Survey on Thresholds from FARE

[GoingNuts]

I know how some of y'all feel about FARE, but this is an opportunity for us to weigh in on an important topic to our community.

From FARE email today:

As you may know, the U.S. Food and Drug Administration is seeking public comment on two matters of great importance to our community. Both of these issues directly speak to how food is labeled for the presence of allergens. First, the FDA is seeking to determine whether it can safely establish threshold levels for major food allergens. Secondly and separately, the FDA is seeking public comment on its proposed rule – required by the Food Safety Modernization Act – on preventive controls (including food allergen controls) within the food manufacturing industry. FARE has convened a working group comprising food allergy parents, allergists and researchers to help inform FARE's response to the FDA on both of these issues.
It is important to us to hear from members of the community on these issues, so we have created a survey to help us get your input. The survey takes about 5-10 minutes to complete and includes questions about the food allergies you are managing, your current behaviors with respect to food labeling and your knowledge about allergen thresholds.
The survey is available at this link: https://www.surveymonkey.com/s/C25NVH8
We hope you will take the time to provide us with your input. Please feel free to share the link and this email with your food allergy networks and support groups.
Thank you for your participation and for your support of FARE. 

[CMdeux]

DONE.

And I doubt that they are going to like what I said, but I said it anyway.

And I gave them enough information that they SHOULD find it difficult to ignore it, since I was quite open about variable thresholds for different allergens within our household.

[ajasfolks2]

I muse . . . is this survey going to produce a false sense of security?


*sigh*


Or is it just me.   

[GoingNuts]

They probably didn't like what I had to say either.  Believe me.

[LinksEtc]

Edited - link was no longer working. 

[gufyduck]

Question #17: Would you purchase a food that contains the allergen(s) you are avoiding if you could be assured that the amount of that allergen present in the food is only capable of triggering a mild allergic reaction, such as tingly lips or an itchy throat? 

[CMdeux]

#15 was the one that I had the most trouble answering-- because we have three different FA people in our household, and seven different food allergies, and only two of those allergens are managed identically (peanut and treenut in my DD).



We KNOW that for her, cleaned lines are not always good enough. 

And "cleaned" is unpredictable, frankly.

I also included notes in my comments about "Limit of Detection" and "limit of determination" and sampling problems.  There IS NOT a method sufficient for all allergens in all foods for ALL allergic individuals.

IS. NOT.

[PurpleCat]

Done...but.....

This survey makes me nervous.  In my opinion, there is no "safe" amount.  I hope they tread carefully and make a good decision.

[lakeswimr]

This makes me nervous.  I told them so.  How are they going to guarantee anything?  How will they guarantee the allowed xcontam stays under this so called OK limit in the first place?  xcontam is not predictable, stable or constant by its nature.  I worry that just like FAAN's focus on the top 8 to the exclusion of the other 10% of FAs they may focus on whatever percent can eat some xcontam and the result might be very bad for everyone else. 

[booandbrimom]

I wrote at length what I thought about all this in my blog...but to sum it up in a few sentences here: don't get hung up on the science, or the badly-worded survey questions, or other topics like non-top-8, and miss a real opportunity with this one.

Having a quantifiable level of protein declared by manufacturers gives us a legal protection we do not have today. I am still haunted by the story of the college kid who bought an vending-machine cookie and died from a subsequent reaction. When his parents sued the manufacturer, they lost...because the jury essentially said he should have known better than to have eaten the cookie, even though there was no declared peanut.

I worry that the food industry will use negative comments from the survey against us.

[CMdeux]

I hear ya, Boo...

on the other hand, I struggle with the notion that the experts have a choice here-- they can get it "right" or they can get it "now" and the two things probably aren't the same thing.

The one probably saves lives by making it easier for 90% of FA people to trust labels and NOT take risks about thing that they think are just CYA (but don't know are)...

but it may also make it impossible for my DD to eat anything processed again without considering it a food challenge. 

I don't know what the right thing is, there.  Maybe it just isn't the same thing for all allergens.

My fear is that it isn't the same thing for the entire spectrum of triggering doses, and THAT is an almost insurmountable problem.  Freedom for the majority there comes at a price for the minority who are already most likely to die from unavoidable exposure.     They should have the same rights, too. 


With all due respect, I disagree with this:

Having a quantifiable level of protein declared by manufacturers gives us a legal protection we do not have today.

Maybe.  But it also STRIPS any rights below that quantified level and gives them a pass to LIE to us about shared lines, just the way Kraft has done to me for years.  We were burned by them with mild-to-moderate reactions so many times that we gave up on them entirely, remember?   I know that their jello and marshmallow products are on shared lines with treenut or peanut.  I know it... but they won't TELL me so. 

I worry that this says "we only care about the easily accomodated."  If it's a FIRST STEP, that's fine.  But I don't think that anyone ought to be pretending that this "solves" the larger problem if that is the case. 

A permissible threshold, whatever it turns out to be, IS going to present some problems for a small subset of allergic people, and "problems" there is a polite euphemism for dangerous and expensive, or deadly, accidental ingestions that send them to emergency rooms or morgues. 


I can easily see the defense saying "Yeah, but the food DOESN'T contain* the allergen.  Must have been 'idiopathic' anaphylaxis, then.  Not OUR fault... we clean and test our lines, so not possible."     

* as defined by "the guideline."

So someone is still going to be 'eat at your own risk' anyway.  My problem with this is that the "someone" involved is already at the most restricted and vulnerable end of the spectrum. 

People like my DH and I find labeling Byzantine, illogical, and annoying in the extreme.  But we don't find it terrifying.  DD's allergies (and threshold) make it terrifying.  I don't see this changing that, since people like her supposedly don't exist.

The kinds of initial ingestions that get reported out of studies on desensitization?  Frankly, what they are reporting as an "average" tolerated dose boggles my mind when I consider what we know my DD's threshold to be.   If a threshold gets set at 100 mg-- or even 25 mg-- per serving... on the basis of the "fact" that the center of the tolerance distribution is at 250 mg (which it isn't-- this number is made up for the purposes of this post), and therefore "everyone" can tolerate 25mg without danger...

I think that is WRONG if it means that companies will no longer TELL us if something is on shared lines.  If they'll divulge it, great... but I'm skeptical, based on my experiences over the past decade. 

Would I rather that the food industry gave up?  Did nothing at all?  No, of course not.  But I think that at the moment, actually REPORTING a level of average contamination is beyond the scope of what is feasible.  And that is likely to be the best (eventual) answer for everyone involved. 

Think about that-- M&M's label... peanut tested at 40+/- 10 ppm.

Then people really COULD decide for themselves whether or not that was safe for themselves.  On the basis of actual INFORMATION.  Unfortunately, without knowing what the actual limit of detection is, it doesn't do any good to say it's "below the limit of detection."  Because hey, if my "method" of determination is..... visual?  That's whole peanuts per serving.  If it's by... LICKING the sample... it's still probably a couple of peanuts per serving, and it's going to vary depending on how spicy or cold the food is when I taste test.  Is it 'safe' if I say it's below my limit of detection?

Maybe for someone it is.  But for a lot of someone elses, it certainly is not.   

Sorry.  I don't think that is "getting lost in the science."  I think that this particular science isn't yet up to this particular task, and pretending that it is is dangerous for some food allergic persons.      I want to believe.  I do.  But I haven't seen anything yet that convinces me that anything good is going to come of this for people like my DD.  I'm worried for those people. 

[booandbrimom]

I do completely understand your point that an arbitrary threshold would not be a safe threshold for every individual. But why does that mean we shouldn't push to have thresholds quantified in the first place? I would so much rather know "average peanut content <1 mg" than "made in a factory that also processes peanut." The first statement gives me much more information than the second. What I DO with it is up to me.

There is also a difference between saying "this food has <1 mg peanut" and saying "this food is safe for all peanut individuals." I understand how you think one might morph into the other, but they are not the same.

I guess I just don't see it as somehow picking on the weakest in our community. I see it simply as information. Not perfect information, not completely useful information, but information. Better than what we have today.

Unless you buy into the likely food-industry argument that these labels will likely just scare consumers away from peanut-containing foods they're already safely eating? 

[booandbrimom]

http://www.sixwise.com/newsletters/05/06/29/how_many_insect_parts_and_rodent_hairs_are_allowed_in_your_food.htm

Just sayin'...do we really think we're just better off shutting our eyes and singing "la la LA I can't HEAR you" about peanut that's already in food?

[CMdeux]

There is also a difference between saying "this food has <1 mg peanut" and saying "this food is safe for all peanut individuals." I understand how you think one might morph into the other, but they are not the same.

The thing is, though, that is my fear.

I talk to our allergist all the time-- he's active in pursuing and keeping up with the research community, and he's "one of them" in that he's "in" that crowd and hangs out with them at meetings and keeps up with them...  so he knows stuff well ahead of presentation/publication, even.

There are things that simply aren't knowns.  Is it concentration?  Is it quantity?  Nobody knows.  Are all matrices the same?  Again, nobody knows.  As you know, this stuff has mattered to us as we've dosed with baked egg.  We're all just fumbling around in the dark, though.  We kind of know what seems to work for most people (which is what JHU passes our upon passing a full baked egg challenge), but what about those who don't start with that kind of tolerance?

Anyway.  Tangent.

The thing is, some of these people really believed that peanut OIL is completely safe for people with peanut allergy.  That was Taylor's standard line, and it's where FAAN (and most of the big name clinicians) got the info from.  He stopped saying that it "doesn't contain peanut protein" only after I challenged that.  Maybe it was coincidence and this was also about the same time as allergists began reporting patients who reacted to peanut oil.  I don't really know.

My point is just that history strongly suggests that food manufacturers AND the research community tend to not believe it until they have to believe it.  And you bet food manufacturers will argue that it isn't necessary to claim "< 1 mg" but they'll argue that this will be "misleading" and that since it MIGHT be "0mg" they should be perfectly justified in leaving it off and calling it "peanut free."  What will the research community have to say to them?  Probably not much.



That's one sort of bad thing about all of the oral challenges that have been conducted in the past decade; the fact is that allergists probably used to believe that the average triggering dose was far higher than it actually is.  But until they begin evaluating thresholds via oral challenge for ANYONE diagnosed with a peanut allergy (or any other food allergy), then they only have part of the picture.    There's still that pesky 1%, or 0.5%, or however many there are... who have allergies that seem to resist desensitization, and be very low (<1mg) threshold.  So far, research studies have only hinted at the characteristics of that population.  The thing is, though, people who have a 2-4 peanut threshold almost don't need advisory labeling to start with.  <sigh>  Advisory labeling is about that 1% to start with.


Would I like all food to be tested for the top 10 and bear advisory labels indicating levels?  ABSOLUTELY.  Because I'm not so foolish (anymore) as to think that peanut is special there-- there ARE people who need that label for milk, soy, or sesame.

Is this practical?  No, probably not.

Is it even possible to do this with EVERY batch that rolls off of a production line?  (Kidding.  This is clearly not currently possible-- it would require robust in-line sensors, and while that kind of technology is theoretically possible, it's both expensive and non-robust at the moment).

[CMdeux]

As long as it is crystal clear that whatever action is taken, it's a FIRST step, not the whole journey, then I don't have a problem with it.

I just don't think that my fears (above) are unrealistic.  Pair mandatory advisory labeling with accepted threshold advice, sure... but also make disclosure to consumers MANDATORY if they call.  That way you close the loophole that leaves people like my DD twisting in the wind.  No more "that's a secret and we clean our lines, so go away."