Improving the Use of Science in Regulatory Policy

bridges vol. 23, October 2009 / Feature Articles

By David Goldston and Josh Trapani

"... Some of the problems at the intersection of science and policy are systemic; they will not magically vanish ..."

The use of science in the formulation of regulatory policy has been a political flashpoint in the U.S. in recent years.  While the issue came to a head and garnered more public attention during the administration of President George W. Bush, some of the problems at the intersection of science and policy are systemic; they will not magically vanish with a change of administrations or a shift in the composition of the Congress.  

A recent report from the Bipartisan Policy Center is designed to help resolve those systemic problems.  (The full text of the report, which includes an Executive Summary, can be found at .)  The report's fundamental point is that too often policy makers conflate science questions and policy questions when debating regulatory matters, and this can confuse the discussion, obscure the real issues and prompt spurious charges about science.  In effect, the report says, problems occur not only when science is "politicized," but also when politics are "scientized," that is when debates that are actually about economics or ethics or policy choices are framed as questions about the validity of findings in the natural or physical sciences.  

The report recommends specific steps the Obama Administration should take to help avoid this confusion of science and politics, and to make the development of regulatory policy more transparent by, for example, clarifying rules concerning conflicts of interest.  

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The report, "Improving the Use of Science in Regulatory Policy," was written by a panel of 13 experts - Republicans and Democrats, liberals and conservatives.  For example, the panel included both John Graham, who as the director of the Office of Information and Regulatory Affairs was considered the "regulatory czar" in the Bush Administration, and Kevin Knobloch, the president of the Union of Concerned Scientists, the organization that was the leading critic of the Bush Administration's use of science.

The panel was co-chaired by former Congressman Sherwood Boehlert of New York, a Republican, who was the chair of the U.S. House Committee on Science from 2001 through 2006, and Donald Kennedy, the former editor of Science and former president of Stanford University, who served as the head of the Food and Drug Administration under President Jimmy Carter.  That such a diverse panel was able to come together on a specific set of recommendations reflects a desire to get beyond the debates of recent years, and to create what the report calls "a more transparent and credible process that fully acknowledges the complexities of reaching scientific conclusions; and in which the disagreements over political ideology, economics and values that are at the heart of many regulatory disputes will be debated openly and fully, not transmogrified into a political battle waged through science."       

The report's most notable recommendations include these:

·    Make clear what science questions needed to be answered to write a regulation.  The notices published in the Federal Register when regulations are proposed or promulgated should make clear what science questions and what policy questions needed to be answered to formulate the regulation, and what science was most influential in drafting the regulation.  The notices might also describe what additional science, if any, would help resolve remaining questions.  The notices might also describe two additional policy options that would be consistent with the science.  

·    Provide greater focus on science in advisory committees.  Federal agencies should empanel scientific advisory committees - committees that are composed exclusively of members with relevant scientific expertise (as opposed to stakeholders) - to address science questions relevant to regulatory policy.  Those panels should not make policy recommendations.  Members of such advisory committees should be appointed as Special Government Employees, a category that makes them subject to conflict-of-interest and other federal ethics rules.

·    Ensure greater transparency in the committee appointment process.  Agencies should consider using the Web to get recommendations for whom to appoint to advisory committees and for getting comments on potential advisory committee members.

·    Require greater disclosure by members of scientific advisory committees.  Members of scientific advisory committees should be required to disclose to the government and to the public far more information on their backgrounds and finances than is currently the case.  Disclosure forms should seek information on activities going back at least five years.

·    Institute clearer conflict-of-interest rules.  The government should set clear and consistent rules about what constitutes a conflict of interest for members of a scientific advisory committee, and should distinguish clearly between conflict of interest and bias.  Agencies should try not to appoint advisory committee members with conflicts of interest, but when they do appoint an individual with a conflict that should be publicly announced and justified.  The legal standard for when it is legitimate to appoint a member with a conflict should be changed to the one used by the National Academy of Sciences.  Chairs or co-chairs of committees should never have conflicts.

·    Consider allowing a limited number of closed committee meetings if appointment procedures become more transparent.  If procedures are put in place to make the selection of scientific advisory committee members more transparent, then the government could consider allowing scientific advisory committees to have a limited number of closed meetings under specific circumstances.  Allowing closed meetings would require Congress to amend the Federal Advisory Committee Act.

·    Ensure greater transparency in the use of scientific literature.  The process agencies and advisory committees use to review the scientific literature related to a regulation should be more transparent and thorough.  Agencies and committees should be explicit about the criteria they use to determine which scientific papers to review and how those papers are evaluated, and should pay more attention to the methodology used in cited work.  In general, papers that have not been peer reviewed should be treated with skepticism, but they should not be automatically excluded.

·    Clarify what constitutes Confidential Business Information.  The Confidential Business Information designation, which limits public access to information, is legitimate, but appears to be overused.  Agencies should consider ways to ensure that the category is being used legitimately, such as requiring businesses to provide a brief but substantive justification for requesting protection.

·    Encourage greater participation in, and improve the quality of peer review.  Federal agencies, universities and scientific journals need to experiment with ways to encourage more scientists to serve as peer reviewers and to experiment with different peer review procedures to see what will improve the quality of reviews.

If these recommendations are implemented, the report says, "[S]cience will be better protected and political values will be more fully debated, enhancing the process of regulatory policy making, and ultimately democracy itself.  The result should be better regulatory policy that protects the public both from needless regulations and from needless dangers."

The report has been well received, and the Obama Administration has been taking it into consideration in preparing its rules on scientific integrity and regulatory reform.

The report was funded by the David and Lucile Packard Foundation, the William and Flora Hewlett Foundation and the ExxonMobil Foundation - the funding itself designed to ensure a balanced report.  The Bipartisan Policy Center began selecting the panel members in the spring of 2008 (in the midst of the Presidential primary season), and the panel was assembled by that fall.  The panel met three times, the first in January 2009, and the report was released in August.


About the authors: David Goldston, the Chief of Staff of the U.S. House Committee on Science from 2002 through 2006, directed the Bipartisan Policy Center's project on science and regulatory policy.  Josh Trapani, a former AAAS science fellow, was the project's staff director.