Late last week, the White House released a memorandum that calls for the Environmental Protection Agency, the Food and Drug Administration and the U.S. Department of Agriculture to review and update their regulations related to products of biotechnology. This Coordinated Framework, which was established in 1986 and updated in 1992, separates responsibility for regulating genetically engineered crops, also known as genetically modified organisms (GMOs), and other biotechnology products between the three agencies.
In a blog post explaining the memo, four Executive Branch officials said they recognize that “the current regulatory system for biotechnology products effectively protects health and the environment,” but advances in science and technology and the complexity of the current regulations and guidance necessitate modernization of the regulations.
The memorandum directs the agencies to:
- Update the Coordinated Framework by clarifying the roles and responsibilities of the agency and identify which products or product areas each agency is responsible for;
- Develop a long-term strategy to ensure that the agencies are equipped to assess risks associated with future biotechnology products and changing technology; and
- Commission an external, independent analysis of the future landscape of biotechnology to identify potential new risks and risk assessment frameworks and to review areas of risk or non-risk that are well understood.
The White House expects the updated Coordinated Framework and regulations will ensure public confidence in the regulatory system and improve the transparency, predictability, coordination and efficiency of biotechnology regulation.
The agencies will hold three listening sessions over the next year in different parts of the country to allow the public to participate in the Coordinated Framework update. The first session will be held this fall in Washington, D.C., and IDFA plans to participate.
For more details read the White House memorandum, “Modernizing the Regulatory System for Biotechnology Products” and Improving Transparency and Ensuring Continued Safety in Biotechnology. The authors of both documents are:
- John P. Holdren, assistant to the President for Science and Technology and director of the White House Office of Science and Technology Policy;
- Howard Shelanski, administrator of the Office of Information and Regulatory Affairs at the Office of Management and Budget;
- Darci Vetter, chief agricultural negotiator at the Office of the U.S. Trade Representative; and
- Christy Goldfuss, managing director of the White House Council on Environmental Quality.