Assessment of potential adjuvanticity of Cry proteins

Saurabh S Joshi, Brian Barnett, Nancy G Doerrer, Kevin Glenn, Rod A Herman, Corinne Herouet-Guicheney, Penny Hunst, John Kough, Gregory S Ladics, Scott McClain, Sabitha Papineni, Lars K Poulsen, Jean-Baptiste Rascle, Ai-Lin Tao, Ronald van Ree, Jason Ward, Christal C Bowman

3 Citationer (Scopus)

Abstract

Genetically modified (GM) crops have achieved success in the marketplace and their benefits extend beyond the overall increase in harvest yields to include lowered use of insecticides and decreased carbon dioxide emissions. The most widely grown GM crops contain gene/s for targeted insect protection, herbicide tolerance, or both. Plant expression of Bacillus thuringiensis (Bt) crystal (Cry) insecticidal proteins have been the primary way to impart insect resistance in GM crops. Although deemed safe by regulatory agencies globally, previous studies have been the basis for discussions around the potential immuno-adjuvant effects of Cry proteins. These studies had limitations in study design. The studies used animal models with extremely high doses of Cry proteins, which when given using the ig route were co-administered with an adjuvant. Although the presumption exists that Cry proteins may have immunostimulatory activity and therefore an adjuvanticity risk, the evidence shows that Cry proteins are expressed at very low levels in GM crops and are unlikely to function as adjuvants. This conclusion is based on critical review of the published literature on the effects of immunomodulation by Cry proteins, the history of safe use of Cry proteins in foods, safety of the Bt donor organisms, and pre-market weight-of-evidence-based safety assessments for GM crops.

OriginalsprogEngelsk
TidsskriftRegulatory Toxicology and Pharmacology
Vol/bind79
Sider (fra-til)149-155
Antal sider7
ISSN0273-2300
DOI
StatusUdgivet - aug. 2016

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