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  1. Domestic MOUs

MOU 225-21-010

PARTNERSHIP AGREEMENT
between
U.S. FOOD AND DRUG ADMINISTRATION
and the
UTAH DEPARTMENT OF AGRICULTURE AND FOOD DIVISON OF REGULATORY SERVICES

I. Purpose

The purpose of this Partnership Agreement (PA) is to coordinate and expand food protection efforts between the U.S. Food and Drug Administration Office of Human and Animal Food Operations West – Division 4 (“HAF-W4” or “FDA”) and the Utah State Department of Agriculture and Food Division of Regulatory Services (UDAF) (together referred to as “the partners”). This PA will support FDA in the implementation and enforcement of the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. § 301 et seq.). Included within the FDA’s responsibilities under the Act is the responsibility for regulation of human and animal foods processed in facilities located in the state of Utah covered under regulations administered by FDA, such as 21 CFR Part 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; covered facilities). Similarly, this PA will support Utah in the implementation and enforcement of Section 4-5-104 of the Utah State Code.

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

II. Duration of Agreement

This agreement covers a period of three (3) 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 if warranted, and renew with consent of the partners. Review of the PA and goals will be conducted annually. This PA may be amended or modified by mutual consent of either partner. Either partner on their initiative may submit a proposed amendment or modification in writing for both parties to review and agree upon. Modifications and amendments will be tracked and documented during the annual review and maintained for historical purposes. This PA is effective upon signing and shall remain in effect for the duration of the agreement unless terminated by either partner upon thirty (30) day advance written notice to the other partner.

III. Definitions and Acronyms

C.F.R. – Code of Federal Regulations
DIDP – Division of Information and Disclosure Policy
FDA – Food and Drug Administration
HAF-W4 – Office of Human and Animal Food Operations West – Division 4
IFSS – Integrated Food Safety System
NCI – Non-contract Inspections
OEI – Official Establishment Inventory
ORA/OP/DI – Office of Regulatory Affairs, Office of Partnerships, Division of Integration
PA – Partnership Agreement
Partners – HAF-W4 and UDAF
RRT – Rapid Response Team
SME – Subject Matter Experts
UDAF – The Utah Department of Agriculture and Food - Division of Regulatory Services

IV. Goals, Objectives, and Intended Outcome

The Food and Drug Administration (FDA) and state partners are committed to pursuing the vision of an Integrated Food Safety System (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.

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 either the partner. Partners seek to enhance regulatory cooperation, improve coordination and ensure greater reliance on each other for follow-up 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 FDA and UDAF 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 mutual reliance and set a foundation for the ongoing development of an integrated food safety system.

The work towards mutual reliance through this current PA will focus on key areas:

  1. Data/Information Sharing
  2. Official Establishment Inventory (OEI) maintenance; comparison and reconciliation of inventories to minimize inspection duplication
  3. Work Planning and Risk Prioritization/Categorization, including inspection frequency mandates
  4. Exploring ways to support collaborative inspection, compliance, enforcement, and corrective actions (e.g., non-contract, non-high-risk inspection sharing)
  5. Training of field staff
  6. Identifying, establishing, and monitoring key mutual reliance metrics

V. Responsibilities of the Agreement

FDA:

  1. Information Sharing:
    1. FDA will leverage technology to support information exchange
    2. FDA will work with UDAF on a regular basis to compare, reconcile, and maintain FDA firm inventories
    3. FDA will explore ways to support collaborative inspection, compliance, enforcement, and corrective actions (e.g., non-contract, non-high-risk inspection sharing) with UDAF
  2. Inspection Sharing and Reduction of Duplication: FDA will explore options for counting non-contract, non-high-risk inspections conducted by UDAF as part of HAFW4’s inspection mandate
  3. Training: FDA will provide UDAF with technical expertise, training and support to state regulatory personnel, as requested; pending availability

UDAF:

  1. Information Sharing:
    1. UDAF will maintain a long-term Food and Feed 20.88 Information Sharing Agreement with the appropriate agency and regulatory divisions to be able to share inspectional, investigative, compliance, laboratory, and regulatory information with FDA
    2. UDAF will consult DIDP prior to sharing any FDA-provided documentation
    3. UDAF will leverage technology to support information exchange
    4. UDAF will work with FDA on a regular basis to compare, reconcile, and maintain UDAF firm inventories
    5. UDAF will explore ways to support collaborative inspection, compliance, enforcement, and corrective actions with FDA
    6. UDAF will continue to participate in a Rapid Response Team (RRT)
  2. Inspection Sharing and Reduction of Duplication: UDAF will explore options for counting non-contract, non-high-risk inspections conducted by HAF-W4 as part of UDAF’s mandated inspections
  3. Training: UDAF will provide FDA technical expertise and training to federal regulatory personnel, as requested; pending availability

JOINT:

  1. Information Sharing:
    1. The partners will meet annually to explore ways to share inventory to support work planning
    2. The partners will meet to explore ways to implement joint work planning and inspection coordination
    3. The partners will continue to explore ways to expand oversight activities (including responding to consumer or industry complaints) for jointly regulated firms
  2. Inspection Sharing and Reduction of Duplication:
    1. Joint inspections may be requested by either partner where the partners notify each other if they desire to accompany any planned inspection
    2. Independent inspection by either partner may occur at a firm in the same year. Both parties will coordinate these independent inspections to maximize, to the greatest extent possible, the time between inspections
    3. The partners will continue to coordinate in emergency and outbreak situations utilizing the state’s RRT for response
  3. 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 which includes ongoing PA outputs and outcomes to document program accomplishments and areas for enhancement

VI. Resources

FDA: HAF-W4 will provide UDAF technical assistance and support upon request; pending availability

STATE AGENCY: UDAF will provide FDA technical assistance and support; upon request; pending availability

JOINT: HAF-W4 and UDAF will work with ORA/OP/DI SMEs to identify, establish, and monitor key mutual reliance metrics for performing an annual evaluation of the PA. Both entities will participate in this collaborative activity.

VII. Legal Authority

The purpose of this PA is to foster interaction, cooperation, and coordination between the parties in the furtherance of the public health. No consideration has been given or received by either party to enter 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 parties agree that no remedies at law or equity will be sought by either party for nonperformance of this agreement. It does not impose additional legal duties, rights, benefits, responsibilities, or remedies of either the parties or of any third party. This PA imposes no duty on either party to act or to refrain from acting.

VIII. Information Disclosure Provision

Access to non-public information, where appropriate, shall be governed by separate Confidentiality Disclosure Agreements entered into under the authority of 21 C.F.R. § 20.88 and in which UDAF will agree and certify in writing that they shall not further release, publish or disclose such information and that they shall protect such information in accordance with the provisions of 21 U.S.C. § 331(j), 21 U.S.C. § 360j(c), 18 U.S.C. § 1905, 5 U.S.C. § 552(a), 21 C.F.R. Part 20 and other applicable laws and regulations governing the confidentiality of such information. No proprietary data, trade secrets or personal privacy information shall be disclosed among the Partners unless permitted by applicable law. Parties seeking to enter into Confidentiality Disclosure Agreements should contact ORA’s Office of Strategic Policy and Operational Planning/ Division of Information Disclosure by sending a request via email to ORAInfoshare@fda.hhs.gov.

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 partners actions. If new areas for developing partnership activities are identified, this PA will be revised and agreed upon by FDA and UDAF partners. When appropriate, this PA may be resubmitted for approval by the signatories of this agreement prior to annual renewal.

X. Statement of No Financial Obligations

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

XI. Conclusions and Recommendation

Joint partners agree to the parts written in this document.

Approved and Accepted for the Food and Drug Administration:

--/S/--

Erik P. Mettler
Assistant Commissioner
FDA Office of Regulatory Affairs
Office of Partnership and Operational Policy
April 15, 2021

--/S/--

Michael Rogers
Assistant Commissioner
FDA Office of Regulatory Affairs
Office of Human and Animal Food Operations
April 20, 2021

--/S/--

LaTonya Mitchell, Ph.D.
Denver District Director and Program Division Director
FDA Office of Regulatory Affairs
Office of Human and Animal Food Operations West – Division 4
April 20, 2021

Approved and Accepted for (partnering agency):

--/S/--

Travis Waller
Director of Regulatory Services
Utah Department of Agriculture and Food
April 21, 2021

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