From: Science

Wendy Wagner1, Elizabeth Fisher2, Pasky Pascual3

Good laws need good science; however, good science is never guaranteed. Debate over the use of science in law is nearly as old as the laws themselves. With “science wars” waging in health and environmental regulation for at least three-quarters of a century, it is tempting to conclude that recent proposals for reforming regulatory science are similar to what has occurred in the past. They are not. They mark a sharp departure with the past because they legally constrain how agency scientists conduct the initial literature review and synthesis informing policy. Because the reforms generally take the form of legislation or regulation, they do not simply suggest best practices for conducting scientific analyses but establish legal lines that cannot be crossed. Moreover, even though they create legal ground rules for scientific deliberations, the reforms have not been developed by the scientific community, but by members of Congress and political officials. In providing a birds’-eye view of the legal developments in regulatory science over the past 50 years, we identify just how idiosyncratic these current reforms are and why the scientific community needs to be aware of their implications.


Early 1990s to mid-2010s: Increased opportunities to challenge the agency’s scientific record and scientific analyses

Although court challenges allowed stakeholders to hold agencies accountable for their use of science, they did not allow stakeholders to challenge the scientific record itself as it was being developed. Reforms during this time period opened up opportunities for stakeholders to challenge the rigor of this underlying science, although generally not in ways that were enforced by courts. The Information Quality Act, for example, was passed in 2001 to afford aggrieved parties the right to challenge the reliability of information used by an agency at any point, regardless of whether that information was being used to inform a rule or policy. In another piece of legislation, Alabama Senator Richard Shelby inserted a single sentence into a 4000-page budget bill requiring federally funded researchers to provide their data to anyone who requested them under the Freedom of Information Act, explicitly targeting data underlying a controversial but well-regarded (and reviewed) epidemiological study of health impacts of fine particulate air pollutants (the Harvard Six Cities study) (9).


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