1. The Challenge of Food Allergen Thresholds Steven M. Gendel and Sherri Dennis FDA Center for Food Safety and Applied Nutrition Office of Science

2. Food Allergy No cure – avoidance of allergenic food Individuals and families become avid readers of food labels Labels should be informative and accurate

3. Food Allergy – What Is Different? Allergic response is to a food component that is nutritious for most of the populationAllergic response is to a food component that is nutritious for most of the population Sensitivity and severity (biological endpoints) have large range in the populationSensitivity and severity (biological endpoints) have large range in the population Sensitivity and severity can vary in an individualSensitivity and severity can vary in an individual No applicable animal models or in vitro testsNo applicable animal models or in vitro tests

4. Allergen Thresholds Why are we interested now?Why are we interested now? –Food Allergen Labeling and Consumer Protection Act (FALCPA) – –Requires label to disclose certain allergenic ingredients

5. Eight Most Common Allergenic Foods or Food Groups Identified in FALPCA MilkMilk EggEgg WheatWheat Fish (e.g., bass, flounder, cod)Fish (e.g., bass, flounder, cod) Crustacean shellfish (e.g., crab, shrimp)Crustacean shellfish (e.g., crab, shrimp) SoybeansSoybeans PeanutsPeanuts Tree Nuts (e.g., almonds, pecans, walnuts)Tree Nuts (e.g., almonds, pecans, walnuts)

6. Ingredients Subject to Law Major food allergens: an ingredient that is, or contains protein derived from, one of the eight foods or food groups Includes incidental additives, flavors Exceptions: Any highly refined oil derived from a major food allergen Food ingredient exempt from labeling under a petition or notification process specified in law

7. Exemption Standards Petition - “does not cause an allergic response that poses a risk to human health”Petition - “does not cause an allergic response that poses a risk to human health” Notification - “does not contain allergenic protein”Notification - “does not contain allergenic protein”

8. Allergen Thresholds Scientific Questions: Does a level exist below which “does not cause” or “does not contain” apply (i.e., a threshold)? If so, how can this level be established?

9. Threshold Report Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food

10. Purpose of the Report To identify approaches to establish thresholds for major food allergens and glutenTo identify approaches to establish thresholds for major food allergens and gluten To identify advantages, disadvantages, and data needs for each approachTo identify advantages, disadvantages, and data needs for each approach

11. Approaches To Establish Thresholds For Food Allergens Analytical Methods-BasedAnalytical Methods-Based Safety Assessment-BasedSafety Assessment-Based Risk Assessment-BasedRisk Assessment-Based Statutorily DerivedStatutorily Derived

12. Analytical Methods-based Approach Based on sensitivity of methodsBased on sensitivity of methods Used when validated methods are availableUsed when validated methods are available Not directly linked to public health outcomesNot directly linked to public health outcomes Moderate data needsModerate data needs

13. Safety Assessment-Based Approach LOAELs or NOAELs from clinical dataLOAELs or NOAELs from clinical data Uncertainty factors based on data gapsUncertainty factors based on data gaps Moderate data needsModerate data needs

14. Risk Assessment-Based Approach Response distributions from clinical dataResponse distributions from clinical data Quantitative estimates of risk and uncertaintyQuantitative estimates of risk and uncertainty Greatest data needsGreatest data needs Most technically rigorous approachMost technically rigorous approach

15. Statutorily Derived Approach Based on “highly refined oil” language in FALCPABased on “highly refined oil” language in FALCPA Link between thresholds established using this approach and public health unclearLink between thresholds established using this approach and public health unclear

16. Risk Assessment Example Undeclared peanuts in a baked product – model overview

17. Risk Assessment Example Undeclared peanuts in a baked product – risk characterization