Comments on Peer Review Bulletin Reveal Strong Opposition

A majority of the near 200 comments received by the Office of Management and Budget (OMB) on its Draft Peer Review Bulletin opposed the proposal, calling for its complete withdrawal. OMB’s Aug. 29, 2003 draft bulletin on peer review proposed a more uniform standard of peer review for all federal agencies. The bulletin would establish a variety of strict requirements for agencies conducting peer review including that all "significant regulatory information" be peer reviewed, that a public comment period be added to all peer reviews and that agencies obtain input and approval of their peer review policies from OMB’s Office of Information and Regulatory Affairs (OIRA) and the White House Office of Science and Technology Policy (OSTP). Who Commented Scientists, academics and individuals submitted 107 out of the 187 comments listed in OMB’s docket, comprising the majority of comments OMB received on the bulletin. Industry, including companies, industry associations and corporate law firms, was the second largest segment of submissions with 49 comments. The docket contained 25 comments from the public interest sector with submissions from non-profit organizations, scientific societies, and academic associations. OMB also received 6 comments from government sources including state agencies and congressional offices. Opposition The majority (108) of the comments opposed OMB’s draft bulletin, according to OMB Watch’s tally. Most of these objections came from the academic scientists and public interest groups. These comments ranged from opposing the entire bulletin to voicing intense criticism to some of the bulletin’s fundamental aspects. Among the specific criticisms raised were assertions that OMB did not claim the legal authority to develop government wide peer review policies, that the draft bulletin would not accomplish its goal, and that the proposed policies would result in delay of regulatory action and manipulation of science for political and corporate interests. A large number of these comments requested that OMB eliminate the bulletin. For example David Michaels, a George Washington University Professor and ex-regulator for the Department of Energy, stated that “OMB's proposed bulletin is fundamentally flawed; implementation will not appreciably improve the quality of science used in regulation. I strongly recommend it be withdrawn.” Sheila Jasinoff, a Professor at Harvard’s Kennedy School of Government, agreed by commenting, “These criticisms suggest that the proposal in its present form will not achieve the goals of the Information Quality Act and may undermine the goals and purposes of public health and environmental legislation. The proposal should be withdrawn or else radically revised so as to leave much greater discretion within the expert regulatory agencies to tailor their review practices consistently with their legal mandates and policy missions.” Many also advised OMB to start engaging scientists and government agencies in a more open and participatory process if it wished to improve government peer review through policy development. For instance, Physics Professor Steven Federman from the University of Toledo, a former panelist for NASA peer review noted: “Recognizing that peer review of science in the regulatory context is an important process, the scientific community should be engaged in this discussion. … The OMB should withdraw the proposed Bulletin and engage the scientific community in an open, transparent process.” Supporters OMB received 66 comments that strongly supported the agency’s draft bulletin. The majority of supportive comments came from industry submissions and ranged from approval to minor criticisms and recommendations. These submitters supported OMB’s authority to design such broad peer review policies and claimed that the proposed policies would greatly enhance the reliability of government regulations. The Styrene Information and Research Center recommended OMB “finalize this Bulletin expeditiously, after review of submitted comments.” The American Petroleum Institute stated that it “agrees with the need for peer review guidance, and expresses its strong support for OMB's development of the Peer Review Bulletin.” Many of the more detailed supportive comments dismissed the negative consequences warned of in comments submitted by those opposing the draft bulletin. In several of these comments, the main criticisms were that the proposed policies should be more stringent or used more broadly. The Chlorine Chemistry Council supported the bulletin, but recommended going an additional step and removing management of peer review from the agencies entirely. The American Chemistry Council recommended expanding the scope of the bulletin to “require external peer review, not only for especially significant information, but also for all influential/significant regulatory information that is either; precedential or novel, particularly controversial, or highly complex.” Mixed/Neutral OMB also received mixed or neutral comments from a small handful of submitters. Only 13 comments appeared to take no position on the overall draft bulletin. Most of these comments came from individuals whom submitted specific minor criticisms or general support of improving peer review without explaining their position on the overall draft bulletin.
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