The application of peer review to the science involved in regulatory decision making is a relatively new phenomenon. As regulatory agencies are increasingly called upon to make decisions and issue rules on the basis of increasingly complex science, they have developed quality assurance programs that share characteristics with editorial peer review and peer review for allocation of funding. The federal regulatory agency with the most well-known engagement in the peer review process is the Environmental Protection Agency (EPA), whose regulatory needs require research involving an extraordinarily wide range of science and technology disciplines.
The EPA’s Science Advisory Board (SAB) was first appointed, following Congressional Authorization, in 1978; its broad mission includes “reviewing the quality and relevance of the scientific and technical information being used or proposed as the basis for Agency regulations.” Despite the existence of the SAB, regulated parties, generally polluters or producers of hazardous products, have claimed that the science used by EPA in developing regulations, risk assessments, and other EPA activities was biased or otherwise questionable. They have called for peer review, or better peer review, of the EPA documents in question. In responding to these concerns, both the EPA and the National Academy of Sciences have convened groups of experts to evaluate the quality of science at the Agency. In 1992, for example, the EPA appointed a committee of independent academic scientists, who issued the report "Safeguarding the Future: Credible Science, Credible Decisions." After reviewing the production and evaluation of science at the EPA, these observers recommended that "quality assurance and peer review should be applied to the planning and results of all scientific and technical efforts to obtain data used for guidance and decisions at EPA, including such efforts in the program and regional offices. Such a requirement is essential if EPA is to be perceived as a credible, unbiased source of environmental and health information, both in the United States and throughout the world." (p. 7)
Since the first Bush Administration, EPA policy has required that major scientific and technical work products related to agency decisions be peer reviewed, with independent or external peer review required for those documents supporting the most important decisions. In 1998, Carol Browner, EPA Administrator in the Clinton Administration, issued a detailed handbook to ensure uniform implementation of the peer review policy. This policy, revised and reissued in 2000, has been endorsed by several subsequent reports. It stipulates that scientific and technical work products that both support a regulatory program or policy position and meet certain additional criteria, the first of which is that the work product “establishes a significant precedent, model, or methodology,” (p. 26-7) shall be considered candidates for peer review. This policy recognizes that many of the studies and reviews used to support regulatory activity are not novel, but rather summaries and recapitulations of work that had already been subjected to other quality assurance processes and therefore not in need of additional review.
Read more:
Background: Background on peer review of scientific information.
Recent developments in peer review of regulatory science: Information about the stated purpose of the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA) guidelines (first proposed in August 2003) and criticisms of the proposal.
Proposal revisions: Revisions to the proposal, published in April 2004, and the final proposal, published in December 2004.
Additional Resources
