| Scientific and Legal Perspectives on Science
Generated for Regulatory Activities Carol J. Henry and James W. Conrad, Jr. American Chemistry Council, Arlington,
Virginia, USA Abstract
This article originated from a conference that asked "Should scientific work conducted for purposes of advocacy before regulatory agencies or courts be judged by the same standards as science conducted for other purposes?" In the article, which focuses on the regulatory advocacy context, we argue that it can be and should be. First, we describe a set of standards and practices currently being used to judge the quality of scientific research and testing and explain how these standards and practices assist in judging the quality of research and testing regardless of why the work was conducted. These standards and practices include the federal Information Quality Act, federal Good Laboratory Practice standards, peer review, disclosure of funding sources, and transparency in research policies. The more that scientific information meets these standards and practices, the more likely it is to be of high quality, reliable, reproducible, and credible. We then explore legal issues that may be implicated in any effort to create special rules for science conducted specifically for a regulatory proceeding. Federal administrative law does not provide a basis for treating information in a given proceeding differently depending on its source or the reason for which it was generated. To the contrary, this law positively assures that interested persons have the right to offer their technical expertise toward the solution of regulatory problems. Any proposal to subject scientific information generated for the purpose of a regulatory proceeding to more demanding standards than other scientific information considered in that proceeding would clash with this law and would face significant administrative complexities. In a closely related example, the U.S. Environmental Protection Agency considered but abandoned a program to implement standards aimed at "external" information. Key words: Administrative Procedure Act, agency proceedings, conflict of interest, financial disclosure, industry science, Information Quality Act, interested persons, peer review, regulatory science, right to publish, scientific quality. Environ Health Perspect 116:136–141 (2008) . doi:10.1289/ehp.9978 available via http://dx.doi.org/ [Online 7 November 2007]
This article is part of the mini-monograph "Science for Regulation and Litigation." Address correspondence to J.W. Conrad Jr., Conrad Law & Policy Counsel, 1615 L St. NW, Suite 1350, Washington, DC 20036 USA. Telephone: (202) 822-1970. Fax: (202) 822-1971. E-mail: jamie@conradcounsel.com At the time this article was accepted, C.J.H. and J.W.C. were both employed by the American Chemistry Council. Received 12 December 2006 ; accepted 5 July 2007.
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