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Executive Summary


The Food Allergen Labeling and Consumer Protection Act of 2004 (P.L. 108-282) (FALCPA) amends the Federal Food, Drug, and Cosmetic Act (FFDCA) and requires that the label of a food product that is or contains an ingredient that bears or contains a “major food allergen” declare the presence of the allergen as specified by FALCPA. FALCPA defines a “major food allergen” as one of eight foods or a food ingredient that contains protein derived from one of those foods. A food ingredient may be exempt from FALCPA’s labeling requirements if it does not cause an allergic response that poses a risk to human health or if it does not contain allergenic protein. FALCPA also requires FDA to promulgate a regulation defining the term “gluten-free.”

This report summarizes the current state of scientific knowledge regarding food allergy and celiac disease, including information on dose-response relationships for major food allergens and for gluten, respectively. The report presents the biological concepts and data needed to evaluate various approaches to establish thresholds that would be scientifically sound and efficacious in relation to protection of public health. Each approach has strengths and weaknesses, and the application of each is limited by the availability of appropriate data. It is likely that there will be significant scientific advances in the near future that will address a number of the limitations identified in this report.

The Threshold Working Group expects that any decisions on approaches for establishing thresholds for food allergens or for gluten would require consideration of additional factors not covered in this report. Furthermore, one option that is implicit in the report’s discussion of potential approaches is a decision not to establish thresholds at this time.

Approaches to Establish Thresholds

The report identifies four approaches that could be used to establish thresholds:

  • Analytical methods-based-thresholds are determined by the sensitivity of the analytical method(s) used to verify compliance.

  • Safety assessment-based-a “safe” level is calculated using the No Observed Adverse Effect Level (NOAEL) from human challenge studies and an appropriate Uncertainty Factor (UF) applied to account for knowledge gaps.

  • Risk assessment-based-examines known or potential adverse heath effects resulting from human exposure to a hazard; quantifies the levels of risk associated with specific exposures and the degree of uncertainty inherent in the risk estimate.

  • Statutorily-derived-uses an exemption articulated in an applicable law and extrapolates from that to other potentially similar situations.

Revised Threshold Report Page 2 of 108

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