Last July, the White House called 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 separates responsibility for regulating genetically engineered crops, also known as genetically modified organisms (GMOs), and other biotechnology products between the three agencies.
As part of the update process, the agencies are holding listening sessions in different parts of the country to allow the public to participate. The first session was held last October in Washington, D.C., and the White House this week announced the dates and locations of the remaining two sessions.
The second meeting will be held March 9 at an EPA office in Dallas, and the third will be held March 30 at the University of California – Davis in Davis, Calif. Additional details on meeting times, agendas and how to participate will be announced in a Federal Register notice and on agency websites prior to the meetings.
In addition, the National Academies of Sciences, Engineering, and Medicine announced a new consensus study being conducted as part of a White House initiative. Sponsored by the three agencies, the study will focus on “Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System.”
Enhancing Public Confidence and Transparency
The memorandum, "Modernizing the Regulatory System for Biotechnology Products," 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 memorandum and a White House blog post titled “Improving Transparency and Ensuring Continued Safety in Biotechnology,” were written by:
- 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.
For more information, contact Emily Lyons, IDFA director of regulatory affairs and counsel, at email@example.com.