The recent Abbott Nutrition infant formula investigation in the US, is a reminder that food safety risk can sit in the production environment as well as the product. HACCP International Global Certification manager, Rachel Meryment, looks at what manufacturers should consider when selecting, maintaining and reviewing equipment and materials.
Food manufacturers rightly devote enormous attention to ingredients, allergens, process controls and finished product testing. But food safety risk does not begin and end with the food itself.
The equipment, surfaces and materials surrounding a production process can all influence food safety. So too can water management, cleaning, maintenance and the condition of equipment over time.
The recent Abbott Nutrition settlement in the US provides a timely reminder of why these areas matter.
On 14 September, Abbott agreed to pay almost US$385 million to resolve allegations concerning powder infant formula and nutritional therapy products manufactured between 2018 and 2022 at facilities in Sturgis, Michigan, and Casa Grande, Arizona. The US Department of Justice alleged that certain products had not been manufactured in compliance with applicable requirements. The settlement resolves disputed allegations and does not constitute a finding of fault or liability. Abbott denies the allegations.
While the legal issues are specific to Abbott, the case raises a much broader question for food manufacturers. What happens when the production environment itself becomes part of the food safety risk?
Looking beyond the product
The FDA investigation of Abbott's Sturgis facility in 2022 identified significant operational deficiencies.
FDA investigators identified environmental Cronobacter sakazakii, cracks in spray dryers, water leaks and condensation, as well as concerns relating to process controls and the maintenance of food-contact surfaces. The FDA did not establish definitive evidence that conditions at the facility caused the reported infant illnesses.
The lesson for the wider industry is therefore not that a particular equipment fault caused a particular illness. Rather, it is that food safety depends on selecting equipment suited to its intended environment and maintaining it appropriately throughout its working life.
Rather, it is that food safety depends on both selecting equipment that is suitable for the intended environment and maintaining it appropriately throughout its working life. Preventative maintenance is already an established part of Codex HACCP plans and GFSI-benchmarked food safety management systems, and this case highlights the importance of following those procedures consistently.
A crack in equipment may create an area that is difficult to clean effectively, and create an environment for the growth of bacteria, mould, and difficult to remove biofilms. Moisture in a dry-processing environment can increase the water activity of the food product and, in turn, increase microbiological risk. A degraded surface may also no longer perform as intended.
These are not simply engineering issues. They can become food safety issues.
Is the product suitable for its intended use?
Selecting products and equipment for food facilities requires more than accepting a broad claim that something is “food safe” or “food grade”.
The key questions are who has made that assessment, what evidence supports it, and whether the product has been evaluated for the specific environment and application in which it will be used.
A product may be suitable in one application and not in another. The strength of any “food safe” claim depends on the evidence behind it and its relevance to the intended use.
A flooring system suitable for a dry storage area may not be appropriate in a wet processing environment. Likewise, equipment that requires disassembly for effective cleaning may not be suitable for a clean-in-place (CIP) system.
Food safety suitability can therefore involve considerations such as materials, design and construction, cleanability, potential contamination hazards, operating conditions, installation requirements and maintenance.
That assessment should start before the product enters the facility.
Procurement is a food safety decision
Procurement is often viewed through the lens of price, performance, durability and supply. In a food environment, it also forms part of food safety management.
Before approving equipment, materials or other non-food products, manufacturers should understand exactly what the product is intended to do and where and how it will be used. Instructions for use, safety data sheets, technical documentation and certification can all help establish whether the product is appropriate for the intended application.
Could it come into direct or indirect contact with food? How will it be cleaned? What operating conditions will it experience? Could deterioration introduce a physical, chemical, microbiological or allergen hazard? What maintenance or replacement will be required?
The next question is equally important:
What evidence supports the supplier's claims?
That evidence might include technical specifications, information about materials, relevant testing, instructions and limitations of use, maintenance requirements or independent certification.
The type and level of evidence needed will depend on the product and the food safety risk involved. More documentation does not automatically mean better evidence. It needs to be relevant to the exact product and the way it will actually be used.
This applies to far more than processing machinery.
Flooring, walls, drainage, cleaning chemicals and equipment, lubricants, protective clothing, lighting, pest control products and monitoring equipment can all influence food safety, even when they are not intended to become part of the food itself.
Suitability can change
Initial approval confirms that a product is suitable at that point in time. Food businesses also need to consider whether it remains suitable as equipment wears, operating conditions change or maintenance issues arise.
Routine inspection and effective preventative maintenance help identify damaged surfaces, worn seals and cracked or corroded equipment before they compromise food safety. Changes in cleaning regimes, production conditions, suppliers, formulations or intended use may also require reassessment.
Food businesses need to know what deterioration looks like, what maintenance is required and what should trigger a review.
At procurement, the question is: Is it suitable?
During its working life: Is it still suitable?
Don’t overlook cleaning and maintenance products
Food businesses should also consider the suitability of consumables used to clean, maintain and operate equipment. Gloves, sanitisers, lubricants and cleaning tools may come into direct or indirect contact with food or food-contact surfaces.
The same questions apply: is the product suitable for that application, and what evidence supports that assessment? A sanitiser may need to be suitable for food-contact surfaces, while a cleaning tool should not introduce a physical contamination risk.
Where independent certification fits
Independent product certification can provide an additional layer of evidence during supplier and product approval. HACCP International assesses non-food products, equipment, materials and services for suitability in food handling environments.
Third-party assessment can help verify supplier claims and provide procurement, quality and food safety teams with evidence that relevant food safety factors have been considered.
Certification does not replace the food business’s own hazard analysis, correct installation, sanitation, inspection or maintenance. It supports a better-informed decision at the point of selection.
From selection to ongoing control
The broader lesson is that product selection, maintenance and verification should not sit in separate silos. Procurement may determine what enters a food facility, but food safety also depends on how that product performs once it is there. Independent certification can strengthen the evidence behind the initial decision, while ongoing inspection and maintenance help ensure that decision remains sound.
About the author
Rachel Meryment is Global Certification Manager at HACCP International, which provides independent certification of non-food products, equipment, materials and services used in food handling and manufacturing environments.
