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 ofUnderstanding (MOU) establishes policies and procedures to 

enhance the exchange ofinformation between participating agencies ofthe U.S. 

Department of Agriculture (USDA) and the Food and Drug Administration (FDA) ofthe 

U.S. Department ofHealth 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 

A. 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 offood borne 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 

Page 1 of 12 
MOU 225-12-0007 

and private lands working cooperatively with other levels of government and with the 

private sector. 

1. The Farm and Foreign Agricultural Services (FF AS) 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 farmers and ranchers in business and 

improve the stability and strength ofthe 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 ofmeat, 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 ofFood 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 ofa safe, sustainable, 

competitive, and nutritious U.S. food and fiber system, as well as strong 

communities, families, and youth. USDA science infonns program, policy, and 

regulatory decisions. 

B. 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 

Page 2 of 12 
MOU 225-12-0007 

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. 

C. 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 ofthe 

Participants. 

ID. 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 ofrecords, 

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 and efficient execution ofthe responsibilities ofthe 

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. 

Page 3 of 12 
MOU 225-12-0007 

B. [nformation Safeguards 

The Participants mutually agree that: 

I. Proper safeguards against unauthorized use and disclosure ofthe 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 ofpolicies 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 oflnformation Act [5 U.S.C. 552], the confidentiality provisions ofthe 

Food Security Act of 1985 [7 U.S.C. 2276], Section 1619 ofthe Food, 

Conservation, and Energy Act of2008 [7 U.S.C. 8791], the confidentiality or 

non-disclosure provisions ofany other agreement entered into by a Participant, 

and other applicable Federal laws and implementing regulations. Pursuant to 

section 301(j) ofthe 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 ofthe 

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 ofthe 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 ofany 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 oflnformation 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 requester that it has referred the FOIA request to another agency and 

that a response will issue directly from that agency. 

IV. Limitations 

A. This MOU represents the broad outline ofthe Participants' present intent to share 

non-public information in areas ofmutual interest consistent with programmatic goals 

Page 4 of 12 
MOU 225-12-0007 

and resources that will assist in public health protection and the effective and efficient 

execution ofthe responsibilities ofthe Participants. 

B. 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. 

C. This MOU and all associated understandings or agreements will be subject to the 

applicable policies, rules, regulations, and statutes under which the Participants 

operate. 

D. 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. 

E. The MOU does not restrict any Participant from protecting information in connection 

with research that has not been peer reviewed. 

F. Nothing in this MOU shall obligate any Participant to any current expenditure or 

future expenditure ofresources in advance ofthe availability of appropriations from 

Congress. 

V. Other Understandings and Agreements 

A. This MOU is intended to serve as an overarching statement ofthe intention ofthe 

Participants to enhance information sharing among and between the Participants. 

B. This MOU does not nullify or negate any existing understandings or agreements 

among or between the Participants. 

C. 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. 

D. The Participants mutually agree to promote and advance the purpose ofthis MOU to 

enhance information sharing, when necessary, beyond any existing understandings or 

agreements. 

E. This MOU does not preclude any Participant from entering into additional, separate 

understandings or agreements with another Participant. 

VI. Liaison Officers 

A. To facilitate the activities carried out undet this MOU, the Participants will establish a 

single liaison for each agency participating in this MOU. 

Page 5 of 12 
MOU 225-12-0007 

B. The initfal liaisons are those specified in Appendix C to this MOU. 

C. 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 

A This MOU will become effective when signed by all the Participants. 

B. This MOU will continue in effect unless modified or terminated by mutual written 

consent ofthe Participants upon a 60-day advance written notice to the other 

Participants. 

C. The Participants agree that they will review this MOU every three years to determine 

whether it should be modified or terminated. 

Page 6 of 12 
_

MOU 225-12-0007 

APPROVED AND ACCEPTED FOR THE DEPARTMENT OF AGRICULTURE 

By: 

- # _:...,...... -' 

, __,,. - / /- ,-·- / 

,,,,,-;.,:~<.r,/41/ X:::::,.,..-41_ 

Michael T. Scuse 

Acting Under Secretary 

Farm and Foreign Agricultural Services 

Elisabeth A, Hagen, M. 

Under Secretary 

Food Safety 

Date : 12/22/11 

~~,__awa4L 

Catherine E. Woteki, Ph.D. 

Under Secretary 

Research, Education, and Economics 

Date:12/22/11 

kbv~ 

Kevin Concannon 

Under Secretary 

Food, Nutrition, and Consumer Services 

Date: 2/22 11 

ward Avalos 

Under Secretary 

Marketing and Regulatory Programs 

Date-: 12/22/11 

APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION 

By: 

~~1-7~~~

Commissioner 

~g~/ ofFood and Drugs 

HHS Food and Drug Administration 

Date:1/19./12 

Page 7 of 12 
MOU 225-12-0007 

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 20.6l(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 ofthe 

information asked for may be helpful, it is not required for purposes ofmaking 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 ofAgriculture 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 ofthis 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 ofinformation in response to the 

request. Although identifying each piece ofinformation (e.g., record, data, report, or 

document) provided may be helpful, it is not required for purposes ofresponding 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 ofAgriculture 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 ofthe originating 

agency, with advance notice to the originating agency." 

With the inclusion ofthis statement, responders would not have to use a particular format 

or include other pre-specified text. 

Page 8 of 12 
MOU 225-12-0007 

APPENDIXB 

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. 

Understanding Purpose Parties and/or Effective Expiration Provision or 

or Agreement Participants Date Date Paragraph 

Amended and 

Superseded 

225-99-2001 Facilitate an exchange HHS-FDA 02-23-1999 Indefinite Section IV, 

of information about and Paragraph 9, 

establishments that are USDA-FSIS and 

subject to the AppendixB 

jurisdiction of both 

FDA and USDA. 

225-72-2009 Cooperation and HHS-FDA 03-04-2011 Indefinite Section 4 and 

information sharing in and Appendix A 

inspection of food USDA-AMS 

products and 

establishments. 

225-11-0002 Establishing terms of HHS-FDA 07-01-2011 07-01-2016 Section JV and 

collaboration in areas and Appendix A 

of common interest USDA-REE 

and shared 

responsibility, and 

fostering the 

development of 

collaborative projects 

related to food safety 

and nutrition. 

225-11-0012 Communicate and HHS-FDA 09-29-2011 09-11-2016 Section IV and 

cooperate in the timely and AppendixB 

and full exchange of USDA-AMS, 

information to FSA, and 

optimize controls FNS 

essential to minimizing 

potential for the 

distribution or use of 

USDA foods which 

may be unsafe. 

Page 9 of 12 
MOU 225-12-0007 

APPENDIXC 

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 ofFood Safety 

Special Nutrition Programs 

Food and Nutrition Service 

3101 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 

Page 10 of 12 
MOU 225-12-0007 

Assistant Administrator 

Office ofProgram 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 2073 7 

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 

Page 11 of 12 
MOU 225-12-0007 

Agricultural Research Service 

5601 Sunnyside Ave, GWCC 4-2194 

Beltsville MD 20705-5138 

Phone: 301-504-4616 

mary. torrence@ars. usda. gov 

National Institute ofFood and Agriculture 

Jan Singleton, PHD, RD 

Director, Food Safety Division 

National Institute ofFood and Agriculture 

800 9th Street, SW 

Room 2454 Waterfront Centre 

Washington, DC 20024 

Phone: 202-401-1954 

j singleton@nifa. usda. gov 

HHS Food and Drug Administration 

Office of Foods 

JeffFarrar 

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 

Howard Sklamberg 

Deputy Associate Commissioner for Regulatory Affafrs 

10903 New Hampshire Ave. 

Silver Spring, MD 20993 

(301) 796-8314 

howard.sklamberg@fda.hhs.gov 

Page 12 of12 
APPENDIXD 

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

MEMORANDUM OF UNDERSTANDING 

Between The 

FOOD SAFETY AND INSPECTXON SERVICE 

UNITED STATES DEPARTMENT OF AGRICULTURE 

And The 

FOOD ANO DRUG ADMINISTRATION 

UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES 

I . PURPOSE 

Thfs agreement between the Food ahd Drug Administration, Depa rtment of Health 

and Human Services (FDA) and the Food Safety and Inspection Service, United 

States Department of Agriculture (FS1S) 1 is intended to facilitate an exchange of 

information between the agencies about establishments and operations that are 

subject to the jurisdiction of both agencies. This exchange of information wlll permit 

more efficient use of both agencies= resources and will contribute to improved 

public health protection. 

II. BACKGROUND 

In a May 1997 Report to the President entitled AFood Safety From Farm to Table• A 

National Food-Safety Initiative,@ the agencies primarily responsible for food safety 

made several recommendations to improve public health protection from foodborne 

illness. Several recommendations addressed the issues of increasing cooperation 

among agencies and, more specifically, of ensuring that the resources and 

experience of FDA and FSIS are used as efficiently as possible to avoid duplication of 

efforts. 

To advance the purposes of the President=s Food Safety Initiative, FDA and FSIS 

have re-evaluated a previous Memorandum of Understanding on coordination of 

Jnspectional efforts signed by FSIS on July 14, 1983 and by FDA on July 25, 1983. 

The agencies have determined that changes in inspectlonal activities, available 

resources, and food safety hazards necessitate updating that agreement. Therefore, 

FDA and FSIS have entered Into this Memorandum of Understanding to address 

today=-s public health needs. 

Page 1 of35 
UL STATUTORY AUTHORITIES 

FSIS is responsible for implemen ting and enforcing the Federal Meat Inspection Act 

(21 U.S.C. 601, et seq.), the Poultry Products Inspection Act (21 U,S.C. 451, et 

seq.), and parts of the Egg Products Inspection Act (21 U.S.C. 1031, et. seq.), In 

carrying out its responsibilities under these acts, FSIS places inspectors in meat and 

poultry slaughterhouses and in meat, poultry, and egg processing plants. FSIS also 

conducts inspections of warehouses, transporters, retail stores, restaurants, ancf 

other places where meat, poultry, and egg products are handled and stored. In 

addition, FSIS conducts voluntary inspections under the Agriculture Marketing Act (7 

U,S,C. 1621, et seq.). 

FDA Is responsible for implementing and enforcing the Federal Food, Drug, and 

Cosmetic Act (21 U.S,C. 301, et seq.), the Public Health Service Act (42 U.S,C. 201, 

et. seq), the Fair Packaging and Labeling Act (15 U.S.C. 1451 et. seq), and parts of 

the Egg Products Inspection Act. In carrying out Its responsibilities under these acts, 

FDA conducts inspections of establishments that manufacture, process, pack, or 

hold foods, with the exception of certain establishments that are regulated 

exclusively by FSIS. FDA also Inspects vehicles and other conveyances, such as 

boats, trains, and airplanes, In which foods are transported or held in interstate 

commerce. 

Nothing in this agreement shall lessen the responsibilities or authorities of FSIS or 

FDA under their statutory authorities, 

IV. SUBSTANCE OF AGREEMENT 

1. List of District Level Contacts 

The agencies agree to develop, maintain, and annually update a list of their districts 

and of persons to contact at the district management level. In addition to the annual 

updates to these lists, each district agrees to promptly inform its counterpart district 

of any change in the contact person for that district. The agencfes also agree to 

develop and maintc:1in a list of the district offices responsible for each state and r ' 

territory. Each agency agrees to promptly inform the other agency of any changes in I 

the jurisdiction of district offices or in the field organization of the agency. These. 

lists are to be distributed to the district managers of both FStS and FDA. 

2. List of Dual Jurisdiction Establishments 

Page 2 of35 
The agencies agree to develop, maintain, and annually update a list of dual 

jurisdiction establishments (hereinafter ADJEs@), that is, establishments that 

prepare, pack, hold, or otherwise handle both foods regulated by FSIS and foods 

regufated by FDA. This list is to be organized by state and territory and will be 

distributed to the district managers of both FSIS and FDA. When updating this list, 

each agency agrees to identify all DJEs that have discontinued operations that are 

under its jurisdiction. 

3. System of Communication 

The district offices of each agency agree to promptly report to their counterpart 

district offices certain findings, as set forth In paragraphs 5, 6, and 7, relating to 

DJEs. The district office receiving the report agrees to respond with information 

regarding any planned or comp leted follow-up action relating to the reported 

information. District management of both agencies are encouraged to initiate 

contact and to meet annuclllY, or as frequently as necessary, to facilitate the 

exchange of information about establishments and foods prepared, packed, held, or 

otherwise handled by these establishments. The agencies agree to work together to 

develop, put in place, and maintain a system of electronic communication at the 

district level to facil itate the exchange of information about the DJ Es . 

4. Notification of Periodic Inspection 

Each agency agrees to attempt to notify the appropriate contact identified ln 

paragraph l of this section prior to conducting an fnspectlon of a DJE that is not 

under continuous FSIS inspection. In addition, FDA agrees to attempt to notify the 

FSIS inspector prior to inspecting a DJE that is under continuous inspection and to 

invite the FSIS inspector to accompany the FDA investigator on the inspection. 

5, Findings Involving DJEs That Are To Be Reported By Both Agencies 

The district office of each agency is to notify its counterpart district office of the 

following findings in a DJE: 

a. Foods implicated In outbreaks of foodborne Illness, injuries, or 

adverse reactions. f 

b. ,Foods· found to be contaminated or rnlslabeled such that there is a ! 

reasonable probability that the use of or exposure to such products 

will cause serious adverse health consequences. Hazards that 

Page 3 of35 
constitute contamination or mislabeling covered Linder this paragraph 

are attached as Appendix A. 

c. A processing condition or fai lure that is likely to result In food 

contamination leading to outbreaks of foodborne illness, injuries, or 

adverse reactions, 

d. Foods that have been recalled . 

e. Reports of tampering or threats of tampering . 

f. A food handler diagnosed as having a communicable disease that Is 

likely to resu lt in food contamination or outbreaks of foodborne illness 

(e.g., hepatitis). 

g. Convictions of a DJE, or any officer or key employee of a DJE, for 

any felony or more than one misdemeanor involving the DJE or any 

food prepared, packed, held, or otherwise handled in the DJE. 

h. Convictions of an establishment preparing, packing, holding , or 

otherwise handling meat, poultry or egg products solely under state 

regulation and foods regulated by FDA, or any officer or key employee 

of such an establishment, for any felony or more than one 

misdemeanor involving the establishment or any food prepared, 

packed, held, or otherwise handled in the establishment. 

6. Additional Findings Involving DJEs That Are To Be Reported By FSIS to FDA 

tn addition to the findings in paragraph 5, the FSIS district office is to notify its 

counterpart district office of FDA of the followlng finding in a DJE: 

a. FSIS action to withhold the mark of inspection or· to suspend or 

withdraw the grant of inspection. 

7. Additional Fi ndings Involving DJEs That Are To Be Reported By FDA to FSIS 

In addition to the findings in paragraph 5, the FDA district office is to notify its 

counterpart district office of FSIS of the following findings : 

a. Any other processing cond ition in a DJE that could render foods 

bearing a USDA mark of mandatory or voluntary inspection 

adulterated or mislabeled . 

Page 4 of35 
b. Reason to belfeve that an FDA-regulated ingredient that would 

adulterate a meat, poultry, or egg product if used in it has been sent 

to or received by an FSIS-regulated establishment. 

8. Follow-Up Action 

a. The agency receiving notification of a finding listed in paragraphs 5, 

6, or 7 agrees to evaluate it and take appropriate action. 

b. For all reported findings listed in paragraphs 5, 6, or 7, the agency 

receiving the notification agrees to track and use the Information in 

program evaluation, work planning, and consideration of whether 

action against the establishment ls warranted. 

c. The agency receiving the notification of a findi"ng listed in 

paragraphs S, 6, or 7 agrees to respond to the notification within 30 

days by communicating the disposition df the notification to the 

notifying agency at the district management level, including, if 

appropriate, any and all actions planned and taken by the agency 

receiving notification . rn addition, the agencies agree to explore the 

feasibi lity of granting ead1other access to appropriate computer 

monitoring systems to permit interagency tracking of findings fisted in 

paragraphs 5, 6, or 7. 

9. Information Sharing and Confidentiality 

To promote increased cooperation and efficient use of enforcement resources, each 

agency agrees to share information For enforcement purposes upon request by the 

other agency, to the extent permitted by applicable law, All non-public information 

shared between the two agencies pursuant to th is agreement is subj ect to all 

applicable limitations established by statute or regulation on lnteragency sharing of 

information. The current policies and procedures for sharing such info rmation are 

attached as Appendix B. 

10. Training 

The agencies agree to develop and provide approprlate training in the inspectional 

techniques and processes of each agency as the agencies determ ine is necessary to 

ensure that the contacts for each agency have an appropriate understanding of the 

workings of the other agency. This understanding will help ensure the successful 

implementation of this agreement. The agencies agree to develop and initiate the 

Page 5 of35 
training as qufckfy as possible. The district managers of both agencies are 

encouraged to evaluate training needs during annual meetings, or as frequently as 

necessary, to determine whether additional training is warranted. 

11. Joint Enforcement Activities 

The agencies agree to establish a group to explore the feasibility of joint 

enforcement activities, This group is to report Its findings and recommendations by 

March 1, 1 999 to the Commissioner of FDA and the Administrator of FSI S. 

12. Re-evaluation of the Agreement 

The agencies agree to re-evaluate the effectiveness of thrs agreement after It has 

been in effect for one year. The agencies also agree to explore the feasibility of 

expanding their cooperative activities after one year, or sooner if the agencies agree 

that It is appropriate to do so. 

V. PERIOD OF AGREEMENT 

The agencies agree to begin implementing this agreement within 30 days from 

execution by both parties. This agreement wHl be effective indefinitely. It may be 

modified by mutual consent or terminated by either party upon 30 days= written 

notice to the other. 

VI. PREVIOUS AGREEMENTS 

This agreement supersedes the Memorandum of Understanding on coordination of 

inspectional efforts signed by FSJS on July 14, 1983 and by FDA on July 25, 1983, 

This MOU does not modify any other existing agreements between USDA and FDA. 

VII, NAME AND ADDRESS OF PARTICIPATING AGENCIES 

Food Safety and Inspection Service Food and Drug Administration 

1400 Independence Ave,, S.W, 5600 Fishers Lane 

Washington, DC 20250-3700 Rockville, MD 20857 

vm, LIAISON OFFICERS 

For FSIS: For FDA: 

John Mccutcheon Gary Pierce 

Associate Deputy Administra tor, Director, Division of Emergency and 

Office of Field Operations rnvestigational Operations 

Page 6 of35 
rood Safety Inspection Service Food and Drug Administration 

1400 rndependence Ave., S.W. 5600 Fishers Lane (HFC-130) 

Washington, DC 20250-3700 Rockville, MD 20857 

(202) 720-5190 (301) 827-5655 

APPROVED AND ACCEPTED FOR APPROVED AND ACCEPTED FOR 

THE FOOD SAFETY INSPECTION THE FOOD AND DRUG 

SERVICE ADMINISTRATION 

By: By: 

Thomas J. Billy Michael A. Friedman, M.D. 

Title: Administrator, FSTS Title : Deputy Commissjoner 

For Operations. FDA 

Date: 

Vpdated: 03/15/99 

Page 7 of35 
MOU number: 225-72-2009 

Me11:1oriu1dum of Understanding 

between 

the Agricultural Marketing Service 

and 

the Food and Drug Administration 

Concerning Information Sharing a.nd Other Activitie., Related to the Audlting, Inspection, 

and Grading of Food Products 1/ 

1. Purpose 

Cooperation and infonnation sharing in the inspection offood products and establishments.' 

2.. Background 

The Food and DrugAdroinistratlon (FDA) of the Depanment ofHealth and Human 

Services is charged with the enforcement of the Federal Food, Drug, and Cosmetic Act 

(FFDCA) and other laws. In fulfilling its responsibilities under the FFDCA, FDA's 

activities are directed toward protecting the public heal th by ensuring that foods are safe and 

whoJesome and truthfully and informatively labeled. This is accomplished, in part, by 

inspecting the produ.ction, processing, and distribution of foods and eltlllilining samples 

thereof to ensure compliance with applicable requirements. FDA also promulgates 1U1der 

the FFDCA mandatory standards of Identity, quality, and fill of containers for food products 

after appropriate notices and hearings. 

The Agricultural Marketing Service (AMS) ofthe U.S. Department ofAgriculture, under 

the authority ofthe Agricultural Marketing Act of 1946, carries out certain voluntary 

servlce functions designed to aid in the efficient marketing of agricultural products. These 

include developing commercial grade standards and specifications for foods, furnishing 

auditing, inspection and grading services (including the issuance of certificates ofquality 

and/or condition) and auditing reports to producers, processors, shippers, buyers, or other 

interested parties. The major purpose is to assist producers in preparing quality wholesome 

products that meet users' requirements aod to provide objective information concerning the 

grade quality, or condition ofa product, which will assist interested patties engaged in 

1 This agreement does not apply to egg products, inspection of which is covered by the Egg Products lnapcclion 

Act: to meat or poultry produc1s, inspection of which is covered by the Meat lnspectioo A.ct and the Poultry 

Products Inspection Act (USDA Food Safety and Inspection Service); nor to gralns, including rice, dry bo111Js, 

peas, or lentils, inspection ofwhich Is covered by the U.S. Grain Standards Act (USDA Grain Inspection, Packers 

and Stockyards Administration). 

1 

Page 8 of35 
marketing functions. In addition to inspection and grading seivices for products, AMS 

offers voluntary audit, survey, and verification services at product locations and facilities. 

AMS' regulatory authority facilitates fair trade practices among the industry through 

education, mediation, arbitration. licensing and enforcement of the Perishable Agricultural 

Commodities Act of 1930. 

The two agencies have certain related objectives in carrying out their respective Iegulatory 

and service activities. Therefore, the agencies believe it is desirable from the standpoint of 

public health protection to set forth in this Memorandum of Understanding (MOU) the 

working a.rrangemeo,ts that are being followed or adopted in the interest ofeach agency 

discharging as efteotively as possible its responsibilities related to inspection/grading and 

standardization activities for food products. The MOU recognizes that AMS' audit, survey, 

and verification services contribute to the protection of consumers by helping agricultural 

producers fulfill their responsibility to ensure that their products are safe and meet 

applicable FDA requirements. The,MOU also recognizes that FDA may take into 

consideration information resulting from AMS services in making risk-based 

determinations, such as in establishing inspection priorities. In addition, the MOU 

recognizes that FDA is the competent authority in the United States for the safety ofthese 

food products, and that determinations made by AMS do not change or diminish PDA's 

authority under the FFDCA. Nothing in this MOU, or any determination made by AMS, 

would restrict FDA from conducting its own inspection or taking regulatory action, nor 

would it affect the legal responsibilities ofestablishments under the FFDCA. 

3. Substance of the Agreement 

A. The Agricultural Marketing Service will: 

I) supply to FDA-designated offices, upon request, complete lists of all fanns, packing 

plants, handlers, and food processors that are operating under AMS continuous or other 

resident or temporary inspection or g.ading contracts or contractual audit services. This 

list will include the type ofservice provided and the food products involved; 

2) immediately advise tl1e appropriate FDA office of those plants subject to withdrawal or 

suspension ofservice, termination of contract, or denial ofinspection seiviccs because 

ofsanitation or other current good manufacturing practice or good agricultural practice 

deficiencies. AMS will notify the appropriate FDA office ofthose facilities that appear 

not to confoon to agricultural best practices that relate to food safety or to FDA's 

current Good Manufacturing Practice regulation under 21 CFR part 11 o; 

3) investigate any report from FDA that a grower, packer, or processor operating under 

contract with AMS has not corrected objectionable conditions found to exist by FDA, 

and take action in accordance with AMS regulations and contracts; 

4) decline to inspect, grade, or audit samples ofproducts that are known to have heen 

seized by FDA, or that are known to be involved in FDA enforcement actions. This 

docs not preclude reinspection oflegally authorized samples by AMS ifthe FDA. 

2 

Page 9 of35 

II 
seizure or other enforcement action involved products that had previously been 

inspected or graded by AMS; 

5) decline to assign a U.S. grade or pennit the use of Government official marks or other 

approved identification on a food product ( l) that is known or believed by AMS to be 

adulterated 1mder the FFDCA or other applicable federal statute, or (2) that AMS has 

otherwise found not to be suitable for grade assignment because of possible 

adulteration, contamination, or food safety risk; 

6) decline to provide auditing, inspection, and grading services to a facility (1) that is 

known or believed by AMS to have significant violations of the FFDCA, or other 

applicable statute, that are uncorrected or reoccurring, or (2) for which FDA has 

provided notification to AMS that FDA has found unsanitary conditions; 

7) notify the appropriate FDA office with infoimation on any lot ofproduct which, upon 

inspection, is known or believed to fail to comply with FDA requirements, unless AMS 

verifies, in coordination with FDA, that such product is appropriately reconditioned or 

relabeled to comply with FDA requirements oris segregated and disposed of for 

nonfood use or otherwise lawfully shipped or sold; 

8) furnish to FDA upon request, any pertinent information concerning the grade or quality 

determination relative to specific lots ofproducts inspected or graded by AMS that have 

been proceeded against or are being considered for any action by FDA; 

9) record on the audit, inspection or grading report any pertinent codes or other marks that 

will serve to identify the specific goods, which are audited, inspected, or graded; 

lO)when requested by FDA, provide assistance necessary to facilitate investigations 

required to ensure public health; 

1I) for product areas where FDA has provided the appropriate training to AMS, routinely 

advise contract establishments ofpertinent FDA requirements and provide information 

on compliance and points of contact at FDA; 

12) upon FDA request, sample and analyze specific lots of agricultural commodities for 

investigations involving potential regulatory violations; provide feedback to FDA on 

results ofsampling and analysis, ifrequested; provide support for associated requests 

for testimony in related court actions; and follow FDA protocols related to chain of 

custody, sampling, and analysis for lots when samples and analysis are perfonned for 

FDA, or obtain approval from FDA for using alternative methodologies; 

13) notify the appropriate FDA office immediately of any presumptive or confirmed 

positive findings of human pathogens of public health significance or residues of 

pesticide and/or environmental contaminants in products inspected by AMS that exceed 

tolerances, action levels, or otherwise adulterate the food; 

3 

Page 10 of35 
14) furnish to FDA upon request any pertinent reports AMS generates that include general 

.information on deficiencies in current good manufacturing practice or good agricultural 

practice; 

15) notify the appropriate FDA office of those facilities that fail to conform to current good 

manufacturing practices or good agricultural practices ·related to food safety; 

16) cooperate with FDA in responding to food safety emergencies involving food products, 

within resource constraints; 

17) notffy FDA in writing whenever an employee or AMS inspector has been asked to 

testify in a case in which FDA is a party, Decline to testify for a private entity unless 

that entity has complied with §AMS' "Touhy'' regulations including issuance ofa 

subpoena (7 CFR §l.2l4 & §1.215 er seq.); and 

18) iofoan FDA about firms that have repeated violations of AMS requlrements. 

B, The Food and Drug Administration wilh 

1) maintain guidance documents on its website or otherwise provide these documents to 

AMS upon request, which AMS can use in providing audit services for industry; 

2) as appropriate, invite the AMS inspector/grader present at a plant operating under 

contract with AMS to accompany the FDA investigator during his or her inspection of 

such plant. The FDA investigator may point out or discuss with the AMS 

inspector/grader the conditions noted which may be violations of the FFDCA; 

3) request from the AMS contact designated in this document any information related to 

grade quality or food safety for a specific £inns or lot(s) ofproduct(s) against which 

FDA is taking action or is considering taking action and that is/are known or believed to 

have been inspected or audited by AMS. FDA may take into consideration the results 

of AMS inspection certificates and other available data; 

4) request from the A.i\llS contact designated in this document, for specific facilities under 

FDA Investigation or action, !Illy pertinent infonnation concerning AMS audits related 

to identity preservation, food safety, or food defense; 

5) immediately notify the AMS contact designated in this docwnent concerning the details 

ofobjectionable conditions whenever such conditions are found to exist in processing or 

packing plants or primary production locations where AMS is conducting inspections of 

products or conducting audits offacili1ies and/or best practices, or in other food plants, 

when FDA believes such infoi::mation would be ofvalue to AMS in its auditing, survey, 

or verification services, or Its inspection and grading activities~ 

4 

Page 11 of35 
6) whenever possible, mark the claimant's samples of seized products in such a manner 

that AMS inspectors will recognize such post,seizure samples; 

7) provide AMS with access to documented protocols for sampling, analysis, and chain of 

custody for lots when samples and analyses are performed at FDA 's request; 

8) provide to the AMS contact designated in this MOU to keep AMS informed of the 

criteria used by FDA to assist AMS in understanding which conditions FDA would 

consider actionable under the FFDCA and other statutes. FDA will also discuss and 

identify FDA training information and material that could be beneficial to A.1\.1S; 

9) on request of AMS, review labels, legends, stamps, Md other official marks and claims 

for products packed under the various audit, grading, and/or inspection services of AMS 

from the standpoint ofpossible conflict with the misbranding JJrovisions of the FFDCA; 

10) notify AMS when FDA has sent a warning letter to a facility covered under AMS' 

inspection and auditing services. Notify AMS when FDA intends to take or is taking 

regulatory action against a food product or facility, except where it may be inappropriate 

in the context of criminal action; and 

11) notify AMS in writing whenever an employee or FDA inspector has been asked to 

testify in a case in which AMS is a party. Decline to testify for a private entity unless 

that entity has complied with FDA's ''Touhy" regulations, including issuance ofa 

subpoena. (21 CFR 20.1 and 20.2). 

C. AMS and FDA mutually agree that each agency will: 

1) maintain close working relations with each other, both in headquarters as well as in the 

field, Appropriate AMS and FDA personnel will meet periodically, as resources pemtit, 

for purposes ofprogram planning, coordination, evaluation, and review concerning 

inspectional matters of mutual interest and to serve as a clearinghouse for questions and 

problems as may arise. Provide a list ofregional office contacts; 

2) partici_pate in meetings with industry, as resources pennit, to promote better 

communication and understanding ofregulations, policy, and statutory responsibilities, 

and to improve sMitation and food-handling practices;. 

3) cooperate in the development of the other's regulations, guidance and programs related 

to relevant products, as appropriate; 

4) make fonnal training courses available to the other's personnel, as resources pennit; 

5) take advantage of the inspectional capabilities of the other to achieve the maximum 

utilization of resources, when appropriate and as resources permit; 

5 

Page 12 of 35 
6) exchange data and cooperate in the development ofsampling plans, methodology, and 

guidelines for determining natural and unavoidable defects common to products audited, 

inspected, and graded by AMS; 

7) work with industry toward greater efficiency in connection with improvement in coding 

and traceability methods; 

8) cooperate in the handling of those cases ofmisbranding which also come under the 

provisions of the Perishable Agricultural Commodities Act of 1930, as amended; and 

9) develop procedures that include proper safeguards against unauthorized use and 

disclosure ofthe non-public information exchanged under this MOU. 

4. Information Sharing 

The procedures established under Section 3.C. must include proper safeguards against 

unauthorized use and disclosure of the non-public 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 shared and used consistent with the Trade 

Secrets Act [18 U.S.C. § 1905J, 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 

Jnfonnation Act [5 U.S.C. § 552J, any other applicable Federal law and regulations 

implementing it. Pursuant to FFDCA section 30l(j) [21 U.S.C. 331 (J)j, FDA will not reveal 

to AMS arty method or process which is entitled to protection as a trade secret. Any 

Federal Pllrtner may decide not to share information or expertise in response to a particular 

req_uest for infonnation, or to limit the scope ofinformation and expertise sharing in 

response to a particular request. See Process for Information Sharing under Appendix A. 

Access to the non-public infonuation shared under this MOU shall be restricted to 

authorized FDA and AMS employees, agents, and officials who require access to perform 

their official duties in accordance with the uses ofthe 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, clvU and criminal penalties contained in applicable Federal laws 

for the unauthorized disclosure of confidential information. 

If an agency that has received infonnation 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 directly to the requestor regarding the releasability of the inforrn11tion. In such 

cases, the agency making the referral will notify the requestor that a referral bas been made 

-and that a response will issue directly from the other agency. 

5, Limitations 

This MOU represents the broad outline of the Pa:.-ties'present intent to collaborate in areas 

of mutual interest to FDA and AMS. It does hot create binding, enforceable obligations 

6 

Page 13 of35 
against either Agency. All activities undertaken pursuant to the MOU are subject to the 

availability of personnel, resources, and funds. With the exception of MOU number: 225-

72-2009 (dated June 25, 1975), this MOU does not affect .or supersede any existing 

agreements or arrangements between the Parties and does not affect the ability of the Parties 

to enter into other agreements or arrangements related to this MOU. This MOU and all 

associated agreements will be subject to the applicable policies, rules, regulations, and 

statutes under which FDA and AMS operate. Nothing in this MOU shall obligate FDA and 

AMS to any C1ltfent expenditure or future expenditure ofresources in advance ofthe 

av,tilability of appropriations from Congress. 

6. Liaison Officers 

To facilitate the activit[es carried out under this MOU, each agency will establisb a single 

agency liaison. The initial liaisons will be: 

For FDA: 

David Glasgow 

Director, Division of Domestic Field Investigations 

ELEM, Room 2136, HFC-130 

12420 Parklawn Drive 

Rockville, MD 20852-1740 

Phone: 301 ~796-5403 

Email: David.Glasgow@fda.hhs.gov 

For AMS : 

Erin-Morris 

Deputy Associate Administrator 

1400 Independence Ave, SW, 

Room 3077-S, Mail Stop 0201 

Washington, DC 20250-1300 

Phone: 202-690-4024 

Email: Erin.Morris@ams.usda.gov 

Each agency may designate a new liaison at any time by notifying the other in writing. !fat 

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. 

7., J:lfectlve Da te, Terms, Termination and Modification 

This agreement will become effective when signed by both parties and it will continue in 

effect unless modified by mutual written consent at any time or tenninated by either party 

upon a 60 day advance written notice to the other. The parties agree that they will review 

this agreement every three years to determine whether it should be modified or terminated. 

This MOU supersedes the Memorandum of Understanding (MOU number: 225-72-2009) 

dated June 251 1975. 

7 

Page 14 of35 
Approved and Accepted for the Agricultural Marketing ScrVice 

Signed by: ~ 5P~ 

Administrator 

Agricultural Marketing Service 

Date: f-e,b. \, l , '\ l 

Approved and Accepted for the Food imd Drug Administration 

~j:;:i~~q;7~ 

Food and Drug Administration 

Date: March 4, 2011 

8 

Page 15 of35 
APPENDIX A 

Process for Information Sharing 

Pursuant to Section 4 of the Memorandum of Understanding (MOU) entered into by the Food 

and Drug Administration (FDA) and the Agricultural Marketing Service (AMS) any Federal 

partner "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 4. 

When, under the current MOU, staff at the FDA or AMS 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 ofthe inforrnation 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-AMS 

Memorandum of Understanding. We agree not to disclose any shared infonnation in any 

manner without your written permission or as required by law with advance notice to 

the originating agency." With the inclusion of this sta,tement, requesters 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-AMS Memorandum of Understanding, this communication may 

contain privileged and/or confidential information exempt from public disclosure. Tt 

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. 

I' 

9 

Page 16 of35 
MOU Number; 225-11-0002 

MEMORANDUM OF UNDERSTk'.'DING 

Between 

THE UNITED STATES FOOD AND DRUG ADMINISTRATION 

And 

I THE UNITED STATES DEPARTMENT OF AGRICULTURE 

RESEARCH.EDUCATION. and ECONOMICS l 

Establishing terms of collaboration in areas ofcommon ioterest and shared responsibility, 

and fostering the development of collaborative projects related to food safety and nutrition 

II. BackllfOund 

The United States Food and Drug Administration (FDA).. and the Uni ted 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 disciplfoes Llmt directly and indJrectly affect human and aoimal health including food 

safety and nutrition. 

FDA is responsible for protecting and promoting the public health by ensuring, among other / 

things, the safety ofbuman 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 f' 

the Commissioner includes the Center for Food Safety and Applied Nutrition (CFSAN), the I 

Center for Veterinary Medicine (CVM) and the foods-related activities of the Office of 

Regulatory Affairs (ORA). CFSAN's mi sion includes both food safely 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; und 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 impoi;ts, 

i1JSpectionS!, and enforcement policy. 

The USDA agencies within REE - the Agricultural Research Service (ARS), the Econom.ic 

Research Service (ERS), the National Agricultural St.atistics Service (NASS), and the 

National Institute ofFood and Agriculture (NlF A) (replaces-fonner Cooperative State 

Research, Education, and I:.xtension Service) - provide federal 1eaderslup in creating and 

Page 1 of7 

Page 17 of35 
disseminating knowfodge spanning the biological, physical. and social sciences related to 

agricultural research, economic analysis, statistics, extension, and higher educa1ion. 111e 

mission oflhe 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 ofagricultural food production data to infom1 research relative to food safety and 

nutrition issues. The mission ofN.IFA is to advance knowledge for agriculture, the 

environment, human health and well-being, and communities by supponing research, 

education, and extension programs in tl1e 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 Mcmorandwn of Understanding (MOU) the basis for 

development of scientific collaborations between the Participants in t11e areas of food safety 

and nutri1ion . 

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 coJlaboratively pursued. 

The Participants recognize that cooperation is a matter of working together toward common 

goals of mutual interest, not merely cooperative financing or sharing ofresearch and related 

activities. The Participants also recognize that successful cooperation occurs only tlirough 

.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 

responsibil [ties and authority of citller Partfoi_paut for independent action. 

JU . Substance ofAgreement 

The Participants agree to collaborate in areas ofmotual interest. Areas may include but are 

uot Limited to food pathogen and contaminant detection methods, pre- and post-harvest food L 

safety interventions and control strategies, nutrition monitoring methods and data, food 

composition analyses and databases, biomarkers ofe,cposure, nutritional status, and disease l 

I risk, ao.d economic analyses relevant to food safety and nutritional issues. CoJlaborations are I 

I expected 10 gather scientific data that wi11 provide guidance for regulatory and policy 

decisions, and may change as priorities in both food safety and nutrition evolve. l 

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. 

1n order to assure tJiat these collaborations are pursued in a continual and timely fashion, the 

Participants may meettwice a year, ormore frequently if-the need arises, alternating meeting 

sites between the two agencies, aod may share information, reports on progress, and explore 

new areas for collaboration. These meetings will be coordinated by programmatic leaders in 

Page 2 of? I

I 

f 

Page 18 of35 
food safety and nutrition, For the purpose offacilitation in these collaborations, CFSAN and 

ARs have agreed to be the coordinators for their respective agencies. 

Additionally it is agreed that: 

l. Rights to any invention.~ resulting from collaborative research will be determined 

based on current U.S. Govemment patent regulations and any other applicable 

statutes and regulations. 

2. Each Participant will comply with the other Participant's ,security procedures and 

policies regarding access to and use of facilities. Either Participantmayrestrict or 

limit access to its property and facilities, at any time, for any reason. 

3. 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 ofexpenses will be 

agreed 1o in advance of any collaboration, in compliance with all applicable federal 

requirem.ents, and subject to the limitations in Section V ofthis MOU. 

4. In accordance with Section 101 l ofthe Federal Food, Drug, and Cosmetic Act [21 

U.S.C. § 399c] and Section 405 of Title N ofU1e Agric;ultural Research, El(tension, 

and Education Reform Act [7 U.S.C. § 7625], FDA and NIFA will collaborate on 

the establishment of a competitive grant program witltin 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 lo the limitations in Section V of this MOU. 

1V. Information sharing 

The Participants recognize the need for proper safeguards against unauthorized use and 

disclosure ofnon-public information exchanged pursuant to this MOU. Proper safeguards 

shall include the adoption ofpolicies and procedures to ensure that the infonnation shared 

under this MOU shall be shared and used consistent with the Trade Secrets Act [18 U.S,C. § 

1905J, the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], lhe Privacy Act of 

1974, as amended [5 U.S.C. § 552a], the Freedom oflnformation Act [5 U.S.C. § 552], and 

their implementing regulations, and any other applicable Federal law and its implementing 

regulations. Pursuant to Section 30 l(j) of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 33l(i)], FDA will not reveal to REE any method or process wluchis 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 uoder Appendix A 

Access to the information shared under this MOU sha11 be restricted to authorized FDA and 

REE employees, agents, and officials who require access to perform their official duties io 

accordance with the uses ofinformation as authorized by thls MOU, unless authorized in 

Page 3 of 7 

Page 19 of35 
writing by the agency that provided the infonnation or otherwise required by Jaw. Such 

personnel shall be advised of(\) the confidential nature of this information; (2) safeguards 

required to protect the information; and (3) the administrative, civil, and criminal penalties 

for noncompliance contained i.o applicable Federal laws. Contractors, their subcontractors, 

and agents requiring access to the infom1ation shared under this agreement will be required 

to sign a business associate agreement by which they wiJ Icommit 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 infonnation und.er this MOU receives a FOIA request for shared 

lnfonnation, it will refer the request to the agency that shared the infozmation for the latter 

agency to respond directly to the requestor regarding the releasability of the infonnation 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 ofpersonnel, 

resources, and funds. This MOU does not affect or supersede any existing or future 

agreements or arra}\gements 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 US, Department .of Agriculture's Research, Education and 

Economio Agencies operate. 

VI. Liaison Officers 

A. Administrative ICenter 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 

Page4 of7 

Page 20 of35 
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.Partnersnip Team 

Center for Food Safety and Applied Nutril ion 

food and Drug Administration 

5100 Paint Branch Parkway (HFS-006) 

College Park, MD 20740 

(301) 436-198.l 

Deputy Director, Office ofResearch 

Center for Veterinary Medicine 

Food andDrug Administration 

8401 Muirkirk Rd 

Laurel, MD 20708 

(301) 210-4213 

Director, Office of Regional Operations 

1 

l Office of Regulatory Affairs 

Food and Drug Administration 

10903 N.:w Hampshire A venue 

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 oew 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 ro 

fulfill those functions, the agency will name.a new liaison and notify the other agency 

through the designated liaison. 

I 

Page S of7 I 

t 

Page 21 of35 
VU. Tenn. Termination. and Modification 

This MOU becomes effective on the date ofthe last signature and continues for S years. It 

may be modified or tenninated by mutual written consent of both parties or may be 

terminated by either party μpan a 60-day advance written notice to the other party. 

APPROVED AND ACCEPTED FOR HIE FOOD A1'11J DRUG ADMINISTRATION 

BY~~ Date:June 30, 2011

Signatureofauthrizedreprentative 

Margaret A Hamburg, M.D. 

Commissioncr·ofFood and Drugs 

Food and Drug Administration 

APPROVED AND ACCEPTED FOR THE DEPARTMENT OF AGRICULTURE, 

RESEARCH, EDUCATION, AND ECONOMTCS 

BY: ~ ~~- -~-_-___,,_____fa.__ Date: >'/I/.;u;;; 

Signature ofauthorized representative ' 

Cathie Woteki, Ph.D. 

Under Secretary for-Research, Education, and Economics 

United Stat~s Department of Agriculture 

Page 6 of7 

Page 22 of35 
APPENDIX A 

Process for Information Sharing 

Pursuant to Section IV ofthe Memorandum ofUnderstanding (MOU) entered into by the 

Food and Drug Administration (FDA) and the United States Department of Agriculture 

Research. Education and Economics Agencies (REE), ei !her Participant "may decide not lo 

share infotmation or ,expertise in response to• a particular request for information, or to limit 

the scope ofinfonnation and expertise sharing in response to aparticular 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 ofthe information asked for may be 

helpful, it would not be :required for pmposes ofmaking a request. However, the following 

language should be included in th.e request: 

"Informatiort that.JS shared under this request will be under the FDA-REE 

Memorandum ofUnderstanding. We agree not to disclose any shared information in 

any manner without yoμr written pennission or as required by law with advance 

l101ice lo 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 

aclmowledges transmission ofinformation in response to the request. Although identifying 

each piece ofinformation/document provided may be helpful, it would not be required for 

purposes ofresponding 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 confidenllal inforrnation exempt from public 

disclosure. lt 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 1o use a partfoular 

format or include other prec5pecified text.. 

1, 

Page 7 of7 

Page 23 of35 
Unit.cl State• Depan,mnf of 

AQr1culture 

Farm.ind 

Foreign 

Ag/iCIJltural 

Services 

Farm 

Ser.1ce 

Agency 

1400 lndep9ndenai 

AYenue, &/i 

Stop code 0550 

Room3080 

W_,,lnQIOn, DC 

2025(M)572 

USDA 

c::--

MEMORANDUM FOR THE ADMINISTRATOR 

/ SEP 2 9 2011 FROM: JamesW.Mon ~,£,_ 

Deputy Admini mmodity Operations 

SUBJECT: Memorandum ofUnderstanding with FSA, AMS, FNS and FDA 

Enclosed is a Memorandum ofUndmtanding (MOU) between Farm Service Agency, 

Agricultural Marketing Service, Food Nutrition Service and the Food and Drug 

Administration for your signature. The pUI])Ose ofthe MOU is to establish a framework 

for co=unication to minimize the potential distribution of unsafe USDA Foods. All of 

the other agencies have already approved and accepted the MOU. 

If you have any questions regarding this document, please eontactme. 

ESA USCA is an oqu.al apportunlly provider and am player, 

Page 24 of35 
MOU Number: 225-11-0012 

MEMORANDUM OF UNDERSTANDING 

Between 

UNITED STATES DEPARTMENT OF AGRICULTURE'S 

AGRICULTURAL MARKETING SERVICE, 

FARM SERVICE AGENCY, and 

FOOD AND NUTRITION SERVICE 

and 

DEPARTMENT OF HEALTH AND HUMAN SERVICES' 

FOOP AND DRUG ADMINISTRATION 

Toe United States Department ofAgriculture's (USDA) Agricultural Marketing Service (AMS), 

Farm Service Agency (FSA), Food and Nutrition Service (FNS), and the Department of Health 

and Human Services' (HHS) Food and Drug Administration (FDA), collectively referred to as 

the Parties, intend to facilitate the exchange ofinformation among the Parties related to FDAregulated foods procured or subject to procurement by USDA. For the purpose of this 

Memorandum ofUnderstanding (MOU) the term "USDA Foods" v.rill mean commodities 

procured by USDA for use in domestic nutrition assistance programs. 

I. PURPOSE 

Toe purpose ofthis MOU is to establish a framework for the Parties to communicate and 

cooperate in the timely and full exchange ofinformation to optimize controls essential to 

minimizing potential for the distribution or use of USDA Foods which may be unsafe. 

II. STATUTORY AUTHORITIES AND RESPONSIBILITIES 

FDA is charged with the enforcement ofthe Federal Food Drug, and Cosmetic Act (FFDCA) (21 

U.S.C. § 301, et seq.), which defines "food" as any "articles used for food or drink •u [or] for 

components ofany such article" (21 U.S.C. § 321(f)). FDA also implements and enforces the 

Public Health Service Act (42 U.S.C. § 201, et seq.), the Fair Packaging and Labeling Act(l5 

U.S.C. § 1451 et seq.); and other statutes. In carrying out its responsibilities under these statutes, 

FDA conducts inspections of establishments that manufacture, process, pack, or hold foods, with 

the exception of certain establishments that are regulated excl\lSively by USDA's Food S~ety 

Inspection Service (FSJS). FDA inspects food and food samples during processing and 

distribution. When FDA determines that food is not compliant with statutory and regulatory 

Page 25 of35 
.requirements, FDA works with manufacturers to ensure the removal of the food from the market 

FDA can also take enforcement action. 

FNS administers the USDA domestic nutrition assistance programs and provides USDA Foods 

to its programs, such as the National School Lunch Program, the Commodity Supplemental Food 

Program, The Emergency Food Assistance Program, and the Food Distribution Program on 

Indian Reservations pursuant to authorities in the Richard B. Russell National School Lunch Act 

(42 U.S,C. 1751 et seq.), the Child Nutrition Act ofl966 (42 U.S.C. 1771 et seq.), the 

Agriculture and Consumer Protection Act ofl973 (7 U.S.C. 612c note), and the Emergency 

Food Assistance Act of 1983 (7 U.S.C. 7501 et seq.), 

Pursuant to Section J5 of the Commodity Distribution Refonn Act and WIC Amendments of 

1987 (7 U.S.C. 612c note), the Secretary ofUSDA may use funds available to implement 

Section 32 ofthe Act of August 24, 1935, (7 U.S.C. 612c), to reimburse State agencies and 

others for the removal of USDA Foods distributed under a domestic nutrition assistance program 

if the Secretary determines that ihe commodities pose a health or safety risk. 

lJSDA, through AMS and FSA, pl:II'Chases and delivers USDA Foods to State distributing 

agencies and other entities for donation in the domestic nutrition assistance programs. 

In addition to acquiring food products on behalf ofFNS using funds appropriated for FNS 

programs, AMS carries out a wide range of program activities that facilitllte the marketing of 

domestic agricultural products as authorized by Section 32 ofthe Act of August 24, )935; the 

Agricultural Marketing Act of 1946, the Perish.able Agricultural Commodities Act, and more 

than 50 other statutes. Many ofthe USDA Foods purchased by AMS must meet specific grade 

and specification requirements established by the various inspectio.ns and grading activities of 

AMS including the Fruit and Vegetable Programs, Poultry Programs, and Uvestock and Seed 

Programs. AMS typically contracts with manufacturers to fulfill program needs. Also, some 

non-manufacturers participate by utilizing subcontracts to fulfill AMS commoclity contracts. 

AMS-procures Group A USDA Foods listed in Appendix A, Section A 

1n addition to acquiring food products on behalf ofFNS using funds appropriated for FNS 

programs, FSA is responsible for the management of commodities acquired by the Commodity 

Credit Corporation under various statutes; including the Food, Conservation and Energy Act of 

2008 the Agricultural Act of 1949, as amended, and the Commodity Credit Co:poration Charter 

Act FSA also contracts for commercial storage and distribution of USDA Foods purchased for 

the Food Distribution Program on Indian Reservations and the Commodity Supplemental Food 

Program. FSA procures Group B USDA Foods listed in Appendix A, Section B. 

2 

Page 26 of35 
ill. SUBSTANCE OF THE AGREEMENT 

The Parties agree: 

A. FDA, FNS, AMS, and FSA will .maintain points of contact (POC} at the headquarters and 

district office levels, including email distribution lists, to ensure 1he agencies can respond 

effectively to questions that arise regarding the safety ot security of FDA-regulated 

USDA Foods. In addition, the Parties agree to inform 1heir respective counterparts 

annually, or as necessary, ofany change in the designated contact persons or changes in 

the areas of responsibility or in the organization of the agency. 

The names ofthe POCs will be distributed to the managers ofFDA, FNS, AMS, and FSA who 

have relevant responsibilities. 

B. FDA, FNS, AMS, and FSA will share in a timely manner among respective liaison 

offices and contacts (provided for under A above) information and updates on 

complaints, reports, or events that compromise FDA-regulated USDA Foods and may 

affect the health and safety of USDA nutrition assistance program recipients, and to 

cooperate on investigations into the food safety significance ofcomplaints and 

occurrences ofoutbreaks offoodbome illness, injuries, or adverse reactions in connection 

with FDA-regulated USDA Foods. 

C, For food products involved in recalls monitored by FDA or subject ofan FDA consumer 

alert, FDA Will inquire ofthe vendor whether the product(s) in question were acquired by 

any USDA procurement agency or barter partner for use in the domestic nutrition 

assistance programs. If so, FDA will, in a timely manner, provide to FNS, AMS and 

FSA complete information about types ofFDA-regulated foods procured by USDA that 

are subject to a recall or an FDA consumer alert, as well as the actual or anticipated 

distribution ofsuch foods. Upon request, FNS, AMS and FSA will provide information 

to FDA in a timely manner _about how USDA Foods ar¢ procu.ed and distributed by 

USDA, 

D. AMS and FSA will cooperate in obtaining samples for analysis by FDA ofthose FDAregulated USDA Foods that FDA believes may pose a health risk. FDA will share the 

ao_alytical results with affected USDA agencies in a timely manner. 

E. FDA will share with FNS, in a timely manner, information on FDA's investigations 

regarding foodbome illnesses linked to FDA-regulated USDA Foods. This infonnation 

may influence whether a USDA procurement agency will place a hold on certain 

products, pending the analytical results described in D above, or other FDA scientific 

conclusions or determinations. 

F. "When an FDA regulated food that also is a USDA Food is tmder FDA investigation, FNS 

will arrange, within IO business days ofnotification of the investigation, discussions 

3 

Page 27 of35 
between FDA and the affected USDA agencies to determine the course of the FDA 

investigation and findings. FDA will assist USDA in determining the most appropriate 

action to take to protect the health of the recipients of the USDA Food(s) in question. 

G. FDA and the appropriate USDA agencies will work cooperatively to develop 

communication strategies1 including FDA press releases and stakeholder announcements, 

for potential references to USDA Foods. 

H. AMS and FSA will require all oftheir vendors to comply with all State and Federal 

guidelines. 

l, As requested by FDA, FNS, AMS, and FSA will assist FDA in conducting recall audits 

involving FDA-regulated USDA Foods. 

IV. INJ!ORMATION SHARING 

The terms of this agreement shall include appropriate safeguards agains1 unauthorized use and 

disclosure of the non-public information exchanged under this MOU. Pursuant-to FFDCA 

section301G) [21 U.S.C. 3310)), FDA willnot reveal to FNS, AMS or FSA any method or 

process which is entitled to protection as a trade secret FDA, FNS, AMS, and FSA shall 

establish appropriate safeguards to protect the confidentiality of the information and to prevent 

unauthorized access to the information provided by other Federal partners. While recognizing 

that the overall purpose of this MOU is to facilitate infonnation sharing, any Federal partner may 

decide not to share information or expertise in response to a particular request for information, or 

to limit the scope ofinformation and expertise sharing in response to a particular request. See 

Process for Information Sharing under Appendix B. 

Access to the in:foi:mation sh.ared under this MOU shall be restricted to authorized FDA, FNS, 

AMS,_and FSA employees and officials who require access to perform their official duties in 

accordance with the uses of the information as authorized by this MOU. Such perliOnnel shall be 

advised of(I) th.e confidential nature ofthe information and (2) safeguards required to protect 

the information. 

FDA, FNS, AMS, and FSA agree to promptly notify the other Federal partners of any actual or 

suspected unauthorized disclosure ofinformation shared under this MOU. 

If an agency that has received information under this MOU receives a Freedom ofInformation 

Act (FOIA) request for which there are responsive records that originated with the other agency, 

it will refer the request to the information-sharing agency for it to respond. directly to the 

requestor regarding whether tb.e information can be released. In such cases, the agency making 

the referral will notify the requester that a referral bas been made and that a response will be 

issued directly from the other agency. 

4 

Page 28 of 35 
V. LIMITATIONS 

This MOU represents the broad outline of the Parties' intent to enter into specific agreements for 

collaborative efforts in aJTeaS ofmutual interest to FDA, FNS, AMS, and FSA All activities 

undertaken pursuant to the MOU are subject to the availability ofpersonnel, resources and funds_ 

This MOU does not affect or supersede any existing or future agreements or arrangements 

among the Parties and does not affect the ability ofthe Parties to enter into other agreements or 

arrangements related to this MOU. This MOU will be subject to the applicable statutes, 

regulations and policies affecting FDA, FNS, AMS, and FSA. 

VI, LIAISON OFFICES AND CONTACTS FOR PARTIES 

Recall Operations Staff, 

Division of Compliance.Management and Operations 

Office ofEnforcement 

Office ofRegulatory Affairs 

Food and Drug Administration 

10903 New Hampshire Avenue 

BLDG 32, Room 4353 

Silver Spring, MD 20993 

Office ofCrisis Management 

Office of Emergency Operations 

Food and Drug Administration 

10903 New Hampshire Avenue 

Bldg32 

Silver Spring, MD 20993 

1-866-3004374 (24 hours) 

USDAFNS 

U.S. Department ofAgriculture 

Food and Nutrition Service 

Office ofFood Safety 

3101 Park Center Drive 

Room628 

Alexandria, VA 22302 

USDAAMS 

U.S. Department ofAgriculture 

Agricultural Marketirrg Service 

Fruit and Vegetable Programs 

5 

Page 29 of35 
1400 Independence Ave., S.W. 

Stop2632 

Washington, DC 20250-2632 

USDAAMS 

U.S. Department of Agriculture 

Agricultural Marketing Service 

Poultry Programs 

1400 Independence Ave., S.W. 

Stop 0256 

Washlngton, DC 20250-0256 

USDA AMS 

U.S. Department ofAgriculture 

Agricultural Marketing Service 

Livestock and Seed Programs 

1400 Independence Ave., S.W. 

Stop 0249 

Washington, DC 20250-0249 

USDA FSA 

U.S. Department of Agriculture 

Farm Service Agency 

Deputy Administrator, Commodity Operations 

Stop 0550 

1400 Independence Ave., S.W. 

Washington, DC 20250-0550 

VIl. EFFECI'IVEDATE, DURATION, TERMJNATION AND MODIFICATION 

This MOU shall become effective upon signature ofall Parties and will continue in effect for a 

period offive years. It will be evaluated after it bas been in effect for one year, at which time the 

agencies agree to explore the feasibility of expanding cooperative activities. TheMOU may be 

extended or modified by mutual written agreement ofthe Parties. The MOU may be terminated 

upon a 30-day advance notice by any of the Parties. 

6 

Page 30 of35 
VIII. SIGNATURES OF RESPONSIBLE PARTIES 

APPROVED AND ACCEPTED FOR TilE FOOD AND DRUG ADMlNISTRATION 

Date: September 16 . 20 l l 

Margaret A. Hamburg, M.D. 

<;ommissionerofFood and Drugs 

DHHS Food and Drug Administra1ion 

APPROVED AND ACCEPTED FOR THE AGRICULTURAL MARKETING SERVICE 

By~~ Jgll8.tureofaUthorizedprcsentative 

David R Shipman 

Acting Administrator 

USDA Agricultural Marketing Service 

APPROVED AND ACCEPTED FOR TTiE FOOD AND NUTRITION SERVICE 

Audrey Ro~ 

Administrator 

USDA Food and Nutrition Service 

7 

Page 31 of35 
APPROVED AND ACCEPTED FOR THE FARM SERVICE AGENCY 

By: --.L./Jf{fct""--~~;;_:;__ . __ Date:

Signature of authorized representative 

Bruce Nelson 

Administrator 

USDA Farm Service Agency 

8 

Page 32 of35 
APPENDIX A 

List of Foods Procured by USDA Agencies 

Additions and deletions to the list ofUSDA Foods purchasedfor use in USDA domestic nutrition 

assistance programs may be modifiedat ,any time without notice and shall not require a 

modification to this agreement. Please refer to the Agency website for a complete list of 

available products. 

A. Agricultural Marketing Service, Group A Co=oclities 

The AMS, Poultry Programs, Co=odity Procurement Division acts as the purohasing agent for 

the following perishable foods that are distributed through FNS administered programs. 

Commodity Procurement Division 

Telephone: 202/720-4517 

btlJl://www.ams.usda.gov/AMSv1. 0/CommodityPurchasing 

Almonds 

Canned and frozen apples, including juice 

Canned and frozen apricots 

Canned and frozen asparagus 

Canned and dry beans 

Canned and frozen green beans 

Frozen blackberries 

Dried and frozen blueberries 

Canned, fresh and frozen carrots 

Canned, frozen and dried cherries, including cherry/apple juice 

Canned and frozen corn 

Bottled com syrup 

Canned, frozen and dried cranber.ry products, including cranberry/apple juice 

Dried dates 

Dried fruit nut mix 

Dried figs 

Canned grape juice 

Canned grapefruit juice 

Canned mixed fruit 

Canned mixed vegetables 

Fresh oranges, including canned and concentrated orange juice 

Canned and frozen peaches 

Canned and fresh pears 

Canned and frozen peas 

9 

Page 33 of35 
Dried and.canned plums 

Canned, dehydrated, fresh and frozen potatoes 

Canned pumpkin 

Dried raisins 

Frozen raspberries 

Canned spinach 

Frozen strawberries 

Canned, fresh and frozen sweet potatoes 

Canned and fresh tomato products, including juice 

Canned vegetable soup 

Walnuts 

Fresh, frozen, cooked and canned beef products 

F_roren, cooked and canned pork products 

Frozen and canned bison products 

Canned, .frozen and pouch salmon prodads 

Canned and pouch tuna products 

Frozen and cooked catfish products 

Frozen lamb products 

Fresh, frozen and canned chicken products 

Fresh, frozen and canned turkey products 

Frozen geese products 

Frozen egg products 

fresh Shell eggs 

Bulk whole eggs 

Dried egg mix 

B. Farm Service Agency, Group B Commodities 

The Domestic Procurement Division 

Telephone; 816-926-6124 

http://www.fsa. usda. gov/FSA/webapp?area=homc&subject--coop&topic=pas 

Bakery Flour Sunflower Seed Products 

Bakery Mix Rice Products 

Com Products Vegetable Oil Products 

Crackers Bulk Chedd.ir Cheese 

Fortified Ready-to-Eat Cereal Moz:z.arella Cheese 

Instant Rice Cereal Process Cheese 

Processed Cereals Evaporated Milk 

Macaroni & Cheese Infant Fonnula 

Pasta Products Ultra High Temperature Milk 

Wheat Flour Jnstant Nonfat Dry Milk 

Peanut Products 

10 

Page 34 of35 
APPENDIXB 

Process for Wormation Sharing 

While recognizing that the overall purpose oftbis MOU is to facilitate information sharing, 

pursuant to Section 4 ofthis MOU, any .Federal partner may decide not to sh.are 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 jn the process described below 

changes Section 4. 

When. under the current MOU, staff at the FDA or the appmpriate USDA agency 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 ofthe infoonation requested may 

be helpful, it would not be required for pwposes 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-AMS-FSA-FNS 

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 ofthis statement, requestors would not have to 

use a particular format or include oilier pre-specified text. 

A response to a request should also be in writing, but it, too, can be an informal email that 

acknowledges transmission ofinformation in response to the request. Although identifying each 

piece ofinformation/document provided may be helpful, it would not be required for putposes of 

responding to a request. However, the following language should be included in the response: 

"J>ursuant to the FDA-AMS-FSA-FNS Memonmdwn of1Jnderstanding, 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 lawwith 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. 

11 

Page35 of35