What are the pathogen testing requirements in the FSMA?
What are the pathogen testing requirements in the FSMA? We are a bakery with very low risk of pathogens. I was told we will be required to do pathogen testing of non-product zones. What is the point? How many sites should we test? We have one packaging area that is seperate from the rest of the facility. Could someone share their program?
Okay! I know this one! You need an "Environmental Monitoring Program"
Pathogens you test for will be pathogens you are at high risk for. So for me in chocolate, we monitor for Salmonella. I don't know anything about bakeries, but if you look for recalls, you will find the most common pathogens. What you're trying to do is identify a problem before it gets to your product zone / food contact surface. If I find Salmonella in a drain, I know someone washed equipment with Salmonella on it. And then I go Salmonella hunting.
You want to test according to risk - so if you're truly low risk, you shouldn't have to test very often. Take a large initial swab set of door ways, drains, anywhere high traffic or wet/warm, equipment stands & sides, crevices, along pipes, etc. If you don't find anything taking up house, hooray! Set it to monthly . If you go a few months without a hit, set it to quarterly. If you find something, you have to swab more frequently. I've never found anything in my plant, but I swab biweekly. I started with weekly swabs but the risk/time/cost math didn't add up. Always send to a certified lab.
You're going to want to think in zones - zone 1, food contact surface, zone 2 next to a food contact surface, zone 3 gross stuff in the factory, zone 4 outside of the factory.
Never swab zone 1 for pathogens. If you get a positive on a food contact surface, that's trouble. Instead swab for indicator organisms, like e bac.
Swab zone 2 a lot, and zone 3 drains and floor scrubbers like all the time.
You need to also set a corrective action for if you do find a positive. How to clean, what the corrective action timeline is, etc. For my program we clean and swab on presumptive, divert foot traffic if possible, and initiate a corrective action within 72 hours (fix the leak, clean more frequently, whatever gets rid of it). Then we swab around the area like a 360 spider web - find out where its hiding. Clean hot spots and swab until you get negatives. Some companies dont swab in presumptives, they wait. On one hand, you hope you never have to do this. On the other hand, presumptives are common and I find it gives my staff experience cleaning gross spots and paying attention to micro risk. It's more critical when you're dealing with agricultural / dirty field stuff. If you're confident there are no pathogens, you won't need Plan B.
Get some advice from someone else in baking though, I really don't know a thing about that process.
Dear Miss Tammy,
no idea regarding FSMA's specific textual expectations but you have encountered the topic as eloquently described in previous post of Risk Assessment of the Environment, ie potential Env.hazards / control.
There are a few procedures (predictably often borrowed from allergen testing equipment suppliers) already posted on this forum which pictorially elaborate how you select/handle the zones, like as in previous post.
However i also recall in USA there are specific regulatory programs,eg ex FSIS, etc for certain pathogens like L.mono.
But I would think you are fully aware of local bakery regs already ?
Rgds / Charles.C
Dear Miss Tammy:
Have a look at the attachment for your reference.
We found it from the internet and noticed that it is very useful.
Attached Files
Heart felt "Thank you" to all. The PEM document will be most helpful. I would really like to "pick the brain" of someone experienced in Food Safety in bakeries. We have numerous customer audits, and they all have an opinion on everything we do. I am trying to educate myself and not just take their word for what are correct procecdures. Many of them audit a variety of food plants, and don't understand that what is appropriate for one type of processing operation is not needed in a bakery!
Dear Miss Tammy,
Some further environmental monitoring documents here -
http://www.ifsqn.com...indpost&p=67055
There are also additional documents on monitoring environmental Listeria in the sub-link of above but probably more directed to wet processes.
Rgds / Charles.C
Thank you very much Charles. Just what I needed as I try to educate myself on the subject!
Never swab zone 1 for pathogens. If you get a positive on a food contact surface, that's trouble. Instead swab for indicator organisms, like e bac.
Many major companies are beginning to require this.
3 organisms most tested for are salmonella, listeria and E. coli.
I was told we will be required to do pathogen testing of non-product zones. What is the point?
The current thinking is that do come in the building, but are they under control, are you getting rid of them? I recently had an auditor not happy because I did not have a single listeria hit. Though it was clear that my program was intense and thorough. Auditor relented but thought I should start swabbing forklifts so I could get a hit. I'm a lady so I won't say here what I thought of that plan.
How many sites should we test?
You will need to decide that based on your processes and building.
I recently had an auditor not happy because I did not have a single listeria hit. Though it was clear that my program was intense and thorough. Auditor relented but thought I should start swabbing forklifts so I could get a hit. I'm a lady so I won't say here what I thought of that plan.
I've had a (n expensive) consultant tell me the same thing - if I can't find it then I'm not looking for it hard enough. This was in a location that had a history of bad, bad Salmonella contamination a few years earlier. I have years of experience in a micro lab, and I swabbed some pretty bad lookin stuff, like LTL Trailer floors hauling raw rice patties etc. So I had our contract lab come out and train me on swabbing technique, swabbed the bottoms of employees shoes and zone 4 more often...nothing! I started a PROJECT TEAM of swabbers. 10 swabs a shift, 3 shifts (it was a gigantic building and we had ~20 QA and 10 Sanitation employees + supervisors, so not as extreme as it sounds). I swabbed TRUCKER SHOES. I swabbed every. overhead. pipe.
After a couple months of this, my factory manager was adding up lab costs, which would have been justifiable if there was an issue, and promptly cut us back to pre consultant swabbing routines.
The job was awful and I wasn't working there much longer than that, so I'll never know, ...but...
Where the flip was that Salmonella hiding?
I've had a (n expensive) consultant tell me the same thing - if I can't find it then I'm not looking for it hard enough. This was in a location that had a history of bad, bad Salmonella contamination a few years earlier. I have years of experience in a micro lab, and I swabbed some pretty bad lookin stuff, like LTL Trailer floors hauling raw rice patties etc. So I had our contract lab come out and train me on swabbing technique, swabbed the bottoms of employees shoes and zone 4 more often...nothing! I started a PROJECT TEAM of swabbers. 10 swabs a shift, 3 shifts (it was a gigantic building and we had ~20 QA and 10 Sanitation employees + supervisors, so not as extreme as it sounds). I swabbed TRUCKER SHOES. I swabbed every. overhead. pipe.
After a couple months of this, my factory manager was adding up lab costs, which would have been justifiable if there was an issue, and promptly cut us back to pre consultant swabbing routines.
The job was awful and I wasn't working there much longer than that, so I'll never know, ...but...
Where the flip was that Salmonella hiding?
My environments were cold so was more worried about listeria. Most of my buildings have been old and am surprised we did not an issue. But we did try and we kept the chemical companies happy making sure we have everything sanitized. :eek_yello:
Dear magenta_m,
Although a positive detection is presumably the Gold standard, many people consider the analytical detection of Salmonella more an art than a science. Add that to the limitations of environmental sampling and the challenge can be sustantial. The most sensitive detection methods often also involve real money. And IIRC it is often not permissible to culture pathogens like Salmonella within manufacturing facilities in USA. ? > more money.
It appears that alternative (indicator) approaches such as Enterobacteriaceae have never caught on in USA although well regarded in many other locations. Maybe insufficiently exciting. :smile:
Rgds / Charles.C
Dear magenta_m,
. And IIRC it is often not permissible to culture pathogens like Salmonella within manufacturing facilities in USA. ? > more money.
I know! What's that about? No positive controls on site make me sad, as I started life in a lab.
It appears that alternative (indicator) approaches such as Enterobacteriaceae have never caught on in USA although well regarded in many other locations. Maybe insufficiently exciting. :smile:
Rgds / Charles.C
You mean for zones 2-4? I thought it was standard for FCS...though I do need to back it up with some research. I haven't looked around much for e bac / salmonella correlation studies. Perhaps some light summer reading for me on Google Scholar :rofl2:
(a) I know! What's that about? No positive controls on site make me sad, as I started life in a lab.
(b) You mean for zones 2-4? I thought it was standard for FCS...though I do need to back it up with some research. I haven't looked around much for e bac / salmonella correlation studies. Perhaps some light summer reading for me on Google Scholar :rofl2:
Dear magenta_m,
(a) It's due a fear of cross-contamination, ie a "leakage" from the lab. to the production area (somehow).
(b) I get the impresssion from this forum that, for food in USA, micro. testing of envir. (every Zone) essentially means with respect to Salmonella (S) or Listeria (L), ie pathogens only. ?
This is to my understanding sort of opposite to typical situation in EU. The latter's opinion, I think, is that seeking (S,L) directly is akin to needle in the haystack, ie -ve results not very meaningful plus a lot of work/cost involved. So preferable to use indicators. Nonetheless I think some L is still done (no experience) since not readily inferred from indirect parameters like Entero..ae (and also maybe L easier to do lab screening with isolated in-house labs [elsewhere are less feared than in USA :smile: ]).
However, the OP's USA crunch is presumably what is actually specified by FSMA, if anything ?
Rgds / Charles.C