Press Release

Keith Matthews Authors Chapter in American Chemical Society Volume Addressing ‘Legal Challenges in the Agrochemical Industry’

Focusing on Recent Improvements to Regulatory Approaches to Agricultural Biotechnology
November 13, 2020

Washington, DCKeith A. Matthews, of counsel in Wiley’s Environment & Product Regulation Practice, has authored a chapter in the book Navigating Legal Challenges in the Agrochemical Industry – published by the American Chemical Society (ACS), a client of the firm. The chapter, “Continuing Evolution of the Coordinated Framework: Implications for Agriculture Biotechnology,” focuses on recent improvements to U.S. regulatory policies applicable to agricultural biotechnology under the comprehensive federal guidance document that is intended to ensure the safety of ag biotech products in the United States.

The Coordinated Framework for Regulation of Biotechnology was first published in 1986 and updated in 1992. The Obama Administration initiated a broad-based update and revision of the Coordinated Framework to make it more relevant in the age of CRISPR and other advanced genetic techniques. The Trump Administration made significant strides in implementing these updated policies.

In his chapter on the continuing evolution of the Coordinated Framework, Mr. Matthews describes how federal policymakers initially made the critical decision to base the Coordinated Framework on existing statutes that provide regulatory jurisdiction to the Coordinated Framework agencies: the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA). Mr. Matthews argues that the decision to rely on existing statutes was a crucial mistake, as each agency has struggled over time to “coordinate” their regulatory actions applicable to biotechnology products that fell within their respective jurisdictions. That coordination has been challenging because each agency operates under widely different statutory purposes and regulatory standards.

The chapter analyzes the Obama Administration’s efforts to update the Coordinated Framework’s regulatory approach so the actions of the three federal agencies could be better coordinated, and to improve federal oversight of agricultural biotechnology in light of advances in genetic technologies that are occurring at warp speed. The Trump Administration made significant progress in implementing these updated approaches.

Mr. Matthews has more than 25 years of private sector and government experience in environmental law related to chemical substances regulation, biopesticides, and genetically engineered organisms. He is a former Director of the Biopesticides and Pollution Prevention Division in the EPA’s Office of Pesticide Programs. He previously served in EPA’s Office of General Counsel, first as a staff attorney, and then as an Assistant General Counsel where he supervised attorneys providing legal counsel to programs in the agency’s Office of Air and Radiation, Office of Pesticide Programs, and the Office of Research and Development.

For more details on the ACS book and Mr. Matthews’ chapter, please click here.

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