User:Jjjjjjjjjj/genetically modified food controversies

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


 * WikiComment
 * This seems to go against what is going in California right now with Proposition 37 -- TV ads, editorials, petitions, celebrity advocacy -- a whole big debate -- so it seems inaccurate to say that imply that here in the United States it is not controversial....Let me add here the links to the web site for one side and for the other side:


 * http://www.carighttoknow.org/


 * http://www.noprop37.com/


 * Furthermore, there is evidence that the proposition will pass:


 * http://glendora.patch.com/articles/prop-37-should-genetically-modified-foods-be-denoted-in-labels-74b686e4

"A poll conducted at the end of September found that 76.8 percent of Californians plan to vote “yes” on 37, with 71 percent stating their primary reason was because “people have the right to know what is in their food."

"Another poll found that more than 60 percent of Californians support Prop. 37."


 * which -- I think -- would mean that California would be the only state in the U.S. to require labeling...


 * I'm not an expert on GMO food -- however that there is some debate in the U.S. seems pretty clear (maybe comparatively less than in Europe and Japan -- but as Proposition 37 indicates this could be increasing)


 * For further evidence I can just list (in a rough chronological order) a bunch of the web sites that I visited when looking into this:


 * User:Jjjjjjjjjj/List_of_sites_visited_for_article_genetically_modified_food_controversies


 * Perhaps we could re-word this as something like: "In the United States, GM crops are more widely grown and the introduction of these products has been comparatively less controversial, but has still generated debate (see for example Proposition 37 in Labeling)"


 * Jjjjjjjjjj (talk) 04:45, 24 October 2012 (UTC)

These national differences have led to differing regulatory regimes - see regulation of the release of genetic modified organisms.

The key areas of controversy related to genetically modified (GM) food are: risk of harm from GM food, whether GM food should be labeled, the role of government regulators, the effect of GM crops on the environment, and GM crops' context as part of the industrial agriculture system.

There has never been a long-term study of the effects of a diet including GM food on humans, so no one can be certain whether such diet is as more, less, or as harmful as a diet without GM foods.
 * WikiComment -- Epidemiological Study


 * Have people sought to extrapolate from differences in cancer rates, life expectancy, etc. between Europe and the U.S.? (controlling for all sorts of other factors)...


 * Jjjjjjjjjj (talk) 04:45, 24 October 2012 (UTC)


 * as it says below... the only way to know what something does to people, is it to test it in people. that is what happens for example with drugs.  but even then the knowledge is not perfect.. nobody knows how aspirin, for example, will exactly effect you compared to me.  So for anything we put in our bodies, it is ALWAYS a question of percentages.. of risk.     that is why the article talks about risk.   you are right, we extrapolate from animal and other studies to try to gauge the risk to humans.   and as the article says - no, nobody has tried to gauge the long term effects on humans.   if you think about it, the study is actually impossible to do well, scientifically.   first it would take hundreds, maybe thousands, of people, to be statistically powerful enough to draw conclusions.   and you would have to think about how to gather data accurately over a long, long period of time...  people would have to record everything they eat (food derived from GMOs is in so many different things) and exactly how much.... you would just end up with mountains of data and it would be difficult/impossible to draw conclusions from it.  the alternative would be to really control the environment of fewer people (maybe a few hundred) over a long period of time so that you could really control variables... but this is also unrealistic.   a long term study of the effects of GM food on people that would be scientifically meaningful is really impossible...  Jytdog (talk) 12:18, 24 October 2012 (UTC)

Therefore, discussion of the safety of GM food is a matter of assessing the risk of harm. While it is not possible to make general statements on the safety of all GM foods, to date no adverse health effects in humans have been documented, and there is now broad scientific and regulatory consensus that GM food on the market is safe to eat.


 * WikiComment
 * Looking at question #8 the WHO says:
 * http://www.who.int/foodsafety/publications/biotech/20questions/en/

"GM foods currently available on the international market have passed risk assessments and are not likely to present risks for human health."
 * So in using the word "likely" they don't rule it out entirely.
 * yes it is a matter of risk.  If you don't know this, you should know it now - NOTHING is 100% safe.   Many foods, like tomatoes and beans, contain toxins and if you eat too much of them they will make you sick.   Do you know what drug causes the most harm to people? Acetaminophen.  Tylenol.  Available over the counter all over the country.  (people  take too much over long periods of time and hurt their kidneys).  Nothing is 100% safe.  The thing that really kills me is this -- both in Europe and the US - and especially via internationally organizations like the OECD and the WHO/FAO -- hundreds - lierally hundreds - of good scientists and very well meaning regulators have thought very hard about the safety of GM food and have put together very careful, conscientious ways to evaluate the risks.   And all the anti-GM people just ignore all that.  just ignore it.  It kills me.   There was an article in slate about how the anti-GM people are the climate-change-denier of the left.   And it hit on something important there.   Just like mainstream science says climate change is happening but people deny that science because they don't like the conclusions.... people who are afraid of GM food just ignore -- ignore -- what mainstream science says about it.  Kills me. Jytdog (talk) 12:18, 24 October 2012 (UTC)


 * Here is a link to the article in Slate:


 * http://www.slate.com/articles/health_and_science/science/2012/09/are_gmo_foods_safe_opponents_are_skewing_the_science_to_scare_people_.html


 * In terms of climate change, and people who are taking the miniority view -- I recall that there was an article in The New York Times which mentioned the views of climate contrarians:


 * http://www.nytimes.com/2010/12/22/science/earth/22carbon.html?pagewanted=all


 * And the paper sought to present their views to the public in an unbiased way.
 * About most of the contrarians, I would say the article mocks them: "The Internet has given rise to a vocal cadre of challengers who question every aspect of the science — even the physics, worked out in the 19th century, that shows that carbon dioxide traps heat. That is a point so elementary and well-established that demonstrations of it are routinely carried out by high school students."  The article is somewhat more respectful of Richard Lindzen, and and makes it clear that he and people like him are a tiny minority whose views are not accepted:  "However, the contrarians who have most influenced Congress are a handful of men' trained in atmospheric physics. They generally accept the rising carbon dioxide numbers, they recognize that the increase is caused by human activity, and they acknowledge that the earth is warming in response. ....Among the most prominent of these contrarians is Richard Lindzen of the Massachusetts Institute of Technology, who contends that as the earth initially warms, cloud patterns will shift in a way that should help to limit the heat buildup. Most climate scientists contend that little evidence supports this view...."   The article is absolutely clear that the scientific consensus is that 1) global warming is happening; 2) it is driven by rising CO2, and 3) it will cause dramatic changes to our planet.  It doesn't present those three things as scientifically controversial at all.   It describes political controversy, not scientific controversy.Jytdog (talk) 12:19, 26 October 2012 (UTC)


 * One might ask the question whether in science if an idea is wrong then it will be selected out -- in a natural process over time -- as long as people behave rationally. Just like people gradually discarded the idea of a flat earth.


 * This can be better because if things move too quickly there may then be a backlash -- perhaps that is what one is seeing in California.


 * Jjjjjjjjjj (talk) 08:50, 26 October 2012 (UTC)


 * Certainly the "yes on prop. 37" camp is able to list numerous studies which are consistent with their point of view on this...


 * https://d3n8a8pro7vhmx.cloudfront.net/prop37/pages/67/attachments/original/1348032282/Peer_reviewed_studies_on_GM_food_health_risks.pdf?1348032282


 * That document is a summary from this one which was written by Michael Antoniou, Claire Robinson, and John Fagan:


 * http://earthopensource.org/files/pdfs/GMO_Myths_and_Truths/GMO_Myths_and_Truths_1.3a.pdf


 * Almost all the research on those pages is from fringe scientists like Pustazai or Seralini, whose work has been widely discredited my mainstream scientists and regulatory bodies.Jytdog (talk) 15:46, 24 October 2012 (UTC)


 * Looking at the palces where the scientists work or graduated from (King's College London, Cornell, etc.) I don't think we could say that they are at fringe institutions.
 * You should not confuse the institution where person X works, with person X's scientific judgements. Utterly different.  Scientists are academics, have tenure, and can say whatever they want.  That absolutely does not mean that the institution and its faculty stand behind any of those statements.Jytdog (talk) 12:19, 26 October 2012 (UTC)


 * Well, it's one thing that one could consider. But of course that's only one thing. Just because a scientific paper is written by somebody at a prestigious institution doesn't mean that the paper is correct.


 * I have heard (and the professor.html piece hereis consistent with this)

that corporations influence who gets to study the seeds -- and who gets the grants.

Jjjjjjjjjj (talk) 22:20, 26 October 2012 (UTC)


 * The fact that regulatory agencies (both national and international) have said it is basically safe would indicate that scientific consensus is the technology is a viable way to improve agriculture.


 * However, there are scientists who are taking the opposite view on this -- or may just be calling for greater caution and more tests and study.


 * I remember back in the early 2000's people were saying that cell phones are completely safe.


 * I was just sitting in the doctor's office one day, and I saw a news report saying that there is evidence that cell phone use can be harmful to one's health over the long term.


 * http://www.theatlantic.com/health/archive/2012/10/italian-supreme-court-says-cell-phones-cause-brain-tumors-how-to-address-your-concerned-mother/263936/
 * http://well.blogs.nytimes.com/2011/02/22/cellphone-use-tied-to-changes-in-brain-activity/
 * The scientists who did this study were VERY careful to say “Unfortunately this particular study does not enlighten us in terms of whether this is detrimental or if it could even be beneficial,” Dr. Volkow said. “It just tells us that even though these are weak signals, the human brain is activated by them.” The opposite of Seralini who did a crappy study and drew dramatic conclusions from the results.


 * In the case of GMO technology and in the case of cell phones -- whatever the actual presence/lack of long term-effects -- businesses have an incentive to have it be decided that the technology is safe.
 * Businesses also have a huge incentive to only release products that safe, lest they incur huge liabilities.  Look at the story in the article on the Pioneer Hi-Bred effort to make soybeans with a protein from brazil nut.  Pioneer developed and lab-tested the product for toxicity as they always do, found surprisingly allergenic reactions, and promptly killed the project and never tried to commercialize it.Jytdog (talk) 12:19, 26 October 2012 (UTC)


 * (cigarettes are another example)
 * cigarettes are a great example. The scientific community came to understand in the1930's that cigarette smoking was harmful and the consensus only grew with time.   It took a long time for politicians to catch up.  It is true that tobacco companies suppressed evidence that cigarettes were harmful and lied about it.  Best comparison again is to climate change where oil companies argue against it but scientific consensus says it is happening.  In the case of GM food, Greenpeace et al are analogous to oil companies and cigarette companies, standing in opposition to mainstream science.


 * One could also compare which countries have approved it, and the economic disparity in various countries as measured by the Gini coefficient:


 * Countries who have approved it: article/what-countries-have-banned-gmo-crops?cid=PROD-redesign-right-next  (note that that is a link to the examiner web site just put http://  and then examiner  and  then .com before it -- I think that's legit -- but Wikipedia blocks it -- the article says that Britain officially supports GMO crops -- which is consistent with this information here, and I think consistent with the information here)


 * Or if you just Google for "what countries have banned GMO" the examiner article will be up at the top search results. Jjjjjjjjjj (talk) 09:07, 26 October 2012 (UTC)


 * Gini_Index
 * https://www.cia.gov/library/publications/the-world-factbook/rankorder/2172rank.html?countryName=Uganda&countryCode=ug&regionCode=afr&rank=47#ug
 * http://www.equalitytrust.org.uk/docs/why-inequality-matters.pdf (page 12 of the book)


 * The U.S. and the U.K. have greater economic disparity than the rest of Western Europe, and it was in these countries that GMO technology is supported/utilized (although in Britan there is distrust of it -- according to the examiner article).


 * The U.S and U.K. are countries which historian Peter Dobkin Hall and economist David Soskice refer to as has liberal market economies (while other countries such Japan, Germany and the Scandinavian countries has coordinated market economies)


 * This is from their book called Varieties of Capitalism.


 * I learned about this from Prosperity Without Growth by Tim Jackson.


 * Jjjjjjjjjj (talk) 08:50, 26 October 2012 (UTC)


 * I added one reference up there to a book with the title: A decade of EU-funded GMO research -- although the Wikipedia article quotes this source as finding GMO food to be safe -- opponents report at this link:


 * https://d3n8a8pro7vhmx.cloudfront.net/prop37/pages/67/attachments/original/1348032282/Peer_reviewed_studies_on_GM_food_health_risks.pdf?1348032282


 * that some of the studies in the summary book indicate possible health risks.


 * In any event -- one rewording would be:


 * While it is not possible to make general statements on the safety of all GM foods, to date no adverse health effects in humans have been documented,[1] and numerous studies indicate that GM food is safe to eat.


 * Jjjjjjjjjj (talk) 04:45, 24 October 2012 (UTC)

An OECD task force wrote in 2000: "Much experience has been gained in the safety assessment of the first generation of foods derived through modern biotechnology, and those countries that have conducted assessments are confident that those GM foods they have approved are as safe as other foods."

Nonetheless, some scientists, a US National Academy of Sciences task force, and advocacy groups such as Greenpeace and World Wildlife Fund have concerns that risks of GM food have not been adequately identified and managed. Calls for change range from requiring more rigorous testing of GM food, to banning GM food.


 * WikiComment
 * I think it makes sense to also let people know that advocacy groups claim there are conflicts of interest: Jjjjjjjjjj (talk) 04:45, 24 October 2012 (UTC)
 * People say all kinds of things. People say that Seralini has dramatic conflicts as well.  I don't think this is reasonable.Jytdog (talk) 15:46, 24 October 2012 (UTC)

Advocacy groups also make the claim that scientists are tied to business interests which influence public statements.

French scientist Gilles Eric Séralini has been an outspoken critic of current standards of toxicity testing, and his laboratory has published papers communicating its analyses of others' studies, and its own original toxicity research. His conclusions have been that GM food and commonly used herbicides have a high risk of being harmful to humans; his conclusions and studies have been deeply and widely criticized by the scientific and regulatory community. See section below in Controversial Cases on the lab's papers and the responses to them.

Labeling of GM food provides consumers with the opportunity to choose the risks to which they are exposed, but also exposes food producers to risks of economic harm, should consumers take such labeling as a sign that food from GMOs is not safe enough. Some countries require labeling of GM food and others do not; regulations concerning labeling are a source of international controversy and of controversy within individual countries.

This article covers controversies over genetic engineering - especially its use in agriculture, animal husbandry, and aquaculture (in other words, food production) and the use of its fruits as food. There are separate articles on other aspects of genetic engineering. The genetic engineering article focuses on history and methods of genetic engineering, and on applications of genetic engineering and of GMOs. The article on GMOs focuses on what organisms have been genetically engineered and for what purposes. The two articles cover much of the same ground but with different organizations (sorted by application in the genetic engineering article; sorted by organism in the GMO article). There are separate articles on genetically modified food per se (what foods that we eat are the products of GM crops or animals?), genetically modified crops (which have more to do with agriculture than food), and regulation.

Public perception


Social science surveys have documented that individuals are more risk averse about food than institutions, and there is widespread concern within the public about the risks of biotechnology, desire for more information about the risks themselves and the risk/benefit distribution of GM food, and a desire for choice in being exposed to risk. The introduction of wonder-products such as DDT and PCBs and their subsequent withdrawal after unforeseen problems were discovered, has undermined public trust in companies that introduce products that are pervasively used, and in the government agencies meant to regulate them. There is also a widespread sense that social and technological change is speeding up and people feel powerless to affect this change; diffuse anxiety driven by this context becomes focused when it is food that is being changed.

In 2002, Oregon Ballot measures gave voters in that state one of the first opportunities in the United States to directly address that issue. The measure, which would have required the labeling of genetically engineered foods, failed to pass by a ratio of 7 to 3.

In 2006, the Pew Initiative on Food and Biotechnology made public a review of survey results from 2001-2006. The review showed that Americans' knowledge of genetically modified foods and animals was low through the period. An example of this ignorance (not cited in the Pew review), were protests against Calgene's Flavr Savr transgenic tomato that described the GM tomato as being made with fish genes, confusing it with DNA Plant Technology's Fish tomato experimental transgenic organism, which was never commercialized. The Pew survey also showed that despite continuing concerns about GM foods, American consumers do not support banning new uses of the technology, but rather seek an active role from regulators to ensure that new products are safe.

A 2010 Deloitte survey found that 34% of U.S. consumers were very or extremely concerned about GM food, a 3% reduction from 2008. The same survey found a strong gender difference in opinion: 10% of men were extremely concerned, compared with 16% of women, and 16% of women were unconcerned, compared with 27% of men.

According to a 2003 study, only 2% of Britons were said to be "happy to eat GM foods", and more than half of Britons were against GM foods being available to the public. A 2012 survey by the British Science Association found that "opposition has weakened, with 15.2% of 2,058 people being "fairly unconcerned" now compared with 6% of 1,363 citizens in 2003. The "very unconcerned" count has remained largely the same, while the proportion of "very concerned" people has dropped from 23.8% to 17.2%."

A 2009 review article of European consumer polls concluded that opposition to GMOs in Europe has been gradually decreasing. Approximately half of European consumers accepted gene technology, particularly when benefits for consumers and for the environment could be linked to GMO products. 80% of respondents did not cite the application of GMOs in agriculture as a significant environmental problem. Many consumers seem unafraid of health risks from GMO products and most European consumers did not actively avoid GMO products while shopping. The 2010 "Eurobarometer" survey, which assesses public attitudes about biotech and the life sciences in Europe, found that "cisgenics, GM crops produced by adding only genes from the same species or from plants that are crossable by conventional breeding, evoke a different reaction than the those with genes from more distant species. In all EU countries, our example of the cisgenic production of apples receives higher support (55%) than transgenic apples (33%), with the former attracting majority support in 24 countries."

In Australia, GM foods that have novel DNA, novel protein, altered characteristics or has to be cooked or prepared in a different way compared to the conventional food have, since December 2001, had to be identified on food labels. A 2007 survey by the Food Standards Australia and New Zealand found that 27% of Australians looked at the label to see if it contained GM material when purchasing a grocery product for the first time. Further controversy erupted in 2009 when Graincorp, the nations largest grain handler, announced it would mix GM Canola with its unmodified grain. Traditional growers, who largely rely on GM-free markets, had been told they would need to pay to have their produce certified GM free. Graincorp reversed its decision the same year. Critics such as Greenpeace and the Gene Ethics Network have renewed calls for more labelling.

Opponents of genetically modified food often refer to it as "Frankenfood", after Mary Shelley's character Frankenstein and the monster he creates. The term was coined in 1992 by Paul Lewis, an English professor at Boston College who used the word in a letter he wrote to the New York Times in response to the decision of the US Food and Drug Administration to allow companies to market genetically modified food. The term "Frankenfood" has become a battle cry of the European side in the US-EU agricultural trade war. The irony of this term has been pointed out; in the tragic and ambiguous story of the original novel, the monster is fundamentally decent, is rejected by people who are afraid of its appearance, does violence at first only in self-defense and then in the course of revenge against its creator, and is finally killed by a hysterical mob.

Industrial agriculture
GM crops play a key role in contemporary large scale agriculture, which involves monoculture, heavy use of herbicides and pesticides, use of equipment that requires large amounts of fuel, and heavy water use. The market for organic food products has grown substantially worldwide and in the US, driven to a great extent by concern over the healthiness of the products of industrial agriculture and by environmental concerns, as described in the article on organic food. Vandana Shiva, the founder of the group Navdanya, is an example of those who protest this paradigm: "We need biodiversity intensification that works with nature's nutrient and water cycles, not against them."

Labeling
While some groups advocate the complete prohibition of GMOs, others call for mandatory labeling of genetically modified food or other products, while others call for no labeling of GM food.

Outside the U.S., the entire European Union and other countries such as Australia, China, Japan, and Russia require GMO labeling. There are other countries that make GMO labeling voluntary and many other countries have plans to introduce GMO labeling

As of May 2012, the U.S. state of California is scheduled to vote November 6th on the labeling of genetically modified food (Proposition 37). The argument is that consumers have a right to know the content of their food and to choose to avoid it if they wish, while advocates such as DuPont, Monsanto, and Syngenta and the Council for Biotechnology Information, which represents agribusinesses, call this an attempt to scare consumers and make them feel that the food is unsafe. Biotechnology labeling is not required by the Food and Drug Administration (FDA), but it has been adopted by over 40 countries. According to public disclosures, the Council for Biotechnology Information and The Grocery Manufacturers Association, which also opposes this initiative, have each made matching donations of $375,000 to fight the initiative.

A website posted by P. Bryne of the Colorado State University Extension, provides a concise list of pros and cons of labeling food derived from GMOs, with further detail. The list of pros and cons is reproduced here: Pros and Cons of Mandatory Labeling There are many arguments both in favor of and against mandatory labeling of GE foods. Those arguments are summarized below.

Pro-labeling Arguments
 * Consumers have a right to know what’s in their food, especially concerning products for which health and environmental concerns have been raised....
 * Surveys indicate that a majority of Americans support mandatory labeling. (However, such surveys often do not specify the effect on food prices.)
 * At least 21 countries and the European Union have established some form of mandatory labeling.
 * For religious or ethical reasons, many Americans want to avoid eating animal products, including animal DNA.

Anti-labeling Arguments
 * Labels on GE food imply a warning about health effects, whereas no significant differences between GE and conventional foods have been detected. If a nutritional or allergenic difference were found in a GE food, current FDA regulations require a label to that effect.
 * Labeling of GE foods to fulfill the desires of some consumers would impose a cost on all consumers. Experience with mandatory labeling in the European Union, Japan, and New Zealand has not resulted in consumer choice. Rather, retailers have eliminated GE products from their shelves due to perceived consumer aversion to GE products.
 * Consumers who want to buy non-GE food already have an option: to purchase certified organic foods, which by definition cannot be produced with GE ingredients.
 * The food system infrastructure (storage, processing, and transportation facilities) in this country could not currently accommodate the need for segregation of GE and non-GE products....

Objectivity of regulatory bodies
Groups opposing the release of genetically modified organisms or their use as food have questioned whether regulatory authorities in various countries are too close to companies that seek approval for their products, or have received bribes from such companies.

Critics in the US have protested in regards to the appointment of pro GM lobbyists to senior positions in the FDA. Michael R. Taylor, a former Monsanto lobbyist, was appointed as a senior adviser to the FDA on food safety in 1991. Following his tenure at the FDA, Taylor became a vice-president of Monsanto. On 7 July 2009, Taylor returned to government as Senior Advisor to the Commissioner of the US Food and Drug Administration for the Obama administration.

Also in the US, Dennis Wolff is expected to take up the position of Under-Secretary of the newly created Agriculture for Food Safety. Wolff is the Pennsylvania Secretary of Agriculture who successfully lobbied to ban organic farmers from labeling their products as being GM free and was a proponent of the "ACRE" initiative which gave the Pennsylvania state attorney general's office the authority to sue municipalities that banned GMOs. Several anti-GMO organisations have organised petitions opposing Wolff's appointment and have also conducted letter writing campaigns protesting the conflict of interest.

The Canadian Biotechnology Advisory Committee that reviewed Canada's regulations in 2003 was accused by environmental and citizen groups of not representing the full spectrum of public interests and for being too closely aligned to industry groups.

Most of the Chinese National Biosafety Committee are involved in biotechnology leading to criticisms that they do not represent a wide enough range of public concerns.

The Welsh advocacy group GM Free Cymru argues that governments should use independent studies rather than industry studies to assess crop safety. GM Free Cymru has also stated that independently funded researcher, Professor Bela Darvas of Debrecen University was refused Mon 863 Bt corn to use in his studies after previously publishing that a different variety of Monsanto corn was lethal to two Hungarian protected insect species and an insect classified as a rare (although this information was investigated by the European Union who concluded that the results were not scientifically valid and contradicted several other scientifically accepted studies ).

Health risks of consuming GM food
There has never been a long-term study of the effects of a diet including GM food on humans, so no one can be certain whether such diet is as more, less, or as harmful as a diet without GM foods. Therefore, discussion of the safety of GM food is a matter of assessing the risk of harm. Governments worldwide assess and manage the risks associated with the release of genetically modified organisms and the marketing of genetically modified food. There are differences in risk assessment of GM food, and therefore in the regulation of GMOs, between countries, with some of the most marked differences occurring between the USA and Europe. Regulation also varies within 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. For specific regulatory frameworks, see Regulation of the release of genetic modified organisms.

There is now broad scientific and regulatory consensus that food on the market derived from GM crops is safe enough to eat. The European Commission Directorate-General for Research and Innovation 2010 report on GMOs noted that "The main conclusion to be drawn from the efforts of more than 130 research projects, covering a period of more than 25 years of research, and involving more than 500 independent research groups, is that biotechnology, and in particular GMOs, are not per se more risky than e.g. conventional plant breeding technologies." A 2008 review published by the Royal Society of Medicine noted that GM foods have been eaten by millions of people worldwide for over 15 years, with no reports of ill effects. Similarly a 2004 report from the US National Academies of Sciences stated: "To date, no adverse health effects attributed to genetic engineering have been documented in the human population." A 2004 report by Working Group 1 of the ENTRANSFOOD project, a group of scientists funded by the European Commission to identify prerequisites for introducing agricultural biotechnology products in a way that is largely acceptable to European society, concluded that "the combination of existing test methods provides a sound test-regime to assess the safety of GM crops." The US pro-GM group AgBioWorld has also argued that GM foods have been proven safe.

Among those scientists and regulators who are part of the consensus that currently marketed GM food is safe enough, there is also a consensus that there is a continuing need for improved testing technologies and protocols to identify and manage risk even better. An OECD consensus document from 2010 describing the application of cutting-edge analysis techniques to GMO regulation concluded: "Molecular characterisation in and of itself is not a sufficient means of predicting the risk/safety of recombinant-DNA plants. However, molecular characterisation may be useful in focusing other components of the risk/safety assessment that assess the phenotype of the plant, such as characterisation of the levels of nutrients, anti-nutrients, endogenous toxicants or allergens, or changes in plant fitness. To date, the most appropriate available scientific procedures and technology have been used in the molecular characterisation of recombinant-DNA plants. Experience from the use of these procedures and technology form the basis of this document. Based on the current pace of technological advancement, it is expected that new methodologies may be applied to the molecular characterisation of recombinantDNA plants should such technologies prove to have added value as a mechanism of hazard identification in food, feed and environmental risk/safety assessments. "

However, some scientists and advocacy groups such as Greenpeace and World Wildlife Fund have concerns that known risks are not managed well enough, and that there is too much potential for currently unknown risks to emerge. Some groups, such as the Organic Consumers Association, Greenpeace, and The Center for Food Safety claim the long-term health risks which GM could pose, or the environmental risks associated with GM, have not yet been adequately investigated. In Japan, the Consumers Union of Japan is opposed to GMO foods. They also claim that truly independent research in these areas is systematically blocked by the GM corporations which own the GM seeds and reference materials. A 2011 article by Séralini et al. noted that "it must be said that very few tests on humans have been carried out up to now."

In general, little distinction is made in debates over the safety of GM food, concerning the method of genetic engineering. However, in 2012, the European Food Safety Authority (EFSA) Panel on Genetically Modified Organisms (GMO) released a "Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis" in a response to a request from the European Commission. The opinion was, that while "the frequency of unintended changes may differ between breeding techniques and their occurrence cannot be predicted and needs to be assessed case by case," "similar hazards can be associated with cisgenic and conventionally bred plants, while novel hazards can be associated with intragenic and transgenic plants." In other words, cisgenic genetic engineering approaches should be considered similar in risk to conventional breeding approaches, each of which are less risky than transgenic approaches.

Definition of substantial equivalence
The starting point for the safety assessment of genetically engineered food products by regulatory bodies is to assess if the food is "substantially equivalent" to their counterparts, which themselves are the products of genetic manipulation via traditional methods of cross-breeding and hybridization. For more detail see Substantial equivalence definition in Regulation of the release of genetic modified organisms.

Controversies over definition and application of substantial equivalence
The application of substantial equivalence has been criticized. For example, in a speech in 1999, Andrew Chesson of the University of Aberdeen, speaking from within the scientific and regulatory consensus, warned that substantial equivalence testing "could be flawed in some cases" and that some current safety tests could allow harmful substances to enter the human food chain.

In a commentary in Nature in 1999, Millstone et al. argued that the substantial equivalence standard was pseudo-scientific and was the product of politics and business lobbying—they claimed it was created primarily to reassure consumers and to aid biotechnology companies in avoiding the time and cost of more rigorous safety testing. They argued that all GM foods should have extensive biological, toxicological and immunological tests and that the concept of substantial equivalence should be abandoned. This commentary was controversial and was criticized for providing a misleading presentation of history and for distorting existing data and applying bad logic and of presenting an oversimplified version of safety assessments. For example, Kuiper et al. responded to this criticism by noting that equivalence testing does involve more than chemical tests and may include toxicity testing. An opinion piece in the Los Angeles Times in 2001 by Barbara Keeler and Marc Lappe supported legislation in the US Congress to set aside the substantial equivalence standard and instead mandate that safety studies be performed.

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

A 2008 paper by Cheng et al. showed that genetic engineering of soybeans causes smaller unintended changes than are seen with traditional breeding. A 2002 paper by Ridley et al. showed that genetically engineered maize was equivalent to conventional maize for proximates, fiber, amino acids, fatty acids, vitamin E, nine minerals, phytic acid, trypsin inhibitor, and secondary metabolites. Baudo et al. in a 2006 paper compared transgenic wheat with conventionally bred wheat and concluded that "...transgenic plants could be considered substantially equivalent to untransformed parental lines."

Some academic labs are starting to use contemporary "-omics" techniques to explore the equivalence of GM foods with their conventional counterparts. A 2004 paper found equivalence between a GM tomato variety and its existing counterpart. A 2005 paper used metabolomics approach and found equivalence between one strain of GM potato and its conventional counterpart. A 2008 paper by di Carli et al. compared genetically engineered Lycopersicon esculentum (a tomato) and Nicotiana benthamiana (a close relative of tobacco) with their untransformed counterparts and concluded that genetic engineering did not significantly affect the plants' proteomic profile.

Studies of transgenic plants compared to wild-type plants
A survey of publications describing comparisons between the intrinsic qualities of GM and non-GM reference crop lines (comparing genomes, proteomes, and metabolomes of the plants themselves, not the plants' effects on an organism eating them) indicates that transgenic modification of crops has less impact on gene expression or on protein and metabolite levels than has the variability generated by conventional breeding (which is usually considered as safe).

Reviews of animal feeding studies
A 2012 review of more than 24 long-term animal feeding studies conducted by public research laboratories, concluded that none of these studies discovered any safety problem linked to long-term consumption of GM food. A 2009 review by Magaña-Gómez et al. found that although most studies concluded that GM foods do not differ in nutrition or cause any detectable toxic effects in animals, some studies did report adverse changes at a cellular level caused by some GM foods, concluding that "More scientific effort and investigation is needed to ensure that consumption of GM foods is not likely to provoke any form of health problem". A review published in 2009 by Dona and Arvanitoyannis concluded that "results of most studies with GM foods indicate that they may cause some common toxic effects such as hepatic, pancreatic, renal, or reproductive effects and may alter the hematological, biochemical, and immunologic parameters". However responses to this review in 2009 and 2010 note that the Dona and Arvanitoyannis concentrated on articles with an anti-GM bias that have been refuted by scientists in peer-reviewed articles elsewhere - for example the 35S promoter, stability of transgenes, antibiotic marker genes and the claims for toxic effects of GM foods. In 2007, a review by Domingo of the toxicity by searching in the Publimed database using 12 search terms, cited 68 references, found that the "number of references" on the safety of GM/transgenic crops was "surprisingly limited" and questioned whether the safety of genetically modified food has been demonstrated; the review also remarked that its conclusions were in agreement with three earlier reviews by Zdunczyk (2001), Bakshi (2003), and Pryme and Lembcke (2003). However, an article in 2007 by Vain found 692 research studies focusing on GM crop and food safety and identified a strong increase in the publication of such articles in recent years. Vain commented that the multidisciplinarian nature of GM research complicates the retrieval of GM studies and requires using many search terms (he used more than 300) and multiple databases.

A 2005 review by Flachowsky et al. concluded that first-generation genetically modified foods had been found to be similar in nutrition and safety to non-GM foods, but noted that second-generation foods with "significant changes in constituents" would be more difficult to test, and would require further animal studies.

A 2004 review of animal feeding trials by Aumaitre et al. found no differences among animals eating genetically modified plants.

See also the discussion of the Séralini lab's studies, above.

Human exposure to pesticides produced in GM foods
A 2011 study, the first to evaluate the correlation between maternal and fetal exposure to BT toxin (a protein having insecticidal effects on certain insects, produced by a gene from a soil bacterium Bacillus thuringiensis) produced in genetically modified maize and to determine exposure levels of the pesticides and their metabolites, reported the presence of pesticides associated with GM foods in both non-pregnant women and pregnant women and their fetuses. The paper and the media reports around it were criticized for overstating the results. Food Standards Australia New Zealand (FSANZ), the food safety regulatory authority for New Zealand and Australia, took the unusual step of posting a direct response: "The assay method (ELISA) used for Cry1Ab protein was not tested (validated) for its suitability to measure Cry1Ab in human blood. Other reports in the scientific literature have shown that the ELISA assay is not suitable for this purpose. In mammals, the Cry1Ab protein is degraded in the stomach. If any fragments of the Cry1Ab protein were to pass through into the blood stream, they would be present at levels much lower than could be quantified by the assay method used in the study. The authors do not provide any evidence that GM foods are the source of the protein. No information was gathered on the diet of any individual in the study so the assertion that the detection of Cry1Ab is linked to ingested GM food is, at best, speculative. Several insecticidal formulations (e.g. Delfin, Dipel) contain a blend of crystallised proteins, (including Cry1Ab) and livingBtkspores that germinate into the bacterium that then produces the proteins. These formulations have been applied worldwide, including in Australia, for decades. They are applied to crops such as broccoli, cauliflower, celery, melons, potatoes, spinach, tomatoes, cucumbers, turnip, grapes, kiwi-fruit, citrus, avocados. They are used both commercially and by home gardeners and are permitted for use on organically-certified crops. In comparison, the consumption of food derived from GM corn containing the Cry1Ab protein (no other currently commercialised GM crop species contain this gene) is recent and relatively minor. The corn lines containing the Cry1Ab protein are mostly used for animal feed and for processing into refined products such as corn syrup and corn starch which, because of processing, contain negligible levels of any protein. None of the GM corns produced so far are popcorn or sweetcorn lines and are therefore not consumed directly. Therefore, ingestion of Cry1Ab by humans via GM corn is not likely to be significant compared to conventional and organic produce sources. There have been claims in the media that the paper is proof GM foods are not safe for human consumption. However, the paper does not discuss the safety implications of finding Cry1Ab in the human body and the authors make no mention of any abnormalities in either the subjects or, in the case of those who were pregnant at the time of the study, the subsequent process of birth or the health of the mothers and babies postpartum. The paper has been found to be unconvincing by several authors and organizations.

Gene transfer from food to humans
As of January 2009, there has only been one human feeding study conducted on the effects of genetically modified foods. The study involved seven human volunteers who had had previously had their large intestines removed for medical reasons. These volunteers were to eat GM soy to see if the DNA of the GM soy transferred to the bacteria that naturally lives in the human gut. Researchers identified that three of the seven volunteers had transgenes from GM soya transferred into the bacteria living in their gut before the start of the feeding experiment. As this low-frequency transfer did not increase after the consumption of GM soy, the researchers concluded that gene transfer did not occur during the experiment. In volunteers with complete digestive tracts, the transgene did not survive passage through intact gastrointestinal tract. Anti-GM advocates believe the study should prompt additional testing to determine its significance. Other studies have found DNA from M13 virus, GFP and even ribulose-1,5-bisphosphate carboxylase (Rubisco) genes in the blood and tissue of ingesting animals.

Two studies on the possible effects of giving genetically modified feed to animals found that there was no significant differences in the safety and nutritional value of feedstuffs containing material derived from genetically modified plants.

Specifically, the studies noted that no residues of recombinant DNA or novel proteins have been found in any organ or tissue samples obtained from animals fed with GMP plants.

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

A well-known case of a GM plant that did not reach the market due to it producing an allergic reaction was a new form of soybean developed by Pioneer Hi-Bred in the early 1990s, intended for animal feed. In a bid to use genetic engineering to improve soybean nutritional quality for animal feed use, a gene coding for a protein was transferred from the Brazil nut into soybeans. This new protein increased the levels in the GM soybean of the natural essential amino acid methionine, which is commonly added to poultry feed. Investigations of the allergenicity of the GM soybeans were conducted by Pioneer, including radioallergosorbent testing, immunoblotting, and skin-prick testing. The tests revealed that they produced immune reactions in people with Brazil nut allergies, since the methionine rich protein chosen by Pioneer Hi-Bred happened to be a major source of Brazil nut allergy - it turned out to be an allergen. Although this soybean strain was not developed as a human food, Pioneer Hi-Bred discontinued further development of the GM soybean, due to the difficulty in ensuring that none of these soybeans entered the human food chain.

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

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

"The recent Prescott et al. paper in JFAC contains a very interesting study on the immunogenicity of amylase [starch digestion enzyme] inhibitor in its native form (isolated from beans) and expressed as a transgene in peas. First of all, amylase inhibitor is a food protein, but also a "toxic" protein because it inhibits our digestive amylases. This is one of the reasons you have to cook your beans! (The other toxic bean protein is phytohemagglutinin and it is much more toxic).

This particular amylase inhibitor is found in the common bean (other species have other amylase inhibitors). Even though it is a food protein, it is unlikely ever to be used for genetic engineering of human foods because it inhibits our amylases. What the results show is that the protein, when synthesized in pea cotyledons has a different immunogenicity than when it is isolated from bean cotyledons (the native form). This is somewhat surprising but may be related to the presence of slightly different carbohydrate chains."

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

A GM salmon has been developed and presented to the FDA for approval, which as of May 2012 has not been granted. Concerns have been raised that GM fish could exacerbate or cause fish allergies

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

Purity of Foodchain
Another concern is inclusion of GM commodities, intended not for human consumption (for example, approved only for animal feed or industrial use) into the human food supply. In 2000, Aventis StarLink corn, which had been approved only as animal feed due to concerns about possible allergic reactions in humans, was found contaminating corn products in U.S. supermarkets. An episode involving Taco Bell taco shells was particularly well publicized which resulted in sales of StarLink seed being discontinued. The registration for the Starlink varieties was voluntarily withdrawn by Aventis in October 2000. Aid sent by the UN and the US to Central African nations was also found to be contaminated with StarLink corn and the aid was rejected. The US corn supply has been monitored for Starlink Bt proteins since 2001 and no positive samples have been found since 2004. In response, GeneWatch UK and Greenpeace International set up the GM Contamination Register in 2005. In another example, American exports of rice to Europe were interrupted in 2006 when much of the U.S. crop was confirmed to be contaminated with unapproved engineered genes. An investigation by the USDA’s Animal and Plant Health Inspection Service (APHIS) was unable to determine the cause of the contamination.

Environmental risks and benefits
Concerns have been raised about effects of genetically-engineered crops on non-target species, and about gene flow to other plants and to bacteria. On the other hand, GM crops have their supports from an environmental standpoint. These may be both direct effects, on organisms that feed on or interact with the crops, or wider effects on food chains produced by increases or decreases in the numbers of other organisms.

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

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

As an example of benefits, insect-resistant Bt-expressing crops will reduce the number of pest insects feeding on these plants, but as there are fewer pests, farmers do not have to apply as much insecticide, which in turn tends to increase the number of non-pest insects in these fields.

A 2012 study on the effects of using Bt cotton in six northern provinces of China from 1990 to 2010 concluded that GM crops deliver significant environmental benefits. Bt cotton halved the use of pesticides and doubled the level of ladybirds, lacewings and spiders. The environmental benefits extended to neighbouring crops of maize, peanuts and soybeans.

A 2006 study of the global impact of GM crops, published by the UK consultancy PG Economics, concluded that globally, the technology reduced pesticide spraying by 286,000 tons in 2006, decreasing the environmental impact of herbicides and pesticides by 15%. By reducing the amount of ploughing needed, GM technology led to reductions of greenhouse gases from soil equivalent to removing 6.56 million cars from the roads.

Defining environmental harm
In order for any assessment of the potential effects of GM foods on health, biodiversity and the environment to be meaningful, an international consensus needs to be agreed upon as to what constitutes "environmental harm". To date, there has been no such consensus. Oliver Sanvido, with the Swiss State Secretariat for Economic Affairs, has identified four factors that create difficulty in coming to consensus on definitions of "environmental harm" internationally, and within any given country:1) scientific difficulty in assessing whether an observed change exceeds the existing variability within an environment, especially when and where appropriate baseline data is lacking; 2) difficulty in ascribing a particular environmental change to a particular cause; 3) the long time periods necessary for some changes to become apparent; 4) differences in goals and values of stakeholders that prevent agreement on policy:  "An agreement on a strictly scientific and objective definition of harm is however difficult. The notion of harm or benefit depends on our negative or positive evaluation of a change. What we choose and define to represent harm is based on a certain normative background. In practice, any decision-making process is thus never simply based on scientific data, but it is always influenced by ethical values, as well as political, social, and economical factors."

Current definitions of environmental harm include:
 * "Any damage representing a measurable adverse change in a natural resource/resource service." (European Directive 2004/35/EC on Environmental Liability)
 * "Changes that go beyond natural range of variability for a particular asset of value." (German Advisory Council on the Environment, SRU, 2004)
 * "Measurable (or otherwise observable) loss or damage (...) that has adverse (and significant) impact upon conservation and sustainable use of biodiversity." (Cartagena Protocol on Biosafety, CBD, 2009)
 * "A significant adverse effect on a biotic conservation resource (animal, plant, fungi, microorganism) or an abiotic conservation resource (soil, water, climate) that has an impact on (1) the value of the conservation resource in whole or part, (2) on the conservation resource as an ecosystem component, or (3) on the sustainable use of the conservation resource or the ecosystem with which the conservation resource is associated."

Use of agrochemicals
A 2009 study published by Charles Benbrook of the Organic Center stated that the use of genetically engineered corn, soybean, and cotton increased the use of agrochemicals by a net 318.4 million pounds (159,200 tons) over the preceding 13 years. Use of Bt corn and cotton had delivered a reduction in insecticide use totaling 64.2 million pounds over the period, but use of herbicide-resistant crops had increased herbicide use by 383 million pounds (191,500 tons). The report noted that herbicide use on GE acres veered sharply upward in crop years 2007 and 2008 - the increase in those years accounted for 46% of the increase in herbicide use over the 13 years - and accounted for that sharp increase by the proliferation of herbicide-resistant weeds. The report notes that over the period, a total of 3,826,546,336 pounds of herbicide were applied, so the 383 million pounds represents an increase of 10%.

Environmental impacts for Bt crops appear to be positive during the first ten years of Bt crop use (1996–2005). One study concluded insecticide use on cotton and corn during this period fell by 35.6 million kg of insecticide active ingredient, which is roughly equal to the amount of pesticide applied to arable crops in the EU in one year. Using the environmental impact quotient (EIQ) measure of the impact of pesticide use on the environment, the adoption of Bt technology over this ten-year period resulted in 24.3% and 4.6% reduction, respectively, in the environmental impact associated with insecticide use on the cotton and corn area using the technology.

In 2010, the U.S. National Academy of Sciences reported that genetically engineered crops had resulted in reduced pesticide application and reduced soil erosion from tilling. The report also stated that the advent of glyphosate-herbicide resistant weeds—that have developed because of the use of engineered crops—could cause the genetically engineered crops to lose their effectiveness unless farmers also use other established weed management strategies.

The use of glyphosate in fields with glyphosate-resistant crops changed the herbicide use profile away from atrazine, metribuzin, and alachlor, which reduced the dangers of herbicide runoff into drinking water.

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

A study published in 2012 gathered data over ten years on the monarch butterfly population that wintered in Mexico on the one hand, and the number of butterfly larvae in the US Midwest, the density and acreage of milkweed, on which these larvae exclusively feed, and the density of larvae per milkweed. The study found a clear correlation, and a high likelihood of causation, between the dramatic reduction in the amount of milkweed in farm fields due to successful eradication of milkweed in farm fields using glyphosate-resistant crops in combination with glyphosate and a reduction in adult monarch butterfly populations in Mexico. The New York Times reported that the study "raises the somewhat radical notion that perhaps weeds on farms should be protected. 'There’s a change in agricultural thinking, because the weed-free field was the gold standard,' said May Berenbaum, head of entomology at the University of Illinois. Still, she and other insect experts say it is unrealistic to expect farmers to give up the herbicide-tolerant crops — so efforts should be made to preserve or grow milkweed elsewhere, perhaps on farmland set aside for conservation. Monarch Watch is encouraging gardeners to grow milkweed."

With respect to transgenic crops expressing Bt toxins, there are two key environmental advantages:
 * The toxin expression is contained within the plant system, hence only those insects that feed on the crop perish.
 * The toxin expression replaces the use of synthetic pesticides in the environment. The latter observation has been documented.

The proteins produced by Bt have been used in sprays for insect control in France since 1938 and the USA since 1958 with no ill effects on the environment reported.

Bt toxins are a potential alternative to broad-spectrum insecticides. The toxicity of each Bt type is limited to one or two insect orders; it is nontoxic to vertebrates and many beneficial arthropods, because Bt works by binding to the appropriate receptor on the surface of midgut epithelial cells. Any organism that lacks the appropriate receptors in its gut cannot be affected by Bt.

An analysis of laboratory settings by an academic lab (Lövei et al.) found that Bt toxins can affect nontarget organisms, usually organisms closely related to the intended targets. Typically, exposure occurs through the consumption of plant parts, such as pollen or plant debris, or through Bt ingestion by their predatory food choices. The methodology used by Lövei et al. has been called into question by a group of academic scientists who wrote "We are deeply concerned about the inappropriate methods used in their paper, the lack of ecological context, and the authors’ advocacy of how laboratory studies on non-target arthropods should be conducted and interpreted".

Emergence of secondary pests
Several studies have documented surges in "sucking pests" (which are not affected by Bt toxins) within a few years of adoption of Bt cotton. In China, the main problem has been with mirids, which have in some cases "completely eroded all benefits from Bt cotton cultivation". A 2009 study in China concluded that the increase in sucking pests depended on local temperature and rainfall conditions and increased in half the villages studied. The increase in insecticide use for the control of these secondary insects was far smaller than the reduction in total insecticide use due to Bt cotton adoption. Another study published in 2011 was based on a survey of 1,000 randomly selected farm households in five provinces in China and found that the reduction in pesticide use in Bt cotton cultivars is significantly lower than that reported in research elsewhere, consistent with the hypothesis suggested by recent studies that more pesticide sprayings are needed over time to control emerging secondary pests, such as aphids, spider mites, and lygus bugs.

Similar problems have been reported in India, with both mealy bugs and aphids although a survey of small Indian farms between 2002 and 2008 concluded that Bt cotton adoption has led to higher yields and lower pesticide use, decreasing over time.

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

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

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

Environmental contamination via evolution of resistant pests
Resistance evolves naturally after a population has been subjected to intense selection pressure in the form of repeated use of a single herbicide or insecticide.

Weeds resistant to the herbicide glyphosate have been called "Superweeds". In response, farmers are hand-weeding, using tractors to turn over soil between crops, and using other herbicides in addition to glyphosate. Agricultural biotech companies are also developing genetically engineered crops resistant to other herbicides. "Bayer is already selling cotton and soybeans resistant to glufosinate, another weedkiller. Monsanto’s newest corn is tolerant of both glyphosate and glufosinate, and the company is developing crops resistant to dicamba, an older pesticide. Syngenta is developing soybeans tolerant of its Callisto product. And Dow Chemical is developing corn and soybeans resistant to 2,4-D, a component of Agent Orange, the defoliant used in the Vietnam War."

For Bt-crops, in November 2009, Monsanto scientists found the pink bollworm had become resistant to the first generation Bt cotton in parts of Gujarat, India - that generation expresses one Bt gene, Cry1Ac. This was the first instance of Bt resistance confirmed by Monsanto anywhere in the world. Bollworm resistance to first generation Bt cotton has also been identified in the Australia, China, Spain and the United States.

Environmental contamination via gene flow
Other possible negative effects might come from the spread of genes from modified organisms to unmodified relatives, which in the case of GM crops, would produce species of weeds resistant to herbicides. and in the case of GM fish, could disrupt the ecosystem. In 2009 the government of Mexico created a regulatory pathway for approval of genetically modified maize, but because Mexico is the center of diversity for maize, concerns have been raised about the effect that genetically modified maize could have on local strains.

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

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

Transgenes have the potential for significant ecological impact if the plants can increase in frequency and persist in natural populations. These concerns are similar to those surrounding conventionally bred plant breeds. Several risk factors should be considered:
 * Can the transgenic plant pass its genes to a local wild species, and are the offspring also fertile?
 * Does the introduction of the transgene confer a selective advantage to the plant or to hybrids in the wild?

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

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

There are at least three possible avenues of hybridization leading to escape of a transgene:
 * Hybridization with non-transgenic crop plants of the same species and variety.
 * Hybridization with wild plants of the same species.
 * Hybridization with wild plants of closely related species, usually of the same genus.

However, there are a number of factors which must be present for hybrids to be created.
 * The transgenic plants must be close enough to the wild species for the pollen to reach the wild plants.
 * The wild and transgenic plants must flower at the same time.
 * The wild and transgenic plants must be genetically compatible.

In order to persist, these hybrid offspring:


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

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


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

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

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

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

On 18 August 2006, American exports of rice to Europe were interrupted when much of the U.S. crop was confirmed to be contaminated with unapproved engineered genes. An investigation by the USDA’s Animal and Plant Health Inspection Service (APHIS) was unable to determine the cause of the contamination.

In 2007, the U.S. Department of Agriculture fined Scotts Miracle-Gro $500,000 when modified genetic material from creeping bentgrass, a new golf-course grass Scotts had been testing, was found within close relatives of the same genus (Agrostis) as well as in native grasses up to 21 km away from the test sites, released when freshly cut grass was blown by the wind.

A study published in 2010 by scientists at the University of Arkansas, North Dakota State University, California State University and the US Environmental Protection Agency showed that about 83 percent of wild or weedy canola tested contained genetically modified herbicide resistance genes, and they also found some plants that contained resistance to both herbicides, a combination of transgenic traits that had not been developed in canola crops. "That leads us to believe that these wild populations that contain modified genes have become established populations." According to the researchers, the lack of reports in the US suggests inadequate oversight and monitoring protocols are in place in the US.

Contamination is a problem for farmers in Australia where non-GM crops sell for up to 28% more per ton than GM crops. Australia predominantly supplies GM-Free markets such as the EU and Japan. Western Australia lifted a ban on planting GM crops in January 2010 and in December, Canola farmer Steve Marsh found his crop had been contaminated by windblown GM Canola seeds leading to the loss of his crop. Marsh had his contracts cancelled and later lost organic certification leading him to sue a neighbouring farmer in what will be a landmark case, as this is the first court case involving GM contamination in Australia. South Australia is the only mainland Australian state to still have a legal ban on commercial GM crop production, which also includes a ban on seeds being transported through the state. GM advocates cite the inevitability of contamination as a reason to lift the ban. In October 2011, controversy erupted when Business SA, with the support of the industry lobby group AusBiotech, made a push in support of overturning the ban.

"Terminator" and "traitor"
One means that has been explored to avoid environmental contamination is a technology dubbed 'Terminator'. This uncommercialized technology would allow the production of first-generation crops that would not generate seeds in the second generation because the plants yield sterile seeds, which would prevent the escape of genetically modified traits from cross-pollinating crops into wild-type species by sterilizing any resultant hybrids. Some environmentalist groups, while considering outcrossing of GM plants dangerous, feel the technology would prevent re-use of seed by farmers growing such terminator varieties in the developing world and is ostensibly a means to exercise patent claims. However, other environmental groups welcome the terminator gene as a means of preventing GM crops from mixing with natural crops. Similarly, the hypothetical trait-specific Genetic Use Restriction Technology, also known as 'Traitor' or 'T-GURT', requires application of a chemical to genetically modified crops to reactivate engineered traits. This technology is intended both to limit the spread of genetically engineered plants. Genetic Use-Restriction Technology is under development by the US government, many academic labs, and companies including Monsanto and AstraZeneca. There are technologies evolving that contain the transgene by biological means and still can provide fertile seeds using fertility-restorer functions. Such methods are being developed by several EU research programs, among them Transcontainer and Co-Extra.

These technologies have also caused controversy, as the technology itself, and the patents on them, would allow companies to further control the market for seeds, and would be another means to require farmers to pay yearly to reactivate the genetically engineered traits of their crops.

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

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

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

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

Some have raised concerns that industrialized nations have not tested GM technology on tropical plants, focusing on those that grow in temperate climates, even though undeveloped nations and the people that need the extra food live primarily in tropical climates.

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

Agricultural economics
One of the key reasons for this widespread adoption is the perceived economic benefit the technology brings to farmers, including those in developing nations. For example, the system of planting glyphosate-resistant seed and then applying glyphosate once plants emerged provided farmers with the opportunity to dramatically increase the yield from a given plot of land, since this allowed them to plant rows closer together. Without it, farmers had to plant rows far enough apart to control post-emergent weeds with mechanical tillage. Likewise, using Bt seeds means that farmers do not have to purchase insecticides, and then invest time, fuel, and equipment in applying them.

Critics contend that yields are not higher, and argue that chemical use is higher for herbicide-resistant GM crops.

Overall economics
A 2010 study by US scientists, found that the economic benefit of Bt corn to farmers in five mid-west states was $6.9 billion over the previous 14 years. They were surprised that the majority ($4.3 billion) of the benefit accrued to non-Bt corn. This was speculated to be because the European Corn Borers that attack the Bt corn die and there are fewer left to attack the non-GM corn nearby.

Claims of major benefits to farmers, including poor farmers in developing countries, have been made by advocates of the technology, and have been challenged by opponents. The task of isolating impacts of the technology is complicated by the prevalence of biased observers, and by the rarity of controlled comparisons (such as identical seeds, differing only in the presence or absence of the Bt trait, being grown in identical situations). The main Bt crop being grown by small farmers in developing countries is cotton, and a recent exhaustive review of findings on Bt cotton by respected and unbiased agricultural economists concluded, "the overall balance sheet, though promising, is mixed. Economic returns are highly variable over years, farm type, and geographical location".

Yield
A 1999 study by Charles Benbrook, Chief Scientist of the Organic Center, found that genetically engineered Roundup Ready soybeans did not increase yields, on a plant-by-basis (not taking into account the increased number of plants that can be grown in field due to closer row-spacing). The report reviewed over 8,200 university trials in 1998 and found that Roundup Ready soybeans had a yield drag of 5.3% across all varieties tested. This "yield drag" is similar to what is observed when other traits are introduced into soybeans by conventional breeding and may not be due to the Roundup Ready trait or the genetically modified nature of the crop since Monsanto has recently released Roundup Ready 2 soybeans, which are claimed to yield 7–11% higher than RR version 1. There have been no reports of "yield drag" with the other Roundup Ready crops maize, sorghum or canola.

Research published in Science in 2003 has shown that the use of genetically modified Bt cotton in India increased yields by 60% over the period 1998–2001 while the number of applications of insecticides against bollworm were three times less on average.

In 2009 the Union of Concerned Scientists summarized numerous peer-reviewed studies on the yield contribution of genetic engineering in the United States. This report examined the two most widely grown engineered crops—soybeans and maize (corn). Unlike many other studies, this work separated the yield contribution of the engineered gene from that of the many naturally occurring yield genes in crops, but it did not take into account the closer row-spacing that herbicide-resistant crops permit. The report found that engineered herbicide tolerant soy and maize did not increase yield at the national, aggregate level. Maize engineered with Bt insect resistance genes increased national yield by about 3 to 4 percent. Engineered crops increased net yield in all cases. The study concluded that in the United States, other agricultural methods have made a much greater contribution to national crop yield increases in recent years than genetic engineering. United States Department of Agriculture data record maize yield increases of about 28 percent since engineered varieties were first commercialized in the mid 1990s. The yield contribution of engineered genes has therefore been a modest fraction—about 14 percent—of the maize yield increase since the mid 1990s.

A 2010 article supported by CropLife International summarised the results of 49 peer reviewed studies on GM crops worldwide. On average, farmers in developed countries experienced increase in yield of 6% and in underdeveloped countries of 29%. Tillage was decreased by 25–58% on herbicide resistant soybeans, insecticide applications on Bt crops were reduced by 14–76% and 72% of farmers worldwide experienced positive economic results.

In 2009 it was reported that 82000 ha of Bt corn in South Africa failed to produce seeds. Monsanto claimed average yield was reduced by 25% in those fields affected, it compensated the farmers concerned and the corn varieties were affected by a mistake made in the seed breeding process. Marian Mayet, an environmental activitist and director of the Africa Centre for Biosecurity in Johannesburg, called for a government investigation and asserted that the biotechnology was at fault, "You cannot make a 'mistake' with three different varieties of corn". In 2009 South African farmers planted 1900000 ha of GM maize (73% of the total crop).

Intellectual property
Traditionally, farmers in all nations saved their own seed from year to year. However since the early 1900s hybrid crops have been widely used in the developed world and seeds to grow these crops must be purchased each year from seed producers. The offspring of the hybrid corn, while still viable, lose the beneficial traits of the parents, resulting in the loss of hybrid vigor. In these cases, the use of hybrid plants has been the primary reason for growers not saving seed, not intellectual property issues. However, for non-hybrid biotech crops, such as transgenic soybeans, seed companies use intellectual property law and tangible property common law, each expressed in contracts, to forbid farmers from saving seed. For example, Monsanto's typical bailment license (covering transfer of the seeds themselves) forbids saving seeds, and also requires that purchasers sign a separate patent license agreement: "The purchase of these seeds/bailment/transfer of these seeds conveys no license under said patents to use these seeds or perform any of the methods covered by these patents. A license must first be obtained before these seeds can be used in any way...  Progeny of these seeds cannot be cleaned or used as planting seed or transferred to others for planting.  This seed may only be offered for sale and distribution by authorized seed companies or their dealers."

Corporations say that they need product control in order to prevent seed piracy, to fulfill financial obligations to shareholders, and to invest in further GM development. DuPont spent approximately half its $2 billion R&D budget on agriculture in 2011 while Monsanto spends 9-10% of their sales in their research and development effort every year. The Action Group on Erosion, Technology and Concentration reported in 2008, "Monsanto, BSAF, DuPont, Syngenta, Bayer and Dow (and their biotech partners) have filled 532 patent documents on so-called "climate ready" genes at patent offices around the world."

Detractors such as Greenpeace say that patent rights give corporations a dangerous amount of control over their product. Others claim that "patenting seeds gives companies excessive power over something that is vital for everyone." Regarding the issues of intellectual property and patent law, an international report from the year 2000 states:

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

Monsanto has filed patent infringement suits against 145 farmers, but has proceeded to trial with only 11. Although in some of those 11 cases, a defense of unintentional contamination by gene flow was used, Monsanto won all 11 cases. Monsanto Canada's Director of Public Affairs has stated that "It is not, nor has it ever been Monsanto Canada's policy to enforce its patent on Roundup Ready crops when they are present on a farmer's field by accident...Only when there has been a knowing and deliberate violation of its patent rights will Monsanto act."

One example of such litigation is the Monsanto v. Schmeiser case. This case is widely misunderstood: "The fear about a company claiming ownership of a farmer’s crop based on the inadvertent presence of GM pollen grain or seed is...widespread and ...unfounded." In 1997, Percy Schmeiser, a canola breeder and grower in Bruno, Saskatchewan, discovered that a section of one of his fields contained canola that was resistant to herbicide Roundup by spraying it with Roundup, leaving only the resistant plants. He had not purchased roundup-resistant canola; it was apparently sown from seed blown onto his land from neighboring fields. He later harvested and saved the seed from this area, and replanted the saved seed in 1998. During the 1998 growing season, Monsanto approached Schmeiser and asked him to take a license to the patent covering the transgenic seed he had planted; Schmeiser refused, claiming that he owned the physical seeds he had harvested in 1997 and had the right to do with them as he wished. Monsanto sued Schmeiser for patent infringement and prevailed in the initial case. Schmeiser appealed and lost, and appealed again to the Canadian Supreme Court, which in 2004 ruled 5 to 4 in Monsanto’s favor.

Market dynamics
The seed industry is dominated by several seed and biotechnology firms. Firms have engaged in vertical integration, causing structural changes in the seed industry.

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

Market power gives seed and biotechnology firms the ability to set or influence price, dictate terms, and act as a barrier to entry into the industry. It also gives firms the bargaining power over governments in policy making. Keith Mudd from the Organization for Competitive Markets says: "The lack of competition and innovation in the marketplace has reduced farmer's choices and enabled Monsanto to raise prices unencumbered."

In 2001, the USDA published an article showing that the concentration of market power in the seed industry has led to economies of scale that facilitated market efficiency because production costs have decreased, however, the move by some companies to divest their seed operations calls into question the long-term viability of these conglomerates. Two economists, guest speakers on the AgBio Forum cite that the huge market power possessed by the small number of biotechnology companies in crop biotechnology could be beneficial in raising welfare despite the pricing strategies they practice because "even though price discrimination is often considered to be an unwanted market distortion, it may increase total welfare by increasing total output and by making goods available to markets where they would not appear otherwise." In the case of Bt cotton in the United States, agriculture economists calculated that "world surplus [increased by] $240.3 million for 1996. Of this total, the largest share (59%) went to U.S. farmers. The gene developer, Monsanto, received the next largest share (21%), followed by U.S. consumers (9%), the rest of the world (6%), and the germplasm supplier, Delta and Pine Land Company (5%)."

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

International Trade
GM food and GM crops have been the subject of international trade disputes. Such a dispute arose between the US and Europe in the early 2000s.

Europe
Until the 1990s, Europe's regulation was less strict than in the United States. In 1998, the use of MON810, a Bt expressing maize conferring resistance to the European corn borer, was approved for commercial cultivation in Europe. However, in the 1990s, a series of unrelated food crises created consumer apprehension about food safety in general and eroded public trust in government oversight of the food industry - most importantly, the infection of cows with bovine spongiform encephalopathy and the mishandling of food safety by European authorities. A 2003 survey by the Pew Research Center found that the highest disapproval rating was found in Germany and France with 81% and 89% disapproving. The survey also showed a strong tendency for women to be more opposed to GM foods than men. In 1998, a de facto moratorium led to the suspension of approvals of new genetically modified organisms (GMO) in the European Union pending the adoption of revised rules to govern the approval, marketing and labelling of biotech products.

The approval of GM crops in the US in the mid-1990s precipitated strong public concern in Europe and led to a dramatic decrease in US exports to the EU. "Prior to 1997, corn exports to Europe represented about 4% of total U.S. corn exports, generating about $300 million in sales. Starting in 1997, however, the U.S. largely stopped shipping bulk commodity corn to the EU because such shipments typically commingled corn from many farms, including genetically modified varieties not approved by the EU. The change was dramatic. For example, before 1997, the U.S. sold about 1.75 million tons of corn annually to Spain and Portugal, the two largest importers of U.S. corn in the EU. But in the 1998–99 crop year, Spain bought less than a tenth of the previous year’s amount and Portugal bought none at all."

In May 2003 the Bush administration officially accused the European Union of violating international trade agreements, in blocking imports of U.S. farm products through its long-standing ban on genetically modified food. Robert Zoellick announced the filing of a formal complaint with the WTO challenging the moratorium after months of negotiations trying to get it lifted voluntarily. The complaint was also filed by Argentina, Canada, Egypt, Australia, New Zealand, Mexico, Chile, Colombia, El Salvador, Honduras, Peru, and Uruguay. The formal WTO case challenging the EU's regulatory system was in particular lobbied by U.S. biotechnology giant Monsanto Company and France's Aventis, as well as by US agricultural groups such as the National Corn Growers Association.

In response, in June 2003, the European Parliament ratified a three-year-old U.N. biosafety protocol regulating international trade in genetically modified food, expected to come into force in fall 2003 since the necessary number of ratification was reached in May 2003. The protocol lets countries ban imports of a genetically modified product if they feel there is not enough scientific evidence the product is safe and requires exporters to label shipments containing genetically altered commodities such as corn or cotton. It makes clear that products from new technologies must be based on the precautionary principle and allow developing nations to balance public health against economic benefits.

In addition, in July 2003, European environment ministers and the European Parliament agreed to new controls on GMOs that could eventually lead the then 15 members bloc to re-open the Union's markets to new genetically modified products in 2004. The new labeling and traceability rules, which cover both food and feed, require any products with a GMO content of more than 0.9 percent to be labelled. Labelling is also required for products that have been derived from GMOs, but where the GM content might no longer be detectable (such as soy oil produced from genetically modified soy). The threshold for the presence of unapproved GMOs is 0.5 percent provided that the GMOs have been judged as safe for human health and the environment by the relevant Scientific Committees or the European Food Authority. This amount will be set for 3 years. After 3 years, all food containing non-authorized GMO will be banned. Animals fed with transgenic cereals are not covered by the labeling requirements. Traceability of GMO products is mandatory, from sowing to final product. Genetically modified goods will have to carry a special harmless DNA sequence (a DNA code bar) identifying the origin of the crops, making it easier for regulators to spot contaminated crops, feed, or food, and enabling products to be withdrawn from the food chain should problems arise. A series of additional sequences of DNA with encrypted information about the company or what was done to the product could also be added to provide more data. (see Mandatory labeling). Following the entry into force of the new regulations, the first genetically modified food product (canned maize) since 1998 was approved for marketing in the European Union in May 2004. While a number of other biotech products have been approved since then, approvals remain controversial. European ministers have continuously failed to reach a decision in support of or against the applications, highlighting the big divide among member states. As a result, the approvals were granted by the European Commission, which is entitled to take a decision in case ministers fail to do so.

In 2006, the World Trade Organization ruled that European Union restrictions on genetically engineered crops violated international trade rules. The United States, Canada, and Argentina, who together grew 80 percent of all biotech crops sold commercially at that time, had complained that the EU had a 'de facto' moratorium on such crops after 1999. The countries argued that the EU's regulatory process was far too slow and its standards were unreasonable given that the overwhelming body of scientific evidence finds the crops safe. The ruling had little immediate effect as the EU had already lifted its moratorium on GM crops in 2004.

The 2003 EU legislation provided an opt-out provision for member states. In January 2005, the Hungarian government announced a ban on importing and planting of genetic modified maize seeds, which was subsequently authorized by the EU. In March 2010, Bulgaria imposed a complete ban on genetically modified crop growing either commercially or for trials. The cabinet of Boyko Borisov initially imposed a 5-year moratorium, but later extended it to a permanent ban after widespread public protests against the introduction of genetically modified crops in the country. In late 2011 several diplomatic cables were leaked, revealing that GMO imports and cultivation policies in Bulgaria were supported by the United States through its diplomatic mission in Sofia.

In late 2007, the U.S. ambassador to France recommended "moving to retaliation" against France and the European Union in an attempt to fight the French ban and changes in European policy toward genetically modified crops, according to a U.S. government diplomatic cable obtained by WikiLeaks. The U.S. ambassador to France recommended retaliation to cause "some pain across the EU."

Africa
Some African nations have refused emergency food aid from developed countries, fearing that the food is unsafe. During a conference in the Ethiopian capital of Addis Ababa, Kingsley Amoako, Executive Secretary of the United Nations Economic Commission for Africa (UNECA), encouraged African nations to accept genetically modified food and expressed dissatisfaction in the public's negative opinion of biotechnology.

Litigation in the US
Four federal district court suits have been brought against Animal and Plant Health Inspection Service, the agency within USDA that regulates genetically modified plants. Two involved field trials (herbicide-tolerant turfgrass in Oregon; pharmaceutical-producing corn and sugar in Hawaii) and two the deregulation of GM alfalfa. and GM sugar beet. Initially APHIS lost all four cases, with the judges ruling they failed to diligently follow the guidelines set out in the National Environmental Policy Act.

Alfalfa
In 2005, after completing a 28-page Environmental Assessment (EA) the United States Department of Agriculture (USDA) granted Roundup Ready Alfalfa (RRA) nonregulated status under Code of Federal Regulations Title 7 Part 340, called, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,” which regulates, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Monsanto had to seek deregulation to conduct field trials of RRA, because the RRA contains a promoter sequence derived from the plant pathogen figwort mosaic virus. The USDA granted the application for deregulation, stating that the RRA with its modifications: "(1) Exhibit no plant pathogenic properties; (2) are no more likely to become weedy than the nontransgenic parental line or other cultivated alfalfa; (3) are unlikely to increase the weediness potential of any other cultivated or wild species with which it can interbreed; (4) will not cause damage to raw or processed agricultural commodities; (5) will not harm threatened or endangered species or organisms that are beneficial to agriculture; and (6) should not reduce the ability to control pests and weeds in alfalfa or other crops." Monsanto started selling RRA and within two years, more than 300,000 acres were devoted to the plant in the US.

The granting of deregulation was opposed by many groups, including growers of non-GM alfalfa who were concerned about gene flow into their crops. In 2006, the Center for Food Safety, a US non-governmental organization that is a critic of biotech crops, and others challenged this deregulation in the California Northern District Court Organic growers were concerned that the GM alfalfa could cross-pollinate with their organic alfalfa, making their crops unsalable in countries that ban the growing of GM crops. The District Court ruled that the USDA's EA did not address two issues concerning RRA's effect on the environment and in 2007, required the USDA to complete a much more extensive Environmental impact statement (EIS). Until the EIS was completed, they banned further planting of RRA but allowed land already planted to continue. The USDA proposed a partial deregulation of RRA but this was also rejected by the District Court. Planting of RRA was halted.

In June 2009, a divided three-judge panel on the 9th U.S. Circuit Court of Appeals upheld Breyer's decision. Monsanto and others appealed to the US Supreme Court

On 21 June 2010, in Monsanto Co. v. Geertson Seed Farms, the Supreme Court overturned the District Court decision to ban planting RRA nationwide as there was no evidence of irreparable injury. They ruled that the USDA could partially deregulate RRA before an EIS was completed. The Supreme court did not consider the district court's ruling disallowing RRA's deregulation and consequently RRA was still a regulated crop waiting for USDA's completion of an EIS. The USDA chose not to allow partial deregulation as the EIS was almost complete. Their 2,300 page EIS was published in December 2010. It concluded that RRA would not affect the environment.

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

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

The Center for Food Safety appealed this decision in March 2011 but the District Court for Northern California rejected this motion in 2012.

Sugar beets
In 2005, based on the results of an Environmental Assessment and a Plant Pest Risk Assessment the USDA deregulated Monsanto's Roundup Ready genetically engineered sugar beets.

In 2008 the Center for Food Safety and others filed a lawsuit in the United States District Court for the Northern District of California challenging this deregulation. In 2009, the district court ordered the USDA to prepare a much more detailed Environmental Impact Statement. In August 2010, Judge White of the District Court ordered a halt to the planting of the genetically modified sugar beets in the US. He said that "the Agriculture Department had not adequately assessed the environmental consequences before approving them for commercial cultivation."

In February 2011, a federal appeals court for the Northern district of California in San Francisco, citing the decision by the Supreme Court on GM alfalfa, overturned the previous ruling by Judge Jeffrey S. White to destroy juvenile GM sugar beets, ruling in favor of Monsanto, the USDA and four seed companies. The appeals court concluded that "The Plaintiffs have failed to show a likelihood of irreparable injury. Biology, geography, field experience, and permit restrictions make irreparable injury unlikely."

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

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

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

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

A long-term study on the economic impacts of Bt cotton in India, published in the Journal PNAS in 2012, showed that Bt cotton has increased yields, profits, and living standards of smallholder farmers.

India regulators cleared the Bt brinjal, a genetically modified eggplant, for commercialisation in October 2009. Following opposition from some scientists, farmers and environmental groups a moratorium was imposed on its release in February 2010 "for as long as it is needed to establish public trust and confidence".

Availability of GM seed for testing
The value of current independent studies is considered by some to be problematic because, due to restrictive end-user agreements, independent researchers cannot obtain GM plants to study. Cornell University's Elson Shields, the spokesperson for a group of scientists who oppose this practice, submitted a statement to the United States Environmental Protection Agency (EPA) protesting that "as a result of restrictive access, no truly independent research can be legally conducted on many critical questions regarding the technology". Scientific American noted that several studies that were initially approved by seed companies were later blocked from publication when they returned "unflattering" results. While recognising that seed companies' intellectual property rights need to be protected, Scientific American calls the practice dangerous and has called for the restrictions on research in the end-user agreements to be lifted immediately and for the EPA to require, as a condition of approval, that independent researchers have unfettered access to GM products for testing. In February 2009, the American Seed Trade Association (ASTA) agreed that they "would allow researchers greater freedom to study the effects of GM food crops." This agreement left many scientists optimistic about the future, but there is little optimism as to whether this agreement has the ability to "alter what has been a research environment rife with obstruction and suspicion."

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

GMOs' proponents note that because of the safety testing requirements imposed on GM foods, the risk of introducing a plant variety with a new allergen or toxin using genetic modification is much smaller than using traditional breeding processes. Transgenic genetic engineering can have less impact on the expression of genomes or on protein and metabolite levels than conventional breeding or plant (non-directed) mutagenesis. Toxicologists note that "conventional food is not risk-free; allergies occur with many known and even new conventional foods. For example, the kiwi fruit was introduced into the U.S. and the European markets in the 1960s with no known human allergies; however, today there are people allergic to this fruit."

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

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

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

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

Séralini studies and responses
In 2004 Monsanto sought approval in Europe to introduce a rootworm resistant (MON863) maize, which led to controversy over acceptance by regulatory bodies of industry-funded toxicity studies and over the design of those studies. Pr Gilles Eric Séralini, who was on the committee that reviewed MON863 for the French government, was a major figure in those controversies and continues to be a critic of toxicity study design.

In 2004 the GMO Panel of the European Food Safety Authority (EFSA) twice concluded that it had no reservations about recommending the authorisation of MON863, and published its opinion on MON863 maize. The report described the data that Monsanto provided, and referenced changes in some blood cell parameters and in kidney weights of rats that were tested. Because of concerns in general but specifically referencing these changes, Greenpeace sued for release of the rat feeding studies that Monsanto had provided. A German court released the original study in June 2005. With the full study in hand, critics of GM foods, including Séralini, pointed to differences in kidney size and blood composition found in this study, suggesting that the observed differences, as well as the design of the studies, raised questions about the regulatory concept of substantial equivalence.

In 2007, Séralini and two other authors from Caen University and the University of Rouen published a study of these data, funded by Greenpeace. This study found that the weights of female weight increased by 3.7%, while male weight decreased by 3.3%. These weight changes could be indicative of organ dysfunction. Triglyceride levels increased in females, and urine phosphorus and sodium excretions decreased in males. Séralini also claimed that MON 863 adversely affects liver and kidney function, as well as causes varying degrees of damage to the adrenal glands, heart, spleen, and other components of the haematopoietic system. The study concluded that experiments longer than 90-days must be conducted before the safety of MON 863 can be known, as chronic organ problems are rarely evident within such a short amount of time. Greenpeace cited the study in a press release, in which it demanded that MON 863 be completely recalled from the global market and called for a strict review of current testing methods.

The Séralini 2007 paper prompted the European Food Safety Authority (EFSA) to reexamine the safety data on this strain of corn. This task force also asked countries from the European Union if they had any new data on MON 863 or new views on the original Monsanto toxicity study and had a technical meeting with the authors of the 2007 CRIIGEN paper. The EFSA concluded that the observed small numerical decrease in rat kidney weights were not biologically meaningful, and the weights were well within the normal range of kidney weights for control animals. There were no corresponding microscopic findings in the relevant organ systems, and they stated that all blood chemistry and organ weight values fell within the "normal range of historical control values" for rats. In addition the EFSA review stated that the statistical methods used in Séralini 2007 paper were incorrect. These conclusions were reported by Markos Kyprianou (European Commissioner for Health and Consumer Policy) to the European Parliament on 9 July 2010. The EFSA's critical conclusions (and also those of the French Commission du Génie Biomoléculaire ) were the subject of a subsequent article in Le Figaro, titled "European Experts claim GMO is harmless".

Food Standards Australia New Zealand also reviewed the 2007 Séralini study and concluded that "...all of the statistical differences between rats fed MON 863 corn and control rats are attributable to normal biological variation."

The Séralini 2007 paper was also assessed by a panel of independent toxicologists from the US, Germany, UK and Canada funded by Monsanto; that panel also dismissed the findings on the grounds that it "...failed to demonstrate a dose–response relationship, reproducibility over time, association with other relevant changes (e.g., histopathology), occurrence in both sexes, difference outside the normal range of variation, or biological plausibility with respect to cause-and-effect.".

In 2009 the Séralini lab published another re-analysis study. (This paper is often called the "Vendômois et al. 2009" paper as the first author listed on the paper is Joël Spiroux de Vendômois; however the paper came from the Séralini lab and Séralini is listed as the last author.)   This paper re-analyzed toxicity data submitted by Monsanto for NK603 (glyphosate resistance) maize, and included three rat feeding studies published by Monsanto scientists on MON 810 (Bt corn). The Séralini 2009 article concluded that the three crops caused liver, kidney, and heart damage in the rats.

The European Food Safety Authority reviewed the 2009 Séralini paper and concluded that the authors' claims were not supported by the data in their paper, that many of their fundamental statistical criticisms of the 2007 paper also applied to the 2009 paper, and that there was no new information that would change the EFSA's conclusions that the three GM maize types were safe for human and animal health, and for the environment.

The French High Council of Biotechnologies Scientific Committee (HCB) also reviewed the Séralini 2009 study and concluded that it "..presents no admissible scientific element likely to ascribe any haematological, hepatic or renal toxicity to the three re-analysed GMOs." The HCB also questioned the authors' independence, noting that, in 2010, the Séralini web page still showed a 2008 Austrian anti-GM article which had been previously withdrawn by the authors themselves as flawed.

Food Standards Australia New Zealand concluded that the results from the 2009 Séralini study were due to chance alone.

A 2011 review by the Séralini lab, which used 19 published animal feeding studies as well as data from several animal feeding studies submitted for regulatory approval, continued to find that GM food had liver and kidney effects that were sex and dose dependent, and advocated for longer and more elaborate toxicology tests for regulatory approval.

In September 2012 the Séralini lab published a paper entitled "Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modiﬁed maize". The abstract indicates: "The health effects of a Roundup-tolerant genetically modiﬁed maize (from 11% in the diet), cultivated with or without Roundup, and Roundup alone (from 0.1 ppb in water), were studied 2 years in rats. In females, all treated groups died 2–3 times more than controls, and more rapidly. This difference was visible in 3 male groups fed GMOs. All results were hormone and sex dependent, and the pathological proﬁles were comparable." The study used 200 Sprague-Dawley rats, 100 male and 100 female, and divided them into twenty groups with 10 rats each; ten experimental conditions were tested on male rats and separately on female rats for two years. The paper's method section states: "For each sex, one control group had access to plain water and standard diet...; six groups were fed with 11, 22 and 33% of GM NK603 maize either treated or not with R (Roundup). The ﬁnal three groups were fed with the control diet and had access to water supplemented with respectively 1.1x10-8% of R (0.1 ppb of R or 50 ng/L of glyphosate, the contaminating level of some regular tap waters), 0.09% of R (400 mg/kg, US MRL of glyphosate in some GM feed) and 0.5% of R (2.25 g/L, half of the minimal agricultural working dilution)."

After the study was released there was widespread criticism of the study, and much of the criticism claimed that Séralini's conclusions were impossible to justify given the statistical power of the study. Sprague-Dawley rats have a lifespan of about two years and have a high tendency to get cancer over their lifespan - 86% of males and 72% of females get cancer under normal conditions.


 * WikiComment


 * That source may not meet WP:RS -- it's a rather informal blog post -- anyway -- Andrew Kniss admits at the beginning of the post that he is not an expert on animal feeding studies, and his argument is basically an exercise showing that there can be greater variation with smaller sample sizes....however -- he does link in the post to a scientific paper:


 * http://www.ncbi.nlm.nih.gov/pubmed/521452


 * I've just read the abstract -- I'm not sure if I can get the full paper or not -- I don't know how Kniss is getting:


 * 86% for males
 * 72% for females


 * It says in the Abstract that there were 100 rats


 * They don't say whether they divided the rats up evenly or not -- however if we assume that they did -- then


 * 42/50 = 84% for males
 * 39/50 = 78% for females


 * Jjjjjjjjjj (talk) 04:45, 24 October 2012 (UTC)

The Séralini experiment lasted the normal lifespan of these rats, and the longer the experiment goes, the more statistical "noise" there is. So for the experiment to have adequate statistical power, all the groups - control groups and test groups - would have to include at least 65 rats per arm in order to sort out any experimentally caused cancers from cancers that would occur anyway - but the Séralini study had only ten per group. Others questioned the statistical methods, and said that the results were difficult to interpret because the amount of food given to the rats was not reported nor the growth rate of the rats, both of which factors effect development of cancer in the rat strain used in the study. The Washington Post quoted Marion Nestle, the Paulette Goddard professor in the Department of Nutrition, Food Studies and Public Health at New York University and food safety advocate: "'[I] can’t figure it out yet....It’s weirdly complicated and unclear on key issues: what the controls were fed, relative rates of tumors, why no dose relationship, what the mechanism might be. I can’t think of a biological reason why GMO corn should do this.....So even though I strongly support labeling, I’m skeptical of this study.'"  The German agency which assesses risk in foodstuffs, the Federal Institute for Risk Assessment, the German Federal Office of Consumer Protection and Food Safety, the French Higher Biotechnologies Council , the French National Agency for Food Safety , the Flemish Institute for Biotechnology and Food Standards Australia New Zealand also reviewed the paper and found the conclusions of the paper invalid. The European Food Safety Authority concluded that "reporting and analysis of the study, as outlined in the paper, are inadequate" and "no conclusions can be made" and offered to Seralini et al "the opportunity to provide further information on their study." Following the release of EFSA study, the European Federation of Biotechnology (a biotech industry advocacy group) called for the authors to retract their paper, described the publication as "a dangerous case of failure of the peer-review system, which threatens the credibility not just of the journal but of the scientific method overall," and urged "the scientific community to improve the quality of the peer-review process in order to avoid in the future similar results, that only create unjustified panic and do not serve society."

The Seralini group has responded to some of these criticisms. In response to the criticism that not enough rats were used, Seralini provided only a denial as opposed to statistical reasoning: "The 20 animal control group is big enough to get a measure of tumour frequency. You don't need to look at hundreds of animals. If he (Prof Anthony Trewavas, one of the critics) believes this, then he should also agree that the studies done by others including industry are also invalid."

The method by which the Séralini team publicized their 2012 paper has been widely criticized as well. The original Agence France-Presse story noted: "Breaking with a long tradition in scientific journalism, the authors allowed a selected group of reporters to have access to the paper, provided they signed confidentiality agreements that prevented them from consulting other experts about the research before publication." The confidentiality agreement contained a severe penalty for breaching the agreement: “A refund of the cost of the study of several million euros would be considered damages if the premature disclosure questioned the release of the study.” An editorial at the prestigious scientific journal, Nature, noted: "With such strong claims and the predictably large effect they will have on public opinion, researchers should take care how they present their findings to the public and the media. They should spell out their results clearly; emphasize the limitations and caveats; and make it clear that the data still need to be assessed, and replicated, by the scientific community. That didn’t happen. The paper was promoted in a public-relations offensive, with a related book and film set for release this week. Furthermore, journalists wishing to report the research had to sign confidentiality agreements that prevented them from contacting other scientists for comment on the paper until after the embargo had expired. Some, to their credit, refused, or accepted and then revisited the story critically once their hands were no longer tied by these outrageous restrictions. The result was the exclusion of critical comment in many of the breaking stories — the ones that most people will remember." National Public Radio's program, On the Media, discussed the way the paper was released to the media on 28 Sep 2012, with Carl Zimmer, a science journalist, who was especially critical of science journalists who allowed themselves to be manipulated, saying "Science journalists need to talk to scientists whenever they are reporting on research. It's especially important when it's extremely controversial. We've had this huge debate over genetically modified food, screaming matches around the world. In California they are considering whether to label genetically modified food, and the people who are advocating for that immediately grabbed onto this study.... So, you have to be able to check with other scientists, other experts, to see whether the science really holds up. And in this case, as soon as other scientists took a look at this paper, they said, 'Whoa, the science is a mess.'... This (signing confidentiality agreements and reporting only what the authors have to say) is wrong. I learned that the BBC ... had been offered the paper a day in advance, if they signed this confidentiality agreement. And they just said, 'Forget it.' They walked away. You are not going to be doing any legitimate reporting if you take that paper and can't talk to anybody else. What you're going to come out with, is bad journalism." Zimmer had earlier posted on his blog at Discover magazine, "This is a rancid, corrupt way to report about science. It speaks badly for the scientists involved, but we journalists have to grant that it speaks badly to our profession, too. If someone dangles a press conference in your face but won’t let you do your job properly by talking to other scientists, WALK AWAY. If someone hands you confidentiality agreements to sign, so that you will have no choice but to produce a one-sided article, WALK AWAY. Otherwise, you are being played."

On October 19, 2012, six French national academies of science issued a joint statement - "an extremely rare event in French science" ) - condemning the study and the journal that published it.  "In withering terms, it dismissed the study as 'a scientific non-event'"


 * WikiComment
 * Okay, I went through the content here on the Séralini studies and responses. Just wanted to make two comments (not sure if these will eventually lead to revisions but just wanted to make them as comments):


 * 1.In the Nature piece there is a picture showing Séralini with the book:


 * http://www.nature.com/news/hyped-gm-maize-study-faces-growing-scrutiny-1.11566


 * http://www.amazon.com/Tous-Cobayes-pesticides-chimiques-ebook/dp/B009B7FDQY


 * It is called Tous Cobayes! -- which translated in English means: "All Guinea Pigs!".


 * And then there is also a movie with the same name out (although the title ends with a question mark): Tous Cobayes?


 * http://www.allocine.fr/film/fichefilm_gen_cfilm=211766.html


 * http://www.imdb.com/title/tt2411114/


 * 2. The Nature article is quoting that about 67% of males are expected to die at 104 weeks, and that about 50% of females are expected to die at 104 weeks.

Moreover, the study used Sprague-Dawley rats, which both reviews note are prone to developing spontaneous tumours. Data provided to Nature by Harlan Laboratories, which supplied the rats in the study, show that only one-third of males, and less than one-half of females, live to 104 weeks


 * This is a similar figure to what I find at these links in terms of the life expectancy of the rats:


 * http://www.huntingdon.com/assets/Posters/Poster0458.pdf?1340119893


 * (although looking at that above link I wonder if the figures for the males and the females got reversed when reported in the Nature article)


 * When I tried to post this to Nature they banned me for some reason. It may have been because there was this external link:


 * http://www.huntingdon.com/assets/Posters/Poster0458.pdf?1340119893


 * And so the system that it was spam.


 * Or maybe I got the CAPTCHA wrong twice.


 * Jjjjjjjjjj (talk) 08:50, 26 October 2012 (UTC)


 * So they wrote me back, and said that it was a problem with the spam filter, and the comment got posted. Jjjjjjjjjj (talk) 06:28, 1 November 2012 (UTC)


 * Males: 55 +/- 8.3%


 * Females: 67 +/- 5.7%


 * http://www.harlan.com/download.axd/117b20f991764a5e98e32d366d83e876.pdf?d=spraguedawley%2520rat

The median survival time was 24.5 months for virgins and 25 months for breeders


 * Which is consistent with about 50% dying within two years.


 * However, if I am understanding the paper right, the Sprague-Dawley rats discussed in the 2012 Séralini paper seem to survive longer.


 * Link to the paper:


 * http://www.sciencedirect.com/science/article/pii/S0278691512005637


 * I did a spreadsheet to summarize the data from figure 1 of the paper:


 * https://s3.amazonaws.com/dkf/analysis_of_mortality_Long_term_toxicity_of_a_Roundup_herbicide_and_a_Roundup-tolerant_genetically_modified_maize.xlsx


 * I'm getting that only 25% of those in the control died, (5 out of 20) and only about 39% (70 out of 180) of those in the treatment groups died.


 * 25% and 39% both being less than the 67% and 50% figure (the weighted average of which is 58.5%)


 * Now -- on the other hand -- there are other figures out there


 * http://en.wikipedia.org/wiki/Laboratory_rat

...The typical life span is 2.5–3.5 years...


 * http://www.nlac.mahidol.ac.th/nlacmuEN/p_animal_Rat.htm

...Average life span, 2-3 years...


 * http://cancerres.aacrjournals.org/content/16/3/194.abstract

...Sprague-Dawley rats in this laboratory was 760 ± 21 days...


 * http://www.taconic.com/user-assets/Documents/spraguedawley_booklet.pdf

...Life Span 24 - 36 Months...


 * I'm not sure exactly how this is defined. One might imagine that if average life span is reported as 2-3 years then that means it is unlikely that an animal dies before 2 years and that it is unlikely that an animal lives beyond 3 years.


 * However, this seems inconsistent with the figures from the Nature story, and other figures reported above from:


 * http://www.huntingdon.com/assets/Posters/Poster0458.pdf?1340119893


 * and


 * http://www.harlan.com/download.axd/117b20f991764a5e98e32d366d83e876.pdf?d=spraguedawley%2520rat


 * Jjjjjjjjjj (talk) 04:45, 24 October 2012 (UTC)

Protests
In 1983, a biotech company, Advanced Genetic Sciences (AGS) applied for U.S. government authorization to perform field tests with the ice-minus strain of P. syringae, but environmental groups and protestors delayed the field tests for four years with legal challenges. In 1987, the ice-minus strain of P. syringae became the first genetically modified organism (GMO) to be released into the environment when a strawberry field in California was sprayed with the ice-minus strain of P. syringae. The results were promising, showing lowered frost damage to the treated plants. Dr. Lindow also conducted an experiment on a crop of potato seedlings sprayed with ice-minus P. syringae. He was successful in protecting the potato crop from frost damage with a strain of ice-minus P. syringae. Both test fields were attacked by activist groups the night before the tests occurred: "The world's first trial site attracted the world's first field trasher."

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

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