MON863
Encyclopedia
MON 863 is a genetically engineered
Genetic engineering
Genetic engineering, also called genetic modification, is the direct human manipulation of an organism's genome using modern DNA technology. It involves the introduction of foreign DNA or synthetic genes into the organism of interest...

 variety of maize
Maize
Maize known in many English-speaking countries as corn or mielie/mealie, is a grain domesticated by indigenous peoples in Mesoamerica in prehistoric times. The leafy stalk produces ears which contain seeds called kernels. Though technically a grain, maize kernels are used in cooking as a vegetable...

 produced by Monsanto
Monsanto
The Monsanto Company is a US-based multinational agricultural biotechnology corporation. It is the world's leading producer of the herbicide glyphosate, marketed in the "Roundup" brand of herbicides, and in other brands...

.

History

Following legal action by parties including the Swedish Board of Agriculture and Greenpeace
Greenpeace
Greenpeace is a non-governmental environmental organization with offices in over forty countries and with an international coordinating body in Amsterdam, The Netherlands...

, a Münster
Münster
Münster is an independent city in North Rhine-Westphalia, Germany. It is located in the northern part of the state and is considered to be the cultural centre of the Westphalia region. It is also capital of the local government region Münsterland...

 appeals court ruled that Monsanto would be forced to publicly reveal its research data.

Modified mechanisms

MON 863 is genetically altered to express a modified version of Cry3Bb1
Cry3Bb1
-External links:* at the United States Environmental Protection Agency...

, a delta endotoxin which originates from Bacillus thuringiensis
Bacillus thuringiensis
Bacillus thuringiensis is a Gram-positive, soil-dwelling bacterium, commonly used as a biological pesticide; alternatively, the Cry toxin may be extracted and used as a pesticide. B...

. This protects the plant from corn rootworm
Diabrotica
Diabrotica is a widespread genus of beetles, sometimes referred to as cucumber beetles or corn rootworms, in the family Chrysomelidae. Members of this genus include several destructive agricultural pest species.-Range:...

. Unlike MON 810
MON 810
MON 810 is a variety of genetically modified maize developed by Monsanto Company and marketed with the trade name YieldGard. It contains a gene from the bacterium Bacillus thuringiensis that expresses a toxin poisonous to some pest insects, such as the European Corn Borer...

, Bt 11, and Bt 176 which each produce a modified Cry1Ab, MON 863 instead produces a modified Cry3Bb1 toxin and contains nptII, a marker gene
Marker gene
A marker gene is a gene used in molecular biology to determine if a nucleic acid sequence has been successfully inserted into an organism's DNA. There are two types of marker genes: a selectable marker and a marker for screening.-Selectable marker:...

 for antibiotic resistance
Antibiotic resistance
Antibiotic resistance is a type of drug resistance where a microorganism is able to survive exposure to an antibiotic. While a spontaneous or induced genetic mutation in bacteria may confer resistance to antimicrobial drugs, genes that confer resistance can be transferred between bacteria in a...

.

2007 CRIIGEN study

Monsanto's research data was analyzed in 2007 by researchers from the Committee of Independent Research and Information on Genetic Engineering, Caen University and the University of Rouen
University of Rouen
The University of Rouen is a French university, in the Academy of Rouen.-See also:* List of public universities in France by academy...

 and funded by Greenpeace. This study found that the weights of rats fed with MON 863 varied significantly when compared to the control groups. 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. This 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. Furthermore, according to Séralini, the data is clear in that MON 863 adversely affects liver
Liver
The liver is a vital organ present in vertebrates and some other animals. It has a wide range of functions, including detoxification, protein synthesis, and production of biochemicals necessary for digestion...

 and kidney
Kidney
The kidneys, organs with several functions, serve essential regulatory roles in most animals, including vertebrates and some invertebrates. They are essential in the urinary system and also serve homeostatic functions such as the regulation of electrolytes, maintenance of acid–base balance, and...

 function, as well as causes varying degrees of damage to the adrenal glands, heart
Heart
The heart is a myogenic muscular organ found in all animals with a circulatory system , that is responsible for pumping blood throughout the blood vessels by repeated, rhythmic contractions...

, spleen
Spleen
The spleen is an organ found in virtually all vertebrate animals with important roles in regard to red blood cells and the immune system. In humans, it is located in the left upper quadrant of the abdomen. It removes old red blood cells and holds a reserve of blood in case of hemorrhagic shock...

, and other components of the haematopoietic system.

The European Food Safety Authority evaluation of 2007 CRIIGEN study

In response to a request from the European Commission
European Commission
The European Commission is the executive body of the European Union. The body is responsible for proposing legislation, implementing decisions, upholding the Union's treaties and the general day-to-day running of the Union....

, the European Food Safety Authority
European Food Safety Authority
The European Food Safety Authority is an agency of the European Union that provides independent scientific advice and communication on existing and emerging risks associated with the food chain, created by European Regulation 178/2002....

 set up a task force to evaluate the 2007 CRIIGEN reanalysis of the original Monsanto rat feeding study on MON 863 maize. 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 task force observed that "...differences in test parameters of exposed male and female rats were in general neither dose-related nor sex-dependent and were therefore considered as isolated phenomena occurring by chance." They also noted that variations in test results were relatively small and mostly within the range of natural variation. They did not consider any of the adverse effects reported by CRIIGEN as biologically relevant. They concluded that MON 863 "...would not have an adverse effect on human and animal health or the environment in the context of its proposed use." These conclusions were reported by Markos Kyprianou
Markos Kyprianou
' is a Cypriot politician who served as a Minister of Foreign Affairs until his official resignation in July 19 2011, following the events of the Evangelos Florakis Naval Base explosion. A member of the Democratic Party, he was formerly Cyprus's Finance Minister and the European Commissioner for...

 (European Commissioner for Health and Consumer Policy
European Commissioner for Health and Consumer Policy
The Commissioner for Health and Consumer Policy is the member of the European Commission. The current Commissioner John Dalli. The portfolio is responsible for matters of public health, food safety, animal health, welfare and consumer affairs.-Kyprianou:...

) to the European Parliament
European Parliament
The European Parliament is the directly elected parliamentary institution of the European Union . Together with the Council of the European Union and the Commission, it exercises the legislative function of the EU and it has been described as one of the most powerful legislatures in the world...

 on 9th 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
Le Figaro
Le Figaro is a French daily newspaper founded in 1826 and published in Paris. It is one of three French newspapers of record, with Le Monde and Libération, and is the oldest newspaper in France. It is also the second-largest national newspaper in France after Le Parisien and before Le Monde, but...

, titled "European Experts claim GMO is harmless", to which Séralini responded: "Our paper was not particularly alarmist, but by far, one of the longest and most detailed study ever published on a toxicological analysis on mammals consuming a commercialized GMO." There were also "39 signs of toxicity were observed on the livers and kidneys of the laboratory mammals consuming genetically modified (GM) maize MON863 over a 3 month period", and there was "confirmed tissue damage after the consumption of the MON863 GM maize, in the kidneys of young male rats aged 5 months, with a chronic nephropathy at stage 18/20 (the non-GM control group was only 14/20). This was also described by the Monsanto team themselves and then written between the lines", according to Séralini. Greenpeace also cited the study in a press report, in which it demanded that MON 863 be completely recalled from the global market and called for a strict review of current testing methods.

Expert Panel evaluation of 2007 CRIIGEN study

A panel of experts from the US, Germany, UK and Canada was commissioned to evaluate CRIIGEN's new conclusions from the original Monsanto rat feeding toxicity data and funded by Monsanto. The panel objected to CRIIGEN's 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."

Food Standards Australia New Zealand review of 2007 CRIIGEN study

Food Standards Australia New Zealand
Food Standards Australia New Zealand
Food Standards Australia New Zealand is the governmental body responsible for developing food standards for Australia and New Zealand .FSANZ develops food standards after consulting with other government agencies and stakeholders...

 reviewed the 2007 CRIGEN study and concluded that "...all of the statistical differences between rats fed MON 863 corn and control rats are attributable to normal biological variation."

2009 CRIIGEN study

In December 2009, a second CRIIGEN study was published in the International Journal of Biological Sciences
International Journal of Biological Sciences
The International Journal of Biological Sciences is an open access scientific journal published by Ivyspring International Publisher. It pulbishes original articles, reviews, and short research communications in all areas of biological sciences. Articles are archived in PubMed Central and abstracts...

. This was a statistical re-analysis of three feeding trials that had previously been published by others as establishing the safety of genetically modified corn. In the study, findings of hepatorenal toxicity were reaffirmed, and concerns of metabolic consequences were further raised.

French High Council of Biotechnologies Scientific Committee opinion on 2009 study

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

The European Food Safety Authority GMO Panel deliberations on the 2009 study

An evaluation by the European Food Safety Authority (EFSA) GMO Panel of the 2009 statistical re-analyses concluded that the author's claims were not supported by the data in their paper. They noted that many of their fundamental statistical chriticisms of the 2007 paper also applied to the 2009 paper. There was no new information that would change the EFSA's conclusions that the three GM maize types were safe for human, animal health and the environment

Food Standards Australia New Zealand Review of 2009 CRIIGEN study

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

Legal status

MON 863 is approved for use in Australia
Australia
Australia , officially the Commonwealth of Australia, is a country in the Southern Hemisphere comprising the mainland of the Australian continent, the island of Tasmania, and numerous smaller islands in the Indian and Pacific Oceans. It is the world's sixth-largest country by total area...

, Canada
Canada
Canada is a North American country consisting of ten provinces and three territories. Located in the northern part of the continent, it extends from the Atlantic Ocean in the east to the Pacific Ocean in the west, and northward into the Arctic Ocean...

, China
China
Chinese civilization may refer to:* China for more general discussion of the country.* Chinese culture* Greater China, the transnational community of ethnic Chinese.* History of China* Sinosphere, the area historically affected by Chinese culture...

, the European Union
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...

, Japan
Japan
Japan is an island nation in East Asia. Located in the Pacific Ocean, it lies to the east of the Sea of Japan, China, North Korea, South Korea and Russia, stretching from the Sea of Okhotsk in the north to the East China Sea and Taiwan in the south...

, Mexico
Mexico
The United Mexican States , commonly known as Mexico , is a federal constitutional republic in North America. It is bordered on the north by the United States; on the south and west by the Pacific Ocean; on the southeast by Guatemala, Belize, and the Caribbean Sea; and on the east by the Gulf of...

, New Zealand
New Zealand
New Zealand is an island country in the south-western Pacific Ocean comprising two main landmasses and numerous smaller islands. The country is situated some east of Australia across the Tasman Sea, and roughly south of the Pacific island nations of New Caledonia, Fiji, and Tonga...

, the Philippines
Philippines
The Philippines , officially known as the Republic of the Philippines , is a country in Southeast Asia in the western Pacific Ocean. To its north across the Luzon Strait lies Taiwan. West across the South China Sea sits Vietnam...

, Russia
Russia
Russia or , officially known as both Russia and the Russian Federation , is a country in northern Eurasia. It is a federal semi-presidential republic, comprising 83 federal subjects...

, Singapore
Singapore
Singapore , officially the Republic of Singapore, is a Southeast Asian city-state off the southern tip of the Malay Peninsula, north of the equator. An island country made up of 63 islands, it is separated from Malaysia by the Straits of Johor to its north and from Indonesia's Riau Islands by the...

, South Korea
South Korea
The Republic of Korea , , is a sovereign state in East Asia, located on the southern portion of the Korean Peninsula. It is neighbored by the People's Republic of China to the west, Japan to the east, North Korea to the north, and the East China Sea and Republic of China to the south...

, Taiwan
Taiwan
Taiwan , also known, especially in the past, as Formosa , is the largest island of the same-named island group of East Asia in the western Pacific Ocean and located off the southeastern coast of mainland China. The island forms over 99% of the current territory of the Republic of China following...

, and the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...

.
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