Results of a 90-day safety assurance study with rats fed grain from corn borer-protected corn

Food and Chemical Toxicology

Volumn 44, Issue 7, 2006, Pages 1092-1099

  Hammond, B G ^a   Dudek, R ^a   Lemen, J K ^a   Nemeth, M A ^a  

^a MONSANTO COMPANY   (United States)

Author keywords

Corn borer protected; Corn: genetically modified; MON 810; Rat feeding study

Indexed keywords

CRY1AB PROTEIN; PROTEIN; UNCLASSIFIED DRUG;

AGRONOMIC TRAIT; ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; BLOOD CHEMISTRY; BODY WEIGHT; CONTROLLED STUDY; CORN; DIET; DNA MODIFICATION; EUROPEAN CORN BORER; FEEDING; FEMALE; FOOD INTAKE; GENOME; GRAIN; MALE; MICROSCOPY; NONHUMAN; NUTRITIONAL ASSESSMENT; ORGAN WEIGHT; PATHOLOGY; RAT; RISK ASSESSMENT; URINALYSIS;

ANIMALS; BLOOD CELL COUNT; BLOOD CHEMICAL ANALYSIS; BODY WEIGHT; DIET; EATING; FEMALE; INSECT CONTROL; MALE; ORGAN SIZE; PLANTS, GENETICALLY MODIFIED; RATS; SEX CHARACTERISTICS; ZEA MAYS;

ANIMALIA; HEXAPODA; RODENTIA; ZEA MAYS;

EID: 33744903623     PISSN: 02786915     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.fct.2006.01.003     Document Type: Article

References (35)

1. Bakan B., Melcion D., Richard-Molard D., and Cahagnier B. Fungal growth and fusarium mycotoxin content in isogenic traditional maize and genetically modified maize grown in France and Spain. Journal of Agricultural and Food Chemistry 50 (2002) 728-731
2. Betz F.S., Hammond B.G., and Fuchs R.L. Safety and advantages of Bacillus thuringiensis-protected plants to control insect pests. Regulatory Toxicology and Pharmacology 32 (2000) 156-173
3. Borzelleca J.F. A proposed model for safety assessment of macronutrient substitutes. Regulatory Toxicology and Pharmacology 23 (1996) S15-S18
4. CAST, 2003. Council for Agricultural Science and Technology. Mycotoxins. Risks in Plant, Animal, and Human Systems. Council for Agricultural Science and Technology. Task Force Report No. 139, Ames, Iowa, pp. 54-56.
5. Codex, 2003. Joint FAO/WHO Food Standards Programme. Codex Alimentarius Commission. Report of the Fourth Session of the Codex Ad Hoc Intergovernmental Task Force on Foods Derived from Biotechnology. Alinorm 03/34A. Available from: .
6. TM, 2002. Acute version 7.77. Exponent, Inc., Washington, DC, USA.
7. Donkin S.S., Velez J.C., Totten A.K., Stanisiewski E.P., and Hartnell G.F. Effects of feeding silage and grain from glyphosate-tolerant or insect-protected corn hybrids on feed intake, ruminal digestion, and milk composition in dairy cattle. Journal of Dairy Science 86 (2003) 1780-1788
8. Dybing E., Doe J., Groten J., Kleiner J., O'Brien J., Renwick A.G., Schlatter J., Steinberg P., Tritscher A., Walker R., and Younes M. Hazard characterization of chemicals in food and diet: dose response, mechanisms and extrapolation issues. Food and Chemical Toxicology 40 2/3 (2002) 237-282
9. EFSA, 2004a. Guidance document of the scientific panel on genetically modified organisms for the risk assessment of genetically modified plants and derived food and feed. 8 November 2004, Available from: .
10. EFSA, 2004b. The European Food Safety Authority. EFSA Journal 49, 1-24. Available from: .
11. EPA, 1996. Bacillus thuringiensis Cry1A(b) delta-endotoxin and the genetic material necessary for its production in all plants. Exemption from requirement of a tolerance. Federal Register 61, 40340-40343.
12. EPA, 1998. EPA Registration Eligibility Decision (RED) Bacillus thuringiensis. EPA 738-R-98-004, March.
13. FAO, 1996. Biotechnology and food safety. Report of a Joint FAO/WHO Consultation, Rome, Italy, 30 September-4 October, 1996. FAO Food and Nutrition Paper 61.
14. Federici B.A. Case study: Bt crops - a novel mode of insect control. In: Atherton K.T. (Ed). Genetically Modified Crops. Assessing Safety vol. 22 (2002), Taylor and Francis, New York 164-200
15. Hammond B., Stanisiewski E., Fuchs R., Astwood J., and Hartnell G. Safety assessment of insect protected crops: testing the feeding value of Bt corn and cotton varieties in poultry, swine and cattle. In: Jackson J.F., Linskens H.F., and Inman R.B. (Eds). Testing for Genetic Manipulation in Plants. Molecular Methods of Plant Analysis vol. 22 (2002), Springer-Verlag, New York 119-137
16. Hammond B.G., Campbell K., Pilcher C., DeGooyer T., Robinson A., McMillen B., Spangler S., Riordan S., Rice L., and Richard J. Lower fumonisin mycotoxin levels in the grain of Bt corn grown in the United States in 2000-2002. Journal of Agricultural and Food Chemistry 52 5 (2004) 1390-1397
17. Hammond B., Dudek R., Lemen J., and Nemeth M. Results of a 13 week safety assurance study with rats fed grain from glyphosate tolerant corn. Food and Chemical Toxicology 42 (2004) 1003-1014
18. Hofte H., and Whitely H.R. Insecticidal crystal proteins in Bacillus thuringiensis. Microbiology Reviews 53 (1989) 242-255
19. James, C., 2003. Global Review of Commercialized Transgenic Crops: 2002. Feature: Bt Maize The International Service for the Acquisition of Agri-biotech Applications (ISAAA). No. 29.
20. Leath M.N. Economics of production, marketing, and utilization. In: White P.J., and Johnson L.A. (Eds). Corn. Chemistry and Technology (2003), American Association of Cereal Chemists, Inc. 241-286
21. Marasas W.F., Riley R.T., Hendricks K.A., Stevens V.L., Sadler T.W., Gelineau-van Waes J., Missmer S.A., Cabrera J., Torres O., Gelderblom W.C., Allegood J., Martinez C., Maddox J., Miller J.D., Starr L., Sullards M.C., Roman A.V., Voss K.A., Wang E., and Merrill Jr. A.H. Fumonisins disrupt sphingolipid metabolism, folate transport, and neural tube development in embryo culture and in vivo: a potential risk factor for human neural tube defects among populations consuming fumonisin-contaminated maize. Journal of Nutrition 134 (2004) 711-716
22. McClintock J.T., Schaffer C.R., and Sjoblad R.D. A comparative review of the mammalian toxicity of Bacillus thuringiensis-based pesticides. Pesticide Science 45 (1995) 95-105
23. Miller J.D. Factors that affect the occurrence of fumonisin. Environmental Health Perspectives 109 2 (2001) 321-324
24. Munkvold G.P., Hellmich R.L., and Rice L.P. Comparison of fumonisin concentrations in kernels of transgenic Bt maize hybrids and nontransgenic hybrids. Plant Disease 83 (1999) 130-138
25. OECD, 1993. Safety Evaluation of Foods Derived by Modern Biotechnology: Concepts and Principles. Organization for Economic Co-operation and Development (OECD), Paris.
26. OECD, 1997. Report of the Workshop on the Toxicological and Nutritional Testing of Novel Foods. Organization for Economic Co-operation and Development (OECD) SG/ICGB(98)1.
27. Pariza M.W., and Johnson E.A. Evaluating the safety of microbial enzyme preparations used in food processing: update for a new century. Regulatory Toxicology and Pharmacology 33 2 (2001) 173-186
28. Sanders P.R., Lee T.C., Groth M.E., Astwood J.D., and Fuchs R.L. Safety assessment of insect-protected corn. In: Thomas J.A. (Ed). Biotechnology and Safety Assessment (1998), Taylor and Francis 241-246
29. Siegel J.P. The mammalian safety of Bacillus thuringiensis-based insecticides. Journal of Invertebrate Pathology 77 (2001) 13-21
30. Sjoblad R.D., McClintock J.T., and Engler R. Toxicological considerations for protein components of biological pesticide products. Regulatory Toxicology and Pharmacology 15 (1992) 3-9
31. Taylor M.L., Hartnell G.F., Riordan S.G., Nemeth M.A., Karunanandaa K., George B., and Astwood J.D. Comparison of broiler performance when fed diets containing grain from YieldGard (MON 810), YieldGard × Roundup Ready (GA21), non-transgenic control, or commercial corn. Poultry Science 82 (2003) 823-830
32. Weber, T.E., Richert, B.T., Kendall, D.C., Bowers, K.A., Herr, C.T., 2000. Grower-finisher performance and carcass characteristics of pgs fed genetically modified "Bt" corn. Purdue University 2000 Swine Day Report. Available from: .
33. WHO, 1991. Strategies for assessing the safety of foods produced by biotechnology. Report of a Joint FAO/WHO Consultation. World Health Organization, Geneva.
34. WHO, 1995. Application of the principles of substantial equivalence to the safety evaluation of foods or food components from plants derived by modern biotechnology. Report of a WHO Workshop. World Health Organization, Geneva, WHO/FNU/FOS/95.1.
35. WHO, IPCS, 1999. International Programme on Chemical Safety - Environmental Health Criteria 217: Bacillus thuringiensis, Geneva, Switzerland.