MEMORANDUM OF UNDERSTANDING 

BETWEEN THE 

FOOD SAFETY AND INSPECTION SERVICE 

AND THE 

UNITED STATES DEPARTMENT OF AGRICULTURE 

ANIMAL AND PLANT HEALTH INSPECTION SERVICE 

VETERINARY SERVICES 

ARTICLE 1 - PURPOSE 

This Memorandum ofUnderstanding (MOU) documents the procedures and responsibilities 

under the collaborative effort between the Animal and Plant Health Inspection Service (APHIS) 

and the Food Safety and Inspection Service (FSIS) in assessing root cause in outbreaks of 

foodbome illness in humans. 

ARTICLE 2 - BACKGROUND 

Assessments ofdisease occurrence, regardless ofthe disease etiology, encompass a range of 

activities including but not limited to definition ofscope, observational study design, 

questionnaire development, collection of data and samples, and statistical analysis and reporting. 

FSIS foodbome-related illness investigations are multifaceted, multidisciplinary undertakings 

that involve collecting and analyzing data from epidemiological, laboratory, and environmental 

assessments (see PSIS Directive 8080.3). 

ARTICLE 3 - MUTUAL RESPONSIBILITIES 

FSIS and APHIS mutually understand that: 

1. This MOU in no way restricts APHIS or FSIS from participating in similar activities with 

other public or private agencies, organizations, and individuals. 

2. This MOU is neither a fiscal nor a funds obligation document. Any endeavor involving 

reimbursement or contribution funds between the parties to this instrument will be 

handled in accordance with applicable laws, regulations, and procedures, including those 

for government procurement and printing. Such endeavors will be outlined in separate 

agreements that shall be made in writing by representatives ofthe parties and 

independently authorized by appropriate statutory authority. Signing this instrument does 

not provide or create such authority. 

3. Approval ofFSIS and VS staff participation on foodbome-related illness root cause 

assessment teams and of information disclosure practices will be in accordance with 

existing VS protocols and FSIS Emergency Management Committee guidance. 

4. If an outbreak is ongoing when a root cause assessment is initiated, the assessment team 

may want to provide frequent, descriptive updates on the outbreak, including specific 

findings and actions being taken. In these situations, information may be disseminated to 
VS and FSlS public health partners, including the Centers for Disease Control and 

Prevention, the Food and Drug Administration, State Departments ofHealth, or FSIS 

product consumers. 

5. Once the root cause assessment is complete and the outbreak is controlled there may be 

opportunities to do further detailed root cause and statistical analyses. The analyses could 

help FSIS and VS better understand factors associated with the outbreak. A better 

understanding ofthe root cause processes will help identify options for preventing or 

controlling future outbreaks. These detailed evaluations will be disseminated to producers 

and plant owners (as appropriate) and broadly to the industry to effect changes in 

production. The evaluations would also likely be submitted for peer review in 

professional journals. VS and FSIS will collaborate in writing the evaluations to provide 

appropriate perspective. This will also docwnent the methods and procedures for root 

cause assessment collaborations between the two Agencies. 

~ The Agencies mutually agree that ifpractices that endanger the health ofthe public are 

identified during an APHIS investigation, the producer may be informed as expeditiously 

as possible that cessation ofsuch practices might mitigate the food safety issue. The 

decision to share such information with the producers in question will be made jointly by 

the Agencies. 

7. The Agencies mutually agree that the information and data obtained, produced, 

maintained during, or derived from root cause assessments and as a pa1i offoodbomerelated illness investigations, criminal investigation, or other authorized regulatory 

activity, will be protected against tmauthorized use, disclosure, or release. This includes 

implementing proper safeguards and procedures consistent with MOU 225-12-007 to, at a 

minimum, prevent unauthorized use and disclosure ofthis information; limit access to 

this information and data to employees, agents, and officials of the Agencies who require 

access to such information and data to perform their official duties; and prevent the use, 

disclosure, or release of any information and data protected by law, including the Trade 

Secrets Act [18 U.S.C. 1905 et seq.), the Privacy Act of 1974, as amended [5 U.S.C. 552a 

et seq. ], the Freedom oflnfom1a6on Act [5 U.S.C. 552 et seq. ], the Food Security Act of 

1985 [7 U.S.C. 2276 et seq.], and Section 1619 ofthe Food, Conservation, and Energy 

Act of2008 [7 U.S.C. 8791]. Moreover, the Agencies agree, consistent with MOU 225-

12-007, to promptly notify each other of any requests for this information and data and of 

any actual or suspected unauthorized release, disclosure, or use ofthis information and 

data. 

ARTICLE 4 - FSIS RESPONSIBILITIES 

FSIS agrees to designate the Applied Epidemiology StaffDirector as its authorized 

representative. This individual will be responsible for collaboratively administering the activities 

conducted under this MOU. 

FSIS furthermore agrees to: 

1. Submit request to the FSIS Emergency Management Committee (EMC), per Directive 

5500.2, for consideration and approval for collaboration with APHIS-VS. 

2. Route for review routine requests for coordination in assessing root causes offoodborne2 
related rnnesses to the VS Chief Epidemiologist in accordance with established VS 

protocols. 

3. Make requests requiring an immediate decision on implementation ofthe MOU (within 

48 hours) to the APHIS VS Deputy Administrator (or his designee). 

4. Follow procedures detailed in FSIS Directives (see Table I). 

5. Give VS a summary ofthe foodbome-related illness cluster or outbreak: and a statement 

ofrequest to include the relative urgency and priority needed for action. 

ARTICLE 5 - STATEMENT OFNO FINANCIAL OBLIGATION 

Signing this MOU does not place FSIS under any financial obligation. Each signatory party is to 

use and manage its own funds in cruTying out the purpose ofthis MOU. This MOU does not 

authorize transfers offunds or items ofvalue. 

ARTICLE 6 -APHIS RESPONSIBILITIES 

APIDS agrees to designate the VS ChiefEpidemiologist as its authorized representative. This 

individual is responsible for collaboratively administering the activities conducted under this 

MOU. 

APHIS furthermore agrees to: 

1. Review FSIS requests for coordination in assessing root causes offoodbome-related 

illnesses (by conducting an epidemiological investigation) with reference to making 

findings that allow decision makers and producers to make science-based decisions on 

intervention or mitigation strategies. 

2. Review FSIS requests for coordination in assessing root causes offood borne-related 

illnesses in light of FSIS and VS authorities, potential costs and benefits, and resource 

availability to conduct root cause assessments. 

3. Provide details of the request to senior VS leadership. The urgency ofa needed decision 

will determine the appropriate level of VS review. 

A. Make requests requiring an immediate decision to implement the MOU (within 48 

homs) to the Assistant Administrator for the Office ofPublic Health Science, FSIS. 

B. Requests not requiring an immediate decision will be sent to the VS Leadership Team 

for assessment within 5 business days. 

4. Communicate the VS senior leadership decision to trigger an assessment or the rationale 

behind not proceeding with the assessment to FSIS before any assessment activity occurs. 

5. Determine the size and required expertise ofthe team to conduct the APHIS investigation 

depending on the specific situation and scope ofthe assessment requested. VS, in 

consultation with FSIS, will also determine specific skills required to meet the 

assessment objectives. Assessments conducted at the field level will use local personnel 

whenever possible. Teams may also include FSIS staff as collaborators. 

6. Determine the deployment ofteam members based on the assessment objectives. In many 

cases local staff selected as team members may be able to conduct the on-the-ground 

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assessment with help from other team members occurring remotely. Some assessments 

may rely solely on remote assistance. In some cases a full assessment team consisting of 

epidemiologists, laboratory personnel, field veterinary medical officers, and others may 

be deployed to conduct an assessment. Funding of assessment team deployment will be 

determined at the time of team assembly. 

7. Acquire voluntary participation and collaboration in its epidemiological investigation 

with individual producers or companies associated with the outbreak in question to 

identify on-farm risk factors for disease occurrence or spread that could be controlled or 

mitigated by some intervention in current or future situations. The size, scope, and 

complexity ofthe assessment will affect the timing, format, and venue for 

communicating results. 

8. Summarize and disseminate the results ofthe assessment in ways that provide flexibility 

in communicating among investigators, decision makers, and producers participating in 

the assessment. 

ARTICLE 7 - STATEMENT OF NO FINANCIAL OBLIGATION 

Signing this MOU does not place APHJS under any financial obligation. Each signatory party is 

to use and manage its own funds in carrying out the purpose ofthis MOU. This MOU does not 

authorize transfers offunds or items of value. 

ARTICLE 8 - LIMITATIONS OF COMMITMENT 

This MOU and any continuation thereof shall be contingent on the availability offunds 

appropriated by the Congress ofthe United States. The parties understand and agree that any 

monies allocated for purposes covered by this MOU shall be expended in accordance with its 

terms and the manner prescribed by the fiscal regulations and/or administrative policies ofthe 

party making the funds available. Transfer offiscal resources will require a separate agreement 

by the parties. 

ARTICLE 9 - CONGRESSIONAL RESTRICTION 

Under 41 USC 22, no member of, or delegate to, Congress shall be admitted to any share or part 

ofthe MOU or to any benefit to arise therefrom. 

ARTICLE 10 - AMENDMENTS 

This MOU may be amended at any time by mutual agreement ofthe parties in writing. 

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ARTICLE 11-TERMINATION 

This MOU may be terminated by either party on 60 days written notice to the other party. 

ARTICLE 12 -EFFECTIVE DATE AND DURATION 

This MOU shall become effective upon the date of signature by both parties and shall continue 

indefinitely. It may be modified or discontinued at the request ofeither party on 60 days written 

notice to the other party. 

UNITED STATES DEPARTMENT OF AGRICULTURE 

FOOD SAFETY AND INSPECTION SERVICE 

Date 

UNITED STATES DEPARTMENT OF AGRICULTURE 

ANIMAL AND PLANT HEAL TH INSPECTION SERVICE 

Date Administrator 

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Table 1: FSIS and APIDS Roles and Responsibilities 

FSJS Foodborne-Related Illness 

Investigation Roles and 

Responsibilities 

Outbreak Assessment Stage APHIS Epidemiological 

Investigation Roles and 

Responsibilities 

Applied Epidemiology Staffofthe 

Office ofPublic Health Science 

coordinates investigation of 

foodborne-related illness in 

accordance with PSIS Directive 

8080.3. 

Compliance Investigation Division 

ofthe Office ofProgram Evaluation, 

Enforcement, and Review manages 

investigations in accordance with 

FSIS Directive 80 I 0.2. 

Detection offoodbome-related 

illness outbreak resulting in 

traceback to FSIS-regulated product 

None. 

Recall Management and Technical 

Analysis Staff coordinates recall of 

adulterated and mislabeled product 

in accordance with PSIS Directive 

8080.1. 

Product recall. None. 

FSIS will conduct Incident 

Investigation Team Reviews in 

accordance with FSIS Directive 

6500.2. 

The Office ofField Operations will 

conduct Food Safety Assessments in 

accordance with FSIS Directive 

5100.1. 

The Applied Epidemiology Staff 

(AES) ofthe Office ofPublic Health 

Science identifies triggers to share 

data and request APHIS assistance. 

Plant and product specific data 

analysis. 

Participation on investigation 

working group teleconferences as 

appropriate for situational awareness 

when potential preharvest link is 

suspected. 

Consultation. 

Collaboration on questionnaires and 

collection ofdata. 

OPHS submits the request to the 

FSIS Emergency Management 

Council (EMC) per FSIS Directive 

5500.2 for consideration. 

Upon FSJS approval request for 

collaboration is forwarded to 

APHIS-VS. 

Identification of potential 

production-level link for source of 

contamination. 

Participation on investigation 

working group teleconferences as 

appropriate for situational awareness 

when potential preharvest link is 

suspected. 

Consultation. 

Review ofrequest and decision to 

commit resources 

Independent FSIS investigation. 

Tbe EMC pursues independent 

investigation per FSIS Directive 

5500.2. 

Upon EMC conclusion, decision for 

independent FSIS investigation is 

forwarded to APHIS-VS. 

On-farm/production level 

assessment. 

Solicits industry/producer 

participation. 

Leads data acquisition and analysis. 

Joint for public statements and press 

releases. 

Reporting. Joint for public statements and press 

releases. 

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