PARTNERSHIP AGREEMENT BETWEEN U.S. FOOD AND DRUG ADMINISTRATION DIVISION OF HUMAN AND ANIMAL FOOD WEST 1 AND THE MINNESOTA DEPARTMENT OF AGRICULTURE

I.    PURPOSE

The purpose of this partnership agreement (PA) is to document and formalize a commitment to ongoing coordination and collaborative efforts between the U.S. Food and Drug Administration Division of Human and Animal Food West 1 (HAF-W1) and the Minnesota Department of Agriculture (MDA), (together referred to as “the Partners”).

This PA will support FDA’s implementation and enforcement of the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. § 301 et seq.). FDA responsibilities under the Act include the regulation of human and animal food that is manufactured/processed in the State of Minnesota. The Partners share statutory responsibilities for regulating human and animal food such as food manufactured/processed by facilities subject to the requirements in 21 C.F.R. Part 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food) and 21 C.F.R. Part 507 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Food for Animals).

Similarly, this PA will support MDA’s implementation and enforcement of Chapters 17, 25, and 31 of the Minnesota State Statutes. Continuous conformity with, and implementation of, the manufactured food regulatory program standards and animal feed regulatory program standards is a foundational concept and must be maintained as the Partners work toward achieving domestic mutual reliance and supporting the development of a national integrated food safety system (IFSS).

This PA does not affect or supersede any existing or future agreements, arrangements, contracts, or cooperative agreements between the Partners and does not affect the ability of the Partners to enter into other agreements or arrangements related to this PA.

II.    DURATION OF AGREEMENT

This agreement covers a period of three years from the date of signature. This time frame will give the Partners sufficient time to measure the program outcomes that have resulted from the PA, modify the agreement if warranted, and renew it with consent of the Partners. The Partners will conduct an annual review of this PA and its goals. This PA may be amended or modified by mutual consent of the Partners. Either partner, on its own initiative, may submit a proposed amendment or modification to the PA in writing for the Partners to review and agree upon. Modifications and amendments will be tracked, documented during the annual review, and maintained for historical purposes. This PA is effective upon signing by the Partners. It will remain in effect unless either partner terminates the agreement by providing thirty (30) days written notice to the other partner.

III.    DEFINITIONS and ACRONYMS

• C.F.R. – Code of Federal Regulations DI – FDA Division of Integration
• DIDP – FDA Division of Information Disclosure Policy FDA – Food and Drug Administration
• HAF-W1 – FDA Human and Animal Food Operations – West 1 IFSS – National Integrated Food Safety System
• MDA – Minnesota Department of Agriculture OEI – Official Establishment Inventory
• PA – Partnership Agreement Partners – HAF-W1 and MDA
• U.S.C. – United States Code

IV.    GOALS, OBJECTIVES, AND INTENDED OUTCOME

The FDA and MDA are committed to pursuing the vision of an IFSS. A key step in the pursuit of that vision is achieving domestic mutual reliance. Domestic mutual reliance is a seamless partnership that enables FDA and states with comparable regulatory public health systems, as trusted partners, to fully rely on, coordinate with, and leverage one another’s work, data, and actions to achieve the public health goal of a safer national food supply.

Once achieved, domestic mutual reliance will allow for more efficient and effective use of resources, and collaboration on risk-informed decision-making about activities that may be carried out by the Partners, including enhanced regulatory cooperation, improved coordination, and greater reliance on each other for follow-up and coordination when a regulatory concern arises. The Partners will benefit from leveraging each other’s resources to improve industry compliance with regulatory requirements, with a goal of improving public health and consumer protection.

The initial goals of this PA are to achieve the maximum protection of food safety without duplication of inspections and regulatory action between the Partners. The work towards mutual reliance through this current PA will focus on key areas:

1. Data and Information Sharing
2. Official Establishment Inventory (OEI) reconciliation and maintenance
3. Identifying, establishing, and monitoring key mutual reliance metrics

V.    RESPONSIBILITIES

FDA:

A.    Data and Information Sharing, in accordance with federal laws and regulations:

1. FDA will work with MDA on a regular basis to understand, define, compare, reconcile, and maintain the OEI.
2. FDA will leverage technology to support data and information sharing.

MDA:

A.    Data and Information Sharing, in accordance with state laws and regulations:

1. MDA will maintain a long-term Food and Feed 20.88 Information Sharing Agreement with the appropriate agency and regulatory divisions to be able to receive inspectional, investigative, compliance, laboratory, and regulatory information from the FDA.
2. MDA will consult with DIDP prior to sharing any FDA-provided documentation.
3. MDA will provide firm inventory information of regulated establishments to FDA to assist in maintaining the OEI.
4. MDA will leverage technology to support data and information sharing.

JOINT:

A.    PA Monitoring and Evaluation

1. The Partners will identify, establish, and monitor key mutual reliance metrics.
2. The Partners will complete a joint annual evaluation report that includes ongoing PA outputs and outcomes to document program accomplishments and areas for enhancement.

VI.    RESOURCES

FDA: HAF-W1 will provide MDA with technical assistance and support.

MDA: MDA will provide HAF-W1 with technical assistance and support.

JOINT: The Partners will work with DI subject matter experts to identify, establish, and monitor key mutual reliance metrics and perform an annual evaluation of the PA. Both entities will participate in collaborative activities.

VII.    LEGAL STATUS

The purpose of this PA is to foster interaction, cooperation, and coordination between the parties in furtherance of the public health. No consideration has been given or received by either party to this agreement. It is not legally binding and does not constitute a promise on the part of either party for performance. It does not create a legally enforceable contract and the Partners agree that no remedies at law or equity will be sought by either party for non-performance of this agreement. It does not impose additional legal duties, rights, benefits, responsibilities, or remedies on either partner or on any third party. This PA imposes no duty on either partner to act or to refrain from acting.

VIII.    INFORMATION DISCLOSURE

Access to non-public information, where appropriate, shall be governed by separate Confidentiality Disclosure Agreements in accordance with 21 C.F.R. Part 20. Under 21 C.F.R. § 20.88, state agencies must agree and certify in writing that they shall not further release, publish, or disclose FDA non-public information and that they shall protect such information from public disclosure. No proprietary data, trade secrets or personal privacy information shall be disclosed among the Partners unless permitted by applicable law. To confirm the applicability of an existing 20.88 agreement or to enter into Confidentiality Disclosure Agreements, Partners should contact ORA’s Office of Strategic Policy and Operational Planning, Division of Information Disclosure (DIDP) by sending a request via email to [email protected]. Partners will consult with ORA’s Office of Strategic Planning and Operational Policy/ Division of Information Disclosure Policy prior to sharing any FDA-provided documentation by sending a request via email to [email protected].

IX.    ASSESSMENT AND EVALUATION

The Partners will make all reasonable attempts to meet, at a minimum annually, to discuss the current partnership, monitor key mutual reliance metrics, evaluate its usefulness, and make modifications, as needed.

An annual review for each key mutual reliance metric will be completed by representatives from each partner.

During the annual review and evaluation, the Partners will jointly prepare options for follow-up actions. If new areas for developing partnership activities are identified, this

PA may be revised and agreed upon by the Partners. When appropriate, this PA may be resubmitted for approval by the Partners prior to annual renewal.

X.    STATEMENT OF NO FINANCIAL OBLIGATIONS

The signing of this PA does not constitute a financial obligation on the part of the FDA or MDA. Each signatory will use and manage its own funds in carrying out the purpose of this PA. Transfers of funds or items of value are not authorized under this PA.

XI.    CONCLUSION AND RECOMMENDATION

Joint Partners agree to the parts written in this document. During the annual review, the Partners will jointly prepare and approve options for follow-up partner actions, when appropriate.

ENDORSEMENTS

[Signatories of Responsible Parties Must Include Printed Name, Signed Name, and Date of Signature]

Accepted for the U.S. Food and Drug Administration: 

/s/
Erik P. Mettler
Assistant Commissioner
FDA Office of Regulatory Affairs
Office of Partnerships and Operational Policy
Date: 02/18/2022

/s/
Michael Rogers
Assistant Commissioner
FDA Office of Regulatory Affairs
Office of Human and Animal Food Operations
Date: 02/18/2022 

/s/
Michael Dutcher, DVM
District Director
FDA Office of Regulatory Affairs
Office of Human and Animal Food Operations West – Division 1
Date: 02/17/2022

Accepted for (partnering agencies):

/s/
Katherine Simon    
Division Director
Food & Feed Safety Division Minnesota Department of Agriculture
Date: 02/16/2022