Goal
The goal of this project is to determine if current data and risk assessment tools can be applied to establishing thresholds for food allergens.
Project Rationale
Considering the potential relevance of a scientifically robust and credible process for establishing threshold levels for allergens in foods consistent with FDA recommendations (http://www.cfsan.fda.gov/~dms/alrgn2.html)and in the consideration of exemption requests under FALCPA, this project will investigate whether a risk assessment for food allergen thresholds would be beneficial in developing a scientifically credible and well-grounded pragmatic approach that would have a positive impact on measures for protecting public health.
Approach
The project will be carried out in two stages. First, a Steering Committee will conduct a preliminary assessment of the feasibility and likelihood of success of the project. If the assessment proves favorable, an expert working group will be assembled to write a consensus paper on the potential for using risk assessment to establish food allergen thresholds. The Steering Committee, selected by ILSI RF/RSI, met in May 2006 at the ILSI offices in Washington, DC. The Steering Committee adopted the objectives set for it by the ILSI Research Foundation, defined the scope more precisely (e.g., limited to IgE-mediated allergic reactions by ingestion), and discussed a wide range of issues. The Steering Committee will begin with three initiatives to assess the potential success of risk assessment as a tool to establish thresholds for food allergens:
· Mine the published literature (possibly accessing supplemental data from the authors’ clinics, as necessary) to compile and characterize the data available to establish dose-response curves.
· Assess the approach and tools available, as well as the data required, to characterize population intake distributions of inadvertent allergenic contaminants, using a case study.
· Investigate the theoretical lower limit on the minimal eliciting dose (MED) based on mechanism of allergic response.
Current Status
The Steering Committee is currently evaluating the published literature to establish dose-response curves for peanut consumption as well as evaluating the possibility of establishing intake distributions for inadvertent allergenic contaminants. The Steering Committee expects to submit a white paper for publication in early 2007.
This project is being supported by the ILSI North America Technical Committee on Food and Chemical Safety.