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I I I I I I I I I I I I U.S. SENATE COMMITTEE ON ENVIRONMENT & PUBLIC WORKS SUBCOMMITTEE ON CLEAN AIR & NUCLEAR REGULATION SENATOR JOSEPH I. LIEBERMAN, CHAIRMAN Hearing to discuss the possible health effects to non-smokers of environmental tobacco smoke Wednesday, May 11, 1994 9:30 a.m. Hart Senate Office Building, Rm. 216 WITNESS LIST Panel I The Honorable Carol M. Browner Administrator U.S. Environmental Protection Agency Washington, D.C. The Honorable M. Joycelyn Elders, M.D. Surgeon General U.S. Public Health Service Washington, D.C. Panel II I I I I I I Dr. Christopher Coggins Principal Research & Development Toxicologist R.J. Reynolds Winston-Salem, North Carolina Dr. Aubrey Taylor Professor and Chairman Department of Physiology University of Southern Alabama School of Medicine (On behalf of the American Lung Association) (Over)

I Panel III Dr. Jane Gravelle Senior Specialist in Economic Policy Congressional Research Service Washington, D.C. (Accompanied by Dr. Dennis Zimmerman Specialist in Public Finance Congressional Research Service) Dr. William Blot National Cancer Institute Consultant, EPA, Science Advisory Board Bethesda, Maryland I I I I I I I I I I I I I I I I

I I I I 63 How about that? SENATOR LIEBERMAN: Thank you, Senator Lautenberg. I actually have more questions but I'm going to submit them to you in writing, and hope that my colleagues will do the same, so we can move on to the third panel. It's been waiting quite a while. , I want to thank you, Dr. Taylor and Dr. Coggins, for being here and for your testimony. I I I I I I I I I I I DR. TAYLOR: Thank you, all, very much. SENATOR LIEBERMAN: Our third panel, Dr. Jane Gravelle, Senior Specialist in Economic Policy, Congressional Research Service, accompanied by Dr. Dennis Zimmerman, who's a Specialist in Public I can. DR. TAYLOR: Thank you all very much. SENATOR FAIRCLOTH: Dr. Taylor? DR. TAYLOR: Yes, sir. SENATOR FAIRCLOTH: I want a yes-or-no answer. DR. TAYLOR: Okay. SENATOR FAIRCLOTH: Is suntanning dangerous to your health? DR. TAYLOR: Suntanning can cause skin cancer. It certainly SENATOR FAIRCLOTH: All right. DR. TAYLOR: But everybody, I think, is quite aware of that. But see, I don't have to go into the sun unless I want to. I have that prerogative. I have the prerogative to also put on some suntan protection agent. But I don't have any prerogative when I go take my grandson -- I tell you what I really [unintelligible]. I have a grandson who has asthma. SENATOR FAIRCLOTH: I'm sorry. DR. TAYLOR: No. Let me -- I want to get this out. I have a grandson who has asthma. And what I did is that I walked -- we go into a restaurant, and if someone's smoking back in the smoking section, which isn't all the restaurant, he will immediately start wheezing. This is my grandson. And I've seen a lot of people wheezing, get sick, but it scares the hell out of me when my grandson gets sick. SENATOR LIEBERMAN: You made your point. Thank you. I

I 64 Finance; and Dr. William Blott of the National Cancer Institute, a consultant to EPA and its Science Advisory Board, from Bethesda, Maryland. Folks, thanks for your patience. Some of you have been referred to earlier on. So we look forward to hearing from you at this point. Dr. Gravelle, you're first. DR. JANE GRAVELLE: Mr. Chairman and members of the committee, my colleague Dennis Zimmerman and I would like to thank you for the invitation to discuss the statistical basis for estimates of the health effects of passive smoking. I would like to begin by noting that we're economists and our area of expertise relates to economic analysis and the associated areas of statistical inference and quantification of effects for purposes of the cost-benefit analysis and related economic_ policies. Our involvement in this issue was the result of a research paper on the proposed cigarette tax. In order to assess economic efficiency issues, it was necessary to examine any costs that smokers might impose on nonsmokers. This led us to a review of the methodology used to assess the scientific evidence on passive smoking. We realize that this passive-smoking issue is a controversial one. Let us begin by emphasizing what we are not saying. We are not saying the Environmental Protection Agency's analysis was done incorrectly or that the studies they analyzed were done incorrectly. We are not reaching conclusions about the biological and medical issues, which are outside our area of expertise. And we do not intend any numbers that we have calculated to represent a risk assessment. Our evaluation of the statistical evidence on passive smoking let to two conclusions. First, the evidence that passive smoking causes disease is far less certain than the effects for active smoking. Second, the health costs of these potential passive- smoking effects, which we translated into a tax per pack, are likely to be small, although there is likely to be some uncertainty attached to these estimates. The reasons for that view our outlined in our written testimony, which we would like to submit for the record. And I would like to highlight the major points made in that testimony. SENATOR LIEBERMAN: Fine. GRAVELLE: Now that I've said all the things we can't do, let me say what we can... SENATOR LIEBERMAN: Go ahead. 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 I I I I I I 65 GRAVELLE: ...say about it. The evidence of a health effect from passive smoking with no threshold observed for health damage -- excuse me. The evidence of a health effect from active smoking with no threshold observed for health damage is not sufficient to demonstrate a passive-smoking effect, since a threshold effect could occur between the lightest active-smoking level studied and the smaller level of passive- smoking exposure. Since theory is not certain, one approach to studying passive-smoking effects is to examine epidemiological or statistical studies. Given the small risks that are often found for passive smoking, the statistical problems are of greater concern for passive smoking than for active=smoking studies. That is, when the effects are small, it is more likely that some error in design or specification could be responsible for the results. And given this greater uncertainty, consistently of the results with alternative evidence becomes more critical. In the case of lung cancer, most recently summarized by the Environmental Protection Agency, 30 studies which examined the incidence of lung cancer among nonsmoking wives, depending on whether or not their husbands smoked, were combined into an aggregate study. The following are some of the issues discussed in our written statement that might bring some uncertainty to bear no these statistical studies. Let me say these tend to extend to things other than lung cancer: children's respiratory diseases, heart disease, and other diseases that have been studied. First, some method of aggregating these studies is necessary, but there are certain subjective aspects to performing such a combined analysis. Second, some uncertainty attaches to the estimates in most of the individual studies due to the need to rely on interview data to measure exposure. Third, there is a possibility that results reflect the effects of active smoking due to possible misclassification of former or current smokers as never-smokers. Fourth, the failure to account for other lifestyle factors that might be correlated with marriage to a smoker and that might be independently associated with lung cancer, leading to possible spurious correlation exists. And five, two large new studies which were not included in the EPA study do not seem to us to add certainty to the statistical I

I 66 evidence. Indeed, the results of the largest study finds no overall risk from passive smoking. Now, a possible alternative approach to examining the passive- smoking effects would be an extrapolation for the levels of active smoking, and it is discussed because it provides an alternative measure that might or might not corroborate the direct statistical evidence. The average exposure to passive smoking, as indicated in the EPA study based on cotinine (?) in the urine, is about one-half of one percent, or the equivalent of one-tenth of a cigarette per day. A linear extrapolation produces an estimate of 600 never-smoker deaths, compared to the 2000 never-smoker deaths estimated by the EPA based on statistical studies. * A non-linear extrapolation yields virtually no deaths. These differences are even more pronounced -- these discrepancies between the two approaches are even more pronounced for heart disease, where a linear extrapolation yields about a thousand deaths and the statistical studies show in excess of 30,000 deaths. These results I'll leave to you to judge what you think about these, but we see them as subject to question, since the statistical estimates for passive-smoking heart disease represent 26 percent of active-smoking attributable deaths, despite the much lower level of physical exposure. It's also much, much larger than the lung-cancer, estimated lung-cancer deaths. And the EPA rejected this extrapolation approach for several reasons, and I can elaborate on these later if you'd like, although they did review the literature -- and there's a literature using this linear extrapolation method -- and they actually used the approach themselves with passive smoking, extrapolating from female never-smoker deaths that could be estimated directly from their statistical risk ratios to workplace and other exposures. And I'd like to close by adding that -- I'd like to remind you of the fact that both of these methodologies, direct statistical evidence and physical extrapolation, have inherent problems, but currently they're the only recourse we have in providing you with information on the issues before you. We'd be happy to elaborate further on any of these issues. Thank you. SENATOR LIEBERMAN: Thank you, Dr. Gravelle. Thanks for your testimony and indicating the context in which you entered this discussion. 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 I I I I I I 67 Dr. Blott, welcome. We look forward to your testimony now. DR. WILLIAM BLOTT: Thank you. Good morning, Senator Lieberman and members of the subcommittee. My name is William Blott. I am Chief of the Biostatistics Branch at the National Cancer Institute. I've been on the staff of NCI for about 20 years conducting epidemiologic research on the environmental and host determinants of cancer. Many of these research studies have evaluated the role of tobacco in cancer risk. I'm pleased and honored to be here today to discuss the conclusions of the EPA Science Advisory Board in its review of the EPA draft report on the health effects of passive smoking. In 1990 I was asked to serve as one of about nine consultants to a standing Science Advisory Board at EPA and was requested to address several issues in the draft report on passive smoking. Perhaps the most important issue was whether the evidence was sufficient to conclude that environmental tobacco smoke -- and occasionally I might refer to that as ETS -- is causally related to lung cancer. The Science Advisory Board met in December of 1990 and again in the summer of 1992 to discuss the EPA report and to review testimony on the health effects of ETS exposure. I helped the board prepare its recommendations, which were delivered to the EPA in the fall of 1992; and then the EPA, in January of 1993, released its final report. The Science Advisory Board unanimously concluded, based on the review of the totality of evidence available, that the EPA was justified in categorizing environmental tobacco smoke as a Class A carcinogen. That is, as a substance which can cause cancer in people. The board also concurred with the EPA's assessment that the severity of asthma and the risk of other respiratory diseases in children could be increased form exposure to environmental tobacco smoke. But I will restrict my remarks to its association with cancer. Over 30 epidemiologic studies conducted in the United States and abroad have evaluated risk of lung cancer among nonsmokers exposed to environmental tobacco smoke, primarily by studying lung cancer among nonsmoking women married to smokers. Not all of the studies have reported an excess risk linked to environmental tobacco smoke but the great majority have. This consistency of findings across studies throughout the world establishes that exposure to environmental tobacco smoke is indeed associated with a small but a measurable increase in lung cancer. I

I 68 Several additional features of the data led the Science Advisory Board, myself included, to conclude that the relationship was likely to be causal. That is, that it was the environmental tobacco smoke that was responsible for the increase in lung cancer among passive smokers. First, virtually all of the studies that examined dose- response trends found rising risk of lung cancer with increasing level of exposure to environmental tobacco smoke. The more the spouse smoked, the greater the risk to the nonsmoking partner. This is what would be expected if, in fact, environmental tobacco smoke were a carcinogen. Second, there was no compelling evidence that the association was simply due to bias or to confounding by other risk factors for lung cancer. Although only a few studies adjusted for dietary or other risk factors, those that did tended to show little change in the magnitude of the association between environmental tobacco smoke and lung cancer. Third, increased risks of lung cancer were actually observed at exposure levels found in typical environmental settings. Thus the risk assessment that was performed by EPA did not have to rely on extrapolations from high-dose settings, as is sometimes done when relevant low-dose data are not available. And finally, there is a biological plausibility of the association. We know that cigarette smoking is the dominant cause of lung cancer in this country, and in fact in most others, with upwards of a 20-fold excesses in risk in heavy smokers. Nonsmokers exposed to environmental tobacco smoke inhale many of the same substances that smokers do, although in smaller amounts. Components of tobacco smoke have been detected in the blood and in the urine of nonsmokers, With some of the carcinogenic compounds in tobacco bound to the hemoglobin of passive smokers. Thus there is no doubt that tobacco components are absorbed and metabolized by ETS-exposed nonsmokers. There are differences in the chemical compositions, quantitative differences in the chemical compositions of environmental tobacco smoke and inhaled cigarette smoke, but there are a great man qualitative similarities. It is therefore biologically plausible that this lower level of exposure to tobacco from environmental tobacco smoke results in an increase in lung cancer risk. There is uncertainty as to extent of the increased risk and the exact numbers of cancers among Americans that might result from passive smoking. Such imprecision is a common trait in epidemiologic studies and reflects variations in sample sizes and other characteristics of the available data. Thus the estimate that 3000 lung-cancer deaths per year are due.to environmental I I I I I I I I I I I I I I I k`Ca ~ ~tt I

I I I I I I I I I I I I I I I I I I 69 tobacco smoke exposure is reasonable but it is an approximate figure. The Science Advisory Board recommended that such uncertainty be recognized, but this did not alter our scientif ic judgment that prolonged exposure to environmental tobacco smoke can increase the risk of lung cancer. This was the fundamental conclusion that was drawn by EPA and also by reviews of the National Academy of Sciences and the Surgeon General, and one with which the Science Advisory Board and myself fully concurred. Thank you for this opportunity to come before you. I'll be happy to answer any questions. SENATOR LIEBERMAN: Thank you, Dr. Blott. Let me ask you a question that I'm going to submit in writing to Dr. Coggins, who was on the last panel, because I thought that -- I want you to respond, if you would, to what I thought was at the center of his critique of the EPA study and some of the other evidence, some of the other allegations about the effect of secondhand smoke on people. And that was this whole question of volume, or as he -- dose. DR. BLOTT: Dose. SENATOR LIEBERMAN: In other words, yes, perhaps the chemical components of the smoke that people inhale when they smoke and the chemical components of secondhand smoke are similar, but the dose is so different that it stretches the imagination to think that secondhand smoke could actually be such a determinant of cancer. He testi -- Dr. Coggins indicated in his testimony that the maximum amount of secondhand smoke to which a nonsmoker is exposed is equivalent to approximately one to four or one to five, I think he said, cigarettes per year. And he described -- he said that was such a trivial dose that it is, quote, scientif ically implausible that they can result in meaningful toxicological activity. And I'd say again, playing the -- not playing the role, but as a layman, the thought of one to four cigarettes a year doesn't sound like it could cause all the illness and disease and death that we've heard testified to. So, I know that -- I gather, from having gotten into -- that's the top of the iceberg. That's what we see. Underneath is all this complicated statistical inquiry and methodology. And I gather that some of this may have to do with the physical extrapolation method that Dr. Coggins used. But I wanted to ask you if you would respond to those allegations, because I think they go to the heart of what's at issue here. I

I 70 DR. BLOTT: Well, I think this one to -- the equivalent of one to four cigarettes per years is definitely a minority view. It's the first time I've heard this today. And I think the evidence that's available suggests that the amount of exposure to environmental tobacco -- from environmental tobacco smoke in a nonsmoker... SENATOR FAIRCLOTH: Would you come a little closer to the microphone? DR. BLOTT: That the actual levels experienced by nonsmokers are much greater than that. A comment that was made by Dr. Gravelle was if you lboked at cotinine levels, which cotinine is a metabolite of nicotine, in nonsmokers who are exposed to environmental tobacco smoke, compared to smokers, the ratio might be in the order of somewhere between one to a hundred or one to two hundred. That is, these nonsmokers have a much lower amount of cotinine in their body. But if you figure an average cigarette smoker smokes a pack a day of cigarettes pez year -- a pack of cigarettes per day and there are 365 days per year, you multiply 20 times 365 and you take one percent of that, it's going to be a number much greater than the one to four. The problem in the extrapolations from biomarkers, as they're called, is that there are so many different compounds in cigarette smoke. There may be 4000 different compounds. There are 40 or so carcinogens. And it depends -- the answer you get as to the relative exposure for a smoker, compared to a nonsmoker, exposed to environmental tobacco smoke depends upon which of these biomarkers you choose. If you choose the extreme that Dr. Coggins mentioned, you'll get this bay (?), which I think is not reasonable. You take a cotinine level... SENATOR LIEBERMAN: What's the extreme? DR. BLOTT: Well, that you get the equivalent of one to four cigarettes per year. SENATOR LIEBERMAN! Yeah. Are you familiar with the method used by Dr. Coggins? DR. BLOTT: In general. SENATOR LIEBERMAN: Yeah. DR. BLOTT: The extrapolation method. I I I I I I I I I I I I I I I I I I

I I I 71 SENATOR LIEBERMAN: So you -- am I hearing you correctly that you'd say that the method used was not the appropriate method to use? Or put it this way, that one -- it may be appropriate but one should not draw too firm a conclusion from it because there are -- if I'm hearing you correctly, there are other substances... DR. BLOTT: Right. There are many others. I I I I I I I I I I I I I I SENATOR LIEBERMAN: ...in smoke that may not have been measured by him. DR. BLOTT: Right. And we really don't know what is the best measure of exposure. It could be cotinine. It could be one of the carcinogens in cigarette smoke. For example, there's a carcinogen called 4 aminobiphenyl. If you look at hemoglobin addicts to this particular carcinogen in smokers compared to passively exposed nonsmokers, the ratio is only seven to one. That is, smokers only have seven times more of this compound in their body than environmentally exposed nonsmokers. So, if it turns out that that was the relevant measure, then nonsmokers are getting the equivalent of one-seventh. And if you figure that 20-pack-a-day is an average -- or 20 cigarettes a day for one-pack-a-day smoker is average, one-seventh of that is about three cigarettes a day. Not a year, three cigarettes a day. SENATOR LIEBERMAN: Okay. So that's a dramatic difference. Dr. Coggins was suggesting maximum impact on a nonsmoker breathing in smoke would be one to four cigarettes a year. You're saying under that, under the method you've just described, it could be as high as the effect of three cigarettes per day. DR. BLOTT: Right. We really don't know for sure what it is. But there is this range. SENATOR LIEBERMAN: Right. DR. BLOTT: And what was cited earlier was the extreme low end of that range. SENATOR LIEBERMAN: Yeah. So, is there any basis for concluding that the EPA report is on the other extreme, or is it more balanced? DR. BLOTT: Well, the EPA recognized these problems in dealing with biomarkers, and instead used the directly available epidemiological evidence. It's been mentioned several times today that there have been numerous studies, over 30 different studies of lung cancer and many more of childhood diseases, that actually I

I 72 measured risk associated with household exposure to environmental tobacco smoke. So we have some actual, observable data. If you summarize that data, it turns out that there is a small -- granted that it's small -- but a measurable increase in risk of lung cancer among people who've lived with smokers, even though they don't smoke themselves. SENATOR LIEBERMAN: Okay. Thanks for that answer. DR. Gravelle, to an element of the uncertainty of estimates. In your testimony you discussed the uncertainty of EPA's methodology. And to check the numbers, I think you indicated that you've used the physical extrapolation method. I wonder why you used that method to check EPA's analysis, given the uncertainties associated with the method. Which is to say, as Dr. Blott has just indicated, it does not assess all of the exposures that are parts of secondhand smoke. DR. GRAVELLE: Well, we used it because, while there, are uncertainties in that method, there are also a lot of uncertainties in the statistical studies. We used cotinine itself because that's what the EPA used and that's what all of the literature that the EPA reviewed, with one exception, used, is the cotinine level. Now, there was one study that used the respirate-suspended particulate that Dr. Coggins talked about, which produced very small results. There's uncertainty -- I mean I would -- this is not really my field, but it's clear that there are uncertainties about this method. The EPA used cotinine for a whole variety of corrections to their data. They used it for, they used it for making a correction for classification error. They used it for extrapolating from the 500 direct deaths that you could estimate from the statistical evidence to the other 1000 female never-smoker. In other words, most of the numbers in their study are from this kind of method. Now, it's within the group of passive, rather than from active to passive, but that's certainly an approach that they used and relied on. And the cotinine measures are relied on all through the (unintelligible] study to deal with a whole series of problems. We're not saying that this is a perfect study, but we're just saying we see some serious problems with the statistical studies. And when you see serious problems, you want to go back and try to check it against alternatives. I I I I I I I I I I I I I I I I I I

I I 73 I I SENATOR LIEBERMAN: My time's up but let me just ask this, if I may borrow from Senator Faircloth. Maybe you can give me a one- word answer or something close to it. Accepting that there are uncertainties here in this method, why did you reach the conclusion that they overestimated? Isn't it possible that they could have underestimated the consequences of secondhand smoke? I DR GRAVELLE W ll th ti l i . : e , e par cu ar spec fication problems I I I I I with the epi studies that were identified were -- that were clearly identified with the direction were certainly in the direction that would overstate the study. There are two of those and they're discussed in the EPA study. They're all in the literature: the misclassification issue and the confounding factors. ~ So, those would have both gone in the direction of reducing the estimate, had -- in theory, at least had you been able to correct for them. SENATOR LIEBERMAN: Okay. My time's up. Senator Faircloth. SENATOR FAIRCLOTH: Thank you, Mr. Chairman. Senator Lieberman's going to bring this to a conclusion pretty fast. So if you will be extremely brief in your answers. I DR. GRAVELLE: I'll try. SENATOR FAIRCLOTH: And also Dr. Blott. I My first question is, and very brief, what is the mission of the Congressional Research Service? What's it supposed to do? I DR. GRAVELLE: our mission nonpartisan information to Congress. is to provide objective, I SENATOR FAIRCLOTH: Okay. So it is -- when you all say something, it's right. You have no reason for it to be otherwise. I DR. GRAVELLE: Absolutely. [Laughter] SENATOR FAIRCLOTH: Okay. I DR. GRAVELLE: No. research. I have no other motive than to do SENATOR FAIRCLOTH: I move to Dr. Blott. And if you would be I I very brief. I

I 74 I've been advised that the National Cancer Institute funded the Brownson and the Alejano (?) studies. [Unintelligible] correct pronunciation. The largest U.S. studies every conducted on lung cancer in nonsmokers. My understanding is that the reason that the Science Advisory Board of EPA did not insist on the inclusion of those studies in the EPA risk assessment is that the studies weren't completed in time for the EPA analysis. Were they completed in time? time. DR. BLOTT: I think that's right. They were not ready in SENATOR FAIRCLOTH: They were not ready. You think, you're not sure. DR. BLOTT: That's my impression, they were not ready. SENATOR FAIRCLOTH: That's what EPA said. DR. BLOTT: I think that's the case. SENATOR FAIRCLOTH: However, under its guideline, EPA is required to address the existence of confounders, isn't it? DR. BLOTT: Uh-huh. SENATOR FAIRCLOTH: Isn't this sound scientific practice? DR. BLOTT: The consideration for confounding effects? Yes. SENATOR FAIRCLOTH: If EPA were conducting its own analysis today, wouldn't you recommend that those studies be included? DR. BLOTT: Sure. You know, studies are continually being done. And as time passes, we get new information all the time. SENATOR FAIRCLOTH: Since OSHA is in the process of conducting its own risk assessment, you would advise them to include these studies, too. DR. BLOTT: Uh-huh. SENATOR FAIRCLOTH: All right. Do you have a -- children? DR. BLOTT: Yes. if I may ask a question, do you have SENATOR FAIRCLOTH: Do you take them to the beach? 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 I I I I I I 75 DR. BLOTT: Sometimes I do. Yes. SENATOR FAIRCLOTH: Well, aren't you exposing them to a high risk of cancer later on in life? Many studies have indicated that children exposed to sun early are at high risk for cancer. Isn't that a pretty dangerous thing you're doing with your children? DR. BLOTT: Sunlight exposure is a risk factor for skin cancer, for the regular type and for melanoma, which can be fatal. When we go to the beach we attempt to take precautionary measures, including sunscreens and avoid burning. SENATOR FAIRCLOTH: Oh, I understand that. But why not just not go? We're closing down smoking because it's a risk of cancer.' How about french fries at fast-foods? Do you ever let children eat those? DR. BLOTT: Sometimes my kids do. Yes. SENATOR FAIRCLOTH: Well, what do you to do that? You give them a stomach lining or something? DR. BLOTT: I think the issue is whether or not we have enough evidence before us right now to declare that exposure to environmental tobacco smoke is harmful. And I think we do. SENATOR FAIRCLOTH: I have one more question. You're married. DR. BLOTT: Yes. SENATOR FAIRCLOTH: Does your wife smoke? DR. BLOTT: No, sir. SENATOR FAIRCLOTH: If she did, would you divorce her? DR. BLOTT: [Laughter] SENATOR LAUTENBERG: Depends on the alimony. SENATOR LIEBERMAN: You could plead the Fifth here. DR. GRAVELLE: [Laughter] DR. BLOTT: I think it's unlikely that she would ever smoke cigarettes. SENATOR FAIRCLOTH: That wasn't the question. If she did, would you divorce her? I

I 76 DR. BLOTT: I don't know what would happen in that situation. It's unlikely I would divorce her. SENATOR FAIRCLOTH: The point I am making is clear. SENATOR LAUTENBERG: Indeed. SENATOR FAIRCLOTH: We have gone to fairies -- angels dancing on needle points into this smoking. We are completely ignoring every other risk factor for cancer. The beach, you take your children. As Dr. Taylor said earlier, his children could not go to a restaurant, he didn't want them to go or whatever, because there was smoke in it. His grandchildren. I assume they go to the beach. Most do. So we're taking one issue and making it the whipping boy, and we are blithely going like a blinded and deafened horse to the battle on every other cancer issue. We talk about -- you talk about putting a 60-cent sun lotion on your children and take 'em to the beach, and it doesn't concern you. Yet -- I'll not say you. People of your mind-set go into a spasm if you go into a restaurant and there's smoking in one dark corner of it. I just -- I think we ought to be fair. I thank you. SENATOR LIEBERMAN: Thank you, Senator Faircloth. We're trying hard to assess different forms of threat to the American people. And I do want to say, Dr. Blott, that I'm reassured that your marriage has survived the threats that may have been placed on it. DR. BLOTT: Thank you. SENATOR LIEBERMAN: Senator Lautenberg. SENATOR LAUTENBERG: Thank you very much. Do you drag your kids to the beach, just pull them along by a hand, over the curbs and all that, to get them down to the beach? DR. BLOTT: No, sir. SENATOR LAUTENBERG: Or do they voluntarily go? DR. BLOTT: It's voluntary. I I I I I I I I I I I I I I I Ca I ~ - c. ,n ~ c.~ I

I I I I I I I I I I I I I I I I 77 SENATOR LAUTENBERG: Yeah. So what happens when they're in a room with smokers? Do they get a chance to voluntarily block it out, or do they have to take what's in there? DR. BLOTT: They might not get a voluntary chance. You're right. SENATOR LAUTENBERG: My kids go to the beach. I try to convince them to cover up. I try to convince them not to take the unnecessary risk, at least to make their own independent decisions to what to do. Dr. Gravelle, one of the things that concerns me. You suggested -- admitted, I might say, because my background's in economics, too, that you're both economists. Is that true, Dr. Zimmerman? [Affirmative indication] SENATOR LAUTENBERG: Okay. So here we are, the three of us, in an unscientific science. Although my education is not as extensive as yours. DR. GRAVELLE: No, no. SENATOR LAUTENBERG: Have you ever -- you have medical science people in CRS, do you not? DR. GRAVELLE: That's correct. SENATOR LAUTENBERG: Why didn't they do this report, or their response to the report? DR. GRAVELLE: Well, the passive-smoking issue in our cigarette tax paper was a fairly minor subset of a lot of different things we did. And we consulted very closely with them. The report was read and approved. And I spent a lot of time with the Science Policy Division doing this report. SENATOR LAUTENBERG: Did they -- they weren't asked to do the -- to write the analysis of the EPA study? You did... DR. GRAVELLE: Our paper was not about -- I'm sorry. This is a small part of this paper on cigarette taxes that had to do with passive smoking. SENATOR LAUTENBERG: So it was focused primarily on the tax issue and the assumptions. I

I 78 Were the assumptions about the risk essential to the determination of what the revenues might flow, what revenues might flow from the taxes? DR. GRAVELLE: Well, we looked at, you know, revenue yield. We looked at the price elasticities. You,look at the path of revenue over time. We did all those things. But the part of the paper that this was related to was really measuring spillover cost and trying to compare those to existing cigarette taxes. And one of the spillovers, obviously, was -- that we had to look at was the passive-smoking issue. SENATOR LAUTENBERG: So, was the assertion that the methodology might not have been precise, in your view, did you have to make the case by getting to the health effects? Because if you were interested in the financial yield on this, then I'm trying to understand why it is that we got into the question of whether or not the health-effects analysis was... DR. GRAVELLE: Well, as you know, when you -- one of the efficiency issues that you would look at in doing an economic analysis is whether smokers are having the right sort of price signals when they buy cigarettes. And part of those price signals are effects that they have on other people that are not price. And one of those effects -- there are lots of different kinds of effects we looked at. Health care costs, direct health care costs of smokers was one we spent a lot of time on. And one aspect of that that we felt was crucial to that analysis was the passive- smoking ef f ect . SENATOR LAUTENBERG: Okay. So you're saying the net yield, because the savings might not have been there as a result of non- ill-health effects. DR. GRAVELLE: That's right. There are two basic kinds of spillover effects. One is the potential medical effects, basically because we charge the same insurance premiums for smokers and -- we don't differentiate by smoking status. That's one effect. And you have to look at that over a whole lifetime. And the second effect would be the passive smoke -- well, actually we talked about other things. We talked about annoyance and all the things we could think of and measured all the things we could try to measure. And there's a whole series of issues we looked at. SENATOR LAUTENBERG: I'm going to commission a study by CRS on annoyance and see how much that costs the government every... DR. GRAVELLE: That one's hard to measure. SENATOR LAUTENBERG: But how about us, one to the other, here? 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 I I I I I I I I 79 Anyway, what -- was your CRS report peer-reviewed by outside experts in any way? DR. GRAVELLE: In general, the process through which we go in receiving a request, answering a request, reviewing a request is confidential, at the wish of Congress. I will say that we have internal review in our subject area. We have internal review in cross-disciplinary subject areas, other subject areas that are relevant to our studies. We have internal review. We have external review when it's appropriate. We do -- as you know, literally, we handle thousands and thousands of requests every year, and so there's not a consistent review process. I'd say that the'study -- there was a good look at this study from lots of sources, congressional sources, non- congressional sources, or discussions that we carried on with people that was -- it was, in my view, a very carefully examined study. SENATOR LAUTENBERG: Yeah. It didn't have the same type, for the reasons stated, peer review as the EPA study. I mean the EPA... DR. GRAVELLE: Well, we have a different -- we have no regulatory authority. We have, you know, no influence on the regulatory authority. And, of course, if there were to be criticisms after a paper is released that we thought were valid, we certainly change our papers. And we've done that before. Every once in a while, answering all the questions, you make a mistake. There's no problem with that. SENATOR LAUTENBERG: Have you had any criticism related to your observations? DR. GRAVELLE: No, sir. SENATOR LAUTENBERG: The EPA Administrator stated, and several other people, that she believes that ETS can cause as much as -- as many as 3000 lung-cancer deaths a year. You seem to suggest that there are only -- you suggest that there are only -- there might only be 600 deaths per year related to ETS. You therefore -- in your comments you say, "Our evaluation was that the statistical evidence does not appear to support a conclusion that there are substantial health effects of passive smoking." When -- how much more than 600 deaths does it have to be to get to be to be substantial? I

I 80 DR. GRAVELLE: Well, I guess substantial is sort of in the eyes of the beholder. The risk -- let's even take the EPA numbers. Let's take the 3000 deaths. I would characterize those as small risk.. Perhaps you wouldn't. They are in the same general magnitude, let's say, of the risk of driving a small car instead of a large car, which is safer than a small car. The lifetime risk is in the neighborhood of one-tenth to two-tenths of a percent. And since the chance of dying is 100 percent. So, compared to many other risks -- you face risks all the time. And it's one of the things of economics that I think is very valuable in looking at this subject is people do face risks of all sorts of different types all the time. We live risky lives. And the question is, I think, what risks do you want to correct at what costs? Is it worth it? Is it large enough? And... SENATOR LAUTENBERG: If it's my kid it's large enough. I can tell you that. Also, I make sure that my children -- they're adults now, but my grandchild -- that they use seatbelts. The risk of dying in a car accident, compared to the number of miles driven each day, is pretty darn small. DR. GRAVELLE: That's right. SENATOR LAUTENBERG: But why take the extra risk if you don't have to? Why should the 600 who might die -- and if you're wrong, perhaps it is 3000 -- why should we take that risk if we don't have to? Aren't we obliged to protect the public health? Six hundred -- and it's alleged, and I haven't heard you challenge that, that much of this risk is to small children and that the 150,000 incidents a year of some asthmatic response to smoke -- are those insubstantial risks, in your mind, Dr. Gravelle? DR. GRAVELLE: We calculated in our paper the only number that we could come up [with], in terms of translating to a cigarette tax, of the medical cost of hospitalization, which I think was about one-tenth to three-tenths of a percent per pack. But I want to say with respect -- there's a couple of observations you can make about children. A lot of this is going to occur in the home and with the parents, if it does occur, and a place that I think is beyond the reach of regulation. SENATOR LAUTENBERG: Yeah, but now you're getting into the health-analysis side of things, which you said you didn't want to. DR. GRAVELLE: I'm sorry. SENATOR LAUTENBERG: I mean, you wanted to focus... DR. GRAVELLE: I said I think that's beyond the reach of regulation. 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 I I SENATOR LAUTENBERG: Yeah, I understand. But you also said it's largely in the home. And we can start a whole debate, but the red light's on. And like any other driver, I just speed up when the red light's on. But the fact is that if we look at the risk, the preventable risk of people developing disease or having a problem with their health, it's a result of the exposure.. I think we have to somehow or other separate it from the pure financial analysis and say, okay, if we save 300 of these people, 600, 800, 2000, that's a decision we have to make in policy. Thank you. Thanks very much. SENATOR LIEBERMAN: Thank you, Senator Lautenberg. Let me just follow up with one question, based on what Senator Lautenberg was just asking. It was my understanding that in the financial-impact analysis that you made, you focused on the lung-cancer deaths, the 3000 lung-cancer deaths, and did not include the suggestions, the conclusions, actually, in the EPA report about the impacts on children, for instance, in bronchitis and the middle-ear infections and all the rest. Is that correct? DR. GRAVELLE: As we said, we looked at the only one we could make some sort of attempt to quantify, and the one that I think they've stressed a great deal. And these are -- I mean, numbers like 3000 look big. But in a country where ten million people die every year and where there's, you know, 260 million people or so, I mean that's not -- I mean, it sounds very cold-hearted but it's not big. SENATOR LIEBERMAN: No, I understand. All I want to point out, for the sake of clarity, is that the numbers that you presented were based on the lung-cancer deaths. I just wanted to... DR. GRAVELLE: No, no. About the cigarette tax? SENATOR LIEBERMAN: Yeah. DR. GRAVELLE: No. We tried to do extrapolations for all the adult diseases. SENATOR LIEBERMAN: But how about the kids, though? DR. GRAVELLE: And the kids, we looked at what we could -- the numbers we could come up with. They would be very small. i SENATOR LIEBERMAN: Okay. So you did try to -- you did try to ~  include in your... 4:4 . ~:.~ I

I 82 DR. GRAVELLE: To the extent that we could try to quantify it. Some things just can't be quantified. SENATOR LIEBERMAN: The 150 to 300 thousand cases of bronchitis and pneumonia and hospitalizations. DR. GRAVELLE: Yeah. We looked at this. SENATOR LIEBERMAN: Okay. I thank you, all of you. SENATOR LAUTENBERG: Could I ask for an insertion in record of the article that appeared in the New York Times, Saturday, May 7th, entitled "Tobacco Company [unintelligible]." SENATOR LIEBERMAN: Without objection, we'll definitely enter it in the record. I thank Dr. Gravelle and Dr. Blott and all the other witnesses. I think this has been a very informative hearing. Obviously, there are different points of view, which is what we wanted to expose here and discuss. But I do think that we've established a good factual record for us to consider as we move these bills through this Congress. And I thank all of you for participating and helping us in that way. The record of the hearing will remain open for three weeks so that we may submit additional questions to you if we'd like, and you may add to your testimony if you'd like. I thank all of you. The hearing is adjourned. I I I I I I I I I I I I I I I r.~ .~ ~ .0 I