U.S. agencies are working together to address regulation of biotechnology products

In formulating the current coordinated framework for regulating biotechnology, the U.S. Food and Drug Administration (FDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA) have used horizon scanning in the search for novel biotechnology products.

biotechnological regulationbiotechnological regulation

U.S. regulatory agencies operating in three sectors: agriculture and environment, have developed a joint plan to “update, streamline and clarify” regulations and oversight mechanisms for biotechnology products.

The plan, developed by the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA), helps achieve U.S. President Biden’s goals, including improving “transparency, predictability, coordination and efficiency.” biotechnology regulatory system, as detailed in Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure U.S. Bioeconomy.”

The order directed the three agencies to improve implementation of the coordinated biotechnology regulatory framework, the FDA said.

The coordinated framework includes a timetable and procedures for implementing regulatory reform. For example, determining which laws or guidelines require change or the potential need for new such policies or rules.

The Biotechnology Regulation: a response to the Implementing Regulation

Following the issuance of a request for information (RFI) and consultation with the Office of Science and Technology Policy (OSTP), the U.S. FDA, EPA, and USDA received comments from the public (88 in total). A letter of signature was also obtained from 6,000 industry representatives. This included organizations such as biotechnology developers, manufacturers and academia.

The FDA emphasized that the collaborators’ plan also meets another of the president’s goals: ensuring public confidence in the biotechnology regulatory system.

According to the FDA, the actions in the plan will focus on five main areas of regulation of biotechnology products:

  1. Modified plants
  2. Modified animals
  3. Modified microorganisms
  4. Human medicines, biological products and medical devices
  5. Cross-cutting issues

Together, the agencies propose:

  • clarify and improve regulatory oversight of genetically modified plants, animals and microorganisms
  • update and expand information exchange to improve and expand communication and coordination of surveillance of modified microorganisms
  • conduct a pilot project on engineered microbes to determine the feasibility and costs of developing a web-based tool that can inform developers about the appropriate regulatory agency for a given product category.

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