GMO Myths and Truths

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agency that assesses the safety of GM crops. Based on its assessment, the agency recommends approval or rejection of the crop for use in food or animal feed. The final decision is made by the government. In Europe, the relevant agency is the European Food Safety Authority (EFSA). Typically the EU member states fail to agree on whether to approve a GM crop, with most voting not to approve it, but the vote does not achieve the “qualified majority” required to reject the GMO. The decision passes to the European Commission, which ignores the desires of the simple majority of the member states and approves the GMO. Worldwide, safety assessments of GMOs by government regulatory agencies are not scientifically rigorous. As in the US, they do not carry out or commission their own tests on the GM crop. Instead, they make decisions regarding the safety of the GMO based on studies commissioned by the very same companies that stand to profit from the crop’s approval. The problem with this system is that industry studies have an inbuilt bias. Published reviews evaluating studies assessing the safety/hazards of various products or technologies have shown that industry-sponsored or industry-affiliated studies are more likely to reach a favourable conclusion about the safety of the product than independent (non-industry-affiliated) studies. The most notorious example is industry studies on tobacco, which succeeded in delaying regulation for decades by sowing confusion about the health effects of smoking and passive smoking. 32 But a similar bias has been found in studies on other products, including pharmaceuticals 33,34 and mobile phones. 35 Studies on GM crops and foods are no exception. Two published reviews of the scientific literature show that industry-sponsored or – affiliated studies are more likely than independent studies to claim safety for GMOs. 36,37 Another problem is the frequently unpublished status of the studies that companies submit to regulatory agencies. The fact that they are not published means that they are not readily available for scrutiny by the public or independent scientists. Unpublished studies fall into the category of socalled “grey literature” – unpublished documents of unknown reliability. Such grey literature stands in stark contrast with the gold standard of science, peer-reviewed publication. The peer-reviewed publication process, while far from perfect, is the best method that scientists have come up with to ensure reliability. Its strength lies in a multi-step quality control process: ● The editor of the journal sends the study to qualified scientists (“peers”) to evaluate. They give feedback, including any suggested revisions, which are passed on to the authors of the study. ● Based on the outcome of the peer review process, the editor publishes the study, rejects it, or offers to publish it with revisions by the authors. ● Once the study is published, it can be scrutinised and repeated (replicated) by other scientists. This repeat-testing is the cornerstone of scientific reliability, because if other scientists were to come up with different findings, this would challenge the findings of the original study. The lack of availability of industry studies in the past has resulted in the public being deceived over the safety of GMOs. For example, industry’s raw data on Monsanto’s GM Bt maize variety MON863 (approved in the EU in 2005) were only forced into the open through court action by Greenpeace. Then independent scientists at the France-based research organisation CRIIGEN analysed the raw data and found that Monsanto’s own feeding trial on rats revealed serious health effects – including liver and kidney toxicity – that had been hidden from the public. 38,39 Since this case and perhaps as a result of it, transparency has improved in Europe and the public can obtain industry toxicology data on GMOs from EFSA on request. Only a small amount of information, such as the genetic sequence of the GMO, can be kept commercially confidential. 40 Similarly, the Australian and New Zealand food safety agency FSANZ makes industry toxicology GMO Myths and Truths 26
data on GMOs available on the Internet. However, in the US, significant portions of the data submitted to regulators are classified as “commercially confidential” and are shielded from public scrutiny. 41 2.1.5. Europe’s comparative safety assessment: Substantial equivalence by another name Europe’s GMO safety assessment process is still evolving. The European Food Safety Authority (EFSA) is in danger of following the US FDA in adopting the concept of substantial equivalence in its GM food assessments – but under another name. EFSA does not use the discredited term “substantial equivalence” but has replaced it with another term with the same meaning: “comparative safety assessment”. The change of name was suggested in a 2003 paper on risk assessment of GM plants. 42 The paper was co-authored by the chair of EFSA’s GMO Panel, Harry Kuiper, with Esther Kok. In 2010 Kok joined EFSA as an expert on GMO risk assessment. 43 In their paper, Kuiper and Kok freely admitted that the concept of substantial equivalence remained unchanged and that the purpose of the name change was in part to deflect the “controversy” that had grown up around the term. 42 At the same time that Kuiper and Kok published their 2003 paper, they were part of a task force of the industry-funded International Life Sciences Institute (ILSI), that was working on re-designing GMO risk assessment. 44 In 2004 Kuiper and Kok co-authored an ILSI paper on the risk assessment of GM foods, which defines comparative safety assessment. The other coauthors include representatives from GM crop companies that sponsor ILSI, including Monsanto, Bayer, Dow, and Syngenta. 45 EFSA has followed ILSI’s suggestion of treating the comparative safety assessment as the basis for GM safety assessments. EFSA has promoted the concept in its guidance documents on assessment of environmental risks of GM plants 46 and of risks posed by food and feed derived from GM animals, 47 as well as in a peer-reviewed paper on the safety assessment of GM plants, food and feed. 48 In 2012, the EU Commission incorporated the industry- and EFSA-generated concept of the comparative safety assessment into its draft legislation on GM food and feed. 49 A major problem with the comparative safety assessment is that, as the name suggests, the authorities are beginning to treat it as a safety assessment in itself, rather than as just the first in a series of mandatory steps in the assessment process. In other words, EFSA and the EU Commission are moving towards a scenario in which GM crops and foods that pass this extremely weak initial screening may not be subjected to further rigorous testing. 2.1.6. GM foods would not pass an objective comparative safety assessment The comparative safety assessment is a weak test of safety. Yet if it were applied objectively, GM crops and foods would not pass even this stage of the risk assessment. This is because as is explained above (2.1.2), many studies on GM crops show that they are not substantially equivalent to the non-GM counterparts from which they are derived. There are often significant differences in the levels of certain nutrients and types of proteins, as well as unexpected toxins or allergens. GM proponents have sidestepped this problem by widening the range of comparison. Adopting a method originally used by Monsanto in an analysis of its GM soy, 50,51 they no longer restrict the comparator to the GM plant and the genetically similar (isogenic) non-GM line, but recommend as comparators a range of non-isogenic varieties that are grown at different times and in different locations. Some of this “historical” data even dates back to before World War II. 52 ILSI has created a database of such published data, including data on unusual varieties that have untypically high or low levels of certain components. EFSA experts use this industry database to compare the composition of the GM plant with its non-GM counterparts in GMO risk assessments. 44,53 If, on the basis of this “comparative safety assessment”, EFSA experts judge the GM crop to be equivalent to its non-GM counterpart, it is assumed to be as safe as the non-GM variety. 44,54 GMO Myths and Truths 27
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: of a protein (prion), a difference
Page 29 and 30: 2.1.8. GM corporations and the US g
Page 31 and 32: the defamation and intimidation cam
Page 33 and 34: lacked proper controls. Both claims
Page 35 and 36: 18. Pusztai A, Bardocz S, Ewen SWB.
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
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5.4 Myth: GM Bt crops reduce insect
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has called GM crops “pesticide pl
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5.6 Myth: Roundup is a benign and b
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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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GMO Myths and Truths

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