TORONTO – Looking into the root cause of incidents can help efforts to prevent future issues, according to recent presentations by the new International Association for Food Protection (IAFP) president.
Tim Jackson took up the role of president at the conclusion of IAFP 2023 in Toronto, Canada, replacing Michelle Danyluk. Jackson is also a senior science advisor for food safety with the U.S. Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN).
In one of several talks, Jackson said FDA separates root cause analysis (RCA) and root cause investigation with the latter helping inform the former to find out what caused the problem.
Complexities and potential controls
A root cause investigation occurs mainly during an outbreak to investigate potential failures and involves traceback information, firm inspections, records and verification data. A RCA looks at information generated during the response and tries to understand how an event occurred.
The first presentation focused on RCA to identify causes of viral and parasitic outbreaks. In the U.S., several hepatitis outbreaks have been linked to fresh and frozen berries in recent years while norovirus is another issue. Also, Cyclospora cayetanensis has been associated with ready-to-eat and other types of fresh produce in the U.S. and Canada but Cryptosporidium, Giardia and Toxoplasma gondii are other concerns.
Challenges include investigations being conducted after an outbreak or issue is over; analytical testing is statistically limited and often inconclusive; fresh produce has a short shelf life and may not be available for analysis; in multi-component or assembled products the supply chain is complex; limited tools for analysis of some agents and insufficient evaluation of underlying causes.
Control measures at the growing stage include condition and treatment of irrigation water and proximity to animal production. During harvesting, hygienic design of equipment and tools and worker cleanliness are important. At the cooling and packing or storage and distribution stages, pest control must be considered.
Jackson spoke about the “Swiss Cheese Model” with the idea being a variety of defenses lining up to prevent problems occurring and if an issue gets past one defense it might be blocked by the next one. He said product testing is statistically limited and hygiene indicators like E. coli in water testing do not necessarily line-up with the presence of pathogens.
“Usually there is no smoking gun found. In that case, you need to identify all potential root causes and implement corrective or preventive actions around those systems that are needed to control the hazard. In many cases ongoing verification may be needed. Root cause investigations and RCA require resources across stakeholders and disciplines,” he said.
Outbreaks and recalls are visible indications of food safety system failures. Less visible are near misses uncovered by verification of processes, materials, growing and manufacturing environments through measurements, inspections and sampling programs.
In a second talk, Jackson said more outbreaks are being seen because advances in whole genome sequencing and other technology are helping link cases from the background noise.
“In some cases we see outbreaks over and over again that happen every year, occasionally there is one like a Black Swan, that happens out of the blue but we want to make sure that we’re not just reacting to outbreaks but that we’re thinking about what we learned and helping to prevent them from happening again,” he said.
“One example is enoki mushrooms, we had recurrent issues of Listeria monocytogenes from certain regions in Asia. We don’t know exactly what the failure is in manufacturing to cause the issue. A prevention strategy was developed that looks at communication and stakeholder engagement. We’re translating the Produce Safety Rule into Korean. During outreach to understand differences in enoki mushroom consumption we discovered that in Asia they are boiled, in the U.S. we don’t think we have to cook mushrooms. We have an import alert on mushrooms from certain countries and are conducting research to understand risks and controls.
“The second example is Cronobacter sakazakii in powdered infant formula. We saw some recurrent issues from assessments of these manufacturers. We met with stakeholders to talk to them about the challenges. We issued a recommendation letter based on what we’ve seen in our inspections but there’s other work to establish a medical foods team, develop a tool for data-driven inspection and compliance, update the infant formula compliance policy guide, conduct education for FDA regulatory staff to target what the concerns are and there are long term actions around regulations and guidance development.”
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