3 replies to this topic

[CaptainCalzone]

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!

[kconf]

In my opinion - when it is found within product itself. But I would be thoroughly investigating any zone 1 positives. Also, confirm with your lab for speciation. Do vector swabbing to find the spot. Then swab again after sanitation. 

 

In scenario 1- If you can identify the source, and are confident that it did not originate from raw material, you shall not report. 

[kfromNE]

The FDA doesn't require you to notify them if you have a EMP positives. Zone 2 and 3 do not require them to be notified. When you would have to notify the FDA - only if you tested zone 1 and you can't capture those items in-house inventory which would result in a Class I recall. 

 

Also, what do you mean by pathogens. Are you testing specific pathogens or indicator organisms. 

Edited by kfromNE, 13 August 2024 - 07:01 PM.

[Tony-C]

Hi CaptainCalzone,

 

The main pathogen for dried dairy products is Salmonella, so I assume that the pathogen you are referring to is Salmonella.

 

For me this would depend on where the swab was taken from in your zone 3. A positive from a drain where all other swabs were clear would not warrant the same action as a positive on a food contact surface.

 

For example in a similar situation but for wet environments typically, Control of Listeria monocytogenes in Ready-To-Eat Foods: Guidance for Industry, states:

H. Corrective Actions If You Detect Listeria monocytogenes on a Food-Contact Surface

2. Recommendations regarding an RTE food

If you detect L. monocytogenes on an FCS, you should either reprocess with a validated listericidal control measure, divert to a use in which the food will not be consumed by humans or animals, send for use in food to be consumed by animals where appropriate, or destroy that lot of RTE food, and consider whether there is product in commerce that should be recalled.

 

Kind regards,

 

Tony