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June 21, 2006
The United States Food and Drug Administration (FDA) has issued a new guidance document titled "Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use." The intent of this guidance to industry is to help prevent the inadvertent introduction of allergens or toxins into the food and feed supply. More specifically, this guidance describes the procedure for early food safety evaluation of new proteins in new plant varieties that are under development for food use. In most cases, the proteins expected to become components of food, whether as a result of the use of traditional or modern biotechnology methods, will be the same or quite similar to proteins commonly found in food. FDA believes that any food safety concern related to such material entering the food supply would be limited to the potential that a new protein in food from the plant variety could cause an allergic reaction in susceptible people or could be a toxin in people or animals.
FDA's report, "Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food", is now available. 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.
