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A genetically modified soybean is a soybean (Glycine max) that has had DNA introduced into it using genetic engineering techniques.[1]: 5 In 1996, the first genetically modified soybean was introduced to the U.S. by Monsanto. In 2014, 90.7 million hectares of GM soybeans were planted worldwide, making up 82% of the total soybeans cultivation area.[2]
The genetic makeup of a soybean gives it a wide variety of uses, thus keeping it in high demand. First, manufacturers only wanted to use transgenics to be able to grow more soybeans at a minimal cost to meet this demand, and to fix any problems in the growing process, but they eventually found they could modify the soybean to contain healthier components, or even focus on one aspect of the soybean to produce in larger quantities. These phases became known as the first and second generation of genetically modified (GM) foods. As Peter Celec describes, "benefits of the first generation of GM foods were oriented towards the production process and companies, the second generation of GM foods offers, on contrary, various advantages and added value for the consumer", including "improved nutritional composition or even therapeutic effects."[3]: 533
Roundup Ready soybeans (The first variety was also known as GTS 40-3-2 (OECD UI: MON-04032-6)) are a series of genetically engineered varieties of glyphosate-resistant soybeans produced by Monsanto.
Glyphosate kills plants by interfering with the synthesis of the essential amino acids phenylalanine, tyrosine and tryptophan. These amino acids are called "essential" because animals cannot make them; only plants and micro-organisms can make them and animals obtain them by eating plants.[4]
Plants and microorganisms make these amino acids with an enzyme that only plants and lower organisms have, called 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS).[5] EPSPS is not present in animals, which instead obtain aromatic amino acids from their diet.[6]
Roundup Ready Soybeans express a version of EPSPS from the CP4 strain of the bacteria Agrobacterium tumefaciens, expression of which is regulated by an enhanced 35S promoter (E35S) from cauliflower mosaic virus (CaMV), a chloroplast transit peptide (CTP4) coding sequence from Petunia hybrida, and a nopaline synthase (nos 3') transcriptional termination element from Agrobacterium tumefaciens.[7] The plasmid with EPSPS and the other genetic elements mentioned above was inserted into soybean germplasm with a gene gun by scientists at Monsanto and Asgrow.[8][9] The patent on the first generation of Roundup Ready soybeans expired in March 2015.[10]
First approved commercially in the United States during 1994, GTS 40-3-2 was subsequently introduced to Canada in 1995, Japan and Argentina in 1996, Uruguay in 1997, Mexico and Brazil in 1998, and South Africa in 2001. GMO Soybean is also approved by the United Nations in 1999.
The Chinese Ministry of Agriculture announced on April 29, 2022, the approval of the drought-tolerant event, called HB4.
GTS 40-3-2 can be detected using both nucleic acid and protein analysis methods.[11][12]
Following expiration of Monsanto's patent on the first variety of glyphosate-resistant Roundup Ready soybeans, development began on glyphosate-resistant generic soybeans. The first variety, developed at the University of Arkansas Division of Agriculture, came to the market in 2015. With a slightly lower yield than newer Monsanto varieties, it costs about 1/2 as much, and seeds can be saved for subsequent years. According to its innovator, it is adapted to conditions in Arkansas. Several other varieties are being bred by crossing the original variety of Roundup Ready soybeans with other soybean varieties.[10][13][14]
HB4 soybean, whose technical name is IND-ØØ41Ø-5 soybean, is a variety produced through genetic engineering to respond efficiently to drought conditions.
The HB4 soybean was created to more efficiently tolerate abiotic stress such as drought or hypersaline conditions. These characteristics result in increased yield compared to unmodified varieties. In 2015, HB4 soybean was approved in Argentina, then in Brazil (May 2019), the United States (August 2019), Paraguay (2019),[15] Canada (2021)[16] and the People's Republic of China (2022).[17]
Monsanto developed a glyphosate-resistant soybean that also expresses Cry1Ac protein from Bacillus thuringiensis and the glyphosate-resistance gene, which completed the Brazilian regulatory process in 2010. This is a cross of two events, MON87701 x MON89788.[18][19]
Soybean has been genetically modified to improve the quality of soy oil. Soy oil has a fatty acid profile that makes it susceptible to oxidation, which makes it rancid, which limits its usefulness in the food industry.[20]: 1030 Genetic modifications increased the amount of oleic acid and stearic acid and decreased the amount of linolenic acid.[20]: 1031 By silencing, or knocking out, the delta 9 and delta 12 desaturases.[20]: 1032 [21] DuPont Pioneer created a high oleic fatty acid soybean with levels of oleic acid greater than 80%, and started marketing it in 2010.[20]: 1038
The regulation of genetic engineering concerns the approaches taken by governments to assess and manage the risks associated with the development and release of genetically modified crops. There are differences in the regulation of GM crops between countries, with some of the most marked differences occurring between the US and Europe. In the US, the American Soybean Association (ASA) is generally in favor of allowing new GM soy varieties. The ASA especially supports separate regulation of transgenics and all other techniques.[22] Soy beans are allowed a Maximum Residue Limit of glyphosate of 20 milligrams per kilogram (9.1 mg/lb)[23] for international trade.[24] Regulation varies in a given country depending on the intended use of the products of the genetic engineering. For example, a crop not intended for food use is generally not reviewed by authorities responsible for food safety.[25][26] Romania authorised GM soy for cultivation and use but then imposed a ban upon entry into the EU in 2007. This resulted in an immediate withdrawal of 70% of the soybean hectares in 2008 and a trade deficit of €117.4m for purchase of replacement products. Farmer sentiment was very much in favour of relegalisation.[27]
There is a scientific consensus[28][29][30][31] that currently available food derived from GM crops poses no greater risk to human health than conventional food,[32][33][34][35][36] but that each GM food needs to be tested on a case-by-case basis before introduction.[37][38][39] Nonetheless, members of the public are much less likely than scientists to perceive GM foods as safe.[40][41][42][43] The legal and regulatory status of GM foods varies by country, with some nations banning or restricting them, and others permitting them with widely differing degrees of regulation.[44][45][46][47]
A 2010 study found that in the United States, GM crops also provide a number of environmental benefits.[48][49][50]
Critics have objected to GM crops on several grounds, including ecological concerns, and economic concerns raised by the fact that these organisms are subject to intellectual property law. GM crops also are involved in controversies over GM food with respect to whether food produced from GM crops are safe and whether GM crops are needed to address the world's food needs. See the genetically modified food controversies article for discussion of issues about GM crops and GM food. These controversies have led to litigation, international trade disputes, and protests, and to restrictive legislation in most countries.[51]
Monsanto's patent on the first generation of Roundup Ready products expires in March 2015....
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USDA's withdrawal...
We have reviewed the scientific literature on GE crop safety for the last 10 years that catches the scientific consensus matured since GE plants became widely cultivated worldwide, and we can conclude that the scientific research conducted so far has not detected any significant hazard directly connected with the use of GM crops.
The literature about Biodiversity and the GE food/feed consumption has sometimes resulted in animated debate regarding the suitability of the experimental designs, the choice of the statistical methods or the public accessibility of data. Such debate, even if positive and part of the natural process of review by the scientific community, has frequently been distorted by the media and often used politically and inappropriately in anti-GE crops campaigns.
Currently available transgenic crops and foods derived from them have been judged safe to eat and the methods used to test their safety have been deemed appropriate. These conclusions represent the consensus of the scientific evidence surveyed by the ICSU (2003) and they are consistent with the views of the World Health Organization (WHO, 2002). These foods have been assessed for increased risks to human health by several national regulatory authorities (inter alia, Argentina, Brazil, Canada, China, the United Kingdom and the United States) using their national food safety procedures (ICSU). To date no verifiable untoward toxic or nutritionally deleterious effects resulting from the consumption of foods derived from genetically modified crops have been discovered anywhere in the world (GM Science Review Panel). Many millions of people have consumed foods derived from GM plants - mainly maize, soybean and oilseed rape - without any observed adverse effects (ICSU).
There is broad scientific consensus that genetically engineered crops currently on the market are safe to eat. After 14 years of cultivation and a cumulative total of 2 billion acres planted, no adverse health or environmental effects have resulted from commercialization of genetically engineered crops (Board on Agriculture and Natural Resources, Committee on Environmental Impacts Associated with Commercialization of Transgenic Plants, National Research Council and Division on Earth and Life Studies 2002). Both the U.S. National Research Council and the Joint Research Centre (the European Union's scientific and technical research laboratory and an integral part of the European Commission) have concluded that there is a comprehensive body of knowledge that adequately addresses the food safety issue of genetically engineered crops (Committee on Identifying and Assessing Unintended Effects of Genetically Engineered Foods on Human Health and National Research Council 2004; European Commission Joint Research Centre 2008). These and other recent reports conclude that the processes of genetic engineering and conventional breeding are no different in terms of unintended consequences to human health and the environment (European Commission Directorate-General for Research and Innovation 2010).
But see also:
Domingo, José L.; Bordonaba, Jordi Giné (2011). "A literature review on the safety assessment of genetically modified plants" (PDF). Environment International. 37 (4): 734–742. doi:10.1016/j.envint.2011.01.003. PMID 21296423. In spite of this, the number of studies specifically focused on safety assessment of GM plants is still limited. However, it is important to remark that for the first time, a certain equilibrium in the number of research groups suggesting, on the basis of their studies, that a number of varieties of GM products (mainly maize and soybeans) are as safe and nutritious as the respective conventional non-GM plant, and those raising still serious concerns, was observed. Moreover, it is worth mentioning that most of the studies demonstrating that GM foods are as nutritional and safe as those obtained by conventional breeding, have been performed by biotechnology companies or associates, which are also responsible of commercializing these GM plants. Anyhow, this represents a notable advance in comparison with the lack of studies published in recent years in scientific journals by those companies.
Krimsky, Sheldon (2015). "An Illusory Consensus behind GMO Health Assessment". Science, Technology, & Human Values. 40 (6): 883–914. doi:10.1177/0162243915598381. S2CID 40855100. I began this article with the testimonials from respected scientists that there is literally no scientific controversy over the health effects of GMOs. My investigation into the scientific literature tells another story.
And contrast:
Panchin, Alexander Y.; Tuzhikov, Alexander I. (January 14, 2016). "Published GMO studies find no evidence of harm when corrected for multiple comparisons". Critical Reviews in Biotechnology. 37 (2): 213–217. doi:10.3109/07388551.2015.1130684. ISSN 0738-8551. PMID 26767435. S2CID 11786594. Here, we show that a number of articles some of which have strongly and negatively influenced the public opinion on GM crops and even provoked political actions, such as GMO embargo, share common flaws in the statistical evaluation of the data. Having accounted for these flaws, we conclude that the data presented in these articles does not provide any substantial evidence of GMO harm.
The presented articles suggesting possible harm of GMOs received high public attention. However, despite their claims, they actually weaken the evidence for the harm and lack of substantial equivalency of studied GMOs. We emphasize that with over 1783 published articles on GMOs over the last 10 years it is expected that some of them should have reported undesired differences between GMOs and conventional crops even if no such differences exist in reality.
and
Yang, Y.T.; Chen, B. (2016). "Governing GMOs in the USA: science, law and public health". Journal of the Science of Food and Agriculture. 96 (4): 1851–1855. Bibcode:2016JSFA...96.1851Y. doi:10.1002/jsfa.7523. PMID 26536836.It is therefore not surprising that efforts to require labeling and to ban GMOs have been a growing political issue in the USA (citing Domingo and Bordonaba, 2011). Overall, a broad scientific consensus holds that currently marketed GM food poses no greater risk than conventional food... Major national and international science and medical associations have stated that no adverse human health effects related to GMO food have been reported or substantiated in peer-reviewed literature to date.
Despite various concerns, today, the American Association for the Advancement of Science, the World Health Organization, and many independent international science organizations agree that GMOs are just as safe as other foods. Compared with conventional breeding techniques, genetic engineering is far more precise and, in most cases, less likely to create an unexpected outcome.
The EU, for example, has invested more than €300 million in research on the biosafety of GMOs. Its recent report states: "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." The World Health Organization, the American Medical Association, the U.S. National Academy of Sciences, the British Royal Society, and every other respected organization that has examined the evidence has come to the same conclusion: consuming foods containing ingredients derived from GM crops is no riskier than consuming the same foods containing ingredients from crop plants modified by conventional plant improvement techniques.
A report issued by the scientific council of the American Medical Association (AMA) says that no long-term health effects have been detected from the use of transgenic crops and genetically modified foods, and that these foods are substantially equivalent to their conventional counterparts. (from online summary prepared by ISAAA)" "Crops and foods produced using recombinant DNA techniques have been available for fewer than 10 years and no long-term effects have been detected to date. These foods are substantially equivalent to their conventional counterparts."REPORT 2 OF THE COUNCIL ON SCIENCE AND PUBLIC HEALTH (A-12): Labeling of Bioengineered Foods" (PDF). American Medical Association. 2012. Archived from the original (PDF) on 2012-09-07. Retrieved August 30, 2019.
Bioengineered foods have been consumed for close to 20 years, and during that time, no overt consequences on human health have been reported and/or substantiated in the peer-reviewed literature.
Several scientific organizations in the US have issued studies or statements regarding the safety of GMOs indicating that there is no evidence that GMOs present unique safety risks compared to conventionally bred products. These include the National Research Council, the American Association for the Advancement of Science, and the American Medical Association. Groups in the US opposed to GMOs include some environmental organizations, organic farming organizations, and consumer organizations. A substantial number of legal academics have criticized the US's approach to regulating GMOs.
Overall finding on purported adverse effects on human health of foods derived from GE crops: On the basis of detailed examination of comparisons of currently commercialized GE with non-GE foods in compositional analysis, acute and chronic animal toxicity tests, long-term data on health of livestock fed GE foods, and human epidemiological data, the committee found no differences that implicate a higher risk to human health from GE foods than from their non-GE counterparts.
Different GM organisms include different genes inserted in different ways. This means that individual GM foods and their safety should be assessed on a case-by-case basis and that it is not possible to make general statements on the safety of all GM foods.
GM foods currently available on the international market have passed safety assessments and are not likely to present risks for human health. In addition, no effects on human health have been shown as a result of the consumption of such foods by the general population in the countries where they have been approved. Continuous application of safety assessments based on the Codex Alimentarius principles and, where appropriate, adequate post market monitoring, should form the basis for ensuring the safety of GM foods.
These principles dictate a case-by-case premarket assessment that includes an evaluation of both direct and unintended effects.
In our view, the potential for GM foods to cause harmful health effects is very small and many of the concerns expressed apply with equal vigour to conventionally derived foods. However, safety concerns cannot, as yet, be dismissed completely on the basis of information currently available.
When seeking to optimise the balance between benefits and risks, it is prudent to err on the side of caution and, above all, learn from accumulating knowledge and experience. Any new technology such as genetic modification must be examined for possible benefits and risks to human health and the environment. As with all novel foods, safety assessments in relation to GM foods must be made on a case-by-case basis.
Members of the GM jury project were briefed on various aspects of genetic modification by a diverse group of acknowledged experts in the relevant subjects. The GM jury reached the conclusion that the sale of GM foods currently available should be halted and the moratorium on commercial growth of GM crops should be continued. These conclusions were based on the precautionary principle and lack of evidence of any benefit. The Jury expressed concern over the impact of GM crops on farming, the environment, food safety and other potential health effects.
The Royal Society review (2002) concluded that the risks to human health associated with the use of specific viral DNA sequences in GM plants are negligible, and while calling for caution in the introduction of potential allergens into food crops, stressed the absence of evidence that commercially available GM foods cause clinical allergic manifestations. The BMA shares the view that there is no robust evidence to prove that GM foods are unsafe but we endorse the call for further research and surveillance to provide convincing evidence of safety and benefit.
The largest differences between the public and the AAAS scientists are found in beliefs about the safety of eating genetically modified (GM) foods. Nearly nine-in-ten (88%) scientists say it is generally safe to eat GM foods compared with 37% of the general public, a difference of 51 percentage points.
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