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AFFI reviews current screening methods for public health and regulatory policy

September is the month of Food Safety Education and, in recognition, the American Frozen Food Institute (AFFI) and the International Fresh Produce Association (IFPA) will host a virtual meeting Food Safety Forumwhere they will bring together global research experts, industry professionals and food safety policy leaders to discuss emerging issues related to non-culturable foodborne pathogens.

Enteric viruses such as hepatitis A, noroviruses, and protozoan parasites such as Cyclospora and Cryptosporidium are foodborne pathogens associated with different types of food and have been implicated in outbreaks. Concerns about these pathogens have led to calls for more routine product testing and surveillance throughout the food supply chain; however, the detection of these pathogens has several limitations.

Speakers at the Food Safety Forum will discuss the technical challenges and regulatory issues associated with detecting these pathogens and interpreting the results.

The following are excerpts from interviews with Jennifer McEntire, IFPA Director of Food Safety and Standards, and Sanjay Gummalla, AFFI Senior Vice President of Scientific Affairs, discussing the importance of the forum and scientific discussions from the perspective of food safety and public health.

Questions: Why is the Food Safety Forum now addressing non-culturable foodborne pathogens and why are AFFI and IFPA encouraging participation from industry, government and academia?

McEntire (IFPA): While concern has increased over the prevalence of these pathogens in foods, they present distinct detection problems not seen with bacterial pathogens. This forum will outline the differences between bacterial and nonculturable pathogens such as Hepatitis A, Norovirus, and Cyclospora. For example, they cannot be propagated through pre-enrichment, selective enrichment, or selective seeding, which are the gold standards used in the identification of bacterial pathogens such as Salmonella either listeria. Awareness of this topic is relevant to all food safety professionals.

Gummala (AFFI): Unlike bacterial pathogens that can be grown in large numbers in a laboratory, enteric viruses must be isolated from food or the environment by concentration and purification, followed by nucleic acid extraction, before a method can be applied. detection such as PCR. The forum will help attendees better understand these steps and the implication of positive findings, and public health and regulatory considerations. All stakeholders should have a better understanding of this topic as requests for food product testing increase.

Questions: Do these pathogens grow in food? If we can’t culture these pathogens and they don’t grow on food, how do we determine contamination?

Gummala (AFFI): No, they don’t grow on food and that’s a good thing. But since these pathogens cannot be cultured, the question we must ask ourselves is: “is being able to detect a fragment of nucleic acid synonymous with contamination?” While a suspected bacterial pathogen such as E. coli either listeria monocytogenes it can be cultured in a laboratory to confirm its presence and viability, there is no such possibility with nonculturable pathogens. Instead, we use PCR-based methods, such as tests for SARS-CoV-2 detection in clinical settings.

McEntire (IFPA): In the FDA BAM detection protocol for Cyclospora, the agency outlines certain PCR thresholds, but questions remain about the reliability of PCR testing in foods where these pathogens are heterogeneously distributed and may occur only in low numbers. This situation leads to a complex and ambiguous regulatory interpretation of “what” constitutes “an indicator of contamination” and whether a nucleic acid finding determines contamination or adulteration.

Questions: How is sample positivity currently determined?

Gummala (AFFI): While the signal from a PCR test may be positive, evidence of food contamination remains unclear. In addition, confirmatory approaches may support the original PCR-based positive finding, but none of these methods have been adequately investigated, published, or routinely used by the technical community.

McEntire (IFPA): Specifically for Cyclospora, the organism appears to have a complex life cycle and is only infectious during one phase of its life. So even if there’s a positive PCR, you can’t tell which version of the organism was there, even if it’s viable.

Questions: What other components can inform the risk?

McEntire (IFPA): Given the limitations of testing and the uncertainty of what a positive test for the presence of nucleic acid may mean, there are a variety of other factors that must be evaluated during the review of a potentially positive PCR test result. This could include a review of the presence of worker illnesses on the farm or facility, a review of site sanitation, and the use of Good Manufacturing Practices (GMP) or Good Agricultural Practices (GAP). Understanding the full public health risk is important to inform food safety decisions.

​​Questions: What resources are available to help these communities reduce risk from these organisms?

Gummala (AFFI): AFFI recently launched an enteric virus control specialist certification program in association with the International Food Protection Training Institute. This includes courses that address best practices in worker health and hygiene, controlled water use, waste management, and sanitation of equipment and tools. The course is based on AFFI Enteric Virus Control Programa free resource available to all growers and processors of produce.

McEntire: IFPA and AFFI are working closely with the FDA in support of industry prevention strategies for specific product and hazard pairs, including berries and Hepatitis A, and we will share any new insights or insights we gain. For Cyclospora, we have a Technical Bulletin Free for industrial use. But honestly, we need to better understand this organism and the routes of contamination. We don’t want the industry to waste resources implementing programs that will have no impact.

Questions: Why should food safety experts be interested in learning more about nonculturable foodborne pathogens?

Gummala (AFFI): We are at the crossroads of setting significant precedents in our approaches to determining “indicators of contamination,” “adulteration,” and attributing “public health risk” associated with nonculturable pathogens. It is important that all stakeholders in the food safety community understand the limitations in the methods, how we assess contamination and regulatory compliance, and the impact on public health. We are excited to host the Food Safety Forum and drive scientific awareness, debate and understanding of this challenging topic. We welcome food industry professionals to join us virtually on September 21, 2022 at 11am Eastern Time.

This information was provided by AFFI. For more information, see

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