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  1. Domestic MOUs

MOU 225-22-006

MOU 225-22-006 has been amended, effective March 5, 2025.

PARTNERSHIP AGREEMENT BETWEEN U.S. FOOD AND DRUG ADMINISTRATION, WINCHESTER ENGINEERING AND ANALYTICAL CENTER AND THE STATE OF RHODE ISLAND EMERGENCY MANAGEMENT AGENCY

I. PURPOSE

The State of Rhode Island Emergency Management Agency (RIEMA) and the Food and Drug Administration's (FDA) Winchester Engineering and Analytical Center (WEAC) (herein referred to as “the Partners”) enter into this partnership agreement (PA) the purpose of which is to provide technical support in the areas of radioanalytical analyses of food products (to include bottled water) and radioisotopes found in the food monitoring program and collected in accordance with FDA policies and procedures.  This agreement fosters interaction, cooperation and coordination between the partners in the furtherance of public health and each partner’s mission.

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

II. BACKGROUND

WEAC is an FDA specialty laboratory in the Office of Specialty Laboratories and Enforcement Support (OSLES) with responsibility for analyzing for the presence of radionuclides in food. In the event of an actual or simulated emergency, the FDA intends to provide technical support in this area to RIEMA.

III. DURATION OF AGREEMENT

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

IV. DEFINITIONS and ACRONYMS

CERCLA: Comprehensive Environmental Response, Compensation, and Liability Act
CP: Compliance Program
DIDP: Division of Information Disclosure and Policy
DMR: Domestic Mutual Reliance
FDA: U.S. Food and Drug Administration
HFP: Human Foods Program
MOU: Memorandum of Understanding
NRC: U.S. Nuclear Regulatory Commission
OCS: Office of the Chief Scientist
ODP: FDA/HFP Office of Domestic Partnerships
ODP/DDPCI: ODP, Division of Domestic Partnership Coordination and Integration
OSLES: FDA/OCS/Office of Specialty Laboratories and Enforcement Support
PA: Partnership Agreement
POC: Point of Contact
RIEMA: Rhode Island Emergency Management Agency
RCRA: Resource Conservation and Recovery Act
SARA: Superfund Amendments and Reauthorization Act
The Partners: FDA (WEAC) and REIMA
TSCA: Toxic Substances Control Act
WEAC: FDA’s Winchester Engineering and Analytical Center

V. GOALS, OBJECTIVES, AND INTENDED OUTCOME

WEAC is to provide technical support to RIEMA for radiological analyses of food samples, as needed, pending availability. In the event of a crisis that requires the use of FDA analytical resources to be used for its own mission, WEAC may not be able to analyze samples for RIEMA.

WEAC will perform, within the scope of capabilities, upon specific request, analyses for radionuclides that may be required during a nuclear power plant exercise or in the case of an actual emergency using appropriate methods and adequate controls.

Collaboration between partners is intended to support public health and safety in the event of an emergency.  FDA will benefit from this agreement in that it allows sample collection and analyses to occur in a larger area of the United States and allows the agency to work with a regional radiation safety partner during a radiation incident for food safety against radionuclide contaminations.

VI. RESPONSIBILITIES

WEAC: WEAC intends to provide the following services, as needed.  In the event of a crisis that requires the use of FDA analytical resources to be used in support of its own mission, WEAC may not be able to analyze samples for RIEMA.  Upon specific request, WEAC may be asked to perform analyses for radionuclides that are of interest during a nuclear power plant exercise or in the case of an actual emergency using appropriate methods and adequate controls.

  1. Analysis of food products including bottled water. Analysis of radioisotopes found in the food monitoring programs using the Data Quality Objectives/Methods and radionuclides supported by FDA CFSAN in CP 7304.019 Toxic Elements in Foods (I-131, Cs-134, Cs-137, Ru-103, Ru-106, possibly Sr-90 and H-3)
  2. Schedule the analyses and testing as soon as samples are received. RIEMA will be notified if samples cannot be processed on the day of receipt of incident-specific samples. WEAC will provide type of analyses and expected turnaround time.   Sample receipt, storage, accountability, and disposition are accomplished according to WEAC's quality system sample handling procedures.
  3. Provide documentation of the FDA methodology used as found in the food monitoring programs or emergency methods approved through FDA and results obtained.
  4. Accept and process samples Monday - Friday during working hours of 8:00 AM - 4:30 PM. In the event of a critical emergency, night or weekend hours may be authorized.
  5. Provide analytical results with sample analysis summary memo and sample data summary to RIEMA. The results will be reported with the date of collection with the required scientific notation.
  6. Hold all positive samples for proper disposition after notifying RIEMA of the results.
  7. Safely dispose of all materials handled or generated under this PA including excess samples of the wastes being studied. There are three options for disposal of samples: (a) hold for thirty days, (b) return to RIEMA in compliance with all federal, state, and local transportation regulations, or (c) dispose after analysis with negative results.
  8. Dispose samples at approved disposal facilities in compliance with all applicable federal (e.g., CERCLA/SARA, RCRA, TSCA and NRC), state, and local laws and regulations. Shipment shall be in compliance with all federal, state, and local laws and regulations.

RIEMA:

  1. RIEMA will maintain a long-term Food, Feed and Cosmetics Section 20.88 Information Sharing Agreement with FDA to be able receive inspectional, investigative, compliance, laboratory, and regulatory information from the FDA.
  2. Coordinate sample collection procedures with WEAC, provide reference date for the activity results, notify WEAC in advance regarding the number of samples and matrices involved, and deliver samples to the laboratory within a reasonable time to analyze for short-lived radioisotopes.
  3. Submit four-pound samples of the edible portion of poultry, meat, or egg products.  For liquid samples, submit one gallon of product.
  4. Identify the sample using sample identification information included on the sample container label(s), chain-of-custody seal, and chain-of-custody forms.
  5. Double bag, in plastic bags, all samples sent to WEAC. Notify WEAC of any possible contamination of samples to include chemical, radiological, or biological agents in advance of shipment to WEAC.
  6. Inform WEAC of which disposal options to use for samples. The three options are (a) hold for thirty days, (b) return to RIEMA in compliance with all federal, state, and local transportation laws and regulations, and (c) dispose after analysis with negative results.
  7. Dispose samples at approved disposal facilities in compliance with all applicable federal (e.g., CERCLA/SARA, RCRA, TSCA and NRC), state, and local laws and regulations. Shipment shall be in compliance with all federal, state, and local laws and regulations.

JOINT: The partners agree to collaboratively perform an annual evaluation as described below in “Assessment and Evaluation.”

VII. RESOURCES

ACTIVITY LIAISON OFFICIALS:

The partners shall establish a direct line of communication that will ensure timely response to inquiries by the other partner. The following persons are the primary points-of­ contact:

Office of Domestic Partnerships POC:

Deborah Nebenzahl, Partnership Coordination and Integration Specialist, DDCPI
Deborah.Nebenzahl@fda.hhs.gov

FDA Partner POC:

Department of Health & Human Services
Food and Drug Administration
Winchester Engineering and Analytical Center
Brian Baker, Director
109 Holton Street
Winchester, MA 01890-1152
Phone: 781-756-9701
Fax: 781-756-9757
Brian.Baker@fda.hhs.gov

State Partner POC:

Rhode Island Emergency Management Agency
Marc R. Pappas, Director 
645 New London Avenue
Cranston, RI 02920-3003
Phone: 401-946-9996
Fax: 401-944-1891
Marc.pappas@ema.ri.gov

VIII. 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.

IX. INFORMATION DISCLOSURE PROVISION

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.

X. 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.

XI. STATEMENT OF NO FINANCIAL OBLIGATIONS

Signature of this PA does not constitute a financial obligation on the part of the FDA or REIMA. 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 commitment.

XII. 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)

Approved and Accepted for the Food and Drug Administration:

/s/
Erik P. Mettler
Assistant Commissioner
Office of Integrated Food Safety System Partnerships
FDA Human Foods Program
Date Signed: 03/05/2025

/s/
R. Duane Satzger, Ph.D.
Director
Office of Specialty Laboratories and Enforcement Support
FDA Office of Chief Scientist
Date Signed: 02/10/2025

/s/
Brian Baker
Director
Winchester Engineering and Analytical Center
Office of Specialty Laboratories and Enforcement Support
FDA Office of Chief Scientist
Date Signed: 02/10/2025

Approved and Accepted for (partnering agency):

/s/
Marc R. Pappas
Director
Rhode Island Emergency Management Agency
Date Signed: 02/07/2025

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