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MOU 225-11-0002

 

MEMORANDUM OF UNDERSTANDING
 
Between
 
THE UNITED STATES FOOD AND DRUG ADMINISTRATION
 
And
 
THE UNITED STATES DEPARTMENT OF AGRICULTURE
RESEARCH, EDUCATION, and ECONOMICS
 
I. Purpose
 
Establishing terms of collaboration in areas of common interest and shared responsibility, and fostering the development of collaborative projects related to food safety and nutrition.
 
II. Background
 
The United States Food and Drug Administration (FDA), and the United States Department of Agriculture (USDA), Research Education and Economics Agencies (REE), hereinafter jointly referred to as “the Participants,” have a shared interest in scientific progress in the diverse disciplines that directly and indirectly affect human and animal health including food safety and nutrition.
 
FDA is responsible for protecting and promoting the public health by ensuring, among other things, the safety of human food and animal feed by enforcing the Federal Food, Drug and Cosmetic Act, and several related public health laws. FDA’s Office of Foods in the Office of the Commissioner includes the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), and the foods-related activities of the Office of Regulatory Affairs (ORA).  CFSAN’s mission includes both food safety and nutrition and includes regulatory and research initiatives and programs that promote and protect the public health by ensuring that the nation's food supply is safe, sanitary, wholesome, and accurately labeled. CVM’s mission includes regulatory and research initiatives and programs that ensure the safety and effectiveness of animal drugs, feed additives, animal devices and medicated feeds; animal health; and the safety of human foods derived from animals.  ORA is the lead office for all FDA field activities as well as providing FDA leadership on imports, inspections, and enforcement policy. 
 
The USDA agencies within REE – the Agricultural Research Service (ARS), the Economic Research Service (ERS), the National Agricultural Statistics Service (NASS), and the National Institute of Food and Agriculture (NIFA) (replaces former Cooperative State Research, Education, and Extension Service) – provide federal leadership in creating and disseminating knowledge spanning the biological, physical, and social sciences related to agricultural research, economic analysis, statistics, extension, and higher education.  The mission of the ARS intramural food safety program is to provide through research, the means to ensure that the food supply is safe for consumers; and that food and feed meet foreign and domestic regulatory requirements.  ERS conducts research to inform public and private decision-making on economic and policy issues.  The NASS mission is to support the collection of agricultural food production data to inform research relative to food safety and nutrition issues.  The mission of NIFA is to advance knowledge for agriculture, the environment, human health and well-being, and communities by supporting research, education, and extension programs in the Land-Grant University System and other partner organizations.

The Participants have certain related objectives in carrying out their respective regulatory and service activities. Therefore, from the standpoint of public health protection, the Participants believe it is desirable to set forth in this Memorandum of Understanding (MOU) the basis for development of scientific collaborations between the Participants in the areas of food safety and nutrition. 

 
The Participants share a common interest in multiple areas of food safety and nutrition, including training and outreach activities.  The Participants hold interests in exploring additional avenues where mutually supportive activities can be collaboratively pursued.

 
The Participants recognize that cooperation is a matter of working together toward common goals of mutual interest, not merely cooperative financing or sharing of research and related activities. The Participants also recognize that successful cooperation occurs only through mutual understanding and efficient administration of cooperative programs. Nothing in this broad understanding is to be construed as interfering in any way with the basic responsibilities and authority of either Participant for independent action.

 
III . Substance of Agreement

The Participants agree to collaborate in areas of mutual interest.  Areas may include but are not limited to food pathogen and contaminant detection methods, pre- and post-harvest food safety interventions and control strategies, nutrition monitoring methods and data, food composition analyses and databases, biomarkers of exposure, nutritional status, and disease risk, and economic analyses relevant to food safety and nutritional issues.  Collaborations are expected to gather scientific data that will provide guidance for regulatory and policy decisions, and may change as priorities in both food safety and nutrition evolve. Collaborations may also include the development and delivery of information and training, education, outreach, and technical assistance on food safety practices for producers and small processors. 

 
In order to assure that these collaborations are pursued in a continual and timely fashion, the Participants may meet twice a year, or more frequently if the need arises, alternating meeting sites between the two agencies, and may share information, reports on progress, and explore new areas for collaboration. These meetings will be coordinated by programmatic leaders in food safety and nutrition. For the purpose of facilitation in these collaborations, CFSAN and ARS have agreed to be the coordinators for their respective agencies.

 
Additionally it is agreed that:
 
  1. Rights to any inventions resulting from collaborative research will be determined based on current U.S. Government patent regulations and any other applicable statutes and regulations.
 
  1. Each Participant will comply with the other Participant's security procedures and policies regarding access to and use of facilities.  Either Participant may restrict or limit access to its property and facilities, at any time, for any reason. 
 
  1. It is recognized that from time-to-time collaborations developed under this MOU between the Participants may include sharing in expenses that may require compensation of either Participant by the other. The sharing of expenses will be agreed to in advance of any collaboration, in compliance with all applicable federal requirements, and subject to the limitations in Section V of this MOU.
 
  1. In accordance with Section 1011 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 399c] and Section 405 of Title IV of the Agricultural Research, Extension, and Education Reform Act [7 U.S.C. § 7625], FDA and NIFA will collaborate on the establishment of a competitive grant program within NIFA to provide food safety training, education, extension, outreach, and technical assistance to owners and operators of farms, small food processors, and small fruit and vegetable merchant wholesalers, subject to the limitations in Section V of this MOU.
 
IV. Information sharing
 
The Participants recognize the need for proper safeguards against unauthorized use and disclosure of non-public information exchanged pursuant to this MOU.   Proper safeguards shall include the adoption of policies and procedures to ensure that the information shared under this MOU shall be shared and used consistent with the Trade Secrets Act [18 U.S.C. § 1905], the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], the Privacy Act of 1974, as amended [5 U.S.C. § 552a], the Freedom of Information Act [5 U.S.C. § 552], and their implementing regulations, and any other applicable Federal law and its implementing regulations. Pursuant to Section 301(j) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 331(j)], FDA will not reveal to REE any method or process which is entitled to protection as a trade secret. Either Participant may decide not to share information or expertise in response to a particular request for information, or to limit the scope of information and expertise sharing in response to a particular request.  See Process for Information Sharing under Appendix A.
 
Access to the information shared under this MOU shall be restricted to authorized FDA and REE employees, agents, and officials who require access to perform their official duties in accordance with the uses of information as authorized by 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 this information; (2) safeguards required to protect the information; and (3) the administrative, civil, and criminal penalties for noncompliance contained in applicable Federal laws. Contractors, their subcontractors, and agents requiring access to the information shared under this agreement will be required to sign a business associate agreement by which they will commit to keep the information confidential.
 
FDA and REE agree to promptly notify the other agency of any actual or suspected unauthorized disclosure of information shared under this MOU.
 
If an agency in receipt of information under this MOU receives a FOIA request for shared information, it will refer the request to the agency that shared the information for the latter agency to respond directly to the requestor regarding the releasability of the information at issue. 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.
 
V. Limitations 
 
This MOU represents the broad outline of the Participants’ present intent to enter into specific agreements for collaborative efforts in areas of mutual interest to FDA and REE. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds. This MOU does not affect or supersede any existing or future agreements or arrangements among the Participants. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and the participating U.S. Department of Agriculture’s Research, Education and Economic Agenciesoperate. 
 
VI. Liaison Officers
                       
A. Administrative
 
Center for Food Safety and Applied Nutrition, Food and Drug Administration
 
Director
Executive Operations Staff
Center for Food and Applied Nutrition
Food and Drug Administration
5100 Paint branch Parkway
College Park, Maryland 20740-3835
Phone: (301) 436-1600
 
   
U.S. Department of Agriculture
 
Director
USDA Extramural Agreements Division
George Washington Carver Center, Room 3-2169
5601 Sunnyside Avenue
Beltsville, Maryland   20705-5110
Phone: (301) 504-1144
Fax: (301) 504-1262
 
B. Programmatic
 
Food and Drug Administration: 
Team Leader, Liaison and Partnership Team
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway (HFS-006)
College Park, MD 20740
(301) 436-1981
 
Deputy Director, Office of Research
Center for Veterinary Medicine
Food and Drug Administration
8401 Muirkirk Rd
Laurel, MD 20708
(301) 210-4213
 
Director, Office of Regional Operations
Office of Regulatory Affairs
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
 
U.S. Department of Agriculture, REE:
ARS National Program Leaders, Food Safety (NP 108)
ARS National Program Leaders, Human Nutrition (NP 107)
George Washington Carver Center
5601 Sunnyside Avenue
Beltsville, Maryland 20705-5110
Phone: (301) 504- 7050
 
Each agency may designate new liaisons at any time by notifying the other in writing.  If at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the agency will name a new liaison and notify the other agency through the designated liaison.
 
VII. Term, Termination, and Modification
This MOU becomes effective on the date of the last signature and continues for 5 years.  It may be modified or terminated by mutual written consent of both parties or may be terminated by either party upon a 60-day advance written notice to the other party.

 
Approved and Accepted
for the United States Department of Agriculture, Research, Education, and Economics
Signed by: Cathie Woteki, Ph.D.
Undersecretary for Research, Education, and Economics
United States Department of Agriculture
 
Date: July 1, 2011
Approved and Accepted
for the Food and Drug Administration
Signed by: Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Food and Drug Administration
Date: June 30, 2011
 
APPENDIX A
Process for Information Sharing
 
Pursuant to Section IV of the Memorandum of Understanding (MOU) entered into by the Food and Drug Administration (FDA) and the United States Department of Agriculture Research Education and Economics Agencies (REE), either Participant “may decide not to share information or expertise in response to a particular request for information, or to limit the scope of information and expertise sharing in response to a particular request.” Nothing in the process described below changes Section IV.
 
When, under the current MOU, staff at the FDA or REE request from the other agency information that may contain confidential material, the request should be in writing, which includes an informal email, and need only identify the subject for which information is requested.  Although a more specific description of the information asked for may be helpful, it would not be required for purposes of making a request. However, the following language should be included in the request:
 
"Information that is shared under this request will be under the FDA-REE Memorandum of Understanding. We agree not to disclose any shared information in any manner without your written permission or as required by law with advance notice to the originating agency." With the inclusion of this statement, requestors would not have to use a particular format or include other pre-specified text.
 
A response to a request should also 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/document provided may be helpful, it would not be required for purposes of responding to a request. However, the following language should be included in the response: 
 
"Pursuant to the FDA-REE Memorandum of Understanding, this communication may contain privileged and/or confidential information exempt from public disclosure. It may not be disclosed or shared in any manner without our express written consent or as required by law with advance notice to the originating agency." With the inclusion of this statement, responders would not have to use a particular format or include other pre-specified text.