11 replies to this topic

[FoodSafetyAPP]

Hi all. Myself and a colleague are finding ourselves stuck on a listeria sampling query. All products must follow 'absence in 25g' for Listeria Monocytogenes - we supply vulnerable groups. One product that is tested is causing confusing when it comes to how it is tested. IMO and according to the standard we adhere to, Representative samples are to be stored and handled to reflect the reasonably foreseeable conditions of distribution, storage and use. Chilled products shall be stored during the shelf-life trials at 8.0 (DC) and held for a period of four hours at ambient temperatures prior to sampling for Listeria monocytogenes. The product is chilled vegetables but this is the process it follows prior to being released chilled. blanched / part boiled > frozen > received from supplier > frozen > re-packed > thawed > released chilled. My colleague said she once sent the product for sampling when it was chilled (the end product) and it came back with high Listeria but this is due to the nature of the product and no cooking step. She said she now cooks the product (we do not cook this product on site so this takes place just for the sample) before she sends it for sampling as the customer would cook it before consuming. I understand why, however this is not how we sell the product, we sell the product as 'chilled' so the testing isn't accurate for the product we sell, HOWEVER the nature of the uncooked product is very likely to return with high Listeria.  (this applies for 5 day shelf life testing as well - the product is sampled by an external lab who do not cook the product prior to testing, they test on 5 day old part cooked vegetables). I am aware our product release procedure states absence of Listeria. I hope this makes sense and I hope you understand my confusion on what is the right thing to do. According to the standard we should test the product as would be sold? not as would be consumed? **cannot amend title from raw**

Edited by Jacob Timperley, 05 August 2021 - 09:52 AM.

[Scampi]

You are correct--should be absent prior to leaving your facility

 

If you're getting positive hits, you stand the risk of infecting the end users kitchen

 

Are you adding a chem to the flume water to control this?

 

Of course raw agricultural commodities are going to have a positive hit, but you should be controlling the pathogen in house

 

Have any of your enviro samples come back positive?

[Charles.C]

Hi all. 

 

Myself and a colleague are finding ourselves stuck on a listeria sampling query. 

 

All products must follow 'absence in 25g' for Listeria Monocytogenes - we supply vulnerable groups. 

 

One product that is tested is causing confusing when it comes to how it is tested. IMO and according to the standard we adhere to, 

 

Representative samples are to be stored and handled to reflect the reasonably foreseeable conditions of distribution, storage and use. Chilled products shall be stored during the shelf-life trials at 8.0 (DC) and held for a period of four hours at ambient temperatures prior to sampling for Listeria monocytogenes.

 

The product is chilled vegetables but this is the process it follows prior to being released chilled

 

blanched / part boiled > frozen > received from supplier > frozen > re-packed > thawed > released chilled 

 

My colleague said she once sent the product for sampling when it was chilled (the end product) and it came back with high Listeria but this is due to the nature of the product and no cooking step. She said she now cooks the product (we do not cook this product on site so this takes place just for the sample) before she sends it for sampling as the customer would cook it before consuming. 

 

I understand why, however this is not how we sell the product, we sell the product as 'chilled' so the testing isn't accurate for the product we sell, HOWEVER the nature of the uncooked product is very likely to return with high Listeria.  (this applies for 5 day shelf life testing as well - the product is sampled by an external lab who do not cook the product prior to testing, they test on 5 day old part cooked vegetables).

 

I am aware our product release procedure states absence of Listeria. 

 

I hope this makes sense and i hope you understand my confusion on what is the right thing to do. According to the standard we should test the product as would be sold? not as would be consumed? 

 

 

**cannot amend title from raw**

 

Hi FSA,

 

I deduce this is not RTE and I assume not vac/MAP.

 

Accordingly, ^^^(red) seems scientifically illogical.

 

I am unaware of L.mono being a regulatory zero-tolerant pathogen for NRTE products in any Global location ? (at one time did exist in USA raw seafood but was rapidly abandoned).

 

PS - I would anticipate that labelling states must be cooked.

[FoodSafetyAPP]

Scampi - 

 

Are you adding a chem to the flume water to control this? - no 

 

Of course raw agricultural commodities are going to have a positive hit, but you should be controlling the pathogen in house - the product follows all necessary steps to minimise the risk of growth, i presume it is something that is present from supplier end potentially? 

 

Have any of your enviro samples come back positive? - no, all good however the product comes in frozen, and is repacked directly into it's primary packaging and sealed, therefore this product is out of packaging for merely seconds and not physically touching anything

 

 

Charles - 

 

Correct - plastic tray and lid sealed (think ready meal)

 

We supply hospitals and the standard associated with this stipulates absence in 25g. 

[Charles.C]

Scampi - 

 

Are you adding a chem to the flume water to control this? - no 

 

Of course raw agricultural commodities are going to have a positive hit, but you should be controlling the pathogen in house - the product follows all necessary steps to minimise the risk of growth, i presume it is something that is present from supplier end potentially? 

 

Have any of your enviro samples come back positive? - no, all good however the product comes in frozen, and is repacked directly into it's primary packaging and sealed, therefore this product is out of packaging for merely seconds and not physically touching anything

 

 

Charles - 

 

Correct - plastic tray and lid sealed (think ready meal)

 

We supply hospitals and the standard associated with this stipulates absence in 25g. 

 

A "ready meal" may, for example, be RTC, RTE or RTH. It matters.

 

It is typically assumed that L.monocytogenes is ubiquitous in many/most raw materials'  environments.

[Ted S]

Hello FoodsafetyAPP. 

 

To clarify, you are not selling a 'Raw" product since your supplier is blanching/part boiling, etc... This is a processed item even though your end customer will cook to kill. For this reason, it CANNOT leave your facility with Listeria, otherwise it is considered "adulterated" and unacceptable for sale (if in the US). Furthermore, you cannot assume that this product will be cooked properly at the end user each and every time. For this reason, it must leave your facility "Pathogen Free". That is your responsibility as the supplier of this item and as you mentioned, your "release procedure" requires the product to be free of Listeria. In fact, your customer is specifically requiring you to test the refrigerated product for LM. They are not asking you to cook it first. They want absolute assurance that they will receive it free of LM so that it does not contaminate their kitchens during their handling of your item and put their clients at risk. 

 

The real issue is where is the Listeria coming from? Are you testing the incoming from your supplier? Are you requiring this to be Pathogen Free from them? You should be. Since RTE fresh vegetables are used daily on Salad Bars, sold at Grocery Stores, etc.... they are all designed to be free of Listeria. So if the fresh vegetable industry can control Listeria without the use of a heat step, so should your suppler, especially since they are blanching/part boiling and Listeria is managed at temps of 70*C or above. Even more important, if this is coming from your supplier with LM, you are putting your entire operation at risk during your handling/re-packing process since LM is easy to cross contaminate, even in the frozen state. 

 

It sounds like you are not buying the correct product from your supplier (i.e. Listeria Free) and this needs to be further investigated ASAP with your supplier. This is a very serious situation that is not being managed properly and even more important, is putting your customer at risk since you are not consistently meeting their expectations as required. 

 

Thank you. 

 

Ted

[Charles.C]

Hello FoodsafetyAPP. 

 

To clarify, you are not selling a 'Raw" product since your supplier is blanching/part boiling, etc... This is a processed item even though your end customer will cook to kill. For this reason, it CANNOT leave your facility with Listeria, otherwise it is considered "adulterated" and unacceptable for sale (if in the US). Furthermore, you cannot assume that this product will be cooked properly at the end user each and every time. For this reason, it must leave your facility "Pathogen Free". That is your responsibility as the supplier of this item and as you mentioned, your "release procedure" requires the product to be free of Listeria. In fact, your customer is specifically requiring you to test the refrigerated product for LM. They are not asking you to cook it first. They want absolute assurance that they will receive it free of LM so that it does not contaminate their kitchens during their handling of your item and put their clients at risk. 

 

The real issue is where is the Listeria coming from? Are you testing the incoming from your supplier? Are you requiring this to be Pathogen Free from them? You should be. Since RTE fresh vegetables are used daily on Salad Bars, sold at Grocery Stores, etc.... they are all designed to be free of Listeria. So if the fresh vegetable industry can control Listeria without the use of a heat step, so should your suppler, especially since they are blanching/part boiling and Listeria is managed at temps of 70*C or above. Even more important, if this is coming from your supplier with LM, you are putting your entire operation at risk during your handling/re-packing process since LM is easy to cross contaminate, even in the frozen state. 

 

It sounds like you are not buying the correct product from your supplier (i.e. Listeria Free) and this needs to be further investigated ASAP with your supplier. This is a very serious situation that is not being managed properly and even more important, is putting your customer at risk since you are not consistently meeting their expectations as required. 

 

Thank you. 

 

Ted

 

Hi Ted,

 

Re ^^^(red).

 

Sorry but afaik, typically, these comments are all simply incorrect..

 

For example, afaik, "raw" is traditionally interpreted as NRTE (= RTC) and in many countries requires the packaging to state "must be cooked". (If this is not the case in USA perhaps you could provide a link to such exception).

Again, "blanching" is typically interpreted as not designed to apply a specific pathogen log reduction to a food as is appropriate to achieve a RTE status..

[Ted S]

Hi Charles.

 

Thanks for the reply. Below is a definition from the USDA and a link to their website. Processed foods can be both RTE or Non RTE in the US, but if you are buying a processed food from a supplier, they must control the food safety risks in their HACCP/Food Safety plan. We do no rely on the end user to be the only control point regarding food safety. Since this supplied material is also being handled and re-packed by the company, they must source a material that is Listeria free so that they do not put their own facility at risk when handling the product. This should be identified in their HACCP/Food safety Plan as a serious risk (CCP, etc...) that is being pro actively managed by the supplier via a written specification agreement and Certificate of Analysis for each Lot # delivered. It is unrealistic to expect a material such as this to have no guaranteed pathogen control at the supplier level. Their Customer is demanding a Listeria free product to be supplied due to their High Risk situation. How else would you recommend this to be managed if not at the Supplier level?

 

In addition, all of my comments are absolutely correct as related to the US. Raw is raw. Pretty simple. Processed is defined below. In fact, most factories that I have worked for that process "raw" beef, chicken' seafood, vegetables, etc... have separate receiving areas in their facility and heightened GMP's and sanitation controls to manage the potential for cross contamination and to protect the materials that have already been "processed". In addition, "raw" products in the US are also required to be Pathogen Free upon release for sale. Examples of this include raw ground beef, for example, that is constantly being recalled in the US for e.Coli, recalls for "Raw" flour for containing e.Coli, Salmonella, etc.. and so on. 

 

Processed foods defined

According to the United States Department of Agriculture (USDA), processed food is defined as any raw agricultural commodity that has been subject to washing, cleaning, milling, cutting, chopping, heating, pasteurizing, blanching, cooking, canning, freezing, drying, dehydrating, mixing, packaging or other procedures that alter the food from its natural state. This may include the addition of other ingredients to the food, such as preservatives, flavors, nutrients and other food additives or substances approved for use in food products, such as salt, sugars and fats.

Thank you again for your reply. If there is anything else that I need to clarify, please let me know. 

Regards, 

Ted

 

[Charles.C]

Hi Charles.

 

Thanks for the reply. Below is a definition from the USDA and a link to their website. Processed foods can be both RTE or Non RTE in the US, but if you are buying a processed food from a supplier, they must control the food safety risks in their HACCP/Food Safety plan. We do no rely on the end user to be the only control point regarding food safety. Since this supplied material is also being handled and re-packed by the company, they must source a material that is Listeria free so that they do not put their own facility at risk when handling the product. This should be identified in their HACCP/Food safety Plan as a serious risk (CCP, etc...) that is being pro actively managed by the supplier via a written specification agreement and Certificate of Analysis for each Lot # delivered. It is unrealistic to expect a material such as this to have no guaranteed pathogen control at the supplier level. Their Customer is demanding a Listeria free product to be supplied due to their High Risk situation. How else would you recommend this to be managed if not at the Supplier level?

 

In addition, all of my comments are absolutely correct as related to the US. Raw is raw. Pretty simple. Processed is defined below. In fact, most factories that I have worked for that process "raw" beef, chicken' seafood, vegetables, etc... have separate receiving areas in their facility and heightened GMP's and sanitation controls to manage the potential for cross contamination and to protect the materials that have already been "processed". In addition, "raw" products in the US are also required to be Pathogen Free upon release for sale. Examples of this include raw ground beef, for example, that is constantly being recalled in the US for e.Coli, recalls for "Raw" flour for containing e.Coli, Salmonella, etc.. and so on. 

 

Processed foods defined

According to the United States Department of Agriculture (USDA), processed food is defined as any raw agricultural commodity that has been subject to washing, cleaning, milling, cutting, chopping, heating, pasteurizing, blanching, cooking, canning, freezing, drying, dehydrating, mixing, packaging or other procedures that alter the food from its natural state. This may include the addition of other ingredients to the food, such as preservatives, flavors, nutrients and other food additives or substances approved for use in food products, such as salt, sugars and fats.

Thank you again for your reply. If there is anything else that I need to clarify, please let me know. 

Regards, 

Ted

 

Hi Ted,

 

Thks yr comments. It is possible that Semantics are confusing the Science.

 

Just for micro. accuracy, note that despite the Public (and occasionally Official) popularity, "Listeria" is not, per se, a pathogen, L.monocytogenes is a pathogenic species.

 

Afaik, in the USA, Regulatory controls are particularly oriented to the category of RTE foods. It is well-known , I think, that the USFDA Regulatory Policy for L.monocytogenes in RTE foods is, nowadays, Globally unique.

 

Publications/opinions issued by FDA and USDA are well-known to be discordant in certain areas regarding their interpretation/delineation of RTE products. A recent  review of the (convoluted) development of USA's viewpoints is attached for those wishing to give themselves a substantial headache -

 

 Risk Management for L.mono in foods,2021.pdf   2.16MB   23 downloads

(eg see Pgs 3-5)

 

Returning to the OP, my Post 3 remains unanswered with respect to RTE. I will assume product is commercialized as RTE.

 

afai can tell, the OP's product would fall within the jurisdiction of USFDA.

 

I attach the most recent (Producer's) appraisal of the US/FDA situation regarding RTE Fresh Produce. L.monocytogenes is predictably regarded as a zero-tolerant pathogen for this product however the text also contains, inter alia, these notable comments -
 

 

Finished product testing: Routine finished product testing can be of limited value due to the uneven distribution of the organism [L.monocytogenes] in a lot of product and the low frequency of occurrence of the organism of concern. Additionally, a product that tests positive for L. monocytogenes may be the result of contamination that occurred within the facility (which should have been detected by a robust environmental monitoring plan) or could be the result of unavoidable contamination in the growing environment. Therefore, although FDA recommends testing finished product on a periodic basis, XYZ recommends product testing in limited circumstances.

 

A facility may decide to test finished product resulting from a positive result in Zone 1 or as verification of the effectiveness of the environmental monitoring program. FDA draft guidance recommends that products be sampled for L. monocytogenes specifically, and not Listeria spp. This is especially valid for fresh produce items that lack a kill step; Listeria spp. is more likely to be positive than the pathogen, and presence of spp. does not render the product adulterated.

 

 

 Listeria-Guidance within the Fresh Produce Industry,2018.pdf   1.83MB   22 downloads

(Earlier [2017] indications of caveats regarding RTE fresh produce were elaborated in this response to FDA's draft  guidance material -

 Comments on FDA-Lm Guidance for RTE foods,2017.pdf   930.54KB   17 downloads

 

PS - I have avoided discussion of NRTE products since presumably OT.

If you can reference a USFDA or USDA statement concerning  a designated "raw" finished product which is intended (eg labeled) to be fully cooked by the consumer and is Regulatory associated with a zero-tolerance for L.monocytogenes I will be interested, albeit extremely surprised.

(JFI such a requirement was in fact introduced by USFDA for imported "raw" frozen shrimp around 3 decades ago. It was repealed within 12 months due the avalanche of rejections for what was shortly recognized as an environmentally ubiquitous (ie unavoidable) microorganism. Afaik this remains the current situation.)

[ebb30]

Ted, I agree with you, this product should not be "high in Listeria" (or have any).

 

I would also add that cooking the product and submitting it to the laboratory is absolutely not OK, unless you are validating the cooking instructions. I would go as far as to say this is negligence as you know full well that your product has a pathogen and you are saying it does not. If the product is getting blanched/parbroiled then it should be pretty simple to get some log reductions and not get Listeria positives. Especially because you are supplying vulnerable populations. I would strongly suggest you reach out to a food safety consultant and discuss this as you are treading on dangerous grounds that will result in a recall, not to mention anyone who will suffer from listeriosis. 

[Charles.C]

Ted, I agree with you, this product should not be "high in Listeria" (or have any).

 

I would also add that cooking the product and submitting it to the laboratory is absolutely not OK, unless you are validating the cooking instructions. I would go as far as to say this is negligence as you know full well that your product has a pathogen and you are saying it does not. If the product is getting blanched/parbroiled then it should be pretty simple to get some log reductions and not get Listeria positives. Especially because you are supplying vulnerable populations. I would strongly suggest you reach out to a food safety consultant and discuss this as you are treading on dangerous grounds that will result in a recall, not to mention anyone who will suffer from listeriosis. 

 

Hi ebb,

 

^^^^(blue) -  I would particularly recommend some consultations with a food microbiologist.

 

^^^^(red) - Perhaps you should also direct your admonition to the environment.

 

 

Here are some conclusions in the Risk Management attachment in Post 9 -

 

It should be noted that in all the global risk-based strategies implemented or considered, none absolutely assures the elimination of listeriosis. Regulatory efforts should primarily be directed at RTE foods that support the growth of L. monocytogenes. Furthermore, recommendations for regulatory compliance actions such as a product recall should not be made upon finding low levels ( < 100 cfu/g) of the organism in a food not supporting L. monocytogenes growth or in a NRTE food unless: i) the GMP status of the plant is in question; ii) the plant has a prior history of violations, recalls, etc., iii) there is evidence of an illness(es) linked to the product; iv) there are repeat findings of L. monocytogenes in the product and/or v) the product is known to be targeted to at-risk individuals.

 

 

We recommend that, in general, frozen foods labeled with cooking instructions should be considered as NRTE foods and must be cooked prior to consumption, and food safety education and guidance to at-risk consumers regarding cooking instructions should  be  a  priority.  What  is  needed  is  an  evidence-based,  globally harmonized public health approach to the definitions of RTE and NRTE foods along with guidance on how these definitions should be applied in any regulatory policy on L. monocytogenes

 

[Charles.C]

Hi Food SafetyApp,

 

Based on previous threads (and the "8degC"), I deduce yr OP query was probably UK oriented.

 

If so, much of the previous, later, discussion was probably, totally, irrelevant since it was based on the uniquely different US Regulatory situation. (Although the latter was hopefully of some interest to other posters).

 

Regardless, if the commercialised product was your specific target of interest, then the logical sample(s) to send to the lab. would surely be precisely representative of THAT.

 

QED.

 

PS - It's an interesting "Standard".  A guarantee of undetectable L.monocytogenes in a non-thermally processed, chilled storage, raw vegetable sounds extremely challenging (to me).

 

PPS - Note that your "high"  lab result for Listeria is not proof of presence of L.monocytogenes.