29 replies to this topic

[C.Giauque]

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.  

 

I apologize, let me rephrase. I am sending test samples of the beginning of the other batches of different products ran that day after the one that was tested positive after cleaning. I will not be trying to send out any of the batch that has already tested positive. 

[Kara S.]

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".

 

I'm disappointed to hear that senior management is not taking this concern seriously. To assist with your case, please share with them this FDA website on their current view for allergen cross-contact. https://www.fda.gov/...ir facility and

• There is a section that states that while may contains statements are not required by law, they may be placed if you feel cross-contact is unavoidable. However, if the FDA tests your product and finds the presence of cashews, like you did, and they come on-site to find that you have not performed any preventive measure to control this, then they will likely enforce a recall of the product. Those statements are not meant to by-pass cGMPs. 

Additionally, allergen recalls are still the #1 reason for product recalls in the US. You should present this information by showcasing the percentage of recalls that have occurred just this year, followed by the cost implications this would have such as: cost of media coverage to communicate recall, cost to store the recalled product, cost of destruction of the product, cost of overtime, the drop in sales from damaging brand, potential overtime, and so on.  https://www.fda.gov/...s-safety-alerts

 

 

You are correct, there is no allowable threshold for allergens. You can explain this is why manufacturers are not required to validate their sanitation or allergen preventive controls per the regulation. Only process preventive controls must be validated. 

 

If you show them the cost of this recall vs. a couple potential solutions - maybe a dry steam belt cleaner, purging the line for x amount of minutes and reworking that product for the next cashew run, or another form of cleaning you already do, they will be more likely to listen. 

 

While you likely do not have the say in this matter, they should all consider taking a Preventive Controls for Human Food training to understand the regulations they should be adhering to as well as their responsibility. 

[sqflady]

I have experience with a couple of facilities where management commitment to food safety is absent because profits are the driving factor.  My advice.. run.  It is very difficult to overcome greed.

[MDaleDDF]

I'm so embarrassed lol!

 

I was typing passionately, can you tell?

Lol, sorry Scampi, I was just joshin ya.   I knew you'd see the humor...

[Charles.C]

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.

See this Post and associated thread(s) -

 

https://www.ifsqn.co...rix/#entry61940

 

Regarding  "May Contain" statements, their value (ie Pros/Cons) has been widely, sometimes passionately, discussed on this Forum and in the Literature including IRC with respect to Chocolate Manufacturing. Without afaik any Official, quantitative, US conclusion. The (2021) link in Post 15  overviews the US situation and IMO illustrates the somewhat static situation regarding their usage from an official POV. There do exist Risk Assessment Procedures which offer a decision-making methodology for including a Precautionary Statement or not however I doubt that many Processors would choose such a route due to, afaik, lack of Official Guidelines.

 

Nonetheless, quoting from link in Post 15 -

food manufacturers are required to implement controls to ensure accurate labeling of finished foods with respect to the major food allergens and controls to significantly minimize or prevent allergen cross-contact.

The obvious quantitative difficulty is with "significantly" but It appears from your OP that Senior management has totally ignored such operational issues. This would apparently simply fail FDA's minimal requirements and has seemingly resulted in data such as mentioned in OP .