GMO Myths and Truths

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Conclusion to Section 2 The regulatory regime for GM crops and foods is weakest in the US, the origin of most such crops, but is inadequate in most regions of the world, including Europe. The US regime assumes that GM crops are safe if certain basic constituents of the GM crop are “substantially equivalent” to those of their non-GM counterparts – a term that has not been legally or scientifically defined. The European regime applies the same concept but terms it “comparative safety assessment”. But often, when a scientific comparison of a GM crop and its non- GM counterpart is undertaken, the assumption of substantial equivalence is shown to be false, as unexpected differences are found. No regulatory regime anywhere in the world requires long-term or rigorous safety testing of GM crops and foods. Regulatory assessments are based on data provided by the company that is applying to commercialise the crop – the same company that will profit from a positive assessment of its safety. The regulatory procedure for GM crops is not References to Section 2 1. Pollan M. Playing God in the garden. New York Times Magazine. 25 October 1998. http://www.nytimes.com/1998/10/25/ magazine/playing-god-in-the-garden.html 2. US Food and Drug Administration. Statement of policy: Foods derived from new plant varieties. FDA Federal Register. 29 May 1992; 57(104): 229. 3. European Food Safety Authority (EFSA). Frequently asked questions on EFSA GMO risk assessment. 15 May 2006. 4. European Commission. GMOs in a nutshell. 2011. http:// ec.europa.eu/food/food/biotechnology/qanda/a1_en.print.htm 5. Tokar B. Deficiencies in federal regulatory oversight of genetically engineered crops. Institute for Social Ecology Biotechnology Project. June 2006. http://environmentalcommons. org/RegulatoryDeficiencies.html 6. Freese W, Schubert D. Safety testing and regulation of genetically engineered foods. Biotechnol Genet Eng Rev. 2004: 299-324. 7. Kahl L. Memorandum to Dr James Maryanski, FDA biotechnology coordinator, about the Federal Register document, “Statement of policy: Foods from genetically modified plants”. US Food & Drug Administration. 8 January 1992. http://www. biointegrity.org/FDAdocs/01/01.pdf 8. Guest GB. Memorandum to Dr James Maryanski, biotechnology coordinator: Regulation of transgenic plants – FDA Draft Federal Register Notice on Food Biotechnology. US Department of Health & Human Services. 5 February 1992. http://www.biointegrity.org/ FDAdocs/08/08.pdf 9. Matthews EJ. Memorandum to Toxicology Section of the Biotechnology Working Group: “Safety of whole food plants transformed by technology methods”. US Food & Drug independent or objective. The GM crop industry, notably through the industry-funded group, the International Life Sciences Institute (ILSI), has heavily influenced the way in which its products are assessed for safety. ILSI has successfully promoted ideas such as the comparative safety assessment, which maximize the chances of a GMO avoiding rigorous safety testing and greatly reduce industry’s costs for GMO authorisations. The GM crop industry restricts access to its products by independent researchers, so their effects on human and animal health and the environment cannot be properly investigated. Independent researchers who have published papers containing data that is not supportive of GMOs have been attacked by the industry and pro-GMO groups and individuals. This has had a chilling effect on the debate about GM crops and has compromised scientific progress in understanding their effects. Administration. October 28 1991. http://www.biointegrity.org/ FDAdocs/02/02.pdf 10. Shibko SL. Memorandum to James H. Maryanski, biotechnology coordinator, CFSAN: Revision of toxicology section of the “Statement of policy: Foods derived from genetically modified plants”. US Food & Drug Administration. Institution. Date 1992. http://www.biointegrity.org/FDAdocs/03/03.pdf 11. Pribyl LJ. Comments on the March 18, 1992 version of the Biotechnology Document. US Food & Drug Administration. 18 March 1992. http://www.biointegrity.org/FDAdocs/12/ljpp.pdf 12. Pribyl LJ. Comments on Biotechnology Draft Document, 2/27/92. US Food & Drug Administration. 6 March 1992. http:// www.biointegrity.org/FDAdocs/04/04.pdf 13. Sudduth MA. Genetically engineered foods – fears and facts: An interview with FDA’s Jim Maryanski. FDA Consumer. January–February 1993; 11–14. http://web.archive.org/ web/20090202053904/http://www.fda.gov/bbs/topics/consumer/ Con00191.html 14. Bittman M. Why aren’t GMO foods labeled? New York Times. 15 February 2011. http://opinionator.blogs.nytimes. com/2011/02/15/why-arent-g-m-o-foods-labeled/ 15. US Food and Drug Administration. Biotechnology consultation agency response letter BNF No. 000001. 27 January. 1995. http:// www.fda.gov/Food/Biotechnology/Submissions/ucm161129.htm 16. Millstone E, Brunner E, Mayer S. Beyond “substantial equivalence”. Nature. 1999; 401(6753): 525–526. 17. Organisation for Economic Cooperation and Development (OECD). Safety Evaluation of Foods Derived by Modern Biotechnology: Concepts and Principles: OECD Publishing; 1993. GMO Myths and Truths 34
18. Pusztai A, Bardocz S, Ewen SWB. Genetically modified foods: Potential human health effects. In: D’Mello JPF, ed. Food Safety: Contaminants and Toxins. Wallingford, Oxon: CABI Publishing 2003:347–372. 19. Nodari RO, Guerra MP. Implications of transgenics for environmental and agricultural sustainability. Hist Cienc Saude Manguinhos. Jul-Oct 2000; 7(2): 481-491. 20. Zdunczyk Z. In vivo experiments on the safety evaluation of GM components of feeds and foods. Journal of Animal and Feed Sciences. 2001; 10(Supplement 1): 195-210. 21. Zolla L, Rinalducci S, Antonioli P, Righetti PG. Proteomics as a complementary tool for identifying unintended side effects occurring in transgenic maize seeds as a result of genetic modifications. J Proteome Res. May 2008; 7(5): 1850-1861. 22. Lappé M, Bailey B, Childress C, Setchell KDR. Alterations in clinically important phytoestrogens in genetically modified herbicide-tolerant soybean. Journal of Medicinal Food. 1999; 1: 241–245. 23. Shewmaker C, Sheehy JA, Daley M, Colburn S, Ke DY. Seed-specific overexpression of phytoene synthase: Increase in carotenoids and other metabolic effects. Plant J. 1999; 20(4): 401–412X. 24. Jiao Z, Si XX, Li GK, Zhang ZM, Xu XP. Unintended compositional changes in transgenic rice seeds (Oryza sativa L.) studied by spectral and chromatographic analysis coupled with chemometrics methods. J Agric Food Chem. Feb 10 2010; 58(3): 1746-1754. 25. Zhou J, Ma C, Xu H, et al. Metabolic profiling of transgenic rice with cryIAc and sck genes: an evaluation of unintended effects at metabolic level by using GC-FID and GC-MS. J Chromatogr B Analyt Technol Biomed Life Sci. 15 Mar 2009; 877(8-9): 725-732. 26. US Department of Agriculture. Frequently asked questions about biotechnology. 2010. http://1.usa.gov/hVIRYq 27. Vidal J. WikiLeaks: US targets EU over GM crops. The Guardian. January 3 2011. http://www.guardian.co.uk/world/2011/jan/03/ wikileaks-us-eu-gm-crops 28. Euractiv.com. US lobbied EU to back GM crops: WikiLeaks. 4 January 2011. http://www.euractiv.com/global-europe/us-lobbiedeu-back-gm-crops-wikileaks-news-500960 29. EINNEWS. Wikileaks document pushes genetically modified food for African countries. 1 December 2010. http://www.einnews. com/pr-news/248883-wikileaks-document-pushes-geneticallymodified-food-for-african-countries 30. Laskawy T. Wikileaks: State Dept wants intel on African acceptance of GMOs. GRIST. 29 November 2010. http://www. grist.org/article/2010-11-29-wikileaks-state-dept-wants-intel-onafrican-acceptance-of-gmos 31. Domingo JL. Health risks of GM foods: Many opinions but few data. Science. 2000; 288(5472): 1748–1749. 32. Michaels D. Doubt is Their Product: How Industry’s Assault on Science Threatens Your Health: Oxford University Press; 2008. 33. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. British Medical Journal. 2003; 326: 1167. 34. Lexchin J. Those who have the gold make the evidence: How the pharmaceutical industry biases the outcomes of clinical trials of medications. Sci Eng Ethics. Feb 15 2011. 35. Huss A, Egger M, Hug K, Huweiler-Müntener K, Röösli M. Source of funding and results of studies of health effects of mobile phone use: Systematic review of experimental studies. Environmental Health Perspectives. January 2007; 115: 1–4. 36. Diels J, Cunha M, Manaia C, Sabugosa-Madeira B, Silva M. Association of financial or professional conflict of interest to research outcomes on health risks or nutritional assessment studies of genetically modified products. Food Policy. 2011; 36: 197–203. 37. Domingo JL, Bordonaba JG. A literature review on the safety assessment of genetically modified plants. Environ Int. Feb 4 2011; 37: 734–742. 38. Séralini GE, Cellier D, Spiroux de Vendomois J. New analysis of a rat feeding study with a genetically modified maize reveals signs of hepatorenal toxicity. Archives of Environmental Contamination and Toxicology. May 2007; 52(4): 596–602. 39. CRIIGEN. Revelations on the toxicity of GMOs – CRIIGEN reveals serious anomalies observed in rats fed on GMOs. 2005. http://www.criigen.org/SiteEn/index.php?option=com_content&ta sk=blogcategory&id=20&Itemid=87 40. Dalli J. GMOs: Towards a better, more informed decisionmaking process. 17 March 2011. http://bit.ly/zj8BZu 41. Waltz E. Under wraps – Are the crop industry’s strong-arm tactics and close-fisted attitude to sharing seeds holding back independent research and undermining public acceptance of transgenic crops? Nature Biotechnology. October 2009; 27(10): 880–882. 42. Kok EJ, Kuiper HA. Comparative safety assessment for biotech crops. Trends in Biotechnology. 2003; 21: 439–444. 43. European Food Safety Authority (EFSA). Annual declaration of interests – Esther Kok. 3 August 2010. https://doi.efsa.europa.eu/ doi/doiweb/wg/71722 44. Then C, Bauer-Panskus A. European Food Safety Authority: A playing field for the biotech industry. TestBiotech. 1 December 2010. www.testbiotech.de/sites/default/files/EFSA_Playing_Field_ of_ILSI.pdf 45. International Life Sciences Institute (ILSI). Nutritional and safety assessments of foods and feeds nutritionally improved through biotechnology, prepared by a Task Force of the ILSI International Food Biotechnology Committee. Comprehensive Reviews in Food Science and Food Safety. 2004; 3: 38–104. 46. European Food Safety Authority (EFSA) GMO Panel. Guidance on the environmental risk assessment of genetically modified plants. EFSA Journal. 2010; 8(11): 1879–1990. 47. European Food Safety Authority (EFSA). Guidance on the risk assessment of food and feed from genetically modified animals and on animal health and welfare aspects. EFSA Journal. 2012; 10(1): 2501. [2543 pp.]. 48. European Food Safety Authority (EFSA) GMO Panel Working Group on Animal Feeding Trials. Safety and nutritional assessment of GM plants and derived food and feed: The role of animal feeding trials. Food Chem Toxicol. Mar 2008; 46 Suppl 1: S2-70. 49. European Commission. Commission implementing regulation (EU) No…. on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Regulations (EC) No 641/2004 and (EC) No 1981/2006. 2012. 50. Padgette SR, Taylor NB, Nida DL, et al. The composition of glyphosate-tolerant soybean seeds is equivalent to that of conventional soybeans. J Nutr. Mar 1996; 126(3): 702-716. 51. Taylor NB, Fuchs RL, MacDonald J, Shariff AR, Padgette SR. Compositional analysis of glyphosate-tolerant soybeans treated with glyphosate. J Agric Food Chem. Oct 1999; 47(10): 4469-4473. 52. Hilbeck A, Meier M, Römbke J, Jänsch S, Teichmann H, Tappeser B. Environmental risk assessment of genetically modified plants - concepts and controversies. Environmental Sciences Europe. 2011; 23(13). 53. International Life Sciences Institute (ILSI). ILSI Crop Composition Database: Version 42011. http://www. cropcomposition.org/query/index.html 54. European Food Safety Authority (EFSA). Guidance on the submission of applications for authorisation of genetically modified food and feed and genetically modified plants for food or feed uses under Regulation (EC) No 1829/2003. EFSA Journal. 2011; 9(7): 1–27. 55. Royal Society of Canada. Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada. An Expert Panel Report on the Future of Food Biotechnology. 2001. http://www.rsc.ca//files/publications/expert_ panels/foodbiotechnology/GMreportEN.pdf 56. European Parliament and Council. Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on GMO Myths and Truths 35
Page 1 and 2: GMO Myths and Truths An evidence-ba
Page 3 and 4: About the authors Michael Antoniou,
Page 5 and 6: 3.1.5. Regulators currently do not
Page 7 and 8: Truth: Co-existence means widesprea
Page 9 and 10: 1. THE GENETIC ENGINEERING TECHNIQU
Page 11 and 12: 1.2 Myth: Genetic engineering is pr
Page 13 and 14: ornamental plants. 9 It also includ
Page 15 and 16: successfully incorporate the GM gen
Page 17 and 18: “conventionally bred” varieties
Page 19 and 20: inspection. Their scrutiny cannot e
Page 21 and 22: Conclusion to Section 1 GM proponen
Page 23 and 24: 2. SCIENCE AND REGULATION 2.1 Myth:
Page 25 and 26: of a protein (prion), a difference
Page 27 and 28: data on GMOs available on the Inter
Page 29 and 30: 2.1.8. GM corporations and the US g
Page 31 and 32: the defamation and intimidation cam
Page 33: lacked proper controls. Both claims
Page 37 and 38: 3. HEALTH HAZARDS OF GM FOODS 3.1 M
Page 39 and 40: their lambs showed cellular changes
Page 41 and 42: well known to have different effect
Page 43 and 44: developing multi-trait crops becaus
Page 45 and 46: 3.2.2. Schrøder (2007) 23 A study
Page 47 and 48: 3.4 Myth: GM foods have been proven
Page 49 and 50: However, the authors of a 1990 stud
Page 51 and 52: 3.6 Myth: GM Bt insecticidal crops
Page 53 and 54: 3.7 Myth: GM foods are properly tes
Page 55 and 56: acute allergenicity problems to a l
Page 57 and 58: 3.9 Myth: Genetic engineering will
Page 59 and 60: poor and hungry in the Global South
Page 61 and 62: 30. European Food Safety Authority
Page 63 and 64: sheep and pigs fed Roundup Ready ca
Page 65 and 66: 4.1 Myth: Roundup is a safe herbici
Page 67 and 68: 100% of air and rain samples taken
Page 69 and 70: 11. Romano RM, Romano MA, Bernardi
Page 71 and 72: “Over the past decade, corporate
Page 73 and 74: supposedly high-yielding GM soybean
Page 75 and 76: often use more glyphosate herbicide
Page 77 and 78: 5.4 Myth: GM Bt crops reduce insect
Page 79 and 80: has called GM crops “pesticide pl
Page 81 and 82: 5.6 Myth: Roundup is a benign and b
Page 83 and 84: fixation and reduce the growth of r
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5.9 Myth: GM crops bring economic b
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5.10 Myth: GM crops can “coexist
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5.11 Myth: If GM contamination occu
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acterium, thereby creating a “sup
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een found to be unreliable and inco
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emergence of resistant and secondar
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mycorrhizal symbiosis in experiment
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Canada: Organic Agriculture Protect
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6.1 Myth: GM will deliver climate-r
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6.3 Myth: GM will solve the nitroge
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Agriculture cannot continue to depe
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7.1 Myth: GM crops are needed to fe
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A 2003 report on the project calcul
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Previously, agricultural markets we
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and the Caribbean have found that o
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7.3 Myth: GM is needed to provide t
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King produced this example when und
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IAASTD report, commissioned by the
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LifeScientist. 12 March 2012. http:
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mixtures of chemicals in an attempt
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