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MOU 225-23-013

PARTNERSHIP AGREEMENT BETWEEN U.S. FOOD AND DRUG ADMINISTRATION AND THE PENNSYLVANIA DEPARTMENT OF AGRICULTURE 

I. PURPOSE

This Partnership Agreement (PA) is entered into by the Pennsylvania Department of Agriculture’s (PDA) Bureau of Food Safety & Laboratory Services and the United States Department of Health and Human Services (HHS), Food and Drug Administration’s (FDA) Office of Regulatory Affairs (ORA), Office of Human and Animal Food Operation’s East – Division 2 (HAF-E2), (hereinafter referred to as “the Partners”).  The purpose of this agreement is to establish 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 Pennsylvania.  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, inspection sharing, emergency response, industry outreach, and evaluation activities that directly impact food safety and public health.

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

This agreement covers a period of three 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) day advance written notice to the other Partner(s).

III. DEFINITIONS AND ACRONYMS

C.F.R. – Code of Federal Regulations     
DIDP – Division of Information and Disclosure Policy 
FDA – U.S. Food and Drug Administration 
ORA/HAFE2 – Office of Human and Animal Food Operations East, Division 2 
IFSS – Integrated Food Safety System 
ISA – Information Sharing Agreement 
NCI – Non-contract Inspections 
OEI – Official Establishment Inventory 
ORA – Office of Regulatory Affairs
ORA/OP/DI – Office of Regulatory Affairs, Office of Partnerships, Division of Integration 
PA – Partnership Agreement 
The Partners – FDA (ORA/HAF-E2) and PDA
POC – Point of Contact 
RRT – Rapid Response Team 
SME – Subject Matter Experts 
PDA – Pennsylvania Department of Agriculture, Bureau of Food Safety & Laboratory Services
U.S.C. – United States Code 

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. 

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. 

Working toward 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 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 domestic mutual reliance for the regulatory oversight of human 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 IFSS. 

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

A. Legal Authority for Information Sharing and Protection of Public Health

B. Information Technology for Data Sharing and Collaboration

C. Risk-based Inspection Program (e.g., non-contract inspection sharing)

D. Emergency Response

E. Industry and Community Relations

F. Training

G. Domestic Mutual Reliance Planning and Evaluation

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

C. Training:

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

PDA:

A. Legal Authority for Information Sharing and Protection of Public Health:

  1. PDA will maintain a current long-term Food 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. PDA will consult DIDP prior to sharing any FDA-provided documentation.

B. Risk-based Inspection Program:

  1. PDA will work with FDA on a regular basis to compare, reconcile, and maintain PDA firm inventories. 
  2. PDA will explore options for counting human food inspections conducted by HAF-2E as part of PDA's inspections.

C. Training:

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

JOINT:

A. Information Technology for Data Sharing and Collaboration:

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

B. 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 collaborative inspection activities, compliance, enforcement, and corrective actions (e.g., non-contract activities).

C. Emergency Response:

  1. The Partners will continue to coordinate in emergency, recall and outbreak situations utilizing the state's RRT for response. The Partners will participate in after-action review processes to determine opportunities for improvement.

D. Industry and Community Relations:

  1. The Partners will work together on industry outreach opportunities.

E. 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: HAF-E2 will provide PDA with technical assistance and support, upon request and availability.

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

JOINT: The Partners will collaborate with Office of Regulatory Affairs, Office of Partnerships, Division of Integration (ORA/OP/DI) 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. Part 20 under § 20.88 (20.88 agreement). 

Partners shall contact ORA’s Office of Partnerships, Division of Information Disclosure Policy (DIDP) via email at ORAInfoshare@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. 

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 PDA. 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 Partnerships POC: Mari Carpenter, Consumer Safety Officer (CSO), PA Coordinator

FDA Partner POC: Randy Pack, Program Division Director HAF-E2

State Partner POC: Sheri Morris, Assistant Director, Bureau of Food Safety & Laboratory Services

XII. CONCLUSIONS AND RECOMMENDATION

The Partners agree to the provisions in this PA.  

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
FDA Office of Regulatory Affairs
Office of Partnerships and Operational Policy
Date: 09/22/2023

/s/
Michael Dutcher 
Acting Assistant Commissioner
FDA Office of Regulatory Affairs
Office of Human and Animal Food Operations
Date: 09/18/2023

/s/
Randy Pack
Program Division Director
FDA Office of Regulatory Affairs
Office of Human and Animal Food Operations East – Division 2
Date: 09/14/2023

Approved and Accepted for the Pennsylvania Department of Agriculture:

/s/
Lisa Graybeal
Deputy Secretary, Animal Health & Food Safety
PDA Bureau of Food Safety & Laboratory Service
Date: 08/14/2023

/s/
Jeff Warner
Director 
PDA Bureau of Food Safety & Laboratory Service
Date: 08/14/2023

Approved as to Form and Legality:

/s/
Kyla Djannie
Office of Chief Counsel
Pennsylvania Department of Agriculture
Date: 08/14/2023

/s/
Andrew Hanna
Office of General Counsel
Commonwealth of Pennsylvania
Date: 08/24/2023

/s/
David E. Stover
Office of Attorney General
Commonwealth of Pennsylvania
Date: 09/12/2023
 

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