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MOU 225-20-007

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

I. PURPOSE

The purpose of this document is to establish a formal partnership agreement which will coordinate and expand the food protection efforts between the Alaska Department of Environmental Conservation (ADEC) and the U.S. Food and Drug Administration (FDA). This agreement is to loan a Portable Gamma-ray Analysis System to ADEC allowing the state radioanalytical capacity and expertise, emergency response capability and provide continued monitoring of Alaskan Coastal water finfish for radionuclides in response to the Fukushima emergency. ADEC will collect and analyze the samples, providing FDA with the analytical results. FDA will return the final report of analytical results to ADEC.

II. DURATION OF AGREEMENT

This agreement covers a period of three years from the date of signature. This time frame will give all parties sufficient time to measure the program outcomes that have resulted from the partnership agreement, modify if warranted, and renew with consent of the partners. Review of the PA and goals will be conducted face to face annually. This PA maybe amended or modified by mutual consent of all parties. Any partner on their imitative may submit a proposed amendment or modification in writing for all parties to review and agree upon. Modifications and amendments will be tracked and documented during the annual review and maintained for historical purposes. This Partnership Agreement is effective upon signing and shall remain in effect until termination by any partner upon thirty (30) day advance written notice to the other partners.

III. GOALS, OBJECTIVES AND INTENDED OUTCOME

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 project will develop radionuclide capability in the state of Alaska which will be beneficial both for routine annual radionuclide monitoring but more importantly for capacity in emergency response if needed. Additionally, the Food and Drug Administration and Alaska Department of Environmental Conservation have annually been monitoring coastal finfish samples in response to the Fukushima event at the request of the public and the Fukushima Interagency Workgroup.

Our objective is to provide training/expertise on use of the portable gamma-ray analysis system and continued sampling and monitoring of coastal finfish in response to the Fukushima event.

This will ensure increased public health/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 federal agencies thereby saving valuable resources.

IV. RESPONSIBILITIES OF THE AGREEMENT

Food and Drug Administration (FDA):

  1. FDA will loan to ADEC existing equipment (Portable Gamma-Ray Analysis System) needed for sample analysis. The equipment is subject to the same accountability rules as if purchased for FDA use, but may be loaned under an agreement as provided in Staff Manual Guide 2620.4, Loan of Personal Property. See also statement in which “borrower” is responsible for damage and/or repairs of equipment.
  2. FDA will provide initial training to ADEC employees on use of the Portable Gamma- Ray Analysis System.
  3. FDA will provide assistance and technical support for the unit.
  4. FDA will process the data generated from sample analysis and provide a final report of analytical results to ADEC.
  5. FDA will collaborate with ADEC to develop a list of finfish species to be sampled and analyzed.

Alaska Department of Environmental Conservation (ADEC):

  1. ADEC will collect and analyze finfish species and/or food samples from designated areas as mutually agreed upon.
  2. ADEC will ensure these samples are collected in a timely fashion or within agreed upon time frame.
  3. ADEC will package and transport the samples as mutually agreed upon to the ADEC Laboratory.
  4. ADEC will provide two radionuclide standards needed for the portable gamma-ray analysis system.
  5. ADEC will provide data line to provide analytical results to WEAC laboratory.

Joint:

ADEC will share sample collection information in timely manner to FDA to incorporate into the FACTS system.

V. RESOURCES

  1. Partners will provide personnel needed for training session.
  2. Partners will individually fund any travel expenses associated with training.
  3. ADEC will individually fund sample collections performed from their operating budget.

VI. LEGAL AUTHORITY

The purpose of this partnership agreement is to foster interaction, cooperation and coordination between the parties in the furtherance of the public health. No consideration has been given or received by either party to enter this agreement. It is not legally binding and does not constitute a promise on the part of either party for performance. It does not create a legally enforceable contract and the parties agree that no remedies at law or equity will be sought by either party for non-performance of this agreement. It does not impose additional legal duties, rights, benefits, or responsibilities, or remedies of either the parties or of third party. This partnership agreement imposes no duty on either party to act or to refrain from acting.

VII. 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 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 in accordance with the provisions of 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905, 5 U.S.C. § 552(a), 21 C.F.R. Part 20 and other applicable laws and regulations governing the confidentiality of such information. 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 [email protected].

VIII. ASSESSMENT AND EVALUATION

Partners to this PA will make all attempts, at a minimum annually, but may try to meet quarterly to discuss the outcome of current partnership, evaluate usefulness, and make modifications, as needed.

  1. a. Interim monitoring will occur monthly for each functional element.
  2. b. An annual review for each functional element of this PA will be completed by representatives from each partner. Review of the extent to which the PA enhances the sharing of resources to meet each partner’s mission.
    1. Review of the extent to which the PA achieves maximum consumer protection for public and health safety.
    2. Partners will identify new areas for developing partnership activities and agreements.
    3. As necessary and appropriate, evaluate and review materials provided and shared by each partner.

IX. CONCLUSION AND RECOMMENDATION

Based on the annual evaluations performed, the evaluators will jointly prepare several options for follow-up partner actions, if and when appropriate, for approval by the signatories to this agreement.

X. ENDORSEMENTS

Approved and accepted for the Food and Drug Administration:

Erik P. Mettler, MPA, MPH
Assistant Commissioner
Office of Partnerships and Operating Policy

Date: 04/02/2020

Miriam R. Burbach
Seattle District Director
Division of Human and Animal Food Operations West VI

Date: 1/30/2020

Brian Baker
Director
Winchester Engineering & Analytical Center (WEAC)

Date: 12/09/019

Approved and Accepted for the Alaska Division of Environmental Conservation:

Christina Carpenter
Director
Division of Environmental Conservation
Alaska Department of Environmental Conservation

Date: 12/09/2020

ADDENDUM

  1. Section IV “RESPONSIBILITIES OF THE AGREEMENT” of the Partnership Agreement between the U.S. Food and Drug Administration and the Alaska Department of the Environmental Conservation dated April 2, 2020 is hereby modified to add detail to the defined roles and responsibilities pertinent to the data collection, management, and reporting activities related to the gamma-ray analysis of harvested fish (or other matrix) using the portable gammaray analysis system.

    This Addendum does not alter any other provision of the Partnership Agreement, including Section II “DURATION OF AGREEMENT.” The Partnership Agreement continues to cover a period of three years from the date of the last signature in the Partnership Agreement (April 2, 2020).

    This Addendum is effective upon signing and shall remain in effect until the end of that period or until termination of the Partnership Agreement by any party upon 30-day advance written notice to the other party.”

  2. As modified, Section IV “RESPONSIBILITIES OF THE AGREEMENT” shall read as follows:

    IV. RESPONSIBILITIES OF THE AGREEMENT

    Food and Drug Administration (FDA):

    1. FDA will loan to ADEC existing equipment (Portable Gamma-ray Analysis System) needed for sample analysis. The equipment is subject to the same accountability rules as if purchased for FDA use, but may be loaned under an agreement as provided in Staff Manual Guide 2620.4, Loan of Personal Property. See also statement in which “borrower” is responsible for damage and/or repairs of equipment.
    2. FDA will provide initial training to ADEC employees on use of the Portable Gamma-Ray Analysis System.
    3. FDA will provide assistance and technical support for the unit.
    4. FDA will process the data generated from sample analysis and provide a final report of analytical results to ADEC.
    5. FDA will collaborate with ADEC to develop a list of finfish species to be sampled and analyzed.
    6. FDA’s Winchester Engineering and Analytical Center (FDA WEAC) interprets the data, evaluates the quality control (QC), and if any QC anomalies are observed, investigates the outlier(s) and takes corrective action as necessary.
    7. FDA WEAC also monitors long term QC performance and performs periodic trend analysis. Control charts of the data are available to ADEC upon request.
    8. FDA WEAC will notify the ADEC Environmental Health Laboratory (ADEC EHL) via email of the compliance status of QC analyses prior to the release of data.

    Alaska Department of Environmental Conservation (ADEC):

    1. ADEC will collect and analyze finfish species and/or food samples from designated areas as mutually agreed upon.
    2. ADEC will ensure these samples are collected in a timely fashion or within agreed upon time frame.
    3. ADEC will package and transport the samples as mutually agreed upon to the ADEC Laboratory.
    4. ADEC will provide two radionuclide standards needed for the portable Gamma-ray analysis system.
    5. ADEC will provide data line to provide analytical results to WEAC laboratory.
    6. ADEC EHL receives samples, homogenizes the matrix, and places the homogenate in a container, which is placed in the gamma-ray analysis analyzer for data collection per the ADEC EHL standard operating procedure (SOP) number SOP-Chemistry-034.
    7. ADEC EHL will also collect quality control data per its SOP-Chemistry-034.
    8. Once the data are collected, ADEC EHL electronically transfers the files to FDA WEAC.

    Joint:

    1. ADEC will share sample collection information in timely manner to FDA to incorporate into the FACTS system.
    2. Once FDA WEAC completes the data analysis and reports the data to WEAC using the FDA designated data reporting system, FDA Seattle District Office (SEA-DO) reports the data to the Alaska Office of the State Veterinarian (OSV). The OSV notifies ADEC EHL of receipt of the results, allowing ADEC EHL to close out the pertinent work order.

  3. ENDORSEMENTS

    Approved and Accepted for the Food and Drug Administration:

    Erik P. Mettler, MPA, MPH
    Assistant Commissioner
    Office of Partnerships and Operational Policy

    Date: 04/30/2021

    Miriam R. Burbach
    Seattle District Director
    Division of Human and Animal; Food Operations West VI

    Date: 04/29/2021

    Brian Baker
    Director
    Winchester Engineering & Analytical Center (WEAC)

    Date: 04/28/2021

    Approved and Accepted for the Alaska Department of Environmental Conservation:

    Christina Carpenter
    Director
    Division of Environmental Conservation
    Alaska Department of Environmental Conservation

    Date: 04/29/2021

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