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Having a quantifiable level of protein declared by manufacturers gives us a legal protection we do not have today.
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.
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.
In other words, I'm pretty sure that this was never anything more than a set-up to start with. I don't think its allergic consumers derailing this process, in other words. I don't think it was genuine to begin with.
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?
I understand there are concerns. I just hate to see those concerns derail something that might actually have had value to our community. Whether you would have used the information to avoid foods or include foods, a quantitative assessment had value. It would have been the start of holding manufacturers more accountable.
I use past tense because I am already pretty certain of how this will play out. The cost of this, the uncertainty of the science, and the fact that the food industry will use our own comments against us means this is probably DOA.
I hope I'm wrong. But frankly, I think it's another instance of us as a community not being able to hold two thoughts in our head at the same time. How do we square "no amount of peanut is safe" with "we're already eating some peanut in our food?" It's shameful that the industry uses our emotions against us, but I think they do and we let them.
If we don't measure, we don't know, and we can keep our illusion of a peanut-free world. Maybe (emotional) security really is more important than safety. No one wants to count the fly wings.
In other words, I'm pretty sure that this was never anything more than a set-up to start with. I don't think its allergic consumers derailing this process, in other words. I don't think it was genuine to begin with.
I agree (and wrote that in my blog). But my point was we didn't have to take the bait. I wish people would really think through what they want out of FARE instead of rejecting the (imperfect) process!
I wish we could agree as a community that it would be a good thing to measure the allergens in our food. That seems so *simple* to me. Why does it get derailed by crazy conversations about "any amount of allergen is too much" or "it can't be measured" or "thresholds change" or whatever? We spend so much time sniping at each other that there's never consensus. People are too wrapped up with which side of the line they're on (using these numbers to eliminate foods vs. include them) to see that the information would be useful, whichever side.
Where is the fricking outrage that a 21-year-old college kid died after eating cookies that were not labeled for peanut...and the court's response was to shrug and say "geez, he should have known he couldn't eat manufactured food." Why can't we just get behind this as a community, even if it's not perfect?
I use past tense because I am already pretty certain of how this will play out. The cost of this, the uncertainty of the science, and the fact that the food industry will use our own comments against us means this is probably DOA.
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.
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.
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 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 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.
If you responded to the survey, I hope you mentioned that!Yes, I made it my biggest point! I have done this: ate a whole bag of cereal after a half marathon, whilst my system is in overdrive and I'm even more sensitive to allergens... yep. Recipe for disaster? If there was some 'acceptable' level of cross contamination per serving, six servings eaten within 15 minutes could have killed me.
Yes, I made it my biggest point! I have done this: ate a whole bag of cereal after a half marathon, whilst my system is in overdrive and I'm even more sensitive to allergens... yep. Recipe for disaster? If there was some 'acceptable' level of cross contamination per serving, six servings eaten within 15 minutes could have killed me.
Ran across this while reviewing the FARRP site information:
[url]http://www.tno.nl/downloads/food_allergy_in_children.pdf[/url]
CM, thought you would like it especially.
FARE submitted its official comment to the FDA’s public docket on a risk assessment for establishing threshold levels for major food allergens on May 13.
Responses to FARE’s survey may be viewed
Started with acupuncturist 18 years ago for myself, allergist finised helping me
recently. Allergist for kids. Husband self-diagnosed
FARRP is an industry-funded consortium with more than 70 member companies.
FARRP would further note that processing and manufacturing processes likely affect the prevalence, severity and potency of allergenic foods in some cases. In the passage of FALCPA, Congress wisely exempted highly refined oils likely because of good evidence that highly refined peanut and soybean oils were safe for ingestion by peanut- and soybean-allergic individuals (Hourihane et al., 1997; Bush et al., 1985). Highly refined oils contain virtually no detectable protein with the protein being largely removed by the refining process (Rigby et al., 2011). However, the manufacturing of other ingredients derived from commonly allergenic sources as defined by FALCPA also greatly reduces the amount of protein or allergen from the source. Many examples exist including butter ester, butter acid, glucose syrup from wheat, ethanol from wheat, wheat starch, and shea nut oil or butter. FARRP would urge FDA to consider the use of quantitative risk assessment together with data on the protein levels of such ingredients to develop a transparent approach to source labeling exemptions for specific ingredients. Other ingredients, such as soy lecithin, contain trace levels of protein that may merit source labeling under some but not all uses. FARRP likewise encourages FDA to use quantitative risk assessment to make decisions regarding uses of such ingredients which should have source labeling and others which would not. Separately, FARRP has worked with a major soy lecithin manufacturer (Solae) to conduct a quantitative risk assessment on soy lecithin which will be shared as a separate response to this Notice. FARRP would further note that protein-containing ingredients from commonly allergenic sources can occasionally contain only trace levels of the allergenic protein. That appears to be the case with extensively washed fish gelatin (Koppelman et al., 2012). Fish gelatin is primarily collagen obtained from fish skins; washing during fish gelatin manufacturing removes parvalbumin, the primary fish allergen. Clinical evidence indicates that fish gelatin derived from cod is safe for ingestion by cod-allergic individuals except at rather high doses (Hansen et al., 2004). FARRP encourages FDA to take this sort of evidence into consideration when making a source labeling exemption decision on fish gelatin.
FARRP would assert that regulatory thresholds could be appropriately based upon use of the ED01
estimate where sufficient data exist to allow that estimate to be confidently made (for peanut, milk, egg,
and hazelnut) and use of the 95% lower confidence interval of ED05 estimate in other cases (for soybean,
wheat, and crustacean shellfish).
In addition to our direct comments, we fully endorse comments submitted by the Food Allergy Research and Resource Program.
Definition of Tree Nuts Should be Reviewed
We would also request that FDA review comments regarding the list of tree nuts included in the Q&A document, previously submitted by Grocery Manufacturers Association to Docket No. 2005D-0490 on May 14, 2007. These comments identified some concerns with categorizing ten nuts including coconut as a major food allergen, due to the botanical classification and the lack of incidence of severe allergic reactions. IDFA strongly agrees with GMA’s comments that review of the scientific literature establishes there are insufficient data to support the inclusion of beech nut, butternut, chinquapin, ginkgo nut, hickory nut, pili nut, sheanut, chestnut, coconut, and lichee nut in a list of major food allergens. Inclusions of “tree nuts” that have either no history of sensitization and elicitation of allergic reactions (beech nut, butternut, chinquapin, ginkgo nut, hickory nut, pili nut, and sheanut), or only a few cases of mild and non-life threatening reactions (chestnut, coconut, and lichee nut) contradict the intent of FALCPA and leads to an unnecessary elimination of food choices that are enjoyable, nutritious and convenient to allergic consumers
Moreover, GMA and the food associations who have joined this letter believe that the Agency should not require any recalls for packaged food products that may contain trace amounts of an undeclared allergen at or below the established threshold as the risk to human health would be extremely low.
FARE has decided to answer questions 1, 2 and 7 posed by the FDA; we feel that
our areas of expertise are best suited to those questions.
FARE urges FDA to first engage in outreach to the food allergy community to explain how
thresholds would affect families who live with food allergies, and then engage in notice and
comment rulemaking to establish any thresholds.
FARE urges FDA to use its authority under the misbranding provisions of Sec. 403 of the Food Drug and Cosmetic
Act to publish regulations that protect food allergic consumers from confusing and misleading
statements about allergens on food labels.
FDA should specify a small number of cautionary statements
with clearly defined, consistently-applied meanings to indicate whether a processed food that is
not intended to contain major food allergens may contain them due to manufacturing
processes. FARE would be pleased to work with FDA to develop specific language suggestions,
because accurate labeling is critical to allow consumers managing food allergies to make an
informed and safe choice about the products they purchase and feed to their families.
FARE encourages rigorous application of
preventive controls to eliminate the unintended presence of allergens in foods which might
reduce the need for cautionary labeling.
Grocery Manufacturers Association GMA
FDA-2012-N-0711-0063QuoteMoreover, GMA and the food associations who have joined this letter believe that the Agency should not require any recalls for packaged food products that may contain trace amounts of an undeclared allergen at or below the established threshold as the risk to human health would be extremely low.
Those with the lowest thresholds are at greatest RISK OF FATALITY-- not just in a dose dependent manner, as one might anticipate, but in a non-linear fashion as well.
Previously, we have demonstrated for peanut that patients with
histories of severe allergic reactions do not have lower thresholds by comparison to peanut-allergic
patients without such histories (Taylor et al., 2010).
Are only some allergens special that way?
Like I said-- we. don't. know.
If your allergist is comfortable with you consuming refined peanut oil, then you will need to take great care to ensure that you use only products with this type of oil. This will likely involve contacting a manufacturer or restaurant chain, and checking each time.
In the passage of FALCPA, Congress wisely exempted highly refined oils likely because of good evidence that highly refined peanut and soybean oils were safe for ingestion by peanut- and soybean-allergic individuals (Hourihane et al., 1997; Bush et al., 1985). Highly refined oils contain virtually no detectable protein with the protein being largely removed by the refining process (Rigby et al., 2011).
This month’s Food Allergy Buzz Blog Carnival theme is cross contamination
Somewhere between a company deciding whether a trace amount is too small to disclose (see above) or a company that makes a blanket warning on a single ingredient item (see above also), I think there needs to be a real discussion about labeling and disclosure not just for the benefit of food allergic families but all who wish to know what they’re eating.
Mary Jane Marchisotto, senior vice president of research
Marchisotto and Laurie Harada, executive director of Anaphylaxis Canada, together with other advocates and researchers, are working on a paper examining patients’ attitudes toward food allergen threshold labeling, which will be submitted for publication.