Genetically modified food controversies

The genetically modified foods controversy is a dispute over the relative advantages and disadvantages of genetically modified food crops and other uses of genetically modified organisms in food production. The dispute involves biotechnology companies, governmental regulators, non-governmental organizations and scientists. The dispute is most intense in Japan and Europe, where public concern about GM food is higher than in other parts of the world such as the United States. In the United States, GM crops are more widely grown and the introduction of these products has been less controversial.

The key areas of political controversy related to genetically engineered (GE) food are food safety, the effect on natural ecosystems, gene flow into non GE crops and corporate control of the food supply. While it is not possible to make general statements on the safety of all GM foods, to date, no adverse health effects caused by products approved for sale have been documented, although two products failed initial safety testing and were discontinued, due to allergic reactions.

Most feeding trials have observed no toxic effects and saw that GM foods were equivalent in nutrition to unmodified foods, although a few non-peer-reviewed reports speculate physiological changes in response to GM food. Although there is now broad scientific consensus that GE crops on the market are safe to eat, some scientists and advocacy groups such as Greenpeace and World Wildlife Fund call for additional and more rigorous testing before marketing genetically engineered food.

Health risks and benefits

Present knowledge on GM food safety

Worldwide, there is a range of perspectives within non-governmental organizations on the safety of GM foods. For example, the US pro-GM group AgBioWorld has argued that GM foods have been proven safe, while other pressure groups and consumer rights groups, such as the Organic Consumers Association, and Greenpeace claim the long-term health risks which GM could pose, or the environmental risks associated with GM, have not yet been adequately investigated. In Japan, Consumers Union of Japan are opposed to GMO foods. They also claim that truly independent research in these areas is systematically blocked by the GM corporations which own the GM seeds and reference materials.

The European Commission Directorate-General for Research and Innovation 2010 report on GMOs noted that "The main conclusion to be drawn from the efforts of more than 130 research projects, covering a period of more than 25 years of research, and involving more than 500 independent research groups, is that biotechnology, and in particular GMOs, are not per se more risky than e.g. conventional plant breeding technologies." A 2008 review published by the Royal Society of Medicine noted that GM foods have been eaten by millions of people worldwide for over 15 years, with no reports of ill effects. Similarly a 2004 report from the US National Academies of Sciences stated: "To date, no adverse health effects attributed to genetic engineering have been documented in the human population." A 2004 review of feeding trials in the Italian Journal of Animal Science found no differences among animals eating genetically modified plants. A 2005 review in Archives of Animal Nutrition concluded that first-generation genetically modified foods had been found to be similar in nutrition and safety to non-GM foods, but noted that second-generation foods with "significant changes in constituents" would be more difficult to test, and would require further animal studies. However, a 2009 review in Nutrition Reviews found that although most studies concluded that GM foods do not differ in nutrition or cause any detectable toxic effects in animals, some studies did report adverse changes at a cellular level caused by some GM foods, concluding that "More scientific effort and investigation is needed to ensure that consumption of GM foods is not likely to provoke any form of health problem".

A review published in 2009 by Dona and Arvanitoyannis concluded that "results of most studies with GM foods indicate that they may cause some common toxic effects such as hepatic, pancreatic, renal, or reproductive effects and may alter the hematological, biochemical, and immunologic parameters". However responses to this review in 2009 and 2010 note that the Dona and Arvanitoyannis concentrated on articles with an anti-GM bias that have been refuted by scientists in peer-reviewed articles elsewhere - for example the 35S promoter, stability of transgenes, antibiotic marker genes and the claims for toxic effects of GM foods. In 2007, a review by Domingo of the toxicity by searching in the Publimed database using 12 search terms, cited 68 references, found that the "number of references" on the safety of GM/transgenic crops was "surprisingly limited" and questioned whether the safety of genetically modified food has been demonstrated; the review also remarked that its conclusions were in agreement with three earlier reviews by Zdunczyk (2001), Bakshi (2003), and Pryme and Lembcke (2003). However, an article in 2007 by Vain found 692 research studies focusing on GM crop and food safety and identified a strong increase in the publication of such articles in recent years. Vain commented that the multidisciplinarian nature of GM research complicates the retrieval of GM studies and requires using many search terms (he used more than 300) and multiple databases.

Safety assessments

The starting point for the safety assessment of genetically engineered food products is to assess if the food is "substantially equivalent" to its natural counterpart.

The issue of GM food safety was first discussed at a meeting of the Food and Agriculture Organization (FAO), the World Health Organization (WHO) and biotech representatives in 1990. The "substantial equivalence" concept was proposed by the FAO in 1993 and endorsed by the FAO and WHO in early 1996 as a means to reassure consumers by obtaining official approval for genetically modified foods. The testing normally required for new food products can cost millions of dollars and take years of testing before a product gains approval for marketing which was also seen as inhibiting the development of biotechnology companies. The adoption of the concept of substantial equivalence permitted marketing of new foods without any safety or toxicology tests as long as they were not grossly different in chemical composition to foods already on the market.

"Substantial equivalence embodies the concept that if a new food or food component is found to be substantially equivalent to an existing food or food component, it can be treated in the same manner with respect to safety (i.e., the food or food component can be concluded to be as safe as the conventional food or food component)" . The rationale for this approach is that it would be impossible to test all the new crop varieties every year for food safety. Only a few food crops on the market have been shown to cause adverse health effects and all of these were the result of conventional genetic modification, not from genetic engineering To decide if a modified product is substantially equivalent, the product is tested by the manufacturer for unexpected changes in a limited set of components such as toxins, nutrients or allergens that are present in the unmodified food. If these tests show no significant difference between the modified and unmodified products, then no further food safety testing is required. The manufacturer's data is then assessed by an independent regulatory body, such as the U.S. Food and Drug Administration.

However, if the product has no natural equivalent, or shows significant differences from the unmodified food, then further safety testing is carried out. A 2003 review in Trends in Biotechnology identified seven main parts of a standard safety test:

1. Study of the introduced DNA and the new proteins or metabolites that it produces;
2. Analysis of the chemical composition of the relevant plant parts, measuring nutrients, anti-nutrients as well as any natural toxins or known allergens;
3. Assess the risk of gene transfer from the food to microorganisms in the human gut;
4. Study the possibility that any new components in the food might be allergens;
5. Estimate how much of a normal diet the food will make up;
6. Estimate any toxicological or nutritional problems revealed by this data;
7. Additional animal toxicity tests if there is the possibility that the food might pose a risk.

This process was examined further in a review published by Kuiper et al. 2002 in the journal Toxicology, which stated that substantial equivalence does not itself measure risks, but instead identifies differences between existing products and new foods, which might pose dangers to health. If differences do exist, identifying these differences is a starting point for a full safety assessment, rather than an end point. The authors concluded that "The concept of substantial equivalence is an adequate tool in order to identify safety issues related to genetically modified products that have a traditional counterpart". However, the review also noted difficulties in applying this standard in practice, including the fact that traditional foods contain many chemicals that have toxic or carcinogenic effects and that our existing diets therefore have not been proven to be safe. This lack of knowledge on unmodified food poses a problem, as GM foods may have differences in anti-nutrients and natural toxins that have never been identified in the original plant, raising the possibility that harmful changes could be missed.

The application of substantial equivalence has also been more strongly criticized. For example, in a speech in 1999, Andrew Chesson of the University of Aberdeen, stated that substantial equivalence testing "could be flawed in some cases" and that some current safety tests could allow harmful substances to enter the human food chain. In a commentary in Nature, Millstone et al. argued that all GM foods should have extensive biological, toxicological and immunological tests and that the concept of substantial equivalence based solely on chemical analyzes of the components of a food should be abandoned. They stated that this is necessary since it is currently impossible to predict the biological properties of a substance only from knowledge of its chemistry. This commentary was controversial and was criticized for misleading presentation of data and presenting an oversimplified version of safety assessments. For example, Kuiper et al. responded to this criticism by noting that equivalence testing does involve more than chemical tests and may include toxicity testing.

Medical writer Barbara Keeler and Marc Lappé argued in a 2001 article in the Los Angeles Times that the differences between genetically modified and conventional foods challenge the presumption of equivalence. Using Roundup ready soy that has been on the market since 1995 as an example, they noted the differences when compared to its unmodified counterpart. Significantly lower levels of protein than unmodified soy. Significantly lower levels of phenylalanine, an essential amino acid and as a dietary supplement, the reason doctors advise the consumption of soy products. Levels of trypsin inhibitor were 27% higher and after toasting, lectin was double that found in conventional soy; both are known allergens. GM soy also has 29% less choline, a B-complex vitamin. Round up ready soy had also stunted the growth of rats in Monsanto's study but had not affected cattle although it had increased the fat content of their milk. The authors do not maintain that modified soy is a hazard but that the FDA accepting such significant differences as being substantially equivalent illustrates the need for more rigorous testing, and preferably not by the biotech industries themselves.

However, a 2008 paper by Cheng et al. showed that genetic engineering of soybeans causes smaller unintended changes than are seen with traditional breeding. A 2002 paper by Ridley et al. showed that genetically engineered maize was equivalent to conventional maize for proximates, fiber, amino acids, fatty acids, vitamin E, nine minerals, phytic acid, trypsin inhibitor, and secondary metabolites. Baudo et al. in a 2006 paper compared transgenic wheat with conventionally bred wheat and concluded that "...transgenic plants could be considered substantially equivalent to untransformed parental lines." A 2008 paper by di Carli et al. compared genetically engineered Lycopersicon esculentum (a tomato) and Nicotiana benthamiana (a close relative of tobacco) with their untransformed counterparts and concluded that genetic engineering did not significantly affect the plants proteanic profile.

The value of current independent studies is problematic as, due to restrictive end-user agreements, researchers are forbidden by law from publishing independent research in peer-reviewed journals without the approval of the agritech companies. Cornell University's Elson Shields, the spokesperson for a group of scientists who oppose this practice, submitted a statement to the United States Environmental Protection Agency (EPA) protesting that "as a result of restrictive access, no truly independent research can be legally conducted on many critical questions regarding the technology". Scientific American noted that several studies that were initially approved by seed companies were later blocked from publication when they returned "unflattering" results. While recognising that seed companies' intellectual property rights need to be protected, Scientific American calls the practice dangerous and has called for the restrictions on research in the end-user agreements to be lifted immediately and for the EPA to require, as a condition of approval, that independent researchers have unfettered access to GM products for testing.

The Welsh pressure group GM Free Cymru argues that governments should use independent studies rather than industry studies to assess crop safety. GM Free Cymru has also stated that independently funded researcher, Professor Bela Darvas of Debrecen University was refused Mon 863 Bt corn to use in his studies after previously publishing that a different variety of Monsanto corn was lethal to two Hungarian protected insect species and an insect classified as a rare.

Allergenicity

Worldwide, reports of allergies to all kinds of foods, particularly nuts, fish and shellfish, seem to be increasing, but it is not known if this reflects a genuine change in the risk of allergy, or an increased awareness of food allergies by the public. Some environmental organizations, such as the European Green Party and Greenpeace, have suggested that GM food might trigger food allergies, although other environmentalists have implicated causes as diverse as the greenhouse effect increasing pollen levels, greater exposure to synthetic chemicals, cleaner lifestyles, or more mold in buildings. A 2005 review in the journal Allergy of the results from allergen testing of current GM foods stated that "no biotech proteins in foods have been documented to cause allergic reactions".

A well-known case of a GM plant that did not reach the market due to it producing an allergic reaction was a new form of soybean intended for animal feed. The allergen was transferred unintentionally from the Brazil nut into genetically engineered soybeans, in a bid to improve soybean nutritional quality for animal feed use. This new protein increased the levels in the GM soybean of the natural essential amino acid methionine, which is commonly added to poultry feed. Investigation of the GM soybeans revealed that they produced immune reactions in people with Brazil nut allergies, since the methionine rich protein chosen by Pioneer Hi-Bred happened to be a major source of Brazil nut allergy. Although this soybean strain was not developed as a human food, Pioneer Hi-Bred discontinued further development of the GM soybean, due to the difficulty in ensuring that none of these soybeans entered the human food chain.

In November 2005 a pest-resistant field pea developed by the Australian CSIRO for use as a pasture crop was shown to cause an allergic reaction in mice. Work on this variety was immediately halted. The protein added to the pea did not cause the reaction in humans or mice in isolation, but when it was expressed in the pea, it exhibited a subtly different structure which may have caused the allergic reaction. The immunologist who tested the pea noted that crops need to be evaluated case-by-case.

Plant scientist Maarten J Chrispeels has made these comments about this example:

The recent Prescott et al. paper in JFAC contains a very interesting study on the immunogenicity of amylase [starch digestion enzyme] inhibitor in its native form (isolated from beans) and expressed as a transgene in peas. First of all, amylase inhibitor is a food protein, but also a "toxic" protein because it inhibits our digestive amylases. This is one of the reasons you have to cook your beans! (The other toxic bean protein is phytohemagglutinin and it is much more toxic). This particular amylase inhibitor is found in the common bean (other species have other amylase inhibitors). Even though it is a food protein, it is unlikely ever to be used for genetic engineering of human foods because it inhibits our amylases. What the results show is that the protein, when synthesized in pea cotyledons has a different immunogenicity than when it is isolated from bean cotyledons (the native form). This is somewhat surprising but may be related to the presence of slightly different carbohydrate chains.

These cases of products that failed safety testing can either be viewed as evidence that genetic modification can produce unexpected and dangerous changes in foods, or alternatively that the current tests are effective at identifying any safety problems before foods come on the market.

Genetic modification can also be used to remove allergens from foods, which may, for example, allow the production of soy products that would pose a smaller risk of food allergies than standard soybeans. A hypo-allergenic strain of soybean was tested in 2003 and shown to lack the major allergen that is found in the beans. A similar approach has been tried in ryegrass, which produces pollen that is a major cause of hay fever: here a fertile GM grass was produced that lacked the main pollen allergen, demonstrating that the production of hypoallergenic grass is also possible.

Biological process

The use of genetically modified organisms has sparked significant controversy in many areas. Some groups or individuals see the generation and use of GMO as intolerable meddling with biological states or processes that have naturally evolved over long periods of time, while others are concerned about the limitations of modern science to fully comprehend all of the potential negative ramifications of genetic manipulation. Other people see this as a continuation in the role humanity has occupied for thousands of years in selective breeding.

Foodchain

The safety of GMOs in the foodchain has been questioned by some environmental groups, with concerns such as the possibilities that GMOs could introduce new allergens into foods, or contribute to the spread of antibiotic resistance. According to a study published in 1999, there was no current evidence to suggest that the processes used to genetically modify food were inherently harmful. However, a number of more recent studies have raised concern, and environmental groups still discourage consumption in many countries, claiming that GM foods are unnatural and therefore unsafe. Such concerns have led to the adoption of laws and regulations that require safety testing of any new organism produced for human consumption.. Some of the specific concerns about GMO include damage to kidneys and livers, both of them vital in removing toxins from the body. Some studies show such damages to kidneys and livers in laboratory animals. Also, a long term study involving an international group of scientists from Norway released a study in July 2012 showing "horizontal transfer of genes". Ashild Krogdahl, one of the scientists in that group, said: “A frequent claim has been that new genes introduced in GM food are harmless since all genes are broken up in the intestines. But our findings show that genes can be transferred through the intestinal wall into the blood; the genes from the GMO have been found in blood, muscle tissue and liver in sufficiently large segments to be identified.”

GMOs' proponents note that because of the safety testing requirements imposed on GM foods, the risk of introducing a plant variety with a new allergen or toxin using genetic modification is much smaller than using traditional breeding processes. Transgenesis has less impact on the expression of genomes or on protein and metabolite levels than conventional breeding or plant (non-directed) mutagenesis. An example of an allergenic plant created using traditional breeding is the kiwi. One article calculated that the marketing of GM salmon could reduce the cost of salmon by half, thus increasing salmon consumption and preventing 1,400 deaths from heart attack a year in the United States.

Labeling

While some groups advocate the complete prohibition of GMOs, others call for mandatory labeling of genetically modified food or other products. Other controversies include the definition of patent and property pertaining to products of genetic engineering. According to the documentary Food, Inc. efforts to introduce labeling of GMOs has repeatedly met resistance from lobbyists and politicians affiliated with companies like Monsanto. Outside the U.S., the entire European Union and other countries such as Australia, China, Japan, and Russia require GMO labeling. There are other countries that make GMO labeling voluntary and many other countries have plans to introduce GMO labeling

Testing

Bruce Stutz's article, "Wanted: GM Seeds for Study," highlights a story of two dozen scientists who spoke out against the research restrictions put forth by companies producing genetically modified (GM) seeds such as DuPont, Monsanto, and Syngenta. In February 2009, after scientists warned the U.S. Environmental protection Agency (EPA) "that industry influence had made independent analyses of transgenic crops impossible," the American Seed Trade Association (ASTA) agreed that they "would allow researchers greater freedom to study the effects of GM food crops." This agreement left many scientists optimistic about the future, but there is little optimism as to whether this agreement has the ability to "alter what has been a research environment rife with obstruction and suspicion."

Transgenic organisms

Another important controversy is the possibility of unforeseen local and global effects as a result of transgenic organisms proliferating. The basic ethical issues involved in genetic research are discussed in the article on genetic engineering.

Some critics have raised the concern that conventionally bred crop plants can be cross-pollinated (bred) from the pollen of modified plants. Pollen can be dispersed over large areas by wind, animals, and insects. In 2007, the U.S. Department of Agriculture fined Scotts Miracle-Gro $500,000 when modified genetic material from creeping bentgrass, a new golf-course grass Scotts had been testing, was found within close relatives of the same genus (Agrostis) as well as in native grasses up to 21 km (13 mi) away from the test sites, released when freshly cut grass was blown by the wind.

GM proponents point out that outcrossing, as this process is known, is not new. The same thing happens with any new open-pollinated crop variety—newly introduced traits can potentially cross out into neighboring crop plants of the same species and, in some cases, to closely related wild relatives. Defenders of GM technology point out that each GM crop is assessed on a case-by-case basis to determine if there is any risk associated with the outcrossing of the GM trait into wild plant populations. The fact that a GM plant may outcross with a related wild relative is not, in itself, a risk unless such an occurrence has negative consequences. If, for example, an herbicide-resistance trait were to cross into a wild relative of a crop plant it can be predicted that this would not have any consequences except in areas where herbicides are sprayed, such as a farm. In such a setting the farmer can manage this risk by rotating herbicides.

The European Union funds research programs such as Co-Extra that investigate options and technologies on the coexistence of GM and conventional farming. This also includes research on biological-containment strategies and other measures to prevent outcrossing and enable the implementation of coexistence.

If patented genes are outcrossed, even accidentally, to other commercial fields and a person deliberately selects the outcrossed plants for subsequent planting then the patent holder has the right to control the use of those crops. This was supported in Canadian law in the case of Monsanto Canada Inc. v. Schmeiser.

Environmental risks and benefits

Concerns have been raised about effects of genetically-engineered crops on non-target species, and about gene flow to other plants and to bacteria. On the other hand, GM crops have their supports from an environmental standpoint.

Environmental benefits

Many agricultural scientists and food policy specialists view GM crops as an important element in sustainable food security and environmental management. This point of view is summarized in the ABIC Manifesto:

On our planet, 18% of the land mass is used for agricultural production. This fraction cannot be increased substantially. It is absolutely essential that the yield per unit of land increases beyond current levels given that: The human population is still growing, and will reach about nine billion by 2040; 70,000 km² of agricultural land (equivalent to 60% of the German agricultural area) are lost annually to growth of cities and other non-agricultural uses; Consumer diets in developing countries are increasingly changing from plant-based proteins to animal protein, a trend that requires a greater amount of crop-based feeds.

Other scientists, such as Dr. Charles Benbrook, argue that improvement of global food security is hardly being addressed by genetic research and that a lack of yield is often not caused by insufficient genetic resources. Regarding the issues of intellectual property and patent law, an international report from the year 2000 states:

If the rights to these tools are strongly and universally enforced - and not extensively licensed or provided pro bono in the developing world - then the potential applications of GM technologies described previously are unlikely to benefit the less developed nations of the world for a long time (i.e. until after the restrictions conveyed by these rights have expired).

Environmental concerns

Unintended toxicity on non-target species

The large scale growth of GM plants may have both positive and negative effects on the environment. These may be both direct effects, on organisms that feed on or interact with the crops, or wider effects on food chains produced by increases or decreases in the numbers of other organisms. As an example of benefits, insect-resistant Bt-expressing crops will reduce the number of pest insects feeding on these plants, but as there are fewer pests, farmers do not have to apply as much insecticide, which in turn tends to increase the number of non-pest insects in these fields. A 2006 study of the global impact of GM crops, published by the UK consultancy PG Economics, concluded that globally, the technology reduced pesticide spraying by 286,000 tons in 2006, decreasing the environmental impact of herbicides and pesticides by 15%. By reducing the amount of ploughing needed, GM technology led to reductions of greenhouse gases from soil equivalent to removing 6.56 million cars from the roads. However, a 2009 study published by the Organic Center stated that the use of genetically engineered corn, soybean, and cotton increased the use of herbicides by 383 million pounds (191,500 tons), and pesticide use by 318.4 million pounds (159,200 tons). A 2012 study of the effects of using Bt cotton in six northern provinces of China from 1990 to 2010 concluded that GM crops deliver significant environmental benefits. Bt cotton halved the use of pesticides and doubled the level of ladybirds, lacewings and spiders. The environmental benefits extended to neighbouring crops of maize, peanuts and soybeans.

As an example of a concern about environmental risk, a lab at Cornell University published an article which caused worry in the US that Bt-corn pollen might affect the monarch butterfly. However this concern was disproved by six comprehensive articles in the Proceedings of the National Academy of Sciences in 2001. Monarch populations increased, despite increased Bt corn probably due to reduced pesticide use. Other possible effects might come from the spread of genes from modified plants to unmodified relatives, which might produce species of weeds resistant to herbicides. In some areas of the US "superweeds" have evolved naturally; these weeds are resistant to herbicides and have forced farmers to return to traditional crop management practices.

There has been controversy over the results of a farm-scale trial in the United Kingdom comparing the impact of GM crops and conventional crops on farmland biodiversity. Some claimed that the results showed that GM crops had a significant negative impact on wildlife. They pointed out that the studies showed that using herbicide resistant GM crops allowed better weed control and that under such conditions there were fewer weeds and fewer weed seeds. This result was then extrapolated to suggest that GM crops would have significant impact on the wildlife that might rely on farm weeds. The President of the Royal Society, the body that had carried out the trials, stated that "To generalize and declare 'all GM is bad' or 'all GM is good' for the environment as a result of these experiments is a gross over-simplification", arguing that although the trials showed that the combination of some GM crops with long-lasting herbicides were bad for biodiversity, using other GM crops without these herbicides increased biodiversity.

Environmental contamination via gene flow

Genetically modified plants can spread the trans gene to other plants or – theoretically – even to bacteria. Depending on the transgene, this may pose a threat to the environment by changing the composition of the local ecosystem. Therefore, in most countries environmental studies are required prior to the approval of a GM plant for commercial purposes, and a monitoring plan must be presented to identify potential effects which have not been anticipated prior to the approval.

In July 2005 British scientists showed that transfer of a herbicide-resistance gene from GM oilseed rape to a wild cousin, charlock, and wild turnips was possible.

Transgenes have the potential for significant ecological impact if the plants can increase in frequency and persist in natural populations. These concerns are similar to those surrounding conventionally bred plant breeds. Several risk factors should be considered:

• Can the transgenic plant pass its genes to a local wild species, and are the offspring also fertile?
• Does the introduction of the transgene confer a selective advantage to the plant or to hybrids in the wild?

Many domesticated plants can mate and hybridise with wild relatives when they are grown in proximity, and whatever genes the cultivated plant had can then be passed to the hybrid. This applies equally to transgenic plants and conventionally bred plants, as in either case there are advantageous genes that may have negative consequences to an ecosystem upon release. This is normally not a significant concern, despite fears over 'mutant superweeds' overgrowing local wildlife: although hybrid plants are far from uncommon, in most cases these hybrids are not fertile due to polyploidy, and will not multiply or persist long after the original domestic plant is removed from the environment. However, this does not negate the possibility of a negative impact.

In some cases, the pollen from a domestic plant may travel many miles on the wind before fertilising another plant. This can make it difficult to assess the potential harm of crossbreeding; many of the relevant hybrids are far away from the test site. Among the solutions under study for this concern are systems designed to prevent transfer of transgenes, such as Terminator Technology, and the genetic transformation of the chloroplast only, so that only the seed of the transgenic plant would bear the transgene. With regard to the former, there is some controversy that the technologies may be inequitable and might force dependence upon producers for valid seed in the case of poor farmers, whereas the latter has no such concern but has technical constraints that still need to be overcome. Solutions are being developed by EU funded research programmes such as Co-Extra and Transcontainer.

There are at least three possible avenues of hybridization leading to escape of a transgene:

• Hybridization with non-transgenic crop plants of the same species and variety.
• Hybridization with wild plants of the same species.
• Hybridization with wild plants of closely related species, usually of the same genus.

However, there are a number of factors which must be present for hybrids to be created.

• The transgenic plants must be close enough to the wild species for the pollen to reach the wild plants.
• The wild and transgenic plants must flower at the same time.
• The wild and transgenic plants must be genetically compatible.

In order to persist, these hybrid offspring:

• Must be viable, and fertile.
• Must carry the transgene.

Studies suggest that a possible escape route for transgenic plants will be through hybridization with wild plants of related species.

1. It is known that some crop plants have been found to hybridize with wild counterparts.
2. It is understood, as a basic part of population genetics, that the spread of a transgene in a wild population will be directly related to the fitness effects of the gene in addition to the rate of influx of the gene to the population.  Advantageous genes will spread rapidly, neutral genes will spread with genetic drift, and disadvantageous genes will only spread if there is a constant influx.
3. The ecological effects of transgenes are not known, but it is generally accepted that only genes which improve fitness in relation to abiotic factors would give hybrid plants sufficient advantages to become weedy or invasive.  Abiotic factors are parts of the ecosystem which are not alive, such as climate, salt and mineral content, and temperature. Genes improving fitness in relation to biotic factors could disturb the (sometimes fragile) balance of an ecosystem. For instance, a wild plant receiving a pest resistance gene from a transgenic plant might become resistant to one of its natural pests, say, a beetle. This could allow the plant to increase in frequency, while at the same time animals higher up in the food chain, which are at least partly dependent on that beetle as food source, might decrease in abundance. However, the exact consequences of a transgene with a selective advantage in the natural environment are almost impossible to predict reliably.

Issues with Bt maize

A well publicized claim associated with Bt crops (or transgenic maize) was the concern that pollen from Bt maize might kill the monarch butterfly. This report was puzzling because the pollen from most maize hybrids contains much lower levels of Bt than the rest of the plant and led to multiple follow-up studies. One possible issue revealed in these studies is the possibility that the initial study was flawed; based on the way the pollen was collected, in that they collected and fed non-toxic pollen that was mixed with anther walls that did contain Bt toxin. A collaborative research exercise was carried out over two years by several groups of scientists in the US and Canada, looking at the effects of Bt pollen in both the field and the laboratory. This resulted in a risk assessment that concluded that any risk posed by the corn to butterfly populations under real-world conditions was negligible. The USDA has stated that the weight of the evidence is that Bt crops do not pose a risk to the monarch butterfly. An independent 2002 review of the scientific literature concluded that "the commercial large-scale cultivation of current Bt–maize hybrids did not pose a significant risk to the monarch population" and noted that despite large-scale planting of GM crops, the butterfly's population is increasing.

In 2007 Andreas Lang, Éva Lauber and Béla Darvas criticized these studies, arguing that there can be a great difference in the effects between the acute exposure tested for and chronic exposure. Moreover, they stated that the "worst case conditions" performed were not in fact worst case scenarios, as laboratory conditions with ample food supply and a favorable climate ensure healthy subjects. They instead believe that in the wild, low temperatures, rain and parasites and disease might exacerbate a Bt effect on butterfly larvae. Their own experiments suggested that some butterfly species were negatively affected by such chronic exposure. Jörg Romeis, who conducted the original studies, replied that if species of Butterfly are affected as Darvas claims that a "more comprehensive assessment will be needed and, depending on the degree and nature of concern, this may extend to field testing".

A 2001 report in Nature presented evidence that Bt maize was cross-breeding with unmodified maize in Mexico, although the data in this paper was later described as originating from an artifact and Nature stated that "the evidence available is not sufficient to justify the publication of the original paper". A subsequent large-scale study, in 2005, failed to find any evidence of contamination in Oaxaca. However, other authors have stated that they also found evidence of cross-breeding between natural maize and transgenic maize.

There is also a risk that for example, transgenic maize will crossbreed with wild grass variants, and that the Bt-gene will end up in a natural environment, retaining its toxicity. An event like this would have ecological implications. However, there is no evidence of crossbreeding between maize and wild grasses.

In 2009 it was reported that 82,000 hectares (200,000 acres) of Bt corn in South Africa failed to produce seeds. Monsanto claimed average yield was reduced by 25% in those fields affected, it compensated the farmers concerned and the corn varieties were affected by a mistake made in the seed breeding process. Marian Mayet, an environmental activitist and director of the Africa Centre for Biosecurity in Johannesburg, called for a government investigation and asserted that the biotechnology was at fault, "You cannot make a 'mistake' with three different varieties of corn". In 2009 South African farmers planted 1,900,000 hectares (4,700,000 acres) of GM maize (73% of the total crop).

As of 2007, a phenomenon called Colony Collapse Disorder (CCD) was noticed in bee hives all over North America, and elsewhere. Although it is not certain if this is a new phenomenon, initial ideas on the possible causes ranged from poor nutrition, infections, parasites and pesticide use. More unusual speculations included radio waves from cellphone base stations, climate change, and the use of transgenic crops containing Bt. The Mid-Atlantic Apiculture Research and Extension Consortium published a report on 2007-03-27 that found no evidence that pollen from Bt crops is adversely affecting bees. Several researchers in the US have since attributed CCD to the spread of a new virus called Israeli acute paralysis virus, although other parasites and the increase in use of neonicotinoid pesticides have also been implicated.

World Hunger

Some claim that the use of GM technology is important to help farmers to increase food production to avoid existing poverty, hunger, and malnutrition. “While new technology must be tested before it is commercially released, we should be mindful of the risks of not releasing it at all,” says Per Pinstrup-Andersen, professor of Food, Nutrition and Public Policy at Cornell University. Per Pinstrup-Andersen argues, “Misguided anti-science ideology and failure by governments to prioritize agricultural and rural development in developing countries brought us the food crisis.” He states that the challenge we face is not the challenge of whether we have enough resources to produce, but whether we will change our behavior.

While it is evident that there is a food supply issue, the question is whether GM can solve world hunger problems, or if there are better ways to address the issue. Several scientists argue that a second Green Revolution with increased use of GM crops is needed to meet the demand for food in the developing world. Others argue that there is more than enough food in the world and that the hunger crisis is caused by problems in food distribution and politics, not production. Recently, environmentalist Mark Lynas has changed his mind on the issue with respect to the need for additional food supplies.

“Genetic modification is analogous to nuclear power: nobody loves it, but climate change has made its adoption imperative,” says economist Paul Collier of Oxford University. "Declining genetic modification makes a complicated issue more complex. Genetic modification offers both faster crop adaptation and a biological, rather than chemical, approach to yield increases."

Impoverished nations

Some groups believe that impoverished nations will not reap the benefits of biotechnology because they do not have easy access to these developments, cannot afford modern agricultural equipment, and certain aspects of the system revolving around intellectual property rights are unfair to "undeveloped countries". For example, The CGIAR (Consultative Group of International Agricultural Research) is an aid and research organization that has been working to achieve sustainable food security and decrease poverty in undeveloped countries since its formation in 1971. In an evaluation of CGIAR, the World Bank praised its efforts but suggested a shift to genetics research and productivity enhancement. This plan has several obstacles such as patents, commercial licenses, and the difficulty that third world countries have in accessing the international collection of genetic resources and other intellectual property rights that would educate them about modern technology. The International Treaty on Plant Genetic Resources for Food and Agriculture has attempted to remedy this problem, but results have been inconsistent. As a result, "orphan crops", such as teff, millets, cowpeas, and indigenous plants, are important in the countries where they are grown, but receive little investment.

Agricultural surpluses

Patrick Mulvany, Chairman of the UK Food Group, accused some governments, especially the Bush administration, of using GM food aid as a way to dispose of unwanted agricultural surpluses. The UN blamed food companies and accused them of violating human rights, calling on governments to regulate these profit-driven firms. It is widely believed that the acceptance of biotechnology and genetically modified foods will also benefit rich research companies and could possibly benefit them more than consumers in underdeveloped nations.

Intellectual property and market dynamics

The seed industry is dominated by several seed and biotechnology firms. Firms have engaged in vertical integration, causing structural changes in the GM industry. It is reported that the speed of alliances within the industry makes competition almost non-existent.

Monsanto has purchased Asgrow and DeKalb Genetics Corporation to increase their market to 14 percent. Monsanto has also purchased Holden, which increased their influence in the branded seeds sales. They have also acquired Cargill's international seed business. Novartis combined with Ciba-Geigy and Northrup King to increase their market share in the seed industry. Dow Agrosciences bought Mycogen and a portion of Illinois Foundation Seeds. It is reported that in 2011, 73% of the global market is controlled by 10 companies.

Market power gives seed and biotechnology firms the ability to set or influence price, dictate terms, and act as a barrier to entry into the industry. It also gives firms the bargaining power over governments in policy making. Keith Mudd from the Organization for Competitive Markets says: "The lack of competition and innovation in the marketplace has reduced farmer's choices and enabled Monsanto to raise prices unencumbered." Detractors such as Greenpeace say that patent rights give corporations a dangerous amount of control over their product. Others claim that "patenting seeds gives companies excessive power over something that is vital for everyone."

Corporations say that they need product control in order to prevent seed piracy, to fulfill financial obligations to shareholders, and to invest in further GM development. DuPont spends $1.4 billion in research and development while Monsanto spends 9-10% of their sales in their research and development effort every year. The Action Group on Erosion, Technology and Concentration reported in 2008, "Monsanto, BSAF, DuPont, Syngenta, Bayer and Dow (and their biotech partners) have filled 532 patent documents on so-called "climate ready" genes at patent offices around the world."

In 2001, the USDA published an article showing that the concentration of market power in the seed industry has led to economies of scale that facilitated market efficiency because production costs have decreased, however, the move by some companies to divest their seed operations calls into question the long-term viability of these conglomerates.. Two economists, guest speakers on the AgBio Forum cite that the huge market power possessed by the small number of biotechnology companies in crop biotechnology could be beneficial in raising welfare despite the pricing strategies they practice because "even though price discrimination is often considered to be an unwanted market distortion, it may increase total welfare by increasing total output and by making goods available to markets where they would not appear otherwise."

In the case of Bt cotton in the United States, agriculture economists calculated that "world surplus [increased by] $240.3 million for 1996. Of this total, the largest share (59%) went to U.S. farmers. The gene developer, Monsanto, received the next largest share (21%), followed by U.S. consumers (9%), the rest of the world (6%), and the germplasm supplier, Delta and Pine Land Company (5%)."

In March 2010, the US Justice Department and the U.S. Department of Agriculture held a meeting in Ankeny, Iowa to look at the competitive dynamics in the seed industry. Christine Varney, who heads the antitrust division in the Justice Department, said that her team was investigating whether biotech-seed patents are being abused to extend or maintain companies’ dominance in the industry. A key issue is how Monsanto sells and licenses its patented trait that allows farmers to kill weeds with Roundup herbicide while leaving crops unharmed - the gene was in 93 percent of U.S. soybeans grown in 2009. About 250 family farmers, consumers and other critics of corporate agriculture held a town meeting prior to the governmental meeting to protest Monsanto for what they see as manipulation of the market by buying up independent seed companies, patenting the seeds and then raising seed prices. One corn and soybean farmer said he has a hard time finding seed to plant that is not controlled by Monsanto: "This monopolistic system is rigged against family farmers." The group hopes to re-establish farmer rights to save seed from their harvested crops and replant it. However, as an attorney who is not directly involved stated: "'At the end of the day, they (state and federal prosecutors and farmers) may not be able to do much with it because of the scope of those patents. In almost all the cases, the courts come out on the side of intellectual property.'"

Private investments

The development and implementation of policies designed to encourage private investments in research and marketing biotechnology that will meet the needs of poverty-stricken nations, increased research on other problems faced by poor nations, and joint efforts by the public and private sectors to ensure the efficient use of technology developed by industrialized nations have been suggested. In addition, industrialized nations have not tested GM technology on tropical plants, focusing on those that grow in temperate climates, even though undeveloped nations and the people that need the extra food live primarily in tropical climates. Some European scientists are concerned that political factors and ideology prevent unbiased assessment of GM technology in some EU countries, with a negative effect on the whole community.

Environmental contamination

In May 2012, a group called "Take the Flour Back" led by Gerald Miles protested against plans by a group from Rothamsted Experimental Station, based in Harpenden, Hertfordshire, England, to stage an experimental trial to use genetically modified wheat to repel aphids. The researchers, led by John Pickett, wrote a letter to the group "Take the Flour Back" in early May 2012, asking them to call off their protest, aimed for May 27, 2012.. One of the members of Take the Flour Back, Lucy Harrap, said that the group was concerned about spread of the crops into nature, and cited examples of outcomes in the United States and Canada. Rothamsted Research and Sense About Science ran question and answer sessions with scientists about issues of contamintion.

Trade in Europe and Africa

In response to negative public opinion, Monsanto announced its decision to remove their seed cereal business from Europe, and environmentalists crashed a World Trade Organization conference in Cancun that promoted GM foods and was sponsored by Committee for a Constructive Tomorrow (CFACT). Some African nations have refused emergency food aid from developed countries, fearing that the food is unsafe. During a conference in the Ethiopian capital of Addis Ababa, Kingsley Amoako, Executive Secretary of the United Nations Economic Commission for Africa (UNECA), encouraged African nations to accept genetically modified food and expressed dissatisfaction in the public's negative opinion of biotechnology.

"Terminator" and "traitor"

An often-cited controversy is a "Technology Protection" technology dubbed 'Terminator'. This uncommercialized technology would allow the production of first-generation crops that would not generate seeds in the second generation because the plants yield sterile seeds. There are several patents for this so-called "terminator" gene technology; some are owned by Delta and Pine Land Company and the United States Department of Agriculture. Delta and Pine Land was bought by Monsanto Company in August 2006. Similarly, the hypothetical trait-specific Genetic Use Restriction Technology, also known as 'Traitor' or 'T-GURT', requires application of a chemical to genetically modified crops to reactivate engineered traits. This technology is intended both to limit the spread of genetically engineered plants, and to require farmers to pay yearly to reactivate the genetically engineered traits of their crops. Genetic Use-Restriction Technology is under development by companies including Monsanto and AstraZeneca.

In addition to the commercial protection of proprietary technology in self-pollinating crops such as soybean (a generally contentious issue), another purpose of the terminator gene is to prevent the escape of genetically modified traits from cross-pollinating crops into wild-type species by sterilizing any resultant hybrids. Some environmentalist groups, while considering outcrossing of GM plants dangerous, feel the technology would prevent re-use of seed by farmers growing such terminator varieties in the developing world and is ostensibly a means to exercise patent claims. However, other environmental groups welcome the terminator gene as a means of preventing GM crops from mixing with natural crops.

Hybrid seeds were commonly used in developed countries long before the introduction of GM crops. Some hybrid crop seeds cannot be saved, so purchasing new seed every year is already a standard agricultural practice for a majority of farms.

There are technologies evolving that contain the transgene by biological means and still can provide fertile seeds using fertility-restorer functions. Such methods are being developed by several EU research programs, among them Transcontainer and Co-Extra.

Industrial agriculture

GM crops play a key role in contemporary large scale agriculture, which involves monoculture, heavy use of herbicides and pesticides, use of equipment that requires large amounts of fuel, and heavy water use. Vandana Shiva, the founder of the group Navdanya, is an example of those who protest this paradigm: “We need biodiversity intensification that works with nature’s nutrient and water cycles, not against them.”

Legal issues in the US

In May 2000, the Clinton administration’s Council on Environmental Quality and the Office of Science and Technology established a committee. This committee was set up to conduct a six-month investigation into the safety of the foods and to make sure that all federal regulations were upheld. After the investigation, the committee was to report and if necessary make suggestions in order to improve the process. The committee did a large amount of research, but did not make any recommendations.

Alfalfa

In 2006, a coalition of groups led by the Center for Food Safety raised concerns about environmental impacts that they believe the United States Department of Agriculture (USDA) failed to address before approving planting of Roundup Ready alfalfa. Organic growers were concerned that the GM alfalfa could cross-pollinate with their organic alfalfa, making their crops unsalable in countries that ban the growing of GM crops. In response, the California Northern District Court ruled that the United States Department of Agriculture (USDA) was in error when it approved planting. According to the presiding judge, Charles Breyer, the law required the USDA to first conduct a full environmental study, which had not been done. In June 2009, a divided three-judge panel on the 9th U.S. Circuit Court of Appeals upheld Breyer's decision. Monsanto appealed to the US Supreme Court and on 21 June 2010, in Monsanto Co. v. Geertson Seed Farms, they issued its first ruling regarding GM crop. The impact of the US Supreme Court ruling was somewhat unclear, with both sides appearing to claim victory. While Monsanto claimed technical victory the planting of GM alfalfa was halted.

In January 2011, despite protests from organic groups, Agriculture Secretary Tom Vilsack announced that the USDA had approved the unrestricted planting of genetically modified alfalfa. Agriculture Secretary Tom Vilsack commented "After conducting a thorough and transparent examination of alfalfa ... APHIS [Animal and Plant Health Inspection Service] has determined that Roundup Ready alfalfa is as safe as traditionally bred alfalfa." About 20 million acres (8 million hectares) of alfalfa were grown in the US, the fourth-biggest crop by acreage, of which about 1% were organic. Some biotechnology officials forecast that half of the US alfalfa acreage could eventually be planted with GM alfalfa.

Christine Bushway, CEO of the Organic Trade Association said "A lot of people are shell shocked. While we feel Secretary Vilsack worked on this issue, which is progress, this decision puts our organic farmers at risk." The Organic Trade Association issued a press release in 2011 saying that the USDA recognized the impact that cross contamination could have on organic alfalfa and urged them to place restrictions to minimise any such contamination. Following the decision, organic farming groups, organic food outlets, and activists responded by publishing an open letter saying that planting the "alfalfa without any restrictions flies in the face of the interests of conventional and organic farmers, preservation of the environment, and consumer choice." Commenting on the ruling, in a Joint Statement U.S. Senator Patrick Leahy and Representative Peter DeFazio said the USDA had the "opportunity to address the concerns of all farmers", but instead "surrender[ed] to business as usual for the biotech industry." The Center for Food Safety appealed this decision but in 2012 the US District Court for Northern California rejected this appeal.

Sugar beets

There is also a somewhat similar case involving sugar beets before the same California Northern District Court. This is a case involving Monsanto's breed of pesticide-resistant sugar beets. While Judge Jeffrey S. White (issuing his ruling in the spring of 2010) allowed the planting of GM sugar beets to continue, he also warned that this may be blocked in the future while an environmental review is taking place.

On 13 August 2010, Judge Jeffrey S. White ordered the halt to the planting of the genetically modified sugar beets in the US. He indicated that "the Agriculture Department had not adequately assessed the environmental consequences before approving them for commercial cultivation."

In 2010, before the ruling, 95% of the sugar beet grown in the US was GM. About half the sugar supply in the US came from sugar beet.

In February 2011, a federal appeals court for the Northern district of California in San Francisco overturned a previous ruling by Judge Jeffrey S. White to destroy juvenile GM sugar beets, ruling in favor of Monsanto, the Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) and four seed companies. The court concluded that " The Plaintiffs have failed to show a likelihood of irreparable injury. Biology, geography, field experience, and permit restrictions make irreparable injury unlikely."

In February 2011, The USDA allowed commercial planting of GM sugar beet in the US under closely controlled conditions. Michael Gregoire from APHIS said "After conducting an environmental assessment, accepting and reviewing public comments and conducting a plant pest risk assessment, APHIS has determined that the Roundup Ready sugar beet root crop, when grown under APHIS imposed conditions, can be partially deregulated without posing a plant pest risk or having a significant effect on the environment." GM sugar beet opponents such as Earthjustice said the USDA action circumvents court orders, and vowed they would fight the USDA in court.

India

Controversies over GM crops and GM food in India have recapitulated many of the issues discussed in this article, but have unique aspects as well.

In India, GM cotton yields in Maharashtra, Karnataka, and Tamil Nadu had an average 42% increase in yield with GM cotton in 2002, the first year of commercial GM cotton planting. However, there was a severe drought in Andhra Pradesh that year and the parental cotton plant used in the genetic engineered variant was not well suited to extreme drought, so Andhra Pradesh saw no increase in yield. Drought resistant variants were developed and, with the substantially reduced losses to insect predation, by 2011 88% of Indian cotton was GM. Though disputed the economic and environmental benefits of GM cotton in India to the individual farmer have been documented. However, recently cotton bollworm has been developing resistance to Bt cotton and the Indian Agriculture Ministry linked farmers' suicides in India to the declining performance of Bt cotton for the first time. Consequently, in 2012 the state of Maharashtra banned Bt cotton and ordered a socio-economic study of its use by independent institutes.

Controversial cases

Pusztai affair

Main article: Pusztai affair

The Pusztai affair is a controversy that began in 1998 after Arpad Pusztai, an expert on plant lectins, went public with research he was conducting with genetically modified potatoes. Prior to Pusztai's research, no peer-reviewed studies regarding the safety of genetically modified food had been published and the controversy led to Pusztai's research being peer reviewed in 1999.. In a short interview in 1998, he reported that rats fed potatoes engineered to express lectin, a natural insecticide in snowdrop plants, had stunted growth and a repressed immune system. Confusion arose as to what gene had been inserted into the potato and Pusztai was suspended by the Rowett Institute's director, Philip James. A media frenzy resulted, Pusztai's contract was not renewed and he and his wife were banned from speaking publicly.

In October 1998 the Rowett Institute published an audit criticizing Pusztai's results, which, along with Pusztai's raw data, was sent to six anonymous reviewers who criticized Pusztai's results. Pusztai responded that the raw data was "never intended for publication under intense scrutiny". Pusztai sent the audit report and his rebuttal to scientists who requested it, and in February 1999, twenty-one European and American scientists released a memo supporting Pusztai. Stanley Ewen, who worked with Pusztai, conducted a followup study supporting Pusztai's work and presented the work to a lectin meeting in Sweden.

In October 1999 Pusztai's research was published (co-authored with Stanley Ewen) in the journal The Lancet. Because of the controversial nature of his research, the data in this paper was seen by a total of six reviewers when presented for peer review; four of these reviewers judged the work acceptable, although a fifth "deemed the study flawed but favored publication to avoid suspicions of a conspiracy against Pusztai and to give colleagues a chance to see the data for themselves". The paper did not mention stunted growth or immunity issues, but reported that rats fed on potatoes genetically modified with the snowdrop lectin had "thickening in the mucosal lining of their colon and their jejunum" when compared with rats fed on non modified potatoes. Three Dutch scientists criticized the study on the grounds that the unmodified potatoes were not a fair control diet, and that any rats fed only on potatoes will suffer from a protein deficiency; Pusztai responded to these criticisms by stating that the protein and energy were comparable, and that "a sample size of six is perfectly normal in studies like this".

Bioequivalence study of a corn cultivar

A controversy arose around biotech company Monsanto's data on a 90-Day Rat Feeding Study on the MON863 strain of GM corn. In May 2005, critics of GM foods pointed to differences in kidney size and blood composition found in this study, suggesting that the observed differences raises questions about the regulatory concept of substantial equivalence. Anti-GM campaigner Jeffrey M. Smith, writing in Biophile Magazine, quoting comments from Pusztai and Seralini,has stated that nutritional studies typically use young, fast-growing animals with starting weights not varying by more than 2% from the average whereas Monsanto's research design used a mix of young and old animals with starting weights ranging from 198.4 to 259.8 grams. Seralini and two other authors published a study of these data, funded by Greenpeace, in 2007 making similar points.

The raising of this issue prompted the European Food Safety Authority (EFSA) to reexamine the safety data on this strain of corn. The EFSA concluded that the observed small numerical decrease in rat kidney weights were not biologically meaningful, and the weights were well within the normal range of kidney weights for control animals. There were no corresponding microscopic findings in the relevant organ systems, and they stated that all blood chemistry and organ weight values fell within the "normal range of historical control values" for rats. In addition the EFSA review stated that the statistical methods used by Séralini et al. in the analysis of the data were incorrect. The European Commission has approved the ΜΟΝ863 corn for animal and human consumption. Food Standards Australia New Zealand reviewed the 2007 Seralini et al. study and concluded that "...all of the statistical differences between rats fed MON 863 corn and control rats are attributable to normal biological variation."

Greenpeace stated in a 2007 press release that Séralini et al. had completed a similar analysis of the NK603 strain of corn and came to similar conclusions as they did in their previous study. Séralini et al. included this in a re-analysis of three existing rat feeding studies published in 2009.

The European Food Safety Authority reviewed the 2009 Seralini et al. paper and concluded that the author's claims were not supported by the data in their paper. They noted that many of their fundamental statistical criticisms of the 2007 paper also applied to the 2009 paper. There was no new information that would change the EFSA's conclusions that the three GM maize types were safe for human, animal health and the environment The French High Council of Biotechnologies Scientific Committee (HCB) also reviewed the 2009 study and concluded that it "..presents no admissible scientific element likely to ascribe any haematological, hepatic or renal toxicity to the three re-analysed GMOs." The HCB also questioned the author's independence. Food Standards Australia New Zealand concluded that the results from the 2009 Séralini et al. study were due to chance alone.

Contamination issues

In the 1990s genetically modified Flax tolerant to herbicide residues in soil was developed by the Crop Development Centre (CDC) at the University of Saskatchewan in Canada.

In 2000, Aventis StarLink corn, which had been approved only as animal feed due to concerns about possible allergic reactions in humans, was found contaminating corn products in U.S. supermarkets. An episode involving Taco Bell taco shells was particularly well publicized which resulted in sales of StarLink seed being discontinued. The registration for the Starlink varieties was voluntarily withdrawn by Aventis in October 2000. Aid sent by the UN and the US to Central African nations was also found to be contaminated with StarLink corn and the aid was rejected. The US corn supply has been monitored for Starlink Bt proteins since 2001 and no positive samples have been found since 2004.

GeneWatch UK and Greepeace International set up the GM Contamination Register in 2005.

In 2011, researchers (scientists from the University of Arkansas, North Dakota State University, California State University and the US Environmental Protection Agency) discovered large persistent populations of genetically engineered canola 1 (Rapeseed) lining roadsides across the whole of North Dakota. Comprising up to 45% of roadside plants sampled, it was also found that the GE Rapeseed was able to hybridise to create novel combinations of transgenic traits. Despite reports of contamination from Australia, Germany, the UK, France and Japan over the ten years since GE Rapeseed was introduced, according to the researchers, the lack of reports in the US suggests inadequate oversight and monitoring protocols are in place in the US.

Destruction of trial crops

Within the UK and many other European countries many trial crops have been destroyed by protesters: for public research experiments alone, 80 acts of destruction have been compiled. The protesters claim the destruction of the crops creates opportunities to be heard. The primary concern of the campaigners though is contamination of existing crops could destroy existing markets. (organic produce) Scientists take many precautions to minimise the risks as much as possible and admit the risk of contamination is small. However, campaigners counter with examples of widespread contamination that has already occurred despite assurances and promises from scientists. The scientists give several reasons for the need for trials - climate change, a growing global population and reduced use of chemicals. The campaigners draw attention to natural and organic solutions to reduce chemical use and question the usefulness of the trials (e.g. field trials in the UK for a crop designed for Africa) k Environment News Service (http://s.tt/1ktea)

Public perception

An advocate for full disclosure in food labeling

Research by the Pew Initiative on Food and Biotechnology has shown that in 2005 Americans' knowledge of genetically modified foods and animals continues to remain low, and their opinions reflect that they are particularly uncomfortable with animal cloning. In one instance of consumer confusion, DNA Plant Technology's Fish tomato transgenic organism was conflated with Calgene's Flavr Savr transgenic food product. The Pew survey also showed that despite continuing concerns about GM foods, American consumers do not support banning new uses of the technology, but rather seek an active role from regulators to ensure that new products are safe.

Only 2% of Britons were said to be "happy to eat GM foods", and more than half of Britons were against GM foods being available to the public, according to a 2003 study. However a 2009 review article of European consumer polls concluded that opposition to GMOs in Europe has been gradually decreasing. Approximately half of European consumers accepted gene technology, particularly when benefits for consumers and for the environment could be linked to GMO products. 80 % of respondents did not cite the application of GMOs in agriculture as a significant environmental problem. Many consumers seem unafraid of health risks from GMO products and most European consumers did not actively avoid GMO products while shopping.

In Australia, GM foods that have novel DNA, novel protein, altered characteristics or has to be cooked or prepared in a different way compared to the conventional food have, since December 2001, had to be identified on food labels. However, multiple surveys have shown that while 45% of the public will accept GM foods, some 93% demand all genetically modified foods be labelled as such. A 2007 survey by the Food Standards Australia and New Zealand found that 27% of Australians looked at the label to see if it contained GM material when purchasing a grocery product for the first time. Labelling legislation has been introduced and rejected several times since 1996 on the grounds of "restraint of trade" due to the cost of labelling. The controversy erupted again in 2009 when Graincorp, the nations largest grain handler, announced it would mix GM Canola with its unmodified grain. Traditional growers, who largely rely on GM-free markets, had been told they would need to pay to have their produce certified GM free. Graincorp reversed its decision the same year. Critics such as Greenpeace and the Gene Ethics Network have renewed calls for more labelling.

Opponents of genetically modified food often refer to it as "Frankenfood", after Mary Shelley's character Frankenstein and the monster he creates, in her novel of the same name. The term was coined in 1992 by Paul Lewis, an English professor at Boston College who used the word in a letter he wrote to the New York Times in response to the decision of the US Food and Drug Administration to allow companies to market genetically modified food. The term "Frankenfood" has become a battle cry of the European side in the US-EU agricultural trade war.

Critics have protested in regards to the appointment of pro GM lobbyists to senior positions in the FDA. Michael R. Taylor has been appointed as a senior adviser to the FDA on food safety and Dennis Wolff is expected to take up the position of Under-Secretary of the newly created Agriculture for Food Safety. Taylor is a former Monsanto lobbyist credited as being responsible for the implementation of "substantial equivalence" in place of food safety studies and for his advocacy that resulted in the Delaney clause that prohibited the inclusion of "any chemical additive found to induce cancer in man.. or animals" in processed foods being amended in 1996 to allow the inclusion of pesticides in GMOs. Wolff is the Pennsylvania Secretary of Agriculture who successfully lobbied to ban organic farmers from labeling their products as being GM free and was a proponent of the "ACRE" initiative which gave the Pennsylvania state attorney general's office the authority to sue municipalities that banned GMOs. Several anti-GMO organisations have organised petitions demanding Taylor's resignation and opposing Wolff's appointment and also conducted letter writing campaigns protesting the conflict of interest.

Religious issues

Main article: Religious views on genetically modified foods

As of yet, no GM foods have been designated as unacceptable by religious authorities.

See also

• International trade of genetically modified foods
• Environmental issues with agriculture
• Ice-minus bacteria
• Corngate
• Arpad Pusztai
• Nayakrishi

External links

Opponents

• Soil Association
• Center for Food Safety
• Greenpeace
• Sierra Club

Advocates

• Council for Biotechnology Information
• AgBioWorld
• BioTech Now

Governmental

• German Federal Ministry of Education and Research
• UK Food Standards Agency
• European Food Safety Authority
• Government of Canada BioPortal

Medical and scientific

• NIH National Library of Medicine
• Royal Society