Biotech Updates

FDA, EPA, and USDA Release New Documents on Biotechnology Regulation

November 15, 2023

The Food and Drug Administration (FDA), the Environmental Protection Agencies (EPA), and the US Department of Agriculture (USDA) released two documents on the Unified Website for Biotechnology Regulation. The documents are released as a response to President Biden's Executive Order 14081.

The first document is a Report on Stakeholder Outreach Related to Ambiguities, Gaps, Uncertainties in Regulation of Biotechnology Under the Coordinated Framework. The three agencies requested information from the public which led to several themes that emerged, such as (1) requests for greater Regulatory Clarity, 2) requests for greater Regulatory Coordination and Harmonization, 3) requests for Regulatory Reform or Revision, and 4) comments on Regulatory Resources. The commenters also said that the Unified Website for Biotechnology serves as a vital tool for providing clarity. They also suggested improvements, such as leveraging it as a one-stop shop for stakeholder questions and stakeholder updates.

The second document is The Coordinated Framework for the Regulation of Biotechnology: Plain language information on the biotechnology regulatory system for regulating biotechnology products. The Coordinated Framework for the Regulation of Biotechnology outlines a comprehensive US regulatory policy for ensuring the safety of biotechnology products. It was implemented in 1986 and most recently updated in 2017. This policy supports innovation, protects health and the environment, and promotes trust in the regulatory system.

Read more from EPA.

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