The Challenge of Food The Challenge of Food Allergen ThresholdsAllergen Thresholds

Steven M. Gendel and Sherri Dennis FDA

Center for Food Safety and Applied Nutrition

Office of Science

Food AllergyFood Allergy

• No cure – avoidance of allergenic food

• Individuals and families become avid readers of food labels

• Labels should be informative and accurate

Food Allergy – What Is Food Allergy – What Is Different?Different?

• Allergic response is to a food Allergic response is to a food component that is nutritious for component that is nutritious for most of the populationmost of the population

• Sensitivity and severity (biological Sensitivity and severity (biological endpoints) have large range in the endpoints) have large range in the populationpopulation

• Sensitivity and severity can vary Sensitivity and severity can vary in an individualin an individual

• No applicable animal models or in No applicable animal models or in vitro testsvitro tests

Allergen ThresholdsAllergen Thresholds

• Why are we interested now?Why are we interested now?– Food Allergen Labeling and Food Allergen Labeling and

Consumer Protection Act Consumer Protection Act (FALCPA)(FALCPA)

– Requires label to disclose certain allergenic ingredients

Eight Most Common Eight Most Common Allergenic Foods or Food Allergenic Foods or Food

Groups Identified in Groups Identified in FALPCAFALPCA• MilkMilk

• EggEgg• WheatWheat• Fish (e.g., bass, flounder, cod)Fish (e.g., bass, flounder, cod)• Crustacean shellfish (e.g., crab, Crustacean shellfish (e.g., crab,

shrimp)shrimp)• SoybeansSoybeans• PeanutsPeanuts• Tree Nuts (e.g., almonds, pecans, Tree Nuts (e.g., almonds, pecans,

walnuts)walnuts)

Ingredients Subject to Ingredients Subject to LawLaw

• 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

Exemption StandardsExemption Standards

• Petition - “does not cause an Petition - “does not cause an allergic response that poses a allergic response that poses a risk to human health”risk to human health”

• Notification - “does not Notification - “does not contain allergenic protein” contain allergenic protein”

Allergen ThresholdsAllergen 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?

Threshold ReportThreshold Report

Approaches to Establish Approaches to Establish Thresholds for Major Food Thresholds for Major Food Allergens and for Gluten in Allergens and for Gluten in FoodFood

Purpose of the ReportPurpose of the Report

• To identify To identify approachesapproaches to to establish thresholds for major establish thresholds for major food allergens and glutenfood allergens and gluten

• To identify advantages, To identify advantages, disadvantages, and data disadvantages, and data needs for each approachneeds for each approach

Approaches To Establish Approaches To Establish Thresholds For Food Thresholds For Food AllergensAllergens

• Analytical Methods-Based Analytical Methods-Based • Safety Assessment-BasedSafety Assessment-Based• Risk Assessment-BasedRisk Assessment-Based• Statutorily DerivedStatutorily Derived

Analytical Methods-Analytical Methods-based Approachbased Approach• Based on sensitivity of Based on sensitivity of

methodsmethods• Used when validated methods Used when validated methods

are available are available • Not directly linked to public Not directly linked to public

health outcomeshealth outcomes• Moderate data needsModerate data needs

Safety Assessment-Safety Assessment-Based ApproachBased Approach• LOAELs or NOAELs from LOAELs or NOAELs from

clinical data clinical data • Uncertainty factors based on Uncertainty factors based on

data gapsdata gaps• Moderate data needsModerate data needs

Risk Assessment-Risk Assessment-Based ApproachBased Approach• Response distributions from Response distributions from

clinical data clinical data • Quantitative estimates of risk Quantitative estimates of risk

and uncertaintyand uncertainty• Greatest data needsGreatest data needs• Most technically rigorous Most technically rigorous

approachapproach

Statutorily Derived Statutorily Derived ApproachApproach• Based on “highly refined oil” Based on “highly refined oil”

language in FALCPAlanguage in FALCPA• Link between thresholds Link between thresholds

established using this established using this approach and public health approach and public health unclearunclear

Risk Assessment Risk Assessment Example Example

Undeclared peanuts in a baked product – model overview

Risk Assessment Risk Assessment Example Example

Undeclared peanuts in a baked product – risk characterization