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MOU 224-09-0006

 

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
 
ARTICLE 1 – PURPOSE
 
The parties to this Memorandum of Understanding (MOU) are the U.S. Department of Defense, hereinafter referred to as "DoD," and the U.S. Department of Health and Human Services, Food and Drug Administration, hereinafter referred to as "FDA." The purpose of this MOU is to establish a mutually acceptable understanding between DoD and FDA that will strengthen global and national food protection, including food safety and food defense in routine and emergency situations. The goals of the collaboration
are to:
 
a)     Enhance information sharing and collaboration between Federal partners.
b)     Promote efficient utilization of interagency expertise, technologies, and tools to improve product risk identification, validation, and analysis.
c)      Build interagency infrastructure and processes to increase Food Protection in a global food supply.
 
This MOU supersedes existing MOUs, MOAs, 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 (NRF).
 
ARTICLE 2 – AUTHORITIES
 
FDA and DoD agree to take actions under this collaboration that are consistent with existing laws and regulations. Nothing in this MOU shall be construed as a change to current requirements under the statutes and regulations administered and enforced by DoD and FDA, including but not limited to: Title 10 U.S. Code, the Public Health Service Act, the Federal Food, Drug, and Cosmetic Act; Department of Defense Directives 6400.4, Veterinary Services, 5136.01, Assistant Secretary of Defense for Health Affairs, 3025.15, Military Support to Civil Authorities (MSCA), and 3025.15, Military Assistance to Civil Authorities.. 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 FDA or DoD that is additional to those established for DoD or FDA by Federal statutes and regulations.
 
ARTICLE 3 - MUTUAL RESPONSIBILITIES
 
DoD and FDA mutually agree to:
a)     Conduct a DoD-FDA teleconference, which may include other agencies, when an actual or potential food protection incident or emergency has been detected or declared by FDA in accordance with this MOU.
b)     Develop information sharing networks and processes on facility audits and inspections, recalls, import alerts, 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 (FERN) and electronic Laboratory Exchange Network (eLEXNET).
d)     Collaborate in the development of food protection capabilities, including training, joint inspections, meetings and conferences, risk communications, assessment and risk management, and appropriate emergency preparedness and response plans.
e)     Collaborate in appropriate joint agency and interagency exercises and training events, including but not limited to: food protection, laboratory capabilities, special event programs, and food defense intelligence.
f)       Identify and provide points of contact (POC)/liaisons between the agencies for both routine and emergency situations and exercises.
 
ARTICLE 4 - DoD RESPONSIBILITIES
 
DoD will:
a)     Designate the Director, Department of Defense Veterinary Service Activity (DODVSA), as its authorized representative responsible for collaboratively administering the DoD veterinary activities conducted in accordance with this MOU.
b)     In an emergency situation, appoint a senior Army Veterinary Corps Officer to function as the 000 Veterinary Liaison Officer (DVLO) with FDA to provide liaison with FDA and serve as the incident site point-of-contact/ liaison for DoD veterinary functions in accordance with this MOU. The DVLO will coordinate all information and actions, and receive requests for DoD assistance from FDA.
c)      Provide access to DoD food protection information within existing security constraints and proprietary information requirements in accordance with this MOU.
d)     Retain the right to disapprove or require FDA to modify as a condition of approval any request in accordance with this MOU.
 
ARTICLE 5 - FDA RESPONSIBILITIES
 
FDA will:
a)     Designate the Associate Commissioner for Foods (ACF) as the authorized representative responsible for collaboratively administering the overall activities conducted under this provision of the 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 will coordinate all information and actions and receive requests from and to 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.
d)     Retain the right to disapprove or require DoD to modify as a condition of approval any request in accordance with this MOU.
e)     As needed, and following the procedures at Article 6, provide for the development of a separate Interagency Agreement, modification of this Agreement and/or Economy Act orders to fund required travel, temporary duty or other ancillary costs incurred by DoD as a result of maintaining a DVLO at FDA where FDA has made a request for additional assistance in an emergency situation.
 
ARTICLE 6 - FORMAL REQUESTS FOR DoD RESOURCES
 
FDA agrees to:
 
a)     Submit written requests for DoD assistance to the DoD Executive Secretariat, Office of the Secretary of Defense, prior to the appointment of a DVLO. Once a DVLO is appointed, FDA will submit requests for DoD assistance to the DVLO. 
b)     Identify specific requirements in a Request for Assistance (RFA) through a funded and approved mission assignment that includes when and where resources are needed, an estimated length of time the resources are required, a certified fund citation, billing instructions, payment information, and acquisition authority.
c)      In accordance with the Economy Act, 31 U.S.C. § 1535, FDA will ensure that required funds are available to reimburse DoD for requested goods and services provided and that the request is in the best interest of the government, and that the goods and services requested cannot be provided as conveniently or cheaply by a commercial enterprise. The request will comply with FAR Subpart 17.5, to include the appropriate Determination and Finding.
d)     In response to an emergency/event, the ACF or his/her delegate will convene a conference call with the DVLO and Department of Defense representatives (e.g. DVLO, Combatant Command Staff Veterinarian, Joint Director of Military Support) to assess the situation and determine appropriate actions.
 
ARTICLE 7 - EMERGENCY SITUATIONS
For the purposes of this MOU, an emergency is defined as a sudden, generally
unexpected 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 a food safety or food defense event or natural disaster, 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 8 - SAFEGUARDING &LIMITING ACCESS TO SHARED INFORMATION
 
The procedures established under Article 3.b. must include proper safeguards against unauthorized use and disclosure of the information exchanged under this MOU. Proper safeguards shall include the adoption of policies and procedures to ensure that the information shared under this MOU shall be used solely in accordance with Trade Secrets Act [18 U.S.C. § 1905]; the Federal Food, Drug, and Cosmetic Act (FFDCA) [21 U.S.C. 301 et seq.]; the Privacy Act of1974, as amended [5 U.S.C. § 552a]; the Freedom of Information Act [5 U.S.C. § 552]: and their implementing regulations, as well as the Health Insurance Portability and Accountability Act Privacy Rule [45 C.F.R. Parts 160 and 164]. Pursuant to the FFDCA section 3010) [21 U.S.C. § 3310), FDA will not reveal to DoD any method or process which is entitled to protection as a trade secret.
 
Access to non-public information shared under this MOU shall be restricted to
authorized FDA and 000 employees, agents and officials who require access to
perform their official duties in accordance with the uses of information as authorized in this MOU, unless authorized in writing by the agency that provided the information or otherwise required by law. Such personnel shall be advised of (1) the confidential nature of the information, (2) safeguards against unauthorized disclosure of confidential information, and (3) the administrative, civil, and criminal penalties for the unauthorized disclosure of confidential information. DoD contractors, their subcontractors, and agents who are determined to be business associates of the DoD and require access to any protected health information shared under this agreement will be required to sign a business associate agreement.
 
If an agency that has received information under this MOU receives a Freedom of Information Act (FOIA) 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 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.
 
ARTICLE 9 - RESTRICTION ON USE OF INFORMATION
All information provided by the Federal partners shall be used solely for the purposes outlined in Article 1. If either Federal partner desires to use the information provided by the other Federal partner under this MOU for any purpose other than those outlined above, the requesting agency shall make a written request to the other agency describing the additional purposes for which it seeks to use the information. If the agency receiving this request determines that the request to use the information provided hereunder is acceptable, it shall provide the requesting agency with written approval of the additional use of the information.
 
ARTICLE 10 - 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 000 under MOU Article 6, the Economy Act, and FAR Subpart 17.5.
 
ARTICLE 11 - LIMITATIONS OF COMMITMENT
 
This MOU and any continuation thereof shall be contingent upon the availability of funds. It is understood and agreed that any monies allocated for purposes covered by this MOU shall be obligated and expended in accordance with the terms and the manner prescribed by the fiscal regulations and/or administrative policies of the parties to this agreement. 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 Article 6, the Economy Act, and FAR Subpart 17.5.
 
ARTICLE 12 - AMENDMENTS AND TERMINATION
 
This MOU may be amended or terminated in writing at any time by mutual agreement of the parties. Either party may terminate this MOU by written notice to the other party, with no less than 60 days advance notice.
 
ARTICLE 13 - EFFECTIVE DATE AND DURATION
 
This MOU shall become effective upon date of final signature by both parties, and shall continue for five years, unless sooner terminated in accordance with Article 12. This MOU will be evaluated annually during a scheduled meeting between the parties.
 
ARTICLE 14 - POINTS OF CONTACT
 
U.S. DEPARTMENT OF DEFENSE
 
Bob E. Walters, D.V.M., Diplomate ACVPM
Colonel, U.S. Army Veterinary Corps
Director, 000 Veterinary Service Activity
703-681-3062, BobWalters@us.army.mil
 
U.S. DEPARTMENT OF HEALTH OF HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
 
Steven M. Solomon, DVM
Deputy Associate Commissioner for Policy
Office of Regulatory Affairs
301-827-3108, Steven.Solomon@fda.hhs.gov
 
Approved and Accepted
for the Department of Defense
Signed by: Paul N. Stockton
Assistant Secretary of Defense
(Homeland Defense and Americas’ Security Affairs)
Date: January 11, 2010
Approved and Accepted
for the Department of Defense
Signed by: Ellen P. Embrey
Deputy Assistant Secretary of Defense (Force Health Protection and Readiness) Performing the Duties of the Assistant Secretary of Defense (Health Affairs)
Date: November 30, 2009
 
Approved and Accepted
for the Department of Defense
Signed by: Eric B. Schoomaker
Lieutenant General
The Surgeon General
U.S. Army
Date: November 29, 2009
Approved and Accepted
for the Food and Drug Administration
Signed by: Margaret A. Hamburg, M.D.,
Commissioner of Food and Drugs
Date: September 16, 2009