MOU 225-82-4003
Memorandum of Understanding
Between The Defense Personnel Support Center
Department of Defense
and The Food and Drug Administration
Department of Health and Human Services
I. PURPOSE
The purpose of this agreement is to formalize an understanding between the Defense Personnel Support Center (DFSC), Philadelphia, PA, and the Food and Drug Administration (FDA), Rockville, MD, under which FDA assumes the responsibility for providing to DPSC notices of food and cosmetic recalls and of any hazardous food situation brought to FDA's attention that may involve military sales, and the DPSC assumes the responsibility for notifying FDA of food and cosmetic products found to be hazardous or unfit for their intended use or otherwise in violation of the Federal Food, Drug, and Cosmetic Act (the act). This agreement is intended to clarify responsibilities and to maintain continuity of cooperative effects regardless of personnel changes.
II. BACKGROUND
FDA and DPSC have for several years, by verbal agreement, cooperated in the evaluation, notification, and coordination of actions concerning food and cosmetic deficiencies and recall situations through telephonic, written, or TWX communications.
FDA is charged with the enforcement of the act. It is FDA's policy that recalls are an appropriate method for removing or correcting marketed consumer products that violate the laws administered by FDA. Within FDA, the Emergency and Epidemiological Operations Branch (EEOB) serves as the agency focal point for information, advice, and direction regarding the field operations aspects of all recalls. Included among EEOB responsibilities is the notification of certain Federal agencies, such as DPSC, which have mutual complimentary responsibilities for recalls. Included among EEOB responsibilities is the notification of certain Federal agencies, such as DPSC, which have mutual or complimentary responsibilities for recalls.
The Director of Subsistence for DPSC has been designated as the sole agent for the Department of Defense (DoD) to coordinate all activities related to the handling of food and cosmetic products deemed adulterated, misbranded, or hazardous. This includes responsibility for assuming expeditious notification and coordination of all food and cosmetic recall actions within worldwide military channels and with other Federal agencies serviced by the DoD overseas communication network.
III. SUBSTANCE OF AGREEMENT
A. DPSC will:
1. Evaluate reports of adulterated or misbranded foods and cosmetics received from within DoD, from FDA, and from other sources to determine actions to be taken by DoD.
2. Telephone FDA to advise of and to discuss any deficiencies in FDA-regulated products brought to DPSC's attention by DoD or other sourves. If requested by FDA, DPSC will provide a copy of the complaint report and military laboratory analysis.
Normal duty hour notification will be made directly to the Emergency and Epidemiological Operations Branch (EEOB), 1866-300-4374 or 301-796-8240.
Off-duty notification will be made to FDA's answering service, 202-737-0448. Name, telephone number, and reason for the call will be feft with the answering service, so that EEOB personnel may return the call.
3. Provide FDA with an information copy of "ALLFOODACT" messages transmitted.
4. Serve as liaison between FDA and worldwide military commanders/installations in regard to recalls or other actions concerning foods and cosmetics.
5. Establish standard operating procedures for off-hour Duty Oficers to contact responsible personnel to activate DPSC's recall/alert system upon off-hour contact by FDA.
B.FDA will:
1. Provide DPSC with information on all food and cosmetic recalls via the "Initial Notification of Recall" document routinely distributed to all FDA field offices and other government agencies.
2. Provide DPSC with telephonic notification, before release if possible or as soon as possible thereafter, of messages or press releases of all class I food and cosmetic recalls, or other food and cosmetic situations that may be of significance to the military. This notification will enable DPSC to expeditiously release "ALLFOODACTS" messages.
Normal duty hour notification will be made directly to the Acquisition Support Section, DPSC-STQA, 215-952-2956/2957.
Off-hour notification will be made to the HQ DPSC Staff Duty Officer, 215-952-2341.
3. Coordinate with DPSC on all appropriate followup actions, including evaluation of reported product deficiencies, verification of recall notification to consignees, and determination of disposition of recalled products.
4. Provide DPSC with a list of military consignees of products recalled under class I or II designations as such information becomes available. FDA will also provide information on military consignees of food or cosmetic products that are not under recall but that may be in violation of the provisions of the act.
IV. NAME AND ADDRESS OF PARTICIPATING PARTIES
A. Department of Defense,
Defense Personnel Support Center,
2800 S. 20th. St.,
Philadelphia, PA 19101.
B. Food and Drug Administration,
5600 Fishers Lane,
Rockville, MD 20857.
V. LIAISON OFFICERS
A. For the Defense Personnel Support Center:
Chief, Acquisition Support Section (DPSC-STQA),
Directorate of Subsistence,
Defense Personnel Support Center,
Philadelphia, PA 19101,
215-952-2956/2957.
B. For the Food and Drug Administration:
Director, Emergency and Epidemiological
Operations Branch (HF0-510),
Executive Director of Regional Operations,
5600 Fishers Lane,
Rockville, MD 20857,
1866-300-4374 or 301-796-8240.
VI. PERIOD OF AGREEMENT
This agreement becomes effective upon signature of both parties and will continue indefinitely. It may be revised by mutual consent or terminated by either party upon 180 days written notice.
Approved and Accepted
for the Defense Personnel Support Center
Signed by: Bobbe E. Hunsiker, Lt. Col., USAF
Director, Installation Services
Date: February 22, 1982
Approved and Accepted
for the Food and Drug Administration
Signed by: Joseph P Hile
Association Commissioner for Regulatory Affairs
Date: March 23, 1982