Abstract
It is estimated that up to 12 million Americans have food allergies, which occur when the immune system mistakenly responds to a food protein believing it to be harmful. Not all proteins are allergens, and the properties that make some `novel proteins' allergenic are not completely understood. There is currently no single endpoint that can predict the allergenic potential of a protein, and a weight of evidence approach is utilized. This presentation will review the current state-of-the-science of this approach by focusing on the safety assessment of genetically modified crops which includes the evaluation for protein allergenicity. Specifically, this approach, as defined by the Codex Alimentarius commission, evaluates: whether the gene source is allergenic; sequence similarity to known allergens; and protein resistance to pepsin in vitro. If concerns are identified, serological studies may be necessary to determine if a protein has IgE binding similar to known allergens. Since there was a lack of standardized/validated methods to conduct the allergenicity assessment, a multi-sector, multi-national committee was assembled in 2000 under ILSI HESI to address this issue. Over the last eight+ years, the Protein Allergenicity Technical Committee (PATC) has convened workshops and symposia with allergy experts and government authorities to refine methods that underpin the assessment for potential protein allergenicity. This presentation will highlight this ongoing effort, summarizing workshops and formal meetings, referencing publications and describing outreach activities. The purpose is to outline the `state-of-the-science' in predicting protein allergenicity in the context of current international recommendations for novel protein safety assessment, and to identify approaches that can be improved and future research needs.
