Tobacco Documents Online

~1 c J c.,~:•x ( ' MMOP-Mm ~ Nov 1 19 m oFPtCS OF R6S[AacH Ano oEVaLOAMEnT SIIBJECT: Science Advisory Board Review of the Draft Report "Health Ettects of PassiVe smoking: Assessment of Lunq Cancer in Adults and Raspiratory Disordess in Children.° EPA/soo/6-90/006A FROM: william H. Farland, Ph.D. Director Office of Research and Devblopment (RD-689) Oftice of Health and Environmental Asaessm UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHiNGTON. D.C. 20460 , rector leen Claussen L'Ti Offica cf Atmospheria and Zndoor Air Programs OFfice of Air and Radiation (ANR-445) . TO: Robert Flaak DFO Yn,door Air Quality and Total Human Brposuxe Committee Sciencc Advisory Board (A101F) Wa are hereby requesting scienco Advisory Board (s2lB) review of the abovQ titled draft report on tha hQalth risk assessment of passive smoking. The doctuaent was prepared by the HuMari Health Assessment Group, Office ot Research and Development at the request of the Indoor Air Division, Office of Air and Radiation, under the authority of Title IV of Superfund (The Radon Gas and Indoor Air Quality Resedreh Act of 1986) to provido information and guidance on the potential hazards of indoor air pollutants. The Draft Report has been available for public review and comnant since June 25, 1990, with a 90-day comment•period which closed Oct. 1, 1990. over 3,500 copies were distributed and 107 public comments have been received as of Oct 10, 1990. A summary of these comments is now being prepared and we will provide it to you shortly. The Draft Report reviews and analyzes the data on the respiratory effects of environmental tohacoo smoke (E`1`S) with heavy emphasis on the epidemiologic data and ctatistical (meta) analysis. One major portion of the Report (Chapters 3 and 4) examines the weight of evidence for lung cancer in adults. It concludes that under EPA's carcinogen assesement guidelines, ETS would he classified as a Category A or known human carci.nogen. It also estimates from the epidemxology, not modeling, data that on average 3,800 lung cancar deaths per year in U.S. nonsmokers ` J

2 are attributable to ETS. The final chapter of the report examines the epidemiological evide.nct for non-cancer respiratory disorders in ehildren and concludes that the detrimentai reapiratory effacts described are aesociated with exposure to ETS, but that a causal association has not been established. The Draft Report alao contains four appsndica. Appendix A provides a detailed summary and analysis of eleve.n recent case- control studies of ETS and lung cancer. gppendix B presents pertinent atat.hematical formulae and relationships. Appendix C dascribes the dosimetry of ETS and Appendix D prosents a potential framework for dose-response modeling for ETS and lung cancWr. Tha Agency seeks tr.a advice of the SAB on tha accuracy and oompletanass of the entire document and on the quastion of whether its conclusions on the weight of evidence of ETS caused cancer and other respiratory disease are well considered based on the data and accepted scientific practices. In addition, we would likQ the SAB to addresc the following specific issues: A. Lung canccr in Adults i. FI3s EPA met the requiremants stated in its carcinogen guidel.ines for characterizing ETS in Category A, i.e_ is the evidence sufficient to conclude that ETS is causally associated with lung cancer? ii. Is spousal samoking a proper measure of ETS exposure to assess lung cancer risk? iii. Are the diFferences in relative risk observed between studies in the U.B. and those overseas of concern, dnd if so, to what degrae? iv. Is xeta-Atialysis an appropriate tool to use in the document and has it been applied correctly? Have the epidemiological studies been properly evaluated and combined using this technique? v. Hava the most important confounders been properly addressed? Has the issue of misclassif!cation (clasQifying current and former smokers as never smokers) been adequately addressed and the proper adjustmdnt$ made? Are there other confounders which could be addressed in greater detail? vi. Does the document characterize the uncertainties, both in tne weight-of-evidEnce and the number of attributable deatAs, appropriataly? vii. Has the ctuantitative risk of lung cancer been properly assessed? Would it be more properly assessed by a dose response assessment using either cotinine oc respirable suspended particulates as surrogate measures of exposure (Appendix C)? Would ,; I

3 modeling approachee (Appendix D)? Should a dose- response model be developed for ETS-radon interaction effects? viii. 5hould tho Draft Report attsmpt to distinguish between the effects of home vs. workplace exposure to ETS? B. Respiratory Disorders in Children f. Has the weight of evidence for ETS relatod respiratory disorders in children been proparly characterizefl? A draft report with a detailed description and analysis of 26 recent studies has recently bean prepared and is anclvsed. Yt is in a form similar to that of AppendiY A. Should it bQ included in a revised report as Appendix E? ii. Have confounders in the epidemiologic studiea been adequately addressed? iii. Should a meta analysis approach be attempted as in the lung cancer analysis? N cn 0 ~ ~ ~ W 03 ~ I