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The Office of Management and Budget (OMB) has proposed that independent scientists conduct searching reviews of the technical information that federal agencies use in writing regulations and making policy. Agencies would have to upgrade their scientific “peer review” procedures significantly under a new OMB bulletin that is already receiving major attention from a host of agencies, the scientific community, nonprofit activist organizations and industry. See 68 Fed. Reg. 54023 (Sept. 15, 2003). Critics cite potential regulatory delays and a new level of intrusion of the White House’s OMB into agency decision-making by its Office of Information and Regulatory Affairs headed by John Graham. But the bulletin may help ensure that basic scientific and technical conclusions are formulated more objectively, with an early and complete record of what a broader range of independent scientists think about the science behind new federal initiatives. If the science can be made stronger at the inception, then regulatory disputes could be less contentious, more science-based, less subject to last-minute political intervention and more quickly resolved because they are less shrouded in mystery about how the agencies reach technical conclusions that underpin the costliest regulations and most important policies. The bulletin builds on the Information Quality Law, Pub. L. 106-554, under which 28 major information-quality challenges have been filed by private citizens, industry associations, liberal and conservative nongovernmental organizations, and even federal entities (not the deluge or delay some predicted). See Frederick R. Anderson, “Data Quality Act,” NLJ, Oct. 14, 2002, at B9. The bulletin is the latest step in what is rapidly becoming an information “due process” movement, rather than just another traditional OMB government information-oversight measure. Some agencies fail to use peer review adequately or at all, according to OMB. It criticizes agencies for heavy use of their own staffs and of outside peer reviewers who depend on agency contracts and grants, and for repeated use of the same reviewers whose reviews favor agency positions. Thus OMB seeks to correct an imbalance between the existing rigorous vetting of industry reviewers and the less exacting standards applied to federal and federally supported scientists. ‘Formal, independent, external’ peer review The bulletin proposes governmentwide, OMB-supervised “formal, independent, external” peer review procedures for “especially significant” regulatory information that may require 200 or more draft technical documents to be reviewed yearly. It provides for unbiased, unconflicted selection of peer reviewers and for a detailed written charge to reviewers. Most information covered will be for use in major regulations ($100 million impact), but if information has a “clear and substantial” impact on important public policies or important private- sector decisions (also $100 million), or high interagency interest, or implications for the administration’s policy priorities, it would be covered as well. The bulletin will certainly have an early and broad impact on the technical justifications federal agencies must prepare. A few examples include global-warming climate analysis; vehicle safety and gasoline mileage studies; studies of energy availability, use and environmental impact; controversial major pollution, chemical and pesticide risk studies; biotechnology assessments; cleanup studies of waste sites; the secretary of Health and Human Services’ annual report on cancer-causing chemicals; workplace ergonomics science; health risk studies on, e.g., food contaminants; endangered species habitat designations by the Department of the Interior; and some terrorism assessments (but the bulletin exempts foreign affairs and national security documents). The bulletin mandates technical review long before-even years before-the usual probing through agency rule-making and judicial review. It requires each agency to start early by reporting annually on “existing, ongoing, or contemplated” regulatory science documents. This public “roster” of important developing federal information and science will appear long before already-required “regulatory agendas” and “regulatory calendars.” The roster will reveal the unfolding scientific case for regulation well in advance, together with the specific peer-review process the agency proposes to use. The public nature of the roster means that other agencies, state and local government, industry and the public have an opportunity to suggest appropriate peer-review procedures, as well as to provide comments on the document itself for use by the peer reviewers. Such “early warning” to stakeholders means they cannot sit on their hands and let the scientific case develop, then challenge it in later regulatory proceedings. Much is left to be fashioned later by agencies, under OMB oversight. Existing guidelines and practices will have to be rewritten, at least somewhat. The bulletin asks the agencies to tailor the intensity of peer review to the importance of their documents, which opens up the possibility of many “hybrids” of peer review. The Office of Information and Regulatory Affairs may add suggestions and help fashion peer reviews that fit the complexity, importance or controversy surrounding the documents’ subject matter. One intriguing OMB recommendation is use of technical panels that would join in writing one peer review. Public comment may suggest other specific methods. Having come this far, the question remains whether the OMB itself or a new entity should directly arrange peer review of agency documents. The closest the bulletin comes to this approach is to suggest that an agency may want to hire an outside firm to oversee peer review, provided its independence is assured. But this suggestion may have been made only to provide agencies with a way to avoid the strictures of the Federal Advisory Committee Act. The success of bulletin review depends on the role of the Office of Information and Regulatory Affairs. The same is true for the basic Information Quality Act scheme and Executive Order 12866 requirements that provide the backdrop for this bulletin. The bulletin defines the office’s role in supervision, assistance and oversight, one that stops abruptly short of involvement in the actual selection of the peer reviewers. The impact, governmentwide, of any one agency’s science receives special attention in the bulletin. Departments with energy, defense, agriculture, social services and commerce portfolios must bear, along with the private sector, the cost and regulatory consequences of science developed by the Environmental Protection Agency, the Interior Department and other agencies. The bulletin states that OMB may bring additional agencies-not just federal, but state and local ones as well-into peer review to obtain their comments. In fact, the bulletin suggests that if all bulletin requirements are met, interagency comment may constitute the entire peer review. The OMB may make interagency comments public and may direct their inclusion in the record when regulations are written. The process is intended to be transparent throughout. The four basic steps are selection of reviewers whose identities and affiliations are made public; public technical comment provided to the reviewers; public written peer reviews; and public written agency responses to each peer review. Such transparency is not practiced by the leading scientific journals, which keep the identities and critiques of their reviewers secret. The difference between OMB peer review and scientific-journal peer review is bound to receive major attention in the comment process. Reconciling the two is vital if the new notice-and-comment peer review in a fishbowl is to obtain support from the scientific community. Scientists who agree to review “especially significant regulatory information” may embroil themselves in public controversy and assume a workload that far exceeds peer reviewing for a scientific publication. A few hours in one’s office reviewing someone’s paper is a far cry from publicly reviewing a long federal document that relies on scores of technical papers. Going beyond scientific-journal peer review The OMB’s rigorous transparency standard would seem to require lifting the veil of secrecy surrounding the peer review of any journal article on which an agency relies in regulation. But the bulletin says that journal review “may generally be presumed to be adequate,” although it may be rebutted by a “persuasive” showing that the journal’s review was flawed. Yet journal peer review does not come close to satisfying the strict standards the bulletin would impose for “especially significant” information, and the draft bulletin’s deference to journal peer review may have to be abandoned. The new transparent, searching and independent “federalized” peer review of especially significant regulatory science will need to go well beyond journal peer review. No journal would certify its articles as ready for “prime time” in policy making. Agency reliance on a study for high-stakes, high-cost regulation is a different matter entirely. Peer reviews and agency responses must be included in the administrative record of decision, which will become part of the record on judicial review. A court trying to make sense of an agency’s defense of a regulation would benefit from an external, formal critique by scientists who do not have close ties to the agency in question-not to mention prior public technical comment and the agency’s focused responses to peer-review criticisms. A court may be more inclined to immerse itself in the technical issues involved in a regulation, and less inclined to defer to agency discretion, once provided with a distilled, clear picture of the key scientific issues that an agency had to resolve. A question left open is if courts can review agency failure to apply the bulletin. This question also remains open under the Information Quality Law and guidelines on which this bulletin would be based. Comments are due on Dec. 15. Frederick R. Anderson is a partner in the Washington office of New York’s Cadwalader, Wickersham & Taft. He will co-chair a panel discussion of the OMB bulletin at the annual meeting of the American Bar Association’s Administrative Law and Regulatory Practice Section at 3:30 p.m. on Nov. 6 at the New Washington Convention Center.

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