12 replies to this topic

[Josharp186]

Hello, 

 

I work for a Spice company. We do not import directly and all product procured comes treated for pathogens with a negative COA for both Salmonella and E. Coli. I also perform environmental pathogen swabs for both of these organisms monthly. 

 

I have been re-evaluating the program and looking for scientific background for each environmental concern just to have the risk analyzed and make sure I am not doing too much or too little. We have never had a positive finding for either of these pathogens. Auditors keep recommending different strategies, some more and some less and its not become helpful at this point. 

 

My main question, why is E. Coli recommended for the environmental monitoring? I have spoken with other spice producers and they swab for this. I am not finding literature and studies about environmental risks for this pathogen. The risks seem to be associated with unsterilized raw material. If my product is coming in with COA my employees are city slickers not working on farms is the risk viable enough to keep swabbing? 

 

There is extensive FDA guidance around salmonella but I am failing to find environmental suggestions around E. Coli. Coliform swabs would make sense to monitor employee GMPs I suppose but that's not pathogenic E. Coli. 

 

TLDR; Does guidance exist for spice manufacturing recommending the monitoring of E. Coli in the environment?

 

Thank you.

 

 

[kconf]

Because all ecoli are also coliforms, but not all coliforms are ecoli. As long as you do not have a coliform that is ecoli, you are good. Certain strains, such as 057 are toxic. 

[Josharp186]

Post with quotes below

Edited by Josharp186, Yesterday, 03:09 PM.

[Josharp186]

Because all ecoli are also coliforms, but not all coliforms are ecoli. As long as you do not have a coliform that is ecoli, you are good. Certain strains, such as 057 are toxic. 

Right, monitoring for coliform would essentially tell me there is not O57. But this would not be a huge concern from employees unless they are visibly sick. Humans are not typically vectors for this. 

Do you have any suggestions for my other questions?

[kconf]

You said it would make sense to test coliforms. What would that tell you? 

 

What method is your lab using for ecoli detection? 

[Josharp186]

You said it would make sense to test coliforms. What would that tell you? 

 

What method is your lab using for ecoli detection? 

I should specify, and maybe redact that sentence, I am just theorizing on what coliform (if any) would make sense to swab? Employee GMPs and handwashing would, in my opinion, be of higher risk than tracking in pathogenic E. Coli. When I worked cheese, I used to trend coliform, yeast/mold, and APC after zone 1 cleans as well as employee gloves. But we didn't swab for E. Coli in the environment.

 

Our test method currently is looking for E. Coli through PCR(BAM Chp 4)

[kconf]

Right. Tell me more about your process then. 

[Josharp186]

Right. Tell me more about your process then. 

Spices are purchased from approved suppliers domestically. Spices and seasonings are all treated through ETO, PPO, or Steam prior to acquisition. Spices are then packaged from raw material state into consumer size bottles and sachet pouches within high care rooms. We do not blend or mix, this all occurs with blending suppliers. Process is fairly simple with little points for outside contamination or from untreated material. 

[jfrey123]

I'm 10 years out of my old spice company but can confirm the e. coli concern was just kind of "common" industry knowledge everyone repeated often.  Closest explanation I got back then was that e. coli is a common concern from vegetables in general, and despite spices being dried and even treated with COA testing, it remains a concern due to the parent materials.  They'd also point to employee GMP practices, specifically improper handwashing after restroom use, as a common source of e. coli spread and hence a hazard to include.

 

While not environmental specific, the FDA's hazard analysis guide (Draft Guidance for Industry Hazard Analysis and Risk-Based Preventive Controls for Human Food: Appendix 1 (January 2024)) has some of the most up to date pathogen guidance for spices and seasonings in general which I have seen.  Check pg 74-75.

 

Back to that old spice job of mine, we purposely kept our operation for grinding and blending as dry as possible, and we had years of negative pathogen swabbing data showing our practices were good overall.  To address auditor concerns that we weren't looking hard enough, we added discretionary swabbing to our routine monitoring spots to try and show each month we are looking at hard to clean areas with proper scrutiny.  

[kconf]

jfrey beat me to it. 

[Josharp186]

I'm 10 years out of my old spice company but can confirm the e. coli concern was just kind of "common" industry knowledge everyone repeated often.  Closest explanation I got back then was that e. coli is a common concern from vegetables in general, and despite spices being dried and even treated with COA testing, it remains a concern due to the parent materials.  They'd also point to employee GMP practices, specifically improper handwashing after restroom use, as a common source of e. coli spread and hence a hazard to include.

 

While not environmental specific, the FDA's hazard analysis guide (Draft Guidance for Industry Hazard Analysis and Risk-Based Preventive Controls for Human Food: Appendix 1 (January 2024)) has some of the most up to date pathogen guidance for spices and seasonings in general which I have seen.  Check pg 74-75.

 

Back to that old spice job of mine, we purposely kept our operation for grinding and blending as dry as possible, and we had years of negative pathogen swabbing data showing our practices were good overall.  To address auditor concerns that we weren't looking hard enough, we added discretionary swabbing to our routine monitoring spots to try and show each month we are looking at hard to clean areas with proper scrutiny.  

 

Thank you for this! I appreciate the insight from a prior spice guy. I have been using the FDA guidance for Filth in Spices which goes very much in depth on salmonella and has little to no info on E. Coli. There is some mention but this basically stems back to the parent material and agricultural processing. 

 

What you shared gives similar sentiment to what I have been researching, the table lists this specifically: 

"2 The SMEs identified Salmonella spp., but not pathogenic E. coli, as a known or reasonably foreseeable (“potential”) biological hazard in this subcategory based on a 2022 FAO/WHO report (FAO/WHO 2022b)." 

 

This is where I think there is some disconnect. It does feel like there is an industry standard to monitor but the data and industry guidance does not correlate. 

 

Our process is also kept as dry as possible which helps quite a bit. Our auditors have given us mixed feedback. Some saying we need to do more but the past two stating we were doing too much. Coming from cheese, I definitely built out too strong of a PEM program initially. 

[GMO]

It's interesting the comment around cheese, I wouldn't recommend using APCs as an environmental indicator as the starter cultures could cause false positives.  But Coliforms, yes.  In product, in the environment either coliforms or enterobacteriacae can be good indicators of overall hygiene and and would have a positive you can then sub type to potential E Coli and then HUS causing strains below that if needed.  I'd certainly have a hygiene indicator of some kind if you can.

[Josharp186]

It's interesting the comment around cheese, I wouldn't recommend using APCs as an environmental indicator as the starter cultures could cause false positives.  But Coliforms, yes.  In product, in the environment either coliforms or enterobacteriacae can be good indicators of overall hygiene and and would have a positive you can then sub type to potential E Coli and then HUS causing strains below that if needed.  I'd certainly have a hygiene indicator of some kind if you can.

 

APC was indicator swabs used only on zone 1 after full sanitation. It was a way to measure cleanliness as well. Cultures did create false positives but in this case it was to make sure we started without any bacteria, even the good ones.