Not to decide is to decide: ignoring susceptibility is not `good science'

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I am going to talk about good science and bad science today. For more than 15 years, I have been watching the EPA from afar—and the other risk-reducing agencies—being beaten up for perpetrating bad science. I guess I’m guilty of contributing to some of that criticism over time, but now that I’m part of the regulatory apparatus I have reinforced my long-held view that there is a lot of good science being practiced at the agencies, and in fact, that a lot of the progress made over the last decades is in danger of being eroded by some fairly relentless and fairly uninformed attacks on risk assessment practice. But the issue of human susceptibility to environmentally and occupationally-related disease, particularly to cancer, is different: rather than being an issue where sound science is in danger of being replaced by something less so, it is an issue the agencies have misunderstood and mismanaged. However it is also one where we may still have a chance to turn things around and turn what has been a fairly unenlightened approach to risk assessment into what really is good science. I’m concerned for a number of reasons that this opportunity is being missed and that EPA in particular may in fact be moving in the wrong direction. As I heard Dale Hattis speaking earlier, I realized it now is 13 or 14 years since I was a first year graduate student in public policy, and I was looking around for a master’s thesis topic, when the people at the Kennedy School suggested I contact Dr Hattis. He said, basically, ‘why don’t you write about the fact that the U.S. federal regulatory agencies ignore human variability with respect to risk assessment for cancer?’ It seems to me that the intervening 14 years have not seen a very good track record of responding to an identified problem. So I’m going to first try to explain the title of my talk a bit more, set up a thought experiment, discuss what I think we can say currently about the extent of human interindividual variability with respect to carcinogenesis, talk about the National Academy of Sciences Committee that I served on from 1991 to 1994 and the recommendations that we made, and then conclude by assessing where we stand currently and why we seem to be at an impasse.