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  1. FDA Memoranda of Understanding

MOU 225-12-0007

Memorandum of Understanding between the U.S. Department of Agriculture, Farm and Foreign Agricultural Services, Food, Nutrition, and Consumer Services, Food Safety Marketing and Regulatory Programs, Research, Education, and Economics and the U.S. Department of Health and Human Services, Food and Drug Administration, concerning information sharing related to food safety, public health, and other food-associated activities.

I. Purpose

This Memorandum of Understanding (MOU) establishes policies and procedures to enhance the exchange of information between participating agencies of the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) related to food safety, public health, and associated regulatory, marketing, trade, and research activities substantially affecting the public health.

II. Background 

  1. The USDA is the U.S. executive department responsible for developing and executing federal policy and laws for food, agriculture, nutrition, natural resources, rural development, and related areas. The USDA provides leadership in these areas based on sound public policy, the best available science, and efficient management. The USDA mission focuses on several key activities, including expanding markets for agricultural products and international economic development, expanding job opportunities and improving housing, utilities, and infrastructure in rural America, enhancing food safety by taking steps to reduce the prevalence of foodbome hazards from farm to table, improving nutrition and health by providing food assistance and nutrition education and promotion, and managing and protecting America's public and private lands working cooperatively with other levels of government and with the private sector.
    1. The Fann and Foreign Agricultural Services (FFAS) mission area, within USDA, and its agencies - the Farm Service Agency (FSA), the Foreign Agricultural Service (FAS), and the Risk Management Agency (RMA) - enhance the export opportunities for agricultural products and administer programs that deliver commodity, credit, conservation, disaster, marketing, and emergency assistance programs that help keep the Nation's fanners and ranchers in business and improve the stability and strength of the agricultural economy.
    2. The Food, Nutrition, and Consumer Services (FNCS) mission area, within USDA, and its agencies - the Center for Nutrition Policy and Promotion (CNPP) and the Food and Nutrition Service (FNS) - administer federal domestic assistance programs, provide foods through these assistance programs, and link scientific research to the nutrition needs of consumers in order to harness the Nation's agricultural abundance to end hunger and improve health in the United States.
    3. The Food Safety (FS) mission area, within USDA, and its public health agency, the Food Safety and Inspection Service (FSIS), ensure that the Nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and properly labeled and packaged.
    4. The Marketing and Regulatory Programs (MRP) mission area, within USDA, and its agencies - the Agricultural Marketing Service (AMS), the Animal and Plant Health Inspection Service (APHIS), and the Grain Inspection, Packers and Stockyards Administration (GIPSA) - administer programs that facilitate the efficient, fair domestic and international marketing ofthe Nation's agricultural products and ensure the health and care ofthe Nation's animals and plants.
    5. The Research, Education, and Economics (REE) mission area, within USDA, and it agencies - the Agricultural Research Services (ARS), the Economic Research Service (ERS), the National Agricultural Statistics Service (NASS), and the National Institute of Food and Agriculture (NIFA) - 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 to support the creation of a safe, sustainable, competitive, and nutritious U.S. food and fiber system, as well as strong communities, families, and youth. USDA science informs program, policy, and regulatory decisions.
  2. FDA is responsible for protecting and promoting the public health by ensuring, among other things, the safety of human food and animal feed by administering and enforcing the Federal Food, Drug, and Cosmetic Act (hereinafter the FD&C Act) and several related public health laws. In fulfilling its responsibilities under the FD&C Act, FDA's activities are directed toward protecting the public health by ensuring that foods are safe and wholesome and truthfully and informatively labeled.  This is accomplished, in part, by inspecting the production, processing, and distribution of foods and examining samples thereof to ensure compliance with applicable requirements.
  3.  The USDA, FFAS, FNCS, FS, MRP, and REE, and the FDA (hereinafter jointly referred to as "the Participants"), have certain related objectives in carrying out their respective food safety, public health, and associated regulatory, marketing, trade, and research activities. The Participants believe it is desirable, from the standpoint of public health protection, to enhance the exchange of information between the USDA agencies and FDA related to food safety, public health, food defense, disaster and emergency response, and associated activities, that will assist in public health protection and in the effective and efficient execution of the responsibilities of the Participants.

III. Substance of the Understanding

A. Information Sharing

The Participants mutually agree that each agency will: 
  1. Coordinate, collaborate, and cooperate with each other in the exchange of records, data, reports, and other information, which is otherwise not publicly available, on issues related to food safety, public health, and associated regulatory, marketing, trade, and research activities.
  2. Furnish, upon request, pertinent records, data, reports and other information regarding food safety, food defense, facility inspection, surveillance, compliance, enforcement, laboratory, product distribution, disaster and emergency response, audit, research, and other records, data, reports, and other related information, which is otherwise not publicly available, that will assist in public health protection and the effective andefficient execution of the responsibilities of the Participants.
  3. Receive, review, and respond, in a timely manner, to requests for records, data, reports, and other non-public information made pursuant to this MOU.\
  4. Follow the process for information sharing and exchange established by Appendix A to this MOU.
  5. Develop internal procedures, including for the receipt, review, and response to requests for information, that each Participant agency will use to facilitate the exchange of non-public information, pursuant to this MOU, and to protect against unauthorized use or disclosure of any non-public information shared or exchanged pursuant to this MOU. 

B. Information Safeguards

The Participants mutually agree that:

  1. Proper safeguards against unauthorized use and disclosure of the non-public information shared or exchanged pursuant to this MOU are necessary for effective implementation of this MOU.
  2.  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 FD&C Act as amended [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], the confidentiality provisions of the Food Security Act of 1985 [7 U.S.C. 2276], Section 1619 of the Food, Conservation, and Energy Act of2008 [7 U.S.C. 8791], the confidentiality or non-disclosure provisions of any other agreement entered into by a Participant, and other applicable Federal laws and implementing regulations. Pursuant to section 301(j) of the FD&C Act [21 U.S.C. 331(j)], FDA will not reveal to any Participant any method or process that is entitled to protection as a trade secret.
  3. Access to the non-public information shared under this MOU shall be restricted to the employees, agents, and officials of the Participants, who require access to such information to perform their official duties in accordance with the uses of the information as authorized in this MOU, unless otherwise authorized in writing by the Participant agency that provided the information or as required by law. All 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 contained in applicable Federal laws for the unauthorized disclosure of confidential information.
  4. The Participants agree to notify promptly each other of any actual or suspected unauthorized disclosure of any information shared pursuant to this MOU.
  5. If a Participant agency that has received information under this MOU receives a Freedom of Information Act (FOIA) request where there are responsive records, which originated with another Participant agency, the agency will refer the FOIA request to the other agency for it to respond directly to the FOIA requestor.  In such cases, the Participant agency, which received the FOIA request, will notify the FOIA requestor that it has referred the FOIA request to another agency and that a response will issue directly from that agency. 

IV. Limitations

  1. This MOU represents the broad outline of the Participants' present intent to share non-public information in areas of mutual interest consistent with programmatic goals and resources that will assist in public health protection and the effective and efficient execution of the responsibilities of the Participants.
  2. This MOU does not create binding, enforceable obligations against any Participant, and all activities undertaken pursuant to this MOU are subject to the availability of personnel, resources, and funds.
  3. This MOU and all associated understandings or agreements will be subject to the applicable policies, rules, regulations, and statutes under which the Participants operate.
  4. This MOU does not restrict any Participant from protecting any records, data, reports, or other information, which is otherwise not publicly available, when the Participant determines that sharing the information is contrary to law or regulation.
  5. The MOU does not restrict any Participant from protecting information in connection with research that has not been peer reviewed.
  6. Nothing in this MOU shall obligate any Participant to any current expenditure or future expenditure of resources in advance of the availability of appropriations from Congress. 

V. Other Understandings and Agreements 

  1. This MOU is intended to serve as an overarching statement of the intention of the Participants to enhance information sharing among and between the Participants.
  2. This MOU does not nullify or negate any existing understandings or agreements among or between the Participants.
  3. This MOU amends and supersedes certain specified provisions on information sharing set forth in other understandings or agreements, which are identified in Appendix B to this MOU.
  4. The Participants mutually agree to promote and advance the purpose of this MOU to enhance information sharing, when necessary, beyond any existing understandings or agreements.
  5. This MOU does not preclude any Participant from entering into additional, separate understandings or agreements with another Participant. 

VI. Liaison Officers 

  1. To facilitate the activities carried out under this MOU, the Participants will establish a single liaison for each agency participating in this MOU.
  2. The initial liaisons are those specified in Appendix C to this MOU.
  3. Each agency may designate a new liaison, at any time, by notifying the Participants in writing. If, at any time, an individual designated as a liaison under this MOU becomes unavailable to fulfill those functions, the participating agency will name a new liaison and notify the other Participants through the designated liaison. 

VII. Effective Date, Terms, Termination, and Modification 

  1. This MOU will become effective when signed by all the Participants. 
  2. This MOU will continue in effect unless modified or terminated by mutual written consent of the Participants upon a 60-day advance written notice to the other Participants. 
  3. The Participants agree that they will review this MOU every three years to determine whether it should be modified or terminated. 

Approved and Accepted
for the Department of Agriculture

Signed by: Michael T. Scuse
Acting Under Secretary
Farm and Foreign Agricultural Services
Date: December 22, 2011

Approved and Accepted
for the Department of Agriculture

Signed by: Kevin Concannon
Under Secretary
Date: December 22, 2011

Approved and Accepted
for the Department of Agriculture

Signed by: Michael T. Scuse
Acting Under Secretary
Farm and Foreign Agricultural Services
Date: December 22, 2011

Approved and Accepted
for the Department of Agriculture

Signed by: Kevin Concannon
Under Secretary
Date: December 22, 2011   

Approved and Acceptedfor the Department of Agriculture
Signed by: Catherine E. Woteki, Ph.D. Under Secretary
Research, Education, and Economics
Date: December 22, 2011

Approved and Acceptedfor the Food and Drug Administration
Signed by: Margaret A. Hamburg, M.D., Commissioner of Food and Drugs
Date: January 19, 2012      

APPENDIX A - Process for Information Sharing 

When, pursuant to this MOU, a Participant requests, from another Participant, records, data, reports, or other information, which is otherwise not publicly available, and the information requested may include confidential material or confidential commercial information [21 CFR 20.6I(b)], the request should be in writing, which includes an informal email, and need only identify the information requested and the purpose for which the information is 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 the MOU between the U.S. Department of Agriculture and the U.S. Food and Drug Administration Concerning Information Sharing Related to Food Safety, Public Health, and Other Food-Associated Issues. 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, requestors 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 the MOU between the U.S. Department of Agriculture and the U.S. Food and Drug Administration Concerning Information Sharing Related to Food Safety, Public Health, and Other Food-Associated Issues. This communication and the information included may contain privileged and/or confidential material or confidential commercial information 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 our express written consent of the originating agency, 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.

APPENDIX B - Other Understandings and Agreements 

Pursuant to paragraph V.C., this MOU amends and supersedes certain specified provisions on information sharing set forth in other understandings or agreements.  The following table identifies the specified provisions or paragraphs on information sharing within the listed understandings or agreements that are amended and superseded by this MOU. 

APPENDIX C - Agency Liaisons

 
USDA Farm and Foreign Agricultural Services

Farm Service Agency

Sandra G. Wood
Assistant Deputy Administrator for Commodity Operations
Farm Service Agency
1400 Independence Ave., SW
Room 3080-S, Mail Stop 0550
Washington, DC 20250-0550
Phone: 202-720-3217
Sandra.wood@wdc.usda.gov 

Foreign Agricultural Service

Cathy McKinnell
Division Director, International Regulations and Standards
Office of Agreements and Scientific Affairs
Foreign Agricultural Service
1400 Independence Ave., SW
Room 5916-S, Mail Stop 1010
Washington, DC 20250-1010
Phone: 202-690-0776
cathy.mckinnell@fas.usda.gov 

USDA Food, Nutrition, and Consumer Services 

Food and Nutrition Service

Brenda Halbrook, M.S., R.D.
Director, Office of Food Safety
Special Nutrition Programs
Food and Nutrition Service
310I Park Center Drive
Suite 512
Alexandria, VA 22302
Phone: 703-305-2608
brenda.halbrook@fns.usda.gov 

USDA Food Safety 

Food Safety and Inspection Service 

William C. "Bill" Smith
Assistant Administrator
Office of Program Evaluation, Enforcement and Review
Food Safety and Inspection Service
1400 Independence Ave., SW
Room 3133-S, Mail Stop 3796
Washington, DC 20250-3796
Phone: 202-720-8609
william.smith@fsis.usda.gov 

USDA Marketing and Regulatory Programs 

Agricultural Marketing Service 

Erin Morris
Deputy Associate Administrator
Agricultural Marketing Service
1400 Independence Ave., SW
Room 3077-S, Mail Stop 0201
Washington, DC 20250-0201
Phone: 202-690-4024
erin.morris@ams.usda.gov 

Animal and Plant Health Inspection Service

Joseph F. Annelli, DVM, MS
One Health Coordinator
Veterinary Services
Animal and Plant Health Inspection Services
4700 River Rd, Room 4B-02(a)
Riverdale, MD 20737
Phone: 301-734-8094
joseph.f.annelli@aphis.usda.gov 

Grain Inspection, Packers and Stockyards Administration

John B. Pitchford
Director, Departmental Initiatives and International Affairs
Grain Inspection, Packers and Stockyards Administration
1400 Independence Ave., SW
Room 2409M-South, Mail Stop 3620
Washington, DC 20250-3620
Phone: 202-720-0226
john.b.pitchford@usda.gov 

USDA Research, Education and Economics 

Agricultural Research Service

Mary E. Torrence, DVM, PhD, DACVPM
National Program Leader, Food Safety
Agricultural Research Service
5601 Sunnyside Ave, GWCC 4-2194
Beltsville MD 20705-5138
Phone: 301-504-4616
mary.torrence@ars.usda.gov 

National Institute of Food and Agriculture

Jan Singleton, PHD, RD
Director, Food Safety Division
National Institute of Food and Agriculture
800 9th Street, SW
Room 2454 Waterfront Centre
Washington, DC 20024
Phone: 202-401-1954
jsingleton@nifa.usda.gov 

HHS Food and Drug Administration 

Office of Foods

Jeff Farrar
Associate Commissioner for Food Protection
10903 New Hampshire Ave.
Silver Spring, MD 20993
(301) 796-4500
jeff.farrar@fda.hhs.gov 

Office of Regulatory Affairs

Martha Myrick
Office of Regulatory Affairs
(240) 402-5840

Martha.Myrick@fda.hhs.gov

APPENDIX D -  (As Referenced in Appendix B of MOU 225-12-0007)

 

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