MOU 225-22-006
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 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 the partners to enter other agreements or arrangements related to this partnership.
II. BACKGROUND
WEAC is an FDA specialty laboratory. WEAC has, among other things, the responsibility for analyzing for the presence of radionuclides for the FDA. 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 three (3) years from the date of signature. This time frame will give the partners sufficient time to measure the program outcomes that have resulted from the PA, modify the PA if warranted, and renew it with consent of the partners. Review of the PA and its goals will be conducted annually, face to face or virtually. This PA may be amended or modified by mutual consent of all partners. Any partner on their initiative may submit a proposed amendment or modification in writing for all partners to review and agree upon. Modifications and amendments will be tracked and documented during the annual review and maintained for historical purposes. This PA is effective upon signing by both partners and shall remain in effect until termination by any partner upon thirty (30) day advance written notice to the other partners.
IV. DEFINITIONS and ACRONYMS
CERCLA: Comprehensive Environmental Response, Compensation, and Liability Act
CFSAN: Center for Food Safety and Applied Nutrition
CP: Compliance Program
FDA: U.S. Food and Drug Administration
NRC: U.S. Nuclear Regulatory Commission
OP: FDA’s Office of Partnerships
PA: Partnership Agreement
RIEMA: Rhode Island Emergency Management Agency
RCRA: Resource Conservation and Recovery Act
SARA: Superfund Amendments and Reauthorization Act
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 (1-131, 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.
3. Provide documentation of the FDA methodology used as found in the food monitoring programs or emergency methods approved through FDA CFSAN 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 initially by e-mail to RIEMA. This will be followed up by forwarding an analytical worksheet. 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 will:
1. RIEMA will maintain a long-term Food, Feed and Cosmetics Section 20.88 Information Sharing Agreement with the appropriate agency and regulatory divisions 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
POINTS OF CONTACT:
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:
FDA:
Department of Health & Human Services
Food and Drug Administration
Brian Baker, Director
109 Holton Street
Winchester, MA 01890-1152
Phone: 781-756-9701
Fax: 781-756-9757
Brian.Baker@fda.hhs.gov
RIEMA:
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
The purpose of this partnership agreement is to foster interaction, cooperation and coordination between the partners in the furtherance of the public health. No consideration has been given or received by either partner to enter this agreement. It 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 agreement. It does not impose additional legal duties, rights, benefits, or responsibilities, or remedies of either the partners or of third party. This partnership agreement 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 Confidentiality Disclosure Agreements in accordance with 21 C.F.R. Part 20. Under 21 C.F.R § 20.88, 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 or to enter into Confidentiality Disclosure Agreements, Parties 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 Parties will consult with ORA’s Office of Strategic Planning and Operational Policy/ Division of Information Disclosure Policy prior to sharing any FDA-provided documentation by sending a request via email to ORAInfoshare@fda.hhs.gov
X. ASSESSMENT AND EVALUATION
The partners will meet annually to perform an assessment of this PA by completing an annual evaluation report (fillable .pdf provided by OP) which includes ongoing PA outputs and outcomes that document program accomplishments and, if necessary, identify areas for enhancement. When appropriate, this PA may be resubmitted for approval to 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 either partner. Each signing partner is to use and manage its own funds in carrying out the purpose of this commitment. Transfers of funds or items of value are not authorized under this commitment.
XII. CONCLUSION AND RECOMMENDATION
The partners agree to the parts written in the document.
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
ORA Office of Partnerships and Policy
FDA Office of Regulatory Affairs
Date Signed: 02/18/2022
/s/
Brian Baker
Director
ORS Winchester Engineering and Analytical Center
FDA Office of Regulatory Affairs
Date Signed: 12/03/2021
Approved and Accepted for (partnering agency):
/s/
Marc R. Pappas
Director
Rhode Island Emergency Management Agency
Date Signed: 12/03/2021