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Comments of ani Expert Group1 of Statisticians and Epidemiologists on t'he Concepts of Risk Assessment in, the U.S. EPA Reportc Respiratory Health Effects of'Passiwe Smoking:. Lung Cancer and Other Disorders (EPA1600/6-90/006F; December 1992) The assessment of' environmentat risk is a problem of major concern. In December 1992 United States EmvironmentaT Protectioni Agency published a report: "Respiratory Health Effects of' Passive Smoking". In this report the: results of epidemiologic studies were analysed according to, the U.S. EPA's Guidelines for Carcinogenic Risk Assessment (U.S. EPA, 19g6a). EPA's major conclusion was: "In adults: ETS is a human lung carcinogen, responsible for approximately 3',(700 lung cancer deaths anually in U.S. nonsmokers". The validity of the database and methodological concepts on which this conclusion is based are subjeet of diverging opinions and heterogeneous diseussions. It is intended to gather comments of' an expert group~ of epidemiologists and statisticians on selected questionss concerning the statistical and' epidemiological methods of risk assessment and the validity of the data and methodological concepts appl'aed, in the EPA report. The following problems and questions should be commented: 1. Estimation of environmental, tobacco smoke exposure (chapt. I of EPA report), Validity of questionaires for assessing ETS' exposure (3'.13) (Prof. Dr: P. Atteslander, Augsburg, FRG) 2. Hazard identification (chapL 4 and 5 of EPA report) i Validity and! limitations of epidemiologic studies to: quantify very small excess risks; impact of political goals and consequences: to lifestyle of populations). (Prof. Dr. A. Flew, UK) Validity of statisical inference (5.2 and: 5.3) (tests of'effects and trend tests; problem of'multiple testing) (Prof. Dr. J. Berger, Hamburg, FRG) Risk estimates with continuous exposure; Validity of exposure models in, EPA repoM (Prof. Dr. U. Feldmann„ Homburg/'Saar, FEG)l Prof. Palacek, Prague (topic not yet fixed) 1

3. The interpretatibn, of the results of the epidemiologic studies The validity of the "weight-of-evidence analysis" and~ assessment of causality in EPA report (chapt. 1 and 5.6) (Prof. Dr. P. Urbach, Londbn UK). Conclusions from the results of the epidemiolbgiic studies (Are the conclusions drawn by EPA from the results of the epidemiologic studies j ustifaed ?). ('Gary L. Huber, IvID,, T'yler,, T'X„ USA) ~ 4. Population risk of'lungcancer from passive smoking (chapt. 6 of EPA report) The concept of attributable risk and the estimation of population~ risk from epidemiologic studies (is the concept of attributable risk applied correctly in EPA report to estimate population risk ?) (Prof. Dr. B. Schneider„ Hannover, FRG) 5'. Passive smoking and respiratory disorders. other then cancer (chapt. 7' and 8) Validity of studies and conclusions for impact of E'I1S'. to disorders other than cancer, drawn in EPA report (Gary L. Huber, MD, Tyler, 'PX,, USA) 2