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  1. Domestic MOUs

MOU 225-21-019

PARTNERSHIP AGREEMENT BETWEEN U.S. FOOD AND DRUG ADMINISTRATION
DIVISION OF HUMAN AND ANIMAL FOOD EAST-4 AND THE FLORIDA
DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES

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 East-4 (HAF-E4) and the Florida Department of Agriculture and Consumer Services (FDACS), (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.). FDA’s responsibilities under the Act include the regulation of human foods that are manufactured/processed in facilities located in the State of Florida covered under FDA regulations, such as 21 C.F.R. Part 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food). Similarly, this PA will support Florida’ adoption of FDA regulations in the implementation and enforcement of Chapter 500, Florida State Statutes:
https://www.flsenate.gov/Laws/Statutes/2018/Chapter500. Continuous conformity with the manufactured food regulatory program standards is a foundational concept and must
be maintained as the partners work toward achieving domestic mutual reliance and set a foundation for the ongoing development of an integrated food safety system (IFSS) in the
State of Florida.

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. Review of the PA and its goals will be conducted annually. 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 and documented during the annual review and maintained for historical purposes. This PA is effective upon signing by both of the partners and shall remain in effect until termination by any partner upon thirty (30) days advance written notice to the other partner.

III. DEFINITIONS and ACRONYMS

C.F.R. – Code of Federal Regulations
DI – FDA OP Division of Integration
DIDP – FDA Division of Information Disclosure Policy
FDA – U.S. Food and Drug Administration
FDACS – Florida Department of Agriculture and Consumer Services
FSMA – FDA Food Safety Modernization Act
HAF-E4 – FDA Division of Human and Animal Food East-4 U.S.C. – United States Code

IV. GOALS, OBJECTIVES, AND INTENDED OUTCOME

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.

Once achieved, domestic mutual reliance will allow for more efficient and effective use of resources, 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 will focus on key element areas:

  1. Official Establishment Inventory (OEI) reconciliation and maintenance
  2. Data and information sharing
  3. Work planning and risk prioritization/categorization
  4. Enhancing collaboration on inspections, compliance, enforcement, and corrective actions (i.e., non-contract, non-high-risk, no action indicated inspection sharing)
  5. Training of field staff
  6. 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 FDACS on a regular basis to compare, reconcile, and maintain the OEI inventory
  2. FDA will leverage technology to support information exchange
  3. Using a reconciled, shared inventory, FDA will work with FDACS to explore ways to enhance work planning

B. Inspection Sharing and Prevention of Duplication: FDA will support collaborative inspection, compliance, enforcement, and corrective actions with FDACS

C. Training: FDA will provide FDACS with technical expertise, training and support for FDACS regulatory personnel, as requested and pending availability.

FDACS:

A. Data and Information Sharing:

  1. FDACS 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. FDACS will consult with DIDP prior to sharing any FDA-provided documentation
  3. FDACS will provide inspectional information of regulated establishments to FDA to assist in maintaining the OEI
  4. FDACS will leverage technology to support information exchange
  5. Using a reconciled, shared inventory, FDACS will work with FDA to explore ways to enhance work planning

B. Inspection Sharing and Prevention of Duplication: FDACS will explore ways to support collaborative inspection, compliance, enforcement, and corrective actions with FDA

C. Training: FDACS will provide FDA with technical expertise, training, and support for regulatory personnel, as requested and pending availability.

JOINT:

A. Data and Information Sharing:

  1. The partners will meet, at least annually, to share reconciled inventory that supports work planning
  2. The partners will meet, at least annually, to enhance procedures for implementing 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

B. Inspection Sharing and Reduction of Duplication:

  1. Partners will support continued implementation and possible expansion of collaborative counting of non-contract, non-high-risk, no action indicated inspections conducted by FDA as part of FDACS statutory inspection mandate
  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. Both parties will coordinate these independent inspections to maximize, to the greatest extent possible, the time between inspections
  4. The partners will continue to coordinate in emergency and outbreak situations

C. 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-E4 will provide FDACS with technical assistance and support.

FDACS: FDACS will provide HAF-E4 with technical assistance and support.

JOINT: The partners will work with ORA/OP/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 PROVISION

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, Parties 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. Parties 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 ORAInfoshare@fda.hhs.gov.

IX. STATEMENT OF NO FINANCIAL OBLIGATIONS

Signature of this PA does not constitute a financial obligation on the part of the FDA or FDACS. 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.

X. 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.

XI. CONCLUSION AND RECOMMENDATION

The partners agree to the parts written in this document, pending availability of resources.

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
Date Signed 10/06/2021
Assistant Commissioner
FDA Office of Regulatory Affairs
Office of Partnerships and Operational Policy

/s/
Michael Rogers
Date Signed 10/06/2021
Assistant Commissioner
FDA Office of Regulatory Affairs
Office of Human and Animal Food Operations

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

/s/
Ramon A. Hernandez
Date Signed 10/06/2021
District Director
FDA Office of Regulatory Affairs
Division of Human and Animal Food East-4

Accepted for (partnering agency):

/s/
Paul J. Pagano
Date Signed 10/05/2021
Matthew Curran
Director of Food Safety
Florida Department of Agricultural and Consumer Services

/s/
Joey B. Hicks
Date Signed 10/05/2021
Director of Administration
Florida Department of Agricultural and Consumer Services

 

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