RTE Listeria and L. Mono Reporting?
If we test our RTE finished product for Listeria and it comes back positive, do we have to report this to a regulatory agency? Do we have to determine if it's L. mono, and are reporting requirements different if so?
Short answer: no to reporting and no to requiring further testing for L.mono. Recommendation though: treat it as an L. mono positive internally. Do a thorough investigation and figure out where it's coming from, document the process, and eliminate the harborage. Destroy the product. If you send product out that later tests positive for L. mono - then yes, this is different and would require full recall and report.
Hi Glenn,
Strangely the article in yr link seems to be undated.
The first link in article gives for me a "not found".
The second link yields a draft pdf dated 2017.
Just curious.
@MsMars - it might depend on the Product ?
If we test our RTE finished product for Listeria and it comes back positive, do we have to report this to a regulatory agency? Do we have to determine if it's L. mono, and are reporting requirements different if so?
Have it tested for Lm. Start the internal recall now. Hold the product until the results come back (takes a few days). If it is Lm and there is product out in commerce - you must do a recall and report to it to a regulatory agency. If it's Lm and you have all product under your control - you don't need to inform any regulatory agency. Destroy the product and do an internal investigation to find the source.
If it's a non-pathogenic listeria species - perform an internal investigation to find the source.
In our facility we use this as our guidance document: https://www.fda.gov/...ready-eat-foods
If it reached your customers then yes you report it and it's a recall. If not then no. It's an internal issue.
Also worth factoring in customer base, i.e. RTE foods going to vulnerable consumers may have different parameters for L.mono and will potentially require reporitng of any listeria presence, even non-pathogenic.