7 replies to this topic

[MECR0731]

We are a fresh-cut facility with RTE arils and use Primus. As of this year 2026, is it necessary to test for pathogens such as salmonella and e.coli in zone 1? A positive in this area will result most likely result in a recall since we are dealing with fresh cut fruit, right? would it be okay to consider just testing for pathogens in zones 2,3 and 4? Zone 1 would be tested for listeria spp (Listeria spp also tested in zones 1,2,3 and 4) and for indicators as well (TPC).  The final product is tested for pathogens (Salmonella and E.coli as well as listeria spp).                                                             

 

Also, a first positive on Listeria spp. in zone 1 would not call for a product hold, right? (with a negative for Listeria in product) 

 

 

[MECR0731]

Also, the method used by the lab would be BAX (PCR), which would render the positives a "presumptive positive." right?  However, this should be treated as a positive, since a reputable lab is being used, right? 

[Scampi]

I cannot understand why you think you shouldn't test for pathogens in zone 1 if they are a risk to your process and you have controls in place (you do, right?)

[TimG]

I cannot understand why you think you shouldn't test for pathogens in zone 1 if they are a risk to your process and you have controls in place (you do, right?)

I too was 'strongly advised' if I started an env mon program to never test zone 1 first but to test at the zone decided in the RA and then move in from there if anything is found.

I was told a combination of seriousness of the issue (zone 1) and false positives could be costly.

Thankfully I've never transitioned over to higher risk product, so I've never had to research that directive.

[humpal]

From my understanding it does not technically say you are required to hold product in zone 1, however, in my experience, i would always hold product. I think that would be a corporate decision to make. I personally would not allow FSQA Manager to make that decision.

[Scampi]

here is some really good guidance

https://www.freshpro...of-listeria.pdf

 

FDA recommends testing product contact surfaces (for Listeria spp.) and occasionally testing finished product (for L. monocytogenes), the results of which are more difficult to interpret in operations that lack a kill step, like fresh produce. Like all FDA guidance (unless it expressly says otherwise), the guidance contains “nonbinding recommendations”; i.e., they are not enforceable as written, but do reflect FDA’s current thinking. FDA also references the Investigations Operations Manual 2018 when defining zoning in the processing facility (US FDA, 2018c).

 

https://www.fsis.usd...RTE_Testing.pdf

[MDaleDDF]

If it were me I'd Ultrasnap protein swab zone 1, zone 2 I would test for paths you're at risk for (I do listeria, salmonella, APC, enterobac and Y+M, but it will vary depending on your product.  I dunno about fruit).    Zone 3 I do listeria and salmonella, zone 4 investigative only....

[MECR0731]

Thank you all for your answers.  Yes, we currently test for pathogens as well as Listeria spp. on zone 1. The reason I am asking is because we had a consultant say we could probably get away with testing fro indicators and Listeria app, not pathogens (not for e.coli or salmonella on zone 1 unless there was a reasonable reason to investigate zone 1, like multiple positives on other zones or a positive on zone 2.)