Updating US Biotechnology Policy

In 2022 the US White House directed the US Environmental Protection Agency (EPA), the US Food and Drug Administration (FDA), and the US Department of Agriculture (USDA) to clarify and streamline regulations for commercialization of biotechnology products, aiming for a science-and risk-based, predictable, efficient, and transparent regulatory system that would accelerate innovation and grow America's bioeconomy.

The agencies have now responded. They have published an ambitious plan for improving regulation of genetically modified plants, animals, microorganisms, human drugs, biologics, and medical devices which includes, among many other items:

• More information sharing between agencies

• Clarification of regulations for genome edited plants to ensure the requirements are proportional to the actual risks.

• More procedural guidance and faster response for participants in FDA’s voluntary consultation program - helping stakeholders understand food safety and leading to higher quality submissions.

• Accelerated rulemaking on which foods should be defined as bioengineered foods.

• Clarification on which modified microorganisms are subject to regulation.

• A promise of new guidance for labeling cultured meat and poultry products within 2024.

By December, the agencies intend to post brief, plain language summaries of the regulatory roles and processes for specific product use categories on the Unified Website for Biotechnology Regulation.

As one of the leading advising firms in this area, at the forefront of biobased and sustainable materials risk assessment for 10+ years, Vireo Advisors will continue to support regulatory compliance in this changing landscape, helping companies develop regulatory strategies, organize required safety testing and communicate with authorities, as well as prepare and submit dossiers. Contact us to learn more.