Executive Order 12866 (58 Fed. Reg. 51735 [1993]) directs OMB to provide guidance to federal agencies on regulatory development and emphasizes the need for each agency to “base its decisions on the best reasonably obtainable scientific, technical, economic, and other information.” The Paperwork Reduction Act (44 U.S.C. § 3504 [1995]) requires OMB to “develop and oversee the implementation of policies, principles, standards, and guidelines to...apply to Federal agency dissemination of public information.” The Information Quality Act (Public Law 106-554 § 515(a) [2000]), a supplement to the Paperwork Reduction Act, directs OMB to develop guidelines that “provide policy and procedural guidance to Federal agencies for ensuring and maximizing the quality, objectivity, utility and integrity of information” released by federal agencies.

In 2002, in response to the many directives, OMB finalized Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, which defines quality, objectivity, utility, and integrity and requires federal agencies to issue their own information-quality guidelines (67 Fed. Reg. 8452 [2002]). In 2003, OMB issued Circular A-4, Regulatory Analysis, which defines the key elements of a regulatory analysis and provides specific guidance on conducting cost-benefit and cost-effectiveness analyses (OMB 2003). In 2005, OMB published Final Information Quality Bulletin for Peer Review, which requires peer review of important scientific information by qualified experts before release by federal agencies (70 Fed. Reg. 2664 [2005]). In its continuing effort to improve the quality of information and analyses disseminated by federal agencies, OMB issued the draft bulletin (OMB 2006) providing guidance for the conduct of risk assessment.


OMB’s draft bulletin consists of a preamble (22 pages) containing primarily “supplementary information” followed by the actual bulletin (3 1/2 pages) (see Appendix B). The bulletin provides key definitions, goals for risk assessment, general risk assessment and reporting standards, and special standards for influential risk assessment. The bulletin also presents information on applicability, updates, certification, deferrals and waivers, responsibilities of executive offices, effective date, and judicial review. The supplementary information includes background on

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