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  1. FDA Memoranda of Understanding

MOU 225-16-020

MOU 225-16-020

MEMORANDUM OF UNDERSTANDING BETWEEN
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 inthis Memorandum of Understanding  (MOU).  The purpose of this MOU is to establish a mutually acceptable understanding between DoD and FDA that will strengthen global and national food [1] protection in routine and emergency situations.  Throughout this MOU, "food protection [2] is used to describe and encompass  both food safety [3]  and food defense. [4]  The goals of the collaboration are to:

a. Promote and facilitate effective interagency information sharing and collaboration between Federal partners.

b. Promote efficient utilization of interagency expertise, technologies, and tools to improve product risk identification, validation, analysis, and actions.

c. Strengthen interagency infrastructure and processes to increase food protection and food security in a global food supply.

This MOU supersedes  existing Memorandum  Of Agreements, MOUs, supplements,  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.

______________________________________

1. Under the Federal Food, Drug, and Cosmetic Act, the tenn "food" means (I) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article Food includes food additives and dietary supplements (21 U.S.C. § 321 ). 

2. DoDD 6400.04E; HSPD 9: Food protection includes food safety and food defense. Food protection is a tenn used by DoD.

3. DoDD 6400.04E: Food safety defines food that is free from physical hazards and dangerous levels of pathogenic microorganisms and hazardous chemicals.

4. Food Defense Tools & Education Materials; DoDD 6400.04E. Food defense is the collective term used by the FDA, USDA, DHS, etc. to encompass activities associated with  protecting the nation's food supply from deliberate or intentioned acts of contamination or tampering. This tenn encompasses other similar verbiage (e.g., bioterrorism (BT), counter-terrorism (CT))
 

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 the FDA, including but not limited to: Title 10, U.S. Code; Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) (FD&C Act); the Dietary Supplement Health and Education Act of 1994; the FDA Food Safety Modernization Act; the Public Health Service Act (42 U.S.C. Ch 6A); Homeland Security Presidential Directive (HSPD) 9: Defense of United States Agriculture and Food; Presidential Policy Directive (PPD) 8: National Preparedness; PPD-21: Critical Infrastructure Security and Resilience; DoD Directive (DoDD) 6400.04E, DoD Veterinary Public and Animal Health Services; 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) 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; DoDI4000.19, Support Agreements; and Army Regulation 40-657, Veterinary/Medical Food Safety, Quality Assurance, and Laboratory Service. Furthermore, 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 DoD and FDA together are to:

a. Conduct, when appropriate, a DoD-FDA teleconference, which may include other agencies, when an actual or potential food or food protection incident or emergency has been detected or declared by FDA, or when DoD or other agency has detected actual or potential adverse health outcomes related to food or food protection issues, in accordance with this MOU.

b. 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 and
 conferences; risk communications; 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 information relating to health surveillance. the Defense Health Agencts Armed Forces Health Surveillance Branch (AFHSB) is to establish a data use agreement directly with the FDA to outline information and data sharing relating to military members 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 situation. unless otherwise specified, DoD and FDA are to retain responsibility for supervision and management of their assigned personnel.

ARTICLE 4-DoD RESPONSIBILITIES DoD is to:

a. Designate the Chief, Defense Health Agency, Public Health Division. Veterinary Services Branch (DHA VS), also referred to as DoD Veterinary Service Activity (DODVSA), as its authorized representative responsible for collaboratively administering the DoD food protection activities conducted in accordance with this MOU.

b. Designate the Chief, Inter-Agency Coordination (Food Protection) Officer to function as the DoD Veterinary Liaison Officer (DVLO) with FDA to provide liaison with FDA for routine, daily operations.

c. In an emergency situation, and when necessary, appoint a senior Veterinary Corps Officer to function as the DVLO with FDA to provide liaison with FDA and serve as the incident point-of-contact/liaison for DoD food protection functions in accordance with this MOU. The DVLO is to coordinate all information and actions, and receive requests for DoD assistance from FDA.

d. Provide access to DoD food protection information within existing security constraints and information disclosure restrictions in accordance with this MOU and following the procedures in Articles 7 and 8.
 

ARTICLE 5 - FDA RESPONSIBILITIES

FDA is to:

a. Designate the Assistant Commissioner for Operations (or designee) (ACO) as the authorized representative responsible for collaboratively administering the overall activities conducted under this MOU.

b. Appoint a senior FDA official to serve, 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 proprietary information requirements in accordance with this MOU and following the procedures in Articles 7 and 8.

d. In an emergency situation, FDA may develop a separate interagency agreement between the FDA and DoD to request DoD services, in accordance with the Economy Act (31 U.S.C.§ 1535), including maintaining a DVLO at FDA.

e. In response to an emergency/event, through the ACO or designee, convene a conference call with the DVLO and DoD representatives (e.g.,DVLO, Combatant Command Staff Veterinarian, Joint Staff. OASD (Homeland Defense and Global Security). OASD (Health Affairs), Defense Health Agency) to assess the situation and determine appropriate actions.

ARTICLE 6-EMERGENCY SITUATIONS

For the purposes of this MOU. an "emergency" is defined as a sudden, generally unexpected 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. When a potential or actual emergency is determined by FDA, DoD resources may be requested by FDA when its capabilities have been or are expected to be exceeded.

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 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 USC§ 1905),
the Privacy Act (5 USC§ 552a), other FOIA exemptions not mentioned above (5 USC § 552(b}), the FD&C Act (21 USC §§ 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 the Trade Secrets Act (18 U.S.C. § 1905); the FD&C Act (21 U.S.C. §§ 301 et seq.); the Privacy Act of 1974 (5 U.S.C. § 552a); the Freedom of Information Act (5 U.S.C. § 552); the confidentiality provisions of the Food Security Act of 1985 (7 U.S.C. § 2276); 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. Participants are to follow the process for information sharing and exchange in Appendix A of this MOU.

ARTICLE 8- RESTRICTION ON USE OF INFORMATION

Access to information shared or exchanged under this MOU is to be restricted to authorized Participants' employees, agents, and officials who require access to perform their official duties related the uses of information covered by this MOU and its appendix.

a. Such personnel are to be advised of (1) the confidential nature of the information, (2) safeguards required to protect the information, and (3) the administrative, civil, and criminal penalties for noncompliance contained in applicable Federal laws.

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.

A Participant is to notify the other Participant promptly of any actual or suspected unauthorized disclosure of any information shared pursuant to this MOU.

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.

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 compulsory process, including, but not limited to, a FOIA request, subpoena, discovery request, or litigation complaint or motion.

a. If a Participant that has received information under this MOU receives a FOIA request where there are responsive records that originated with the other Participant, this Participant 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.

b. 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 party 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

This MOU and any continuation thereof is contingent upon the availability of funds. Any monies 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.

ARTICLE 11 -AMENDMENTS, OTHER TERMS, AND TERMINATION This MOU may be amended or terminated in writing, duly signed by authorized representatives, at any time by mutual decision of the Participants. Either participant may terminate this MOU by written notice to the other party, with no less than 60 days advance notice.

a. Disputes: Any dispute relating to this MOU, subject to any applicable law, Executive Order, Directive, or Instruction, is to be resolved by consultation between the Parties or elevated through the Participants respective chains of command for resolution.

b. This MOU embodies the entire set of understandings between the Participants regarding the MOU's subject matter.

ARTICLE 12- EFFECTIVE DATE AND DURATION

This MOU is to become effective upon date of final signature of the Participants, and is to be evaluated biennially during a scheduled meeting between the Participants. The MOU will remain in effect unless one of the parties provides notice to the other that it does not intend to continue with this MOU.

ARTICLE 13- POINTS OF CONTACT

The names of DoD and FDA staff listed below represent the current persons in these assigned roles at the date of signing of this MOU.

U.S. DEPARTMENT OF DEFENSE

Timothy H. Stevenson, D.V.M., Diplomate ACVPM Colonel, U.S. Army Veterinary Corps
Chief, Defense Health Agency, Public Health Division, Veterinary Services Branch
(DHAVS)
7700 Arlington Blvd.
Falls Church, VA 22042-5140
Phone: 703-681-3062 timothy.h.stevenson2.mil@mail.mil

Primary DVLO (per Article 4)
Chief, Inter-Agency Coordination (Food Protection) Officer
Defense Health Agency, Public Health Division, Veterinary Services Branch (DHA VS)
7700 Arlington Blvd.
Falls Church, VA 22042-5140
Phone: 703-681-3061 dha.ncr.veterinary.mbx.vetsvcs-dcsa@mail.mil

Homeland Defense Integration and Defense Support of Civil Authorities
Office of the Assistant Secretary of Defense (Homeland Defense & Global Security)
2600 Defense Pentagon, Room 30247
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, NationalMilitary Command Center
3000 Joint Staff Pentagon
Washington. D.C. 20318
Phone: 703-693-5662 osd.pentagon.ousd-policy.mbx.crm-lno-nmcc@mail.mil

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

Kathleen Gensheimer, M.D.
Office of Foods and Veterinary Medicine/CORE
CPK2 RM3142
University Station- 4300 River Road
College Park, MD 20740
Phone:240-402-1608 Kathleen.Gensheimer@fda.hhs.gov

Ellen F. Morrison
Assistant Commissioner for Operations
Office of Regulatory Affairs
10903 New Hampshire Avenue
White Oak, Building 31, Room 3526
Silver Spring. MD 20993
Phone: 301-796-8257 Ellen.Morrison@fda.hhs.gov

Carl Pavetto, Director
Office of Safety. Security, and Crisis Management
Primary FDA Emergency Liaison (per Article 5)
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone: 301-796-8406
24-hour Emergency Number: 1-866-300-4374 emergency.operations@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 RESPONSIBLE PARTIES

Tom Atkin
Acting Assistant Secretary of Defense
(Homeland Defense and Global Security
November 22, 2016

Karen S. Guice, M.D., M.P.P.
Acting Assistant Secretary of Defense (Health Affairs)
November 15, 2016

Howard Schlamberg, J.D.
Deputy Commissioner for Global   Regulatory Operations and Policy
Food and Drug Administration
Department of Health and Human Services
September 14, 2016

Stephen Ostroff, M.D.
Deputy Commissioner for Foods and Veterinary Medicine
Food and Drug Administration
Department of Health and Human Services
September 14, 2016

APPENDIX A
 

Process for Information Sharing

When, pursuant to this MOU, a Participant requests, from another Participant, records, data, reports, or other information, which are otherwise not publicly available, and the information requested may include confidential material or confidential commercial information (21 CFR 20.61(b)), the request will be in writing, which includes an informal email, and need only identify the information requested and the purpose for which the information is being requested. Although a more specific description of the information asked for may be helpful, it is not required for purposes of making a request. However, the following language is to be included in the written request for information:

"This information is requested and will be shared under MOU 224-16-020 between the U.S. Department of Defense and the U.S. Food and Drug Administration Concerning Information Sharing Related to Food Protection (Food Safety and Food Defense). We agree not to disclose any shared information, in any manner, other than within the requesting agency, for official business purposes, without your written permission, with advance written notice to the originating agency."

With the inclusion of this statement, the requesting Participant would not have to use a particular format or include other pre-specified text.

A response to a request pursuant to this MOU also should be in writing, but it, too, can be an informal email that acknowledges transmission of information in response to the request. Although identifying each piece of information (e.g., record, data, report, or document) provided may be helpful, it is not required for purposes of responding to a request under this MOU. However, the following language is to be included in the written response:

"This information is being provided pursuant to MOU 224-16-020 between the U.S. Department of Pefense and the U.S. Food and Drug Administration Concerning Information Sharing Related to Food Protection (Food Safety and Food Defense). This communication and the information included may contain privileged and/or confidential material or confidential commercialinformation exempt from public disclosure. This information may not be disclosed or shared in any manner, other than within the requesting agency, for official business purposes, without the express written consent of the originating agency, with advance notice to the originating agency."

With the inclusion of this statement, the responding Participant would not have to use a particular format or include other pre-specified text.