title: Assessment of possible allergenicity of hypothetical ORFs in common food crops using current bioinformatic guidelines and its implications for the safety assessment of GM crops.
abstract: Before a genetically modified (GM) crop can be commercialized it must pass through a rigorous regulatory process to verify that it is safe for human and animal consumption, and to the environment. One particular area of focus is the potential introduction of a known or cross-reactive allergen not previously present within the crop. The assessment of possible allergenicity uses the guidelines outlined by the Food and Agriculture Organization (FAO) and World Health Organization's (WHO) Codex Alimentarius Commission (Codex) to evaluate all newly expressed proteins. Some regulatory authorities have broadened the scope of the assessment to include all DNA reading frames between stop codons across the insert and spanning the insert/genomic DNA junctions. To investigate the utility of this bioinformatic assessment, all naturally occurring stop-to-stop frames in the non-transgenic genomes of maize, rice, and soybean, as well as the human genome, were compared against the AllergenOnline (www.allergenonline.org) database using the Codex criteria. We discovered thousands of frames that exceeded the Codex defined threshold for potential cross-reactivity suggesting that evaluating hypothetical ORFs (stop-to-stop frames) has questionable value for making decisions on the safety of GM crops.
authors.affiliation: Pioneer Hi-Bred International, Inc., DuPont Agricultural Biotechnology, Wilmington, DE 19880, USA. Gregory.Young@cgr.dupont.com
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Young
authors.forename: Shiping
authors.initials: S
authors.lastname: Zhang
authors.forename: Henry P
authors.initials: HP
authors.lastname: Mirsky
authors.forename: Robert F
authors.initials: RF
authors.lastname: Cressman
authors.forename: Bin
authors.initials: B
authors.lastname: Cong
authors.forename: Gregory S
authors.initials: GS
authors.lastname: Ladics
authors.forename: Cathy X
authors.initials: CX
authors.lastname: Zhong
mesh_terms: D000485:Allergens; D000595:Amino Acid Sequence; D019295:Computational Biology; D018556:Crops, Agricultural / Q000235:genetics* / Q000276:immunology*; D016208:Databases, Factual; D005512:Food Hypersensitivity; D059022:Food Safety; D030841:Food, Genetically Modified / Q000009:adverse effects; D017408:Guidelines as Topic; D006801:Humans; D008969:Molecular Sequence Data; D010940:Plant Proteins / Q000276:immunology*; D030821:Plants, Genetically Modified
chemical_list: D000485:Allergens; D010940:Plant Proteins