Public Interest Comment on The Environmental Protection Agency’s Proposed Rule Strengthening Transparency in Regulatory Science

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Susan E. Dudley

May 18, 2018

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The George Washington University Regulatory Studies Center improves regulatory policy through research, education, and outreach. As part of its mission, the Center conducts careful and independent analyses to assess rulemaking proposals from the perspective of the public interest. This comment on the Environmental Protection Agency’s proposed rule to strengthen the transparency of its regulatory science does not represent the views of any particular affected party or special interest, but is designed to evaluate the effect of the proposal on the reliability of the scientific information underlying EPA’s regulatory decisions.


In this proposal, EPA aims to strengthen the transparency of the science it considers “pivotal” to its significant regulatory actions by ensuring that “the data and models underlying the science is publicly available in a manner sufficient for validation and analysis.” It cites existing authorities and policies, but acknowledges, “EPA has not previously implemented these policies and guidance in a robust and consistent manner.”

The rule would not directly regulate non-governmental entities, but instead would require “EPA to ensure that the regulatory science underlying its actions is publicly available in a manner sufficient for independent validation.”[1] The preamble says the policy is “designed to provide a mechanism to increase access to dose response data and models underlying pivotal regulatory science in a manner consistent with statutory requirements for protection of privacy and confidentiality of research participants, protection of proprietary data and confidential business information, and other compelling interests.”[2] In the long run, through this rule, EPA aims “to change agency culture and practices regarding data access so that the scientific justification for regulatory actions is truly available for validation and analysis.”[3]

The proposal defines “dose response data and models” as those “used to characterize the quantitative relationship between the amount of dose or exposure to a pollutant, contaminant, or substance and the magnitude of a predicted health or environmental impact.”[4]Pivotal regulatory science” refers to “specific scientific studies or analyses that drive the requirements and/or quantitative analysis of EPA final significant regulatory decisions.”[5]Regulatory decisions” are limited to “significant regulatory actions” as defined in Executive Order 12866.[6] “Regulatory science means scientific information, including assessments, models, criteria documents, and regulatory impact analyses, that provide the basis for EPA final significant regulatory decisions,” and research data is used as “defined in Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.”[7]

The rule would require EPA to:

  1. Clearly identify all regulatory science it relied on in selecting a regulatory action and make those studies available to the public “to the extent practicable.”[8]
  2. Consistent with laws and sensitive to privacy, confidentiality, and national and homeland security, “ensure that dose response data and models underlying pivotal regulatory science are publicly available in a manner sufficient for independent validation.”[9]
  3. “Describe and document any assumptions and methods used,” including the scientific basis for those assumptions, as well as analysis “showing the sensitivity of the modeled results to alternative assumptions.”[10]
  4. “Give explicit consideration to high quality studies” that may challenge existing default assumptions including “parametric dose-response or concentration-response models; a robust set of potential confounding variables; nonparametric models that incorporate fewer assumptions; various threshold models across the dose or exposure range; and models that investigate factors that might account for spatial heterogeneity.”[11]
  5. “Conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions,” consistent with existing peer review requirements and exemptions.[12]

It is unusual for an agency to provide guidelines such as these through a rulemaking rather than internal guidance; however, the transparency of this rulemaking approach is consistent with the goals of the proposal, and the robustness and legitimacy of any final policy will be enhanced if it is supported by the record the agency develops as it solicits public comment.[13] A 30-day comment period may not provide enough time for constructive input on key issues, however, and a May 12, 2018 memorandum from a working group of EPA’s Science Advisory Board (SAB) argues that this “action merits further review by the SAB.”[14]

EPA also seeks comment on its legal authority for the rulemaking, and the appropriateness of the proposed policies to regulatory decisions developed pursuant to its various statutory mandates. This is important, but this comment will leave those issues to others and focus on the intrinsic merits of the proposal.

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[1]    Proposed §30.1. 83 FR 18773

[2]    83 FR 18770

[3]    83 FR 18770

[4]    Proposed §30.2. 83 FR 18773

[5]    Proposed §30.2. 83 FR 18773

[6]    Proposed §30.2. 83 FR 18773

[7]    Proposed §30.2. 83 FR 18773

[8]    Proposed §30.4. 83 FR 18773

[9]    Proposed §30.5. 83 FR 18773

[10]   Proposed §30.6. 83 FR 18774

[11]   Proposed §30.6. 83 FR 18774

[12]   Proposed §30.7. 83 FR 18774

[13]   Establishing agency administrative practices and procedures via rulemaking is not unprecedented. For example, without legislative mandate, the U.S. Food and Drug Administration used informal rulemaking to codify its Good Guidance Practices. 65 FR 56477, September 19, 2000.

[14]   Alison Cullen, Chair, SAB Work Group on EPA Planned Actions for SAB Consideration of the Underlying Science, Memorandum to Members of the Chartered SAB and SAB Liaisons “Preparations for Chartered Science Advisory Board (SAB) Discussions of Proposed Rule: Strengthening Transparency in Regulatory Science RIN (2080-AA14)” May 12, 2018.$File/WkGrp_memo_2080-AA14_final_05132018.pdf