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  • Washington Highlights

    EPA Issues Final Rule on Scientific Research


    Heather Pierce, Senior Director, Science Policy & Regulatory Counsel
    Stephen Heinig, Director, Science Policy

    The Environmental Protection Agency (EPA) issued a final rule on Jan. 6 that is entitled “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information.”

    The rule, which is effective immediately, codifies the circumstances under which the agency should give more weight to scientific studies underlying regulatory decision-making. The AAMC and other science groups previously raised concerns that the rule would undermine the impact of the scientific peer review process and would allow the agency to selectively disregard well-designed clinical studies while asserting that the move would increase transparency.

    The AAMC submitted comments with the Association of American Universities, the Association of Public and Land-grant Universities, and the Council on Governmental Relations in response to the 2018 notice of proposed rule-making and the 2020 supplemental notice of proposed rule-making, “Strengthening Transparency in Regulatory Science” [see Washington Highlights, July 13, 2018, May 22, 2020]. In both letters, the groups opposed the move by the agency and asked in 2020 that the agency withdraw the proposed rule and supplemental notice entirely.

    In 2020, the joint letter clarified that “our member organizations take the need for evidenced-based policymaking and commitment to scientific integrity and transparency seriously, and we welcome the opportunity to assist the EPA in achieving those objectives. However, the proposed rule does not further those goals and should not be revised through the [supplemental proposed rule process] but rather rescinded entirely.”