2 replies to this topic

[esperanza373]

Hello everyone,

We are currently revising an Environmental Monitoring Program (EMP) for a fresh-cut pomegranate arils processing facility. The facility has divided the production and post-harvest areas into the four hygienic zones (Zone 1–4), as recommended. Their routine environmental pathogen panel includes Salmonella spp., Listeria spp., E. coli, and TPC (indicator).

We are designing the response and corrective action protocols for presumptive positive and confirmed positive results. A colleague suggested a two-phase approach:

1. Presumptive positive response, and

2. Confirmed positive response.

In our plan, we are applying zero tolerance for Salmonella and Listeria spp. in all four zones—meaning any presumptive or confirmed positive in Zones 1–4 requires immediate action, including holding finished product and conducting a root-cause investigation.

However, for E. coli, the suggested approach only requires product hold and release decisions if the detection occurs in Zones 1 or 2, but not for Zones 3 and 4, even though E. coli is also part of the EMP pathogen panel.

My questions are:

🟢 Is it valid and defensible to apply hold-and-release only for E. coli detections in Zones 1 and 2, but not Zones 3 and 4?
🟢 What is the regulatory or risk-based rationale behind treating E. coli differently from Salmonella/Listeria within the EMP response structure?
🟢 Can this be justified based on the role of E. coli as an indicator organism rather than a zero-tolerance pathogen, even though we are using it in our EMP pathogen panel?
🟢 Would it be better to create a separate response protocol for indicator organisms (E. coli, TPC) versus true pathogens (Listeria and Salmonella), rather than grouping all under the same EMP corrective action matrix?

I would truly appreciate any guidance, references to FDA guidance (FSMA, RTE guidance, draft EMP document), NACMCF, or GFSI/PrimusGFS validation of this approach.

Thank you in advance for your insights!

[Scampi]

In short, the presence of e-coli in a raw agricultural product should be expected  (although perhaps less so in tree fruits)    it's presence in zone 3 or 4 should NOT have the same response as zone 1 or 2   as it gets tracked in on feet 

 

I would have the program response based on which pathogens is found where and not by pathogen specifically

[kconf]

Yes, it is valid. It depends on what you swab in zone 3 and 4. If you swab restrooms or shoe mat, for example, you will likely find e coli. But that has nothing (hopefully) to do with zone 1 and 2, let alone the actual product. 

 

For pathogens, you are correct, you cannot take a chance. 

 

I would track the pattern on TPC, coliform, EC on overall hygiene of your facility.