Bipartisan Center Report On Science In Federal Regulation

Aug 5: A bipartisan panel of top scientific and regulatory experts released recommendations calling on the White House and Federal agencies to make specific changes in the regulatory process to clearly distinguish scientific questions from policy disputes. The report comes from the Science for Policy Project (SPP), a project of the Bipartisan Policy Center (BPC). BPC is a non-profit organization that was established in 2007 by former Senate Majority Leaders Howard Baker, Tom Daschle, Bob Dole and George Mitchell to provide a forum where tough policy challenges can be addressed in a pragmatic and politically viable manner.

The SPP is co-chaired by former Rep. Sherwood Boehlert (R-NY), past chair of the House Science Committee, and Donald Kennedy, former editor of Science; and eleven other ideologically diverse members from business, academia, government and non-profits. Boehlert said, "The fundamental theme of the report is that the Administration needs to put in place procedures to try to distinguish science questions from policy questions. Often, policy disputes are cast as fights over science. This damages the credibility of science and obscures the real issues that ought to be debated. For example, how much risk a substance poses to human health or the environment is a science question; how much risk is acceptable is a policy question."

The report recommends requiring new information when regulations are proposed by agencies such as U.S. EPA and the FDA, and enhancing the credibility of Federal advisory committees to ensure the integrity of science in regulatory policymaking. Many of these recommendations are relevant to the White House and Federal agency effort to implement President Obama's March 9, 2009 Presidential Memorandum on Scientific Integrity [See WIMS 3/10/09]. An interim version of the SPP report was released in March, and the White House has reviewed that report as part of its work to issue guidelines on scientific integrity and regulatory reform, which are expected soon. The report's recommendations include:

• Clarity regarding key science questions needed to write specific regulations. Federal Register notices for proposed regulations 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 make clear what additional science would help resolve remaining questions and might offer policy alternatives that are consistent with the science.
  
• Greater focus on science in advisory committees. Federal agencies should empanel scientific advisory committees – committees that are composed solely of members with relevant scientific expertise – to address science questions relevant to policy, and those panels should not make policy recommendations. Members of such committees should be Special Government Employees, a category that makes them subject to conflict of interest and other ethics rules.
  
• Greater transparency in committee appointment process. The process for appointing committees should be more transparent, with agencies taking steps including seeking names through the Web and asking for comments on proposed individuals on the Web.
  
• More disclosure by committee members. Members of scientific advisory committees should be required to disclose to the government and to the public far more information on their backgrounds than is currently the case so the government and the public can evaluate their qualifications and determine whether their service raises any concern about conflicts of interest or bias.
  
• Clearer conflict of interest rules. The government should set clear rules about what constitutes a conflict of interest for a member of a scientific advisory committee. The government should distinguish clearly between conflict of interest and bias.
  
• Greater transparency in committee selection might allow a limited number of closed committee meetings. If procedures are put in place to make the selection of 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.
  
• Transparency in the use of scientific literature. The process agencies and scientific advisory committees use to review the scientific literature should become more transparent and thorough. In general, papers that have not been peer reviewed should be treated with skepticism, but they should not be automatically excluded.
  
• Legitimate use of Confidential Business Information. The Confidential Business Information designation, which limits public access to information, is legitimate but appears to be overused.
  
• Greater participation in, and improved quality of peer review. Federal agencies, universities and scientific journals need to experiment with ways to encourage more scientists to act as peer reviewers and to experiment with different peer review procedures to see what will improve the quality of reviews.

The Science for Policy Project is funded by the David and Lucile Packard Foundation, the William and Flora Hewlett Foundation, and ExxonMobil Foundation. The project was directed by David Goldston, the former chief of staff of the House Science Committee.

Access a release from BPC (click here). Access the complete 47-page report (click here). Access the BPC website for more information (click here).