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#1 Mr. Incognito

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Posted 18 November 2013 - 08:14 PM

I have a question that I'm not sure I've found the answer to anywhere.

 

When testing for soy cross contamination of wheat, within the United States, what level of soy in the wheat is high enough to consider it contaminated?

 

I'm sure someone is going to say 1ppm but I'm guessing that there has to be some consideration to a level of typical reaction to soy I just don't know where to find it.

 

Thanks,

 

Merle


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#2 Charles.C

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Posted 19 November 2013 - 03:23 AM

I have a question that I'm not sure I've found the answer to anywhere.

 

When testing for soy cross contamination of wheat, within the United States, what level of soy in the wheat is high enough to consider it contaminated?

 

I'm sure someone is going to say 1ppm but I'm guessing that there has to be some consideration to a level of typical reaction to soy I just don't know where to find it.

 

Thanks,

 

Merle

 

Dear Merle,

 

Based on the general consumer food situation in USA, eg labeling as controlled by USFDA,  I predict the answer will be a minimum of  one “positive detection” of soybean allergen in a, presumably, lot of product declared to be free of soyabean contamination. Maybe this is what you meant by 1ppm (eg a limit of  routine detection, LOD ?) ??

 

As I understand the grain business in USA is controlled by USDA. There are apparently tolerances for mixing by other grains but I rather doubt this extends to allergen considerations.

 

I could not see any specific (USDA) references however the document attached  considers the issue of grain mixing / soyabean detection within the overall topic. Specific instances of  some regulatory actions outside USA are referenced (eg pg50 et seq).

Attached File  all1 - risk assessment trace and undeclared allergens in processed foods, 2013.pdf   4.66MB   136 downloads

 

The (retail) regulatory issue as I’m sure you are aware is concerned with actionable “thresholds” .

Attachment all2 below seems to be the classic USFDA reference. I hv added a 2012 link to “update”. VITAL also presents some quantitative assessments / guidelines.

In most cases / most locations, AFAIK, regulators  currently set  the threshold  as  “zero tolerance”  although a few specific exceptions exist, eg gluten.

Attached File  all2 - Thresholds major food allergens, gluten USA 2006.pdf   497.05KB   90 downloads

http://www.foodnavig...-food-allergens

http://www.allergenb...net/vital/vital

 

 

The FARRP website is another impressive US source of allergen data / information.

http://farrp.unl.edu/farrpresources

 

 I daresay an exact answer to yr query does exist but may take some  finding. Until then, I opt for zero (nil detection).

 

Rgds / Charles.C


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Charles.C


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#3 Mr. Incognito

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Posted 19 November 2013 - 12:14 PM

Thanks for looking Charles.  I think we are in the unintentional area where we have a small residual level from the fields and they haven't come up with a threshold level.


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#4 moskito

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Posted 22 November 2013 - 06:09 PM

Dear Merle,

 

the most recent and in my opinion best procedure is developed in Australia. It is called Vital (Version 2 now), which people are involved being member in the former FDA Threshold Group.

http://www.allergenb...net/vital/vital

 

The system is based on clinical studies and allows risk assessment by provided excel file. You will find there that soy is a rather weak allergen i.e. you will need a rather high contamination for creating an allergenic reaction. Nevertheless there are always some very sensitive individual, but for soy those people are seldom.

 

Rgds

moskito


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#5 Mr. Incognito

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Posted 22 November 2013 - 06:42 PM

Moskito thanks for this.  I'm going to read into it for sure.

 

I did see, on cursory searching, that Soy was a pretty weak allergen and it said that children are the ones who show the most susceptibility to it.

 

Thanks again.

 

Merle


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#6 Charles.C

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Posted 23 November 2013 - 12:01 AM

Dear Merle,

 

the most recent and in my opinion best procedure is developed in Australia. It is called Vital (Version 2 now), which people are involved being member in the former FDA Threshold Group.

http://www.allergenb...net/vital/vital

 

The system is based on clinical studies and allows risk assessment by provided excel file. You will find there that soy is a rather weak allergen i.e. you will need a rather high contamination for creating an allergenic reaction. Nevertheless there are always some very sensitive individual, but for soy those people are seldom.

 

Rgds

moskito

 

Dear moskito,

 

One practical problem is that, AFAIK / my previous post, the  VITAL allergen limits presented have not anywhere been implemented for  official accept / reject control purposes of product lots. (This usage does not necessarily involve the same criteria as  compared to viewpoints on the ability of VITAL to provide a risk assessment tool for allergenic factors)

 

As far as i could see, the only significant usage of VITAL,so far, is in Australia / NZ where the concept seems to  be implemented (see No.4 below) as an additional (to mandatory text), alternative,  "precautionary" labelling statement within the existing family of allergen texts such as -

 

 (1)  may contain traces of…‟
 (2)  made in the same premises as products containing…‟
 (3)  made on the same equipment as products containing…‟
 (4)  may be present...

 

an example of subsequent consumer reaction(s) is here -

Attached File  FSANZ allergens labelling study full report , 2009.pdf   3.58MB   50 downloads

 

Rgds / Charles.C

 

PS - added later the above comments are not intended to imply that the present situation is regarded as fully adequate from a consumer's health POV.  Existing negative aspects / some alternative proposals to current situation  are discussed here -

Attached File  probabilistic risk assessment for allergen thresholds, FARRP,sept.2013.pdf   972.86KB   62 downloads

 

http://www.ifst.org/...gen_management/


Edited by Charles.C, 23 November 2013 - 09:19 AM.
added PS

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#7 moskito

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Posted 23 November 2013 - 03:58 PM

Dear Charles,

 

today I know only one country (Switzerland) having implemented in food law a limit for labellíng of allergens (1000ppm). This limit has no relation to any clinical effect, of course.

All other countries make a difference between food law (allergens in the list of ingredients) and precuational labelling -> product safety law -> insurance.

From clinical point of view we know that the dose response on allergens is very individual and no help for a decision exists for responsible persons in the food industry. The FDA threshold group and lateron Vital for me is the only system assisting me in my decision on precautional labelling. But at the end of the day it is my decision.
E.g. Steve Tayler and Rene Crevel were and are involved in the FDA and in the Vital group. Vital is today the only available tool to support my decision and it can be applied by not to much in allergens experienced people, what is necessary for many small and very small companies in food industry. Nevertheless there is scientific and medicinal experience included but no legally binding.

The dose response on allergens is very individual, the analytic covers some problems (-> antibody, which are not the IgE; heat treatment which can reduce or eliminate detectability etc.), what allergens should be covered, exclusion of highly sensitive persons ??, using NOEAL or LOEAL, etc etc -> for me it is still a long way to legally binding limits. In the meantime people have to make decision - not easy and the more you look into details the more questions arises.

 

Rgds

moskito


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#8 allergenen

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Posted 24 November 2013 - 07:09 PM

The Canadian government has preformed a risk assesment on soy contamination in wheat, which is relevant for the orginal question of Merle: http://www.hc-sc.gc....oy-soya-eng.php

 

PS VITAL is more and more used in The Netherlands/ Europe.


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#9 Charles.C

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Posted 24 November 2013 - 10:53 PM

The Canadian government has preformed a risk assesment on soy contamination in wheat, which is relevant for the orginal question of Merle: http://www.hc-sc.gc....oy-soya-eng.php

 

PS VITAL is more and more used in The Netherlands/ Europe.

 

Dear allergenen,

 

Thks for the input. It's an interesting statement of the Canadian viewpoint relating to their "work-in-progress" on the allergenic situation for soy in grains. The source should certainly be knowledgeable / concerned on this topic.

 

However it unfortunately contains zero validatory data other than a cross-link to a "general purpose" website and an onward request source for more information. Would at a minimum  IMO have been useful to see a comment as to what was considered to be a threshold level ?

 

i noticed this comment in my previous attachment -

 

Agricultural commodity cross-contamination of soybean was detected in 62.8% of samples representing all forms of wheat flour. Conservative probabilistic risk assessments predict a risk of allergic reaction occurring in the most sensitive soy-allergic individuals.

As usual, the question is where / how to set the "acceptable" probabilities ? And so emerges the labelling problem.

 

I also noticed this related CFIA  link -

 

http://www.inspectio...2/1360691654497

 

This document had (to me) a faintly evasive character although perhaps unfounded. The cross-links did not appear to offer much direct clarification again.

 

The link below does quote  some (FARRP) external data / soy contamination levels, and the source's corollary conclusion that there is no need for soy-allergenic individuals to avoid wheat products. No specific threshold values are quoted in the link. The maximum in the range quoted appears (to me) to substantially exceed the soy / VITAL action-levels shown on website example (eg 20ppm-50gm serving size). Strange, perhaps there is a mis-match of data somewhere ?

 

http://www.manitobac...lour-soy-what
/

 

Rgds / Charles.C


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Charles.C


#10 Juliane Dias

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Posted 24 November 2013 - 10:58 PM

For peanuts:

Threshold for peanut: risk characterization based upon  diagnostic oral challenge of a series of 286 peanut-alergic individuals

Food and Chemical Toxicology

48 (2010) 814-819


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#11 Charles.C

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Posted 24 November 2013 - 11:15 PM

For peanuts:

Threshold for peanut: risk characterization based upon  diagnostic oral challenge of a series of 286 peanut-alergic individuals

Food and Chemical Toxicology

48 (2010) 814-819

 

Dear Juliane Dias,

 

Thks yr input and welcome to the forum ! :welcome:

Perhaps you might like to inform what the result for the threshold was, eg in ppm ?

 

Rgds / Charles.C


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#12 Juliane Dias

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Posted 24 November 2013 - 11:47 PM

Hello Charles,

The abstract mentions: "The ED10 and ED05 is 14.4 and 7.3 mg respectively". The lecture was delivered in Brazil and the presentation can be downloaded here.

 

Attached Files


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#13 Charles.C

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Posted 25 November 2013 - 01:08 PM

Hello Charles,

The abstract mentions: "The ED10 and ED05 is 14.4 and 7.3 mg respectively". The lecture was delivered in Brazil and the presentation can be downloaded here.

Dear Juliane Dias,

 

Thks for the file.

 

For the benefit of readers unfamiliar with this topic (like myself :smile:  ), may help to add that ED(p) refers to an eliciting dose of the allergen  at which a proportion (p) of the allergic population would be likely to react.

 

Rgds / Charles.C


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#14 Charles.C

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Posted 25 November 2013 - 01:23 PM

Dear Merle,

 

After re-reading the attachment (all1) which I posted earlier, I realized that I had completely missed the most relevant section to yr OP since it came right at the end !. Perhaps you have already scanned the whole document more thoroughly than myself ? :smile:

 

This last chunk (eg pgs 209 et seq) probably typifies, within some occasionally rather heavy maths,  the "justification"  for some of the elsewhere found opinions of "no risk" from soy contaminated wheat flour as linked in my recent post.

 

The text (implicitly) addresses my previously stated confusion as to why  material which would seemingly qualify for  precautionary Vital labeling is  also  categorizable as presenting no significant risk in terms of probable rates of allergic incidents. Unfortunately, as far as I can see, the explanation given is somewhat circular. It suggests that  some flaws must exist in the  theoretical risk assessment  since significant allergic-incident rates are in fact predicted but comparable rates are apparently not seen in practice.  Speculation over the nature of such  flaws is illustrated in the following 2  text extracts. Similar comments appear in the presentation of both the peanut and soya case studies included. It's all rather confusing (to me). Perhaps some other reader here will extract a clearer interpretation. :smile:  It is necessary to read the details of the document to fully appreciate the twists and turns.

 

Soy protein was found at concentrations up to 236 ppm in wheat flour, a dose of  7.1 mg soy protein per 30 g serving. No published soy challenges have reported an objective allergic reaction from doses at or below 7.1 mg soy protein. Despite this observation, the quantitative risk assessment indicates that the user risk from soy commingling with wheat flour is rather substantial predicting 2850 reactions per day among soy-allergic consumers in the U.S. alone. Since no published reports exist of  reactions that might be attributable to soy comingling with wheat flour, clinical allergists are either overlooking all of these cases (unlikely if 2850 occur per day in the U.S.) or the quantitative risk assessment is overstating the actual risk. A thorough examination of the inputs to the quantitative risk assessment suggests that are several factors that could result in an overestimation

. …………………..>>

 

However, the level of predicted risk (23.4 ± 4.9 per 100 soy-allergic user eating occasions) occurring if wheat flour contained the maximum level of soy contamination (10%) allowed by USDA grain standards is 100-fold higher. Perhaps consideration should be given to lowering these allowable levels of soy commingling to assure protection of soy-allergic consumers.

 

I later noticed that the above work is about to be shortly published  with more details added.The preliminary abstract  displays a  rather surprisingly "no-need-to-worry"  context reminiscent of my previously quoted links. The "get-out" from above mentioned discrepancy is ascribed to -

 

However, the predicted reactions occur at exposure levels below the lowest eliciting dose observed to provoke objective reactions in clinical oral soy challenges. Given this low level of predicted risk and the lack of evidence for allergic reactions among soy-allergic consumers to wheat-based products, the avoidance of wheat-based products by soy-allergic consumers does not appear to be necessary.

 

I suspect this is another way of saying that the "present"  theory has "encountered" some practical limitations which take precedence. :smile: The potential implication to Vital labelling  decisions  seems to not yet be considered.

 

Regardless, the content does indicate that the 10% tolerance mentioned earlier is applicable as a USDA criterion for (gross) wheat / soy cross-contamination. But the abstract does not mention anything about the "100-fold higher" mentioned above.

 

Some of the opinions inevitably involve a decision as  to what is considered an "acceptable" incident rate, or to quote the unusual phraseology in Juliane's file, how to handle the "exquisitely" sensitive soy-allergic members of the population. Statistical logic unfortunately cannot avoid appearing quite "cold-blooded" at times.

 

Rgds / Charles.C


Edited by Charles.C, 26 November 2013 - 03:31 AM.
opinions rearranged

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#15 Mr. Incognito

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Posted 25 November 2013 - 06:18 PM

So reading through it I found that it says that USDA allows 10% of "other grains" to be in wheat.  So as to say it's allowed to have 10% soybean or 100,000 ppm.

 

CODEX international grain standards allow 1.5% or 15,000 ppm.

 

HACCP would have you take the lower of the two so we would be looking for under 15,000 ppm I'm sure (I'm still reading this over again and again so I may write more as I read)

 

Yes that is the same type of though pattern as "Your arm is worth $50,000.  If I accidentally chop it off I owe you that much and no more." But sometimes that cold logic is necessary to give standard norms for compensation or risk flow.


Edited by MerleW, 25 November 2013 - 06:28 PM.

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