1. Home
  2. About FDA
  3. Partnerships: Enhancing Science Through Collaborations With FDA
  4. FDA Memoranda of Understanding
  5. Domestic MOUs
  6. MOU 225-25-008
  1. Domestic MOUs

MOU 225-25-008

PARTNERSHIP AGREEMENT BETWEEN U.S. FOOD AND DRUG ADMINISTRATION AND THE CALIFORNIA DEPARTMENT OF PUBLIC HEALTH - FOOD AND DRUG BRANCH

I. PURPOSE

This Partnership Agreement (PA) is entered into by the California Department of Public Health Food and Drug Branch (CDPH-FDB) 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 1 (OHFIW1), Office of Human Food Inspectorate West 2 (OHFIW2), and Office of Import Operations Division of West Coast Imports (OIO DWCI) (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 California.  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, evaluation activities, prevention, detection, and response activities that directly impact food safety and public health.

This PA does not affect or supersede any existing 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 (3) 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) days advance written notice to the other Partner(s).

III. DEFINITIONS AND ACRONYMS

CDPH-FDBCalifornia Department of Public Health, Food and Drug Branch
C.F.R.Code of Federal Regulations
DIDDivision of Information Disclosure
DMRDomestic Mutual Reliance
FDAU.S. Food and Drug Administration
IFSSIntegrated Food Safety System
ODPOffice of Domestic Partnerships
ODP/DDPCIODP, Division of Domestic Partnership Coordination and Integration
OHFIW1Office of Human Food Inspectorate Division West 1
OHFIW2Office of Human Food Inspectorate Division West 2
OIO DWCIOffice of Import Operations, Division of West Coast Imports
PAPartnership Agreement 
POCPoint of Contact
The PartnersFDA (OHFIW1, OHFIW2, DWCI) and CDPH-FDB

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 and import operations for which both participants have statutory responsibilities. Continuous conformity with applicable regulatory program standards is a foundational concept to 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.  DMR Planning and Evaluation
C.  Information Technology (for Data Sharing and Collaboration)
D.  Training
E.  Risk-Based Inspection Program  

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

C. Training:

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

CDPH-FDB: 

D. Information Sharing and Protection of Public Health:

  1. CDPH-FDB will maintain a current Food and Imports 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 the FDA.
  2. CDPH-FDB will consult DID prior to sharing or disclosing any FDA-provided information or documents resulting from any public records request. 

E. Risk-based Inspection Program: 

  1. CDPH-FDB will work with FDA on a regular basis to compare, reconcile, and maintain CDPH-FDB firm inventories.
  2. CDPH-FDB will explore options for counting human food inspections conducted by OHFIW1 and OHFIW2 as part of CDPH-FDB’s inspections.

F. Training:

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

JOINT:

G. Information Technology for Data Sharing and Collaboration:

  1. The Partners will continue to explore ways to enhance collaborative oversight activities (including responding to consumer and industry complaints) for jointly regulated firms.
  2. The Partners will leverage technology to support information exchange.

H. 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.

I. 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: OHFIW1, OHFIW2, and DWCI will provide CDPH-FDB with technical assistance and support, upon request and availability.

CDPH-FDB: CDPH-FDB 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.

FDA will look to CDPH to clearly identify nonpublic information as coming from them with headers or watermarks.

If the information provided to FDA by CDPH is the subject of a Freedom of Information Act (FOIA) request, FDA would not publicly disclose information that the agency determines to be confidential commercial, trade secret, personal privacy information, or otherwise exempt from disclosure.  See, e.g., 5 U.S.C. 552(b)(4), 5 U.S.C. 552(b)(6), the Trade Secrets Act (18 U.S.C. 1905), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(j)).  However, the agency would disclose information that it is required to make public under applicable law and regulations.  See, e.g., 5 U.S.C. 552, 21 CFR 20.111.  For example, information is generally not exempt from mandatory disclosure under FOIA if it is (a) in the public domain or publicly known, or (b) it becomes part of the public domain or publicly known by publication or otherwise, not due to any unauthorized act by any FDA employee.  Furthermore, information submitted to FDA seeking FDA review or authorization of a product would be subject to applicable regulations (e.g., 21 CFR 171.1(h)).  Should FDA receive a FOIA request for any CDPH-provided information, including any information claimed to be confidential commercial, trade secret, or personal privacy information, FDA would consider the markings and other input from CDPH when making its disclosure determination.  

If FDA is required, for example by law, regulation, or court order, to disclose information that CDPH has marked confidential, FDA would provide CDPH as much advance written notice of such a disclosure as is feasible or required under the circumstances.

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 CDPH-FDB. 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 POCs:
Darla Bracy, Division Director OHFIW2; Acting Division Director OHFIW1 
Kathleen Turner, Division Director DWCI

State Partner POCs:
David Mazzera, PhD, Chief, Division of Food and Drug Safety, CDPH; and
Benson Yee, Chief, Food and Drug Branch, CDPH

XII. CONCLUSIONS AND RECOMMENDATION

The Partners agree to the provisions in this PA.  

PARTNERSHIP AGREEMENT BETWEEN U.S. FOOD AND DRUG ADMINISTRATION AND CALIFORNIA DEPARTMENT OF PUBLIC HEALTH FOOD AND DRUG BRANCH

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 for Integration
Office of IFSS Partnerships
FDA Office of Human Foods Program
Date: 09/05/2025
   
/s/
Michael Dutcher
Deputy Associate Commissioner for Food Products
Office of Inspections and Investigations
Date: 09/04/2025   

/s/
Dan Solis
Assistant Commissioner
FDA Office of Inspections and Investigations
Office of Import Operations
Date: 09/02/2025

/s/
Darla Bracy
Division Director OHFIW2
Acting Division Director OHFIW1
Office of Inspections and Investigations
Office of Human Food Inspectorate Division West 2
Date: 09/02/2025

/s/
Kathleen Turner, DVM
Division Director
FDA Office of Inspections and Investigations
Office of Import Operations, Division of West Coast Imports
Date: 08/28/2025

PARTNERSHIP AGREEMENT BETWEEN U.S. FOOD AND DRUG ADMINISTRATION AND CALIFORNIA DEPARTMENT OF PUBLIC HEALTH FOOD AND DRUG BRANCH

Accepted for the California Department of Public Health - Food and Drug Branch:

/s/
David Mazzera, PhD
Chief, Division of Food and Drug Safety       
California Department of Public Health - Food and Drug Branch
Date: 08/27/2025

/s/
Benson Yee
Chief, Food and Drug Branch 
California Department of Public Health - Food and Drug Branch
Date: 08/27/2025

Back to Top