Allergic Living magazine is closely following scientific investigations of whether it’s possible to identify a “safe level” of peanut in manufactured foods. Editor Gwen Smith wrote a feature article on this controversial topic in the Winter 11-12 issue of the magazine.
Following are some key points from her interview with lead investigators Dr. Steve Taylor and Dr. Joseph Baumert of the Food Allergy and Resource Program (FARRP).
Bio information: Dr. Taylor is a food scientist and the director of FARRP at the University of Nebraska-Lincoln with degrees in food science and biochemistry. Dr. Baumert is a food scientist and co-director of FARRP, with degrees in animal science and food science.
Gwen Smith: Gentlemen, thank you for your time today. Let’s start with the bigger picture for AL readers: What is the purpose of establishing a safe level of peanut for the peanut-allergic?
Steve Taylor: The purpose would be to establish target levels for the food industry and for public health agencies such as the Food & Drug Administration to use to guide product labeling.
GS: And you’ve spoken before of the concerns for consumers with allergies in the family ….
Joseph Baumert: This is very important. What we see is with the proliferation of these precautionary or “may contain” labels. Without some benchmark level that regulatory agencies or food companies can go by to know when there is a legitimate need to use that type of advisory labeling, it continues to proliferate. It’s to the point now where consumers are confused as to whether there’s actual risk involved.
On the consumer side, as an endpoint, we’d like for those individuals to be able to feel confident that if a product has a precautionary label on it, there’s a definite reason that they should avoid. Whereas, if it doesn’t have that [may contain] label, it’s because it does not fit that benchmark dose below which the vast majority of allergic individuals would not react if they bought that product. That would open up a lot more choices for allergic consumers.
ST: I think you can appreciate the predicament the food company faces without thresholds. They really don’t want anybody getting sick from their product.
But without the guidance of thresholds, they may slap terminology like “manufactured on shared equipment with peanuts” or “manufactured in the same facility as peanuts”, or “may contain peanuts” on a whole litany of products where the risk of peanut exposure is really pretty small. Now, we have to make sure that it’s so small that there would be almost no risk of a reaction.
GS: Now if I’m the average parent of a peanut-allergic child, probably I’d probably contend that the safe level of peanut in a food product is zero. But for you two, as the experts on food science, you would say that, no, a level of zero isn’t possible. Can you explain to readers, who aren’t food scientists, why that’s so?
ST: Zero isn’t feasible. Logically, you can never attain zero. Unless you’re willing to live in a plastic bubble, you cannot completely avoid the allergenic food. It will be on the floor, in the air, in other foods – to some very low degree that doesn’t cause a reaction in you. In toxicology, every chemical has safe doses. Allergen residues are noteworthy because of the safe level is very, very low.
From a practical perspective, the consumers have been given absolutely the right advice, and that is to avoid as completely as possible the allergen to which they are reactive. When we say that safe doses of allergenic foods exist for everyone, we have to be very sure that people understand what that means; that we’re not telling them they can chuck their avoidance diets. They can’t.
GS: But how do we wrap our heads around the concept of a safe level – or “threshold dose” in food science terminology – when many of us are avoiding even the slightest peanut residue?
ST: [He says we need more context.] In the clinical diagnostic studies, especially the ones done a few years back, they used to do food challenges of allergic individuals and they started those challenges at doses of 100 milligrams up to 500 milligrams. That’s well above zero. And those doses did not provoke reactions in every case. In many cases, they had to escalate the doses beyond that in order to document that the person was allergic to the food. But some people did react to the very first dose, and some of them had fairly significant reactions. But I point out that was hundreds of milligrams, which is well above zero.
We now know that for peanut that in very low dose challenge studies that have been done on hundreds of individuals now, that the most sensitive ones react to less than a milligram of peanut, down to a half a milligram of peanut.
GS: This leads to the question, though, if you do see such a range in allergic response in peanut allergy, how do you come up with a safe level? How do you make one size fit all?
ST: When you look at threshold doses [the level at which an individual reacts] over a large population – as we have for peanut – you find that some people react as levels as low as one-half a milligram. But, other people do not begin to react until eight or 10 grams of peanut, and that’s equivalent to a handful of peanuts.
They [the latter group] have a pretty easy time with their avoidance diet, they’d have to make a pretty king-sized mistake in order to have an allergic reaction. But the people at the lower end of that curve are exquisitely sensitive and probably are at risk of experiencing reactions even with their best attempts to avoid. We have to be very cautious about those most highly sensitive individuals.
[Dr. Baumert mentions that FARRP has now established the peanut threshold levels of 750 individuals through oral challenges in clinical settings. Dr. Taylor notes that if you plot those findings on a curve, you can predict what levels will be safe for 90 or 95 or even 99.9 percent of the population. But statistically, you could never get to 100 percent.]
ST: What we would like to do is to have enough data that we know it protects 99 percent of the peanut-allergic population. [For the remaining 1 per cent], we think reactions will be mild. But we can’t promise that no one will have a reaction.
GS: Now, you’ve discovered what you think is the safe level of peanut for the 99 percent of allergic individuals. [This will be discussed in the Winter issue of Allergic Living magazine.] But that was based on analysis of 750 subjects in France and the Netherlands. I understand you will be doing further research?
ST: Some people might have a concern, can we rely on this European data to predict what would happen [to patients] in the U.S. and Canada? We are continuing to do research and we are about to start what we call the “One-Shot Experiment”.
[He explains that as potentially peanut-allergic subjects as they show up at certain allergy clinics and as part of their appointment], they will be given this one dose that we have chosen …. So we’ll see if the dose distribution curve [which they’ve created from past studies] is predictive where a much wider range of people are tested in a lot more centers. It’s a very easy thing for the doctor to give the patient one little thimble of stuff to drink.
[Patient consent is given to take part. They can decline.]
GS: Will the “One Shot” be at your predicted safe level?
ST: We’re going higher than that. We’re going to use a dose that 5 percent of peanut-allergic individuals are predicted to react at and now we’ll see if they really do. This “dose distribution” is really important. We have to make sure that it’s right. If it’s wrong, we’ll need to start all over.
No one should be ready for us to do this yet [offer up a safe level]. You ask us if we have a threshold level yet? Yes, we do. But we’re not going to recommend it [to public health agencies for review] until sometime after this One-Shot Experiment.
GS: In the food-allergy community, fears about food safety still trump convenience and choice. Do you agree this “safe level” discussion will be controversial with the community?
ST: I think it will be controversial, alright. Many of these consumers are understandably anxious and I think especially if their child has experienced one of these reactions or in the first days or months after diagnosis, when you’re still trying to figure out how to keep your child safe. My peanut-allergic daughter is 33 so I’m relaxed now [Taylor chuckles, then turns serious]. But I wouldn’t blame consumers at all for being skeptical until we document that this is OK through the One-Shot Experiment.