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In preparing this report, the Threshold Working Group conducted literature searches, gathered extensive scientific information about food allergy and celiac disease, and consulted technical experts. This information was used to identify approaches that could be used to establish thresholds, and to evaluate the strengths, weaknesses, and data needs of each approach. A notice of availability for the draft report was published in the Federal Register (70 FR 35258), and the report was made available through the FDA Docket and the CFSAN web site. The FDA requested that interested persons submit comments, scientific data, and information to FDA Docket No. 2005N-0231 during a 60- day period, ending August 16, 2005. Eighteen letters were received, including comments from consumer groups, the food industry, trade associations, experts on food allergens and gluten, and individual consumers.

In the Federal Register of May 23, 2005 (70 FR 29528), FDA announced a meeting of the Food Advisory Committee (FAC) to be held on July 13, 14, and 15, 2005. Members of the public were invited to participate in the meeting. The FAC was asked to consider whether the draft report was scientifically sound in its analyses and approaches and whether the report adequately considered available relevant data on food allergens and on gluten. The meeting included presentations on issues related to the diagnosis and treatment of food allergies and celiac disease, the quality of life for affected consumers, analytical methods to measure allergens and gluten in foods, and clinical studies to characterize dose-response relationships. In seeking the Committee’s advice, FDA posed a series of specific scientific questions. The transcript of the meeting is available at http://www.fda.gov/ohrms/dockets/ac/cfsan05.html. The Committee’s answers to the specific scientific questions is available at http://www.fda.gov/ohrms/dockets/ac/05/minutes/2005- 4160m1_summary%20minutes.pdf. A summary of the public comments received at the Food Advisory Committee meeting and in the public docket with a brief indication as to how the revised report responds to each comment is available at http://www.cfsan.fda.gov/~dms/wh-alrgy.html.

The Committee concluded that CFSAN’s draft report includes a comprehensive evaluation of the currently available data and descriptions of all relevant approaches that could be used to establish thresholds for major allergens and gluten in food. The Committee suggested that, while the safety assessment-based and risk assessment-based approaches are distinct, they are not mutually exclusive. For example, statistical analyses could be incorporated into a traditional safety assessment by considering dose-response distributions. The Committee felt that the risk assessment-based approach is scientifically the strongest of the approaches, and that it should be used in a transparent manner with appropriate consideration of data uncertainties, when sufficient data become available. The Committee agreed that the criteria identified in the draft report for evaluating the available data were appropriate. The Committee also recommended that data from highly relevant, well designed studies be considered in establishing thresholds, even if they have not yet been published or peer-reviewed.

Revised Threshold Report Page 10 of 108

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