title: Scientific and legal perspectives on science generated for regulatory activities.
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.
authors.affiliation: American Chemistry Council, Arlington, Virginia, USA.
authors.forename: Carol J
authors.initials: CJ
authors.lastname: Henry
authors.forename: James W
authors.initials: JW
authors.lastname: Conrad
mesh_terms: D016265:Conflict of Interest; D033161:Government Regulation; D017712:Peer Review, Research; D011287:Prejudice; D011786:Quality Control; D012586:Science / Q000331:legislation & jurisprudence* / Q000592:standards