence interval), any number of non-ETS risk factors could be the actual cause. For example, EPA apparently failed to 22 Gravelle, supra note 16. 23 Ross C. Brownson, et al., "Passive Smoking and Lung Cancer in Women," American Journal of Public Health, November 1992, vol. 82, pp. 1525-1529. 24 25 28 Gravelle, at page CRS-48. Huber, et al., at page 53. Ibid. 11
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adjust its results for the age of the study participants.27 As people grow older, they become more likely to develop cancer, including lung cancers. Poor dietary habits can contribute to the development of cancer, and-these traits may be shared by spouses to some degree. The EPA did adjust its results to reflect the likelihood that people who are counted as nonsmokers are misclassified because of the way the question was posed or simply because they lied on their questionnaire. However, the EPA did not accept the degree of smoker misclassification that has been suggested by some who have researched this particular question." One further point: the EPA Report focuses on lung cancer and ETS in the home, since it relied upon studies of the,nonsmoking spouses of smokers. Yet it is being used to draw conclusions about worl'pface eWosvire and lung cancer risks. But workplace studies of ETS do not support 's-conclusions. In the final analysis, therefore, the EPA report is an inadequate•bas.a fed,eral ban on workplace ~ smokmg.29 y . 1\ EPA_ and the Economics of ETS To its credit, the EPA admits to the appropriateness of "biological plausibility" in ETS risk analysis. That is, if no known chemical or biological reaction could explain the observed health problem, it will not be blamed automatically on ETS exposure. This is an appropriately cautious, if somewhat insufficient, filter for theories of harm from environmental exposures of all types. 27 Ibid., at page 54. 28 U.S. EPA Report, at Appendix B. 29 A major component of the indictment against ETS is the impact -- real and potential -- on children. Yet children would be one of the least benefited classes under H.R. 3434 (legislation prohibiting smoking in most public places). Most childhood exposure to ETS occurs in the home, which remains unregulated. The scientific literature on ETS does provide some indication that ETS is a risk factor for certain respiratory problems in infants and children under 18 months of age. This is an important issue, but it is one that must be dealt with in the home and in daycare facilities. 12
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Unfortunately, the EPA is not similarly cautious with its economic analysis. In an analysis of the Smoke-Free Environment Act of 1993, EPA produced estimates of potential economic benefits that are literally incredible.30 The bill under consideration "would effectively ban or restrict smoking in most [nonresidential] indoor environments.n31 EPA's analysis found that this, or similar, legislation "could achieve net benefits (i.e., benefits minus costs) ranging from $39 billion to $72 billion per ,year.' These figures were widely reported in the press.33 Indeed, the claimed economic benefits of smoking bans are perhaps the primary impetus for several current legislative proposals.' If this study is any indication, the EPA's economic calculations are no more rigorous than its risk assessments.3s How did EPA generate such impressive-tconomic benefits? Most of the calculated costs and benefits were relatively'aiino-4particularly when one considers how many establishments would be covered under~ill: . However, $33 billion to $60 billion of the EPA's "net benefits" are derived ffJ"°~~,single category: surveys of how much people would be willing to pay to avoid a pr e death due to ETS exposure. This controversial technique is being used to a growin degree mmany environmental fields. In this case, the EPA found that individuals were "willing to pay" an average of $4.8 million each to avoid a premature death from ETS exposure. It is economically impossible -- not just "difficult" or "unlikely" -- for many individuals to spend the $4.8 30 U.S. EPA, "Costs and Benefits," supra, note 3. 31 Ibid., at page ES-1. 32 Ibid., at page ES-2. 33 See, for example, John Schwartz, "EPA Estimates Smoking Ban Could Save Up to $72 Billion" Washington Post, April 22, 1994. 34 See, for example, Gravelle, supra, note 16. 35 Which raises the question of just how effective recent proposals would be that would require EPA to conduct cost-benefit analyses. Congress has considered several such proposals during debate over whether to raise the EPA to Cabinet level. 13
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million, so it matters little how much they say they would be "willing" to spend. In addition, insurance is available for both cancer and for other catastrophic illnesses, yet the premiums are but a fraction of the EPA's survey results. Could it be that insurance firms are unaware of this "willingness" to pay, and are missing out on multimillion dollar profits? Yet the EPA did not stop there. In addition, it estimated the net benefits of reduced illnesses by using another willingness-to-pay survey. The assumption this time was that individuals would be willing to pay $1.5 million per avoided illness. Therefore, the cumulative net health benefits to society of a smoking ban would range, according to EPA's figures, from $35 billion to $66 billion annually. EPA administrator Carol Browner has. carried these highly misleading assertions V to an absurd level. In her testimony on,- e Snioke-Free Environment Act before a U.S. resentatives subcommittee she,~~ that "If one considered the economic House of Rep '•[Ti value that people assign to reduced risk of dea~ estimate would be on the order of $157 billion to $470 billion per year."' ~ ~~ The EPA's use and publicizing of "willingness=to-pay" sd•rveys in this instance . - ~ violates any sound "economic plausibility" test. And it is only through the use of these flawed techniques that the EPA is able to assert tens of billions of dollars in theoretical economic benefits from a smoking ban. If the EPA were limited to more r:,alistic economic measurements, the cost-benefit analysis of public smoking bans would produce much smaller figures, thereby reducing political support for federal action. The EPA and its private sector contractors find willingness-to-pay surveys to be of great political value. For example, the Exxon Valdez oil spill in Prince William Sound, Alaska encouraged economic researchers to survey the general public at the height of 36 Carol M. Browner, Administrator of the U.S. Environmental Protection Agency, in testimony before the subcommittee on Health and the Environment, Committee on Energy and Commerce, U.S. House of Representatives, February 7, 1994, at page 9. This quote is a reference to EPA's estimate of the benefits from a reduction in smoker mortality. The total estimated value from direct medical cost savings and reductions in lost wages is from $5 to $16 billion annually. 14
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outrage over the accident. One estimate of the "value" of the waterway (in pristine condition) ranged from $5 to $10 billion.3' Yet if the same survey were conducted on each mile of U.S. coastline in turn, the "values" derived would reach astronomical figures. This is because of the simple fact that, if you aren't required to actually spend the money, there is no theoretical limit to your economic behavior.' The remainder of EPA's estimated "net benefits" are derived from calculated savings from reduced maintenance and cleanup costs minus the added costs of creating smoking lounges and enforcement. It seems almost petty to criticize these comparatively minor points, but even here EPA can be accused of exaggeration. For example, the EPA estimated potential total savings through reduced housekeeping and maintenance costs to range from $5 billion to $10 billion per year.39 One indoor air expert testified before Congress in March, 1994 and stated that "savings of this magnitude in housekeeping and maintenance costs are-more figments of the imagination than hard ~~.. data.n40 `~ . .. Economist Robert Tollison,!form ' ector of the Bureau -of Economics at the Federal Trade Commission, has anal , ed :li ''s cost-benefit analysis and found it to . ~ g' See: Roger Bate, "Pick A Number: A Critique of Contingent Valuation Methodology and Its Application in Public Policy," Competitive Enterprise Institute, Washington, DC, January, 1994. Also see: Robert K. Niewijk, "Misleading Quantification: The Contingent Valuation of Environmental Quality," Regulation, Number 1, 1994, pp. 60-71. 38 I i 3s U.S. EPA, Costs and Benefits, at page 16. These figures are not corrected for the fact that many U.S. businesses already impose bans or restrictions on smoking. 40 Gary Robertson, President of Healthy Buildings International, Inc., in testimony before the Subcommittee on Health and the Environment, Committee on Energy and Commerce of the U.S. House of Representatives, March 17, 1994, at page 4. 15
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be "fundamentally flawed.n41 According to Tollison, EPA's "cost-benefit analysis involves the kind of numbers game for which government agencies have been justly criticized."`Z In so doing, Tollison raises the specter that EPA has seemingly fitted economic analysis to the policy conclusions it desired. Tollison found telling weaknesses within the EPA cost benefit analysis. For example, EPA assumes in its cost-benefit analysis that eliminating exposure to ETS in workplaces and in public places would significantly reduce the incidence of heart disease. Incredibly, savings attributalbe to the EPA's hypothesized decrease in the incidence of heart disease among nonsmokders account for the overwhelming majority of all dollar benefits estimated by the EPA to be associated with national smoking restrictions, according to Tollison. Yet, the EPA's well-publicized risk assessment was primarily . concerned with alleged lung and. respiritory colnplications from ETS -- not heart disease. ~ In fact, the EPA never developed a 61 ~_ ssment between ETS and heart disease undoubtedly believing that the evidence fo4.c'sks were weak. Instead, it merely assumed that such causation exists even though We EPA nor any other government agency has concluded that ETS is a cause of heart disease. This paper does not take the stance that net economic benefits from a smoking ban are impossible, but simply that the EPA has grossly exaggerated its economic estimates. The fact that it consistently does so, coupled with its careful manipulation of the science, reveals that the EPA is not providing the American public and policy makers with impartial data. The American people deserve better. Conclusions Exposure to ETS is not a uniform risk, if it is a risk at all. Even the EPA Report admits there is a strong dose-related health response for active smokers. It is logical that there would be a dose-related response for ETS, as there is with every other 41 Robert D. Tollison, Duncan Black Professor of Economics, George Mason University, in a statement submitted before the Subcommittee on Clean Air and Nuclear Regulation, Committee on Environment and Public Works, U.S. Senate, May 11, 1994. 42 ~bid. 16
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potential risk factor confronting humanity. In any event, indoor air problems are not limited to tobacco smoke. The best method for dealing with all potential indoor air problems simultaneously is to provide adequate ventilation. This would insure that exposure levels (to whatever substance from whatever source) were kept well below potentially harmful levels. Skeptics should consider that whenever a tobacco firm makes a statement in regard to smoking and health, it is generally discounted by its critics because of the "special interest" it holds in the issue. This is no less applicable to the "special interests" of the EPA. The bureaucracies of the federal government are strongly interested in /1justifying budget increases and increasingthe scope and importance of their assigned responsibilities. Yet that does not excuse ~rilt:disregard for the scientific method or sound economic analysis. EPA personnel~ ty to conduct the best science possible and report the results fully and ho~es.tly9VII* ,~.~. If the EPA were merely attempting to provet that secondhand smoke is an annoyance to many people, it would be on solid ground: However, 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. However pure the motivations of EPA personnel in this matter, it is unacceptable to distort the science for the sake of a policy goal. The Environmental Protection Agency's ETS stance has an Alice-in-Wonderland quality of "sentence first -- verdict afterwards." While Congress may eventually decide to ban smoking in public buildings it cannot do so under the pretense of sound science or economics. ### 17

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