9/18/2003 White House Issues Draft Guidance on Peer Review Science in The Regulatory Process - 9/16 AIBS Public Policy Report

The administration has largely ignored this criticism and has now released a new draft guidance it contends will ensure significant federal regulations are based on the best available science. Policymakers have long argued that decisions should be based on the best available information.

The draft guidelines released by the White House's Office of Management and Budget (OMB) point to a decade of bipartisan reports and legislation calling for regulatory processes to be based on peer reviewed data. OMB notes that the plan would not impact the peer review processes or the grant application process at the National Science Foundation or the National Institutes of Health.

The draft plan, expected to be implemented in early 2004, would provide federal agencies and OMB with the ability to ensure the regulatory process is more transparent and free of conflict of interest, according to OMB. For example, OMB notes that some scientists that receive funding from a regulatory agency may review studies that agency may latter use to issue regulations. OMB is concerned that these scientists may feel compelled to favorably review information that supports the agencies proposed regulations.

Critics ranging from environmental groups to civil rights advocates consider the peer review plan nothing more than a tool the White House will use to impede the issuance of regulations or to prevent new rules from being implemented altogether. They point, in part, to the fact that the guidance was largely crafted by OMB regulators favorable to big-business and who have deep ties to organizations opposed to federal regulation.

Critics further argue that the peer review guidance would largely be used to prevent the U.S. Forest Service and the U.S. Army Corps of Engineers from issuing any regulations not friendly to supporters of the Bush administration.

Briefly, as defined in the draft OMB peer review guidance, a peer review relevant to the regulatory process "is a scientifically rigorous review and critique of a study's methods, results, and findings by others in the field with requisite training and expertise." According to OMB, the new peer review guidance "would 'supplement' those requirements for the peer review of 'significant regulatory information'." This refers to scientific or technical information that (i) qualifies as "influential" under OMB's information quality guidelines and (ii) is relevant to regulatory policies. In general, the guidelines are designed to be used when a regulation may cost a private sector entity an excess of $100 million over a multi-year period.

The entire draft proposal is available for review at http://www.whitehouse.gov/omb/pubpress/2003-34.pdf.

OMB will receive comments from scientists on the draft proposal through October 28, 2003. Of particular interest to OMB are the opinions of scientists on the breadth and scope of the proposal:

Should provisions be strengthened, modified, or removed? Will the provisions (e.g., conflict of interest and disclosure requirements) discourage qualified scientists from participating in the peer review process? Would provisions of this proposal unnecessarily burden participating scientists or discourage qualified scientists from participating in agency peer reviews?

Because of security-related delays in mail processing for the White House, comments should be submitted electronically to: OMB_peer_review@omb.eop.gov. Please put the full body of your comments in the text of the electronic message and as an attachment.

Please include your name, title, organization, postal address, telephone number, and e-mail address in the text of the message.

Comments may also be submitted via facsimile to (202) 395-7245.


  


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