MOU 225-22-029

MOU 225-22-029 has been amended, effective August 31, 2026.

PARTNERSHIP AGREEMENT BETWEEN U.S. FOOD AND DRUG ADMINISTRATION AND THE COMMONWEALTH OF PUERTO RICO DEPARTMENT OF CONSUMER AFFAIRS

I. PURPOSE

This Partnership Agreement (PA) is entered into by The Commonwealth of Puerto Rico Department of Consumer Affairs (DACO) and the United States Department of Health and Human Services, Food and Drug Administration’s (FDA), Office of Inspections and Investigations (OII), Office of Human Food Inspectorate East 4 (OHFI E-4) (hereinafter referred to as “the Partners”).  The purpose of this agreement is to assist the Partners in strengthening their public health missions by fostering interaction and cooperation and furthering the development of an Integrated Public Health Safety System (IPHS) in the United States Territory of Puerto Rico.  To meet these objectives, this PA promotes streamlined and efficient processes to coordinate and enhance communication, increase program familiarity, maximize efficiency, and minimize duplication through the exchange of FDA regulated food, drug, medical device, biological product, tobacco product, and cosmetic safety information.  The Partners understand the importance of leveraging resources to improve public health and safety effectiveness and share mutual interest in collaborating on information sharing, emergency response activities, risk-based inspection programs, and partner training activities that directly impact safety of FDA-regulated products and public health.

This PA does not replace 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, including those that may relate to this PA. 

II. DURATION

This agreement covers a period of five (5) 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

C.F.R.	Code of Federal Regulations
DACO	The Commonwealth of Puerto Rico Department of Consumer Affairs
DID	FDA Division of Information Disclosure
DMR	Domestic Mutual Reliance
FDA	U.S. Food and Drug Administration
FERN	Food Emergency Response Network
HFP	FDA Human Foods Program
IFSS	Integrated Food Safety System
IPHS	Integrated Public Health System
ODP	FDA Office of Domestic Partnerships
ODP/DDPCI	FDA ODP, Division of Domestic Partnership Coordination and Integration
OIFSSP	FDA Office of Integrated Food Safety System Partnerships
OII/OHFI E-4	FDA OII/Office of Human Food Inspectorate Division East 4
OII	FDA Office of Inspections and Investigations
PA	Partnership Agreement
POC	Point of Contact
PRET	FDA Partnership for Regulatory Education and Training
RLTS	FDA Regulatory and Laboratory Training System
RRT	Rapid Response Team
SME	Subject Matter Expert
The Partners	OFHI E-4 and DACO
U.S.C.	United States Code

IV. GOALS, OBJECTIVES, AND INTENDED OUTCOMES

The Partners are committed to pursuing and furthering the vision of an IPHS by coordinating efforts in support of the Partners’ public health missions.  The intent of this PA is to minimize duplicative efforts, strengthen each other’s knowledge and expertise, and leverage each Partner’s regulatory resources towards a more effective, coordinated, and harmonized regulatory framework.

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.  The Partners will also strive to reach a state of Domestic Mutual Reliance (DMR) which enables FDA and U.S. Territories 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. 

Activities conducted by the Partners 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 et seq.).  FDA’s responsibilities under the Act include the regulation of products, including foods, drugs, medical devices, biologics, tobacco, and cosmetics, that are manufactured, imported, or distributed within the Commonwealth of Puerto Rico.

Similarly, this PA supports Puerto Rico’s adoption of FDA regulation and standards in the implementation and enforcement of consumer product requirements under the ‘Organic Law of the Department of Consumer Affairs’ (Law Number 5 of April 23, 1973).  Specifically, this collaboration helps to ensure the safety and effectiveness of mutually regulated products during special emergency situations when they are offered or held for sale or distribution within the Commonwealth of Puerto Rico.

Collaborative work and resource optimization will emphasize:

A. Legal Authority for Information Sharing and Protection of Public Health
B. Training
C. Risk-based Inspection Program through enhancement and coordination of investigatory information, communication, and regulatory activities
D. Emergency Response through management of activities
E. Partnership Planning and Evaluation

V. RESPONSIBILITIES

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

1. The Partners will utilize legally recognized agreements, such as information disclosure agreements created pursuant to 21 C.F.R. § 20.88, to coordinate information sharing.  These agreements may include:
   1. Critical information about emergencies, recalls, product sampling, inspectional findings, enforcement activities and surveillance work;
   2. Information on signals, trends and emerging situations for which the Partners have jurisdiction;
   3. Anticipated risk-based priorities; and
   4. Conditions and procedures outlining requirements for DACO to consult with FDA DID prior to sharing or disclosing any FDA provided information or documents.

B. Training

1. To enhance proficiency and competency of staff members in partnering agencies, the Partners will provide, where appropriate, technical expertise and training for regulatory personnel, as requested and subject to availability. Activities may encompass but are not limited to:
   1. Leveraging training resources to enhance operation uniformity, competence, communication, and cooperation;
   2. Leveraging Food Emergency Response Network (FERN), Territory and FDA training resources and materials such as Partnership for Regulatory Education and Training (PRET) and Regulatory and Laboratory Training System (RLTS), when possible;
2. Notifying Partners of upcoming training courses/opportunities;
   1. Sharing available training resources;
   2. Integrating training faculty, when feasible, to best utilize expertise and increase communication and mutual understanding; and
3. Providing on-the-job training and shadowing opportunities.  Training may address, but is not limited to:
   1. Responding to large-scale outbreak of contaminated commodities or other emergencies to protect public health
   2. Responding to intentional adulteration or contamination of jointly regulated commodities

C. Risk-based Inspection Program, Enhanced Regulatory Activities:

1. The increasingly global nature of FDA-regulated products necessitates the use of risk-analysis principles in decision-making to address threats to public health and ensure supply chain and product protection across the U.S. and its Territories. This PA is intended to enhance regulated product safety through, where appropriate, activities that may encompass but are not limited to:
   1. Conducting and coordinating joint regulatory operations to reduce duplication of efforts and leverage each other’s regulatory and enforcement authorities for greater protection of public health;
   2. Clarifying regulatory roles; 
   3. Optimizing use of personnel, equipment, and facilities to ensure rapid sharing of critical information; 
   4. Providing regulatory, laboratory, and compliance operational support, pending resource availability; 
   5. Providing consultation on inspection approach or enforcement strategy when appropriate for jointly regulated commodities;
   6. Identifying potential issues or roadblocks, and developing strategies to minimize and prevent public health, regulatory, and compliance risks and challenges; and 
   7. Enhancing electronic communication tools.

D. Emergency Response:

1. The Partners will continue to coordinate in emergency, recall and outbreak situations utilizing the Territory’s Rapid Response Team for response. The Partners will participate in after-action review processes to determine opportunities for improvement.
2. Emergency situations, such as efforts to remove from the market certain unapproved products that are purported to diagnose, prevent, treat, mitigate, or cure disease, serve as a trigger for increased communication between the Partners.
3. The Partners will engage in training and exercises to further support prompt, coordinated, and effective investigatory operations and analyses of samples during commodity investigations and foodborne illness outbreaks, or to detect/identify unapproved ingredients. The Partners will provide support for a coordinated (joint) emergency response with multidisciplinary expertise in epidemiology, microbiology, chemistry, radiology, sanitation, and environmental science.

E. Partnership Planning and Evaluation:

1. On an annual basis, the Partners will collaborate with the Human Foods Program/Office of Integrated Food Safety System Partnerships/Office of Domestic Partnerships, Division of Domestic Partnership Coordination and Integration, and Subject Matter Experts to discuss metrics for this PA and determine areas for enhancements.

VI. RESOURCES

Resources will be identified to accomplish objectives and may include as needed, but are not limited to:

A. Personnel
B. Time
C. Training
D. Databases, and
E. Guidance and technical support

All activities undertaken pursuant to this PA are subject to availability of personnel and resources.

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 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.

IX. ASSESSMENT AND EVALUATION

This PA may be amended, modified, or terminated 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 FDA or DACO. 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 AND LIAISON OFFICIALS

FDA ODP POC:
Deborah Nebenzahl, Partnership Coordination and Integration Specialist, DDPCI

FDA OHFI E-4 POC:
Ramon Hernandez, Program Division Director
Maradali De Leon, Director of Inspections and Investigations
Leslie Mendoza, State Liaison

DACO:
Lcdo. Hiram J. Torres Montalvo, Secretary

XII. CONCLUSIONS AND RECOMMENDATION

The Partners agree to the provisions in this PA.  

ENDORSEMENTS

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: 08/31/2026

/s/
Michael Dutcher
Deputy Associate Commissioner for Food Products
FDA Office of Inspections and Investigations
Date: 08/27/2026

/s/
Ramon Hernandez
Program Division Director
FDA Office of Human Food Inspectorate East, Division 4
Date: 08/25/2026

Accepted for the Commonwealth of Puerto Rico
Department of Consumer Affairs:

/s/
Hiram J. Torres Montalvo
Secretary
Puerto Rico Department of Consumer Affairs
Date: 08/19/2026