Clarifying Current Roles and Responsibilities for Biotechnology Products

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.

• The first public meeting was held on October 30, 2015, at the FDA’s White Oak Campus to inform the public about the activities described in the July 2015 memorandum, invite oral comments from interested parties, and provide information about where and how to submit written comments, data, or other information.
• The second public meeting will be held on March 9, 2016 at EPA’s Region 6 Office in Dallas, Texas. For more information about the meeting, including an agenda, visit EPA’s website.
• The third public meeting will be held on March 30, 2016, at the University of California’s Davis Conference Center in Davis, California. Information about that meeting, including an agenda and how to register, will be placed in the docket and on the USDA website prior to the meeting. 

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.

• Case studies: The “case studies” document is intended to present illustrative examples for developers who believe they have, or are uncertain as to whether they may have, a biotechnology product that is subject to regulation under one or more of the Federal laws described in the Coordinated Framework for Regulation of Biotechnology. All the case studies are of hypothetical products. They were selected because they cover multiple biotechnology product areas with different characteristics and intended uses and because they illustrate how agencies coordinate their oversight under the Coordinated Framework for the Regulation of Biotechnology. To access this document, click here.
• Table of authorities related to biotechnology products: The table summarizes current responsibilities and the relevant coordination across USDA, EPA, and FDA for the regulatory oversight of biotechnology products. The information in the table should not be interpreted as a guarantee that specific products in any of the product areas described in the table have been in the past, or will be in the future, determined to be safe by the relative regulatory agencies. To access this document, click here.

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.