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  1. Domestic MOUs

MOU 225-20-007

MOU 225-20-007 has been amended, effective March 20, 2024.

PARTNERSHIP AGREEMENT BETWEEN U.S. FOOD AND DRUG ADMINISTRATION AND THE ALASKA DEPARTMENT OF ENVIRONMENTAL CONSERVATION

I. PURPOSE

This Partnership Agreement (PA) is entered into by the Alaska Department of Environmental Conservation (AK DEC) 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 West – Division 6 (HAFW6), Office of Regulatory Science Winchester Engineering and Analytical Center (WEAC) (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 mission by fostering interaction and cooperation and setting a foundation for the ongoing development of an Integrated Food Safety System (IFSS) in Alaska.  The Partners will establish streamlined and efficient processes to coordinate and enhance communication, increase program familiarity, maximize efficiency, and minimize duplication.  The Partners share mutual interest in collaborating on radio-analytical testing activities that directly impact food safety and public health and understand the importance of leveraging resources to increase effectiveness.  This agreement provides support of the state radio-analytical capacity and expertise, emergency response capability using the Portable Gamma-ray Analysis System and provides monitoring of Alaskan Coastal water seafood for radionuclides in response to the Fukushima emergency.

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

AK DEC – Alaska Department of Environmental Conservation
AK DEC EHL – Alaska Department of Environmental Conservation, Environmental Health Laboratory
C.F.R. – Code of Federal Regulations  
DIDP – Division of Information and Disclosure Policy 
DMR – Domestic Mutual Reliance
FDA – U.S. Food and Drug Administration 
FACTS – Field Accomplishments and Compliance Tracking System 
IFSS – Integrated Food Safety System 
ORA/HAFW6 – Office of Human and Animal Food Operations West, Division 6 
ORA/ORS/WEAC – Office of Regulatory Affairs, Office of Regulatory Science, Winchester Engineering Analytical Center
ORA – Office of Regulatory Affairs
ORA/OP/DI – Office of Regulatory Affairs, Office of Partnerships, Division of Integration 
OSV – Alaska Office of the State Veterinarian 
PA – Partnership Agreement 
The Partners – FDA (ORA HAF-W6, WEAC) and AK DEC 
POC – Point of Contact 
QC – Quality Control
SME – Subject Matter Experts 

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 (DMR). 

DMR 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, DMR 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.

Currently the United States has limited radio-analytical capacity nationwide due to resources required for establishing and sustaining laboratory infrastructure and expertise, and a global shortage of radio-analytical expertise.  This PA will continue development of radionuclide capability in the state of Alaska which will be beneficial for routine annual radionuclide monitoring and more importantly for capacity in the event of emergency response if needed.  Additionally, the FDA and AK DEC have annually been monitoring coastal seafood samples in response to the Fukushima Daiichi nuclear accident at the request of the public and the Fukushima Interagency Workgroup. 

This PA will document and formalize an agreement about ongoing coordination and collaborative efforts between the Partners to establish DMR for the regulatory oversight of human and animal food for which both participants have statutory responsibilities.  A key objective is to provide training/expertise on the use of the portable gamma-ray analysis system and continued sampling and monitoring of marine seafood species in response to the Fukushima Daiichi nuclear accident.  This will ensure increased protection of public health and safety in the event of a crisis, promote the interagency cooperation needed to successfully achieve common goals in public health, and avoid duplication of sampling efforts by the state and FDA thereby saving valuable resources.

The work towards DMR through this PA will focus on the following key areas:

A. Data and Information Sharing
B. Laboratory Support
C. Training
D. Emergency Response
E. Identifying, establishing, and monitoring key metrics

V. RESPONSIBILITIES

FDA: 

A. Data and Information Sharing:

  1. FDA will provide a final report of analytical results to AK DEC.
  2. FDA will provide Quality Control (QC) charts of the data to AK DEC upon request.
  3. FDA will notify AK DEC of the compliance status of the QC analysis prior to release of the data.

B. Laboratory Support:  

  1. FDA will provide assistance, troubleshooting as needed, and technical support for the Portable Gama-ray Analysis System.  This may also include Proficiency Testing support.
  2. FDA will process data generated from sample analysis by AK DEC.
  3. FDA will collaborate with AK DEC to develop and maintain a list of seafood species to be sampled and analyzed.
  4. FDA will interpret, evaluate QC data, and if any QC anomalies are observed will investigate outliers and take corrective action as needed.
  5. FDA will monitor long term QC performance and perform periodic trend analysis.

C. Training:  

  1. 1. FDA will provide training to AK DEC employees on use of the Portable Gamma-ray Analysis System, as requested and subject to availability.

AK DEC: 

A. Data and Information Sharing:  

  1. AK DEC will maintain the appropriate long-term 20.88 Information Sharing Agreement so that AK DEC is able to receive and protect laboratory and regulatory information from the FDA.

B. Laboratory Support:  

  1. AK DEC will collect and analyze seafood species and/or food samples from designated areas as mutually agreed upon.
  2. AK DEC will ensure samples are collected in a timely fashion or within agreed upon time frame.
  3. AK DEC will package, and transport samples as mutually agreed upon to the AK DEC Laboratory.
  4. AK DEC will provide two radionuclide standards needed for the portable Gamma-ray Analysis System.
  5. AK DEC will collect quality control data per Partner agreed upon procedures.
  6. AK DEC will electronically transfer analytical results and files to FDA.

JOINT:

A. Data and Information Sharing:

  1. The Partners will meet no less than two times a year for annual planning and activity coordination, such as laboratory, review of emergency response and training activities.
  2. The Partners will discuss radio-nuclide sample goals, and schedule meetings with appropriate program and agency staff as needed.
  3. The Partners will share data in a timely manner and FDA will incorporate data into the FDA FACTS system.
  4. FDA WEAC will complete a review of the analytical package and report data to FDA HAF-W6.  FDA HAF-W6 will report data to the Alaska Office of the State Veterinarian (OSV).  OSV will notify AK DEC Environmental Health Laboratory (EHL) of receipt of the results, allowing AK DEC EHL to close out the sample in their system.

B. Laboratory Support

  1. The Partners will adhere to agreed upon sample collection, sample preparation, and sample analysis procedures.
  2. The Partners will coordinate on sampling as needed.

C. Emergency Response:

  1. The Partners will work to coordinate response, recall oversight activities, 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. 

D. PA Monitoring and Evaluation:

  1. The Partners will continue to explore ways to enhance collaborative oversight of activities.
  2. The Partners will identify, establish, and monitor key mutual reliance metrics. 
  3. 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: WEAC and HAF-W6 will provide AK DEC with technical assistance and support, and training upon request and subject to availability.

AK DEC: AK DEC will provide FDA technical assistance and support, and training upon request and subject to 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.  Each Partner will self-fund any travel expenses associated with training.

VII. LEGAL STATUS

No consideration has been given or received by any Partner to this PA. This PA is not legally binding and does not constitute a promise on the part of any 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 any Partners for non-performance of this PA. It does not impose additional legal duties, rights, benefits, or responsibilities, or remedies of any of the Partners or of a third party. This PA imposes no duty on any 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 the Partners shall contact ORA’s Office of Partnerships, Division of Information Disclosure Programs (DIDP) by sending a request via email to ORAInfoshare@fda.hhs.gov.

IX. ASSESSMENT AND EVALUATION

This PA may be amended or modified by mutual written 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 AK DEC. 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 are not authorized under this PA. 

XI. ACTIVITY LIAISON OFFICIALS

Office of Partnerships POC:  Deborah Nebenzahl, Consumer Safety Officer (CSO), PA Coordinator

FDA Partner WEAC POC: Brian Baker, Director, WEAC

FDA Partner HAF-W6 POC: Miriam Burbach, Program Division Director, HAF W-6

State Partner POC:  Patryce D. McKinney, Chief, Environmental Health Laboratory

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] 

Accepted for the Food and Drug Administration:

/s/
Erik P. Mettler
Assistant Commissioner 
FDA Office of Regulatory Affairs
Office of Partnerships and Operational Policy
Date: 03/20/2024

/s/
Michael Dutcher 
Assistant Commissioner 
FDA Office of Regulatory Affairs 
Office of Human and Animal Food Operations 
Date: 03/19/2024

/s/
Paul Norris
Director
FDA Office of Regulatory Affairs
Office of Regulatory Science
Date: 03/18/2024

/s/
Brian Baker
Director
FDA Office of Regulatory Affairs 
Office of Regulatory Science - Winchester Engineering and Analytical Center
Date: 03/13/2024

/s/
Miriam Burbach
Program Division Director
FDA Office of Regulatory Affairs 
Office of Human and Animal Food Operations West – Division 6
Date: 03/12/2024

Accepted for (Partnering agency(s)):

/s/
DeeAnn Fetko
Acting Director 
Division of Environmental Health 
Alaska Department of Environmental Conservation
Date: 03/12/2024

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