11 replies to this topic

[Robicheaux]

Hi all,

 

Just last week our company got into a bit of a mess with FSIS while running a meat product and I am curious what your thoughts are. We make RTE meat frozen entrees with some slight variations in the formulations of each one. Last week we used our extruder pump to fill ravioli with an egg, wheat, and milk allergen filling. This filling also contains ricotta cheese which is important. At the conclusion we flushed as much of the filling as possible through the pump. Next we loaded up the pump with a meat filling containing an identical allergen profile but it does not contain ricotta cheese. The amount of the first "cheese" filling left over being incidentally pumped into the meat filling is minimal; maybe 1% for the first 20 seconds and then trace amounts after that. At the conclusion of the the collective ravioli run our FSIS inspector noticed that the entire line was not fully washed down to prevent the trace amount of cheese filling being pumped into the meat ravioli. He then proceeded to tag all of our product which was run after the changeover until it could be re-labelled to include the ricotta cheese (misbranding). Obviously if there was any allergen concern this would be a red alarm situation however there is no concern on that front. Our inspector is essentially raising any and every raw material to the level of an allergen in terms of risk by claiming misbranding. I have been looking for a regulatory provision that would allow trace amounts of ingredients to be transferred without claiming misbranding but am coming up short. I know there are exceptions for things like processing aides but I don't think left over ricotta cheese would be included in that. 

 

Any ideas would be really helpful because our company has been doing it this was for decades and having to do a full wash down of cooker, freezers, pump, conveyers, etc. would significantly reduce our ability to make product. Thanks!

 

 

[jdpaul]

https://www.fda.gov/.../81606/download

 

if you search this guidance it talks about trace amounts, incidental materials, and sulfites

 

Incidental materials have no functional or technical effect on the finished product and do not need to be declared

 

Ricotta cheese is a dairy allergen and must be branded (it is not incidental) and therefore misbranding fairly consistent

[jdpaul]

Though the second product contains a similar allergen profile, it makes me wonder if the inspector tagged those on the basis that ricotta cheese in trace amounts cannot be removed from the label since it is not an incidental material.

 

You may also find this useful which includes more information on exemptions for food labelling

 

https://www.accessda...=21:2.0.1.1.2.7

Edited by jdpaul, 09 December 2020 - 01:53 PM.

[kfromNE]

To satisfy the inspector - with the first few that are run - not use them. When I worked at company that made sauces - when switching over from similar allergen products - we didn't use the first few bottles. This was due to product residuals from the previous item. I know other companies do similar things as well.

[Slab]

The amount of the first "cheese" filling left over being incidentally pumped into the meat filling is minimal; maybe 1% for the first 20 seconds and then trace amounts after that.

 

How has this been determined? How would a FSIS inspector or production staff verify this?

 

The definition of 'misbranding' under 9 CFR 301.2 is fairly cut and dry.

 

 

 

Misbranded. This term applies to any carcass, part thereof, meat or meat food product under one or more of the following circumstances:

(1) If its labeling is false or misleading in any particular;

 

If it has been determined by analytical methods to be incidental then FSIS can rule as such on a case by case basis. FALCPA states that a food allergen has to be listed as an ingredient by its common name, but I don't think you fall under this jurisdiction. 

Edited by Slab, 09 December 2020 - 04:45 PM.

[jdpaul]

From the food labelling guide

 

 

7. Is it necessary to declare ingredients in “trace”, i.e., incidental amounts? Can sulfites be considered incidental additives?

 

Answer: FDA does not define “trace amounts”, however, there are some exemptions for declaring ingredients present in “incidental” amounts in a finished food. If an ingredient is present at an incidental level and has no functional or technical effect in the finished product, then it need not be declared on the label. An incidental additive is usually present because it is an ingredient of another ingredient. Note that major food allergens (as discussed on pages 20-24), regardless of whether they are present in the food in trace amounts, must be declared. Sulfites added to any food or to any ingredient in any food and that has no technical effect in that food are considered to be incidental only if present at less than 10 ppm. 21 CFR 101.100(a)(3) & (4)

Edited by jdpaul, 09 December 2020 - 04:56 PM.

[dfreund]

change the changeover procedure to ensure no allergen transfer

or

discard the 1%, then prove by testing that the product after the 1% has no detectable allergen

 

Just a suggestion, please challenge this through a process authority to validate it is an effective solution.

 

You cannot be too careful with an allergen.

[kfromNE]

change the changeover procedure to ensure no allergen transfer

or

discard the 1%, then prove by testing that the product after the 1% has no detectable allergen

 

Just a suggestion, please challenge this through a process authority to validate it is an effective solution.

 

You cannot be too careful with an allergen.

You misunderstood the issue. The allergen isn't an issue. There's still milk in the next item but not in the form of ricotta cheese. The inspector was making an issue with the label and ingredient statement. Since there was a little bit of residual (ricotta cheese) from the previous item, he thought it should be labeled with ricotta cheese.

[kfromNE]

Hi all,

 

Just last week our company got into a bit of a mess with FSIS while running a meat product and I am curious what your thoughts are. We make RTE meat frozen entrees with some slight variations in the formulations of each one. Last week we used our extruder pump to fill ravioli with an egg, wheat, and milk allergen filling. This filling also contains ricotta cheese which is important. At the conclusion we flushed as much of the filling as possible through the pump. Next we loaded up the pump with a meat filling containing an identical allergen profile but it does not contain ricotta cheese. The amount of the first "cheese" filling left over being incidentally pumped into the meat filling is minimal; maybe 1% for the first 20 seconds and then trace amounts after that. At the conclusion of the the collective ravioli run our FSIS inspector noticed that the entire line was not fully washed down to prevent the trace amount of cheese filling being pumped into the meat ravioli. He then proceeded to tag all of our product which was run after the changeover until it could be re-labelled to include the ricotta cheese (misbranding). Obviously if there was any allergen concern this would be a red alarm situation however there is no concern on that front. Our inspector is essentially raising any and every raw material to the level of an allergen in terms of risk by claiming misbranding. I have been looking for a regulatory provision that would allow trace amounts of ingredients to be transferred without claiming misbranding but am coming up short. I know there are exceptions for things like processing aides but I don't think left over ricotta cheese would be included in that. 

 

Any ideas would be really helpful because our company has been doing it this was for decades and having to do a full wash down of cooker, freezers, pump, conveyers, etc. would significantly reduce our ability to make product. Thanks!

Another idea - contact the USDA in regards to the label. See what they say. I would hope they would say you don't need to add it as an ingredient. This should satisfy the inspector since you have said you are contacting the USDA and working on it. Once you get the decision, this should prevent you from dealing with this problem from another inspector or the same one when they rotate back into your plant.

https://www.fsis.usd...tituent-updates

[dfreund]

You misunderstood the issue. The allergen isn't an issue. There's still milk in the next item but not in the form of ricotta cheese. The inspector was making an issue with the label and ingredient statement. Since there was a little bit of residual (ricotta cheese) from the previous item, he thought it should be labeled with ricotta cheese.

Adding ricotta to the ingredient list will then create a misrepresentation of ingredients past the first 1% , if indeed the ricotta is then gone.  Perhaps a less than 2% statement including ricotta ingredients will be sufficient?

[Robicheaux]

Thanks for the replies everyone. I apologize I have been radio silent the last week due to a family matter. This is all very interesting/annoying to me on an academic (regulatory) level because in real life I imagine very few people have any concern over trace amounts of ricotta. To address a couple of the comments above. First I tried to explain to the inspector that we would flush the pump with the non-ricotta filling and throw out the first few pounds. This was unacceptable to him. Beside the pump, in his view, every aspect of the whole line was contaminated including the scoop at the end of the freezer tunnel which is bagging the frozen ravioli. Everything needed to be fully cleaned again. There was mention above about validating the 1% that I had indicated was left over. That number was just an estimate as we have never verified that analytically. However whether or not it is 10%, 1%, or .001% makes no difference in the mind of the inspector. 

 

I am glad that kfromNE mentioned above the fact that plants switch over products all the time though and flushing is a common practice. This is only the second plant that I have worked in and there has never been a full wash down in either except for in the case of an allergen mismatch. Nor could I possibly imagine any plant doing this from the stand point of practicality. I have filled out a million supplier risk assessments for customers and 99% of them ask if we re-work like to like, allergen integrity is maintained. I would guess only 5% of them ask if we re-work same to same. Apparently lots of fsqa folks agree with me. 

 

I think I will submit an ask FSIS just to see what they say as well. Thanks again for all of your collective brains and I'll be sure to update.

[Ruthie1]

I am sure I am missing information, but would switching your production order be an option? Run the product with the ricotta mixture after the the mixture without? That way you can say there is no carry over on any of the product. Obviously, this does not help with the product that has already been run, but it would save a headache going forward.

I think it is as simple as discarding the first few pounds of product to ensure that any ricotta is flushed out, since milk is already an allergen present.