June 12, 2006
Dr. Nancy Beck
Office of Information and Regulatory Affairs
Office of Management and Budget
725 17th Street, NW
New Executive Office Building
Washington, DC 20503
RE: Proposed Risk Assessment Bulletin
The Salt Institute, on behalf of the nation’s salt producers, has recorded itself in favor of the several initiatives of Congress and OMB to improve the quality, integrity, objectivity, transparency, reproducibility and public access to scientific data employed by the federal government to support public policy. We support this proposed Risk Assessment Bulletin and offer a couple thoughts for possible modifications.
Many public policy decisions should be informed by accurate and objective scientific information. It is crucial to the quality of identifying policy options that the scientific analysis be separated from the policy-making process. We should consider it “cooking the books” to have policy assumptions built-in to the scientific analysis. Thus, the objectivity and reproducibility of the analytic techniques is paramount.
In Sections IV and V, “General and Influential Risk Assessment and Reporting Standards,” we would strengthen the language calling for weighing “both positive and negative studies in light of each study’s technical quality.” We agree completely, but a more powerful way to express this is to emphasize that the evidentiary standards and acceptable analytic techniques need to be specified in advance, along the lines recommended by the U.S. Preventive Services Task Force. Then, and only then, should the literature be assessed to determine which studies meet pre-established quality criteria. If the studies are analyzed and sorted into “pro” and “con” groups, any post-facto selection criteria would be suspect as being chosen to bias the analysis.
In these same sections, we note the disparate requirements for reproducibility for general risk assessments, where reproducibility is not required, and “influential” assessments where this criterion would be enforced. We believe this standard should be imposed across-the-board.
Having participated actively in risk assessment consultations in the past, we feel the provisions for public participation should be broadened and that the draft assessment be provided for public comment. In many cases, it would be helpful to the agency conducting the assessment to include a stakeholders’ consultation in designing and conducting the assessment and the Bulletin might encourage agencies to consider this technique.
There are a number of other general and specific improvements that have been identified by the National Association of Manufacturers and we recommend they be given your serious and positive consideration.
Sincerely,
Richard L. Hanneman
President
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