title: Measurement of endogenous allergens in genetically modified soybeans--short communication.
abstract: The measurement of endogenous allergens is required by the European Commission (EC) as part of the compositional analysis for GM products from host plants that are common causes of food allergy, such as soybean (EC Implementing Regulation No. 503/2013). In each case, the EC Implementing Regulation indicates that analysis be conducted on identified allergens as specified in the Organization of Economic Cooperation and Development (OECD) consensus documents on compositional considerations for new plant varieties. This communication discusses the methods available to measure endogenous allergens as well as the endogenous soybean allergens that should be analyzed. It is suggested herein that in conjunction with the 2012 OECD consensus document on soybean, any list of soybean allergens should be based on clinically relevant data among publicly available allergen databases and peer-reviewed scientific publications, and the ability to measure the identified allergen. Based on a detailed analysis of the scientific literature, the following key points are recommended: (1) the acceptance of serum-free, quantitative analytical method data as an alternative to traditional IgE reactivity qualitative or semi-quantitative data for evaluation of endogenous soybean allergen content; (2) eight of the 15 potential allergens listed in the OECD soybean consensus document (Gly m 3, Gly m 4, Gly m Bd28K, Gly m Bd30K, Gly m 5, Gly m 6, Gly m 8, and Kunitz trypsin inhibitor) have both appropriate supporting clinical data and sufficient sequence information to be evaluated in comparative endogenous soybean allergen studies; and (3) the remaining seven proteins (Gly m 1, Gly m 2, unknown 50kDa protein, unknown 39kDa protein, P-22-25, lipoxygenase and lectin) lack sufficient data for clear classification as confirmed allergens and/or available sequence information and should not be currently included in the measurement of endogenous soybean allergens in the compositional analysis for the EU.
authors.affiliation: DuPont Pioneer Agricultural Biotechnology, DuPont Experimental Station, 200 Powder Mill Road, Wilmington, DE 19803-0400, USA. Electronic address: Gregory.s.ladics@usa.dupont.com.
authors.forename: Gregory S
authors.initials: GS
authors.lastname: Ladics
authors.affiliation: BASF Plant Science, 26 Davis Drive, Research Triangle Park, NC 27709, USA.
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Budziszewski
authors.affiliation: Dow AgroSciences, 9330 Zionsville Rd, Indianapolis, IN 46077, USA.
authors.forename: Rod A
authors.initials: RA
authors.lastname: Herman
authors.affiliation: Bayer SAS, Bayer CropScience, 355 rue Dostoievski, CS 90153 Valbonne 06906 Sophia Antipolis, France.
authors.forename: Corinne
authors.initials: C
authors.lastname: Herouet-Guicheney
authors.affiliation: Monsanto Company, Product Characterization Center, 800 North Lindbergh Blvd., St. Louis, MO 63167, USA.
authors.forename: Saurabh
authors.initials: S
authors.lastname: Joshi
authors.affiliation: BASF Plant Science, 26 Davis Drive, Research Triangle Park, NC 27709, USA.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Lipscomb
authors.affiliation: Syngenta Crop Protection, LLC, 3054 E. Cornwallis Road, Research Triangle Park, NC, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: McClain
authors.affiliation: Monsanto Company, Product Characterization Center, 800 North Lindbergh Blvd., St. Louis, MO 63167, USA.
authors.forename: Jason M
authors.initials: JM
authors.lastname: Ward
mesh_terms: D000485:Allergens / Q000235:genetics / Q000276:immunology*; D005062:European Union; D005512:Food Hypersensitivity / Q000235:genetics / Q000276:immunology*; D006801:Humans; D030821:Plants, Genetically Modified / Q000276:immunology*; D018570:Risk Assessment / Q000379:methods; D013025:Glycine max / Q000235:genetics / Q000276:immunology*
chemical_list: D000485:Allergens
keywords: Analytical methods; Endogenous allergens; Genetically modified crops; Soybean