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.

Enhancing Credibility of Chemical Safety Studies: Emerging Consensus on Key Assessment Criteria

“…The BPC and Henry and Conrad (2008) both recommended the National Academies (2003) policy on this topic as a good model. The BPC (2009) also noted the disagreement within its own panel regarding whether disclosure should be limited to current interests.…”

“…Henry and Conrad (2008) previously presented a detailed discussion of the GLP regulations that the U.S. EPA and FDA require experimenters to follow in conducting studies to be submitted under FIFRA, TSCA, and FFDCA (FDA 2006; U.S. EPA 1989a, 1989b).…”

“…Four of the five underlying sets of criteria note this fact expressly (Henry and Conrad 2008), constitute a code of good scientific practice (IARC 2008), or call for PIs to adhere to such standards (Brockway and Furcht 2006; Rowe et al 2009). Accordingly, we recommend that any implementation of this criterion judge studies meeting GLPs as more credible than those that do not.…”

“…The check mark (✓) indicates complete or substantial adoption; the qualified check mark (~✓) indicates partial adoption; and the dash (—) indicates absence.aBPC (2009).bRowe et al (2009).cHenry and Conrad (2008).dIARC (2008).eBrockway and Furcht (2006).…”

Conrad and Becker’s “10 Criteria” Fall Short of Addressing Conflicts of Interest in Chemical Safety Studies

“…Henry and Conrad (2008) were funded by the American Chemistry Council, and Rowe et. al.’s paper on financial conflicts and scientific integrity in nutrition research (Rowe et al 2009) was supported by the International Life Sciences Institute (ILSI) North America.…”