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  1. Domestic MOUs

MOU 225-21-016

MOU 225-21-016 has been amended, effective July 29, 2025.

PARTNERSHIP AGREEMENT BETWEEN U.S. FOOD AND DRUG ADMINISTRATION, UNIVERSITY OF HAWAII, AND THE STATE OF HAWAII BY ITS DEPARTMENTS OF AGRICULTURE AND HEALTH

I. PURPOSE

This Partnership Agreement (PA) is entered into by and among the University of Hawaii (UoH), the State of Hawaii by its Department of Agriculture (HDOA) and Department of Health (HDOH), and the U.S. Food and Drug Administration (FDA) Office of Inspections and Investigations (OII), Office of Import Operations (OIO), Division of West Coast Imports (DWCI), together referred to as “the Partners.”

The purpose of this PA is to formalize the Partners’ mutual commitment to coordinate protection efforts of food, cosmetics, drugs, medical devices, biological products, and tobacco products in support of their respective public health and consumer protection missions. This PA applies to imported commodities regulated by the Partners and will support FDA in the enforcement of the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. § 301 et seq.) and the Public Health Service Act (42 U.S.C. § 262).

This PA does not affect or supersede any existing agreements, arrangements, contracts, or cooperative agreements among the Partners and does not affect the ability of the Partners to enter into other agreements or arrangements related to this PA.

II. DURATION OF AGREEMENT

This PA 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) day advance written notice to the other Partner(s).

III. DEFINITIONS and ACRONYMS

C.F.R.: Code of Federal Regulations 
DID: Division of Information Disclosure
DWCI: Division of West Coast Imports 
FDA: Food and Drug Administration
FERN: Food Emergency Response Network https://www.fernlab.org/
FSMA: FDA Food Safety Modernization Act 
FSVP: Foreign Supplier Verification Program 
IFSS: Integrated Food Safety System
IPHS: Integrated Public Health System
Imported commodities: Food, drugs, cosmetics, biologics, medical devices, and tobacco
GAP: Good Agricultural Practices 
GLP: Good Laboratory Practices 
GMP: Good Manufacturing Practice
HDOA: Hawaii State Department of Agriculture 
HDOH: Hawaii State Department of Health 
HHS: U.S. Health and Human Services
OII: Office of Inspections and Investigations
ODP: Office of Domestic Partnerships
ODP/DDPCI: ODP, Division of Domestic Partnership Coordination and Integration
OIO: Office of Import Operations 
OIO DWCI: OIO, Division of West Coast Imports
OIO IOE: OIO, Import Operations and Enforcement 
PA: Partnership Agreement
POC: Point of Contact
The Partners: DWCI and HDOA, HDOH, UoH
UoH: University of Hawaii
VQIP: Voluntary Qualified Importer Program

IV. GOALS, OBJECTIVES AND INTENDED OUTCOME

The Partners are committed to pursuing and furthering an Integrated Public Health System (IPHS) by coordinating efforts in support of the Partners’ public health missions, an initial goal is to support regulatory oversight of imported commodities for which each Partner has statutory responsibilities. The intent is to minimize duplicative efforts, strengthen each other’s knowledge and expertise, and leverage Partner’s regulatory resources towards a more effective, coordinated, and harmonized regulatory framework.
Collaborative work and resource optimization will emphasize:
A. Legal authority for information sharing and protection of the public health;
B. Enhance and coordinate investigatory communication and regulatory activities;
C. Training;
D. Industry and community relations;
E. Resource and research opportunities; and
F. Emergency response.

The Partners will collaboratively identify training opportunities, surveillance projects, exercises, communication and outreach, and other activities that strengthen relationships among the Partners, within the import community, and across public health and agriculture sectors. The Partners will identify and define objectives, audiences, requirements, coordination, oversight, and execution of activities.

Partners agree that nothing in this PA relieves any party from its responsibilities to protect public health and safety nor any legal responsibilities.

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 pursuant to 21 C.F.R. § 20.88, to better coordinate information sharing, such as:
    a. Critical information about emergencies, recalls, product sampling, inspectional findings, and surveillance work; 
    b. Information on emerging situations for which partners have jurisdiction; 
    c. Anticipated risk-based priorities; and
    d. Conditions and procedures outlining requirements for UoH/HDOA/HDOH to consult with FDA DID prior to sharing or disclosing any FDA provided information or documents.

B. Enhance and Coordinate Investigatory Communication and Regulatory Activities.

The increasingly global nature of imported commodities necessitates the use of risk-analysis principles in decision-making to address threats to public health, facilitate FDA and state-regulated commodity protection, and strengthen import product supply chain security. 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. Identifying potential issues or roadblocks, and developing strategies to minimize and prevent public health, regulatory, and compliance risks and challenges; and
  6. Enhancing electronic communication tools.

C. Training.

To enhance proficiency and competency of staff members in partnering agencies, Partners will provide, where appropriate, technical expertise and training for State and Federal 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 FERN, State and FDA training resources and materials, when possible;
  3. Notifying Partners of upcoming training courses/opportunities
  4. Sharing available training resources;
  5. Integrating training faculty, when feasible, to best utilize expertise and increase communication and mutual understanding; and
  6. Providing on-the-job training and shadowing opportunities.

D. Industry and Community Relations.

This portion of the PA is focused on education and outreach program activities.  Excluding exchange of nonpublic information, Partners will work to integrate academic and regulatory science and knowledge that will help industry comply with FDA laws and regulations, promote community public health knowledge and supply chain security of imported products, and provide notification of emerging public health issues.

Activities may focus on any area of regulated commodities and programs including but not limited to:

  1. Products under FDA’s and/or State authority;
  2. Import safety related to pathogens, contaminants, and toxins;
  3. Regulations, regulatory science, and policies throughout the supply chain;
  4. Food-safety risk management and consumer behavior;
  5. Imported unapproved and counterfeit drug interdiction efforts;
  6. Community outreach to alert, provide education and notifications of public health issues;
  7. FSVP;
  8. VQIP; and
  9. GMP.

E. Resource and Research Opportunities:

Partners will look for opportunities and strategies to support staff recruitment, development and retainment, and identify potential research opportunities that are mutually beneficial to furthering each partner’s mission.

F. Emergency Response:

  1. The Partners will work to provide training and exercises to support prompt coordinated response, information sharing and the leveraging of each partner’s regulatory authority and lab analyses (as necessary) in emergency and outbreak situations.
  2. The Partners will work to evaluate and review processes after actions to determine opportunities for improvement.

FDA: DWCI will provide UoH, HDOA, and HDOH with technical assistance and support, upon request and availability.

UoH, HDOA, and HDOH: UoH, HDOA, HDOH 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.

VI. 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.

VII. 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.

If an agency that has received information under this PA receives a Freedom of Information Act request for which there are responsive records that originated with the other agency, to the extent practicable, it will refer that request to the other agency for it to respond directly to the requestor regarding the releasability of the information. In such cases, the agency making the referral will notify the requestor that a referral has been made and that a response will issue directly from the other agency.

VIII. 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.

IX. STATEMENT OF NO FINANCIAL OBLIGATIONS

Signature of this PA does not constitute a financial obligation on the part of the FDA, UoH, HDOA, or HDOH. 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.

X. RESOURCES

ACTIVITY AND LIAISON OFFICIALS

Office of Domestic Partnerships POC: 
Deborah Nebenzahl, Partnership Coordination and Integration Specialist, DDPCI

FDA Partner POCs:
CAPT Nazmul Hassan, Deputy Office Director, OIO
Kathleen Turner, DVM, Division Director DWCI
Carla Fernandez, Supervisor DWCI
Marissa Chan, Supervisor DWCI

State Partner POCs:

HDOH
Kenneth S. Fink, M.D., M.G.A., M.P.H., Director HDOH
Kathleen Ho, Deputy Director for Environmental Health 
Matthew Kurano, Administrator, Environmental Health Services Division
Michael Burke, Environmental Health Program Manager, Food and Drug Branch

HDOA
Sharon Hurd, Chairperson HDOA
Jonathan Ho, Plant Quarantine Branch, Branch Manager

UH
Vassilis L. Syrmos, Vice President for Research and Innovation 
Aimee Grace, MD, Director Office of Strategic Health Initiatives

XI. CONCLUSION 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)

Accepted for the Food and Drug Administration:

/s/   
Erik P. Mettler, MPA, MPH
Assistant Commissioner
Office of Integrated Food Safety System Partnerships 
FDA Human Foods Program
Date: 07/29/2025

/s/
Dan R. Solis
Assistant Commissioner for Import Operations
FDA Office of Import Operations
Date: 07/29/2025

Accepted for (partnering university and agency(s)):

/s/
Wendy F. Hensel, Ph.D.
President
University of Hawaii
Date: 07/22/2025

/s/
Kenneth S. Fink, M.D., M.G.A., M.P.H.
Director of Health
Hawaii Department of Health
Date: 07/09/2025

/s/
Sharon Hurd
Chairperson
Hawaii Department of Agriculture 
Date: 07/03/2025

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