Toxicological evaluation of proteins introduced into food crops

References

• Adel-Patient K, Guimaraes VD, Paris A, et al. (2011). Immunological and Metabolomic impacts of administration of Cry1Ab protein and MON 810 maize in mouse. Plos ONE, 6, e16346
   PubMed Web of Science ®Google Scholar
• Albillos SM, Menhart N, Fu TJ. (2009). Structural stability of amandin, a major allergen from almond (Prunus dulcis), and its acidic and basic polypeptides. J Agric Food Chem, 57, 4698–705
   PubMedGoogle Scholar
• Alderborn A, Sundström J, Soeria-Atmadja D, et al. (2010). Genetically modified plants for non-food or non-feed purposes: straightforward screening for their appearance in food and feed. Food Chem Toxicol, 48, 453–64
   PubMed Web of Science ®Google Scholar
• Bates SL, Zhao JZ, Roush RT, Shelton AM. (2005). Insect resistance management in GM crops: past, present and future. Nat Biotechnol, 23, 57–62
   PubMed Web of Science ®Google Scholar
• Behe MJ, Lattman EE, Rose GD. (1991). The protein-folding problem: the native fold determines packing, but does packing determine the native fold? Proc Natl Acad Sci USA, 88, 4195–9
   PubMed Web of Science ®Google Scholar
• Betz FS, Hammond BG, Fuchs RL. (2000). Safety and advantages of Bacillus thuringiensis-protected plants to control insect pests. Regul Toxicol Pharmacol, 32, 156–73
   PubMed Web of Science ®Google Scholar
• Bloom JD, Arnold FH. (2009). In the light of directed evolution: pathways of adaptive protein evolution. Proc Natl Acad Sci USA, 106, 9995–10000
   PubMed Web of Science ®Google Scholar
• Bogani P, Minunni M, Spiriti MM, et al. (2008). Transgenes monitoring in an industrial soybean processing chain by DNA-based conventional approaches and biosensors. Food Chem, 113, 658–64
   Google Scholar
• Brake J, Faust MA, Stein J. (2003). Evaluation of transgenic event Bt11 hybrid corn in broiler chickens. Poultry Sci, 82, 551–9
   PubMed Web of Science ®Google Scholar
• Branden C, Tooze J. (1991). Introduction to protein structure. New York, NY: Garland Publishing
   Google Scholar
• Buljan M, Bateman A. (2009). The evolution of protein domain families. Biochem Soc Trans, 37, 751–5
   PubMed Web of Science ®Google Scholar
• Cantor CR, Schimmel PR. (1980). Biophysical chemistry, part 2, techniques for the study of biological structure and function. New York, NY: W. H. Freeman and Company, 409–66
   Google Scholar
• Caspary WF. (1992). Physiology and pathophysiology of intestinal absorption. Am J Clin Nutr, 55, 299S–308S
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention (CDC) National Center for Environmental Health. (2001). Investigation of human health effects associated with potential exposure to genetically modified corn. CDC, Atlanta, Georgia [Online]. Available from: http://www.cdc.gov/nceh/ehhe/Cry9Creport/ [last accessed 13 March 2013]
   Google Scholar
• Chao E, Krewski D. (2008). A risk-based classification scheme for genetically modified foods I: conceptual development. Regul Toxicol Pharmacol, 52, 208–22
   PubMedGoogle Scholar
• Codex Alimentarius Commission. (2009). Foods derived from modern biotechnology. Rome, Italy: FAO/WHO, 1–85
   Google Scholar
• Codex Alimentarius Commission, Committee on Methods of Analysis and Sampling (CCMAS). (2010). Proposed draft guidelines on performance criteria and validation of methods for detection, identification, and quantification of specific DNA sequences and specific proteins in food. (At step 5/8 of the procedure). ALINORM 10/33/23. Appendix III. Rome, Italy: FAO/WHO, 47–68
   Google Scholar
• Concon JM. (1988). Naturally occurring antinutritive substances. In: Concon JM, ed. Food toxicology, part a. principles and concepts. New York, NY: Marcel Dekker Inc., 405–62
   Google Scholar
• Constable A, Jonas D, Cockburn A, et al. (2007). History of safe use as applied to the safety assessment of novel foods and foods derived from genetically modified organisms. Food Chem Toxicol, 45, 2513–25
   PubMed Web of Science ®Google Scholar
• Craik DJ, Daly NL, Waine C. (2001). The cystine knot motif in toxins and implications for drug design. Toxicon, 39, 43–60
   PubMed Web of Science ®Google Scholar
• Creighton TE. (1993). Proteins: structures and molecular properties. 2nd edn. New York: W.H. Freeman and Company
   Google Scholar
• Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India. (2008). Protocols for food and feed safety assessment of GE Crops [Online]. Available from: http://igmoris.nic.in/files%5CCoverpage1.pdf [last accessed 2 May 2011]
   Google Scholar
• Delaney B, Astwood JD, Cunny H, et al. (2008a). Evaluation of protein safety in the context of agricultural biotechnology. Food Chem Toxicol, 46, S71–97
   PubMed Web of Science ®Google Scholar
• Delaney B, Zhang J, Carlson G, et al. (2008b). A gene-shuffled glyphosate acetyltransferase protein from Bacillus licheniformis (GAT4601) shows no evidence of allergenicity or toxicity. Toxicol Sci, 102, 425–32
   PubMed Web of Science ®Google Scholar
• de Luis R, Lavilla M, Sánchez L, et al. (2009). Immunochemical detection of Cry1A(b) protein in model processed foods made with transgenic maize. Eur Food Res Technol, 229, 15–19
   Web of Science ®Google Scholar
• Doolittle RF. (1990). Searching through sequence databases. Methods Enzymol, 183, 99–110
   PubMed Web of Science ®Google Scholar
• European Food Safety Authority (EFSA). (2005a). Opinion of the scientific panel on genetically modified organisms on a request from the commission related to the notification (Reference C/DE/02/9) for the placing on the market of insect-protected genetically modified maize MON 863 × MON 810, for import and processing, under Part C of Directive 2001/18/EC from Monsanto (Question No EFSA-Q-2003-089). EFSA J, 251, 1–22
   Google Scholar
• EFSA. (2005b). Opinion of the scientific panel on genetically modified organisms on an application (Reference EFSA-GMO-UK-2004-06) for the placing on the market of insect-protected glyphosate-tolerant genetically modified maize MON863 × NK603, for food and feed uses, and import and processing under Regulation (EC) No 1829/2003 from Monsanto (Question No EFSA-Q-2004-154). EFSA J, 255, 1–21
   Google Scholar
• EFSA. (2005c). Opinion of the scientific panel on genetically modified organisms on an application (Reference EFSA-GMO-BE-2004-07) for the placing on the market of insect-protected glyphosate-tolerant genetically modified maize MON863 × MON810 × NK603, for food and feed uses, and import and processing under Regulation (EC) No 1829/2003 from Monsanto (Question No EFSA-Q-2004-159). EFSA J, 256, 1–25
   Google Scholar
• EFSA. (2005d). Opinion of the scientific panel on genetically modified organisms on an application (reference EFSA-GMO-NL-2004–02) for the placing on the market of insect-tolerant genetically modified maize 1507, for food use, under Regulation (EC) No 1829/2003 from Pioneer Hi-Bred International/Mycogen Seeds (Question No EFSA-Q-2004-087). EFSA J, 182, 1–22
   Google Scholar
• EFSA. (2006). Guidance document of the scientific panel on genetically modified organisms for the risk assessment of genetically modified plants and derived food and feed. EFSA J, 9, 1–100
   Google Scholar
• EFSA. (2007a). Opinion of the scientific panel on genetically modified organisms on an application (Reference EFSA-GMO-NL-2005-12) for the placing on the market of insect-resistant genetically modified maize 59122, for food and feed uses, import and processing under Regulation (EC) No 1829/2003, from Pioneer Hi-Bred International, Inc. and Mycogen Seeds, c/o Dow Agrosciences LLC (Question No EFSA-Q-2005-045). EFSA J, 470, 1–25
   Google Scholar
• EFSA. (2007b). Opinion of the scientific panel on genetically modified organisms on applications (references EFSA-GMO-UK-2005–19 and EFSA-GMO-RX-GA21) for the placing on the market of glyphosate-tolerant genetically modified maize GA21, for food and feed uses, import and processing and for renewal of the authorisation of maize GA21 as existing product, both under Regulation (EC) No 1829/2003 from Syngenta Seeds S.A.S. on behalf of Syngenta Crop Protection AG (Questions No EFSA-Q-2005-226 and EFSA-Q-2007-147). EFSA J, 541, 1–25
   Google Scholar
• EFSA. (2008). Safety and nutritional assessment of GM plants and derived food and feed: the role of animal feeding trials. Food Chem Toxicol, 46, S2–70
   Web of Science ®Google Scholar
• EFSA. (2009a). Public consultation on the updated guidance document of the scientific panel on genetically modified organisms (GMO) for the risk assessment of genetically modified plants and derived food and feed. Prepared by the GMO Unit. (Question No EFSA-Q-2003-005E). EFSA Sci Rep, 293, 1–18
   Google Scholar
• EFSA. (2009b). Scientific Opinion. Application (Reference EFSA-GMO-NL-2005-15) for the placing on the market of the insect-resistant and herbicide-tolerant genetically modified maize 1507 × 59122, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Mycogen Seeds, c/o Dow AgroSciences LLC and Pioneer Hi-Bred International, Inc. as represented by Pioneer Overseas Corporation. Scientific Opinion of the Panel on Genetically Modified Organisms (Question No EFSA-Q-2005-123). EFSA J, 1074, 1–28
   Google Scholar
• EFSA. (2009c). Scientific Opinion. Application (Reference EFSA-GMO-UK-2005-21) for the placing on the market of the insect-resistant and herbicide-tolerant genetically modified maize 59122 × 1507 × NK603 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Pioneer Hi-Bred International, Inc. Scientific Opinion of the Panel on Genetically Modified Organisms (Question No EFSA-Q-2005-248). EFSA J, 1050, 1–32
   Google Scholar
• EFSA. (2009d). Applications (references EFSA-GMO-NL-2005–22, EFSA-GMO-RX-NK603) for the placing on the market of the genetically modified glyphosate tolerant maize NK603 for cultivation, food and feed uses, import and processing and for renewal of the authorisation of maize NK603 as existing products, both under Regulation (EC) No 1829/2003 from Monsanto. Scientific Opinion of the Panel on Genetically Modified Organisms (Questions No EFSA-Q-2005-249, No EFSA-Q-2008-075). EFSA J, 1137, 1–50
   Google Scholar
• EFSA. (2010a). Scientific Opinion on the assessment of allergenicity of GM plants and microorganisms and derived food and feed. EFSA Panel on Genetically Modified Organisms (GMO Panel). EFSA J, 8, 1700
   Google Scholar
• EFSA. (2010b). Scientific Opinion on application (EFSA-GMO-NL-2007–39) for the placing on the market of insect resistant and herbicide tolerant genetically modified maize MON89034 ×MON88017 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto. EFSA Panel on Genetically Modified Organisms (GMO). EFSA J, 8, 1564
   Google Scholar
• Federici B, Siegel J. (2008). Safety assessment of Bacillus thuringiensis and Bt crops used in insect control. In: Hammond, B.G., ed. Food safety of proteins in agricultural biotechnology. Boca Raton, FL: CRC Press, 45–102
   Google Scholar
• Finamore A, Roselli M, Britti S, et al. (2008). Intestinal and peripheral immune response to MON810 maize ingestion in weaning and old mice. J Agric Food Chem, 56, 11533–9
   PubMed Web of Science ®Google Scholar
• Flachowsky G, Halle I, Aulrich K. (2005). Long term feeding of Bt-corn – a ten generation study with quails. Arch Anim Nutr, 59, 449–51
   PubMed Web of Science ®Google Scholar
• Ganfornina MD, Sánchez D. (1999). Generation of evolutionary novelty by functional shift. Bioessays, 21, 432–9
   PubMedGoogle Scholar
• Gardner MLG. (1988). Gastrointestinal absorption of intact proteins. Annu Rev Nutr, 8, 329–50
   PubMed Web of Science ®Google Scholar
• Gilissen LJW, Metz PLJ, Stiekema WJ, Nap JP. (1998). Biosafety of E. coli β-glucuronidase (GUS) in plants. Transgenic Res, 7, 157–63
   PubMed Web of Science ®Google Scholar
• Goldberg M, Gomez-Orellana I. (2003). Challenges for the oral delivery of macromolecules. Nat Rev Drug Discov, 2, 289–95
   PubMed Web of Science ®Google Scholar
• Goodman RE, Vieths S, Sampson HA, et al. (2008). Allergenicity assessment of genetically modified crops—what makes sense? Nat Biotechnol, 26, 73–81
   PubMed Web of Science ®Google Scholar
• Greenfield NJ, Huang YJ, Palm T, et al. (2001). Solution NMR structure and folding dynamics of the N terminus of a rat non-muscle alpha-tropomyosin in an engineered chimeric protein. J Mol Biol, 312, 833–47
   PubMedGoogle Scholar
• Griffitts JS, Haslam SM, Yang T, et al. (2005). Glycolipids as receptors for Bacillus thuringiensis crystal toxin. Science, 307, 922–5
   PubMedGoogle Scholar
• Groten JP, Schoen ED, van Bladeren PJ, et al. (1997). Subacute toxicity of a mixture of nine chemicals in rats: detecting interactive effects with a fractionated two-level factorial design. Fund Appl Toxicol, 36, 15–29
   PubMedGoogle Scholar
• Grothaus GD, Bandla M, Currier T, et al. (2006). Immunoassay as an analytical tool in agricultural biotechnology. J AOAC Int, 89, 913–28
   PubMed Web of Science ®Google Scholar
• Hamman JH, Enslin GM, Kotze AF. (2005). Oral delivery of peptide drugs: barriers and developments. BioDrugs, 19, 165–77
   PubMed Web of Science ®Google Scholar
• Hammond B, Cockburn A. (2008). The safety assessment of proteins introduced into crops developed through agricultural biotechnology: a consolidated approach to meet current and future needs. In: Hammond BG, ed. Food Safety of Proteins in Agricultural Biotechnology. Boca Raton, FL: CRC Press, 259–88
   Google Scholar
• Hammond BG, Jez JM. (2011). Impact of food processing on the safety assessment for proteins introduced into biotechnology-derived soybean and corn crops. Food Chem Toxicol, 49, 711–21
   PubMed Web of Science ®Google Scholar
• Hammond, BG, Koch, MS. (2012). A review of the food safety of Bt crops. In: Sansinenea, E, ed. Bacillus thuringiensis Biotechnology. New York, NY: Springer, 305–25
   Google Scholar
• Heick J, Fischer M, Pöpping B. (2011). First screening method for the simultaneous detection of seven allergens by liquid chromatography mass spectrometry. J Chromatogr A, 1218, 938–43
   PubMed Web of Science ®Google Scholar
• Herman R, Gao Y, Storer N. (2006). Acid-induced unfolding kinetics in simulated gastric digestion of proteins. Regul Toxicol Pharmacol, 46, 93–9
   PubMed Web of Science ®Google Scholar
• Herouet C, Esdaile DJ, Mallyon BA, et al. (2005). Safety evaluation of the phosphinothricin acetyltransferase proteins encoded by the pat and bar sequences that confer tolerance to glufosinate-ammonium herbicide in transgenic plants. Regul Toxicol Pharmacol, 41, 134–49
   PubMed Web of Science ®Google Scholar
• Herouet-Guicheney C, Rouquié D, Freyssinet M, et al. (2009). Safety evaluation of the double mutant 5-enol pyruvylshikimate-3-phosphate synthase (2mEPSPS) from maize that confers tolerance to glyphosate herbicide in transgenic plants. Regul Toxicol Pharmacol, 54, 143–53
   PubMed Web of Science ®Google Scholar
• Hofmann C, Lüthy P, Hütter R, Pliska V. (1988a). Binding of the delta endotoxin from Bacillus thuringiensis to brush-border membrane vesicles of the cabbage butterfly (Pieris brassicae). Eur J Biochem, 173, 85–91
   PubMedGoogle Scholar
• Hofmann C, Vanderbruggen H, Höfte H, et al. (1988b). Specificity of B. thuringiensis delta-endotoxins is correlated with the presence of high-affinity binding sites in the brush border membrane of target insect midguts. Proc Natl Acad Sci USA, 85, 7844–8
   PubMed Web of Science ®Google Scholar
• Illergård K, Ardell DH, Elofsson A. (2009). Structure is three to ten times more conserved than sequence—a study of structural response in protein cores. Proteins, 77, 499–508
   PubMed Web of Science ®Google Scholar
• ILSI. (2007). Sampling and Detection Methods for Products of Modern Agricultural Biotechnology in NAFTA Countries. ILSI International Food Biotechnology Committee (IFBiC) Workshop, October 11–12, 2007. Washington, DC: IFBiC
   Google Scholar
• IPCS (International Programme on Chemical Safety). (1999). Environmental Health Criteria, 217, Microbial Pest Control Agent Bacillus thuringiensis. Geneva, Switzerland: WHO
   Google Scholar
• Juberg DR, Herman RA, Thomas J, et al. (2009). Acute and repeated dose (28 day) mouse oral toxicology studies with Cry34Ab1 and Cry35Ab1 Bt proteins used in coleopteran resistant DAS-59122-7 corn. Regul Toxicol Pharmacol, 54, 154–63
   PubMed Web of Science ®Google Scholar
• Kier LD, Petrick JS. (2008). Safety assessment considerations for food and feed derived from plants with genetic modifications that modulate endogenous gene expression and pathways. Food Chem Toxicol, 46, 2591–605
   PubMed Web of Science ®Google Scholar
• Kilara A, Sharkasi TY. (1986). Effects of temperature on food proteins and its implications on functional properties. Crit Rev Food Sci Nutr, 23, 323–95
   PubMed Web of Science ®Google Scholar
• Kristjánsson MM, Kinsella JE. (1991). Protein and enzyme stability: structural, thermodynamic, and experimental aspects. Adv Food Nutr Res, 35, 237–316
   PubMedGoogle Scholar
• Kroes R, Renwick AG, Cheeseman M, et al. (2004). Structure-based thresholds of toxicological concern (TTC): guidance for application to substances present at low levels in the diet. Food Chem Toxicol, 42, 65–83
   PubMed Web of Science ®Google Scholar
• Kroghsbo S, Madsen C, Poulsen M, et al. (2008). Immunotoxicological studies of genetically modified rice expressing PHA-E lectin or Bt toxin in Wistar rats. Toxicology, 245, 24–34
   PubMed Web of Science ®Google Scholar
• Ladics GS, Cressman R, Herouet-Guicheney C, et al. (2011). Bioinformatics and the allergy assessment of agricultural biotechnology products: industry practices and recommendations. Reg Toxicol Pharmacol, 60, 46–53
   PubMed Web of Science ®Google Scholar
• Lambert B, Buysse L, Decock C, et al. (1996). A Bacillus thuringiensis insecticidal crystal protein with a high activity against members of the family Noctuidae. Appl Environ Microbiol, 62, 80–6
   PubMed Web of Science ®Google Scholar
• Lattman EE, Rose GD. (1993). Protein folding—what’s the question? Proc Natl Acad Sci USA, 90, 439–41
   PubMedGoogle Scholar
• Leiner IE. (1994). Implications of antinutritional components in soybean foods. Crit Rev Food Sci Nutr, 34, 31–67
   PubMedGoogle Scholar
• Margarit E, Reggiardo MI, Vallejos RH, Permingeat HR. (2006). Detection of Bt transgenic maize in foodstuffs. Food Res Int, 39, 250–5
   Web of Science ®Google Scholar
• Mathesius CA, Barnett JF Jr, Cressman RF, et al. (2009). Safety assessment of a modified acetolactate synthase protein (GM-HRA) used as a selectable marker in genetically modified soybeans. Regul Toxicol Pharmacol, 55, 309–20
   PubMed Web of Science ®Google Scholar
• McClintock JT, Schaffer CR, Sjoblad RD. (1995). A comparative review of the mammalian toxicity of Bacillus thuringiensis-based pesticides. Pesticide Sci, 45, 95–105
   Google Scholar
• McNaughton JL, Roberts M, Rice D, et al. (2007). Feeding performance in broiler chickens fed diets containing DAS-59122–7 maize grain compared to diets containing non-transgenic maize grain. Anim Feed Sci Technol, 132, 227–39
   Google Scholar
• Meade SJ, Reid EA, Gerrard JA. (2005). The impact of processing on the nutritional quality of food proteins. J AOAC Int, 88, 904–22
   PubMed Web of Science ®Google Scholar
• Mendelsohn M, Kough J, Vaituzis Z, Matthews K. (2003). Are Bt crops safe? Nat Biotechnol, 21, 1003–9
   PubMed Web of Science ®Google Scholar
• Mezzomo, BP, Miranda-Vilela AL, Friere IS, et al. (2013). Hemtotoxicity of Bacillus thuringiensis as spore-crystal strains Cry1Aa, Cry1Ab, Cry1Ac, or Cry2Aa in Swiss albino mice. J Hematol Thromb Dis, 1, 104
   Google Scholar
• Mills ENC, Jenkins JA, Alcocer MJC, Shewry PR. (2004). Structural, biological, and evolutionary relationships of plant food allergens sensitizing via the gastrointestinal tract. Crit Rev Food Sci Nutr, 44, 379–407
   PubMed Web of Science ®Google Scholar
• Moore AD, Björklund ÅK, Ekman D, et al. (2008). Arrangements in the modular evolution of proteins. Trends Biochem Sci, 33, 444–51
   Google Scholar
• Moreno-Fierros L, Garcia N, Gutierrez R, et al. (2000). Intranasal, rectal and intraperitoneal immunization with protoxin Cry1Ac from Bacillus thuringiensis induces compartmentalized serum, intestinal, vaginal and pulmonary immune responses in Balb/c mice. Microbes Infect, 2, 885–90
   PubMed Web of Science ®Google Scholar
• Noteborn HPJM, Bienenmann-Ploum ME, van den Berg JHJ, et al. (1995). Safety assessment of the Bacillus thuringiensis insecticidal crystal protein CRYIA(b) expressed in transgenic tomatoes. In: Engel KH, Takeoka GR, Teranishi R, eds. Genetically modified foods: safety issues. Washington, DC: American Chemical Society, 134–47
   Google Scholar
• O’Hagan DT, Palin KJ, Davis SS. (1988). Intestinal absorption of proteins and macromolecules and the immunological response. Crit Rev Ther Drug Carrier Syst, 4, 197–220
   PubMedGoogle Scholar
• Organization for Economic Co-Operation and Development (OECD). (1995). OECD Guideline for the testing of chemicals. Repeated dose 28-day oral toxicity study in rodents. Available from: http://www.oecd-ilibrary.org/docserver/download/9740701e.pdf?expires=1363167171&id=id&accname=guest&checksum=078085077D9F4B4935D1D08FDB351206 [last accessed 13 March 2013]
   Google Scholar
• OECD. (2007). Consensus document on safety information on transgenic plants expressing Bacillus thuringiensis-derived insect control proteins. In: Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology. Paris, France: OECD
   Google Scholar
• Pace CN, Fu H, Fryar KL, et al. (2011). Contribution of hydrophobic interactions to protein stability. J Mol Biol, 408, 514-28
   PubMed Web of Science ®Google Scholar
• Padgette SR, Re DB, Barry GF, et al. (1996). New weed control opportunities: development of soybeans with a Roundup Ready gene. In: Duke SO, ed. Herbicide-Resistant Crops. Boca Raton, FL: CRC Lewis Publishers, 53–84
   Google Scholar
• Pariza MW, Cook M. (2010). Determining the safety of enzymes used in animal feed. Regul Toxicol Pharmacol, 56, 332–42
   PubMedGoogle Scholar
• Pariza MW, Foster EM. (1983). Determining the safety of enzymes used in food processing. J Food Prot, 46, 453–68
   PubMed Web of Science ®Google Scholar
• Pariza MW, Johnson EA. (2001). Evaluating the safety of microbial enzyme preparations used in food processing: update for a new century. Regul Toxicol Pharmacol, 33, 173–86
   PubMed Web of Science ®Google Scholar
• Parrott W, Chassy B, Ligon J, et al. (2010). Application of food and feed safety assessment principles to evaluate transgenic approaches to gene modulation in crops. Food Chem Toxicol, 48, 1773–90
   PubMed Web of Science ®Google Scholar
• Pearce RJ. (1989). Thermal denaturation of whey protein. Bull Int Dairy Fed, 238, 17–23
   Google Scholar
• Privalle L, Bannon G, Herman R, et al. (2011). Heat stability and its utility in the assessment of the potential allergenicity of novel proteins. Reg Toxicol Pharmacol, 61, 292–5
   PubMed Web of Science ®Google Scholar
• Punta M, Coggill PC, Eberhardt RY, et al. (2012). The Pfam protein families database. Nucleic Acid Res, 40, D290–301
   Google Scholar
• Pusztai A, Bardocz S. (1995). Lectins: biomedical perspectives. London: Taylor and Francis
   Google Scholar
• Pyler EJ, Gorton LA. (2009). Baking science & technology Vol. II: formulation and production, 4th edn. Kansas City, MO: Sosland Publishing Co
   Google Scholar
• Rackis JJ. (1974). Biological and physiological factors in soybeans. J Am Oil Chem Soc, 51, 161A–74A
   PubMed Web of Science ®Google Scholar
• Randhawa GJ, Singh M, Grover M. (2011). Bioinformatic analysis for allergenicity assessment of Bacillus thuringiensis Cry proteins expressed in insect-resistant food crops. Food Chem Toxicol, 49, 356–62
   PubMed Web of Science ®Google Scholar
• Rappuoli R, Montecucco C. (1997). Guidebook to protein toxins and their use in cell biology. New York, NY: Sambrook and Tooze Publications at Oxford University Press
   Google Scholar
• Rehm T, Huber R, Holak TA. (2002). Application of NMR in structural proteomics: screening for proteins amenable to structural analysis. Structure, 10, 1613–18
   PubMedGoogle Scholar
• Rooney LW, Serna-Saldivar SO. (2003). Food use of whole corn and dry-milled fractions. In: White PJ, Johnson LA, eds. Corn chemistry and technology, 2nd ed. St. Paul, MN: American Association of Cereal Chemists, Inc., 495–535
   Google Scholar
• Rose GD, Creamer TP. (1994). Protein folding: predicting predicting. Proteins, 19, 1–3
   PubMedGoogle Scholar
• Sacchi VF, Parenti P, Hanozet GM, et al. (1986). Bacillus thuringiensis toxin inhibits K+-gradient-dependent amino acid transport across the brush border membrane of Pieris brassicae midgut cells. FEBS Lett, 204, 213–18
   Google Scholar
• Scheideler SE, Rice D, Smith B, et al. (2008). Evaluation of nutritional equivalency of corn grain from DAS-Ø15Ø7–1 (Herculex I) in the diets of laying hens. J Appl Poult Res, 17, 383–9
   Google Scholar
• Schultz RM, Liebman MN. (2002). Proteins I: composition and structure. In: Devlin TM, ed. Textbook of biochemistry with clinical correlations, 5th ed. New York, NY: Wiley-Liss, 93–157
   Google Scholar
• Seed J, Brown RP, Olin SS, Foran JA. (1995). Chemical mixtures: current risk assessment methodologies and future directions. Regul Toxicol Pharmacol, 22, 76–94
   PubMed Web of Science ®Google Scholar
• Séralini GE, Mesnage R, Clair E, et al. (2011). Genetically modified crops safety assessments: present limits and possible improvements. Environ Sci Europe, 23, 1–10
   Google Scholar
• Shah RB, Ahsan F, Khan MA. (2002). Oral delivery of proteins: progress and prognostication. Crit Rev Ther Drug Carrier Syst, 19, 135–69
   PubMed Web of Science ®Google Scholar
• Siegel JP. (2001). The mammalian safety of Bacillus thuringiensis-based insecticides. J Invertebr Pathol, 77, 13–21
   PubMed Web of Science ®Google Scholar
• Sjoblad RD, McClintock JT, Engler R. (1992). Toxicological considerations for protein components of biological pesticide products. Regul Toxicol Pharmacol, 15, 3–9
   Web of Science ®Google Scholar
• Stagg NJ, Thomas J, Herman RA, Juberg DR. (2012). Acute and 28-day repeated dose toxicology studies in mice with aryloxyalkanoate dioxygenase (AAD-1) protein expressed in 2,4-D tolerant DAS-40278-9 maize. Regul Toxicol Pharmacol, 62, 363–70
   PubMed Web of Science ®Google Scholar
• Stagg NJ, Ghantous HN, Ladics GS, et al. (2013). Workshop proceedings: challenges and opportunities in evaluating protein allergenicity across biotechnology industries. Int J Toxicol, 32, 4–10
   PubMedGoogle Scholar
• Steiner HY, Halpin C, Jez JM, et al. (2013). Editor's choice: evaluating the potential for adverse interactions within genetically engineered breeding stacks. Plant Physiol, 161, 1587–94
   PubMed Web of Science ®Google Scholar
• Taylor ML, Hartnell G, Nemeth M, et al. (2005). Comparison of broiler performance when fed diets containing corn grain with insect-protected (corn rootworm and European corn borer) and herbicide-tolerant (glyphosate) traits, control corn, or commercial reference corn—revisited. Poult Sci, 84, 1893–9
   PubMed Web of Science ®Google Scholar
• Taylor M, Hartnell G, Nemeth M, et al. (2007). Comparison of broiler performance when fed diets containing grain from second-generation insect-protected and glyphosate-tolerant, conventional control or commercial reference corn. Poult Sci, 86, 1972–9
   PubMed Web of Science ®Google Scholar
• Taylor SL, Moneret-Vautrin DA, Crevel RWR, et al. (2010). Threshold dose for peanut: risk characterization based upon diagnostic oral challenge of a series of 286 peanut-allergic individuals. Food Chem Toxicol, 48, 814–19
   PubMed Web of Science ®Google Scholar
• Terry CF, Harris N, Parkes HC. (2002). Detection of genetically modified crops and their derivatives: critical steps in sample preparation and extraction. J AOAC Int, 85, 768–74
   PubMed Web of Science ®Google Scholar
• Thomas K, Herouet-Guicheney C, Ladic G, et al. (2007). Evaluating the effect of food processing on the potential human allergenicity of novel proteins: international workshop report. Food Chem Toxicol, 45, 1116–22
   PubMed Web of Science ®Google Scholar
• Thomas K, MacIntosh S, Bannon G, et al. (2009). Scientific advancement of novel protein allergenicity evaluation: an overview of work from the HESI Protein Allergenicity Technical Committee (2000–2008). Food Chem Toxicol, 47, 1041–50
   PubMed Web of Science ®Google Scholar
• Thornton JM, Orengo CA, Todd AE, Pearl FMG. (1999). Protein folds, functions and evolution. J Mol Biol, 293, 333–42
   PubMedGoogle Scholar
• United States Environmental Protection Agency (US EPA). (2000). Mammalian toxicity assessment guidelines for protein plant pesticides. Meeting report. In: SAP Report No. 2000-03B. Arlington, VA: Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP)
   Google Scholar
• US EPA. (2009). Position Paper on Scientific Issues Associated with the Data Required to Register Plant-Incorporated Protectants. Washington, DC: US EPA Office of Prevention, Pesticides, and Toxic Substances, Office of Pesticide Programs, Biopesticides and Pollution Prevention
   Google Scholar
• US EPA. (2010). Biopesticides Registration Action Document: Modified Cry3A Protein and the Genetic Material Necessary for its Production (Via Elements of pZM26) in Event MIR604 Corn SYN-IR604–8. Washington, DC: US EPA
   Google Scholar
• US FDA. (1992). Statement of Policy: Foods Derived From New Plant Varieties. Food for human consumption and animal drugs, feeds, and related products: Foods derived from new plant varieties; policy statement, 22984. Vol. 57, No. 104, Friday, May 29, 1992, p. 22984, Department of Health and Human Services, Food and Drug Administration [Docket No. 92N-0139]. Available from: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Biotechnology/ucm096095.htm [last accessed 13 Mar 2013]
   Google Scholar
• van Boekel M, Fogliano V, Pellegrini N, et al. (2010). A review on the beneficial aspects of food processing. Mol Nutr Food Res, 54, 1215–47
   PubMed Web of Science ®Google Scholar
• Van Rie J, Jansens S, Höfte H, et al. (1989). Specificity of Bacillus thuringiensis delta-endotoxins: importance of specific receptors on the brush border membrane of the mid-gut of target insects. Eur J Biochem, 186, 239–47
   PubMedGoogle Scholar
• Van Rie J, Jansens S, Höfte H, et al. (1990). Receptors on the brush border membrane of the insect midgut as determinants of the specificity of Bacillus thuringiensis delta-endotoxins. Appl Environ Microbiol, 56, 1378–85
   PubMed Web of Science ®Google Scholar
• Vazquez-Padron RI, Moreno-Fierros L, Neri-Bazan L, et al. (2000). Characterization of the mucosal and systemic immune response induced by Cry1Ac protein from Bacillus thuringiensis HD 73 in mice. Braz J Med Biol Res, 33, 147–55
   PubMed Web of Science ®Google Scholar
• Venktesh A, Prakash V. (1993). Functional properties of the total proteins of sunflower (Helianthus annuus) seed—effect of physical and chemical treatments. J Agric Food Chem, 41, 18–23
   Web of Science ®Google Scholar
• Weber N, Halpin C, Hannah LC, et al. (2012). Crop genome plasticity and its relevance to food and feed safety of genetically engineered breeding stacks. Plant Physiol, 160, 1842–53
   PubMed Web of Science ®Google Scholar
• Webster’s New Collegiate Dictionary. (1973). Springfield, MA: Merriam Co
   Google Scholar
• World Health Organization (WHO) GEMS. (2006). Food contamination monitoring and assessment programme. Geneva, Switzerland: WHO. Available from: http://www.who.int/foodsafety/chem/gems/en/index1.html [last accessed 13 Mar 2013]
   Google Scholar