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Parkz58

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Posted 03 October 2016 - 03:00 PM

Hello Everyone,

 

I am in a quandary.  We are processing oats, which are inherently non-allergenic (no gluten in oats)...however, the very nature of oat production, especially in regards to storage and transportation practices from farm to grain elevator, shows that there is a history of, and therefore a potential for, cross-contamination with other grains through incidental/accidental/residual mixing or other contact.

 

We are going to be starting off our production as livestock feed-grade only, but plan to transition to pet food grade and then to human food grade.

 

My question is simple, yet somewhat complex when you drill down on it:  If we don't use any ingredients that are inherently allergenic, and don't have any other allergenic substances in our facility, do we still need to have an allergen swabbing/sampling program?

 

The answer is obviously no if we're simply making animal feed, but when we transition to pet food, and then food-grade, it becomes much more difficult to answer.

 

We are making no claims of being organic, gluten-free, or anything else like that on our labels.

 

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.

 

So, putting all of that together...what are your thoughts??

 

Thanks,

 

Brian



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Posted 04 October 2016 - 10:23 AM

Dear Brian,

 

Looking to the short term development of your company, I would answer Yes to your question. This allows you to:

  • Identify the allergens you are dealing with
  • Quantify the level of allergens
  • Have a better idea of the costs of an allergen free program
  • Prepare the company for certification against a GFSI recognized standard
  • Provide more precise information about allergens to the Higher Management of your company
  • Make eventual strategic choices for opportunities
  • Improve the confidence and the satisfaction level of your customers

I hope to have informed you sufficiently. In case of other questions, please don't hesitate to contact me.

 

Kind regards,

 

Gerard Heerkens



Parkz58

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Posted 04 October 2016 - 01:54 PM

Thank you for your response, Gerard...I appreciate it.

 

However, the very reason why I'm asking this question is because the cost of the allergen program is somewhat prohibitive (we are a VERY small company), and I already know what allergens we'd potentially be dealing with (wheat and a slight possibility of soy).  Levels would be VERY low, as our process involves multiple aspiration and screening steps, which will remove nearly all (and likely, all) offending allergenic grain.  At this stage, our customers don't care one bit about allergens in our product - this would really only come into the forefront if we eventually transition to certified gluten-free, but that transition would almost certainly require us to change our suppliers to certified gluten-free growers.

 

The only hesitation I have at this point about totally scrapping any allergen program would be our pursuit of SQF certification, which we plan to pursue within the next year.



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Posted 04 October 2016 - 07:37 PM

Equipment allergen programs only make sense if you're introducing known allergens to the line, then running a product without that allergen and want to validate it's removal. It seems like your concern is that the products received could have cross-contamination, and it should be addressed upstream, not in your sanitation program.

 

There are two approaches you could take that would be validations as opposed to an ongoing verification program, which is much cheaper even though it's less effective at catching problems.

 

1. Do you have an expectation from your suppliers that they provide an allergen-free product?

 

If this is so, then you would want to test product samples from say, one shipment a year from each supplier (maybe during harvesting season of allergens of concern, where you might be more afraid of contamination). This helps you confirm that you are receiving an allergen free product with data, and holds your suppliers accountable to their own allergen programs. Sample testing of that type of product requires a blender, and you can run each test for 30-40 bucks in-house if you wanted to (just accept the liability of being the tester, and some customers may require it to be 3rd party).

 

2. If not the suppliers, do you have an expectation that your manufacturing process creates an allergen free product?

 

This is even easier, and the interval depends on you. Simply come up with a way to "test" your process by introducing an appropriate amount of oats with soybeans contaminating them into your screening and other steps, and then testing the product that comes out the other side. This should happen at minimum annually or whenever you change the equipment. But allows you to do very little testing overall while providing a scientific evaluation of your equipment.

 

This would be a great minimum start to a program to give you confidence before moving into these new markets, but remember, you cannot test your way to food safety. Validating your suppliers, processes, and testing at an interval that provides confidence (remember, if 5% of product is contaminated you only have a 1/20 chance of seeing it on each test!), is what you'll need to make sure you provide safe product. It's unfortunate that grains all got exemptions to basically all of the FSMA final rules. Good luck!


Austin Bouck
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Posted 04 October 2016 - 08:28 PM

Earth20, thank you!  I think your approach matches our process and needs pretty well.  I will dig into it some more and see if we can make that work for us.



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Posted 05 October 2016 - 11:06 AM

Dear Brian,

For a human food SQF certified system, you will need to implement an allergen management program.

Kind regards,

Gerard Heerkens



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Posted 07 October 2016 - 03:09 PM

Earth 2O, I have been mulling over what you wrote the other day, and am wondering if you can help me think through a few issues...I've quoted you to make this easier, and my entries are in red:

 

Equipment allergen programs only make sense if you're introducing known allergens to the line, then running a product without that allergen and want to validate it's removal. It seems like your concern is that the products received could have cross-contamination (that is correct), and it should be addressed upstream, not in your sanitation program.  The biggest problem with this approach is that our one and only ingredient is a raw agricultural commodity, purchased from grain elevators that receive and store astonishing amounts of a variety of grains, and have little concern for minimal cross-contamination.

 

There are two approaches you could take that would be validations as opposed to an ongoing verification program, which is much cheaper even though it's less effective at catching problems.

 

1. Do you have an expectation from your suppliers that they provide an allergen-free product? (Not exactly.  Our Raw Material Specification states in the Allergen section:  "Does not inherently contain any allergens. Allergens can only be introduced by cross-contamination with other grains that contain allergens. Ensure that the supplier guarantees the ingredient has been isolated from any wheat or soy (raw grain, products or by-products)."  So, while we expect that there is care taken to guarantee isolation, there is no requirement for cleaning common equipment like combines, bins, augers, etc.).

 

If this is so, then you would want to test product samples from say, one shipment a year from each supplier (maybe during harvesting season of allergens of concern, where you might be more afraid of contamination). This helps you confirm that you are receiving an allergen free product with data, and holds your suppliers accountable to their own allergen programs. Sample testing of that type of product requires a blender, and you can run each test for 30-40 bucks in-house if you wanted to (just accept the liability of being the tester, and some customers may require it to be 3rd party). (I think this may be our best bet, because even if there is minimal cross-contamination, it should still produce low enough results to come in under the 20 ppm suggested limit).

 

2. If not the suppliers, do you have an expectation that your manufacturing process creates an allergen free product?  (Our manufacturing process should, theoretically, reduce any concentration levels of allergens that may have been present in the raw material.  We utilize scalpers, screeners, aspirators, etc. - each step should (again, theoretically) remove some of any present allergens.  How much?  We don't know.  But our process, at the very minimum, would do nothing to increase the risk).

 

This is even easier, and the interval depends on you. Simply come up with a way to "test" your process by introducing an appropriate amount of oats with soybeans contaminating them into your screening and other steps, and then testing the product that comes out the other side. This should happen at minimum annually or whenever you change the equipment. But allows you to do very little testing overall while providing a scientific evaluation of your equipment.  (While I like this idea in theory, I don't know how feasible it is in the real world for our facility.  We have a dry system, which is designed to primarily be self-cleaning via product flushing.  This would potentially contaminate a very large amount of product that follows through the system, or else we'd have to thoroughly clean the system in a way that it's really not designed to be done.  I have to think about this one some more...)

 

This would be a great minimum start to a program to give you confidence before moving into these new markets, but remember, you cannot test your way to food safety. Validating your suppliers, processes, and testing at an interval that provides confidence (remember, if 5% of product is contaminated you only have a 1/20 chance of seeing it on each test!), is what you'll need to make sure you provide safe product. It's unfortunate that grains all got exemptions to basically all of the FSMA final rules. Good luck!  (Thanks!  But what do you mean, it's unfortunate that grains all got exemptions?  I don't recall reading or hearing about that...what exactly do you mean, and where in the final rules is it located?)

 

Earth2O, you definitely have helped me think about this allergen control program in a new way.  I had been thinking purely in terms of product testing, because of my background...but this approach seems so much more appropriate.  Thanks again!!

 

Brian



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Posted 07 October 2016 - 04:32 PM

Hi Brian, I'll do my best!

 

1. Do you have an expectation from your suppliers that they provide an allergen-free product? (Not exactly.  Our Raw Material Specification states in the Allergen section:  "Does not inherently contain any allergens. Allergens can only be introduced by cross-contamination with other grains that contain allergens. Ensure that the supplier guarantees the ingredient has been isolated from any wheat or soy (raw grain, products or by-products)."  So, while we expect that there is care taken to guarantee isolation, there is no requirement for cleaning common equipment like combines, bins, augers, etc.).

This is a great specification. As you move into human food, include the 20ppm limit so that if you have a lot that fails, you can reject it on the basis of your specification.

 

If this is so, then you would want to test product samples from say, one shipment a year from each supplier (maybe during harvesting season of allergens of concern, where you might be more afraid of contamination). This helps you confirm that you are receiving an allergen free product with data, and holds your suppliers accountable to their own allergen programs. Sample testing of that type of product requires a blender, and you can run each test for 30-40 bucks in-house if you wanted to (just accept the liability of being the tester, and some customers may require it to be 3rd party). (I think this may be our best bet, because even if there is minimal cross-contamination, it should still produce low enough results to come in under the 20 ppm suggested limit).

Be careful with your assumptions. 20ppm is not as high as you may think (see link for visual). On your failures, you may not even see the contamination. Allergen verification is tricky business and very easy to fail. Because your process has not been validated to remove allergens (as discussed below), your corrective action would be to re-route the lot to a non-human use (probably your easiest rework based on current business model) or reject the lot entirely. Most cheap allergen tests aren't quantitative either, so you'll get a pass/fail reading based on a limit, check the limit of the test and make sure you're not using an extra sensitive test, or one that isn't sensitive enough. That being said, I don't work with raw grains, and I know the standards are going to be different at that level. My best guess is that those upstream processors sell the grains from "transitions" from one silo to another probably sell them first for animal use, then once likelihood of cross contamination is low, sell that section for human use.

 

2. If not the suppliers, do you have an expectation that your manufacturing process creates an allergen free product?  (Our manufacturing process should, theoretically, reduce any concentration levels of allergens that may have been present in the raw material.  We utilize scalpers, screeners, aspirators, etc. - each step should (again, theoretically) remove some of any present allergens.  How much?  We don't know.  But our process, at the very minimum, would do nothing to increase the risk).

I agree, as long as you remain a single-allergen facility, and your process is not designed to remove allergens, then your allergen program remains exclusively supplier-based. If this ever changes, and you use your setup to remove potential allergens, then the program needs to change, and you need to have a strict cross-contamination prevention program between raw and processed product. Essentially, treat incoming grains like raw beef, and outgoing grains as cooked beef, keeping equipment, tools, and personnel separated (within reason).

 

This is even easier, and the interval depends on you. Simply come up with a way to "test" your process by introducing an appropriate amount of oats with soybeans contaminating them into your screening and other steps, and then testing the product that comes out the other side. This should happen at minimum annually or whenever you change the equipment. But allows you to do very little testing overall while providing a scientific evaluation of your equipment.  (While I like this idea in theory, I don't know how feasible it is in the real world for our facility.  We have a dry system, which is designed to primarily be self-cleaning via product flushing.  This would potentially contaminate a very large amount of product that follows through the system, or else we'd have to thoroughly clean the system in a way that it's really not designed to be done.  I have to think about this one some more...)

This is inherently the problem with challenge studies, and the solution is generally to use a surrogate. If this was a micro-validation, I would use a non-pathogenic bacteria rather than introducing e. coli to my equipment. You may be able to do this with a non-USA allergen like mustard seed, but again that wouldn't be a very good validation because mustard seed would be handled differently from soy contamination. The best way to do with would be to use the allergen of concern, but do it while you're doing a long run of livestock products, so that if you failed the validation and contaminated your equipment you can "flush" it with product that can still be sold without meeting the allergen standard.

 

This would be a great minimum start to a program to give you confidence before moving into these new markets, but remember, you cannot test your way to food safety. Validating your suppliers, processes, and testing at an interval that provides confidence (remember, if 5% of product is contaminated you only have a 1/20 chance of seeing it on each test!), is what you'll need to make sure you provide safe product. It's unfortunate that grains all got exemptions to basically all of the FSMA final rules. Good luck!  (Thanks!  But what do you mean, it's unfortunate that grains all got exemptions?  I don't recall reading or hearing about that...what exactly do you mean, and where in the final rules is it located?)

Grains in the "raw" state essentially got a free pass, placing the burden on grain processors like yourself, which makes supplier approval and compliance enforcement more difficult for raw ag.

 

The entire FSMA produce rule, in the exemptions section: "The rule does not apply to: Food grains, including barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, and oilseeds (e.g. cotton seed, flax seed, rapeseed, soybean, and sunflower seed)" http://www.fda.gov/F...A/ucm334114.htm

 

Exemptions from food transportation rule: "Transportation activities performed by a farm"http://www.fda.gov/F...A/ucm383763.htm

 

Exempt from preventative controls: "The definition of a ‘farm’ is clarified to cover two types of farm operations. Operations defined as farms are not subject to the preventive controls rule...Secondary Activities Farm: This is an operation not located on the Primary Production Farm that is devoted to harvesting, packing and/or holding raw agricultural commodities. It must be majority owned by the Primary Production Farm that supplies the majority of the raw agricultural commodities harvested, packed, or held by the Secondary Activities Farm." http://www.fda.gov/F...A/ucm334115.htm

 

Earth2O, you definitely have helped me think about this allergen control program in a new way.  I had been thinking purely in terms of product testing, because of my background...but this approach seems so much more appropriate.  Thanks again!!

 

Brian

 

Final thoughts:

Remember that even though you may consider these verification events critical to food safety, because you have no control in place it would not be a CCP. This is a prerequisite program in which you approve suppliers and verify they are meeting your raw material specification at some interval using testing. I would also encourage you to make that testing as meaningful as possible by taking it directly from the transport vehicle, targeting seasons where multiple crops may be stored or harvested on shared vehicles and containers, and grabbing from the beginning of the lot, where leftovers from the previous product are most likely to be included, or in sweepings/fines where non-whole seeds may collect and act as a source for contamination. You could also go crazy and instead test the fines from your screeners and such, and establish a threshold amount of allergen containing material that is collected and concentrated there, but I have no idea what limits would be or how indicative that might be.

 

Also, don't get trapped in thinking that among an entire lot of product (so many tons of product) the concentration is <20ppm. That doesn't matter. What matters is whether a single consumer might eat a single meal with a higher concentration. If I'm allergic to peanuts, and throw one peanut into 5 boxes of hamburger helper in a lot of 1,000,000 boxes, the concentration for the lot is well below 1ppm. But for the consumers who get those 5 boxes, the concentration is much higher, and your lot statistics don't matter.

 

Best of luck with approaching this! Remember to keep scope small, risk assess, and take baby steps with implementation. And absolutely critical, don't test for curiosity alone. Never test product unless you have an agreed upon corrective action for a positive result. You cannot unlearn a positive result or test it away, so be prepared to rework, recall, or destroy any product you test.


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

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Parkz58

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Posted 07 October 2016 - 06:44 PM

Earth2O, you have been a wealth of information and detailed thinking on the issue, and I can't thank you enough!

 

I am going to work on our allergen control program today, and your insights have been invaluable in helping me sort through everything and coming to a much clearer understanding of where we need to be on this.

 

Brian



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Posted 08 October 2016 - 03:04 AM

Hi Parkz,

 

I will hypothesise an initial viewpoint from a CB's POV.

 

Is there historically any evidence to support that cross-contamination is a realistic likelihood ?.

 

If yes, is there any literature documentation regarding how other people have "controlled" such an issue and validated their procedure.

 

Risk assessment/management 101.

 

(The common problem for the producer of course is whether any such procedures are realistic for a small producer, technically and/or financially.)

 

 

PS -

People producing products where the raw material has a known history of contamination by low levels of Regulatory zero-tolerant pathogens like salmonella face an analogous challenge.

 

For such cases it is statistically (and often equipment-wise) impossible for a typical receiver to screen the material at a practical level so as to have any substantial confidence in the meaning of a negative lab. detection result. The principal benefit is to detect gross contamination.

 

Hence FS Standards's perpetual focus on Supplier Approval.

 

PPS - Not my area but offhand I would doubt that the procedures you mentioned would ensure removal of contaminants down to a 20ppm level. But perhaps the equipment people offer such validations ?

 

@Earth, 

if 5% of product is contaminated you only have a 1/20 chance of seeing it on each test!

If n=1, Yes. But i do agree with yr implied pessimism.


Kind Regards,

 

Charles.C


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Posted 10 October 2016 - 02:00 PM

Thanks for your thoughts, Charles.

 

Yes, there is evidence that cross-contamination is a realistic likelihood - General Mills recently went through a big issue when their "gluten-free" Cheerios were found to have trace amounts of gluten in them from cross-contamination (the only possible way it could have happened, since oats are inherently gluten-free).

 

The problem is, I have spent an inordinate amount of time searching for documentation about how others have controlled and validated their procedures...to no avail.  Hence the reason why I have posed this question here.

 

I'm not so certain that your example is truly analogous, though.  Allergen cross-contamination would be in the form of foreign grains mixed in to the oats.  These would be in whole grain form, parts and pieces, or dust.  All of those can be removed to a very high degree by an intensive screening and aspirating process, which we have (multiple screens and aspirators throughout the process flow).  Microbial contamination is often deeper than just the surface, so removal by screening and aspiration would be minimally effective (if at all).

 

I agree that Supplier Approval should be the first line of defense, but the nature of the grain industry makes this difficult.  Very, very few farms only produce one crop, so cross-contamination can (and sometimes does) occur at that level.  Because oats are not easily sourced from the farm level (because there are few farms that can produce enough to meet a customer's steady, high-volume demand), we and others in our industry are forced to purchase from grain elevators and/or brokers.  These "middle men" have no interest in trying to control the methods their farm suppliers employ in preventing cross-contamination - they don't have any legal responsibility to do so (even under FSMA), and it's not economically feasible for them to do so, either.  So, the oats we purchase from a grain elevator may be essentially a mix of oats from multiple farms.  If even one of those doesn't follow GAP, and doesn't thoroughly clean out harvesting equipment, augers, bins, etc., they could effectively cross-contaminate the entire mix.

 

So, short of sourcing oats directly from the farm, with complete control over the farming operations (which, admittedly, some certified organic and/or gluten-free processors do...but at a greatly increased cost and price), we can't have 100% confidence that our Approved Supplier program will actually prevent cross-contamination.



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Posted 10 October 2016 - 02:46 PM

One thing I might recommend (and if this has been mentioned, please forgive me, I did not read everyone's responses completely), is allergen testing after cleaning equipment?  We do this as validation of our cleaning programs, but it also falls under allergen control pertaining to SSOPs.  We do each vessel that contains an allergen, but once you validate it, you could do it say on a monthly basis? These tests are relatively inexpensive.  They are quick tests that take about 10 minutes to complete.

 

Though we have a requirement from our vendors that everything passes all testing, they have their own allergen controls, etc, with the ever changing requirements through the FDA and other regulatory bodies, we always look at it as even though we have those requirements ourself, we want to ensure that what we are sending out is safe.



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Posted 10 October 2016 - 03:32 PM

Hello ncwingnut,

 

Thanks for your thoughts.  Unfortunately, that approach doesn't really help us, as the presence or absence of allergens after cleaning doesn't really mean much to our process.  Our only concern is potential cross-contamination of our sole ingredient before it ever arrives at our plant (because we allow no known/labeled allergenic material in our plant, as part of our allergen control and also our receiving procedures) - therefore, we could prove that our cleaning process results in no remaining allergens, yet our product may still potentially be contaminated.

 

The challenge for us is one that not many other industries face, so a lot of the "normal" allergen control measures simply don't apply to our process or product.



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Posted 10 October 2016 - 03:37 PM

Hi Parkz,

By analogous I really meant from a sampling/ detection POV.
The typical approach for a bulk lot is to visualize that it consists of a collection of small units, eg of 500g size. Any unit which is "allergenic " (>20ppm) is then regarded as defective.
(PS - don't ask me how you do the actual sampling :smile:)


Kind Regards,

 

Charles.C


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Posted 10 October 2016 - 03:39 PM

What about before cleaning, after the product is removed from vessel?  We have done that also.

 

I understand your frustration.  When we first decided to get our SQF certification 6 years ago, they had the hardest time deciding what category to put us in due to the nature of our products, lol.  They tried to put us under grain processing, baking, etc.  Very frustrating process at times when you want to make sure that you cover everything.



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Posted 10 October 2016 - 04:01 PM

OK, thank you for clarifying, Charles.C - that makes a lot more sense.  And yes, one of the big challenges is sampling as well - trying to think of a semi hopper trailer load of oats in terms of 500g segments is practically impossible, and even the accepted probing methods for sampling will fall far short of that level of sample composition.

 

Ncwingnut, that approach might be better, but still may not be truly indicative of what is actually in the product, due to the nature of the potential contamination.  For example, the very process of sending the product down a conveyor may cause allergenic dust to fall off of the oats and rest on the conveyor - testing may then show that the conveyor is contaminated at an unacceptable level, but the product itself may have shaken off enough of the contaminated dust to now be below the acceptable threshold.  See how complicated and difficult this can be?  Well, it sounds like you might have an idea of the complications that go along with deciphering some aspects of food safety...I feel your pain!  LOL



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Posted 11 October 2016 - 08:53 AM

Hi Parkz,

 

Yr situation / concerns  seem to particularly be –

 

(a) focused on whether oats labeled gluten free (with all that’s complexities, eg the extremely “convoluted” FDA 2013 link below /20ppm limit). But, as I understand, you state that this labeling claim is not envisaged  for yr product.

http://www.fda.gov/F...s/ucm362880.htm

 

(b) questioning (assuming labeling as [a], what adventitious (ie unintentional) tolerances to other grain relatives are allowed in product labeled “oats” and if such mixing is permitted, then how about the labeling for any (eg wheat, barley) individually contributed allergenic presences thereby introduced. Again the labeling will IMO define the allergen management program.

 

Presumably the obvious option is advisory labeling (AL) for the (any?) level of contamination considered risk significant even if no official requirement exists. Afaik, from an allergenic POV, a quantitatively defined “official viewpoint on AL for  admixed agri. allergens in  USA/Canada/UK (targets of most queries here) is lacking. Hence perhaps inference from gluten-free ppm considerations.

 

But afaik, USFDA (and USDA?) do not regard the use of  AL as a valid excuse for avoiding practical steps to “eliminate” allergenic contamination where it is considered risk significant. So cleaning/testing/validation would still be required in such cases.

 

The question of what level of  unintentional agri. mixing tolerances are officially permitted  and allergenic-related consequences has come up previously on this forum. Particularly for wheat, barley, oats. And typically causing confusion.

 

Some Examples  -  

 

Wheat (US)  

http://www.ifsqn.com...-contamination/

eg  see attachment all1/Post2, which contains a short summary of US position on agri. admixing (Pgs 50-52).

 

Barley/Oats (US/Canada)

http://www.ifsqn.com...ns/#entry100449

 

 

Barley (UK)

http://www.ifsqn.com...in-the-factory/

 

And probably many others.

 

PS -

BTW, Traceability is also an interesting silo-related agri. conundrum, eg –

http://www.ifsqn.com...lour-in-bakery/


Kind Regards,

 

Charles.C


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Posted 11 October 2016 - 05:59 PM

Hello Charles.C,

 

I always enjoy your responses to my questions, because you approach things differently than I do at times, and you always make me think and question things...very much appreciated!

 

I've responded point-by-point to your response:

 

Hi Parkz,

 

Yr situation / concerns  seem to particularly be –

 

(a) focused on whether oats labeled gluten free (with all that’s complexities, eg the extremely “convoluted” FDA 2013 link below /20ppm limit). But, as I understand, you state that this labeling claim is not envisaged  for yr product.  At this time, we are not worried about trying to label anything "gluten-free", because we are not prepared to make that step yet.

http://www.fda.gov/F...s/ucm362880.htm

 

(b) questioning (assuming labeling as [a], what adventitious (ie unintentional) tolerances to other grain relatives are allowed in product labeled “oats” and if such mixing is permitted, then how about the labeling for any (eg wheat, barley) individually contributed allergenic presences thereby introduced. Again the labeling will IMO define the allergen management program.

 

Presumably the obvious option is advisory labeling (AL) for the (any?) level of contamination considered risk significant even if no official requirement exists. Afaik, from an allergenic POV, a quantitatively defined “official viewpoint on AL for  admixed agri. allergens in  USA/Canada/UK (targets of most queries here) is lacking. Hence perhaps inference from gluten-free ppm considerations.  I disagree on the advisory labeling, as does Canada, in a very similar situation:  http://www.hc-sc.gc....oy-soya-eng.pdf

 

But afaik, USFDA (and USDA?) do not regard the use of  AL as a valid excuse for avoiding practical steps to “eliminate” allergenic contamination where it is considered risk significant. So cleaning/testing/validation would still be required in such cases.  Again, I disagree.  As mentioned above, official FALCPA documentation does not consider such adventitious grain cross-contamination to be worthy of labeling, and there are no further requirements that I can find anywhere that dictate/require taking further steps.  Perhaps when we transition to food-grade production, we will have customers who ask us to test for soy or gluten, but even then, we will not be producing a product that is ready to go straight to consumers - it will be sold in bulk as an ingredient, and there will be further processing steps (even if only packaging), so wouldn't the responsibility be on the final packer/processor to determine possible gluten and/or soy levels as they consider their labeling needs/claims?

 

The question of what level of  unintentional agri. mixing tolerances are officially permitted  and allergenic-related consequences has come up previously on this forum. Particularly for wheat, barley, oats. And typically causing confusion.

 

Some Examples  -  

 

Wheat (US)  

http://www.ifsqn.com...-contamination/

eg  see attachment all1/Post2, which contains a short summary of US position on agri. admixing (Pgs 50-52).

 

Barley/Oats (US/Canada)

http://www.ifsqn.com...ns/#entry100449

 

 

Barley (UK)

http://www.ifsqn.com...in-the-factory/

 

And probably many others.

 

PS -

BTW, Traceability is also an interesting silo-related agri. conundrum, eg –

http://www.ifsqn.com...lour-in-bakery/

Yes, I've actually read this particular thread more than once...some good information, but unfortunately, it doesn't really help us in this situation, as we don't have direct control over the storage and transportation practiced employed by the farms and grain elevators, and they currently have little if any incentive (positively or negatively) to improve in these areas.

 

The bottom line is that we actually don't have any requirement to test for allergens, as I confirmed with an auditor/consultant today.  Our only requirement to test would come from customer specifications.  So, our allergen control program will consist of our procedures that prohibit any incoming marked/labeled allergenic materials, and our receiving process, which includes rigorous visual inspection and rejection if foreign grain contamination exceeds acceptable limits.



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Posted 11 October 2016 - 08:12 PM

Since it was brought up, figured I'd share the link since I used to use it a lot. But this would be for FSIS, not FDA.

http://www.fsis.usda...ling-statements

 

In limited situations, the use of factual labeling statements about a products manufacturing environment, e.g., "Produced in a plant that uses peanuts," may be used where good manufacturing practices, and effective sanitation standard operating procedures (SSOPs), cannot reasonably eliminate the unintended presence of certain ingredients. For example, where chopped peanuts are used in making a dry Thai-style meat sauce mix, the necessity exists for a dry processing environment and, thus, the production equipment cannot be washed with water or other fluids. In this instance, peanut dust may become airborne and unavoidably contaminate other meat or poultry products manufactured in the same production area. In this situation, a statement about the manufacturing environment, as described above, or the use of a "may contain (name of allergenic ingredient)" statement may be used on meat and poultry product labeling. However, this type of statement is not acceptable where it is used as a replacement for poor SSOPs, i.e., cross-contact because of an establishments failure to adequately wash equipment between the manufacture of different lines of products. The Agency believes the indiscriminate use of such elective statements does not promote good manufacturing practices under a HACCP system and is not helpful for consumers. Consequently, the use of factual statements about a product's manufacturing environment, e.g., "Produced in a plant that uses peanuts," and the use of may contain statements, e.g., "may contain peanuts" may only be used in cases where establishments show that adequate SSOPS cannot effectively eliminate the cross contact issue.

 

It's interesting that they seem to contradict themselves immediately with the description of the peanut sauce environment, because I can't imagine any inspector allowing that to actually fly as a reason for unavoidable cross contamination. They would probably ask for separate production days or airflow systems to provide reasonable assurance that the allergen was contained.

 

FDA link: http://www.fda.gov/F...s/ucm106546.htm


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

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Posted 11 October 2016 - 08:22 PM

Thank you, Earth2O, but I agree with your final thoughts...I just don't see this flying in real life scenarios.  In fact, Canada has a similar statement, yet comes down to a different conclusion:

 

http://www.hc-sc.gc....oy-soya-eng.pdf

 

"Health Canada would like to inform Canadians with soy allergies that cereal grains, such as wheat, oats or barley, may contain low levels of soy because of the way these grains are grown, harvested, transported and stored.  This cross contamination, or adventitious presence, is not a new issue, but rather has always been present as part of normal agricultural practices. The possibility of this adventitious presence is reflected in cereal grain quality grading standards. Based on the low levels of soy that have been detected in grain-based foods, Health Canada has determined that exposure is not likely to represent a health risk for soy allergic individuals. As such, the department has advised the food industry that the use of food allergen precautionary labeling, in cases where low levels of soy present in grain-based foods has been determined to be due to adventitious presence, is not considered to be the best approach, and would not benefit the interests of soy allergic consumers as it would potentially limit food choices."



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Posted 11 October 2016 - 11:01 PM

Hi Parkz,

 

Thanks for yr comments.

 

There are obviously differences of opinion over these issues, notably risk assessments / the preferred (labelling) approach with respect to allergen-sensitive consumers.

 

I have 2 queries -

 

(1) I was unable to determine whether Canada has the same degree(s) of tolerance to admixing as exists in USA, eg 10% maximum. Any idea ?

 

(2)

Again, I disagree.  As mentioned above, official FALCPA documentation does not consider such adventitious grain cross-contamination to be worthy of labeling,

 

 

I was not aware (or had forgotten) of this fact. Afai can see FALCPA (2004) does not discuss adventitious cross-contamination. Can you indicate the relevant text ? 


Kind Regards,

 

Charles.C


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Posted 12 October 2016 - 01:36 PM

Hello Charles.C,

 

I can see how there could be many ways to approach this specific issue, and I'm sure there are many others who would disagree with me.

 

In the FDA guidance document (http://www.fda.gov/F...s/ucm059116.htm), the following is stated:

 

[Added December, 2005] Is a major food allergen that has been unintentionally added to a food as the result of cross-contact subject to FALCPA's labeling requirements?

No. 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.

 

As for your question regarding Canada, I do not know.  We currently do not sell or ship to Canada; if we ever move in to the international market, we'll obviously have to do some research in to the different requirements of our customer's countries.  If you happen to find out Canada's requirements, I'd be curious to know, too!

 

Thanks again for your thoughts and input - though we may not agree on everything, I appreciate your professional demeanor and ability to discuss these things in a way that is challenging, yet polite.  It's only by us all working together and challenging each other respectfully that we'll get better at food safety, so thanks for being a part of that solution!

 

Brian



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Posted 13 October 2016 - 07:49 AM

Hi Brian,

 

Thanks for the (2006) link. Interesting reading !

 

I guess the (continuing) series of FALCPA Guidances illustrates the scope/complexities of this topic.

 

JFI I extracted a little global context –

 

Attached File  a1 - EC Practice.png   51.37KB   1 downloads

Attached File  a2 - Swiss Practice.png   20.41KB   1 downloads

Attached File  a3 - Australian Practice.png   24.95KB   1 downloads

 

Returning to FALCPA+, Clause 18 is obviously linked with 16/17. It is disappointing that no references to evidential data/justifications are provided.

 

Basically the conclusion from the US and Canadian viewpoints  is that the typical zero tolerance status of soy allergen is modified  for cases where the cause can be described as “adventitious” (ie “cross-contact” allergens).

 

I noted this  (2013) CFIA quote -

 

The adventitious presence of soy in cereal grains can occur due to the manner by which soy and other grains, such as wheat, are grown, harvested, stored and transported. This adventitious presence is not unique to soy, but can occur with other cereal grains and is reflected in the current grain grading standards for quality.

As with all findings of undeclared allergens, the CFIA follows up with the manufacturer or importer, and appropriate action is taken if a non-compliance is found or the situation is determined to pose a significant health risk to Canadian consumers. This may include a request for corrective actions, label changes and/or product recall. If the product is found to have undeclared soy due to adventitious presence, and the situation is unlikely to pose a health risk (Health Risk Determination, Category 3) the CFIA will not be taking any additional action at this time.

The CFIA, together with Health Canada, is advising the food industry that precautionary labelling for soy ('may contain soy') in grain-based products, unless warranted by specific concerns regarding allergen controls or possible cross contamination at the manufacturing level, is not required as it is not expected to be of benefit to the soy allergic community

 

 

The risk classification is –

 

  • Health Risk 1 represents a situation where there is a reasonable probability that the consumption/exposure to a food will lead to adverse health consequences which are serious or life- threatening, or that the probability of a foodborne outbreak situation is considered high.
  • Health Risk 2 represents a situation where there is a reasonable probability that the consumption/exposure to a food will lead to temporary or non-life threatening health consequences, or that the probability of serious adverse consequences is considered remote.
  • Health Risk 3 represents a situation where there is a reasonable probability that the consumption/exposure to a food is not likely to result in any adverse health consequence. The situation identified may be an indication of a breakdown in Good Manufacturing Practices; in Good Agricultural Practices; in Good Practices in Veterinary Medicine or some other relevant factor. 

Hmmmm. Not sure which category of soy-allergic consumer is being  referred to.

 

Nonetheless, some support does exist for the FDA/CFIA approach, eg from FARRP –

Attached File  a4 - soy in wheat flour.png   499.73KB   1 downloads

 

I also spotted these “interesting”  Q/A examples on US Consulting Websites –

I'm using dry lentils in a product and the supplier is telling me that lentils are a rotational crop for wheat and therefore may contain wheat. Does this mean that I need to declare wheat in the Allergen Statement? Or is this an incidental additive that would not contribute any meaningful amount of gluten to the finished product? Any insight you could share would be greatly appreciated.  (July 2013)

 

In the case you described, the possible presence of wheat is unintentional. Therefore, listing wheat is not required in either the Ingredient Statement or a separate Allergen (Contains)  Statement.
You may wish to include an allergen advisory statement such as "May contain wheat" or "May contain trace amounts of wheat due to rotational crop farming practices."

 

 

When we designed our bags for popcorn, we naturally used the label warning from our contract manufacturer "Manufactured in a facility that also processes peanuts, tree nuts and milk ingredients." Our contract manufacturer is no longer using nuts in their products and we are thinking about eliminating the peanut warning. However, to do this economically and not create a whole new printing plate, we would also need to eliminate the warning about milk being processed in the factory. Is it OK to eliminate the milk warning or does that violate a code or present a serious risk to those with milk allergies?  (January 2010)

 

The use of an allergen advisory statement such as the one you use "Manufactured in a facility that also processes peanuts, tree nuts and milk ingredients" is voluntary so you are free to eliminate the statement or any other allergen advisory statement from your labelling if you choose.

 

Looks like there is as yet no global consensus as to the best control approach for adventitious allergenic contamination. Or the potential risks. Threshold values may represent an opportunity to quantitate the options but have so far failed to achieve much global take-up, possibly due uncertainty over their risk interpretations.

 

One thing I did notice is that non-declaring one of the Big8 allergens since considered an unintentional contamination does not seemingly always guarantee no reprisals  if subsequently detected,  eg –

 

Attached File  a5 - A Recall waiting to Happen,2015.pdf   116.03KB   36 downloads

 

PS - this may interest you if not seen already -

 

Attached File  gluten contamination in the Canadian commercial oat supply.pdf   143.09KB   28 downloads

 

 

 


Kind Regards,

 

Charles.C


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Posted 13 October 2016 - 03:54 PM

Hello Charles.C,

 

Thank you for your follow-up...that's a lot of information!

 

I am even more frustrated than before...this whole mess is so confusing.  Why would the FDA publish something that says incidental, unintentional allergens do not require labeling, yet turn around and handle things as evidenced in the information you just shared??  Why is this all so difficult??  Why can't anyone just publish a standard, so that we all know exactly what to do and what not to do?

 

I'm so tired of bouncing back and forth on this issue, just trying to make sure we do the right thing without expending unnecessary time, money and resources, and limiting our market...I feel like a ping-pong ball...



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Posted 25 October 2016 - 04:58 AM

Hi Parkz,

 

Apologies that I totally missed seeing the previous post.

 

One cause for what may appear anomalous handling of situations is the existence of zero-tolerant classifications. Avoidance of such can lead to problematic situations.

A second reason is the legal implication of the terminology "adulteration". I think this is an American speciality.

A third reason is the leverage FDA can exert on Companies to (quietly?) implement recalls via the second reason.

A fourth reason may be what is loosely termed "covering one's back".

 

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".

 

However Top Management may equally prefer comforts such as "Ignorance is Bliss", "No News is Good News", "How to Pass the Buck".  :smile:


Kind Regards,

 

Charles.C





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