Tobacco Documents Online

ENVIRONMENTAL TOBACCO SMOKE ; E HEARING BEFORE THE SUBCOTAMTTEE ON HEALTH AND THE ENVIRONMENT OF THE COMMITTEE ON ENERGY AND COMMERCE HOUSE OF REPRESENTATIVES ONE HUNDRED THIRD CONGRESS FIRST SESSION JULY 21, 1993 Serial No. 103-51 3 11 Printed for the use of the Committee on Energy and Commerce U.S. GOVERNMENT PRINTING OFFICE 74814CC WASHINGTON : 1993 For sale by the U.S. Government Printing Office Superintendent of Documents. Congressional Sales Office, Washington, DC 20402 ISBN 0-16-043355-X .

I COMMITTEE ON ENERGY AND COMMERCE JOHN D. DINGELL, Michigan, Chairman HENRY A. WAXMAN, California CARLOS J. MOORHEAD, California PHILIP R. SHARP, Indiana THOMAS J. BLILEY, JR., Virginia EDWARD J. MARKEY, Massachusetts JACK FIELDS, Texas AL SWIFT, Washington MICHAEL G. OXLEY, Ohio CARDISS COLLINS, Illinois MICHAEL BILIRAKIS, Florida MIKE SYNAR, Oklahoma DAN SCHAEFER, Colorado W.J. 'BILLY" TAUZIN, Louisiana JOE BARTON, Texas RON WYDEN, Oregon ALEX MCMILLAN, North Carolina RALPH M. HALL, Texas J. DENNIS HASTERT, Illinois BILL RICHARDSON, New Mexico FRED UPTON, Michigan JIM SLATTERY, Kansas CLIFF STEARNS, Florida JOHN BRYANT, Texas BILL PAXON, New York RICK BOUCHER, Virginia PAUL E. GILLMOR, Ohio JIM COOPER, Tennessee SCOTT KLUG, Wisconsin J. ROY ROWLAND, Georgia GARY A. FRANKS, Connecticut THOMAS J. MANTON, New York JAMES C. GREENWOOD, Pennsylvania EDOLPHUS TOWNS, New York MICHAEL D. CRAPO, Idaho GERRY E. STUDDS, Massachusetts RICHARD H. LEHMAN, California FRANK PALLONE, JR., New Jersey CRAIG A. WASHINGTON, Texas LYNN SCHENK, California SHERROD BROWN, Ohio MIKE KREIDLER, Washington MARJORIE MARGOLIES-MEZVINSKY, Pennsylvania BLANCHE M. LAMBERT, Arkansas AtaN J. RoTH, Staff Director and Chief Counsel DENNIS B. FITZGIBBONS, Deputy StaJ}'Director MARGARET A. DURBUN, Minority Chief Counsel and Staff Director SUBcoMMITTEE oN HEALTH AND THE ENVIRONMENT HENRY A. WAXMAN, California, Chairman MIKE SYNAR, Oklahoma THOMAS J. BLILEY, JR., Virginia RON WYDEN, Oregon RALPH M. HALL, Texas BILL RICHARDSON, New Mexico JOHN BRYANT, Texas J. ROY ROWLAND, Georgia EDOLPHUS TOWNS, New York GERRY E. STUDDS, Massachusetts JIM SLATTERY, Kansas JIM COOPER, Tennessee FRANK PALLONE, JR., New Jersey CRAIG A. WASHINGTON, Texas SHERROD BROWN, Ohio MIKE KREIDLER, Washington JOHN D. DINGELL, Michigan (Ex Officio) MICHAEL BILIRAKIS, Florida ALEX McMILLAN, North Carolina J. DENNIS HASTERT, Illinois FRED UPTON, Michigan BILL PAXON, New York SCOTT KLUG, Wisconsin GARY A. FRANKS, Connecticut JAMES C. GREENWOOD, Pennsylvania CARLOS J. MOORHEAD, California (Ex Officio) KAREN NELSON, Staff Director GREGORY S. WETSTONE, Counsel PHU.i n' BAxNETr, Counsel CHARLES INGEBRETSON, Minority Counsel • .t . • 0 (II)

2 many American children who cannot do the things that other chil- dren do-go to a McDonald's, attend a baseball game, or even par- ticipate in a family vacation-without fear of encountering tobacco smoke, suffering serious health repercussions, and maybe ending up in a hospital These impacts are entirely preventable, and the Environmental Protection Agency and others are fighting back. Today, EPA Administrator Carol Browner will announce a major new policy designed to protect nonsmokers from involuntary expo- sure to environmental tobacco smoke. The policy seeks to secure for nonsmokers the basic right to freedom from harmful involuntary smoking. EPA's new recommendations will have a dramatic impact. Many cities and States are already moving to control environmental to- bacco smoke, as shown by recent smoking restrictions in California, Hawaii, Vermont, North Dakota, and Utah. This trend was acceler- ated when the EPA report was released last January. The Agency's long awaited policy recommendations will prompt many more State and local initiatives. But ultimately exposure to environmental tobacco smoke is a na- tional environmental problem, and it deserves a national solution. That is why, to protect the public, and especially our children, I am announcing today that I will be introducing legislation to prohibit involuntary exposure to tobacco smoke in all buildings open to the public. Under this legislation, smoking will be banned or restricted to separately ventilated rooms in all public, commercial, and school buildings. This is a bold step, but its premise is simple. Smokers do not have the right to jeopardize the health of nonsmokers, particularly children. Children do have the right to leave their homes without fearing that exposure to environmental tobacco smoke may trigger a life-threatening asthma attack. Incredibly, hundreds of thousands of children can avoid serious health problems without public or private expense. These stagger- ing figures involve staggering health care costs and lost productiv- ity to our society. In order to save those dollars, we need only es- tablish a rational smoking policy for public places. People may decide on their own to smoke, that is their decision, but for those who do not want to smoke,'they shouldn't be forced to breathe in smoke from others and suffer all the adverse health consequences. The legislation is founded on good science and sound health policy. The only reason not to enact it is that the tobacco companies will oppose it. But the special interests of the tobacco companies are no match for the health of our children. The Supreme Court, in the case of Helling v. McKinney, recently ruled that exposure to prisoners of environmental tobacco smoke can be considered an unconstitutional cruel and unusual punish- ment. It is about time the rest of us, and especially our children, get the same protection. We are going to hear from our witnesses, but before we call upon them I want to recognize members of the subcommittee for their opening statements and call on Mr. Bliley first. Mr. BLILEY. Thank you, Mr. Chairman. Mr. Chairman, I am testifying today in order to report to the subcommittee the results of my extensive investigation of the I = 0 . . 0

ENVIRONMENTAL TOBACCO SMOKE 0 WEDNESDAY, JULY 21, 1993 HOUSE OF REPRESENTATIVES, ' COMMITTEE ON ENERGY AND COMMERCE, SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT, Washington, DC. The subcommittee met, pursuant to notice, at 9:50 a.m., in room 2123, Rayburn House Office Building, Hon. Henry A. Waxman (chairman) presiding. Mr. WAXMAN. The meeting of the subcommittee will please come to order. Guests, take their seats. I wonder if we could have the doors in the back closed. This morning's hearing addresses a dangerous, pervasive, and entirely preventable form of indoor air pollution, environmental to- bacco smoke. Not surprisingly, given tobacco's deadly record, stud- ies show the impact of environmental tobacco smoke are pervasive and severe, especially where children are concerned. Experts agree that cancer is one deadly effect, and EPA estimates that environ- mental tobacco smoke causes 3,000 cancer deaths each year among nonsmokers. As we will hear this morning, medical experts, includ- ing the American Medical Association, agree with those figures. Then there is heart disease. Although EPA's recent report only addresses respiratory problems, heart disease is the biggest killer associated with involuntary smoking. The U.S. Surgeon Generall has determined that more than 30,000 lives each year are lost as a result of heart disease from environmental tobacco smoke expo- sure. Environmental tobacco smoke also causes respiratory ailments, especially when children are concerned. Asthma is the most perva- sive ETS health impact. EPA estimates that between 200,000 and ' 1 million American children suffer asthmatic attacks as a result of environmental tobacco smoke. ETS may even cause the onset of asthma in previously healthy children. Passive smoke causes lower respiratory infections such as pneu- monia and bronchitis. More than 50,000 small children are afflicted by such serious infections each year because of ETS exposure, and many thousands are hospitalized. Children also suffer reduced lung function, respiratory irritation, and severe inner ear infections as a result of exposure to environmental smoke. - While these are staggering figures, they are not just empty sta- tistics. There is a saddened family behind every cancer death and a frightened child behind every asthma attack. Today we will hear the story of two of the innocent children who suffer from exposure to environmental smoke. We will hear first-hand what it is like for (1) .A

3 EPA's handling of the controversy surrounding environmental to- bacco smoke, or ETS. As you know, in the past the Oversight and Investigations Sub- committee of this committee has conducted hearings on EPA's abuse of Government contracting requirements. So pervasive is the level of abuse that Chairman Dingell has characterized EPA's pat- tern of .contract mismanagement as a cesspool. EPA's inspector general has recently confirmed that such abuses also have taken , place in connection with a number of EPA contracts involving ETS, and the Oversight and Investigations Subcommittee's own inves- tigation is continuing. In addition to various contractual improprieties, however, my a own investigation suggests that, in its consideration of ETS, the Agency has deliberately abused and manipulated the scientific data in order to reach a predetermined, politically motivated result. EPA's risk assessment on ETS released in January of this year claims that ETS exposure is responsible for approximately 3,000 lung cancer cases per year in the United States. Analysis of the risk assessment reveals, however, that EPA was able to reach that conclusion only by ignori^g or discounting major studies and by de- viating from generally accepted scientific standards. EPA's willingness to distort the science in order to justify its classification of ETS as a Group A or known human carcinogen seems to stem from the Agency's determination early on to advo- cate smoking bans and restrictions as a socially desirable goal. EPA began promoting such policies in the mid to late 1980's os- tensibly as part of its efforts to provide information to the public on indoor air quality issues. The Agency then decided to develop the ETS risk assessment to provide a scientific judgment for smok- ing bans. The risk assessment thus was never intended to be a neutral review and analysis of the ETS science. Rather, it was in- tended from the start to function as a prop for the Agency's pre- determined policy. Not surprisingly, therefore, the process at every turn has been characterized by both scientific and procedural irregularities. In ad- dition to the contracting violations mentioned at the outset, those irregularities include conflicts of interest by both Agency staff in- volved in preparing of the risk assessment and the members of the Science Advisory Board selected to provide a supposedly independ- ent ent evaluation of the document. I will not itemize each and every one of these improprieties. In- stead, I ask unanimous consent that a memorandum providing full _ details of the history of EPA's handling of ETS be included in the record. The memorandum summarizes the results thus far of my investigation into the Agency's handling of ETS and is based on publicly available documents, extensive correspondence between myself and former Administrator Reilly, and interviews conducted by my staff with the responsible EPA officials. [Testimony resumes on p. 72.1 [The memorandum follows:]

4 EPA AND ENVIRONMENTAL TOBACCO SMOKE: SCIENCE OR POLIT3CS? I. INTRODUCTION With almost unprecedented fanfare, the Environmental Protection Agency ("EPA") released at a news conference on January 7, 1993, a risk assessment on tobacco smoke in the air -- often referred to as environmental tobacco smoke ("ETS"). According to the EPA risk assessment, ETS is a "Group A" or "known human" carcinogen that is responsible each year for approximately 3,000 cases of lung cancer among nonsmokers residing in the United States. The risk assessment also claims that ETS is a cause of respiratory problems in infants living in homes in which one or both parents or some other family member smokes. Not surprisingly, the claims contained in EPA's risk assessment on ETS generated substantial publicity, with most major newspapers, television news program and radio stations devoting substantial attention to EPA's conclusions. The publicity was, in aart, a natural and expected response to the rather dramatic claims made in the EPA report. But EPA officials and staff, joined by Secretary Sullivan of the Department of Health and Human Services ("HHS"), also left no stone unturned to ensure heavy media coverage of the report. The EPA/HHS campaign was seeded by periodic "leaks" of drafts 0

5 - 2 - of the report, and those leaks were followed with a heavily promoted press conference and individual interviews. The EPA/HHS representatives made clear at their January press conference that they hoped that the EPA report would lead to additional smoking restrictions by private entities as well as by government at all levels. If the conclusions of the report are valid, that hope is certainly understandable. At the same time, however, if the claims made in the report are invalid, as appears to be the case, the likely consequence will be additional unjustified harassment of and discrimination against smokers -- a consequence that received little attention at the January press conference. The assumption that often is made is that smoking restrictions and other comparable measures are essentially costless. Increasingly, that assumption has been shown to be incorrect. Whether measured in terms of the number of people who are fired or are not hired because they smoke, by unjustified feelings of guilt among smokers or by the erosion of courtesy and tolerance, the campaign against smoking is not the no-lose proposition it often is portrayed as being. In Washington, D.C., for example, which has adopted , workplace smoking restrictions, the consequences of the ETS controversy are unmistakable. At all hours of the working day, people can be seen, even in the middle of winter, huddled near the doorways of office buildings smoking cigarettes. In fact, some employers -- in Washington, D.C., and elsewhere -- 01~

6 - 3 - have gone so far as to require current and prospective employees to submit to a urine test, looking for the telltale sign of nicotine. Over the past several years there has been increasing concern about the politicization of science and other problems at EPA. A two-year investigation by the Subcommittee on Oversight and Investigations of the House Energy and Commerce Committee has uncovered disturbing evidence encompassing everything from cronyism in the award of government contracts to systematic bias in the collection, review and presentation of scientific data. Instead of evaluating scientific issues objectively and providing balanced information to the public, EPA has been found on a number of occasions to have manipulated or suppressed data in a manner that has resulted in unnecessary alarm and confusion. Mounting concern about EPA's misuse of science prompted former EPA Administrator William Reilly to convene an expert panel in 1991 to review EPA's handling of scientific issues and to recommend improvements. The expert panel, which was comprised of eminent scientists from leading institutions across the country, issued a report in March 1992 entitled Safeguarding the Future: Credible Science, Credible Decisions. The report confirmed that, "[c]urrently, EPA science is of uneven quality, and the Agency's policies and regulations are frequently perceived as lacking a strong scientific foundation" (p. 4).

7 - 4 - 0 The expert panel also cautioned EPA that "science should never be adjusted to fit policy, either consciously or unconsciously" (p. 38). Unfortunately, that is precisely what appears to have happened in the case of the risk assessment on ETS -- the abuse of science and the scientific process to further a political agenda. However one views cigarettes and smoking, EPA's misuse of science and disregard for proper legal and scientific procedures should be cause for alarm. In fact, EPA's handling of ETS sets a disturbing precedent for the Agency's consideration of future controversial scientific questions, raising questions about EPA's ability to separate science from politics in carrying out its mission. As the editor of EPA Watch recently observed in response to EPA's release of the ETS report: It's now open season on whatever contam- inant the EPA chooses to label the killer contaminant of the week, with the effect that once again, Americans are going to be stampeded into fearing a substance for reasons which upon close ins~ection are scientifically indefensible.- The discussion that follows describes EPA's activities with respect to ETS -- the procedures the Agency has utilized and the problems that have infected the process , from the beginning. V EPA Blowing Its Own Smoke?, Investor's Business Daily, January 28, 1993, p. Al.

8 - 5 - II. THE HISTORY OF EPA'S INVOLVEMENT IN THE ETS CONTROVERSY A. Puttino EPA's Role Into Context In order to understand EPA's role in the ETS controversy, one must understand how the "passive smoking" issue emerged in the first place. According to Richard Daynard, a well-known antismoking activist, the organized movement to eradicate smoking has proceeded in three distinct phases.?/ During the first phase, activists attempted to persuade smokers to stop smoking on the ground that smoking was bad for the smoker. Although many smokers did stop smoking for that reason, others continued. During the second phase, activists attempted to make smokers feel guilty about their enjoyment of smoking. Again, however, many individuals continued to smoke. The third and current phase, according tc Daynard, marked a more fundamental strategic shift. In this phase, the movement began to focus on the "development" of "evidence" about ETS. If people can be persuaded to believe that tobacco smoke is harmful to nonsmokers, it becomes easiex to persuade both private entities and government authorities to restrict or ban smoking. According to Stanton Glantz, founder of Californians for Nonsmokers' Rights (later christened Americans for Nonsmokers' Rights), the target of such laws is the smoker rather than the nonsmoker. "Although the nonsmokers' rights movement concentrates on protecting the ?/ Presentation by Richard Daynard, International Council for Coordinating Cancer Research: Conference on Cancer Prevention (February 1991).

9 - 6 - nonsmoker rather than on urging the smoker her own benefit, [antismoking legislation] to quit for his or reduces smoking because it undercuts the social support network for smoking by , implicitly defining smoking as an antisocial act."y Neutral and dispassionate scientific inquiry often yields inconvenient results from the perspective of the social activist. So it'has been for EPA with Alar, PCBs and dioxin, to cite only a few examples. ETS must now be added to the list. The scientific data simply do not support EPA's classification of ETS as a"Group A" carcinogen. Of the more than 30 epidemiologic studies of marriage to a smoker and lung cancer among nonsmokers, the overwhelming majority report no statistically significant association. The studies focusing on ETS exposure in the workplace also generally have not reported a statistically significant increased risk. The most recent and largest U.S. case control study, by Brownson and coworkers, confirms the general no-association patternY Although the Brownson study was published in November 1992, two months before EPA completed its report on ETS, the EPA report failed even to cite the Brownson study. The reason, Y S. Glantz, Achieving a Smokefree Society, Circulation, vol. 76, pp. 746-752, 747 (1987). `-/ R.C. Brownson et al., Passive Smoking and Lung Cancer in Nonsmoking Women, Am. Pub. Health, vol. 82, pp. 1525-1530 (1992).

10 , - 7 - undoubtedly, is that EPA's conclusions on lung cancer could not survive inclusion of the Brownson data. Even without the Brownson data, the classification of ETS as a Group A carcinogen required substantial stretching by EPA. To reach that conclusion, the EPA report combined eleven spousal smoking studies from the United States in a so- called "meta-analysis." Of the eleven studies, however, ten reported no statistically significant increase in cancer among nonsmokers purportedly exposed to ETS. To ensure that the meta-analysis would produce the desired results, therefore, EPA had no choice but to manipulate the numbers. Although in the past EPA and the scientific community have used a 95% confidence interval as a means ensuring that study results did not occur by chance, EPA of adjusted the confidence interval downward -- to 90% -- in its report on ETS. As James Enstrom, an epidemiology professor at the University of California, Los Angeles, explained, "[t]hat doubles the chance of being wrong."Y To put it in lay terms, EPA's statistical maneuvering is the equivalent of moving the goal lines at a football game in order to score more touchdowns. The implications of EPA's willingness to lower scientific standards in selected cases are profoundly troubling. As Michael Gough of Congress's Office of Technology Assessment has pointed out, ".[yjou cannot run si Investor's Business Daily, su a note 1. C~ cl~ I

11 -a- science with the government changing the rules all the time."6/ The only claim made in the EPA report for which there is at least statistical support is that ETS can affect the respiratory health of very young children. Most of the studies on that issue are so flawed, however, that it is premature to conclude that the association is causal in nature. In the final analysis, it must be remembered that epidemiologic studies can show only a statistical association. They cannot prove causality. After all, there is a strong association between increased life expectancy and increased consumption of junk food in affluent countries but no one 6/ Ibid. In addition to these deficiencies, classification of ETS as a Group A carcinogen cannot be reconciled with EPA's own Guidelines for Carcinogen Risk Assessment. The Scientific Advisory Board that reviewed the risk assessment acknowledged that the document did not adhere to the Agency's guidelines, but dismissed such concerns with the suggestion that the guidelines simply be changed. The report also selectively uses data that support its conclusions while omitting evidence that does not. For example, the report completely ignores workplace and male exposure data, which do not show any association between exposure to ETS and lung cancer. Such treatment by both EPA and the SAB is unprecedented. No other substance has been classified as a Group A carcinogen in the face of a clear majority of epidemiologic studies showing no statistically significant association or on an assumed similarity with another substance. Other substances that have been considered for classification as known or probable human carcinogens, including electromagnetic fields and diesel exhaust, have been accompanied by considerably stronger evidence of carcinogenicity in both human and animal studies than ETS. Comparing those risk assessments to the ETS report only reinforces the view that the report is intended to support a policy decision to restrict ETS exposure and not to assess risk objectively.

12 - 9 - contends that one is the cause of the other. argue the converse.'-/ In fact, many In light of the weaknesses in the pertinent data, the procedures that have been utilized in "developing the case against ETS" take on a special significance. As one of the world's leading epidemiologists, Dr. Alvan Feinstein of Yale University Medical School, put it in a recent article: In the investigations of [ETS], * * * the various studies are contradictory, some going in positive directions and others not. The inconvenient failure of the evidence to comply with a prime requisite of scientific reasoning for causality, however, has not inhibited the causal accusations. The "prosecution" has simply ignored the inconvenient results and emphasized thosethat are (in a memorable term) "helpful."= A report produced by the Advocacy Institute, a major antismoking organization, entitled Media Strategies for '-/ The risk assessment does not address the data concerning ETS exposure and cardiovascular disease. Two earlier documents prepared by EPA staff, however, an ETS "technical compendium" and a related "workplace policy guide," asserted that ETS exposure is a cause of cardiovascular disease. In fact, exposure to ETS has not been proven to cause or exacerbate cardiovascular disease among nonsmokers. In 1986, the U.S. Surgeon General and the National Academy of Sciences reviewed the data and concluded that there was insufficient evidence even of an association between ETS and cardiovascular disease. U.S. Surgeon General, The Health Conseauences of Involuntary Smoking, U.S. Department of Health and Human Services (1986); National Research Council, Environmental Tobacco Smoke: Measuring Exposures and Assessin"c Health Effects (1986). No studies have been published since 1986 that would alter their conclusions. e/ A. Feinstein, Criti que of Review Article, Environmental Tobacco Smoke: Current Assessment and Future Directions, Toxicologic Pathology, vol. 20(2), pp. 303-305, 304 (1992). . • . .

13 -10- Smokinq Control: Guidelines (NIH 1989), provides a striking illustration of this strategy. Behind every story detailing the "risks" of ETS, the report stated, could be found "(a] scientist wise in the way of 'creative epidemiology,' i.e., the presentation of data -- both scientifically sound and artful -- so as to catch the glint of media attention ***" (NIH Report at 7). The report describes "creative epidemiology" as follows: Michael Daube, who coined the term, defines creative epidemiology as "the ability of the good epidemiologist to rework data so that what is essentially the same information can be presented in a new and interesting form." Thus creative epidemiology marries the science of the researcher with the art and creativity of the media advocate (id. at 21-22). Similarly, Jonathan Samet of the University of New Mexico recently acknowledged that there is much that we do not know and indeed may never know about whether ETS poses a health risk. Notwithstanding those evidentiary deficiencies, however, Dr. Samet made clear that "[i]n the case of environmental tobacco smoke, it would be unfortunate if potentially irresolvable scientific uncertainties thwarted control."9l As a result of this strategy, there is enormous pressure on researchers and scientific bodies investigating ETS to come up with the "right" conclusion. The Brownson 2/ J.M. Samet and M.J. Utell, The Environment and the Lung: Changing Perspectives, J. Am. Med. Ass'n., vol. 266, p. 673 (1991).

14 - 11 - study, for example, apparently caused considerable dismay because it produced the "wrong" results. Defending his decision to pub'lish the study, Dr. Brownson lamented, "I wish our findings had gone in the exact pattern the public health community-would like ***. But one of the criticisms of medical research is that the only thing findings ever show is some kind of health risk. I feel it's important to publish findings, no matter what they show.";0/ Dr. Brownson's eagerness to please the public health community is widely shared. His willingness to release data not in accord with the political objectives of that community unfortunately is not. Again, Dr. Feinstein of Yale has offered a revealing insight. According to Dr. Feinstein: [I]n the current fervor of anti-smoking evangelism, what young scientists would want to risk their career and what older scientists would want to risk their reputation by doing anything that might be construed as support for the "bad guys" of the tobacco industry? What governmental agency would fund research in which the established "accepted" anti-smoking doctrines were threatened by a study proposed by someone -- an obviously deranged skeptic -- who wanted to do an unbiased, objective investigation? (p. 304). In the same article, Dr. Feinstein revealed that he "recently [had] heard an authoritative leader in the world of public health epidemiology make the following statement: 'Yes, it's li Risk Studies Differ on Passive Smoking, Washinaton Times, November 20, 1992, p. A3.

15 - 12 - rotten science, but it's in a worthy cause. It will help us get rid of cigarettes and become a smoke-free society '', (p. 303). Because the debate over ETS has been caught up in the larger, highly emotional controversy about active smoking, the role of EPA in collecting, evaluating and disseminating scientific information about ETS becomes even more important. The Superfund Amendments and Reauthorization Act of 1986 ("SARA") gave EPA the role of "providing information and guidance" to the public on indoor air and radon. 42 U.S.C. S 7401 note. SARA required EPA's research agenda to be reviewed by the Agency's independent Science Advisory Board ("SAB"). The SAB consists of scientists from outside EPA whose role is to assess the factual and theoretical bases for EPA's research and reports. The SAB is supposed to operate as a check on the Agency's use of science in the formulation of regulatory policy -- to ensure that objective scientific inquiry is not subverted to serve political rather than scientific ends. Unfortunately, the SAB has not operated intended in the case of ETS. As a result, there has been little or no brake on the antismoking proclivities of individual EPA staff members. B. Early EPA Staff Initiatives ConcerninQ ETS as y EPA's policy of promoting restrictions on smoking seems to have begun with James L. Repace, an "environmental protection specialist" in EPA's Indoor Air Division. In 1980,

16 even before the first major ETS health claims appeared in the scientific literature, Repace wrote with A.H. Lowrey an article reporting on particulate matter in the air of various environments such as bars, restaurants and bingo parlors, without distinguishing whether those particulates were from ETS or some other substance or activity.ll/ The only "office" measurements made by Repace were in an experimental, enclosed room in which thirty-two cigarettes were smoked in less than one hour, generating ETS levels grossly in excess of those encountered in the real world. Subsequent research has discredited both the methodology and conclusions of the 1980 Repace study.lZ/ On the basis of these observations, however, the article claimed that "indoor air pollution from tobacco smoke presents a serious risk to the health of nonsmokers ***[that] deserves as much attention as outdoor air pollution."1'/ A few years later, Repace published (again with A.H. Lowrey) an article purporting to show that ETS was riskier ui A.H. Lowrey and J.L. Repace, Indoor Air Pollution, Tobacco Smoke and Public Health, Science, vol. 208, pp. 464- 472 (1980). lZi ee, e.a., S. Turner, et al., Measurements of Environmental Tobacco Smoke in 585 Offices, Env. Int., vol. 18, pp. 18-28 (1992); C. Proctor, N. Warren, and M. Bevan, Measurements of ETS in an Air-Conditioned Office Building, Env. Tech. Lett., vol. 10, pp. 1003-1018 (1989). i'/ Repace and Lowrey (1980), supra note 11, at 471.

17 than "all regulated industrial emissions combined."L" This second article by Repace and Lowrey, which represented a crude attempt at-quantitative risk assessment, has been roundly criticized by both government and private sector scientists.lsi Repace's extensive work with political advocacy organizations such as the Group Against Smoke Pollution ("GASP") and Action on Smoking and Health ("ASH") and his 1-IV J.L. Repace and A.H. Lowrey, A Quantitative Estimate of Nonsmokers' Lung Cancer Risk From Passive Smoking, Env. Int., vol. 11, pp. 3-22, at 12 (1985). This study was not funded or sponsored by EPA. Repace apparently undertook the study on his own initiative. The source of his funding has never been revealed. 15, Reviews critical of the Repace and Lowrey risk assessment, calling their methodology and conclusions into question, were completed by EPA's Carcinogen Assessment Group prior to publication of the Repace and Lowrey paper. See E. Anderson, Repace and Lowrey's Estimate of the Lung Cancer Risk from Passive Smoking (undated); H. Gibb, Repace and Lowrey's Estimate of the Nonsmokers' Lung Cancer Risk from Passive Smoking (undated). In addition, the Repace and Lowrey paper was criticized by the Congressional Office of Technology Assessment in Passive Smoking in the Workplace: Selected Issues, pp. 21-22 (May 1986). Other scientific articles criticizing the Repace and Lowrey risk assessment as well as their earlier work on ETS include A. Gross, Risk Assessment Relating to Environmental Tobacco Smoke, Environmental Tobacco Smoke, Proceedings of the International Symposium at McGill University, D.J. Ecobichon and J.M. Wu, (eds.), Lexington Books, Lexington, Mass., pp. 293-302 (1990); N. Balter et al., Causal Relationship Between Environmental Tobacco Smoke and Lung Cancer in Non-Smokers: A Critical Review of the Literature, Proceedings of the 79th Annual Meeting_of the Air Pollution Control Association (1986); A. Arundel et al., Nonsmoker Lung Cancer Risks From Tobacco Smoke Exposure: An Evaluation of Repace and Lowrey's Phenomenological Model, ~ of Env. Sci. and Health, vol. 84(1), pp. 93-118 (1986); M. Lebowitz, The Potential Association of Lung Cancer With Passive Smoking, Env. Int., vol. 12, pp. 3-9 (1986); P. Burch, Health Risks of Passive Smoking: Problems of Interpretation, Env. Int., vol. 12, pp. 23-28 (1986). a

18 - 15 - private and professional focus on smoking raise questions about Mr. Repace's ability to evaluate indoor air issues in a balanced manner. Since the 1970s, Mr. Repace also has been appearing as a paid witness in numerous lawsuits and testifying before various legislative bodies to support governmental restrictions on smoking. Consider in this regard Mr. Repace's statements to the press in reaction to the defeat of an antismoking legislative proposal in Maryland: People aren't going to stand for this. Now that the facts are clear, you're going to start seeing nonsmokers becoming a lot more violent. You're going to see fights breaking out all over. Washington Star, April 5, 1980, p. D-1. Based on my own experiences with Mr. Repace, I do not find these accounts surprising. In 1991, at the invitation of EPA Administrator Reilly, my staff interviewed several EPA employees as part of my and the Oversight Committee's efforts to gather the facts about EPA's procedures in preparing ETS-related documents. When he presented himself in my office, however, Mr. Repace categorically refused to answer any questions. He was accompanied by John Banzhaf, ASH's Executive Director, and Mr. Nantkes of the EPA General Counsel's office. Both were said to be serving as Mr. Repace's attorneys. Within minutes after Mr. Repace left my office, my staff received inquiries from the media characterizing my efforts as "intimidation." During the late 1980s, Mr. Repace became the driving force behind EPA's push to classify ETS as a "Group A" y

19 - 16 - carcinogen. He began by outlining plans for two reports designed to promote the elimination of ETS. Although his plans personally to draft a"handbook" on the subject were not realized, Repace assumed primary responsibility for two long- term projects -- an "ETS literature compendium" and an "ETS workplace smoking policy guide," as well as a smaller project, an "ETS fact sheet." These projects were meant to further the agenda first announced in Repace's 1980 article. Even as Mr. Repace expanded his activities within the Indoor Air Division, he was traveling around the world, at the invitation and expense of smoking organizations, to appear at various conferences and media events to promote antismoking restrictions. For example, Mr. Repace traveled to New Zealand in 1990 to support antismoking legislation in that country. Press coverage of his activities there was typical of Mr. Repace's media appearances, including the identification of Mr. Repace as an EPA employee unaccompanied by the required disclaimer that his views did not then reflect an official EPA position. In numerous media interviews, Mr. Repace has made the baseless assertion that 50,000 people in the U.S. die each year from exposure to ETS and has left the clear impression that these views reflect EPA's official position rather than his personal views. Such demonstrated bias would create a serious conflict of interest issue at any regulatory agency, apparently with the exception of EPA, most likely leading to

20 - 17 - the official's recusal from further involvement in the issue in question. In•fact, Mr. Repace continued to play a key role in the preparation of documents for the public that were represented as neutral and dispassionate analyses of the facts pertaining to ETS despite the advocacy role he was playing in his "private capacity." C. How EPA Used Its Role In Indoor Air Research To Further An Antismoking Agenda 1. The ETS "Fact Sheet" In 1989, Repace prompted the Agency's publication of a "Fact Sheet" on ETS. Despite its name, "Indoor Air Facts Number 5" made extravagant health claims about ETS, going far beyond the conclusions of the 1986 reports of the National Academy of Science ("NAS") and Surgeon General on the same subject. For example, it claimed that exposure to ETS was linked to heart disease, when both the NAS and Surgeon General had found that the available studies did not support that claim. The "Fact Sheet" also took certain statements in the 1986 Surgeon General's report out of context in order to claim a consensus that "passive smoking significantly increases the risk of lung cancer in adults" (p. 1). Whereas the Surgeon General and NAS reports had emphasized critical limitations on their findings of a possible connection between exposure to ETS and lung cancer, the "Fact Sheet" ignored those limitations and treated the purported relationship as irrefutable.

21 The "Fact Sheet" also failed to note that even the limited conclusions of the Surgeon General and NAS reports had been strongly criticized and that other reviewers -- including the World Health Organization's International Agency for Research on Cancer -- had reached different conclusions based upon the same data. See, e.a., IARC Monograph on the Evaluation of the Carcinogenic Risk of Chemicals to Humans: Tobacco Smoking, vol. 38, p. 308 (1986). Furthermore, a number of other studies and reviews published since 1986 contradicted the findings of the Surgeon General and NAS reports with respect to the purported relationship between ETS and lung cancer.1_6/ None of these was mentioned in the "Fact Sheet." Finally, the "Fact Sheet" characterized ETS as "a major contributor of particulate indoor air pollution" (p. 2) while failing to mention the numerous studies showing that lsi A few representative examples include: G. Gori and N. Mantel, Mainstream and Environmental Tobacco Smoke, Rea. Tox. and Pharm., vol. 14, pp. 88-105 (1991); M. Reasor and J. Will, Assessing Exposure to Environmental Tobacco Smoke: Is It Valid to Extrapolate From Active Smoking?, J. Smoking- Related Dis., vol. 2, pp. 111-127 (1991); J. Fleiss and A. Gross, Meta-Analysis in Epidemiology, With Special Reference to Studies of the Association Between Exposure to Environmental Tobacco Smoke and Lung Cancer: A Critique, J. Clin. Epidemiol., vol. 44, pp. 127-139 (1991); F. Adlkofer et al., Exposure of Hamsters and Rats to Sidestream Smoke of Cigarettes, Preliminary Results of a 90-day-Inhalation Study, Proc. Indoor Amb. Air Qual. Conf., London, pp. 252-258 (1988); A. Arundel, T. Sterling and J. Weinkam, Exposure And Risk- Based Estimates of Never Smoker Lung Cancer Deaths in the U.S. in 1980 From Exposure to ETS, Proc. Indoor Amb. Air Qual. Conf., London, pp. 242-250 (1988); J.P. Vandenbrocke, Passive Smoking and Lung Cancer: A Publication Bias?, Br. Med. J., pp. 296, 390-391 (1988).

22 - 19 - inadequate ventilation is the single most important cause of indoor air pollution. Significantly, no SAB panel or expert committee ever reviewed the "Fact Sheet's" claims. Instead, the document was distributed freely to the public as if it contained the official, carefully considered policy of the U.S. government rather than simply the personal opinions of Mr. Repace. 2. What EPA Doesn't Know Paradoxically, EPA elsewhere was quite candid in acknowledging the gaps in its knowledge about ETS. EPA's 1987 report to Congress, for example, recognized that indoor air quality is not only a matter of specific pollution sources but also of the ways in which buildings are designed, operated and used. EPA's indoor air quality program purportedly was designed to "address the problem from both perspectives" (p. 8). In its 1989 report to Congress, EPA indicated that it had "moved to establish a research program to remove the scientific uncertainties" identified in the 1986 NAS report on ETS (vol. I, p. 42). In the same report EPA acknowledged that "(a]ctual human exposure to many of these [indoor air] pollutants is at this time-not well understood" (vol. III, p. 11). The 1989 report also emphasized the need for ventilation research, noting that the "entire building system is implicated in issues of indoor air quality" (vol. III, p. 39) and that much more research is needed concerning the VD- 0

23 -ao- numerous variables that determine 36-39). indoor air quality (id. at At this point, I, among others, expressed concern that there appeared to be a contradiction between EPA's conclusions on ETS in the "Fact Sheet" and the Agency's recognition elsewhere that there were large gaps in its knowledge about ETS. In response, EPA's Assistant Administrator for Air and Radiation, William Rosenberg, denied that there was any scientific doubt. In a June 1989 letter to Senator Warner of Virginia, Mr. Rosenberg stated that "[t]he evidence, in our view, is conclusive for lung cancer and for respiratory symptoms in children" and that "ETS has been shown to cause cancer and other health effects in healthy non- smokers." The "Fact Sheet" and Mr. Rosenberg's letter make clear that the Agency had reached firm conclusions concerning ETS without the benefit of either SAB review or public comment. Aside from the question of whether this position was scientifically justified, it is unclear why the Agency then decided to spend millions of dollars to conduct a formal "risk assessment" on ETS for the ostensible purpose of determining whether ETS does indeed pose a risk to health. 3. The ETS Technical Compendium In November 1989, EPA released,a draft ETS "technical compendium," the second of the Agency's documents concerning ETS. Conceived originally as a reference document, .

24 the compendium consisted of ten (later eleven) chapters on a variety of subjects not always directly related to ETS. With the exception of a draft chapter on "Exposure Assessment of Passive Smoking" by Mr. Repace, the compendium articles were solicited from scientists and consultants outside the Agency. Although ostensibly a collection of scientific information about ETS, the first chapter, written by Thomas E. Novotny, claimed, based on public opinion polls, that the public increasingly believes that ETS is harmful to health and therefore supports smoking restrictions. But public opinion and acceptance of smoking restrictions are obviously irrelevant to the scientific and technical issues of whether the restrictions are justified in the first place. In addition, public opinion on scientific issues often is shaped by dramatic reporting, not by familiarity with the science itself. EPA scientists should have recognized that using public opinion to support a scientific hypothesis -- and ultimately, new regulations -- was irresponsible. That is particularly so when individual agency employees had played such a pivotal role in forming the very public opinion upon which they now were proposing to rely. In addition to the chapter on trends in public attitudes, the compendium contained other articles on active smoking and on economic issues surrounding workplace smoking. The only unifying theme of the compendium is that, in the Agency's view, smoking and ETS are "bad." Like most of the .1

25 - 22 - Agency's outside contractors on ETS, many chapter authors for the compendium, including Stanton Glantz, Jonathan Samet, and, of course, James Repace -- had long been active in the antismoking movement. Although styled (and later defended by the Agency) as a scientific reference document, the compendium was in fact designed as an advocacy document for smoking restrictions. The preface to the compendium indicated that it was intended to be distributed to scientists, public officials, legislators and those in the private sector who are or may be concerned about ETS. The overall purpose was to "provide information necessary to allow the public, government agencies, and the building industry to make well-informed choices regarding exposure to ETS" (p. 2). The letter accompanying the draft compendium indicated that the compendium was an "integral component of (EPA'sj ETS strategy," which was to include a separate "policy-maker's guide" that in turn would be a simplified version of the compendium. It is hard to see how policymakers could make "well- informed" choices on the basis of the information contained in the compendium or the simplified version known as the "policy guide." Both the compendium and the policy guide were initiated and drafted long before the Agency had prepared a formal risk assessment on ETS. By these actions, EPA violated the public trust in three ways. First, EPA conducted an end run around the statute creating the SAB review mechanism. In 1 1

26 - 23 - \ doing so, it not only threatened the integrity of the SAB review process but ran the risk of alarming the public for no good reason. In addition, EPA deliberately permitted policy to drive science rather than the other way around. As the "Fact Sheet" demonstrated, EPA started with the restrictive policy it wanted to promote and then worked backward to "develop" the scientific conclusions necessary to justify that policy. Finally, even though it has no statutory authority to regulate smoking, EPA's Indoor Air Division sought to become the de facto federal ETS regulatory authority by using the "Fact Sheet," the compendium, the policy guide and the ETS risk assessment to frighten employers and state and local regulators into imposing additional restrictions on smoking. 4. Bias In Preparing The Compendium Although still in draft form and not reviewed by the SAB, the compendium received widespread media attention. Robert Axelrad, Director of the Indoor Air Division, had asserted unequivocally in a May 8, 1990, letter to The Tobacco Institute's counsel that EPA was "not interested in promoting any media attention to the documents while they are in draft form and will do everything possible to assure that they are not construed as EPA policy." Notwithstanding Mr. Axelrad's assurances, the compendium was leaked to the press and its more sensational claims openly publicized prior to any scientific review of the document's contents. According to a February 1993 report by the General Accounting Office ("GAO"),

27 - 24 - EPA staff in April 1991, before EPA had completed its own internal review of the document, improperly sent a draft of the compendium to several external reviewers, including Stanton Glantz. Glantz, an outspoken antismoking activist since the 1960s, immediately proceeded to provide a copy to an Associated Press reporter. According to the GAO, Glantz claims that his release of the report was simply a"mistake." Most disturbing was the public dissemination of the chapter on cardiovascular disease. Glantz, one of the authors of that chapter, appeared in Boston -- again with James Repace -- at the World Conference on Lung Health in late May 1990 and gave both a presentation and news interviews on that chapter. Dr. Glantz used the occasion to repeat and underscore the unsupported claim that more than 30,000 nonsmoking Americans die of heart disease each year as a result of exposure to ETS. This activity made a mockery of EPA's procedures for ensuring that its policy documents receive a full and fair review before they are finalized. Glantz has a long record of public statements demonstrating his commitment to that political agenda, notwithstanding the lack of scientific support for his claims concerning ETS. While his training is in mechanical engineering rather than medicine or some other relevant discipline, he has pontificated on every conceivable smoking-related topic, such as advertising and economic issues, about which he plainly can make no claim to professional competence. y

28 - 25 - To cite one example, Dr. Glantz's organization stated in its 1983 annual report that "irrefutable medical and scientific evidence has confirmed what millions of nonsmokers have intuitively known for a long time: Tobacco smoke ***. poses a serious health risk for nonsmokers who breathe secondhand smoke." Thus, Dr. Glantz's mind was closed on the ETS/cardiovascular disease issue three years before the 1986 reports of the Surgeon General and National Academy of Sciences both determined that there was insufficient evidence to support the claim that exposure to ETS presents any increased risk of heart disease. At an April 1990 antismoking conference in Perth, Australia, Glantz made a series of revealing comments. First, he noted that "it's very nice to see that the same ideas that a few of us were advocating in 1983 which were viewed as so strange, radical and hopeless have now really become very mainstream." A self-described "lunatic" on the issue, Dr. Glantz then excoriated the American Cancer Society for its alleged decision to terminate an employee for intemperate behavior in connection with a local smoking ordinance. "He (the employee] may be a little impolitic which I of course view as a plus. But you know activists need (to be] rewarded[.] * * * I had no objection to all the people who were given awards on the first day [of the conference], but I 1 did notice that there was not a single lunatic among them ***." He further confessed that "[t]he main thing the

29 - 26 - science has done on the issue of ETS, in addition to help people like me pay mortgages, is it has legitimized the concerns that people have that they don't like cigarette smoke. And that is a strong emotional force that needs to be harnessed and used." Glantz concluded by stating that "we are all on a roll and the bastards are on the run and I urge you to keep chasing them." I expressed my concern to Mr. Reilly that the selection of Dr. Glantz to write part of the ETS compendium was a grave error in judgment. Glantz's involvement, coupled with leaks of information and inadequacies in the review process, led me to conclude that the Agency's procedures had been seriously compromised. In response, Mr. Reilly assured me that the SAB would be given an opportunity to review the technical compendium and that EPA had not yet decided whether Glantz's chapter would be included in it. Ultimately, however, the technical compendium was not reviewed by the SAB and Mr. Reilly subsequently took the position, contrary to the Agency's prior statements, that the compendium was not a basis for the policy guide or risk assessment. 5. EPA Reneges On Its Pledge To Permit The SAB To Review The Technical Compendium Despite Mr. Reilly's repeated oral and written assurances, the SAB was never given an opportunity to review the compendium. In early 1991, EPA switched course and began to act as if the compendium had never been written. In a 74-814 0 - 93 - 2

30 - 27 - letter to me, Mr. Reilly claimed that SAB review of the compendium was unnecessary since the compendium had "no direct bearing on future agency action." When he was questioned by the House Commerce Committee's Subcommittee on Health and the Environment in April 1991, EPA's Deputy Administrator Henry Habicht could only say the compendium was "on a separate track." That the technical compendium got onto "a different track" is curious, considering especially that when the SAB finally did review the policy guide in December 1990, it requested a "supporting document that explicitly states the technical basis for each of [the policy guide's] summary statements on the state of scientific knowledge." As noted above, EPA originally intended the policy guide to be a simplified version of the compendium. When I asked Mr. Reilly "[w]hat led the agency to redefine the role of the technical compendium," the answer was that the media had interpreted its release to the public as EPA endorsement of the draft document's content. As EPA staff had rather disingenuously told the media at the time the compendium was leaked, that interpretation was inappropriate. The Associated Press reported on May 29, 1991 that -- (m]uch of the controversy over the report has focused on the estimate of 37,000 heart disease deaths attributed to secondhand smoke. khat section was written by Stanton Glantz and Dr. William Parmley of the University of California, San Francisco. Y

31 "Thirty-seven thousand may be a figment of Stan Glantz's imagination and William Parmley's imagination, or it may be a real estimate," said Axelrad [Director of EPA's Indoor Air Division]. . "Any effort or any attempt to imply any kind of endorsement or acceptance by EPA" of the death estimates in the technical compendium "is at this time totally inappropriate," he said. D. The ETS "Policy Guide" 1 In June 1990, EPA released formally the first draft of its policy guide, entitled "Environmental Tobacco Smoke: A Guide to Workplace Smoking Policies." The guide's stated purpose was to provide government and private sector decision makers with information on the technical basis for controlling exposure to environmental tobacco smoke and to describe a variety of technical and policy options for instituting effective smoking restrictions. It has never been clear why EPA prepared and released a risk management document like the policy guide and before that, the "Fact Sheet" and compendium, in advance of any final scientific assessment of the supposed "risk" to be managed. Ordinarily, an agency concerned with public health responds to allegations that a particular substance presents a risk to health by conducting a formal analysis of the scientific data called a "risk assessment." This assumes, of course, that the agency has statutory authority to regulate that substance. If the risk assessment justifies the conclusion that a significant risk exists, the next step is to -1

32 - 29 - develop policies or regulations to mitigate that risk. As the National Academy of Sciences/National Research Council has recognized, risk assessment is concerned with defining the health effects of exposure to hazards, while risk management is the process of selecting the most appropriate policy alternative by integrating risk assessment results with engineering data and social, economic and political concerns. 17/ Obviously, if the risk from ETS at levels typically encountered in the workplace was found to be minimal, there would be no justification for recommending, as did the "Fact Sheet" and policy guide, that smoking be prohibited except in separately ventilated areas. Even Administrator Reilly recently conceded in a letter to me that "beginning the development of an Agency risk assessment after the commencement of work on the draft policy guide gave the appearance of the very situation -- i.e., policy leading science -- that I am committed to avoid." Equally troubling is the fact that the guide even went so far as to encourage ETS-based lawsuits by employees against their employers. In doing so, the policy guide grossly.overstated the legal significance and precedential value of the handful of cases favorable to the policy guide's ZY Committee on the Institutional Means for Assessment of Risks to Public Health, National Academy of Sciences/National Research Council, Risk Assessment in the Federal Government: Manacing the Process, pp. 151, 153 (1983). y i i

33 . - 30 - viewpoint while understating the significance of the vast majority of others, which were not. The perception that the EPA policy guide on workplace smoking crosses the line from information into advocacy is not mine alone. ICF Incorporated, which functioned as the nominal prime contractor for preparation of the policy guide, recently provided me with a marked-up copy of the guide purporting to reflect ICF's own handwritten editorial comments. I discovered that my concerns about the tone and emphasis of the legal discussion in the policy guide were shared by ICF's own internal reviewers. Marginal comments on this section included such observations as "it seems really weird to have a much lengthier discussion on litigation than on the effectiveness of various mitigation alternatives" and "this discussion is too rah-rah -- this chapter should be more objective in tone." For reasons that have never been explained fully, however, ICF apparently was not asked to comment on the draft prior to its public release in June 1990, even though ICF supposedly supervised the preparation of this document by its subcontractor, the Smoking Policy Institute. As will be discussed later, many questions remain about the Smoking Policy Institute's role in preparing the policy guide. The SAB's eventual review of the scientific conclusions in the policy guide was incomplete at best. Prior to the guide's release, EPA had decided to limit the SAB's I

34 - 31 - review to those parts that referred to the risk assessment, to ensure that the latter was "properly characterized." Since the SAB had not yet seen a risk assessment draft it could approve, one must question how it could make sure that the policy guide properly characterized it. Moreover, the policy guide covered a much broader range of issues than the risk assessment. The policy guide had been drafted based on the technical compendium, which, as I have explained, EPA has never given to the SAB to review, and which makes many more health claims than does the ETS risk assessment. These include unsupported assertions that ETS has been shown to cause cardiovascular disease and suggestions that ETS has been assbciated with brain cancer. Such extravagant claims are at odds with EPA's private admissions to other government officials that "[w]e know very little about ETS exposure in the workplace, and cannot estimate the relative significance of workplace vs. home vs. all other sources of exposure; nor can we clarify the significance/role/impact of exposure to other pollutants (e.g., radon and other air carcinogens) in addition/ conjunction with ETS exposure."ll/ If EPA knows "very little" about ETS exposure in the workplace, it is difficult 's This statement was contained in an undated background summary of the risk assessment entitled "Findings in a Nutshell," prepared by EPA sometime in mid-1991. The summary was given to the Occupational Safety and Health Administra- tion, the federal agency that has authority to regulate indoor air quality in the workplace. y

35 - 32 - to understand why it would decide to issue a workplace policy guide. EPA cannot assert, as it did repeatedly in the policy guide, that only smoking bans or separately ventilated smoking lounges are appropriate without occupational exposure data. In the absence of such data, the policy guide's recommenda- tions necessarily reflect only the personal preferences of the guide's authors. I expressed these concerns many times in writing to EPA Administrator Reilly and received noncommittal replies. E. Irregularities In Contract Award Procedures The selection of the policy guide's author, Robert Rosner of the Smoking Policy Institute ("SPI"), raises further questions about the document's objectivity and reliability. SPI is in the business of counselling employers on the implementation of smoking policies and operating smoking cessation clinics. This organization therefore had a vested financial interest in conveying the impression in the policy guide that employers without smoking policies or cessation programs were at risk of lawsuits or worse. In addition, Mr. Rosner had no technical background in any of the areas on which the policy guide purported to reach definitive conclusions.}'-/ These include the possible 19/ According to his resume, Mr. Rosner has a bachelor of science degree in occupational therapy and a master's degree in business administration. His work experience includes jobs as a press intern, restaurant manager, recruitment coordinator of Big Brothers/Big Sisters of Tacoma, radio announcer, founder of an organization "to tackle Seattle's rising crime (continued...) "t

36 - 33 - health effects of exposure to ETS (and other indoor air components), the legal ramifications of workplace smoking policies, public attitudes toward smoking, and the claimed economic consequences of permitting smoking in the workplace. Apart from this obvious conflict of interest and lack of necessary qualifications, the award of the SPI subcontract appears to have violated federal procurement regulations, an impropriety EPA has recognized only grudgingly. As ranking minority member of the Subcommittee on Oversight and Investigations of the House Committee on Energy & Commerce, I uncovered evidence that SPI was improperly sole- sourced on the subcontract, and that the choice was made by Indoor Air Division officials at EPA rather than by the prime contractor, ICF Incorporated. This abuse of the contracting process, as well as the conflict of interest noted above, has been brought to the attention of the EPA Inspector General. Under federal regulations, an agency may not specify the use of a certain subcontractor without competitive bidding. In the case of the policy guide, EPA staff first solicited the Smoking Policy Institute for the job and then sought to funnel the work through the main contractor, ICF 'V( ... continued) rate" and as Executive Director of the Smoking Policy Institute. Nothing in Mr. Rosner's education or professional background suggests that he is "uniquely" qualified to assess the "technical and scientific literature on tobacco smoke exposure and health impacts," as was claimed in an undated memorandum purporting to justify the award of the policy guide subcontract to SPI on a sole-source basis. +11

3? - 34 - Incorporated. In fact, Robert Axelrad telephoned SPI's Rosner in mid-1988, before getting ICF involved, and told Rosner that EPA had $30,000 to spend on the project for that fiscal year and also would provide funding the following year. On July 23, 1988, Mr. Axelrad followed up with a bid solicitation letter to Mr. Rosner: The attached stack of material represents the current status of the technical manual on environmental tobacco smoke which we discussed in our telephone conversation on the 11th. As you will see from a review of this material, substantial portions of the manuscript are still to be written/ assigned/edited. What I am looking for is someone who can take the lead role at this stage in ensuring that the document is: a) conceptually sound; [and] b) a useful addition to the body of knowledge available on environmental tobacco smoke at a reasonable cost. This would entail managing the entire process from this point to completion of a camera-ready manuscript. If you are interested in taking on the task, please send me a letter describing: 1. The conceptual changes you would make, and a revised outline reflecting your suggested changes; 2. A brief description of tasks which you perceive to be necessary to get from here to there; and 3. A reasonably detailed all-inclusive budget for accomplishing the above. As I mentioned to you on the phone, I have approximately $30K to begin the project this fiscal year and am prepared to put limited funds into the effort next year. y

38 - 35 - An arrangement was made in August 1988 that SPI would be paid by making SPI a subcontractor to ICF.'-°/ The "justification" memo that ICF wrote to support the sole-source subcontract stated that SPI was uniquely qualified. There was no support for that claim, however, nor any indication that ICF had made any evaluation of SPI. The drafts of the policy guide written by SPI were not even copied to ICF but went straight to Mr. Axelrad at EPA. The only copy of the policy guide commented upon by ICF was the draft released publicly in June 1990. This raises questions about Mr. Reilly's statement to me in March 1992 that "ICF's role was, and is, more than simply a conduit for payments to the Smoking Policy Institute. In addition to providing comments on the various drafts prepared, ICF managed much of the external review process ***." The documents from ICF's files recently turned over to me suggest that, far from commenting on "various drafts," ICF's first opportunity to comment on the policy guide occurred when the document was '-OV A June 1991 Report by the House Subcommittee on Oversight and Investigations identifies ICF as one of EPA's ten largest contractors, with active contracts having a potential total value of more than $300 million. The Report notes that audits of ICF's work, performed for EPA by the Defense Contract Audit Agency, had found "numerous problems," including instances in which ICF billed EPA for subcontractor charges before ICF had paid the subcontractors (Report, p. 25). Apparently, EPA also has made it a practice to use ICF as a vehicle to provide subcontracts to consultants selected by EPA. As indicated earlier, EPA's cozy relationship with its contractors and negligent management practices in connection with contracting procedures have been the subject of an ongoing investigation by the Oversight Subcommittee. 1 L _ J

39 - 36 - released for public comment. In sum, ICF file documents confirm that its involvement began only after the policy guide was released publicly -- and after I had begun to raise • questions about the propriety of the SPI contract.* The situation with SPI further underscores the fact that a risk assessment was crafted to justify a policy that had been adopted long before. The record clearly shows, first, that EPA staff hand-picked SPI to prepare documents that would advocate workplace smoking restrictions long before any assessment of the science had been completed; second, that EPA arranged for SPI to be signed up as a subcontractor to ICF to circumvent applicable federal procurement requirements; and finally that, in this way, taxpayer funds helped produce what is essentially a marketing and promotion aid for SPI's business. Unfortunately, the SPI contract appears to be but one example of a more general pattern of contractual problems at EPA. In light of widespread revelations about EPA's contracting practices, on July 8, 1992, Chairman Dingell convened the House Commerce Committee's Subcommittee on Oversight and Investigations to conduct hearings on "The Collapse of Contract Management at the U.S. Environmental Protection Agency." The majority of the hearing was devoted to a number of instances of contractual abuse and mismanage- ment at EPA that had been identified by the GAO and the EPA Inspector General.

40 - 37 - Whether the problems with the SPI subcontract would have come to light absent a congressional investigation is an open question. The replies that I received to my inquiries to Mr. Reilly as late as March 1992 were less than forthcoming. In a letter to me dated March 24, 1992, for example, Mr. Reilly unequivocally stated that -- (w]e do not agree that the subcontract issued to the Smoking Policy Institute (SPI) was issued in violation of Federal procurement law. * * * These contracts were competitively awarded in full compliance with all Federal contract laws. The smoking policy guide was well within the scope of the [ongoing EPA/ICF] contracts and ICF's selection of the Smoking Policy Institute was proper based on their determination that the SPI had unique or specialized experience in this area. Mr. Reilly also stated without qualification that "[t]he Smoking Policy Institute was not selected by EPA staff but by ICF," even though Mr. Axelrad had told my staff six months earlier that EPA staff had selected SPI. Even more curiously, at the Oversight hearing on July 8, 1992, Mr. Reilly repeatedly claimed that he lacked knowledge about how SPI was selected, the nature of SPI's supposed "specialized experience," the fact that SPI was in the business of promoting workplace smoking restrictions, or any other information pertinent to the unqualified statements he had made in his March 24, 1992, letter to me. It is impossible to square these oral statements with the prior and }

i 41 - 38 - quite detailed assurances Mr. Reilly had provided to me in writing. Since then, EPA has reversed its earlier public position that the SPI contract was awarded properly. At the July 8 hearing, the Agency's own Chief Financial Officer acknowledged that "this might very well be an improper contracting practice. It may be a pass-through and the designating of the $30,000 may also be improper." Mr. Reilly's most recent letter to me dated July 31, 1992, attaches a memorandum from Mr. Axelrad to his supervisor at EPA, Eileen Claussen. Mr. Axelrad's memorandum acknowledges that his decision to contact SPI outside normal procurement procedures was inappropriate and that his recommendation "probably" caused ICF to select SPI as the subcontractor. Mr. Reilly indicated at the July 8 hearing that he had rQguested an investigation by EPA's Inspector General of the apparent conflict of interest and other improprieties in the award of the SPI contract. Congressmen Dingell and I made a similar request and asked that the Inspector General report his findings to the House Subcommittee on Oversight and Investigations. in March 1993, the Inspector General sent me a letter setting forth his findings. In that letter, the Inspector General states as follows: We believe the award [of the contracts to SPI] was tainted in how it was processed. First, there was no attempt by ICF to seek competi- tion. Second, the actions by an EPA program r or y

42 - 39 - official gave the appearance that he, rather than ICF, selected the subcontractor. The Inspector General also found that "the EPA believed that "it may have been 'unauthorized action' under the EPAAR [EPA Acquisition Regulations]." The Inspector General also indicated that "the procurement should not have proceeded on a non-competitive basis." EPA's contracting improprieties in connection with the preparation of the four ETS documents are not confined to the policy guide. In June 1993, the Inspector General reported to me that similar abuses had occurred in connection with several of the ETS risk assessment subcontracts. The most egregious of these appears to be the subcontract between ICF, once again the prime contractor, and Kenneth G. Brown, Inc., which drafted most of the critical sections on lung cancer. The Inspector General states that in the case of the Brown subcontract, "EPA program personnel and ICF simply circumvented the contracting officers" altogether, clearly a violation of proper procedures. Like the SPI subcontract, the Brown subcontract also was awarded on a non-competitive basis, and the only justification for that decision that could be found was an undated and unsigned "sole source justification" file memorandum. F. The Science Advisory Board's Review Of The Risk Assessment The first drafts of the ETS risk assessment and the c workplace policy guide were released for public comment in 7

43 ~' - 40 - ~ June 1990. At the same time, EPA transmitted the drafts to the SAB, requesting formal review. A hearing before a subpanel of the SAB was held in December 1990. The subpanel reported the results of its review to the SAB Executive Committee in April 1991. The risk assessment was sent back to EPA with directions that it be revised extensively. After major rewriting, a second draft was released in June 1992 and a second SAB hearing was held before essentially the same subpanel in July of that year. Following the SAB's report to the SAB Executive Committee in October 1992, the final risk assessment was released on January 7, 1993. At both the public hearings and in written comments, the validity of most of the risk assessment's assertions was criticized by a number of scientists with expertise in the relevant disciplines. Unfortunately, most of these criticisms were ignored for reasons having nothing to do with science and everything to do with politics. Although the SAB is supposed to function as an independent and unbiased review body, in the case of the ETS risk assessment it became apparent early on that the SAB review process itself had become as intensely politicized as the rest of EPA. 1. How The Panel Was Selected The EPA Science Advisory Board is intended to serve as an independent review body composed of impartial experts from outside the Agency. Its function is to ensure Agency .~------~ y

44 - 41 - accountability and integrity in the use of science.3-V In addition to the seven standing members of the SAB's Indoor Air Quality and Total Human Exposure Committee, the decision was made at EPA to select nine scientists to serve in an ad or capacity on the panel that was to review the draft ETS risk assessment and policy guide. Because they were to review work that had been developed and put forward by Agency staff and others with vocal antismoking records, their ability to conduct a fully objective critique was essential. Therefore, at the outset I expressed concern to EPA that the selection process be above reproach. I also urged EPA to apply certain -- I thought self-evident -- criteria to ensure objectivity. My suggestions included that (1) the SAB panel be limited to recognized authorities with relevant specialties; (2) the members should not have participated in the development of the technical compendium, the policy guide, or the risk assessment, or have already provided comments on them, including serving as EPA contractors or grantees; and (3) they should not have become enmeshed in the political controversy surrounding ETS by having testified for or against smoking restrictions, or by having been active members of groups that had taken a position on the broader issues concerning smoking. U/ United States Environmental Protection Agen cy, Advisory Committee Charter, Science Advisory Board, November 6, 1987. rr"

I 45 - 42 - EPA squarely rejected the second and third criteria. In his reply to me, Mr. Reilly stated it was EPA's belief that there was merit in having individuals who were previously involved, promising that "the extent of any prior involvement will be publicly disclosed at the meeting." In fact, that was not fully done. Regarding activists' filling SAB positions, Mr. Reilly also promised that "should technical conditions require the presence of such an individual on the panel, he or she would be balanced by the presence of an individual who could represent the opposing point of view." Unfortunately, the panel ultimately was not balanced in the way Mr. Reilly had suggested. Not one of the candi- dates suggested by the tobacco industry was even contacted for inclusion on the panel. In contrast, three of six persons suggested by antismoking organizations were chosen, including Dr. David Burns. The selection of Dr. Burns was especially puzzling, given that Mr. Reilly had assured me shortly before Dr. Burns' selection that "experience has shown that the deliberative process is generally not aided if extreme views are represented on the panel itself." Long before EPA appointed him to evaluate the scientific data on ETS, David Burns was spending by his own reckoning half of his time in the antismoking movement. He had claimed in.1988, for example, that ETS caused 3,000 deaths per year (Nonsmoking Ordinance, So Far, Proves To Be No Hazard To Economic Health, Los Anoeles 7

46 - 43 - im s, January 8, 1989, sec. 2, p. 1). He also had testified in several cases in favor of local antismoking measures -- including a 1987 initiative in Del Mar, California that would have banned smoking outdoors, on city sidewalks and in beach areas (UCSD Expert is Smoking's Archenemy, Los Angeles Times, August 21, 1989, sec. 2, p. 1). In addition, Dr. Burns had testified in favor of a tobacco advertising ban that a Canadian trial court subsequently held to be,a violation of the free speech guarantee of the Canadian Constitution (RJR- MacDonald, Inc. v. Le Procureur General du Canada, No. 500-05- 009755-883 (Superior Court of Quebec, July 26, 1991)).?Zi In that testimony, Dr. Burns stated that -- in the two years he worked for the National Clearinghouse on Smoking and Health, he had helped devise programs to discourage smoking; he had served on the American Cancer Society committee responsible for setting policy on tobacco issues; he had served as senior scientific advisor for the 1986 Surgeon General's report on ETS and regarded that work as part of his antismoking efforts; he is a consultant to plaintiffs' counsel in tobacco product liability cases. In his Canadian testimony, Dr. Burns acknowledged that his activities are part of an effort to "see smoking '2~ The decision subsequently was reversed on legal grounds, although determinations concerning the persuasiveness of the expert testimony and other factual matters were left undisturbed. Le Procureur General du Canada v. RJR-Mae onald. Inc., No. 500-09-001296-912 (Quebec Court of Appeals, January 15, 1993).

47 ,J r - 44 - behavior disappear from society" (transcript at p. 10470). He acknowledged that "much of the work that [he did] within the university is to teach on *** the means by which tobacco can be controlled within society" (id. at 4964). Dr. Burns demonstrated his dogmatism when he said that there "is no credible scientist" who would disagree with his views. Finally, Dr. Burns made clear that his single-minded focus is on promoting and supporting restrictions on the use of tobacco in any public place in order to penalize smokers for their decision to smoke. [I]n order to modify smoking behavior, one needs to look at * * * changing the public image of tobacco, changing the locations in which tobacco can be used, to create an environment in the larger society that actually discourages rather than encourages the use of this product (id. at 10462). [T]he key * * * is not simply providing the information * * * it's also to change the larger environment in which that individual functions to make it less conducive to using cigarettes and more rewarding to not use cigarettes (id. at 10462-463). - I'm also not particularly inclined to testify to issues relating to the benefits, if you will, of tobacco or to any of the open scientific questions * * * (~ at 4999). - And to the extent that [the Del Mar smoking ordinance] changes the image of the cigarette smoker and changes the psychological and sociologic rewards of cigarette smoking, then one -- then it contributes to changing the environment in which smoking occurs (JdA. at 10514-515). By his own testimony, therefore, Dr. Burns is incapable of even discussing the "open scientific questions" I

48 - 45 - concerning tobacco use, let alone evaluating scientific data relevant to those questions in an objective manner. I would add, by the way, that Dr. Burns himself has not conducted or published any original scientific research on ETS. Some at EPA recognized, if belatedly, that Dr. Burns' inclusion on the SAB panel would not be appro- priate. In addition to the problems previously mentioned, Burns had been involved in reviewing and commenting on earlier versions of the risk assessment and could hardly be expected to be objective in evaluating a report reflecting his own substantial input. On October 22, 1990, the New York Times reported that SAB Staff Director Dr. Donald Barnes had acknow- ledged that Dr. Burns was not suitable for membership because of his demonstrated bias against smoking. Imagine my surprise when, only two days after the New York Times story appeared, Mr. Reilly informed me that Dr. Burns would be included on the panel after all! The decision not to include Dr. Burns had been followed immediately by claims in the press by antismoking, activists that Dr. Burns had been dropped because of political pressure from the tobacco industry. At the same time, the press also was reporting that some committee members had acted as advisors or peer reviewers for the Council on Indoor Air Research ("CIAR"), a research organization that receives funding from the tobacco industry. Allegations were made that these committee members were biased as a result of their E /~i.1

49 - 46 - association with CIAR. In fact, the allegations were baseless. Four of the six people with CIAR associations already were standing SAB committee members, and not one had been suggested by the tobacco industry. Regardless of the falseness of the charges, public reporting of them placed pressure on the members not to criticize the Agency's drafts lest they be seen as "biased" in favor of the tobacco industry. As one of these individuals, SAB panel chairman Dr. Lippmann, candidly admitted to the press, "[i]t's not that I'm a tool of industry. I'm a bigger tool of government. I've been working for the EPA longer. I have more to lose by offending the EPA than industry." ~~ Another panelist, James Woods, promised the Associated Press on November 20, 1990 -- well before the SAB hearing -- that "the comments he intends to make on the EPA report will demonstrate that he is not biased toward tobacco companies. 'Wait and see what I say at the hearing.'° At this point the process had become so deeply enmeshed in controversy that an objective review by the panel was no longer possible. As a consequence, the only responsible course of action would have been to reconstitute the panel. Even the New York Times called for such a move, in an editorial entitled "Objectivity Up in Smoke." In response, the EPA simply proceeded as if no problem existed. .U/ Impartial Panel for Smoking Study Proves Hard to Find, Los Anceles Times, November 24, 1990, p. A-27.

50 J - 47 - During my investigation, we learned from both Donald Barnes, the SAB staff director, and Robert Flaak, his assistant, that Mr. Flaak deliberately went around his boss, Dr. Barnes, to Dr. Lippmann and enlisted his support in overruling Dr. Barnes' decision not to invite Dr. Burns to join the panel. It would not be unreasonable in these circumstances for a scientist in Dr. Lippmann's position to fear the public consequences of a refusal to give in to the demand of the antismoking lobby on this issue. There also were suggestions that Dr. Lippmann and Mr. Flaak may have met with at least one reporter who had written a series of articles on ETS prior to the December 1990 SAB meeting to discuss the press coverage the meeting might generate based upon the panel's conclusion. Many unanswered questions remain about Mr. Flaak's behind-the-scenes role in conducting off- the-record meetings with antismokers and other activities in connection with the panel's composition. There are questions about the objectivity of other SAB panel members. As mentioned earlier, Jonathan Samet of the University of New Mexico had stated that uncertainties regarding ETS scientific data should not interfere with tobacco control efforts. Like Burns, Samet also had been involved in reviewing earlier drafts of the risk assessment. Before that, he had played a major role in drafting or reviewing portions of the technical compendium and policy guide. In addition, eight of the fifteen panel members were ! I

4 51 - 48 - themselves responsible for scientific studies relied upon in the first or second drafts of the risk assessment -- hardly the type of circumstances that ensure independent evalua- tion.?`/ In response to my written and oral communications of concern about these developments, Mr. Reilly blithely assured me that "the panelists are well qualified to deal with the technical issues that are being directed to them. To the degree that there are differing scientific views on the information under review, the SAB process * * * allow(s] for and mandate(sJ a balanced, open discussion of the issues, with ample opportunity for input from and observation by the public." Of course, all the discussion and "input" in the world will not sway a mind already closed on the issue in question. Ultimately, moreover, no such discussion was permitted and input from the public was sharply limited. When I pressed Mr. Reilly on these points, he replied with a series of non sequiturs. Stating that "it is not easy to select a panel of experts on any 'highly charged emotional and political issue' such as ETS," he then asserted without further explanation that the SaB panel would be capable of providing objective advice and that to delay the process to reconstitute the panel would "not serve the public IV Drs. Benowitz, Blot, Eatough, Hammond, Kabat, Lebowitz, Samet and Weiss had been responsible for scientific studies concerning ETS cited in the first or second drafts of the risk assessment. ~

52 -49- interest." How the public interest was served by EPA's pressing ahead despite the problems th4t had arisen has never been explained. Interestingly, Mr. Reilly made no attempt to deny or refute the specific allegations made against Dr. Burns and other panel members. Equally disturbing, I have learned recently that, as the SAB considered the first draft of the risk assessment, Dr. Steven Bayard, the EPA staff member with principal responsibility for the document, was providing "enthusiastic" support to a grant proposal by Dr. Stanton Glantz and his associates in California for a project designed explicitly to discredit any scientist who has consulted on the ETS issue for the tobacco industry and expressed critical views with regard to the risk assessment. As discussed earlier, Dr. Glantz prepared a chapter of the ETS technical compendium and is a well-known and vocal antitobacco activist. The grant proposal seeks to study "[tjhe tobacco industry and scientific research." The purpose of the study is to arrive at "[a]n understanding of tobacco industry tactics for influencing research on ETS" by identifying whether particular scientists are "funded by the tobacco industry." That Dr. Bayard's January 10, 1991, letter in support of that application offered to continue to cooperate actively with Glantz and his associates at a time when the risk assessment was still under SAB review raises questions about the EPA staff's approach to resolving legitimate scientific criticisms of their work. y

I 53 i --4 - 50 - Rather than addressing those criticisms on the merits, Dr. Bayard's endorsement of the Glantz proposal creates the impression that he is more interested in silencing his critics. Dr. Bayard's participation in this effort is even more alarming given his role in the selection of SAB panelists. Mr. Reilly repeatedly shunted aside bias concerns on the ground that the procedures for selecting SAB members are intended to ensure that members "are free from legal and perceived conflict-of-interest." Later on, however, I wrote to EPA asking for an explanation of how the ETS panel was being selected. In response, EPA informed me that the candidates were being selected by Dr. Bayard, with assistance from Robert Axelrad and James Repace. 2. The Initial SAB Hearing Despite Mr. Reilly's promises, the SAB panel meeting on December 4-5, 1990, was conducted in a manner that effectively prevented scientific viewpoints critical of the two draft ETS documents from being given anything resembling a full and fair hearing. Less than two hours were allowed for presentations by scientists critical of the report. Certain attendees who had personally requested time from the Chairman were foreclosed from speaking under the agenda that had been formulated. The input of several critical points of view was lost, as well as the opportunity for the panel to ask questions and to conduct a dialogue with other scientists. In ~

54 contrast, twice as much time was given to antismoking organ- izations. Although there certainly was enough time to accommodate all who had asked to speak, several scientists who had expressed doubts about the risk assessment and policy guide were denied the chance. No explanation was given for the failure to accommodate these speakers or why the SAB hearing was conducted with such rigidity. Most SAB review panels are conducted in an open and collegial manner that encourages vigorous discussion of all competing scientific viewpoints. Two of the ETS panel members who agreed to review the report did not even attend the first day of the meeting, which was the only time reserved for public comment. Other panel members openly admitted that they had not read any of the written submissions. The panel members did not address or acknowledge the many public comments in their written reviews. No presentations were permitted on the risk assessment chapter dealing with the respiratory health of children. Without providing any opportunity for public comment, EPA had transmitted to the SAB a new "draft report with a detailed description and analysis of 26 studies" on childhood exposure to ETS. Not surprisingly, the document failed to discuss any studies that did not support EPA's preferred conclusions. By inserting it at the last moment and preventing public discussion of the topic at the hearing, I ©

r i I 55 - 52 - meaningful public scrutiny of the Agency's conclusion was excluded. The negative perception created by the SAB was heightened by the Chairman's summary remarks and statements by him and others to the press after the panel adjourned, misleadingly suggesting that the panel had reached a "consensus" on the classification of ETS as a human carcinogen. As the transcript of the meeting shows, there was no such "consensus." Several panel members criticized the draft in key respects. Dr. Jeffrey Kabat, for example, repeatedly questioned important aspects of the methodology used in the draft as well as its treatment of specific studies before concluding that classifying ETS as a Group A carcinogen could be "rash" (II, p. 15). Dr. Kabat stated that "the observations on nonsmokers that have been made so far are compatible with either an increased risk from passive smoking or an absence of risk or I would say that with a risk that's so small that maybe it's not -- you can't measure it with certainty" (ibtd). Others on the panel expressed similar reservations about the draft's conclusions.31/ U/ Dr. Rockette, for example, observed that "there is this issue of the bias and potentially the systematic bias which the meta-analysis will not control for * * *(Y]ou are dealing with an estimate of risk [of] about thirty-percent ***. [M]ost epideaiologists, if they did a single study where they got a thirty percent risk, evian if it [were] statistically significant, [would] not be very excited about it" (II, p. 19). Even Dr. Samet concluded that "the (lung cancer] chapter falls far short of doing an adequate job of hazard identification and needs to go much further, in light (continued...)

I 56 -4 - 53 - The advisory panel also did not consider a number of pertinent studies, including a study by one of its own members, Dr. William Blot of the National Cancer Institute. Dr. Blot had served, along with Dr. Wu-Williams, as one of the principal investigators on one of the largest studies ever conducted on ETS and lung cancer among nonsmokers. However, the new study was not discussed by the panel, even though the study had been accepted for publication in the British Journal of Cancer before the panel met. Amazingly, Dr. Blot himself did not mention the study, which reported no health risks from ETS. After the panel meeting, Dr. Lippmann held a press conference to announce the conclusion that ETS "should be classified as a Class A carcinogen." The impropriety of a supposedly impartial scientific expert attempting to frighten ?'/ ( ... continued ) of the Agency's guidelines on hazard identification * (II, p. 30). With respect to the quantitative risk estimates, the panel voiced even stronger doubts. Dr. Wesolowski stated that he thought "what we're hearing is that we are a little bit weak on exposure, to say the least, and there's going to be a need for a lot of research" (II, p. 82). Dr. Blot agreed, noting that "we're less sure than the chapter presents as to the actual numbers of lung cancer deaths that are due to environmental tobacco smoke ***"(II, p. 87). He also felt that the inclusion of ex-smokers in the draft's risk estimates was "really poorly justified" (II, p. 94). Dr. Laties, one of the few panelists who actually had read the public comments, strongly recommended that a Japanese study by Dr. Hirayama be dropped based on what he characterized as "devastating" criticism by Dr. Kilpatrick, one of the outside scientists who had reviewed and commented on the draft (II, p. 99). EPA's risk estimates in the first draft depended heavily on this early, extremely controversial study. t

I 57 - 54 - the public on the basis of an incomplete and unsupported document speaks for itself. But Dr. Lippmann compounded this breach by misrepresenting the panel's conclusions concerning the strength of the evidence. Among other remarks, Lippmann stated that "if anything, (the evidence] suggests that it is more potent than we had thought" (Evidence Shows That Tobacco Smoke Causes Cancer, Head of EPA Panel Says, Bureau of National Affairs, Daily Reoort for Executives, December 7, 1990, p. A8). Perhaps realizing that he had gone too far, Lippmann subsequently tried to qualify his remarks but succeeded only in being inconsistent. "[TJhis is a classic case where the evidence is not all that strong." Nonetheless, Lippmann asserted, the "weight of the evidence" supports the risk assessment's conclusions (Passive Smoke A Cause of Cancer, Panel Concludes, The Washington Post, December 6, 1990, p. A9). 3. SAB Executive Committee Meeting, A ri1 1991 Dr. Lippmann presented the SAB panel's report to the SAB's Executive Committee meeting in April 1991. This report was curious for several reasons. First, the SAB concluded that the worldwide epideaiologic data on ETS were too weak and inconclusive to support the draft risk assessment's conclusion that ETS is a cause of lung cancer in nonsmokers. In addition, the panel did no•t endorse the Agency's quantitative lung cancer analysis, noting that the "real" number "may be greater or less than the number EPA cites."

58 - 55 - After concluding that the rationale underlying the EPA staff's conclusions about lung cancer could not be sustained, however, the SAB could not bring itself to take the logical, if politically unpalatable, next step and reject EPA's conclusions regarding ETS and lung cancer among nonsmokers. Instead, the SAB endorsed the conclusion that ETS is a "Group A" carcinogen while taking the extraordinary step of urging the EPA staff to attempt to "make the case" against ETS based on extrapolation from data concerning active smoking. In essence, the Agency was being encouraged to do the science backwards -- to maintain its conclusion while going about the task of finding support for it. Not surprisingly, the SAB report did not acknowledge that EPA had largely ignored its own Guidelines for Carcinogen Risk Assessment, 51 Fed. Reg. 3394 (September 24, 1986), in order to reach its apparently predetermined position. Among many violations of the guidelines, EPA had failed to rule out the possibility of bias and other flaws in the ETS studies and also had failed to consider animal studies and other non- epidemiologic data. The SAB's report feebly suggested that the panel "had some difficulty in applying the Guidelines for Carcinogen Risk Assessment, as they are currently formulated," to the ETS data. Particular attention was given to.the report's statement that "[i]f the guidelines for Carcinogen Risk Assessment can be used to cast doubt on a finding that -4 `ep' 00 ~ APP

I 59 J - 56 - inhalation of tobacco smoke by humans causes an increased risk of lung cancer, the situation suggests a need to revise the guidelines" (SAB Rep. 28). This prompted one rtiember of the SAB Executive Committee to note that it sounded a little like saying "if the data doesn't fit the guidelines, the guidelines should be changed." Nevertheless, the Committee accepted the panel's Group A designation despite the clear failure of the data to satisfy the Agency's own guidelines. Following the Executive Committee meeting, Dr. Lippmann once again spoke to the press about the SAB's conclusions. This time Dr. Lippmann's statements were considerably more restrained than his remarks at the December 1990 press conference. This time he stated that "occasional, light exposure (to ETS] is not likely to cause any harm" (United Press international, April 19, 1991). Dr. Lippmann also observed that in his view the risk due to ETS exposure is "probably much less than you took to get here through Washington traffic" (Washin2ton Times, April 19, 1991, p. A-3). On three separate occasions my staff asked Dr. Lippmann, "if one were to apply the guidelines as written could you classify ETS as a Class A known human carcinogen?" On all three occasions, Dr. Lippmann failed to respond to the question. The next day, however, Dr. Lippmann stated at a meeting outside the glare of media attention that if the guidelines were applied strictly there was no clear mechanistic basis for calling ETS carcinogenic. -9

60 - 57 - 4. The Second Draft Risk Assessment EPA staff spent the next year and a half attempting to "make a case" against ETS. The revised risk assessment draft was over 600 pages long, finally being issued on the afternoon of June 18, 1992.11/ Incredibly, however, EPA gave the public just nine working days to comment on it even though the report had doubled in length and a whole new set of flaws had been introduced. Even the Science Advisory Board panel had only until July 20 to review the revised draft and consider outside comments before the public review meeting. The second draft risk assessment was even more curious than the first. As an EPA health scientist who contributed to the draft admitted, the Agency staff had engaged in some "fancy statistical footwork" in the revised risk assessment in order to "fashion [an] indictment" of ETS ( c ence, vol. 257, p. 607 (July 31, 1992)). In the prior draft, EPA's calculations had showed that the epidemiologic studies based on U.S. populations showed no statistically 21/ The second draft revealed for the first time that the authors of several of the chapters had acted as subcontractors to ICF Incorporated. As noted earlier, the EPA Inspector General has concluded that all of those subcontracts were awarded non-competitively and that at least two violated federal contracting procedures. In addition, as with the technical compendium and policy guide, some of the people who contributed to the revised ETS risk assessment are vocal antismoking activists. Judson Wells, who contributed an important appendix to the revised risk assessment on smoker misclassification rates, is a retired chemist who now devotes most if not all of his time to doing volunteer work for the American Lung Association on the ETS issue. Wells' claims about misclassification rates were of vital importance to the lung cancer conclusions of the revised risk assessment. 1

61 . - 58 - significant association between ETS and lung cancer among nonsmokers. In order to reach a statistically significant result in the first draft, EPA therefore had included in its calculations all of the studies of ETS conducted worldwide to tilt the balance in the favored direction. Both EPA and the SAB rejected out of hand arguments by critics that the risk assessment should have considered only the U.S. studies. When EPA staff was revising the risk assessment, however, it was confronted by the Wu-Williams/Blot study, which had been conducted in China and reported a statistically significant negative association between marriage to a smoker and lung cancer among nonsmokers -- the exposure scenario relied upon in the initial risk assessment draft. Inclusion of the Wu-Williams/Blot study in EPA's analysis would have forced EPA to reverse its conclusions about ETS and lung cancer. At the same time, however, EPA had obtained preliminary data.from a large U.S. study that, with some massaging, could be used to support its calculations of risk based exclusively on the U.S. studies. Accordingly, EPA entirely reversed course and decided in the second draft to disregard the non-U.S. studies. Instead, EPA used the U.S. studies only. The Agency also adopted an entirely new standard of statistical significance, presumably because the one used in the prior draft would not have yielded the desired results, even with the inclusion of 74-814 0 - 93 - 3

1 62 - 59 - the new, if incomplete, U.S. study.'-'1 Only by manipulating the numbers in a'manner that violated well-accepted statistical methods was EPA able to claim in the second draft a barely significant association in the U.S. studies. The new draft also relied on the argument suggested by the SAB that because active smoking had been associated with increases in risk, ETS exposure also must be a risk factor. The problem with this argument -- that ETS is in respects a very different substance and is many encountered at far lower levels -- was acknowledged in the revised report.Le/ At the same time, however, its significance seemed to escape those responsible for the report's conclusions. ?'/ Specifically, the revised risk assessment used a 90% confidence interval to judge statistical significance even though (1) a 95% confidence interval had been utilized in all of the underlying studies, (2) a 95% confidence interval is the more accepted measure and (3) EPA had not previously utilized a 90% standard in any previous risk assessment. EPA has never attempted to explain this departure from previous and accepted scientific practice. One commentator noted that "(tJo get scientifically valid data, there are very strict rules and requirements on how and when you can apply meta- analysis, and virtually all of them were violated in the EPA analysis." Investors' Business Dailv, supra note 1. W The draft report stated, for example, that "[t]his assumption (comparing MS and ETS to calculate lung cancer risks) may not be tenable, * * * as MS and SS differ in the relative composition of carcinogens and other components identified in tobacco smoke and in their physicochemical properties in general ***" (p. 6-6). The draft report also acknowledged that "[tJhe concentration of smoke components inhaled by subjects exposed to ETS is small compared with that from active smoking. * * * Breathing patterns for inhalation of mainstream smoke and ETS differ considerably ***. There are also important differences in the physicochemical properties of ETS and MS (see chapter 3). These have been extensively reviewed earlier by the National Research Council * * * and the Surgeon General ***" (pp. 7-2; 7-3). 00

63 - 60 - Similarly, the second draft risk assessment announced that ETS exposure had been established as a cause of respiratory disease in children. The first draft risk • assessment had stated that the data were too inconclusive to draw an inference of causation. No new information became . available between the release of the first and second draft risk assessment to support this shift in the Agency's position. Apparently, EPA staff took the SAB's earlier suggestion that it consider "strengthening" the report's conclusions concerning children as a license to sensationalize further the Agency's claims about ETS. The SAB held public hearings on the revised risk assessment on July 21 and 22, 1992, after having denied requests for more time to submit public comments on these and other problems. The panel submitted its report approving the second risk assessment in October. The panel's conclusions make absolutely clear that it was unconcerned with the scientific soundness of the report's underlying rationale. A brief comparison of the SAB's actions following its first and second review of the risk assessment confirms that the SAB actually disregarded its earlier findings in order to embrace the desired conclusion. The SAB concluded in its second review that extrapolation from active smoking data could not, after all, serve as the sole or predomi- nant basis for the conclusion that ETS is a Group A carcinogen. The SAB had concluded in its first review that the epidemiologic data were too weak to support

I 64 the inference that exposure to ETS causes lung cancer in nonsmokers. The SAB reversed its position in its review of the second draft risk assessment once it became clear that active smoking data could not provide an alternative basis for that conclusion. The SAB concluded in its review of the first risk assessment that all studies of ETS and lung cancer conducted worldwide should be included. In the second review, the SAB decided that EPA need only include the U.S. studies. Had the Agency and the SAB adhered to their original decision to use all ETS studies, the meta-analysis would not have shown a statistically significant risk. The SAB nonetheless concluded that the Agency had established that ETS is a Group A carcino- gen responsible for approximately 3000 lung cancer cases every year in the United States. In the first review, the SAB had concluded that the data were too uncertain for EPA to attach a specific number to the deaths supposedly attributable to exposure to ETS. Put simply, the SAB concluded that ETS is a Group A carcinogen even though neither of the two rationales advanced by EPA staff to justify such classification is scientifically defensible. Thw first review determined that the spousal smoking studies were too weak to support an inference of causation. The second review concluded that the active smoking data could not be used as an alternative ground. Nonetheless, the SAB decided that the total "weight of evidence" supported a Group A classification. Following the SAB's October report, EPA staff rushed to revise and release the final risk assessment. The Agency's haste apparently was motivated in part by the impending change in the Administration. Perhaps of even greater concern to EPA, however, was the release of the Brownson study discussed y

I 65 -i - 62 - above. The fact that the largest U.S. case-control study ever conducted reported no statistically significant association between ETS exposure and lung cancer incidence casts further ~ doubt on EPA's claims. Had the Brownson study been included in EPA's analysis, the Agency's calculations would not have shown a significant risk from ETS even using the Agency's highly suspect statistical methodology. Rather than face this embarrassment, EPA rushed to release the report without considering the Brownson study on the pretext that "it had'to stop somewhere. "'-'/ Together, EPA and the SAS have undermined the process by which risk assessments ought to be conducted: first, by ignoring the substantial scientific controversy about what the ETS studies actually show; and, second, by conducting the forum where that controversy should have been thoroughly aired as a mere rubber stamp proceeding. As a result, EPA's preparation and review of the risk assessment have given the appearance of a scientific show trial to legitimize a predetermined policy. 31/ As noted, EPA "stopped" in a most curious place. It fully incorporates data from a still incomplete study by Elizabeth Fontham and coworker while ignoring the much larger, complete and fully reported Brownson study -- which had been funded in part by NCI. In addition to having several years to run, Dr. Fontham and her group have not yet published any data on ETS/lung cancer confounding factors. I 1

1 --r 66 - 63 - III. CONCLUSIONS EPA's handling of ETS is a symptom, albeit a very severe one, of larger agency problems. These problems encompass not only widespread abuses in the award and oversight of government contracts but also the Agency's general approach to the use of science in policy making. In fact, EPA's risk assessment process as a whole has come under fire. In response, top EPA management moved to revamp internal guidelines governing EPA's use of science in risk assessments. In February 1992, Deputy Administrator Henry Habicht issued a document providing agency-wide guidance on science policy in risk assessment and risk characteriza- tion. Mr. Habicht noted that significant information often was omitted as assessment documents were passed along in the decision-making process, and that "EPA risk assessors and managers need to be completely candid about confidence and uncertainties in describing risks and in explaining regulatory decisions." The guidance also drew from principles articulated earlier by the Risk Assessment Council in November 1991, such as the following. For users of the assessment and for decision-makers who integrate these assessments into regulatory decisions, the distinction between risk assessment and risk management means refraining from influencing the risk description through consideration of non-scientific factors -- e.g., the regulatory outcome -- and from attempting to shape the risk assessment to avoid statutory constraints, meet

I 67 - 64 - regulatory objectives, or serve political purposes. Such management considerations are often legitimate considerations for the overall regulatory decision * * * but they have no rol~~in estimating or describing risk. In other words, science should drive policy, not the other way around. In addition to the new risk assessment guidance, as I mentioned at the outset, the EPA Administrator also had convened an expert panel to assess EPA's use of science, which issued an important report in March 1992 entitled Safeguarding the Future: Credible Science. Credible Decisions. The report confirmed that "[cJurrently, EPA science is of uneven quality, and the Agency's policies and regulations are frequently perceived as lacking a strong scientific foundation" (p. 4). The expert panel also cautioned EPA, in terms that are directly relevant to the Agency's work on ETS, that "science should never be adjusted to fit policy, either consciously or unconsciously" (p. 38). Unfortunately, in the case of ETS there appears to have been a conscious use of science and the scientific process to achieve a political agenda that could not otherwise be justified. While we should applaud the promised willingness of EPA to clean house and revise its methods, we also must question why that was not done in the case of the ETS risk IV Committee on the Institutional Means for Assessment of Risks to Public Health, National Academy of Sciences/National Research Council, Risk se sment in the Federal Goverrnment, pp. 151, 153 (1983). f

68 - 65 - assessment. In his February 1992 policy memorandum, the Deputy Administrator wrote, "we do not expect risk assessment documents that are close to completion to be rewritten" (p. 5). It is difficult to understand why, after acknowledging serious deficiencies in EPA's use of science, the Agency would refuse to correct the flaws in risk assessment projects then under way. Similarly, EPA repeatedly has refused to respond to requests that it reevaluate its handling of the ETS controversy in general and the risk assessment in particular in light of the recommendations contained in Credible Science. This refusal raises questions about EPA's ability and desire to implement fully the reforms urged by Credible Science. It also is deeply disturbing that Administrator Reilly, who professed to be "proud" of Credible Scien e, did not choose to abide by its recosstendations in his own statements about the ETS risk assessment. As noted, continuing the pattern of siedia hype and sensationalism that has marked every aspect of EPA's consideration of ETS, Administrator Reilly and ENS Secretary Sullivan held a joint press conference on January 7, 1993, announcing the finaliza- tion of the risk assessment. The press conference proceeded aa though the Credible Science report and rAcommendations did not exist. One of the iaportant conclusions of Credible Science is that EPA has done a poor job in cosdunicating with the 1

I 69 - 66 - public about the uncertainties in its determinations. In addition, the Agency's own guidance document emphasizes the importance of explaining fully scientific uncertainties in • describing risks. At the January 1993 ETS press conference, however, the Administrator conveyed the clear impression that there is no uncertainty whatsoever so far as ETS is concerned -- that the risk assessment has shown "conclusively" that ETS exposure is responsible for approximately 3,000 cases of lung cancer among U.S. nonsmokers each year and specific numbers of respiratory problems among children.21/ The Administrator also made the ridiculous statement that "the risks associated with environmental tobacco smoke are at least an order of magnitude greater than they are for virtually any chemical or risk that EPA regulates."3/ Among other things, that statement cannot possibly be reconciled with Dr. Lippmann's earlier statement that the risk supposedly associated with ETS is less than the risk of a single trip through Washington traffic. Finally, the Administrator disingenuously claimed that "(mjy philosophy is, first do the scientific analysis, and only then build the policy, determine the priority and ' devise the strategy based on a firm scientific foundation. With this report we have laid the firm foundation upon which ''V Statement by William K. Reilly, Administrator, U.S. Environmental Protection Agency, on Environmental Tobacco Smoke, January 7, 1993, p. 1. 21/ Id.._ at 3. --4

I 70 - 67 - policy can now be built."L" The fact that EPA released, several years ago,~a "Fact Sheet" and a draft policy guide recommending smoking bans and restrictions renders the Administrator's statement misleading at best. Some may argue that applying a double standard to ETS is justifiable, or at least understandable, on the ground that the target of EPA's action is tobacco smoking. Regardless of one's personal beliefs about smoking, however, the spectacle of a huge, well-funded government bureaucracy with enormous power engaged in the deliberate manipulation of the public is profoundly disturbing. Further, if policy decisions are not based on sound science, the integrity of both the political and the scientific processes suffers. As Dr. Feinstein has pointed out -- (t]he "bad guys" * * * are not always right, but if they are denied a fair and proper scientific hearing, neither society nor science will benefit. Society is entitled to make political decisions based on advocacy. The scientific basis for those decisions however, should depend not on political advocacy, but on scholar- ship -- no matter how it is produced or by whom (p. 305). These concerns are not limited to ETS. The suspicion that too many scientists and government officials are using "scare of the month" tactics to generate media attention and mobilize public opinion in support of personal IV Td. at 4.

71 - 68 - political agendas has fueled widespread public cynicism. At some point, people simply stop paying attention. As the public television program "Technopolitics" noted in its June 11, 1991, program on the first draft of the ETS risk assessment -- - [t]he question remains whether the public health scare now being created through leaked draft documents and emotional public appeals is real, or is the anti- smoking movement merely using bad science to organize the nonsmoking majority against the smoking minority? The record of the EPA is not reassuring. On one environmental concern after another, from Alar apples to acid rain to dioxin, the EPA has first put out alarming information and then backed off. Critics charge that the EPA is more interested in being politically correct than scientifi- cally accurate. In essence, EPA has declared war on smokers. Because of EPA's pursuit of sensational headlines at the expense of objective scientific evaluation, some smokers have lost their jobs and many employers are practicing overt discrimination in hiring and promotion based solely on whether a person smokes. People who think that such interference is unlikely to go beyond smoking should be warned: a report last year on the television show "20/20" indicated that moderate social drinking off the job and participation in employer- defined "dangerous activities" also have becoste targets of workplace discrimination policies. Can a government-sponsored "technical compendium" or "policy guide" on those subjects be far behind? EPA's mandate to clean up the nation's air, water, and waste enjoys public support. But conduct by the Agency like its handling of ETS will continue to undermine that support unless the Agency decides to get serious about implementing the recommendations of Credible Science. If EPA's leaders will not step up to the task of reforming from within, it will become necessary for Congress to do the job for thea.

72 Mr. BLUZY. The ETS risk assessment is far from an isolated ex- ample of EPA's approach to the use of science in policy making. The Agency's propensity to scare the public first and ask scientific questions later is both notorious and well documented. Alar, dioxin, and removal of asbestos from schools are other examples. In fact, concern that EPA's pursuit of media headlines rather than good science was undermining the Agency's credibility caused former Administrator Reilly to convene an expert panel in early 1991 to assess EPA's use of science. The expert panel issued a report in March 1992 entitled "Safe- guarding the future: Credible Science, Credible Decisions." The re- port states that currently EPA's science is of uneven quality in the Agency's work on ETS, that science should never be adjusted to fit policy either consciously or unconsciously. Unfortunately, the case of ETS, there appears to have been a conscious misuse of science and the scientific process to achieve a political agenda that could not otherwise be justified. EPA portrays its own lack of confidence in its tortured statistics by refusing to incorporate the results of the ETS lung cancer study by Brownson and coworkers. The Brownson study, one of the larg- est and best designed studies ever conducted, was funded in part by the National Cancer Institute. The study looked at exposure to ETS in a variety of settings--at home, at work, and in social envi- ronments. The study reported no significant association between ETS and lung cancer among nonsmokers in spousal or work set- tings or from childhood. Even using the highly questionable statis- tical methods adopted by EPA in its ETS risk assessment, inclusion of the Brownson study would show no significant risk of lung can- cer from exposure to ETS. Evidently, publication of the Brownson study caused no small de- gree of consternation at EPA. In order to avoid incorporation of the Brownson study's results in the risk assessment, and invalidating EPA's claim that the epidemiology shows a significant risk, EPA refused to issue the final report in early January. Mr. Chairman, given this sort of behavior, in my judgment, we must be very cautious about allowing scientific pronouncements from EPA to drive public policy decisions. Thank you, Mr. Chairman. Mr. WAxmax. Thank you, Mr. Bliley. Mr. Synar. Mr. SYNAR. Thank you, Mr. Chairman. I think it is safe to say that the American public, at a minimum, is troubled, if not mad, that this Congress and this Government has not done enough, or at least more, to protect us against the en- vironmental harms of tobacco. You know, at a minimum, we in this society and we in this Gov- ernment have an obligation to wage a very comprehensive war against the tobacco industry's shameful strategy of attracting chil- dren to this deadly product. The statistics speak for themselves: 50 percent of all children begin smoking before the age of 14, 90 per- cent before the age of their teenage years have ended. The tobacco industry spends $4 billion a year advertising and promoting this product, and they say they do it in order to get peo- ple to switch brands. But you can't switch brands if you are dead, I

73 and that industry's targeting the 400,000 people that they have to replace each year is targeted directly towards the children in our society. This industry would have us believe that Joe Camel Cartoon is out there to get the computer salesman, the 50-year-old auto work- er, to switch brands. I don't believe it, and neither does the Amer- ican public. In fact, we all know what Joe Cartoon Camel is used for, it is to attract adolescents to smoke. If the industry would have us believe that, then they would then beg~'n to target a second group, the preschoolers, and we could likely ezpect to see in the near future Joe Barney as a way to get preschoolers to take up this habit. You know, if this product wasn t so lethal, that would be funny. Today, I am sending a letter to the chairman of R.J.R.-Nabisco, asking him to mitigate some of the damage his company is doing to the youth of this country and to the health of America. I want him to use Joe Camel in a voluntary 6-month advertising campaign telling children the seriousness of smoking, and after that I want him to voluntarily pull old Joe out of business forever. In fact, it would be kind of nice if he would announce that Joe Camel got can- cer from smoking and they put him out to pasture. I want to commend Carol Browner and EPA's efforts to inform our citizens, and I hope that today's he :zing will add the additional evidence that we need to convince the American public, and par- ticularly this industry, of the seriousness of our effort and the com- mitment to this cause. Mr. WAxmArr. Thank you, Mr. Synar. Mr. McMillan. Mr. McMiLi.Atv. Thank you, Mr. Chairman. There is no question that when generally accepted scientific methods demonstrate unacceptable avoidable risk to human health we should act to enable the individual to avoid that risk. That is true of tobacco, automobile exhaust, or pesticides, and many other substances that we consider before this committee. It is interesting to note that while we are discussing the politics of the EPA's report on ETS, there is a hearing scheduled to start about now in the Agriculture Committee questioning the validity of the science behind the EPA's position. I see that we have a lot of the media here. I hope that the media is likewise there. As with most environmental and health issues, there are trade- offs to be considered. Our job, it seems to me, is to determine the true risk and then to deal objectively in finding a solution. We all deserve the opportunity to hear not only about respiratory health concerns that may be interrelated with ETS but also about the sig- nificant questions which exist relative to the scientific studies on the carcinogen categorization` of ETS so that we and the public un- derstand what really is the truth. We all should take real risks seriously, but let us also remember the costs associated with what we have done in the past. I remem- ber alar, dioxin, acid rain, and asbestos, as do the apple growers, the Time Beach residents, the West Virginia coal miners, and the school systems which bore, and still bear, the brunt of asbestos re- moval-perhaps with even greater risk than would have been in- curred by a more objective solution to the problem. C~O ®0 C,O

74 In the light of the significant doubts raised by the scientific methodology used by EPA in this matter, I am concerned that we may head down the same road again by dealing with the problenm emotionally rather than dealing with it objectively. It is my understanding that the Agriculture Committee is esplor- ing doubts about the methodology of Meta-analysis using only a pre-selected subset of data and the EPA's use of a reduced con. fidence level in contradiction to generally accepted scientific meth- ods. These concerns, combined with the perception of a predeter- mined conclusion, do not aid the EPA in bolstering its already tar. nished scientific reputation. Perhaps my colleague, Chairman Din- gell, was correct in stating that the EPA "cooks the books with great vigor." I am very concerned that the focus of this hearing will not give us the opportunity to explore the scientific uncertainties in more detail. Once again we seem to be putting the cart before the horse, I hope the chairman will be willing to include relevant information from the testimony being heard in the Agriculture Committee today and would suggest that the media also focus on that as well, and, further, Mr. Chairman, I would ask unanimous consent to have 5 legislative days to include supplementary documentation and comments for the record, and I yield back the balance of my time. Mr. WAxiHarr. Thank you, Mr. McMillan. Without objection, the unanimous consent requests of both Mr. Bliley and Mr. McMillan will be agreed to. [Testimony resumes on p. 111.] [The following document was submitted:] 1

I 75 2 X6137bf P R O C E E D I N G S aR. FEINSTEIN: I can begin shortly -- CFUIRMAN: All right. I would tell our visitors from the media, we're going to have to cut all the lights off now, at least the kleig lights or the tv lights, because we will -- MR. . No, no, no, added focus to -- CHAIRMAN: We will come back in just a minute with -- we'll come back in just a minute with questions, and you can certainly have your lights on then. DR. FEINSTEIN: Mr. Chairman, one of the things I've learned today CHAIRMAN: • Yes. DR. FEINSTEIN: -- in the first congressional hearing that I've ever ittended is that I always thought in the past that I could tell where I wae from the visual aides. At a scientific meeting if they were using flipover transparencies it was usually statisticians. If they were handing out thick packets of data, it was usually epidemiologists. if they were using slides, it was usually physicians, and if they had big charts and large public

I 76 3 release announcements I discovered that it's a congressional hearing. I am back to the slides that are the medium with which I'm most familiar and I thank.you for letting me -*se them. I also wanted to caunent on -- before showing slides, on some of the problems in making scientific and statistical conclusions. I have a number of statistician friends who will say that statisticians are like lawyers. That you can make a case for the plaintiff and you can make a case for the defense, and if you're a good lawyer you can figure out which way to do that either way, and that is certainly true of statistics in general. One can use statistics to support one side or the other. It's'one of the things that maklis the development and maintenance of scientific standards rather than simply statistical issues such an important one. I would also say that I am absolutely delighted that I have not been asked to try to explain issues in statistical inference. I feel enormously sympathetic to -- have they already escaped? MR. . Yes. DR. FSINSTSINs Oh. To the folks from the EPA who

I 77 4 were given the daunting task of trying to explain issues in statistical inference, and if you as congress persons had difficulty understanding them, you are not alone. There are lots of people in the world of science, most people in the world of medicine, are equally confused by these issues of what is significance,.just what is confidence when you talk about confidence, what are the uriniferous (phonetic) effects of P-values and so on, and so don't be upset if you've had difficulty following it. What I wanted to talk about -- I've got to get this focused -- were some of the issues in judging causation. And back in 1964 in the Surgeon General's famous report that used what is often called either the Surgeon General's or the Bradford Hill criteria, that was the report in which active cigarette smoking was associated with lung cancer and with coronary disease. And they made two very important points in the criteria that they used. one was an entity called the "consistency of the association." That meant that in the various different reports you are looking at, there ought to be very few or no contradictions. And, in fact, in the association between active smoking and lung cancer 27,out of 29

I 78 5 so-called retrospective studies and all seven of seven prospective studies all went in exactly the same direction. The second criterion that was set up in that Surgeon General's Co+mnittee, or Bradford Hill criteria, if you want to call it that, dealt with the strength of the association. They asked for a so-called dose response relationship and they wanted high relative risk ratios. For lung cancer, it turned out that those risk ratios were about 9 to 10 in average smokers and more than 20 in heavy smokers. It is the demand for high risk ratios that has made various distinguished scientists and epidemiologists, such as Ernst winter, one of the first people to documerit the original association between active smoking and, lung cancer, that have made them say, "For a risk ratio to be meaningful it can't be trivially high. It's got to be well above 2, preferably above 3." And the reason for asking risk ratios that are 3 and above and certainly much higher than 2 is that there are so many ways in which different kinds of biases can get into epidemiologic data that you can gekt a risk ratio of 2 just in some instances if one person has been misdiagnosed. So the usual demand for high risk ratios is

I 79 6 that you try to get them above 3 to be confident of things, and certainly well above 2. Now, most of my comments here are dealing with issues in scientific evaluation for the 21st century. I know that the tobacco industry and EPA are involved in mortal combat in this matter, and I'm trying to address the issue of what kind of scientific standards are we going to set as this nation goes into the 21st century with all kinds of risks, hazards and whatnot, being generated every day by our new forms of technology. What tactics do we use to do that? Well, if these are two criteria that were agreed upon back in 1964, both of those criteria were abandoned•in the EPA report. They neglected the criteria for consistency and they neglected the criteria for strength. They pooled a set of inconsistent and low relative risk studies -- and I'm taking the data from Table 5-4 of their report -- when they established the so-called "relationship of passive smoking and risk cancer." The 35 studies we've been hearing about this morning had six in which the relative risk was below 1. They went in the opposite direction. There were fourteen where the relative risk was

80 7 between 1 and 149, of which three were so-called ."significant" at a 90 percent confidence interval level. There were eight in the relative risk range from 1 and a half to 199, with only three of them being significant even at the lower level. And there were seven that went from 2, 2.1. Now, there is certainly a melange, a mixture, of inconsistent results. You got six going definitely the other way, you got fourteen that barely exceed 1, and you got another fifteen that go above 1 and a half, but none of them goes above 2.5 in its risk ratio, none gets to 3 or above, and yet those inconsistent studies, contrary to the agreed-upon consistency demanded in the Surgeon.General's report, those inconsistent studies were pooled and just pot together as though they all went in the same direction. Now we come to this issue of statistical significance, and I'm sorry to harass you further with this after what went on this morning, but I might be able to possibly clarify somethinq. There are certainly traditional criteria that are called an alpha level of .05 set up for two-tailed P-values. The reciprocal of that is a 1 sinus alpha of .95 that was set up for two-tailed

81 8 confidence intervals. That's where we get the idea of the 95 percent confidence interval. Now, this idea of alpha being .05 was an arbitrary custom established by Sir Richard -- Sir Ronald Fisher, who, according to your viewpoint, is either the deity or at least one of the major'popes of biostatistics. Like many other standards, this .05 and the .95 are arbitrary. I suspect if Sir Ronald had said .04 and had gotten there first with his recomaendations, that that might have been what would have been carved in stone. But it so happens .05 got there and it has now been almost universally accepted and demanded by editors, by agencies such as the FDA, by agencies such as the NIH. It may or may. not be a• good criterion, it may or may need flexible adaptations, but if you're going to work in a world that sets certain standards, that's the one that's been generally used. There's an argument that it could be lowered to a one-tail alpha of .1 and that's how you get, in essence, from 95 percent to 90 percent, if appropriate hypotheses and plans are clearly stated in advance of the analysis. Now, every -- almost every statistician I know, if ready to descend, to accept, an alpha of .1, demands that the

82 9 'investigators have stated in writing in advance of any analyses that that's the way they were going to go. I am not aware of any such advance statement by the EPA and it seems clear that they were pretty flexible about it because, as Dr. Bayard stated this morning, they did use 95 percent intervals for other things. So it seems reasonable when they used an alpha of .1 for the 90 percent confidence intervals it must have been that the results didn't get significance at .05. It's kind of the old scientific principle that that says when you got it, flaunt it, and when you don't got it, try to O#b,u,d it. And it seems reasonable that if they had a 95 percent confidence that that's how they would have put it. I know of no investigators anywhere who drop to 90 percent when they can hit bingo at 95 percent. Now, one of the most interesting aspects to me in the EPA data in their own Table 5.8 of their meta-analyses was that they pooled the results for six countries: Greece, Hong Kong, Japan, United States, Western Europe, and China. And when you look at the pooled relative risks in those countries, they range none of them above 2; it's-.95 in China. And when you look at the lower bound of the

I 83 10 90 percent confidence interval, that's the boundary you want to look at. That's got to exceed 1 for you to claim it's statistically significant. Well, in Europe and China, if you look at those boundaries, one might say, "Well, it's gone the other way," and in the United States, with the pooled relative risk of 119, the lower bound qot'to 104. That is about as close as you can shave above the level of 1 without actually getting to it, and when you look at that you can feel sure that if they did it at 95 percent that that would go below 1 and the result would not be statistically significant. In the other three countries, it's hard to tell just how low those lower limits would have gone had 95 percent intervals been used and, alas, the agency did not report what they got with 95 percent intervals so we don't know whether any of these things would have been statistically significant if the 95 percent level had been used for the other data. NoW, we've heard a little today about meta-analysis. And I won't go into the controversy about it, but I can certainly say it is a controversial method, it is not anything about which there is accepted consensus,

84 11 and the feelings about it range from those who say it is basically statistical alchemy or witchcraft, to those who revere it as a great contribution to modern science. But it's certainly controversial. In general, there is consensus that you can combine the results if they come from randomized trials. ' The randomized trials are the kind of things that drug companies have to do when they test medication and want to claim that different medications are beneficial. Randomized trials are especially designed to avoid the various biases, confounding factors and intellectual miscreants that occur in epidemiologic studies. The randomized trials have got suitable precautions for avoiding bias and those meta-analyses that are likely to receive acceptance are the ones where the original studies came from randomized trials. This is also an arbitrary criterion. But it does receive widespread acceptance in medical literature. If the results do not come frcm randomized trials -- and that means they're coming out of epidemiologic studies -- the argument is that the investigators must establish special criteria to avoid, publication bias. That's a problem of studies that were out there but that

85 12 didn't get published, or that didn't qet reported. And they have to focus on studies that tried to avoid in their • internal construction problems in detection bias -- did you go about identifying lung cancer the same way in both groups? Did you identify asthma, heart disease, and whatnot in both groups being compared? Ascertainment bias. When you interviewed people to find out who was exposed or non-exposed to passive smoke, did they know the hypothesis you were tryinq to prove? Did they know whether they were cases or controls? What efforts did you make to avoid biased interviewing when you did that interview? In the EPA, meta-analyses, alas, none of the studies whatsoever done as randomized trials. kione. And no analytic strategies were used by the EPA to identify or reduce prominent sources of bias, because the EPA wasn't doing research here. The BPA was acting as an analyst and processor of the available studies that had been done by other groups. The EPA was, in essence, writing editorials; any kind of cneta-analysis is a type of editorial in which you are dependent upon what is the news that has been provided by other people. And in all these other studies, they were done.pretty much as classical epidemioloqic

I 86 13 studies where almost no provision is made to deal with bias in the interviewing and to deal with bias in the issues of detection of the so-called outcome event. And there are a good many scientific problems here. You've heard comments, and some of the Congress persons have themselves made comments, about studies that were included or excluded. And I have not tried to get a fine-tooth comb and go through all of it. But it seems clear that certain studies were included and excluded, that selected choices were made, and people have argued back and forth about that, but however it was done there doesn't seem to have been an absolutely full deck of everything that was there. The problem of the accuracy of identification of exposure is one of the fundamental scientific lesions in all epidemiologic studies. when you use the so-called "case control technique" that was used in most of the EPA studies, and you then interrogate backward to ask people about exposure, when they know what you're looking for and when the interviewer knows what you're looking for, you've got to take extreme precautions to avoid bias in identifying that.

I 87 14 My colleagues and I, when we do case control studies, set up a whole bunch of decoy hypotheses.. We try to blind our interviewers to knowing who is a.case and control. We even try to blind the patients to knowing whether they were a case and control in the particular study. We go to all kinds of precautions to avoid that sort of bias, and, as far as I know, no such precautions were used in any of the basic studies that the EPA collected. In one study, that absolutely fascinates me, the relative risk for coronary disease was higher for passive than for active smoking. And I await some kind of an advertisement from the industry saying that if you are exposed to passive 3moke that you can avoid coronary disease by becoming an active smoker if you believe the results of that study. There were various other inconsistencies that I won't take time to go through in the passive smoking results for the various cell types of lung cancer. Lung cancer has different kinds of cell types under the microscope. They get called epideraioid, adenose, small cell, large cell -- it is somewhat like brunettes, blondes,

88 15 strawberry blondes, black hair with the small cell strawberry blondes being the most dangerous. At any event,. if the stuff is actually causing lung cancer, it ought to be consistent in these different cell types, and there are a good many inconsistencies in the passive smoking data on that subject. There are just a couple of other things that I wanted to comment on. The first is the role of the Scientific Advisory Board. I wasn't quite sure of just what their role was and I happened to be at a meeting last week attended by Jan Stolwick (phonetic), a colleague of mine at Yale, who was one of the members of the advisory board. And Stolwick made the comnent there that the advisory board had urged the EPA not to make its claim about 3,000 extra smokers, that they had urged the EPA not to do that. Nevertheless, the EPA went ahead and did it. I then said to him, "How many other urgings did your committee make that they disregarded," and he said, "Well, I don't really want to go into that." So I'm not quite sure of just what was the role and the interplay of these two groups, but I have great respect for my colleague, Jan Stolwick, and I would not want to necessarily hold the EPA

89 16 to blame or responsible for having approved everything -- for holding the SAB, the Scientific Advisory Board, responsible for having approved for everything that the EPA did. Finally, in reference to some of the studies on symptoms, such as asthma and symptoms in children, I'm always mindful of a study done by Dr. Walter Spitzer, a Professor of Epidemiology and Health at McGill, that he did in Alberta some years ago on the issue of symptoms that are unaccompanied by objective evidence. There had been, for many years in the province of Alberta, Canada, complaints about sour gas whose fumes from a nearby mine were coming into that comaunity. And for a great many years there had been debates and claims that the sour -- exposure to the sour gas was causing birth defects, cancers, and so on and so forth. And finally, after about ten years of claims, counterclaims, battles, not unlike what we have been observing in this issue, the province of Alberta funded a large-scale study that Walter Spitzer ran. It was eventually published under the title of "subjective Fears and Objective Data," and what Spitzer's group, in what I believe one of- the best epidemiologic

90 17 studies ever done, beautiful.controls, blind interviewing, all of the scientific precautions that you would want, what they found when they took those scientific precautions was that there was no excess of birth defects, there was no excess of cancer, there was no excess of any disease that could be objectively identified. There was an excess of subjective complaints that'were present in people in that coaraunity where the sour gas had been highly heralded as an evil that were not found in a control coninunity where the same alleged exposure had not been heralded as an evil and where the members of the comaunity did not have all those symptoms. But with respect to some of these symptomatic studies, I won't deny what they have found but I would love to see some studies done where there's objective interviewing, where there is careful ascertainment of just what is wrong, not just simply fill out.a questionnaire and process it through the computer. And the last comaent that I want to make really echoes something that I believe several of the Congressmen have alieady said, and that is that decisions for public policy ought to depend on th. goals of public policy. If

91 18 we as a nation want to get rid of cigarette smoking as a matter of public policy, let's make that decision as a matter of public policy. But the scientific evidence used in public policy ought to depend on the standards of science, and that neither science nor public policy is well served if the integrity,og science is sacrificed.to meet the goals of public policy. That's the end of what I have to say, sir. CHAIRMAN: -- Doctor, I think we' 1l go on and have Dr. Guren (phonetic) right now, and then we'll get to questions. DR. GURHtd: My ccmnents. will be very brief. This is because I bring a chemistry background•to the table and I think that the most.important components of this study really are the epidemiology and risk assessment methodology which are being discussed, and others are more qualified to address than I. As I mention in my written statement in terms of an overall assessment of the study, I was definitely impressed with'the-scope of the study anQ the documentation of the issues that were considered but generally felt that the conclusions were presented with a much higher degree of

92 19 certainty than is justified. And this is largely because of the very many uncertainties acknowledged in the report itself and the many assumptions made in reaching the conclusions. Most important, probably, are the relationship between active smoking and passive smoking, and the relationship of spousal exposure to population exposure. And for my view•, given the very small effect that's been detected of assumptions and uncertainties like this ought to be especially worrisome. The EPA, though, has taken on a very difficult and complicated task in this assessment. For example, even the very seemingly simple question, "What is ET5?" is difficult to answer and there was some discussion about that earlier today. ETS is obviously the material in an obviously smoke-filled room but is it also the residual material that's present in that room hours after smoking? Now, STS migrates, and -- throughout the indoor environment, and is it does, it changes in concentration and changes in composition to some degree. So when is ETS no longer ETS? A related question.is whether there's a elifference in health risk associated with a brief exposure to a high concentration of ETS versus a long, chronic exposure to a I I

93 20 low concentration of ETS. And it should be noted that most comnon measures of exposure -- airborne nicotine, cotinine (phonetic) in urine, generally don't detect those kinds of temporal effects. Now, my personal bias is that ETS at some level of exposure is a human carcinogen. But I do not believe that the EPA study proves that and I can't prove that, and therefore, particularly in view of the EPA study, it is not possible at this stage to classify ETS as a known human carcinogen. If the epidemiological findinqs, on the other hand, of spousal exposure are deemed to be correct and significant, then ETS can be classified as a known human carcinogen.but ETS will have to be defined as that material due to cigarette smoking that exists in a resi.iential environment as a -- encountered by spouses. In my opinion, the importance of this study, combined with the questions that it raised, indicates that a formal independent review of the data or of the report may be warranted, that review could possibly include consideration of data or information that's now available that wasn't available at the tise of the report. I believe one other very serious ne.d is for a 1 74-814 0 - 93 - 4 Q ~ s 4 t r

95 22 submitted to you as a term paper or a thesis at Yale, how. would you grade it? DR. FEINSTEIN: Well, let me be clear, now. I made the comnent, sir, I think when you were out of the room that the EPA here did not really do any research. Meta-analyses are not, in my opinion, generally doing research. The research is what is done when you go out and get the original data that were in the original studies that were being pooled. In my opinion, those original studies weren't all that well done and if the student were submittinq it to me I would say, you know, "Can't you do any better than this7" CHAIRMAN: If you are -- well, you are one of the editors of the scientific journal entitled Clinical Epidemiology. What would your journal do with a paper that in its first draft reviewed epidemiologic studies at 95 percent confidence was sent back to the authors for revision and when it was returned, reviewed those same studies using a 90 percent confidence interval? DR. FEINSTEIN: we would think that the authors were extremely adept academic salesmen whose strategies we had previously encountered. It is not a unique thing to

96 23 try to put your best foot forward and to try to get your confidence levels as best you can. There are many circumstances where studies done that are very respectable, where, say, a clinical trial is done in which a mortality rate of 3 percent is lowered to 2 percent, gets reported by the investigators, by the New England Journal, and above the fold in the front page of the New York Times, as a 50 percent reduction in death rate. Which is true. You've lowered the rate from 3 percent to 2 percent -- I guess that's a 33 percent reduction, it's one in three, but it still looks wonderful, but when you look at it very seriously it's from 3 percent to 2 percent. So people are entitled to try to put the best buff they can on their work. We would, I suppose, ask them to try to justify exactly why they did it and we would probably say, you know, "You really can't do it after you've looked at the data. You should have written it way up front in your original protocol." To say that everybody suspected it is probably true, but even so, you've put f,t right into your protocol. CgMRMAlt: We have heard from former administrator

97 24 Rh at EPA that the change from the 95 percent to 90 percent confidence intervals was, quote, "at the request of the scientific coamunity," end quote. Yet, we have also seen that not one of the documents sutmitted by the agency to this subcoamittee gives any evidence of a request for such a change or, indeed, discusses it in any way before the fact. Do you think the change was warranted? What impact does the change have on the risk assessment, and have you any ideas as to why EPA made this change? You may have partially answered some of that. DR. FEINSTEIN: Well, first, sir, I don't understand the term "scientific comnunity." CHAIRMAN: -- DR. FEINSTEIN: What is it and where is it located. Is it in woodstock, New York; is it just outside of Fayetteville? I mean, where is this scientific commtnity? CHAIRMAN: It's not there, I can tell you. (Laughter.) But go ahead. DR. FEINSTEIN: I keep hearing about Congressmen advocating things. Why don't you get one set up in I

98 25 Fayetteville, sir? CHAIRMAN: I' ll do my best. (Laughter.) DR. FEINSTEIN: So I don't know exactly what was meant by "the scientific community." iTsually, when most people that I know talk about the scientific community, what they're saying is, "my friends," or, "the folks I went to dinner with," or, "the ones who attended the last meeting that I went to and who I chatted with." I think that that's in general what that term means. Some folks will restrict the scientific community to "those people whom I know agree with me." It depends on what is meant by that. I would say that the change from 95 to 90 percent will have a great deal of impact in the future, and I'm not talking now about the particular issue of ETS and cancer and other ailments that it is allegedly causing. I'm just talking about as we get into the future, when we start dealing with new kinds of agriculture where there has been some sort of genetic contribution to that, where there are new forms of biodegradability, where there are new forms of biopesticides rather than chemical pesticides, and where we

99 26 then have to say, "What are the consequences of that," and: it means that almost anybody who wants to get up and flaunt or flout any banner they want -- flount -- and wave any banner they want, can do so and should readily be able to conjure that up. I give to a group of fellows with whom I run an annual seminar a particular challenge each year that says, "Go into the statistical abstract of the United States, a publication that I believe is published by the Congress, go through that statistical abstract and pluck out data to support the most outrageously silly contention you can come up with and some new contention that won't seem outrageously silly that you can put together just by massaging those data." It's a challenge that they have each year. We give a little prize to the person who comes up with the best one. The one this year was somebody found a great statistical relationship between the sales of videocassette recorders, VCRs, and the incidence of AIDS. A wonderful statistical relationship. And then if you want plausibility, well, what are they doing while they're watching the VCRs and so on and so forth. CHAIRl9AN: How is a 90 percent confidence interval

100 27 compatible with a 1 tail test? DR. FEINSTEIN: In the usual statistical reasoning, we start with the idea of one of those galsion (phonetic) bell-shaped curves. And we then say that the inter-95 percent under that curve is what we're going to call customary, usual, expected. And the outer 5 percent, which is distributed with 2 and a half percent at this end and 2 and a half percent at the other end, the high and lows, that those are going to be the unusuals, the abnormals, the ones that we will reject as not being compatible with,the idea that they all come from this distribution. And that's a 95 percent two-tail, because you're looking at the two tails, one on either side. When you switch to the one-tailed 90 percent, you're saying, "I don't care about what's going on down here at the low end or I don't care what's going on at the high end. I'm putting all of my focus at one of these ends." And so you take that little 2 and a half percent down there and you shift it over here, which, when you get through all the mathematisizing, makes It a 90 percent level, even though one can then say, in the particular form of the statistical catechism, "I am still doing it 95

101 28 percent reasoning but I'm focusing it all on one side." CHAIRMAN: EPA's guidelines for carcinogen risk assessment require there be sufficient epidemiologic data before a substance can be classified as a Group A carcinogen. we gather that at least one group within EPA believe that the ETS epidemiologic data was not sufficient to make such a claim, yet Doctors Bayard and Farland have today represented that the claim -- that the data is sufficient. Who is right? Is the dataset truly sufficient to classify ETS as a known human carcinogen? DR. FEINSTEIN: Well, in terms of who is right in these two factions that seem to be disagreeing in EPA, I would not want to say. I have not read what was stated by the folks in Cincinnati. I do not know what are the rebuttals that were made by the EPA group, which I assume is somewhere in the Washington area, and I just would not want to get involved in that, sir. CHAIRMAN: Okay. EPA has suggested that whether or not the majority of the ETS studies are statistically significant, it can use a, quote, "weight of evidence," end quote approach to its carcinogen classification. It seems to some of us that we cannot allow an agency to have

102 29 guidelines for carcinogen classification that allow unlimited flexibility on how they judge whether a substance. is a carcinogen or not. What is your opinion of this weight of the evidence position? DR. FEINSTEIN: Well, without getting into the issue of what kinds of guidelines should be imposed on the agency by legislation or whatever, and the issue that I would prefer to avoid since I think it is extremely difficult to try to legislate science. However, I do think the statement made in the so-called Bradford Hill criteria and later used in the so-called Surgeon General's criteria in 1964 that demands consistency in the results is a reasonably good demand. And I think when you have as many studies going in different directions, going inconsistently, and, furthermore, going without high elevated odds ratios or risk ratios, I think both of those demands of the Surgeon General and Bradford Hill criteria were pretty good demands and I would hate to see them countermanded by some kind of mathematical manipulation. ' CHAIRMAN: We have heard some of EPA' s own scientists-were fairly critical of the meta-analysis ~

103 30 approach, but that Dr. Farland has stated this is an example of how EPA will carry out risk assessments in the future. You may have already answered my question, which is what are your opinions of the meta-analysis with low risk observational studies, and was EPA right to use this approach in the risk assessment, is it right to suggest that meta-analysis should be used in the future. And I gather from what you just said that there's a need for a certain consistency here, whatever approach is followed. DR. FEINSTEIN: Well, you know, as you know, Congressman, we,all do things at times to be loyal, and I strongly suspect that somebody at EPA probably set some sort of policy and said, "We would like to get the evidence to prove this point," and I would guess that the folks working at EPA were loyally trying to do their best to satisfy and comply with the folks that they were working for. I think as a general principle for future activities, I would hope that if meta-analyses are to be done that the material that becomes the`constituent of that meta-analysis would be scrutinized with far more immaculate care than was used for the information of -- that the EPA

104 31 pooled. CHAIRMAN: I would yield to Congressman Baesler for questions. REP. BAESLER: Just have -- I want to make sure I understood a couple of things. First of all, Doctor, I believe from your slides the 1964 standards that were set out by the Surgeon General and et al., talking about little or no contradictions, talking about a high relative risk ratio, and your word was preferably above 3, that -- I7R. FEINSTEIN: Sir, the preferably above 3 was not in the Surgeon General's report. REP. BAESLER: Okay. DR. FEINSTEIN: Their term was "strength of the association." The "preferably above 3" was sort of exegetical commentary created in later years. REP. BASSLER: But you think that commentary is correct, though, would you -- DR. FEINSTEIN: I think it's a very useful guide. REP. BAESLER: and you said that, and I think further you talked about that in general when you're doing studies or research and you have made a distinction between

I 105 32 editorializing and researching, because I think you more classified this as editorializing somebody else's research, . that you felt that from what you've heard today and by review of the report, that the EPA study, number one, probably had a little bit more than a few of no contradictions, number two -- DR. FEINSTEIN: Would you say that again, sir? REP. BAESLER: Yes. That you felt that the EPA study as it relates to the ETS suggested a little more than a few contradictions. DR. FEINSTEIN: No, what I said was that when EPA combined the studies into one chowder, that they combined studies that had contradictions. REP. BAESLER: That's right. I understand that. DR. FEINSTEIN: Okay. REP. BAESLER: I'm corrected, that's exactly right, because they were different type studies and they didn't use the same basis of research, at least it wasn't indicated that they did or they did not, which you thought was important. I think. So -- let me, I've lost my thought there. But that you felt that the -- when you gave -- you had the chart about the different countries, the

106 33 highest relative risk was 2. -- was 1-- 2.51. DR. FEINSTEIN: In the various countries, the highest per country was 2. REP. BAESLER: Right. DR. FEINSTEIN: In the individual component studies, the highest was 2 and a half. REP. BRESLER: Right, and that 2 compares to what we're talking about, the 2 or 3 that we talk about earlier being the high relative risk. That's the two numbers I'm comparing. DR. FEINSTEIN: I see. REP. BAESLER: I mean, I'm not in the scientific community. I'm trying to see if I'm comparing apples to apples chere. Am I? In other words, you said after the Surgeon General's study, 3 is what came out of it -- not the Surgeon General's study, but what's generally accepted as a good standard. DR. FEINSTEIN: I think what a lot of people said was, "If it's below 2 we're not even going to regard it as a candidate." REP. BAESLER: I got you. DR. FEINSTEIN: Preferably, it ought to be

107 34 above 3. And in that zone between 2 and 3, that's the room for individual judgments. REP. BAESLER: Yeah. That's ail I have. CHAIRMAN: Thank you very much. we appreciate your being here. Is there anything you'd like to add to what you've said or is there any comment you'd like to make about which we haven't asked you a question? DR. FEINSTEIN: Not really. I thank you for the adventure. I've managed to go through many years doing research. This is the first time I've ever been before a congressional committee, and it is a very enlightening experience. You should charge tuition. (Laughter.) CHAIRMAN: Thank you, sir, very much. We'll excuse you at this time, and if you have to leave, we'll understand, but you're welcome to stay as long as you would like. Thank you, Doctor. Our next -- Dr. Guren, thank you. I understand that you are one of the authors of a recent monograpk} that considered the chemistry and composition of environmental tobacco smoke or ETS. The EPA ETS risk assessment of environmental

108 35 tobacco smoke considers that ETS can be classified as a Group A carcinogen solely on the basis of similarities with, mainstream smoke. Could you list for us the differences for us between active smoking and exposure to ETS? DR. GuREN: There are major differences. of course, in terms of exposure to ETS versus active smoking, the principal differences are in the way that the smoke is inhaled. In the case of passive smoking, it's inhaled under relatively normal inhalation conditions or normal inhalation conditions, and in the case of active smoking it's a matter or drawing the smoke into your mouth, taking a deep inhalation as a rule, and forced exhalation. So the pattern of inhalation is quite different. Now, the other major difference, of course, is that the smoke encountered in active smoking, the mainstream smoke, is much more concentrated. Typically, chemicals present in mainstream smoke are present at concentrations a hundred thousand to a million•times higher than is encountered in passive smoking. one other possible -- possibly.3mportant difference is that there are short-lived species present in mainstream smoke that are, in all probability, not present

109 36 in environmental tobacco smoke. These are reactive species, such as free radicals, and some people have postulated that those kinds of constituents might contribute to lung cancer in active smokers. So there's a very major difference between active smoking and passive smoking. CHAIRMAN: I gather that the 1986 National Academy of Sciences report on ETS listed criteria necessary for the assignment of a proper marker of ETS exposure. What were those criteria? 'DR. GUREN: I'm sorry, I can't recall those criteria that were used at that time. CHAIRMAN: Do you believe that nicotine and the biomarker cotinine are adequate markers? DR. GUREN: They are useful markers but they're not adequate markers, and the reason for that is that nicotine behaves differently in the environment than do many of the other constituents of environmental tobacco smoke and particularly those constituents which are at least suspect to be important for biological impact. But it is most -- the most camaonly used indicator of today and probably will continue to be used for some time.

110 37 CHAIRMAN: EPA used studies that quantified very low levels of cotinine in body fluids to determine the amount of exposure to be expected in women not married to smokers. Is the measurement of cotinine a very -- at very low levels reliable? DR. GUREN:, No, there are a lot -- many difficulties in determining cotinine at very low levels and at generating results with sufficient confidence. CHAIRMAN: Risk assessments are very dependent upon having good exposure data. Do you believe that there is sufficient existing data to accurately characterize the U.S. population's exposure to ETS? DR. GUREN: No, I do not. In fact, I think that this is one of the more important needs in this area in terms of being able to establish the actual population exposure and being able to establish population risk, and information is required both on the quantities ETS constituents that the individuals are exposed to and cotinine levels for comparison. But adequate data does not exist today. CHAIRMAN: You've been very helpful. Thank you for being here, sir. And we appreciate your testimony and the questions you've answered for. And we will excuse you at this time. You're welcome to stay, if you'd like. (End of proceedings as recorded.)

I 111 Mr. WaXvtArr. Dr. Rowland. Mr. RowLArrn. Thank you, Mr. Chairman. In any area of food and drug regulation or clean air or clean water standards or toxic substances, there should be clear, estab- lished guidelines for evaluating and determining health risks. Risk assessment should be based on the best scientific information that is available. When EPA began to develop an assessment of the threat to non- smokers posed by environmental tobacco smoke, there were exist- ing standards for making such a determination, and I would have expected the ultimate finding by EPA would have been based upon these standards. Instead, I understand that EPA did not follow its own guidelines, nor did it follow normally accepted standards in ep- idemiological science. So I will be interested to learn if the standards were changed, how they were changed, and how EPA thinks that these changes affected the results. To change standards in any scientific study is unacceptable under any circumstances, and I want to learn the truth from EPA. V eld back my time, Mr. Chairman. WAxMAIV. Thank you, Mr. Rowland. Mr. Hastert. Mr. HASTERT. Mr. Chairman, I have an opening statement I would like to submit for the record. Mr. WAXMAN. Without objection, that statement will be included in the record. [The opening statement of Mr. Hastert follows:] OPENING STATmcnir os Hox. J. DENxrs HAsxaRT Thank you, Mr. Chairman. I want to join in commending yo for your interest in the issue of the health effects of environmental tobacco smoke. As I think today~s hearing will show, the quality of the air inside of homes and workplaces is Just as important as the cuality sir outdoors Aad so I think it is appropriateni that we are reviewing EPA!s recentofrecommendations to the public concerng the health ef- fects of environmental tobacco smoke. I must be gi'n, however, by noting my conearns with the research and reports that apparently form the basis for EPA's recommendations. As you know, earlier this year EPA completed a risk assessment of the respiratory health effects of environ- mental tobacco smoke. That risk asseesment purported to show that exposure to en- vironmental tobacco smoke is responsible for approximately 3,000 lung cancer deaths each year in nonsmoking adults and that it seriously affects the respiratory health of many thousands of children. Unfortunately, there are msnyque~ ons being raised about the conclusions of EPA's risk assessment. For eaamp er, we will hear suggestions toiay that the risk assessment is seriously flawed because it failed to consider several major studies which reported no association between environmental tobacco smoke and lung can- cer. We will also hear testimony that EPA may have ignored data showing that diet cancer. Finally, we will may cause or contribute substantially to the risks of lung hear that EPA apparently rejected well established statistxcal procedures used to in- terpret study results and used other procedures that lead to the present risk esti- mates. I think it is unfortunate that EPA is relying on this risk assessment document because it raises more questions than it answers about whether environmental to- bacco smoke is a serious health hazard. What's even more troublin~ is that this isn't the only time that questions have been raised about whether E. A's policy judgments are backed by sound, scientific evidence. Consider some other examples. In the early 1980's, EPA concluded that dioxin was a powerful human cau~ogen. But after an entire town in Missouri was evacu- ated and abandoned, Federalofficals decided the risk had been grossly exaggerated.

112 In the mid-1980's, EPA recommended that asbestos be removed from schools. Now, after millions of dollars have been spent to remove asbestos in schools, EPA says the risk is less if most asbestos is left in place. Former EPA Administrator William Reilly created a commission to examine this problem, and in a report entitled Safeguarding the future the Commission concluded that-quote-"EPA science is perceived by many people, both inside and outside the Agency, to be adjusted to fit policy." Mr. Chairman, we have a very urgent need in this country to ident~'y environ- mental priorities and use our limited resources to address the most significant risks first. As EPA's Safeguarding the Future report makes clear, when EPA's policy choices are not based on sound scientific evidence, our chances of identifying the most serious risks, and then marshalling the public will to deal with them, are seri- ously compromised. I hope that we use this hearing to encourage EPA to ensure that its policy choices are based on the best available scientific evidence, and that the reasons for its choices are clearly evident to the American public. Thank you Mr. Chairman. Mr. WAxivIAN. Mr. Kreidler. Mr. KREIDLER. Thank you, Mr. Chairman. I would like to commend you for your efforts to improve air qual- ity and specifically the legislation that you plan to introduce that will address the issues surrounding smoking in public places. Leg- islation comparable to that was enacted in the State of Washington because of my efforts as a State legislator. I certainly believe that comparable legislation is needed at the national level, and look for- ward to joining you in that legislation when it is introduced. I am also pleased that the EPA now has released very important findings on smoking and the exposure to secondhand smoke. That report is something that has been withheld for a long period of time. Something that we have all known for an extended period of time is now available to the public, and the true knowledge of what that represents as a hazard to the Americanpe ople is now known. I lost a father because of emphysema, and no one has to have it driven home more to them than to watch somebody who is strug- gling for life with emphysema, because of a lifetime of smoking, than somebody who had a loved one and lost somebody because of that. My father began smoking at around age 14 and smoked all of his life, and his comment always to me was, "I wish they had told me back then or information had been available earlier in my life as to what those health risks represented." I have a 19-year-old son whom I have smelled tobacco on when he has come back from some of hispo ker parties and things like this, and it is because he is around other kids who started smoking at about the same time my father did. I have grabbed him and told him just exactly how much of a risk that represents and what it is like to watch your father die of emphysema in front of your eyes, and I think I have made that kind of impression on him. The rea- son his friends smoke is because they grew up around other people who had smoked and they didn't really have it driven home to them. I think it is imperative that the dangers of secondhand smoke be driven home to the American people, that we do what we can to convince people that this is hazardous to their health. I can understand the gentleman from Virginia's comments about other pertinent environmental factors in our society, but this is one we can do something about, something we can do something about rather quickly, and we should indeed be doing it.

So I commend the chairman for holding these hearings and bringing this information to the American people. This information is needed, should be discussed, addressed, and I look forward to the proceedings. Thank you, Mr. Chairman. Mr. WAxMAx. Thank you, Mr. Kreidler. Mr. Bilirakis. Mr. BILIxASIS. I have no opening statement, Mr. Chairman. Mr. WAXMAN. I want to thank my colleagues, and, any other member of the subcommittee who wishes to insert an opening statement, without objection they will have that opportunity. [The opening statements of Messrs. Gary Franks and Edolphus Towns follow:] STATEMENT OF HON. GARY A. FRAHI{s Last January EPA released a report that showed a slightly increased risk of can- cer for non-smokers exposed to secondary smoke. Almost immediately, increased public pressure for action developed. But how long will second-hand smoke be con- sidered dangerous? I say this because we all know of the long established pattern of EPA decl somethi.ng dangerous, only to reverse itself when confronted with sound scientifi~ta. Time and time again, we have heard the cry that something is dangerous. Twenty years ago, there were pressures to dredge the Hudson River to remove PCB's. Fortu- nately, these efforts were delayed until the science revealed that dredging would create far greater dangers than leav ing the PCB's locked in the river's sediments. Ten years ago it was dioxin, and the Federal Government spent tens of millions of dollars to evacuate Times Beach, yet last year senior Federal officials and scientists conceded that time and subsequent research had shown the risk was grossly over- stated. Animal studies indicated that cyclamates and saccharin caused cancer-ex- cept it now appears that while massive dasea do cause tumors in animals, day-to- day doses may not have any effect at all on people. Then there was the alar scar. In retrospect, scientists found that the real danger had been grossly overstated, and that radical action had not been necessary. What do these previous EPA reversals tell us about the likelihood that the ETS risk assessment will withstand acrutiny from independent technical experts? Several major shortcomings in the EPA risk assessment suggest that the pattern of reversal will continue. They include: -Excluding from the ETS risk assessment two major studies which reported no association between ETS and lung cancer (Brownson & Stockwell). -Ignoring accepted data which shows that diet may cause or contribute substan- tially to risk of lung cancer. -Rejecting well established statistical procedures which used to interpret study results. Every time a new danger is announced, a cry for immediate action follows. If this pattern continues, EPA will again reverse itsel£ What are the implications of this reversal? I see several. First, it will weaken EPA's credibility and leadership in the United States and before foreign $overnments. Second, it will demonstrate again that recommendations outlined in a report enti- tled Safeguarding the Future: Credible Science, Credible Decisions, designed to strengthen science at EPA, are not being implemented. And, finally, it will also demonstrate that this committee is insensitive to a well established pattern or practice by which EPA produces biased scientific findings. STATF.MEN'r OF HON. EDOLPHus TOWNS Mr. Chairman. I want to thank you far this opportunity to review EPA's risk as- sessment on environmental tobacco smoke. There are many occasions on which we make pubtic policy in advance of scientific evidence. Sometimes, we cannot wait because the potential dangers are too great. Sometimes, the policy does not depend on scientific evidence but on other factors: moral, cultural, or aesthetic.

114 I, along with most of the environmental community, have a deep suspicion of ng risk assessments to drive public policy. Although risk assessment is touted as rscientific" approach, it is heavily influenced by statistics, usually gathered by as~ questions of its subjecta. Like all such surveys, the devil is often in the de- tails. TGVe-both policy makers and the publi~are often not told the details of the scientific models and data used. We are given a conclusion and told it is scientific. I would like to see a common set of rules for doing risk aesesament, outlining pro- cedures and atandards, and have every assessment published in detail with oppor- tunity for public comment. In many areas, scientista use gueas work to eatimate be- tween animal data and human impacts. If more were known about these leaps of faith, then there would be more impetus to atudy these connections and use re- search numbers instead of puesswork. Then I think we could come closer to agree- ment among environmentahsta, scientists, and the re ated community. We might still choose to disre~ard risk assessments because o~ther goals, but we could at least agree on the science in the assessment. There are many reasons for banning smoking in public places. Some are aesthetic, like the smell and haze, some are health-based, because it may be an allergen for some and a respiratory problem for others. But my concern here is that someone had a public policy in mind, however, laud- able, and decided that the science had to support it. One of the bizarre inferences of this study is that the amount of smoke likely to be inhaled passively is much more carcinogenic than the same amount inhaled actively. I would hope that such a conclusion is based on careful scientific testing, and not an effort to match a study's conclusions to a desired public policy. this same method would find diesel fumes and soot much greater carcinogens than the amount of passive smoke consid- ered. Am I the only one struck by the use of a 90 percent confidence level in this study? Every other EPA risk assessment uses the higher scientific standard of 95 percent. The result is that we are now willing to be wrong 1 time in 10 instead of 1 time in 20. If we are willing to lower our confidence in this study, in order to be more protective of human health, then why are we not more protective in every other risk assessment? My concern is that we are using science to ,~'ustify policy decisions we plan to make anyw ap. Science is not the only basis for pubh'c p.hcy, but we should not try to hide behind science. If we bend our scientific standards, orchanqe them, in order to come to the conclusion we wanted, we are not actinp, scientifically. I fear that we will un- dermine the public's confidence in science and m the government's ability to conduct scientific tests objectively. Here, the individual studies were not sensitive enough to conclude that environmental tobaxo smoke was a carcinogen 3o methods and standards were changed until a relation was found. That can work both ways. This report leaves me wondering how many other asaessments said aomething was be- nign, because that fit with the publicpolicy of the day. I hope that we will be able to establish uniform atandards for riak assessments, and subject them to public scrutiny, so that we can all have confidence in what we are debating. But I also hope that we will have the courage to say when we are acting on our convictions, even without scientific evidence. That would be much bet- ter than establishing a precedent that we can make a scientific study support what- ever policy we want. Mr. WAxmAx. We have three other colleagues of ours who are not on this committee, but who have been leaders in this area, who are here to testify: The Honorable Frank Lautenberg, a Member of the U.S. Senate; the Honorable Richard Durbin, a Member of the House of Representatives; and the Honorable Martin Lancaster, who is also a Member of the House of Representatives. I would like to ask the three of you to please take seats at the table. I might indicate that Senator Lautenberg and Mr. Durbin have both introduced bills that would deal with protecting children particularly from secondhand smoke in Government facilities. So they have already been showing leadership on this very issue that is before us today. We are pleased to welcome all three of you to our hearing. Your prepared statements will be in the record in full. What we would like to ask each of you to do is to limit the oral presentation to no

115 more than 5 minutes. I know you have busy schedules, and we have a long list of witnesses as well to make a presentation to us. Senator, why don't you start off. STATEMENT OF HON. FRANK R. LAUTENBERG, A U.S. SENATOR FROM THE STATE OF NEW JERSEY Senator LAU'rENBERG. Thank you very much, Mr. Chairman, and Congressman Bliley. We will try to do our business in 5 minutes. I want to thank you for allowing me to testify before your sub- committee about the adverse health effects of environmental to- bacco smoke and especially its effect on our Nation's children. It is ironic that the more and more scientific peer reviewed infor- mation that we gather which proves that secondhand smoke causes illness and death among nonsmokers, the harder and harder that the tobacco industry fights these findings. They have become the modern-day Flat Earth Society. But we should never be surprised about what the tobacco industry will do to discredit the sound science that tells us that smoking and secondhand smoking kills. They have always put profits first and the human second. In a recent move, the industry has filed a lawsuit seeking to overturn the results of the EPA report that concluded that second- hand smoke is a Class A carcinogen. Rather than accept these peer reviewed scientific findings, they are out hiring more expensive lawyers to try to insist once again that their product is safe. Mr. Chairman, we are not only talking about EPA, we are talk- ing about other agencies of Government that have come out with report after report after report. How many studies more do we need? The 1986 Surgeon General's Report concluded that second- hand smoke caused lung cancer-1986. A 1991 National Institute for Occupational Safety and Health-NIOSH--concluded that sec- ondhand smoke was carcinogenic to workers exposed to it. In 1992, the American Heart Association stated that ETS caused heart disease, and then the EPA report cited 3,000 deaths resulting from environmental tobacco smoke, and then a New England Jour- nal of Medicine study demonstrated that secondhand smoke signifi- cantly exacerbates asthma in a multi-year study, and just as they dispute these serious findings, they continue to fight laws and poli- cies that likely or even may protect children andd adults from sec- ondhand smoke. It wasn't long ago that I stood on the Floor of the U.S. Senate, working with our distinguished friend and colleague, Congressman Durbin over here, and fought successfully to guarantee airline pas- sengers that they could fly without risking their health from breathing secondhand smoke, and I can't tell you, Mr. Chairman, how many times since then total strangers have walked up to me to thank us forgiving them this smoke-free environment. But now, with this latest report from EPA confirming the dan- gers of secondhand smoke, we have to go even further, and just as we are seeing actions in States and localities around the Nation to protect the public from this carcinogen, I believe that it is time for Congress to take action. Following the release of the EPA report in January, I introduced legislation entitled "Pro-Kids" that was introduced in the Senate and would ensure that children that are participating in a feder-

116 ally-funded children's program are protected from exposure to sec- ondhand smoke, and Congressman Durbin, along with the support of the distinguished chairman of this subcommittee, has introduced similar legislation in the House. This legislation would require all recipients of Federal funding for programs that serve children to eliminate smoking or provide designated smoking areas that are separately ventilated to the out- side. This is a common-sense first step to respond to the EPA's findings, and I don't underestimate the barriers that may be placed in the way of even this modest step. If it is possible to take action to protect people from benzene, radon, arsenic, and asbestos, all Class A carcinogens, it ought to be possible to protect our children from secondhand tobacco smoke, and yet I know, and all of us here know, that the tobacco industry is going to dig in, further challenge the scientific conclusions, and fight us every step of the way, and I commend EPA, I must tell you, Mr. Chairman, for developing the ammunition that we need for this fight. No matter how many lawyers the tobacco industry hires, they will not be able to convince even one caring parent that exposing their child to secondhand smoke isn't hazardous. No matter how many so-called public service campaigns they run, they are not K oing to be able to convince us that they care about the public's ealth. In summary, Mr. Chairman, we fight so hard here and through- out this country to protect our citizens, to make sure that they are well and alive. We lost 50,000 of our bravest in Vietnam, and here, every year, we lose over 400,000 to tobacco smoke, and we have got to fight the industry about this issue. I think it is time that we get on with this, the American public is demanding it, and I commend you for holding this hearing, Mr. Chairman. Mr. WAxmAN. Thank you, Senator, for a superb statement. Mr. Lancaster, why don't we hear from you next. Mr. LANCASTER. Thank you, Mr. Chairman. My colleague, Mr. Valentine, had requested to be able to testify today but, because of an inner ear infection, is unable to do so. I would request unanimous consent that his statement be admitted in the record at this point. Mr. WAxiKAN. Without objection, that will be the order. [The statement of Hon. Tim Valentine follows:] STATEMENT oF HON. TIM VALENTIIVE, A REPRE9ENTATIVE IN CONGRESS FROM THE STATE OF NORTH CAROLINA Mr. Chairman, I appreciate the opportunitq to testify before this subcommittee on an issue of great importance to the people I represent and to the American public as a whole. In my capacity as a member of the Public Works Committee, I have already heard testimony on this subject and seen action taken on smoking in Fed- eral buildings resulting from the January announcement by the Environmental Pro- tection Agency that environmental tobacco smoke (ETS) is a Group A carcinogen and a cause of lung cancer in nonsmokers. This issue is receiving heightened cov- erage as is demonstrated by the fact that a subcommittee of the Agriculture Com- mittee is concurrently recei testimony on the EPA's ETS study. On the one hand, it is laudable that two subcommittees of the Congress have taken the time to conduct hearings on the many complex issues that have been raised with respect to the EPA report and policy statements. On the other hand, it is unfortunate that both hearings are occurring simultaneously, preventing people from hearing a full-range of views on these issues. Once I have had a chance to re-

117 view the testimony and transcripts from both of these hearings, I will evaluate the need for additional hearings in the Subcommittee on Technology, Environment, and Aviation on the quality of science in this report, the role and effectiveness of EPA's science advisory apparatus, and the process that EPA uses to generate risk assess- ments. The " EPA, represented here today by its able Administrator, Carol Browner, is about to release a long-awaited document providing policy guidance on the issues of workplace smoking. The members of this subcommittee and the American public need to be assured that this document represents responsible public policy based on quality science. This subcommittee is no doubt aware that a number of important questions have been raised about EPA's report on ETS-whether the report used all the good data available, whether EPA adhered to accepted scientific procedures in drawing its con- clusions, whether it is accurate, and of course, whether it provides the basis for re- sponsible policy making. Such questions about the quality of the science on which EPA bases its regulatory and policy decisions are not new. In fact, these concerns led former Administrator Reilly to establish an independent advisory committee to review the quality of science at EPA and how science is used by EPA to makeregu latory and policy decisions. That group produced the report "Safeguarding the Fu- ture: Credible Science, Credible Decisions," whose recommendations were reviewed at a heari before the Science Committee last year, and whose implementation we intend to f~ow closely. The Panel's report includes 11 major findings, each accom- panied by a recommendation. These findings and recommendations indicate that there are serious problems at the Agency that need fixing. For example: "Currently, EPA science is of uneven quality, and the Agency's policies and regu- lations are frequently perceived as lacking a strong scientific foundation." p. 4. "In many cases, appropriate science advice and information is not considered early or often enough in the decisionmaking process." p. 6 "[EPA] does not have a uniform process to ensure a minimum level of quality as- surance and peer review for all the science developed in support of Agency decision- making." p. 7. "Science should never be adjusted to fit policy. Yet a perception exists that EPA lack adequate safeguards to prevent this from occurriig." p. 24. "EPA should be a source of unbiased information. However, EPA has not always ensured that contras", reputable scientific views are well explored and well-docu- mented from the beginning to the end of the regulatory process." p. 36 The recommendations contained in that report are particularly relevant to this discussion when concerns are being raised that, in the case of secondhand smoke, science at EPA has been adjusted to fit a policy that ispolitically if not scientifically correct. The fact that the chairman of the Science Advieory Board panel that re- viewed the environmental tobacco smoke risk assessment acknowledged that the analysis could not be reconciled with EPA's own risk assessment guidelines, raises concerns about the process EPA uses to generate risk assessments. It is the impera- tive responsibility of this Congress to make certain that we fully understand the issue before us and that our confidence in the EPA's conclusions about environ- mental tobacco smoke is complete. Anything less will be a grave disservice to the people who expect us to make good publicpo licy based on good science. And that is what is critical-protecting our citizens. We must ensure that our public policy decisions are based on credible, peer-reviewed science. Recently, in the Technology, Environment, and Aviation Subcommittee of the Science, Space, and Technology Committee, there was an attempt to severely limit EPA's budget suthonty to conduct scientific research. As chairman of that sub- committee, I successfully opposed such efforts. I believe that environmental research is one of the EPA's most important roles. However, I have serious concerns about the overall quality of science at EPA. As I indicated earlier, I am currently reviewing the need to hold heanngs to ez- amine the process that EPA uses to generate risk assessments. In addition, hearings to e:A**+i*+e the steps EPA is taking to implement the recommendations contained in "Saf ng the Future" are being considered. The purpose of these hearings would be~t,o~find out where EPA stands on the issue of scientific integrity in its as- sessment of environmental risks. The issues of the procedural and scientific short- comings of the EPA's ETS risk assessment which are the subject of Representative Charlie Rose's hearings today and may be referred to in this hearing may also be examined in detail in the context of "Safeguarding the Future". Mr. Chairman, thank you again for the opportunity to address this important issue.

118 STATEMENT OF HON. MARTIN H. LANCASTER, A REPRESENTA- TIVE IN CONGRESS FROM THE STATE OF NORTH CAROLINA Mr. LANCASTER. Mr. Chairman, I appreciate the opportunity to address the members of this subcommittee on the environmental tobacco smoke risk assessment released earlier this year by the EPA and on the follow-up policy recommendations EPA is propos- ing today. Many of us are aware of the great number of workplace smoking controversies that have arisen this year as a result of that report. In fact, so controversial has this issue become that, as reference has been made to earlier today, two subcommittees of the Congress are considering the EPA report today. I hope these efforts will help all of us better understand the complexities of this issue and en- lighten future decisions on the question of environmental tobacco smoke and health. I would like to share a number of concerns about the action EPA is taking today. First, it seems clear that the guidelines EPA has developed on the issue of smoking and health are predicated on a report that is, at the very least, of questionable scientific merit. Since early this year when the final ETS risk assessment was pub- lished, countless news articles and editorials across the country have pointed out the significant scientific flaws that call the re- port's conclusions into question. A number of scientists have noted in congressional testimony and in news articles that the ETS risk assessment is unprecedented in its overall approach and the weakness of its evidence and in the looseness of the standards EPA applied to the data on ETS and health. Congress and EPA itself should address these criticisms clearly and exhaustively before taking action based on this report. Indoor air quality experts testifying on proposals to ban smoking in Federal facilities have pointed out that ETS is rarely the prob- lem that EPA and anti-smoking groups maintain. Investigations of so-called sick buildings by private companies and by the National Institute of Occupational Safety and Health suggest that the major cause of employee complaints is not ETS or any other single pollut- ant but inadequate ventilation which allows all indoor pollutants to accumulate. These experts maintain that improving ventilation is the key to controlling ETS and all other indoor pollutants in modern buildings. It is particularly interesting that the question of smoking versus ventilation arises again today in light of the recent news reports about poor ventilation conditions aboard aircraft. Smoking was banned entirely in 1990, as the Senator recently referred to, de- spite warnings that inadequate ventilation, not smoking, was the primary cause of irritation and complaints of poor health. It is hardly surprising that these complaints about air quality on planes have continued and remain unaddressed despite no smoking on planes for 3 years. Whether or not smoking policies are necessary for purposes of in- door air quality, experts note that some employers wish to estab- lish workplace smoking policies for other reasons. Whether this is the case, however, a number of steps can be taken short of the total bans for elaborate ventilation changes that EPA recommends. These options include arrangement of smoking areas based on air V-1D O *WD dl~ C.~t do ~i_pp (Do ..1 t~:

119 flow patterns to minimize nonsmoker exposure to tobacco smoke and designation of smoking areas that are equipped with separate exhaust. In most buildings, experts say, smokers and nonsmokers can be accommodated effectively and at relatively small expense. A final concern that should be raised about the policy rec- ommendation EPA proposes as they apply to the private workplace is that they are, at best, preliminary. The Occupational Safety and Health Administration, which has jurisdiction over worker health and safety, currently is evaluating the data on ETS, and, as part of its overall investigation of the need for regulation of indoor air quality in the workplace, no policy recommendation should be is- sued by any agency of the Federal Government until OSHA's eval- uation is complete. In summary, Mr. Chairman, it is my view that EPA's policy rec- ommendations are misguided and premature from any number of perspectives. We should not support this Agency in proposing poli- cies that are founded on inadequate science, that represent only a few of the many alternatives available to manage the workplace smoking issues, and that predate a complete investigation by the Agency with jurisdiction and expertise. I thank the members of the subcommittee for the opportunity to address this important issue. Mr. WAxmArt. Thank you, Mr. Lancaster. Mr. Durbin. STATEMENT OF HON. RICHARD 'J. DURBIN, A REPRESENTA- TIVE IN CONGRESS FROM THE STATE OF ILLINOIS Mr. Dvxsnv. Thanks very much, Mr. Chairman, Mr. Bliley, and members of the subcommittee. I appreciate the opportunity to tes- tify today. There is a stalker in America following our children, hoping to lure them into danger. There is a serial killer targeting our kids, working to addict them to a deadly product. That stalker is tobacco. That serial killer is tobacco. Tobacco companies exploit our children with their deadly prod- ucts and their shameless advertisements. It is no overstatement to say that tobacco products addict, maim, and kill America's chil- dren. Four hundred thousand Americans die each year of tobacco- related diseases. A million and a half others quit or die of other causes. Now how do the tobacco companies replace these 2 million smok- ers? They recruit our children at the rate of 3,000 a day, or 1 mil- lion new smokers each year. As Congressman Synar has said, most people start smoking when they are kids. The tobacco companies know that. You see it in their advertising, not only in what the substance of the advertising is going to be but where they place it. Let me just say that it is interesting to listen to the debate un- fold in this subcommittee between the Environmental Protection Agency's scientific findings and the tobacco industry's "scientif c findings". If there was ever an oxymoron, it is the term "tobacco company scientist." Why this Congress should give any credibility to the scientific claims of an industry which has falsified, distorted, and denied scientific data for decades is beyond me.

120 Let me say to the Environmental Protection Agency and Mrs. Browner, stay the course, stick with the science. You have obvi- ously struck a nerve in the tobacco boardrooms. They are suing you, they are holding hearings, they are doing everything in their power to stop the effort to control secondhand smoke which is kill- ing and maiming Americans, and particularly the most vulnerable among us, our children. With the information we have from the EPA study, we know that adults who intentionally expose children to secondhand smoke are, at least, careless and, at worst, abusive. The parent who smokes in a car with the windows rolled up with small children exposes those children to bronchitis, pneumonia, and the onset of asthma. If that same parent refused to provide warm clothing for an infant and exposed that child to the dangers of pneumonia, we would not hesitate to step in and protect the child. Can we do anything less for a child exposed to secondhand smoke? I want to commend the chairman for the legislation which he has announced this morning, it is an obvious step to be taken to protect innocent people, and I would like to also report some success that has taken place already during this Congress. In the agriculture appropriations bill which I brought to the Floor several weeks ago, we included a provision which prohibited smokers from exposing children to secondhand smoke in WIC clinics across America. This program, which serves pregnant women and yo~ung children, is cer- tainly the obvious place to start to protect children from smoking. I am happy to report to you that that legislation not only passed the Floor of the House but recently was incorporated in the Senate version of the bill, and I understand as well that the Senate is hop- ing to make this permanent law rather than to require that we put the lan guage in the bill each year. I think that is an important step forward. To my colleague, Mr. Lancaster, I might say that Mr. Lautenberg and I have fought the tobacco industry over the prohibition of smoking on airplanes. They predicted that there would be fist fights in the aisles of airplanes as disgruntled smokers came for- ward to challenge the flight attendants. It never happened. In fact, there were fewer than one complaint per million passengers be- cause of this law which Senator La.utenberg and I worked on sev- eral years ago. I would say to my colleague from North Carolina, if he believes there are complaints today about the quality of air in airplanes, imagine what we would have if we continued to allow people to smoke in that confined environment. Try to think for a moment what would happen if we decided tomorrow to repeal this law and allow this return to smoking. I think you would find across Amer- ica the kind of revolt which you might expect from people who are now sensitized to the kind of abuse that they have had to put up with for years from the presence of smokers. I would just say that two things must be done immediately. First,po licies must be established to protect kids from exposure to secondhand smoke in public places; and, second, smokers and par- ents must be firm that they will not smoke or allow smoking to take place around vulnerable children in places where the lads spend a lot of time.

121 The passage of the legislation which I have introduced with Sen- ator Lautenberg, Congressman Mazzoli, and Congressman Hansen would go a long way to prohibiting smoking in Federal programs and facilities that could endanger kids. The passage of the legisla- tion which my colleague from California suggested this morning would go even further. I salute his efforts in this regard and thank you for this opportunity to testify. [The prepared statement of Mr. Durbin follows:]

122 RICHARD J. DURBIN araso[ w,ar ca~.emt a, aw.orw.r,as tu.®rn. a aa.c.amr r IW.O.VeBLw, ,y.~.. . a..~.. ~,w a (rOt1gCt8s of thC %11iLtd,$tfltCS monac of Rqccsarcatinca Seshingcnn, PC zuns-i3w TESTIMONY OF THE HONORABLE ftICBABD J. DUBBIH BEFORE TNE SUBCOMMITTEE ON HEALTH AND THE ENVIYO2DD?NT COMMITTEE ON ENERGY AND COMMERCE JULY 21, 1993 ®m+a°i~•.,w m..~. wrs.auws o,n.u.rx ,Par »~1, Y,l H M/iaMll a HM ~,..H.,.H » , »...o,.~... .a,..,.. v„aWaaH., .,.~.,.. Mr. Chairuan, I would like to comend you for your longstanding co®itaent to the protection of nonsnokers from secondhand smoke and thank you for the opportunity to testify today. Testimony presented at today's hearing highlights the compelling need to protect our children from exposure to environmental tobacco smoke. When the Environvental Protection Agency released its report on secondhand suoke in Jaauary, the portion of tha report that received tha greatest attention was the designation of environmental tobacco smoke as a Group A carcinogen like asbestos, benzene, and arsenic. But the EPA study also found a variety of issaediate health problem that affect children long before the carcinogens in secondhand smoke have their longer-tarm impact. EPA found that exposure to secondhand snoke is the source of a variety of illnesses in children. Exposure to secondhand smoke causes 150,000 to 300,000 lower respiratory tract infections such as bronchitis and pneumonia in young children each year; causes additional episod.s of asthma and increased severity of asthm symptoms in children who already have asthma; and aay be a risk factor for 8,000 to 26,000 nav cases of asthma annually in children who would not otherwise become asthmatic. While such of the unnecusary exposure to secondhand smoke encountered by children takes place in the hoae, children ara also vulnerable in other settings. For example, in a study released in February, the Centers for Disease Control found that .ore than 18% of the 3.9 million U.S. children in licensed or accredited day care centers may be exposed to secondhand smoke. These centers do not have a nonsmoking policy to protect the 752,000 children they serve. While we can't stop people fro. smoking in their own homes, there ara places where tha federal government has the authority, and the obligation, to protect children from exposure to secondhand smoke.

124 Provisions of H.R. 710 The PR0-RIDS Act (PBeventing Our Kids fro. Inhaling Deadly Smoke) Introduced by Reps. Richard Durbin, James Hansen, and Romano Mazzoli SMOKING IN THE FEDERAL {iOR[PIaCE 1. EPA shall develop, within 180 days, guidelines for instituting and enforcing a nonsaoking policy at each federal agency, which will prohibit smoking except in separately ventilated areas. 2. As soon as is practicable, the head of each Executive agency shall adopt a nonsmoking policy that aeets the requirements of the EPA guidelines. The Director of the Administrative Office of the U.S. Courts shall adopt a nonsmoking policy for Judicial Branch buildings. The House Building Comission, the Senate Rules Comittee, and the Architect of the Capitol shall adopt nonsmoking policies for Legislative Branch buildings. 3. The Administrator of the General Services Administration shall certify that each Executive agency's policy aeets the requirements of the EPA guidelines. 4. Agency heads may publicly petition for a waiver, which may be granted if (1) unusual extenuating circumstances prevent enforcement and the agency establishes and enforces an alternative policy protecting individuals to the maximum extent possible, or (2) the agency establishes an alternative policy that provides protection equal to that of the EPA guidelines. 5. Agencies subject to collective bargaining agreements shall engage in collec- tive bargaining to ensure implementation, and may exempt work areas for up to 1 year that are covered by a previous agreement permitting smoking. SMOKING IN FEDERALLY-B1IHDED CHIIDRBB'S PROGitAKS 6. Any entity using federal funds to provide health services to children under age 18 or to provide other services primarily to children under age 18 shall establish and .ake a good-faith effort to enforce a nonsmoking policy that prohibits smoking except in separately ventilated areas, beginning with the first fiscal year after enactmont. 7. Entities may petition the agency fundir.g thes for a waiver, which may be granted if the conditions in #4 are aat Entities subject to collective bar- gaining agreements that per.it smoking may request a waiver of up to 1 year. 8. Entities that fail to establish or make a good-faith effort to enforce the nonsmoking requirement ara subject to civil penalties of up to $1,000 per violation per day, which would be assessed by the head of the agency that provided the federal funds, with an opportunity for a hearing. The agency head could reduce or waive the penalty and take into account mitigating factors and the violator's willingness to abide by the law in the future. TECH9ICAL ASSISTANCE AND OUTRP.ACH ACYIVITIES 9. EPA and HHS shall provide technical assistance to agency heads and other persons who request it, including information on smoking cessation programs for employees and information to assist in compliance with this Act. 10. EPA shall establish an Environmental Tobacco Smoke Advisory Office and an outreach program to inform the public of the dangers of secondhand aaoka, operate a telephone hotline, and provide information to those requesting it.

124 Provisions of H.R. 710 The PRO-KIDS Act (PReventing Our Kids fro. Inhaling Deadly S.oke) Introduced by Reps. Richard Durbin, James Hansen, and Romano tiazzoli SMOKIRG IN THE PEDERAI. {iOR&PIIICE 1. EPA shall develop, within 180 days, guidelines for instituting and enforcing a nonsmoking policy at each federal agency, which will prohibit smoking except in separately ventilated areas. 2. As soon as is practicable, the head of each Executive agency shall adopt a nonsmoking policy that meets the requirements of the EPA guidelines. The Director of the Administrative Office of the U.S. Courts shall adopt a nonsmoking policy for Judicial Branch buildings. The House Building Commission, the Senate Rules Committee, and the Architect of the Capitol shall adopt nonsmoking policies for Legislative Branch buildings. 3. The Administrator of the General Services Administration shall certify that each Executive agency's policy meats the requirements of the EPA guidelines. 4. Agency heads may publicly petition for a waiver, which may be granted if (1) unusual extenuating circumstances prevent enforcement and the agency establishes and enforces an alternative policy protecting individuals to the maximum extent possible, or (2) the agency establishes an alternative policy that provides protection equal to that of the EPA guidelines. 5. Agencies subject to collective bargaining agreements shall engage in collec- tive bargaining to ensure implementation, and may exempt work areas for up to 1 year that are covered by a previous agreement permitting smoking. SMOKING IN FEDERALLY-FUNDED CHILDRE6'S PROGRAMS 6. Any entity using federal funds to provide health services to children under age 18 or to provide other services primarily to children under age 18 shall establish and make a good-faith effort to enforce a nonsmoking policy that prohibits smoking except in separately ventilated areas, beginning with the first fiscal year after enactaent. . 7. Entities may petition the agency funding thea for a waiver, which may be granted if the conditions in #4 are met Entities subject to collective bar- gaining agreements that permit smoking may request a waiver of up to 1 year. 8. Entities that fail to establish or make a good-faith effort to enforce the nonsmoking requirement are subject to civil penalties of up to $1,000 per violation per day, which would be assessed by the head of the agency that provided the federal funds, with an opportunity for a hearing. The agency head could reduce or waive the penalty and take into account mitigating factors and the violator's willingness to abide by the law in the future. TECHNICAL ASSISTANCE AND OUTREACH ACTIVITIES 9. EPA and HHS shall provide technical assistance to agency heads and other persons who request it, including information on smoking cessation programs for employees and information to assist in compliance with this Act. 10. EPA shall establish an Environmental Tobacco Smoke Advisory Office and an outreach program to inform the public of the dangers of secondhand smoke, operate a telephone hotline, and provide information to those requesting it.

125 Mr. WAXMAN. Thank you very much, Mr. Durbin. I want to thank the three of you for your presentations to us. I think they are very helpful. I don't want to ask you questions, because we have other wit- nesses and I know you have other appointments. Without any ob- jections from the members of the panel I would like to move on and dismiss this panel. Thank you very much for being with us. Mr. WAXMAN. I am pleased now to call forward the Honorable Carol Browner, the administrator of the Environmental Protection Agency, and with her is Dr. Morton Lippman, chairman of the EPA Science Advisory Board, from the Nelson Institute of Environ- mental Medicine at NYU Medical Center. Ms. Browner, we are delighted to have you with us. We appre- ciate the fact that you are not only here but have taken the leader- ship role that you have in this area. Your prepared statement will be in the record in full. We would like to ask you, if you would, to try to limit the presentation to no more than 5 minutes. STATEMENTS OF HON. CAROL BROWNER, ADMINISTRATOR, ENVIRONMENTAL PROTECTION AGENCY; AND MORTON LIPPMAN, CHAIRIVIAN, EPA SCIENCE ADVISORY BOARD, NEIf SON INSTITUTE OF ENVIRONMENTAL MEDICINE, NEW YORK UNIVERSITY MEDICAL CENTER Ms. BROWNER. Certainly, Mr. Chairman. Good morning, Mr. Chairman, Congressman Bliley, and members of the subcommittee. I appreciate the opportunity to be here before you today to discuss the adverse health effects of exposure to sec- ondhand tobacco smoke and what Americans can do to reduce the health risks associated with exposure to secondhand smoke. I am pleased to be joined by Dr. Morton Lippman, professor of environmental medicine at New York University Medical Center. He was the chair of the EPA Science Advisory Board that reviewed the EPA risk assessment on two separate occasions and that con- ducted public hearings. He is a specialist in pulmonary and. res- piratory health disease, and is considered one of the outstanding members of the medical profession as it relates to these various se- rious issues that we are discussing today. In January of 1993, the Environmental Protection Agency pub- lished an assessment of the respiratory health risks of passive smoking. That report is titled "Respiratory Health Effects of Pas- sive Smoking: Lung Cancer and Other Disorders." The report con- cludes that exposure to environmental tobacco smoke is responsible for approsimately 3,000 lung cancer deaths each year in non- smoking adults in the United States and seriously affects the res- piratory health of hundreds of thousands of children. Because of the health implications of exposure to secondhand ke documented in the EPA report as well as two other com- sive Government reports issued in 1986 by the U.S. Surgeon al and the National Research CouEncil of the Academy of Sciences, EPA is today recommending actions that we believe will prevent involuntary public exposure to indoor secondhand smoke. Based on the weight of the available scientific evidence, EPA con- cluded that widespread exposure to secondhand smoke in the Unit- 74-814 0 - 93 - 5

126 ed States presents a serious and substantial public health risk. The major findings included in the report are as follows: (1) Secondhand smoke is a human lung carcinogen. Environ- mental tobacco smoke is classified as a known human, or Group A, carcinogen under EPA's carcinogen assessment guidelines. This classification is reserved for those compounds or mixtures that have the strongest evidence of a cause and effect relationship in humans. Other agents that have been classified by EPA as Group A carcinogens include arsenic, chromium, nickel, radion, vinyl chlo- ride, to name a few. (2) The report also finds that secondhand smoke has subtle but significant other effects on the respiratory health of adult non- smokers. These include coughing, phlegm production, chest discom- fort, and reduced lung function. (3) The report also finds that young children are particularly sen- sitive to adverse effects from secondhand smoke. Infants and young children whose parents smoke are among the most seriously af- fected by exposure to secondhand smoke, with increased risk of lower respiratory tract infections such as pneumonia and bron- chitis. EPA estimates that passive smoking is responsible for be- tween 150,000 and 300,000 lower respiratory tract infections in in- fants and children under 18 months of age annually, resulting in between 7,500 and 15,000 hospitalizations each year. Children who have been exposed to secondhand smoke are also more likely to have reduced lung function and symptoms of res- piratory irritation such as coughing, excess phlegm, and wheezing. Passive smoking may lead to a buildup of fluid in the middle ear, which is the most common cause of hospital operations for young children in this country. . Asthmatic children are especially at risk. EPA estimates that ex- posure to secondhand smoke increases the number of episodes and the severity of symptoms for between 200,000 and 1 million asth- matic children. Passive smoking is a risk factor for the thousands of nonasthmatic children who develop the condition each year. EPA firmly believes that the scientific evidence is sufficient to warrant actions to protect nonsmokers from involuntary exposure to secondhand smoke. We are conducting a broad public outreach program to commu- nicate the findings of the report, and we are pleased to announce a major step in EPA's public education program about the hazards of exposure to environmental tobacco smoke. Today, we will release a new public information brochure which recommends actions to prevent involuntary exposure to secondhand smoke in indoor environments. The recommendations contained in the brochure are intended to help parents, decisionmakers, and building occupants take steps to protect nonsmokers from exposure to secondhand smoke. The brochure also contains messages for smokers about how they can help protect the people around them. (4) EPA recommends that people not smoke in their home orpe r- mit others to do so particularly if infants, toddlers, and nonsmokers are present. If a family member or a baby-sitter smokes indoors, we rec- ommend increased ventilation in the area where smoking takes place by opening windows or using exhaust fans.

127 . (5) EPA also recommends that every organization that deals with children-schools, day care facilities, and other places where chil- dren spend time-have a smoking policy that effectively protects children from exposure to secondhand smoke. (6) In the workplace, EPA recommends that every company have a policy that effectively protects nonsmokers from involuntary ex- posure to secondary smoke. While separating smokers and non- smokers within the same area, such as an office, may reduce expo- sure, nonsmokers may still be exposed to recirculated smoke and drifting smoke into nonsmoking areas. Steps that can be taken to protect the nonsmokers include pro- hibiting smoking indoors or limiting smoking to rooms that have been specially designed to prevent smoke from escaping to other areas of the building. I might add that our recommendation as it relates to smoking rooms is consistent with the recommendations of R.J. Reynolds and the American Society of Heating, Refrigeration, and Air Condi- tioning Engineers. Later this year we plan to publish a guide to assist the private sector businesses interested in establishing workplace smoking policies. The guide will provide helpful information about how to evaluate smoking policies and how they might seek to establish a policy if one does not exist. (7) Finally, as to smoking in other public areas such as res- taurants and bars, we are recommending and the brochure that we are releasing today explains, ways to deal with the placement of smoking areas so that there is adequate ventilation and again, to minimize nonsmoker exposure. In summary, Mr. Chairman, EPA believes that exposure to envi- ronmental tobacco smoke provides sufficient risk to recommend preventing involuntary exposure in all indoor environments. The Agency recommends that parents, decision makers, and all of us who occupy buildings take appropriate steps to reduce exposure to secondhand smoke. That concludes my opening comments, and I would ask that the rest of my statement be inserted in the record, please. Mr. W~,x~tArr. Yes, it will be in the record in full. [The prepared statement of Ms. Browner follows:]

128 TESTIMONY OF CAROL BROWNER ADMIMSTRATOR U.S. ENVIRONMENTAL PROTECTION AGENCY BEFORE THE SUBCOMbIITTEE ON HEALTH AND THE ENVIRONMENT COMMTPfEE ON ENERGY AND COMMERCE U.S. HOUSE OF REPRESENTATIVES JULY 21, 1993 Good nwrning, Mr. Chairman and Members of the Subcommittee. Thank you for the opportunity to appear before you today to discuss the adverse health effects of exposure to environmental tobacco smoke (ETS) and what Americans can do to reduce their health risks associated with exposure to secondhand smoke. Environmental tobacco smoke, also called secondhand smoke, is a mixture of the smoke given off by the burning end of a cigarette, pipe, or cigar and the smoke exhaled from the lungs of smokers. This mixture contains more than 4,000 substances, more than 40 of which are lcnown to cause cancer in humans and animals and many of which are strong irritants. Exposure to secondhand smoke is called involuntary smoking or passive smoking. In January 1993, the Environmental Protection Agency (EPA) published an assessment of the respiratory health risks of passive smoking, entitled `Respirotory Heolth Effects of Passive S)roking: Lung Cancer and ONttr Dfsorders". The report concludes that exposure to environmental tobacco smoke is responsible for approximately 3,000 lung cancer deaths each year in nonsmoking adults in the United States and that it seriously affects the respiratory health of hundreds of thousands of children. Because of the healtb6 implications of exposure to secondhand smoke documented in our recent report, as well as in two comprehensive government reports issued in 1986 by the U.S. 1

129 Surgeon General and the National Research Council of the National Academy of Scieaces, EPA is today recommending actions to prevent involuntary public exposure to indoor secondhand smoke. Under the authority of Titie IV of the Superfund Amendments and Reauthorization Act, . the "Radon Gas and Indoor Air Quality Research Act of 1986', EPA is directed to conduct research and disseminate information on all aspects of indoor air quality. As part of this effort, in 1988 the EPA undertook an assessment of the respiratory health effects of passive smoking. • Ihis assessment was intended to: update the earlier reports of the Surgeon General and the National Research Council; classify ETS according to EPA's carcinogen assessment guidelines; assess the respiratory effects of exposure to secondhand smoke in children; and, if possible, quantify the extent of risk. The report summarizes the findings of the Agency's extensive investigation of the respiratory health risks from exposure to environmental tobacco smoke. It incorporates comments from two open public reviews and recommendations from EPA's Science Advisory Board - a panel of independent scientific experts in this field. The Science Advisory Board endorsed the conclusions of the report and the methodologies used. In particular, the Board ,unanimously endorsed the report's classification of ETS as a human lung carcinogen. Based on the weight of the available scientific evidence, EPA conctuded that the widespread exposure to secondhand smoke in the United States presents a serious and substantial public health risk. The major Wings included in the report are: • Secoedhamd smoke is a humaa lung carcinogen. It is responsible for approximately 3,000 lung cancer deaths annually in nonsmokers in the United States. ETS is classified as a known 2 r

130 human, or Group A, carcinogen under EPA's carcinogen assessment guidelines. This classification is reserved for those compounds or mixtures that have the strongest evidence of a cause-and-effect relationship in humans. Other agents classified by EPA as Group A carcinogens include radon, asbestos and benzene. • ETS has subtle but significant other effects on the respiratory health ot adult nonsmokers. These include coughing, phlegm production, chest discomfort, and reduced lung function. • Young children are particularly sensitive to adverse effects from secondhand smoke: - Infants and young children whose parents smoke are among the most seriously affected by exposure to secondhand smoke, with increased risk of lower respiratory traet infections such as pneumonia and bronchitis. EPA estimates that passive smoking is responsible for between 150,000 and 300,000 lower respiratory tract infections in infants and children under 18 months of age annually, resulting in between 7,500 and 15,000 hospitalizations each year. - Children who have been exposed to secondhand smoke are also are more likely to have reduced lung function and symptoms of respiratory irritation such as cough, excess phlegm, and wheezing. - Passive smoking can lead to a buildup of fluid in the middle ear, tfie most common cause of hospitalization of children for an operation. - Asthmatic children are especially at risk. EPA estimates that exposure to secondhand smoke increases the number of episodes and the severity of symptoms for between 200,000 and 4 3 ! , C.~

131 one million asthmatic children. Passive smoking is a risk factor for the thousands of non- asthmatic children who develop the condition each year. EPA firmly believes that the scientific evidence is sufficient to warrant actions to protect nonsmokers from involuntary exposure to secondhand smoke. EPA is conducting a broad public outreach program to communicate the findings of the report. I am pleased to announce today a major step in EPA's public education program about the hazards of exposure to environmental tobacco smoke. EPA is today releasing a new public information brochure, titled Whar You Can Do About Secondhand Smoke, which recommends actions to prevent involuntary exposure to ETS in indoor environments. The recommendations contained in the brochure are intended to help parents, decisionmakers, and building occupants take steps to protect nonsmokers from exposure to secondhand smoke. The brochure also contains a message for smokers about how they can help protect people around them. • EPA rec.ommends that people not smoke in their home or permit others to do so. If a family member smokes indoors, we recommend increased ventilation in the area where smoking takes place by opening windows or using exhaust fans. We also recommend that smoking should not occur if children are present, particularly infants and toddlers. Baby-sitters and others who work in the home should not be allowed to smoke in the house or near children. • EPA recommends that every organization dealing with children - schools, day care facilitiKs, and other places where children spend time - have a smoking policy that effectively protects children ft om exposure to environmental tobacco smoke. 4

132 • In the workplace, EPA recommends tlwt every company have a smoking policy that effectively protects nonsmokeis from involuntary exposure to tobacco smoke. Many businesses and organizations already have smoking policies in place, and more and more are instituting them, but these policies vary in their effectiveness. Simply separating smokers and nonsmokers within the same area, such as a cafeteria, may reduce exposure, but nonsmokers will still be exposed to recirculated smoke and smoke drifting into nonsmoking areas. Prohibiting smoking indoors or limiting smoking to rooms that have been specially designed to prevent smoke from escaping to other areas of the building are the two options that will effectively protect nonsmokers. The costs associated with establishing properly designed smoking rooms vary from building to building, and are likely to be greater than simply eliminating smoking entirely. Employer-supported smoking cessation programs are an important part of any smoking policy. Approximately 25 percent of Americans smoke. While working in a smoko-&ee building may encourage some smokers to quit, a smoking policy should provide support for smokers who want to kick the habit. Those smokers who choose to continue will, most certainly, necessitate a policy that protects non-smokers from involuntary exposure. • If smoking is permitted in a restaerant or bar, placement of smoking area+ should be determined with some knowkdge of the ventilation characteristics of the spaee, to minimize nonsmoker exposure. More and more individual restaurants and restaurant chains are prohibiting smoking in their facilities, and cities and counties across the United States are restricting smoking in resta,nms within their jurisdictions. 5 1

I 133 This brochure and the recommendations it includes have been reviewed by the 21 federal agencies of the Interagency Committee on Indoor Air Quality, as well as the American Medical Association and the American Lung Association. We are planning to distribute it as widely as possible. EPA plans to publish a guide later this year to assist private sector businesses that are interested in establishing workplace smoking policies. The guide will provide information about evaluating existing smoking policies or establishing a policy if one does not exist. in summary, Mr. Chairman, EPA believes that exposure to environmental tobacco smoke provides sufficient risk to recommend preventing involuntary exposure in all indoor environments. The Agency recommends that parents, decisionmakers, and all of us who occupy buildings take appropriate steps to reduce exposure to secondhand smoke. This concludes my prepared testimony. I would be happy to address any questions you may have. I 6

134 Mr. WAm&AN. Dr. Lippman, I understand you have a statement as well, and we would like to hear from you. STATEMENT OF MORTON LIPPMAN Mr. LipPmArr. Thank you, Mr. Chairman. I am here in my capacity as chair of the EPA Science Advisory Board committee that provided external scientific peer review of the initial and final public review drafts of EPA's risk assessment documents. The committee consisted of 18 scientists having a suffi- ciently broad range of scientific expertise to cover the many and complex issues raised by the EPA documents. Fourteen of us are employed by academic institutions. One was an employee of the National Cancer Institute, one an employee of the Department of Energy National Lab, one an employee of the State of California, and one worked for a not-for-profit institute. Collectively, our ex- pertise covered the disciplines of medicine, chemistry, engineering, exposure assessment, dosimetry, toxicology, bio-statistics, and epi- demiology. It was a particularly rewarding experience to work with this dis- tinguished group of unbiased researchers as we studied and evalu- ated the relatively massive draft documents and the voluminous background literature as well that was reviewed and analyzed. We individually came to this task knowing it would be challenging. We were all familiar with the literature on the effects of both active smoking on respiratory health and of the 1986 landmark report on ETS by the Surgeon General and the National Research Council. In fact, both of these reports had concluded: one, ETS exposure in- creases the risk of lung cancer in nonsmokers; and, two, that the children of smokers have more respiratory symptoms and disease than children of nonsmokers. They also noted, however, that the relative risks for these effects were relatively low, that the esti- mates of risk were subject to the influences of compounding factors as well as other biases that can affect findings on population-based studies, and that more research to investigate these factors was needed. The authors of the ETS risk assessment at EPA had the benefit of both these earlier analyses and of the experience gained in over 5 additional years of published research on the extent of population exposure to ETS, its physical and chemical properties, observed re- sponses to exposures by lab animals and humans, analytical tech- niques for evaluating potential bias, and the emerging technique of Meta-analysis. Meta-analysis can provide increased statistical power by combining data from a series of studies on relatively small populations that have sufficient similarity in response meas- ures and data format. It can also assist in more precisely determin- ing the level of risk, and, in fact, the Meta-analysis was a nec- essary exercise for EPA to more quantitatively determine the risks if they were going to the process of labeling it as a Class A carcino- gen. While the volume of data had increased substantially since the 1986 reports, there were, in fact, no unambiguous breakthrough re- sults. However, the additional data-and it was substantial-pro- vided incremental evidence that clarified some issues and added to the weight of evidence on others.

135 My committee met on June 25, 1990, to review the first external review draft. In our report of April 1991, based on critical comment and discussion by members of the committee, members of the pub- lic at our meetings, and interactive discussions of EPA staff present at the public meeting, we called for extensive revisions of the draft, especially with regard to the analyses of the evidence for respiratory effects in children and the need to quantify these risks. We also recommended changes to sharpen and clarify the extent of lung cancer risks to nonsmokers living with smokers. Based upon our recommendations and other input received by EPA, the Agency prepared a second external review draft. My com- mittee reviewed this in July of 1992 and forwarded our evaluation of this report to the SAB executive committee, which approved it unanimously in October of 1992. In summary, we found the EPA staff had been very responsive to our recommendations and sugges- tions, had produced much stronger evidence for the conclusions it reached, and therefore we endorsed its use of the scientific data base. As others have noted, and I won't repeat here, there are quan- titative effects-3,000 cancers, under 150,000 to 300,000 exacer- bations of pneumonia, bronchitis, and bronchiolitis, and exacer- bation of symptoms in asthmatic children up to 1 million. Other findings were conclusive in terms of there being excess effects but were nonquantitated: increased prevalence of cough, sputum, and wheeze; increased prevalence of middle ear effusion, reduced lung capacity. Other effects: There was evidence, the chairman sited heart evi- dence, but we had to agree with EPA that the data were not yet sufficient to come to a causal conclusion on that. Asthma in pre- viously asymptomatic children, increased risk of Sudden Infant Death Syndrome, these were other things where there was evi- dence, but neither the EPA nor our committee felt that it was ap- propriate to come to conclusion on those effects. Further research there is clearly needed. [The prepared statement of Mr. Lippman follows:7 STATEMENT OF MOBTON LIPPMAN I am Morton Lippmann, Professor of Environmental Medicine at New York Uni- versity Medical Center. I am here in my capacity as Chair of the EPA Science Advi- sory Board (SAB) Committee that provided external scientific peer review of the ini- tial and final public review drafts of the EPA's risk assessment documents on the respiratory health effects of environmental tobacco smoke (ETS). The committee consisted of eighteen scientists having a sufficiently broad range of scientific exper- tise to cover the many and complex issues raised by the EPA documents. Fourteen of us are employed by academic research institutions. One (Blot) is employed by the National Cancer Institute; one (Daisey) by a Department of Energy National Lab- oratory; one (Wesolowski) by the State of Califorma; and one (Kabat) by a not-for- profit research institute. Collectively, our expertise covered the disciplines of medi- cine, chemistry, engineering, exposure assessment, dosimetry, toxicology, biostatistics, and epidemiology. It was a rewarding experience for me to work with my colleagues on this commit- tee as we studied and evaluated these massive EPA drafts and the voluminous background literature that was reviewed and analyzed within them. We came to this task knowing that it would be challenging. We were all familiar with the lit- erature on the effects of active smoking on respiratory health, and the 1986 reports on the health effects of ET'S produced by the Surgeon General and the National Re- search Council. Both of these landmark reports had concluded that: 1) ET°S expo- sure inereases the risk of lung cancer in nonsmokers; and 2) that the children of

136 smokers have more reapiratory symptoms and disease than children of nonsmokers. They also noted that the relative risks for these effects were relatively low; that the estimates of risk were subject to the influences of confounding factors and other bi- ases that can affect the findings of population based studies; and that more research to investigate these factors was needed. The authors of the EPA Risk Assessment had the benefit of these earlier analyses and of the experience gained in over 5 additional years of research on the extent of population exposure to ETS, its physical and chemical properties, observed re- sponses to exposures by laboratory animals and humans, analytical techniques for evaluating potential bias, and the emerging technique of Meta-analysis. Meta-analy- sis can provide increased statistical power by combining data from a series of stud- ies on relatively small populations that have sufficient similarity in response meas- ures and data format. It can also assist in more precisely determining the level of risk. While the volume of data had increased substantially since the 1986 reports, there were no unambiguous "breakthrough" results. However, the additional data available to EPA provided incremental evidence that clarified some issues and added to the "weight-of-the-evidence" on others. The initial EPA External Review Draft of June 25,1990 was reviewed by my com- mittee at a public review session on December 4 and 5, 1990. Our report of 4/19/ 91 , based upon critical comment and discussion by the members of the committee, members of the public, and interactive discussions with EPA staff present at the public meeting, called for extensive revisions of the draft, especially with regard to the analyses of the evidence for respiratory effects in children and the need for quantification of these risks. We also recommended changes to sharpen and clarify the extent of lung cancer risks to nonsmokers living with smokers. Based upon our recommendations, and on other input received by EPA, a revised Review Draft was prepared for SAB review. My committee reviewed this draft at a public meeting on July 21 and 22, 1992, and the SAB forwarded its evaluation to the Agency on November 20, 1992. We found that the EPA Staff had been very responsive to our recommendations and suggestions, and had produced much stronger evidence for the conclusions it reached. The final EPA document (EPA/600/ 6-90/006F - Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders) of December 1992 incorporated further changes recommended in our No- vember 20 report. Our committee was unanimous in endorsing the EPA risk assessment as a reason- able and balanced summary of current knowledge on some selected health effects of ETS for which the weight-of-the-evidence permits judgments to be made. The ef- fects produced by ETS were described in terms of both quantitative and qualitative findings. Quantitative findings include: -appronmately 3,000 lung cancer deaths per year among nonsmokers. -150,000 to 300,000 cases of lower respiratory illness (p neumonia, bronchitis, and bronchiolitis) per year in children less than 18 months of age, resulting in 7,500 to 15,000 hospitalizations. -esacerbations of asthma symptoms in 400,000 to 1 million children. Qualitative fin ' include: -increased prev ence of cough, sputum, and wheeze in children and adults. -increased prevalence of middle ear effusion in children. -reduced lung capacity in children and adults. -increased risk of lower respiratory illness in children between 18 months and 3 years of age. Other effects of ETS were examined and the committee agreed with EPA that the data were insufficient to come to firm conclusions on causality. These included: -increased rates of cardiovascular mortality in adults. -induction of asthma in previously asym ptomatic children. -increased risk of sudden infant death syndrome (SIDS). -increased rates of upper respiratory tract iafections. Further research is needed to determine if a causal link with these possible effects can be established. In endorsing the main conclusions drawn by EPA in its ET'S risk assessment, the SAB is essentially say~'ng that EPA has examined, analyzed, and utilized the sci- entific data base available to it in an appropriate and reasonable manner. It is also important to note that the data base is evolutionary, and that the risks of ETS will become better quantified as more research is done. The data come from a broad range of studies and investigators addressing~ scientific hypotheses of their own choos' . Hardly any of it was generated with EPA support, and none of it was gen- eratedor submission to regulatory agencies for approval. This situation is unlikely to change in the foreseeable future. For example, EPA has recently terminated its . ,

137 program of investigator-initiated grants for health research, and ETS research is not a high priority item in the NIH agenda. The critics of the EPA Risk Assessment can always find deficiencies in one aspect or another of most of the individual studies utilized by EPA, especially when they are examined for conformance to standardized protocols used by petitioners to FDA or EPA for product or process approvals. For ETS, as for criteria air pollutants, EPA and its scientific advisors are forced to utilize imperfect data bases, and to form weight-of-the-evidence judgments on the basis of the applicable data base as a whole. In the case of ETS, the data base on respiratory health effects is very exten- sive, and sufficiently coherent with respect to the consistency of human experience with both active and passive cigarette smoke exposure, toxicological evidence, and inhalation exposure characteristics and dosimetry for the committee to generate a consensus judgment that the conclusions of the ETS Risk Assessment are ade- quately justified. Mr. WAXMAN. Thank you very much, Dr. Lippman. The rest of that statement is going to be in the record, but we do have to keep to this time limit. Let me start off by indicating to you, Administrator Browner, that the report that you are releasing today is an important docu- ment, because this is going to empower American people, particu- larly parents, with new tools to be able to protect their children from secondhand smoke, and I want to commend you and all the people at the Agency who have done an excellent job. It seems to me that the thrust of your initiative is that Ameri- cans should have a right to a smoke-free environment. Do you agree with that? Ms. BROWNER. Yes, Mr. Chairman, I would agree with that. Mr. WAXMAN. Ms. Browner, your testimony and the EPA's recent report on environmental tobacco smoke paint a troubling picture of the impacts of pervasive exposure to environmental tobacco smoke in our society. The impacts on children are especially compelling: up to 300,000 very small children afflicted by lower respiratory in- fections, such as pneumonia and bronchitis; between 200,000 and 1 million asthmatic children placed at risk. It seems like a lot of children in our country suffer because of exposure to environmental tobacco smoke. Today we are going to hear from two children who are going to tell us about their personal experiences because of their fear of even going out to places that other children would attend, public places, fear that they are going to have the tobacco smoke thrust upon them and what it is going to do to them. I mentioned in my opening statement that I intend to introduce legislation to help these kids and many thousands like them by re- stricting smoking in buildings open to the public, and I will look forward to working with you on this initiative. I know you haven't had a chance to review it, but I would hope that you would be in- terested in pursuing legislation and working with us in that re- gard. Ms. BROWNER. Mr. Chairman, we would be more than happy to work with you with respect to legislation. Mr. WAXMAN. Thank you. As they always have when studies found smoking to be a health hazard, the tobacco industry is now fighting hard to make these studies linking environmental tobacco smoke look controversial. They always want to make it look like it is unsettled science.

I 138 We have four decades of the tobacco industry trying to use a smoke screen of trying to say the science isn't clear. It seems that the tobacco industry is engaged in a hopeless battle, given the strength of the studies and the already squandered credibility of this industry. But, Ms. Browner, could you tell us how confident you feel about EPA's scientific analysis that supports the EPA's conclusions that environmental tobacco smoke causes cancer and respiratory disease? Ms. BROWNER. Mr. Chairman, since coming to the Agency in Jan- uary, I have had the opportunity to look at the risk assessment, to visit with the scientists within the Agency who participated in the development of the risk assessment over the last several years. I believe that the risk assessment is based on the total weight of the evidence available, and that the Agency did the job that it is sup- posed to do, that it has come forward with a report that rec- ommends a series of actions that we all can take to protect the American public to protect their health from exposure to secondary smoke. Mr. Chairman, if I could just say one thing about the brochure that we are releasing today, I would ask this committee and the public, if they could take one message away, that is, please help us protect children from smoking, from cigarette smoking. It does have an effect on children, and we have a responsibility to protect those children. Mr. WAXMAN. Thi§ is an important initiative, and it is based on good science. Dr. Lippman, do you have any comments on how confident you might feel in light of the tobacco industry throwing darts at the sci- entific work that has been done in furnishing this analysis to sup- port the EPA's conclusions? How confident do you feel that the en- vironmental tobacco smoke causes cancer and respiratory disease? Mr. LIPPMAN. Speaking for myself and on behalf of the entire committee, we had a clear consensus that the EPA had made very reasonable use of the data and had adequately justified its conclu- sions, and we had the best academic epidemiologists and bio-stat- isticians we could get on our committee. Mr. WAXMArr. I want to thank you very much. I have further questions. We may have an additional round. But appreciate those comments. Mr. Bliley. Mr. BLmEY. Ms. Browner, I have much ground to cover but, un- fortunately, as you can see, little time. So I request that you limit your answers to a simple yes or no for a series of simple questions with a chance to elaborate at the end, and I thank you for your in- dulgence. Ms. Browner, before you is a timetable of EPA actions on the en- vironmental tobacco smoke issue: "July 1988, Robert Axelrad of EPA solicits Smoking Policy Institute to take lead role in the prep- aration of ETS technical report, or technical manual." Is it not true that this compendium, while billed as technical in nature, actually had a policy direction? Ms. BROWNER. Mr. Bliley, I know you want a yes or no answer, but I believe there may be confusion about four different studies in that statement, so I can't answer yes or no. There are four dif- .

139 ferent documents that are involved in this issue, and I believe there may be a confusion regarding two of them. I can elaborate if you would like me to. Mr. BLILEY. The compendium was a single document, I believe. Ms. BROWNER. Yes, but the Smoking Policy Institute issue to the best of my knowledge, did not focus on the compendium; rather, it focused on a workplace guide that has not yet been published by the Agency. Mr. BLILEY. Was this compendium ever reviewed by the Science Advisory Board? Ms. BROwNER. The compendium has never been published by the Agency, to the best of my knowledge. It was a compendium of a number of scientists. The articles appeared with individual sci- entists' names at the end of each of them. It has been represented in the press as an EPA document, but it has never been published as an EPA document. Mr. BLILEY. But the draft was released. Ms. BROWNER. It has never been published as an EPA document, to the best of my knowledge. Mr. BLILEY. But it was released to the public. Ms. BROWNER. Well, documents are constantly released from the EPA under the FOIA and other requirements. That is different from the Agency saying, "We are releasing this document." That document was never released by EPA, to the best of my knowledge. Mr. BLILEY. Moving on, "In August 1988, EPA consents to sub- contractor agreement between Smoking Policy Institute and ICF, Inc., to draft ETS workplace smoking policy guide." Was not this contract arranged by Mr. Axelrad? Ms. BROWNER. As I understand the inspector general's investiga- tion of this matter, Mr. Axelrad was involved in a subcontractor agreement between the Smoking Policy Institute and ICF. It has been fully investigated by the inspector general, and there has been no finding of inappropriate results. Mr. BLILEY. Did not the inspector general say that the contract was tainted in how it was processed and that the actions by an EPA program official gave the impression that the program official, rather than ICF, selected the subcontractor? Didn't the Agency admit in a letter to me that sole sourcing in Agency policy guide to a known anti-smoking advocate in the business of promoting smoking bans before the risk assessment was completed created an appearance of having prejudged the issue? Ms. BROWNER. Mr. Bliley, you are correct that the inspector gen- eral did find improprieties in the management of the contract, but he did not find improprieties in terms of the work that was done. But yes, we agree that the management of that contract was not handled appropriately. Mr. BLILEY. I agree, but he wasn't asked to do that either, he was only asked to look into the propriety of the letting of a con- tract. Ms. BROWNER. Except the report does address the other issue. Mr. BLILEY. In June 1989, EPA's Office of Air and Radiation re- leases a fact sheet, "Indoor Air Facts, Number 5," concluding that ETS is a known cause of lung cancer and respiratory symptoms and has been linked to heart disease.

140 "In 1989 and 1990, EPA prepares draft ETS risk assessment doc- ument." Ms. Browner, would you agree with this chronology of events? Ms. BROWNER. Mr. Bliley, I am not familiar with the "fact sheet" that you make reference to. I am familiar with the draft workplace guide, and perhaps that is what you are referring to; I don't know. I have never seen a fact sheet. That is not to suggest there isn't one; I haven't seen it. Mr. BLILEY. I see. Mr. WAximAN. Thank you, Mr. Bliley. Mr. Synar. Mr. SYNAR. Thank you, Mr. Chairman. Dr. Lippman, if I told you we could prevent 150,000 to 300,000 children from getting respiratory illnesses, would you consider that a public health success? Mr. LIPPMAN. Well, yes. Mr. SYNAR. If I told you we could prevent 20,000 new asthmatic people from being created, would that be a public health success? Mr. LIPPMAN. For your hypothetical question, the answer is yes. Mr. SYNAR. Dr. Lippman, the Science Advisory Board doesn't al- ways agree with EPA, does it? Mr. LIPPMAN. Of course not. Mr. SYNAR. Have you found a pattern that when you don't agree with them on a position like this, that the industry that you sup- port, or if you take the industry's position, they usually say it is great science, but when you disagree with the industry, they don't think they are very well served? Mr. LIPPMAN. I hope we have earned the deserved reputation for being impartial and calling it as we see it. Mr. SYNAR. But you do get re~ular criticism when you don't agree with industry and they don t think it is as good a science when you do agree? Mr. LIPPMAN. Frankly, I have never taken much notice of the criticisms we get from industry. Mr. SYNAR. Ms. Browner, do you have children? Ms. BROWNER. Yes, Mr. Synar, I have a 5Yzyear-old son. Mr. SYNAR. Would you allow your 5YZyear-old son to attend a school where the teacher smoked in the classroom regularly? Ms. BROWNER. No, Mr. Synar, I would not. Mr. SYNAR. I think the point I am trying to make is, you know, we can sit here and argue about the scientific data back and forth, but the fact is that the public is evolving that way. I think just the mere reflection of people walking into a restaurant and probably 89 percent of them asking for a nonsmoking area is a reflection that they have come to the conclusion that the evidence is sufficient. Ms. Browner, let me ask you one final question. President Clin- ton has yet to move on the Executive Order regarding the Federal Government's indoor air restrictions. When is that action going to be taken? Ms. BROWNER. I understand that the White House is working on it literally as we speak, and we would certainly look forward to an announcement in the not too distant future. Mr. SYNAR. Thank you. Thank you, Mr. Chairman. _

141 Mr. WAXMArr. Thank you, Mr. Synar. Mr. McMillan. Mr. MCMiLr.Atv. Thank you, Mr. Chairman. Ms. Browner, I would like to pursue a little bit the issue of risk assessment, because frequently before this committee we address that basic issue, and I think it is fundamental in terms of making objective decisions, and I believe we want to make objective deci- sions. I gather that carcinogen risk assessments performed by the EPA have, since 1986, been subject to a series of defined guidelines and that an intra-agency EPA working group is currently drafting revisions to the guidelines for cancer risk assessment. I would like to ask some general questions with regard to the manner in which the EPA undertakes carcinogen risk assessments before moving to the specifics of ETS. Could you describe to us the EPA's guidelines for carcinogen risk assessment and, in particular, what those guidelines say with re- gard to the classification of a substance as a Group A carcinogen? Ms. BROWNER. Mr. McMillan, the risk assessment guidelines of 1986 are the existing guidelines available to the Agency in its work to determine those substances which we believe have the highest likelihood of causing cancer in humans. The original version was put forward in 1976. The 1986 version is a final version and expan- sion of the procedures amendment to that, and it is something that we are constantly looking at so that we bring the very best science to bear. The one other thing I might just offer about the guidelines, and if I could read a brief sentence from the guideline itself: "These guidelines describe the general framework to be followed in devel- oping an analysis of carcinogenic risk," and then it goes on. But the reason I read that is because that is exactly what this guideline is. It is a scientific framework within which we do our work, and it is a framework that does change as new information becomes avail- able which is appropriate and widely accepted in the scientific com- munity in this country. Mr. McMILLAN. What other substances have been so classified? Ms. BROwrrER. I mentioned several of them in my opening state- ment. There are 16; environmental tobacco smoke is the 16th sub- stance that has been so classified, and we could provide you with a list. I can read you the ones that I can pronounce. Mr. McMm.AN. No, I don't think you need to do that. It might take up the rest of our time. But would, for example, automobile exhaust be one of them? Ms. BROWNER. Automobile exhaust-we don't classify it in terms of where the substance is found. Benzene is included. Obviously, benzene is involved in gasoline production. Mr. MCMu.LAN. Automobile exhaust-is that describing where it is found? Ms. BROWNER. Automobile exhaust is made up of a variety- what is the word I want?-chemicals. Thank you, Dr. Lippman. Mr. MCMILLw.v. Is environment: ,: tobacco smoke made up of a variety of components? Ms. BROWNER. Yes, and those were looked at in this study, in the risk assessment study.

142 Mr. MCMILLAN. I presume you might undertake to address the issue of automobile exhaust. Ms. BROwrrER. Excuse me? Mr. MCMn.LAN. Would you expect to undertake a study of auto- mobile exhausts? Ms. BROWNER. Well, obviously, we are working very diligently to implement the Clean Air Act, and part of the Clean Air Act does focus on mobile sources. We do have a responsibility to look at mo- bile sources. Whether or not it is appropriate to undertake a Group A type analysis in terms of cancer I can t speak to. Mr. MCMir.i.AN. Would you describe what type of epidemiologic studies typically are considered by EPA in carcinogen risk assess- ment? Ms. BROWNER. It is a broad category, and Dr. Lippman may be able to speak to that from a scientific perspective. I can speak to it specifically in terms of the total weight of evidence, and we actu- ally have a chart we could show you to demonstrate what we did in this particular case, if that would be helpful. Mr. MCMnLArr. OK. So it would be based on more than a single study? Ms. BROWNER. Yes. If I could, we could put it up very quickly, and I think it is very helpful to the members of the committee in terms of all of the different things that were looked at in the pro- duction of the risk assessment. Mr. Chairman, if I may, the first chart shows all of the categories of information that were looked at. There are five different cat- egories. In only 1 of the 5 categories are the 30 studies mentioned, and we can further explain what we did in terms of those 30 stud- ies. But, I think if you look at this, you see that we weren't just looking at one category of information. In fact, we were looking at a broad array of information in developing the risk assessment as it relates to secondhand smoke. Mr. WAXmArr. The gentleman's time has expired. Mr. MCMILLAx. I will have to go over and read the chart. I can't read it from here. Ms. BROWNER. We can give you a copy. Mr. Wmm.a,N. As a matter of fact, we would like to receive a copy for the record. Ms. BROWNER. Certainly. [The chart follows:]

WEIGHT OF EVIDENCE FOR CLASSIFYING ENVIRONMENTAL TOBACCO SMOKE (ETS) AS A KNOWN HUMAN(GROUP ALUNG CARCINOGEN Active Smoking ETS and D t d Supporting Causes Lung "Active Smoke" ocumen e E i 30 Epidemiolo S y Evidence From Cancer With Both Contain xposure n E d Studiee of ET Animal Studies No Evidence the Same 40 v® a ry y i t E and Lung and Genetic of a Threahoid Carcinogens ronmen nv s Cancer Tests Mf6pmog

144 Mr. WAxmAx. Mr. Rowland. Mr. RowLarrD. Thank you very much, Mr. Chairman. I don't want to discuss with you whether or not environmental tobacco smoke is harmful. What I want to discuss with you is the methodology that was used in arriving at the determination that you have made and following up on Mr. McMillan's questions re- garding the guidelines that you went by. As I understand it, there is a confidence level that is scientif- ically accepted under these guidelines that you used. What is that guideline that is generally accepted? What level? Ms. BROWNER. There is a confidence factor of 95 percent that is frequ~ently used, although others are acceptable. Mr. ROWLAND. That is exactly what I wanted to know. That is the confidence level that is used. Is that right? A 95 percent con- fidence level is what is used. Ms. BROWNER. Dr. Rowland, if I might I will, if it is OK with the chairman, call on Dr. Lippman. There is a difference in terms of one tail versus two tail when it comes to a confidence factor, and we do have a chart to explain that to the members. Mr. ROWLAND. Well, you explain to me what you mean by "tail." Ms. BROWNER. Yes. If we could put the chart up, I think that might be the easiest way, if that is acceptable to the chairman. Mr. RowLAxD. I don't know how much time that is going to take. Maybe I can understand it if we don't take too much time with the chart. Ms. BROWNER. Maybe we could ask Dr. Lippman to explain. Mr. ROWLAND. Yes, I would ask Dr. Lippman to explain that. Ms. BROWNER. Thank you. Thank you, Mr. Rowland. Mr. LiPpmArt. If you have no idea which direction to expect a dif- ference, you would conventionally use a two tail test. That is, there is a distribution on a normal curve of likelihoods, and a 95 percent confidence interval on a two tail test would have 2.5 percent at one extreme and 2.5 percent at the other extreme. But based on the first chart showing that the epidemiology was supporting information in the weight of the evidence argument and there is so much information on the dose response relationship with the tobacco smoke, EPA took the position that a one tail test was appropriate. In that case, you have the equivalent of con- fidence by looking at the 5 percent at the one tail, and so based on the prior evidence, as shown in this chart, one comes to the con- clusion that the 90 percent on a one tail test is equivalent to 95 percent on the two tail test, and that is simply the way statisti- cians describe these results. [The chart follows:]

145 PROBABILlTY THAT ENVIRONMENTAL TOBACCO SMOKE CAUSES ... Best Esdmate . . Adverse Respiratory No N,r Evidence The Effects In Children Active smoldny Causes 95% Confidence Intervai Best EsUmate' Adverse Respirrtory Effects • 90% Confidence ` Interval

146 Mr. ROWLAND. Did you have results based on the 95 percent con- fidence level? Ms. BROWNER. As I understand it, the decision to go with the one tail versus the two tail was made before the studies were looked at, and that was a scientifically supportable decision. Mr. ROWLAND. Just answer my question yes or no, if you will. Did you have results based on a 95 percent confidence level? Ms. BROWNER. No, because the other decision was made. Mr. ROWLAND. So you never did any studies that were based on a 95 percent confidence level. Is that correct? Mr. LippmAN. The Meta-analysis which you are referring to and the question of whether it met the conventional 5 percent uncer- tainty limit was based on the one tail of 95 percent confidence. However, that is only one way of looking at the epidemiologic evi- dence. EPA's document and our report made note of all the other statistical methods that one can and EPA did use in which you come to likelihoods of 1 in 10,000 or even smaller on the basis of the number of studies going in one direction versus another direc- tion. Clearly, if it was entirely due to chance, you would have a dis- tribution of positive and negative findings. This was not the case. The overwhelming number of individual studies showed a positive association between environmental tobacco smoke exposure and ex- cess lung cancer. Mr. ROWLAND. So you did have some results based on a 95 per- cent confidence level? Mr. LippmAN. Well, beyond 95 percent confidence level except in the Meta-analysis where it was close to a 95 percent confidence level. Mr. ROWLAND. Then, after you made the additional study, the confidence level that was used was different. Mr. LippmAN. There were no additional studies. The industry says that the-- Mr. RowLAtvD. The statistics that you used were based on a dif- ferent confidence level. Mr. LippmAN. No. Mr. RowLaND. No? Mr. LippmAN. No. Mr. ROWLAND. Then what is the difference between you have explained to me the difference, I believe, between a 95 percent con- fidence level and a 90 percent confidence level. It is scientifically acceptable to make the change during a scientific study? That is the question I want answered. Mr. LippmAN. I am responding on what EPA did and what we thought of it. I am not responding directly for EPA. EPA made a defensible judgment which was endorsed unanimously by our com- mittee, including half a dozen expert bio-statisticians and epi- demiologists. Mr. RowrANO. I see my time has expired, but I do not believe I have an answer to my question. Mr. WAxMAN. The gentleman's time has expired. Mr. Hastert.

147 Mr. HASTERT. Thank you, Mr. Chairman. I certainly want to wel- come Administrator Browner and Dr. Lippman to the subcommit- tee. I have been in another subcommittee with Chairman Synar look- ing at the science of the EPA, and so I would like to pursue this issue a little bit, Dr. Lippman, please answer the following ques- tions with yes or no as much as possible. The questions-build upon those that Dr. Rowland has just fin- ished asking. Many questions have been raised concerning the manner in which EPA conducted the statistical analysis of risk as- sessment of environmental tobacco smoke, ETS. Normally, the most complex statistic calculated in this room is who has the most votes, so I would like to try to determine exactly what the EPA did in determining that environmental tobacco smoke, ETS, poses a statistically significant cancer risk. First, Dr. Lippman, I would like to determine if you agree with the following statements from several textbooks on statistics. These statements concern the critical importance of setting confidence in- tervals before an experimental analysis begins. First, "It is impor- tant to select a probability level before the sample result is com- puted in order to avoid allowing the sample results to enter into the decision of what will be an acceptable criterion for the rejection of the null hypothesis." That comes out of "Political and Behavioral Science." Do you agree, yes or no, with that? Mr. LippmAN. Well, it is a reasonable statement for a scientific text. Mr. HASTERT. Thank you. Second, "The selection of probability levels takes place during the planning phase of the experiment." That comes out of "Basic Biostatics and Medicine, an Epidemiology." Do you agree-yes or no? Mr. LippmAN. A very reasonable statement. Mr. HASTERT. Third, from a book entitled "The Future of Meta- analysis," "Obviously, the choice of analysis has an effect on what may be revealed by the data analysis. If the procedure is not con- strained before the data collection, biases, self-serving or otherwise, may be introduced." Do you agree or disagree? Mr. LrnpzvtAN. You are reading from a text. How can I disagree with it? Mr. HASTERT. I disagree with some texts. Dr. Lippman, in conducting your clinical research, have you low- ered a confidence level to provide statistical significance after you have already analyzed your data and calculated your test statis- tics? Mr. LippmAN. No. Mr. HASTERT. Dr. Lippman, you are quite aware that many ques- tions have been raised about the way in which the ETS risk assess- ment was conducted. One question concerns EPA's lowering the statistic 95 percent confidence level to the 90 percent level between the draft and final reports of the ETS risk assessment. First, did the original draft risk assessment of May 1990 use a 95 percent confidence level in the report's statistical analysis? Mr. LippmAN. I believe it did.

148 Mr. HASTERT. Second, the 11 U.S. studies included in the final ETS risk assessment, where all of these U.S. studies done at a 95 percent confidence interval? Yes or no? Mr. LipPmArt. I believe that is the case. Mr. HASTERT. Out of the 11 U.S. studies included in the ETS risk assessment, how many studies reported an overall statistically sig- nificant risk for ETS at the standard 95 percent confidence level? Mr. LIPPMAN. One. Mr. HASTERT. Do you know which one that was? Mr. LIPPMAN. The name escapes me. Mr. HASTERT. If you could come back with the answer, I would appreciate it. Mr. LIPPMAN. It was the one that relied most heavily on an anal- ysis. Mr. HASTERT. Our information says that none of the studies reached the 95 percent level, but we will go beyond that. Now, isn't it true that the Meta-analysis of the U.S. ETS studies are statistically nonsignificant at a standard 95 percent confidence interval? Mr. LIPPMAN. It is at 95 percent on a one tail test. Mr. HASTERT. Let's recap for a second then. Your draft assess- ment used a 95 percent confidence level. All 11-we have a discrep- ancy on one test-studies used a 95 percent confidence level. We disagree, but our information says none of the 11 studies nor the Meta-analysis of the 11 studies would be statistically significant at 95 percent. Mr. LIPPMAN. That would not have changed our conclusion, EPA's conclusion or our endorsement of the conclusion, that it was a Class A carcinogen. Mr. HASTERT. All right. Then, Dr. Lippman, EPA did something very interesting at this point. It manipulated the statistical stand- ard. In the first report, didn't EPA switch to a 90 percent con- fidence interval? Mr. LIPPMAN. I am not personally a bio-statistics expert, but we had a large number of these people on our panel. If there was any- thing unkosher about the way the statistics were handled, you would have heard about it in our committee report. Mr. WAxmA1v. The gentleman's time has expired. Mr. HASTERT. I thank the chairman. Mr. WaxmN. Thank you, Mr. Hastert. Mr. Kreidler, I think you were here next. Mr. KREIDLER. Thank you, Mr. Chairman. I would like to ask some questions of Dr. Lippman. I should point out, I have had undergraduate and graduate courses in statistics but would be the first to admit I have forgotten more than I learned at that time, so perhaps you could help me with a couple of issues. I want to ask you about the strength of the scientific evidence supporting the EPA's tobacco risk assessment. As I understand it, EPA looked at 30 epidemiological studies; 24 of these studies found a positive correlation between ETS and lung cancer; 9 of these studies are statistically significant. Is that correct? Mr. LIPPMAN. I think so. I can't be sure of the ezact numbers, but the thrust is correct.

149 Ms. BROWNER. If I might, Mr. Chairman, we now have a descrip- tion of the 30 studies that were looked at and the findings and terms of the different questions posed to the categories of studies in terms of statistical significance. We have put that in a chart in an effort to help the committee understand this difficult statistical issue, and I think that is true. Mr. KREIDLER. OK [The chart follows:]

150 30 EPIDEMIOLOGY STUDIES OF ETS AND LUNG CANCER Analysis of Individua, Studies 24 of 30 Studies Comparing "Ever" vs. I "Never" Exposed Showed Increased Risk 17 of 17 Studies Which Characterized by Exposure Levei Showed anIncrgased Risk at the Highest Ex posure L i eve ~ 14 Studies Showed Positive Dose- Response Trends 9 VYe1re 9 1were i1OWere Statistically Statistically Statisticaiiy Significant Significant Significant 1-in•10,000 1-in-10 million 1-in-a billion probability of occurrence by chance META-Analysis Combines Positive and Nonpositive Studies Within Countries J5of6 L.", Country Groupings Showed an Increased Risk 4of6 Were Statistically SigIA-cant 14n-10,000

151 Mr. KREIDLER. Dr. Lippman, what is the possibility that these results could be due to chance as opposed to a real underlying cor- relation? Mr. LIPPMAN. We concluded that the chance was very, very small based on these kinds of analyses that are displayed as well as the full weight of the evidence, and also I must note that there are far more than 30 epidemiologic studies covered in this document. You are only talking here about the environmental tobacco smoke/lung cancer epidemiology. We had extremely convincing epidemiology on the respiratory effects in children that were even better statis- tically defined than the lung cancer. Mr. KREIDLER. Is it correct to say that the odds are more than 10,000 to 1 of a real underlying correlation? Mr. LippmAN. Well, one has heard often that statistics can prove anything, and these statistics are a part of the evidence-that is, the likelihood that you would have directional changes different than these, and one shows on this chart 1 in 10,000 to 1 in a billion likelihood. On the other hand, the Meta-analysis, which is a crude tool, shows a less positive statistical conclusion, and that has been where the focus has been. But we have looked at the weight of the evidence. Mr. KREIDLER. I am going to get to that one. EPA performed similar analysis looking at the 17 most com- prehensive studies in the data base. Nine of these studies are eta- tistically significant. The EPA report says that the possibility of this being due to chance is less than 1 in 10 million. That would correlate with what you presented as information? Mr. LippmAN. Well, that is the EPA information, and we found it, as the EPA statement, scientifically defensible. Mr. KREIDLER. Dr. Lippman, the Tobacco Institute tries to mis- lead the public on this point. They say the studies do not show sta- tistical significance to that 95 percent level we have been talking about. They say the EPA deliberately lowered the threshold of sta- tistical significance to 90 percent to bolster the results. I want to ask you about these assertions. First, I understand that the basis of the industry argument is that EPA applied that one tail test that is being talke about of statistical significance to determine the statistical significance of the individual studies. Perhaps you could further elaborate since you were given the opportunity to say yes or no to those questions. Was there anything improper? Mr. LippmAN. Well, obviously, if it was, we would have said so. Our statisticians found that they had appropriately handled the data, and admitted the statistical certainty based on the Meta- analysis was the weakest of all of these ways of looking at the data. Mr. KREIDLER. I also understand that the one tail test shows a positive effect to that 95 percent confidence level, not the 90 per- cent that is being suggested by the Tobacco Institute. Is that cor- rect? Mr. LippmAN. On the one tail basis, that is correct. Mr. KREIDLER. So the tobacco industry is simply wrong when it argues that the statistical test applied by EPA to individual studies

152 a was improper and did not show an effect at a 95 percent confidence level? Mr. LIPPMAN. They are not wrong in a technical sense that if they insist on doing a two tail test it would fail the significance level. Mr. WAxmAN. The gentleman's time has expired. Mr. KREIDLER. Thank you very much, Mr. Chairman. Mr. WAXMAN. Mr. Greenwood. Mr. GREENWOOD. Thank you, Mr. Chairman. Dr. Lippman, in the last sentence of the second paragraph of your statement, you said that one of your conclusions was that more research was needed to investigate these factors. Needed to learn what? Needed to conclude what? What do we need to study to get to what level of conclusion? Mr. LIPPMAN. I don't think there is any doubt about the quan- titative findings, approximately 3,000-that is an approximation- excess lung cancer deaths, and the larger numbers of effects in kids, but if the chairman's belief that there are 30,000 premature deaths from heart disease is true, that would be an even greater public health impact, and there is literature that says that. While we are not prepared to say that one published paper was sufficiently conclusive to endorse it, clearly that is an area where we need more research. The SIDS and other things need more re- search, and in the process we will refine the numbers on the lung cancer and the other things as well. Mr. GREENWOOD. OK. I am the father of two little girls who are six and seven. They both have had surgery on their inner ear, so I am particularly sen- sitive to some of this testimony. I would want to protect them from any exposure, any risk, but I don't know very much from the docu- ments I have seen about what the research said about the intensity of exposure. For instance, my wife and I wouldn't send our daughters to a day care setting in a mobile home with a three-pack-a-day day care worker. We wouldn't do that instinctively. But I am not so sure that we would avoid going to restaurants where they have smoking sections or that we would avoid going to malls. What do any of these studies tell us about the intensity of the exposure? Are we studying people who lived at close quarters for many, many years with smokers, or are we studying people who have had incidental exposures in environments where there is a fairly diluted amount of environmental smoke? Mr. LIPPIKarr. Is that to me? Mr. GREErrwooD. Yes, please. Mr. Li'PPMAtv. Well, clearly, in toxicology we know that the dose makes the poison, and if you are exposed to lesser amounts there is a lesser probability of adverse effect. We don't have as much good data on exactly how much exposure there was in each of these studies. That is an area, clearly, where more research is needed. And your instinct is right: Stay out of the areas with the highest levels of exposure, and don't panic if you occasionally get a whiff of tobacco. Mr. GREErrwooD. OK.

I 153 Much has been made of the 95 percent versus 90 percent con- fidence level, and in a rudimentary fashion I understand your rea- soning. My question is, who made the decision-and I would ad- dress this to Ms. Browner-who made the decision at EPA to shift in what appears to be midstream from a 95 percent confidence level to a 90 percent confidence level? Ms. BROWNER. The decision to go from a two tail to a one tail was made by EPA. It was reviewedd by the Science Advisory Board, and it was found to be acceptable statistical and scientific analysis. Mr. GREENwooD. Do we know what motivated that decision? Was the decision made after a look at some of the studies; using a two-tailed system didn't get certain results, and so a decision was made to go to one tail? Ms. BROWNER. Mr. Greenwood, when I asked that question of the staff and my colleagues at EPA who have been working on this issue, they indicated that it was not made after some of the infor- mation had been looked at specific to the risk assessment. Obvi- ously, we have been looking at this issue for more than a decade now in terms of tobacco smoke. Mr. BLILEY. Would the gentleman yield on that point? Mr. GREENWOOD. I yield. Mr. BLILEY. Thank you. Ms. Browner, has the EPA, in any other risk assessment that it has done-it has done a number of them over the course of time- ever in the middle of its assessment decided to go from a 95 per- cent risk to a 90 percent risk for any other situation? Ms. BROwNER. Mr. Bliley, I do not know the answer to that ques- tion. I don't know that the Agency has ever gone from a two tail to a one tail. It is acceptable scientific work, but I don't know that the Agency has done that. Mr. BLILEY. Do you know, Dr. Lippman? Mr. LIPPMAN. No, I don't know. Mr. BLILEY. I thank the gentleman for yielding. Mr. GREENWOOD. Thank you. The line of questioning from the staff has to do with the Brownson study versus a Fontham study. Let me direct this to Dr. Lippman. The reasoning seems to be that one study, the Fontham study, was used although it was incomplete. In fact, it came to con- clusions about risk. In comparison the Brownson study, which was apparently the most statistically significant study ever taken, at the 95 percent confidence level showed no ETS effect. What can you tell me about why one study was incorporated and the other was not? Mr. LIPPNtArr. The Fontham study-which I couldn't remember the name of earlier-showed the statistically significant effect, and it was, at the time it was incorporated as a docket in the proceed- ings, the most complete and the best documented study. The subsequent study just arrived too late in the process. We can't tell the EPA from the SAB to stop the process, we review what the EPA gives us, and, in fact, that study concluded that there was a statistically significant association between environ- mental tobacco smoke exposure and lung cancer in the highest ex- posure group. One expects to see positive results if you are going to find them in the high exposure group and not necessarily in the

154 group as a whole, which may include people whom you described as getting an occasional whiff of smoke. So there is nothing inconsistent with the subsequent data which we couldn't use because it came too late and the bulk of the data which were used. Mr. WAXMAN. The gentleman's time has expired. Mr. Brown. Mr. BROwrr. Thank you, Mr. Chairman. I would respond briefly to my colleague, Mr. Bliley on the Brownson study. The report concluded: "In summary, our study and others conducted during the past decade suggest a small but consistent elevation in the risk of lung cancer in nonsmokers due to passive smoking. Proliferation of Federal, State, and local regu- lations that restrict smoking in public places and work sites is well founded," Doctor, if I could follow up that way. Ms. Browner, you mentioned in your testimony 3,000 deaths from secondhand smoke and also 150,000 to 300,000 respiratory tract infections in infants and children under 18 months of age. How are you able to isolate that, if you will, with the other con- taminants in indoor air? How are you able to be that certain and isolate that as secondhand smoke? Ms. BROWNER. Mr. Brown, we look at a variety of information. In this case, we looked at 30 studies and other information. I would ask Dr. Lippman to explain how we do it scientifically in terms of making those isolations. But the risk assessment that is of interest to the subcommittee today was not based on just one analysis, it was based on a whole variety of analyses and is the result of the total weight of the evidence. How we make those separations when we look at the individual studies is something that I think would be more appropriately answered by Dr. Lippman, if you don't mind. Mr. BROwrr. Dr. Lippman, please. Mr. LipPmAv. Yes. In the same manner that each individual study from the epidemiologic literature for cancer was examined, each individual study for the respiratory effects in kids was exam- ined for appropriate analysis, and that would, in these studies, in- clude a control population. That is, you pick a matching population that is as similar as it can possibly be in every aspect except that the parent doesn't smoke, and therefore the other indoor pollutants would presumably be comparable. Mr. BROWN. Ms. Browner, on a more practical level, you have been a strong advocate already, as many members of this sub- committee, particularly the chairman, have been in some more reg- ulation of secondhand smoke. With the cost of any regulation, with the cost of-Ms. Browner, you talked about separate ventilation systems if you have smoking areas and nonsmoking areas. Are you in a position, or do you see yourself soon in a position, to advocate outright bans on smoking in public places? Ms. BROwrrER. Mr. Brown, if you look at the authorities available to the Environmental Protection Agency to do the job of protecting the public health, they are diverse and many. In this particular in- stance, we have authority under SARA to look at indoor air issues, to do broad research, and then to make recommendations. We are not making regulatory decisions today. Rather, we are seeking to inform parents, the public, and decisionmakers about what they

155 can do to help protect children and the nonsmoking adults of this country from exposure to secondhand smoke. There is not a regulatory action involved in our announcement today, but, rather, part of our responsibility as the environmental Agency of this country to educate the public, to give them informa- tion in terms of how they can deal with the exposures they may encounter, whether it be in the workplace, home, or other locations. Mr. BROWN. Understanding that, Ms. Browner, but understand- ing also the seriousness of the deaths and the respiratory tract in- fections, understanding the cost to employers of separate ventila- tion systems, if you will, and understanding your role in all of this and the education that you do and all of that, do you see yourself in a position soon to ask this subcommittee to ask Congress for an outright ban? Ms. BROWNER. Well, we are obviously interested in working with the subcommittee, working with the Congress, in whatever they deem is appropriate in terms of Government action. We believe that we have done what we have a responsibility to do, which is the assessment and then making that information available to the public in conjunction with actions that they can take. Mr. BROwN. Thank you, Mr. Chairman. Mr. WAxn2AN. Thank you, Mr. Brown. Mr. Richardson. Mr. RiCxARDSON. Dr. Lippman, most of what we have been dis- cussing deals with a part of the EPA report, the cancer component, but what seems to me the most disturbing is the significant im- pacts on children, and, as I understand it, the impacts on children that suffer asthma effects or respiratory infection, they have not been challenged. Is that correct? Mr. LIPPmAN. The industry challenge, as I understand it, is on the cancer risk assessment. Mr. RrCxARDSON. So I take it that no one has challenged that. Is that correct? Mr. LrPPMAN. I have not heard of a challenge. Ms. BROWNER. To the best of our knowledge, Mr. Richardson, that is right; no one is challenging the children's portion of the findings. Mr. RicHARDSON. Ms. Browner, based solely upon the need to protect children from respiratory impacts, it is sensible to establish policies to reduce this involuntary exposure? Ms. BROWNER. We certainly believe so, and that is what our bro- chure seeks to do, is provide information to people. Mr. RiCHAx.DSON. Now, on your brochure, Ms. Browner, you are recommending that any designated area in businesses, restaurants, commercial establishments, should be separately ventilated to as- sure that tobacco smoke is not recirculated in the building. Why isn't it enough to just have separately designated areas? Ms. BROWNER. Different buildings' ventilation systems are struc- tured in different ways in terms of the amount of fresh air they are bringing into the system at any one time and the percentage of re- cycled air. So while you may be in an office or on the floor of a building where there is no smoking, if there is smoking in other parts of the building and the ventilation system is recycling that air, you may find.yourself exposed. ~ ~ G7 ~ a4~ ~ O

156 I will say that the recommendations we have made with regard to smoking rooms and how they should be managed are consistent with those of R.J. Reynolds and the American Society of Heating, Refrigerating, and Air Conditioning. Mr. RICHARnsON. Now, in the publication you are also rec- ommending-EPA is recommending-that every employer "have a policy that protects employees from involuntary exposure to tobacco smoke." Does this apply also, or would this guideline apply also, to employees, for instance, that work in restaurants? Ms. BROWNER. We believe that individual businesses, obviously, need to make decisions that are appropriate to their business, res- taurants, and bars, et cetera. In the brochure we have sought to tell patrons what they can do in terms of reducing their exposure. Mr. RICxARDSON. My last question deals with, I think, something that was raised early on in the hearing, and that is the EPA con- tract allegations. As I understand it, 5 years ago a contractor was directed by an EPA official to have work done by a specific contrac- tor but the inspector general basically concluded that there was no conflict of interest. Is that right? Ms. BROwNER. The Insp ector General found that there was an inappropriate contact made by an EPA employee to a subcontractor prior to the contractor/subcontractor relationship being formally es- tablished. The IG did find that action to be inappropriate, and we are dealing with that. He did not find, however, that the study, the work done under the contract and subcontract, was tainted by that communication. Mr. RICHARDSON. In other words, the Agency's scientific conclu- sions weren't tainted. Ms. BROWNER. Exactly. Mr. RICHARDSON. But it was a procedural mistake. Ms. BROWNER. It was a procedural mistake, and we recognize that. Mr. RICHARDSON. That study, as I understand, had nothing to do with the initiative that you announced today. Ms. BROWNER. That is correct. That subcontract dealt with the workplace guidance which has not been issued by the Agency. It did not deal with the brochure we are issuing today. Mr. RICHARDSON. I ust want to conclude again that what was disturbing to me was the impact on children, that it is uncontested, and the question then becomes, what do we do about it? On the cancer component, the other part, obviously there is controversy and different views. Ms. Browner, you have talked about this new policy that you want to get out. Does EPA have the resources, the educational re- sources? I mean are you going to do public service announcements? This is a massive undertaking. Ms. BROWNER. We do have a brochure; we have a distribution mechanism in place. We will be working with other organizations to make sure that this brochure is widely distributed so that indi- viduals who do not smoke can take actions that we think will help protect them from passive smoking exposure. Mr. WAxmAN. Thank you very much, Mr. Richardson. Mr. Bliley. Mr. BLILEY. Thank you, Mr. Chairman.

157 Ms. Browner, my staff tells me that EPA has never-ndver- used a 90 percent risk factor on any other study. I would appre- ciate .you having someone search the records at EPA, and if I am in error please so advise. Ms. BROWNER. Certainly. [The information follows:] The Environmental Protection Agency has used 90 percent confidence intervals in many of its health risk assessments to present confidence bounds on estimates based on both human and animal studies. The following studies used 90 percent confidence intervals: 1. EPA used 90 percent confidence intervals in its estimation of the number of lung cancer deaths annually due to radon exposure via inhalation. (Technical Sup- port Document for the 1992 citizen's Guide to Radon, EPA 400-R-011, May 1992). 2. EPA used 90 percent confidence intervals in its "Uncertainty Analysis of Risks Associated with Exposure to Radon in Drinking Water", Jan. 29, 1993, reviewed by the Radiation Advisory Committee of the Science Advisory Board. 3. EPA used 90 percent confidence intervals (yielding upper limit unit risk esti- mates) in all its risk assessments when extrapolating from high dose animal studies to low environmental human exposures. 4. EPA used 90 percent confidence intervals for cancer potency estimates based on human studies for the following four compounds - cadmium, methylene, chloride, nickel and dioxin. "Updated Mutagenicity and Carcinogenicity Assessment of Cadmium", EPA/600/ 8-83/025F. June 1985. Final Report. "Health Assessment Document for Nickel and Nickel Compounds", EPA/600/8-83/ 012FF. Sept. 1986. Final Report. "Technical Analysis oPNew Methods and Data Regarding Dichloromethane Haz- ard Assessments." EPA/600/8-87/029A. June 1987. External Review Draft. "A Cancer Risk-Specific Dose Estimate for 2,3,7,8-TCDD, Appendix A." EPA/600/ 6-88/077Ab. June 1988. Mr. BLILEY. The Fontham study, I am also advised, does not re- port a statistically significant association between ETS and lung cancer in its original report. It is only when the Agency applies the adjustment to 90 percent that it does. How much emphasis is given in the risk assessment to the Fontham study? Ms. BROWNER. Mr. Bliley, I think the study you refer to deals with lung cancer, not with children, and, as the chart to the left indicates, there were 30 studies looked at in developing the risk as- sessment. Mr. BLILEY. Isn't it a fact that the Fontham study was given a Tier 1, first-class rating by EPA? Ms. BROWNER. I do not know the answer to that. Dr. Lippman may; I do not. Mr. LIPPMAN. Yes, it was a Tier 1. Mr. BLILEY. Tier 1. Were you aware at the time that the Fontham study was unfin- ished? Mr. LIPPMAN. My understanding was that it was in press, so therefore we could use it. It had been through peer review and was in press. Mr. BLILEY. I see. Were you also aware of the Brownson study? Mr. LIPPMAN. That was not in the same category. It had not been through peer review. Mr. BLILEY. I see. It was finished, and did not the Brownson study find a statis- tically significant effect on ETS at the 95 percent confidence level? 74-814 0 - 93 - 6

158 Mr. LIPPMArr. We did not examine that study. It was not avail- able to us. It may have been finished, but we were not aware of it at our last meetin~. Mr. BLILEY. Wasn t it published prior to the release of your risk assessment? Mr. LIPPMAN. I can't say whether it was published prior to the release of EPA's document. It was not available to us, had not been peer reviewed, at the last time the SAB review committee met. Ms. BROWNER. Mr. Bliley, if I might Mr. BLILEY. Well, why wasn't it available? Maybe you can shed some light on that. Ms. BROWNER. It had not been peer reviewed at the time of the last meeting of the Science Advisory Board. It was peer reviewed and, as I understand, was published Mr. BLILEY. Was the Fontham study peer reviewed? Ms. BROWNER. It had not been peer reviewed such that the Science Advisory Board, being scientists, would have thought it ap- propriate to look at it. That is my understanding. It was subse- quently peer reviewed and published before the risk assessment was published. We agree with that part of the statement. Mr. BLILEY. Was the Fontham study peer reviewed before it was used since it was unfinished? Ms. BROWNER. Was the Brownson study, to the best of my knowl- edge, was reviewed? Mr. BLILEY. The Fontham. Ms. BROWNER. Oh, I don't know the answer to that. Mr. LIPPMAN. Yes, we reviewed it on the basis that it had been peer reviewed. Mr. BLILEY. I see. Well, the only thing I would draw to this is, it looks like you use the Fontham study even though it is incomplete; you adjust the risk factor down to 90 percent from 95 percent; and you exclude the Brownson study altogether even though it was partially funded by NIH and was one of the largest studies ever done. Maybe it is noth- ing but mere coincidence, but it does give the appearance that someone might be cherry picking. Thank you, Mr. Chairman. Mr. WAximA1v. Thank you, Mr. Bliley. Ms. Browner and Dr. Lippman, there may be other members who wish to ask questions, and I want you to be available to respond to those questions in writing. We do have to move on. We have other witnesses waiting. Dr. Rowland, did you have something you wanted to ask? Mr. ROWLAND. I am still not clear on this, and I wanted to ask an additional question or two about that, but time does not permit. Mr. WaxrntAlv. I would like us to have those additional questions in writing. Ms. Browner, did you want to make a comment? Ms. BROWNER. Yes, Mr. Chairman. Just in closing, I would like to say that I personally believe that the assessment undertaken by the Agency, and published by the Agency, is an accurate assess- ment. It was within our responsibility as the Agency that has pri- mary responsibility in this country for protecting the public health from environmental exposures.

159 I think the fact that the Science Advisory Board on two occasions looked at this and unanimously agreed with the findings is an indi- cation of the quality of the science that went into this product. The final thing I would say is, I believe that I have a responsibil- ity, where I know there to be things in the environment that are affecting the children of this country, to make that known to the public and to make known what they can do, what parents can do and others can do, to protect our children. So I appreciate the opportunity to appear before you today on this very important topic. Mr. WAxmx. Ms. Browner, I want to indicate to you that I want to put in the record at this point a scathing attack on the tobacco industry in the Wall Street Journal that appeared on February 11, 1993. It indicates that the tobacco industry consistently, for dec- ades, has tried to raise uncertainty about the science. They try to use this game plan of trying to show confusion about what the con- sensus, the overwhelming consensus, indicates, that cigarette smoking is harmful and that exposure to cigarette smoking from others, or not even smoking but doing it indirectly, is also very dangerous. I want to commend you on your report today, and I want to indi- cate that what we have seen is this same game plan by the tobacco industry being played out today in this hearing. There is a clear consensus among those with no financial interest at stake-the Surgeon General, the U.S. Centers for Disease Con- trol, the American Medical Association, the American Lung Asso- ciation, the American Cancer Society, and now the U.S. Environ- mental Protection Ag ency-that environmental tobacco smoke causes a broad array of serious adverse health effects. The tobacco industry's "make weight" arguments do nothing to alter that reality. All this business about 90 percent or 95 percent or this study or that study is simply a way to try to obfuscate what is really the facts before us. My staff has prepared a fact sheet that goes through some of the most egregious distortions of the tobacco industry on the ETS issue. I want to insert that fact sheet and the Wall Street Journal article in the record at this point. I think people ought to know ex- actly what their game plan is. It hasn't changed in 40 years, and they are still using it even at this hearing today and in the lawsuit that you have to now fight by the tobacco industry. For them to say that EPA has rigged the science is really the ultimate in chutzpah. Thank you very much for being with us. [The fact sheet and Wall Street Journal article follow:]

160 .... ,~, A.,. G,, a.., a... ~. n.uaawcr. nior..aaan.xvww. ~n wvse.aaea+ ~.ouarwanao. ~.. .~ ...,...a ~ ~ ,o,.. ®mn.n *aw,ic w roR smr. n„c w.cn..r r wm... ~.w.. w~s e a.mewaao. ra.rtnv..u aun:..n..am~, ~ uow~au nis.ae.eow.a ai.o ru.~nw~wwm.o. .ww o o.aai r.o.w a ow.cn. +l~/ ~atioK sTUf owt~M U.S. HOUSE OF REPRESENTATIVES COMMITTEE ON ENERGY AND COMMERCE SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT 2<15 RAYBURN HOUSE OFFICE BUILDING WASHINGTON. DC 20515-a11S WOM( R021220.aN2 FACTSHEEr: THE TOBACCO INDUSTRY'S EFFORTS TO DISCORT THE RISKS OF ENVIRONMENTAL TOBACCO SMOKE On February 11, 1993, a front-page article in the Wall Street Journal described the tobacco industry's efforts to refute the adverse health effects of smoking as "the longest running misinformation campaign in U.S. business history." The industry has now adopted a similar tactic to counter public concern about the dangers of environmental tobacco smoke (ETS), the second-hand cigarette smoke breathed by nonsmokers. Its press releases and other public statements deliberately distort the record of the serious public health threats from ETS. The industry's most recent effort tries to discredit the U.S. Environmental Protection Agency's report on the respiratory health effects of passive smoking. The 530-page EPA report, which took four years to complete, concluded that ETS causes lung can'cer and other severe respiratory illnesses. The report was reviewed twice by a panel of 18 independent experts, who endorsed the methodology and unanimously concurred with its conclusions. The National Cancer Institute also endorsed the EPA report. This fact sheet compares the tobacco industry's claims about EPA's report on ETS with the real record. ai The epidemiological data showing that ETS causes thousands of cases of lung cancer each year is "weak and inconclusive." Tobacco Institute, "Sutntnary of Criticisms of EPA Report" (Jan. 7, 1993) Facts The scientific record in support of a correlation between ETS and lung cancer is very strong. Of the 30 epidemiologic studies from 8 countries analyzed in the EPA report, 24 (80%) show a correlation between ETS and lung cancer. Nine of the studies show a statistically significant increase in cancer rates for persons exposed to ETS.

161 In the case of an individual study, a "statistically significant" increase in lung cancer means that the possibility that chance could explain the increase is low -- 5% or less. In the case of the 30 ETS studies, the possibility that chance could explain the occurrence of 9 studies with statistically results is even lower - less than 0.01%. The link between ETS exposure and lung cancer becomes a virtual certainty when one examines the results of the 17 most sophisticated studies, which differentiated among levels of ETS exposure. All 17 of these studies show increased cancer risks in the highest exposure group, with 9 being statistically significant. The probability of these results occurring by chance is less than 1 in 10 million. Fourteen of the studies provided enough data to examine whether there is a dose- response relationship between the level of ETS exposure and the incidence of lung cancer. All 14 studies show a positive dose-response relationship; 10 of these are statistically significant. The probability of these results occurring by chance is less than 1 in 1 billion. claim 'BPA's calculation of purported risk from U.S. studies fails to include one of the largest U.S. studies ever conducted, a recently published study sponsored in part by the National Cancer Institute. This research reported no statistically significant overall increase in nonsmoker lung cancer based on reported exposure to ETS:' Tobacco Institute, "EPA Report Scientifically Deficient" (Jan. 7, 1993) Facts Although the EPA report did not discuss this study (Brownson et al, "Passive Smoking and Lung Cancer in Nonsmoking Women," Am. J. of Public Health, Nov. 1992), this was only because the study was published after the cutoff date for literature review. In fact, the Brownson study supports EPA's finding that ETS causes lung cancer. In direct contradiction to the claim of the Tobacco Institute, the study found a statistically significant association between high-level exposure to ETS and lung cancer: "In summary, our study and others conducted during the past decade suggest a small but consistent elevation in the risk of lung cancer in nonsmokers due to passive smoking. The proliferation of federal, state, and local regulations that restrict smoking in public places and work sites is well founded." In addition, the only two other two studies published since the EPA report have also found a statistically significant relationship between ETS and lung cancer. 2

162 Claim "Of 11 U.S. studies combined in EPA's risk calculation, not a single one originally reported a statistically significant overall relative risk." Tobacco Institute, "EPA Report Scientifically Deficient" (Jan. 7, 1993) ac Contrary to the claim of the Tobacco Institute, 5 of the 11 U.S. studies originally reported statistically significant increases in cancer risk associated with exposure to ETS. These results are particularly compelling because 7 of the U.S. studies were very small (studying fewer than 50 lung cancer cases in nonsmokers) and thus had limited "power" to identify true correlations. Claim "The combined relative risk for the ... studies is not statistically significant using generally accepted statistical guidelines. ... Only by applying 90% confidence limits as opposed to the 95% limits generally used -- the equivalent of grading on a bell curve - - can EPA claim statistical significance." Tobacco Institute, "EPA Report Scientifically Deficient" (Jan. 7, 1993) Facts The Tobacco Institute is deliberately confusing two statistical terms: "significance levels" and "confidence intervals." The traditional measure of statistical significance is a "significance level" of 95%, which indicates that there is a 95% probability of an increased risk. A "confidence interval;' by contrast, expresses only the probability that the actual degree of correlation lies within a given range.. As one part of its analysis of the relationship between ETS and lung cancer, EPA pooled the results of the epidemiological studies together in what is called a"meta- analysis." In this meta-analysis, EPA used both a 95% significance level and a 90% "confidence interval" - a common and proper statistical approach. In 4 out of the 6 country groupings studied in the meta-analysis, the pooled results showed ETS to be correlated with lung cancer at the statistical "significance level" of 95% - exactly the level urged by the Tobacco Institute. Clim 'The ETS risk assessment continues to excuse the weaknesses of the direct data with the claim that active smoking and ETS are similar. Previous scientific reviews of ETS - including reviews by the U.S. Surgeon General and the National Academy of Sciences - have cautioned against such comparisons, noting that significant differences in exposure levels and routes of exposure make the comparison scientifically questionable." Tobacco Institute, "EPA Report Scientifically Deficient" (Jan. 7, 1993) 3

163 Facts This claim by the Tobacco Institute implies that the Surgeon General and the National Academy of Sciences doubt EPA's conclusion that ETS causes lung cancer. In fact, the exact opposite is true. In 1986, both the Surgeon General and the National Academy of Sciences released reports concluding that ETS causes lung cancer. Moreover, contrary to the suggestion of the Tobacco Institute, ETS and mainstream smoke are chemically similar and so are likely to cause similar health effects. ETS is a mixture of exhaled mainstream smoke and "sidestream smoke" from the burning end of the cigarette. The same 40 known or suspected human carcinogens identified in mainstream smoke have been found in sidestream smoke. Indeed, sidestream smoke, which comprises more than 75% of ETS, may actually be more potent than mainstream smoke, because it is less completely combusted and has not been "filtered." CI- aim "The ... claim that ETS is a cause of respiratory symptoms and diseases in children is similarly based on a selective interpretation of the underlying studies." Tobacco Institute, "EPA Report Scientifically Deficient" (Jan. 7, 1993) acts In addition to finding that ETS causes lung cancer, EPA also found that ETS produces severe respiratory problems for children, including 150,000 to 300,000 cases of bronchitis and pneumonia each year in young children and worsening asthma in up to one million children. EPA's conclusions were based on an assessment of over 100 scientific studies. The conclusions corroborate earlier findings by both the U.S. Surgeon General and the National Academy of Sciences. Despite numerous opportunities to do so, the tobacco industry has never presented evidence to support its accusation or otherwise to counter EPA's conclusions of health impacts to children. In fact, although tobacco companies recently sued to overturn EPA's finding that ETS causes lung cancer, the companies did not challenge EPA's findings that ETS harms children.

164 1 rir, w ALL J 1 Ktt1 J U U K1VAL _.~ 199? Dow lonef & Compan.. ln. ,411 R,rhrr Re~ed % OL. CC\\1 NO. 29 t f t E -1 Eanc+ THURSDAY. FEBRUARY I I. 199) Smoke and Mirrors How Cigarette Makers Keep Health Question 'Open' Year After Year Council for Tobacco Research Is Billed as Independent But Guided by Lawyers An Industry Insurance Policy By ALIX M. FREEDMAN And LAURIE P. COHEN SIe/f Rtge/tM o/THE wALL STlEET JOLL aL This is the story of the longeu-mmaing misinformation cam- paign in U.S. business history, and how it may ultimately back- fire on its corporate sponsors. The tale opens in 1954. Cigareue smol®g, ike ta8 fina and the new music called rock-and-rotl, was fun and gl.mocous. But a warning had jttst been sounded that tmoldng might not be good for you. A xientist at Memorial Sloan-Kettering Cancer Center had painted tobacco tars on the backs of mice and produced tumors. The tobacco industry met this sudden threat head-on. In full-page newspaper ads headlined "A Frank Statement to Cigarette Smokers," tobacco companies announced that a new research gtoup, funded by the industry but indepeadent, would examine "all phases of tobacco use and health." Its solemn pkdge: "We accept an interest in peopk's health as a basic responsibility, paramount to every other consideration in our business." The tob.cso industry's main vdtide for damage control was up and running. Sowing Doubt For abnoa four doodet. the Council for Tobacco Research in New York has been the hub of a massive effort to cast doubt on the links between smoking and diame. Sponsored by U.S. tobacco compania and long nm behind the semes by tobacco-industry lawyers. the os- tensibly independent council has spent milli.om of dollars advandng sympathetic sdehce. At the same thoe. 'n has sotrtetilrcs disregardtd. or even cut off, studies of its own that impiinted smoking u a heakh hazard. "• When CTR researchas found out that cigarettes were bad and it was better not to smoke, we didn't publida that" in press «leasa, says tkrotha Cohen, who for 24 years until her retirement in 1989 wrae summaries of grantee research for the Council's annual report. The CTR is just a ltsi}bying thing. We were lobbying for dgaretta."_ • Many companies under attack for their products have underwnt- ten research to buttress safety claims. What sets the tobacco industry apart is the scope, aggresstvessas and pcststence of its under- taking. For decades mal tobaaro companies hase acted tn:on.en to combat the growing bad) of otdenca linking thnr producu tu an:r.. heart disease and emph.sema. Cheap Insurance The U.S. Centers for Disease Control today links 131.000 deaths a year to smoking. The surgeon general has declared smoktng "the single largest presentable cause of death and dt>- ability." citing "bverwhe{mtng" evidence from no kss than 50.000 studies. Yet the wisp of uncertainty supplied b' , the Council has always been enough to protect the S50 billion tn• dustry in Congress and especially in court, and tobacco com- panies have never paid a dime in product liabilin claim3. Addison Yamatt• a former Brown & W illiamson Co. law • yer and ex-ehavman of the Council• says the passage ot time hasn't altered his faith in this view expressed at a Council mect- ing in 1975: The "CTR is (the) best and cheapest insurance the tobacco industry can bu), and without it, the industry would have to invent CTR or would be dead." Michael Pettuhuk• a fomter chairman of the Federal Trade Conunission, fuds the industn,•'s defense extraordinary: "There never has been a health hazard so perfectly proven as smok- ing, and it is a measure of the Council's success that it is able to create the illusion of controversy in what is so eleganth a closed scientific case." . A Legal Peril But now the device the industry hu so long used to deflect attack has become its biggest vulnerability. That is because the Supreme Court lan year said smokers can sue. accustng ehe in dustry of deliberately hiding or disoning smoking's dangere. And the U.S. attorney's office in Brooklyn. N.Y.. is condua- ing a criminal investigation into whether the industry used the Council to defraud the public. Whether anything will come of the criminal inquln - and whether plaintiffs can convince juries that the industry did in fact misrepresent health hazards - are very much open que,- tions: just last month, one )ury• rejected allegations of a:on- spiraey. But if plaintiffs should begin to succeed, perhap• b) gaining access to now-secret Council documents. they could turn on its head what up to now has been an almost totally winntng industry strategy. The Council for Tobacco Research declined to respond to questions about its aai.ities• as did aU of the Big Six tobacco companies - Phillip Morris Cos.. RJR Nabisco Holding• Corp.. American Brands Inc.. B.4.T. Industries PLC (parent of Brown & Williamson). Loews Corp. (parent of Lorillardl and Brooke Group Ltd. (parent of Ltggett Group). At the outset. many in the industry thought the late-195? crisis posed by the Sloan-Kettering mouse research wu enure- ly manageable. With the Council, "the industry was told that in the best of worlds, we'd do a great service to mankind." says James Bowling, a former Philip Morris director. "Our product either would be econented or, if involved (in causing cancer4lsev'd identify the ingredients and we'd take them out. We iftougdLZhis was man•elous." So apparently did some scientists. The Council snagged a noted figure. Clarence Cook Little. as its scientific director. Thanks to his renown u a former University of Michuan presa

165 able to attract an illustrious scientific advisory board, whtch :ulled through proposals from a who's who of American scien- asts w ho sought its research grants. Over the years, it has doled out more than S:00 million. But the Council's role was never just research. It was largely a creature of Hill & Knowhon, the public relations firm, which cigarette merchants retained when the mouse research carne out. Hill & Knowlton installed the Council in the Emplre State Buiki- ing in New York, one floor beneath its own offices. with one of the PR firm's staffers as the supposedly independent research council's executive director. Hill & Knowlton also began pub- lishin; a newsletter that reported such news items as "Lung Cancer Found in Non-Smoking Nuns," and it helped authors generate books with titles Gke "Smoke Without Fear" and "Go Ahead and Smoke." Sorne people, indudmg many in the rtews media, were skep- tical of the Council. "To reporters, the Council was never in- dependent," says Earl Ubell, a veteran science reporter at WCBS-'f V in New York. "It was a wholly owned subsidiary of the tobacco industry." But in the interest of balance, jour- nalists writing on smoking and health routinely included the Council's views. And many smokers lacked the professional skepticism of reporters. "You would have to have lived in that era to under- stand - they kept providing false reassurances, so I had no idea that smoking was so very dangerous," says Janet Sack- man, who once appeared in ads as Miss Lucky Strike and who now has throat canxr. As early as 1958, however, the Council had strong inmria- rions from studies it financed that smoking could be dangerous. "Cigarette smoke condeasate is a weak morne skia arcvngea," said a Coundl-fmanced study completed in that year. Ensuing Couodl-finaooed taearch found more links to df- ease. In 1961, a study of 140 autopdrs at a Veterans hoapral in Iowa Ciry, Iowa, said "a history of cigarette smoking is sPg- nificantly related to the incidence of urdaoma." In 1963, researchers at Philadelphia Cxneral Hospital and the Univeni- ty of Pennsylvania linked chronic smoking to earlier coronary artery disease and a higher incidence o. coronary occlusion. The Council summarized such results in its annual reports, but it often chose other research to stress to the public. Ms. Cohen, who wrote the summaries, cites a 1965 study that said pregnant women who sawked had smaller babies and were more likely to give birth prematurely. But the industry in 1992 submitted to Congrea a study the Council hadn't finatKed, say- ing that smokers had no greater risk of premature babies and that low birth weight wasn't a problem. •'In the '60s." says Ms. Cohen, "there was so much bad news about smoking that there really wasn't much the CTR could put out, but anything they could find they would use." THE LAWYERS STEP IN By 1964, keeping the case open was no longer just shrewd public relations; it had become a legal imperative. As more Americans came to believe smoking could kill, the number of tobacco liability suits jumped to 17 from seven the year before. And in that year, the Surgeon General labeled smoking a health hazard. It "was a serious, stunning shock," says Mr. Bowling, the former Phillip Morris director. "That's the stage at which the lawyers became a lot more involved." Needing a defense from science as never before, yet dread- ing the legal exposure that adverse research would bring, the industry created within the Council a Special Projects division - with lawyers, not scientists, at the helm. Much of what it did was shrouded in mystery. "Everything was cloak-and- dtrcctor ot thc Cbunal. ^M c• wcrcu't ahowcd on tneir 11.wt."' The core of the lawyer<' operation was a.ast databasc. vtnr- ma the world's literature on tobacco and health. data on ioe, and strategy documents. The lawti•ers began shuttling the globe. looking for research and ecpen witnesse Thn cought out studies supporting causation of lung cancer by factors other than smoking and research suggesting the compiec origin of all diseases linked to tobacco. Overtures to scientists usually were handled by outside law firms, especially Jacob. Medinger, Finnegan & Hart in New York. It also served as counsel to the Council, and its Edw in Jacob took the lead role at the Special Projects unit. This ar- rangement offered crucial advantages. Notes Ro. Aforsc, a former research chfef at R.1. Reynolds: "As soon as Mr.lacob funded" a scientific study, "it was a prisileged relattonshtp and it couldn't come into court" because of legal rules protecting attorney-client communications. "So they could do projens that they could bury if they chose." How often they may have done that is unclear, because (,500 Council documents are under seal in a federal suit in New Jersey, withheld under the anorney-client pri.ilege. In any case, the industry had other options, such as halting funding atter an initial phase. Mr. Jacob and the firm of Jacob Sfedinger declined to comment. SCIENTISTS SIGN UP In 1972, the Special Projects unit gave Hugh Fudenberg. an immunologist, funding to determine whether some people are genetically predisposed to emphysema. Early results tndt- cated up to Io9# might be. Dr. Fudenberg planned "to warn high-risk people not to smoke," he says. but before he could his funding was discontinued without ex- planation, "They may have cut me off because it would have been negative for them; " he speculates. A researcher named Geoffrey Ashton learned the limits of the Council's independence in 1976. He was imited by Mr. Jacob to study whether there might be some gennic factor un- derKmg both smoking and certain diseases. But the ctud. nc~ cr got funded. Dr. Ashton says the lawyer told him "the presi- dents of the tobacco companies had turned down the proposal because they didn't think the outcome would be useful to them." This case. like sereral others, points up the sometimecg perplextng relatianship between sciemists and the tobacco Coun- cil. Dr. Ashton says he was "very apprehensive" about cast- ing his lot with the industry. What finally won him over' "Noi to shock you, but scientists are always looking for money to further their research:" Dr. Ashton says. Likewise, a pharmatrobgist. Charles Puglia. did a special project for the Council's lawyers from 1979 to 1961, although he believed smoking to be dangerous. He explains: "It was early on in my career and it got me started with a laboratory." While these scientisas hesitated to accept tobacco funding but finally said yes, others, such as Theodore Finley. hesitated and finally said no. Dr. Finley, encouraged by Jacob Medinger lawyers to apply for cigarette research fundin_. devidcd to c\ - amine whether emphysema can result from a reduction that smokers face in a protective lining of the lung. He soon backed out. "If my theory was correct, it would have discredited cigarettes," he says. "But it would be hard to talk about the evils of tobacco while being supported by them at the same time. This was dirty money - I felt like a prostitute." The researchers the Council cultivated most assiduously were those of a different breed: contrarianc whose work di.- puted the perils of tobacco. For instance. James F. Smith did two controversial studies in the 1960s and 1970s saying smoke-

166 ~atd it raised the risk ol oral cancer.) Although Dr. Smith all but repudiated his own conclusions on CBS's "60 %tinutes" in 1985 - urging the public to avoid smokeless :obacco - a short time later he acknowledged he accepted an offer of several thousand dollars from Jacob Medinger lawyers to review scientific literature in preparation for a tobacco liability suit. The plaintiff was the mother of an Oklahoma youth who had died of oral cancer after using smokeless tobacco for sevett years. The Jacob Medinger fnm and other defense lawyers won the suit, invoking Dr. Smith's studies as independent research. But there are indications he had longstanding ties to the Coun- dl; one court document shows his first study was eatmarked a "priority" for funding by Council lawyers 20 years earlier. Dr. Smith says the Council paid for equipment at his depan- meat's lab at the Univessty of Tennessee when he was doing his smokeless tobacco studies, though it didn't finance the studies. REWARDING RESEARCH Two other favorite scientists of the Council were Carl Selt- ur and Theodore Sterling. Dr. Seltzer, a biological anthropol- ogist. believes smoking has no role in heart disease and has alleged in print that data in the huge 45-yar, 10,000-person Framingham Heart Study - which found otherwise - have been distorted by antitobacto researchers. Framingham Direc- tor William Castelli scoffs at Dr. Seltzer's critique but says it "has had some impaa in keeping the debate alive." Dr. Sterling, a statistician, disputes the validity of popula- tion studies linking smoking to illness, arguing that thetr nar- row focus on smoking obscures the more likely disease cause - occupational exposure to tosic fumes. For both men, defying conventional wisdom has been re- warding. Dr. Sehaa says be has received "well over $1 mil- lion" from the Council for reseatdt. Dr. Sterl'mg got $1.1 million for his Special Projects work in 1977-g2, court records show. In relying on such reseatch, the tobacco industry is "ez- ploiting the margins of soieace," contends Anthony Colucd, a former top researcher and later director of scientific litiga- tion support at A.J. Reynolds. He offers an analogy: •'There's a forest full of data that says tobacco kills people, and sitting on one tree is a lizard with a different biochemical and physio- logical makeup. The industry focuses on that lizard - that tiny bit of margiaal evidence." R.J. Reynolds is stting Dr. Colueci, an outspoken critic, to keep him from testifying in a trial or talking to the media about tobacco liabitiry, and accuses him of demanding a big consult- ing contract to keep quiet. Dr. Cohtcd says Reynolds "manipu- lated the negadadom" so it can now portray them as an extortion attempt. He adds: "This is a clear demonstration of the extent to which a tobacco company will go to silence some- one who is telling the trtnh." The Special Projects unit worked in a variety of ways to protect tobacco companies. Lobbying in Congress against ad- vertising curbs, the industry in 1962 submitted to Congress a researcher's statement that peer pressure. not advertising, in- duced young people to smoke. Congress wasn't told that the research had been funded by Council attorneys. This was no accident. At a meeting of toMao-comp.nY lawyers the year before, Mr. Jacob explained that the reason for funding that particular research as a Special Project was to conceal the researcher's ties to the irsdustry. "We did not want it out in the open." Mr. Jacob said, according to the meating transcript as cited in a Newark. N.J., federal judge's opinion. The Council's lawyers weren't content for long to confine thes nda tti vn ts cncros.h on the snwhmc nxatch cmatut- ing from the putatively independent Council itself. Oftcn. the Coutwtl and ns lawyers shared or swapped projects and sctennsts. B, 1963, the Council had begun putting researchers under contract for many studies. This gave it the right to control both a study's design and publication of the results. However, as a contractor, the Council could be held responstble for wnh- holding negative findings. So its operatives would do their ut- most to ensure that ugly surprises didn't arise. This contributed to a parting of the ways with Hill d Knowlton. "The lawyers had this thing under control," recalls Loet Vdntans, a former chief executive of the PR firm. It quit the account in the late 1960s, he says, out of frustration that the industry "for legal reasons felt it couldn't admit to ans- thing lon tobacco and health) because then it would be sued out of eustence." Says Robert Kersey, a former head of tobacco research at Ligfxtt: "Almast everything that transpired had to be done un- der the advice of counsel so that nothing ... would incur a potential liability." SMOKING RODENTS In 1968, the Council contracted with Mason Research In- stitute in Worcester. Mass., to evaluate "smoktng machtnes" for animal inhalation studies and do toxicity tests on rodents. As the study drew to a close in 1972. Mason researcher \has- nig Hagopian was astonished when scientists from the Council and from R.J. Reynolds began turning up weekly at his lab. where he says they sat for hours taking notes. They made sure that only the most gettetialty vigorous (that is, cancer-resistam) rodents were going to be used, he says, and dictated which cigarettes and bow many puffs were administered to them. '•lt got to the point where they were directing the course of the study," says Dr. Hagopian. "It was nowhere near as objective as if it had been funded by" the government. Although he did complain to Mason's president. Dr. Hagoplan concedes he and other researchers mainly "looked the other way." They wanted to make sure the contract was renewed so they could do the critical experiments on whether smoke affects rodents' lung tissues. However, the Council ran- celed funding before Mason began the animal study. The Council pulled out the big guns after another stud). at Bio-Research Institute in Cambridge. Mass. When Syrian hanisters were exposed to smoke twice a day for 59 to >b weeks. 40% of those of a cancer-susceptible strain and 49.of a resw tant strain developed malignant tumors. Before publishing the study in 1774, the institute's founder. Freddy Homberger, sent a manuscript to Robert Hockett, then scientific director of the- Council. Dr. Homberger says he had to do so because halfway through his study, the Council had changed it from a grant to a contract "so they could control publication - they were quite open about that." Soon thernfter, Dr. Hockett and Mr. Jacob, the lawryer, hastened to Dr. Homberger's summer home in Maine. Their mission? "The> didn't want us to call anylhtng cancer-" Ur. Homberger testified years later at the Rose Cipollone tobacco liability trial in federal court in Newark. N.J. "They wanted it to be pseudo-epitheliomatous hyperplasia, and that is a eu- phemism for lesions preceding cancer. And we said no. this isn't right. It is a ancer." T mberger adds that S1r. jatwb told htmM would" er a penny more" if the paper was published withoareifaking the chantes. He compromised. At the last minute, he changed the linal proofs to read "micro-invasive" tancer, meaning a microscopic

167 n:ait;:nancv. Despite this. hi, lab was nescr lunded bc thc Council again. Dr. Hontberger would come to regret his concession. And the Council would find a use for it - on the same occasion on which it eventually would use research from another lab, Microbiological Associates of Bethesda. Md. WHAT KIND OF CANCER? The Council contracted with that lab to do the world's lar- gest inhalation study, involving more than 10,000 mice. To do it. the Council spent hundreds of thousands of dollars in a quest for the perfect smoking machine, one that prevented mice from either holding their breath or overdosing on car- bon monoxide. The lab initially had considered freedom, says Carol Henry, who was iu director of inhalation toxicology. But after nine years of work and $12 million. the team was told in 1982 that it could no longer meet with Council staffers unless a lawyer was present. "We had never done science through lawyers before, and we told them it was unacceptable," says Dr. Henry. She says a Jacob Medinger lawyer told her, "•That's the way it is." The scientists knuckled under. If the Council had canceled before all phases of the first experiment were done, 40 staffers might lose their jobs and nine years' worth of data would never come to Gght. In the frrst experiment. in which mice inhaled the equiva- lent of five cigarettes a day, frve days a week, for 110 weeks, 19 out of 978 mice got cancer - versus seven out of 651 con- trols. However, the tumors weren't squamous-cell carcinomas, the kind usually seen in human lung cancer. And there was a 109h possibility the results were due to charsce, whereas sden- tisu prefer no more than 57.. Even so, Dr. Henry says the study built a "very strong ax•' that dgarettes can iaduea cancers in anirttaLs. This was to be the first of several ex- periments. But lawyers from Jacob Medinger told Microbiological the project would go no further. "When a contract is canceled given these kinds of results," Dr. Henry says, "reasonable scientists might conclude the liability issue must have suddenly become apparent to this group." In fact, says Dr. Kreisher, the Council's former associate scientific director, Council law- vers "worried like he8" about it. Microbiological and the Council pased ways, but the tobacco industry got plenty of mileage out of the Mittobio- logical mice. In 1984, the Council issued a news release not- ing the absence of squamous-cell lung cancer in the lab's study. The timing wasn't coinddential: That year lawyers from Lig- gett, Phillip Morris and Lorillard began taking depositions in the landmark case of Mrs. Cipollorte, a New Jersey woman whose family claimed she had died of smoking-related squamous-cell lung ancer. And at the federal trial four years later, a witness for the defense said the fact that the smoking mice didn't get squamous-cell carcinoma (although some did get cancer) showed that "cigarette smoke has not been shown to be a cause of lung cancer." The witness also put Dr. Homberger's Syrian hamsters to good use. Smoking hadn't produced any more than "micro- invasive" tumors in the hamsters, rrotedthe.vitness, toxicol- ogist Arthur Furst. Dr. Homberger, regretting he had agreed under pressure to use this milder wording, calls this use of his repott "baloney," adding: "It was cancer beyond any question, not only in our opinion but in the view of the experts who looked at the slides." Dr. Furst declined to comment. The tobacco companies succeeded in planting doubt in .t+mh' turor. ..I d:dn', ..'.,•: :1 we• I`n•,cn .ac.r.•. ,t ..., smoAurg.au.,ed her lun.:an:er." ,a>, luror Barbar.t kc.ln. She says that under pre»ure trom other jurors. hc and i,.o othcr holdouts went alon. W nh a finding in fa. or of the Cipot- lones, but managed to hold the damages to 5400.000 instead ot the S20 million some wanted to gr.e. The award was based on false safeq assurance, by cigarette companies in their pre-1966 advertising. An appeals coun oserturned the verdict, saying the plain- tiffs had to prove Mrs. Cipollone had relied on the ad claim,. In December. the Cipollones withdrew the suit rather then rctn it, citing the cost. The advent of this suit had coincided with the end of the Council's contract and Special Projects research, as wrll as the waning influence of Jacob Medinger, which departed un- der pressure in 1984. Tobacco industry lawyers say privatelv that executives and attorneys grew fearful that the Coun:il. though designed to deflect liabi6t}, would wind up tncurrtng just that, because it could be portrayed as having breached a public pledge to do independent research. LEGAL LANDSCAPE SHIFTS In fact, by the mid-1980s, the industry had begun to face the very suits against the Council that it feared. In one, the Cipollone family's lawver, Ntarc Edell, sued the Council in 1984 on behalf of Susan Haines. the daughter of a Iuna-cancer victim. To prove his claims of fraud and conspirac%. \1r. Edell has been trying to get access to the 1,500 Council documents the industry has kept secret by invoking attomey-client privilege. Such privilege can be abrogated in case of fraud, and last year a federal judge-in Newark, citing possible evi- dena of fraud, set in motion the process of making documents available to Mr. Edell. The judge, H. Lee Sarokin. who had been hearing tobacco lawsuits for a decade. wrote a scathing opinion saying that the tobacco industry may be "thc Amc of concealment an,l w,tmormattuu." A federal appeals court removed him from the caac last September for failing to maintain the appearance of tmpar- tiality. A new judge will decide the critical tssue of whether the industry must di.vlge anv of the 1. 500 Council documents. In the meantime. plaintiffs' attomeys are pinning their hopes on the Supreme Coun't ruling last June. The ruhng. which grew out of the Cipollone case, said that although cigarette warning labels prevent smokers from bringing "failure to wam" cases, plaintiffs may frle suits alleging that cigarette makers intentionally hid or misrepresented tobacco'c health hazards. This has led some to view the Council tor Tobacco Research as the key to recovering damages trom the industry. But doing so may not be easy. At the end of January. a state court jury in Belleville. 11l., rejected the allegation that companies had conspired to play down tobacco's dangers. Some say winning such a case may depend on getnn& acces, to sealed Council documents. Also lacing an upmh oautc is mc crtnunal imeettgauun by the U.S. Attorney in Brooklyn. N.Y. Prosecutors are fac- ing statute-of-limitations problems because the Special Projects unit was disbanded more than fsve years ago. But what may prove the best protection for the tobacco industry is the readiness of certain scientists to read the c, t- dence differently from the majority. Says Dr. Colucci. the ex- Reynolds employee: "The scientists can come from Mars, but no matter how obscure or how misbegoueu, a, long a- the> are willing to tell the scientific lie that 'it's not proven,' the tobacco industry is off the hook." 

168 Mr. WAxMAN. For our next panel I want to call forward some geople who have some very relevant things to say about this issue efore us today. I want to call forward Dr. Richard Heyman, a member of the Committee on Substance Abuse, American Academy of Pediatrics; Dr. Jeffrey Wagener, director of the Pediatric Pul- monary Department, Children's Hospital, Denver, Colo., on behalf of the American Lung Association; Max Graham, who is accom- panied by Dr. Leroy Graham, his father; and Michelle Woodard, ac- companied by Ms. Kathleen Dart Woodard, her mother. If you would all come forward, we would appreciate it. We want to welcome you. Thank you very much for coming. I know it has been a long wait, especially for the children, to get this chance to come up here and talk to us. We just want to hear what you have to say, and if you think it is useful for us and the American people to know this information, that is why we are here. As we try to make decisions, we want the best information possible. Dr. Graham, I don't know in what order you would like to pro- ceed. Ms. Woodard, do you want to start off? STATEMENTS OF LEROY GRAHAM, PHYSICIAN, ATLANTA, GA, ACCOMPANIED BY HIS SON, 1VlA%; KATHLEEN DART WOODARD, HASLE'I'T, MI, ACCOMPANIED BY HER DAUGH- TER,IVIICHELLE; JEFFREY WAGENER, DIRECTOR, PEDIATRIC PULMONARY DEPARTMENT, DENVER CHILDREN'S HOS- PITAL, ON BEHALF OF COALITION ON SMOKING OR HEALTH; AND RICHARD B. HEYMAN, ON BEHALF OF AMERICAN ACAD- EMY OF PEDIATRICS Mr. LEROY GRAHAM. Max is a 51/zyear-old young man with mod- erately severe asthma. Like many other children with asthma, Max's symptoms are episodic and often quite unpredictable. When his asthma does flare, he coughs and often becomes quite short of breath. These symptoms significantly limit his ability to play or in- volve himself in extended physical activities. The mucus that often fills his airways will sometimes cause him to gag and eventually vomit. Also, like many other children with asthma, passive exposure to cigarette smoke frequently with result in an exacerbation of Maz's asthma. Such an exacerbation or flare may persist over several days~ despite involved, complex, and often confining treatment. While Max's immediate home environment is indeed smoke free, shopping trips, public entertainment, or sporting events, and ez- tended family gatherings have all involved exposure to cigarette smoke and a resultant worsening of Max's asthma. Max can recall a holiday visit to a relative's home where the smoking, even relegated to a distant portion of the house, made him cough, become breathless and quite sick. Max, do you think you could tell the people about what happened when we went to the baseball game? Mr. MAx GBAHA1ut. There was a guy smoking, and so I had to trade seats because he was making me do bad, and so I had to trade seats. Mr. LEROY GxAHANt. And what did his cigarette smoke do to you? Mr. MAx GRAHAM. It made me cough. Mr. LEROY GRAHAM. And what else?

169 Mr. MR. MAx GRAHAM. Throw up. Mr. LEROY GRAHAM. Yes. So I guess my perspective as both a pediatric lung specialist, which I am, and the parent of a child with asthma, I feel that young citizens like Max who are often powerless victims of passive smoking should be protected from such exposure in public places. It is also my hope and I think indeed the hope of most parents of asthmatics that educational and legislative efforts should be in- tensified to minimize and eventually eliminate such exposure in private areas as well. Thank you. Mr. WAXMAN. Thank you very much, Dr. Graham. Ms. Woodard. STATEMENT OF HATHLEEN DART WOODARD Ms. KATHLEEN WOODARD. My name is Kathleen Dart Woodard, and I am the mother of an asthmatic child. Michelle, my daughter, first became ill on her third birthday and was first hospitalized shortly thereafter. Although she wasn't officially diagnosed with asthma for almost another year, she suffered from lower res- piratory illnesses frequently. She has had pneumonia 15 times, been hospitalized 4 times, and has missed an average of 17 days per year from school. Although there are many triggers for asthma, environmental pollution, which includes tobacco smoke, is one very serious factor. After the diagnosis of asthma, our family began the long, long process of educating ourselves as to what preventive steps we could take to help Michelle control this illness. We quickly learned that Michelle could not participate in activities that are normal for other children. She could not go to other children's houses to play, especially if there was a smoker in the house. One of the consequences of this was that other children simply quit asking her to play. She could not go to restaurants because even in the nonsmoking sections the cigarette smoke drifts over to other sections. We could not go to motels to stay because of the pos- sible triggers present. We even stopped going to family gatherings, especially at holidays, because of the cigarette smokers in the fam- ily. They simply didn't understand that just because Michelle was in another room that the smoke would still affect her, and we soon grew weary of those trips to the emergency room after one of these events. It was easier to simply stay home than to experience the crises, the increased medications, the traumas of repeated hospital visits, and, of course, the frequent and adverse behavioral changes due to the medications used for treatment of asthma. As a chronically ill child, Michelle takes five separate medica- tions a minimum of three times per day. When ill or exposed to en- vironmental tobacco smoke, these medications increase and others are added. Some are orally taken, some inhaled, some with the use of a machine which we take everywhere we go. Because of these medications and the other preventive steps we have taken, Michelle's asthma is, for the most part, under control, but this has its drawbacks too. Many people have said to me, `But she looks fine." Well, she is doing well, but only because we have worked very hard to control her illness, to structure her life more

170 than other children, to limit activities that are common to other children. Respiratory illnesses like asthma are not readily visible illnesses, just as the triggers and causes are not readily visible. Tobacco smoke in another room of a building where there is a child like Michelle can and does affect her, sometimes immediately, some- times delayed. There is no inexpensive closed ventilation system that can guar- antee that a child with a chronic respiratory illness will be pro- tected. These children need a safe environment in which to learn, in which to play, in which to live. Safety hazards are not always immediately noticed or immediately visible, and tobacco smoke is one of them. Children with asthma and other respiratory illnesses do suffer when there is tobacco smoke nearby. I read just the other day that asthma, along with AIDS and tu- berculosis, are the only chronic illnesses on the rise in the world today. Many of our children are developing asthma, and these chil- dren are not always recognized as children with special needs. In our society, we have become knowledgeable about and sensitive to persons with various disabilities, handicaps, and other limitations. Children with asthma or other chronic respiratory illnesses also need our help to provide them with as safe an environment as pos- sible. I urge you to please consider the effects of this illness and consider the seriousness of tobacco smoke as a trigger, and I ask you to please think of the many children whose daily lives are af- fected. Thank you. STATEMENT OF MICHELLE WOODARD Ms. MICBEt.L.E WOODARD. Hi. My name is Michelle Woodard. I am a 9-year-old going into the fourth grade at Murphy Elementary School in Haslett, MI. It has been hard having asthma because I haven't been able to go to my grandpa's house for a long time because they smoke. But then they went into the hospital because they were very, very ill. After that, the doctors told them that if they smoked again they would die, so they don't smoke at all now. Now I get to see them as much as I want. Also, I couldn't go to some of my aunts, uncles, and older cousins because they smoked and it was harder for me to breathe when I was around them. Some of them still smoke, but some of them have stopped smoking so I get to see them a little bit more often. I don't get to go to some family holiday parties because some peo- K le still smoke and that bothers me. I also can't go to some friends' ouses because their parents smoke and that really affects me. Sometimes I can't go to restaurants even if we are not in the smok- l area because I can still smell the smoke. ome problems that I atart having when I am around smoke are: I get dizzy, I start to sneeze, I can't breathe very well, and some- times get headaches, and I don't feel very good. The worst that could happen is, I would get too much smoke in my lungs and go into the hospital. It hurts when I go into the hospital, and I don't likeitatall.

171 So if there could be no smoking in schools, it would help other kids who have asthma and it would help me. If there could be less smoking at other places besides schools, • I could participate in more events. Mr. WAX1KArr. Thank you very much, Michelle. We appreciate that and everything that you and Max both have said to us. Dr. Wagener, why don't we hear from you next. STATEMENT OF JEFFREY WAGENER Mr. WAGENER. Mr. Chairman and members of the subcommittee, I am Dr. Jeff Wagener. I am an associate professor of pediatrics at the University of Colorado, and I am director of the Pediatric Pul- monary Department at the Children's Hospital in Denver, Colo. My clinical practice includes providing care for children and young adults with all forms of lung disease, including asthma, cystic fibrosis, and recurrent pneumonia. I am appearing today on behalf of the American Heart Association, the American Lung As- sociation, and the American Cancer Society, who have united into the Coalition on Smoking or Health. My testimony will focus on the need to protect our children's health. It is not directed toward the smoking by individuals with a choice but concerns individuals exposed to tobacco smoke without having a choice. In caring for children with asthma, all too fre- quently I see children arriving in the emergency room in acute dis- tress with a history of feeling fine until they entered a smoke-filled room or had to sit near a smoking adult either indoors or outdoors. The combination of exhaled and burning smoke has been called involuntary, passive, or secondhand smoke. However, more recently it is increasingly referred to as environmental tobacco smoke, or ETS, to recognize that it impacts on all aspects of one's respirable environment. Pediatricians recognize that ETS affects not only the air the children breathe but also the environment they live in prior to birth. Scientific data has consistently shown that ETS affects children in four ways: First, prior to birth ETS from maternal smoking affects normal development, resulting in babies that are inappropriately small or at higher risk of being born prematurely, have smaller than normal lungs, and may have an abnormal breathing pattern which places them at an increased risk for sudden infant death, or SIDS. Second, following birth, children living in a smoking environment have an increased risk for developing symptomatic lower and upper respiratory tract illnesses and have markedly increased risk for needing costly hospitalization for illnesses which usually do not re- quire hospitalization in ETS nonezposed children. Third, there is increasing evidence that children who are born at risk for developing asthma are more likely to develop symptomatic asthma, require increasing amounts of inedications to treat their asthma, have more frequent emergency room visits for asthma, and end up hospitalized for their asthma if they are repeatedly exposed to ETS. Finally, young children frequently exposed to ETS are more like- ly to become smokers themselves when they grow older and have a choice about smoking. Children learn, unfortunately, in this situ- ation from adults. When these children take up smoking as they

172 get older, they then enter a population with absolutely proven higher. risk for premature heart disease, chronic lung disease, and fatal lung cancer. Earlier this year, the Environmental Protection Agency released an exhaustive review of the effects on children from ETS. Although the tobacco industry has repeatedly tried to deny or refute the find- ings of this report as it pertains to adult cancer risk from ETS, the results concerning respiratory disease in children is scientifically sound and can be little debated. This risk assessment determined the following: 200,000 to 1 mil- lion children with already diagnosed asthma have a significant worsening of their symptoms directly due to ETS; 150,000 to 300,000 cases annually of lower respiratory tract illness in young children is contributed to by ETS; and, finally, 7,500 to 15,000 hos- pitalizations in younger children result from ETS. At my hospital, 15,000 hospitalizations for lower respiratory tract illness would equate to between $45 million and $68 million annually in medical costs given the average cost per patient with this diagnosis. Re- member, this is an entirely preventable problem. Most of these studies look at children exposed to ETS at home. However, I would also like to discuss briefly the evidence dem- onstrating risk outside the home. As with many toxins, tobacco smoke has a dose response effect. The more smoke one is exposed to, the greater the effect on lung growth and development of lung disease. However, with the child who has asthma, ETS acts as a trigger of acute problems. Similar to something an asthmatic child might be allergic to, tobacco smoke, even in minute amounts, can stimu- late a life-threatening asthma exacerbation. In a study at the Na- tional Jewish Center in Denver, 20 percent of children identified ir- ritants like tobacco smoke as one of their top three most frequent triggers for acute asthma. More impressive is a study conducted in Tucson, Arizona, which finds that children are better off in nonsmoking day care than stay- ing home if their primary care provider smokes. As was expected, children attending day care with several other children were at higher risk for respiratory infections than were infants and young children who stayed at home. This, however, was true only if the care taker was a nonsmoker. If the home care taker was a smoker, then the child actually did better in day care. We feel it is important to support the bills that have been pre- viously proposed, such as House Bill 701 and House Bill 2147. We also would strongly support the initiative that Mr. Waxman has made, and I appreciate the opportunity to speak before you. Thank you very much. [The prepared statement of Mr. Wagener follows:] STATEMENT OF JEFFREY WAGENER, ON BEHALF OF THE COALITION ON SMOKING OR HEALTH Mr. Chairman and members of the subcommittee on Health and the Environment, I am Dr. Jeff Wagener, Director of the Pediatric Pulmonary Department at the Chil- dren's Hospital in Denver, Colorado. My clinical practice includes providing care for children and young adults with all forms of lung disease including asthma, cystic fibrosis, and recurrent pneumonias. I am also an associate professor of pediatrics at the University of Colorado Medical School. I am appearing today on behalf of the .e.1

173 American Lung Association, American Cancer Society, and the American Heart As- sociation, united as the Coalition on Smoking or Health. The Coalition on Smoking or Health was formed in 1982 and since then has been working to educate public policy leaders about issues related to tobacco, disease pre- vention, and health promotion. The Coalition has been successful in such projects as banning smoking on domestic airline flights, revising warning labels on cigarette packages and advertising, and obtaining warning labels on smokeless tobacco pr.~ ects. In addition, the Coalition is active on the State level, and has achieved sev- eral successes in limiting exposure to environmental tobacco smoke indoors and lim- iting youth access to tobacco. Tobacco use continues to be a major public health problem in the United States. Tobacco use is the leading cause of preventable death accounting for over 487,000 deaths annually in the United States. The Coalition on Smoking or Health believes strong efforts should be made to discourage tobacco use in all segments of the popu- lation including youth, women, and minority populations who increasingly are tar- geted geted by the tobacco industry. The Coalition also places emphasis on the need to protect nonsmokers, adults, and particularly children from the number one cause of preventable lung disease-tobacco smoke. My testimony will focus on the need to protect our children's health. However, it is not directed toward smoking by individuals with a choice, but is about individuals exposed to tobacco smoke without having a choice. In caring for children with asth- ma, all toofrequently I see children arriving in the emergency room in acute dis- tress with the history of feeling fine until they entered a smoke filled room or had to sit near a smoking adult either indoors or outdoors. Imagine how upsetting it must be for a child to have to leave a Colorado Rockies baseball game when a per- son sitting nearby refuses to stop smoking, even when they are informed that his smoke is ezacerbating the child's asthma. Smoke leaving the burning end of a cigarette, pipe, or cigar contains even higher concentrations of toxic chemicals including arsenic, tar and nicotine then exhaled smoke. this combination of exhaled and burning smoke has been called involuntary passive, or secondhand smoke. However, more recently, it is increasingly referre~ to as environmental tobacco smoke or ETS to recognize that it impacts on all as- pecta of one's "respirable" surroundings. In fact, pediatricians recognize that ETS ef- fects not only the air that children breathe, but also the environment they live in prior to birth. Scientific data has consistently shown that ETS effects children in four ways: 1. Prior to birth, ETS from maternal smoking effects normal development result- ing in babies that are inappropriately small and frail, that may be born pre- maturely, who have smaller than normal lungs, and may have an altered control of their normal breathing pattern. 2. Following birth, and most dramatically d ng the first 2 years of life, children living in a smoking environment have an increased risk for developing symptomatic lower and upper respiratory tract illnesses and have a markedly increased risk of needing costly hospitalization for illnesses which usually do not require hospitaliza- tion in ETS non-exposed children. 3. There is increasing evidence that children born with a risk for developing asth- ma are more likely to develop symptomatic asthma, require increasing amounts of medications to treat their asthma, have more frequent emergency room visits for asthma, and end up hospitalized for their asthma if they live in a household where ~ they are exposed to ETS. 4. Finally, young children frequently exposed to ETS are more likely to become smokers themselves when they grow older and have a choice about smoking. Studies have shown that the single greatest predictor of children's smoking is whether the parents smoke. children learn, unfortunately in this case, from adults. When these ' children take up smoking as they get older, they then enter a population with abso- lutely proven, although often still deiued by the tobacco industry, high risk for pre- mature heart disease, chronic lung disease, and fatal lung cancer. Earlier this year the Environmental Protection Agency released an exhaustive re- view of the effects on children from ETS. Although the tobacco industry has repeat- edly tried to deny or refute the findings of this report as it pertains to adult cancer risks from ETS, the results concerning respiratory disease in children can be little debated. This report, released on January 7th of this year, comprehensively re- viewed essentially all scientific publications since the 1986 National Research Coun- cil and Surgeon General's reports pertaining to childhood effects of ETS. Risk as- sessments determined in this report include: 1. 8,000 to 26,000 cases of childhood asthma per year are attributable to ETS, 2. 200,000 to 1 million children with already diagnosed asthma have a significant worsening of the symptoms due to ETS, 11Z 74-814 0 - 93 - 7 ~ Cr"~ ~ ~ ZZ 00

174 3. 150,000 to 300,000 cases annually of lower respiratory tract illness in young children under 18 months of age is contributed to by ETS: and 4. 7,500 to 15,000 hospitalizations in these younger children result from ETS. At my hospital, 15,000 hospitalizations for lower respiratory tract illness would equate to between $45 million and $68 million annually given our average cost per patient with this diagnosis. In Federal terms this may not be a large amount of money, but remember that this is an entirely preventable problem. Finally, the EPA report notes the Surgeon General's findings that 700 infants die yearly from sudden infant death syndrome, or SIDS, with ETS identified as a attributable cause. Most of these studies look at children exposed to ETS at home; however, I would also like to discuss the evidence demonstrating risk outside the home. As with many toxins, tobacco smoke has a dose response effect. We know that a smoker is more likely to develop lung disease than a non-smoker. Children who live in households where the primary careg~ver is a smoker are more likely to develop lung disease than children living in households where the working parent is the only smoker. Thus, the more smoke one is exposed to, the greater the effect on lung growth and the development of 1ung disease. However, for the child with asthma, ETS acts as a trigger for acute problems. Similar to something an asthmatic child might be allergic to, tobacco smoke, in even minute amounts, can stimulate a life threatening asthma exacerbation. In a study at the National Jewish Center in Denver 20 percent of children identified irritants like tobacco smoke as one of their top three most frequent triggers for asthma at- tacks. In reviewing this with the emergency room physicians at the Children's Hos- pital in Denver, they report over 50 percent of children being seem for an acute asthma exacerbation have been ezposed to ETS. Even more impressive is a report conducted in Tucson, Arizona which finds that children are better off in non-smokinq day care than stayu' ~g home if their primary care provider smokes. This large stucCy followed infants for several years to identify contributing factors for developing respiratory infections and asthma. As was ex- pected, children attending day care with several other children wee at higher risk for respiratory infections than were infants or young children who stayed home. This, however, was true only if the caretaker at home was a non-smoker. If the home caretaker was a smoker, then the child did better in a non-smoking day care. I am not here to debate whether adults should elect to smoke or not. Instead, the question is whether children should be forced to smoke. ETS is harmful to the grow- ing lung, that is clear. ETS, both indoor and outdoor, can worsen respiratory symp- toms in children with pre-existing 1ung disease, that is clear. That chronic exposure to smoking will increase a child'slikelihood to begin smoking is obvious. So the final question is, WVhy do we encourage society to worsen the health of our children?" A first step in protecting our children is support for H.R. 710, The PRO-KIDS Act introduced by Representative Dick Durbin. H.R 710 requires federally-funded chil- dren's programs to establish a nonsmoking policy prohibiting smoking indoors, ex- cept in areas of their facilities which are not normally used to serve the children and which are ventilated separately from the children's areas. This provision applies to all federally-funded health programs serving children, and all other federally- funded programs that primarily serve children, mcluding schools, Head Start, WIC, and day care pro . Further, Mr. hs~i*~*nAn and members of the subcommittee, I want to point out that it seems inconceivable to us that with all of the scientific evidence now impli- cating environmental tobacco smoke as a cause of disease in nonsmokers that there has not been expeditious effort to use the jurisdiction of this subcommittee to re- quire that cigarette packages and advertisements carry warning labels and other in- formation about the dangerous effects of environmental tobacco smoke. This is par- tially due to the fact that no regulatory agency has any authority to ensure that the public is protected and properly warned about the dangers of cigarette smoking. Only the U.S. Congress has had any authority to act, and it has been extremely slow in acting, as evidenced by the lack of warnings about not only environmental tobacco smoke but also addiction, stroke, osteoporosis, and use of tobacco products with preexisting conditions or with birth control pills, just to name a few. Where are the assurances and the labeling that tells the public what thousands of chemical additives are being dumped into tobacco products, some of which may add to envi- ronmental tobacco smoke hazards? One of the solutions to this dilemma is to ensure that regulatory authorities are vested in appropriate Federal regulatory agencies which can, at Congress's statutory insistence, take the necessary actions to protect the health and welfare of the Amer- ican public. The Coalition along with over 70 other national organizations is on record supporting H.R. 2147, introduced by Congressman Synar and 25 other Mem- bers of the House, that would give the Food and Drug Administration the authority , I I

175 to regulate tobacco products in a comparable manner with the way in which other legal products are regulated for health and safety purposes. On behalf of the American Lung Association, I would like to thank you for the opportunity to testify before this subcommittee. I encourage you to think of how we, as adults, can improve the health of children and eventually contribute to a lower cost of medical care. Mr. WAxmAN. Thank you very much, Dr. Wagener. Dr. Heyman. STATEMENT OF RICHARD B. HEYMAN Mr. HEYMArr. Good morning, Mr. Chairman. My name is Richard Heyman. I am a practicing pediatrician from Cincinnati, Ohio. It is a pleasure to appear before you today on be- half half of the American Academy of Pediatrics whose 45,000 fellows are dedicated to the health, safety, and well-being of infants, chil- dren, adolescents, and young adults. We appreciate the subcommit- tee's holding this hearing to examine the serious consequences of secondhand tobacco smoke, especially as it affects our Nation's chil- dren, and there should be no doubt that secondhand smoke poses serious health consequences for children. All children potentially suffer from secondhand smoke, but it can have a crippling effect, as we have heard, on children with chronic respiratory infections. We have heard two poignant stories today of children who, in effect, are prisoners of their own home because on many occasions they can't venture out safely into public because of the possibility of encountering environmental tobacco smoke. Accordingly, the Academy strongly supports Federal legislative efforts to restrict smoking in places where children are present as a means of eliminating the serious health consequences of second- hand smoke. One such proposal has been introduced by Congress- man Durbin and Senator Lautenberg. As a first step toward this goal, the Academy has endorsed their Pro-Kids legislation which this subcommittee heard about earlier this morning. The Academy also looks forward very much to working with Chairman Waxman has he develops legislation which would protect children from secondhand smoke in all public places where children are present. Smoking is the leading cause of preventable death in the United States today and is responsible for approximately 20 percent of such deaths annually. The Environmental Protection Agency's re- port port on the respiratory health effects of passive smoking is a land- mark document which extensively reviews the research which has been done involving, among other things, children and environ- mental tobacco smoke. • My purpose today is to highlight some of this information as it relates to children and particularly share with you my perspective as a practicing pediatrician who spends his life treating these chil- dren who are exposed to environmental tobacco smoke. As we have heard, there are a number of ways in which environ- mental tobacco smoke impacts upon children. There is clear evi- dence that smoking by a woman who is pregnant puts that fetus at risk, and in a country which is a developed country such as the United States, which has one of the highest rates of infant mortal- ity and morbidity, we cannot ignore the fact that, smoking by a pregnant woman puts that fetus at its very own special risk for en-

176 vironmental tobacco smoke exposure and to the pulmonary damage which results from that. The relationship of environmental tobacco smoke to sudden in- fant death syndrome has already been alluded to, and while the EPA stops short of statistically stating that tobacco smoke is relat- ed to SIDS, there can be no question that children who are born with compromised respiratory function are at higher risk for sud- den infant death during infancy. I would like to hone in on the two areas which affect me the most as a private practicing pediatrician. I spend my days treating the ear infections, the upper respiratory infections, the sinus infections of children who are brought to my office on a repeated basis. Day in and day out, I see the same faces, children who get one upper respiratory infection after another because children's mucous mem- branes and their upper respiratory tracts are developing organs, and these developing organs are especially sensitive to environ- mental toxins such as tobacco smoke. We can sit here and talk about two tail tests and one tail tests and 95 percent and 90 percent, but that doesn't make any dif- ference to the scenario that I see and my 45,000 colleagues see in their offices, and that scenario is a parade of one child after an- other with upper resp iratory infection, sinus infection, middle ear infection, one time after another in the office repeatedly, and what an incredible irony it is to me-and it happens on a daily basis- as I am looking at a poor mother who is missing work, at a child who is missing school, at a child whose life is imp acted, who isn't hearing properly, who isn't learning properly, and I may comment to this mother casually, "By the way, Mrs. Jones," as I look at her purse where the cigarettes are there, "it really would be helpful, as I have talked to you before, if you stopped the smoking." We don't have to worry, those of us who are out in the trenches prescribing the antibiotics and treating these issues, we don't have to worry about one tail and two tail or 90 and 95 percent, we just have our job to do, but you are looking at the children and the fam- ilies who are impacted by this. I would like to sum up by simply saying that exposure to ETS in childhood is causally related to a wide variety of medical prob- lems, and we applaud the EPA's report for raising this critical issue in reference to children. [The prepared statement of Mr. Heyman follows:] STATEMENT OF RdCHARD B. HEYMAN, AMERICAN ACADEMY OF PEDIATRICS Good morning, Mr. Chairman. My name is Richard B. Heyman, M.D. I am a prac- ticing pediatrician from Cincinnati, Ohio. It is a pleasure to appear before you today on behalf of the American Academy of Pediatncs, whose 45,000 fellows are dedi- cated to the health, safety and well-being of infants, children, adolescents and young adults. We appreciate the subcommittee holding this hearing to examine the serious consequences of second-hand smoke, especially as it affects our Nation's children. There ahould be no doubt that second-hand smoke poses serious health con- sequ~~ences for children. AlI chiidren potentially suffer from second-hand smoke, but it can have a crippling affect on children that have chronic respiratory disorders. For these children, walk- ing into a room of second-hand smoke can cause significant physical discomfort. This, in effect, makes these children prisoners in their own environment. The Fed- eral Government should restrict smoking in all places where children are present, places like child care facilities, Head Start programs, and school buildings. Accord- ingly, the Academy strongly supports Federal legislative efforts to restrict smoking , I

177 in places where children are present as a means of elimineting the serious health consequences of second-hand smoke. One such proposal has been introduced by Con- gressman Durbin and Senator Lautenberg. As a first step toward this poal, the Academy has endorsed their "PRO-KIDS" legislation which would establish anti- smoking policies in federally owned or leased buildings where children are present. The Academy also looks forward to working with Chairman Waxman as he develops legislation which would protect children from second-hand smoke in all public places where children are present. Smoking is the leading cause of preventable death in the United States, and is responsible for approximately 20 p_ercent of deatlis annually. The Environmental ProtectionAg ency~s report on the "Respiratory health Effects of Passive Smoking" ~ is a landmark document which extensively reviews the research that has been done involving, among other things, children and enviro imental tobacco smoke (ETS). My purpose today is to summarize some of the information as it relates to children, and emphasize the tremendous importance of reducing exposure of our young people to , ETS Ch .ildren are affected by tobacco and environmental tobacco smoke in a variety of ways: 1. There is clear evidence that smoking during pregnancy places the fetus at risk; 2. Infants are at an increased risk to sudden infant death syndrome (SIDS) when they are exposed to second-hand smoke; 3. Adolescents who smoke tend to associate with young people who smoke-there- by increasing their exposure to ETS; 4. Exposure to ETS has major effects on the physical and psychosocial well-being of children. I would like to expand on some of these items. Cigarette smoking by pregnant mothers is a major cause of infant mortality and low birthweight, for these infants are exposed to their own special form of environ- mental tobacco smoke (ETS). It is estimated that elimination of smoking would re- duce infant deaths by 10 percent and decrease the incidence of low birth-weight by as much as 25 percent. Infants exposed to significant levels of cigarette smoke while in utero are at in- creased risk for sudden infant death syndrome (SIDS). There are valid studies which suggest that the child's ability to learn may be affected as well. Thus, exposure to mother's cigarette smoking by the developing fetus impedes normal growth and development. The data are solid and statistically valid: cigarette smoking by pregnant women is harmful to their babies and must be discouraged at all costs. As a developed Nation with one of the highest rates of infant mortality and morbidity, these are facts that we can ill afford to ignore. Children exposed involuntarily to cigarette smoke, especially d the first 2 years of life, are at increased risk for a variety of medical maladieost promi- nently, they have a higher rate of upper respiratory infections, involving middle ear effusions. As a pediatrician, I see kids in my office day every day for treatment of colds, runny noses, post nasal drips and the like. These are kids who are missing school and whose parents are missing work because the child care centers won't take their children when they are ill. These are the children who are in the office week after week-on one course of treatment after another--and never really get well. I some- times times feel like I am pouring water on a fire while the parent is adding fuel to the fire Pmtrying to put out! And it's frustratin$ for the parents to come in at wit's end because their kids are sick and they can t sleep and they have to miss work and so on. And I tell them "STOP SMOKIIdG" and your kids will stop getting sick so often. And they just stare and look at me wondering why Pm picking on THEM • when they're there to get their child taken care ot! Children have poor immune response to viral and other infectious agents. Kids are in close quarters much of the time-breathing, sn and drooling on each other. If the mucous membranes that line their mouths an respiratory tracts are damaged and irritated by toxins such as ETS, they are more susceptible to the germs spread from other children. This leads to the mescapable conclusion that we must encourage parents to do everythingble to minimize their children's expo- sure to environmental~pollutants such as E'TS. A significant side effect of all these upper res iratory infections is the occurrence of middle ear infections. The middle ear~-w contains the sensitive organs in- volved in hearing-is lined by the same type of delicate membrane as is the rest of the respiratory tract. And so it too is a target of ETS. Children exposed to smok- in2 at home show a s' cant increase in the prevalence of abnormal fluid in the middle ear space-fluid which impairs hearing and the ability to interpret sound.

178 There is good evidence that children who have lo -term problems with the mid- dle ear fluid may experience delay in cognitive and~anguage development. This is a common problem which pediatricians deal with every day, and one which has sig- nificant imphcations. Children with delayed acquisition of speech and language may be stigmatized because they speak strangely and have trouble learning. Teachers maq not understand them; their peers may ostracize them. Their self esteem suffers. Ultimately, these children may need to have "tubes" placed in their eardrum. These polyethylene tubes, inserted surgically under general anesthesia, allow the pressure to equalize either side of the eardrum and help to restore non-nal hearing. Asthma is one of the main causes of school absenteeism and hospital admissions for children. A pediatrician's practice is made up of a number of children who suffer from wheezing on a chronic and recurrent basis. These are children who may be un- able to participate fully in physical activities, and who may find that every res- piratory infection challenges their ability to breathe. The inhalation of cigarette smoke is a major factor in exacerbating asthma, and has been causally linked to the onset of the disease. A number of studies have concluded that asthmatic chil- dren whose parents smoke are more likely to require hospitalization, more likely to need emergency room treatment, and tend to need more medication to control their disease. I am repeatedly struck by how often I treat asthmatic children, and cas- ually notice the pack of cigarettes in the mother's open purse. I've mentioned this irony to families many times, and more than once the child has nodded his head in agreement that mom's smoking tends to make breathing problems worse. I'd also like to comment bnefly on the decrease in pulmonary function docu- mented to occur in children exposed to ETS. ETS affects children's pulmonary func- tion in two ways. It creates the inflammation and mucous production which results in the wheezing that has already been mentioned. Furthermore, young lungs are growing lungs, and damage inflicted during childhood may lead to suboptimal devel- opment of pulmonary function which can persist into adulthood. Nothing is more poignant than the syndrome of unexplained sudden death in in- fancy. Apparently healthy babies suddenly die for no apparent reason. SIDS is actu- ally the leading cause of death in infants aged 1 month to 1 year. A busy practice such as mine will experience one of these tragedies every year, as the incidence of this syndrome ap~roaches 2 per thousand live births. The EPA report summarizes a number of studies from this country as well as abroad which ezamined many dif- ferent factors possibly involved in SIDS. The EPA takes a strikingly cautious stand on this issue, noting the statistical fact that infants whose mothers smoke are at increased risk for SIDS but not asserting that smoking is a risk factor. I believe that parental smoking is a risk factor. Anything that damages the airways of young infants is dangerous and could place them at risk for SIDB. Children and adolescents are notoriously impressionable, and are constantly influ- enced by and looki gfor role models. Being around people who smoke makes young people feel that smnolnng is normal. Seeing tobacco advertisementa depicting smok- ers as beautiful, seay , adventurous, successful, cool, admired, independent, strong, brave and happy makes young people think they can `buy" those attributes in each pack of cigarettes. Observing smokers who use cigarettes to deal with anxiety, anger, depression, hunger and fear makes young people think that nicotine is an antidote for those unpleasant feelings. "Passive smoking'-if we expand the defini- tion to include the psychological effects-has broader implications than even the EPA report delineates. In summary, exposure to ETS in childhood is causally related to a wide variety of medical problems, and the EPA report "Respiratory Health Effects of Passive Smoking" is a major and valuable reference. We applaud the Environmental Protec- tion Agency for raising the critical issue of environmental tobacco smoke and their special attention to the serious impact it has on children. Again, the American Academy of Pediatrics thanks you for the opportunity to tes- tify and we stand ready to work with the subcommittee to remove this hazard from our children's environment. Mr. WAxmAN. Thank you very much, Dr. Heyman. I wish some of my colleagues who were here earlier, who were so concerned about one tail or two tail studies or 90 percent or 95 percent, could have heard the testimony of this panel, because what you are telling us that children, because they are children, have a lot of upper respiratory problems, sinus problems, ear infec- tions, anyway, but whenever they are exposed to tobacco smoke it only makes it worse. Is that right, Dr. Heyman?

179 Mr. HEnvtax. Yes, Mr. Chairman, that is correct. Mr. WAXMAN. And all this dispute about the 90 percent, 95 per- cent, and all of that had nothing to do with the respiratory prob- lems, it only had to do with the nitpicking that the tobacco indus- try is using to attack the studies with regard to cancer. But just putting that aside, just talking about cancer for kids, they are having trouble breathing when they are in public places where there is tobacco smoke around, and that is for all kids, but for those kids who have asthma the problem is like a nightmare. Michelle and Max, you have just given us some really worthwhile information. Michelle, when you want to go to a restaurant or baseball game or to the mall or some other public building, is it a problem for you if there are people around that are smoking? Ms. MICHELLE WOODARD. Yes. Mr. WAxwtArt. And what does that mean? Do you have to stay away from some of those places? Ms. MICHELLE WOODARD. Well, I still go there and stuff but maybe not as often, like if there is a big crowd that comes in and they all smoke or something, and then I would tell my mom, and she would take me to another part so that it wouldn't be a problem and I wouldn't start sneezing and coughing and some of the things I told about in my speech. Mr. WAxMAx. And, Max, do you ever feel that you have to stay away from places you would like to go because you always have to worry that somebody may be smoking around you? Mr. MAx GRu4A1K. Sometimes I like to go some places, but some places I don't want to go because there's always some people who are smoking, and my dad tells me where he wants me to go. Mr. WAxNtArr. So if you wanted to go to a restaurant or some other public place, you and your family have to be concerned about whether there is going to be that smoke around. It is a problem. Mr. MAx GRAxLAm. Well, some places I like to go, like some malls or something like that. Mr. WAXMAN. You know, we have a law in this country that says if people are handicapped, at public facilities they have got to de- velop ramps so that they can have access to those places, and if we have children who are particularly sensitive to tobacco smoke, we ought to protect them and make those places available to them, and it is not just for them, it is for all kids, because all kids are going to be adversely affected. We know this now by virtue of the Environmental Protection Agency report. It is just unequivocal, they are going to be affected by the tobacco smoke, not because they are smoking but because others around them are smoking. The way I look at this is, this is going to be a fight between the tobacco companies on the one hand and the Mazes and the Michelles and millions of others like them, and we have got to pro- tect the children of this country and not keep them away from places that they want to attend and their family wants to have ac- cess to because others are smoking. It is so cheap, it is so inexpensive, to prevent these medical prob- lems simply by saying, if you are in a public place, you can't smoke unless there is a special ventilation that will allow smokers in a section that will keep the nonsmokers' rights protected.

180 Isn't that what we are talking about, Dr. Wagener? Mr. WAGENER. I certainly agree with that. I think that not only is it inexpensive to avoid smoke, but we save money from medical costs either by not having children getting sick or, even more im- portantly, by not having children take up the habit of cigarette smoking Mr. WAxmA1v. There is an article in today's L.A. Times, inciden- tally, by a young woman who described the fact that when she was a child, people around her never even thought about the idea of, if they were smoking, they had to stop smoking in order to avoid the problems that she and others might feel when they breathe in that smoke. People had thought, maybe as recently as 5 years ago, that it was quixotic to suggest that smokers should maybe forego smoking for any period of time when they were around other people. I think that time has long passed. We have seen it in the air lines that smokers can stop smoking while they are around others in order to protect the rights of the nonsmokers, and we should acknowl- edge it now for all public places, not just Government public places but all public places where people have access to and are, in effect, denied access because their health is threatened. I want to thank all of you for being here. I thought your testi- mony was terrific, and the kids, to come all the way from Michigan and Atlanta, we really want to thank you very much and your par- ents for bringing you. Thank you very much. For our last witnesses today, I want to call forward three people: Dr. Lonnie Bristow, who is chairman of the Board of Trustees of the American Medical Association; Dr. Gio Batta Gori on behalf of the Tobacco Institute; and Ms. Athena Mueller, general counsel of Action on Smoking and Health. Mr. WAXMArr. We want to welcome you to our subcommittee hearing today. Your prepared statements will be in the record in full. What we would like to ask of each of you is to limit the oral presentation to no more than 5 minutes. Dr. Bristow, why don't we start with you. STATEMENTS OF LONNIE R. BRISTOW, CHAIRMAN, BOARD OF TRUSTEES, AMERICAN MEDICAL ASSOCIATION; GIO BATTA GORI, PRESIDENT, INTERNATIONAL SOCIETY OF REGU- LATORY TOXICOLOGY AND PHARMACOLOGY; AND ATHENA MUELLER, GENERAL COUNSEL, ACTION ON SMOKING AND HEALTH Mr. BRtsZ'ow. Thank you very much, Mr. Chairman and mem- bers of the subcommittee. My name is Lonnie Bristow. I am an internist from San Pablo, Calif., and I am the chairman of the Board of Trustees of the American Medical Association, and on behalf of that Association I am pleased to have this opportunity to express our views about the very real and significant adverse health effects of environmental to- bacco smoke, or ETS. Too many of our patients are ill due to ETS, and the public health aspects of protection from ETS cannot be emphasized too strongly. Exposure to ETS, which is brought about when non-

181 smokers inhale thousands of chemicals during passive smoking, may kill as many as 53,000 Americans each year. It is estimated that about 35,000 of those deaths are from heart disease, 3,000 from lung cancer, and about 12,000 from other cancers. This means that passive smoking is the third leading cause of premature death in the United States, exceeded only by direct smoking itself and al- cohol. In addition, ETS imposed upon children causes 150,000 to 300,000 cases of bronchitis and pneumonia each year, and it wors- ens asthma in up to 1 million children annually. Physicians who care for children have long been aware of the clinical evidence linking parental smoking with a variety of res- piratory diseases in children, and the EPA report released this past January concluded that: one, ETS is causally associated with lung cancer in nonsmoking adults and should be classified as a Group A carcinogen; and, two, ETS produces an increased risk of develop- ment of acute upper and lower respiratory tract problems in chil- dren exposed in the home. The AMA concurs and strongly supports the findings of the EPA. The presence of carcinogens in ETS should not be in question, nor should it be surprising to anyone that such chemicals are actu- ally abundant in ETS, which contains at times a higher concentra- tion of some carcinogens than mainstream smoke itself. The tobacco industry continues to deny any relationship exists between smoking and ill health of any kind. We disagree, Mr. Chairman. Our experience in treating the deadly results of tobacco smoke cannot be denied or ignored. Tobacco use kills over 435,000 Americans each year. Tobacco is lethal not only to individuals who use it directly but also to those who have not assumed its risks, and because the EPA report strengthens the data on adverse health consequences of smoking and broadens the hazard to in- clude the nonsmoking majority of the population, the tobacco in- dustry and its allies will continue to oppose it, as is evidenced by their recent suit against the EPA. Let me say in that regard that the AMA issued a June 23 state- ment pledging that we would file an amicus brief supporting the EPA should that case actually go to court. In that same June 23 communication, I personally challenged any member of the tobacco industry to walk with me through hos- pital wards anywhere in the country, to meet and talk to cancer victims, and to see the evidence of tobacco's deadly effect on those who are so cruelly being exploited for commercial profit, and to date I have received no reply of any kind. So let me today take this opportunity to again personally invite tobacco industry executives to contact me and to join me on such a tour. I ask them to see a few of the patients whose lives have been destroyed by cancer, to hear their personal stories, and to take the experience back with them to their boardrooms. I urge the tobacco industry executives to do this as a measure of their good faith with the American people, to do it as an expression of their interest in the future of American children, such as those you have heard a moment ago. Failure to accept this challenge again would be to .admit a callous disregard for the citizens of this Nation and for a new generation who deserves far better.

182 Let me conclude simply by saying that the public will be well served by continued education about ETS and by actions to protect it from this health hazard. Removing tobacco smoke from the envi- ronment will save lives and reduce health care costs, twin goals that the AMA and its member physicians strongly support. In this regard, the AMA has developed model State legislation to prohibit smoking in hospitals, nursing homes, public schools, and other public places. We believe that the time for action is now, and, Mr. Chairman, we support the Durbin legislation and look forward to working with the chairman on your proposed legislation. This ends my formal statement, but, if I may, I would ask your indulgence for a few moments to share a personal observation from my practice. The toughest job any physician has is to tell a patient that they have cancer, and in my practice when that experience oc- curs invariably the patient asks, "Why me? Why is this occurring in my life?" They are looking for a plausible explanation. Once they have a plausible explanation, they are able to get on with the next phase, which is how to fight that cancer, and it is important to have patient participation. When that explanation is not plausible, such as in the case of an individual who does not smoke and has lung cancer, it makes treatment that much more difficult. Mr. Chairman, people die saying, "Why me?" People who try to live healthy life styles deserve to be protected from lethal effects of environmental tobacco smoke that has been not of their creation. Thank you, Mr. Chairman. [The prepared statement of Mr. Bristow follows:]

183 STATEMENT of the American Medical Association to the HEALTH AND THE ENVIRONMENT SUBCOMMITTEE HOUSE COMbH'ITEE ON ENERGY AND COMMERCE Presented by Lonnie R. Bristow, MD RE: Adverse Health Effects of Exposure to Environmental Tobacco Smoke July 21, 1993 Mr. Chairman and Members of the Subcommittee: My name is Lonnie R. Bristow, MD, and I am an internist from San Pablo, California. I am the Chairman of the Board of Trustees of the American Medical Association (AMA). Accompanying me today is Jeffery M. Stokols of the AMA's Division of Federal Legislation. On behalf of the AMA, I am pleased to have this opportunity to express our views about the very reat and significant adverse health effects of environmental tobacco smoke (ETS), commonly known as "passive smoking." The AMA represents the physicians of this country who care for the patients at risk for disease and premature death from the effects of tobacco use. Too many of our patients are ill due to ETS. In speaking for physicians and their patients, the public health aspects of protection from ETS cannot be emphasized too strongly. The American people stand to benefit immeasurably by reducing the pervasiveness of this hazard. Exposure to ETS, brought about when nonsmokers inhale thousands of chemicals during "passive smoking," may kill as many as 53,000 Americans annually. It is estimated that about 35,000 of these

184 2 deaths are from heart disease, 3,000 from lung cancer, and about 12,000 from other cancers. This means that "passive smoking" is the third leading cause of premature death in the United States, exceeded only by direct smoking and alcohol. For example, the ETS cancer mortality alone is higher than the total cancer mortality figures from all the other environmental hazards regulated by the Environmental Protection Agency (EPA) and other government agencies, combined! These include substances such as all regulated outdoor air pollutants, asbestos, benzene, arsenic, radiation, pesticides, active and inactive hazardous wastes, all workplace chemicals, and all other consumer products. In addition, ETS imposed upon children causes 150,000 to 300,000 cases of bronchitis and pneumonia each year, and worsens asthma in up to I million children annually. The EPA document, "Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders" (EPA/600/6-90/006B), released in January of this year, addressed some of the major health effects of ETS. This report concluded that ETS: 1) is causally associated with lung cancer in nonsmoking adults and should be classified as a Group A carcinogen, with approximately 3,000 excess deaths yearly, and 2) produces an increased risk of development of acute lower-respiratory infections, middle ear effusions, asthma, and respiratory irritation in children exposed in the home. The AMA strongly concurs with the EPA findings. We believe that ETS should be classified as a human carcinogen, and strongly support the findings of the EPA. THE RISK OF LUNG CANCER AMONG NONSMOKERS DUE TO ETS At least three major reviews have been published regarding the health effects of ETS. These reports identified and analyzed many of the studies under review which served as the basis for the EPA document. The 1986 Surgeon Genetal's report, a 1986 review by the National Academy of Sciences, and a review paper published in Britain in the same year all linked ETS to respiratory illnesses in

185 3 children and to lung cancer in nonsmokers. Since those studies were published, other reports have been published that continue to affirm the carcinogenicity of ETS. The National Institute of Occupational Safety and Health (NIOSH) recently reviewed the data concerning ETS in its Current Intelligence' Bulletin #54 (June 1991) and concluded that ETS is potentially carcinogenic and that "simply eliminating tobacco use from the worlCplace" is the best method of dealing with this hazard. We concur with these findings as well, and believe that the data is clear and overwhelmingly convincing. We also believe that no threshold exists for known carcinogens. Governmental agencies such as the Food and Drug Administration and the Occupational Safety and Health Administration (OSHA) operate under these assumptions, and have acted to remove chemicals and additives which have been implicated in carcinogenesis from the food supply. The EPA, OSHA, and the Consumer Product Safety Commission have also acted in similar cases involving toxic contamination/workplace exposures involving agents such as asbestos and ethylene dibromide. Furthermore, the presence of carcinogens in ETS should not be in question, nor should it be surprising that such chemicals are abundant in ETS. Mainstream tobacco smoke contains over 4,000 identified substances, nearly four dozen of which ate carcinogenic. ETS, composed of sidestream smoke from the smoldering cigarette, exhaled mainsttsam smoke, and other components which escape from the cigarette during smoking, also contains many of these toxic and carcinogenic substances. Still other components in ETS are known to be either co-carcinogenic tumor initiators or tumor accelerants. For example, ETS contains a higher concentration of some carcinogens than mainstream smoke, including the volatile amines and the nitrosamines. In addition, ETS contains benzene, tobacco-specific nitrosamines, and radioactive decay products such as Polonium-210.

186 4 Theories of carcinogenesis generally involve repeated exposure over time to an irritant, chemical toxin, or radioactive particle leading to abnormal tissue growth that we identify as cancer. It is not surprising that ETS has been given a "Class A" carcinogenicity label, based upon what is known about the dose and time factors involved in smoke-induced carcinogenesis. Absorption of tobacco-specific smoke constituents such as nicotine and other biological markers has been measured sufficiently in ETS-exposed persons to conclude that such exposure is ubiquitous, and that the effects of the toxins in smoke do occur in nonsmokers. The histologic types of lung cancers most frequently found in ETS exposure, for example, are similar to those associated with active smoking. It bears repeating here that the EPA study estimates that about 3,000 excess lung cancer deaths per year are attributable to ETS. Mortality figures in this range clearly represent a significant public health threat that demands attention from the health and regulatory communities. RESPIRATORY DISEASE IN ETS-EXPOSED CHILDREN Physicians who care for children have long been aware of the clinical evidence linking parental smoking with a variety of respiratory diseases in children. We now teach medical students and resident physicians to inquire about exposure to cigarette smoke in cases of recurrent ear effusions, bronchitis, pneumonia, and asthma. Many studies have confumed the relationship between ETS and these illnesses in children. Exposure to ETS has been linked with increased emergency room utilization by children for respiratory complaints, increased hospitalizations due to these illnesses, more school absences, and increased health care costs for smoke-exposed children. These problems are especially troublesome in very young children and those bom prematurely or with low birthweight, many of whom may have been exposed to the toxins in tobacco in utero.

187 5 The EPA document addresses these issues and the literature concerning childhood illness due to ETS exposure. As is the case with the lung cancer section of the EPA document, there is biologic plausibility in the assumptions made and in the conclusions reached. There are demonstrable measures of allergy (increased IgE levels among smoke-exposed children) and decreased pulmonary function in the at-risk group. Middle ear disease may be mediated by decreased mucociliary function in the Eustachian tubes similar to the effect of smoke on the lungs, or perhaps the inflammatory effect of smoke constituents. Studies that implicate cigarette smoke exposure as a causal factor in asthma are clinically compelling. There is an increased utilization of medical care among smoke-exposed children and, as with the other illnesses studied, there exists a dose-response relationship. Airway hyper-reactivity, inflammatory changes in the airways, and the heightened allergic response by exposed children may all be implicated in this problem. Again, up to a million cases of asthma each year may be exacerbated by exposure to tobacco smoke, and as many as 20,000 new cases of the disease initiated annually by ETS exposure. Parents, daycare and nursery workers, physicians, teachers, and others who are in daily contact with children need to be made aware of these findings, since this very vulnerable group needs our protection most of all. Restaurants, schools, and other public places frequently visited by children should be areas targeted by the health community as well as federal, state, and local policymakers for total elimination of tobacco smoke.

188 6 PUBLIC POLICY IMPLICATIONS Finally, as advocates for patients, we must comment briefly upon what we believe are important public policy issues at stake. We believe that it is imperative that the public, physicians, employers, and public policymakers become educated about the problems posed by ETS. The costs to the nation in terms of human suffering and death are simply too great to be ignored. The EPA report and other findings about ETS will lend great support to public health officials, regulatory agencies, and medical organizations as they attempt to inform and protect the public from this threat to its health. President Clinton could help this process greatly by signing an executive order making all federal building and facilities smoke free. The public perceives risk differently when it recognizes the difference between an assumed risk and one which is imposed upon it, without the control or consent of those who may be affected. Compared to outdoor air pollutants, for example, ETS exposure has been estimated to be 100 times more serious as a cause of mortality. This is important, because a well-informed public will, in many jurisdictions, help decide how to reduce the risk of ETS. One of the principal means of eliminating the risk will be fitrther efforts to restrict where tobacco can be smoked. Ballot initiatives, strong local and state clean indoor air acts, and other measures to enhance health protection from the lethal effects of cigarette smoke exposure will be some of the methods employed as remedies to enhance public health in this matter. During last week's Major League All-Star baseball game, for instance, fans were treated to a smokefree stadium in which they and their families could enjoy the great American pastime. General public education to reduce direct smoking prevalence must also be pursued. Families with children and their physicians must clearly understand the risks of childhood exposure to ETS and act

189 7 accordingly. The EPA document and the subsequent campaign developed by the Centers for Disease Control and Prevention on passive smoke exposure should help make this risk communication message more personally meaningful. Legislators and other public policymakers will undoubtedly continue to hear from groups who profess a"scientific" interest in the validity of this issue and who will attack it on the basis of the EPA's methodology and conclusions. The tobacco industry continues to deny a relationship between smoking and ill health of any kind. We disagtse. Our experience in treating the deadly results of tobacco smoke cannot be denied. We believe that the tobacco industry fears that public awareness of the risks imposed by ETS exposure will make smoking less socially acceptable, lead to an increase in smokefree workplaces and other public venues, and will reduce its revenues as a consequence. We believe that the tobacco industry fears the continued erosion of its market in this country and as well, the impact of the EPA report on advertising, marketing, and litigation. Sentiment against the use of cartoon figures in cigarette advertisements and the findings in the Cipoolone case by the US Supreme Court have damaged the industry. Tobacco use kills over 435,000 Americans each year, tobacco is the only consumer product that kills when used as intended by the manufacturer! Tobacco is lethal, not only to individuals who use it directly, but also to those who have no assumed its risks. Because the EPA report strengthens the data on the adverse health consequences of smoking and broadens the hazard to include the nonsmoking majority of the population, the tobacco industry and its allies will continue to oppose it, as evidenced by their recent suit against the EPA. In this regard, the AMA on June 23 issued a statement supporting the EPA's findings on passive smoking. The AMA will steadfastly support the EPA in this matter, and will submit an amicus brief to the Court if the suit is heard.

190 8 In the June 23 communication, I(on behalf of the AMA) challenged any member of the tobacco industry to walk with me through hospital wards anywhere in the country, to meet and talk to cancer victims and see more evidence of tobacco's deadly effect on those who are so cruelly exploited for commercial profit. To date I have received no reply of any kind to my challenge. I again, at this time, take the opportunity to personally invite tobacco industry executives to contact me and to join me on such a tour. I ask them to see a few of the people whose lives have been destroyed by cancer, to hear their personal stories and to take the experience back with them to their board rooms. I urge the tobacco industry executives to do this as a measure of their good faith with the American people, to do it as an expression of their interest in the future of American children, 3,000 of whom succumb every day to the lure of "Old Joe Camel" and other tobacco advertising by lighting their first cigarette, and in the interest of the five million of today's children who will die of tobacco-related diseases, if this trend continues. Not to accept this challenge would be to admit a callous disregard for the citizens of this nation and for a new generation who deserves far better. CONCLUSION The AMA strongly supported the adoption of the EPA report, and we urge the continued dissemination of its findings and action based on them. The AMA believes that the public will be well served by continued education about ETS and action to protect it from this health hazard. Removing tobacco smoke from the environment will save lives and reduce health care costs-goals that the AMA and its member physicians strongly support. In this regard, the AMA has developed model state legislation to prohibit smoking in hospitals, nursing homes, and public elementary or secondary schools, as well as other public places. We believe that the time to act is now!

191 Mr. WAXMAN. Thank you very much, Dr. Bristow. Dr. Gori. STATEMENT OF GIO BA1TA GORI Mr. Golti. Mr. Chairman, members of the committee, I am Dr. Gio Gori. I am a toxicologist with training in epidemiology and a long-time interest in cancer causation and risk assessment. I am president of the International Society for Regulatory Toxicology and Pharmacology, and I am a fellow of the Academy of Toxi- cological Sciences. My resume is attached to my written statement. The Tobacco Institute asked me to express my concern as a sci- entist about the EPA's report on ETS. These views are my own and are not necessarily those of the Institute. The EPA relies on the assumption that ETS is equivalent to the smoke the smokers inhale. However, interestingly, this assertion is both asserted and denied in different chapters of the ETS report. In reality, because of extreme dilutions and environmental aging, fewer than a dozen components of ETS can be measured and their concentrations a thousand to million-fold below the corresponding levels that are permitted in the workplace by the Occupational Safety and Health Administration. The EPA report itself shows that in the course of an entire year the average nonsmoker may inhale less tar than the active smok- ing of one single cigarette. Because of these vanishing dilutions, the similarity of active smoking and ETS cannot be defined beyond vague conjectures. Among the epidemiologic studies of ETS exposure, some report a slight increase of risk. Others indicate a reduced risk or the ab- sence of risk. This is the reality of epidemiology. Sixteen studies of ETS exposures in workplaces show no combined elevation of risk; 23 studies of ETS exposures since childhood show no combined ele- vation of risk. Even the 11 studies used by EPA to calculate the combined risk of nonsmoking wives of smokers are conflicting. Moreover, as we have heard, the EPA ignored the latest studies on ETS funded by the National Institutes of Health which do not sup- port the Agency's conclusion. Many biases plague the ETS studies-publication bias whereby only positive studies are published, exposure recall bias, and oth- ers. Now studies published not by the tobacco industry but sponsored generally by the NIH show that over 5 percent of self-reported non- smokers are actually smokers. The EPA used an arbitrary 1 per- cent misclassification adjustment when even a 3 percent adjust- ment would have voided their conclusions. The Agency did not con- duct studies of its own, it simply reviewed studies performed by others. Despite results compatible with increased or decreased risk, the Agency arbitrarily decided to consider only increased risk re- ports. Also, the EPA, as we have heard, subverted acceptable statistical standards and doubled from 5 to 10 percent the margin of error it usually accepts in - determining statistical significance. The arbi- trariness of this gambit is apparent if we consider that the Agency would reject regulatory petitions based on less than the 5 percent standard.

192 Now despite much epidemiologic evidence to the contrary, EPA also discounted manifest confounders of lung cancer risk and also respiratory diseases in children, such as differences in nutrition, disease experience, physical activity, socio-economic status, occupa- tion, and others, all confounders that are more than capable of ac- counting for the small risk attributed to'ETS by the Agency. EPA, as we have heard, claims to have used the weight of evi- dence approach. However, it is plain to any dispassionate observer that it made a very selective use of the available data, emphasizing only those that support its objectives. The EPA report on ETS may be an effective policy instrument, but its claims of scientific support are misrepresented. Surely EPA thinks that tobacco control is a legitimate public health issue, but does the end ever justify the means? Should good intentions forgive an official report that otherwise would guarantee severe censure to any individual scientist or academic institution? Mr. Chairman, members of the committee, these are no trivial partisan questions in defense of the tobacco industry. They obvi- ously reach far beyond the ETS issue. Ultimately, their answer will determine the credibility of science and its continuing public sup- port, and, more important, they will determine whether civic insti- tutions deserve the public's trust. That concludes my statement, Mr. Chairman. [The prepared statement of Mr. Gori follows:]

193 STATEMENT OF GIO BATTA GORI Misber ChadmtaM I ad and GantlMW+: My naaw Is Go Gad. I am a t"doologiet with training in epddernfology and broad lntnests in smoking and ]raltb, cancer causation and risk a.eeMOSesrt, aed aver 100 sclendtic pub8ationa to my a+.dit. I am PreeWent of the Tnternatlonul9oclatr of R,agulatoey 1bxioology and PtuaaacD3ogy. in the 60'a and 70's I was Deputy Dhecbor for Cancer Causa and Prevention at the Natlonal Cancer Iretitute, whav I readved the Public Health Superlor Service Award in 1977 for separate acttvittes as Dlrecboe of ttm Smoking and Health Program. My full curriculum vitae ia appended to the written statraleata suhnMtted at tNa hlath* The'Ibbaeoo Institute asked me to explain my eoncems as a sdendst about tha report m aivironmentat tdbaaco.moica (B19) released by the Bnvirocmnental Protection Agency (ffi'A) on Tanuary 7,199& 9Etl my stabeaaeao hem+e am my own and do not :,eeesearily:e{xesern thoee of Tlw Zbbacca Institube. The EPA report Is a glaslag example of the misuse of sdrnce in euQport of prer.~oeoeived policy aima. It 9s not vniqae, but it ia pos.ibly the most egmgious example in a traditian d adantl8c abuse at EPA. In 1991, an indapend.nt blw rfton panel was aonvened by ttwi-Adaniaiatratfle Reilly to inve.ttgabe aowsatfons efjmh sclanee" at the wgency. The panel metcluded that the Agency does not have a oohrrant uirnae agenda and snffiers fim poor sdwti9a a edibility benuse it trs nat ae=-ad adaquatQ external suppoet from tbe scientific eon:unnidty at large. Moce to the point, tthe panel eoncluded that EPA's science oEban saaena to have b.w adjusted to .ndoas* paliry, an sped®lly rei.vant - I when considering ttn Agency's iepoat on ETS. 2

194 EP.Ks foraer reaearch dirirtar, Dr. Brich arotthanier, recently lamaat.d that the agency too often pays mora attentbn to medIa headlines than to scientific evidence. At ft briefing following the press release of the 8T5 sapork, Dr. Bretthauer aclaromkdged that the ffi'A. i 26 billion coet esnmate for Clean Air Act impbemantatfa+ aWy prevent fewer than 1001ung cancer caees a year, and peafiape none at all. Yisim im a typtcal exampie ae ovar-segulatk+m by EPA witbout caeaftle adernNfc snppozt. Indeed, the Agencys staff dixioeed Its predispositiat with reapecx to HT3 Iong befrne the report was evea drafted. In 1999 EPA disseminated a so called 'fact aheet" aaaerting that ETS was a known cavaa of lung cancer and other diseaaes. The tam claim was made in a 1990 draft policy guide aimcd at banning sawldng In worlcplaae& Ia ita final report itself, the agancy haa no hesitation in writing that ita analysis was based " on the Lydad hypotluaia. ..that a positive amodation exlsts between ezpoeure to E35 aad lung ossca" (1, pase 5-2). The agency and its Science Advisory Board conceded tii3t S!5 could be daasified as a Group A cardaogen only by disragarding the agency'a guidelims for aadno®en aeeeaaxnent - guidelines that are cnvfuily woeded according to 8cmly hehi scientIR principles. In a telUng atatenent the W pand reviewing ttie E'i5 risk ae1, et declared: "If the guidelines for Carcinogen Risk Aseeeement can be used to eaat daubt on a finding ttutt hit.latton of bobaceo aawke by humana causes an ine+eaeed risk of lung cancm the albutlon suggests a need to revise the gui3e13nes." (SAB repoek page 7.8)• A first reqai*rieauat of fPA's gnidetinea - and also an imtuitivety coaact oee -Ia that the wubatana considered be poritively idantlfled. Howam, what is EPA dealing 3

195 with? The report Itself is foraed moetiy to speculate about STB oOMpornnb. Only about twenty have been identi8ed with eame cordkimux as being from ETB, aithon6h most could come ham otia sources as welL Otitier components cancrat be nuestuW betauae of extreme dllutloa How could it be possible to give this Immaterial Si5 ghost a etwddng image? EPA solvea the problem by arbitrarily declaring that aTS is squivalent to the aawlae that mnoker, isdale. Never mind that the agency's 3cienoe Advisory Board admoniahed EPA's staff that the alleged equivalency of B'Y'S and dgarette ®moias could not be sc.isndAcally sustained. Never mind that the EPA report itaelf discoutts this similarity in its !fne print. Never mind that exposures to Si5 oaanponentt are tens ai tlwuaands w a million fold iesa than for cigarette amojoase, and far below the ieveis permitted inwaekpi.ces by the Qc.cupeftnat Safety and Fieaith Adairdatration. In fact, if WA were aacrec.~t It would be necessary to deeiganate as human carcinogens o®mason things such as vehide exhausts, wood and gas flres iahomes, grill and barbecue fuaw and others, simply because they beer similatltiee to coke oven emissions, which EPA already classifies as known human cardaogQns. In truft this contrived ldarnlficatian of B'i5 with active cigarette aanohe was needed to bolster the weak and is=wueive results of EI5 epidemiologic attdia. Ot 30 such atudlar from all over the wadd, ortiy dx repoetad eiVdEkant statistical associations between marriaXe to a smoker aM 2ung cancer rish, and some actaally repaebed decreased risb.llte EPA based ita riah aNeetment on 11 U5 studies, noae ehtLdcxlly sirkificaft 1b clainn atgtd8cwaoe, howw.t, EPA rasoeMd to what tHe Agasxy steff adrnowLdged waa "fattey atatistlcal footwedc'.'t!f! Pmblt invdved doublirg the 4 a I

196 statistical "corAdersce interval" fs+cnn t~s standard 9% margin uswity posted - and employed In early draRs of the HPA report - to a 10% macgtn. Nattteegf, as it by magk the results became etatistically significant Yet; what any self respecting sdeatbt would perceive here is not oonddence Intervals, but satfier a aonfldenae gama There Is more. TWo new and large US shdies pabliehed pebe to the rrlew of the 815 report would have made ** pooled result statistically ztit ®ignificard -.ven under ttw relaxed shuudards adapted by the EPA. The agency simply lgnaed tlwes studies. it also ignored that 12 out of 14 epideadologic studies of B15 In workplaces failed to detect any elevatian of lung cancer rWc. Sorne would argue tfiat statbdcal.igni8canos is open to interpretation. Stiri, In epidemiology the S% standard Is univettaIIy prescribed as a minimum rtquirament. TNe is Mecially true for epidemidogic sttuHa of pobentfal low level rieics dot hutg canom which are nobdously difRcult to oonduct and inerrpret Far iastano., etrm Is firm evidenae tt,ae difEerences In caet, physicai acNvity, disease experlency aodoeoonoasic statua, occupation, and ottw variables can influence the small reported aAsodatton between marriage to a smoker and riaic of lung cancer. One wnnot look at Si'S aloin, as the agency has dncu. 8 is as 1t police cimne upon a d3shtttanoa lavolving several people, but,urreeted only one because he'looacea• suspicious. 'lb coc8 rm ffi'A's fixation on ST3, consider only tiut the apocy disadned the epidennioiogic evidence on electco-mapetlc Be1de, even thaigh 20 of eom.40 avaiLbie studies were statistically significant and reported ciroer riaks substantially larga ttwn thoee attdbutad to EM Z'hus, BPA's claim that E'15 cau.s 30001nng pnoers a year is a political !lgnnsnt oE imagtnatlon ac4Woed by unw.rraabed aeeamptioaaT, selective aae of cYb, aeliul 5

197 procedural manipuLtians„ and th. ca*dvQd iriwicn of mat>bmWd ptEddan. On ada+nti8c grcands, a zero ezeeas of lung canoe: 4 just as tmabie - if not ma+.l.nabL - t!m EPA's a+sadors. Tlbe absurdity of SPA'a mtimatia statWs out in a reverse analysis moerda.. Indeed, if the risk that EPA attrlbtttes to 05 Is applied to amokazs, with t}Itlr Mgtfet sxposure leve]sjvirtually all tTS dgaritle acrolpna should dia vf lung cancs witlft oaie year (4). We may +miG why is the agmxy doing this7 No om eould be so naive io 1ldnk etrat the first pr.eacupa8on of the agancy ie public wdfare. Ita immediat+e , eda are expanding ti* support for an army of employees, and reiafordag tte dcuncW and political dout of Its managarent and ita many ftti9uentlal advocates. Sitm tlw agency Itself was itadmd because of public eoztoetn, it mnst loeep stoldft the Ma oEles, tha penalty being irralavanee and oblivion. We cannot forget EPA's periodic, eordy, but 8ctiarmi scares about athyiene dbwa*W, alar, dioxtii, envlronmental asbasto., aM hundreds of astasaas;ttabla cattaadaants aE afr and wabec Scientists wlto reviewed the EPA repoet dltagree privately with its cocK3usiau, evere t3iough th.y fed the n.ad to Wm in pub8c with an agency t3W inltamm much of ttn reaearch fnnds tiwy flbtain. Many ot thaat scientists have stro% tks to mi8tu~t antlam~g orgatdrstiosr. IIPA and its a..odates must balieve thatt6e end fu.dfies whntsver auara ia thw crwada against tohacoo. M who could Geel sak if audt iegalized peenimpttans were tolerated? In the end, who ai+all coz1 ei the eomltdlca't A regulatory agency does not ltilsll the public acpeclatlacu of due pcoQa.r ti it operatea under Its vwn rules cn tite basis of unwarrutted assumptions. In a;s epen Aod.ty wch anagenct eepresettta an amiaas threat te bask hudotnsand sttwid not 6 74-814 0 - 93 - 8

It, t+ C I I

I i 199 Mr. WAxmAN. Thank you very much, Dr. Gori. We are being summoned to the House Floor for the purposes of a vote, so we are going to recess so the members of the subcommit- tee can vote and get back as quickly as possible, we hope no more than 5 or 10 minutes, to hear the last testimony and then ask a few questions. So we will now recess. [Brief recess.] Mr. WAxmArr. The meeting of the subcommittee will come back to order. I would like to- now call on Ms. Mueller for her testimony. STATEMENT OF ATHENA MUELLER Ms. MUELLER. Mr. Chairman, my name is Athena Mueller. I am general counsel of Action on Smoking and Health, the organization which John Banzhaf founded over 26 years ago in order to safe- guard the rights of nonsmokers, and I actually would very much thank you for holding this hearing and also for the promise of legis- lation which is greatly needed. Because of time limitations, I shall just read the summary and ask that the rest should be put in the record. Action on Smoking and Health is grateful for this hearing as a means of informing the public of the hazard to nonsmokers of envi- ronmental tobacco smoke. For nearly 26 years, ASH has acted as the legal action arm of the nonsmoking community and its support- ers throughout the United States who are deeply concerned with the hazard of ETS and demand appropriate action to protect them. ETS must be recognized as a major hazard which causes the deaths of 53,000 Americans each year from heart disease, lung can- cer, and other cancers. Half of these deaths, 26,500, are related to exposure to ETS in the workplace. Deaths from ETS exceed deaths owed to accidents, homicides, and AIDS. ASH since 1987 has been attempting, so far without success, to K ersuade OSHA, the Agency responsible for occupational safety and ealth, to ban workplace smoking except in a separately ventilated room. This would prevent at least the 26,500 annual deaths related to exposure to ETS in the workplace. OSHA is reluctant to saves these lives although in the past it has regulated air pollutants with lower death rates and at the cost of millions of dollars to employ- ers. A smoking ban would be cost negative as management could expect many savings in insurance, sickness, janitorial, and produc- tivity costs if smoking were abolished. In the absence of regulation and in cases where State or local legislation or corporate policies afford nonsmokers no protection, legal action may be taken. In the past, sensitive nonsmokers have been successful under Workers' Compensation, discrimination, and other laws, including the Federal Rehabilitation Act of 1973 in the case of the handicapped employees of Federal agencies, Federal contractors, and recipients of Federal funds. The Americans with Disabilities Act has extended the protection against disability discrimination to employees in the private sector, State, and local services, entities controlling private accommoda- 'tions and transportation. Sensitiive nonsmokers are already availing themselves of proceedings under the ADA.

200 As regards future developments, a recent decision, to which you, Mr. Chairman, referred, in the United States by the Supreme Court, has held that action may be taken by a nonsmoker to pre- vent the development of future illness caused by exposure to ETS. This is a decision which could be of assistance to healthy non- smokers who wish for protection from ETS before they are made ill. In finishing, I would just like to read two quotations from dif- ferent purposes. The first is, I think, to indicate how very much your legislation is going to be needed. Mr. Charles Adkins, OSHA's director of health standards, has been quoted as saying in the July 1993 issue of Occupational Hazards, "Doing nothing about work- place smoking is still one of our options, but it is not a very viable one. We will have to do something, but it is certainly not going to be quick or easy." 1VIr. Adkins envisages a 3-to 5-year delay in making a rule to reg- ulate workplace smoking or 5 to 8 years when other, less important air pollutants are included. Since, under the most favorable time- table, it will take OSHA 3 years to prepare a regulation, requiring employers to post a "No Smoking" sign, it is clear that victims and potential victims of ETS will have to look to other means to protect their health and lives. Finally, in contrast with that and also, I think, it had a bearing which one of the members of the committee said earlier, as to how much exposure to ETS is safe, ETS endangers many lives, and no exposure is safe. As a former chairman of the board of ASH, the late Dr. Charles F. Tate, an eminent authority on cardio-pul- monary disease, used to say a- cancer begins with a mutation of a single cell. No one should be exposed to that threat because of the unnecessary presence in public places or workplaces of a Group A carcinogen such as ETS. Thank you. I would be glad to answer questions. [Testimony resumes on p. 220.] [The prepared statement of Ms. Mueller follows:]

201 mFemrMONY OF ATHENA MUELLER GENERAL COUNSEL OF BCTION ON SMOKING AND HEALTH (ASH) My name is Athena Mueller and I am General Counsel of Action on Smokina and Health (ASH) the organization founded by John F. Banzhaf III nearly 26 years ago to protect the rights of the nonsmoking majority. I- INTEREST OF ASH IN HEARING ON ETS ` ASH is a national, charitable, non-profit, tax-exempt, legal- action, educational and scientific organization entirely supported by tax-deductible contributions, devoted solely to the problems of smoking and the rights of nonsmokers. Most of its 70,000 supporters are "involuntary smokers," i.e., people who do not voluntarily smoke but are forced against their will to inhale tobacco smoke in the workplace and in other public places. Many of these people also have asthma, hay fever, sinusitis, allergies, and other conditions which make them especially susceptible to the adverse health effects of ambient tobacco smoke. Many have children with asthma or other sensitivity to environmental smoke (ETS). ASH and/or its Executive Director and Chief Counsel, John F. Banzhaf III, have frequently been successful in taking legal action on problems related to smoking. Thus, for example, as a result of the decision in Banzhaf v. F.C.C., 405 F.2d 1082 (D.C. Cir. 1968), radio and television stations were forced to make hundreds of ~ millions of dollars worth of free time available for anti-smoking messages, and eventually drove cigarette commercials off the air. e ASH action in Capital Broadc stinc Co. v. Mitchell, 333 F. Supp. 582 (3-judge, D.D.C. 1971), aff'd 405 U.S. 1000 (1972) successfully defended the constitutionality of the law banning cigarette

202 -2 - commercials. ASH started the nonsmokers' rights movement by requesting no-smoking sections on airplanes, and sued the former CAB when it made smoking regulations which violated Federal Law. ($69 v. 9$$ 699 F.2d 1209 (D.C. Cir. 1983)). ASH also participated, as amious curiae, in Dunagin v. Citv of Oxford. Miss., 718 F.2d 738 (5th Cir. 1983) which held that advertising for products which can be banned can also be banned. ASH has been involved or assisted in various legal actions or procedures brought by nonsmokers to protect their rights or to obtain redress for injury to their health. II ETS IS A MAJOR ENVIRONMENTAL HA2ARD The expert testimony of the learned medical and scientific organizations which has been presented is no surprise to ASH. As long ago as 1986, the Surgeon General and National Research Council stated that ETS is a cause of lung cancer in nonsmokers, and in 1991 NIOSH found that ETS is "a potential workplace carcinogen" and that the exposure of nonsmokers should "be reduced to the lowest feasible concentration." The recent EPA Report is in accord with earlier reports and studies. The death toll from exposure to ETS has been estimated at 53,000 annually. As shown on the attached chart (marked "E 1") this exceeds deaths from auto accidents, homicides and AIDS. A breakdown of these 53,000 deaths from heart disease (37,000), lung cancer (3,700) and other cancers (12,000) and a citation of the studies which support these figures is shown in Exhibit "E 2" attached. This breakdown does not, of course, include the thousands of cases of illness and disability caused by

203 -S - t t these diseases even when they do not prove fatal. Of the 53,000 deaths each year from ETS, half (26,500) represent deaths resulting from workplace exposure. The identification of a grave public health hazard is only the first step in dealing with it. Measures to abate the hazard should be taken without delay. Any sense of urgency appears, however, to be lacking in the occupational Safety and Health Administration (OSHA) which ASH has been trying to persuade (since 1987) to regulate ETS in the workplace. Yet, by OSHA's own calculations, 75 million nonsmoking Americans are exposed at work, every day, to ETS starting, in countless individuals, the process of illness and death with dire consequences to society and the nation's economic health. Mr. Charles Adkins, OSHA's director of Health Standards has been quoted as saying in the July 1993 issue of "Occupational Hazards" (see exhibit marked "E 3") "Doing nothing about workplace smoking is still one of our options, but it's not a very viable one --- we will have to do something, but it's certainly not going to be quick or easy." Mr. Adkins envisages a three to five year delay in making a rule to regulate workplace smoking, or five to eight years if other less-important air pollutants are included. Since under the most favorable time table, it will take OSHA three years to prepare a regulation requiring employers to post a "no-smoking" sign it is clear that victims and potential victims of ETS will have to look to other means to protect their health and lives. In passing it may, however, be noted that OSHA has regulated other

workplace air contaminants responsible for far fewer deaths than the 26,500 workplace related ETS victims each year. Such regulations, moreover, cost employers millions of dollars to implement (see "E 4") whereas banning smoking (except in a separately ventilated smoking room) would (for the cost of a no smoking sign) actually save employers thousands of dollars per worker in health costs, insurance, janitorial costs, etc.

205 _{ 1 t III LEGAL ACTIdN AS A MEANS OF ENt~ING EXP9SURE TU ETS if prompt protection cannot be expected from federal regulation, and where no state or local legislation or corporate policy affords protection, nonsmokers (and, in particular, sensitive nonsmokers) must use legal action as a means of saving their health and lives. The courts have already recognized the right to protection from ETS exposure in a variety of legal proceedings, under several legal theories including common law, negligence, workers' compensation, unemployment insurance, and discrimination against nonsmokers (see cases cited in "E5"). In addition, the passing of the Americans with Disabilities Act (ADA) (42 USC Secs. 12101 et seq) completes a federal system for the protection of the disabled among whom must be included the 30 to 40 million Americans (AMA estimate) who suffer a serious sensitivity to ETS. The ADA (which protects disabled persons' in private employment, private accommodations, State and local government services and transportation) complements the Rehabilitation Act of 1973 (29 USC 794) (RA) which requires reasonable accommodation for the handicaps of federal employees, and the employees of federal contractors or others in receipt of federal funds. The terms "disabled" used in the ADA and "handicapped" used in the RA were described by the Congressional (House) Committee concerned as "comparable". The Committee explained that: The use of the term "disability" instead of "handicap" and the term "individual with a disability" instead of "individual with handicaps" represents an effort by the

206 Committee to make use of up-to-date, currently accepted terminology. In regard to this legislation, as well as in other contexts, the Congress has been apprised of the fact that to many individuals with disabilities the terminology applied to them is a very significant and sensitive issue. The decision by Congress to equate these two terms is, however, of great importance to sensitive nonsmokers because the decisions of courts and administrative tribunals which protected nonsmokers by application of the RA are thereby made available as precedents for similar protection under the ADA. Both statutes prohibit discrimination against handicapped or disabled persons and provide that employers must furnish reasonable accommodation unless it would cause undue hardship to the enterprise to do so. Numerous courts and administrative tribunals have now recognized that an individual with asthma, cardiac or pulmonary disease or other sensitivity to ETS suffers a substantial impairment which limits such major life activities as breathing and working. To such persons, a barrier of ETS in a public place or workplace serves to deny access to service or work no less than absence of a ramp would bar access to an individual in a wheel chair. Among examples of RA cases which are precedents for the ADA are -- -- Parodi v Merit Systems Protection Board 690 F2d 731 (9th Cir. 1982) in which the U.S. Court of Appeals for the 9th Judicial Circuit held that a sensitive Federal Government employee who suffered from exposure to tobacco smoke in the workplace, was entitled to disability benefits unless the Government could show

207 - 7- that an appropriate substitute position was available; as no appropriate position was available, the case was settled on the basis of the employee receiving a disability retirement pension plus a$50,000 lump sum payment; -- Vickers v Veterans Administration 548 F. Supp. 85 (1982) where a federal District Court held that a federal government employee whose hypersensitivity to tobacco smoke limited his capacity to work in any environment which was not completely smoke-free was a "handicapped person" for the purpose of the R.A., but that his employer, had, in fact made reasonable accommodation; and -- Flaniken v Office of Personnel Manaaement. U.S. Merit Systems Protection Board, Dallas Field Office. No. DA831L10001, (1980) when the MSPB found that a sensitive federal government employee was entitled to a disability retirement annuity where she had contracted chronic laryngitis caused by cigarette smoke and environmental pollution. ASH is at present assisting a number of sensitive nonsmokers with disability complaints and actions under the ADA where violations range from the exclusion of sensitive nonsmokers from restaurants because of the presence of ETS to the exposure to ETS of a child with asthma (with resulting damage to health) at local government educational facilities. Also, it is sad to say, legal action is sometimes required to protect children from ETS even in home surroundings. The increasingly large body of expert evidence on the harmful effects of tobacco smoke on children has caused the presence of ETS in the home to emerge as a custody issue especially where the child or

208 -t - children concerned has a serious sensitivity to tobacco smoke. One family court (Nassau County, NY) has stated that the health risk posed by second hand smoke in the home is a factor that "must be considered, as would alcohol consumption for example, when viewing the suitability of a household environment in which a child is to be placed" (See "E6"). These divorce and custody suits provide another example of the way in which legal action may be used to protect individuals from exposure to ETS. IV POSSIBLE FUTURE USE OF LEGAL ACTION TO PROTECT HEALTHY NONSMOKERS FROM EXPOSLR?? TO ETS Hitherto, it may be noted, the law has generally come to the assistance of nonsmokers only when their health is already impaired, whether as a result of exposure to ETS or otherwise. This has led to the unfortunate situation that an individual has to become disabled before protection is available -- a dismal prospect for the (so far!) healthy nonsmoker. The recent decision of the U.S. Supreme Court in Hellina v McKinnev (decided June 18, 1993; 61 LW 4648) (See "E7") may, however, indicate the court's awareness of the problem when it held that it was not improper for the Court of Appeals to decide whether a prisoner's claim could be based on possible future effects of exposure to ETS in the state penitentiary. This decision may, in future, be assistance to healthy nonsmokers who want to terminate their exposure to ETS before it ruins their health. V CONCLUSION In conclusion it may be stressed that ETS endangers many lives, and no exposure is safe. As a former Chairman of the Board of ASH the late Dr. Charles F. Tate (an eminent authority on cardio-pulmonary disease) used to say "A cancer begins with the mutation of a single cell". No one should be exposed to that threat because of the unnecessary presence in public places or workplaces of a Group A carcinogen such as ETS. *W10 t.P ~J'~ © -k !

209 BREAKDOWN OF ANNUAL DEATHS FROM VARIOUS CAUSES Although active smoking, which claims 434,000 victims each year, is the largest preventable cause of death, passive smoking (exposure to ETS) claims 53,000 lives, more than auto accidents, homicides or the highly publicized deaths from iIIegal drugs or AYQS. Details of the breakdown are shown below: Annual Deaths, Various Causes Active Smokingi 434,000 Alcoholic Beverages2 105,000 Passive Smokin~ 53,000 Auto Accidents 43,500 Homicides5 24,020 AIDS6 22,334 Fires? 4,200 Radon, to nonsmokers° 4,000 Cocaine & Crack9 2,483 Heroin & Morphine10 1,976 I U.S. Centers for Disease Control, 1988; Z U.S. Centers for Disease Control 1987; 3 U.S. Surgeon General, 1992; 4 Nat'l Safety Council, 1991; S U.S. Senate Judiciary Comm. Rpt., 1991; 6 U.S. Centers for Disease Control, 1991; 7 Nat'l Safety Council, 1991; ° Repace, Risk Analy., V.10, No. 1, 1990, 27; q Nat'l inst. on Drug Abuse, 1990; 10 Nat'l Inst. on Drug Abuse, 1990

210 BREAKDOWN OF ANNUAL DEATHS FROM PASSIVE SM9KING AND CITATION OF SOME SUPPORTING STUDIES "An estimated 53,000 Americans die each year from exposure to tobacco smoke of others." Dr. Antonia C. Novello, U.S. Su=geon General. 1. Breakdown of annual deaths from cassive smokina leu»osure to ETS1 Heart Disease .................... 37,000 Lung Cancer ....................... 3,700 Other Cancers .................... 12,000 Total ............................ 53,000 Source: Glantz, et al., Passive Smoking and Heart Disease, Circulation, 1991t83:1:i-12: see also Wells, An estimate of adult mortality in the U.S. from passive smoking, Envir Int 1990;2:638. 2. ~=FT.C~3~~ti~F7t= RKin4 EPS to heart d Studies linking ETS to heart disease include the following: Butler, The relationship of passive smoking to various health outcomes among Seventh-Day Adventists in California, Seventh World Conference on Tobacco and Health 1990; 316. Garland, et al., Effects of Passive Smoking on Ischemic Heart Disease Mortality of Nonsmokers, am J Epidemiol 1985; 121;645-650. Gillis, et al., The Effect of Environmental Tobacco Smoke in Two Urban Communities in the West of Scotland, Euro J. Resp Dis 1984; 65(suppl. 133):121-126. HE, Women's passive smoking and coronary heart disease, Chung-Hua- Yu-Fang-I-Hsueh-Tsa-Chin 1989; 23:19.22. Helsing, et al., Heart Disease Mortality in Nonsmokers Living with Smokers, Am J Epidemiol 1988; 127,915-922. Hole, et al, Passive Smoking and cardiorespiratory health in a general population in the west of Scotland, Br Med J. 1989;299i423- 427. Humble, Passive smoking and twenty year cardiovascular disease

mortality among nonsmoking wives in Evans County, Georgia, Am J Public Health 1990; 80:599-601. Lee, et al., Relationship of Passive Smoking to Risk of Lung Cancer and Other Smoking-Associated Diseases, Br J of Cancer 1986t54,97- 105. Hirayama, T., Lung Cancer in Japan: Effects of Nutrition and Passive Smoking in Lung Cancer; Causes and Prevention, M. Mizell, et al., eds., pp 175-195, Verlag Chemie Int'l, New York, 1984. Martin, M.J. Increased Incidence of Heart Attacks in Nonsmoking Women Married to Smokers. Paper presented at annual meeting of American Public Health Association, 1986. Steedland, K. Passive Smoking and the risk of heart disease, JAMA (1992) 267:94-99. Swendsen, et al., Effects of passive smoking the multiple risk factor intervention trial, Am J Epidemiol 1987; 126-783-795 3. Epidemiological studies linking ETS to lung cancer. Ambient tobacco smoke contains more than 40 chemicals known to cause cancer. (1) It has been shown in many studies to cause lung cancer in nonsmokers (2), a conclusion which has been accepted by numerous scientific and medical bodies (3) based upon overwhelming evidence (4) provided by the epidemiological studies cited below: (1) Surgeon General's Report, 1989 at 85: "By the criteria for carcinogenicity of chemicals as set by the International Agency for Research on Cancer, 1986, the carcinogens identified to date in tobacco smoke include 11 PAHs (polynuclear aromatic hydrocarbons), 4 N-hererocyclic hydrocarbons, 9 N-nitrosamine, 3 aromatic amines, 3 aldehydes, 6 volatile carcinogens, 6 inorganic compounds, and the radioelement polonium-210." (2) Akiba et al., Passive Smoking and Lung Cancer Among Japanese Women. Cancer Research 46(9):4804-4807, Sept. 1986. Brownson, et al., Risk Factors in Adenocarcinoma of the Lung, Am J Epidemiol 125(l):25-34, Jan. 1987. Chan, et al., Lung Cancer in Nonsmokers in Hong Kong. In: Grundmann, E. Clemmesen, J. Muir, (eds). Geographical Pathology in Cancer Epidemiology, Cancer Campaign, Vol 6, New York Gustav Fisher Verlag, 1982, 199-202; Correa et al., Passive Smoking and Lung Cancer. Lancet 2 (8350) :595- 597 Sept. 1983. Dalager, et al, The Relation of Passive Smoking to Lung Cancer, 2

212 . Cancer Research 46(9):4808-4811, Sept 1986. Gao, et al., Lung Cancer Among Chinese. Women. Int'1 J of Cancer 40(5):604-609, Nov. 1987. Garfinkel, L., Time Trends in Lung Cancer Mortality Among Nonsmokers and a Note on Passive Smoking, J of the Nat'1 Cancer Inst 66(6):1061-1066, 1981: Garfinkel, et al., Involuntary Smoking and Lung Cancer: A Case- Control Study. J of the Nat'1 Cancer Inst 75(3):463-469, Sept. 1985. Gillis, et al., The Effect of Environmental Tobacco Smoke in Two Urban Communities in the West of Scotland, Euro. J of Resp. Dis. 65(Suppl. 133):121-126, 1984. Hirayama, T., Cancer Mortality in Nonsmoking Women With Smoking Husbands Based on a Large-Scale Cohort Study in Japan, Prev. Med. 13(6):680-690, Nov. 1984. Humble, et al., Marriage to a,S=oker and Lung Cancer Risk. Am J of Public Health 77(5):598-602, May 1987. Kabat, et al., Lung Cancer in Nonsmokers, Cancer 53(5):1214-1221, March 1, 1984. Koo, et al., Is Passive Smoking an Added Risk Factor for Lung Cancer in Chinese Women? J of Experimental and Clinical Cancer Research 3(3):277-283, July-Sept. 1984. Lee, et al., Relationship of Passive Smoking to Risk of Lung Cancer and Other Smoking-Associated Diseases. Br J of Cancer 54(1):97-105, July 1986. Pershagen, et al., Passive Smoking and Lung Cancer in Swedish Women. Am J Epidemiol. 125(1):17-24, Jan. 1987. Trichopoulos, et al., Lung Cancer and Passive Smoking: Conclusion of Greek Study. (letter). Lancet 2(8351):677-678 Sep. 1983; Wu, et al., Smoking and Other Risk Factors in Lung Cancer for Women, J or the Nat'l Cancer Inst. 74(4):747-751, April 1985. (3) The conclusion that ambient tobacco smoke causes lung cancer has been accepted by numerous scientific and medical bodies including the American Cancer Society, American Heart Association, American Lung Association, American Medical Association, American Public Health Association, Consumers' Union, National Academy of Sciences, U.S. Public Health Service, and the World Health Organization (WHO). 3

i 213 (4) "In examining a low-dose exposure to a known carcinogen, it is rare to have such an abundance of evidence on which to make a judgment, and given this abundance of evidence, a clear judgment can now be made: exposure to (Environmental Tobacco Smoke) is a cause of lung cancer." Surgeon General's Report of 1986 at 10. 4. Enidemioloaical studies linking ETS to other cancers. A number of studies, cited below, indicate that ETS exposure can cause other cancers in nonsmokers, just as tobacco use does in smokers. Slattery, et al., Cigarette Smoking and Exposure to Passive Smoke are Risk Factors in Cervical Cancer, JAMA, Vol 261(11), 1593-1598, Mar. 1989. Hirayama, T., Cancer Mortality in Nonsmoking Women With Smoking Husbands Based on a Large-Scale Cohort Study in Japan, Prev. Med. 13(6):680-690, Nov. 1984. Gillis, et al., The Effect of Environmental Tobacco Smoke in Two Urban Communities in the West of Scotland, Eur. J Resp. Dis. 65(Suppl. 133):121-126, 1984. Reynolds, et al, Passive Smoking and Cancer Incidence: Prospective Evidence from the Alameda County Study. Paper presented at the Society for Epidemiologic Research, Amherst, Mass., June 1987. Miller, G.H. Cancer, Passive Smoking and Non-employed and Employed Wives, West J Ned 140, 632-635, 1984. Sandler, et al., Passive Smoking in Adulthood and Cancer Risk, Am. J Epidemiol. 121,37-48, 1985. 4

214 (EJ3 WILL OSHA BAR THE DOOR To WORKPLACE SMOKING? Though most employers already have smoking policies, recent reports on the dangers of secondhand smoke have put enormous pressure on OSHA to snuff out workplace smoking. By Gregg LaBar• . ;. ou get the impression that if OSHA offiaals had their way, ey would rather not devote Yth their liauted resources to a controver- sial societal issue such as smokeng. They don't have much of a choice, how- ever, geven the environment of legisla- tion, lawsuits, and employer and em- ployee concerns about the adverse health effects of smoking. 'Doing nothing about workplace smoking is still one of our options, but it's not a very viable one,' admits Charles Adkins, OSHA's director of health standards programs. ' We will have to do something, but it's certainly not going to be quick or easy.' Adk'uu said OSHA is considering two standards-setting approaches designed to protect nonsmokers from exposure to passive tobacco smoke at work: The agency will either develop a smoking- speafichealth standard, or it will try to address workplace smoking as part of a broad-based generic rulemaking on in- door air quality (IAQ). An official an- nouncement could come as earl y as this month in response to a lawsuit by Ac- tion on Smoking and Health (ASH), a Washington,D.C, antismoking group. An OSHA spokesman said the re- view of options has been very careful because smoking is a highly emotional issue and because if OSHA tackles smoking on its own, presumably there will be no action on IAQ. He said the at- traction of developing a smoking-only standard is that, despite all of the ac- companying emotion and politics, it could still be completed faster (in three to five years) than an IAQ rule (which would take five to eight years). At press time, it appeared the agency was leaning toward the more inclusive IAQ approach-a decision that would please labor unions and tobacco manufao- tunss but infuriate publichealth activists. Employers, at least 85 percent of whom al- luly 1993/Occupational Harards 27

215 COMPARISON OF BENEFITS AND COSTS FOR REGULATION OF ETS COMPARED WITH EXISTING AND PROPOSED OSHA STANDARDS TO REDUCE WORKPLACE HAZARDS By oSHA's own estimate, 75 million nonsmoking workers are exposed to ETS in the workplace, and many of these must be included among the 53,000 nonsmokers who die each year as a result exposure to ETS. According to the earlier-cited study by Repace "50% of the average population risk from passive of and Lowrey, smoking is estimated to be workplace related." This would indicate an annual death rate of 26,500 for nonsmokers exposed to ETS in the workplace. The benefits and costs of ETS control in the workplace may be demonstrated by comparison with existing and proposed OSHA Standards. Proposed ETS Standard Standard Benefit ETS Workplace To save at least Negative. The Standard (to protect 26,500 lives expense of 75 million workers) annually. "nonsmoking" signs Workdays lost not would be more than available but offset by the probably exceed economic savings those shown below of a smoke-free workplace

I 216 Examoles of Current OSHA Standards Standard Benefit Cost 1. Regulation to To save about 200 $823.8 million protect workers from lives annually and (about $4 million AIDS, hepatitis, etc. about 10,000 a life) (to protect 4.7 infections million health care workers) 2. Hazardous Waste To save at least About $154 million operations and 32 lives and per year Emergency Response 18,700 lost Standard (29 CFR § workday injuries 1910.120) Requires annually use of existing technology 3. The Excavations To save 74 lives, About $306 million Standard (29 CFR 1926 and over 800 lost per year Subpart P) Requires workday injuries use of existing annually technology and recognized safety practices 4. Grain Handling To save 18 lives Between $5.9 Facilities Standard and 394 injuries million and $33.4 (29 CFR 1910.272) annually million Simple housekeeping measures 5. Process Safety To save 330 lives $888.7 million Management Standard and 1977 injuries annually for first (29 CFR 1910.119) annually. five years; $470.8 Planning, work million annually practice and training in following five to reduce risk of years fire and explosion 6. Permit Required To save 54 lives $202.4 million per Confined Spaces (29 and 5,041 lost year CFR 1910) Permit workday accidents system for entry into and 5,908 non-lost confined spaces workday accidents 2 'PO&

"o s» 9 8; &@ pCr ° S 6 S .. . . . R"'RR" ~ ~ ps 8 ~e ~~~~~b~b~8 Ii:I ~c ~~9 r~~~.8 °~,~' ~t~ o g ~ 3 ti o ~ ~ A Fr p . tip .7 2 e o p A o^'~~.~ °n>~~~u9R5 ,~~• os ! p o8 "a ~a~~ 00 3f ya ^! ~, p a r'~(}^ ^°^E~ ~~~ F•° ^ 2'.'e Sp• >9(} ^ e~+~ Iy S.6 - o"~.~-°^~ 5'~ ~ 5 aEC B~.~ ~o~ o. (~ Q ~ +i `7 ~ P. a ~ a4 F -O .7 F, o D' O p ~. p n O ~ Li a s ° k.~ E&°p~yag~ "kodtbbbQo R Fr o~ _p,~a~ ~~ z'^p_p6x~c^g 1 $ iyB..F k: Lt y. ~, PP-- 2S ~_ R•o C. s.p.. C ~' S T 6 a r Gi p. p 4 11[ CR O S~' ~J t! y~ pppp A- ~;E:~' ~~~!,~7!'T~~~~ ~S~F0.l~MC~itil1• P F ~~ a~ ~H ~~ ~ } ~•. 4 s ~ € ,~ t R ~~y~Fx/. ( PF~ ~Y=yS 'p !';eII tFq ~lp~~~S,5,~k1"4~ ~z~~!. s~pi='~q~ ~~X.~~f7~~? ~`=E•7'f+Y~(~~kN0.FF~6~EC 4l40Um©g

218 sy ~` SPECIAL REPORT ON INVOLUNTARY SMOKING 71151-1]5. . Er.". E e aL (In5) d yvau5 -.Sa.d w -ks..aP.ae,r m......aa.,o. ov MfUitt . FEti6. t.G n il. (INS) ENsv d p..w aar4q u idY d,iaJro. E..v: NoU I>q,c. atn925f. . NASSE+e• V d nn1) Wa a..s...J •- . d Iu.aSr .~ m a. drlia Aa.. 1... aTr. ni. IDO9.at9. . RA VFFMANN. F. a.l. n9.n AY P.+-k" . J.1a.e n.,mmm,: a nh Lm 5. d,: ,'rUe. 6ms A.. 1. E+du~ol. 117].Htl. • aZNiNFi. M n d OSU) T1e r6,®n d pa... mF.c v pla.avr frera a asdr d t151 dfic. w4a.v Pm. M.1 uf5Lt9. . IO.EnmAt1M. n.G, a il. (19u) E-a---~--- svrti lds- C.A tdaem. la..w. Fui°-- - • SPbOOfrL. MD. (9N) i1- d(av d rm.ml ,abvr _d. ~. .r r„ .m m a.ar a..` m. .w, . aW.x ud .~..Y.aa (a.dis. Ev. J. R.4r, Dig. v5:5R595. . IFDOVnZ. MD a J. (ln.) 0.sar.a,vr .Wd ,. -k,.s e.w d r,.ar s~n. a.. f9y95o . sQmrIIiC a3F a+I. (19)f) L~ Ars,a ,q.rasr d'.er. ar ~u[ ~ 4mJw. Aa. I EF~~ SOiva]t5. . TM3A U. il. (19)9) F15aa d pvmul ariave a.ak~ a A. 9.Imdvr I.avo- d aWlaru. Aa. l. tpLd. umsu . rACM i!. e d (19n) t<q<.a,aa .af9 d de dlav d a..n..I mdu.r a. palsavr M1.nic. :.L7A,.. N, E.a 1• Md 70l.inJUS, . TA4n(al. nP. e d Ox.) 71a UC]a ppui.uw ndw d sruc d- .apraa.r &-. VB. R.Smirp b.,..as Sav.ol -b.. a./ &a&- •, Ia.E S.a Aa.. aa., Rapr. Dia lIfJ95tn. . v[DAt. a.E . d(59M) Ruk 4m, (¢r .18i®d n.pe,rr .ee. Aa 54. Aapr. Aa 1)p I n.5n. ..Allr. Jx a d. O9u) ra.,. Aw. w-.a ,.d ,.,F....r YakY d ddi.. Y..t ia a rm. A.. Ra.. R.'.. nu Izk5ic3)4. ..Fls, S.r. n.t onq Fa,.m -6ac ,. ,des• .,.q.asr i9.a•, awaa. a.aWy. a.d S..d d pirrr R.mu.a Feq.Mes a..p4 d ddtra Aa. A... Ryn. tl.. n2in.im. nvtnti /ll. a.L (t911/ S.an ...m+r+~o...rota+~.~+Ef ava.d e ~~ rY..N E.aJ. )4L7G17A~3..O+CONNOa. G.7. rt.L nn>1 TSe dn d ra.w a.eia.t- Sa.®,- ud s... r..r+..~. d d ddi- ad 9.r~ aih As An. ll.yc. D:. nSd07q. • trJO~frG S~D. a d. Qx/) 5<.pedfnl s.ir d ~d.a~r Soa. iwlqs i di8sei dd.az., u/ .Ar .iiY.1 Aa 4c Ilqn. oi n4fJ5. lm(OYGN6, Qv. s J. O9V) R.i,ma a. ria.r L.®a.1 La..ii.*~q d m¢ um.d.tY pa~w ...6.g : a.-p .uaa.a. r.E.;. .x.u.x LAOFFt1ANN. F. a d(In911 Fa.rTd Geva,d.d a. 4, ca.Er. . d3r- att Ho 9.R r. S,a 8. rAASc TWW4•_dr. Aal. F¢d-d. nT.IDHMf. • atAN. [Y. <d (1515Y) t.W4am . d'ud~ d le. Wd.~4 Anl IN. d1. N9i14t395. . nr1CARA. L a A(Inq aqie~er 1.YY ia d J. :4> ...rat diia As 1... A.*ar. •Da N1:ISn.51)1.. sItAQSAN. nP.a.l. nnA 71.rtlsrYir d.li..r das- A.. 4.. aq:c Pc aq:10.151. . MA17niEZ. FD. a at Q!R) Iaa.W :oi.u d aab... siii. d arFiq aafas. ralr.inQltit en r..ua. WA..,a....re,. ~ 711s1L L a d p5fq 7fe Nas•.i} d a.ad a.~ pad 4ar.. ~Sr. a.rt.ud e.r :.4.ar.4 Ma AancJ.9k51tS•ttn . NALYE R1 a d Qni) s.Y.:hrt d.6 •r~+~~. . r.. ,e a.*. Aa.. J. na dL. ncum•ma . avatAN. At a d.1197q a.Yia•iwd rda.asSWlffY..IL7AL N.. d Qn9) sd1. if [ 66 p.ia•a .idt iaua Oi hAir. Qf.ia lt~OHU. . YA[IAY.YH aatp)q 7L a.aoma. da..aeW arti.t .:Y.M ar ta d'.L. a1.d. A..1. ErL.+t taKSS. a5nrlYAN. HJ...1. (ISp) RaLe..Srsmfk tni•d de Nada.l L.~. d d.tdllrY! r11ir. D.wiqa.as Sm5 f.yea.. E'ia•apd sr1r. Ar. N.Y. Ad. td. sn:wa . NAC.73ian. w a r. os91)) Gws. -Ies. • nak baa. a.V..4.sY v.i~ , Pe..V+..+ .dr. An. J. hiii H.Y n19-02. ..QitJmL EA. a d. Q9511 Ra.V La ia 6s: 9ar d i. N~ Z.W/ oa. 4rY dr. N.2 M1 J. t04M The courts protect children from ETS Even prior to the release of the EPA Report, courts in Illinois, Louisiana, Michigan, Missouri, New York, Penn- sylvania, Tennessee, and Texas have all considered the harmful effects of sec- ondhand tobacco smoke on children. With new evidence about the extent of the dangers now available in an official government report, several trends al- ready underway are likely to accelente. ETS AS CUSTODY ISSUE With the change from 'fauli to 'no- fault' divorce laws, judges no longer are able to simply apply mechanical rules and award custody to the party found not to be at fault. Similarly, the movement towards sexual equality means that judges can no longer assume that a mother is always a better care provider than a father, and fathers are increasingly seeking custody. Therefore, more judges are facing situations in which two parents, both apparently equally qualified and with- out any'black marks' such as problems with illegal drugs or alcohol, are each seeking custody. In such cases, the danger of exposing the child to ETS is more likely to be a factor in making the determination. Several courts have now ruled that it is a relevant factor which may be raised by the parties and considered. At least one court has gone further, stating that the health risk posed by secondhand smoke in the home was a factor that 'must be considered, as would alcohol consumption for exam- ple, when viewing the suitability of a household environment in which a child is to be placed' Satalino v. Satalino, No. 11440-86, Nassau County, NY 10/10/90. COURT ORDERS In addition to denying or limiting visitation rights based upon the concern about ETS, judges are also growing increasingly willing to issue court or- ders prohibiting exposing the child to tobacco smoke. This is true even where a statme does not authorize the 'The controversy over whether smokers damage the health of peo- ple they live with has found its way into child custody cases - and that's bad news for smokers.' Marcus, 'Parent's Smoking Be- comes Issue in Child Custody Cases,' Wall Street Journal, 10/18/90 'Parents who smoke in front of their children may get burned in child custody and visitation dis- putes.' Dumas, 'Smoking Could Become Custody Battle Weapon,' laroyns WK.Efy, 6/24/91 'The Trial Judge found t}ut the failure of the mother and gtand- mother to discontinue smoking when recommended by the rltild's physician was strong eviden« of a lack of proper concern for the wel- fare of the child. A belated cessa- tion of smoking might evidence a desire for the custody of the child rather than concern for the welfare of the child• M'rtchell v. Mkchell, 1991 WL 63674 (Tenn.App., 1991). issuance of such ordets. See Roofeh v. Roofeb, 525 N.Y.S.2d 765 (Nassau Cry, 1988). LOSS OF CUSTODY In extreme cases, custody may be lost over the issue of smoking. In 1989 in Denton, MD, a judge placed a three- yearold girl with severe asthma in a foster home when her parents contin- ued to smoke around her. In the Mitchell case noted above, custody was denied to a mother who had previously smoked in the presence of her child, even though she bad subse- quently stopped. For assistance in raising these issues in legal proceedings, please have your lawyer contact ASH's attorneys. This i. a epaid 's.e of the ASN S.iaq wd NrGi Reua. (ISSN 1CN6907X7/. Copytithmd by Aaion on Smoking and Hdth (ASH), 2013 H St. NW. w>5b., DC 2000f, (202) i594)10. ASH is a utiood aapmftt, racanwpt oq.oiraioo oance55ad .ith the pmbl®a of Saoit* aad SLe tSghn of soo9makac ASH u.uitdy appond by Sad.6stible mot,iMniooa, and equLr mxribamn >ed.e the A4i Re9ua Prieood poniom of de dSN Rei. ,ary be rcprimed vith cadit to ASH.

219 61 LW 4698 The United States LAW WEEK 6-15- SaUiuaa, 500 U. S. (1991) (O'CoNNOR, J., dissenting). WILLIAM BENTLEY BALL. Hsrrisburg, Pa. (BALL-SKELLY, MURREN & CONNELL, THOMAS J. BERNING, and SOUTH- ERN ARIZONA LEGAL AID INC.. on the briefs) fot pctitioners; WILLIAM C. BRYSON. Acting Solidtor Gencral (STUART M. GERSON. Asst. Atty. Gen.. JOHN G. ROBERTS JR., Dpty. Sol. Gen., RONALD 1. MANN. AsatM to Sol, Gen., JEFFREY C. MAR- TIN, Dept. of Edueation Gen. Counsel, and SUSAN CRAIG, Asst. Gen. Counsel, on the briefs) for US. u amicus curfae supporting petitionetr JOHN C. RICHARDSON. Tuacn, Ariz. (GARY F. URMAN. and DECONCINI MCDONALD BRAMMER YETW W & LACY P.C., on the briefs) for respondent. No. 91-1958 DONALD L. HELLING, ET AL., PETITIONERS u. WILLIAM McKINNEY ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT Syllabus No. 91-195g. Argued January 13, 1993--Decid.d June 18, 1993 Respondent MeKinney. a Nevada state pnsoner, filed ouit ag.inat petitioner pnson ofBnals, elaiming that Ius Involuntary exposure to environmenW tubaeeo smoke (ETS) from his ceilmate's and other inmates' dgaretGs posed an unreasonable ruk to hts health, thus subjecting him to erud and unusual pemshment in vndatton of the Eighth Amendment. A federal magtstrate granted petitionen' motton for a direeted verdiet, bet the Court of Appeals reversed in part, holding that MeKinney should have been permitt.d to prave that his E7S eapoaure was suf6dsnt to catutituM an unresaonable danger to his funtr, health. It redRrm.d ita deddun after this Court r.mutded for further consideration in light of wi4w v. S.ire, 501 U. S. _, In whiah the Court held that Eighth Amendment elaime arising fmm eonfinement eonditiona not formally impo.ad as • sentence for a enme requirm proof of a sobj.etive aompnnent, and that whare the daum alleges mhemane confinsment <ondtiona or failure to attend to a pnseneri medical ne.ds, the standard for that state of mmd is the •deliber.te indiR rene: standard of Esr.Be v. Ga,nb4. 429 U. S. 97. 't7te Court of Appuls held that Sdts"s subj.ctive component did not vitiate that eoart's d.termination that it would be eru,i and unusual punishment to haeaa a pnsnner in m environment exposing him to ETS levels that pose an unreasonable risk of harmmg his health--the objecttve eomponent of Mrltinmy9 elanm. Hefd: 1. It wu net improper for the Court of Appuls to decide the qu.suon whether MeKf nn.y i<latm cauld be based on possible future eRecu of ETS. From ita ex.minatian of the record, the eourt wr appanntly of the view that the daimed entitlemmt to a~oke-ft.. .nvtranment subsum.d the cium that E"f5 expason eould endang.r onek futun, not just eurrent- health. 2 By alleging that petition.rs have, with dehbsrate inefitferenee. upond hio to ETS levels that pw an unrersnnahle risk to hb future health. McRinney has stated an Eighth Amendment elaim on whieh relid could be grsntd. An iryunenon rannot be deni.d to inmates who piainly prove an unsf., BfMlu.abning mndition on the ground that nothing yet has happan.d to them. Sa. Hrtm v. F1nnry, 437 U. S. 678, 631 '(Lua, pebtienses' antral thews that only deliberate ipdi6mna to tmnates' eumnt serious hnlth prcblems is actionable xt rej.A.d Sinee the Court raunet at this iunetun nsle that MeSinney cannot possibly prove an Eighth Amendm.nt violation based on E1S espo.urs, it dso would be prsmsture to bue a raverpi m th. F.deral Gav.rnmentL argament that the harm from ETB upau» u ap.eulatiw, with no ndt euffieiently gnw to tmpliute a serious medical need, and that the expmmrs, is not eantnty te eurrent standards of denn<y. On remand, the Distriet Court must give MeKinney the opportanity to ptow his allegationa, whieh will e.qmn tLat he establish both ths subjeets.e end ebjectiv. elements n.ee..ary to prove an Eighth Mnendment vfolanon. VAth respect to the objective factor, he may have di/0eany, sshowing that he is being e:posed to unr.asonably high ETS l.vals, sinre he has baen movd ta a nw prison and no longer h." a e.llmat. who ctok.a, and smee a new state prvan poliq re.enets wnoldng to antain areas and makes reaaonable elfmt. to t.apeet ewrttakwJ wiahr with regard to doobie banking. He muat dw 11ww that the risk sf which he complains ts not one that todayi wdety dwe.e. ta telerace. 71,e -.ublective fscteq deliberate tndsfferenn, should be det.rmtned in light of the prison authorities' cur'rant attrtudes and conduet, wh,ch, evtdeneed by the new Bmokmg polt<y, may have ehang,ed considerably nnee the Court of Appuli judgment. 'Rro lnqutry into this factor alsn would be an appropnate vehiele to eonn_der argumenta regarding the reahun af pnwn admini.tration. 959 F.2d 853, alRnn.d and nmanded. WHITE, J., dehvered the opinion of the Court, in whtch REHHVUI:7. C. J., and But•KStuH, SfevFJ+s, O'CoNnotL KPHNEnY, and SnulEft, JJ., jotned. THOttAS. J., filed a dissenting optnton, in which St•.u.u, J., Jmned. JUSTICE WHITE delivered the opiaion of the Court. This case requires us to detide whether the health risk posed by involuntary exposure of a prison inmate to environmental tobacco smoke (ETS) can form the basis of a claim for relief under the Eighth Amendment. I Respondent is serving a sentence of imprisonment in the Nevada prison system. At the time that this case arose, respondent was an inmate in the Nevada State Prison in Caraon City. Nevada. Respondent filed a pro se dvil rights complaint in United States District Court under Rev. Stat. § 1979, 42 U. S. C. ¢ 1983, naming as defend- ants the director of the prison, the warden, the associate warden, a unit counselor, and the manager of the prison store. The complaint, dated December 18, 1986, alleged that respondent was assigned to a cell with another inmate who smoked five packs of dgarettes a day. App. 6. The complaint also stated that cigarettes were sold to inmates without properly informing of the health hazards a nonamohing inmate would encounter by gharing a room with an inmate who smoked, Id., at 7-8, and that certain cigarettes burned continuously, releaaing some type of chemical, Id., at 9. Respondent complained of certain health problems allegedly caused by exposure to dgarette smoke. Respondent sought injunctive relief and damages for, inter alfa, subjecting him tu cruel and unusual punishment by jeopardizing his health. Id., at 14. The parties consented to a jury ttial before a magis- trate. The magistrate viewed respondeat's suit as present- ing two istues of law: (1) whether respondent had a constitutional right to be housed in a smoke-free environ- meat, and (2) whether defendants were deliberately indifferent to respondent's serious meaical aeeds. App. to Pet. for Cert. I2-D3. The magistrate, after citing applica- ble authority, concluded that respondent bad no constitu- tional right to be b-ee from cigarette smoke: while "society may be moving toward an opinion u to the propriety of non-smoking and a smoke-free en.iraoameat,' society cannot yet completely agree "on the resolution of theae issues." Id., at D3, D6. The magistrate found that respondent nonetheless could state a daim for deliberate indifference to serious medical needs if he could prove the underlying facts, but held that respondent had failed to present evidence showing either medical problems that were traceable to dgarette smoke or deGberate indifference to them. Id., at D6-D10. The magistrate therefore granted petitioners' motion for a directed verdict and granted judgment for the defendanta. Id., at D10. The Court of Appeals affirmed the magistrate's grant of a directed verdict on the issue of deliberate indifference to respondent's immediate medical symptoms, Mdfutne9 v. Anderson, 924 F. 2d 1500, 1512 (CA9 1991). The Court of Appeals also held that the defendants were immune from liability for damages since there was at the time no clearly established law imposing liability for eioosing

220 Mr. WAxiMAx. I want to thank you very much, each of you, for your testimony today. I indicated at the beginning of this hearing that I plan to be in- troducing legislation that would prohibit involuntary exposure to tobacco smoke in all buildings accessible to the public including commercial, public, and school buildings. I would just like to ask each of you whether you think that is a good idea and would gen- erally support such legislation. Ms. Mueller. Ms. MUELLER. I think I have already indicated it would have 100 percent support from ASH. Mr. WAXMAN. Dr. Bristow. Mr. BRIsTOw. I think it is a marvelous idea, Congressman. I think its time has certainly come. Mr. WAXMAN. Dr. Gori. Mr. Goxi. Mr. Chairman, I am not here to object to the policy, I am here to object to the justification of the policy on existing science. Mr. WAxMAv. OK. I have no further questions. I want to thank you very much for your testimony. I think it has been very helpful to us as we make this record from today's hearing. Thank you very much. Mr. Synar, did you want to ask questions? Mr. SYNAR. I have one real quick one. Dr. Gori, do you recall being a witness in the FTC v. Brown and Williamson, the American subsidiary of American Tobacco? Mr. GoFtI. Yes, I do. Mr. SYNAR. This was a 1983 District Court case. Do you recall the financial relationship between Brown and Williamson and your research facility? Mr. GoRi. Yes, I do. Mr. SYNAR. When you were asked under cross examination how much money Brown and Williamson gave you in return for your testimony, you revealed in that case that they had contributed $3 million in research fundini to your place of research, the Franklin Institute. Was that correct. Mr. Go2tt. I believe that was correct. It was not money given to me, it was given for the research of the Franklin Institute, yes. Mr. SntAx. All right. Could you answer for the record how much money the tobacco industry has donated to the research facilities since then? Do you have information for the record? Mr. GoR.i. I haven't the faintest idea. Mr. SYNAR. Could you provide that for the record? Mr. GoRi. To which facilities? Mr. SYNAR. To the facilities that you are associated with. Mr. GORi. At that time, I was associated with the Franklin Insti- tute. Mr. SYNAR. Right. Mr. Goxi. I have left the Franklin Institute since 1988, Mr. Synar. Mr. SYNAx. What about all the ones that you are with presently? What about the Health Policy Center? Mr. GORr. The Health Policy Center? Mr. SYrrAR. Yes.

221 Mr. GoRi. I am in a general consulting practice. I get some money out of the Tobacco Institute. Mr. SYrrAx. Could you provide for the record how much that is? Mr. GoRi. How much that is? Mr. SYNAR. Yes. Mr. GoRi. I don't know that that is necessary. Mr. SYNAR. Will you provide that for the record? Mr. GoRi. I will have to look into the matter, yes. Mr. SYNAR. Will you provide that for the record? Mr. GoRi. I will have to consult with counsel before I can give you that answer, Mr. Synar. Mr. SYNAR. Mr. Chairman, I would request we could get that in- formation. Who are your clients at the Health Policy Center, Doctor? Mr. GoRi. A variety of companies-food companies, chemical companies- Mr. SYNAR. Could you provide a list of your clients? Mr. GORI. Sure. I can, yes. Mr. SYNAR. And would you also provide where you get all your funds for operating? Mr. GoRI. Mine is not a nonprofit organization, Mr. Synar, so I don't know that I have to provide you with that information. Mr. SYNAR. Well, we would request it. Are you telling us you don't want to provide it? Mr. GoRi. No, I'm not telling you. I am telling you that I will have to consult with counsel before I provide you with that infor- mation. Mr. SYNAR. OK. Well, we would request that, and if you don't. provide it then we may want to come back and ask you other ques- tions. Mr. GoRi. Of course. Mr. SYNAR. Thank you. Mr. GoRi. I would hope that, if you ask me that question, you would also ask all the other people that have appeared here where their funds are coming from. Mr. SnvAx. I have no problem with that. If the Chair would like to make that same request of all of them, it would be great. Mr. GoRi. It would be only fair. Mr. SYNAR. Absolutely. I have no problem with that whatsoever. Mr. WAxmArt. We appreciate your testimony, and if there are fur- ther questions from members of the subcommittee we will submit them to you in writing and would appreciate a response for the record. That concludes our hearing for today. We stand adjourned. [Whereupon, at 12:55 p.m., the subcommittee was adjourned.] [The following statements were submitted for the record:] ~ 0-i

222 BUILDING OWNERS AND MANAGERS ASSOCIATION (BOMA) INTEItNATIONAL Second-hand smoke in the workplace 's a growing concern for building owners and managers across the country. 'Ihe Building Owners and Managers Association (BOMA) International appreciates the opportunity to submit comments to the subcommittee. Americans spend the majority of their day indoors, and building owners and managers have a responsibility to their tenants to provide and maintain healthy indoor air. A healthy indoor environment is a marketplace concern, important in attracting and retaining tenants. Increased media and legislative attention, however, has caused this to become a higher profik issue in recent years. Reliable information is needed to address this situation effectively and responsibly. BOMA members have long pushed for research on the sources o>; and contributors to, indoor air quality problems - and we are adamant about the need for good guidance. BOMA International has worked with industry groups and government agencies in developing our efforts on indoor air quality. We have also implemented a strong campaign to distribute sound guidance to improve the indoor air quality management programs in the commercial property community. In cooperation with the EPA and our local associations around the country, we have held a nationwide series of over 50 seminars based on the EPA manual Building Air Qualitv. The Environmental Protection Agency's classification of second-hand smoke as a"Class A" carcinogen further emphasizes the responsibility of building management to protect the health of office building tenants, their employees, and their guests and clients who may be expcued to this known carcinogen. Second-hand smoke has long been considered a severe nuisance to non-smokers, and has been a suspected health hazard for some time as well. EPA's confirmation of tobacco smoke as a known carcinogen merely corroborates what we have suspected for some time. This finding also makes it imperative that building owners and managers take steps to protect their tenants from this indoor air health hazard. Indoor air quality problems may be prevented through a combination of management practices - - maintaining the filtration and ventilation systems, bringing in adequate outside air, and controlling the contaminant sources. In buildings that do not have separate ventilation systems for designated smoking areas, second-hand smoke is distributed into non-smoking areas of the building, endangering the well-being of non-smokers. Most office buildings do not have separately ventilated smoking areas. BOMA firmly believes that the most effective course of action is to reve contaminants from being introduced into the workplace in the first place. Second-hand smoke is one of the leading contributors to indoor air pollution, and banning smoking in the workplace would significantly improve the quality of the air we breathe.

i Ri In January, BOMA Internatioaal's Board of Governors unanimously passed a resolution to support a federal ban on smoking in the workplaoe, We see this resolution as a responsible and pragmatic step forward. In conclusion, second-hand smoloe is one of the primary contributors to indoor pollution and a serious health ha7ard. Building owners and managers have a responsibility to their tenants to protect their indoor enviroamdtt. BOMA International will continue to educate building owners, managers, and tenants on the health tism and recommend that the federal government implement a smoking ban in the .uockplaoe. . . . Foanded in 1907, the Bmldies Owners and Managers Association (BOMA) International is a dynamic federation of 96 local asrodatioos .vlwae members own or manage over 7 billion square feet of commercial properties and faa7ities in North America. 1be nxmbet:hip - comprised of building orwners, managers, developas, leasing ptofessionals, facility managets, asset managets and the providers of aoods ann stivices - collectively represents all facets of the commercial real estate industry. BOMA is Brmly established as the respected resource on national matters affecting the industry, such as the Americans with Disabilities Act (ADA), Indoor Air Quality (IAQ), the phase.out of difaco8uorocarbons (CFCs), passive loss rules, and more.

Virginia Group to Alleviate Smoking in Public, Inc. GASPR P.O. Box 38134 Richmond, Virginia 23231 804-795-2006 '._ to know that even one liJe has breathed easier because you have ftved -this ts to have srrcaeeded" RW. Fme,am STATEMENT BY: Anne Morrow Donley, Executive Director Virginia Group to Alleviate Smoking in Public, Inc., for U.S. Congressional Hearings, Wednesday, July 21, 1993. "NONSMOKERS, AND OTHER TOBACCO VICTIMS, pause in your rage against injustice and feel sorry for the poor little rich tobacco executives. After years of knowingly creating a dangerous product, which used as intended will kill about one out of every three of its consumers, and murder 53,000 bystanders each year in the U.S.A. alone, the tobacco industry faces actual government regulation of where the toxic polluting product may NOT be used - around people who dare to breathe in public. Imaeine. tobacco may have to be treated like other addictive But a wealthy industry with no scruples never gives up in the fight against truth and health. These flat-earth society types managed to stack the EPA Science Advisory Board with several people who have strong ties to tobacco, they even offered million dollar grants to board members, but the board still came out nailing secondhand smoke as a killer and Group A carcinogen. Now tobacco's bullies are again reverting to strong-atm tactics: (1) harassing the Environmental Protection Agency at taxoaver expense, and intimidating scientists along the way, (2) fi ting confirmation of President Clinton's choice for Sureeon General, and (3) increasing economic blackmail on businesses. [See attachments of Philip Morris letter to businesses, and partial list of economic blackmail.] "Therefore, the tobacco executives - many of whom do not smoke or spit their own products - have filed a frivolous lawsuit forcing the government to use tax 1 to defend science and truth. Tobacco's two faithful water boys, Charlie Rose and Tom Bliley, are working with tax dollars to try to subvert truth Congressionally. Bliley has held several meetings reminiscent of Joe McCarthy, questioning the EPA staff on their writing, typing, researching the report on secondhand smoke. Rose has now convened a Congressional hearing (tax $5S) to investigate the scientific procedures used in making the report Rose's staff is quick to maintain that Rose has been wanting to call this hearing ever since the report was publicly released in January, and the timing has nothing to do with the confirmation hearings for Surgeon General or tobacco's lawsuit against the EPA. Rose's staff has said that if Rose is not satisfied with the answers he gets, there will be a series of hearings. Why is the EPA forced to testify when all of this C under litroetinn7 The tobacco industry is only satisfied with one thing - profit at any cost. regardless of who navs. When will the people have a hearing to investigate tobacco influence on public policy? "It's time this country had a Congressional hearing and investigation for the pgople by ~r the people and of tr ' the fu•m that's wasting taxpayer money to keep smoke rape and harassment legal In s country. Nothing in the U.S. Constitution guarantees even legal drug pushers the right to force everyone to breathe the deadly byproducts against their will. Secondhand smoke is invasive, life• threatening, and unpopular. The tobacco industry is the only gr,oup demanding Public srnoking, "Secondhand smoke is the third leading cause of preventable death in this country, killing 53,000 Americans EACH year of secondhand smoko related illnesses, but it's still le to smoke inside government buildings, schools, around children, and in the workplace. An executive order, and acts of Congress could make REAL drug-free zones in schools and elsewhere. "There is public behavior and private behavior. Smoking should be done only in private, among consenting adults. Smoking has no place in schools, the workplace, nursing homes, bowling alleys, testautants, skating rinks, stadiums, airports, transportation, government buildings, in any place that people are accessing. Real health reform begins with require, dd and enforced NO SMOKING in all of these places. "The smoker may have the legal choice to drug, but no smoker should have the legal right to hurt another person. "Without any scientific studies, the Nose Knows that secondhand smoke hurts. The studies reveal that secondhand smoke is a killer. The EPA Report is only one in a series of reports (National Academy of Sciences, Surgeon General, National Institute of Occupational Safety and Health, etc.] of the dangers of secondhand smoke to the healthy nonsmoker - including children. "Tobacco may be number one on some lists, but it still smells like number two ".

Virginia Group to Alleviate Smoking in Public, Inc. GASPR P.O. Box 38134 Richmond, Virginia 23231 804-795-2006 - to k110W /IW/ alYl1 olq I(rt /IGi EIE/" MfLr Ifq1lm yOt LN n)" - fI1Zf If /I M/N JrCON11L" RW. FAQfOU 1993 TOBACCO INTIMIDATION OF SCIENTISTS AND BUSINESSES NATIONWiDE: Ford Motor Company: The Tobacco Institute called for a nationwide boycott of Ford when it instituted no-smoking regulations. Republican Women for Choice in Washington, D.C.: $10,000 from the tobacco industry preceded cancellation of a speech by a Virginia respiratory therapist on women, tobacco, and health. Despite tobacco industry offers of funding and other ties to several members of the EPA's Science Advisory Board, including a $1.2 million grant offered while the EPA Report on secondhand smoke was in the works, the Board voted unanimously that ETS is a Group A carcinogen. Congressmen Charlie Rose (N.C.) and Thomas Bliley (VA), have actively opposed the report issued by the EPA on secondhand tobacco smoke. Their ties to the tobacco industry and loyalty to that drug industry are well known. NORTH CAROLINA: Philip Morris gave $50,000 to a children's museum, Discovery Place, Charlotte, N.C., in 1991 provided that smoking would be permitted in the meeting room where both children and adults may gather. Similar gifts have been made to Virginia schools and colleges which are not yet smoke-free. VIRGINIA• C & P Telephone Company: On March 7, 1986 Philip Morris ran an ad in the RicJnnond News Leader criticizing C & P Telephone Co. for regulations on workplace smoking. C & P later went smoke-free. The union sued, but C & P won. Hechingers: In 1990 they went smoke- free, and Philip Morris instituted a boycott of Virginia's Hechingers stores. Hechingers stayed smoke-free, but later left Virginia. Little Caesars Pizza: In 1990 they went smoke-free in the Richmond area; tobacco pressure was felt from employees and from other food companies owned by that tobacco company. Little Caesars remained smoke-free. Arby's Fast Food Restaurant: In 1990 they went smoke-free in Richmond and faced tobacco pressure to permit smoking, e.g., individuals ordered large amounts of food and then.refused to pay for it. Notices were apparently posted on Philip Morris bulletin boards regarding Arby's policy. Arbys stayed smoke-free, and business has been increasing. Life of Virginia Insurance Company: They were not smoke-free until a tobacco executive was no longer on the board. Many insurance companies are reluctant to be on panels discussing smoke-free policies since Philip Morris moves its insurance account about every three years from one company to another. Richmond International Airport Commission: Philip Morris has had a spot on the board, and the airport continues to have customers and employees complain about the smoking. . Ukrops Grocery Stores: These religious & community oriented stores refuse to open on Sundays or sell alcoholic beverages but do sell tobacco products and refuse to be smoke- free. Philip Morris targeted Ukrops in a newsletter sent out to more than 10,000 people regarding No Smoking signs in the stores. Ukrops managers have told the press the most frequent customer suggestion is to be smoke- free, but they are "loyal" to their Philip Morris customers. In Roanoke, 1992, a country music center opened with a big Marlboro ad behind the mike, smoking permitted everywhere, and news reports said fans would probably help nonsmokers. A"water bar", however, is to be provided for non-drinkers. Before the Virginia Indoor Clean Air Act, the Virginia Employment Commission responded to employee requests for restrictions on smoking by formulating a policy which they first sent to Philip Morris for approval. The policy only demanded No Smoking where it was a fue hazard. PM approved. Rather than declare the workplace smoke-free, Virginia State Tax Commissioner W. Forst used tax dollars to purcltace a "gas mask" for employee Suzanne Bennett who had developed bronchitis from the smoke in her workplace. After she filed a worker's compensation case, another employee filed a grievance, and GASP paid several visits to various officials, more No-Smoking areas were developed on December 1, 1992, but the workplace is not yet smoke-free, and the worker's comp. case not yet settled.