At less than a month away from 2024, we wanted to share some key highlights of 2023 from the food hygiene and sanitation industry sectors within North America:
(a) Foodborne illnesses and food recalls on the rise
According to the CDC, foodborne illness causes 1 in 6 Americans (or 48 million people) to get sick, 128,000 people to be hospitalized, and 3,000 people to die each year. Apart from the human cost, foodborne illness also causes the US economy to lose a whopping $15.6 billion or more yearly.
Here are notable sanitation-related outbreaks (1) from 2023:
- Packed frozen strawberries from wholesale and retail outlets were implicated in the Hepatitis A virus outbreak, potentially indicating poor employee hygiene practices during packing and handling.
- Packed raw oysters were the source of a Norovirus outbreak in restaurants and retail service chains, likely because of a lack of well-developed food safety and sanitation culture in these settings.
- Listeria monocytogenes illnesses across various states were linked to minimally processed, cut, and packed lettuce manufactured at a processing facility.
In terms of North American trends in food recalls, according to a credible industry statistics report (2), food allergens, bacteria, and foreign material remained the top three agents responsible for most of the recalls, although a bulk of undeclared allergens were likely due to mislabeling rather than allergen cross-contact issues. Foreign material contamination continued to be an issue, with fragments of wood, metal, plastics, glass, rocks, and even rodent droppings ending up in food products. Surprisingly, the same report says that 2023 as whole may witness more annual food recalls than what we have seen over the last 5 years!
Below are some sanitation-related recalls (3) from 2023:
- There was a massive recall of raw milk cheddar cheese packages from Canadian shelves due to Listeria monocytogenes contamination during processing.
- A huge recall of packaged flour was issued due to Salmonella contamination during the grinding and packing operations at a milling company.
- Oatmeal cookies were recalled from shelves due to potential contamination with wood pieces.
(b) Recent BRCGS audits and FDA inspections on sanitation non-conformances
BRC Global Standard for Food Safety Issue 9 was launched in August 2022, and transition audits began in February 2023. After almost a year of certification audits under this new Issue (4), the given top 5 non-conformities revealed significant gaps in sites’ hygiene and sanitation programs were:
- Premises and equipment were not maintained in a clean and hygienic condition (Clause 4.11.1)
- Processes were not in place to manage the use, storage, and handling of non-food chemicals to prevent chemical contamination (Clause 4.9.1.1)
- The design and construction of equipment was not based on risk; hence the equipment was not of hygienic design that would prevent product contamination (Clause 4.6.2)
- Doors, either external or internal, were not maintained in a good condition (Clause 4.4.8)
- The walls were not finished and maintained properly to prevent the accumulation of dirt, minimize condensation and mold growth, and to facilitate cleaning (Clause 4.4.1)
The violations observed during FDA inspections reveal a similar story regarding non-conformances in FDA-registered plants. In fiscal year 2023 (5), the following top 10 equipment and environmental sanitation-related non-conformities were observed during inspections:
- 21 CFR 117.35(a): Sanitary operations - plant maintenance = The facility was not maintained in a clean and sanitary condition.
- 21 CFR 117.35(c): Pest control = Sanitation of the premises may be inadequate to prevent any pest ingress and infestation.
- 21 CFR 117.80(c): Manufacturing, packing, holding - controls = Such controls could be inadequate to prevent or significantly minimize microbiological or allergen cross-contamination issues, which may affect food products.
- 21 CFR 117.40: Equipment and utensils – design and maintenance = Equipment and utensils may not be hygienically designed or constructed so that they can be adequately cleaned or maintained.
- 21 CFR 117.20(b): Plant construction and design = The facility was not hygienically designed or constructed to facilitate maintenance and sanitary operations.
- 21 CFR 117.35(a): Sanitary operations - plant sanitation = There was inadequate or inappropriate cleaning and/or sanitization of equipment, utensils, and other surfaces of importance.
- 21 CFR 117.35(d): Sanitation of food-contact surfaces – frequency = Regular cleaning and sanitization of food-contact surfaces such as utensils or equipment at a frequency based on risk assessment was not practiced.
- 21 CFR 117.135(c)(3): Sanitation preventive controls = There were inadequate sanitation preventive controls necessary to significantly minimize or prevent food safety hazards of concern.
- 21 CFR 117.93: Storage and distribution = There were instances when food wasn’t stored or transported under conditions that would protect it against various kinds of contamination.
- 21 CFR 117.20(a): Grounds = The outside environment around the plant was not kept in a condition that would protect food against contamination incidents.
For information on the last six years of trending FDA inspection sanitation observations (6), please take a look at the informational poster we presented at IAFP 2023. This data, collected from the fiscal years 2006-2022, can help you assess the common weak points in food safety and sanitation plans.
(c) New Listeria control policy in Canada
A revised Canadian policy on Listeria monocytogenes for ready-to-eat (RTE) foods (7) came into effect on Oct. 1, 2023. This replaced the 2011 version. The updated policy now considers the following sanitation-related factors that could introduce Listeria into foods during the post-processing areas before food is packaged:
- Infrastructure
- Plant layout (traffic control, separation of equipment and utensils between raw and RTE areas, etc.)
- Equipment design and maintenance (for example, equipment that require disassembly, like slicing equipment)
- Effectiveness of sanitation
- Employee training and practices
More importantly, Listeria monocytogenes is notorious for surviving difficult environment as microbial biofilms. Therefore, mechanical or manual cleaning is necessary to remove stubborn soils and destroy early maturing biofilms. Our white paper on biofilm control (8) is available at: The Role of Manual Cleaning in Biofilm Removal (ipaper.io).
A Look Ahead at Food Safety in 2024
The key food-safety-related developments to look out for in 2024 are as follows:
(a) Cronobacter sakazakii, an infectious agent of concern
After the 2022 US outbreak linked to powdered infant formula, the Council of State and Territorial Epidemiologists has voted to include Cronobacter sakazakii on the CDC’s notifiable diseases surveillance system by 2024. (9) Some other foodborne pathogens on the current list of nationally notifiable diseases include Salmonella, Escherichia coli, and Listeria monocytogenes.
Cronobacter sakazakii is an environmental pathogen found in nature primarily in soils and on common surfaces. It is found almost everywhere and thrives in low moisture or low water activity foods of less or equal to 0.85 (aw). The pathogen affects mainly the spinal cord of neonates, or babies less than 6 months old, typically resulting in a fatality. The best control for preventing the spread of this pathogen in dry facilities is to avoid moisture in dry areas.
More importantly, manufacturers of low-moisture products such as infant milk powders (where Cronobacter is a pathogen of concern) will need to have environmental monitoring and sanitation controls such as appropriate dry sanitation programs. Further information about Cronobacter control in dry environments (10) is available at: Controlling Cronobacter: A Pathogen of Concern in Dry Environments and Low-Moisture Foods - Remco (remcoproducts.com).
(b) PFAS, a matter of regulatory focus for food contact applications
Per- and polyfluoroalkyl substances, or PFAS, are a diverse group of synthetic chemicals that resist grease, oil, water, and heat. For these reasons, PFAS have historically been used in following food contact applications – including items like:
- Coating on non-stick cookware
- Resin that makes up the gaskets or O-rings on food processing equipment
- Processing aids for manufacturing food contact polymers used on food equipment
- Grease-proofing agents used in fast food wrappers
However, these so-called “forever chemicals” do not decompose naturally, are persistent in the environment, bio-accumulate in the body, and are toxic to human health.
Moreover, these chemicals also contaminate drinking water supplies and have therefore become a US regulatory focus when it comes to using them for food-contact surface applications (11).
(c) Upcoming global standard versions and updates
In 2024, the following global food safety standard updated versions will come into effect:
