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Top 5 Most Frequently Cited Violations in Food Establishment Inspections & Prevention Tips

By Chip Manuel, Ph.D., GOJO Industries, Inc., and Hal King, Ph.D., Managing Partner, Active Food Safety

May 2023 – For over 30 years, the U.S. Food and Drug Administration’s (FDA) Food Code1 has served as a model set of regulations for safeguarding public health and ensuring the safety of food when offered to the consumer in retail food establishments. It represents FDA's best advice for a uniform system of provisions that address the safety and protection of food offered at retail and in food service. In response to an everchanging landscape of consumer food practices and preferences, emerging business models, and evolving science, the FDA Food Code changes over time. Generally, the Code is updated every 2 to 5 years, and the most recent edition of the Code is the 2022 Edition. Given that the most recent version of the Food Code is “hot off the presses,” we thought it would be a good time to reflect on the types of violations most frequently seen in retail food establishments.

To do that, we enlisted the help of experts in this field. The Top 5 Violations across the U.S. were pulled together with the help of a third-party proprietary technology that aggregates and standardizes public health inspection data. The analysis was done against a large representative sample of data from local health department jurisdictions across the U.S. We then asked Dr. Hal King, Managing Partner of Active Food Safety, to help provide advice on how establishments can best prevent these violations.

Top 5 U.S. Health Inspection Violations for 2022 Based on Applicable Code Section of the FDA Food Code

  1. Equipment, Food-Contact Surfaces, Nonfood-Contact Surfaces, and Utensils
  2. Cleaning, Frequency, and Restrictions
  3. Good Repair and Proper Adjustment - Equipment
  4. Time/Temperature Control for Safety Food, Hot and Cold Holding
  5. Certified Food Protection Manager

#1: Equipment, Food-Contact Surfaces, Nonfood-Contact Surfaces, and Utensils (Applicable Code Section 4-601.11) – 7.92% of all violations
#2: Cleaning, Frequency, and Restrictions (Applicable Code Section 6-501.12) – 7.28% of all violations

Experts’ Take: The top two most frequently encountered violations are very similar to one another, with each dealing with different aspects of cleaning within a facility. Section 4-601.11 - Equipment, Food-Contact Surfaces, Nonfood-Contact Surfaces, and Utensils, establishes the objective of cleaning within a facility – to prevent the accumulation of organic matter, food debris, and soil within a facility that could attracted unwanted pathogenic microorganisms and pests. Accumulation of soil could also reduce the efficacy of sanitizers used. This section requires food-contact surfaces to be “clean to sight and touch” and free of “grease deposits and other soil accumulations”, while also requiring nonfood-contact surfaces to be free of accumulation of “dust, dirt, food residue, and other debris”. The second section, 6-501.12 - Cleaning, Frequency, and Restrictions, establishes the need for facilities to clean their physical facilities “as often as necessary to keep them clean.” Basically, facilities should establish a schedule for regular cleaning frequency.

Intuitively, it makes sense why the two most frequently encountered inspection violations are related to cleaning. If a food-contact surface or a nonfood-contact surface are visibly dirty, they are easy to spot during health department inspections. Cleaning takes time (labor) and resources to do properly, which may be challenging for a lot of establishments that are struggling with the current labor shortages. Nevertheless, the public health importance of cleaning within a retail food establishment cannot be overstated. Organic material such as food debris can interfere with the effectiveness of many surface sanitizers and disinfectants used within a facility. Excessive soil buildup may lead to the proliferation of pathogenic bacteria, which can establish niches in these nutrient-rich environments (Listeria monocytogenes is a great example of this). Likewise, unclean surfaces with grease, fats, and oils are more difficult to sanitize properly, and can reduce the efficacy of sanitizers against pathogens. Not only is excessive uncleanliness a public health risk, but it is also a risk to a food establishment’s business, as a guest’s perception of a facility is often tied to its cleanliness.

There are several steps establishments can take to prevent the risk of these violations tied to a lack of cleaning:

  • Build a Solid Cleaning Foundation – Cleaning is an important task that takes resources, such as time, labor, cleaning products, and cleaning tools. These are foundational aspects of a cleaning program – if any of these are missing, then the risk for encountering violations related to cleanliness are much higher. Are staff being given adequate time to clean these surfaces properly? Are staff provided with the right tools, including effective cleaning (and sanitizing) chemistries, effective cleaning tools (brushes, mops, etc.) that are in working condition? Are management and senior staff emphasizing the importance of cleanliness? Are they monitoring employees to ensure proper cleaning is being performed? These are all excellent questions that should be asked periodically by individuals who help manage a food safety program within an establishment. Doing so will help build the foundation for a cleaning program that can reduce the risk of inspection violations.
  • Adopt “Best in Class” Practices and Tools Where Possible – Once the foundation of a cleaning program is laid, then the program itself can be revised over time for continuous improvement. Standard Operating Procedures (SOPs) should be periodically reviewed internally especially if there is a change in menu or facility design (e.g., adding raw protein like chicken into the food preparation process). External review by a Food Safety expert can also be valuable, as their outside perspective can provide advice for improvements while reducing redundancies that might impact labor. These SOPs can also help with preparedness for emergency situations, such as boil water advisories or public health emergencies. Choosing the best cleaning products for your specific facility will also help reduce the time it takes to effectively clean. The type of cleaning products used in an establishment ideally should be matched to the type of soil that is of a concern – not all products have equal effectiveness in the presence of various soils. Many modern products are also dual use in the sense that they are simultaneously cleaners and sanitizers/disinfectants. This may help reduce the time it takes to clean and sanitize effectively.
  • Create a culture of “Clean” – It is crucial that all members within a facility understand the importance of maintaining clean facilities. This starts with the management team – often if management deems something important, then many of the staff will see this and emphasize that importance. Asking your customers about the cleanliness of your foodservice establishment can also provide important feedback to the team; especially since issues with cleanliness can affect the customer experience and lead to reduced sales. This can have a big impact on the effectiveness of a cleaning program within a facility.

#3: Good Repair and Proper Adjustment - Equipment (Applicable Code Section 4-501.11) – 5.52% of all violations
#4: Time/Temperature Control for Safety Food, Hot and Cold Holding (Applicable Code Section 3-501.16) – 5.45% of all violations

Experts’ Take: The third and fourth most frequently encountered violations are also closely tied to one another. Section 4-501.11 – Good Repair and Proper Adjustment, is a broad section that covers equipment used in a facility. In general, this section states that all equipment used in a facility should be maintained in a state of good repair. A refrigerator that is no longer able to keep food cold, a hot bar that is no longer able to keep food warm, and a ware washing machine that is not dispensing sanitizer or reaching sanitization temperatures, are all excellent examples of equipment failures that can lead to a violation of this applicable Code section.

Equipment failure can then lead to a violation of the next most frequently encountered. Section 3-501.16 – Time/Temperature Control for Safety Food, Hot and Cold Holding, is arguably one of the most important sections of the FDA Food Code. This section is focused around hot and cold holding of food after it has been prepared. Foods that support the growth of pathogenic bacteria are subject to this section and are often called TCS foods. When provisions of this section are not followed, the proliferation of dangerous bacteria or their toxins in food can occur, which may lead to outbreaks. This section describes a temperature range of 41oF to 135oF as the temperature “Danger Zone.” When TCS foods are held for long periods of time in this temperature range, growth of harmful bacteria such as Listeria monocytogenes, Bacillus cereus, and Clostridium perfringens and production of toxins can occur. Numerous outbreaks have occurred due to failure of hot or cold holding requirements, emphasizing the importance of this section at reducing foodborne illness outbreaks.

How can these equipment and temperature control failure violations be controlled?

  • Routine Equipment Validation and Inspection – Equipment for handling and holding of food within a food establishment is often one of the most significant investments an operator or owner makes. Similar to an automobile, these pieces of equipment often require routine inspections and preventive maintenance in order for them to operate properly over a long period of time. Keeping a routine equipment inspection schedule (e.g., every quarter) that includes validation of the equipment being in good repair is ideal. Newer hot and cold holding equipment can alert operators if a problem is encountered. Speaking of repairs and replacements, it is a good idea for funds to be budgeted for these situations in advance – replacement of this type of equipment can easily reach into the tens of thousands of dollars.
  • Proper Equipment Use – Even if hot and cold holding equipment are in a good state of repair and functionality, failures can still occur if the equipment is not used correctly. For example, coolers and display cases for cold holding rely on circulating cold air to maintain temperatures. If these pieces of equipment are overfilled with food, they can often stop working correctly, which can lead to elevated temperatures. Always refer to the manufacturer’s supplied instructions for information related to proper equipment use.
  • Thermometer Use – So, you’ve invested in new equipment and followed instructions on use. How do you ensure everything is working properly? Use a calibrated thermometer! Thermometers should be on hand and widely used for many food holding and cooking procedures, like checking the temperature on cooked food to ensure the proper temperature was met during heating for pathogen kill. For holding of foods, ensure food is not being held within the “Danger Zone,” which as we mentioned previously is 41oF to 135oF. Proper thermometer use in a food establishment is a great way to reduce the chances of encountering a violation of our #3 and #4 most frequently encountered health code violations. And don’t forget to clean and sanitize thermometers in between uses to prevent any cross-contamination potential!

#5: Certified Food Protection Manager (Applicable Code Section 2-102.12) – 4.06% of all violations

Experts’ Take: This specific section of the FDA Food Code requires the “person in charge” (e.g., the manager) at the establishment to be a certified “Food Protection Manager.” To be certified, the individual must pass a knowledge test as part of an accredited course. According to the FDA, “Food protection managers have an important role in formulating policies, verifying food employees carry out these policies, and communicating with these same employees to give information about recommended practices to reduce the risk of foodborne illness.” A certified manager should be present at all times food is being prepared, handled, or sold.

Managers who are certified Food Protection Managers carry more knowledge related to foodborne illness risks than those without this training and certification. This knowledge naturally flows down to the staff members they manage. Does this translate to reduce risk for foodborne illness outbreaks? Research by both the FDA2 and Centers for Disease Control and Prevention3 suggests so, with evidence pointing to the lack of a Food Protection Manager as a major risk factor for foodborne illness outbreaks.

There are many accredited programs where individuals can obtain a certification, with many offering in-home tests that take less than a full day. The Conference for Food Protection establishes the criteria for these certification programs, and The American National Standards Institute (ANSI) serves as the accrediting body. More information on programs available can be found here https://anab.ansi.org/credentialing/food-protection-manager.

Closing Thoughts – While the FDA Food Code will evolve over time, core food safety principles important for reducing foodborne illness will always remain the same. It is interesting that many of these core principles are reflected in the top violations encountered across the U.S. Maintaining clean facilities not only improves guest experience, but it also helps reduce the chance of pests and pathogenic organisms from establishing themselves in the facility. Practicing proper hot and cold holding, along with maintenance of equipment can help reduce the chance of pathogenic bacteria growing to dangerous levels in food that has been prepared. Finally, ensuring the person in charge is also a certified food protection manager will help to ensure that best practices for food safety are followed by all employees.

For more information on PURELL® Foodservice Surface Sanitizing Wipes and Spray, visit GOJO.com/surfaces.

1. United States Food and Drug Administrations. 2022 United States Food Code. Available at https://www.fda.gov/food/fda-food-code/food-code-2022
2. U.S. Food and Drug Administration. 2009. FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (2009). Available at https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/default.htm
3. Hedberg, C.W., S.J. Smith, E. Kirkland, V. Radke, T.F. Jones, C.A. Selman and the EHS-Net Working Group. 2006. Systematic Environmental Evaluations to Identify Food Safety Differences between Outbreak and Nonoutbreak Restaurants. J. Food Protect. 69(11): 2697-2702.

Controlling Cross Contamination to Reduce Risk

Did you know that germs can hide on surfaces, even if surfaces appear clean? These hidden germs can transfer to other surfaces, or even worse, to food, where they can cause an outbreak. This is called cross-contamination, and can happen when contaminated hands, surfaces, or utensils, come into contact with food. If left uncontrolled, cross-contamination increases the chance of a food establishment causing an outbreak. In fact, according to the Centers for Disease Control and Prevention (CDC), cross-contamination is a major contributing factor to foodborne outbreaks in retail food establishments 1.

Here are several ways that food establishments can keep cross-contamination under control:

Practice Proper Personal Hygiene

Poor personal hygiene can facilitate pathogen spread in a food establishment, especially through hands. In fact, the most common contributing factor for foodborne illness outbreaks in a food establishment is contact with food by contaminated hands of a food handler1. Minimize risk by ensuring all employees are trained to wash hands frequently and thoroughly, especially when handling raw meat products and when switching between food handling tasks. Disposable gloves, when used properly, can help prevent hands from being contaminated. Make sure to emphasize the importance of staff cleanliness, hygiene, and proper work attire, especially hair and beard restraints. Finally, adopt policies and procedures, such as a sick leave policy, to prevent sick workers from reporting to work. Ill food handlers are a major risk factor for the spread of pathogens including norovirus, the number one cause of foodborne illness.

Store and Handle Food Safely

Safe storage and handling of food goes a long way in preventing cross-contamination in a food establishment. Higher risk foods, such as uncooked and raw meat and poultry items, should be stored in well-sealed containers to prevent any risk of cross-contamination by dripping. Ideally, these foods should be stored in a separate area away from fruits, vegetables, and any ready-to-eat food items. Additionally, raw foods should never be placed above ready to eat or cooked foods. When preparing food, be sure to separate raw and ready to eat utensils and food contact surfaces from one another. Never prepare a ready to eat food on a utensil or surface that was just used for preparing raw foods without first properly cleaning and sanitizing. If budget allows, consider color coded utensils, cutting boards, and other food contact surfaces to help minimize cross contamination between raw and ready to eat.

Implement Sanitation Best Practices

Dirty surfaces can be a source of pathogens in a food establishment. While you can prevent sick employees from reporting to work, it is much more difficult to prevent sick guests from entering your establishment. Sick guests can be a source of pathogens, such as norovirus. Adopting frequent cleaning, sanitizing, and disinfecting practices in an establishment is therefore crucial. First, ensure all staff are trained on sanitation chemicals, especially on how and when to use them. Second, make sure to adopt standard operating procedures (SOPs) that are easy to execute. For example, frequent disinfection of touchpoints (e.g., faucets, door handles, and toilets) in restrooms can reduce the risk of a norovirus outbreak in a food establishment2. Adopting a norovirus clean up plan for diarrhea and vomit will help reduce risk and is a requirement in many jurisdictions. If using a reusable towel with a bucket of sanitizer solution for wiping down tables, consider changing to a ready-to-use food contact sanitizer with disposable paper towels, or a disposable food contact surface sanitizing wipe. Reusable towels and cloths for wiping down tables can be a source of cross-contamination3. Finally, strive to create a culture of sanitation compliance, and ensure that sanitation procedures are being followed with staff being held accountable. Adopting sanitation chemicals with fast kill times will help to increase compliance.

BE PREPARED

Cross contamination puts many establishments at risk for spreading foodborne illness, but it does not have to happen in your establishment. Adhering to key sanitation and hygiene best practices can keep cross-contamination under control. Is your sanitation program up to speed? Contact your GOJO/PURELL representative to find out more.

1. https://www.cdc.gov/mmwr/volumes/68/ss/ss6801a1.htm

2. Duret, S., Pouillot, R., Fanaselle, W., Papafragkou, E., Liggans, G., Williams, L., & Van Doren, J. M. (2017). Quantitative Risk Assessment of Norovirus Transmission in Food Establishments: Evaluating the Impact of Intervention Strategies and Food Employee Behavior on the Risk Associated with Norovirus in Foods. Risk analysis : an official publication of the Society for Risk Analysis, 37(11), 2080–2106. https://doi.org/10.1111/risa.12758

3. https://www.foodsafetymagazine.com/magazine-archive1/augustseptember-2018/is-it-time-to-change-how-we-clean-and-sanitize-food-contact-surfaces-with-reusable-wiping-towels/


Foodborne Illness – By the Numbers

Foodborne illness can be caused by a wide variety of bacteria and viruses. FDA cites five highly infectious pathogens that can easily be transmitted by food workers and cause severe illness. These five foodborne pathogens, also known as the 'Big 5,' include norovirus, hepatitis A virus, Salmonella, Shigella, and Escherichia coli (E. coli)1. As a food service professional, you are probably familiar with these names, but are you familiar with the dramatic impact these (and other) foodborne pathogens have in the United States each year?

The numbers are staggering:

- 48 million – The number of cases of foodborne illness each year in the United States2

- $51 billion – The annual economic impact of foodborne illness in the United States3

- $3,968 to $2.6 million – The cost of a single foodborne illness outbreak for a restaurant4

These figures emphasize the dramatic public health and economic impact foodborne illness has in the United States each year. It is easy to see that a single outbreak could easily put a restaurant out of business for good. Additionally, with the adoption of new technologies such as whole genomic sequencing, outbreak detection is as good as it has ever been. Given the stakes, it is imperative that operators do all that they can to prevent the chances of a foodborne illness outbreak from happening.

What are some easy ways restaurants can reduce the risk of foodborne illness?

First, make proper hand hygiene a high priority in your restaurant. Hands are a frequent source of cross-contamination within a restaurant and can potentially cause a foodborne illness outbreak. Hand hygiene starts with good handwashing technique and frequency, so ensure staff are trained properly. Gloves are intended to prevent bare-hand contact in a food preparation setting, which is very important for preventing foodborne illnesses from pathogens like norovirus. In fact, proper handwashing and gloving are two of the best ways to reduce the risk of a norovirus outbreak in a restaurant5.

Second, adopt sanitation best practices in your restaurant. Always ensure that food contact surfaces and utensils are cleaned and sanitized between tasks, and make sure to frequently disinfect touchpoints such as bathroom door handles and faucet handles, as these surfaces can contribute to the spread of foodborne pathogens such as norovirus. If possible, choose to have a standard policy that includes a daily or twice daily disinfectant schedule. During outbreak situations, consider escalating the frequency of disinfecting touchpoints to every hour, or as frequently as possible for your establishment. Ensure that employees do not come to work sick. Sick employees are major risk factors for the spread of potentially deadly foodborne illnesses such as E. coli, Salmonella, and norovirus. Make sanitation best practices a part of your daily culture and focus on executing these tasks correctly and frequently.

Finally, always strive to improve compliance within your restaurant. Whether that is improving handwashing compliance, adhering to Standard Operating Procedures (SOPs) for cleaning compliance, or ensuring proper use of sanitizers and disinfectants, these will all have a measurable impact on reducing risk of foodborne illness. To help drive a culture of compliance,  be sure to choose high performing products with quick kill times and an ingredient safety profile that staff will enjoy using.

With products backed by decades of scientific expertise and trusted by guests for providing effective protection from germs, The PURELL SOLUTION™ for Foodservice shows you care enough to provide the very best to those who matter most—the ones who take the orders and people who place them.

1. https://www.fda.gov/food/retail-food-industryregulatory-assistance-training/retail-food-protection-employee-health-and-personal-hygiene-handbook#foodborne_illness

2. https://www.cdc.gov/foodborneburden/index.html

3. Robert Scharff. Economic Burden from Health Losses Due to Foodborne Illness in the United States. J Food Prot 1 January 2012; 75 (1): 123–131.

4. Bartsch SM, Asti L, Nyathi S, Spiker ML, Lee BY. Estimated Cost to a Restaurant of a Foodborne Illness Outbreak. Public Health Rep. 2018;133(3):274-286.

5. Duret, S., Pouillot, R., Fanaselle, W., Papafragkou, E., Liggans, G., Williams, L., & Van Doren, J. M. (2017). Quantitative Risk Assessment of Norovirus Transmission in Food Establishments: Evaluating the Impact of Intervention Strategies and Food Employee Behavior on the Risk Associated with Norovirus in Foods. Risk analysis : an official publication of the Society for Risk Analysis, 37(11), 2080–2106.

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