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approach, priority should be given to establishing a research program to acquire the knowledge and data needed.

d. Statutorily-Derived Approach. The FALCPA does not include requirements or exemptions that could be used to establish a statutorily-derived threshold for gluten. Also, the law does not define the term "gluten-free." Potentially, a threshold could be established using the international standards currently under review by Codex (Codex Alimentarius Commision, 2003. However, the proposed Codex standards do not appear to be based on either a scientific rationale for a distinction between naturally gluten-free foods and foods processed to be free of gluten, or a systematic evaluation of clinical data related to the effect of gluten on acute or chronic celiac disease etiology. The levels being considered by Codex seem to be based on anecdotal evidence and on the levels of gluten that are presumed to be historically present in foods that have been called “gluten- free.”

Finding 10. There appear to be no suitable statutory requirements or exemptions that would serve as the rationale for using for a statutorily-derived approach to establish a threshold for gluten. This approach is not viable.

Although the FALCPA directs FDA to establish a definition for the term “gluten-free” for food labeling, the quantity and quality of the data needed to accomplish this on a scientific basis are severely limited at the current time relative to all three of the potentially viable approaches. This was aptly summarized by the consensus statement published after a conference of experts convened by the National Institutes of Health which noted that "The strict definition of a gluten-free diet remains controversial due to the lack of an accurate method to detect gluten in food products and the lack of scientific evidence for what constitutes a safe amount of gluten ingestion" (NIH, 2004). These experts concluded that additional research is needed to "Define the minimum safe exposure threshold of gluten in the diet relative to celiac disease" (NIH, 2004).

In view of the consensus opinion stated in the NIH report, the Threshold Working Group concluded that Finding 6 should be reemphasized. Any approach used to establish a threshold for gluten to protect consumers with, or susceptible to, celiac disease should be used in an iterative manner and reexamined periodically to consider new knowledge, data, and approaches.

Revised Threshold Report Page 65 of 108

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