PARTNERSHIP AGREEMENT BETWEEN U.S. FOOD AND DRUG ADMINISTRATION AND THE NEW YORK STATE DEPARTMENT OF AGRICULTURE & MARKETS

I. PURPOSE

This Partnership Agreement (PA) is entered into by the New York State Department of Agriculture and Markets (NYSAGM) 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 1 (HAFE1), Office of Import Operations Division of Northeast Imports (DNEI), Office of Regulatory Science Northeast Food and Feed Laboratory (NFFL) (hereinafter referred to as “the Partners”). The purpose of this document is to establish a formal partnership which is intended to assist the Partners in strengthening the public health by fostering interaction and cooperation to establish a streamlined and efficient process to coordinate and 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 New York. 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 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 any Partner to enter into other agreements or arrangements related to this PA.

II. DURATION OF AGREEMENT

This PA covers a period of three (3) years from the date of signature. 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 upon signing and shall remain in effect until termination by any Partner upon thirty (30) day advance written notice to the other Partner.

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/HAFE1 – Office of Human and Animal Food Operations East, Division 1
IFSS – Integrated Food Safety System
ISA – Information Sharing Agreement
NCI – Non-contract Inspections
ORA/ORS/NFFL – Office of Regulatory Affairs, Office of Regulatory Science, Northeast Food and Feed Laboratory
OEI – Official Establishment Inventory
ORA/OIO/DNEI – Office of Regulatory Affairs, Office of Import Operations, Division of Northeast Imports (DNEI)
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 HAFE1, DNEI, NFFL) and NYSAGM
POC – Point of Contact
RRT – Rapid Response Team
SME – Subject Matter Experts
NYSDAGM – The New York State Department of Agriculture & Markets, the Division of Food Safety & Inspection, the Division of Milk Control & Dairy Services, and the Division of Food Laboratory
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.

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 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 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 IFSS.

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

1. Sharing Data and Information
2. Official Establishment Inventory (OEI) maintenance; comparison and reconciliation of inventories to minimize inspection duplication
3. Investigation of outbreaks and complaints
4. Exploring ways to enhance and support sample collection and laboratory capability, capacity, analysis, and reporting
5. Work Planning and Risk Prioritization/Categorization, including inspection frequency mandates
6. Exploring ways to support collaborative inspection, compliance, enforcement, and corrective actions (i.e., non-contract, non-high-risk inspection sharing)
7. Training of field staff
8. Emergency and Incident Response
9. Recall Oversight
10. Industry and Consumer Education
11. Identifying, establishing, and monitoring key metrics

V. RESPONSIBILITIES

FDA:

1. Data and Information Sharing:
   1. FDA will, in accordance with federal laws and regulations, work with NYSAGM on a regular basis to compare, reconcile, and maintain FDA OEI food firm inventories.
   2. FDA will explore ways to enhance and coordinate investigatory communication and activities for domestic and imported products.
2. Inspection Sharing and Reduction of Duplication:
   1. FDA, as part of HAFE1’s inspection mandate, will explore ways to enhance collaborative counting of non-contract, non-high-risk inspections conducted by NYSAGM.
3. Training:
   1. FDA will provide NYSAGM with technical expertise, training, and support to state regulatory personnel, as requested and subject to availability.

NYSAGM:

1. Data and Information Sharing:
   1. NYSAGM will maintain the appropriate long-term 20.88 Information Sharing Agreement so that NYSAGM is able to receive and protect inspectional, investigative, compliance, laboratory, and regulatory information from the FDA.
2. Inspection Sharing and Reduction of Duplication:
   1. As part of NYSAGM’s scheduled inspections, will explore ways to enhance collaborative counting of non-contract, non-high-risk inspections conducted by HAFE1.
3. Training:
   1. NYSAGM will provide FDA with technical expertise and training, as requested and subject to availability.

JOINT:

1. Data and Information Sharing:
   1. The Partners will meet no less than two times a year for work planning and regulatory activity coordination, such as inspectional and laboratory activities.
   2. The Partners will continue to explore ways to enhance collaborative oversight of activities (including responding to consumer or industry complaints and recall efforts) for jointly regulated firms.
   3. The Partners will explore ways to leverage technology to support data and information sharing and exchange.
2. Inspection Sharing and Reduction of Duplication:
   1. Joint inspections may be requested by either Partner.
   2. The Partners will coordinate to minimize duplication of inspectional activities and maximize time between routine inspections of firms independently inspected by both Partners within the same year.
3. Regulatory Activities
   1. The Partners will explore ways to support collaborative regulatory activities (e.g., inspectional activities, laboratory, compliance, enforcement, and corrective actions)
4. Laboratory Analysis
   1. The Partners will explore ways to enhance collaborative use of laboratory analytical results to initiate appropriate compliance actions based on Federal and state analytical data.
5. Recall Oversight
   1. The Partners will work to enhance communication, coordinate recall activities, minimize duplicative efforts, and maximize use of resources as well as authorities to protect public health.
6. Emergency Response:
   1. The Partners will work to coordinate response, information sharing and the leveraging of lab analyses (if necessary) in emergency and outbreak situations.
   2. The Partners will work to evaluate and review processes after actions to determine opportunities for improvement.
7. Industry and Consumer Education:
   1. The Partners will work together to explore ways to enhance communication and outreach opportunities to industry and consumers.
8. 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: HAFE1, DNEI, and NFFL will provide NYSAGM with technical assistance and support, upon request and availability.

NYSAGM: NYSAGM 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 21 C.F.R. § 20.88 (20.88 agreement), 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, to enter into a 20.88 agreement, and prior to sharing any FDA-provided information Partners shall contact ORA’s Office of Strategic Planning and Operational Policy, Division of Information Disclosure Policy (DIDP) by sending a request via email to [email protected].

IX. ASSESSMENT AND EVALUATION

This PA may be amended or modified by mutual consent of the Partners. 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 its usefulness, and make modifications, 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. This 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 NYSAGM. 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: Deborah Nebenzahl, Consumer Safety Officer (CSO), PA Coordinator

FDA Partner POC: Ronald Pace, Program Division Director, HAFE1

State Partner POC: Daniel McCarthy, Director, NYSDAGM, Division of Food Safety and Inspection

XII. CONCLUSIONS AND RECOMMENDATION

The Partners agree to the provisions in this PA.

ENDORSEMENTS

Accepted for the Food and Drug Administration:

/s/
Robert M. Califf M.D., MACC
Commissioner of Food and Drugs
U.S. Food and Drug Administration
U.S. Department of Health and Human Services
Date: 02/15/2023

Accepted for New York State Department of Agriculture and Markets:

/s/
Richard A. Ball
Commissioner
New York State Department of Agriculture and Markets
Date: 02/15/2023

Signatories for the Food and Drug Administration:

/s/
Erik P. Mettler
Assistant Commissioner
FDA Office of Regulatory Affairs
Office of Partnerships and Operational Policy
Date: 02/13/2023

 

/s/
Michael Rogers
Assistant Commissioner
FDA Office of Regulatory Affairs
Office of Human and Animal Food Operations
Date: 02/13/2023

 

/s/
Dan Solis
Assistant Commissioner
FDA Office of Regulatory Affairs
Office of Import Operations
Date: 02/10/2023

 

/s/
Paul Norris
Director
FDA Office of Regulatory Affairs
Office of Regulatory Science
Date: 02/10/2023

 

/s/
Ronald Pace
Program Division Director
FDA Office of Regulatory Affairs
Office of Human and Animal Food Operations East – Division 1
Date: 02/10/2023

 

/s/
Theresa Smedley
Acting Program Division Director
FDA Office of Regulatory Affairs
Office of Import Operations – Division of Northeast Imports
Date: 02/10/2023

 

/s/
John Leazer
Director
FDA Office of Regulatory Affairs
Office of Regulatory Science – Northeast Food and Feed Laboratory
Date: 02/10/2023

 

Signatories for New York State Department of Agriculture and Markets:

/s/
Stephen McGrattan
First Deputy Commissioner
New York State Department of Agriculture and Markets
Date: 02/09/2023

 

/s/
Jennifer Trodden
Deputy Commissioner
New York State Department of Agriculture and Markets
Date: 02/09/2023

 

/s/
Daniel McCarthy
Director
New York State Department of Agriculture and Markets
Division of Food Safety and Inspection
Date: 02/09/2023

 

/s/
Casey McCue
Director
New York State Department of Agriculture and Markets
Division of Milk Control and Dairy Services
Date: 02/09/2023

 

/s/
Maria Ishida
Director
New York State Department of Agriculture and Markets
Food Laboratory
Date: 02/09/2023