Scientific and Legal Perspectives on Science Generated for Regulatory Activities

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Research | Mini-Monograph

Scientific and Legal Perspectives on Science Generated for Regulatory Activities

Carol J. Henry and 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]

http://www.ehponline.org/docs/2007/9978/abstract.html

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This article is part of the mini-monograph " Science for Regulation and

Litigation. "

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