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  1. Domestic MOUs

MOU 225-21-016

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 Regulatory Affairs (ORA), Office of Enforcement and Import Operations (OEIO), 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 imported food, cosmetic, drug, and medical device protection efforts in support of their 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.).

This PA does not affect or supersede any existing or future 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 three (3) years from the date of final signature by all the Partners. This time frame will give the Partners sufficient time to measure the program outcomes that have resulted from the PA, propose modifications to the PA if warranted, and renew the PA by consent of all the Partners. Review of the PA and goals will be conducted annually, either face-to-face or virtually. This PA may only be amended or modified in writing with the consent of all the Partners. Any Partner may propose an amendment or modification to this PA for all the Partners to review and agree upon. Any modifications or amendments made to the agreement will be maintained by the Partners for future reference. 
This PA is effective from the date of signature of all Partners and shall remain in effect for the duration of the three (3) years unless any Partner terminates the PA upon thirty (30) days advanced written notice to all the other Partners.

III.   DEFINITIONS and ACRONYMS

C.F.R.: Code of Federal Regulations
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
Imported commodities: Food, drugs, cosmetics, biologics, and medical devices
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
OEIO: Office of Enforcement and Import Operations
ORA: FDA Office of Regulatory Affairs
Partnership: Collaboration, cooperation
PA: Partnership Agreement
Proficiency: Skill, expertise, competence
UoH: University of Hawaii
VQIP: Voluntary Qualified Importer Program

IV.    GOALS, OBJECTIVES AND INTENDED OUTCOME

As we formalize our commitment to coordinate 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 and further mutual reliance.

Collaborative work and resource optimization may include:

A.    Enhance and coordinate investigatory communication and activities for imported products
B.    Partner training
C.    Educational and community outreach 
D.    Identify research opportunities 
E.    Manage emergency response activities
F.    PA Monitoring, Assessment, and Evaluation

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 for these activities.

All Partners agree that nothing in this PA relieves any party from its responsibilities to protect public health and safety nor any regulatory responsibilities granted to their respective agencies.

A.    Investigatory Coordination/Communication for Imported Products:

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 food defense. This PA is intended to enhance import safety through activities that may encompass but are not limited to: 

1.    Conducting and coordinating joint import operations to reduce duplication of efforts
2.    Clarifying regulatory roles
3.    Optimizing use of personnel, equipment, and facilities to ensure rapid sharing of critical information 
4.    Providing operational support 
5.    Enhancing electronic communication tools 
6.    Utilizing legally recognized agreements such as information disclosure agreements pursuant to 21 C.F.R. § 20.88, where applicable, to better coordinate information sharing, such as:
a.    Critical information about emergencies, recalls, product sampling, inspectional findings, and surveillance work (obtained under section 801 of the Act)
b.    Information on emerging situations for which partners have jurisdiction 
c.    Anticipated risk-based priorities

B.    Partner Training:

This PA aims to enhance the proficiency and competency of staff members in partnering agencies. Activities may encompass but are not limited to:     

1.    Leverage training resources to enhance import operation uniformity, competence, communication, and cooperation
2.    Leveraging FERN, State and FDA training resources and materials, when possible 
3.    Notifying all Partners of upcoming training courses/opportunities
4.    Sharing of available training sites
5.    Integrating training faculty, when feasible, to best utilize expertise and increase communication and mutual understanding

C.    Educational and Community Outreach:

The goal of this portion of the PA is to outline education and outreach program activities by describing approaches, processes, and tools that facilitate the exchange of scientific, technical, and regulatory information. This does not include the exchange of nonpublic information. 

This PA provides a basis for cooperative education and training for FDA’s implementation of FSMA, FDA Program Alignment initiatives and an Integrated Food Safety System (IFSS). Integrating academic and regulatory science into outreach and training will help industry comply with FDA laws and regulations.
A focus of this activity will be to increase knowledge of effective, available practices that promote import safety throughout the supply chain and enhance the use of risk analysis models and tools for decision making associated with imported commodities. 
Outreach and educational activities may focus on any area of regulated commodities and programs. Initial efforts will emphasize:

1.    Imported products under FDA’s 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.    FSVP
7.    VQIP
8.    GMP

D.    Identify Exercise and Research Opportunities:

1.    Conduct joint operations to address public health issues 
2.    Establish joint communication plan for industry/trade outreach
3.    Establish a working group to focus on emerging public health issues

E.    Manage Emergency Response 

The purpose of this section is to provide training and exercises to further support prompt, coordinated, and effective investigatory operations, and analyses of samples during imported commodity investigations and foodborne illness outbreaks. The Partners will provide support for (joint) emergency response with multidisciplinary expertise in epidemiology, microbiology, chemistry, radiological, sanitation, and environmental science. Training may address, but is not limited to: 

1.    Responding to large-scale outbreak of contaminated imported food or other emergencies to protect public health
2.    Responding to terrorist events or contamination of imported products

F.    PA Monitoring, Assessment and Evaluation

1.    The Partners will meet, at least annually, to evaluate the progress of the PA during the completed period(s). 
2.    The Partners will evaluate whether the PA enhances sharing of resources to meet each partner’s mission 
3.    As necessary and appropriate, the Partners will evaluate, and review materials provided by each partner
4.    The Partners will identify, establish, and monitor key mutual reliance metrics for performing an annual evaluation of this PA
5.    The Partners will collectively provide an “Annual Evaluation fillable .pdf” which includes ongoing outputs and outcomes 

V.    RESPONSIBILITIES OF THE AGREEMENT

FDA:

  • DWCI will serve as an educational resource for all the Partners to help support accountability, commitment to public health, communication, integrity, respect, and quality within their import programs. With these core values emphasized, both consumer protection and public health will be enhanced.

STATE PARTNERS: 

  • UoH:  
  1. Will ensure proper information sharing agreements with FDA are in place to pursue operationalizing shared activities
  2. Identify collaborative opportunities, such as identifying potential issues that the Partners may encounter (e.g., COVID-19), and develop strategies to minimize and prevent future risk/problems 
  • HDOA: 
  1. Will ensure proper information sharing agreements with FDA are in place to pursue operationalizing shared activities 
  2. Identify collaborative opportunities, such as participating in training and education, conducting outreach, assisting in import investigations, and collaborating in emergency response activities
  3. Will fulfill basic level of training to enter into funding opportunities (e.g., MFRPS, Emergency Food Response)
  • HDOH:
  1. Will ensure proper information sharing agreements are in place to pursue operationalizing shared activities 
  2. Identify collaborative opportunities, such as participating in training and education, conducting outreach, assisting in import investigations, and collaborating in emergency response activities
  3. Will fulfill basic level of training to enter into state contracts (e.g., MFRPS, Emergency Food Response)
  • JOINT: 
  1. The Partners will work together to develop a three-year Strategic Plan that outlines how to implement the PA 
  2. Signatories for each Partner will assign coordinators, as needed, for each goal of this agreement
  3. Coordinators will ensure progress, clear lines of communication, and appropriate dissemination of information to managers
  4. The Partners will identify, establish, and monitor key mutual reliance metrics with assistance from ORA/Office of Partnerships
  5. The Partners will complete a joint annual evaluation report, with support from the ORA/Office of Partnerships, which includes ongoing PA outputs and outcomes to document program accomplishments and areas for enhancement 

VI.    RESOURCES

Resources will be identified to accomplish objectives and may include as needed, but are not limited to: 
1.    Personnel
2.    Time
3.    Equipment lending 
4.    Training
5.    Databases and technological transfer
6.    Guidance and technical support
7.    Funding sources/opportunities

The Partners agree to demonstrate mutual commitment to shared goals and objectives within their operational and fiscal resource constraints. There is no intended or implied funding associated with this PA. Nothing in this agreement obligates any of the Parties to any current or future expenditure of resources.

VII.    LEGAL AUTHORITY

The purpose of this PA is to foster interaction, cooperation, and coordination between the Partners to support public health. No consideration has been given or received by the Partners to enter into this agreement. This PA does not create a legally enforceable contract, and the Partners agree that no remedies at law or equity will be sought for non-performance. Further, this PA does not impose other legal duties, rights, benefits, responsibilities, or remedies. 

VIII.    INFORMATION DISCLOSURE PROVISION

Access to non-public information, where appropriate, shall be governed by separate Confidentiality Disclosure Agreements entered into under the authority of 21 C.F.R. 
§ 20.88 and in which the Hawaii state partners will agree and certify in writing that they shall not further release, publish or disclose such 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. Parties seeking 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.

IX.    STATEMENT OF NO FINANCIAL OBLIGATIONS

Signing this PA does not constitute a financial obligation on the part of the Partners. Each Partner will use and manage its own funds to carry out this PA. Permanent transfers of funds or items of value are not authorized under this PA.

X.    CONCLUSION AND RECOMMENDATION

The Partners agree to the provisions written in this PA, subject to availability of resources.


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


Approved and Accepted for the Food and Drug Administration:


/s/
Erik P. Mettler, MPA, MPH
Assistant Commissioner 
FDA Office of Regulatory Affairs
Office of Partnership and Operational Policy
Date: 03/10/2022                         


/s/
Dan Solis
Assistant Commissioner for Import Operations 
FDA Office of Regulatory Affairs
Office of Enforcement and Import Operations
Date: 03/09/2022


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


/s/
David Lassner, Ph.D
President                     
University of Hawaii
Date: 02/15/2022


/s/
Dr. Elizabeth A. Char, MD
Director of Health
Hawaii Department of Health
Date: 02/28/2022


/s/
Phyllis Shimabukuro-Geiser
Chairperson
Hawaii Department of Agriculture
Date: 02/15/2022

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