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Advantages. The primary advantage to the statutorily-derived approach is that it is derived from FALCPA’s exemption for highly refined oils from labeling provisions in the FALCPA.

Limitations. The primary limitation of this approach is that it is based on an extrapolation of a level derived from a statutory exemption rather than a rigorous, systematic evaluation of all the available scientific data. Because not all the eight major food allergens are used to produce highly refined oil, the use of a statutorily-derived threshold for all food allergens would be based primarily on the protein levels in highly refined soy or peanut oil. Another current significant limitation is the lack of data on the levels of protein in highly refined oils. Based on the data that are currently available and estimates of the amount of oil consumed as a food or food ingredient, it is likely that a threshold based on this approach would be unnecessarily protective of public health.

Finding 5. The statutorily-derived approach provides a mechanism for establishing thresholds for allergenic proteins in foods based on a statutory exemption. Potentially, this approach could be used to set a single threshold level for proteins derived from any of the major food allergens. This approach might yield thresholds that are unnecessarily protective of public health compared to thresholds established using the safety assessment-based approach or the risk assessment- based approach. However, confirming this would require additional data. If this approach is employed to establish thresholds, it should be used only on an interim basis and should be reevaluated as new knowledge, data, and risk assessment tools become available.

D. Gluten Threshold: Evaluation and Findings Section 206 of the FALCPA requires that the term "gluten-free" be defined for use on food labels. The law neither describes how gluten-free should be defined nor states whether there is a safe level of gluten.

This section provides an evaluation of the available data to support various approaches for establishing a threshold for gluten. A threshold, if established, could be the basis for decisions on whether to use the term “gluten-free” on product labels.

  • 1.

    Evaluation of Data Availability and Data Quality

    • a.

      Sensitive Populations. Like food allergies, celiac disease affects only a small

proportion of the U.S. population (estimated at 1%) (NIH, 2004). Susceptibility to celiac disease is genetically determined and is linked to the presence of the DQ2 or DQ8 HLA alleles. However, carrying these alleles does not necessarily lead to celiac disease. Both acute and chronic morbidity have been well documented for individuals with symptomatic celiac disease. A gluten-free diet has been shown to greatly reduce the risk for cancer and overall mortality for these individuals. The potential benefit of a gluten- free diet has not been established for individuals with silent or latent celiac disease.

b. Biomarkers. Unlike food allergies, clinical signs and symptoms do not appear to be reliable markers of disease activity because many individuals affected with celiac disease

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