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

doi:10.1016/j.yrtph.2016.04.005

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

Department of Clinical Medicine

3 Citations (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.

Original language	English
Journal	Regulatory Toxicology and Pharmacology
Volume	79
Pages (from-to)	149-155
Number of pages	7
ISSN	0273-2300
DOIs	https://doi.org/10.1016/j.yrtph.2016.04.005
Publication status	Published - Aug 2016

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Journal Article

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10.1016/j.yrtph.2016.04.005

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Joshi, S. S., Barnett, B., Doerrer, N. G., Glenn, K., Herman, R. A., Herouet-Guicheney, C., Hunst, P., Kough, J., Ladics, G. S., McClain, S., Papineni, S., Poulsen, L. K., Rascle, J-B., Tao, A-L., van Ree, R., Ward, J., & Bowman, C. C. (2016). Assessment of potential adjuvanticity of Cry proteins. Regulatory Toxicology and Pharmacology, 79, 149-155. https://doi.org/10.1016/j.yrtph.2016.04.005

Joshi, SS, Barnett, B, Doerrer, NG, Glenn, K, Herman, RA, Herouet-Guicheney, C, Hunst, P, Kough, J, Ladics, GS, McClain, S, Papineni, S, Poulsen, LK, Rascle, J-B, Tao, A-L, van Ree, R, Ward, J & Bowman, CC 2016, 'Assessment of potential adjuvanticity of Cry proteins', Regulatory Toxicology and Pharmacology, vol. 79, pp. 149-155. https://doi.org/10.1016/j.yrtph.2016.04.005

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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.",

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AU - Joshi, Saurabh S

AU - Barnett, Brian

AU - Doerrer, Nancy G

AU - Glenn, Kevin

AU - Herman, Rod A

AU - Herouet-Guicheney, Corinne

AU - Hunst, Penny

AU - Kough, John

AU - Ladics, Gregory S

AU - McClain, Scott

AU - Papineni, Sabitha

AU - Poulsen, Lars K

AU - Rascle, Jean-Baptiste

AU - Tao, Ai-Lin

AU - van Ree, Ronald

AU - Ward, Jason

AU - Bowman, Christal C

PY - 2016/8

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N2 - 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.

AB - 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.

KW - Journal Article

U2 - 10.1016/j.yrtph.2016.04.005

DO - 10.1016/j.yrtph.2016.04.005

M3 - Review

C2 - 27105772

SN - 0273-2300

VL - 79

SP - 149

EP - 155

JO - Regulatory Toxicology and Pharmacology

JF - Regulatory Toxicology and Pharmacology

ER -

Assessment of potential adjuvanticity of Cry proteins

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