2.1 MYTH:

GM foods are strictly regulated for safety


GM food regulation in most countries varies from non-existent to weak

“Monsanto should not have to vouchsafe the safety of biotech food. Our interest is in selling as much of it as possible. Assuring its safety is the FDA’s job.”
– Philip Angell, Monsanto’s director of corporate communications1 (the FDA is the US government’s Food and Drug Administration, responsible for food safety)

“Ultimately, it is the food producer who is responsible for assuring safety.”
– US Food and Drug Administration (FDA)2

 “It is not foreseen that EFSA carry out such [safety] studies as the onus is on the [GM industry] applicant to demonstrate the safety of the GM product in question.”
– European Food Safety Authority (EFSA)3

Industry and some government sources claim that GM foods are strictly regulated.4 But GM food regulatory systems worldwide vary from voluntary industry self-regulation (in the US) to weak (in Europe). None are adequate to protect consumers’ health.

2.1.1. The regulatory process in the USA

“One thing that surprised us is that US regulators rely almost exclusively on information provided by the biotech crop developer, and those data are not published in journals or subjected to peer review... The picture that emerges from our study of US regulation of GM foods is a rubber-stamp ‘approval process’ designed to increase public confidence in, but not ensure the safety of, genetically engineered foods.”
– David Schubert, professor and head, Cellular Neurobiology Laboratory, Salk Institute, commenting on a comprehensive peer-reviewed study of US government’s regulation of GMOs that he co-authored5,6

GM foods were first commercialised in the US in the early 1990s. The US food regulator, the Food and Drug Adminstration (FDA), allowed the first GM foods onto world markets in spite of its own scientists’ warnings that genetic engineering is different from conventional breeding and poses special risks, including the production of new toxins or allergens.7,8,9,10,11,12 The FDA overruled its scientists in line with a US government decision to “foster” the growth of the GM industry.13 The FDA formed a policy for GM foods that did not require any safety tests or labelling.

The creation of this policy was overseen by Michael Taylor, FDA’s deputy commissioner of policy – a position created especially for Taylor. Taylor was a former attorney for the GM giant Monsanto and later became its vice president for public policy.14

Contrary to popular belief, the FDA does not have a mandatory GM food safety assessment process and has never approved a GM food as safe. It does not carry out or commission safety tests on GM foods. Instead, the FDA operates a voluntary programme for pre-market review of GM foods. All GM food crops commercialised to date have gone through this review process, but there is no legal requirement for them to do so. Companies that develop GM crops are allowed to put any GMO (genetically modified organism) on the market that they wish, though they can be held liable for any harm to consumers that results from it.

The outcome of the FDA’s voluntary assessment is not a conclusion, underwritten by the FDA, that the GMO is safe. Instead, the FDA sends the company a letter to the effect that:

  • The FDA acknowledges that the company has provided a summary of research that it has conducted assessing the GM crop’s safety
  • The FDA states that, based on the results of the research done by the company, the company has concluded that the GMO is safe
  • The FDA states that it has no further questions
  • The FDA reminds the company that it is responsible for placing only safe foods in the market
  • The FDA reminds the company that, if a product is found to be unsafe, the company may be held liable.15

Clearly, this process does not guarantee – or even attempt to investigate – the safety of GM foods. While it does not protect the public, it may protect the FDA from legal liability in the event that harm is caused by a GM food.

2.1.2. The sham of substantial equivalence

“The concept of substantial equivalence has never been properly defined; the degree of difference between a natural food and its GM alternative before its ‘substance’ ceases to be acceptably ‘equivalent’ is not defined anywhere, nor has an exact definition been agreed by legislators. It is exactly this vagueness that makes the concept useful to industry but unacceptable to the consumer…
“Substantial equivalence is a pseudo-scientific concept because it is a commercial and political judgment masquerading as if it were scientific. It is, moreover, inherently anti-scientific because it was created primarily to provide an excuse for not requiring biochemical or toxicological tests.”
– Millstone E, Brunner E, Mayer S. Beyond “substantial equivalence”. Nature. 1999; 401(6753): 525–526.16

The US FDA’s approach to assessing the safety of GM crops and foods is based on the concept of substantial equivalence, which was first put forward by the Organisation for Economic Cooperation and Development (OECD), a body dedicated not to protecting public health but to facilitating international trade.17

Substantial equivalence assumes that if a GMO contains similar amounts of a few basic components such as protein, fat, and carbohydrate as its non-GM counterpart, then the GMO is substantially equivalent to the non-GMO and no compulsory safety testing is required.

Claims of substantial equivalence for GM foods are widely criticized as unscientific by independent researchers.18,19,20,21 A useful analogy is that of a BSE-infected cow and a healthy cow. They are substantially equivalent to one another, in that their chemical composition is the same. The only difference is in the shape of a minor component of a protein (prion), a difference that would not be picked up by a substantial equivalence assessment. Yet few would claim that eating a BSE-infected cow is as safe as eating a healthy cow.

When claims of substantial equivalence have been independently tested, they have been found to be untrue. Using the latest molecular analytical methods, GM crops have been shown to have a different composition to their non-GM counterparts. This is true even when the two crops are grown under the same conditions, at the same time and in the same location – meaning that the changes are not due to different environmental factors but to the genetic modification.

Examples include:

  • GM soy had 12–14% lower amounts of cancer-fighting isoflavones than non-GM soy.22
  • Canola (oilseed rape) engineered to contain vitamin A in its oil had much reduced vitamin E and an altered oil-fat composition, compared with non-GM canola.23
  • Experimental GM rice varieties had unintended major nutritional disturbances compared with non-GM counterparts, although they were grown side-by-side in the same conditions. The structure and texture of the GM rice grain was affected and its nutritional content and value were dramatically altered. The authors said that their findings “provided alarming information with regard to the nutritional value of transgenic rice” and showed that the GM rice was not substantially equivalent to non-GM.24
  • Experimental GM insecticidal rice was found to contain higher levels of certain components (notably sucrose, mannitol, and glutamic acid) than the non-GM counterpart. These differences were shown to have resulted from the genetic manipulation rather than environmental factors.25
  • Commercialised MON810 GM maize had a markedly different profile in the types of proteins it contained compared with the non-GM counterpart when grown under the same conditions.21
  • GM crops also have different effects from their non-GM counterparts when fed to animals (see 3.1.1).

2.1.3. The US government is not impartial regarding GM crops

The US government is not an impartial authority on GM crops. In fact, it has a policy of actively promoting them.26 Through its embassies and agencies such as the US Department of Agriculture (USDA), the US government pressures national governments around the world to accept GM crops. This has been made clear in a series of diplomatic cables disclosed by Wikileaks, which reveal that:

  • The US embassy in Paris recommended that the US government launch a retaliation strategy against the EU that “causes some pain” as punishment for Europe’s reluctance to adopt GM crops.27
  • The US embassy in Spain suggested that the US government and Spain should draw up a joint strategy to help boost the development of GM crops in Europe.28
  • The US State Department is trying to steer African countries towards acceptance of GM crops.29,30

This strategy of exerting diplomatic pressure on national governments to adopt GM crops is undemocratic as it interferes with their ability to represent the wishes of their citizens. It is also inappropriate to use US taxpayers’ money to promote products owned by individual corporations.

2.1.4. The regulatory process in Europe and the rest of the world

“I suggest to biotechnology companies that they publish results of studies on the safety of GM foods in international peer-reviewed journals. The general population and the scientific community cannot be expected to take it on faith that the results of such studies are favourable. Informed decisions are made on the basis of experimental data, not faith.”
– Domingo JL. Health risks of GM foods: Many opinions but few data. Science. 2000; 288(5472): 1748–1749.31

Many governments, including those of the EU, Japan, Australia, and New Zealand, have an 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 pharmaceuticals33,34 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 so-called “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 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 co-authors 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 plants46 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 Further rigorous testing is not required, so unexpected changes in the GM crop are unlikely to be identified. Also, testing for interactions between the genome of the GM crop and the environment is not required.

However, the degree of similarity that a GM plant needs to have to non-GM counterparts in order to pass this comparative safety assessment has never been defined. A comparative assessment of a GM plant often reveals significant differences in its composition that are outside the ranges of other non-GM varieties, including historical varieties. But even in these extreme cases, according to scientists who have served on regulatory bodies, the differences are often dismissed as “biologically irrelevant” (see 3.1.2).52

Independent scientists have heavily criticised substantial equivalence and comparative safety assessment as the basis of safety assessments of GM crops.6,16,52,55

2.1.7. Weakening comparative assessment further by widening the range of comparison

The comparative safety assessment is itself a flawed basis for assessing GMO safety. Yet recent developments have further weakened this already inadequate method.

An EU Directive on the deliberate release of GMOs requires that the comparator against which the GMO should be assessed for safety should be “the non-modified organism from which it is derived”.56 The EU regulation on GM food and feed agrees that the comparator should be the non-GM counterpart.57

These rules ensure that the GM crop or food is compared with its genetically similar (isogenic) non-GM counterpart. The comparator will have the same genetic background, but without the GM transformation. So the comparison is correctly designed to find changes caused by the genetic modification process – which should be the purpose of a GMO safety assessment.

Historically, EFSA has followed this principle in its Guidances and Opinions. Yet in a Guidance published in late 2011, EFSA departed from its past practice and EU legislative requirements and broadened the range of acceptable comparators. EFSA even proposed to allow the use of GM plants, rather than the usual non-GM isogenic line, as comparators for stacked events (crops containing multiple GM traits) and concluded that in some cases plants from different species might be accepted as comparators.58 EFSA’s new approach is in line with industry’s practices.50,51 But whether it complies with EU legislation is questionable.

More importantly, the approach of comparing a GM crop with unrelated or distantly related varieties grown at different times and in different locations is scientifically flawed. In order to determine any unintended disruption to gene structure and function and consequent biochemical composition brought about by the GM transformation process, the only valid comparator is the non-GM isogenic line, when the two have been grown side-by-side at the same time. This serves to minimize variables external to the GM transformation process. Thus any changes seen are likely to be caused by the GM process and not some other factor. In contrast, comparisons with unrelated or distantly related varieties grown at different times and in different locations introduce and increase external variables and serve to mask rather than highlight the effects of the GM transformation.

In parallel with the trend of widening the range of comparison in the comparative assessment of a GM plant’s composition, industry and regulators have adopted a similar scientifically invalid approach to assessing the health effects of a GMO in animal feeding trials. In these cases, they dismiss statistically significant changes seen in the animals fed the GMO as compared with those fed a non-GM diet as “not biologically meaningful” or “within the range of biological variation” (see 3.1.2–3.1.4 for a detailed discussion of this practice and how it places public health at risk).

These practices run counter to good scientific method and could be described as a way of “disappearing” inconvenient findings of the experiment in question by bringing in data from other experiments until the convenient answer (that the GMO is no different from its non-GM counterpart) is reached.

2.1.8. GM corporations and the US government have designed the GMO regulatory process around the world

The agricultural biotechnology corporations have lobbied long and hard on every continent to ensure that weak assessment models are the norm. Often working through the US government or nonprofit groups, they have provided biosafety workshops and training courses to smaller countries that are attempting to grapple with regulatory issues surrounding GM crops. The result, according to critics, has been models for safety assessment that favour easy approval of GMOs without rigorous assessment of health or environmental risks.

For example, a report by the African Centre for Biosafety (ACB) described how the Syngenta Foundation, a nonprofit organization set up by the agricultural biotechnology corporation Syngenta, worked on “a three-year project for capacity building in biosafety in sub-Saharan Africa”. The Syngenta Foundation’s partner in this enterprise was the Forum for Agricultural Research in Africa (FARA), a group headed by people with ties to Monsanto and the US government.

The ACB identified the Syngenta Foundation/FARA project as part of an “Africa-wide harmonisation of biosafety policies and procedures” that will “create an enabling environment for the proliferation of GMOs on the continent, with few biosafety checks and balances”.59

In India, the US Department of Agriculture led a “capacity building project on biosafety” to train state officials in the “efficient management of field trials of GM crops”60 – the first step towards full-scale commercialisation. And in 2010, a scandal erupted when a report from India’s national science academies recommending release of GM Bt brinjal (eggplant/aubergine) for cultivation was found to contain 60 lines of text copy-pasted almost word for word from a biotechnology advocacy newsletter – which itself contained lines extracted from a GM industry-supported publication.61

2.1.9. Independent research on GM foods is suppressed

“Unfortunately, it is impossible to verify that genetically modified crops perform as advertised. That is because agritech companies have given themselves veto power over the work of independent researchers… Research on genetically modified seeds is still published, of course. But only studies that the seed companies have approved ever see the light of a peer-reviewed journal. In a number of cases, experiments that had the implicit go-ahead from the seed company were later blocked from publication because the results were not flattering... It would be chilling enough if any other type of company were able to prevent independent researchers from testing its wares and reporting what they find… But when scientists are prevented from examining the raw ingredients in our nation’s food supply or from testing the plant material that covers a large portion of the country’s agricultural land, the restrictions on free inquiry become dangerous.”
– Editorial, Scientific American62

The problem of basing the regulatory process for GM crops on industry studies could be solved by considering independent (non-industry-affiliated) science in the risk assessment. But independent studies on GM foods and crops are rare, because independent research on GM crop risks is not supported financially – and because industry uses its patent-based control of GM crops to restrict independent research. Research that has been suppressed includes assessments of health and environmental safety and agronomic performance of GM crops.41 Permission to study GM crops is withheld or made so difficult to obtain that research is effectively blocked. For example, researchers are often denied access to commercialised GM seed and the non-GM isogenic lines.

Even if permission to carry out research is given, GM companies typically retain the right to block publication.63,64 The industry and its allies also use a range of public relations strategies to discredit and silence scientists who publish research that is critical of GM crops.65

In 2009, 26 scientists took the unusual step of making a formal complaint to the US Environmental Protection Agency. They wrote, “No truly independent research can be legally conducted on many critical questions involving these crops.”66 An editorial in Scientific American reported, “Only studies that the seed companies have approved ever see the light of a peer-reviewed journal. In a number of cases, experiments that had the implicit go-ahead from the seed company were later blocked from publication because the results were not flattering.”62

In response, a new licensing agreement for researchers on GM crops was reached between US Department of Agriculture (USDA) scientists and Monsanto in 2010.67 However, this agreement is still restrictive, which is not surprising given that the US Department of Agriculture has a policy of supporting GM crops and the companies that produce them (see 2.1.3). Whether this new policy will make a real difference remains to be seen.

The limited amount of independent research that is conducted on GM foods and crops is often ignored or dismissed by regulatory agencies. In addition, findings of harm, whether in independent or industry studies, are explained away as not “biologically relevant” (see 3.1.2).

2.1.10. Researchers who publish studies that find harm from GM crops are attacked

There is a well-documented history of orchestrated attacks by GM proponents on researchers whose findings show problems with GM crops and foods. The GM proponents adopt a variety of tactics, including criticizing the research as “bad science”, finding any small flaw or limitation (which almost all studies have) and claiming that this invalidates the findings, and using personal (ad hominem) attacks against the researcher.

Scientific debate is nothing new and is to be welcomed: it is the way that science progresses. A researcher publishes a study; another researcher thinks that certain aspects could have been done better and repeats it with the desired modifications; these findings in turn are added to the database of knowledge for future researchers to build on. But the trend of attempting to silence or discredit research that finds problems with GMOs is unprecedented and has grown in parallel with the commercialization of GM crops.

Unlike in traditional scientific debate, too often the criticism does not consist of conducting and publishing further research that could confirm or refute the study in question. Instead, the critics try to “shout down” the study on the basis of claims that are spurious or not scientifically validated.

There are numerous cases of this pattern, of which the following are just a few examples.

Gilles-Eric Séralini

In 2007 Professor Gilles-Eric Séralini, researcher in molecular biology at the University of Caen and president of the independent research institute CRIIGEN, and his research team published a re-analysis of a Monsanto 90-day rat feeding study that the company had submitted in support of application for the approval of its GM maize MON863. Approval was granted for food and feed in the EU in 2005. Monsanto tried to keep the feeding trial data secret, claiming commercial confidentiality, but it was forced into the open by a court ruling in Germany.

Séralini’s re-analysis of the Monsanto data showed that the rats fed GM maize had reduced growth and signs of liver and kidney toxicity. Seralini concluded that it could not be assumed that the maize was safe and asked for such studies performed for regulatory purposes to be extended beyond 90 days so that the consequences of the initial signs of toxicity could be investigated.38

After Séralini and his team published this and other papers showing harmful effects from GM crops and the glyphosate herbicide used with GM Roundup Ready crops, he was subjected to a vicious smear campaign. The smears appeared to come from the French Association of Plant Biotechnologies [Association Française des Biotechnologies Végétale] (AFBV), chaired by Marc Fellous.

Séralini believed the researchers Claude Allegre, Axel Kahn, and Marc Fellous were behind the defamation and intimidation campaign in France. He sued Fellous for libel, arguing that the campaign had damaged his reputation, reducing his opportunities for work and his chances of getting funding for his research.

During the trial, it was revealed that Fellous, who presented himself as a “neutral” scientist without personal interests, and who accused those who criticise GMOs as “ideological” and “militant”, owned patents through a company based in Israel. This company sells patents to GM corporations such as Aventis. Séralini’s lawyer showed that other AFBV members also have links with agribusiness companies.

The court found in Séralini’s favour. The judge sentenced the AFBV to a fine on probation of 1,000 Euros, 1 Euro for compensation (as requested by Séralini) and 4,000 Euros in court fees.68

Emma Rosi-Marshall

In 2007 Emma Rosi-Marshall’s team published research showing that Bt maize material got into streams in the American Midwest and that when fed to non-target insects, it had harmful effects. In a laboratory feeding study, the researchers fed Bt maize material to the larvae of the caddis fly, an insect that lives near streams. The larvae that fed on the Bt maize debris grew half as fast as those that ate debris from non-GM maize. And caddis flies fed high concentrations of Bt maize pollen died at more than twice the rate of caddis flies fed non-Bt pollen.69

Rosi-Marshall was subjected to vociferous criticism from GM proponents, who said that her paper was “bad science”. They complained that the study did not follow the type of protocol usual for toxicological studies performed for regulatory purposes, using known doses – even though such protocols are extremely limited and are increasingly coming under fire from independent scientists for being unable to reliably detect risks (see “Jorg Schmidt…” below). Rosi-Marshall replied that her study allowed the caddis flies to eat as much as they wanted, as they would in the wild.65

The critics also objected that laboratory findings did not give accurate information about real field conditions. Rosi-Marshall responded that only in the laboratory is it possible to control conditions tightly enough to allow firm conclusions.

Henry I. Miller of the pro-free-market think tank, the Hoover Institution, co-authored and published an opinion piece in which he called the publication of Rosi-Marshall’s study an example of the “anti-science bias” of scientific journals and accused the authors of scientific “misconduct”. According to Miller, the authors’ main crime was failing to mention in their paper another study that concluded that Bt maize pollen did not affect the growth or mortality of filter-feeding caddis flies.70 Rosi-Marshall responded that she had not cited these findings because they had not been peer-reviewed and published at the time and because they focused on a different type of caddis fly, with different feeding mechanisms from the insects in her study.65

Rosi-Marshall and her co-authors stand by their study. In a statement, they said, “The repeated, and apparently orchestrated, ad hominem and unfounded attacks by a group of genetic engineering proponents has done little to advance our understanding of the potential ecological impacts of transgenic corn.”65

Jorg Schmidt, Angelika Hilbeck and colleagues

A laboratory study (Schmidt, 2009) showed that GM Bt toxins increased the mortality of ladybird larvae that fed on it, even at the lowest concentrations tested. The study showed that claims that Bt toxins are only harmful to a limited number of insect pests and their close relatives are false. Bt toxins were found to harm non-target organisms – ladybirds – that are highly beneficial to farmers.71 Ladybirds devour pests such as aphids and disease-causing fungi.

Based on this study and over 30 others, in 2009 Germany banned the cultivation of Monsanto’s Bt maize MON810, which contains one of the Bt toxins that Schmidt’s team found to be harmful.71 This triggered two opinion pieces that questioned the scientific basis of the German ban72,73 and one experimental study (Alvarez-Alfageme et al, 2011) that claimed to disprove the adverse effects of the Bt toxins on ladybird larvae. The authors of the experimental study found no ill effects on ladybird larvae fed on Bt toxins and said that the “apparent harmful effects” found by Schmidt were due to “poor study design and procedures”.74

The following year a study (Hilbeck et al, 2012) by some of the same authors as Schmidt’s study was published, confirming its findings. This study too found that Bt toxins increased the mortality of ladybird larvae. The researchers addressed the main criticisms raised by Alvarez-Alfageme and gave reasons why that study had found no effect. The main reason given was that Alvarez-Alfageme had chosen to expose the ladybird larvae only in a single dose fed over 24 hours and then allowed them to recover by feeding them Bt toxin-free food.75 Schmidt, on the other hand, had exposed the larvae continuously over 9–10 days75 – arguably a far more realistic scenario.

In a separate commentary on the controversy, some of the authors of the confirmatory study criticised the confrontational tone, unscientific elements, and “concerted nature” of the three studies that attacked Schmidt’s initial findings. The authors noted that the “dogmatic ‘refutations’” and “deliberate counter studies” that routinely appear in response to peer-reviewed results on potential harm from GMOs were also a feature of the debate on risks of tobacco, asbestos, the controversial food packaging chemical bisphenol A, and mobile phones.

The authors also criticised the “double standards” that led the European Food Standards Authority (EFSA) to apply excessive scrutiny to papers that draw attention to the risks of GM crops while overlooking obvious deficiencies in studies that assert the safety of GM crops.

For example, Hilbeck and co-authors pointed to major deficiencies in a routine biosafety test performed for regulatory purposes in the approval process of GM Bt crops. The test is supposed to look for toxic effects on non-target insects. In the test protocol, larvae of the green lacewing, a beneficial pest predator insect, are given moth eggs coated in Bt toxin to eat.

However, as Hilbeck and her team noted, lacewing larvae feed by piercing the eggs and sucking out the contents – meaning that they are “truly incapable of ingesting compounds deposited on the exterior of the eggs”.

In other words, this supposed biosafety test is incapable of detecting toxic effects even when they occur. This deficiency has even been noted by the US Environmental Protection Agency. And yet, the authors noted, no criticisms of these clearly inappropriate tests were levelled by Alvarez-Alfageme and the other critics of Schmidt’s paper.76

Arpad Pusztai

On 10 August 1998 the GM debate changed forever with the broadcast of a current affairs documentary on British television about GM food safety. The programme featured a brief but revealing interview with the internationally renowned scientist Dr Arpad Pusztai about his research into GM food safety. Pusztai talked of his findings that GM potatoes had harmed the health of laboratory rats. Rats fed GM potatoes showed excessive growth of the lining of the gut similar to a pre-cancerous condition and toxic reactions in multiple organ systems.

Pusztai had gone public with his findings prior to publication for reasons of the public interest, particularly as the research had been funded by the British taxpayer. He gave his television interview with the full backing of his employers, the Rowett Institute in Scotland.

After the broadcast aired, a political storm broke. Within days, Pusztai had been gagged and fired by the Rowett, his research team was disbanded, and his data was confiscated. His telephone calls and emails were diverted. He was subjected to a campaign of vilification and misrepresentation by pro-GM scientific bodies and individuals in an attempt to discredit him and his research.77,78,79,80,81

What caused the Rowett’s turnaround? It was later reported that there had been a phone call from Monsanto to the then US president Bill Clinton, from Clinton to the then UK prime minister Tony Blair, and from Blair to the Rowett.77

Untruths and misrepresentations about Pusztai’s research continue to be circulated by GM proponents. These include claims that no GM potatoes were fed at all and that the experiment lacked proper controls. Both claims are easily shown to be false by a reading of the study, which subsequently passed peer-review by a larger-than-usual team of reviewers and was published in The Lancet.82

Criticisms of the study design are particularly unsound because it was reviewed by the Scottish Office and won a GBP 1.6 million grant over 28 other competing designs. According to Pusztai, it was also reviewed by the BBSRC, the UK’s main public science funding body.77 Even Pusztai’s critics have not suggested that he did not follow the study design as it was approved – and if his study had lacked proper controls, the BBSRC and the Scottish Office would have faced serious questions.

Interestingly, one of the critics who claimed that Pusztai’s experiment lacked proper controls83 had previously co-authored and published with Pusztai a study on GM peas with exactly the same design.84 In fact, the only notable difference between this study and Pusztai’s GM potatoes study was the result: the pea study had concluded that the GM peas were as safe as non-GM peas, whereas the potato study had found that the GM potatoes were unsafe.

Pusztai’s GM potato research continues to be cited in the peer-reviewed literature as a valid study.

Ignacio Chapela

In 2001 biologist Ignacio Chapela and his colleague David Quist tested native varieties of Mexican maize and found that they had been contaminated by GM genes.85 The findings were of concern because at the time, Mexico had banned the planting of GM maize out of concern for its native varieties. Mexico is the biological centre of origin for maize and has numerous varieties adapted to different localities and conditions. The GM contamination came from US maize imports.

Chapela started talking to various government officials, who, he felt, needed to know. As his findings were approaching publication in the journal Nature, events took a sinister turn. Chapela said he was put into a taxi and taken to an empty building in Mexico City, where a senior government official threatened him and his family. Chapela had the impression that he was trying to prevent him from publishing his findings.86,77,87

Chapela went ahead with publication. Immediately, a virulent smear campaign against him and his research was launched, with most of the attacks appearing on a pro-GM website called AgBioWorld. While AgBioWorld has many scientists among its subscribers, the attacks were not fuelled by scientists, but by two people called Mary Murphy and Andura Smetacek. Murphy and Smetacek accused Chapela of being more of an activist than a scientist. Smetacek suggested that Chapela’s study was part of an orchestrated campaign in collusion with “fear-mongering activists (Greenpeace, Friends of the Earth)”.77

Murphy and Smetacek successfully shifted the focus from the research findings onto the messenger. The journal Science noted the “widely circulating anonymous emails” accusing researchers, Ignacio Chapela and David Quist, of “conflicts of interest and other misdeeds”.88 Some scientists were alarmed at the personal nature of the attacks. “To attack a piece of work by attacking the integrity of the workers is a tactic not usually used by scientists,” wrote one.89

Investigative research by Jonathan Matthews of the campaign group GMWatch and the journalist Andy Rowell traced Murphy’s attacks to an email address owned by Bivings Woodell, part of the Bivings Group, a PR company with offices in Washington, Brussels, Chicago and Tokyo. Bivings developed “internet advocacy” campaigns for corporations and had assisted Monsanto with its internet PR since 1999, when the biotech company identified that the internet had played a significant part in its PR problems in Europe.77

Attempts to uncover the identity of Murphy and Smetacek led nowhere, leading the journalist George Monbiot to write an article about the affair entitled, “The fake persuaders: Corporations are inventing people to rubbish their opponents on the internet”.90

Chapela’s finding that GM genes had contaminated native Mexican maize was confirmed by tests carried out by the Mexican government, as reported in Chapela’s published study and in a separate article.85,91

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