MOU 225-24-024

PARTNERSHIP AGREEMENT BETWEEN U.S. FOOD AND DRUG ADMINISTRATION AND UTAH DEPARTMENT OF AGRICULTURE AND FOOD

I. PURPOSE

This Partnership Agreement (PA) is entered into by the Utah Department of Agriculture and Food (UDAF) and the United States Department of Health and Human Services, Food and Drug Administration’s (FDA) Office of Inspections and Investigations, Office of Human Food Inspectorate West 4 (OHFIW4), (hereinafter referred to as “the Partners”).  The purpose of this agreement is to maintain 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 Utah.  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 three 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

C.F.R.        Code of Federal Regulations  
DID        Division of Information Disclosure
DMR        Domestic Mutual Reliance
FDA        U.S. Food and Drug Administration 
IFSS        Integrated Food Safety System 
ODP        Office of Domestic Partnerships
ODP/DDPCI    ODP, Division of Domestic Partnership Coordination and Integration 
OHFIW4      Office of Human Food Inspectorate Division West 4
PA        Partnership Agreement 
POC        Point of Contact 
The Partners    FDA (UDAF and OHFIW4) 
UDAF        Utah Department of Agriculture and Food

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 (DMR).

DMR 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 DMR 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 DMR for the regulatory oversight of human 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 DMR and set a foundation for the ongoing development of an IFSS.

The work towards DMR 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.  Information Technology for Data Sharing and Collaboration 
D.  Training
E.  Risk-Based Inspection Program 
F.  Industry and Community Relations
G.  Emergency Response

V. RESPONSIBILITIES

FDA:

A. Information Technology for Data Sharing and Collaboration: 

1. FDA will leverage technology to support timely information exchange.

B. Risk-based Inspection Program:

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

C. Training:

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

UDAF:

A. Information Sharing and Protection of Public Health:

1. UDAF will maintain a current long-term Food 20.88 Information Sharing Agreement, 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 FDA.
2. UDAF will consult DID prior to sharing or disclosing any FDA-provided information or documents. 

B. Risk-based Inspection Program: 

1. UDAF will work with FDA on a regular basis to compare, reconcile, and maintain UDAF firm inventories. 
2. UDAF will explore options for counting human food inspections conducted by OHFIW4 as part of UDAF's inspections.

C. Training:

1. UDAF 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.

B. Risk-Based Inspection Program:

1. The Partners will meet no less than annually to explore ways to share food 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 non-contract activities, such as collaborative inspection activities to achieve compliance.

C. Emergency Response:

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

D. Industry and Community Relations:

1. The Partners will work together on industry outreach opportunities.

E. DMR Planning 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: OHFIW4 will provide UDAF with technical assistance and support, upon request and availability.

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

JOINT: The Partners will collaborate with Office of Domestic Partnerships, Division of Domestic Partnership Coordination and Integration (ODP/DDPCI) Subject Matter Experts 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. § 20.88 (20.88 agreement).  Partners shall contact Office of the Commissioner, Division of Information Disclosure (DID) via email to FDAinfoshare@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 FDA or UDAF. 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 Domestic Partnerships POC: Maxyne Lam, Partnership Coordination and Integration Specialist, DDPCI

FDA Partner POC: Mark Harris, Division Director, OHFIW4

State Partner POC: Travis Waller, Director of Regulatory Services, Utah Department of Agriculture and Food

XII. CONCLUSIONS AND RECOMMENDATION

The Partners agree to the provisions in this PA.

ENDORSEMENTS

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

/s/
Erik P. Mettler
Assistant Commissioner for Integration
Office of IFSS Partnerships
FDA Office of Human Foods Program
Date: 01/17/2025

/s/
Michael Dutcher
Acting Deputy Associate Commissioner for Food Products
FDA Office of Inspections and Investigations
Date: 01/16/2025

/s/ cc Edward Harris
Mark Harris
Division Director
Office of Inspections and Investigations
Office of Human Food Inspectorate Division West 4
Date: 01/10/2025

Approved and Accepted for the Utah Department of Agriculture and Food:

/s/
Travis Waller
Director of Regulatory Services
Utah Department of Agriculture and Food
Date: 01/08/2025

/s/
Coreen Cogswell
Manufactured Food Program Manager
Utah Department of Agriculture and Food
Date: 01/08/2025