EPA, FDA, & USDA Issue Biotechnology Regulatory Plan

The three agencies will work together to implement the plan.

Kristen Kazarian, Managing Editor

May 9, 2024

2 Min Read
EPA, USDA & FDA come up with biotechnology plan
The agencies have identified 5 major areas of biotechnology product regulation where these actions will focus.Felipe Gustavo S Borges / iSTock / Getty Images Plus via Getty Images

The US Environmental Protection Agency (EPA), the US Food and Drug Administration (FDA), and the US Department of Agriculture (USDA) have developed a biotechnology plan to implement regulatory reform, including identification of regulations and guidance documents that can be updated, streamlined, or clarified, and identification of potential new guidance or regulations, where needed.

On September 12, 2022, President Biden issued Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure Bioeconomy,” with the goal of accelerating biotechnology innovation and growing America's bioeconomy across multiple sectors, including health, agriculture, and energy. Among other objectives, the executive order aims to support the safe use of biotechnology products by clarifying and streamlining regulations in service of a science and risk-based, predictable, efficient, and transparent regulatory system.

The executive order describes biotechnology as “technology that applies to and/or is enabled by life sciences innovation or product development.”

The new plan by the three agencies helps meet the President's goals of ensuring public confidence in the biotechnology regulatory system and improving its transparency, predictability, coordination, and efficiency. With engagement from developers and stakeholders, and horizon scanning for novel biotechnology products, the agencies worked collaboratively to develop a cohesive plan. The plan incorporates processes and timelines to implement regulatory reform, such as identifying guidance and regulations to update, streamline, or clarify, and identifying the potential need for new guidance or regulations. The plan supports a whole-of-government approach to the regulation of biotechnology products.

The agencies have identified five major areas of biotechnology product regulation where these actions will focus:

  • Modified plants

  • Modified animals

  • Modified microorganisms

  • Human drugs, biologics, and medical devices

  • Cross-cutting issues

EPA, the FDA and USDA intend to implement the following joint efforts:

  • clarify and streamline regulatory oversight for genetically engineered (GE) plants, animals and microorganisms;

  • update and expand their information sharing through an MOU to improve and broaden communication and coordination of oversight of modified microbes;

  • undertake a pilot project focused on modified microbes to explore and consider the feasibility and costs of developing a web-based tool that informs developers about which agency may regulate a given product category.

The Federal Government established the Coordinated Framework for the Regulation of Biotechnology in 1986 and most recently updated it in 2017. It describes the comprehensive federal regulatory policy for ensuring the safety of biotechnology products, including how EPA, FDA, and USDA share responsibility for regulating many of the products of biotechnology in the US. The Executive Order directs the three agencies to improve how they implement the Coordinated Framework.

In response to the Executive Order, the three regulatory agencies, in consultation with the Office of Science and Technology Policy (OSTP), issued a Request for Information (RFI) to the public to solicit information on regulatory ambiguities, gaps, uncertainties, or inefficiencies in the Coordinated Framework. The agencies received 88 distinct public comments, including a sign-on letter from more than 6,000 members from biotechnology developers, producers, manufacturers, non-governmental organizations, and academia.

The agencies will continue to engage with all interested stakeholders as they implement the plan.

About the Author(s)

Kristen Kazarian

Managing Editor

Kristen Kazarian has been a writer and editor for more than three decades. She has worked at several consumer magazines and B2B publications in the fields of food and beverage, packaging, processing, women's interest, local news, health and nutrition, fashion and beauty, automotive, and computers.

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