MEMORANDUM OF UNDERSTANDING 

BETWEEN THE 

UNITED STATES DEPARTMENT OF AGRICULTURE 

FOOD SAFETY AND INSPECTION SERVICE (FSIS) 

AND THE 

UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES 

CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) 

NATIONAL CENTER FOR EMERGING AND ZOONOTIC INFECTIOUS DISEASES 

(NCEZID) 

NATIONAL CENTER FOR ENVIRONMENTAL HEALTH (NCEH) AND 

AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY (ATSDR) 

REGARDING 

FOODBORNE HEALTH HAZARDS ASSESSMENTS ASSOCIATED 

WITH FSIS-REGULATED PRODUCT 

ARTICLE 1 - PURPOSE AND BACKGROUND 

The purpose ofthis memorandum of understanding is to define expectations related to 

interagency assessments offoodborne health hazards potentially associated with PSIS-regulated 

products, meat, poultry, and egg products. This memorandum of understanding will expand PSIS 

and CDC/ ATSDR collaborative One Health efforts by providing a more comprehensive and 

multidisciplinary approach to health hazard assessments, including assessments ofPSISregulated establishments associated with or potentially associated with foodborne illness. 

CDC/ATSDR and PSIS currently collaborate on assessments of health hazards associated with 

PSIS-regulated products. The agencies more commonly collaborate on foodborne illness cluster 

and outbreak investigations which can include food tracebacks, assessments ofPSIS-regulated 

establishments, and food recalls and associated alerts to consumers about food products that may 

be the source of infections. In response to the identification of an illness cluster or outbreak, or 

an environmental hazard, CDC, ATSDR, state, and local health departments collect exposure 

histories from case-patients, generate hypotheses regarding the source ofthe illnesses, and 

perform epidemiological studies to test hypotheses and identify statistical association of illness 

with a food vehicle or other source. PSIS supports hypothesis-generation by reviewing current 

and historical compliance and food testing data. PSIS ensures case-patient interview questions 

are designed to capture data and information that will aid in traceback investigations and support 

regulatory actions. PSIS and state and local agencies lead on food tracebacks, collections of 

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investigative food and environmental samples for testing, and on-site environmental assessments 

at food establishments. The various investigative activities often are performed as soon as 

possible and in parallel. Epidemiological, laboratory, traceback, and other data along with 

findings from on-site assessments provide evidence to support a conclusion ofthat product is 

implicated in causing illnesses. This memorandum of understanding does not modify existing 

interagency collaborative work described abo.ve, but instead focuses on the engagement ofCDC/ 

ATSDR personnel in select regulatory, environmental, and health hazard assessments, including 

those undertaken at FSIS-regulated establishments as part of foodborne illness investigations. 

Over the last two decades, CDC participated in a small number ofthe FSIS-led establishment 

assessments. The intent ofthis memorandum of understanding is to enhance opportunities for 

CDC/ATSDR to participate in FSIS-led in-plant assessments ofFSIS-regulated establishments 

and in other health hazard assessments. As part of the assessment team, CDC/ATSDR 

epidemiologists, environmental health scientists, and other subject matter experts will be able to 

leverage their expertise. CDC/ ATSDR personnel can aid in the interpretation of data and 

findings in light of epidemiological and other data and help in the identification of environmental 

antecedents and a root cause ofthe contamination event. It is expected that CDC/ ATSDR would 

not patiicipate in all FSIS assessments, but rather a smaller number of assessments where 

CDC/ATSDR expetiise would enhance the assessment. This memorandum of understanding 

outlines FSIS, CDC, and ATSDR mutual roles and responsibilities for the training of personnel 

and the planning for and conduct of interagency assessments at PSIS-regulated establishments as 

part offoodborne illness investigations and other health hazard assessments. 

ARTICLE 2 - DEFINITIONS 

FSIS-regulated establishment - An establishment producing a meat, poultry, or egg product 

under FSIS inspection. A federal grant of inspection is issued by FSIS to an establishment 

provided they have a· suitable facility and, for meat and poultry establishments, operate under a 

Hazard Analysis and Critical Control Point (HACCP) food safety plan and sanitation standard 

operating procedures. The slaughter of food animals and processing of food products that are 

amenable to the Federal Meat Inspection Act, Poultry Products Inspection Act, or Egg Products 

Inspection Act and applicable FSIS regulations must be performed under FSIS inspection or 

under an equivalent state inspection program. 

Assessment - a systematic evaluation ofthe nature, quality, or ability of someone or something, 

including a review of available data and information. The assessment may follow established 

methodologies, such as FSIS incident investigation team or health hazard evaluation board 

methodologies, and includes the efficient organization, collection, analysis, and reporting of data 

and information. A food safety assessment is more detailed than a routine inspection and focuses 

on conditions in the establishment, including use of a hazardous substance potentially or known 

to be in a food item or at a site, and may include an evaluation as to whether exposure to the 

substance might cause any harm to people. A food safety assessment aims to fill data and 

information gaps and identify environmental. antecedents and a root cause ofthe contamination 

event. Multi-disciplinary assessment teams have expertise in ensuring evidence chain-ofcustody, analysis ofrecords and data, interviewing, selecting and collecting samples for 

laboratory analysis. They maintain contact and coordinate activities with agency officials who 

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are not a part ofthe assessment team. The teams review microbial testing and other data to assess 

probable causes of food safety failures and where it would be most useful to take samples. They 

also communicate findings and make recommendations to industry and agency officials. 

Environmental antecedents - significant events in the food facility environment that preceded 

the contamination event. 

Illness cluster - a noted group of illnesses often detected through laboratory-based surveillance, 

' such as PulseNet, or through a consumer complaint, which are defined by time and/or place and 

not yet determined to be associated with a common exposure. 

Outbreak - two or more cases of similar illness associated with a common exposure. 

Hazard - A dangerous phenomenon, substance, human activity, or condition that may cause loss 

of life, injury or other health impacts, property damage, loss of livelihoods and services, social 

and economic disruption, or environmental damage. A health hazard is a hazard that may impact 

human health. A food safety hazard is any biological, chemical, or physical property that may 

cause a food to be unsafe for human consumption. Biological hazards are infectious agents 

(including living organisms and prion proteins) that can make food unsafe to eat. Chemical 

hazards can be either naturally-occurring or added. Physical hazards are extraneous materials 

that are not expected in a food and may cause illness or injury. 

Investigation - a formal or systematic examination or inquiry into an event or incident. The term 

"incident investigation" refers to the investigation into any type of incident, whereas the term 

"foodborne illness cluster" or "outbreak" defines a type of incident. Traceback investigation and 

environmental investigation are often activities that support or are components ofthe overall 

foodborne illness investigation. FSIS defines an investigation as a fact-gathering and analytical 

activity conducted to develop and document facts relevant to apparent violations, food safety 

incidents, or other allegations to support FSIS decisions, investigative findings, and enforcement 

or legal actions. 

ARTICLE 3 - FSIS ROLES AND RESPONSIBILITIES 

The Food Safety and Inspection Service (FSIS) is the public health agency in the U.S. 

Department ofAgriculture responsible for verifying that the nation's commercial supply of meat, 

poultry, and egg products is safe, secure, wholesome, and correctly labeled and packaged. As 

part ofthe FSIS role in protecting public health, FSIS may invite CDC/ ATSDR to participate in 

FSIS-led assessments of PSIS-regulated establishments. 

Training 

I. FSIS agrees to train CDC/ATSDRpersonnel on: 

• statutes that FSIS operates under, 

• regulations that the meat, poultry, and egg products industries must comply with, 

• what defines industry proprietary and commercial confidential information, 

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• current PSIS establishment assessment approaches, such as assessments by PSIS incident 

investigation teams, 

• current PSIS Health Hazard Evaluation Board procedures, and 

• how CDC/ATSDR personnel would operate on PSIS-led establishment assessment teams. 

IL PSIS agrees to train CDC/ATSDR identified personnel within 30 days from when the names 

are provided to PSIS. The training will be provided in a classroom'style setting in Atlanta, 

Georgia. 

III. PSIS recommends that CDC / ATS DR identify personnel for training who are seasoned 

professionals and are not in temporary or training positions, such as the Epidemic Intelligence 

Service program. 

IV. PSIS agrees to provide the trained .CDC/ATSDR personnel with an orientation session on 

regulatory and personal safety considerations at PSIS-regulated establishments in the Atlanta, 

Georgia commuting area within 60 days oftraining completion. 

V. The training and orientation will not exceed 5 days in length. 

VI. PSIS will only invite trained and oriented CDC/ATSDRpersonnel to participate on PSIS-led 

establishment assessment teams. PSIS may invite CDC/ATSDR to participate in or contribute to 

other assessments, such as those performed by convened PSIS Health Hazard Evaluation Boards. 

VIL PSIS agrees to provide the training and orientation of CDC/ATSDR personnel at no cost to 

CDC/ATSDR. PSIS will not fund CDC/ATSDR travel for training, orientation, or participation 

in PSIS on-site establishment or other assessments. 

Planning for Assessments 

I. PSIS will consider the inclusion oftrained CDC/ATSDR personnel in PSIS meetings 

convened to plan establishment assessments undertaken in response to foodborne illness clusters 

and outbreaks. 

IL PSIS may include CDC/ATSDR personnel in assessment planning meetings regardless of 

whether CDC/ ATSDR personnel will join the establishment assessment team or have undergone 

the PSIS training and orientation sessions. PSIS can also consider including CDC/ATSDR 

Epidemic Intelligence Service Officers in planning meetings. 

III. PSIS will consider having CDC/ ATSDR personnel join the establishment assessment team 

when the epidemiologic data is key evidence in support of product implication, and public health 

subject matter experts can aid in the identification of a root cause of and environmental 

antecedents to the adulteration event. The determinationofwhether epidemiologic data is key 

evidence may be made during a call between the two agencies. 

Assessments ofPSIS-Regulated Establishments 

I. PSIS agrees to consider the inclusion of trained and oriented CDC/ ATS DR personnel on 

PSIS-regulated establishment assessment teams. PSIS acknowledges that these CDC/ATSDR 

personnel will only be utilized on select assessment teams·and with the consent ofthe 

, establishment. 

II. PSIS will secure permission from CDC/ATSDR to share CDC/ATSDR-provided data, 

information, and interpretation before sharing with establishment management. When such 

permission has been obtained, it is preferable a CDC/ATSDR team member provide the data to 

establishment management. 

III. The PSIS assessment team leader will include the CDC/ ATSDR team members in all team 

meetings and communiques, to ensure that CDC/ ATSDR team member perspectives and 

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suggestions are given full consideration and to leverage CDC/ATSDR expertise during the 

assessment. The PSIS assessment team leader will try to include all team members in all 

meetings; however, the team leader has the discretion to assign team members to disparate tasks 

to assure the timely completion of the team's work. 

IV. PSIS will collaborate with CDC/ATSDR personnel on the development of an assessment 

report to be submitted to the National Voluntary Environmental Assessment Information System 

(NVEAIS) for establishment assessments which CDC/ATSDR participated in. 

ARTICLE 4 - CDC, NATIONAL CENTER FOR EMERGING AND ZOONOTIC 

INFECTIOUS DISEASES (NCEZID) ROLES AND RESPONSIBILITIES 

CDC is the nation's premier public health agency- working to ensure healthy people in a 

healthy world. The CDC National Center for Emerging and Zoonotic Infectious Diseases 

(NCEZID) works to prevent and control a broad range of infectious diseases through public 

leadership, partnerships, science, and systems. In carrying out these activities, NCEZID works 

collaboratively across CDC and with external partners to conduct, coordinate, support, and 

evaluate public health efforts to prevent and minimize morbidity and mortality due to infectious 

diseases, promoting a One Health approach involving the interface of animal, human, and 

environmental factors. 

Training 

I. CDC NCEZID agrees to identify CDC personnel to be trained and participate as part of FSISled assessment teams, recognizing the PSIS suggestion for seasoned professionals who are not in 

temporary or training positions. These personnel will be selected to represent specific skills and 

expertise that would be of most use to support the PSIS-led assessment team. 

II. CDC NCEZID will identify two individuals for training within 30 days of the start ofthis 

MOU and no more than 30 days after trained and oriented personnel are no longer available. 

III. CDC NCEZID will only send trained and oriented personnel to participate on PSIS-led 

assessment teams as non-regulatory team members. 

Planning for Assessments 

I. CDC NCEZID, upon invitation from PSIS management, will participate in PSIS meetings 

convened to plan assessments undertaken in response to foodborne health hazards, including 

those that result in illness clusters and outbreaks 

IL CDC staff can participate in assessment planning meetings regardless of whether CDC 

personnel will join the establishment assessment team in the field. 

III. CDC staff will participate in discussions with PSIS staff to make determinations ofwhether 

epidemiologic data is key evidence for an assessment. 

Assessments 

I. CDC NCEZID personnel who are deployed as part of PSIS-led assessment teams will work as 

an integral part ofthe team and as such will serve under the direction ofthe PSIS team leader for 

the duration of the deployment. Participation as part of the team may be virtual (via telephone or 

webinar) both prior to and after the deployment. 

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II. CDC NCEZID acknowledges that trained CDC personnel will only be utilized on select 

assessment teams. 

III. CDC NCEZID will promptly respond to PSIS requests to share the CDC-provided data, 

information, and interpretation with establishment management. NCEZID will make a CDC 

team member available to provide epidemiologic data to establishment management, when 

needed. 

ARTICLE 5 - CDC, NATIONAL CENTER FOR ENVIRONMENTAL HEALTH (NCEH) 

AND THE AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY (ATSDR) 

ROLES AND RESPONSIBILITIES 

CDC is the nation's premier public health agency- working to ensure healthy people in a 

healthy world. The CDC National Center for Environmental Health (NCEH) and the Agency for 

Toxic Substances and Disease Registry (ATSDR), plan, direct, and coordinate a national 

program to maintain and improve the health of the American people by promoting a healthy 

environment and by preventing premature death and avoidable illness and disability caused by 

environmental toxic exposures. NCEH and ATSDR assist domestic and international agencies 

and organizations to prepare for, and respond to natural, technologic, humanitarian, and 

terrorism-related environmental emergencies. 

Training 

I. CDC NCEH agrees to provide training in general environmental assessment techniques for 

food facilites involved in foodborne outbreaks through on-line e-training modules and possibly 

in-person training sessions with FSIS, together with an introduction to the National Voluntary 

Environmental Assessment Information System (NVEAIS). CDC/ATSDR will provide this 

training at no cost to PSIS but will not fund travel for PSIS personnel attending the training. 

II. CDC NCEH and ATSDR agree to receive training and orientation of their staff from PSIS 

trainers, and for orientation of CDC/ ATSDR personnel to PSIS-regulated establishments and 

outbreak responses. 

III. CDC NCEH and ATSDR will each identify two individuals for training within 30 days of 

the start ofthis MOU and no more than 30 days after trained and oriented personnel are no 

longer available, acknowledging the PSIS suggestion to identify seasoned professionals who are 

not in temporary or training positions 

IV. CDC NCEH and ATSDR will only send trained and oriented personnel to participate on 

PSIS-led assessment teams as non-regulatory team members. 

Planning for Assessments 

I. CDC NCEH and ATSDR will be invited to participate in FSIS meetings convened to plan 

assessments undertaken in response to foodborne health hazards, including those that result in 

illness clusters and outbreaks. 

II. Should an assessment of an PSIS-regulated establishment be required, CDC NCEH and 

ATSDR staff can participate in assessment planning meetings regardless of whether they will 

join establishment assessment teams in the field. 

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III. CDC NCEH and ATSDR staff will participate in discussions with FSIS staff to make 

determinations of whether epidemiologic data is key evidence for an assessment. 

IV. CDC NCEH and ATSDR may provide technical support, exposure/risk assessment, and 

subject matter expertise to FSIS during assessments of foodborne health hazards, adding to 

existing FSIS expertise in FSIS, in any of the following areas: 

• Microbiological, chemical, toxicological, or radiological hazards associated with 

contaminated or potentially contaminated FSIS-regulated product 

• Exposure/Risk Assessments for contaminated FSIS-regulated product to consumers or inplant personnel 

Establishment Assessments 

I. CDC NCEH and ATSDR agree to consider the inclusion oftrained personnel in FSIS· 

establishment assessment teams. FSIS acknowledges that trained CDC/ ATSDR personnel will 

only be utilized on select assessment teams. 

In the event of a serious incident involving radioactive contamination of food, the CDC 

NCEH unit that leads on radiation incidents may call on (a) the interagency Advisory 

Team for Environment, Food and Health as defined by the Nuclear/Radiological Incident 

Annex of the National Response Framework (including USDA members); and (b) staff 

from the Department of Health and the radiation control agency in each state impacted by 

the incident, as needed. 

II. CDC NCEH and ATSDR personnel who are deployed as part ofFSIS-led assessment teams 

will work as an integral part of the team and as such will serve under the direction of the FSIS 

team leader for the duration of the deployment. Participation as part ofthe team may be virtual 

(via telephone or webinar) both prior to and after the deployment. 

III. CDC NCEH and ATSDR will promptly respond to FSIS requests to share the CDC/ATSDRprovided data, information, and interpretation with establishment management. Whenever 

possible, it is preferable that a CDC/ATSDR team member with appropriate training and 

credentials be present to provide establishment management with the data, information, and 

interpretation that CDC/ATSDR developed and/or secured, barring the provision of any 

confidential or other restricted information. 

IV. CDC NCEH and ATSDR will provide the FSIS and CDC-cleared assessment report for 

inclusion in the National Voluntary Environmental Assessment Information System NVEAIS. 

ARTICLE 6 - MUTUAL RESPONSIBILITIES 

Communication and Collaboration 

I. Each agency agrees to promote effective communication and strong collaborations during the 

assessment planning, establishment assessment, and during post-assessment activities. 

II. Each agency agrees to seek out agency subject matter expertise not described in this 

memorandum of understanding but identified as needed to assure the performance of a 

comprehensive assessment aimed at protecting public health. 

III. Each agency agrees to utilize the FSIS assessment team lead to resolve issues that arise any 

FSIS establishments. 

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IV. Each agency agrees to keep the FSIS Liaison to CDC apprised of significant issues. The 

FSIS Liaison will pass along to the other agency or agencies that an issue has been raised and 

will assist in the resolution of such issues, concerns, or challenges. 

V. Each agency will strive to use the same slide set for briefings of other entities on the 

investigation and strive to have mutually agreed upon interpretations of investigative findings, 

conclusions, recommendations. 

Handling ofData, Information, including industry proprietary and commercial 

confidential information, Reports, Requests for Information under FOIA, 

Abstracts, Presentations, Manuscripts, Publications 

I. Each agency agrees to maintain as confidential, data and information, as required by law or 

agency's protocol regarding disclosure of information. 

II. Each agency will apprise the other agency when requests for information under a FOIA 

related to foodborne health assessments associated with PSIS-regulated products have been 

received ' 

III. Each agency agrees to apprise the other agency in a timely manner regarding the 

development of abstracts, presentations, and manuscripts on the investigation. Each agency 

agrees to strive to include a co-author from the other agency. 

IV. Each agency will provide drafts of abstracts, presentations, and manuscripts to the other 

agency for clearance (co-authorship) or courtesy review (no co-authorship) in advance of 

submission to conference, journal, etc. 

ARTICLE 7 - PROTECTION OF DATA 

Handling of Confidential Information 

Confidential information, as used in this clause, means unpublished information or data 

submitted by or pertaining to an organization and PSIS-regulated establishment. FSIS will create 

unique identifiers that will not include company or corporation name and address to maintain 

confidentiality ofthe PSIS-regulated establishment. FSIS and CDC/ATSDR Federal employees 

will use the unique identifiers in correspondence, presentation, and publications. To the extent 

consistent with U.S. Federal law, confidential information, as defined above, will not be 

disclosed without the prior written consent ofthe individual, institution or organizations. A 

determination of consent will be made within 45 days of submission ofthe request. 

ARTICLE 8 -EFFECTIVE DATE 

This memorandum of understanding will be in effect upon final signature of all parties. The 

memorandum of understanding will be reviewed every five years, or per request of FSIS or 

CDC/ATSDR, for programmatic relevancy and updated as agreed upon by PSIS and CDC 

NCEZID, CDC NCEH, and ATSDR. 

The undersigned approve the terms and conditions ofthis memorandum of understanding and 

represent that they have the requisite authority to enter into it. 

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Alfred V. manza, Administra or Date 

Food Safety and Inspection Service 

United States Department of Agriculture 

Betll'i>. Bell, jU).,Director 

National Center for Emerging and Zoonotic Infectious Diseases 

Centers for Disease Control and Prevention 

United States Department ofHealth and Human Services 

Robin M. Ikeda, MD, MPH, RADM, USPHS Date 

Deputy Director, Office ofNoncommunicable Diseases, 

Injury and Environmental Health, and 

Acting Director, National Center for Environmental Health, and 

Agency for Toxic Substances and Disease Registry 

Centers for Disease Control and Prevention 

United States Depat1ment of Health and Human Services 

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