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EPA Issues Proposed Rule to Harmonize EPA-specific Regulations in Revised Common Rule

On December 6, 2018, the U.S. Environmental Protection Agency (EPA) announced it was proposing a rule (83 Fed. Reg. 62760) to harmonize the EPA-specific regulations regarding research involving human subjects conducted or sponsored by EPA or submitted to EPA for regulatory purposes with the revised regulations of the Federal Policy for the Protection of Human Subjects (Common Rule) issued on January 19, 2017 (82 Fed. Reg. 7149).  Specifically, EPA is proposing to amend subparts C, D, K, and M of its regulations relating to human research.  Subpart K, titled “Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-Pregnant, Non-Nursing Adults,” contains the majority of the revisions.  Subparts C and D will be revised to update several numerical citations and subpart M will be revised to correct a typographical error. 

By way of background, the Common Rule governs research with human subjects conducted or supported by federal agencies, but EPA has also promulgated parallel requirements governing research conducted by third parties and then submitted to EPA for regulatory purposes.  In particular, Subpart K addresses human research that may be conducted by third parties and then utilized to support registration of pesticides.   Congress mandated various revisions to the Common Rule (including additional requirements for research involving pregnant women, fetuses, and children), and EPA is now modifying the EPA-specific requirements for human research to assure consistency and uniformity.  These changes are also intended to assure that a single Institutional Review Board (IRB) review meeting the requirements of the Common Rule will be sufficient for any given study.

The proposed rule states that subpart K, “in establishing a process for review of third-party research involving intentional exposure of human subjects, borrows heavily from the provisions contained in the previous version of the Common Rule,” and that it will be revised to “maintain consistency of [IRB] review between agency-conducted or agency-sponsored human research and third-party human research.”  EPA states the consequence of not resolving these discrepancies will be to “create confusion and, more seriously, potential compliance and/or legal liabilities for researchers, institutions, and sponsors who must follow EPA regulations.”  Comments on the proposed rule are due by February 4, 2019

Compliance with the revisions to the Common Rule originally was set for January 19, 2018, but it has been extended to January 21, 2019.  The compliance date for the “cooperative research” Section remains January 20, 2020.  This proposed rule to revise the requirements for third-party research submitted to EPA would not make substantive changes to the previously adopted final revisions to the Common Rule.  The final rule states that cooperative research projects are “those projects covered by this policy that involve more than one institution,” any institution located in the United States that is engaged in cooperative research must “rely upon approval by a single IRB for that portion of the research that is conducted in the United States,” and the reviewing IRB “will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the federal department or agency supporting the research.”

More information on the revision to the Common Rule is available in our blog item “Federal Agencies Announce Revision to Modernize Federal Policy for the Protection of Human Subjects”.

©2019 Bergeson & Campbell, P.C.

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About this Author

Lisa Campbell, Bergeson PC, Federal Insecticide Fungicide Rodenticide Act attorney, TSCA lawyer, environmental statutes legal counsel, regulation compliance law
Partner

Lisa Campbell founded Bergeson & Campbell, P.C. (B&C®) with Lynn Bergeson. Today her practice focuses on many aspects of pesticide and chemical regulation. She counsels clients on a wide range of issues pertaining to exposure and risk assessment, risk communication, and related legal and regulatory aspects of pesticide programs under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). She also counsels B&C clients on various chemical-specific programs under the Toxic Substances Control Act (TSCA) as well as chemicals regulation and...

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Timothy Backstrom, Bergeson Campbell PC, Endangered Species Act attorney, EPA litigation, FIFRA lawyer, Clean Air regulation legal counsel, FOIA law
Of Counsel

Timothy Backstrom spent some 25 years in the U.S. Environmental Protection Agency’s (EPA) Office of General Counsel (OGC) working on pesticide, toxic substances, and air quality issues before coming to Bergeson & Campbell, P.C. (B&C®). He offers an extraordinary understanding of how EPA operates, as well as established relationships with many key players at EPA. He brings substantial litigation experience in both federal courts and administrative adjudications. He served for many years as the OGC’s designated administrative law expert and, among many accomplishments, he headed the trial team when EPA intervened in a hearing concerning a request for an exemption from the Endangered Species Act (ESA) for the northern spotted owl.

Besides insider knowledge of EPA, Mr. Backstrom delivers an unusual depth of expertise on pesticide registration issues and air toxics regulation, and a unique understanding of the EPA program requiring registration and testing of fuels and fuel additives. Having a technical background has allowed Mr. Backstrom to develop significant scientific expertise in toxicology and risk assessment. In the context of pesticide adjudications, he has presented and cross-examined numerous scientific witnesses. For many clients, he has identified additional options or theories that were not previously under consideration to resolve regulatory issues and to advance their business objectives.

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