Tobacco Documents Online

ORIGINAL UNITED STATES ENVIRONMENTAL PROTECTION AGENCY SCIENCE ADVISORY BOARD INDOOR AIR QUALITY AND TOTAL HUMAN EXPOSURE COMMITTEE - - - - - - - - - - - - - - - - - - -X In the matter of: . ENVIRONMENTAL TOBACCO . VOLUME I SMOKE REVIEW PANEL : ---X Tuesday, July 21, 1992 Main Ballroom Holiday Inn 4610 North Fairfax Drive Arlington, Virginia 22203 The ENVIRONMENTAL TOBACCO SMOKE REVIEW PANEL MEETING of the Indoor Air Quality and Total Human Exposure Committee of the Science Advisory Board was convened, pursuant to notice, at 9:15 a.m. APPEARANCES: MEMBERS: DR. MORTON LIPPMANN, Chairman DR. JAN A. J. STOLWIJK, Vice Chairman DR. JOAN DAISEY DR. VICTOR G. LATIES DR. PAUL LIOY DR. JONATHAN M. SAMET DR. JE'ROME J. WESOLOWSKI CONSULTANTS: DR. DELBERT EATOUGH DR. S. KATHERINE HAMMOND DR. GEOFFR9Y KABAT DR. MICHAEL D. LEBOWITZ DR. HOWARD ROCKETTE DR. SCOTT'T. WEISS ) o4nxEtican cR~o~u 2~e I202i 296-0261 "i/-4 17031644-7636 4

APPEARANCES: (Cont.) SCIENCE ADVISORY BOARD STAFF: MR. A. ROBERT FLAAK MS. CAROLYN OSBORNE EPA STAFF: DR. DON BARNES DR. JENNIFER JINOT DR. FARLAND • DR. STEVEN BAYARD OTHER APPEARANCES: DR. FERNANDO MARTINEZ DR. KENNETH BROWN DR. JUDSON WELLS SPEAKERS: DR. PAUL SWITZER DR. MAXWELL LAYARD DR. PETER LEE DR. STEPHEN SEARS DR. GIO GORI DR. JOHN TODHUNTER DR. PHILIP WITORSCH DR. GARY GIOVINO DR. JOHN BANZHAF DR. ELIZABETH FONTHAM DR. RON DAVIS DR. CLARK HEATH DR. JEFE WAGENER DR. MICHAEL OGDEN o~{me~.Ecan eRe~ioa.tezs ZC 1ZoZi Z96-OZ6, e1/"q 17031644-7636 1-2

1-3 C O N T E N T S PAGE Welcome and Opening a 5 Overview, Introductions and Disclosure 11 Overview of Draft Document Presentation by Dr. Farland 30 Presentation by Dr. Steven Bayard 38 Committee Review of Appendices A - E Appendix A - Reviews of Epidemiological Studies on ETS and Lung Cancer 46 Appendix B - Method for Correcting Relative Risk for Smoker Misclassification 53 Appendix C - Review format for case-control studies 71 Appendix D - Lung cancer mortality rates attributable to spousal ETS in individual epidemiologic studies 75 Appendix E - Statistical Formulae 77 Committee Review of Chapters 4, 5 and 7 80 Chapter 4 - Hazard Identification I: Lung cancer In active smokers, long-term animal bioassays, and genotoxicity studies 81 Chapter 5 - Hazard Identification II: Interpretation of epidemiologic studies on ETS and lung cancer 92 Chapter 7 - Passive smoking and respiratory disorders other than cancer 109 Public Comment Period 145 Presentation by: 146 Dr. Paul Switzer, Tobacco Institute Ln Dr. Stephen Sears, R.J. Reynolds Ln 185 Dr. Maxwell Layard, Tobacco Institute ,`,°, 158 m I-A OD P~112EZCCR/2//112EZCCR/2 <=REliOZtE4s. N 2~e /ZOZ1 Z96-OZ6, Nc4 /7031 644-7636

1-4 CONTENTS: (Cont.) PAGE Dr. John Todhunter, Tobacco Institute 214 Dr. Gio Gori, Tobacco Institute 203 Dr. Philip Witorsch, Tobacco Institute 226 Dr. Peter Lee, Tobacco Institute 168 Dr. John Banzhaf, Action on Smoking OR Health 242 Dr. Ron Davis, Coalition on Smoking OR Health 269 Dr. Clark Heath, Coalition on Smoking OR Health 278 Dr. Jeff Wagener, Coalition on Smoking OR Health 283 Dr. Gary Giovino, CDC 238 Dr. Elizabeth Fontham, Speaking on own Behalf 255 W OTriLE'ZGCQ/2 GRE#o'LtEti 2$c tZOZ1 Z96-0Zbl eUrIq t7031 644-7636

1-5 1 2 3 4 5 6 8 9 10 11 12 13 14 19 20 21 22 23 P R O C E E D I N G S (9:15 a.m.) MR. FLAAK: I'd like to welcome everybody here today and we're going to start our meeting now. Dr. Lippmann will be starting off the meeting in just a moment. WELCOME AND OPENING THE MEETING DR. LIPPMANN: On behalf of the Indoor Air Quality and Total Human Exposure Committee of the Science Advisory Board, I welcome you to this review of the EPA risk assessment document entitled Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders. Bob is with us this year. Last year he might have used his broken shoulder to avoid another assignment. He Pa r4; 4.t-f2. left us to d3ss#pate in the Desert Storm exercise, and Sam Rondberg of the SAB staff filled in ably for him. This year, however, it's up to Bob to help us pull together our deliberations and get out this Committee's report on the review of the document in good order. I hope he doesn't use his bad right arm as an excuse for any delay in getting this done, but I'm sure he won't. This, as I indicated in my opening remark, is a second meeting on a document of this title, or a similar title. We had a meeting previously in which we looked at a N OD A* cn2E2CCR/2 GJ`E#o%EEZS. ZC /zozf z96-o26Y q~vq 0031644-7636

1-6 1 2 3 4 5 6 7 8 9 10 11 12 13 14 19 20 21 22 23 first draft, gave our comments and suggestions for improvement. The Agency decided that it was sufficient grounds to do a major rewrite, which they've done. They've made a very serious attempt to address the concerns we identified and have come back with a document that clarifies their position on the state of the science in lung cancer amongst spouses in relation to ETS exposure, and perhaps have done considerably more writing concerning the relationships between ETS and respiratory effects in children, something that we had specifically asked them to do. So this Committee, largely the same committee that participated in the previousf4rround, will be offering comments and suggestions on the adequacy of this current draft for the purpose of the risk assessment. We're fortunate that Dr. Scott Weiss, who was a corresponding member last time, unable to be with us then, is here today to be a full participant. We have added Dr. Paul Lioy to the panel. He's just coming in now, so this is his first time as a reviewer on this issue. Two people who were present the last time had schedule conflicts and could not be with us this time. Dr. Blot and Dr. Benowitz regret that they will not be physically o4inEZF.can :~Re#ozfeas ZC 12021 296-o26, ~V04 /7031 644-7636

1-7 ) 1 2 3 4 5 6 8 9 10 11 12 13 14 19 20 21 22 23 here, but they have provided us with extensive written commentary and in the appropriate places I will read some of their commentary so that we can benefit from that. Two of our members are not here today: Dr. Larson, a recently appointed member,to the Committee; and Dr. Woods, who was a participant last time, are today participating in a review'of the engineering lab's work on indoor air. There was an unfortunate overlapping of interest, and some of our engineering members of this panel are also members ad hoc of the engineering committee's panel on research on indoor air issues. I, myself, spent yesterday with the engineering panel, along with Drs. Larson and Woods, but I needed to be here today and left our participation in that panel's work in the capable hands of Woods and Larson for today. That work will be finished today and they will participate with us tomorrow in the review. And the fact that we're discussing the chapters out of order has something to do that. Their primary review assignments will be covered tomorrow. I will turn the position of speaker for the moment over, first, to Don Barnes, the Staff Director for the EPA Science Advisory Board, and then to Bob Flaak, the Designated Federal Officer for this particular Committee. Don? <vqinEZIcan -.-=-Re#o%EEas 25C /zoz/ zqb-oz6i q'6q /703/ 644-7636

t ) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 1-8 DR. BARNES: Again, on behalf of the EPA and the Administrator, I'd like to welcome everyone to this review. I'd like to say just a few words putting this review in context. , First of all, I know that some of you in the back are having difficulty hearing. Just as it is in church, there are plenty of seats up here in the front pews, if you'd like to come forward before the collection, we'd be more than glad to have you. Please don't wait for the first hymn, just please come forward. The Science Advisory Board was established by Congress in 1978. The purpose of that particular legislation was to make sure that EPA had some outside review of the technical documents that supported EPA regulations. So we always like to say that our rruare on the Science Advisory Board is to provide critical review of the technical underpinnings of EPA's positions. Our role is.not to comment on those positions themselves -- that is the risk management or policy positions which are built upon their technical underpinnings -- but to look at the technical basis for that material. It is then up to the risk managers, it is up to the administrators, it is up to the EPA officials to go ahead and then structure the ,V7I72EZCCQI2 G!`E/2o'LtEY, 25C I202l 296-02b, q'04 [7031644-7636 Ln ~ cn W N OD 1i

1-9 1 2 3 4 5 6 8 9 10 11 12 13 14 19 20 21 22 23 policy on top of that. So our purpose here today is not to examine what EPA is going to do about environmental tobacco smoke. our purpose here today is to look at the analysis that they have conducted upon which they will then build that policy. The Science Advisory Board is used to doing these sorts of reviews. As I say, we've been doing that for about a decade and a half now. The total Science Advisory Board consists of about 80 members. All of these are people who are outside of EPA. They're all outside of the-Federal Government. They are scientists and engineers from across the country drawn from academic institutions, groups that are affiliated with industry, people who have affiliations with environmental groups. Our only concern is we have people who are technically qualified to review these issues. Also, we conduct our operations under the Federal Advisory Committee Act, and that Act explicitly says that the panels we put together should be balanced, balanced in terms of range of technically viable ranges of technical opinion on the issues before us. What you see before us today is one of 10 committees into which those 80 members are divided. We want to refer to the Environmental Engineering Committee which is cqmEZfcan IrRE#ozteu. 1~. C /zozf z96-oz6r 4~ 17031 644-7636

I-10 2 4 10 11 12 13 14 15 16 17 18 19 20 21 22 23 meeting today in Research Triangle Park. This is the Indoor Air Total Human Exposure Committee which is meeting here today. There are eight other committees which meet on a periodic basis throughout the year. Various committees of the Board meet roughly between 50 and 60 times a year. So, roughly, once a week someplace there is Science Advisory Board meeting, if not in your neighborhood, at least somewhere. During the year; these 50 to 60 meetings result in somewhere in the order of 30 and 40 reports. All of these reports are available to the public. I should mention that all of the meetings are open to the public, as is this one. This particular Committee, as I've mentioned, is the Indoor Air Quality and Total Human Exposure Committee. It has been supplemented, in addition to the members of the Committee, by people that we have drawn in for this particular review who have special expertise in this issue before us; that is, environmental tobacco smoke. These people are serving as consultants to the Board, so not everyone is here as a member, but they are all technically qualified to serve with us on this issue. In closing, let me just say a word about the anticipated schedule of.what happens from this point on. For dgm.EZf.can eRe#o%fets1 l~e t202J 296-OZ6, 'U-4 /7031644-7636