Hello,
I am trying to write a procedure to ensure FSMA requirements regarding EMP, specifically regarding confirmed pathogen hits - particularly in dried dairy products - regarding EMP positives of pathogens.
Currently, the policy that was adopted by my predecessor had outlined the vectoring procedure, sampling requirements, cleaning requirements, etc. etc., but there is no information or guidance on when a situation goes from "unlikely" to "reasonable probability". I have tried searching through the FDA, FSMA, and FSIS guidance documents but the only requirement I have found for mandatory reporting is "reasonable probability".
For example, when considering guidance for my team if I provide the two below scenarios I would most likely receive multiple different answers!
Scenario 1: If a pathogen is detected in an EMP swab in a raw processing area, is it to be considered unlikely that exposure to the product would cause harm as the product would go through a pasteurization step within a closed environment - as identified by HACCP analysis that the pasteurization eliminates this risk?
Scenario 2: If a pathogen is detected in an EMP swab in zone 3 in a post-lethality processing area is there any "reasonable probability" that exposure to the product could cause harm?
I think I have read that in the EU, even EMP swabs in post-lethality areas that are positive for pathogens need to be reported to the health authorities - as we do not have such a clear law like that here, in your opinion would the only time you would consider a "reasonable probability" therefore making the reporting of the issue mandatory, to be when a positive pathogen is found within product itself or within Zone 1 testing?
Thanks!