Lieberman, Durbin Seek Withdrawal of Peer Review Proposal That Thwarts Protective Regulation

WASHINGTON – Governmental Affairs Committee Ranking Member Joe Lieberman, D-Conn., and Oversight of Government Management Subcommittee Ranking Member Richard Durbin, D-Ill., Tuesday asked the Office of Management and Budget to withdraw a skewed scientific peer review proposal that could hamper agency programs to protect the public health and safety, consumers, and the environment. The two senators stressed their support for rigorous, scientific peer review. But, the proposal, they wrote in a letter to OMB Director Joshua Bolton and Office of Information and Regulatory Affairs Administrator John Graham, shows a “consistent tilt against the efforts of agencies to protect the public.”

“Far from reducing bias in reviews of agencies’ use and dissemination of scientific information,” Lieberman and Durbin wrote, “this proposal is skewed against protective regulation, and could enable even more White House meddling in agencies’ efforts to rely on objective regulatory science.” Below is a copy of the letter: March 23 , 2004 The Honorable Joshua Bolten Director The Office of Management and Budget 725 17th Street NW Washington, DC 20503 The Honorable John D. Graham Administrator Office of Information and Regulatory Affairs Office of Management and Budget 725 17th Street, N.W. Washington, D.C. 20503 Dear Mr. Bolten and Dr. Graham: We are writing to urge you to withdraw the Proposed Bulletin on Peer Review and Information Quality, published in the Federal Register by OMB’s Office of Information and Regulatory Affairs (OIRA) on September 15, 2003. The proposal requires that, before disseminating any significant regulatory information, an agency must undertake “scientifically-rigorous peer review,” and, if the information supports major regulatory activity, the agency must follow a strict regimen of “formal, independent, external peer review” prescribed by OIRA. We strongly support the rigorous evaluation of scientific information used and disseminated by regulatory agencies, including the vetting of agencies’ scientific evaluations with those who are best in their field and are willing to devote the time to such a review. However, we are concerned that this proposal would not achieve such a goal, but would instead impair the ability of agencies to protect the public health, safety, and the environment. Moreover, far from reducing bias in reviews of agencies’ use and dissemination of scientific information, this proposal is skewed against protective regulation, and could enable even more White House meddling in agencies’ efforts to rely on objective regulatory science. The specific requirements of the Bulletin show a consistent tilt against the efforts of agencies to protect the public. Without citing any evidence showing that scientists who receive government funding actually exhibit bias, the proposed Bulletin explicitly instructs against allowing scientists who work for the agency, or who receive funding from the agency, however indirectly (such as through a university), to participate in peer review. Yet the Bulletin does nothing to discourage the appointment of scientists who receive industry funding or have other ties to affected industries, unless they have an actual financial interest in the scientific matter at issue. Thus, even where the scientific information under consideration is produced by the regulated industry, not by the agency, the proposed rules would welcome review by industry-funded scientists, but not by agency-funded scientists – a particularly stark example of the Bulletin’s pro-industry skew. Moreover, the procedures that the Bulletin requires would impose substantial costs and would delay agencies’ efforts to release scientific information or use it to protect the public. The peer review regimen prescribed in the Bulletin is lengthy and expensive: the agency must establish the purpose and scope of the review, suitable reviewers must be enlisted, public comments must be solicited and provided to the reviewers, the review must be conducted and a report prepared, and the agency must prepare a response to the report. The end result will be many months of additional delay in agency efforts to prevent harm to health and safety, and substantial agency resources will be spent that could otherwise be used to protect the public – all without any apparent effort by OMB to ascertain the actual costs of its proposal, or to demonstrate whether an actual problem exists in agency review procedures that this proposal is designed to solve. It is curious that OIRA – an office known for insisting on cost-benefit analyses – provides no estimate of costs, nor documentation of the benefits gained or specific harms that will be reduced by the proposal. We suggest that the proposed rules do not pass OMB’s own test of good rulemaking. This proposal would not only govern the development of major scientific policies and rules, but also, because the definitions are so broad, would require agencies to delay urgent actions and warnings to protect public safety and health while the peer review requirements are being satisfied. The Bulletin would authorize the OIRA Administrator to waive peer review requirements where an agency presents a compelling rationale, but it is seriously overreaching for OMB to make itself the gate-keeper for every emergency warning issued or action taken by a regulatory agency. It is absurd for OMB to put public health and safety at risk by requiring USDA, for example, to seek and obtain the OIRA Administrator’s permission before acting to forestall a “mad cow” disease outbreak, or for Food and Drug Administration (FDA) to seek and obtain such permission before issuing urgent warnings about adverse reactions to use of a pharmaceutical, or for the Environmental Protection Agency to seek and obtain such permission before taking action to forestall an imminent and substantial endangerment to the public health, safety, or the environment. The Bulletin would also enable the Administration to further politicize science, by giving the White House unfettered power to expedite or delay the release of scientific information and to influence the manner in which it is reviewed by agencies. Not only will the OIRA Administrator have power to waive peer review when the Administration determines that immediate release is desirable, but the Administrator would also be empowered to impose this OMB-supervised process of peer review – including the requirement that the agency consult in advance with OIRA and the White House science and technology office concerning the review – whenever the Administrator asserts that the information is “relevant to an Administration policy priority.” This White House has already built a very troubling record of distorting regulatory science for political ends over the past three years. For example, it stripped critical data on climate change from an EPA report earlier this year and prevented EPA employees from disseminating their best professional advice regarding air quality around Ground Zero in Manhattan following the 9/11 terrorist attacks. Last month a group of 60 prominent scientists, including 20 Nobel Prize winners, released a statement criticizing the Administration’s handling of scientific information, stating, “When scientific knowledge has been found to be in conflict with its political goals, the administration has often manipulated the process through which science enters into its decisions. This has been done by placing people who are professionally unqualified or who have clear conflicts of interest in official posts and on scientific advisory committees; by disbanding existing advisory committees; by censoring and suppressing reports by the government’s own scientists; and by simply not seeking independent scientific advice.”1 The OMB’s proposed rules, by institutionalizing the requirement that expert agencies work with the White House in conducting scientific reviews, would further undermine the public’s confidence in the Administration’s handling of scientific information. Indeed, the reaction of many scientists and science and health organizations to this proposal has been negative;2 and a leading academic expert on the role of peer review in public-policy decision making – whose published work Dr. Graham commended to this Committee in 1999 when we were considering legislation to impose uniform requirements for peer review on regulatory agencies3 – has written that “the Bulletin fundamentally misconceives the nature of science and the function of peer review,” and “[t]he 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 mission.” The legislation was never enacted, for many of the same reasons that now trouble us about this proposed Bulletin.4 We find the proposed Bulletin on peer review to be ill-conceived. We believe strongly that the expert agencies that Congress authorized to implement regulatory policy should decide how best to review scientific information, not politicized offices close to the White House. We urge you to withdraw this proposed Bulletin. Sincerely, Joseph I. Lieberman Ranking Member, Committee on Governmental Affairs Richard Durbin Ranking Member, Subcommittee on Oversight of Government Management ——————————————————————————– 1 The signatories include 20 Nobel Prize winners, 19 recipients of the National Medal of Science, and many former agency heads and science advisors under both Republican and Democratic administrations. See “President’s Science Policy Questioned; Scientists Worry That any Politics Will Compromise Their Credibility,” The Washington Post, February 19, 2004, page A02. 2 Scientific, medical, and public-health organizations that submitted comments opposing the proposed Bulletin include: the National Academy of Sciences, the Association of American Medical Colleges, the Federation of American Scientists, and the Council on Government Relations (an organization of research universities). 3 In testimony before this Committee on April 21, 1999, Dr. Graham described the work of Professor Sheila Jasanoff. S. Hrg. 106-179, April 21, 1999, page 43. Dr. Graham testified that Professor Jasanoff, who is now the Pforzheimer Professor of Science and Technology studies at Harvard University, had found that peer review of analyses performed by agencies is often desirable. 4 See Report of the Committee on Governmental Affairs to accompany S.746, S. Report No. 106-110, July 20, 1999, page 73.