Tobacco Documents Online

ICF International Square, 1850 K Street, Northwest, Washington, D.C. 20006 (202) 862-1100 February 6, 1986 Dr. Sheldon C. Sommers The Council for Tobacco Research -- U.S.A., Inc. 900 Third Avenue (Fourth Floor) New York, New York 10022 Dear Charlie: Enclosed are the various handouts and materials from the Public Meeting on Passive Smoking at the National Academy of Sciences on January 29, 1986. As you may be aware, public meetings such as this one are often held to provide additional information to a committee that is studying an issue. The information flow is one-way in these cases, that is, the committee members ask questions of those making presentations but do not answer any questions. Thus, the information presented at this meeting reflects the interests of the speakers and their desire to inform lot influence) the committee. No attempts were made by the committee to direct or select the types or numbers of presentations. There were seven presentations by academicians representing the Indoor Air Pollution Advisory Group, which is, as ~ understand it, a group funded by The Tobacco Institute. The first speaker from this group, Sorell Schwartz, a pharmcologist from Georgetown University, acknowledged support from the tobacco industry but did not address specifics. No other mention was made of their source of support. This group had somewhat technical presentations of preliminary results regarding Environmental Tobacco Smoke (ETS) as it related to their various specialties. The other presentations were not surprising given the affiliations of the speakers. I have tried to briefly summarize the comments of each speaker on the following pages. If you would like more detail on some or all, let me know since I did take extensive notes.

Dr. Sheldon C. Sommers February 6, 1986 Page Two You may be interested to know that several R.J. Reynolds representatives were present, including Wally Hayes, Charlie Nystrom, and Charlie Green, who presented data showing that while nicotine from mainstream smoke is recovered almost entirely with the particulate phase, that nicotine from side stream smoke is associated almost entirely with the gas phase. If you have any questions, please do not hesitate to call. Sincerely, Carol J. ttenry, Ph.D., D.A.B.T. Vice President, Toxicology CJH:cdw Enclosure

SUMMARY OF MAJOR POINTS MADE BY SPEAKERS AT THE PUBLIC MEETING FOR THE COMMITTEE ON PASSIVE SMOKING January 29, 1986 1. Sorell Schwartz, Georgetown University, Indoor Air Pollution Advisory Group (IAPAG): Concerned about use of a biological marker to determine quantitative exposure to environmental tobacco smoke (ETS); developed a computer simulation model for pharmacokinetic data; concluded nicotine levels in body fluids alone is not a reliable marker of exposure to ETS, but nicotine in combination with cotinine maybe. 2. Lawrence Gar{inkel, Coalition on Smoking and Health: Presented and reiterated data from 2 of his previously published studies that lung cancer increased in non-smoking women of husbands who smoked; difficulties with the data were suggested in the discussion following the presentation, in particular, that the odds ratio was higher for women exposed over 5 years (1.25) compared to that for women exposed over 25 years (1.13). 3. S.J. Kilpatrick, Medical College of Virginia, IAPAG: Major area of concern is the epidemiology of ETS and the relationship between ETS and lung cancer; discussed 4 major papers: Hirayama (1981) and the update of 1985, a Sandler paper, and two from Garfinkel 1981, 1985; he suggested that rigorous evaluation of these papers would not support the claim that ETS is a cause of lung cancer. 4. A. 3udson Wells, Volunteer, American Lung Association: Reviewed the literature on Passive Smoking and compiled data on morbidity, mortality, disease pat=erns, active versus passive smoking, and smoke deposition pat~erns~ he identified 17 studies~ analyzed 8 and determined of the 463 cases, the combined risk for female lung cancer was 1.5. His conclusions were that more studies are needed, that overall there appears to be an association between passive smoking and lung disease, and that the cancer pattern from passive smoking appears to be different from direct smoking. Pertinent question by Dr. Spengler of the Committee: since smokers are also passive smokers, why do the changes in cancer patterns not show up in some smokers? Answer: direct smokers die before passive-smoker diseases appear. 5. J. Topping, Staff Director, Office of Air and Radiation, EPA (leaving his position at EPA to join private sector): From a recent paper in American Review of Respiratory Disease, an estimate has been made that ETS alone is responsible for 5000 deaths per year; emphasized that more research is needed but that from a regulatory position, the exposure risk from ETS should be reduced. EPA has proposed a health standard for particulates for 10 microns or less ~did not give the level) and reaffirmed the standard for carbon monoxide at 9 ppm for an S hour average for ambient air; he reiterated ~hat the Surgeon General has recommended a smoke-free society by the year 2000

-2- and that such efforts will involve curtailment of smokers; he stated, however, that passive smoking in the home should not be subject.to regulation in the home. 6. P. Witorsch, George Washington University, IAPAG: Reviewed published reports on the relationship between ETS and cardiorespiratory disorders; most studies suffer from extensive deficiences in design or execution so as to render conclusions meaningless, especially verification of exposure to ETS; the questionniares used in these studies have not be "validated." 7. C.Burchfield, University of Michigan: Presented results from the "Tecumseh, Michigan" study, a longitudinal study of 25 years duration; smoking related issues were not designed into this study originally; he presented data abstracted from this larger study involving a population of 3,400 children, 0-19 years of age; he attempted to correlate parental smoking habits, measures of passive smoking, and respiratory symptoms and illness; concluded that in general, the results are consistent with a relationship between parental smoking and respiratory diseases in children; recommended specific studies designed with passive smoking issues included at onset. Pertinent questions from the Committee: did not address active smoking issue in teenagers, or several other variables that could influence conclusions (parental education, family size, etc.). 8. M. Reasor, West Virginia University, IAPAG: Presented chemico.- physico properties of sidestream smoke compared to mainstream smoke and tried to point out how much i5 not known: identified research needs, including the need to define ETS and its actual composition, amount of contribution ETS makes to indoor air pollution, effect of aging on sidestream smoke and how chemico-physico properties may change with time after generation, and how the chemical composition may vary under different smoking condiLions. 9. S. DiNardi, University of Massachusetts at Amherst, IAPAG: Concerned with exposure assessment of indoor air pollution and methods in quantifying the respiratory suspended particles (RSP); emphasized the poor technical approaches in the field to-date in that personal air samplers could be used but in general have not been used to quantify exposure to ETS; emphasized the lack of a specific chemical marker for ETS and that nicotine, while specific, may not be appropriate; reviewed the paper by Repace/Lowry and concluded that the background ambient levels were inappropriately measured; believes that experimental chambers are not appropriate but that a surrogate house is for such studies so that ventilation and absorption of materials can be controlled. Quoted data from Spengler regarding mean impact of smoking on indoor air of 20 ~g RSP/m3/smoker; "The Netherlands" group has reported 2-5 ~g RSP/m3/smoker. 10. G. Robertson, ACVA Atlantic, Inc.: His companv~as measured the air quality in 125 office buildings; determined that the major air pollutants are widespread allergic fungi and bacteria; concluded that ETS accounts for 4 percent of the problem of indoor air pollution in the buildings they have

-3- surveyed; they do not use questionniares, but rather characterize air samples; primary cause of problems is poorly designed or incorrectly operated heating and ventilation systems. ETS is often the only visible pollutant and is, in their view, a marker for poor ventilation systems. 11. A. Munzer, American Thoracic Society and American Lung Association: Lung disease is susceptible to changes in public policy; called for elimination of effects of sidestream smoke; knowledge is incomplete yet evidence as a whole says danger is there; social regulation will constrain smokers, however suggests that health improvement in children and improvement in mortality rates will support such actions; further sta~ed that social regulation must be based on scientific fact, cost benefits, and public support. 12. G. Oberdoerster, University of Rochester Medical Center, IAPAG: Reviewed pulmonary toxicology factors of ETS and compared results to mainstream smoke; factors such as non-invasive markers of tobacco smoke (ETS and mainstream), dose of particulates and gas phase, particle size, deposition and clearance patterns, and potential differences in concentration of chemicals depending on particle size; he suggested extensive research needs, including animal inhalation studies of fate of the ETS constituents. 13. C. Green, R.J. Reynolds Co.: Has been studying the vapor-particulate phase of ETS; major conclusions reached is that mainstream nicotine is found with the particulate phase and that sidestream nicotine is found with the vapor-phase; used Cambridge filters, XAD-4 resins, and electrostatic precipitators to collect samples; concluded that environmental nicotine behaves differently from mainstream smoke nicotine and is not a marker of particulate phase. Pertinent question from the Committee: what component(s) should be used as a marker for ETS particulates? No recommendations at this time. 14. J. Banzhaf, Action on Smoking and Health: There are a large number of people who have health conditions that are sensitive to the effects of tobacco: they suffer immediate health hazards and require medication, etc.; physical symptoms do not lead to mortality or morbidity but do require treatment; legislative bodies have not distinguished between short-term and long-term effects; there has been a clear distinction between ambient tobacco smoke and evidence of harm for industrial chemicals, yet this is not sensible; posed several questions for the Committee to address including the issue of clear evidence of harm from ambient smoke and that this issue should be uppermost for the Committee to consider. 15. N. Ba~ter, Georgetown University, IAPAG: Reviewed literature and attempted to address the issue of ETS and chronic health effects and other confounding factors involved in the studies; Radon gas is an important indoor air pollutant that has not been controlled for in the epidemiological studies, in particular in the Garfinke] studies of lung cancer patients for the New Jersey area; recommended additionai, well-designed epidemiological studies and animal studies under controlled exposure conditions.

-4- 16. B. Rubin, Queens University, Ontario: Presented some evidence from an unpublished study that cystic fibrosis children from homes with smokers had diminished lung function compared to those cystic fibrosis children from homes with no smokers; study was not designed to address this question; many variables were uncontrolled. He made many disclaimers for his data. Pertinent question: was the study controlled for family size? No and thus there could be a trivial explanation for results. 17. N. hynch, Franklin Institute: Presented data on plasma nicotine and expired carbon monoxide in passive smokers; data were taken from a larger study that was not designed to address the issue; concluded that plasma nicotine increased in passive smokers and that plasma nicotine is a more sensitive marker for exposure than expired carbon monoxide. Pertinent questions from the committee: why wasn't cotinine measured? How to account for certain data that do not appear to be consistent? Conclusions are probably not justified.

October 15, 1985 Committee on Passive Smokin~ Statement of Task The Office of Air and Radiation of the Environmental Protection A~encv (EPA) and the Office of Smoking and Health of the Department of Health and Human Services have contracted with the Board on Toxicology and Environmental Health Hazards to evaluate the problem of obtainin~ optimal measurements of exposure to tobacco smoke by nonsmokers in eDidemiolo~ical studies and to evaluate the literature reKardin~ health effects of such exposures. Specifically, the study will include a toxicologic profile of sidestream and exhaled smoke; review of its biological, chemical and physical characterization; identification of potential biochemical markers of exposure to a variety of the constituents of tobacco smoke; review of existing literature on the epidemiology of passive smoking; recommendations for future exposure monitorinR, modeling, and epidemiologic research. ~

PUP~POSE AND STRUCTURE OF THE PUBLIC MEETING January 29, 1986 COMMITTEE ON PASSIVE SMOKING Committees of the National Research Council hold a public meetin~ when the suoject of their study is of more than usual interest to the general public. The purpose of such meetings is to provide an opportunity for all interested parties to provide data, other information, and views which may assist the Committee as it prepares its report. The public meeting is not the only opportunity for persons outside the Committee to make a contribution to the study. The Committee welcomes any and all information submitted in writin~ durin~ the course of its work and may, at its discretion, invite persons to make presentations at a Committee meeting. The public meeting is structured to permit interested parties to present information and for the Committee members to ask ouestions of the speakers. Except for describing the scope of work which the committee will address, the me' ~rshiD of the co=rmittee, and the National Research Council proce=~ under which it will operate, no other information is yet available to the public. The committee is in an early stage of its deliberations where information is being gathered and evaluated. The committee will not reach conclusions until a much later stage of its work. Each speaker will have 15 minutes to make a presentation. Following each presentation, a five minute period is scheduled to permit members of the Committee to ask questions of the speaker. Members of the audience who wish to ask questions of the presenters may suOmit these in writing to the Committee for use if time permits. Forms for submitting questions are in the information package distriOuted at the registration desk and a staff person will be available to take the questions to the committee. At the end of the day, there will be an opportunity for additional ouestions from the floor. The proceedings are being recorded to provide a permanent record for the internal use of the Committee and its staff. No separate publication of the proceedings is planned. The committee's findings and recommendations will be published at the conclusion of the study in the form of a National Research Council report.

COMMITTEE ON PASSIVE SMOKING NATIONAL RESEARCH COUNCIL, COMMISSION ON LIFE SCIENCES BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY PUBLIC MEETING January 29, 1986 NAS LECTURE ROOM 9:00 a.m. Health Effects 9:25 a.m. 9:50 i0 : I0 10:30 i0:50 Ii:i0 11:30 ii:50 OPENING REMARKS Dr. Alvin Lazen, Executive Director Commission on Life Sciences National Academy of Sciences Dr. Barbara Hulka, Chairman Committee on Passive Smoking PRESENTATIONS Sorell Schwartz, Ph.D. Indoor Air Pollution Advisory Group Department of Pharmacology, Georgetown Univ. Lawrence Garfinkel, Ph.D. Coalition on Smoking or Health including the American Cancer Society, American Heart Association and American Lung Association S.J. Kilpatrick, Ph.D. Department of Biostatistics, Medical Col. Va. Indoor Air Pollution Advisory Group A. Judson Wells, Ph.D. Special Assistant (Volunteer) American Lung Association Break John Topping Staff Director, Office of Air and Radiation Environmental Protection Agency Philip Witorsch, M.D. Div. of Pulmonary Diseases and Allergy George Washington Univ. Medical Center Indoor Air Pollution Advisory Group Cecil Burchfiel, Ph.D. and Millicent Higgins, M.D., Dr. P.H. Department of Epidemiology, University of Michigan Also Cardiac Research, Veterans Admin., Denver, CO and Assoc. Director for Epidemiology and Biometry, NHLBI 12 : I0 Lunch

Composition of Smoke and Assessment Procedures 1:20 1:40 2:00 2:20 2:40 Mark J. Reasor, Ph.D. Department of Pharmacology and Toxicology West Virginia University Indoor Air Pollution Advisory Group Salvatore R. DiNardi, Ph.D. Sch. of Health Sciences, Div. of Public Health University of Massachusetts at Amherst Indoor Air Pollution Advisory Group Gray Robertson ACVA Atlantic, Inc. Alfred Munzer, M.D. American Thoracic Society and American Lung Assoc. Guenter Oberdoerster, D.V.M, Ph.D. Department of Radiation Biology and Biophysics University of Rochester Medical Center Indoor Air Pollution Advisory Group 3:00 Break 3:20 3:40 4:00 4:20 4:40 5:00 Charles R. Green, Ph.D. R.J. Reynolds Tobacco Co. John Banzhaf and Athena Mueller Action on Smoking and Health Nancy Baiter, Ph.D., and Vincent Castranova, Ph.D. Department of Biology, Georgetown University and Department of Physiology, West Virginia Univ. Indoor Air Pollution Advisory Group Bruce Rubin, M.D. Dept. Pediatric Pulmonary Medicine, Queens University/~P~?a~'~ Neil Lynch, Ph.D. Franklin Institute, Chevy Chase, MD Discussion and Closing Remarks Barbara Hulka, Chairman