23 replies to this topic

[verino98]

Hi, everyone

Referring to RTE exposed area, is FSIS/USDA expectation that I list LISTERIA as hazard in my HACCP plan? 

I mean, must I list Listeria as hazard?

I'm not saying to handle it as NRLTO, but not list it at all.

Obv, there will be programs in place to handle Listeria and other hazards but I need to know if USDA/FSIS have expectation about some hazard that must be listed.

I've already read all HACCP guidelines, but nothing about that. 

 

 

 

[G M]

It's based largely on your ingredients and processing environment.  It is up to you to define what your hazards are, but if you're handling nutrient dense material like meat and don't include listeria as a hazard, they're going to look hard at your risk analysis and supporting documentation to understand why it isn't included.

 

More specifically for RTE items [CFR 9.III.E § 430.4 Control of Listeria monocytogenes in post-lethality exposed ready-to-eat products] makes the presumption that Lm is a risk and expects details on how it is managed.

 

You could theoretically avoid it, if you were making some kind of non-exposed item that was cooked in its packaging, or pasteruized like a hotdog smoothie or whatever.

[kfromNE]

You must be able to prove why you made those decisions. Easiest way is with reputable sources - best are the USDA and from universities. Along with the USDA, I use these sources when looking at hazards. Then let the inspectors know what my sources are. I receive very few questions on our hazards listed in our HACCP plans. 

 

https://meatsci.osu....ation-materials

 

https://foodsafety.w...edu/meat-haccp/

[verino98]

We will be slicing deli meat in a cleanroom -like environment under alternative 3. 

I'm wondering if I can omit Listeria as hazard at slicing step...

[G M]

We will be slicing deli meat in a cleanroom -like environment under alternative 3. 

I'm wondering if I can omit Listeria as hazard at slicing step...

 

I'm confused. If you're recognizing 430.4 Alt 3 you're already acknowledging the risk of Lm.  At that point you're already committed to some sanitation measures to control known biological hazards.  

 

Alternative 3. Use of sanitation measures only.

iii. An establishment that chooses Alternative 3 is likely to be subject to more frequent verification testing by FSIS than an establishment that has chosen Alternative 1 or 2. An establishment that chooses Alternative 3 and that produces deli meat or hotdog products is likely to be subject to more frequent verification testing than one that does not produce such products.

 

 

It seems highly unlikely that you'll be able to put together enough evidence to convince FSIS your product has no reasonable risk of Lm.

[jfrey123]

Why would you want to skip listing it as a hazard?  That's a hard sell to run a deli slicing station and not acknowledge listeria.  You can address it in the HA through your sanitation program just like every other meat processor does, but to skip it entirely...?

[AZuzack]

I have read your question differently than the other posters.  Under biological potential hazards you should list Bacteria species by name because there are different controls for some species and different species present different risks at different steps of the process.  So yes Listeria should be specifically listed.   For Example, if you're dealing with raw pork to make a sliceable ham log, USDA wants to see the parasites (Trichinella is one) listed in the HACCP Plan from receipt of raw pork to the kill step.  On the other hand, if you are receiving the already cooked ham log and slicing it, then Trichinella risk would be handled by a COA from the supplier guaranteeing appropriate lethality temperature was met.  

[kfromNE]

I have read your question differently than the other posters.  Under biological potential hazards you should list Bacteria species by name because there are different controls for some species and different species present different risks at different steps of the process.  So yes Listeria should be specifically listed.   For Example, if you're dealing with raw pork to make a sliceable ham log, USDA wants to see the parasites (Trichinella is one) listed in the HACCP Plan from receipt of raw pork to the kill step.  On the other hand, if you are receiving the already cooked ham log and slicing it, then Trichinella risk would be handled by a COA from the supplier guaranteeing appropriate lethality temperature was met.  

 

That would work if it stayed in a closed system but once the package is open, you have to consider the different environmental pathogen risks. Since listeria is the most 'hearty' of the the bacteria, it is almost always mentioned. 

 

So like Jfrey said - you need to acknowledge it however you may not have to do anything about it. We acknowledge temperature abuse/bacteria can grow at multiple steps in our hazard analysis. However we don't take a temperature at every single step of the process. We take temperatures at critical points. 

[GMO]

We will be slicing deli meat in a cleanroom -like environment under alternative 3. 

I'm wondering if I can omit Listeria as hazard at slicing step...

 

You are aware of the HUGE numbers of serious including fatal incidents around Listeria monocytogenes and slicers right?

[kfromNE]

Another option for you. Ask the question to the HACCP specialist at the land grant university in your state. So the person (usually a professor in the food science or animal science department) that teaches the HACCP course. 

 

Then cite them if asked by the USDA. 

[GMO]

Look, I know that the rest of the world does HACCP one way and the US does it another but I'm genuinely confused why you wouldn't want to specifically mention it.

 

In UK and EU interpretation of HACCP and probably other countries as well (I have less experience) you'd normally list the hazards of concern in your scope.  For cooked deli meats, I cannot see how Listeria monocytogenes would not be a hazard of concern.  Even if you have great control at a supplier (if they're cooking) or even if you were HPP in pack etc.  There are still either controls where you're going through a kill step or there is a piece of equipment which is renowned for being a pain in the a** to clean.

 

Having lived through more than one issue with Listeria monocytogenes, the control of it cannot be ignored in RTE high risk foods.  

 

What I'm slightly scared of and please tell me if I'm jumping to WAY off kilter conclusions here....

 

Are you asking because you don't want to test for it?

[verino98]

Hi everyone, maybe you're misunderstanding my point.

We will be handling Listeria with all procedures and programs possible. I'm just wondering if I can omitt Listeria at slicing point. 

 

I'm saying, according to how the USA develop HACCP plan, I'll address Listeria at receiving step. My US consultant said there is no need to address it again later. It's only about handling products properly for the rest of the process. We will only be slicing.

 

Does it sound correct to you?

 

My background is Italian, so european regulations..

[GMO]

No it doesn't sound correct.

 

Let me explain.  Slicers are notorious (even in the EU where I worked most of my career) for being difficult to clean.  You will not eradicate Listeria monocytogenes from your facility, even if you are controlling for it at intake because it will be present outside of your high risk / clean room and will, on occasions, make it inside.  You will have lots of controls around that but when it makes it inside, from time to time it will get absolutely embedded within that slicer.

 

So control of cleaning / sanitation of that slicer is absolutely [insert swear word here] important.

 

Let me give you some reading so you understand.

 

Cross-contamination between processing equipment and deli meats by Listeria monocytogenes - PubMed

Modeling Transfer of Listeria monocytogenes from Slicer to Deli Meat During Mechanical Slicing | Foodborne Pathogens and Disease

Practices for Cleaning and Sanitizing Meat Slicers to Control Listeria

Transfer of foodborne pathogens during mechanical slicing and their inactivation by levulinic acid-based sanitizer on slicers - ScienceDirect

Study Finds Persistent Rates of Listeria in Retail Delis | Food Safety News

2008 Canada listeriosis outbreak - Wikipedia

[Scampi]

The Maple leaf listeria recall for LM source was THE SLICERS!!!!!!!

 

https://www.canada.c...s-outbreak.html

 

We are supposed to learn from history, not repeat it

[Setanta]

My go to in these instances is: 'What if I'm wrong?'

 

If the consensus here is wrong, you will have done a bit extra work, but kept your facility cleaner and documented that. It is all about breaking the chain of contamination.

 

If you are wrong, people will probably get sick. 

[verino98]

Thank you guys.

 

My question was only from a "formal" point of view.

Listeria control will be addressed through SSOP, SOP, GMP etc.

[G M]

Formally you don't even need to specify which species presents the hazard at that specific step, you can just recognize a general biological hazard and say what is done to control it.

 

You do need to recognize L.m. as a general hazard to your process though, but this can be done in a separate document from the hazard analysis or flow chart.  I do this in a "known hazards" document that precedes them both.  My step by step hazard analysis just says things like "growth of pathogens" or "contamination from ruptured packages" without bothering to specify which bacterial species are a problem for that specific process.  The controls in place will handle them all.

[GMO]

Formally you don't even need to specify which species presents the hazard at that specific step, you can just recognize a general biological hazard and say what is done to control it.

 

 

I cannot speak to US legislation but that would be a ticket to a major non conformance in most other parts of the world.  How on earth is it possible to ensure you are specifying the correct control measure if you're not being specific about the hazard?  

[GMO]

Thank you guys.

 

My question was only from a "formal" point of view.

Listeria control will be addressed through SSOP, SOP, GMP etc.

 

HACCP is not just a document to be put on the shelf.  It's a process to help guide you as to the controls you need.  That will include verification (for example sanitation auditing, swabbing, sampling, record review etc) and will also include which specific methodology of sanitation.

 

So, for example in the Maple Leaf example referenced above, one of the processes they employed was steam sanitation of their slicers.  Would you do that if you were not bothered about Listeria monocytogenes?  Nope.  Would you swab that machinery extensively for Listeria spp and indicator organisms if L. monocytogenes was not a concern?  Nope.

I'm going to beat this drum until people start listening.

 

HACCP is not just for compliance, it's for making food safe.  

[jfrey123]

Thank you guys.

 

My question was only from a "formal" point of view.

Listeria control will be addressed through SSOP, SOP, GMP etc.

 

Cool.  I'm in agreement with handling listeria through SSOP, SOP, GMP's, etc.  But, imho, you MUST address and mention listeria at the point of slicing.  If you're mechanically slicing, you're generating heat.  Buildup of the meat on your slicer likely gets above refrigeration temps, and you run a risk of creating a listeria generating environment.  Just because it's deli meat that you've addressed listeria with at point of receiving (I'm assuming through supplier approval, COA's, and periodic testing), you're now altering the meat from the form you received it.  You are creating a hazard by cutting the meat, and growth of listeria is a potential at that step.

 

I'm not saying you have to then redo a kill step after slicing, I don't know your process or finished product well enough.  But listeria on slicers is a KNOWN hazard, and if you skip it then at best an auditor will question why your qualified individual failed to identify it.  At worst, you'll kill someone.  To my knowledge, it is wholly acceptable to address this with your SSOPs at this stage, so you list listeria as a biological hazard and state you address it with the PRPs you've addressed.  Show your auditor, show your customer, what you're doing to make sure listeria is not introduced to a deli meat at your slicing step.

[G M]

I cannot speak to US legislation but that would be a ticket to a major non conformance in most other parts of the world.  How on earth is it possible to ensure you are specifying the correct control measure if you're not being specific about the hazard?  

 

If I say that the known hazards are E.coli, Salmonella and Listeria because of X meat ingredient in my product, in the following hazard analysis am I going to have three different sets of GMPs listed as control measures? No. The single GMP program is written to address all the identified hazards. Do you list three separate refrigeration temperatures as a minimum requirement to cover each one, especially when ten of those steps are in the same room? No. A single temperature is selected to control all of the identified hazards. 

 

The controls are selected specifically because they manage all of the previously listed hazards, so listing them all in each and every step is pointlessly redundant.  I've had dozens of federal regulators, GFSI auditors, customer auditors etc. read those HACCP plans.  No one has ever even mentioned that I said "outgrowth of pathogens" instead of "outgrowth of E.coli, Salmonella, Listeria, Clostridium perfringens, and Staphylococcus aureus" in a dozen steps.

[GMO]

If I say that the known hazards are E.coli, Salmonella and Listeria because of X meat ingredient in my product, in the following hazard analysis am I going to have three different sets of GMPs listed as control measures? No. The single GMP program is written to address all the identified hazards. Do you list three separate refrigeration temperatures as a minimum requirement to cover each one, especially when ten of those steps are in the same room? No. A single temperature is selected to control all of the identified hazards. 

 

The controls are selected specifically because they manage all of the previously listed hazards, so listing them all in each and every step is pointlessly redundant.  I've had dozens of federal regulators, GFSI auditors, customer auditors etc. read those HACCP plans.  No one has ever even mentioned that I said "outgrowth of pathogens" instead of "outgrowth of E.coli, Salmonella, Listeria, Clostridium perfringens, and Staphylococcus aureus" in a dozen steps.

 

I can only say you would in the UK because you have different conditions which are there to control different things.  A control measure for a spore former is not the same as a facultative anaerobe which can grow at chill temperatures.  Therefore you need to be specific.  

[Scampi]

This seems pretty clear to me--Listeria and it's controls must be in your haccp plan

 

https://www.ecfr.gov...0/section-430.4

 

"Listeria monocytogenes can contaminate RTE products that are exposed to the environment after they have undergone a lethality treatment. L. monocytogenes is a hazard that an establishment producing post-lethality exposed RTE products must control through its HACCP plan or prevent in the processing environment through a Sanitation SOP or other prerequisite program. RTE product is adulterated if it contains L. monocytogenes, or if it comes into direct contact with a food contact surface that is contaminated with L. monocytogenes. Establishments must not release into commerce product that contains L. monocytogenes or that has been in contact with a food contact surface contaminated with L. monocytogenes without first reworking the product using a process that is destructive of L. monocytogenes."

[kfromNE]

Consultants are great but your best bet is to also verify your HACCP plan with the USDA inspector or a professor at your land grant university (both technically free). Then keep track of who approved it. Then if new USDA inspector questions it, you can say you consulted so and so.