Formal Agreement between USDA and FDA Relative to Cooperation and Coordination
PART 1 – BACKGROUND: The U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) are committed to increasing regulatory and operational efficiency and improving program effectiveness through enhanced collaboration and coordination on areas of mutual interest. These areas include matters that: substantially affect the public health, provide information to Americans about the food they consume, or have an impact on trade and the economic well-being of the American public.
PART 2 – PURPOSE: The purpose of this agreement is to document and formalize ongoing coordination and collaborative efforts between the USDA and the FDA relative to issues of shared concern.
USDA and FDA will constitute interagency workgroups to improve coordination on issues of common concern including, but not limited to, the following:
Dual-Jurisdiction Food Facilities: USDA and FDA share jurisdiction over food products in interstate commerce. USDA regulates certain meat, poultry and egg products under the Federal Meat Inspection Act (FMIA), Poultry Products Inspection Act (PPIA) and Egg Products Inspection Act (EPIA) and implementing regulations; FDA regulates all other foods not within the scope of these statutes and regulations, using its authorities under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. Under the shared responsibilities of the current framework, a number of food processing facilities fall under the jurisdiction of both FDA and USDA. Jurisdiction over certain types of facilities may change due to the reinterpretation of policies. In the interest of regulatory efficiency and the effective execution of their respective responsibilities, and to further information sharing outlined in MOU 225-99-2001, USDA and FDA share the goals of identifying and potentially reducing the number of establishments subject to the dual regulatory requirements of USDA and FDA, bringing greater clarity and consistency to jurisdictional decisions under USDA and FDA’s respective authorities, including transition period, and decreasing unnecessary regulatory burdens.
Produce Safety: The FDA Food Safety Modernization Act’s (FSMA) produce safety rule is the first regulatory framework specific to produce farms. In the interest of improving the effectiveness of their respective programs and protecting and promoting the public health through the FSMA produce safety regulations, USDA and FDA are committed to enhancing their collaboration and cooperation on produce safety activities.
Federal Regulation of Biotechnology Products: Pursuant to the Agricultural and Rural Prosperity Task Force’s Report to the President, USDA and FDA are committed to modernizing the Coordinated Framework for the Regulation of Biotechnology and the U.S. agricultural biotechnology regulatory system to develop efficient, science-based regulatory practices for products of biotechnology by working in partnership with other federal agencies on the corresponding National Strategy for Modernizing the Regulatory Systems for Biotechnology Products.
PART 3 – AUTHORITIES: Nothing in this agreement shall lessen the responsibilities or authorities of USDA or FDA under their respective statutory authorities.
PART 4 – STATEMENT OF NO FINANCIAL OBLIGATION: Signature of this agreement does not constitute a financial obligation on the part of USDA or FDA. Each signatory party is to use and manage its own funds in carrying out the purpose of this agreement. Transfers of funds or items of value are not authorized under this agreement.
PART 5 – LIMITATIONS OF COMMITMENT: This agreement and any continuation thereof shall be contingent upon the availability of funds appropriated by the Congress of the United States. It is understood and agreed that any monies allocated for purposes covered by this agreement shall be expended in accordance with its terms and the manner prescribed by the fiscal regulations and/or administrative policies of USDA and FDA making the funds available. If the fiscal resources are to transfer, a separate agreement must be developed by USDA and FDA. This agreement and all associated understandings or agreements will be subject to the applicable policies, rules, regulations, and statutes under which the Participants operate. This agreement does not nullify or negate any existing understandings or agreements between the USDA and FDA, or between either USDA or FDA and any third party. This agreement does not preclude either Participant from entering into additional, separate understandings or agreements with the other Participant or with any third party.
PART 6 – CONGRESSIONAL RESTRICTION: Under 41 USC 22, no member of, or delegate to, Congress shall be admitted to any share or part of the agreement or to any benefit to arise therefrom.
PART 7 – AMENDMENTS: This agreement may be amended at any time by mutual agreement of the participants in writing.
PART 8 – EFFECTIVE DATE, DURATION, AND TERMINATION: This agreement shall become effective upon the date of final signature and shall continue for 10 years but may be modified or discontinued at the request of either participant. Each participant shall provide in writing 60 days' notice in advance of the effective date desired for termination of this agreement or any major modification. The provisions of this agreement shall be reviewed annually.
Signed the 30th day of January 2018 in Washington, DC.
Secretary of Agriculture
Scott Gottlieb, M.D.
Commissioner of Food and Drugs