Comparison of grain from corn rootworm resistant transgenic DAS-59122-7 maize with non-transgenic maize grain in a 90-day feeding study in Sprague-Dawley rats

Food and Chemical Toxicology

Volumn 46, Issue 6, 2008, Pages 1994-2002

  He, X Y ^a   Huang, K L ^a,b   Li, X ^a   Qin, W ^a   Delaney, B ^c   Luo, Y B ^a,b  

^a CHINA AGRICULTURAL UNIVERSITY   (China)

^b AGRO ENVIRONMENTAL PROTECTION INSTITUTE   (China)

^c PIONEER HI BRED INTERNATIONAL INC   (United States)

Author keywords

Bt protein; Feeding study; Subchronic; Transgenic corn

Indexed keywords

BACTERIAL PROTEIN; PHOSPHINOTHRICIN ACETYLTRANSFERASE;

ANIMAL EXPERIMENT; ARTICLE; CHRONIC TOXICITY; CONTROLLED STUDY; DIET; FEEDING BEHAVIOR; FEMALE; FLOUR; FOOD INTAKE; GRAIN; HERBICIDAL ACTIVITY; MAIZE; MALE; NONHUMAN; PLANT ROOT; PROTEIN EXPRESSION; RAT; SPRAGUE DAWLEY RAT;

ACETYLTRANSFERASES; ANIMALS; BACILLUS THURINGIENSIS; BLOOD CELL COUNT; BLOOD CHEMICAL ANALYSIS; BODY WEIGHT; EATING; FEMALE; INSECTS; MALE; ORGAN SIZE; PEST CONTROL, BIOLOGICAL; PLANTS, GENETICALLY MODIFIED; RATS; RATS, SPRAGUE-DAWLEY; SEX CHARACTERISTICS; WEIGHT GAIN; ZEA MAYS;

BACILLUS THURINGIENSIS SEROVAR BERLINER; COLEOPTERA; RATTUS; STREPTOMYCES VIRIDOCHROMOGENES; ZEA MAYS;

EID: 42749097659     PISSN: 02786915     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.fct.2008.01.039     Document Type: Article

References (41)

1. Betz F.S., Hammond B.G., and Fuchs R.L. Safety and advantages of Bacillus thuringiensis - protected plants to control insect pests. Regul. Toxicol. Pharmacol. 32 (2000) 156-173
2. Chinese standard GB15193.13-2003. Toxicology Assessment Procedure and Method for Food Safety.
3. Chinese standard GB/T5009.3-2003. Inspection of Grain and Oilseeds: Methods for Determination of Moisture.
4. Chinese standard GB/T5009.4-2003. Inspection of Grain and Oilseeds: Methods for Determination of Ash.
5. Chinese standard GB/T5009.5-2003. Inspection of Grain and Oilseeds: Methods for Determination of Crude Protein.
6. Chinese standard GB/T5009.6-2003. Inspection of Grain and Oilseeds: Methods for Determination of Crude Fat.
7. Chinese standard GB/T5009.10-2003. Inspection of Grain and Oilseeds: Methods for Determination of Crude Fiber.
8. 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. .
9. Delaney B. Strategies to evaluate the safety of bioengineered foods. Int. J. Toxicol. 26 (2007) 389-399
10. Ellis R.T., Stockhoff B.A., Stamp L., Schnepf H.E., Schwab G.E., Knuth M., Russell J., Cardineau G.A., and Narva K.E. New Bacillus thuringiensis binary insecticidal proteins active on western corn rootworms, Diabrotica virgifera virgifera LeConte. Appl. Environ. Microbiol. 68 (2002) 1137-1145
11. EPA, 1998. EPA Registration eligibility decision (RED) Bacillus thuringiensis. US Environmental Protection Agency. 738-R-98-004.
12. FAO, 1996. Biotechnology and food safety. Report of a joint FAO/WHO consultation. FAO Food and Nutrition Paper 61, Food and Agriculture Organization of the United Nations, Rome, Italy.
13. FAO/WHO, 2000. Safety aspects of genetically modified foods of plant origin. Report of a Joint FAO/WHO Expert Consultation on Foods Derived from Biotechnology. Geneva, Switzerland, 29 May-2 June 2000. FAO Food and Nutrition Paper, 29, Food and Agriculture Organization of the United Nations, Rome, Italy.
14. Hammond B., Dudek R., Lemen J., and Nemeth M. Results of 13 week safety assurance study with rats fed grain from glyphosate tolerant corn. Food Chem. Toxicol. 42 (2004) 1003-1014
15. Hammond B.G., Dudek R., Lemen J.K., and Nemeth M.A. Results of 90 day safety assurance study with rats fed grain from corn borer-protected corn. Food Chem. Toxicol. 44 (2006) 1092-1099
16. Hammond B., Lemen J., Dudek R., Ward D., Jiang C., Nemeth M., and Burns J. Results of 90-day safety assurance study with rats fed grain from corn rootworm-protected corn. Food Chem. Toxicol. 44 (2006) 147-160
17. Herman R.A., Schafer B.W., Korjagin V.A., and Ernest A.D. Rapid digestion of Cry34Ab1 and Cry35Ab1 in simulated gastric fluid. J. Agr. Food Chem. 51 (2003) 6823-6827
18. Herman R.A., Storer N.P., Phillips A.M., Prochaska L.M., and Windels P. Compositional assessment of event DAS-59122-7 maize using substantial equivalence. Regul. Pharmacol. Toxicol. 47 (2007) 37-47
19. Herouet C., Esdaile D.J., Mallyon B.A., Debruyne E., Schulz A., Currier T., Hendrickx K., van der Klis R.J., and Rouan D. 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 (2005) 134-149
20. ILSI (International Life Sciences Institute), 1996. The Safety Assessment of Novel Foods: Guidelines Prepared by ILSI Europe Novel Food and Task Force. International Life Sciences Institute, European Branch, Brussels, Belgium.
21. ILSI (International Life Sciences Institute), 2006. International Life Sciences Institute Crop Composition Database. International Life Sciences Institute, Washington DC. .
22. Li Y.H., Piao J.H., Zhuo Q., Chen X.P., Chen X.B., and Yang X.G. Subchronic toxicity test of transgenic rice. J. Hyg. Res. 33 5 (2004) 575-578 (in Chinese)
23. MacKenzie S.A., Lamb I., Schmidt J., Deege L., Morrisey M.J., Harper M., Layton R.J., Prochaska L.M., Sanders C., Locke M., Mattsson J.L., Fuentes A., and Delaney B. Thirteen week feeding study with transgenic maize grain containing event DAS-Ø15Ø7-1 in Sprague-Dawley rats. Food Chem. Toxicol 45 (2007) 551-562
24. Malley L.A., Everds N.E., Reynolds J., Mann P.C., Lamb I., Rood T., Schmidt J., Layton R.J., Prochaska L.M., Hinds M., Locke M., Chui C.-F., Claussen F., Mattsson J.L., and Delaney B. Subchronic feeding study of DAS-59122-7 maize grain in Sprague-Dawley rats. Food Chem. Toxicol. 45 (2007) 1277-1292
25. McClintock J.T., Schaffer C.R., and Sjoblad R.D. A comparative review of the mammalian toxicity of Bacillus thuringesis-based pesticides. Pestic. Sci. 45 (1995) 95-105
26. McNaughton J.L., Roberts M., Rice D., Smith B., Hinds M., Schmidt J., Locke M., Bryant A., Rood T., Layton R., Lamb I., and Delaney B. 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 (2007) 227-239
27. Moellenbeck D.J., Peters M.L., Bing J.W., Rouse J.R., Higgins L.S., Sims L., Nevshemal T., Marshall L., Ellis R.T., Bystrak P.G., Lang B.A., Stewart J.L., Kouba K., Sondag V., Gustafson V., Nour K., Xu D., Swenson J., Zhang J., Czapla T., Schwab G., Jayne S., Stockhoff B.A., Narva K., Schnepf H.E., Stelman S.J., Poutre C., Koziel M., and Duck N. Insecticidal proteins from Bacillus thuringiensis protected corn from corn rootworms. Nat. Biotechnol. 19 (2001) 668-672
28. Munkvold G.P., Hellmich R.L., and Showers W.B. Reduced Fusarium ear rot and symptomless infection in kernels of maize genetically engineered for European corn borer resistance. Phytopathology 87 (1997) 1071-1077
29. Munkvold G.P., Hellmich R.L., and Rice L.R. Comparison of fumonisin concentrations in kernels of transgenic Bt maize hybrids and nontransgenic hybrids. Plant Dis. 83 (1999) 130-138
30. Noteborn H.P.J.M., Bienemann-Ploum M.E., van den Berg J.H.J., Alink G.M., Zolla L., Reynaerts A., Pensa M., and Kuiper H.A. Safety assessment of the Bacillus thuringiensis insecticidal crystal protein CRY1Ab expressed in transgenic tomatoes. In: Engel K.-H., Takeoka G.R., and Teranishi R. (Eds). Genetically Modified Foods-Safety Aspects. ACS Symposium Series vol. 605 (1995), American Chemical Society, Washington, DC 134-147
31. OECD, 1993. Safety Evaluation of Foods Produced by Modern Biotechnology: Concepts and Principles. Organization for Economic Co-operation and Development, Paris, France.
32. OECD, 1996. Food Safety Evaluation. Organization for Economic Co-operation and Development (OECD), Paris, France.
33. OECD, 1997. Report of the OECD Workshop on the Toxicological and Nutritional Testing of Novel Foods. Aussois, France, 5-8 March 1997. Organization for Economic Co-operation and Development (OECD), Paris, France.
34. OECD, 1998. OECD Guidelines for Testing of Chemicals No. 408. Repeated Dose 90-Day Oral Toxicity Study in Rodents. Organization for Economic Co-operation and Development (OECD), Paris, France.
35. OECD, 2002. Consensus Document on the Compositional Considerations for New Varieties of Maize (Zea mays): Key Food and Feed Nutrients, Antinutrients, and Secondary Plant Metabolites. Organization for Economic Co-operation and Development, Paris, France. ENV/JM/MONO(2002)25.
36. Reeves P.G., Nielsen F.H., and Fahey G.C. AIN-93 Purified diets for laboratory rodents: final report of the American Institute of Nutrition Ad Hoc Writing Committee on the reformulation of the AIN-76A rodent diet. J. Nutr. 123 (1993) 1939-1951
37. Taylor M.L., Hyun Y., Hartnell G.F., Riordan S.G., Nemeth M.A., Karunanandaa K., George B.B., and Astwood J.D. Comparison of broiler performance when fed diets containing grain from YieldGard Rootworm (MON863), YieldGard Plus (MON810 x MON863), non-transgenic control, or commercial reference corn hybrids. Poultry Sci 82 (2003) 1948-1956
38. Wang Z.H., Wang Y., Cui H.R., Xia Y.W., Altosaar I., and Shu Q.Y. Toxicological evaluation of transgenic rice flour with a synthetic cry1Ab gene from Bacillus thuringiensis. J. Sci. Food Agr. 82 (2002) 738-744
39. WHO, 1991. Strategies for assessing the safety of foods produced by biotechnology. Report of a Joint FAO/WHO Consultation. World Health Organization, Geneva, Switzerland.
40. WHO, 1995. Application of the principles of substantial equivalence to the safety evaluation of foods and food components from plants derived from modern biotechnology. Report of a WHO Workshop. World Health Organization, Geneva, Switzerland. WHO/FNU/FOS/95.1.
41. Zhuo Q., Chen X.P., Piao J.H., Gu L.Zh., Li N., and Yang X.G. Study on food safety of genetically modified rice which expressed cowpea trypsin inhibitor by 90 day feeding test on rats. J. Hyg. Res. 33 (2004) 176-179 (in Chinese)