EPA Proposes Rule to Make Agency Science Available to Public

In the April 30, 2018 Federal Register the US EPA published a proposed rule designed to improve public access to the science underlying the agency’s major regulatory decisions.  The proposed rule would apply only to the science behind final regulations.  The science behind other agency actions, such as enforcement and permitting, is excluded.

The proposal has two main elements.  First, the rule would require EPA to identify all studies relied upon in any final rulemaking.   To the extent practicable, the agency is directed to make all such studies available to the public.

Second, the proposal would require EPA to ensure that “dose response data and models” underlying “pivotal regulatory science” are publicly available in a manner sufficient for independent validation.  The phrase “dose response data and models” is defined to include the data and models used to characterize the quantitative relationship between the amount of dose or exposure to a pollutant and the magnitude of a predicted health or environmental impact.  “Pivotal regulatory science” means the specific scientific studies or analyses that drive the requirements and/or quantitative analysis of EPA final significant regulatory decisions.  In practice, these broad definitions would encompass the science behind the major regulatory actions under most environmental statutes.  For example, rulemaking on NAAQS revisions under the Clean Air Act, TMDLs under the Clean Water Act, and RQ thresholds under EPCRA and CERCLA would likely all fall within the scope of the proposal.  Arguably, any final regulation establishing or amending a numerical emission limit or quantitative reporting requirement would be subject to the rule and the underlying studies would be required to be available for “independent validation.”

Under the proposal, “independent validation” means providing the public with the information necessary for the public to understand, assess, and replicate findings of a study, including:

  • Data (where necessary, data would be made available subject to access and use restrictions);
  • Protocols necessary to understand, assess, and extend conclusions;
  • Computer codes and models involved in the creation and analysis of such information;
  • Recorded factual materials; and
  • Detailed descriptions of how to access and use such information.

Why is this potentially controversial?

Because sound environmental policy should be based on strong science, one might question why a rule purporting to increase transparency about science would even be controversial.  The main concern voiced by opponents of the proposed rule is that it will have a chilling effect on epidemiological studies by requiring personal identifiers of study subjects to be made public.  In other words, no one will agree to participate in a study if there is a risk that their personal medical information would be disclosed.  While this concern could likely be addressed through a robust privacy protection provision in the rule, we expect many of the public comments will be addressing this issue.  The more interesting policy issue is what extent should agency science be shared with a potential skeptical public

The public comment period for the proposal is open through May 30, 2018.

Chris Smith