USDA, EPA, and FDA Post Report on Stakeholder Comments on Coordinated Framework for the Regulation of Biotechnology and Plain-Language Regulatory Information

Lexology November 14, 2023
Bergeson & Campbell PC

On November 13, 2023, the U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA) posted the following documents on the Unified Website for Biotechnology Regulation:

• Report on Stakeholder Outreach Related to Ambiguities, Gaps, Uncertainties in Regulation of Biotechnology Under the Coordinated Framework (Report on Stakeholder Outreach) (Mar. 11, 2023); and

• The Coordinated Framework for the Regulation of Biotechnology: Plain language information on the biotechnology regulatory system (Plain Language Document) (Nov. 2023).

As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative to accelerate biotechnology innovation and grow America’s bioeconomy...

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