Tobacco Documents Online

ORDM 1µ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY OFFICE OF RESEARCH AND DEVELOPMENT ENVIRONMENTAL CRITERIA AND ASSESSMENT OFFICE CINCINNATI, OHIO d5268 March 24, 1992 SUBJECT: OHEA-C-361 - Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders FROM: Terry Harvey, D.V.M. Director TO: Linda Bailey-Becht 7t Technical Information Staff, OHEA (RD-689) Attached you will find ECAO-CIN's evaluations of the document identified above that you sent us on March 11, 1992 and requesting comments by today (verbally confirmed by Bill and Jeanette). The primary requests of ECAO-CIN on page 2 of Bill's memo of March 9, 1992 have been satisfied by Pat Murphy (3/23) and Rick Hertzberg's (3/21) attached reviews. As you will note from the comments, no one liked the 11 day time allotted for review and thus a very quick product is attached as the best we could accomplish in the time available. I suggest the document manager(s) consider more time for evaluation to balance the seriousness of this document as applied to the public health and the intrinsic value of doing it right on this key health topic. I have personally reviewed only the "Summary and Conclusions" and have these comments: 1. I am concerned with the extrapolation of data from females to males in the married, never smokers (p. 1-3). There are sex differences for both cancer and non-cancer health effects. I suggest clarification of this variable to affirm inadequate male data and reinforcing the EPA cancer guideline proviso where inadequate data exist. i\z O 2. It is confusing to the reader to skip back and forth from W~;,- "EIS" to "passive smoking" (pg. 1-1). I suggest an ~ improved scientific description is "PETS" or "Passive '~ Exposure To Tobacco Smoke." In any case, use one set of ~ terms and define it upon first usage. ~ ~ W ~ Printed on Recycled Paper

3. To be technically accurate and avoid confusion, the document summary Pg. 1-1) should not use the generic term "cancer" unmodified as to the type the causal effects have been clearly shown based on histological malignancy type, e.g., squamous cell carcinoma vs. adenocarcinoma. Great confounders will emerge if this is not carefully articulated (see Pat Murphy, Pg. 5). If you can technically show causal association, do; where you can't, don't infer it. 4. The non-cancer asthma effect must be clarified medically to show effects primarily in a sensitive asthmatic subpopulation having pre-dispositions component-like genetic risks and not displayed as public health risk to the general non-predisposed population. 5. I suggest a full discussion of carcinogen category A vs. B, based on the absence of definitive data of PETS in humans. Like it or not, EPA should live within its own categorization framework or clearly explain why we chose not to do so. You may wish at some stage to present this assessment to CRAVE to obtain Agency consensus and assure wider peer review. ECAO-CIN will be most happy to spend further time improving the quality of this document. Let us know how we can be of further help. cc: W. Farland (RD-689) J. Wiltse (RD-689)

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