In my view and based on my experience, S. 746, the “Regulatory Improvement Act of 1999,” would remedy a pernicious problem that has increasingly bedeviled the U.S. rule-making process. That problem is a lack of rigor that gives rise to an absence of transparency in decision-making at many of the steps in the regulation development process, especially including the role of the Office of Information and Regulatory Affairs (OIRA).
Absence of transparency can occasion delay, denial, and politicization . . . or at least the suspicion thereof. At this point, I should point out that I am not condemning any particular administration; I have worked more with the four administrations that preceded the present one.
Briefly described, the concept of transparency embraces openness, fairness, and a detailed description of the decision-making process. For matters involving public health, it furthermore implies that the decision will be science-based. Transparency is a standard we now demand of all other nations. The current trade disputes between Europe and the U.S. are essentially over science-based decision-making that can only be evaluated in the presence of transparency.
If transparency is required of our trading partners, it is axiomatic that we must operate in a like manner. To do less is unethical and terribly risky in today’s trading environment. S. 746 would convert the current black box approach to one that is transparent.
S. 746 institutionalizes three widely accepted tools for risk managers, including governments. These are cost-benefit analysis, risk assessment, and peer review.
My area of experience is in public health regulation. Cost-benefit analysis would not normally be applied to public health measures because no cost can ethically be affixed to human health, suffering, and death. Risk assessment, on the other hand, has become the universal language of scientific and public health deliberation. And peer review is the surety bond of science.
Risk assessment may be briefly described as the process of threat identification coupled with likelihood estimation, with the end result being risk determination. For example, pasteurization of cheese is thought by some to be commercially objectionable, but when the threat of cheese-borne disease is identified and the likelihood of that disease is calculated, the risk associated with not pasteurizing is generally found to be unacceptably high.
The opposite of risk assessment is intuitive decision-making, which may be based on either whimsy or politics or both.
Peer review is the scientific equivalent of the old adage, “two heads are better than one.” Its practical application comes when a panel of qualified individuals evaluate scientific papers, research projects, or the like. When used in the government, peer review has been successful. FDA’s system of Generally Recognized as Safe (GRAS) is a form of peer review. This grew out of the 1958 Food Additives Act. GRAS affirmation generally means that if you can empanel a group of qualified individuals and they as a group attest that a substance is safe for the intended use at the recommended level, then FDA can consider it safe. The product-specific advisory committees in FDA’s Center for Drug Evaluation and Research constitute another useful example of peer review.
Peer review can and does broaden the expertise available to the government, and it makes the process more open and democratic. In my personal and professional experience, OIRA could very much benefit from peer review.
S. 746 will lead to better, more efficient government. I am convinced the bill provides a framework wherein regulatory initiatives can be fairly and openly judged in a transparent manner.
My conclusion is that the bill will institutionalize risk assessment as the calculus for regulatory decision-making. To the extent that this is the case, S. 746 will bring the U.S. in congruence with its international trading partners, and the long-sought goal of science-based decision-making will at last have been realized.
Excerpted from Dr. Lester M. Crawford’s testimony before the Senate Committee on Governmental Affairs, April 21, 1999. The complete text of Dr. Crawford’s testimony is available on CeresNet.Org, the Web site of The Center for Food and Nutrition Policy, at http://www.ceresnet.org/dr.htm.
