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Risk-based approaches for decisions around the use of precautionary allergen labeling (PAL) statements and incident management have been mentioned in recent industry and regulatory guidance documents. Many of these guidance documents reference the recommendations of the ad hoc Food and Agriculture Organization (FAO) and the World Health Organization (WHO) expert consultation on the risk assessment of food allergens that was convened between 2020 and 2023 to evaluate the feasibility of using data from clinical threshold studies to derive reference doses for the priority allergenic food sources. These reference doses are proposed to be utilized in a risk assessment framework which can be used by the food industry to make decisions around the use of PAL statements but could also be utilized as component of incident management. The framework includes elements of quantitative risk assessment where the consideration of finished product consumption quantities and data from sample analysis using allergen-specific methods for quantification of allergen residues are used to calculate potential allergen residue exposure doses. The sensitivity and accuracy of the analytical methods used to support this quantitative risk assessment approach is critical. This presentation will provide an overview of the application of analytical methods to support a risk-based approach to incident management. Considerations on the variability of the testing method(s), target protein(s), reporting units and potential conversion factors will be discussed using case studies as an illustration.
