Regulatory Science Transparency: Assessment Of Environmental Protection Agency’s Proposed Rule on Strengthening Transparency in Regulatory Science

Authors

  • A. Alan Moghissi Georgetown University
  • Richard A. Calderone Georgetown Univeristy
  • Lisa M. Jaeger Bracewell, LLP, Washington DC
  • Lismary Real
  • Yousef Alessa
  • Mansour Alsharif
  • Henry Debrah
  • Destini Garrison
  • Anita Ginigeme
  • Bralen Lamoureux
  • Yanzhuo Li
  • Yuhan Lin
  • Camden Ogletree
  • Hadeel Shadid
  • Saher Sohail
  • Soha Sohail
  • Misti Persaud
  • Natalie Ephraim
  • Joohye Oh
  • Tianze Pan
  • Lauren Trippe

DOI:

https://doi.org/10.21423/JRS-V07MOGHISSI

Keywords:

Environmental Protection Agency Transparency Rule, pivotal regulatory science, regulatory science transparency, best available regulatory science, controlled transparency, dose response, mathematical model

Abstract

In its proposed rule, Strengthening Transparency in Regulatory Science, the Environmental Protection Agency (EPA) requires transparency in certain areas of regulatory science. The proposed rule mandates public access to the details of studies that address dose response and models. This paper is the result of a study conducted by graduate students at Georgetown University. The study relied upon a specific process for selecting a small number from an exceptionally large number of responses to study the subject. The evaluation of the responses was largely based on Best Available Regulatory Science (BARS) and Metrics for Evaluation of Regulatory Science Claims derived from BARS. The results of the study indicate that opposition to the EPA's proposed rule is largely based on the claim that its implementation would eliminate key studies that contain confidential data from consideration during the regulatory process. Although the proposed rule would allow exemptions from the public access requirements, there is opposition to making exemptions available at the discretion of the EPA Administrator. The study concluded that a regulatory science process called "controlled transparency" would be a reasonable solution to compliance with transparency requirements while protecting confidential information.

https://doi.org/10.21423/jrs-v07moghissi

Author Biographies

A. Alan Moghissi, Georgetown University

Department of Microbiology & Immunology

Georgetown University

Richard A. Calderone, Georgetown Univeristy

Microbiology & Immunology

Professor and Chair

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Witherspoon, N. O. (2018, July 18). Comment submitted by Nsedu Obot Witherspoon, MPH, Executive Director, Children's Environmental Health Network (CEHN) on the Environmental Protection Agency (EPA) Proposed Rule: Strengthening Transparency in Regulatory Science [Disagree]. Retrieved from https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-4597

Wood, S. F. (2018, May 14). Comment submitted by Susan F. Wood, PhD, Executive Director, Jacobs Institute of Women's Health on the Environmental Protection Agency (EPA) Proposed Rule: Strengthening Transparency in Regulatory Science [Agree]. Retrieved from https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-0063

Yamamoto, A. J. (2018, May 30). Comment submitted by Andrew J. Yamamoto, Esq., Editor and Scott D. Pinsky, Esq. Environmental Law Editor, InternationalMosaic.com on the Environmental Protection Agency (EPA) Proposed Rule: Strengthening Transparency in Regulatory Science [Disagree]. Retrieved from https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-1037

Yamamoto, A. J. & Pinsky, S. D. (2018, August 13). Comment submitted by Andrew J. Yamamoto, Esq., Editor and Scott D. Pinsky, Esq., Environmental Law Editor, InternationalMosaic.com on the Environmental Protection Agency (EPA) Proposed Rule: Strengthening Transparency in Regulatory Science [Disagree]. Retrieved from https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-5995

Zarembka, A. (2018, August 30). Comment submitted by A. Zarembka on the Environmental Protection Agency (EPA) Proposed Rule: Strengthening Transparency in Regulatory Science [Disagree]. Retrieved from https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-8655

Zirasri, R. (2018, Aug 22). Comment submitted by R. Zirasri on the Environmental Protection Agency (EPA) Proposed Rule: Strengthening Transparency in Regulatory Science [Disagree]. Retrieved from https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-9291

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2019-09-12

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