29 replies to this topic

[C.Giauque]

Hello IFSQN,

 

I am the Food Safety Coordinator here at a chocolate manufacturing facility and had a question regarding allergen thresholds. I am located in the USA and when referring to the FDA's CFR I had noticed that the FDA has not established a threshold level for any allergens. This is where my problem lies. At my company we do quarterly finished product allergen testing, and this quarter I received results that, in my eyes, are undesirable. I had sent some finished product samples to be tested for traces of cashew after a short run of cashew product on the same enrober. The results came back as 37.9 ppm, which I believe is a pretty significant amount. I have told senior management time and time again that we should clean out our enrobers after every allergen change, but I cannot get them to understand that even though they are only running very few, the allergenic material is stubborn and stays behind for the next product run. I know that if I present my concerns to them they will tell me it is not a big deal because they do not have a good grasp on Food Safety and its importance. I guess my question is, what would you advise me to do in a situation like this? We currently do not have any established allergen thresholds since this did not seem to concern the previous person in my position; and if I try to establish my own thresholds I will be met with a lot of uneducated pushback from senior management. Can anyone point my in a good direction to build my case?

 

Thank you in advance.

Edited by C.Giauque, 28 July 2023 - 05:26 PM.

[Lohio1991]

We work with enrobers as well.

 

When we run peanuts, trree nut etc, and are finished with that product we do a Full allergen wash and have ATP and allergen swabs done on multiple parts of the machine. The cooling tunnels in the enrober have a bad habit of product getting stuck in the sides and tunnel itself. I would suggest for safety to do as you are suggesting and after any allergen changeover to do a full allergen wash and inspection. We use a generic allergen swab, not specific to any type of allergen. We make sure those swabs are passing with no trace of any allergen before and new product is started. We don't have limits to allergens, it must pass and no allergens be present. This is what my company does. 

[kfromNE]

A few options. 1. Make sure you have your concerns documented. In what you describe - you will cause someone an allergic reaction (potentially deadly too). You could easily have a recall too. Don't get blamed for management not taking allergens seriously. 

2. Not great idea but an option - add cashews, etc. to the list of ingredients of your other products. 

 

 

Websites concerning allergens in the USA. UNL (University of Nebraska at Lincoln) is the expert on allergens in food manufacturing in the USA. 

https://www.foodallergy.org/

 

https://farrp.unl.edu/ 

 

https://www.fda.gov/...s-safety-alerts - undeclared allergens are one of the most common causes recalls. 

[C.Giauque]

A few options. 1. Make sure you have your concerns documented. In what you describe - you will cause someone an allergic reaction (potentially deadly too). You could easily have a recall too. Don't get blamed for management not taking allergens seriously. 

2. Not great idea but an option - add cashews, etc. to the list of ingredients of your other products. 

 

 

Websites concerning allergens in the USA. UNL (University of Nebraska at Lincoln) is the expert on allergens in food manufacturing in the USA. 

https://www.foodallergy.org/

 

https://farrp.unl.edu/ 

 

https://www.fda.gov/...s-safety-alerts - undeclared allergens are one of the most common causes recalls. 

 

We do include a "May Contain" precautionary statement on all of our labels. However, I do not believe this to be an excuse of poor allergen control cGMPs. I also want to push for a recall on these items because I know these numbers can potentially cause a serious allergic reaction to someone with a tree nut/cashew allergy. However, I know when I bring this up to senior management they will come back and say since the FDA does not have any established thresholds they do not deem it to be necessary (I have had a similar situation to this not too long ago). I have had our company president tell me before personally that he is, "willing to take those risks".

Edited by C.Giauque, 28 July 2023 - 05:54 PM.

[C.Giauque]

We work with enrobers as well.

 

When we run peanuts, trree nut etc, and are finished with that product we do a Full allergen wash and have ATP and allergen swabs done on multiple parts of the machine. The cooling tunnels in the enrober have a bad habit of product getting stuck in the sides and tunnel itself. I would suggest for safety to do as you are suggesting and after any allergen changeover to do a full allergen wash and inspection. We use a generic allergen swab, not specific to any type of allergen. We make sure those swabs are passing with no trace of any allergen before and new product is started. We don't have limits to allergens, it must past and no allergens be present. This is what my company does. 

 

Thank you for replying!

 

Are you able to share some of the methods/SSOPs your company has for allergen change over? I would love to have a strong foundation in creating one that works for my company.

[Scampi]

I think an absolute maximum of 10 ppm POST clean residue would suffice along with a precautionary statement

 

37.9 ppm is simply way too high to be acceptable and I would be withdrawing and reworking that product into one containing tree nuts

 

 

Conclusion: The risk of asthma and anaphylactic shock to sesame and peanut is confirmed. Minimal reactive quantities show that, in order to guarantee a 95% safety for patients who are allergic to egg, peanut and milk, and on the basis of consumption of 100 g of food, the detection tests should ensure a sensitivity of 10 p.p.m. for egg, 24 p.p.m. for peanut and 30 p.p.m. for milk proteins. Oil allergies being considered, the limit of sensitivity should fall to 5 p.p.m.

https://pubmed.ncbi....h.gov/12911777/

 

another, 5 ppm

https://www.qualitya...ergen-labeling/

 

a calculation you could use

https://emportllc.co...-action-levels/

[Charles.C]

I suggest a request to FDA as to what is the referenced / desired test sensitivity which is associated with a negative result.

 

Numbers/interpretations in references are relevant but not necessarily agreed with by FDA,

[G M]

...However, I know when I bring this up to senior management they will come back and say since the FDA does not have any established thresholds they do not deem it to be necessary ...

 

No stated threshold means the acceptable level is ZERO.  If you know it is not zero as a result of testing, then you know the product is adulterated.  Sadly, some companies will deliberately avoid this kind of testing so they do not become aware of such a failure.  

 

The US regulators do not consider any detectable amount of allergen in a product that it is not an ingredient of to be acceptable.  If it is not listed as an ingredient, then it is undeclared.

 

"may contain" or "produced on equipment that also" will not protect you legally.  You are still fully legally obligated to prevent cross contamination.  The main function of those statements is to scare away people with allergies from your product, not to indemnify.

 

I certainly don't envy the situation you're in, but if the FDA comes knocking you're best off having done your due diligence to inform the managers/owners of this process failure, with some documented communications.

[hello.fizz]

There might be some guidance on threshholds at these links

https://allergenbure...ustry-guidance/

https://vital.allerg.../vital-science/

[Charles.C]

There might be some guidance on threshholds at these links

https://allergenbure...ustry-guidance/

https://vital.allerg.../vital-science/

Hi fizz,

 

Thks but unfortunately, afaik, the FDA has no operational acceptance of VITAL/related concepts. The latter despite the voluminous related documentation has Globally few official implementations.

 

Post 8 is probably the US reality although I have not seen any specific evidence regarding the protective inapplicability noted regarding "may contain" statements ?.

[kingstudruler1]

How do you address the allergen risk in your preventive control plan?   You answered the question already - you're not.   Which is in violation of the fsma.

 

The FDA evaluates allergens on a case-by-case basis.   My guess is that they would not look favorably on your result.   this is especially true when coupled with your lack of control.  

 

Is "whoever" ok with discussing the results with the FDA ?    You probably have unsafe product on the market.    

[C.Giauque]

How do you address the allergen risk in your preventive control plan?   You answered the question already - you're not.   Which is in violation of the fsma.

 

The FDA evaluates allergens on a case-by-case basis.   My guess is that they would not look favorably on your result.   this is especially true when coupled with your lack of control.  

 

Is "whoever" ok with discussing the results with the FDA ?    You probably have unsafe product on the market.    

 

This is the issue, I inherited our system along with its plethora of vulnerabilities. I am aware of our lack of good allergen preventive controls and have been actively fighting against senior management to make changes to our Food Safety Plan as a whole. During our last GMP audit as well as our last BRC audit these things have also been pointed out by the auditors, things that I've been pointing out since I have started this job. I present my case to senior management, but they genuinely believe "common sense" is enough for them. It really puts my integrity into question. Yes I can document these discussions, and I am. However, I want to actually be able to get through to senior management and gain their support and trust.

[Scotty_SQF]

You may be getting to a point where they are just not going to listen.  Then you have to make a decision if this company is worth risking your career and livelihood over.

[G M]

Mice will play.

 

Getting a letter from the FDA, or an injured consumers lawyer, might be what it takes to change their mind.  The FDA not inspecting/auditing most facilities for years at a time doesn't really help motivate good stewardship.  The persistent motivators of production targets and earnings often ring more loudly.

 

Do they have good recall insurance?  Undeclared allergens have been the number one reason for recalls for years.

[kingstudruler1]

This is the issue, I inherited our system along with its plethora of vulnerabilities. I am aware of our lack of good allergen preventive controls and have been actively fighting against senior management to make changes to our Food Safety Plan as a whole. During our last GMP audit as well as our last BRC audit these things have also been pointed out by the auditors, things that I've been pointing out since I have started this job. I present my case to senior management, but they genuinely believe "common sense" is enough for them. It really puts my integrity into question. Yes I can document these discussions, and I am. However, I want to actually be able to get through to senior management and gain their support and trust.

 

I do understand what you are saying.  

 

I am surprised that BRC let it go.  Probably why many are losing faith in GFSI.....

 

Your current food safety plan is not adequate to protect your customers and your brand.   This has now been proven by your quarterly test.  The plan should now be reevaluated (if the other reasons were not enough) and changes made.  

 

There is no FDA acceptable level of allergenic protein nor is there required to be.  https://www.fda.gov/...ergen-landscape

 

You probably should be recalling product right now.  

 

Unfortunately, there is no mutually beneficial solution.   Some things you just have to do.   

 

If they are still of the mind set of "we haven't killed anyone yet" so no need to change or act.  I'm not sure what will change their mind.   Are you saying they are full on Parnell bros?

 

If these simple truths are beyond them and there is no hope for change, I too would suggest you run.  

Edited by kingstudruler1, 01 August 2023 - 06:18 PM.

[lynzy05]

I am having the same issue with tree nuts. My company just do not want to establish a cleaning procedure for changeover if its tree nuts to peanuts. The senior management believe that since they are both nuts, it is a waste of labour cost to have the production team do a full down cleaning instead of a blow down. If the person making the decision just do not want to listen then I would have this in writing because you shouldn't risk your career over this. 

 

The "may contain" in the label is a voluntary statement and it says in the interpretation of the BRC standard that it should not be used to base your procedure on. Do you have any senior quality managers that could help back you up? Sometimes just because of the title, they tend to listen to them more.

[DeadPresident]

I am having the same issue with tree nuts. My company just do not want to establish a cleaning procedure for changeover if its tree nuts to peanuts. The senior management believe that since they are both nuts, it is a waste of labour cost to have the production team do a full down cleaning instead of a blow down. If the person making the decision just do not want to listen then I would have this in writing because you shouldn't risk your career over this. 

 

The "may contain" in the label is a voluntary statement and it says in the interpretation of the BRC standard that it should not be used to base your procedure on. Do you have any senior quality managers that could help back you up? Sometimes just because of the title, they tend to listen to them more.

I tend to agree with your management, its the same allergen. 

[Scotty_SQF]

I tend to agree with your management, its the same allergen. 

 

How is it the same allergen?  It is specifically called out as a different one by all the governments.  Peanuts aren't a true nut, they are more legume and just called peanuts if I remember right.  Grown and harvested completely different.  I know people who are allergic to peanuts, but not tree nuts.  I'm just trying to understand how they would be 'the same allergen'.

Edited by Scotty_SQF, 02 August 2023 - 01:50 PM.

[DeadPresident]

I stand corrected. I haven't worked in an allergen facility in years and I thought that most tree nut allergen testing kits would also pick-up peanuts. 

[Scampi]

Peanuts and tree nuts are NOT in the same category as per post #18

 

Not even close----------folks, do yourselves a favour and google some basic facts

 

If you have the responsibility of protecting food safety and your customers, it is your job to ensure your well educated and if you're not willing to do that, please find another avenue of work

 

The number of allergen related food recalls keeps going up-------now I know why (I'm looking at you dead president)

[MDaleDDF]

 your well educated

 

*you're

 

lol.

[Scampi]

*you're

 

lol.

I'm so embarrassed lol!

 

I was typing passionately, can you tell?

[C.Giauque]

Can we please remain respectful on this post? Undeclared allergens are a serious topic and I want this post to remain a tool to help those who may find themselves in a similar situation as me. We are all on this forum to help one another and continue to learn and grow within Food Safety. Thankfully we have not yet sent out the product that tested positive for cashew proteins and I am currently holding said product. I have immediately sent out more samples from later that day to try and determine just how much product was adulterated. I will let you know how the discussion goes with management.

 

Thank you.

Edited by C.Giauque, 02 August 2023 - 03:10 PM.

[DeadPresident]

Peanuts and tree nuts are NOT in the same category as per post #18

 

Not even close----------folks, do yourselves a favour and google some basic facts

 

If you have the responsibility of protecting food safety and your customers, it is your job to ensure your well educated and if you're not willing to do that, please find another avenue of work

 

The number of allergen related food recalls keeps going up-------now I know why (I'm looking at you dead president)

You're right. That was very lazy of me to not even do a simple google search. 

 

Glad to not be working with allergens anymore. 

[kingstudruler1]

Can we please remain respectful on this post? Undeclared allergens are a serious topic and I want this post to remain a tool to help those who may find themselves in a similar situation as me. We are all on this forum to help one another and continue to learn and grow within Food Safety. Thankfully we have not yet sent out the product that tested positive for cashew proteins and I am currently holding said product. I have immediately sent out more samples from later that day to try and determine just how much product was adulterated. I will let you know how the discussion goes with management.

Thank you.

Be carefull with this.  You can't test the product "good'.  The allergenic protein product may release is slugs.   some product may have alot some may not have any.  

Edited by kingstudruler1, 02 August 2023 - 11:52 PM.