I often describe FDA’s current posture toward finding pathogens in food facilities as a “three strikes and you’re out” approach. As FDA conducts its routine inspections, the agency is increasingly conducting swab-a-thons designed to detect the presence of pathogenic Listeria and/or Salmonella in food processing environments and equipment. The regulators are often well-trained (and highly-motivated) to search in the most difficult to clean and sanitize locations in food facilities, thus maximizing the potential for finding organisms of concern.

With the development and adoption of Whole Genome Sequencing (WGS), both FDA and USDA are now doing additional analysis to tease out the specific genetic DNA signature of pathogens when they are found in food processing environments. Once uploaded into the GenomeTrakr database, the genetic signatures can be compared against each other, other environmental findings, and even human isolates. If, while conducing its swab-a-thon activities, FDA finds the same strain of pathogenic Listeria or Salmonella in a food facility on three or more occasions, the agency will likely conclude that the pathogen is persistent and that the food company’s cleaning and sanitation programs are not effective. In addition to concluding that the company is unable to control the cleanliness and sanitation of its food processing environment, the agency will likely also issue, on the “third strike,” a Warning Letter to the company, threatening to pull its registration if the strain is not eliminated. In many instances, regardless of the true merits of the underlying Warning Letter, it can be the equivalent of a death sentence for the company as its customers may respond by sending their business elsewhere.

FDA’s policy has caused difficulty for many companies operating in legacy facilities with legacy equipment. Indeed, much of the food produced in the U.S. today is manufactured using equipment that was designed and built long before the presence of pathogens became a major focus in ready-to-eat food production. In many instances, the equipment and infrastructure are simply not designed to be easily disassembled, cleaned and sanitized. For this reason, it may actually prove, in many cases, to be nearly impossible for those facilities to completely eradicate resident strains without investing millions of dollars in new equipment and facility improvements. If the dollars are not available to do so, many of those companies will be forced to shutter their doors.

And, this may also be true without any real effect on food safety, if the resident strains are actually being controlled in critical areas and thus being kept away from the food being produced. So, while working to ensure that resident strains are completely eliminated from food facilities is a clearly noble goal, I wonder whether the cost of doing so in some cases may be greater than the ultimate benefit. As FDA and USDA continue to do more sampling in food facilities, the agencies should constantly be reminded that a resident strain won’t make people sick, even in legacy facilities and equipment, unless it is proven to actually contaminate food.

Regulating legacy facilities and equipment out of existence?

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