Society For Risk Analysis Annual Meeting 2006

T2-I Symposium: Food allergies: Issues in establishing thresholds

Chair: Sherri Dennis

Up to 6% of children and 4% of the total US population have IgE-mediated food allergies. Accurate and informative food labeling is critical for these allergic consumers because they need to rely on strict avoidance to prevent potentially serious reactions. The Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 requires that the label of a food product that is or contains an ingredient that bears or contains a major food allergen declare the presence of the allergen. An important scientific issue associated with the implementation of FALCPA is the existence of threshold levels below which it is unlikely that a food allergic individual would experience an adverse effect. This session will explore the science of food allergies, the application of risk and safety assessments to establishing thresholds, and the identification of data sources that can be used to understand the prevalence of allergies.

T2-I.1 Food allergens: Challenges for risk assessment. Luccioli S*; US FDA

Abstract: Food allergens are unique food ingredients that present interesting challenges with regards to risk assessment and establishment of safe exposure doses. Many of these challenges stem from the fact that food allergy involves complex IgE-mediated immunological mechanisms which make it difficult to establish a reproducible and/or quantifiable biological endpoint in relation to dose of exposure. Food allergies are increasingly reported to affect a growing subset of the population, and exposure to allergen(s) can have a variety of clinical outcomes, including death, depending on many factors which include the dose, type and preparation of allergen as well as the particular sensitivities of the consumers at risk. Moreover, dose-response data to food allergens from oral food challenges or from anecdotal reports of exposure in the current food supply are not always reliable given the general lack of allergen dose characterization or standardization of challenge methods. The goals of this presentation are to (1) provide background information on the science of IgE-mediated food allergies and (2) to introduce related issues to be discussed during the symposium session including methods of obtaining data on food allergen exposures and data deficiencies that impact the assessment of risk from exposure to food allergens.


T2-I.2 Approaches to establishing food allergen thresholds. Gendel S*, Dennis S; US FDA

Abstract: Accurate and informative labeling is critical for allergic consumers and their families because they need to rely on strict avoidance of specific foods and ingredients to prevent potentially serious reactions. An important scientific issue associated with the implementation of the 2004 Food Allergen Labeling and Consumer Act is the existence of threshold levels below which it is unlikely that sensitive individuals would experience an adverse effect. The FDA Threshold Working Group identified four approaches that could be used to establish thresholds for allergens in foods: analytical methods-based, safety assessment-based, risk assessment-based and statutorily derived. In evaluating the viability of these approaches, the Working Group described the strengths, weaknesses, and data needs of each. To begin exploring the application of a risk assessment-based approach, a conceptual model was developed to identify the influential factors to be considered for a risk assessment involving the presence of undeclared peanuts in a baked food product. This conceptual model provides a basis for identifying important data gaps and uncertainties.


T2-I.3 Application of risk assessment methods to food allergens. Olin SS*, Fitzpatrick JW; ILSI Research Foundation

Abstract: In May 2006 the US Food and Drug Administration released its final report, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food. Responding to and building upon that analysis, the International Life Sciences Institute Research Foundation has embarked on a project to determine if current data and risk assessment tools can be applied to establishing thresholds for food allergens. A multidisciplinary 10-member Steering Committee from four countries, drawn from government, industry, academia, the public interest sector, and other organizations, is charged with guiding the project. A three-pronged attack on the problem is being developed: (1) mining the published literature (possibly accessing supplemental raw data) to compile and characterize the data available to establish dose-response curves; (2) assessing the approach and tools available, as well as the data required, to characterize population intake distributions of inadvertent allergenic contaminants, using a case study; and (3) investigating the theoretical lower limit on the minimal eliciting dose based on mechanism of allergic response. Consideration also is being given to collection of data from unpublished diagnostic studies in clinical files to develop a more complete representation of the entire population of allergic individuals. Priority research needs for establishing thresholds will be identified as the project proceeds. This talk will present the results and conclusions to date and next steps.


Date added to February 2007
Pub. date from document: December 2006