Survey on Thresholds from FARE

[lakeswimr]

I can understand how you feel CM.  I know your child reacted to their stuff but they are one of the few companies that labels for sesame and treats it like a top 8.  DS has not ever reacted to their stuff so we use it.  If he ever reacts we will rethink this but right now we have been good with their stuff for over 8 years. 

Hain Celestial--I feel about them the way you do about Kraft, only they have been a lot ruder on the phone IMO. 

And one time White Wave reps actually YELLED at me to not use their product with DS rather than answer my questions, even if the answer was truly that they didn't know. 

I have had many a very nice experience or at least a polite person who couldn't/would't give me info, too. 

[SilverLining]

I would like sesame to be covered under current labeling laws.  I think it should be already but FAAN's study found it didn't have the numbers in the US to be covered.  I have doubts about this.

When Canada included sesame in the labelling manufacturers opposed it because the number of people with sesame allergy apparently didn't support it either.  However, because it has been proven (?) that sesame allergy tends to be anaphylactic more then other allergens (including peanut) and also,  anaphylaxis can be caused with smaller amounts of protein, it was included.

[SilverLining]

I think that the science is being driven by demand and perceived needs.  The researchers don't all of them live food allergies day to day, and they aren't always very clued in to what those real needs/difficulties actually are.

Until the science is behind it, it does not belong on a product label.

[lakeswimr]

That's very interesting, SilverLining.  I always thought sesame had the #s in Canada so why don't we have similar numbers here.  If it doesn't have the numbers yet I think it will because more and more people seem to be dealing with it.  It is certainly on the rise.

I think that I can agree with Boo that it would be good to know if there is some amount under which no one will react.  But I question how that will be used by the industry.  Can they control xcontam that well?  Those that do spend a lot of extra effort and probably money like Turtle Mountain which batch tests for a bunch of allergens down to parts per million, etc.  If this increases the number of companies willing to do that, great.  But I don't think that will happen. 

I remember watching the Silk soy milk recall happen in slow motion on another board.  Someone reported their child reacted to it soon after my son started refusing it in any and all forms.  A bunch of others had also posted that their children would no longer drink it.  The person who had the child have a serious ana reaction called the company and was assured there could not be xcontam, they tested by batch or something, etc.  Not possible.  The person sent the sample for testing and it came back HIGHLY xcontamed.  The person meanwhile told the company, the still denied it was possible.  A second person had their child have ana, contact the company and get told the same stuff!  No possible, etc.  !!!  This is AFTER they knew the test results.  It took, I believe, several months for the recall to happen.  So, given stuff like that I'm not so sure I trust the industry.  What choice do we have?  Well, my choice is to be pretty picky which companies I trust based on talking with them. 

[LinksEtc]

Lakeswimr, I also feel strongly that sesame should be labeled, but I don't think this threshold docket is the place for that effort.  FDA was very careful to say "major food allergens" in their wording ... Any non-top8 comments would be ignored for being outside the scope of this docket.



ETA these related links:

FDA to Assess Safe Food Allergen Levels

sesame seeds labeling: US specific (laws, loopholes)

[lakeswimr]

Thanks for pointing that out.  That just came out as OT as I was listing what I would like.  Hard not to add that in for wants for the future. 

[booandbrimom]

I think that I can agree with Boo that it would be good to know if there is some amount under which no one will react. 

I didn't actually say that. I do realize some people have very low thresholds and that there is no perfect threshold that truly protects everyone, other than 0%. Yes, there will be people who cannot safely eat foods that would be unlabeled in this new scheme. However, those people are no worse off than they are today, since cautionary labeling is completely voluntary.

What I said is that it would be a good thing to know the quantity of an allergen in foods, regardless of where people fall threshold-wise. Right now, we have no way of knowing if a product is made on a shared line, other than a) the manufacturer deigning to tell us, and/or b) a reaction. If manufacturers had to declare a range for their products, it would give us a proxy for whether products are done on shared lines.

Let's say a cookie you buy contains 20 mg of peanut from cross-contamination. Today, that cookie might say "may contain" on the label. Or, it might say NOTHING. The mfr. may not give you any information if you call. If manufacturers were required to test and batch label, that same cookie would have to say something like "peanut content may exceed 20 mg". If they test 20 batches over 20 days and even one of them comes up high, they would have to label it with the highest value. And that means greater safety, because our kids don't have to go through eating that cookie 19 times without a problem, and then have a reaction on the 20th time.   

I did not mean to imply the science was not ready to do this testing. Food labs in manufacturing facilities do this testing every day. This is not new technology. I was saying I understand people's frustration that every batch, every cookie, can't be tested. But that doesn't mean we should let perfect be the enemy of better.

[lakeswimr]

OK, I think I better understand you know, Boo.  Thanks for explaining. 

I'm not sure it would be able to work the way you envision or even that that is the point of this survey.  I do not believe the FDA will mandate batch testing and the industry isn't going to volunteer to do it, either.  I think it would be a very once in a while thing and that is what worries me.  xcontam is not a constant so they can do occasional testing and get meaningless or worse, inaccurate results (likely IMO).  No info is better than wrong info.  Maybe I'm wrong but I can't picture all companies adopting batch testing. 

I would be worse off if this took the place of me being able to call and get info from the places that will give me info now.  I have places that I call and that say, "not required to give that info so we aren't going to give it" when I ask anything beyond what the law requires.  I can imagine this having a similar effect. 

Right now I have to call all companies anyway and that isn't going to change with this. 

People who are ultra sensitive could be worse off than they are today if companies hide what they are doing behind this new way of labeling. 

[CMdeux]

I did not mean to imply the science was not ready to do this testing. Food labs in manufacturing facilities do this testing every day. This is not new technology.

I'm suggesting that this MAY not necessarily be so.

There exist standard protocols in critical batch testing in any industry.  They are known to be matrix-limited, and to require validation (basically, big data) in any new application.

I fear that the science IS NOT actually ready, but that there are people who think that it is.

Foods are not a uniform matrix, and food allergen proteins will partition differently in different foods by virtue of their denaturation, temperature-related characteristics, and chemical behavior within the matrix.  That creates enormous sampling problems that the pharmaceutical industry basically doesn't have to manage in manufacturing.

Oh, sure, "protein" testing works pretty well.

But that isn't useful here-- because pretty much any food is going to come up positive...  so then you get into specificity assays, ALL of which have limitations, and different limitations/intereferents for different assays.

So even occasional line testing is still a job for someone with significant training and expertise if it's going to be accurate enough to mean anything, and you'll need to do it regularly (every 10 hours of run time on a line, for example) BEFORE you can say what it means. 

All for information that John Q. Public will neither appreciate nor (mostly) understand.   

That kind of cost is NOT something that industry is going to absorb without being forced to do so.  They really don't have any reason to.

I mean, ask yourself this--

what is the difference between

20 mg

and


20 mg + or - 15 mg

? 

Is one of those safer than the other?  Is one of them more informative than the other?  Would you be more willing to buy one over the other?  Why?

Spoiler (click to show/hide)

My answer is that I would NEVER buy the former because it indicates that the company doesn't understand analytical statistics, and that the latter indicates to me that the assay is running near the limit of determination, and that it's possible that the assay is inaccurate.  I wouldn't buy either one of them for that reason.  What I might like better is 25 mg + or - 2 mg. 

[CMdeux]

I know that I've said this kind of thing before, and it always sounds like schmaltz, I know...

but I'm really grateful that the science and public awareness and clinical research have come far enough that we can even HAVE this kind of conversation now.

It really wouldn't have been possible ten years ago.  So there has been progress!

[ajasfolks2]

Amen, sista!!!

 

[booandbrimom]

I do not believe the FDA will mandate batch testing and the industry isn't going to volunteer to do it, either.  I think it would be a very once in a while thing and that is what worries me.  xcontam is not a constant so they can do occasional testing and get meaningless or worse, inaccurate results (likely IMO).  No info is better than wrong info.  Maybe I'm wrong but I can't picture all companies adopting batch testing. 

The reason this is all coming up now is something called the Food Safety Modernization Act. That act was motivated primarily by the peanut-butter deaths. (There's a certain irony in that benefiting the food-allergy community...)

The reason they are asking for input now is that the devil is in the details. The act calls for preventive controls (including food allergen controls) within the food manufacturing industry. However, how those should be implemented are open to interpretation. The food industry is fighting like crazy to have them be very minimal.

Here's the fact sheet:

http://www.fda.gov/Food/FoodSafety/FSMA/ucm334115.htm

[booandbrimom]

This one has the research list if anyone is interested. Comprehensive overview of all literature that's been published on thresholds:

http://www.gpo.gov/fdsys/pkg/FR-2013-01-16/html/2013-00125.htm

Sure cure for insomnia.

[CMdeux]

Frankly, if they'd keep tracking information on SUPPLIERS, that would be a HUGE step in the right direction.

If they'd track production schedules (and supply streams and batch recipes INTO them), THAT would be a huge step in the right direction.


Both of those things would make for FAR more streamlined investigation and would make it actually possible for the FDA to begin doing the job of being real watchdogs.


Not coincidentally, it would also mean that there is no WAY that Lakeswimr or I could call a company and (truthfully) be told "we don't know."  SO maybe we should be asking for MANDATORY disclosure upon demand.  WRT allergens and processing, I mean.  I'd be very happy with that.  Do away with advisories entirely and let me call-- but MAKE manufacturers answer.

I feel like asking for allergen measurements at this point in time is...

well, it's like hoping to vanquish the windmill.   

Yeah, that threshold thing... I just get so discouraged when I read that literature.  Because it so systematically excludes the tails.  And that, really and truly, is where we NEED the most information.  That is, is someone who can "pass" a food challenge one day and still not really eat the allergen in unlimited fashion "allergic?"  Or do they get a different label?    There are people like my DH who are truly allergic but have no need to carry epinephrine because they have such a high threshold that the odds of them EVER having that kind of gross ingestion without being aware of it are.... well, improbable to the point of ridiculous.  But he's food allergic, too.  He counts.

But the only studies that have truly NOT excluded people on the "high risk" end of the scale, on the other hand, demonstrated that there may really be no safe level, or at least if there is, it's really low.  REALLY low. 


It's really hard to reconcile those two groups with the "average" experience of being food allergic. 

[ajasfolks2]

Related and interesting reading for some here, perhaps:

http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm106779.htm



http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm106042.htm