Sample6 DETECT/L & USDA: Enrichment-Free in an Enrichment World
DETECT/L received the Performance Tested Method (PTM) certification by the AOAC Research Institute (AOAC-RI) in April of 2014. That’s the first time an enrichment– free, in-shift pathogen test received this certification.
However, our customers were confused because there is language in the FSIS guidelines on ready-to-eat foods with regards to the control of Listeria in the environment is conflicting. Local FSIS inspectors, too, were unsure what the USDA's position is so there were a lot of questions and not enough answers. We worked with our customers and the USDA to sort that out. Let’s dive in quickly to understand what the actual language is, but I promise I keep the regulator-ese to a minimum!
“1) An enrichment step is used to allow for recovery of injured organisms and growth of Listeria to levels that can be detected by most testing methods. Many commonly used testing methods are unable to detect levels below 100 cells/sample. Therefore, it is important that the enrichment step be designed to allow low levels of cells that may be present in the sample to grow to detectable levels. It is also important to allow injured cells time to recover so that they can be detected by the testing method. In most cases, at least an 8-hour enrichment is needed to achieve adequate levels of Lm growth for detection. A one-hour resuscitation step is not an enrichment step, and would likely not be sufficient to detect low levels of Listeria spp.
These are good and high standards for the safety of RTE food as there is no kill step in between the end of production and your mouth!r Lm.” Interestingly they also specifically note that plating without enrichment is also insufficient: “NOTE: Direct plating methods (e.g., media that is added directly to an agar plate or dehydrated media) that do not include an 8-hour enrichment step would be unlikely to detect low levels of Listeria spp. or Lm.”
However, there had never been an AOAC certified in-plant, in-shift enrichment free test before. And behind the guidelines, there is a great team at the USDA who is interested supporting new novel technologies that keep the food supply safe.
So, we reached out to the USDA FSIS and here's what happened:We were enthusiastically welcomed to educate them on our new technology and debate pros and cons. In fact we learned the USDA holds quarterly seminars to learn about new technologies in the marketplace and maintains an active outreach program. We presented to a select group from all divisions at the USDA on August 6, and the reception of our test after review of the scientific basis and certification information was great. Shortly thereafter three things happened:
- We have been included in the Food pathogen Kit table (L092) available on the USDA website as a resource.
- The USDA FSIS issued a first, and promised to issued more, specific responses to any question that a producer of a FSIS-inspected plant has on this test via the askFSIS mechanism.
- Last but certainly not least we're working with the USDA to issue a specific FAQ that puts greater nuance on the acceptability of enrichment-free tests as well as procedures to ask for guidance on the acceptability of said test.
Sample6 DETECT/L test meets the USDA FSIS standards for use in their facilities and we are proud to contribute to the increase in food safety!
So does this mean that an enrichment is no longer required?
Only if you are using DETECT. The guidelines were set up based on the state of the art technology at the time. The USDA made a determination in the past that science wasn't sufficiently advanced to warrant jeopardizing the safety of the food supply by moving away from stringent performance criteria. Based on a clear understanding of our test, the USDA has approved DETECT for use.