Transgenic corn
As Transgenic maize ( GM maize , GM maize ) is genetically modified maize designated.
In the case of transgenic maize varieties, certain genes from other organisms are introduced into the maize genome with the aim of improving the control of insect pests in Bt maize and facilitating weed control in herbicide-resistant maize or herbicide-tolerant maize .
Like other applications of green genetic engineering , transgenic maize is also controversial , especially among the European public . Sections of science and representatives from politics and industry point to increases in yield and income, a reduction in the use of herbicides and the associated lower environmental impact as well as easier weed control. Representatives from environmental and consumer groups, political parties as well as some experts assume ecological and health risks. Potential health and environmental risks have been the subject of controversy for years, particularly in the EU and Germany. In several EU countries, including Germany, the cultivation of transgenic maize is prohibited. In particular, political decision-makers cited potential environmental risks as reasons.
However, there is broad scientific consensus that transgenic maize does not pose any higher health risks than maize from conventional breeding.
Genetic goals
Depending on the desired property, the plants can have the following characteristics (also in combination):
- Resistance to broad spectrum herbicides (such as Roundup ) to make weed control easier.
- Insect resistance (e.g. to the corn rootworm or European corn borer )
- Resistance to various insect pests through the introduction of Bt toxins , which are deadly for certain insect species ( Bt maize ).
- As the first representative of this target group of GM plants, drought- tolerant maize is bred.
- The aim of the research is, for example, better digestion of corn starch and thus more effectiveness in the production of bioethanol or improved feed properties.
Overview of genetically modified maize varieties
There are hundreds of genetically modified maize varieties around the world. They are classified according to the transformation event , the so-called event , by the Agency International Service for the Acquisition of Agri-Biotech Applications (ISAAA) and their approval is registered in the various countries. This file contains a total of 231 events for maize, with several properties often being combined in one event (stacked events). Among the commercial varieties, most events concern herbicide tolerance with 203 events, followed by insect resistance (202), altered product quality (12), drought tolerance (6), pollination control (6) and enlarged cob (1).
| Brand name | Event | Herbicide tolerance | Herbicide tolerance | Insect Resistance Genes |
|---|---|---|---|---|
| glyphosate | Glufosinate | |||
| Agrisure GT | GA21 | + | ||
| RoundUp Ready 2 | NK603 | + | ||
| Liberty Link | T25 | + | ||
| Herculex | TC1507 | + | Cry1F | |
| Agrisure RW | MON810 * | Cry1 Fig | ||
| YieldGard ™ Rootworm RW | MON863 | Cry3Bb1 | ||
| Agrisure CB / LL | Bt11 | + | Cry1 Fig | |
| Maximizer ™ | Bt176 | + | Cry1 Fig | |
| Agrisure GT / CB / LL | Bt11 + GA21 | + | + | Cry1 Fig |
| SmartStax | MON88017 + MON89034 + DAS59122-7 + TC1507 | + | + | Cry3Bb1 + Cry1A.105 + Cry2Ab2 + Cry34Ab1 + Cry35Ab1 + Cry1F |
| Agrisure Viptera 3220 | Bt11 + GA21 + MIR162 + TC1507 | + | + | Cry1Ab + Vip3Aa20 + Cry1F |
Herbicide tolerant corn
To make it easier to control weeds when growing maize, herbicide resistance genes have been integrated into the maize genome. Initially, the Monsanto company introduced glyphosate resistance so that the GM maize RoundUp Ready 2 (Event NK603) is resistant to glyphosate (brand name Roundup ). The company Bayer AG put the gene for resistance to glufosinate , to perform a resistance to glufosinate (brand name Liberty to achieve). This transgenic corn is being marketed as Liberty Link (Event T25).
As certain weeds became resistant to these herbicides after a few years, individual maize varieties have been developed that contain both glyphosate and glufosinate resistance. Since weeds that are resistant to both glyphosate and glufosinate also appeared in some cases, other resistance genes were also introduced into maize plants. In 2017 the maize varieties areOptimum ™ GAT ™ andEnlist ™ approved for cultivation, which impart resistance to the herbicides sulfonylureas and 2,4-dichlorophenoxyacetic acid .
Insect-resistant corn
Bt corn
GM maize, which is insect-resistant , was developed to prevent insect damage from eating maize . For this purpose, genes of the bacterium Bacillus thuringiensis were introduced . B. thuringiensis is a global common soil bacterium whose subspecies over 200 different proteins ( Bt toxins produce), each specific to certain species of insects on the larvae of the orders beetles , butterflies , Diptera and Hymenoptera and nematodes cause death. These include important maize pests such as the European corn borer ( Ostrinia nubilalis ), the western corn rootworm ( Diabrotica virgifera ) and the Ypsilone owl ( Agrotis ipsilon ). In North and South America, the autumn army worm ( Spodoptera frugiperda ), the western bean cutter ( Striacosta albicosta , Western Bean Cutworm ) and the stalk borer ( Papaipema nebris ) also occur. The genetically modified plant forms an initially non-toxic precursor of the toxin (protoxin). It is only converted into the active form in the intestines of certain insects. This toxin binds to certain receptors on the insect's intestinal wall and begins to break them down, resulting in starvation . Bt toxins are considered harmless to humans, vertebrates and plants. They are biodegradable, but are released into the soil via the roots. Studies came to different results with regard to the rate of degradation (a few days to several months), which primarily depends on various soil properties. B-toxins have been used as preparations (suspensions) for decades in biological crop protection and are also approved in organic farming , for example against the European corn borer under the trade name Dipel ES .
The constant presence of protoxin in the plant differs from the periodic application of biological or chemical insecticides in that the harmful insects are constantly exposed to the poison. Another difference compared to the use of Bt suspensions is that pests eat the poison directly with their food (corn plant) instead of ingesting the suspension separately. Compared to conventional maize, which is sprayed with chemical insecticides, Bt maize has greater precision, since pests are controlled in a more targeted manner and non-target organisms that do not feed on maize are not affected.
Well-known suppliers of Bt maize are Monsanto , Syngenta , Pioneer Hi-Bred and Corteva .
The first data on resistance to Bacillus thuringiensis toxins appeared in 2002, and in 2016 twelve independent cases were described in which maize pests were resistant to certain Bt toxins. In order to cover up the development of resistance to the Bt toxins, several Bt toxins were initially used at the same time. So contains SmartStax Monsanto six different Bt toxins. Since this approach was only partially successful, completely different toxins from Bacillus thuringiensis , the so-called Vip proteins, were used, which act via a different receptor in the intestinal wall of the insects. These Bt toxins are also often combined with several other Bt toxins, for example in the Agrisure Viptera 3220 maize variety .
RNA interference
A completely different approach to circumventing the development of resistance to Bt toxins is to fight the pest through RNA interference by stably inserting short pieces of DNA from genes of the harmful insects . Since the RNA interference requires a sequence similarity between the introduced DNA piece and the gene in the target organism, a high specificity is possible with a suitable choice of the sequence. A 240 base pair DNA sequence from the Sfn7 gene of the western corn rootworm shows high specificity against the western corn rootworm and is only effective against a few closely related beetle species. Several maize varieties that contain this 240 base pair piece of DNA from the Western corn rootworm Snf7 gene have been approved for commercial cultivation in several countries since 2015.
Changed product quality
Animal feed maize (phytase maize)
A high proportion of the phosphate in plants is bound in phytate and cannot be ingested by non-ruminating farm animals such as pigs and poultry. The absorption of phosphate can be made possible by adding phytase to animal feed. The Chinese authorities approved phytase maize for cultivation in 2009. Phytase maize was developed by Chinese research institutes and, as a result of an introduced gene, forms the enzyme phytase, which enables pigs and poultry to utilize the phytate phosphorus contained in maize feed. At the same time, the environmental impact is reduced, since liquid manure and manure are less contaminated with phosphates.
Alternatively, the endogenous phytate concentration in a crop can be reduced by inactivating the IPK1 gene, which is responsible for phytate synthesis, through genome editing . The corresponding genome-edited maize is not classified as a genetically modified organism in the USA .
Storage Tolerant Corn (Avidin Corn)
With the avidin maize, a transgenic maize has been developed in the laboratory that is able to produce the chicken egg protein avidin in concentrations of over 100 ppm. Avidin protects the maize against pest infestation during storage, since when the avidin is ingested, the biotin is bound in the harmful insects and the pests die from a lack of biotin. However, the lower availability of biotin due to the presence of avidin makes transgenic maize unsuitable as food crops, so that no corresponding maize variety has been developed for commercial cultivation.
Ethanol Corn (Amylase Corn)
Corn is increasingly grown for the production of ethanol (in the USA about 40% of the corn cultivation area). Here, the vegetable starch is converted into sugar by adding amylases , which is then converted into bio- alcohol through alcoholic fermentation . The company Syngenta has the maize Enogen ™ developed that contains a heat-stable bacterial alpha-amylase and thus enables a more efficient starch degradation. As there are concerns that Enogen maize could contaminate normal maize varieties and thus the quality of maize products could be impaired, the farmers should sign a contract with Syngenta to ensure a safe delivery to the processing plants.
Corn with increased lysine content
Since maize contains relatively little lysine , an essential amino acid for human and animal nutrition , attempts are being made using genetic engineering methods to increase the lysine content. In the transgenic maize variety LY038 (trade name Mavera TM ) the content of free lysine was increased by stimulating the lysine synthesis by introducing a gene from the bacterium ( Corynebacterium glutamicum ). Mavera TM has been approved for commercial cultivation as animal feed in the USA since 2006, but has barely established itself in the market.
Corn with enlarged ears
So far, hardly any GM plants have been developed that have a larger biomass. The maize variety MON87403 from Monsanto is the only maize variety that forms enlarged ears by introducing a gene from the narrow wall of the field . It has been approved for cultivation in the USA and Canada since 2015. It is still unclear whether it will establish itself in commercial cultivation.
Drought tolerant corn
In bacteria of the species Bacillus subtilis , which survive extreme cold, the cspB gene was identified, which can also help plants through stressful situations such as drought . A drought-resistant maize equipped with this cspB gene, which was jointly developed by BASF and Monsanto , has been grown commercially as Genuity® DroughtGard ™ since 2011 and has been approved as food and feed in the European Union since 2015. Field trials by more than 2000 farmers in the so-called corn belt of the USA show an increase in yield of around 7% and are therefore on par with conventional dry breeding. Corresponding maize varieties are to be released to farmers in Africa without a license.
Fertilization control
Commercial maize is predominantly a hybrid of two different inbred lines , as these hybrids have much better yield characteristics due to the heterosis effect . In order to obtain pure hybrids, male pollen donors are planted with female pollen donors, whereby self-pollination must be prevented. Since maize is a monoecious plant with female cobs and male paniculate inflorescences , removing the male inflorescences can prevent pollen recipients from self-pollination. In order to avoid this time-consuming manual work, Bayer AG produced sterile male maize ( InVigor ™ Maize ) in which the gene that codes for a bacterial RNase is active in the tapetum of the pollen sacs and thus suppresses pollen formation. The corresponding hybrids are transgenic.
As an alternative, the Pioneer company has developed a system in which the hybrids are not transgenic. For this purpose the SPT maintainer line 32138 was produced, which is homozygous male-sterile. Three gene constructs were introduced into this line in order to control male fertility reversibly. The resulting hybrid lines contain no transgene and the SPT maintainer line has been approved for cultivation in the USA since 2011.
Cultivation
GM maize is grown on a large scale and used primarily as food crops for livestock and for the production of bioethanol . The acreage has increased steadily since 2011, with only a slight decrease in 2014 and 2015. In 2016, 60.6 million hectares of GM maize were planted worldwide , which corresponds to around 33% of the total area of maize cultivation and makes transgenic maize the second largest transgenic crop after soy . Of this, 6 million hectares were insect-resistant , 7 million hectares were herbicide-resistant and the remaining 47.6 million hectares were maize, which was simultaneously insect and herbicide-resistant (stacked traits). Other traits are of little commercial interest.
Most of the cultivation fields in 2016 are in the USA and Brazil . The rest is spread over 14 countries. In the EU , GM maize has only been grown in Spain, Portugal, Slovakia and the Czech Republic since 2015. This corresponds to a share of less than 0.2% of the global area. GM varieties account for around 35 percent of maize production in Spain. In 2017, apart from Spain, GM maize was only grown in Portugal. In relation to all 28 EU member states, the proportion of GM maize is very low at 1.5 percent of the total cultivated area .
There are certain cultivation rules for Bt maize , which are intended to avoid the development of resistance to eating insects. Accordingly, 20% of the area (in some areas even 50%) must be cultivated as retreats with varieties that are harmless to insects.
Economic impact
Genetically modified maize varieties are rarely grown in the European Union . However, 27 different genetically modified varieties are approved for import as food and feed.
For 2015, global revenue growth from increased yields and reduced production costs for herbicide-resistant and insect-resistant corn was calculated to be $ 1.8 billion and $ 4.46 billion, respectively . The economic benefits of growing GM maize are confirmed in a comprehensive analysis of published data by the National Academies of Sciences, Engineering, and Medicine . This applies in particular to insect-resistant maize, while in the case of herbicide-resistant maize, simplified cultivation is seen as advantageous. The study indicates that the data situation with regard to an increased income can vary greatly in individual cases. A study published in 2019 shows that in Spain and Portugal, where Bt maize has been planted on 30 to 35% of the maize areas since 1998, the yield has increased by 11.5%, resulting in an income per hectare that has increased by 173 euros .
Admission regulations
There is no globally standardized procedure for the approval of GM plants and therefore also not for GM maize. Every country has its own laws. An overview can be found in the database GM Approval Database , which is continuously compiled by the international nonprofit organization International Service for the Acquisition of Agri-biotech Applications (ISAAA) . As a rule, approval for cultivation is separate from approval as food and feed.
Approval guidelines in Europe
In the European Union , approvals as feed and food for 50 transgenic maize lines were obtained in 2018. In 2018, only the MON810 maize variety with insect resistance is permitted for cultivation . Since 2015, it has been possible for every country in the EU to decide independently to ban GM plants on its territory. This exit clause, which is used by 17 member states, including Germany and Austria, and four regions, prohibits the cultivation of MON810 in these countries. The opt-out clause was introduced in the EU in order to simplify the approval procedures, which were sometimes highly controversial in different countries. However, it has not significantly improved the problem of GMO approval in the EU.
Due to the still prevailing legal uncertainty regarding GMO admixtures in seeds, authorities in Germany react inconsistently to small proportions of GMO seeds in conventional batches. In 2009, according to the authorities, minor traces (0.1%) of line NK603 were found in maize seeds at the detection limit , which is approved as food and feed, but not for cultivation.
Outside the EU, the three GM maize lines Bt176 , Bt11 and MON810 are approved for import as food and feed in Switzerland . In addition, there is a general ban on growing GM plants in Switzerland until 2021. In Russia , 12 GM maize varieties are only permitted as food and feed.
Admission regulations outside of Europe
In North and South America , especially in Argentina, Brazil, Canada, Colombia, Paraguay, Uruguay and the USA, there are approvals for the use of a wide variety of GM maize varieties as food and feed as well as for cultivation. However, there are sometimes considerable differences. In Mexico, the country of origin of the maize culture, there are only approvals as food and feed.
In Africa there are only approvals for various GM maize varieties as feed, food and cultivation in South Africa. Only cultivation is permitted in Egypt.
In Asia and Oceania , approvals for cultivation in Australia, the Philippines and Vietnam have been obtained. Approvals for food and feed only exist in China, Japan, Indonesia, Malaysia and South Korea, as food in Taiwan, New Zealand and Thailand, and in Turkey as animal feed.
Labeling requirement in the EU
In the EU , genetically modified maize must be identified in food, for example with the reference to genetically modified maize or from genetically modified maize . Chemically modified food additives (additives of the second generation) from genetically modified maize, such as modified maize starch , do not have to be labeled separately. In addition, animal products obtained by feeding genetically modified maize have not yet received an award. Since August 2005 this can be imported into the EU for this purpose.
Honey with traces of genetically modified maize
In 2005, the Kaisheim hobby beekeeper Karl Heinz Bablok found DNA from MON810 and genetically modified proteins in maize pollen in his beehives and DNA from MON810 in his honey . Since he no longer considered the honey to be marketable and usable , he sued the Free State of Bavaria, which was growing MON810 for research purposes at a distance of about 500 meters from Bablok's property, for damages. In May 2007 the Augsburg Administrative Court ordered the operator of one of the fields to prevent MON810 from blooming - by harvesting early or by cutting off the individual inflorescences. This is the only way to prevent bee colonies near the maize field from also collecting transgenic maize pollen. Honey containing MON810 pollen is not permitted as a food, the court argued. One month later, this decision was initially overturned by the Bavarian Administrative Court. In September 2011 the European Court of Justice (ECJ) ruled that pollen from GM plants should not be regarded as GMOs and honey with pollen content from GM plants as a product with ingredients from GMOs, and that honey with GM traces in the pollen was subject to Regulation 1829 / 2003 falls. With this, the ECJ contradicts the previous legal practice, according to which pollen was regarded as a natural component of honey and thus it was irrelevant whether there were GM traces in the pollen. In addition, honey was previously considered an animal product (which is not covered by Regulation 1829/2003). The ruling must label the honey ingredient pollen if the proportion of pollen from approved GM plants is more than 0.9% of the total pollen content. Honey and food supplements containing pollen from non-approved GM plants are prohibited from placing on the market , as is the case for non-approved GMOs . MON810 is not approved under 1829/2003, but under the old regulation 90/220; honey with traces of MON810 in the pollen is therefore also not marketable, although it is approved as feed and food under 90/220. The judgment also has an impact on imported honey from countries in North and South America in which GM crops are grown, some of which are not permitted as feed or food in the EU. The judgment could also have far-reaching consequences for releases for research purposes with GM plants. If the possibility that individual GM pollen grains could find their way into honey or that traces of genetically modified seeds and genetically modified proteins could find their way into pollen is sufficient to take legal action against the operators of field experiments, field experiments may no longer be possible.
Experience with transgenic maize
Some experience can be derived from the cultivation of GM maize in North and South America, although this only applies to herbicide and insect-resistant maize varieties, since the other varieties are grown in too small quantities.
Effects of herbicides on the environment
The environmental impact of herbicides when using herbicide-resistant maize is lower than with conventional cultivation, which is also carried out with herbicides. In 2014, for example, the introduction of herbicides worldwide was 6% lower based on weight and, since the more environmentally friendly chemicals are used for herbicide-resistant maize varieties, the reduced impact on the environment, which is measured using the Environmental Impact Quotient, is 12.1% specified. This positive effect was found in all the countries examined, although there are significant differences.
It is unclear whether these findings will still apply in the future, as the widespread use of herbicides has led to the emergence of herbicide-resistant weeds , so that more environmentally harmful herbicides are used with corresponding herbicide-resistant maize varieties such as Optimum ™ GAT ™ and Enlist ™ , which is not only necessary increased costs, but can also lead to increased environmental pollution. It is also pointed out that the unilateral use of herbicides for weed control can lead to monocultures and neglect traditional crop rotation, which negatively affects soil fertility.
Impact of Bt maize varieties on the environment
Experiments conducted at the University of Illinois at Urbana-Champaign indicated that, under certain environmental conditions, Bt maize has a higher nitrogen use efficiency and a greater tolerance to low nitrogen levels than maize without the Bt genes. In the experiments, Bt maize required an average of 38% less nitrogen than conventional maize to maximize yield. This can curb the use of nitrogen fertilizers.
The use of insect-resistant GM maize varieties has led to a reduced environmental impact from spraying insecticides . Between 1996 and 2014, Bt maize cultivation worldwide saw a 52% lower consumption of insecticides. Since the type of insecticides used is essentially unchanged, the amount applied also corresponds to a 56% lower environmental impact due to the Environmental Impact Quotient . In Spain and Portugal, too, where Bt maize has been planted on 30 to 35% of the maize areas since 1998, the amount of insecticides sprayed on genetically modified maize fields has decreased by 37%.
Long-term observations of pest populations in the USA have shown that the use of Bt plants has not only resulted in lower pest infestation in Bt fields, but also in lower pest infestation in conventional fields ( positive externality ). American corn farmers who did not grow Bt corn have thus benefited from other farmers growing Bt corn. This reduced pest infestation also affects other crops, such as sweet corn , bell peppers and kidney beans , and has a positive effect on organic farming itself .
A meta-analysis of several field studies has shown that Bt toxins from GM maize varieties have a specific effect and do not affect beneficial organisms such as flower bugs , tube aphids , spiders , ground beetles and ladybugs . An exception is the brackish wasp Macrocentrus cingulum , which parasitizes the European corn borer and is therefore probably indirectly affected because it lacks its preferred food.
Problem of coexistence
In Mexico, the country of origin of the maize , the cultivation of GM maize varieties is prohibited in order to avoid outcrossing with land races of maize. Despite this ban, Bt toxin and herbicide resistance genes have been detected in various landraces and it is believed that this is mainly due to illegally imported seeds and forage maize from the United States of America. It is feared that valuable traits of the original races could be irretrievably lost.
In recent years teosinte , the original plant of cultivated corn, has appeared as an invasive species in Spain. Molecular biological studies have shown that Spanish teosinte is a hybrid between teosinte and a cultivated maize that cannot be identified. Since the Spanish teosinte is a stubborn weed in some maize crops, a warning is given against treating herbicide-tolerant maize varieties with the appropriate herbicide in the presence of the Spanish teosinte for a long period of time, as this pressure of selection means that herbicide-tolerant Spanish teosinte is created even with rare gene transfers , and thus Spanish teosinte as herbicide-resistant weeds.
Development of resistance of the pests
The use of insect-resistant GM maize varieties has led to the development of resistance, so that the effect on various types of pests is reduced or even largely absent. This development of resistance affects several different Bt toxins and took place on average within five years. Resistance to six different Bt toxins has been observed in the western corn rootworm . The conscious planting of non-GM maize varieties can slow down the development of resistance, although the use of other control measures, such as crop rotation and targeted spraying of insecticides, is also important.
Decreased mold infestation
In addition to the internal protection of plants from specific pests, studies in several countries have shown that Bt maize is far less contaminated with molds and the associated, mostly carcinogenic toxins of the fungi. This is due to the reduced damage caused by feeding, which at the same time prevents the accumulation of water in the feeding ducts and thus prevents the fungi from growing. The reduced content of toxins is particularly true for fumonisins , while the effect on aflatoxins is controversial.
Safety as food and feed
Like other transgenic plants, transgenic maize varieties are only approved as food or feed if extensive studies have shown that they are just as harmless to health as the corresponding conventional maize varieties. Comparative analyzes of the nutritive, anti-nutritive, toxic and allergenic ingredients are to be carried out in order to be able to determine possible unintended changes triggered by the genetic modification. Current guidelines for the safety assessment of genetically modified plants and foods made from them were issued in 2004 by the European Food Safety Authority (EFSA) and the Codex Alimentarius Commission responsible for international food standards in June 2003. They are based on the principle of substantial equivalence described by an OECD working group in 1993 and further developed by FAO and WHO in the following years . In Germany, the Federal Office for Consumer Protection and Food Safety is responsible for the safety assessment of genetically modified food and feed in consultation with the Robert Koch Institute and the Federal Institute for Risk Assessment (BfR).
The American Society for Microbiology publicly stated in 2000 that there was no convincing evidence that plants made using biotechnology and under FDA supervision are high risk or unsafe. Rather, they offer a potential improvement in nutrition, taste and shelf life.
The Society of Toxicology published a position paper in 2002, in which it concluded that the safety of contemporary foods made using biotechnological methods is equivalent to the safety of traditional foods. However, this does not mean that all future genetic modifications are just as safe.
The American Society of Plant Biologists is of the opinion that the risks of genetic engineering processes are comparable to those of conventional breeding.
The American Society for Cell Biology sees genetically modified plants not as a threat to public health, but rather as an opportunity to improve it.
The International Science Council , the international umbrella organization of scientific societies and academies, determined in 2003, based on around 50 scientific reviews published between 2000 and 2003, that there was no evidence of negative effects of the consumption of foods with genetically modified ingredients. However, future genetically modified foods with new properties should be examined on a case-by-case basis.
Unexpected and unintended changes in the composition of organisms occur in all forms of genetic modification, including genetic engineering , according to a joint publication by the Institute of Medicine and the National Research Council (2004). Whether such changes lead to health effects depends on the nature of the changed substances and their biological consequences. So far, no negative health effects have been documented in humans that can be traced back to genetic engineering.
The British Medical Association (2004) and The Royal Society (2002) concluded in their reviews that there was no robust evidence that GM foods were unsafe, but called for further research and observation. According to an information brochure published by the Royal Society in 2016, all currently available GM foods are at least as safe as conventional foods.
In 2004, 14 Italian scientific organizations (including the Accademia Nazionale delle Scienze ) published a consensus document on the food safety of genetically modified organisms. Accordingly, the approved GM organisms are safe for human and animal nutrition.
The Union of the German Academies of Sciences (2004), produce food from transgenic plants no risk. Transgenic maize is several investigations under relative to an infestation with Fusarium less stressed than conventional maize and evaluate in this context as healthier. According to a publication by the Austrian Federal Environment Agency (2002), however, a lower degree of infestation of Bt maize with Fusaria compared to other methods can only be determined if absolutely no measures are taken against the European corn borer. The method of shelling the corn stalks and plowing them cleanly lowers the European corn borer infestation on the one hand and is also an effective measure to prevent fusarium infestation in the subsequent crop, often corn again. A review published in 2010 found that in 19 of 23 studies carried out in different countries, the mycotoxin infestation of Bt maize was lower than that of conventional maize. A review published in 2007 concluded that there is strong evidence worldwide for significantly lower levels of fumonisins in Bt maize under field conditions . There are also indications of lower exposure to deoxynivalenol and zearalenone . Studies have found mixed results with regard to exposure to aflatoxins. According to Munkvold (2014), transgenic maize is the most effective measure for reducing mycotoxin pollution compared to other agricultural methods such as variety selection, sowing date, crop rotation or plowing.
König et al. (2004) write that there is no evidence of possible negative effects from the consumption of transgenic plants. All approved transgenic plants have been extensively tested on a case-by-case basis.
According to a review by Aumaitre (2004), no toxic or other negative effects were found in feeding studies published up to September 2003 with transgenic maize varieties approved as feed.
Flachowsky et al. (2005) summarize in a review that many studies had been carried out and that they had not found any significant differences between the previously commercialized transgenic and conventional plants with regard to the safety or nutritional value of the feed made from them.
According to a study published by the WHO in 2005, the GM foods traded on the international market have undergone risk studies in several countries. It is unlikely, and has not yet been shown, that these foods pose risks to human health.
Domingo (2007) found that the safety studies with transgenic maize varieties published in specialist journals had not found any significant differences to conventional varieties. However, the number of published studies is very small. Domingo called for further and lengthy investigations and questioned the principle of Substantial Equivalence.
The Australian Academy of Science found in 2007 that GM products had been consumed for many years with no proven damage to health and that their safety had been confirmed by many peer-reviewed international studies.
A working group commissioned by the ESFA's Panel on Genetically Modified Organisms to study feeding studies on the safety of transgenic plants as feed and food came to the conclusion in its review published in 2008 that many subchronic feeding studies with transgenic plants on rodents had been carried out in the last 15 years. These studies corresponded to internationally accepted procedures and gave no indications of any negative effects. Numerous cattle feeding studies have also shown that feeds based on transgenic and conventional plants do not differ from one another in terms of nutrient uptake, health and performance, breeding success, milk yield and quality, and other indicators.
Key et al. (2008) point out that genetically modified foods (GM foods) have been consumed by hundreds of millions of people worldwide for more than 15 years without any known negative health effects.
Querci et al. (2008) from the Institute for Health and Consumer Protection (IHCP) of the Joint Research Center believe that there is already extensive accumulated knowledge on safety issues relating to genetically modified products and that this knowledge is sufficient to evaluate the safety of current products. There were no reports of any evidence of any health effects from genetically modified foods submitted to the approval process. At the same time, little is known about the long-term effects of food in general. The safety of genetically modified food is not absolute, but rather in comparison to conventional equivalents. Conventional foods are often evaluated on the basis of their safe consumption in the past. Current experience with long-term studies in the context of approval processes indicated with a reasonable degree of certainty a lack of possible health effects of genetically modified products.
In their review, Lemaux (2008) comes to the conclusion that there is no scientifically valid evidence that GM foods differ from conventional ones with regard to food safety.
Magaña-Gómez and Calderón de la Barca (2009) found no significant differences to conventional maize varieties in most of the safety studies with transgenic maize varieties published between 1998 and 2007, whereas deviations were found in four studies. They call for a more systematic approach to security research. Due to the different results of various studies, more scientific efforts are needed to achieve more confidence in safety research and acceptance of genetically modified foods.
A review published by the European Commission in 2001 of 81 studies over a period of 15 years found no evidence of health risks from transgenic plants. In 2010, the European Commission again published a compendium in which it brought together the results of EU-funded studies by over 400 independent working groups from the period 2001–2010. For over 25 years of research, there has been no evidence that genetically modified plants are associated with higher risks to human health than conventional ones.
According to a review by Domingo and Bordonaba (2011), the number of published safety investigations has increased significantly since 2006. Several studies published between October 2006 and August 2010 on various transgenic maize varieties had shown that these were just as safe as conventional maize varieties. Only the studies by Seralini's group with regard to three transgenic maize varieties had raised concerns (see section Controversies ).
A systematic review article published in 2012 summarized the results of 12 long-term feeding studies (90 days to 2 years) and 12 multi-generation studies (2 to 5 generations). The 24 studies showed no health hazards from genetically modified maize, potatoes, soybeans, rice and triticale. 90 days are also generally sufficient for safety studies.
As part of the National Research Program NRP 59 “Benefits and Risks of the Release of Genetically Modified Plants”, commissioned by the Swiss Federal Council and concluded in 2012 , Karoline Dorsch-Häsler and Karin Hoffmann-Sommergruber carried out an extensive literature study in which they found more than a thousand scientific publications from the last 20 years ago. The literature study came to the conclusion that genetically modified plants do not harm human health according to the current state of knowledge. The use of Bt maize, on the other hand, could have positive health effects, as it can lead to less pollution of food and feed by neurotoxic or carcinogenic mycotoxins . The uptake of foreign DNA and its incorporation into mammalian cells were discussed as possible risks. In feeding studies with goats, for example, Bt gene fragments were found in the blood and also in the milk of the animals. The integration of DNA from genetically modified plants into the genome of an animal is assessed as very unlikely and has not yet been proven in experiments.
The American Medical Association (AMA) issued a June 2012 statement that there is no evidence of specific risks of using rDNA techniques or moving genes between unrelated organisms, and that the risks of transgenic organisms are qualitative from those organisms not modified or modified by other methods. The AMA referred to a publication by the National Academy of Sciences (NAS), which came to the same conclusion in 1987.
A review published in 2013 (Nicolia et al., 2013), which included 1783 scientific safety studies published between 2002 and 2012, concluded that no significant hazards were found from the direct use of GM plants.
A 2014 review summarizes the scientific literature on the effects of GM feed on the performance and health of farm animals (Eenennaam & Young, 2014). Numerous experimental studies then come to the consistent conclusion that there is no difference between GM and conventional feed with regard to these effects on livestock. Furthermore, no study found any significant effects of GM feed on the nutrient profile of the animal end products. GM components in milk, meat and eggs could not be detected or reliably quantified.
A committee of the National Academies ( National Academy of Sciences , National Academy of Engineering , National Academy of Medicine ) published an extensive review in May 2016, according to which there is no evidence of health risks from GM plants compared to conventionally grown plants.
Controversy
A group led by the French biologist Gilles-Eric Séralini , who is located in the Comité de Recherche et d'Information Indépendantes sur le Génie Génétique (CRIIGEN), has published several studies in the past that demonstrate the harmlessness of several transgenic maize varieties from the Monsanto company ( MON863, MON810, NK603) questioned. The group's publications sparked heated controversy. In January 2011, Séralini won a case of "defamation" against Marc Fellous , President of the Association Française des Biotechnologies Végétales, before the 17th chamber of the tribunal correctionnel de Paris . Seralini had questioned Seralini's neutrality in connection with a study on the health effects of genetically modified maize varieties, as Greenpeace co-financed the study. Several research groups and authorities examined the publications and questioned their informative value.
Another controversy arose over a review by Dona and Arvanitoyannis (2009 in Critical Reviews in Food Science and Nutrition ). In it, the authors assume that many years of further research will be necessary to determine the health effects. The results of safety studies on transgenic maize varieties indicated that they cause toxic (hepatic, renal, reproductive) effects and can change haematological, biochemical and immunological parameters. In the same journal, Rickard of CropLife International , an international association of agricultural biotechnology companies, alleged in a letter to the editor (2010) that Dona and Arvanitoyannis' article contained many unsubstantiated claims. The authors showed that they did not have the basic knowledge to assess the safety of transgenic plants and would either not know or consciously ignore many relevant scientific findings. Klaus Ammann also accused Dona and Arvanitoyannis of having extremely filtered their citations with the aim of painting a negative picture of transgenic plants. She also lacks knowledge in the field of food safety. In addition, her article contained a lot of plagiarism , which also came from publications with negative biases, the content of which had recently or long ago been refuted by recognized scientists in respected journals.
Finamore et al. (2008) from the Italian Research Institute for Nutrition and Food came to the conclusion in a feeding study with mice that the GM maize MON810 can lead to significant changes in the immune system of the mice. The study was cited among others by Greece to justify a national cultivation ban on MON810 under the safeguard clause. The EU Commission then commissioned EFSA with a scientific assessment, which was published in 2012. EFSA found that the authors Finamore et al. a. (2008) themselves point out that their study results have an unclear relevance for the feed and food safety of MON810. Against the background of possible distortion effects from mycotoxins, lack of information on the natural variability of the parameters examined, and the biological relevance of the differences found, the EFSA requested further data. At the same time, EFSA referred to several studies that could not identify any differences between MON810 and conventional maize in terms of allergenicity, as well as to its own scientific assessment from 2009, according to which there were no biologically relevant differences in the composition of MON810 (with the exception of the Bt gene) no increased allergenicity potential is expected. Overall, EFSA concluded that the cultivation of MON810 in Greece is unlikely to have any negative effects on animal or human health or the environment.
Velimirov et al. (2008) carried out a multigenerational study that found a negative effect on reproductive ability in mice that were fed NK603xMON810 for several generations. The study was cited among others by Austria to justify a ban on growing MON810 as part of the safeguard clause. The Commission then asked EFSA to produce a scientific assessment, which was published in December 2008. The EFSA stated that several deficiencies in terms of data, methods and statistical calculations had been found that did not allow any interpretation. Therefore, the data contained in the study are unsuitable for questioning the safety of MON810.
Seralini et al. (2007)
The Bt maize variety MON863 from Monsanto contains the Cry3Bb1 gene. Monsanto submitted the approval application for MON863 as feed and food in the EU to the RKI in 2002. The RKI checked the application and found no harmful effects of MON863 with rats on the basis of the 90-day feeding study carried out by Monsanto (the documentation of which comprises more than a thousand pages and which was later published as a short version). In April 2004, EFSA classified MON863 as safe for humans, animals and the environment based on the same study. In the feeding study, male and female rats were fed MON863 in different doses or with the conventional starting line and other conventional maize varieties. There were occasionally statistically significant deviations in the animals' growth as well as in various biological parameters in the animals fed with MON863, which the EFSA assessed as "biologically not relevant".
In the public and among French scientists of the Commission du génie biomoléculaire (CGB), doubts have been expressed as to whether the observed deviations in the rats fed MON863 are within the usual "biological range" or whether they are indicative of health risks are to be evaluated. Further reports were obtained. New tissue, cell and organ examinations showed no different picture. The suspicion that the increased number of white blood cells in some MON863 rats was an indication of “real inflammation” was not confirmed. The CGB experts then joined EFSA's safety assessment. Greenpeace and other groups of critics continued to demand the publication of the complete feeding study, which Monsanto initially refused to do. At the request of Greenpeace, the Münster Higher Administrative Court determined that Monsanto had to disclose the complete documents from the approval process. At a press conference on June 22, 2004 in Berlin, Greenpeace called on the German government to vote against approval. Seralini said there that in view of the striking results it was necessary to repeat the experiments. In October 2004, the EFSA Expert Panel confirmed that the feeding studies did not reveal any health concerns. The EU approval was granted as feed in August 2005 and as food in January 2006.
In March 2007, Seralinis group published the study financially supported by Greenpeace Germany “New Analysis of a Rat Feeding Study with a Genetically Modified Maize Reveals Signs of Hepatorenal Toxicity” based on a re-evaluation of Monsanto's feeding data. Seralini et al. a. came to the conclusion that rats fed MON863 maize kernels showed slight, but dose-dependent, variations in growth in both sexes. In addition, some of the statistically significant deviations, for example in the blood and urine measurements, could be interpreted as evidence of liver or kidney toxicity.
An EFSA working group then examined the analysis of Seralini, met with the authors and re-evaluated the data itself. In addition, a French institute was commissioned with a further analysis of the statistical evaluation of the data. The competent authorities of the Member States were also asked for their comments. According to EFSA, there were sometimes lower and sometimes higher values that could be interpreted as isolated random phenomena. Differences in blood and urine values could not be confirmed in tissue sections and therefore do not indicate organ damage. The hypothesis of Seralini et al. a. that the difference in weight gain is based on a disturbance in the hormonal balance cannot be proven by the experimental data. In contrast to Seralini, EFSA assessed the biological relevance of all statistically significant differences between the animals fed GM maize and the isogenic control group. Overall, the study by Seralini et al. a. no new indications of toxicological effects.
A panel of experts, financially supported by Monsanto, of 6 scientists from the United States, Germany, Great Britain and Canada soon found that the Seralini et al. a. The effects presented could not be traced back to MON863 or were of no relevance, since Seralini et al. a. Neither a dose-response curve , temporal reproducibility , a connection with other changes (e.g. histopathological ), effects in both sexes, differences outside the normal variation , nor a biologically plausible causal mechanism could be demonstrated.
The managing director of the Commission for Genetically Modified Food and Feed of the BfR, Marianna Schauzu, does not consider the differences toxicologically relevant either. The differences were mostly small and were within the historical control data obtained in previous studies with rats of the same strain. The differences showed no dose dependency and they were not supported by differences in other parameters that could indicate an effect in the same organ. Even in the microscopic examinations of the organs and tissues, no effects were observed that would suggest a toxicological relevance of the statistically significant differences in the laboratory parameters. In addition, studies of the composition as well as the allergenic and toxicological potential of MON863 did not reveal any indications of unintended changes.
FSANZ, the licensing authority responsible in Australia and New Zealand, examined the original feeding study in 2005 and did not derive any negative effects from MON863. The publication by Seralini et al. a. According to an independently examined study by FSANZ, this would not justify any new security concerns. All statistical differences between the feeding groups would be within normal biological variation. FSANZ does not require feeding studies for authorization applications for genetically modified foods if the plants are equivalent to conventional plants in terms of their composition ( Substantial Equivalence ). FSANZ had nevertheless evaluated the 90-day feeding study on rats carried out by Monsanto as part of the application for approval in the EU in 2005 and did not derive any risks from it. FSANZ also had acute toxicity studies on mice and a feeding study with chickens, none of which would have provided any evidence of negative effects.
Vendomois et al. (2009)
In December 2009, Seralini's group again published a statistical analysis of the raw data from three feeding studies with MON863, MON810 and NK603. Seralini et al. a. for various reasons deny the statistical significance of the feeding experiments and want to have at least recognized signs of possible toxic effects in their own evaluation of the raw data.
Monsanto denied the allegations, alleging Vendomois et al. a. use inappropriate statistical methods. According to EFSA, the conclusions about possible kidney and liver damage from the maize varieties are not justified by the data presented in the publication. Several of the fundamental static criticisms of Seralini et al. a. (2007) found at Vendomois a. a. (2009) also agree. Vendomois et al. a. (2009) did not allow a toxicological comparison between transgenic and conventional varieties, since
(1) the results were only given in the form of percentage differences in the individual variables and not in the measured units,
(2) the calculated values of the toxicological parameters tested in no reference was made to the normal range of variation of the animal species,
(3) the calculated values of the toxicological parameters tested were not compared with the variability of animals fed with other species,
(4) the statistically significant differences were not consistent across different doses,
(5 ) the purely statistical arguments of the authors are not consistent with the results of the three feeding studies with regard to organ pathology, histopathology and histochemistry. With regard to the allegation by Vendemois et al. a., the three feeding studies were inadequate, said the EFSA that they were all carried out in accordance with internationally defined OECD standards. In a scientific opinion published in March 2010 on a new application from MON863 under modified guidelines, EFSA confirmed its previous findings on the safety of MON863. Additional data was requested from the applicant for the new safety assessment. These were taken into account in the safety assessment, as were a number of new scientific publications, including Seralini et al. a. (2007).
According to FSANZ, Vendomois u. a. no plausible scientific explanation for their hypothesis. They distorted the toxicological significance of their results by not considering any biological aspects other than statistical ones, which does not correspond to a robust toxicological analysis. FSANZ assumes that the reported differences occurred mainly by chance and expressed confidence with regard to the safety of the approved variety MON863.
The French Haut Conseil des biotechnologies ruled that Vendomois et al. a. (2009) just as little as Seralini et al. a. (2007) contain admissible scientific elements that indicate haematological , hepatic or renal toxicity of the three maize varieties. The publication is merely a list of statistical differences without attempting to interpret them biologically or toxicologically. As has been repeatedly emphasized by many authorities, significant statistical differences do not prove the existence of biological disorders. The argument put forward on those differences is therefore not admissible. In addition, the differences mostly occurred in only one gender, one point in time or one dose and there was also a complete lack of reference to the duration of exposure and the strength of the dose. Finally, some of the cited differences are the opposite of an indication of toxic effects that is usually regarded as such.
Seralini et al. (2012)
On September 19, 2012, Seralini's team published a peer-reviewed, two-year long-term study in the journal Food and Chemical Toxicology in which 200 rats were fed a combination of the herbicide-tolerant transgenic maize variety NK603 and Roundup. The rats were divided into a total of nine groups of 20 rats each, with three groups being fed with GMOs in various concentrations, three groups with GMOs and Roundup and three groups with conventional maize which was sprayed with Roundup. Rats served as a control group to which conventional maize was administered without herbicide exposure. According to the study, the most noticeable differences to the comparison group occurred after about a year. According to the study, 50 to 70% of the treated rats died before the end of the two-year observation period, in the control group 30%. In the male rats, liver congestion and liver necrosis occurred 2.5 to 5.5 times more often, severe kidney damage was found 1.3 to 2.3 times more often. Breast tumors developed more frequently in all treated groups, but not always to a statistically significant extent. The authors attribute these differences to endocrine disruptors in Roundup and overexpression in maize. So far, genetically modified plants have usually only been tested for health effects over a period of three months. The EU Commission therefore commissioned the European Food Safety Authority (EFSA) to review the study results.
The study was funded by the Ceres Foundation, to which around 50 companies belong, including companies in the food industry that do not use genetically modified food (including Auchan and Carrefour ).
The publication immediately provoked critical reactions from several scientists who were not involved in the study, who expressed skepticism about the method and the conclusions drawn. The main points of criticism of the study, which are shared by almost all reviews, are in particular statistical weaknesses in the study, caused by the insufficient number of test animals in too many different comparison groups, which makes it difficult to obtain statistically significant results. The second major point of criticism of the study is the fact that the type of rat chosen for the study generally tends to develop these types of tumors more than average, regardless of feeding. The study shows only normal expected statistical fluctuations. For example, one of the comparison groups that was fed the highest proportion of genetically modified maize even had the highest survival rate. Also that Seralini certain data, such as B. Growth rates or the amount of feed given, not published, has been criticized.
Professor Tom Sanders, a nutritionist at King's College London , called the statistical methods unconventional and gave, among other things, a. further information on data on nutritional composition. Plant physiologist Mark Tester ( University of Adelaide ) questioned if the effects were real and transferable to humans, why previous studies hadn't come across them, and why North Americans wouldn't die like flies. The statistician David Spiegelhalter ( University of Cambridge ) described the method, statistics and presentation of results as not conforming to Standard I of a strict study. He pointed out that the control group was very small and also developed tumors. Wendy Harwood of the John Innes Center stated that it was necessary to know the entire data set. She sees the results of the study as an indication of concerns about longer-term exposure to Roundup and formulates further research needs in this regard. Other scientists ( Rothamsted Research , University of Edinburgh , Sainsbury Laboratory , Imperial College London , University of California, Davis , University of Melbourne , Walter and Eliza Hall Institute of Medical Research , University of Vienna , Wayne State University University of Wyoming , University of Florida , Stanford University and University of Illinois , Vlaams Instituut voor Biotechnologie, Anses , University of California, Riverside ) mentioned similar and additional points of criticism of the study. Gerd Gigerenzer and Walter Krämer explained the study by Seralini et al. a. on September 28th for the “unstatistics” for September. From a statistical point of view, the report that genetically modified maize is said to cause cancer can only be described as nonsense. The observed differences in cancer mortality are not significant, so they could very easily have occurred purely by chance. This can also be seen from the fact that the group of rats that were fed the highest proportion of GM maize actually had the highest survival rate. Michael Antoniou , molecular biologist at King's College London and advisor to Seralini's team, sees two key aspects in the results of the study. On the one hand, there is a need to extend feeding studies to two years; on the other hand, with herbicides and pesticides in the context of a toxicity test, not only the individual active ingredient must be tested, but the entire formulation in its agricultural context. Carl Zimmer ( Discover ), Steven Novella ( Yale University ), Thomas Lumley ( University of Auckland ) and other commentators criticized Seralini for not allowing journalists to show the study to other scientists before it was published in order to obtain independent assessments. According to Zimmer, a maximum media effect should be achieved without critical expert voices and called this a "disgusting, corrupt way of doing science communication".
Monsanto wrote in a response on Sept. 20 that the study by Seralini's group did not meet the minimum acceptable standards for such scientific studies, the results were not supported by the data presented, and the conclusions were of no relevance for the purposes of a safety assessment. Monsanto's toxicologists and public health experts identified several fundamental issues with the design of the study. Apart from that, there is no plausible mechanism that could explain the reported results, and the results differ from existing extensive experience and scientific studies.
In the Nouvel Observateur , Joel Spiroux , co-author of the study, commented on points of criticism (September 20). Regarding the criticism that the number of animals examined was too small, Spiroux stated that the total number as well as the number of 20 per test group was analogous to that used by Monsanto in three-month feeding studies. In addition, several toxic parameters were examined. An attempt with a higher basic amount would have overwhelmed the financial framework. The rat line used in the experiment would, due to its stable characteristic expression, e.g. B. in terms of weight u. have been used for a long time worldwide in research on toxicity tests and the effects of genetically modified plants, also by companies that manufacture them. To criticize the fact that the composition of the feed was not disclosed in detail, Spiroux referred to current standards in these studies. He also spoke out in favor of a counter-expertise from independent researchers.
The Association of Biology, Biosciences and Biomedicine in Germany (VBIO) declared on September 21st that the study had significant shortcomings. In the opinion of the VBIO, the study does not provide any new evidence that would justify actionist conclusions.
In a comment by Wirtschaftswoche (September 22nd), Susanne Kutter explains that in the field of green genetic engineering, a factual attitude on the part of science is rare. It is now customary that when a study on the topic is published, the authors are accused of being commercially viable by either the agro-industry or Greenpeace. The reactions to Séralini's study were no exception. The US company Monsanto had issued a four-page letter listing critical voices to Seralini's study in response to the study, "so that journalists in particular should not overlook the critical voices". On the other hand, Séralini refused to make his original data available to EFSA, as he saw a conflict of interest with this authority, which approved the maize variety NK 603. The Séralini study was said to have "become the subject of a mud fight" within a very short time. Therefore, the result and the significance of Seralini's study are difficult to evaluate. On September 22nd, Hervé Kempf from Le Monde raised the question of why a renowned university professor like Séralini had to find money from private foundations for a research project of public interest instead of government agencies commissioning state-based researchers to carry out neutral and in-depth research on the topic would have. Institutions such as the Center national de la recherche scientifique or the Institut national de la recherche agronomique have repeatedly relied on studies - controlled by agricultural corporations - whose complete data set has often not been disclosed due to business secrets. Séralini made this problem public through his actions in the media. Kempf also sees a drama behind the scientific controversy about the harmfulness of the product or the technology, which, based on Shakespeare, reflects the relationship between money and truth.
Numerous scientists from INRA , CNRS and other research institutions criticized the study and its uncritical media reception in a petition published on September 27, recalling a review of 24 studies published in the same journal, all of which confirmed the safety of transgenic foods. They also noted that no health agency has raised any health concerns for the millions of farm animals that have been eating genetically modified plants for more than a decade, including NK603. The scientists are calling for the study to be repeated under the strict supervision of Anses .
The Federal Institute for Risk Assessment (BfR) published a statement on the study on September 28th. The thesis that rats given genetically modified maize for the rest of their lives die earlier than animals fed conventional maize has not been sufficiently proven experimentally. Reiner Wittkowski , Vice President of the Federal Institute, said: "The study has weaknesses in the design as well as in the statistical evaluation, so that the conclusions of the authors are incomprehensible". The statement that long-term consumption of the glyphosate-containing pesticide Roundup may lead to serious health damage and earlier death has not been sufficiently proven. Numerous long-term studies are available on glyphosate as a herbicidal active ingredient. Cancer, higher mortality or influences on the hormonal system of the test animals, as reported by the authors in the publication, were not observed in these studies. The BfR has therefore asked the authors to submit the entire study report including the data on the experimental animals and to compile a questionnaire for a further evaluation of the results.
The Rijksinstituut voor Volksgezondheid en Milieu (RIVM) published an assessment of the study by Seralini et al. a. RIVM comes to the conclusion that the study is unsuitable for determining carcinogenicity. The number of rats is too small and there is no statistical analysis.
FSANZ published a preliminary statement on the study in early October. FSANZ considers the relevance of the study to be limited, mainly due to the small number of test animals, selective data reporting and the incidence of tumors in the rat strain used. The stated toxicity of Roundup is not plausible and contradicts properly designed and carried out long-term studies with the active ingredient glyphosate in several animal species, where no effects were observed at higher doses.
EFSA published an initial evaluation of the Seralini study on October 4th. The agency concluded that the study did not meet the scientific standards to be considered for a risk assessment. EFSA found the study design and the presentation and interpretation of the study results to be inadequate. She asked the authors Seralini et al. a. to provide important additional information.
In a first evaluation of the study published on October 5, the Federal Office for Consumer Protection and Food Safety (BVL) came to the conclusion that the authors' conclusions are not justified. The reasons for this are inadequacies in the study design and the type of data evaluation and data presentation.
The food authority Anses , tasked by the French government with an assessment, published its results on October 22nd. According to Anses, the study by Seralini et al. a. previous registration studies on NK603 and Roundup not in doubt. Anses, however, points to a small number of long-term studies and calls for national and European funding for large-scale studies to fill remaining knowledge gaps about health risks.
On November 28, EFSA published a final assessment of the study. Accordingly, the study does not meet acceptable scientific standards and cannot cast doubt on previous safety assessments of NK603. EFSA also took into account independent assessments of the study by institutions in Belgium (Belgian Biosafety Advisory Council), Denmark ( Denmark's Technical University ), France (Anses, HCB), Germany (BVL, BfR), Italy (Istituto Superiore di Sanità, Istituto Zooprofilattico Sperimentale delle Regioni Lazio e Tosca) and the Netherlands (Nederlandse Voedsel- en Warenautoriteit).
The study was withdrawn by the journal in November 2013 because the “results presented do not allow any conclusions to be drawn”. The authors protested against this. In June 2014 the study was republished slightly modified in Environmental Sciences Europe .
Environmental risks
A minority of experts, environmental organizations and authorities believe that the cultivation of transgenic maize poses various environmental risks. They argue,
- that other organisms can be damaged in addition to the target insects,
- that the cultivation of transgenic maize in Mexico through outcrossing to wild relatives could reduce biodiversity.
A ten-year review of scientific literature and studies by international organizations published in 2007 concluded that there was no scientific evidence of environmental damage from the previously commercialized transgenic plants. Before a new transgenic variety can be approved for cultivation, extensive safety studies are required, which usually take several years. A new variety may only be approved if it has been confirmed to be harmless to the environment. After the start of commercial cultivation of a new variety, monitoring during cultivation is planned in the EU.
The Federal Agency for Nature Conservation (BfN) expresses concerns about the cultivation of maize 1507. The pollen of this maize variety contains around 350 times more insecticide than that of the MON810 variety. As a result, the BfN sees an increased likelihood of negative effects on non-target organisms. Since the poisonous substance is also contained in pollen, the forage plants of protected butterflies can be dusted. The BfN states that there is a need for further research, since, with two exceptions, no species significant for nature conservation were tested in the approval process. Free access to the seeds for independent research on the part of the manufacturers is also required.
Since 1987, the federal government has funded over 140 projects for the safety assessment of GM crops (in particular maize, potatoes, grain, rape), in which over 60 universities and non-university research institutions were involved. In addition to laboratory experiments, numerous field tests were carried out. The BMBF published a balance sheet after 25 years of funding. The results available show no higher risk of environmental damage for the cultivation of GM plants compared to conventionally grown plants.
Non-target organisms
The Bt toxin Cry1Ab is poisonous for some species of the butterfly genus . Unlike the European corn borer , only very few butterfly species feed on maize, but could theoretically be indirectly damaged by Bt maize pollen that ends up on their food. A laboratory study published in 1999 found damage to monarch butterflies when they were fed with Bt maize pollen from Event 11. This led to public fears that the cultivation of Bt maize could reduce populations of the monarch butterfly. Further laboratory experiments found that pollen from the event caused damage to 176 monarch butterfly larvae, whereupon the event was withdrawn from the market. Field studies found no effects on larvae from the widespread Bt maize events (MON810 and Bt 11), which produce 80 times less toxin than event 176. They stated that the amounts of pollen used in laboratory studies were unrealistically high under field conditions, and raised the question See if Event 11 pollen may have been mixed with other parts of the plant. At the events currently permitted, extremely high pollen densities are necessary in order to damage larvae. In addition, field studies found that only a small proportion of 0.8% of the monarch butterfly population was exposed to Bt maize pollen. Other factors to be considered are natural mortality of 80% during the larval phase as well as losses due to habitat destruction, the use of insecticides and collisions with cars.
The argument that insecticides damage the monarch butterfly and other beneficial organisms more than Bt maize is not recognized by Jesse & Obrycki (2000), since according to the authors' calculations only 2% of the maize area in Iowa was treated with insecticides. The industry-related association “International Life Sciences Institute (ILSI)” specifies 5–10% of the areas with insecticide application.
A simulation published in 2010 came to the conclusion that even under pessimistic assumptions, widespread cultivation of Bt maize in Europe would hardly have any negative effects on butterfly species. The authors calculated a maximum mortality rate for peacock butterfly and admiral of less than one of 1572 butterflies, for the cabbage moth one of 392. In the mean of all regions they put it at 5000 for peacock butterfly and admiral, for the cabbage moth at 4367.
The effects on beneficial organisms such as natural enemies and pollinators were studied.
In laboratory and greenhouse studies, natural enemies such as lacewings were negatively affected when their prey was damaged by Bt toxins. Field studies showed that natural predators were less common in Bt fields due to the lower availability of prey. This reduction was judged to be irrelevant for the population size, as lacewing and other natural enemies feed on a polyphagous diet and therefore would not be strongly affected by the reduction of certain prey species.
In addition, other pest control tools would affect the food supply of natural enemies, and most insecticides currently in use (especially broad spectrum insecticides such as pyrethroids and organophosphates ) would have more negative effects on natural enemies than Bt toxins. In addition, many studies show that differences between different conventional maize varieties with regard to effects on non-target organisms are greater than the differences between a Bt maize variety and its conventional counterpart.
In numerous investigations, no statistically significant differences between cultivation areas of conventional maize varieties and Bt maize varieties on soil macroorganisms ( roundworms , springtails , lobsters , mites and earthworms ) could be determined. The researchers recommend further studies, however, since different earthworm species can occur in corn fields depending on the cultivation area. Any threat to regional species from Bt toxins should be clarified in laboratory tests before cultivation.
A meta-analysis published in 2007 evaluated 42 field experiments with invertebrates. Accordingly, non-target organisms are generally more numerous in Bt cotton and Bt maize fields than in conventional fields that have been treated with insecticides. However, certain taxa were more common in conventional fields without insecticide treatment than in Bt fields.
A review published in 2008 on the effects of cry proteins in soil ecosystems concluded that little or no toxic effects of cry proteins on landlice, springtails, mites, earthworms, nematodes, protozoa, and the activity of various enzymes were found in the soil. Most of the few effects found are largely due to differences in location, temperature, plant variety and soil type and are not related to the presence of cry proteins.
A meta-analysis published in 2013 of 13 independent field tests carried out in Spain on 26 arthropod taxa found no significant effects (Comas et al., 2013).
Controversy about the German cultivation ban from 2009 - ladybird larvae
The German government imposed a cultivation ban on MON810 in April 2009, which it justified against the background of the safeguard clause by publishing two new studies. These two studies examined the effects of Bt maize on daphnia (Bøhn et al., 2008) and ladybirds (Schmidt et al., 2009) in laboratory experiments and found negative effects in each case. In a review of the studies published in 2009, the Central Commission for Biosafety stated that they had a number of serious shortcomings and did not prove that MON810 posed a risk to non-target organisms under cultivation conditions. Ricroch et al. a. (2010) examined the study situation and in particular the two new studies. They referred to 41 studies published between 2008 and 2009, almost all of which did not find any negative effects, and 376 publications published between 1996 and 2008 as well as more recent meta-analyzes, which also did not indicate consistent effects. Ricroch et al. a. (2010) came to the conclusion that the German government had ignored the state of knowledge and instead selectively picked out individual studies. Rauschen (2010) attested Schmidt a. a. (2009) several methodological inadequacies and inconsistencies as well as an ignoring of the existing literature, and described the results and interpretations of Schmidt et al. a. (2009) and their claims by the German government as misdirected. Álvarez-Alfageme u. a. (2011), with reference to the inadequacies of Schmidt et al. a. (2009) carried out several experiments under exposure scenarios that were considered more realistic, which ultimately could not confirm a sensitivity of ladybird larvae to Cry1Ab and Cry3Bb1. In 2011, the ZKBS confirmed with reference to Álvarez-Alfageme u. a. (2011) and Porcar et al. a. (2010) that they rate the risks to be expected from the cultivation of MON810 as negligible. The group around Angelika Hilbeck , the Schmidt u. a. (2009), found again in a study published in 2012 that Cry1Ab led to increased mortality in ladybird larvae. Hilbeck et al. a. (2012) accuse the Romeis group of the state research institute Agroscope, Zurich, which came to different results in 2010 with reference to the Hilbeck study, that they exposed the larvae to an insufficient amount of Bt protein in their study and therefore no effect came about. The feeding experiment of the Hilbeck group in 2009 ran continuously over ten days, the Romeis group gave the Bt-containing sugar solution to the larvae only four times, always at the beginning of a new larval stage, over 24 hours. To demonstrate that this experimental set-up was not sufficient, Hilbeck et al. a. In 2012 a comparison test was carried out with European corn borer larvae, against which the Bt gene is lethal. One group was given Bt maize continuously for seven days, the other one single dose over 24 hours. In the first group, all larvae died, whereas in the second only some of the European corn borer larvae died. Romeis et al. a. (2012) emphasized in a reply to Hilbeck et al. a. (2012) that the risk from Cry1Ab is negligible because there is no evidence of damage under realistic exposure levels. In 2012 the group around Bøhn Ricroch u. a. (2010) presented serious scientific errors, inconsistencies and systematic selection of study results (Bøhn et al., 2012).
Honey bees
A link between Bt maize and bee deaths has been suggested by experiments in Germany. A study carried out by the University of Jena between 2001 and 2004 examined the effects of Bt maize pollen on bees. In general, a chronic toxic effect of Bt maize of the varieties Bt176 and Mon810 on healthy honey bee colonies could not be demonstrated. When the bee colonies were infested with parasites (microsporidia) in the first year of the study, significantly more bees that received pollen with Bt toxins as food died. An interaction of the toxin and pathogen on the epithelial cells of the honeybee's intestine is assumed. There were no differences when the bees were given a prophylactic antibiotic.
If one takes into account the extreme test conditions (duration of six weeks, increased Bt toxin content), a toxic effect on healthy bees under natural conditions can be ruled out with great certainty after the extensive studies. This result is underpinned by the fact that honey bees collect only a small amount of maize pollen even in agricultural areas with large maize fields when other plants are available as pollen sources (less than three percent). The Jena study was not published in a specialist journal and could not be replicated .
Canadian scientists found no effect of pollen from Bt maize on bee mortality. Mexican scientists could not find any effect of various syrups with Cry1Ab protein on bee colonies. A thousand times the dose of Cry3b contained in pollen produced no toxic effects on bee larvae, and feeding honey bees with pollen from Cry1Ab maize had no effect on survival rate, intestinal flora, or the development of the hypopharyngeal glands in which the protein-rich food for the brood is found is produced. A meta-analysis published in 2008 of 25 independent studies on the effects of Bt toxins on honeybee mortality found no negative effects of the currently approved transgenic plants on the survival rates of larvae or adult bees.
In addition, only a small proportion of the protein intake of bees consists of pollen. Finally, there is also a lack of geographical correlation between the cultivation of transgenic plants and the occurrence of bee deaths. For example, bees died out in Switzerland where no cultivation takes place.
According to a 2007 review, feeding studies of larvae and adult animals with Cry1Ab showed no effects, and further studies, including field studies, would have confirmed this.
biodiversity
In Mexico , the cultivation of transgenic maize has been banned since 1998 in order to protect landraces and wild relatives from possible outcrossing. According to newspaper reports, however, Mexican farmers are opposing this ban and growing Bt maize. In 2001, Nature published a controversial study that reported a finding of transgenes in Mexican landrace maize. Nature withdrew the publication a few months later because "the data situation did not justify publication". A study published in 2009 found Bt genes in landrace maize in 1% of over 100 fields examined in Mexico. It is unclear whether the genetic engineering of the Bt gene was carried out illegally in land races or whether the genes from regular, illegally grown Bt maize varieties were unintentionally crossed out. After a shortage of maize supply at the beginning of 2007, the Mexican farmers' association demanded the approval of transgenic maize for cultivation. In October 2009, two permits were issued for the experimental cultivation of transgenic maize on almost 13 hectares. One of the topics of the investigations is the question of whether Mexico can reduce its dependence on imports with transgenic varieties. Almost 2,000 scientists protested in a petition against the permits, because they believed that outcrossing to land races could not be prevented. The licensing authorities, however, emphasize that a distance of 500 m to conventional fields is maintained. In addition, sowing should take place at different times, and surrounding farmers should be asked about possible outcrossing. So far there is no scientific evidence that a possible outcrossing of transgenes could reduce the biodiversity of maize. The gene flow, the exchange of genes between cultivated and wild varieties, is a natural process. Whether genes from conventional high-performance varieties or transgenic varieties establish themselves permanently in local varieties and thereby reduce biodiversity ultimately depends on whether they give the offspring a selection advantage. According to the International Maize and Wheat Research Institute , the large number of maize breeds in Mexico is not decreasing simply through crossbreeding from cultivars.
Web links
- Database , transgen.de
- Biological safety research , transgen.de
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- ↑ EFSA Panel on Genetically Modified Organisms: Scientific Opinion on an application (EFSA-GMO-RX-MON863) for renewal of the authorization for continued marketing of existing feed materials, feed additives and food additives produced from maize MON863, under Regulation (EC) No 1829/2003 from Monsanto. In: EFSA Journal. Volume 82010, p. 1562.
- ↑ FSANZ response to de Vendomois et al. (2009), A comparison of the Effects of Three GM Corn Varieties on Mammalian Health, Int. J. Biol. Sci. 5 (7), pp. 706-726. ( Memento of March 29, 2011 in the Internet Archive ) Food Standards Australia New Zealand (FSANZ), 2009, accessed July 30, 2012.
- ↑ J. Spiroux de Vendômois, F. Roullier, D. Cellier, GE Séralini: Opinion relating to the deposition of 15 December 2009 by the Member of Parliament, François Grosdidier, as to the conclusions of the study entitled "A comparison of the effects of three GM corn varieties on mammalian health ". ( Memento from November 5, 2013 in the Internet Archive ) In: Int. J. Biol. Sci. Volume 5, No. 7, 2009, pp. 706-726. High Council of Biotechnologies. Scientific Committee, 2009 (translation by the Food Standards Agency ).
- ↑ a b c Un maïs OGM de Monsanto soupçonné de toxicité. In: Le Monde.fr. 19th September 2012.
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- ^ Experts Question Validity of GMO Cancer Study. ( Memento from June 22, 2015 in the Internet Archive ) VOA, October 16, 2012.
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- ↑ Agnes Ricroch, Jean Baptiste Berge, Marcel Kuntz: Is the German suspension of MON810 maize cultivation scientifically justified? In: Transgenic Research . tape 19 , 2010, p. 1-12 , doi : 10.1007 / s11248-009-9297-5 .
- ↑ Stefan Rauschen: A case of “pseudo science”? A study claiming effects of the Cry1Ab protein on larvae of the two-spotted ladybird is reminiscent of the case of the green lacewing . In: Transgenic Research . tape 19 , no. 1 , 2010, p. 13-16 , doi : 10.1007 / s11248-009-9301-0 .
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- ^ Statement of the ZKBS on recent scientific publications on risk assessment of the maize line MON810. BVL, 2011.
- ↑ Angelika Hilbeck, Joanna M McMillan, Matthias Meier, Anna Humbel, Juanita Schläpfer-Miller, Miluse Trtikova: A controversy re-visited: Is the coccinellid Adalia bipunctata adversely affected by Bt toxins? In: Environmental Sciences Europe . tape 24:10 , 2012, p. 3-12 , doi : 10.1186 / 2190-4715-24-10 .
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