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  1. Domestic MOUs

MOU 225-24-016

PARTNERSHIP AGREEMENT BETWEEN U.S. FOOD AND DRUG ADMINISTRATION AND THE MICHIGAN DEPARTMENT OF AGRICULTURE & RURAL DEVELOPMENT

I. PURPOSE

This Partnership Agreement (PA) is entered into by the Michigan Department of Agriculture & Rural Development (MDARD) and the United States Department of Health and Human Services (HHS), Food and Drug Administration’s (FDA) Office of Regulatory Affairs (ORA), Office of Human and Animal Food Operation’s East – Division 6 (HAF-E6), (hereinafter referred to as “the Partners”). The purpose of this agreement is to establish a formal partnership intended to assist the Partners in strengthening the public health by fostering interaction and cooperation and setting a foundation for the ongoing development of an Integrated Food Safety System (IFSS) in Michigan. To meet these objectives, this PA establishes streamlined and efficient processes to coordinate and enhance communication, increase program familiarity, maximize efficiency, and minimize duplication through the exchange of food safety information. The Partners understand the importance of leveraging resources to increase effectiveness and share mutual interest in collaborating on information sharing, emergency response, evaluation activities, prevention, detection, and response activities that directly impact food safety and public health.

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

This agreement covers a period of five years from the date of latest signature below. This time frame will give the Partners sufficient time to measure the PA outcomes, modify the PA if warranted, and renew the PA with consent of the Partners. This PA is effective when fully executed by the Partners through signing and shall remain in effect until termination by any Partner upon thirty (30) day advance written notice to the other Partner(s).

III. DEFINITIONS AND ACRONYMS

FDA U.S. Food and Drug Administration
IFSS Integrated Food Safety System
ISA  Information Sharing Agreement
MDARD  Michigan Department of Agriculture & Rural Development
ORA  Office of Regulatory Affairs
ORA/HAF-E6  Office of Regulatory Affairs, Office of Human and Animal Food Operations East, Division 6
ORA/OP/DI  Office of Regulatory Affairs, Office of Partnerships, Division of Integration
PA  Partnership Agreement
POC  Point of Contact
RRT   Rapid Response Team
SME   Subject Matter Experts
The Partners  FDA (ORA/HAF-E6) and MDARD

IV. GOALS, OBJECTIVES, AND INTENDED OUTCOMES

The Partners are committed to pursuing the vision of an IFSS. A key step in 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.

Working toward 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 either Partner. Partners seek to enhance regulatory cooperation, improve coordination, and increase 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.

This PA will document and formalize an agreement about ongoing coordination and collaborative efforts between the Partners to establish domestic mutual reliance for the regulatory oversight of human and animal food for which both participants have statutory responsibilities. Continuous conformity with applicable regulatory program standards is a foundational concept and must be maintained as the Partners work towards achieving domestic mutual reliance and set a foundation for the ongoing
development of an IFSS.

The work towards domestic mutual reliance through this PA will focus on the following key areas:

A. Legal Authority for Information Sharing and Protection of Public Health
B. Domestic Mutual Reliance Planning and Evaluation
C. Leveraging of Resources
D. Information Technology for Data Sharing and Collaboration
E. Training
F. Risk-Based Inspection Program
G. Compliance and Enforcement
H. Emergency Response

V. RESPONSIBILITIES

FDA:

A. Risk-based Inspection Program:

1. FDA will work with MDARD on a regular basis to compare, reconcile, and maintain FDA firm inventories.
2. FDA will explore options for counting non-contract inspections conducted by MDARD as part of any FDA inspection mandate.

B. Training:

1. FDA will provide MDARD with technical expertise, training, and support for MDARD regulatory personnel, as requested and subject to availability.

MDARD:

A. Information Sharing and Protection of Public Health:

1. MDARD will maintain a current long-term Food 20.88 Information Sharing Agreement (ISA), and sufficient FDA Commissioned staff within the appropriate agency and regulatory divisions to be able to receive inspectional, investigative, compliance, laboratory, and regulatory information from the FDA.
2. MDARD will consult DIDP prior to sharing or disclosing any FDA- provided information or documents.

B. Risk-based Inspection Program:

1. MDARD will work with FDA on a regular basis to compare, reconcile, and maintain MDARD firm inventories.
 2. MDARD will explore options for counting human and animal food inspections conducted by HAF-E6 as part of MDARD's inspections.

C. Training:

1. MDARD will provide FDA technical expertise and training for federal regulatory personnel, as requested and subject to availability.

JOINT:

A. Information Technology for Data Sharing and Collaboration:

1. The Partners will continue to explore ways to enhance collaborative oversight activities (including responding to consumer or industry complaints) for jointly regulated firms.
2. The Partners will leverage technology to support information exchange to the best of their ability and subject to available resources.

B. Risk-Based Inspection Program:

1. The Partners will meet no less than annually to explore ways to share firm inventories to support work planning.
2. Joint inspections may be requested by either Partner where the Partners notify each other if they desire to accompany any planned inspection.
3. Independent inspection by either Partner may occur at a firm in the same year. The Partners will coordinate these independent inspections to maximize, to the greatest extent possible, the time between inspections.
4. The Partners will explore ways to support collaborative inspection activities.
5. The Partners will explore ways to collaborate on large volume sampling methodologies, equipment, and procedures.

C. Emergency Response:

1. The Partners will continue to coordinate in emergency, recall and outbreak situations utilizing the state's RRT for response. The Partners will participate in after-action review processes to determine opportunities for improvement.

D. Compliance and Enforcement:

1. Partners will explore ways to support collaborative compliance, enforcement, and corrective actions (e.g., non-contract, non high risk, no action indicated).

E. DMR Planning and Evaluation:

1. The Partners will identify, establish, and monitor key mutual reliance metrics.
2. The Partners will participate in joint meetings to plan, provide updates, and discuss metrics. Meetings will include agency leaders and representation from rapid response team, contract, food, feed, dairy, produce, laboratory, enforcement, and compliance, including other invited FDA subject-matter-experts, as available.
3. 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-E6 will provide MDARD with technical assistance and support, upon request and availability.

MDARD: MDARD will provide FDA technical assistance and support, upon request and availability.

JOINT: The Partners will collaborate with Office of Regulatory Affairs, Office of Partnerships, Division of Integration (ORA/OP/DI) Subject Matter Experts (SME) to identify, establish, and monitor key mutual reliance metrics for performing an annual evaluation of the PA.

VII. LEGAL STATUS

No consideration has been given or received by either Partner to this PA. This PA is not legally binding and does not constitute a promise on the part of either Partner 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 Partner for non- performance of this PA. It does not impose additional legal duties, rights, benefits, or responsibilities, or remedies of either the Partners or of a 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 Information Sharing Agreements in accordance with 21 C.F.R. Part 20 under § 20.88 (20.88 agreement).

Partners shall contact ORA’s Office of Partnerships, Division of Information Disclosure Policy (DIDP) via email at ORAInfoshare@fda.hhs.gov to confirm the applicability of an existing 20.88 agreement, to enter into a 20.88 agreement, and prior to sharing any FDA- provided information.

IX. ASSESSMENT AND EVALUATION

This PA may be amended or modified by mutual consent of the Partners in writing. The Partners will review the PA and goals annually. The Partners will make all reasonable attempts to meet (at a minimum) annually to discuss the current PA, monitor key mutual reliance metrics, evaluate the PA’s usefulness, and make modifications to the PA as needed. During the annual review and evaluation meeting, the Partners will jointly prepare options for follow-up. If new areas for developing PA activities are identified and agreed upon, this PA may be revised to reflect them. An updated PA may be submitted for consideration and approval by the signatories of this PA prior to annual renewal.

X. STATEMENT OF NO FINANCIAL OBLIGATIONS

Signature of this PA does not constitute a financial obligation on the part of the FDA or MDARD. Each Partner will use and manage its own funds in carrying out the purpose of this PA. Permanent transfers of funds or items of value is not authorized under this PA.

XI. ACTIVITY LIAISON OFFICIALS:

Office of Partnerships POC: Maxyne Lam, Consumer Safety Officer (CSO), PA Coordinator

FDA Partner POC: William Weissinger, Program Division Director HAF-E6

State Partner POCs:
Tim Slawinski, Director, Bureau of Food Safety and Animal Health, MDARD; and Craig VanBuren, Director, Bureau of Laboratory and Consumer Protection, MDARD

XII. CONCLUSIONS AND RECOMMENDATION

The Partners agree to the provisions in this PA.

PARTNERSHIP AGREEMENT BETWEEN U.S. FOOD AND DRUG ADMINISTRATION AND THE MICHIGAN DEPARTMENT OF AGRICULTURE & RURAL DEVELOPMENT

ENDORSEMENTS

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

Approved and 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: 08/02/2024

/s/
Michael Dutcher
Acting Assistant Commissioner
FDA Office of Regulatory Affairs
Office of Human and Animal Food Operations
Date: 08/01/2024

/s/
William Weissinger
Program Division Director
FDA Office of Regulatory Affairs
Office of Human and Animal Food Operations East – Division 6
Date: 08/01/2024

Approved and Accepted for the Michigan Department of Agriculture & Rural Development:

/s/
Tim Slawinski
Director, Bureau of Food Safety and Animal Health
Michigan Department of Agriculture & Rural Development
Date: 08/01/2024

/s/
Craig VanBuren
Director, Laboratory and Consumer Protection Bureau
Michigan Department of Agriculture & Rural Development
Date: 08/01/2024

 
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