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Allergen program needed for non-allergenic grain processing?


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Parkz58

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Posted 25 October 2016 - 02:14 PM

Hello Charles.C,

 

Thank you for your response.  I am curious what you mean by "zero-tolerant classifications".  I've never heard of such a thing here in the US.

 

The legal term "adulteration" is actually key.  It's divided into intentional and unintentional adulteration, at least from my understanding.  Intentional adulteration is mainly used in the sense of food terrorism and food defense, and carries with it the implication of attempting to cause harm, whether physically, financially, etc.

 

However, unintentional adulteration becomes more difficult to categorize.  Ignorance truly is not bliss, as we've seen from repeated FDA investigations and subsequent recalls, and the trials that often follow, throughout the food industry here in the US.

 

If this were any other sector/category of the food industry, I would agree with you wholeheartedly.  However, the FDA has specifically acknowledged that, in the grain industry, cross-contamination happens.  It's just the way it is.  So, again, I quote the FDA (http://www.fda.gov/f...s/ucm059116.htm):

 

(Oat products may contain adventitious barley, rye, wheat and triticale from the grain handling process as allowed by the U.S. Grain Handling Standards and the Canadian Grain Commission. According to the latest Q&A Document released by the FDA December 12, 2005, labeling of allergens from cross-contact is not required.)

 

"FALCPA's labeling requirements do not apply to major food allergens that are unintentionally added to a food as the result of cross-contact. In the context of food allergens, “cross-contact” occurs when a residue or other trace amount of an allergenic food is unintentionally incorporated into another food that is not intended to contain that allergenic food. Cross-contact may result from customary methods of growing and harvesting crops, as well as from the use of shared storage, transportation, or production equipment."

 

We are making no claims that our product has not had any kind of cross-contamination.  We are making no gluten-free claims, nor are we making any other claims.  So, if the FDA acknowledges that this happens with our product, but doesn't consider it to be a concern, why would we?  It is well known that those with gluten intolerance (here in the US, anyway) will specifically look for the label "Gluten-free" on items.  If the item doesn't have that label, they know there is an inherent risk...especially with grains.

 

So, again, based upon the evidence I've presented, as well as the advice of our SQF-certified auditor consultant, we will not be employing any sort of allergen testing.  Our allergen control program shall consist of prohibiting the receiving of anything into our plant that is labeled or otherwise contains a declared allergen, and strict adherence to our procedures to sample, inspect (and reject, if outside of limits on percentage of foreign grain allowed), aspirate and screen our oats prior to processing.

 

I cannot see any valid reason why we would need to do anything further at this time.  If the rules change, or if we begin to export, we will obviously need to address changes at that time.

 

Brian



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Posted 25 October 2016 - 02:15 PM

 

 

Personally, i suggest you may be wise to do "some" initial testing just to see what level of playing field actually exists. Possibly to also compare different suppliers. "Forewarned is Forearmed".

Absolutely true, however, I recently attended a webinar discussing food safety liability, and they discussed a way for you to do baseline sampling to get an idea of what might be out there, while keeping the results confidential through attorney-client privilege. The applicable section is the 41 minute mark. I have no idea how valid it might be, but it was an interesting idea.

 

http://repositrak.com/recall-fsma-criminal-risk-how-they-affect-your-people-your-brand/

http://repositrak.com/recall-fsma-criminal-risk-how-they-affect-your-people-your-brand/


Austin Bouck
Owner/Consultant at Fur, Farm, and Fork.
Consulting for companies needing effective, lean food safety systems and solutions.

Subscribe to the blog at furfarmandfork.com for food safety research, insights, and analysis.

Parkz58

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Posted 25 October 2016 - 02:25 PM

Hello Earth2O,

 

I don't have time at the moment to listen to the recording, but I'm assuming you're talking about having results sent directly to your attorney, who then simply sends you a letter stating that the results were within specification, right?  It's actually a brilliant idea!

 

Thanks,

 

Brian



Charles.C

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Posted 25 October 2016 - 03:12 PM

Hello Charles.C,

 

Thank you for your response.  I am curious what you mean by "zero-tolerant classifications".  I've never heard of such a thing here in the US.

zero-tolerant is a global term. It means detection = rejection if regulatory relevant. Other than gluten and sulphites, afaik, any label-required US allergens are classified as zero-tolerant. Similar to salmonella.

 

 

The legal term "adulteration" is actually key.  It's divided into intentional and unintentional adulteration, at least from my understanding.  Intentional adulteration is mainly used in the sense of food terrorism and food defense, and carries with it the implication of attempting to cause harm, whether physically, financially, etc.

 

However, unintentional adulteration becomes more difficult to categorize.  Ignorance truly is not bliss, as we've seen from repeated FDA investigations and subsequent recalls, and the trials that often follow, throughout the food industry here in the US.

 

Adventitious allergens may be an exception but, In general, afaik, if a US food product is considered "contaminated", ie no longer wholesome it can be rejected by FDA (detection of fine particles of metal is a common example of this rule). The offender may be "recommended"  to implement a recall so as to to preempt a rejection. The attachment in my previous post implied that adventitious allergens may fall foul of this trap.

 

If this were any other sector/category of the food industry, I would agree with you wholeheartedly.  However, the FDA has specifically acknowledged that, in the grain industry, cross-contamination happens.  It's just the way it is.  So, again, I quote the FDA (http://www.fda.gov/f...s/ucm059116.htm):

Refer the attachment in my previous post. I'm only quoting a reported event,

(Oat products may contain adventitious barley, rye, wheat and triticale from the grain handling process as allowed by the U.S. Grain Handling Standards and the Canadian Grain Commission. According to the latest Q&A Document released by the FDA December 12, 2005, labeling of allergens from cross-contact is not required.)

 

"FALCPA's labeling requirements do not apply to major food allergens that are unintentionally added to a food as the result of cross-contact. In the context of food allergens, “cross-contact” occurs when a residue or other trace amount of an allergenic food is unintentionally incorporated into another food that is not intended to contain that allergenic food. Cross-contact may result from customary methods of growing and harvesting crops, as well as from the use of shared storage, transportation, or production equipment."

 

We are making no claims that our product has not had any kind of cross-contamination.  We are making no gluten-free claims, nor are we making any other claims.  So, if the FDA acknowledges that this happens with our product, but doesn't consider it to be a concern, why would we?  It is well known that those with gluten intolerance (here in the US, anyway) will specifically look for the label "Gluten-free" on items.  If the item doesn't have that label, they know there is an inherent risk...especially with grains.

ditto.

 

So, again, based upon the evidence I've presented, as well as the advice of our SQF-certified auditor consultant, we will not be employing any sort of allergen testing.  Our allergen control program shall consist of prohibiting the receiving of anything into our plant that is labeled or otherwise contains a declared allergen, and strict adherence to our procedures to sample, inspect (and reject, if outside of limits on percentage of foreign grain allowed), aspirate and screen our oats prior to processing.

 

I cannot see any valid reason why we would need to do anything further at this time.  If the rules change, or if we begin to export, we will obviously need to address changes at that time.

 

Brian

Good luck regardless of uncertainties !


Kind Regards,

 

Charles.C


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Posted 19 March 2018 - 01:36 AM

Hi Parkz58,

 

 

I have just come across this thread - a while ago now I realise.  We face a similar dilemma to you, being a processor of maize in Australia.  Our maize is grown on contract in areas where there are also allergens such as soy and peanut grown.  We are reviewing our HACCP plan and struggling with how to deal with the hazard of peanut contamination.  Current plan identifies visual inspection at maize intake as CCP, with loads rejected if peanuts are found.  Similarly with soy and wheat, but final products are on positive release for gluten as we are making a gluten-free claim.  Given the risk to human health of peanut contamination we need to have a strong control on this, but visual inspection feels a bit weak.  I just wondered if, given all the time gone by since this discussion, you had found any clear answers!  Like you, we also suspect that our cleaning and processing would eliminate any contamination that got through the process, but we would need to validate that without challenge testing, given that we don't want to contaminate the plant.  Very keen to hear of any learnings that you might have made.  Thank you so much!

 


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Parkz58

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Posted 19 March 2018 - 01:51 PM

Hi Nicky,

 

Unfortunately, we haven't learned much more since then.  However, we're only going to be producing product for animal (livestock) feed for now, so we don't have to worry about it for the time being.  If/when we ever transition to pet food or human food, we'll definitely have to deal with it then...so I'm keeping my ears open all the time for anything that may help!  If I learn anything, I'll try to remember to share it on here for you and everyone else!



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Posted 19 March 2018 - 08:09 PM

Thank you so much!!  At the moment I'm thinking that we need to cover it with 3 steps - PRP re grower contract to supply grain containing no allergens, CP at the front end being visual inspection of each load (with constraint being sampling, as you pointed out in the original thread), and then a CCP around cleaning - but yet to work out how to validate and verify - I suspect as someone said a challenge test but I don't think we really want to deliberately chuck peanuts in....and then some sort of testing plan as verification.....that's about as far as I've got.






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