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MOU-225-21-020 with FDA HAFW1 and WDATCP

PARTNERSHIP AGREEMENT BETWEEN U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION OFFICE OF HUMAN AND ANIMAL FOOD OPERATIONS- DIVISION 1 WEST AND THE WISCONSIN DEPARTMENT OF AGRICULTURE, TRADE AND CONSUMER PROTECTION - DIVISION OF FOOD AND RECREATIONAL SAFETY

I. PURPOSE

The purpose of this Partnership Agreement (PA) is to set forth a framework for a formal working Partnership between the United States Food and Drug Administration, Office of Human and Animal Food Operations - Division I West ("HAF-W I " or "FDA") and the State of Wisconsin Department of Agriculture, Trade and Consumer Protection, Division of Food and Recreational Safety ("WDATCP"). HAF-W I and WDATCP are herein referred to as "the Partners." The Partners share mutual interest in collaborating on information sharing, compliance, and enforcement activities that directly impact food safety and public health and understand the importance of leveraging resources to increase effectiveness.

This PA is intended to formalize initiatives that enhance communication, increase program familiarity, maximize efficiency, minimize duplication, and set a foundation for the ongoing development of an Integrated Food Safety System (IFSS) in Wisconsin. These initiatives have been demonstrated to enhance integration between the Partners and decrease duplication of routine inspections.

FDA is responsible for implementing and enforcing 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 and animal food. In carrying out this responsibility, FDA conducts inspections of establishments that manufacture, process, pack, or hold food, except for certain establishments that are regulated exclusively by the United States Department of Agriculture (USDA) or are regulated by WDATCP, pursuant to its Partnership with USDA. HAF-WI has regulatory oversight of approximately I,700 manufactured human and animal food firms within the State of Wisconsin.

WDATCP has regulatory oversight of approximately 3,300 manufactured  food firms. WDATCP is given regulatory oversight authority for all manufactured food firms in  Wis. Stat. chs. 97 and 93, as well as Wis. Admin. Code chs. ATCP 65, 70, 71, 81, 83, 85, 87, and 88.

WDATCP is responsible for the licensing and inspection of all food and dairy processing, packaging, and storage facilities within the State of Wisconsin, with the exclusion of facilities that manufacture dietary supplements or infant formula.

WDATCP does not have regulatory oversight over dietary supplements and is not trained in the current good manufacturing practices specific to infant formula. WDATCP will refer dietary supplement and infant formula regulatory matters to HAF-Wl. Matters related to produce inspections and information sharing will be handled pursuant to the State Produce Safety Program Implementation Cooperative Agreement Program. Additionally, the Partners may engage in additional activities, such as pilots beyond this agreement.

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

Unless modified or amended otherwise, this agreement covers a period of three (3) years from the date on which the Partners have signed the PA. This duration will give the Partners sufficient time to measure the program outcomes that have resulted from the PA, modify the PA if warranted, and renew the PA 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 at any time. Either partner may submit a proposed amendment or modification 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, in original, modified, or amended form, is effective upon signing by both of the Partners and shall remain in effect for the duration of the agreement unless terminated 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
DIOP - Division of Information and Disclosure Policy FDA - U.S. Food and Drug Administration
HAF-W I -Office of Human and Animal Food Operations West- Division I IFSS - Integrated Food Safety System
ISA - Information Sharing Agreement NCI - Non-contract Inspections
OEI - Official Establishment Inventory
ORA/OP/DI - Office of Regulatory Affairs, Office of Partnerships, Division oflntegration PA - Partnership Agreement
ThePartners-HAF-Wl and WDATCP
RRT- Rapid Response Team SME - Subject Matter Experts
WDATCP - Wisconsin Department of Agriculture, Trade and Consumer Protection - Division of Food and Recreational Safety
U.S.C. - United States Code

IV. GOALS, OBJECTIVES, AND INTENDED OUTCOME

The Food and Drug Administration (FDA) and state 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 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 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 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 integrated food safety system.

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

A. Official Establishment Inventory (OEI) maintenance, comparison, and reconciliation of inventories to minimize inspection duplication
B. Data and [nformation Sharing
C. Work Planning and Risk Prioritization/Categorization, including inspection frequency
D. Continue to explore ways to share collaborative inspection activities, compliance, enforcement, and corrective actions (e.g., non-contract, non-high-risk, and "no action indicated").
E. Training of field staff
F. Identifying, establishing, and monitoring key mutual reliance metrics

V. RESPONSIBILITIES

FDA:

A. Data and Information Sharing:
FDA will, in accordance with federal laws and regulations, work with WDATCP on a regular basis to compare, reconcile, and maintain FDA OEI food firm inventories

B. Inspection Sharing and Reduction of Duplication: As part of HAF-W I's inspection mandate, FDA will explore ways to enhance collaborative counting of non-contract, non­ high-risk inspections conducted by WDATCP
 
C.Training: FDA will provide WDATCP with technical expertise, training, and support to state regulatory personnel, as requested

WDATCP:

A. Data and Information Sharing:
WDATCP will:

  1. 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. Consult DIOP prior to sharing any FDA-provided documentation
  3. Work with FDA on a regular basis to compare, reconcile, and maintain WDATCP food firm inventories
  4. Continue to participate in a Rapid Response Team (RRT)

B. Inspection Sharing and Reduction of Duplication: As part of WDATCP's scheduled inspections, WDATCP will explore ways to enhance collaborative counting of non­ contract, non-high-risk, no action indicated inspections conducted by HAF-Wl

C. Training: WDATCP will provide FDA with technical expertise and training, as requested

JOINT:

A. Data and Information Sharing:

  1. The Partners will meet no less than two times a year for work planning and inspectional coordination
  2. The Partners will continue to explore ways to enhance collaborative oversight activities (including responding to consumer or industry complaints) for jointly regulated firms
  3. The Partners will leverage technology to support information exchange
  4. Partners will explore ways to support collaborative inspection activities, compliance, enforcement, and corrective actions (e.g., non-contract, non-high­ risk, no action indicated)

B. Inspection Sharing and Reduction of Duplication:

  1. Joint inspections may be requested by either partner
  2. Independent inspection by either partner may occur at a specific firm in the same year. Both Partners 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 procedures.

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-W 1 will provide WDATCP with technical assistance and support, upon request.

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

JOINT: Both Partners will collaborate with ORA/OP/DI SMEs to identify, establish, and monitor key mutual reliance metrics for performing an annual evaluation of the PA.

VII. LEGAL STATUS

The purpose of this PA is to foster interaction, cooperation, and coordination between the Partners in the furtherance of the public health. No consideration has been given or received by either partner to enter this agreement. It 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 agreement. It does not impose additional legal duties, rights, benefits, responsibilities, or remedies on either partner or on a 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 (DIOP) by sending a request via email to

0RA1nfoshare@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 ORAlnfoshare@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 actions. If new areas for developing partnership activities are identified, this PA will be revised and agreed upon by the Partners.

X. STATEMENT OF NO FINANCIAL OBLIGATIONS

Signature of this PA does not constitute a financial obligation on the part of the Partners. 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 are not authorized under this PA.

XI. CONCLUSIONS AND RECOMMENDATION

Both Partners agree to the parts written in this document, pending availability of resources.

PARTNERSHIP AGREEMENT BETWEEN U.S. DEPARTM ENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION OFFICE OF HUMAN AND ANIMAL FOOD OPERATIONS - DIVISION 1 WEST AND THE WISCONSIN DEPARTMENT OF AGRICULT URE, TRADE AND CONSUMER PROTECTION - DIVISION OF FOOD AND RECREATIONAL SAFETY

ENDORSEMENTS

(SIGNATORIES OF RESPONSIBLE PARTIES MUST INCLUDE PRINTED NAME, SIGNED NAME AND DATE OF SIGNATURE)

Accepted for the U.S. Food and Drug Administration:
Digitally signed by:

Erik P. Mettler
--------------------
Erik P. Mettler
Assistant Commissioner
FDA Office of Regulatory Affairs
Office of Partnerships and Operational Policy 
Date Signed: 2021.09 .24

Digitally signed by:
Michael Rogers
------------------------
Michael Rogers
Assistant Commissioner
FDA Office of Regulatory Affairs
Office of Human and Animal Food Operations
Date Signed: 2021.09.27 

PARTNERSHIP AGREEMENT BETWEEN U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION OFFICE OF HUMAN AND ANIMAL FOOD OPERATIONS-DIVISION 1 WEST AND THE WISCONSIN DEPARTMENT OF AGRICULTURE, TRADE AND CONSUMER PROTECTION - DIVISION OF FOOD AND RECREATIONAL SAFETY

Digitally signed by:
Michael Dutcher
------------------------
Michael Dutcher, DVM    
District Director
FDA Office of Regulatory Affairs
Office of Human and Animal Food Operations West - Division 1
Date Signed: 2021.09.28 

Accepted for (partnering agencies):

F,i[i::i,;:}--J e'"'-
--------------------
Assistant Deputy Director
Wisconsin Department of Agriculture, Trade and Consumer Protection
Division of Food and Recreational Safety
Date Signed: 2021.09.30 

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