NEHA Foodborne Illness Risk Factors Guide

Foodborne Illness Risk Factors Guide & Risk Control Plan Toolkit published by the National Environmental Health Association (NEHA), July 2026.

Foodborne Illness Risk Factors Guide & Risk Control Plan Toolkit

A Resource for Regulatory Inspectors A Tool for Retail Food Establishment Operators

July 2026

National Environmental Health Association 1400 S. Colorado Blvd., Ste. 325, Denver, CO 80222-3658 | neha.org

Contributors Chris Boyles, MS, CP-FS, Steritech Kerri Day, MPH, REHS/RS, CP-FS, CPO, US Navy at the NMCFHPC Suzanne Fajgier, REHS/RS, CFOI, CP-FS, CCFS, CPH, Burlington County Health Department Shawn Freund, RS/REHS, CP-FS, Cambridge Inspectional Services Gina Gallo, MS, Dutch Bros Coffee Tia Glave, Catalyst Food Leaders, LLC Ali Goldsand, ABG Food Safety Carly Hegarty, MPS, REHS, City of Milwaukee Health Department

Marcie Herzberg-Lee, MRA, LP.D, Patron Associates Michelle Hill, CP-FS, CFPM, HACCP, Allergen Free Cook Tania Nur, MPH, REHS, Franklin County Public Health Nela Romo, MS, El Pollo Loco Tom Sidebottom, Regulatory Science Consulting, LLC Bill Sparrow, RS/REHS, CP-FS, Ninety Nine Restaurants Christine Sylvis, Southern Nevada Health District Rob Wagner, MPH, RS, Public Health–Seattle & King County Steven Wille, RS/REHS, CEHP, Florida Department of Health Rebecca Wynne, Darden Concepts, Inc.

Adam Kramer, MPH, ScD, RS, Centers for Disease Control and Prevention Nicole L. Dutra, MPH, National Environmental Health Association Gina Bare, MA, RN, National Environmental Health Association

Acknowledgments The National Environmental Health Association (NEHA) gratefully acknowledges the NEHA Food Safety Program Committee for developing this Food Safety Risk Control Plan Guidance Toolkit. Their generous contribution of time, expertise, and insights contributed greatly to the creation of these resources, which will support the advancement of national food safety. NEHA and the committee gratefully acknowledge the Food and Drug Administration (FDA) for its ongoing Risk Factor Studies, which provide the evidence base for these resources, and for the FDA Food Code , which serves as the foundation for food safety regulation across the U.S.

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Foodborne Illness Risk Factors Guide and Risk Control Plan Toolkit About the Toolkit

The National Environmental Health Association’s (NEHA) Food Safety Program Committee has developed a comprehensive set of Risk-Based Control Guidance (RCPG) documents to support regulatory food safety professionals in addressing the most common foodborne illness risk factors identified in retail food establishments. The resources in this toolkit are based on the Food and Drug Administration’s (FDA) 2023 published, “Technical Report: FDA Report On The Occurrence Of Foodborne Illness Risk Factors In Fast-Food And Full-Service Restaurants 2017-2018,” which was the second data collection period during the 2013 Ten-Year Risk Factor Study. The report documents the collected data and the occurrence of food safety practices and behaviors identified as most commonly linked to foodborne illness outbreaks at fast-food and full-service restaurants. Although in whole, there are five foodborne illness risk factors, this toolkit focuses on only four and their associated data items, as these are comprised of specific food safety and protection behaviors offered at retail and in food service, and which were included in FDA’s 2017-2018 data collection period. Risk Factor #5, ensuring that food is obtained from an approved source, was excluded in the latest study by FDA as data confirmed a “low out-of-compliance” for food sources (FDA).

This toolkit focuses on the following Foodborne Illness Risk Factors and the Associated Primary Data Items:

https://www.fda.gov/media/169390/download?attachment

Purpose This toolkit is designed as a practical resource for regulatory food establishment inspectors to use collaboratively with the establishment’s person in charge (PIC) when specific risk factors have been identified as noncompliant during routine inspections.

Foodborne Illness Risk Factors Guide and Risk Control Plan Toolkit Each risk factor data item sheet serves multiple purposes:

1. Education: Provide immediate, evidence-based education about the science behind food safety requirements and the public health implications of noncompliance 2. Root Cause Analysis: Guide constructive dialogue between inspectors and food establishment operators to identify underlying causes of noncompliance, moving beyond surface-level violations 3. Collaborative Problem-Solving: Facilitate a partnership approach to food safety by engaging managers in developing sustainable solutions rather than simply citing violations 4. Sustainable Compliance: Support the development of comprehensive risk control plans that address chronic or repeated violations through systematic food safety management approaches 5. Standardization: Provide consistent, science-based messaging and expectations across jurisdictions while respecting local regulatory authority

Using the Toolkit Step 1: Identify the Risk Factor

During your inspection, when you observe a noncompliant practice related to one of the 10 risk factor data items, select the corresponding risk factor data item sheet. These resources are most effective when: • A violation is observed during the current inspection

• The same or similar violation has been documented in previous inspection reports • The establishment demonstrates a pattern of noncompliance in a specific risk area • The manager or person in charge is present and available for consultation

Step 2: Review the Guidance With the Manager Use the risk factor data item sheet to facilitate an educational conversation with the manager or person in charge. The document is structured to provide: • THE RULE: Clear statement of the regulatory requirement and relevant FDA Food Code • citation • THE SCIENCE: Explanation of the public health rationale and how noncompliance contributes to foodborne illness • ROOT CAUSE ANALYSIS: Framework for identifying contributing factors across people, equipment, economic, and procedural dimensions

This collaborative review helps ensure the manager understands not only what is required but also why it matters for public health protection.

Step 3: Introduce the Risk Control Plan When violations are chronic, repeated, or indicate systemic failures, introduce the Risk Control Plan section of the risk factor data item sheet as a tool for developing a formal, written commitment to achieve compliance. Explain that: • The Risk Control Plan is a structured approach to addressing persistent food safety issues; and • It requires the establishment to develop and implement a food safety management system (FSMS)

Foodborne Illness Risk Factors Guide and Risk Control Plan Toolkit specific to the identified risk factor; and • Research demonstrates that establishments with well-developed FSMSs have significantly fewer high-risk violations; and • The plan creates accountability through documentation, measurable goals, and follow-up mechanisms

Step 4: Collaborate on Risk Control Plan Development Guide the manager through the Risk Control Plan, which addresses: • Risk Identification

o Specific issues observed o Root causes identified o Applicable Food Code provisions

o Areas requiring active managerial control o Management strategies to achieve control

o Required tools and resources o Measurable compliance goals

• Food Safety Management System Components o Procedures o Training o Monitoring

• Time Frame

o Duration of the plan o Communication methods and frequency for reporting progress to the inspector • Commitment o Formal signatures from both the manager/person in charge and the inspector, establishing a partnership agreement

Step 5: Establish Follow-Up Protocols Work with the establishment to determine: • Realistic timelines for implementing the Risk Control Plan • Appropriate follow-up inspection schedule • Communication methods for progress updates • Criteria for determining successful plan completion • Next steps if the plan does not achieve desired outcomes Best Practices For Implementation Maintain a Collaborative Approach

The risk factor data item sheets are designed to support a consultative, problem-solving relationship between inspectors and food establishment operators. Frame the conversation as a partnership to protect public health rather than an adversarial enforcement action.

Foodborne Illness Risk Factors Guide and Risk Control Plan Toolkit Use Professional Judgment Not every violation requires a formal Risk Control Plan. Use these resources flexibly based on: • Severity and frequency of violations • Establishment history and compliance track record • Manager receptiveness and commitment to improvement • Availability of resources and support systems • Local regulatory requirements and enforcement protocols

Document Appropriately Maintain clear documentation of: • Violations observed and discussed • Educational materials provided • Risk Control Plan development and agreements • Follow-up schedules and communication • Progress toward compliance goals

Provide Adequate Time Risk Control Plan development and implementation require time and thoughtful consideration. When possible: • Allow managers time to review guidance documents and consult with staff • Schedule follow-up meetings dedicated to Risk Control Plan completion • Recognize that sustainable change could require phased implementation • Adjust timelines based on the complexity of root causes and available resources Connect to Additional Resources Direct managers to supporting resources referenced in the guidance documents, including: • FDA Food Code and Annexes • FDA Retail Food Risk Factor Studies

• Training programs and certification courses • Industry associations and best practice guides • Equipment suppliers and technical support

Recognize System-Level Barriers Some root causes might be beyond the immediate control of on-site managers, such as: • Corporate policies that conflict with food safety requirements

• Inadequate staffing or high turnover rates • Insufficient equipment or facility limitations • Language barriers or literacy challenges • Economic constraints

When system-level barriers are identified, document these concerns and consider escalation to ownership, corporate management, or appropriate regulatory authorities. Theoretical Foundation The toolkit is grounded in two complementary frameworks:

1. Active Managerial Control (AMC)

Foodborne Illness Risk Factors Guide and Risk Control Plan Toolkit The FDA Food Code emphasizes that food safety cannot be achieved through inspection alone. AMC requires food establishment managers and industry management to take a proactive, systematic approach to controlling risk factors for foodborne illness through preventative actions or procedures. This involves: • Identifying policies, procedures, and practices that require control • Implementing FSMS components • Monitoring practices to ensure procedures are effective • Taking corrective action when necessary 2. Food Safety Management Systems (FSMS) FSMS are the actions that food establishments use to support AMC. Data from the 2017-2018 collection revealed that “establishments with well-developed FSMS had significantly fewer out-of- compliance food safety behaviors/practices that did those with ‘less developed’ FSMS,” (FDA). The components of FSMS generally include the purposeful implementation of: • Procedures: Standard operating procedures, critical limits, responsible parties, documentation • Training: Training protocols, content, responsible trainers, training materials, completion records • Monitoring: Monitoring methods and frequency, critical limits, responsible parties, corrective actions, monitoring documentation These guidance documents support the development and implementation of FSMSs tailored to specific risk factors, creating sustainable pathways to compliance rather than temporary fixes. Legal And Regulatory Considerations This toolkit should be considered an educational tool intended to support regulatory professionals in their work. It is not intended to:

• Replace or supersede local, state, tribal, or federal regulations • Create new regulatory requirements or enforcement authorities • Serve as legal documents or contracts • Limit regulatory discretion or professional judgment • Substitute for formal enforcement actions when required

Inspectors should always apply supporting resources and tools in accordance with their jurisdiction’s: • Adopted food code and regulations • Enforcement policies and procedures • Legal authorities and limitations • Documentation and reporting requirements • Administrative processes for compliance agreements Continuous Improvement NEHA welcomes feedback on these resources. Your insight will inform future updates and ensure these resources continue to meet the practical needs of regulatory professionals and food establishment operators. To provide feedback, please contact us at support@neha.org .

Foodborne Illness Risk Factors & Risk Control Plan Tool

Risk Factor: Poor Personal Hygiene Data Item #1: Employees Practice Proper Handwashing

What’s the Rule? Wash hands before handling food or food- contact surfaces. During food prep, wash hands when switching tasks, before putting on gloves, or any time the hands become contaminated. Wash hands after using the toilet or any other activity that could contaminate them. Proper Hand Washing: Wet hands, apply soap, rub hands together for at least 20 seconds, rinse, then dry. Refer to FDA Food Code: 2-301.12 and 20301.14 What’s the Risk? Germs are present on everyone's hands and employee's hands can contaminate the food they touch. Research shows handwashing for 20 s econds with soap and water can significantly reduce the amount of germs on your hands.

PART 1: Identify continuous or chronic out-of-compliance issues • List all the handwashing issues from previous inspection reports

• Identify any pattern or similarity among the citations • List the corrective actions that have already been tried PART 2: Use the table below to determine the root causes • Chronic issues can have multiple root causes • Identify all the people, equipment, economic, or procedural factors that play a role in your recurring issues • Thistable includes a few examples, but it might not include your specific root cause

PEOPLE

EQUIPMENT

ECONOMICS

PROCEDURES

People not trained on handwashing procedures Physical discomfort from frequent handwashing People not keeping hand sinks easily accessible People not keeping hand sinks stocked and clean Person in charge is not a trained food safety manager

Lack of adequate handwashing sink supplies

Insufficient budget for regularly stocking all hand sinks No budget for adding/relocating hand sinks to be more convenient

Written procedures not clear or correct

Lack of dedicated handwashing sinks

Written procedures not followed

No budget for repairs/preventive maintenance

Procedures are not monitored; monitoring is not documented No process for taking and documenting corrective actions

Handwashing sink not working

Insufficient time committed to train staff on procedures

Warm water not readily available

Insufficient staff scheduled to execute procedures

Handwashing sink not properly designed

Procedure not posted at the point of use

#1 Poor Personal Hygiene: Proper Handwashing Food Safety Management System (FSMS) Once the root cause(s) have been identified, a Food Safety Management System helps the manager prevent recurring issues. Large-scale studies by FDA show that the

number of high-risk food safety issues is greatly reduced when a well-developed Food Safety Management System is in place (see the graph to the right). (Source: FDA Retail Food Risk Factor Studies 2017–2018 )

Food Safety Management System A Food Safety Management System is a specific set of actions taken to prevent the occurrence of high-risk food safety issues within a food establishment. It includes: • Written procedures • Training plans • Monitoring records to control specific operational steps that contribute to foodborne illness

TRAINING ● Include the critical limit in the training ● Spell out the specific steps to carry out the training ● Identify the people responsible for carrying out the training ● Create documentation to

PROCEDURES ● Include the critical limit in the procedure ● Spell out the specific steps to carry out the procedure ● Identify the people responsible for carrying out each step of the procedure ● Create documentation to support this procedure (e.g., SOPs, wall charts, posters)

MONITORING ● Identify the critical limit to be monitored ● Spell out the specific steps for monitoring ● Identify the people responsible for carrying out the monitoring ● List the corrective actions they will take if monitoring identifies an issue ● Create documentation to support this monitoring (logs, checklists, forms)

support this training (e.g., training plan, completion certificates)

References and Resources ● FDA Food Code serves as a model code for state, local, and tribal laws. In addition to the code provisions, Annex 3 includes extensive background on the underlying public health reasons for its provisions, and Annex 4 includes guidance on achieving active managerial control. https://www.fda.gov/food/retail-food- protection/fda-food-code ● FDA Retail Food Risk Factor Studies: The 2017–2018 Occurrence Report and especially its Fact Sheet are the source of the data used in the chart above showing the importance of managers implementing a well- developed food safety management system. 2017–2018 Occurrence Report: https://www.fda.gov/media/169390/download?attachment 2017–2018 Fact Sheet: https://www.fda.gov/media/169391/download?attachment ● CDC Root Causes Overview includes the concept of people, equipment, economics, and procedures. https://www.cdc.gov/restaurant-food-safety/media/pdfs/root-causes-overview- 508.pdf

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Foodborne Illness Risk Factors & Risk Control Plan Tool

Risk Factor: Poor Personal Hygiene Data Item #2: Employees Do Not Contact Ready-to-Eat (RTE) Foods With Bare Hands

Why Do You Need a Risk Control Plan? A Risk Control Plan can reduce your risk of causing a foodborne illness outbreak. The process has three parts: 1) identify your chronic issues, 2) determine the root causes, and 3) create a food safety management system. This guidance document can be used to complete an agreement between you and your local regulator to plan for long-term food safety success. PART 1: Identify continuous or chronic out-of-compliance issues • List all the bare hand contact with RTE food issues from previous inspection reports • Identify any pattern or similarity among the citations • List the corrective actions that have already been tried PART 2: Use the table below to determine the root causes • Chronic issues can have multiple root causes • Identify all the people, equipment, economic, or procedural factors that play a role in your recurring issues • This table includes a few examples, but it might not include your specific root cause

What’s the Risk? Viruses such as norovirus can be spread when contaminated hands touch food. Even thorough handwashing might not adequately remove viruses. Since RTE foods receive no further cooking before they are eaten, bare- hand contact must be avoided to prevent passing viruses on to the consumer.

PEOPLE

EQUIPMENT

ECONOMICS

PROCEDURES

What's the Rule? Do not touch RTE

Insufficient budget for necessary volume of gloves and other utensils Insufficient budget for stocking all appropriate sizes of gloves Impermeable gloves not provided for use below cutting glove

People not trained on procedures to avoid bare-hand contact

Insufficient amount of gloves available

Written procedures not clear or correct

foods with bare hands. Single-use gloves or utensils such as tongs, spatulas, and deli papers are acceptable alternatives.

Insufficient stock of properly fitting glove sizes Insufficient stock of utensils: tongs, spatulas, or deli papers

People not trained to recognize RTE foods

Written procedures not followed

Refer to FDA Food Code: 3-301.11

Physical discomfort from frequent glove use People using bare hands based on their cultural or culinary background Person in charge is not a trained food protection manager

Procedures are not monitored, monitoring is not documented No process for taking and documenting corrective actions

Insufficient time committed to train staff on procedures

Utensils not stored conveniently for use

Utensils not appropriate for food handling

Workers incentivized for speed over food safety

Procedure not posted at the point of use

#2 Poor Personal Hygiene: No Bare Hand Contact With Ready-To-Eat (RTE) Foods Food Safety Management System (FSMS) Once the root cause(s) have been identified, a Food Safety Management System helps the manager prevent recurring issues. Large-scale studies by FDA show that the

support this training (e.g., training plans, completion certificates)

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Foodborne Illness Risk Factors & Risk Control Plan Tool

Risk Factor: Contaminated Equipment/Protection From Contamination Data Item #3: Food Is Protected From Cross- Contamination During Storage, Preparation, and Display

What's the Rule? Separate raw animal foods from ready-to-eat (RTE) foods and all other foods. If storing raw foods above each other, order them from lowest cooking temperature on top to highest on bottom. Clean and sanitize food-contact surfaces between use of different raw animal foods or moving from raw to RTE. Protect food during storage and display with lids, splash guards, sneeze guards, etc. Refer to FDA Food Code: 3-302.11, 3-304.11, 3-304.15, 3-306.13 What’s the Risk? Each type of raw animal food, such as beef, chicken, and fish, can carry different germs and pathogens. It is essential to cook it to the proper temperature, separate raw meats from other foods, use separate cutting utensils and surfaces, and not wash raw poultry.

PART 1: Identify continuous or chronic out-of-compliance issues • List all cross-contamination issues from previous inspection reports

• Identify any pattern or similarity among the citations • List the corrective actions that have already been tried PART 2: Use the table below to determine the root causes • Chronic issues can have multiple root causes • Identify all the people, equipment, economic, or procedural factors that play a role in your recurring issues • This table includes a few examples, but it might not include your specific root cause

PEOPLE

EQUIPMENT

ECONOMICS

PROCEDURES

Storage shelves not labeled to separate foods by cooking temperature

Not enough space available for proper segregation or raw foods Insufficient time committed to train on procedures Insufficient staff scheduled to execute procedures Insufficient amount of gloves and other utensils available

People not trained to separate ready-to-eat foods from other foods People not trained to recognize raw and RTE foods People not trained to separate raw foods by type People not trained to protect foods during storage and display Person in charge is not a trained food protection manager

Written procedures incorrect or unclear to understand

Equipment position exposes food to splash

Written procedures not followed

Equipment not designed for easy cleaning and sanitizing Sneeze guards not positioned to prevent food contamination Utensils for consumer use are improperly stored or not provided

Procedures are not monitored; monitoring is not documented

No process for conducting and documenting corrective actions

Splash barriers and sneeze guards not provided

RTE prep is not conducted prior to raw food prep

#3 Contaminated Equipment: Food Protected From Cross-Contamination

Food Safety Management System (FSMS) Once the root cause(s) have been identified, a Food Safety Management System helps the manager prevent recurring issues. Large-scale studies by FDA show that the number of high-risk food safety issues is greatly reduced when a well-developed Food Safety Management System is in place (see the graph to the right). (Source: FDA Retail Food Risk Factor Studies 2017–2018 )

support this training (e.g., training plans, completion certificates)

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Foodborne Illness Risk Factors & Risk Control Plan Tool

Risk Factor: Contaminated Equipment/Protection From Contamination Data Item #4: Food Contact Surfaces Are Properly Cleaned and Sanitized

What's the Rule? Food contact surfaces must be cleaned and sanitized to eliminate germs. Clean and sanitize all food contact surfaces prior to use, when chance of contamination might have occurred, periodically during continuous use (at least every 4 hours), and after use. Follow the manufacturer directions for chemical and equipment use. Refer to FDA Food Code: 4-501, 4-601, 4-602, 4-702, 4-703 What’s the Risk? To prevent foodborne illness, food contact surfaces must be kept free of dangerous germs. Non food- contact surfaces must be cleaned often to prevent an accumulation of soil or debris that could attract pests. Equipment and chemicals for cleaning and sanitizing are safe and effective only when their specific directions are followed (e.g., temperature, contact time, concentration.)

PART 1: Identify continuous or chronic out-of-compliance issues • List all cleaning and sanitizing issues from previous inspection reports

• Identify any pattern or similarity among the citations • List the corrective actions that have already been tried PART 2: Use the table below to determine the root causes. • Chronic issues can have multiple root causes • Identify all the people, equipment, economic, or procedural factors that play a role in your recurring issues • This table includes a few examples, but it might not include your specific root cause

PEOPLE

EQUIPMENT

ECONOMICS

PROCEDURES

People not trained on cleaning and sanitizing procedures People not maintaining chemicals on-site and connected for use People not following sanitizer testing procedure People not monitoring and documenting test strip results Person in charge is not a trained food protection manager

Insufficient time committed to train staff on procedures Insufficient staff scheduled to execute procedures Purchasing equipment that is not designed for commercial use No budget for repairs and preventive maintenance

Written procedures incorrect or unclear to understand

Sanitizer test strips not available or not usable

Food-contact equipment not maintained as easily cleanable

Written procedures not followed

Procedures are not monitored, monitoring is not documented

Equipment is inoperable

Equipment not functioning to manufacturer data plate or design Equipment not used according to manufacturer instructions

No process for conducting and documenting corrective actions

No budget for replacing unserviceable equipment

No process for taking and documenting corrective actions

#4 Contaminated Equipment: Food Contact Surfaces Cleaned and Sanitized

support this training (e.g., training plans, completion certificates)

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Risk Factor: Improper Holding Time/Temperature Data Item #5: Foods Requiring Refrigeration Are Held at the Proper Temperature

Foodborne Illness Risk Factors & Risk Control Plan Tool

What’s the Risk? Bacteria or other

Why Do You Need a Risk Control Plan? A Risk Control Plan can reduce your risk of causing a foodborne illness outbreak. The process has three parts: 1) identify your chronic issues, 2) determine the root causes, and 3) create a food safety management system. This guidance document can be used to complete an agreement between you and your local regulator to plan for long-term food safety success. PART 1: Identify continuous or chronic out-of-compliance issues • List all cold holding issues from previous inspection reports • Identify any pattern or similarity among the citations • List the corrective actions that have already been tried PART 2: Use the table below to determine the root causes. • Chronic issues can have multiple root causes • Identify all the people, equipment, economic, or procedural factors that play a role in your recurring issues • This table includes a few examples, but it might not include your specific root cause

pathogens that cause foodborne illness can grow rapidly on Time/Temperature Control for Safety (TCS) Food when they are not maintained at proper cold holding at 5 ° C (41 ° F) or less. From the FDA Job Aid: Time and Temperature Control for Safety Foods What's the Rule? Time/Temperature Control for Safety (TCS) Food, Cold Holding, shall be maintained at 5 ° C (41 ° F) or less. Refer to FDA Food Code: 3-501.16 (A) (2)

PEOPLE

EQUIPMENT

ECONOMICS

PROCEDURES

Staff not trained on cold holding procedures Temperatures not being monitored and/or documented Staff not following proper procedures for filling pans, temperature control Staff not following proper procedures to maintain cold holding temperature Person in charge is not a trained food protection manager

Equipment has insufficient capacity for its use Equipment used improperly or not designed for its intended use Equipment malfunctioning, not working properly

Written procedures incorrect or unclear to understand

Written procedures not followed

Procedures are not monitored, monitoring is not documented Procedures do not identify appropriate cold holding containers No process for taking and documenting corrective actions

Equipment not inspected and calibrated regularly

No budget for replacing unserviceable equipment

No preventive maintenance program in place

#5 Improper Holding Time/Temperature: Proper Cold Holding

support this training (e.g., training plans, completion certificates)

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Foodborne Illness Risk Factors & Risk Control Plan Tool

Risk Factor: Improper Holding Time/Temperature Data Item #6: Foods Displayed or Stored Hot Are Held at the Proper Temperature

What’s the Risk? Bacteria or other

Why Do You Need a Risk Control Plan? A Risk Control Plan can reduce your risk of causing a foodborne illness outbreak. The process has three parts: 1) identify your chronic issues, 2) determine the root causes, and 3) create a food safety management system. This guidance document can be used to complete an agreement between you and your local regulator to plan for long-term food safety success. PART 1: Identify continuous or chronic out-of-compliance issues • List all hot holding issues from previous inspection reports • Identify any pattern or similarity among the citations • List the corrective actions that have already been tried PART 2: Use the table below to determine the root causes • Chronic issues can have multiple root causes • Identify all the people, equipment, economic, or procedural factors that play a role in your recurring issues • This table includes a few examples, but it might not include your specific root cause

pathogens that cause foodborne illness can grow rapidly on Time/Temperature Control for Safety (TCS) Food when they are not maintained at proper hot holding at 57 ° C (135 ° F) or greater. Intact whole-meat roasts pose a different level of risk because bacteria are only on the surface of the meat. After proper cooking, they are safe if held at 54.4 ° C (130 ° F) or greater. What's the Rule? Time/Temperature Control for Safety (TCS) Food, Hot Holding, shall be maintained at 57 ° C (135 ° F) or greater. Whole-meat roasts that were cooked to proper temperature and time should be held at 54.4 ° C (130 ° F) or greater. Refer to FDA Food Code: 3-501.16 (A) (1) and 3-401.11(B)

PEOPLE

EQUIPMENT

ECONOMICS

PROCEDURES

People not trained on hot holding procedures People not stirring food to evenly distribute the heat

Equipment used improperly, such as being overfilled

Insufficient time committed to train staff on procedures Insufficient staff scheduled to execute procedures

Written procedures not clear and correct

Equipment not designed for its intended use

Written procedures not followed

Equipment not working properly (e.g., preheated, turned on, proper setting, steam tables filled) Equipment not regularly inspected, thermometers not regularly calibrated No preventive maintenance program for equipment

People not using lids and covers to maintain temperatures

Purchasing equipment that is not designed for commercial use

Procedures do not identify appropriate hot holding containers

People not monitoring and documenting hot holding temps Person in charge is not a trained food protection manager

No budget for repairs and preventive maintenance

Procedures are not monitored, monitoring is not documented No process for taking and documenting corrective actions

No budget for replacing unserviceable equipment

#6 Improper Holding Time/Temperature: Proper Hot Holding

support this training (e.g., training plans, completion certificates)

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Foodborne Illness Risk Factors & Risk Control Plan Tool

Risk Factor: Improper Holding Time/Temperature Data Item #7: Foods Are Cooled Properly

What’s the Risk? If not properly controlled, the cooling process of Time/ Temperature Control for Safety (TCS) Food will create an environment for the remains between 57 ºC (135 ºF) and 5 ºC (41 ° F), the risk increases with time. The toxins produced are tasteless, odorless, and colorless, and have a high probability of causing foodborne illness. growth of spore- forming toxigenic bacteria. If food What's the Rule? Cooked TCS Food shall be cooled: (1) Within 2 hours from 57 ºC (135 ºF) to 21 ºC (70 ° F) and (2) Within a total of 6 hours from 57 ºC (135 ºF) to 5 ºC (41 ° F) or less. TCS Food made from room temperature ingredients shall be cooled to 5 ºC (41 ° F) or less within 4 hours. Use approved cooling methods based on food type. Refer to FDA Food Code: 3-501.14

Why Do You Need a Risk Control Plan? A Risk Control Plan can reduce your risk of causing a foodborne illness outbreak. The process has three parts: 1) identify your chronic issues, 2) determine the root causes, and 3) create a food safety management system. This guidance document can be used to complete an agreement between you and your local regulator to plan for long-term food safety success. PART 1: Identify continuous or chronic out-of-compliance issues • List all cooling issues from previous inspection reports • Identify any pattern or similarity among the citations • List the corrective actions that have already been tried PART 2: Use the table below to determine the root causes • Chronic issues can have multiple root causes • Identify all the people, equipment, economic, or procedural factors that play a role in your recurring issues • This table includes a few examples, but it might not include your specific root cause

PEOPLE

EQUIPMENT

ECONOMICS

PROCEDURES

People not trained on cooling procedures People not trained on cooling equipment options

Equipment has insufficient capacity for this use Improper equipment used, such as deep or insulated pans Ice bath or other cooling method not set up correctly Equipment used improperly or not designed for its intended use Thermometers not available or calibrated

Insufficient time committed to train staff on procedures Insufficient staff scheduled to execute procedures

Written procedures not clear and correct

Written procedures not followed

People not monitoring and documenting cooling temps

Rapid cooling equipment not purchased when needed No budget for repairs and preventive maintenance No budget for replacing unserviceable equipment

Procedures do not identify appropriate cooling tools Procedures are not monitored, monitoring is not documented No process for taking and documenting corrective actions

People leaving food out too long prior to starting cooling Person in charge is not a trained food protection manager

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