By Benjamin Policicchio, PhD and Suzanne M. Sensabaugh, MS, MBA

Part 3 – Interagency Communication and Coordination Between FDA, EPA, and USDA

Welcome to part three of this mini-series revolving around the recently-released 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. In the previous two posts, we provided background relevant to this update and then discussed the roles and responsibilities of the primary agencies that regulate biotechnology products, respectively. In this post, we will discuss interagency communication and coordination that exists between the three major federal agencies, Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA).  The Update can be found at the following link.

Interagency communication is essential for the regulation of products that fall under the purview of more than one agency and may necessitate close coordination prior to final decision making. This communication is achieved through two mechanisms: Formal and Ad Hoc Interagency Working Groups and Memoranda of Understanding (MOU).

Formal and ad hoc working groups are established based on need, with one of the most recent examples of this being the formal development of the Biotechnology Working Group by the July 2015 Executive Office of the President Memorandum under the ETIPC committee. This working group developed this update and the accompanying Strategy and will continue the work initiated to fulfill the goals identified in the 2015 EOP memorandum.

Ad hoc groups are developed as necessary during agencies’ reviews of biotechnology products and are formed to facilitate discussions among relevant agencies. The update provides the following example: “…during the new animal drug review process, FDA may consult with other Federal agencies such as EPA, the U.S. Fish and Wildlife Service (FWS), National Marine Fisheries Service, and/or the U.S. Centers for Disease Control and Prevention (CDC). Similarly, other Federal agencies and departments, such as the National Institutes of Health, Department of Defense, Department of Homeland Security, Department of Commerce, Department of State, and others, are informed and consulted, as necessary and relevant.”

MOU are put in place by FDA, EPA, and USDA to enhance coordination and enable sharing of information among the agencies. The update lists three specific MOUs relevant to biotechnology products:

•    In July 2009, the EPA’s Office of Pesticide Programs’ Biopesticide and Pollution Prevention Division and USDA’s Animal and Plant Health Inspection Service’s Biotechnology Regulatory Services (BRS) entered into a science review work share MOU (09-2000-00520MU) for the purpose of sharing and utilizing science reviews of product characterization of plant incorporated protectants.

•   In February 2011, the EPA, FDA and USDA/APHIS BRS entered into an MOU (10-2000-0058-MU) to support and encourage cooperation and communication among the three agencies in the regulatory oversight over genetically engineered plants and the foods derived from such plants.

•   In October 2012, the EPA Office of Chemical Safety and Pollution Prevention (OCSPP) Office of Pesticide Programs (OPP), USDA/APHIS Plant Protection and Quarantine (PPQ), and USDA/APHIS BRS entered into the Microbial Pesticide Memorandum of Understanding, whereby the above offices agree to share, on a reciprocal basis, information of microbial pesticides related to their respective programs regulating microorganisms.

As a general matter, when FDA, EPA, or USDA need expertise from other agencies to assess fully the safety of a biotechnology product, that expertise can be accessed through interagency communication.

In the final post of this mini-series, we will discuss the roles and responsibilities of each major agency and proposed future reviews of and updates to the Coordinated Framework.

Suzanne Sensabaugh

Suzanne M. Sensabaugh has advanced the development of over 130 biologics, biosimilars, and combination products since 2009. She can be reached at smsensabaugh@hw-fda.com.