(CASAC) Peer Review of EPA's Integrated Science Assessment

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p. 3-105, line 2 The Japanese study discussed in the 1986 Secondary Addendumshould be cited.8
Dr. Doug Crawford-BrownComments on SOx ISA – 2 nd DraftMy comments here focus largely on Chapters 4 and 5, although it was necessary toreview the earlier chapters as well because Chapter 5 especially draws on materials fromthose earlier chapters. It is clear to me that the EPA is getting better at this process ofcreating an ISA. The document is well organized; it is easy to follow the reasoning usedby the authors; and they appear to me to have reached the appropriate summaryconclusions on the ability of SOx to produce effects even at levels below the currentNAAQS, at least for short-term exposures. The document overall provides an adequatebasis “to provide support for future risk, exposure and policy assessments”, in the sensethat it establishes the existence of effects in policy-relevant ranges of exposure, identifiesissues associated with exposure, and identifies sensitive subpopulations. It would not bepossible to use the document alone as the basis for performing an actual risk assessmentbecause there is inadequate assessment of exposures nationally or in specificsubpopulations. But I presume such a formal, quantitative risk assessment would be thetask of the Exposure and Risk Assessment document. Still, I continue to have troubleunderstanding the role of the ISAs in meeting the needs of risk assessment. Thisdocument continues the pattern of being an inadequate basis for such a quantitativeapproach, even if it does systematically review the evidence on which such a quantitativeassessment might ultimately be based.My specific comments are:1. I like the formulation of the questions on page 1-2. They seem to be a refinement ofthese questions in previous ISA documents, recognizing the need not to just consider newinformation but to integrate new information into past assessments.2. On page 1-5, the authors note that associations are not sufficient for proof of a causalrelationship. Later they mention that epidemiological studies provide evidence of anassociation. Still later in the document, they use the epidemiological evidence as a basisfor concluding that there is a causal relationship. This is not consistent, although I thinkthe inconsistency begins with the first claim: that associations do not prove causalitysufficiently. This needs some nuance, as associations ARE an important component ofcausal reasoning, even if not fully compelling. I disagree with views that associations arenot relevant in claims of causality – they can in fact be compelling, rational evidence ifsufficiently well established and reliable.3. In the figure on page 1-6, I note that some aspects of the bottom half of the figure,such as lifestyle, CAN be influenced by community norms, and so are not strictlyindividual-level factors.4. The topic of multifactorial causation on page 1-9 is interesting. But there are realquestions as to whether policy can deal with such complex mixtures, leading perhaps to9
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Page 4 and 5: eorganized to focus on studies usin
Page 6 and 7: The Panel was impressed by the way
Page 8 and 9: Dr. Steven Kleeberger, Professor, L
Page 10 and 11: Mr. Ed AvolComments on SOx ISA 2 nd
Page 12 and 13: to risk estimates that include all
Page 14 and 15: eosinophils in bronchoalveolar lava
Page 18 and 19: different standards in different re
Page 20 and 21: 17. The complexity of the curve in
Page 22 and 23: Page 2-52, lines 5-16 - This sectio
Page 24 and 25: confidence limits for the ED50 in t
Page 26 and 27: Dr. Donna KenskiComments on SOx ISA
Page 28 and 29: 5-3 lines 8-11 This statement is co
Page 30 and 31: p. 2-10, line 6: I don’t think th
Page 32 and 33: Dr. Steven KleebergerComments on SO
Page 34 and 35: Dr. Timothy LarsonComments on SOx I
Page 36 and 37: Dr. Ted RussellComments on SOx ISA
Page 38 and 39: ief section describing the availabl
Page 40 and 41: Dr. Kent PinkertonComments on Sox I
Page 42 and 43: population at risk is an important
Page 44 and 45: exposures in population studies, th
Page 46 and 47: The discussion of uncertainty is br
Page 48 and 49: Dr. Richard SchlesingerComments on
Page 50 and 51: Dr. Christian SeigneurComments on S
Page 52 and 53: Dr. Frank E. SpeizerComments on SOx
Page 54 and 55: Summary and Conclusions ChapterThe
Page 56 and 57: Dr. George ThurstonComments on SOx
Page 58 and 59: 5. Revisions were made to better in
Page 60 and 61: Specific CommentsPage; lines2-3; 10
Page 62: p. 3-11; ll. 7-18: Another reason f

(CASAC) Peer Review of EPA's Integrated Science Assessment

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