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White House Requires Peer Review for Regulatory Science
September 3, 2003—The White House Office of Management and Budget (OMB), released draft guidelines that would require independent peer review for science that underlies significant federal regulations. Some federal agencies already conduct peer reviews of regulatory science, but the new guidelines would establish government-wide standards for peer review.
"A more uniform peer review policy promises to make regulatory science more competent and credible, thereby advancing the Administration's ‘smart-regulation' agenda. The goal is fewer lawsuits and a more consistent regulatory environment, which is good for consumers and business," according to John Graham, Administrator of OMB's Office of Information and Regulatory Affairs (OIRA).
While parties facing regulation generally support the stronger review processes, critics say the proposed guidelines may be a mechanism to stall regulations. According to OMB Watch, a watchdog group, "the guidance could provide the legal basis for industry to delay or even block agencies' emergency activities and other regulatory actions in court if certain aspects of the peer review process have not been completed." OMB Watch and others also expressed concern that the new guidelines, which give OIRA control over agency review processes, would allow political influence to interfere in judging science.
The proposed guidelines may have a significant impact on agencies that promulgate environmental regulations. EPA already follows most of the proposed guidelines, but the Department of Agriculture and the Army Corps of Engineers may have to make changes, according to John Graham.
The draft OMB Bulletin requires "a formal, independent, external peer review" if (1) "the agency intends to disseminate the information in support of a major regulatory action, (2) the dissemination of the information could otherwise have a clear and substantial impact on important public policies or important private sector decisions with a possible impact of $100 million in any year, or (3) the Administrator [of OIRA] determines that the information is of significant interagency interest or is relevant to an Administration policy priority."
According to the draft OMB Bulletin, reviews should be conducted by experts who are independent of the agency involved and free from financial interest in the matter under consideration. Selection criteria exclude people who have "advocated a position on the specific matter at issue," or "conducted multiple peer reviews for the same agency." The Bulletin suggests balancing contrary opinions when unbiased reviewers cannot be found, and releasing a preliminary version of review reports for public comment and evaluation by other agencies.
The new guidelines do not apply to routine statistical information or science that is not directed toward regulatory issues, such as most of the scientific research supported by the National Science Foundation. In order to avoid duplication, peer review undertaken by a scientific journal may generally be presumed to satisfy the proposed guidelines. The draft guidelines have exclusions for national security information, and some types of proceedings, such as permit applications. Waivers can be granted for emergencies and homeland security threats.
OMB's Office of Information and Regulatory Affairs would supervise the peer review processes at all federal agencies. "As described in the proposed Bulletin, each federal agency will report annually to OIRA on the significant regulatory science documents the agency anticipates issuing in the coming year," according to an OMB statement.
The proposed peer review guidelines would supplement the Data Quality Act of 2001 and existing OMB information quality standards. OMB asserts authority and responsibility for federal agency review practices in accordance with a 1993 Executive order from President Clinton, which states: "Each agency shall base its decisions on the best reasonably obtainable scientific, technical, economic, or other information concerning the need for, and consequences of, the intended regulation."
The peer review guidelines were released soon after a lawsuit challenged the quality of data used in the Administration's recent report, "National Assessment of the Potential Consequences of Climate Variability and Change." In mid-August, the Competitive Enterprise Institute filed suit against the White House Office of Science and Technology Policy, alleging that the report violates the Data Quality Act. The matter is still pending, and it is not clear whether courts will judge standards in the Data Quality Act legally binding.
The OMB Bulletin is intended to take effect in February 2004. OMB invites public comment on the draft version before October 28, 2003. The draft OMB Bulletin is available at: http://www.whitehouse.gov/omb/pubpress/2003-34.pdf
Amanda Brewster and Craig Schiffries
National Council for Science and the Environment
1707 H Street, NW, Suite 200
Washington, DC 20006
Tel: 202-530-5810
E-mail: policy@NCSEonline.org
www.NCSEonline.org
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