Without proper controls, Listeria monocytogenes or other pathogens can spread throughout a food processing facility, finding their way into places that are difficult to reach, clean and sanitize. If they find such a home, they can persist over long periods of time, potentially finding their way onto processing equipment and into finished products. In turn, as we all know, FDA (and, increasingly USDA) has been aggressively sampling for pathogens in food facilities, using so-called “swab-a-thons” to investigate a problem or test the effectiveness of food facilities’ sanitation programs. Given the risks associated with the presence of pathogens, our firm has always advocated conducting periodic facility-wide microbiological sampling studies to ascertain whether any strains are persisting in the environment — in essence, to test more, not less.

While conducting a swab-a-thon, FDA will typically collect at least a hundred samples from drains, ducts, processing equipment, and any other place pathogens might hide. Positive samples, if there are any, are genetically fingerprinted using Whole Genome Sequencing and compared to other environmental and clinical isolates in the growing GenomeTrakr database. In the unfortunate event that a positive sample matches an illness (or illnesses) in the database, FDA will likely insist on a recall and/or initiate other aggressive enforcement actions, even if the illnesses occurred years ago. Worse yet is the potential for criminal charges being brought against a company or its executives, which is an additional risk that has become increasingly likely in recent years.

Fortunately, there are measures companies can take to better understand the potential risks within their facilities and significantly reduce the likelihood that the regulators will find pathogens lurking in the environment the next time they visit. One such measure is “to play FDA or USDA for a day,” and conduct your own facility swab-a-thon. Evaluating your facility’s microbiological profile is not only a good way to identify areas of potential concern, but also to eradicate any existing contamination before the contamination can find its way into products.

Subjecting any positive samples to genetic fingerprinting can help to identify the possible presence of resident strains in the facility. Increasingly, our clients are using these techniques to help find resident strains and eliminate them. If, over time, a strain is repeatedly identified, there is a good chance it is resident, rather than transient. Mapping the locations where the serial-isolates are found can be useful in helping to identify likely locations for any potential harborage.

Of course, there may be risks associated with conducting this type of facility-wide investigation, and it is important to protect any potentially compromising information, lest it be used against you by plaintiff lawyers or regulators. To safeguard this type of information, companies can work with their attorneys, who can direct the types and locations of sampling, thereby shielding the information through the use the attorney-client privilege. By using the privilege to protect any information revealed by their own swab-a-thon findings, companies can carry out their mandate — making their products safer and less likely to become contaminated — without having to worry about being punished for going the extra mile to improve their systems and better understand the microbiological profile of their facilities.

In our view, more testing is always better, and doing so can help decrease, or even eliminate, your invisible risks completely.

We should be testing more, not less

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