Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food

U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, Maryland 20740-3835, USA.
Journal of food protection (Impact Factor: 1.85). 05/2008; 71(5):1043-88.
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    • "For each dataset, the individual No Observed Adverse Effect Levels (NOAEL) and the LOAELs were combined to derive population threshold dose distribution curves for each allergenic food using the dose distribution approach as described in Crevel et al. (2008), together with survival analysis methods as used in Taylor et al. (2009, 2010). This approach is widely accepted as one that uses the available data most effectively (Gendel et al. 2008; Madsen et al., 2009). In selecting the eliciting dose (ED) for the allergic population (in which the EDx represents the dose at which x% of the allergic population would be expected to react with objective symptoms), weight was given to the goodness of fit for each parametric model (determined by the log likelihood) as well as visual examination of the fitted probability distribution. "
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    ABSTRACT: For most allergenic foods, limited availability of threshold dose information within the population restricts the advice on action levels of unintended allergenic foods which should trigger advisory labelling on packaged foods. The objective of this paper is to provide guidance for selecting an optimal sample size for threshold dosing studies for major allergenic foods and to identify factors influencing the accuracy of estimation. A simulation study was performed to evaluate the effects of sample size and dosing schemes on the accuracy of the threshold distribution curve. The relationships between sample size, dosing scheme and the employed statistical distribution on the one hand and accuracy of estimation on the other hand were obtained. It showed that the largest relative gains in accuracy are obtained when sample size increases from N = 20 to N = 60. Moreover, it showed that the EuroPrevall dosing scheme is a useful start, but that it may need revision for a specific allergen as more data become available, because a proper allocation of the dosing steps is important. The results may guide risk assessors in minimum sample sizes for new studies and in the allocation of proper dosing schemes for allergens in provocation studies.
    Food and chemical toxicology: an international journal published for the British Industrial Biological Research Association 05/2014; 70. DOI:10.1016/j.fct.2014.05.001 · 2.90 Impact Factor
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    • "The VITAL calculator then determines the final allergen content and compares this to Reference Doses which were defined for major allergenic foods. The initial VITAL action levels were based on minimum eliciting doses for regulated allergenic foods (expressed as doses of protein) collated by the 2006 U.S Food & Drug Administration (FDA) Threshold Working Group [66]. Initially, due to limited data on minimum provoking doses existing at that time, a 10-fold uncertainty factor was applied by VITAL to assure that sufficiently conservative action levels were promulgated. "
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    ABSTRACT: Food allergy appears to be on the rise with the current mainstay of treatment centred on allergen avoidance. Mandatory allergen labelling has improved the safety of food for allergic consumers. However an additional form of voluntary labelling (termed precautionary allergen labelling) has evolved on a wide range of packaged goods, in a bid by manufacturers to minimise risk to customers, and the negative impact on business that might result from exposure to trace amounts of food allergen present during cross-contamination during production. This has resulted in near ubiquitous utilisation of a multitude of different precautionary allergen labels with subsequent confusion amongst many consumers as to their significance. The global nature of food production and manufacturing makes harmonisation of allergen labelling regulations across the world a matter of increasing importance. Addressing inconsistencies across countries with regards to labelling legislation, as well as improvement or even banning of precautionary allergy labelling are both likely to be significant steps forward in improved food safety for allergic families. This article outlines the current status of allergen labelling legislation around the world and reviews the value of current existing precautionary allergen labelling for the allergic consumer. We strongly urge for an international framework to be considered to help roadmap a solution to the weaknesses of the current systems, and discuss the role of legislation in facilitating this.
    World Allergy Organization Journal 04/2014; 7(1):10. DOI:10.1186/1939-4551-7-10
    • "Initially, a VITAL grid was established with 3 Action Levels: Green (low risk; no precautionary labeling); Yellow (possible risk; precautionary ''may be present: ####'' labeling recommended ); Red (higher risk; definitive ''contains ####'' labeling recommended). The initial VITAL Action Levels were established on the basis of the threshold doses of protein from allergenic foods for subjective and objective responses cited by the 2006 US Food & Drug Administration (FDA) Threshold Working Group (Gendel et al., 2008). Because some uncertainty existed surrounding the FDA estimates and the general paucity of the available data on threshold doses at that time, a 10-fold uncertainty factor was applied. "
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    ABSTRACT: In 2011, an expert panel was assembled to establish appropriate Reference Doses for allergenic food residues as a part of the VITAL (Voluntary Incidental Trace Allergen Labeling) program of The Allergen Bureau of Australia & New Zealand (ABA). These Reference Doses would guide advisory labeling decisions for use on food labels. Individual NOAELs and LOAELs were obtained from clinical challenges of food-allergic subjects. Statistical dose-distribution models (log-normal, log–logistic, Weibull) were applied to the individual NOAELs and LOAELs for each allergenic food. The Reference Doses, in terms of mg of total protein from the allergenic food, were based upon either the ED01 (for peanut, cow’s milk), the 95% lower confidence interval of the ED05 (for wheat, soybean, cashew, shrimp, sesame seed, mustard, and lupine), or both (egg, hazelnut) using all appropriate statistical dose-distribution models. Reference Doses were established for 11 allergenic foods ranging from 0.03 mg for egg protein to 10 mg for shrimp protein. Reference Doses were not established for fish or celery due to poor model fits with existing data. Reference Doses were not established for other tree nuts beyond hazelnut and cashew because of the absence of data on NOAELs and LOAELs from individual subjects.
    Food and chemical toxicology: an international journal published for the British Industrial Biological Research Association 01/2014; 63:9–17. DOI:10.1016/j.fct.2013.10.032 · 2.90 Impact Factor
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