On July 2, 2015, the Executive Office of the President (EOP) issued a memorandum directing the primary agencies that regulate the products of biotechnology—the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA)—to update the Coordinated Framework for the Regulation of Biotechnology by clarifying current roles and responsibilities, develop a long-term strategy to ensure that the Federal biotechnology regulatory system is prepared for the future products of biotechnology, and commission an expert analysis of the future landscape of biotechnology products to support this effort. Through these updates, the Administration has the goal of ensuring public confidence in the regulatory system and improving the transparency, predictability, coordination, and, ultimately, efficiency of the biotechnology regulatory system. The Administration is undertaking this update with a view that regulatory approaches should protect health and the environment while reducing regulatory burdens and avoiding unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers.
As part of this process, the Administration announced it would hold three public meetings in different regions of the country.
Second Public Meeting – clarifying current roles and responsibilities through a discussion of case studies of hypothetical products
At the second public meeting on March 9, representatives from EPA, FDA, USDA, and the White House Office of Science and Technology Policy (OSTP) will review progress made on this effort in the months since the release of the July 2015 EOP memorandum and illustrate the current roles and responsibilities of the EPA, FDA, and USDA regarding biotechnology products by discussing case studies of hypothetical products. There will be several opportunities for questions and answers to clarify the information presented during the case studies.
The Administration has made two documents available prior to the March 9 public meeting: a document with eight case studies of hypothetical biotechnology products and a table of oversight authorities related to biotechnology products. These materials, and the facts and scenarios presented in them, are presented for discussion purposes only. They are in draft form and are still under review at the various agencies. When the contents are finalized, the information will be incorporated into the update to the Coordinated Framework for the Regulation of Biotechnology, which will undergo a comment period.
These two documents can be found here. The information presented in these documents will be discussed at the March 9 public meeting. A brief description of each document follows.
If you would like to be kept up to date on the activities related to the July 2015 EOP memorandum, please sign up here.
Robbie Barbero is Assistant Director for Biological Innovation at the White House Office of Science and Technology Policy.
James Kim is a toxicologist in the Office of Information and Regulatory Affairs at the Office of Management and Budget.