[*] Calgene had submitted data on two lines of GM tomatoes, both using the same inserted gene. They voluntarily elected to market only the variety that was not associated with the lesions. This was not required by the FDA, which did not block approvals on the lesion-associated variety. The FlavrSavr tomato has since been taken off the market. After the FlavrSavr, no other biotech company has submitted such detailed data to the FDA. And the superficial summaries they do present to the agency are dismissed by critics as woefully inadequate to judge safety.

[1] Edwin J. Mathews, Ph.D., in a memorandum to the Toxicology Section of the Biotechnology Working Group. Subject: "Analysis of the Major Plant Toxicants." Dated October 28, 1991
[2] Division of Food Chemistry and Technology and Division of Contaminants Chemistry, "Points to Consider for Safety Evaluation of Genetically Modified Foods: Supplemental Information," November 1, 1991, www.biointegrity.org 
[3] Jeffrey M. Smith, Genetic Roulette: The Documented Health Risks of Genetically Engineered Foods, Yes! Books, Fairfield, IA USA 2007
[4] Department of Veterinary Medicine, FDA, correspondence June 16, 1993. As quoted in Fred A. Hines, Memo to Dr. Linda Kahl. "Flavr Savr Tomato: . . . Pathology Branch's Evaluation of Rats with Stomach Lesions From Three Four-Week Oral (Gavage) Toxicity Studies . . . and an Expert Panel's Report," Alliance for Bio-Integrity (June 16, 1993) http://www.biointegrity.org/FDAdocs/17/view1.html
[5] Robert J. Scheuplein, Memo to the FDA Biotechnology Coordinator and others, "Response to Calgene Amended Petition," Alliance for Bio-Integrity (October 27, 1993) www.biointegrity.org
[6] Carl B. Johnson to Linda Kahl and others, "'Flavr Savr' Tomato: Significance of Pending DHEE Question," Alliance for Bio-Integrity (December 7, 1993) www.biointegrity.org
[7] Arpad Pusztai, "Genetically Modified Foods: Are They a Risk to Human/Animal Health?" June 2001 Action Bioscience www.actionbioscience.org/biotech/pusztai.html
[8] Nagui H. Fares, Adel K. El-Sayed, "Fine Structural Changes in the Ileum of Mice Fed on Endotoxin Treated Potatoes and Transgenic Potatoes," Natural Toxins 6, no. 6 (1998): 219?233.
[9] Stanley W. B. Ewen and Arpad Pusztai, "Effect of diets containing genetically modified potatoes expressing Galanthus nivalis lectin on rat small intestine," Lancet, 1999 Oct 16; 354 (9187): 1353-4.
[10] Arpad Pusztai, "Facts Behind the GM Pea Controversy: Epigenetics, Transgenic Plants & Risk Assessment," Proceedings of the Conference, December 1st 2005 (Frankfurtam Main, Germany: Literaturhaus, 2005).
[11] Arpad Pusztai, "Can science give us the tools for recognizing possible health risks of GM food," Nutrition and Health, 2002, Vol 16 Pp 73-84.
[12] John M. Burns, "13-Week Dietary Subchronic Comparison Study with MON 863 Corn in Rats Preceded by a 1-Week Baseline Food Consumption Determination with PMI Certified Rodent Diet #5002," December 17, 2002 www.monsanto.com/monsanto/content/sci_tech/prod_safety/fullratstudy.pdf
[13] R. Tudisco, P. Lombardi, F. Bovera, D. d?Angelo, M. I. Cutrignelli, V. Mastellone, V. Terzi, L. Avallone, F. Infascelli, "Genetically Modified Soya Bean in Rabbit Feeding: Detection of DNA Fragments and Evaluation of Metabolic Effects by Enzymatic Analysis," Animal Science 82 (2006): 193-199.
[14] Comments to ANZFA about Applications A346, A362 and A363 from the Food Legislation and Regulation Advisory Group (FLRAG) of the Public Health Association of Australia (PHAA) on behalf of the PHAA, "Food produced from glyphosate-tolerant canola line GT73," www.iher.org.au/
[15] M. Malatesta, C. Caporaloni, S. Gavaudan, M. B. Rocchi, S. Serafini, C. Tiberi, G. Gazzanelli, "Ultrastructural Morphometrical and Immunocytochemical Analyses of Hepatocyte Nuclei from Mice Fed on Genetically Modified Soybean," Cell Struct Funct. 27 (2002): 173-180
[16] Jeffrey M. Smith, Genetic Roulette: The Documented Health Risks of Genetically Engineered Foods, Yes! Books, Fairfield, IA USA 2007
[17] Arpad Pusztai, "Can Science Give Us the Tools for Recognizing Possible Health Risks for GM Food?" Nutrition and Health 16 (2002): 73?84.
[18] S. Leeson, "The Effect of Glufosinate Resistant Corn on Growth of Male Broiler Chickens," Department of Animal and Poultry Sciences, University of Guelph, Report No. A56379, July 12, 1996.
[19] Malatesta, et al, "Ultrastructural Analysis of Pancreatic Acinar Cells from Mice Fed on Genetically modified Soybean," J Anat. 2002 November; 201(5): 409?415; see also M. Malatesta, M. Biggiogera, E. Manuali, M. B. L. Rocchi, B. Baldelli, G. Gazzanelli, ?Fine Structural Analyses of Pancreatic Acinar Cell Nuclei from Mice Fed on GM Soybean,? Eur J Histochem 47 (2003): 385?388.
[20] Arpad Pusztai, "Can science give us the tools for recognizing possible health risks of GM food," Nutrition and Health, 2002, Vol 16 Pp 73-84
[21] R. Tudisco, P. Lombardi, F. Bovera, D. d?Angelo, M. I. Cutrignelli, V. Mastellone, V. Terzi, L. Avallone, F. Infascelli, "Genetically Modified Soya Bean in Rabbit Feeding: Detection of DNA Fragments and Evaluation of Metabolic Effects by Enzymatic Analysis," Animal Science 82 (2006): 193-199.
[22] Arpad Pusztai, "Can science give us the tools for recognizing possible health risks of GM food," Nutrition and Health, 2002, Vol 16 Pp 73-84
[23] Irina Ermakova, "Experimental Evidence of GMO Hazards," Presentation at Scientists for a GM Free Europe, EU Parliament, Brussels, June 12, 2007
[24] L. Vecchio et al, "Ultrastructural Analysis of Testes from Mice Fed on Genetically Modified Soybean," European Journal of Histochemistry 48, no. 4 (Oct?Dec 2004):449?454.
[25] Oliveri et al., "Temporary Depression of Transcription in Mouse Pre-implantion Embryos from Mice Fed on Genetically Modified Soybean," 48th Symposium of the Society for Histochemistry, Lake Maggiore (Italy), September 7?10, 2006.
[26] I.V.Ermakova, "Genetically Modified Organisms and Biological Risks," Proceedings of International Disaster Reduction Conference (IDRC) Davos, Switzerland August 27th ? September 1st, 2006: 168?172.
[27] Irina Ermakova, "Genetically modified soy leads to the decrease of weight and high mortality of rat pups of the first generation. Preliminary studies," Ecosinform 1 (2006): 4-9.

[28] Irina Ermakova, "Experimental Evidence of GMO Hazards," Presentation at Scientists for a GM Free Europe, EU Parliament, Brussels, June 12, 2007
[29] I.V.Ermakova "GMO: Life itself intervened into the experiments" - Letter, EcosInform N2 (2006): 3-4.

[30] Jeffrey M. Smith, Genetic Roulette: The Documented Health Risks of Genetically Engineered Foods, Yes! Books, Fairfield, IA USA 2007
[31] "Mortality in Sheep Flocks after Grazing on Bt Cotton Fields-Warangal District, Andhra Pradesh" Report of the Preliminary Assessment, April 2006, http://www.gmwatch.org/archive2.asp