MOU 225-16-020
MEMORANDUM OF UNDERSTANDING BETWEEN THE U.S. DEPARTMENT OF DEFENSE AND THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION CONCERNING FOOD PROTECTION (FOOD SAFETY AND FOOD DEFENSE)
ARTICLE 1 - PURPOSE
The U.S. Department of Defense (DoD) and the U.S. Department of Health and Human Services, Food and Drug Administration (FDA) (individually referred to as "a Participant" and collectively referred to as “the Participants”) have reached the understandings in this Memorandum of Understanding (MOU). The purpose of this MOU is to establish a mutually acceptable understanding between DoD and FDA that will strengthen U.S. food protection in routine and emergency situations.
The goals of the MOU collaboration are to:
a. Promote and facilitate effective interagency collaboration between DoD and FDA to strengthen information sharing to inform food protection efforts;
b. Promote efficient utilization of interagency expertise, technologies, and tools to improve product risk identification, validation, analysis, and actions; and
c. Strengthen interagency infrastructure and processes to increase food protection and food security in a global food supply.
This MOU supersedes existing Memorandums of Agreement, MOUs, and amendments between DoD and FDA relating only to food protection; however, this MOU does not supersede those processes and procedures agreed to by DoD and FDA in the National Response Framework.
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ARTICLE X – DEFINITIONS
Catastrophic Incident: Any natural or man-made disaster that results in extraordinary levels of casualties or damage, mass evacuations, or disruption severely affecting the population, infrastructure, environment, economy, national morale, or government functions in an area. A “catastrophic incident” may include an incident with a sustained national impact over a prolonged period of time; an incident that may rapidly exceed resources available to State, local, tribal, and territorial (SLTT) authorities and the private sector in the impacted area; or an incident that may significantly interrupt governmental operations and emergency services to such an extent that U.S. national security could be threatened.
Food: The term “food” has the meaning given that term in 21 U.S.C. § 321(f): “articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article.” For purposes of this MOU, the term “food” includes food additives and dietary supplements.
Food Safety: The term “food safety” has the meaning given that term in DoD Directive (DoDD) 6400.04E: “protection measures necessary to identify, mitigate, or eliminate the risk from unintentional contamination.”
Food Defense: Collective term used by FDA, the U.S. Department of Agriculture, U.S. Department of Homeland Security, and other Federal agencies and departments to encompass activities associated with protecting the nation's food supply from deliberate or intentional acts of contamination or tampering, to include bioterrorism. The term encompasses food-supply related counterterrorism efforts.
Food Protection: Term used to describe and encompass both food safety and food defense (see DoDD 6400.04E).
Emergency: A sudden, generally unexpected or unplanned for natural or manmade event that does or could do harm to people, the environment, resources, animals, property, or institutions, and/or may have negative economic impact, such as an intentional or unintentional food defense or food safety event that threatens the viability of the food supply of the United States.
ARTICLE 2 - AUTHORITIES AND REFERENCES
DoD and FDA are to take actions under this collaboration that are consistent with existing laws and regulations. Nothing in this MOU is to be construed as a change to current requirements under the statutes and regulations pertaining to, administered by, or enforced by DoD or FDA, including, but not limited to:
FDA:
• Title 21, U.S. Code, section 321 et seq., The Federal Food, Drug, and Cosmetic Act (FD&C Act)
• Title 42, U.S. Code, sections 201-291n, The Public Health Service Act
DoD:
• DoDD 6400.04E, DoD Veterinary Public and Animal Health Services
• HSPD-9, Defense of United States Agriculture and Food
• Presidential Policy Directive (PPD) 8, National Preparedness
• National Security Memorandum (NSM) 22,
• DoDD 5111.13, Assistant Secretary of Defense for Homeland Defense and Global Security
• DoDD 5136.01, Assistant Secretary of Defense for Health Affairs
• DoDD 3025.18, Defense Support of Civil Authorities
• DoD Instruction (DoDI) 3025.24 Department of Defense Public Health and Medical Services in Support of Civil Authorities
• DoDI 6440.03 DoD Laboratory Network (DLN)
• DoDI 6200.03, Public Health Emergency Management within the Department of Defense
• DoDI 3025.20, Defense Support of Special Events
• DoDI 6130.05, DoD Nutrition Committee
• DoDI 4000.19, Support Agreements
• Army Regulation 40-657, Veterinary/Medical Food Safety, Quality Assurance, and Laboratory Service
• Defense Logistics Agency Instruction (DLAI) 3221, Veterinary Medical and Inspection Of Subsistence Supplies And Services
Nothing in this MOU constitutes a mandate or requirement imposed on either DoD or FDA that is additional to those established for DoD or FDA by Federal statutes and regulations.
ARTICLE 3 - MUTUAL RESPONSIBILITIES
The Participants commit to:
a. Conduct, when appropriate, a DoD-FDA teleconference, which may include other agencies, when a threat or an actual or potential food or food protection incident, emergency or catastrophic incident has been detected or declared by FDA, or when DoD or another agency has detected actual or potential adverse health outcomes related to food or food protection issues, consistent with this MOU.
b. Continue to develop information-sharing networks and processes to share information on facility audits, recalls and/or advisories, import alerts, adverse food and supplement events, laboratory findings or methods, and other food protection procedures.
c. Share laboratory data and research on food protection, including participation in the Food Emergency Response Network and electronic Laboratory Exchange Network.
d. Collaborate in the development of food protection capabilities, including but not limited to, joint inspections, training and exercises, meetings/conferences, risk communications, threat assessment and risk management, and appropriate emergency preparedness and response plans.
e. Collaborate and participate in joint agency and interagency exercises, training events, on-line training, meetings, and conferences, such as: food protection, laboratory capabilities and diagnostics, National Special Security Events, and food defense intelligence.
f. For the purposes of sharing health-related data related to foodborne illness, consider establishing through DoD’s Defense Health Agency, Armed Forces Health Surveillance Division, a data use agreement to outline information and data sharing relating to military members and Military Health System beneficiaries identified through FDA surveillance systems or a food-related event involving the health or safety of military personnel.
g. Identify and provide points of contact (POCs)/liaisons between DoD and FDA for both routine and emergency situations and exercises (see Article 13).
h. In an emergency or catastrophic incident, unless otherwise specified, retain responsibility for supervision and management of their respective personnel.
i. Develop an implementation plan to identify clear objectives, benchmarks, and goals with respect to this MOU, and to measure the success of the collaboration outlined in this MOU.
ARTICLE 4 - DoD RESPONSIBILITIES:
DoD is to:
a. Designate the Chief, Defense Health Agency, Veterinary Service Division (DHA VS), as its authorized representative responsible for collaboratively administering the DoD food protection activities conducted under this MOU.
b. Designate the Inter-Agency Liaison (Food Protection) Officer to function as the DoD Veterinary Liaison Officer (DVLO) with FDA to liaise with FDA for routine, daily operations.
c. In an emergency or catastrophic incident, and when necessary, appoint a senior Veterinary Corps Officer to function as the senior DVLO with FDA to liaise with FDA and serve as the incident POC for DoD food protection functions as described in this MOU. The senior DVLO is to coordinate all information and actions and validate requests for DoD assistance from FDA before they are sent by FDA to the DoD Executive Secretary.
d. Provide FDA with access to DoD food protection information, to include diagnostic lab results, within existing security constraints and information disclosure restrictions as described in Articles 7 and 8 of this MOU.
ARTICLE 5 - FDA RESPONSIBILITIES
FDA is to:
a. Designate the Assistant Commissioner for Partnerships and Policy (ACPP), as the authorized representative responsible for collaboratively administering the overall activities conducted under this MOU.
b. Appoint a senior FDA official to serve, during routine, daily operations and during an incident/special activity, as the FDA liaison to DoD and incident point-of-contact. The FDA liaison is to coordinate all information and actions and receive requests from DoD for the incident/special activity.
c. Provide access to FDA food protection information within existing security constraints and information disclosure requirements as described in Articles 7 and 8 of this MOU.
d. In an emergency or catastrophic incident, FDA may develop a separate interagency agreement between the FDA and DoD to request DoD services on a reimbursable basis, in accordance with the Economy Act (31 U.S.C. § 1535), including maintaining a DVLO at FDA, and, if warranted, an FDA liaison at DHA VS.
e. In response to an emergency or catastrophic incident, through the ACPP, convene a conference call with the DVLO. The DVLO will invite appropriate DoD representatives (e.g., Combatant Command Staff Veterinarian, Joint Staff, Office of the Assistant Secretary of Defense (OASD) for Homeland Defense and Hemispheric Affairs, OASD for Health Affairs, and the Defense Health Agency) to assess the situation and determine appropriate actions.
ARTICLE 6 - EMERGENCIES AND CATASTROPHIC INCIDENTS
When FDA determines that an event is, or likely will become, an emergency or catastrophic incident that exceeds FDA’s response capabilities, FDA may submit a request for DoD assistance in accordance with the Economy Act.
ARTICLE 7 - INFORMATION SHARING AND SAFEGUARDS
The procedures established under Article 3 must include proper safeguards against unauthorized use and disclosure of the information exchanged under this MOU. The Participants are to establish and use appropriate administrative, technical, procedural, and physical safeguards to ensure that non-public information shared under this MOU will be used and disclosed solely in accordance with applicable laws and regulations.
a. The Participants recognize that exchanged information may contain any of the following types of information: (1) confidential commercial information, such as the information that would be protected from public disclosure pursuant to Exemption 4 of the Freedom of Information Act (FOIA) (5 U.S.C. § 552); (2) personal privacy information, such as the information that would be protected from public disclosure pursuant to Exemption 6 or 7(C) of the FOIA; or (3) information that is otherwise protected from public disclosure by Federal laws and their implementing regulations (e.g., Trade Secrets Act (18 U.S.C. § 1905), the Privacy Act (5 U.S.C. § 552a), other FOIA exemptions not mentioned above (5 U.S.C. § 552(b)), the FD&C Act (21 U.S.C. § 301 et seq.), and the Health Insurance Portability and Accountability Act (HIPAA) (Pub. L. 104-191)).
b. Proper safeguards include the adoption of policies and procedures to ensure that the information shared under this MOU will be shared and used consistent with, as applicable, the Trade Secrets Act; the FD&C Act; the Privacy Act of 1974; FOIA; the confidentiality provisions of the Food Security Act of 1985; the confidentiality or non-disclosure provisions of any other agreement entered into by a Participant; the HIPAA Privacy Rule (45 C.F.R. Parts 160 and 164); and other applicable Federal laws and their implementing regulations.
c. When a request for non-public information, documents, or data, is received, consistent with Article 8, the party who received the request shall notify the other party in writing prior to providing any shared information to the requestor. Notice may contain all substantive requirements of 21 C.F.R. § 20.85 to include the following language: Information is being requested in accordance with Memorandum of Understanding 225-16-020. We agree not to disclose any shared information in any manner without the written permission of the originating [or sharing] agency, or, if such disclosure is required by law, without advance notice to the originating agency.
Information is being requested in accordance with Memorandum of Understanding 225-16-020. We agree not to disclose any shared information in any manner without the written permission of the originating [or sharing] agency, or, if such disclosure is required by law, without advance notice to the originating agency.
ARTICLE 8 - RESTRICTION ON USE OF INFORMATION
Access to information shared or exchanged under this MOU is to be restricted to Participants' employees, agents, and officials whom a Participant has authorized because the employee, agent, or official requires access to perform their official duties related to the purposes of this MOU.
a. Such personnel are to be advised of
i. the confidential, sensitive, and/or nonpublic nature of the information.
ii. safeguards required to protect the information.
iii. the applicable administrative, civil, and criminal penalties for noncompliance.
b. Contractors, and their subcontractors and agents, requiring access to non-public information shared or exchanged under this MOU are to be required to sign a non-disclosure agreement by which they will commit to keep the information confidential.
c. Participants under this MOU have access to information, such as Personally Identifiable Information (PII), and are responsible for protecting that information. A Participant is to notify the other Participant promptly of any actual or suspected unauthorized disclosure or compromise of any information shared pursuant to this MOU. Participants will follow applicable Federal agency breach response and notification procedures, including but not limited to those promulgated pursuant to 44 U.S.C. Chapter 35, Subchapter II, as applicable.
d. It is anticipated that activities covered by this MOU will be unclassified. In the event an exchange of classified information is necessary, the Participants are to coordinate their efforts to safeguard the information properly.
e. The Participant that has received shared information (requesting Participant) is to notify the contact person or designee of the sharing Participant promptly of any attempt by a third party to obtain shared non-public information by available legal process or request, including, but not limited to, a FOIA or Privacy Act (PA) request, subpoena, discovery request, or litigation complaint or motion.
i. If a Participant that has received information under this MOU receives a FOIA request for which responsive records originated with the other Participant, Participant receiving the request is to refer the FOIA request to the other Participant for it to respond directly to the FOIA requestor. In such cases, the Participant that received the FOIA request is to notify the FOIA requestor that it has referred the FOIA request to another agency and that a response will issue directly from that agency.
ii. The requesting Participant is to notify the sharing Participant before complying with any judicial order that compels the release of shared non-public information, so that the Participants may determine the appropriate measures to take, including, where appropriate, legal action.
ARTICLE 9 - STATEMENT OF NO FINANCIAL OBLIGATION
This MOU does not obligate appropriated funds. Each Participant is to use and manage its own funds in carrying out its obligations under the MOU. Transfers of funds, goods, or services are not authorized by this MOU: such transfers require a request for support by FDA and approval by DoD under MOU Articles 5 and 6, the Economy Act, and FAR Subparts 17.5 and 17.7.
ARTICLE 10 - LIMITATIONS OF COMMITMENT
Activities under this MOU, and any continuation thereof, are contingent upon the availability of funds. Any funds allocated for purposes covered by this MOU are to be obligated and expended in accordance with the terms and the manner prescribed by law, fiscal regulations, and/or administrative policies of the Participants. Each Participant is responsible for all costs of its personnel, including pay, benefits, support, and travel. Each Participant is responsible for supervision and management of its personnel.
ARTICLE 11 - MODIFICATION AND DISCONTINUATION
This MOU may be modified or discontinued in writing, duly signed by authorized representatives, at any time by mutual decision of the Participants. Any modification will become effective upon the date of final signature of the Participants, and at that time shall be attached to and incorporated into this MOU in a sequential order. Either participant may discontinue the MOU by written notice to the other Participant, with no less than 60 days advance notice. The MOU may also be discontinued at any time upon the mutual written consent of the Participants.
Disputes between the Participants relating to interpretation or implementation of this MOU will be resolved through consultation of the Participants with one another.
ARTICLE 12 - EFFECTIVE DATE AND DURATION
This MOU is to become effective upon date of final signature of the Participants and will be effective for ten (10) years from that date.
The Participants will review and validate this MOU at the mid-point (year 5) of its effective date.
ARTICLE 13 - POINTS OF CONTACT/LIAISONS
The following POCs, or their successors, have been identified by the Participants to communicate matters concerning this MOU. Each Participant may change its POC upon reasonable notice to the other Participant.
U.S. DEPARTMENT OF DEFENSE
Primary DVLO Liaison (per Article 4)
Chief, Inter-Agency Liaison (Food Protection) Officer
Defense Health Agency Veterinary Service (DHA VS)
7700 Arlington Blvd.
Falls Church, VA 22042-5140
Phone: 301-319-2243
dha.vsd-staff@health.mil
Office of the Deputy Assistant Secretary of Defense for Homeland Defense Integration and Defense Support of Civil Authorities
Office of the Assistant Secretary of Defense (Homeland Defense & Hemispheric Affairs) 2600 Defense Pentagon, Room 3D247
Washington, D.C. 20301-2600
Defense Support of Civil Authorities (DSCA) Hotline 571-256-3984 Office of the Secretary of Defense (OSD) Liaison
Joint Staff J3, National Military Command Center 3000 Joint Staff Pentagon
Washington. D.C. 20318
Phone: 703-693-5662
Email: js.pentagon.j3.mbx.ops-team-osd-lno-nmcc@mail.mil; osd.pentagon.ousd-policy.mbx.crm-lno-nmcc@mail.mil
(mail to: js.pentagon.j3.mbx.ops-team-osd-lno-nmcc@mail.mil; osd.pentagon.ousd-policy.mbx.crm-lno-nmcc@mail.mil)
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION
Kate Nagy
Consumer Safety Officer, Program Expert, Primary FDA/DoD Liaison
Office of Regulatory Affairs/Domestic Division of Human and Animal Foods Operations Branch
Atlanta, GA
Phone: 404-253-1225
Kathryn.Nagy@fda.hhs.gov
Paul Norris, D.V.M., Director
Office of Regulatory Affairs/Office of Regulatory Science Primary FDA Liaison for Laboratory Collaborations 3900 NCTR Road
NCTR-50, Room 404
Jefferson, AR 72079
Phone: 870-543-4099
Paul.Norris@fda.hhs.gov
SIGNATURES OF PARTICIPANTS
FOR DoD:
/s/
Rebecca Zimmerman
Acting Assistant Secretary of Defense (Homeland Defense and Hemispheric Affairs)
Date: 10/23/2024
/s/ p.p. Dr. David Smith
Seileen M. Mullen
Acting Assistant Secretary of Defense (Health Affairs)
Date: 11/20/2024
FOR FDA:
/s/
Donald Prater
Acting Director, Center for Food Safety and Applied Nutrition
Food and Drug Administration
Department of Health and Human Services
Date: 09/17/2024
/s/
Michael Rogers
Associate Commissioner, Office of Regulatory Affairs
Food and Drug Administration
Department of Health and Human Services
Date: 09/19/2024
Mid-Point Review Due Date: _ [Enter date mid-point review due from signature date]
Mid-Point Review completed by: _