On November 13, 2019, the House Committee on Science, Space, and Technology held a hearing on “Strengthening Transparency or Silencing Science? The Future of Science in EPA Rulemaking.” The hearing focused on the U.S. Environmental Protection Agency’s (EPA) April 30, 2018, proposed rule on “Strengthening Transparency in Regulatory Science,” as well as a leaked copy of EPA’s supplemental proposed rule that was published by the New York Times on November 11, 2019. Dr. Jennifer Orme-Zavaleta, Principal Deputy Assistant Administrator for Science, EPA Office of Research and Development (ORD), and EPA Science Advisor, emphasized that the version of the supplemental rule that was leaked to the New York Times was not the most current version and is not the same as the supplemental rule that EPA submitted to the Office of Management and Budget (OMB) for review on November 12, 2019. Because the supplemental proposed rule is currently under OMB review, Dr. Orme-Zavaleta could not comment on it. According to Dr. Orme-Zavaleta, EPA expects to publish the supplemental proposed rule for public comment in early 2020.

The Committee heard from the following witnesses (written testimony is hyperlinked):

Panel 1

• Dr. Orme-Zavaleta.

Panel 2

• Dr. Linda S. Birnbaum, Scientist Emeritus, National Institute of Environmental Health Sciences (NIEHS); Director of NIEHS, 2009-2019;

• Dr. Mary B. Rice, Assistant Professor of Medicine, Harvard Medical School; Pulmonary and Critical Care Physician, Beth Israel Deaconess Medical Center;

• Dr. David Allison, Dean, School of Public Health, Indiana University-Bloomington; Member, “Reproducibility and Replicability in Science” Committee, The National Academies of Sciences, Engineering, and Medicine;

• Dr. Brian Nosek, Co-Founder and Executive Director, Center for Open Science; and

• Dr. Todd Sherer, Chief Executive Officer (CEO), The Michael J. Fox Foundation for Parkinson’s Research.

Dr. Orme-Zavaleta testified that EPA is committed to transparency and providing the public access to its data and research results. After issuing the proposed rule in 2018, EPA has worked to address the thousands of unique comments and solicited feedback from the Science Advisory Board (SAB) on existing mechanisms for secure access to personally identifying information (PII) and confidential business information (CBI). SAB provided its report to EPA in September 2019 and is preparing comments on the proposed rule as a whole. According to Dr. Orme-Zavaleta, EPA developed the supplemental proposed rule to provide clarification on certain terms and aspects of that proposed rule. EPA is committed to ensuring adequate time for public review of the supplemental rule and anticipates releasing it for public comment in early 2020.

During her testimony, Dr. Orme-Zavaleta stated that she wished to clarify a few things regarding the older draft version of the supplemental rule that was leaked to the New York Times: (1) the leaked rule was an outdated version and is not what EPA sent to OMB; (2) the supplemental proposed rule is a supplement to the 2018 proposed rule that contains clarifications, modifications, and additions to certain provisions in the proposed rule; and (3) the proposed rule applies prospectively to regulations and does not apply to already established rules and regulations.

After Dr. Orme-Zavaleta testified, Committee Chair Eddie Bernice Johnson (D-TX) asked about a provision in the 2018 proposed rule that would allow the EPA Administrator to exempt unilaterally a study from the requirements of the rule and whether it is appropriate for a political appointee to have this arbitrary power over EPA science. Dr. Orme-Zavaleta responded that this is an issue on which EPA received a number of comments from a variety of different sectors, and EPA is weighing these comments “very heavily” in developing the final rule.

Representative Paul Tonko (D-NY) noted that the language of EPA’s 2018 proposed rule tracks the language of the Secret Science Reform Act of 2014 (H.R. 4012) introduced in 2014, the Secret Science Reform Act of 2015 (H.R. 1030) introduced in 2015, and the Honest and Open New EPA Science Treatment Act of 2017 (HONEST Act) introduced in 2017. These are bills that Congress has refused to pass. When asked whether EPA was aware that Congress had already rejected legislation similar to the 2018 proposed rule, Dr. Orme-Zavaleta responded that she assumed so, but she does not know.

Members of the second panel noted flaws with the proposed rule. Dr. Birnbaum testified that human studies require confidentiality to be conducted and that it is unethical to reveal individual human data. Dr. Rice stated that the proposed rule would effectively block the use of most epidemiological research studies from EPA rulemaking because it would exclude studies whose underlying data cannot be shared in a public database. Dr. Allison testified as a member of the National Academies Committee on Reproducibility and Replicability in Science, stating that there must be flexibility to allow consideration and discussion of data even when those data have limitations, including, but not limited to, incomplete transparency or reproducibility of some data sets and studies. According to Dr. Nosek, it is important to use the best available evidence for rulemaking, but there will always be occasions when the best available evidence is not fully transparent or has unknown reproducibility. Dr. Sherer stated that if the proposed rule were enacted, thousands of studies would be excluded from EPA’s evaluation when it comes to determining standards, policies, and programs that protect human health and the environment.

Commentary

Given that the supplemental proposed rule is not publicly available, it is impossible to predict whether EPA’s clarifications will resolve the issues many commenters had with the proposed rule. The hearing provided EPA, through Dr. Orme-Zavaleta, an opportunity to clarify that the rule reported on by the New York Times is an outdated draft of the supplemental proposed rule, not a new rule, and not the final supplemental proposed rule. EPA’s plan to issue the supplemental proposed rule for comment in early 2020, consider those comments, and promulgate a final rule in 2020 is ambitious.

Additional Resources

Bergeson & Campbell, P.C. (B&C^®) has prepared the following memoranda regarding EPA’s proposed rule:

• “EPA Releases Strengthening Transparency in Regulatory Science Proposed Rule” (April 20, 2018); and

• “EPA Convenes Public Hearing on Proposed Rule: Strengthening Transparency in Regulatory Science” (July 19, 2018).

The New York Times article on the leaked version of the supplemental proposed rule:

• “E.P.A. to Limit Science Used to Write Public Health Rules” (November 11, 2019).

EPA’s press release responding to the New York Times article:

• “The New York Times’ Several Glaring Inaccuracies ‘That’s Fit To Print’” (November 12, 2019).