MOU Number 225-20-019

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MEMORANDUM OF UNDERSTANDING

BETWEEN THE

FOOD SAFETY AND INSPECTION SERVICE

UNITED STATES DEPARTMENT OF AGRICULTURE

AND THE

FOOD AND DRUG ADMINISTRATION

UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES

This agreement is entered into by the Food and Drug Administration (the FDA), United States 

Department of Health and Human Services (HHS) and the Food Safety and Inspection Service 

(FSIS), United States Department of Agriculture (USDA) (individually referred to as “Agency” 

and collectively referred to as “Agencies”). 

I. Purpose 

The purpose of this Memorandum of Understanding (MOU) is to facilitate the exchange of 

information about dual jurisdiction establishments and operations (hereinafter referred to as 

"DJEs"). These establishments are subject to the jurisdiction of both Agencies. The DJEs under 

this MOU are limited to human food operations and exclude animal food operations, which are 

regulated by the FDA. This exchange of information will permit more efficient use of resources 

and will contribute to improved public health protection.

II. Authority

FSIS is responsible for implementing 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 

product processing plants. FSIS also conducts inspections of warehouses, transporters, retail 

stores, restaurants, and 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.).

The FDA is responsible for implementing and enforcing the Federal Food, Drug, and Cosmetic 

Act (FD&C 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, the FDA conducts 

inspections of establishments that manufacture, process, pack, or hold foods, with the exception 

of certain establishments that are regulated exclusively by FSIS. The 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 and the 

FDA under their statutory authorities.
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III. Background

In February 2014, the Agricultural Act of 2014 (2014 Farm Bill) directed USDA to execute a 

MOU1 with the FDA for the following purposes: 

1. To improve interagency cooperation on food safety and fraud prevention, building upon 

any other prior agreements.

2. To maximize the effectiveness of limited personnel and resources by ensuring that:

a. Inspections conducted by FSIS satisfy requirements under the FD&C Act.

b. Inspections of shipments and processing facilities for fish of the order 

Siluriformes are not duplicative; and 

c. Any information resulting from examination, testing, and inspections conducted is 

considered in making risk-based determinations, including the establishment of 

inspection priorities. 

As a result, MOU 225-14-0009 was signed between the Agencies on April 30, 2014. Both 

agencies agree that the transition of regulatory oversight of Siluriformes outlined in that 

agreement has been completed. This MOU supersedes and replaces it.

In January 2018, the FDA and FSIS announced a formal agreement to make the oversight of 

food more efficient and effective by bolstering coordination between the two Agencies. That 

agreement outlined efforts to increase interagency collaboration and coordination on areas of 

mutual interest in order to achieve improved regulatory efficiency and effectiveness. 

The Agencies determined that changes in inspectional activities, available resources, and food 

safety hazards necessitate updating this MOU, intended to facilitate the exchange of information 

between the Agencies about DJEs. Therefore, the FDA and FSIS have updated this MOU to 

address current public health needs.

IV. Substance of Agreement

The Agencies will exchange information relevant to the other Agency’s inspection of 

establishments under dual-jurisdiction. The Agencies will also share relevant information about 

facilities that hold or distribute human food products regulated by both Agencies, but which are 

not considered DJEs for the purpose of this MOU.

Each Agency agrees to notify the other Agency of the following findings in a DJE

inspection:

1. The finding of foods involved in outbreaks of foodborne illness, injuries, or adverse 

health consequences.

1 The 2014 MOU was a result of the May 1997 Report to the President entitled, “Food Safety from Farm to Table –

A National Food Safety Initiative,” that recommended increased cooperation among agencies responsible for food 

safety. 
MOU Number 225-20-019

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2. The finding of adulterated or mislabeled foods such that there is a reasonable probability 

that the use of or exposure to such products will cause serious adverse health 

consequences.2

3. A processing condition or failure that is likely to result in food contamination leading to 

outbreaks of foodborne illness or serious adverse health consequences.

4. Significant findings in the facility of insanitary conditions such as rodent infestation.

5. Microbiological or other sampling findings in DJEs or products which may provide 

information about sanitary conditions in those establishments or indicate serious adverse 

health consequence of products under either Agency’s jurisdiction. These results will 

include microbe characteristics (e.g., serotype, whole genome sequence, antimicrobial 

resistance profile, etc.) where applicable, and other information related to categorizing 

and tracking pathogens. 

6. The initiation of a recall at a DJE. 

7. Reports of tampering or threats of tampering.

8. A food handler diagnosed as having a communicable disease that is likely to result in 

food contamination or outbreaks of foodborne illness (e.g., hepatitis).

9. 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 or packed in the DJE.

10. Convictions of an establishment preparing, packing, holding, or otherwise handling meat, 

poultry or egg products solely under state regulation and foods regulated by the 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 or packed in the 

establishment.

Both Agencies will also:

1. Develop, maintain, share, and annually update a list of DJEs including establishment 

name, applicable Agency identification number, and establishment address. These 

establishments are limited to those that prepare or pack foods regulated by both Agencies. 

This list, which will be updated yearly, will be organized by state and territory, and 

distributed to the field and headquarters contacts of both Agencies. When updating this 

list, each Agency agrees to identify all DJEs under its jurisdiction, and remove those that 

have discontinued operations.

2. Develop, maintain, share, and annually update a list of field and headquarters contacts

designated for the purpose of this MOU. This list will also include the offices 

responsible for each state and territory. In addition to the annual updates to this list, each 

Agency agrees to promptly inform its counterpart of any changes.

2 The following hazards constitute adulteration or mislabeling: pathogenic organisms; foreign materials; undeclared 

allergens in human food (e.g., peanuts, peanut butter, peanut flour, hydrolyzed peanut protein, pecans, walnuts, 

hazelnuts, filberts, cashews, Brazil nuts, eggs, egg whites, egg yolk, egg albumen, powdered eggs, shrimp, crab, 

crayfish, lobster, oysters, clams, scallops, mussels, almonds, pistachios, cow milk, cream, dry milk, whey, other 

proteins from cow's milk, soy, soybeans, soy protein, soy flour, fish, wheat); undeclared color additives (e.g. FD&C 

Yellow No. 5 and FD&C Yellow No. 6); and undeclared sulfites.
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The FDA will:

1. Notify the FSIS field and headquarters level designees when:

a. Any processing condition is observed in a DJE that could render foods bearing a 

USDA mark of mandatory or voluntary inspection adulterated or mislabeled.

b. There is reason to believe that an FDA-regulated ingredient sent to or received by 

an FSIS-regulated establishment could adulterate a meat, poultry, or egg product 

if used in it.

2. Notify the appropriate FSIS liaison contact prior to conducting an inspection of a DJE 

that is not under continuous FSIS inspection. 

3. Notify and invite the FSIS inspector to accompany the FDA investigator prior to 

inspecting a DJE that is under continuous inspection.

FSIS will: 

Notify the FDA field and headquarters level designees of an FSIS action to withhold the 

mark of inspection or to suspend or withdraw the grant of inspection at a DJE.

V. Information Sharing

Proper safeguards must be used to protect against unauthorized use and disclosure of the nonpublic information exchanged under this MOU. Proper safeguards shall include the use 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 [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], any other applicable Federal law and regulations implementing it. 

Pursuant to FD&C Act section 301(j) [21 U.S.C. 331(j)], the FDA will not reveal to FSIS any 

method or process which is entitled to protection as a trade secret. Either Agency may decide 

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

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

Process for Information Sharing under Appendix A.

Access to the non-public information shared under this MOU shall be restricted to the FDA and 

FSIS authorized employees, agents, and officials who require access to perform their official 

duties in accordance with the uses of the information as authorized in this MOU. It may not be 

further disclosed or shared in any manner without the express written consent of the originating 

Agency. In cases where further disclosure may be required by law, the FDA and/or FSIS will 

respond promptly to a request seeking such permission. For example, the requesting party will 

notify the sharing party before responding to any judicial order that compels the release of shared 

non-public information, so that the parties may determine the appropriate measures to take, 

including, where appropriate, legal action. Employees, agents and officials 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. 

If an Agency that has received information under this MOU receives a Freedom of Information 

Act (FOIA) request for which there are responsive records that originated with the other Agency, 
MOU Number 225-20-019

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to the extent practicable, it will refer that request to the other Agency for it to respond directly to 

the requestor regarding the release of the information. In such cases, the Agency making the 

referral will notify the requestor that a referral has been made and that a response will issue 

directly from the other Agency.

VI. General Provisions

The provisions of this MOU are not intended to add to, nor detract from, any of the statutory 

authorities of each Agency or the regulations promulgated by each Agency under such 

authorities. Each Agency reserves the authority to review, independently of the other, matters of 

concern to their respective authorities.

VII. Previous Agreements

This version supersedes the earlier MOU 225-99-2001.

This agreement supersedes MOU 225-14-0009, related to examination and inspection of 

Siluriformes fish and fish products, signed by the Agencies on April 30, 2014. 

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

VIII. Liaison Officers

All notices and other communication must be in writing and may be by personal delivery, 

registered or certified United States mail, electronic mail, facsimile, to the other Agency

as provided below. Notices will be deemed delivered upon receipt. 

FSIS

Lisa Volk

Program Manager

Office of Field Operations

Food Safety and Inspection Service, USDA

Room 3153 South Building

Washington, DC 20250

Phone: (202) 720-4863

Lisa.volk@usda.gov

FDA

Martha Myrick

Program Expert

Office of Regulatory Affairs

Divisions of Domestic Human and Animal Foods Operation Branch

Phone: (240) 402-5840

martha.myrick@fda.hhs.gov
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IX. Term, Termination, and Modification: 

This agreement is effective upon signing by both Agencies and shall remain in effect from the 

latest signature date unless modified or terminated. This MOU will continue in effect unless 

modified or terminated by mutual written consent of the Agencies upon a 30-day advance written 

concurrence to the other Agency. The Agencies agree that they will review this MOU every five 

years to determine whether it should be modified or terminated.

IN WITNESS WHEREOF, the Agencies hereto have executed this MOU as follows:

Food Safety and Inspection Service, United States Department of Agriculture

______________________________ _______________ 

Food Safety and Inspection Service Date

1400 Independence Ave., S.W.

Washington, D.C. 20250-3700 

 

Food and Drug Administration, United States Department of Health and Human Services 

______________________________ ____7/26/2021___________ 

Food and Drug Administration Date

10903 New Hampshire Avenue

Silver Spring, MD 20993

07/28/2021
MOU Number 225-20-019

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APPENDIX A

Process for Information Sharing

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

and Drug Administration (FDA) and the Food Safety and Inspection Service (FSIS), either 

Agency “may decide not to share information or expertise in response to a particular request for 

information made according to the procedures established under Section IV, or to limit the scope 

of information and expertise sharing in response to a particular request.” Nothing in the process 

described below changes Section V.

When, under the current MOU, authorized FDA and FSIS employees, agents, and officials who 

require access to perform their official duties request from the other Agency information that 

may contain non-public material, the request should be in writing, which includes an informal 

email, and need only identify the subject for which information is requested. Although a more 

specific description of the information asked for may be helpful, it would not be required for 

purposes of making a request. However, the following language should be included in the 

request:

"Information that is shared under this request will be under the FDA-FSIS MOU. We agree not 

to disclose any shared information in any manner without your express prior written permission.”

With the inclusion of this statement, requestors would not have to use a particular format or 

include other pre-specified text.

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

acknowledges transmission of information in response to the request. Although identifying each 

piece of information/document provided may be helpful, it would not be required for purposes of 

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

"Pursuant to the FDA-FSIS Memorandum of Understanding, this communication may 

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

not be disclosed or shared in any manner without our express prior written consent.” 

With the inclusion of this statement, responders would not have to use a particular format or 

include other pre-specified text.