Regulation of the release of genetic modified organisms
Encyclopedia
The regulation of genetic engineering concerns the approaches taken by governments to assess the risks associated with the use of genetic engineering
technology and the development and release of genetically modified organisms (GMO). There are differences in the regulation of GMOs between countries, with some of the most marked differences occurring between the USA and Europe.
, California. The first use of Recombinant DNA
(rDNA) technology had just been successfully accomplished by Stanley Cohen and Herbert Boyer
two years previously and the scientific community recognized that as well as benefits this technology could also pose some risks. The Asilomar meeting
recommended a set of guidelines regarding the cautious use of recombinant technology and any products resulting from that technology. The Asilomar recommendations were voluntary, but in 1976 the US National Institute of Health
(NIH) formed a rDNA advisory committee. This was followed by other regulatory offices (the United States Department of Agriculture
(USDA), Environmental Protection Agency (EPA) and Food and Drug Administration
(FDA)), effectively making all rDNA research tightly regulated in the USA. In 1982 the Organization for Economic Co-operation and Development (OECD) released a report into the potential hazards of releasing genetically modified organisms into the environment as the first transgenic plants were being developed. As the technology improved and genetically organisms moved from model organism
s to potential commercial products the USA established a committee at the Office of Science and Technology
(OSTP) to develop mechanisms to regulate the developing technology. In 1986 the OSTP assigned regulatory approval of genetically modified plants in the US to the USDA, FDA and EPA.
(COMESA) produced a draft policy on GM technology. This proposed policy was sent to all 19 national governments for consultation in September 2010. Under the policy, a member country which wants to grow a new GM crop would inform COMESA who would have sufficient scientific expertise to make the decision as to whether the crop was safe for the environment and for humans. At the moment, few countries have the resources to make their own decisions. Once COMESA had made their decision, permission would be granted for the crop to be grown in all 19 member countries. Member countries would retain the power not to grow the crop in their own country if they wanted. South Africa
is the major grower of Genetically Modified crops in Africa, with smaller amounts grown in Burkina Faso
and Egypt
. The National Assembly of Burkina Faso passed a biosafety law in early 2006, which established a National Biosafety Agency that would regulate GM products with the advice of various governmental and non-governmental advisory committees. In Burkina Faso, the African Biosafety Network of Expertise school, set up by the African Union
and funded by the Bill and Melinda Gates Foundation, opened in April 2010. Its aim is to train and develop African regulators to approve, monitor and track genetically modified crops. Kenya
passed laws in 2011 which allowed the production and importation of GM crops.
, 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. The only other Asian country to currently grow GM crops is the Phillipenes.
On the 15 February 2005, after consulting the Mexican Academy of Sciences
, Mexico's senate passed a law allowing planting and selling of Genetically modified crops. The law requires all genetically modified products to be labelled according to guidelines issued by the Ministry of Health. Initially only GM cotton and soybean was grown in Mexico, but in 2009 the government enacted statutory provisions for the regulation of genetically modified maize. Mexico is the center of diversity
for maize and concerns have been raised about the impact genetically modified maize could have on local strains.
(EU) has possibly the most stringent GMO regulations in the world. All GMOs, along with irradiated food, are considered "new food" and subject to extensive, case-by-case, science based food evaluation by the European Food Safety Authority
(EFSA). The EFSA reports to the European Commission
who then draft a proposal for granting or refusing the authorisation. This proposal is submitted to the Section on GM Food and Feed of the Standing Committee on the Food Chain and Animal Health and if accepted it will be adopted by the EC or passed on to the Council of Agricultural Ministers
. Once in the Council it has three months to reach a qualified majority for or against the proposal, if no majority is reached the proposal is passed back to the EC who will then adopt the proposal. There is also a safeguard clause that Member States can invoke to restrict or prohibit the use and/or sale of a GMO within their territory if they have a justifiable reasons to consider that the approved GMO constitutes a risk to human health or the environment.
In 2010 Austria, Bulgaria, Cyprus, Hungary, Ireland, Latvia, Lithuania, Malta, Slovenia, and the Netherlands wrote a joint paper requesting that individual countries have the right to decide whether to cultivate GM crops. Currently (2010) the only GMO food crop with approval for cultivation in Europe is MON810, a Bt expressing maize
conferring resistance to the European corn borer
, that gained approval in 1998. On 2 March 2010 a second GMO, a potato called Amflora
, was approved for cultivation for industrial applications in the EU by the European Commission and was grown in Germany, Sweden and the Czech Republic that year. Gene flow
will occur between related crops and the EC issued new guidelines in 2010 regarding the co-existence of GM and non-GM crops
. Co-existence is regulated by the use of buffer zones and isolation distances between the GM and non-GM crops. The guidelines are not binding and each Member State can implement their own regulations, resulting in buffer zones ranging from 15 meters (in Sweden) to 800 meters (in Luxembourg). It also provides the possibility to designate GMO-free zones, effectively allowing Member states to ban cultivation of GM crops in their territory without invoking the safe guard clause.
The regulations concerning the import and sale of GMOs for human and animal consumption grown outside the EU involve providing freedom of choice to the farmers and consumers. All food (including processed food) or feed
which contains greater than 0.9% of approved GMOs must be labelled. Twice GMOs unapproved by the EC have arrived in the EU and been forced to return to their port of origin. The first was in 2006 when a shipment of rice from America containing an experimental GMO variety (LLRice601) not meant for commercialisation arrived at Rotterdam
. The second in 2009 when trace amounts of a GMO maize approved in the US were found in a "non-GM" soy flour cargo.
a potato modified with higher levels of starch for industrial purposes. In addition to France and Germany, other European countries that placed bans on the cultivation and sale of GMOs include Austria, Hungary, Greece, and Luxembourg. Poland has also tried to institute a ban, with backlash from the European Commission
. Bulgaria effectively banned cultivation of genetically modified organisms on March 18, 2010.
France adopted the EU laws on growing GMOs in 2007 and were fined €10 million by the European Court of Justice
for the six year delay in implementing the laws. In February 2008 the French government used the safeguard clause to ban the cultivation of MON810 after Senator Jean-François Le Grand
, chairman of a committee set up to evaluate biotechnolgy, said there were "serious doubts" about the safety of the product. Twelve scientists and two economists on the committee accused Le Grand of misrepresenting the report and say they did not have "serious doubts" although questions remained concerning the impact of Bt-maize on health and the environment. The French government submitted a number of studies to back up its claim to the EU. These were given to the EFSA who concluded that there was no new evidence to undermine the previous safety findings and considered the decision "scientifically unfounded". The High Council for Biotechnology subcommittee dealing with economic, ethical and social aspects recommended an additional "GMO-free" label for anything containing less than 0.1% GMO which is due to come in late 2010.
In April 2009 German Federal Minister Ilse Aigner
announced an immediate halt to cultivation and marketing of MON810 maize under the safeguard clause. The ban was based on "expert opinion" that suggested there was reasonable grounds to believe that MON810 maize presents a danger to the environment. Three French scientists reviewing the scientific evidence used to justify the ban concluding that it did not use a case-by-case approach, confused potential hazards with proven risks and ignored the meta-knowledge on Bt expressing maize, instead focusing on selected individual studies.
and also grows GM maize, soybean and sugarbeet. Health Canada
, under the Food and Drugs Act, and the Canadian Food Inspection Agency
are responsible for evaluating the safety and nutritional value of genetically modified foods. Manufacturers and importers supply data to Health Canada for safety assessments, which include its composition, toxic and allergenic potential, nutrients, potential secondary effects and other biological concerns. A decision is then made whether to approve the product for release along with any restrictions or requirements. Labeling of GM food is voluntary. The Canadian regulations were reviewed by the Canadian Biotechnology Advisory Committee between 1999 and 2003, with the conclusion that the current level of regulation was satisfactory. The committee was accused by environmental and citizen groups of not representing the full spectrum of public interests by only having one member of the board of 20 representing non-governmental organisations and for being too closely aligned to industry groups.
, California became the first and only county to impose a ban on the "Propagation, Cultivation, Raising, and Growing of Genetically Modified Organisms", the measure passing with a 57% majority.
(OGTR) took over in 2001. The OTGR is a Commenwealth Government Authority within the Department of Health and Ageing. It was established as part of the Gene Technology Act 2003 and operates according to the Gene Technology Regulations 2001. The OGTR reports directly to Parliament through a Ministerial Council on Gene Technology and has legislative powers.
The OGTR decides on license applications for the release of all genetically modified organisms, while regulation is provided by the Therapeutic Goods Administration
for GM medicines or Food Standards Australia New Zealand
for GM food. The individual state governments are then able to assess the impact of release on markets and trade and apply further legislation to control approved genetically modified products.
The two genetically modified crops grown in Australia are cotton and canola. Genetically modified cotton has been grown commercially in New South Wales and Queensland since 1996. GM canola was approved in 2003 and was first grown in 2008. The Queensland and Northern Territory Governments have not implemented any further legislation beyond the national level, but several other states placed bans on planting certain GM crops. In 2007 the New South Wales government extended a blanket moratorium on GM food crops until 2011, but allowed groups to apply for exemptions. New South Wales approved GM Canola for commercial cultivation in 2008, while the Victorian government let the moratorium on GM Canola expire in 2007. Western Australia passed the Genetically Modified Crops Free Areas Act in 2003 and was declared a GM free area in 2004. In 2008 an exception was made for the commercial cultivation of GM cotton in the Ord River Irrigation Areas. Trials of GM canola were carried out in 2003 and in 2010 the Western Australian governemnt allowed the commercialisation of GM canola. South Australia and Tasmania extended their moratoriums on all genetically modified crops until 2019 and 2014.
, no genetically modified food is grown and no medicines containing live genetically-modified organisms have been approved for use. However, medicines manufactured using genetically modified organisms that do not contain live organisms have been approved for sale, and imported foods with genetically modified components are sold. In 2000 the Government appointed a Royal Commission
to report on issues relating to genetically modified organism
s (GMOs). The Report of the Royal Commission on Genetic Modification
, released in July 2001, concluded that New Zealand should keep its options open with regard to genetic engineering and to proceed carefully in order to minimise and manage any risks. Field trials that have been carried out with GM pine trees and brassica
s have attracted negative public reaction.
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...
technology and the development and release of genetically modified organisms (GMO). There are differences in the regulation of GMOs between countries, with some of the most marked differences occurring between the USA and Europe.
History
The development of a regulatory framework concerning genetic engineering began in 1975, at AsilomarAsilomar Conference Grounds
Asilomar Conference Grounds is a conference center built for the YWCA in 1913 at Asilomar State Beach in Pacific Grove, California. Julia Morgan designed and built 16 of the buildings on the property, of which 11 are still standing. It became part of Asilomar State Beach and Conference Grounds in...
, California. The first use of Recombinant DNA
Recombinant DNA
Recombinant DNA molecules are DNA sequences that result from the use of laboratory methods to bring together genetic material from multiple sources, creating sequences that would not otherwise be found in biological organisms...
(rDNA) technology had just been successfully accomplished by Stanley Cohen and Herbert Boyer
Herbert Boyer
Herbert W. Boyer is a recipient of the 1990 National Medal of Science, co-recipient of the 1996 Lemelson-MIT Prize, and a co-founder of Genentech. He served as Vice President of Genentech from 1976 through his retirement in 1991....
two years previously and the scientific community recognized that as well as benefits this technology could also pose some risks. The Asilomar meeting
Asilomar Conference on Recombinant DNA
The Asilomar Conference on Recombinant DNA was an influential conference organized by Paul Berg discussing the potential biohazards and regulation of biotechnology held in February 1975 at a conference center Asilomar State Beach...
recommended a set of guidelines regarding the cautious use of recombinant technology and any products resulting from that technology. The Asilomar recommendations were voluntary, but in 1976 the US National Institute of Health
National Institutes of Health
The National Institutes of Health are an agency of the United States Department of Health and Human Services and are the primary agency of the United States government responsible for biomedical and health-related research. Its science and engineering counterpart is the National Science Foundation...
(NIH) formed a rDNA advisory committee. This was followed by other regulatory offices (the United States Department of Agriculture
United States Department of Agriculture
The United States Department of Agriculture is the United States federal executive department responsible for developing and executing U.S. federal government policy on farming, agriculture, and food...
(USDA), Environmental Protection Agency (EPA) and Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA)), effectively making all rDNA research tightly regulated in the USA. In 1982 the Organization for Economic Co-operation and Development (OECD) released a report into the potential hazards of releasing genetically modified organisms into the environment as the first transgenic plants were being developed. As the technology improved and genetically organisms moved from model organism
Model organism
A model organism is a non-human species that is extensively studied to understand particular biological phenomena, with the expectation that discoveries made in the organism model will provide insight into the workings of other organisms. Model organisms are in vivo models and are widely used to...
s to potential commercial products the USA established a committee at the Office of Science and Technology
Office of Science and Technology Policy
The Office of Science and Technology Policy is an office in the Executive Office of the President , established by Congress on May 11, 1976, with a broad mandate to advise the President on the effects of science and technology on domestic and international affairs.The director of this office is...
(OSTP) to develop mechanisms to regulate the developing technology. In 1986 the OSTP assigned regulatory approval of genetically modified plants in the US to the USDA, FDA and EPA.
Africa
In 2010, after nine years of talks, the Common Market for Eastern and Southern AfricaCommon Market for Eastern and Southern Africa
The Common Market for Eastern and Southern Africa, is a free trade area with nineteen member states stretching from Libya to Zimbabwe. COMESA formed in December 1994, replacing a Preferential Trade Area which had existed since 1981...
(COMESA) produced a draft policy on GM technology. This proposed policy was sent to all 19 national governments for consultation in September 2010. Under the policy, a member country which wants to grow a new GM crop would inform COMESA who would have sufficient scientific expertise to make the decision as to whether the crop was safe for the environment and for humans. At the moment, few countries have the resources to make their own decisions. Once COMESA had made their decision, permission would be granted for the crop to be grown in all 19 member countries. Member countries would retain the power not to grow the crop in their own country if they wanted. South Africa
South Africa
The Republic of South Africa is a country in southern Africa. Located at the southern tip of Africa, it is divided into nine provinces, with of coastline on the Atlantic and Indian oceans...
is the major grower of Genetically Modified crops in Africa, with smaller amounts grown in Burkina Faso
Burkina Faso
Burkina Faso – also known by its short-form name Burkina – is a landlocked country in west Africa. It is surrounded by six countries: Mali to the north, Niger to the east, Benin to the southeast, Togo and Ghana to the south, and Côte d'Ivoire to the southwest.Its size is with an estimated...
and Egypt
Egypt
Egypt , officially the Arab Republic of Egypt, Arabic: , is a country mainly in North Africa, with the Sinai Peninsula forming a land bridge in Southwest Asia. Egypt is thus a transcontinental country, and a major power in Africa, the Mediterranean Basin, the Middle East and the Muslim world...
. The National Assembly of Burkina Faso passed a biosafety law in early 2006, which established a National Biosafety Agency that would regulate GM products with the advice of various governmental and non-governmental advisory committees. In Burkina Faso, the African Biosafety Network of Expertise school, set up by the African Union
African Union
The African Union is a union consisting of 54 African states. The only all-African state not in the AU is Morocco. Established on 9 July 2002, the AU was formed as a successor to the Organisation of African Unity...
and funded by the Bill and Melinda Gates Foundation, opened in April 2010. Its aim is to train and develop African regulators to approve, monitor and track genetically modified crops. Kenya
Kenya
Kenya , officially known as the Republic of Kenya, is a country in East Africa that lies on the equator, with the Indian Ocean to its south-east...
passed laws in 2011 which allowed the production and importation of GM crops.
Asia
India and China are the two largest producers of genetically modified products in Asia. India currently only grows GM cotton, while China produces GM varieties of cotton, poplar, petunia, tomato, papaya and sweet pepper. Cost of enforcement of regulations in India are generally higher, possibly due to the greater influence farmers and small seed firms have on policy makers, while the enforcement of regulations was more effective in China. GM crops in China go through three phases of field trials (pilot field testing, environmental release testing, and preproduction testing) before they are submitted to the Office of Agricultural Genetic Engineering Biosafety Administration (OAGEBA) for assessment. Producers must apply to OAGEBA at each stage of the field tests. The Chinese Ministry of Science and Technology developed the first biosafety regulations for GM products in 1993 and they were updated in 2001. The 75 member National Biosafety Committee evaluates all applications, although OAGEBA has the final decision. Most of the National Biosafety Committee are involved in biotechnology leading to criticisms that they do not represent a wide enough range of public concerns. India regulators cleared the Bt brinjalBt brinjal
The Bt brinjal is a suite of transgenic brinjals created by inserting a crystal protein gene from the soil bacterium Bacillus thuringiensis into the genome of various brinjal cultivars...
, 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. The only other Asian country to currently grow GM crops is the Phillipenes.
Central and South America
Mexico, Honduras, Costa Rico, Colombia, Bolivia, Paraguay, Chile, Argentina, Uruguay and Brazil all grow GM crops. Brazil and Argentina are the 2nd and 3rd largest producers of GM food behind the USA. The Argentine government was one of the first to accept GM food. Assessment of GM products for release is provided by the National Agricultural Biotechnology Advisory Committee (environmental impact), the National Service of Health and Agrifood Quality (food safety) and the National Agribusiness Direction (effect on trade), with the final decision made by the Secretariat of Agriculture, Livestock, Fishery and Food. The government is looking to tighten the current law which allows farmers to keep seed without paying royalties in a bid to encourage more private investment. In Brazil the National Biosafety Technical Commission is responsible for assessing environmental and food safety and prepares guidelines for transport, importation and field experiments involving GM products. The Council of Ministers evaluates the commercial and economical issues with release. The National Biosafety Technical Commission has 27 members and includes 12 scientists, 9 ministerial representatives and 6 other specialists.On the 15 February 2005, after consulting the Mexican Academy of Sciences
Mexican Academy of Sciences
The Mexican Academy of Sciences is a non-profit organization comprising over 1800 distinguished Mexican scientists, attached to various institutions in the country, as well as a number of eminent foreign colleagues, including various Nobel Prize winners...
, Mexico's senate passed a law allowing planting and selling of Genetically modified crops. The law requires all genetically modified products to be labelled according to guidelines issued by the Ministry of Health. Initially only GM cotton and soybean was grown in Mexico, but in 2009 the government enacted statutory provisions for the regulation of genetically modified maize. Mexico is the center of diversity
Center of diversity
A center of diversity is an area that has a high degree of genetic variation for a particular species or genus of plants that can also be the center of origin for that species. The two areas often, but not always, coincide; the degree of coincidence remains the subject of debate...
for maize and concerns have been raised about the impact genetically modified maize could have on local strains.
Europe
The European UnionEuropean 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...
(EU) has possibly the most stringent GMO regulations in the world. All GMOs, along with irradiated food, are considered "new food" and subject to extensive, case-by-case, science based food evaluation by 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....
(EFSA). The EFSA reports to 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....
who then draft a proposal for granting or refusing the authorisation. This proposal is submitted to the Section on GM Food and Feed of the Standing Committee on the Food Chain and Animal Health and if accepted it will be adopted by the EC or passed on to the Council of Agricultural Ministers
Council of the European Union
The Council of the European Union is the institution in the legislature of the European Union representing the executives of member states, the other legislative body being the European Parliament. The Council is composed of twenty-seven national ministers...
. Once in the Council it has three months to reach a qualified majority for or against the proposal, if no majority is reached the proposal is passed back to the EC who will then adopt the proposal. There is also a safeguard clause that Member States can invoke to restrict or prohibit the use and/or sale of a GMO within their territory if they have a justifiable reasons to consider that the approved GMO constitutes a risk to human health or the environment.
In 2010 Austria, Bulgaria, Cyprus, Hungary, Ireland, Latvia, Lithuania, Malta, Slovenia, and the Netherlands wrote a joint paper requesting that individual countries have the right to decide whether to cultivate GM crops. Currently (2010) the only GMO food crop with approval for cultivation in Europe is MON810, a Bt expressing 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...
conferring resistance to the European corn borer
European Corn Borer
The European corn borer , also known as the European high-flyer, is a pest of grain, particularly maize. The insect is native to Europe, originally infesting varieties of millet, including broom corn. The European corn borer was first reported in North America in 1917 in Massachusetts, but was...
, that gained approval in 1998. On 2 March 2010 a second GMO, a potato called Amflora
Amflora
Amflora is a genetically modified potato owned by BASF Plant Science. Amflora was approved for industrial applications in the European Union market on 2 March 2010 by the European Commission.-History:...
, was approved for cultivation for industrial applications in the EU by the European Commission and was grown in Germany, Sweden and the Czech Republic that year. Gene flow
Gene flow
In population genetics, gene flow is the transfer of alleles of genes from one population to another.Migration into or out of a population may be responsible for a marked change in allele frequencies...
will occur between related crops and the EC issued new guidelines in 2010 regarding the co-existence of GM and non-GM crops
Co-existence of genetically modified and conventional crops and derived food and feed
In the context of agriculture and food and feed production, co-existence means using cropping systems with and without genetically modified organisms in parallel. For co-existence to be assured, the separation and the identity of the respective food and feed products must be maintained at all...
. Co-existence is regulated by the use of buffer zones and isolation distances between the GM and non-GM crops. The guidelines are not binding and each Member State can implement their own regulations, resulting in buffer zones ranging from 15 meters (in Sweden) to 800 meters (in Luxembourg). It also provides the possibility to designate GMO-free zones, effectively allowing Member states to ban cultivation of GM crops in their territory without invoking the safe guard clause.
The regulations concerning the import and sale of GMOs for human and animal consumption grown outside the EU involve providing freedom of choice to the farmers and consumers. All food (including processed food) or feed
Compound feed
Compound feeds are feedstuffs that are blended from various raw materials and additives. These blends are formulated according to the specific requirements of the target animal...
which contains greater than 0.9% of approved GMOs must be labelled. Twice GMOs unapproved by the EC have arrived in the EU and been forced to return to their port of origin. The first was in 2006 when a shipment of rice from America containing an experimental GMO variety (LLRice601) not meant for commercialisation arrived at Rotterdam
Rotterdam
Rotterdam is the second-largest city in the Netherlands and one of the largest ports in the world. Starting as a dam on the Rotte river, Rotterdam has grown into a major international commercial centre...
. The second in 2009 when trace amounts of a GMO maize approved in the US were found in a "non-GM" soy flour cargo.
Adoption
Spain is the largest producer of GM crops in Europe with 76000 hectares (187,799.9 acre) of GM maize planted in 2009 (20% of Spain's maize production). Smaller amounts were produced in the Czech Republic, Slovakia, Portugal, Romania and Poland. France and Germany are the major opponents of genetically modified food in Europe, although Germany has approved AmfloraAmflora
Amflora is a genetically modified potato owned by BASF Plant Science. Amflora was approved for industrial applications in the European Union market on 2 March 2010 by the European Commission.-History:...
a potato modified with higher levels of starch for industrial purposes. In addition to France and Germany, other European countries that placed bans on the cultivation and sale of GMOs include Austria, Hungary, Greece, and Luxembourg. Poland has also tried to institute a ban, with backlash 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....
. Bulgaria effectively banned cultivation of genetically modified organisms on March 18, 2010.
France
France adopted the EU laws on growing GMOs in 2007 and were fined €10 million by the European Court of Justice
European Court of Justice
The Court can sit in plenary session, as a Grand Chamber of 13 judges, or in chambers of three or five judges. Plenary sitting are now very rare, and the court mostly sits in chambers of three or five judges...
for the six year delay in implementing the laws. In February 2008 the French government used the safeguard clause to ban the cultivation of MON810 after Senator Jean-François Le Grand
Jean-François Le Grand
Jean-François Le Grand is a French politician and a member of the Senate of France. He represents the Manche department and is a member of the Union for a Popular Movement Party.-References:*...
, chairman of a committee set up to evaluate biotechnolgy, said there were "serious doubts" about the safety of the product. Twelve scientists and two economists on the committee accused Le Grand of misrepresenting the report and say they did not have "serious doubts" although questions remained concerning the impact of Bt-maize on health and the environment. The French government submitted a number of studies to back up its claim to the EU. These were given to the EFSA who concluded that there was no new evidence to undermine the previous safety findings and considered the decision "scientifically unfounded". The High Council for Biotechnology subcommittee dealing with economic, ethical and social aspects recommended an additional "GMO-free" label for anything containing less than 0.1% GMO which is due to come in late 2010.
Germany
In April 2009 German Federal Minister Ilse Aigner
Ilse Aigner
Ilse Aigner is a German politician and member of the Christian Social Union of Bavaria .Aigner was born in Feldkirchen-Westerham, Rosenheim, Bavaria and entered Angela Merkel's grand coalition cabinet as Federal Minister of Food, Agriculture and Consumer Protection on 31 October 2008...
announced an immediate halt to cultivation and marketing of MON810 maize under the safeguard clause. The ban was based on "expert opinion" that suggested there was reasonable grounds to believe that MON810 maize presents a danger to the environment. Three French scientists reviewing the scientific evidence used to justify the ban concluding that it did not use a case-by-case approach, confused potential hazards with proven risks and ignored the meta-knowledge on Bt expressing maize, instead focusing on selected individual studies.
Canada
Mainland Canada is one of the world's largest producers of GM canolaCanola
Canola refers to a cultivar of either Rapeseed or Field Mustard . Its seeds are used to produce edible oil suitable for consumption by humans and livestock. The oil is also suitable for use as biodiesel.Originally, Canola was bred naturally from rapeseed in Canada by Keith Downey and Baldur R...
and also grows GM maize, soybean and sugarbeet. Health Canada
Health Canada
Health Canada is the department of the government of Canada with responsibility for national public health.The current Minister of Health is Leona Aglukkaq, a Conservative Member of Parliament appointed to the position by Prime Minister Stephen Harper.-Branches, regions and agencies:Health Canada...
, under the Food and Drugs Act, and the Canadian Food Inspection Agency
Canadian Food Inspection Agency
The Canadian Food Inspection Agency is a science based regulatory agency that is dedicated to the safeguarding of food, animals, and plants, which enhance the health and well-being of Canada's people, environment and economy...
are responsible for evaluating the safety and nutritional value of genetically modified foods. Manufacturers and importers supply data to Health Canada for safety assessments, which include its composition, toxic and allergenic potential, nutrients, potential secondary effects and other biological concerns. A decision is then made whether to approve the product for release along with any restrictions or requirements. Labeling of GM food is voluntary. The Canadian regulations were reviewed by the Canadian Biotechnology Advisory Committee between 1999 and 2003, with the conclusion that the current level of regulation was satisfactory. The committee was accused by environmental and citizen groups of not representing the full spectrum of public interests by only having one member of the board of 20 representing non-governmental organisations and for being too closely aligned to industry groups.
United States
The USA is the largest commercial grower of genetically modified crops in the world. For a genetically modified organism to be approved for release it is assessed by the USDA, the FDA and the EPA. USDA evaluated the plants potential to become weeds, the FDA reviewed plants that could enter or alter the food supply and the EPA regulated the genetically modified plants with pesticide properties. Most developed genetically modified plants are reviewed by at least two of the agencies, with many subject to all three. Final approval can still be denied by individual counties within each state. In 2004, Mendocino CountyMendocino County, California
Mendocino County is a county located on the north coast of the U.S. state of California, north of the greater San Francisco Bay Area and west of the Central Valley. As of the 2010 census, the population was 87,841, up from 86,265 at the 2000 census...
, California became the first and only county to impose a ban on the "Propagation, Cultivation, Raising, and Growing of Genetically Modified Organisms", the measure passing with a 57% majority.
Australia
Genetic engineering in Australia was originally (since 1987) overseen by the Genetic Manipulation Advisory Committee, before the Office of the Gene Technology RegulatorOffice of the Gene Technology Regulator
The Office of the Gene Technology Regulator, supports the Gene Technology Regulator, and is a part of the Australian Government Department of Health and Ageing. The Office was established under the Commonwealth Gene Technology Act 2000. This legislation sets forth a nationally consistent regulatory...
(OGTR) took over in 2001. The OTGR is a Commenwealth Government Authority within the Department of Health and Ageing. It was established as part of the Gene Technology Act 2003 and operates according to the Gene Technology Regulations 2001. The OGTR reports directly to Parliament through a Ministerial Council on Gene Technology and has legislative powers.
The OGTR decides on license applications for the release of all genetically modified organisms, while regulation is provided by the Therapeutic Goods Administration
Therapeutic Goods Administration
The Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia . It is a Division of the Australian Department of Health and Ageing established under the Therapeutic Goods Act 1989 ...
for GM medicines or 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...
for GM food. The individual state governments are then able to assess the impact of release on markets and trade and apply further legislation to control approved genetically modified products.
The two genetically modified crops grown in Australia are cotton and canola. Genetically modified cotton has been grown commercially in New South Wales and Queensland since 1996. GM canola was approved in 2003 and was first grown in 2008. The Queensland and Northern Territory Governments have not implemented any further legislation beyond the national level, but several other states placed bans on planting certain GM crops. In 2007 the New South Wales government extended a blanket moratorium on GM food crops until 2011, but allowed groups to apply for exemptions. New South Wales approved GM Canola for commercial cultivation in 2008, while the Victorian government let the moratorium on GM Canola expire in 2007. Western Australia passed the Genetically Modified Crops Free Areas Act in 2003 and was declared a GM free area in 2004. In 2008 an exception was made for the commercial cultivation of GM cotton in the Ord River Irrigation Areas. Trials of GM canola were carried out in 2003 and in 2010 the Western Australian governemnt allowed the commercialisation of GM canola. South Australia and Tasmania extended their moratoriums on all genetically modified crops until 2019 and 2014.
New Zealand
In New ZealandNew 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...
, no genetically modified food is grown and no medicines containing live genetically-modified organisms have been approved for use. However, medicines manufactured using genetically modified organisms that do not contain live organisms have been approved for sale, and imported foods with genetically modified components are sold. In 2000 the Government appointed a Royal Commission
Royal Commission
In Commonwealth realms and other monarchies a Royal Commission is a major ad-hoc formal public inquiry into a defined issue. They have been held in various countries such as the United Kingdom, Australia, Canada, New Zealand, and Saudi Arabia...
to report on issues relating to genetically modified organism
Genetically modified organism
A genetically modified organism or genetically engineered organism is an organism whose genetic material has been altered using genetic engineering techniques. These techniques, generally known as recombinant DNA technology, use DNA molecules from different sources, which are combined into one...
s (GMOs). The Report of the Royal Commission on Genetic Modification
Report of the Royal Commission on Genetic Modification
Report of the Royal Commission on Genetic Modification was published in 2001 by the government appointed Royal Commission on Genetic Modification.Thomas Eichelbaum chaired the Royal Commission on Genetic Modification.-External links:...
, released in July 2001, concluded that New Zealand should keep its options open with regard to genetic engineering and to proceed carefully in order to minimise and manage any risks. Field trials that have been carried out with GM pine trees and brassica
Brassica
Brassica is a genus of plants in the mustard family . The members of the genus may be collectively known either as cabbages, or as mustards...
s have attracted negative public reaction.