9 replies to this topic

[StoneMill]

I work for a flour mill where wheat is the primary ingredient and product. We do manufacture non gluten origin products but we do not nor intend to claim low gluten or gluten free. We are concerned with giving the customer warning of the presence of gluten in our facility/products.Our labels state, "May Contain Wheat". Additionally, "Do Not Eat Raw" is printed on our labels as the kill step is passed to customer. All relevant documents (Specs, COAs, Internal Docs.) state the same and have more detail.

 

Our facility is a dry facility where only dry cleaning via brushes, vacuums, and purges is conducted. We have a thorough sanitation program, training and documentation. To date we have not validated our sanitation for allergens or pathogens. In my time here I have been advised and consulted on many a warning to beginning the process of testing. Especially pathogens. Something inherent in grain. 

 

Note: the facility has resisted moving forward into any scheme. We are currently only annually inspected for GMP. We do not have an environmental monitoring program.

 

1. I understand that the FDA does not approve of allergen statements such as ours to be a replacement for sanitation. Our programs and documentation thorough and shows our due diligence. Do we need to test as well?

 

2. If we do need to test. What would we be accountable for testing? Allergens. Pathogens. Or both? I have my own opinions on testing, but I am a little worried about the possibility of testing for salmonella as it is inherent in grain and I would expect the test to come back positive.

 

3. If testing for pathogens is done, is there any possible way for a dry facility, processing raw gain to clean or control salmonella, E. coli, etc? Even if dry sanitation lowered the salmonella our facility would have already tested positive. Isn't this bad in itself?

 

I have conducted some random allergen testing on our flour milling with mixed results. My tests were fallible and unofficial yet they did show levels high above 20 ppm. Again, gluten free is not something we are aiming for, but the high result made me feel that our sanitation appeared or is inadequate. I felt the result should be lower even if above 20 ppm. This of course, is easier to correct than pathogens should it be proven. This has been presented to management.

 

I have presented  my research and opinion to management. There are good and bad arguments on sides to be fair. Sure. My main case is to continue to research and determine our responsibility. This is why I am opening this to you. I need support and direction with my own understanding on the matter. 

 

Management feels that the allergen warning is there, sanitation is being conducted ("our programs and records have been consistently approved by 3rd party auditors") and the kill step is passed to the customer. "What more do we need to do?"

 

Maybe they are right. I'd feel a lot better if someone ELSE could convince me. Thanks in advance. 

 

 

 

 

 

[SQFconsultant]

I am assuming you are not advertising non-gluten, gluten-free, etc. especially since it is coming out of a plant where wheat is present in abundance.

 

As to allergen testing, if the only allergen you have is wheat, you do not need to be testing.  We have a rather large pie bakery client where the only allergen is wheat and this is there route - never an issue.

 

I am at a bit of a loss for why you do not fully declare that the product contains wheat, not the "may contain wheat", if it contains wheat, it contains wheat.

 

As far as testing goes for pathogens you need to do testing.

 

I've got a client in NYC that makes bakery goods and was getting his flour of about 10 tanker loads a day from a supplier that made mention they don't do any type of testing - this was after they decided to stop doing testing for whatever reason, but failed to mention this to our client. 

 

Our client shut-down, did extensive testing, found a bunch of issues in the silo area and pumpers, cleaned up everything, got a new supplier of flour and proceeded onward.

 

Back to the Gluten and since we an approved GFCP consulting company, the target may be 20ppm, not companies shoot for 12-15ppm to allow for an overage.

[kettlecorn]

Glenn is right about the "May contain..." ambiguity; when it comes down to it, the FDA is not a fan of this kind of allergen statement. Either you have controls in place, including testing, that ensure your product does not contain wheat or you simply take responsibility for the fact you don't. "May contain..." in no way mitigates your liability. 

 

20 ppm is the minimum threshold. If you want to be rigorous (which it seems your company doesn't, since you aren't claiming gluten free), you should shoot for <5 ppm. 

[Charles.C]

Glenn is right about the "May contain..." ambiguity; when it comes down to it, the FDA is not a fan of this kind of allergen statement. Either you have controls in place, including testing, that ensure your product does not contain wheat or you simply take responsibility for the fact you don't. "May contain..." in no way mitigates your liability. 

 

20 ppm is the minimum threshold. If you want to be rigorous (which it seems your company doesn't, since you aren't claiming gluten free), you should shoot for <5 ppm. 

 

Hi Stonemill,

 

I deduce your Facility's current Product/Production scenario only requires  audit for GMP. By FDA ?

 

You make no mention of Risk Assessment or HACCP so I assume not involved so far.

 

Does GMP certification have no quantitative aspects regarding minimising the risk of cross-contamination by allergens ?

 

So what is yr specific current Objective ? eg to get something like (GFSI-recognised) certification or ?

 

If so I suggest you study SQF's elegant and detailed exposition of their viewpoint on allergenic cross-contamination  as related to sanitation.

 

@ kettlecorn, ^^^(red) - I thought that the (labelling acceptable)  opposite opinion is precisely the reason for the pervasive usage of such "caveats" ?

[kettlecorn]

 

@ kettlecorn, ^^^(red) - I thought that the (labelling acceptable)  opposite opinion is precisely the reason for the pervasive usage of such "caveats" ?

 

That is indeed the assumption; however, what it ultimately shows is that either 1) you don't know whether it contains gluten (because you don't have controls in place) or 2) you aren't sure whether your controls are effective (because you don't have validation, testing, etc.). In either case, you're still liable for the presence of allergens. If you go that route, just use "Contains..." 

[StoneMill]

SQF Consultant. Thank you for your response. I have entered my answers into the text below. 

I am assuming you are not advertising non-gluten, gluten-free, etc. especially since it is coming out of a plant where wheat is present in abundance.

Correct. We make no claims of Gluten Free or Low Gluten on any of our non gluten origin products (buckwheat flour, Teff flour, etc.)

 

As to allergen testing, if the only allergen you have is wheat, you do not need to be testing.  We have a rather large pie bakery client where the only allergen is wheat and this is there route - never an issue.

I have been advised on this and this has been our process since I have been in my position here. 

 

I am at a bit of a loss for why you do not fully declare that the product contains wheat, not the "may contain wheat", if it contains wheat, it contains wheat.

Good question.

 

One: When I began my work here I addressed the lack of labeling at the time by adding, "Contains Wheat" and "Do Not Eat Raw" to every product label as well as including "Wheat" in the product name where applicable. The owner/ manager have disliked the blanket statement, "Contains Wheat" for many reasons. My opinion aside, they don't want customers to see this contamination as an ingredient or stated in such a way that it will limit our sales with folks looking for a "purer" version of the product- allergic or not.

 

Two: At various times, our company has been warned that the word, "contains" in the statement, "Contains Wheat" denotes wheat as an ingredient. We have been told we needed to include an ingredient list/statement stating wheat if in fact our product did contain wheat (allergen statement cannot sued as a supplement for inadequate cleaning). I argued my point about the labeling as a warning regarding the inability to control wheat in the facility atmosphere and equipment, but the caution became a gateway for the owner/manager to decide to change the warning to "May Contain Wheat". "Bob's Red Mill does it, why can't we?" has been the thought. I have countered with no success.

As far as testing goes for pathogens you need to do testing.

 

I've got a client in NYC that makes bakery goods and was getting his flour of about 10 tanker loads a day from a supplier that made mention they don't do any type of testing - this was after they decided to stop doing testing for whatever reason, but failed to mention this to our client. 

 

Our client shut-down, did extensive testing, found a bunch of issues in the silo area and pumpers, cleaned up everything, got a new supplier of flour and proceeded onward.

On our scale and with the farms we conduct business with I cannot see the potential for our suppliers (the farms) to conduct testing themselves or put more controls aside from the GAPs they already follow. Of course testing the lots we are planning to purchase/receive could be a practice. I can see taking random samples from the lots we may purchase and having these tested prior to receiving.

 

Regarding our mill. I have looked into testing/environmental monitoring and my research and the risk analysis proves Salmonella is a contaminate we need to control and test for validation of our controls. Where I get held up is in choosing the location to test. Receiving, storage, and holding equipment (bins, tools, etc.). Where I get worried is testing the milling equipment. Through dry cleaning and purging I cannot see how we would be able to minimize the pathogen count. Again, I have never tried. We have never tested to find out what exactly we are up against. This company fears making a sample test, or a random test for Salmonella for we would need to report our findings if positive. 

 

Back to the Gluten and since we an approved GFCP consulting company, the target may be 20ppm, not companies shoot for 12-15ppm to allow for an overage.

[StoneMill]

Hi Stonemill,

 

I deduce your Facility's current Product/Production scenario only requires  audit for GMP. By FDA ?

 

We are accountable for FDA FSMA. The owner/ management subscribe to "ask forgiveness, not permission" ethics. I continue to encourage our facility to move forward, but until our operations are threatened by an authority other than myself we will and have managed to get by without advancing. The only reason we have engaged in a 3rd party GMP audit was due to a customers requirements. A minimum. I have brought our Food Safety Plan into FSMA scheme, but as you may gather from this answer I cannot fully implement most of our plan or various programs due to lack of buy-in and the actual procedures being done.

 

You make no mention of Risk Assessment or HACCP so I assume not involved so far.

 

I have conducted risk assessments for both allergens and pathogens. I am interested in any suggestions or guidance you may have.

 

To be very brief, my risk assessment for allergens shows that the potential for cross contamination cannot be controlled due to environment (dust/residue in the air at all times). The potential for contamination of packaging and non gluten origin ingredients in storage cannot be controlled therefore allergen warning. Originally, "Contains Wheat".

 

Due to configuration of milling equipment it is impossible to visually inspect the entire system after Post-Op cleaning= allergen warning.

 

Pathogens.

Potential for contamination inherent in fields, thus grain/ingredient. Conclusion is testing of lots of grain be conducted prior to purchase/ receiving to ensure detectable levels at a spec. minimum (this has been rejected by owner/management).

Potential for cross contamination/ proliferation in facility controlled through GMPs (including wet sanitation of those tolls, equipment which can be wet snaitized), receiving inspection, storage practices and cleaning (MCS). (testing of receiving, storage zones or wet sanitized equipment has been rejected. Not sure if it was a good idea or not but made some sense to team).

Potential for milling equipment and finished product contamination/ proliferation controlled through GMPs Hygiene, Pre & Post-Op SSOPs and inspections. Validation of cleaning cannot be complete through visual inspection at most of the milling systems are not completely visible. Conclusion is to either test the food contact surfaces or random test finished products for pathogens. This and and any pathogen testing has been rejected as the facility does not want to have to claim a Salmonella positive test for the site.

 

This was brief and I haven't review the RA in reporting here, however any holes or pointers you have I welcome to insight and criticism.

 

Does GMP certification have no quantitative aspects regarding minimising the risk of cross-contamination by allergens ?

 

It does and I am not surprised it has not been addressed. Ducking this bullet has enabled owner/ management from accepting my request to pursue.

 

So what is yr specific current Objective ? eg to get something like (GFSI-recognised) certification or ?

 

Of course GFSI recognized is my goal but I'd asume we are going to ride out the minimum we can do until called out. I'd rather be prepared than ask forgiveness. Its been too hard playing a game of putting out fires and this is where bad mistakes happen. For the most part I just want to make sure we are making safe food and our procedures comply with regulation. Basic FSMA for a start. Heck, let's just try GMP for now. Thinking about your question I am asking myself why am I trying. Whats my point while employed here. Still, I am trying to change the culture here (as long as I work here) to get us caught up to requirements.

 

If so I suggest you study SQF's elegant and detailed exposition of their viewpoint on allergenic cross-contamination  as related to sanitation.

 

Will review. Thanks.

 

@ kettlecorn, ^^^(red) - I thought that the (labelling acceptable)  opposite opinion is precisely the reason for the pervasive usage of such "caveats" ?

[emportllc]

Just to add on, in case it's helpful for your conversations with management- 

 

Wheat and gluten aren't exactly the same thing. It is possible to create gluten-free foods that do include some amount of wheat (wheat starch produced under strict guidelines, or distilled vinegars with careful GMP). At the same time, it is possible to create wheat-free foods that are not gluten-free (breads made with rye or spelt flour, foods sweetened with barley malt, etc). 

 

Gluten-free labeling is voluntary - no one has to label products as gluten-free and if you aren't using that label then you don't have to worry about the 20ppm threshold or anything else in the gluten labeling laws. 

 

 

Allergen management and labeling are not voluntary - everyone has to do it. And thanks to FSMA, everyone has to have (and follow) a plan to minimize allergen cross-contact (even if that cross-contact cannot be entirely eliminated). 

 

So the 'bad' news is that the team does need to try and minimize the amount of wheat getting into non-wheat products even if they can't get it to zero. There should be plans in place for storage, validated and verified allergen cleans between runs, what you'd do if a product containing wheat spilled/leaked/etc, etc. If the FDA comes to visit they won't be happy with 'we looked into it, realized we can't avoid cross contact, included a precautionary label, and called it a day'. 

 

The good news is that by implementing those CGMPs - even if they never bring the risk down to zero and even if the product still has some amount of detectable wheat in it! - management will be better-protected legally and will also be in a stronger position in re: product purity/quality.

[StoneMill]

Thank you emportllc,

 

I appreciate the information. I will continue to push forward.

 

Just to add on, in case it's helpful for your conversations with management- 

 

Wheat and gluten aren't exactly the same thing. It is possible to create gluten-free foods that do include some amount of wheat (wheat starch produced under strict guidelines, or distilled vinegars with careful GMP). At the same time, it is possible to create wheat-free foods that are not gluten-free (breads made with rye or spelt flour, foods sweetened with barley malt, etc). 

 

Gluten-free labeling is voluntary - no one has to label products as gluten-free and if you aren't using that label then you don't have to worry about the 20ppm threshold or anything else in the gluten labeling laws. 

 

 

Allergen management and labeling are not voluntary - everyone has to do it. And thanks to FSMA, everyone has to have (and follow) a plan to minimize allergen cross-contact (even if that cross-contact cannot be entirely eliminated). 

 

So the 'bad' news is that the team does need to try and minimize the amount of wheat getting into non-wheat products even if they can't get it to zero. There should be plans in place for storage, validated and verified allergen cleans between runs, what you'd do if a product containing wheat spilled/leaked/etc, etc. If the FDA comes to visit they won't be happy with 'we looked into it, realized we can't avoid cross contact, included a precautionary label, and called it a day'. 

 

The good news is that by implementing those CGMPs - even if they never bring the risk down to zero and even if the product still has some amount of detectable wheat in it! - management will be better-protected legally and will also be in a stronger position in re: product purity/quality.

[Charles.C]

That is indeed the assumption; however, what it ultimately shows is that either 1) you don't know whether it contains gluten (because you don't have controls in place) or 2) you aren't sure whether your controls are effective (because you don't have validation, testing, etc.). In either case, you're still liable for the presence of allergens. If you go that route, just use "Contains..." 

 

Hi kettlecorn,

 

JFI I attempted to locate  some recent IT examples where US manufacturers were ultimately penalized  for Product Liability due to (unintentional) allergen-related  food  incidents  with/without  the use of related Precautionary Allergen Labeling (PAL) . I couldn’t find any.

 

The reality appears to be that even without PAL, attempts to show allergen-related liability of this type can be a legal minefield.  For example the following pdf (ca 2000) surveys a variety of “nut” cases, several  of which looked to be “slam-dunks” due to no preliminary warning being presented  but soon proved otherwise. These cases predated the common appearance of PAL.

 

 Suing for Peanuts.pdf   1.29MB   26 downloads

 

The next items (1-3)  illustrate some pros/cons/opinions for the use of PAL. The related source documents are attached below.

 

 

EU oriented  

 

1^st one is, IMO,  a logical support for the use of PAL.

 

(1)

This article answers two questions concerning the liability aspects of the use of “may contain” labelling on food packages, such as “This product may contain traces of nuts.” This type of voluntary labelling refers to the unintentional presence of an allergenic foodstuff, the inclusion of which can occur during the production process. Firstly, it is probable that courts consider a food product without a “may contain” warning defective under the Directive, even though this can create unintended consequences. This question is approached in terms of a defect both in design and in warning, since food manufacturers are able to reduce the risk by means of redesigning the production process or by providing a warning. With regard to the second liability question concerning the adequacy of “may contain” warnings, it is not likely that courts will consider the product warning defective in view of the difficulty of providing a better alternative.

(Pape 2009)

 

 

This 2^nd evaluation “sits on the fence”.

(2)

4.5 Conclusion

This chapter described in detail the requirements of product liability. The focus was on

whether using PAL would limit liability under product liability law. There is no standard

answer for this question. 

As  this  chapter  showed,  some  authors  believe  that  an  absence  of  PAL  should

lead to liability. Some authors are of the opinion that FBOs apply PAL for legal defence

reasons. 

In the end, I would conclude that it depends on the circumstances whether a

product can be considered defective  when PAL is used to serve as a warning for the

unintentional presence of a mandatory allergen. If PAL is used as a warning, but it does

not cover the allergen that is present, then obviously a PAL statement is not adequate.

Furthermore, it depends on what kind of precautionary measures has been conducted

by the FBO to eliminate the defectiveness or hazard. Defectiveness will be established

on a case-by-case basis.

(Zhi-yen Chen, 2016)

 

 

 

US oriented

 

I "think"  this 3^rd example is a “qualified” support for PAL

 

(3)

CONCLUSION

The food allergy community deserves continued action to reform advi-

sory  labeling.  The  current  state  of  advisory  labels  results  in  uncertainty

among the consuming public. In  addition,  as a note  for future study, the

approach advocated in this Comment may solidify a consumer’s right to sue

companies for allergic reactions to products, and at the same time, protect

companies that have followed GMPs and appropriately listed cross-contact

risks on their labels. 

At the moment, those protections do not exist on either side. Because of

the voluntary nature of the current precautionary warnings, companies use

them to disclaim liability. The problem for consumers, of course, is that the

same warning could require a little or a lot of care on their [the companies] part to avoid

cross-contact. As such, many warnings are not persuasive as they currently

stand, yet companies can rightfully argue in court that they appropriately

attempted to warn consumers to refrain from consuming their product. On

the  other  side  of  the  coin,  companies  that  are  diligent  and  attempt  to

prevent  cross-contact  are  equally  as  liable  as  companies  that  do  nothing

since GMPs are so vaguely defined, and consumers can make a strong case

for strict scrutiny if they prevail first on a failure-to-warn claim.

 (Besnoff , 2014)

 

 

Take your Pick.

 

 Pal-1.pdf   303.21KB   41 downloads

 PAL- 2.pdf   1.08MB   19 downloads

 Pal-3.pdf   223.23KB   20 downloads

 

@StoneMill - I am curious whose GMP you were audited to ? (Silliker?) IMEX it's rather unusual for GMP audits to require the deep risk assessments such as you describe. Or were some of these exercises  separately for FDA's benefit ?

 

From yr owner's POV, they may regard this Low Risk (FDA's classification?) item as being adequately covered through the relevant GMP. This depends on what is included in the GMP of course.