On July 17, 2018, the U.S. Environmental Protection Agency (EPA) convened a public hearing on the proposed rule "Strengthening Transparency in Regulatory Science." Stakeholder testimony was scheduled for the three sessions: 8:00 a.m. to 12:00 p.m., 12:00 p.m. to 4:00 p.m., and 4:00 p.m. to 8:00 p.m. Bergeson & Campbell, P.C. (B&C^®) attended the morning session.

A few takeaways from the meeting include:

• Congressman Paul Tonko (D-NY) and Congresswoman Suzanne Bonamici (D-OR) provided testimony. Both opposed the rulemaking.
• Approximately 40 other persons, representing about 25 organizations, provided oral comments. Four witnesses offered support for the proposed rule, one appeared ambivalent, and the remaining witnesses opposed the rulemaking. Particularly vocal at the hearing was the Environmental Defense Fund (EDF). Multiple EDF representatives, including Jennifer McPartland, provided testimony.
• Commentaries made in support of the rulemaking included:
  • EPA should develop principles as part of the overall goal of strengthening transparency.
  • Protection of confidential/proprietary information is needed.
  • Reproducibility is the best way to test for scientific accuracy, but if that is not available, reviewing underlying data is helpful.
  • It is possible to de-identify personal information while providing underlying data for review.
  • It is critical that EPA use data that are reproducible.
  • Industry groups have been harmed by EPA using data from studies that were inappropriate or unreasonable.
  • EPA should extend the rule beyond application for final rules or dose effects.
  • Peer-reviewed publications are not the gold standard in identifying good science. If EPA opts to rely on scientific claims that are inconsistent with other information, it should have access to the underlying data for those claims to ensure they are appropriate for regulatory decision-making.
• Parties opposing the proposal rulemaking urged EPA to withdraw the proposal. Specific comments offered in opposition to the proposal included:
  • EPA failed to show that the rule is necessary.
    • The rule is a bad solution in search of a problem.
    • The proposal is misconceived and unnecessary.
    • The rule will not result in greater transparency, but in weaker standards and less protection to Americans.
    • The current methodology for EPA assessment of science works; no changes are needed.
    • The concern with “secret science” does not reflect reality; the rule is not needed and weakens EPA’s foundation.
  • The rule would limit EPA’s ability to use relevant data which, in turn, would impede EPA’s ability to manage risk.
    • The rule is counter to EPA’s mandate to use “best available science” in decision-making for several statutes, including the amended Toxic Substances Control Act (TSCA).
    • Validity of data and research is based on multiple grounds, including peer review. Shared data is not a factor to determine validity. While there is no dispute on the objective of greater transparency, having access to all underlying data is not necessary.
    • Public sharing is not necessary or possible for all scientific data. Data from older studies may no longer be available. Under this rule, those studies could no longer be used in regulatory decision-making.
    • If this rule had been in place previously, EPA would have been unable to issue past risk management actions on lead or air particulates. The landmark studies used as part of the regulatory process for those substances would not have been deemed “acceptable” under the current proposal.
    • The rule is biased toward industry-funded studies because they would have underlying data available.
    • Personal information collected as part of epidemiology studies must be protected. If participants in epidemiology studies do not have the confidence that their personal information will be protected, such studies will no longer be conducted. There are existing laws that protect privacy information that EPA cannot ignore.
  • EPA failed to engage with scientific groups, including the Science Advisory Board, before issuing the rulemaking.
    • Scientific organizations have been unanimous in their opposition of the rule.
  • The proposal cedes too much discretion to EPA as to what studies to accept or deny under the process.
    • This would result in decisions based on political matters rather than science.
  • Implementation of the rule would be costly.
    • EPA did not conduct a reasonable impact analysis.
    • There is no existing infrastructure for data access as envisioned by the rulemaking.
    • Cost analysis for a similar proposal was approximately $25 million.
  • Other concerns:
    • The review by the Office of Management and Budget of the rule is questionable given the short amount of time expended.
    • The rule runs counter to the Administrative Procedure Act (APA).
    • The rule would affect EPA’s ability to engage in mutual acceptance of data agreements with other countries.
    • The rule is too vague as written to provide meaningful comments.

The proposed rule, issued on April 30, 2018, originally had a comment deadline of May 30, 2018, that was later extended to August 16, 2018.

Legislation that aligns with the conceptual underpinnings of the EPA proposal, H.R. 1430, the Honest and Open New EPA Science Treatment (HONEST) Act of 2017, is pending. It passed the House on March 29, 2017, but has languished in the Senate since. Introduced by Republican Lamar Smith (R-TX), the bill would amend the Environmental Research, Development, and Demonstration Authorization Act of 1978 to prohibit EPA from proposing, issuing in final, or disseminating a “covered action” unless all scientific and technical information relied on to support such action: (1) is the best available science; (2) has been specifically identified; and (3) is publicly available in a manner sufficient for independent analysis and substantial reproduction of research results. A “covered action” includes a risk, exposure, or hazard assessment, criteria document, standard, limitation, regulation, regulatory impact analysis, or guidance. Personally identifiable information, trade secrets, or commercial or financial information obtained from a person that is privileged or confidential must be redacted prior to public availability.

This topic shows no sign of slowing down or resolving soon. More information on the rule is available in our memorandum EPA Releases Strengthening Transparency in Regulatory Science Proposed Rule.

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