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  1. Domestic MOUs

MOU-225-21-018 with FDA/ORA HAFW5/DWCI and CDPH-FDB

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

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 5 and Division of West Coast Imports ("HAF-W5", "DWCI or "FDA") and the California Department of Public Health Food and Drug Branch (CDPH­ FDB) (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, 801, 284a et seq.). FDA's responsibilities under the Act include the regulation of human and animal foods manufactured, processed and/or imported in facilities located in the state of California covered under regulations administered by FDA, such as foods manufactured/processed by facilities subject to the requirements in 21 CFR Part 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food) and 21 CFR Part 1.500-1.514 Foreign Supplier Verification Program (FSVP). Similarly, this PA will support California in the implementation and enforcement of California Sherman Food, Drug, and Cosmetic Law - California Health and Safety Code, Division 104, Part 5.

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 partners to enter other agreements or arrangements related to this PA.

II. 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 nonpublic 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. Those seeking to confirm the applicability of an existing 20.88 agreement or 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. 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.

III. 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 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 for the duration of the agreement unless terminated by either partner upon thirty (30) days advance written notice to the other partner.

IV. DEFINITIONS AND ACRONYMS

CDPH-FDB -The California Department of Public Health-Food and Drug Branch
C.F.R. - Code of Federal Regulations
DIDP - Division of lnformation and Disclosure Policy
DWCI-Division of West Coast Imports
FDA- U.S. Food and Drug Administration:
HAF-W5 - Office of Human and Animal Food Operations West-Division 5
IFSS-Integrated Food Safety System
OEI - Official Establishment Inventory
ORA/OP/DI- Office of Regulatory Affairs, Office of Partnerships, Division of lntegration
PA - Partnership Agreement
The Partners-HAF-W5, DWCI, and CDPH-FDB
RRT - Rapid Response Team
SME - Subject Matter Experts

V. GOALS, OBJECTIVES AND INTENDED OUTCOME

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 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.

This PA will document and formalize an agreement about ongoing coordination and collaborative efforts between the FDA and CDPH-FDB 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.    1

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

A. Data/information sharing
B. Official Establishment Inventory (OEI) reconciliation and maintenance; comparison and reconciliation of inventories to minimize inspection duplication
C. Work planning and risk prioritization/categorization, including inspection frequency mandates
D. Exploring ways to support collaborative inspections, compliance, enforcement, and corrective actions (e.g., non-contract, non-high-risk inspection sharing)
E. Training of field staff
F. Identifying, establishing, and monitoring key mutual reliance metrics

VI. RESPONSIBILITIES FDA:
A. Data and Information Sharing:

  1. FDA will leverage technology to support timely information exchange
  2. FDA will work with CDPH-FDB on a regular basis to compare, reconcile, and maintain FDA firm inventories
  3. FDA will explore ways to support collaborative inspections, compliance, enforcement, and corrective actions (e.g., inspection  sharing) with CDPH-FDB

B. Inspection Sharing and Reduction of Duplication: FDA will explore options for counting inspections conducted by CDPH-FDB as part of FDA inspection mandate

C. Training: FDA will provide CDPH-FDB with technical expertise, training and support for CDPH-FDB regulatory personnel

CDPH:
A. Information Sharing:

  1. CDPH-FDB 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. CDPH-FDB will consult DIDP prior to sharing any FDA-provided documentation
  3. CDPH-FDB will leverage technology to support timely information exchange
  4. CDPH-FDB will work with FDA on a regular basis to compare, reconcile, and maintain CDPH-FDB firm inventories
  5. CDPH-FDB will explore ways to support collaborative inspections, compliance, enforcement, and corrective actions with FDA
  6. CDPH-FDB will continue to participate in a Rapid Response Team (RRT)

B. Inspection Sharing and Reduction of Duplication: CDPH-FDB will explore options for  counting inspections conducted by HAF-W5 as part of CDPH-FDB's· inspections

C. Training: CDPH-FDB will provide FDA technical expertise and training for federal regulatory personnel

JOINT:
A. Information Sharing:

  1. The partners will meet annually to explore ways to share food firm inventories 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

B. 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

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

VII. RESOURCES

FDA: FDA will provide CDPH-FDB with technical assistance and support upon request

CDPH-FDB: CDPH-FDB will provide FDA with technical assistance and support; upon request

JOINT: FDA and CDPH-FDB 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.

VIII. 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 any third party. This PA imposes no duty on either partner to act or to refrain from acting.

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 may be revised and agreed upon by FDA and CDPH-FDB partners. When appropriate, this PA may be resubmitted for approval by the partners 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 signatory 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

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

PARTNERSHIP AGREEMENT BETWEEN U.S. FOOD AND DRUG ADMINISTRATION, AND CALIFORNIA DEPRTMENT OF PUBLIC HEALTH

ENDORSEMENTS

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

Accepted for the Food and Drug Administration:

Digitally signed by:
Erik P. Mettler
--------------------
Erik P. Mettler
Assistant Commissioner
FDA Office of Regulatory Affairs
Office of Partnership and Operational Policy
Date Signed: 2021.09.13

Digitally signed by: 
Michael Rogers
------------------------
Michael Rogers
Assistant Commissioner
FDA Office of Regulatory Affairs
Office of Human and Animal Food Operations
Date Signed: 2021.09.13

Signed by: 
Dan Solis
Assistant Commissioner 
Office of Regulatory Affairs
Office of Enforcement and Import Operations
Date Signed: 2021.09.13

Digitally signed by:
Darla Fl. Bracy 
----------------------
Darla Fl. Bracy 
San Francisco District Director and Program Division Director 
FDA Office of Regulatory Affairs
Office of Human and Animal Food Operations West-Division 5
Date Signed: 2021. 09.13 

Digitally signed by:
Kathleen E. Turner
--------------------------- 
Kathleen Turner DVM 
Program Division Director
Office of Enforcement and Import Operations 
Division of West Coast Import (DWCI)
Date Signed: 2021.09.13 

Accepted for (partnering agency):

Signed by:
David Mazzera, PhD
Chief, Division of Food and Drug Safety
California Department of Public Health
Date Signed: 2021.09.13 

Signed by:
Benson Yee
Chief, Food and Drug Branch
California Department of Public Health
Date Signed: 2021.09.13 

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