U.S. Biotechnology Regulation Gets a Facelift

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Key Takeaways

  • EPA, FDA, and USDA update biotech regulatory framework to enhance transparency and efficiency.
  • Regulatory modifications target plants, animals, microorganisms, human drugs, and biologics.
  • The project includes pilot project for web-based regulatory tools and MOU for better data sharing among agencies.

Focused regulatory revamp in biotechnology targets plants, animals, microorganisms, human drugs, and biologics to simplify oversight.

Three key U.S. agencies — the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the Department of Agriculture (USDA) — have jointly rolled out a plan to revamp their regulatory framework for biotechnology products.

The plan, unveiled on May 8, is a direct outcome of President Biden’s 2022 Executive Order 14081. Its key objective is to encourage public trust in the biotechnology regulatory system and enhance its transparency, predictability, coordination, and efficiency.

For this initiative, the agencies have focused on five key areas of biotechnology product regulation:

  • modified plants
  • animals
  • microorganisms
  • human drugs
  • biologics and medical devices
  • cross-cutting issues.

The joint initiative includes simplifying and clarifying regulatory oversight for genetically engineered plants, animals, and microorganisms. The agencies also aim to enhance their information sharing through a Memorandum of Understanding (MOU) to improve communication and coordination of oversight of modified microbes.

A pilot project focusing on modified microbes is also in the pipeline. This project will explore the feasibility and costs of developing a web-based tool that informs developers about which agency may regulate a given product category.

Biotech regulation in the U.S.

The Coordinated Framework for the Regulation of Biotechnology was first established by the federal government in 1986 in response to developing recombinant DNA (rDNA) techniques in the 1970s, which allowed indiscriminate manipulation of gene sequences in organisms.

However, the Framework was updated in 2017 to outline how the three agencies share responsibility for regulating many of the biotechnology products in the United States. This current iteration adds comprehensibility to the framework and clarifies how these agencies can implement the framework better.

To arrive at this new plan, the agencies, in consultation with the Office of Science and Technology Policy, issued a Request for Information to the public to solicit information on regulatory ambiguities, gaps, or inefficiencies in the Coordinated Framework. According to the FDA’s press release, the agencies received 88 distinct public comments, including a sign-on letter from over 6,000 members from biotechnology developers, academia, manufacturers, and non-governmental organizations.