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How safe does transgenic food need to be?

An Erratum to this article was published on 01 December 2013

This article has been updated

Disputes over how to assess a foodstuff's safety continue to play into public fears about transgenic crops.

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Figure 1

Change history

  • 26 September 2013

    In the version of this article initially published, on page 795, reference was made to a paper that argues that 90-day feeding studies should only be done when deemed necessary, with the implication that EFSA had authored the paper. While EFSA does take that position, the paper was authored by scientists at the RIKILT Wageningen UR (H.A. Kuiper and E.J. Kok) and The James Hutton Institute (H.V. Davies). In addition, the EU project described by Esther Kok on page 796 was incorrectly identified as the GMSAFOOD Initiative. It should have read SafeFoods. The errors have been corrected in the PDF and HTML versions of this article.

  • 01 December 2013

    Nat. Biotechnol. 31, 794–802 (2013); doi:10.1038/nbt.2686; published online 10 September 2013; corrected after print 26 September 2013 In the version of this article initially published, on page 795, reference was made to a paper that argues that 90-day feeding studies should only be done when deemed necessary, with the implication that EFSA had authored the paper.


  1. European Commission. A Decade of EU-funded GMO Research 2001–2010 (EU, Luxemburg, 2010).

  2. Joint FAO/WHO Expert Consultation on Biotechnology and Food Safety. (FAO, Rome; 30 September to 4 October 1996).

  3. Marden, E. Risk and regulation: US regulatory policy on genetically modified food and agriculture. Boston Coll. Law Rev. 44, 733–787 (2003).

    Google Scholar 

  4. European Council adopted Directive 90/220/EEC Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms.

  5. Coordinated Framework for Regulation of Biotechnology 51 Fed. Reg. 23302, June 26, 1986.

  6. Food, F. Drug and Cosmetic Act, United States Code, 2006 Edition, Supplement 3

  7. Guidance to Industry for Foods Derived from New Plant Varieties, FDA Federal Register Volume 57 – 1992 Friday, May 29, 1992.

  8. EFSA GMO Working Panel. Safety and nutritional assessment of GM plants and derived foods: the role of animal feeding trials. Food Chem. Toxicol. 46, S2–S70 (2008).

  9. Kuiper, H.A., Kok, E.J. & Davies, H.V. New EU legislation for risk assessment of GM food: no scientific justification for mandatory animal feeding trial. Plant Biotechnol. J. doi:10.1111/pbl12091 (21 June 2013).

  10. Herman, R.A. & Price, W.D. Unintended compositional changes in genetically modified crops: 20 years of research. J. Agric. Food Chem. doi:10.1021/jf400135r (15 February 2013).

  11. Herman, R.A. et al. Value of eight amino acid matches in predicting allergenicity status of proteins: an empirical bioinformatic investigation. Clin. Mol. Allergy 7, 9 (2009).

    Article  Google Scholar 

  12. EFSA Panel on Genetically Modified Organisms (GMO). Scientific Opinion on Guidance for risk assessment of food and feed from genetically modified plants. EFSA Journal 2011; 9(5): 2150. [37 pp.]

  13. Joint FAO/WHO Expert Consultation on Allergenicity of Foods Derived from Biotechnology. Evaluation of Allergenicity of Genetically Modified Foods (FAO, Rome; 22–25 January 2001).

  14. Nordlee, J.A. et al. Identification of a Brazil nut allergen in transgenic soybeans. N. Engl. J. Med. 334, 688–692 (1996).

    Article  CAS  Google Scholar 

  15. Committee on Identifying and Assessing the Unintended Effects of Genetically Engineered Food on Human Health. Safety of Genetically Engineered Foods (The National Academies Press, Washington, DC, 2004).

  16. EFSA GMO Working Panel. Safety and nutritional assessment of GM plants and derived foods: the role of animal feeding trials. Food and Chemical Toxicology, 46, S2-70 (2008).

  17. Kuiper, H.A. et al. Assessment of food safety issues related to genetically modified foods. Plant J. 27, 503–528 (2001).

    Article  CAS  Google Scholar 

  18. Barros, E. et al. Comparison of two GM maize varieties with a near isogenic non-GM variety using transcriptomics, proteomics and metabolomics. Plant Biotechnol. J. 8, 436–451 (2012).

    Article  Google Scholar 

  19. Betton, G. et al. A critical review of the optimum duration of chronic rodent testing for the determination of non-tumourigenic toxic potential: a report by the BTS Working Party on Duration of Toxicity Testing. Hum. Exp. Toxicol. 13, 221–232 (1994).

    Article  CAS  Google Scholar 

  20. Seralini, G.E. et al. Long-term toxicity of a Roundup herbicide and a Roundup tolerant genetically modified maize. Food Chem. Toxicol. 50, 4221–4231 (2012).

    Article  CAS  Google Scholar 

  21. Snell, C. et al. Assessment of the health impact of GM plant diets in long-term and multigenerational animal feeding trials: a literature review. Food Chem. Toxicol. 50, 1134–1148 (2012).

    Article  CAS  Google Scholar 

  22. Domingo, J.L. & Bordonaba, J.G. A literature review on the safety assessment of genetically modified plants. Environ. Int. 37, 734–742 (2011).

    Article  Google Scholar 

  23. Brake, D.G. & Evenson, D.P. A generational study of glyphosate-tolerant soybeans on mouse fetal, postnatal, pubertal and adult testicular development. Food Chem. Toxicol. 42, 29–36 (2004).

    Article  CAS  Google Scholar 

  24. Brake, D.G., Thaler, R. & Evenson, D.P., Evaluation of Bt. (Bacillus thuringiensis) corn on mouse testicular development by dual parameter flow cytometry. J. Agric. Food Chem. 52, 2097–2102 (2004).

    Article  CAS  Google Scholar 

  25. Brasil, F.B. et al. The impact of dietary organic and transgenic soy on the reproductive system of female adult rat. Anat. Rec. 292, 587–594 (2009).

    Article  CAS  Google Scholar 

  26. Buzoianu, S.G. et al. Transgenerational effects of feeding genetically modified maize to nulliparous sows and offspring on offspring growth and health. J. Anim. Sci. 91, 318–330 (2013).

    Article  CAS  Google Scholar 

  27. Buzoianu, S.G. et al. Effects of feeding Bt maize to sows during gestation and lactation on maternal and offspring immunity and fate of transgenic material. PLoS ONE 7, e47851 (2012).

    Article  CAS  Google Scholar 

  28. Walsh, M.C. et al. Effects of feeding Bt MON810 maize to pigs for 110 days on peripheral immune response and digestive fate of the cry1Ab gene and truncated Bt Toxin. PLoS ONE 7, e36141 (2012).

    Article  CAS  Google Scholar 

  29. Walsh, M.C. et al. Effects of feeding Bt MON810 maize to sows during first gestation and lactation on maternal and offspring health indicators. Br. J. Nutr. 109, 873–881 (2013).

    Article  CAS  Google Scholar 

  30. Buzoianu, S.G. et al. Effect of feeding genetically modified Bt MON810 maize to 40-day-old pigs for 110 days on growth and health indicators. Animal 6, 1609–1619 (2012).

    Article  CAS  Google Scholar 

  31. Buzoianu, S.G. et al. The effect of feeding Bt MON810 maize to pigs for 110 days on intestinal microbiota. PLoS ONE 7 e33668 (2012).

    Article  CAS  Google Scholar 

  32. Daleprane, J.B., Feijó, T.S. & Boaventura, G.T. Organic and genetically modified soybean diets: consequences in growth and in hematological indicators of aged rats. Plant Foods Hum. Nutr. 64, 1–5 (2009).

    Article  CAS  Google Scholar 

  33. Daleprane, J.B., Pacheco, J.T. & Boaventura, G.T. Evaluation of protein quality from genetically modified and organic soybean in two consecutives generations of Wistar rats. Braz. Arch. Biol. Technol. 52, 841–847 (2009).

    Article  CAS  Google Scholar 

  34. Daleprane, J.B., Chagas, M.A., Vellarde, G.C., Ramos, C.F. & Boaventura, G.T. The impact of non- and genetically modified soybean diets in aorta wall remodeling. J. Food Sci. 75, 126–131 (2010).

    Article  Google Scholar 

  35. Haryu, Y. et al. Longterm biosafety assessment of a genetically modified (GM) plant: the genetically modified (GM) insect-resistant Bt11 corn does not affect the performance of multi-generations or life span of mice. Open Plant Sci. J. 3, 49–53 (2009).

    Article  CAS  Google Scholar 

  36. Kilic, A. & Akay, M.T. A three-generation study with genetically modified Bt corn in rats: biochemical and histopathological investigation. Food Chem. Toxicol. 46, 1164–1170 (2008).

    Article  CAS  Google Scholar 

  37. Krzyzowska, M. et al. The effect of multigenerational diet containing genetically modified triticale on immune system in mice. Pol. J. Vet. Sci. 13, 423–430 (2010).

    CAS  PubMed  Google Scholar 

  38. Battistelli, S., Citterio, B., Baldelli, B., Parlani, C. & Malatesta, M. Histochemical and morphometrical study of mouse intestine epithelium after a long term diet containing genetically modified soybean. Eur. J. Histochem. 54, 154–157 (2010).

    Article  Google Scholar 

  39. Malatesta, M. et al. Fine structural analyses of pancreatic acinar cell nuclei from mice fed ongenetically modified soybean. Eur. J. Histochem. 47, 385–388 (2003).

    Article  CAS  Google Scholar 

  40. Malatesta, M. et al. A long-term study on female mice fed on a genetically modified soybean: effects on liver ageing. Histochem. Cell Biol. 130, 967–977 (2008).

    Article  CAS  Google Scholar 

  41. Malatesta, M. et al. Ultrastructural morphometrical and immunocytochemical analyses of hepatocyte nuclei from mice fed on genetically modified soybean. Cell Struct. Funct. 27, 173–180 (2002).

    Article  Google Scholar 

  42. Malatesta, M. et al. Ultrastructural analysis of pancreatic acinar cells from mice fed on genetically modified soybean. J. Anat. 201, 409–415 (2002).

    Article  Google Scholar 

  43. Malatesta, M. et al. Reversibility of hepatocyte nuclear modifications in mice fed on genetically modified soybean Eur. J. Histochem Jul-Sep 49, 237–242 (2005).

    CAS  Google Scholar 

  44. Vecchio, L., Cisterna, B., Malatesta, M., Martin, T.E. & Biggiogera, M. Ultrastructural analysis of testes from mice fed on genetically modified soybean. Eur. J. Histochem. 48, 448–454 (2004).

    CAS  PubMed  Google Scholar 

  45. Séralini, G.E. et al. Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize. Food Chem. Toxicol. 50, 4221–4231 (2012).

    Article  Google Scholar 

  46. Rhee, G.S. et al. Multigeneration reproductive and developmental toxicity study of bar gene inserted into genetically modified potato on rats. J. Toxicol. Environ. Health A 68, 2263–2276 (2005).

    Article  CAS  Google Scholar 

  47. Sakamoto, Y. et al. A 52-week feeding study of genetically modified soybeans in F344 rats. J. Food Hyg. Soc. Japan 48, 41–50 [article in Japanese] (2007).

    Article  CAS  Google Scholar 

  48. Sissener, N.H., Sanden, M., Bakke, A.M., Krogdahl, A. & Hemre, G.-I. A long term trial with Atlantic salmon (Salmo salar L.) fed genetically modified soy; focusing general health and performance before, during and after the parr–smolt transformation. Aquaculture 294, 108–117 (2009).

    Article  CAS  Google Scholar 

  49. Steinke, K. et al. Effects of long-term feeding of geneticallymodified corn (event MON810) on the performance of lactating dairy cows. J. Anim. Physiol. Anim. Nutr. (Berl.) 94, 185–193 (2010).

    Article  Google Scholar 

  50. Trabalza-Marinucci, M. et al. A three year longitudinal study on the effects of a diet containing genetically modified Bt176 maize on the health status and performance on sheep. Livest. Sci. 113, 178–190 (2008).

    Article  Google Scholar 

  51. Tudisco, R. et al. Fate of transgenic DNA and evaluation of metabolic effects in goats fed genetically modified soybean and in their offsprings. Animal 1, 10 (2010).

    Google Scholar 

  52. Velimirov, A., Binter, C. & Zentek, J. Biological effects of transgenic maize NK603xMON810 fed in long term reproduction studies in mice. Report, Forschungsberichte der Sektion IV, Band 3. (Institut für Ernährung, and Forschungsinttitut für biologischen Landbau, 2008).

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The FDA's position on foods from new plant varieties (PDF 78 kb)

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DeFrancesco, L. How safe does transgenic food need to be?. Nat Biotechnol 31, 794–802 (2013).

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