Assessment of potential adjuvanticity of Cry proteins.
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.
Monsanto Company, 800 North Lindbergh Blvd., St. Louis, MO 63167, USA. Electronic address: saurabh.joshi@monsanto.com.
Saurabh S
SS
Joshi
BASF Plant Science, 26 Davis Drive, Research Triangle Park, NC 27709, USA. Electronic address: brian.barnett@basf.com.
Brian
B
Barnett
ILSI Health and Environmental Sciences Institute, 1156 Fifteenth St., NW, Suite 200, Washington, DC 20005, USA. Electronic address: ndoerrer@hesiglobal.org.
Nancy G
NG
Doerrer
Monsanto Company, 800 North Lindbergh Blvd., St. Louis, MO 63167, USA. Electronic address: kevin.c.glenn@monsanto.com.
Kevin
K
Glenn
Dow AgroSciences, 9330 Zionsville Rd, Indianapolis, IN 46268, USA. Electronic address: raherman@dow.com.
Rod A
RA
Herman
Bayer SAS, Bayer CropScience, 355 Rue Dostoïevski, 06903 Sophia Antipolis Cedex, France. Electronic address: corinne.herouet-guicheney@bayer.com.
Corinne
C
Herouet-Guicheney
Bayer CropScience, 2 T.W. Alexander Dr., Research Triangle Park, NC 27709, USA. Electronic address: penny.hunst@bayercropscience.com.
Penny
P
Hunst
U.S. Environmental Protection Agency, Office of Pesticide Programs, Ariel Rios Building, MC 7511P, 1200 Pennsylvania Avenue, NW, Washington, DC 20460, USA. Electronic address: kough.john@epa.gov.
John
J
Kough
DuPont Haskell Global Centers for Health and Environmental Sciences, 1090 Elkton Road, Newark, DE 19711, USA. Electronic address: gregory.s.ladics@dupont.com.
Gregory S
GS
Ladics
Syngenta Crop Protection, LLC, 3054 E. Cornwallis Road, Research Triangle Park, NC 27709, USA. Electronic address: scott.mcclain@syngenta.com.
Scott
S
McClain
Dow AgroSciences, 9330 Zionsville Rd, Indianapolis, IN 46268, USA. Electronic address: spapineni@dow.com.
Sabitha
S
Papineni
Allergy Clinic, Copenhagen University Hospital at Gentofte, Niels Andersens Vej 65, Dept. 22, 1st Floor, DK-2900 Hellerup, Denmark. Electronic address: lkpallgy@mail.dk.
Lars K
LK
Poulsen
Bayer SAS, Bayer CropScience, 355 Rue Dostoïevski, 06903 Sophia Antipolis Cedex, France. Electronic address: jean-baptiste.rascle@bayer.com.
Jean-Baptiste
JB
Rascle
Guangzhou Medical University, 250 Changgang Road East, Guangzhou 510260, People's Republic of China. Electronic address: AerobiologiaTao@163.com.
Ai-Lin
AL
Tao
Departments of Experimental Immunology and Otorhinolaryngology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, Room K0-130, 1105 AZ Amsterdam, The Netherlands. Electronic address: r.vanree@amc.uva.nl.
Ronald
R
van Ree
Monsanto Company, 800 North Lindbergh Blvd., St. Louis, MO 63167, USA. Electronic address: jason.m.ward@monsanto.com.
Jason
J
Ward
Bayer CropScience, 2 T.W. Alexander Dr., Research Triangle Park, NC 27709, USA. Electronic address: christal.bowman@bayer.com.
Christal C
CC
Bowman
D000818:Animals; D000083722:Bacillus thuringiensis Toxins; D001426:Bacterial Proteins / Q000235:genetics* / Q000276:immunology / Q000378:metabolism; D003257:Consumer Product Safety; D018556:Crops, Agricultural / Q000235:genetics* / Q000276:immunology / Q000378:metabolism / Q000469:parasitology; D004731:Endotoxins / Q000235:genetics* / Q000276:immunology / Q000378:metabolism; D059022:Food Safety; D018506:Gene Expression Regulation, Plant; D005838:Genotype; D006460:Hemolysin Proteins / Q000235:genetics* / Q000276:immunology / Q000378:metabolism; D006790:Host-Parasite Interactions; D006801:Humans; D007313:Insecta / Q000254:growth & development* / Q000378:metabolism; D010572:Pest Control, Biological / Q000379:methods*; D010641:Phenotype; D030821:Plants, Genetically Modified / Q000235:genetics* / Q000276:immunology / Q000378:metabolism / Q000469:parasitology; D018570:Risk Assessment
D000083722:Bacillus thuringiensis Toxins; D001426:Bacterial Proteins; D004731:Endotoxins; D006460:Hemolysin Proteins; C030956:insecticidal crystal protein, Bacillus Thuringiensis
Adjuvant; Bacillus thuringiensis; Cry proteins; Food/feed safety; GM crops; Genetic modification