title: Bioinformatics and the allergy assessment of agricultural biotechnology products: industry practices and recommendations.
abstract: Bioinformatic tools are being increasingly utilized to evaluate the degree of similarity between a novel protein and known allergens within the context of a larger allergy safety assessment process. Importantly, bioinformatics is not a predictive analysis that can determine if a novel protein will ''become" an allergen, but rather a tool to assess whether the protein is a known allergen or is potentially cross-reactive with an existing allergen. Bioinformatic tools are key components of the 2009 CodexAlimentarius Commission's weight-of-evidence approach, which encompasses a variety of experimental approaches for an overall assessment of the allergenic potential of a novel protein. Bioinformatic search comparisons between novel protein sequences, as well as potential novel fusion sequences derived from the genome and transgene, and known allergens are required by all regulatory agencies that assess the safety of genetically modified (GM) products. The objective of this paper is to identify opportunities for consensus in the methods of applying bioinformatics and to outline differences that impact a consistent and reliable allergy safety assessment. The bioinformatic comparison process has some critical features, which are outlined in this paper. One of them is a curated, publicly available and well-managed database with known allergenic sequences. In this paper, the best practices, scientific value, and food safety implications of bioinformatic analyses, as they are applied to GM food crops are discussed. Recommendations for conducting bioinformatic analysis on novel food proteins for potential cross-reactivity to known allergens are also put forth.
authors.affiliation: Pioneer Hi-Bred International Inc., DuPont Agricultural Biotechnology, P.O. Box 80353, Wilmington, DE 19880, USA. gregory.s.ladics@usa.dupont.com
authors.forename: Gregory S
authors.initials: GS
authors.lastname: Ladics
authors.forename: Robert F
authors.initials: RF
authors.lastname: Cressman
authors.forename: Corinne
authors.initials: C
authors.lastname: Herouet-Guicheney
authors.forename: Rod A
authors.initials: RA
authors.lastname: Herman
authors.forename: Laura
authors.initials: L
authors.lastname: Privalle
authors.forename: Ping
authors.initials: P
authors.lastname: Song
authors.forename: Jason M
authors.initials: JM
authors.lastname: Ward
authors.forename: Scott
authors.initials: S
authors.lastname: McClain
mesh_terms: D000383:Agriculture; D000485:Allergens / Q000009:adverse effects* / Q000737:chemistry / Q000145:classification; D000595:Amino Acid Sequence; D001709:Biotechnology / Q000379:methods*; D019295:Computational Biology; D003257:Consumer Product Safety; D030562:Databases, Protein; D004044:Dietary Proteins / Q000032:analysis / Q000276:immunology*; D030841:Food, Genetically Modified / Q000009:adverse effects* / Q000145:classification; D006287:Health Planning Guidelines; D007221:Industry; D008969:Molecular Sequence Data; D010940:Plant Proteins / Q000032:analysis / Q000276:immunology*; D030821:Plants, Genetically Modified
chemical_list: D000485:Allergens; D004044:Dietary Proteins; D010940:Plant Proteins