2005N-0231 Draft Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Availability
FDA Comment Number : EC5
Submitter : Dr. Susan Hefle Date & Time: 08/10/2005 03:08:22
Organization : University of Nebraska
Category : Academia
Issue Areas/Comments
Comments by: Sue Hefle, Ph.D.
Co-Director, Food Allergy Research & Resource Program
University of Nebraska
Lincoln, NE 68583-0919

Date: August 8, 2005

The Food and Drug Administration should be applauded for the effort made to prepare this document and also to develop methods to establish minimal eliciting doses for major allergenic foods. Rather then reiterate remarks and scientific opinions shared at the Advisory Committee meeting on July 13 in Greenbelt MD, the comments made here are directed at an assumption made in the written document of June 2005.

Comments on II. Food Allergy, G. Exposure, 3. Detecting and Measuring Proteins:

FDA notes that most test systems do not detect specific allergenic proteins. I would not make this assumption; indeed, an FDA scientist was involved in the article cited below that showed that many commercial peanut kits detect Ara h 1 and 2, known peanut allergens. In addition, many tests on the market specifically are designed to detect beta-lactoglobulin, soy Kunitz trypsin inhibitor, shrimp tropomyosin, casein, etc. All of these are well-described allergens. However, as I indicated in my presentation to the Committee on July 13, very specific detection of allergenic proteins is not required for an assay to be specific and sensitive for the allergenic food and certainly, not all of the allergens in the major allergenic foods have been discovered or characterized, and likely will not be for some time to come. In addition, LOAELS and NOAELS for allergenic foods are determined with oral challenges using whole foods, not isolated food allergens; given this, in my expert opinion, assays designed to detect whole allergenic foods are more meaningful, both to food-allergic patients and also to the food industry.

Nogueira MC, McDonald R, Westphal C, Maleki SJ, Yeung JM. Can commercial peanut assay kits detect peanut allergens? J AOAC Int. 2004; 87:1480-1484.