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Regulation of genetically modified organisms

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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.

Genetic engineering is the direct human manipulation of an organism's genome using modern DNA technology.

History

The development of a regulatory framework concerning genetic engineering began in 1975, at Asilomar, 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.[1] The Asilomar meeting recommended a set of guidelines regarding the cautious use of recombinant technology and any products resulting from that technology.[2] The Asilomar recommendations were voluntary, but in 1976 the US National Institute of Health (NIH) formed a rDNA advisory committee.[3] 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.[4] 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.[5] As the technology improved and genetically organisms moved from model organisms 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.[4] In 1986 the OSTP assigned regulatory approval of genetically modified plants in the US to the USDA, FDA and EPA.[6]

Regulation

Africa

In 2010, after nine years of talks, the Common Market for Eastern and Southern Africa (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.[7] South Africa is the major grower of Genetically Modified crops in Africa, with smaller amounts grown in Burkina Faso and Egypt.[8] 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.[9] 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.[10] Kenya passed laws in 2011 which allowed the production and importation of GM crops.[11]

Asia

India and China are the two largest producers of genetically modified products in Asia.[12] 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.[13] 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.[14] 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.[15] 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.[14] 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.[16][17] The only other Asian country to currently grow GM crops is the Phillipenes.[12]

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.[8] 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.[18] 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.[19] 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.[18] 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, Mexico's senate passed a law allowing planting and selling of Genetically modified crops.[20] 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.[21] Mexico is the center of diversity for maize and concerns have been raised about the impact genetically modified maize could have on local strains.[22][23]

Europe

The European Union (EU) has possibly the most stringent GMO regulations in the world.[24] 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.[24] 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.[25]

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[26] and was grown in Germany, Sweden and the Czech Republic that year.[27] 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.[28] 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).[24] 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.[28]

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.[29] 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.[24] 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.[24]

Adoption

Spain is the largest producer of GM crops in Europe with 76,000 hectares (190,000 acres) of GM maize planted in 2009 (20% of Spain's maize production).[30] Smaller amounts were produced in the Czech Republic, Slovakia, Portugal, Romania and Poland.[30] France and Germany are the major opponents of genetically modified food in Europe, although Germany has approved Amflora a potato modified with higher levels of starch for industrial purposes.[31] 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.[32] Poland has also tried to institute a ban, with backlash from the European Commission.[33] Bulgaria effectively banned cultivation of genetically modified organisms on March 18, 2010.[34]

France

France adopted the EU laws on growing GMOs in 2007[35] and were fined €10 million by the European Court of Justice for the six year delay in implimenting the laws.[36] 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.[37] 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.[38] 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".[39] 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.[24][40]

Germany

In April 2009 German Federal Minister Ilse Aigner announced an immediate halt to cultivation and marketing of MON810 maize under the safeguard clause.[41] The ban was based on "expert opinion" that suggested there was reasonable grounds to believe that MON810 maize presents a danger to the environment.[42] 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.[43]

North America

Canada

Mainland Canada is one of the world's largest producers of GM canola[44] and also grows GM maize, soybean and sugarbeet.[8] Health Canada, under the Food and Drugs Act, and the Canadian Food Inspection Agency[45] 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.[46] 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.[47]

United States

See also: Genetic engineering in the United States

The USA is the largest commercial grower of genetically modified crops in the world.[30] 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.[4] Final approval can still be denied by individual counties within each state. In 2004, Mendocino County, 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.[48]

US Department of Agriculture

The Biotechnology Regulatory Services program of the Animal and Plant Health Inspection Service (APHIS) agency within the USDA is concerned with protecting agriculture and the environment from potential pests under the Plant Protection Act of 2000 (part of the Agriculture Risk Protection Act) and the National Environmental Policy Act (NEPA).[4][49] Each transgenic event is regulated separately as the transgene insertion locus varies even when using identical constructs and host genotypes. This could result in different expression patterns or could affect the function of other endogenous genes within the host. The USDA is responsible for approving field trials of GM plants under either the notification or permit procedures.[4] The notification procedure is a streamlined process for the simplest or most familiar genetically engineered plants that meet six criteria (is not a noxious weed, the function of the genetic material is known and characterized, stable integration, no significant risk of creating new viruses and that no animal or human pathogen sequences are present).[50] Most field trials are approved under the notification procedure.[4] The permit procedure is much more elaborate and is required for all genetically engineered organisms that do not meet the notification requirements or any plant-made pharmaceuticals or plant-made industrial products.

APHIS officials are responsible for inspecting the field trials. At least one inspection is carried out for each state listed on a permit, while inspection of field trials authorized by notification is conducted based on the relative risk of each trial.[51] For field trials of organisms that contain pharmaceutical or industrial compounds, inspections are carried out more frequently (five times during establishment and twice yearly after that). If the inspectors are satisfied that there are no regulatory concerns they issue a Notice of Compliance. If the regulations are not being adhered to the inspectors will issue a Notice of Non-Compliance requesting that the deviations be fixed, or for more serious breaches a warning letter requiring a written response and corrective action to be taken within a given time frame.[51] Formal investigations are carried out on developers who may not be adhering to regulations, permit conditions, or other requirements, which can result in civil penalties or criminal charges.

In 1993, the USDA proposal to remove regulatory oversight from GM organisms deemed environmentally benign was approved and four GM plants (Flavr Savr tomato, virus-resistant squash, bromoxynil-tolerant cotton and glyphosphate-tolerant soybean) obtained non-regulatory status that year.[4] Non-regulated status means that permits and notifications are no longer required for introductions of this organism. Applicants can petition APHIS for non-regulated status if the GM organism poses no more of a plant pest risk than an equivalent non-GM organism.[52] APHIS will prepare at least two documents (an Environmental Assessment and a determination of non-regulatory status) under the NEPA while considering the application.

Three federal district court suits have been brought against APHIS challenging their regulation of GM plants. Two involved field trials (herbicide-tolerant turfgrass in Oregon; pharmaceutical-producing corn and sugar in Hawaii) and one the deregulation of GM alfalfa.[4] APHIS lost all three cases, with the judges ruling they failed to diligently follow the NEPA guidelines.

Food and Drug Administration

The FDA is responsible for the safety and security of human and animal food and drugs, including any that are genetically modified. The FDA was responsible for approving the first commercialized GMO, Genetechs genetically modified human insulin (Humulin) in 1982 and the first commercialized GM whole food, Calgenes Flavr Savr tomato in 1994. When evaluating new GM foods or feed the FDA looks for the presence of any new or altered allergens and toxicants and examines changes in the levels of nutritional and anti-nutritional substances.[4] Food and feed that is identical or nearly identical in composition to current products is deemed to be substantially equivalent[53] and is not required to undergo review by the FDA.[54] The FDA has been criticized for using substantial equivalence, with a major accusation being that FDA review is essentially voluntary as almost all GM products are substantially equivalent.[55] However, all GM food and feed currently on the US market have undergone a FDA consultation, where the developer submits the compositional data and FDA scientist compare it to regular food and feed.[4][56]

The FDA consultation focuses on whether the new food or feed contains any new allergens or toxic substances and whether the nutritional components of the food or feed have increased or decreased.[4] The developer submits documentation to the FDA describing the food or feed and a FDA assigned caseworker can then request additional information on expected dietary exposure, in particular if any risk groups (children, elderly etc) might be exposed. As of 2007, the FDA has not identified any genetically modified foods with unexpected changes in the nutrient composition or levels of allergens or toxic substances.[4] However, allergic proteins have been detected when some GM products have undergone testing. Pioneer Hi-Bred inserted a gene from the Brazil nut into transgenic soybean resulting in soy with an enhanced nutritional profile. The inserted gene did not translate into a known allergen at the time, but when tested with serum from people who are allergic to Brazil nut the allergenic nature of the protein was discovered.[57] The development of the transgenic soybean expressing a Brazil nut allergen was stopped after these tests. The FDA consultation process is relatively (when compared to the other agencies regulating GM) informal and they do not approve new GM products. Instead they issue a memo stating whether the new food is the same as or different to the non-modified variety.[4]

The Center for Veterinary Medicine of the FDA regulates genetically modified animals in consultation with Centers at the FDA responsible for regulating pharmaceuticals or other medical products derived from biopharm animals.[58] The FDA also has extra guidelines that apply to genetically modified animals that will be used in the manufacturing and testing of therapeutic products and xenotransplantation.[58] The FDA guidance documents do not establish legally binding laws and are viewed as recommendations, unless specific regulatory or statutory requirements are cited. Any relevant federal, State, or local laws and regulations must also be adhered to.[58]

Environmental Protection Agency

The EPA regulates substances with pesticide characteristics, looking at potential threats to human health or the environment.[4] They claim not to regulate the genetically modified plants, but the pesticides produced by the plants or properties that change the usage of applied pesticides . This includes; plants engineered to produce resistance to herbicides (e.g Roundup Ready), plants that produce their own pesticides (e.g BT) and virus resistant plants. Authority to regulate the pesticide properties in genetically modified organisms was granted in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). The EPA published regulations in 1994 and begun acting on them in 1995. In 1994 they proposed the exemption of three categories of genetically modified plants under their regulation. These were plants where the genetic material originated in sexually compatible plants (cisgenic), plants that used physical barriers to prevent the target pest from attaching itself, and plants expressing viral coat proteins to protect against virus infection.[4] In 2001, rules regarding exemption of cisgenic plants had been finalised. The other two proposed exemptions were still under review in 2010.

The EPA evaluated each submission on a case-by-case basis. The EPA assesses data concerning the characterisation of the end-product of the engineered organism (presently all plants evaluated produce proteins), as well as data on mammalian toxicity, effects on non-target organisms and environmental metabolism.[4] For Bt products the producer must also supply an insect resistance management program. For herbicide resistant plants the EPA co-ordinates with the USDA and FDA, but does not regulate the plant itself. Instead it regulates the herbicide and its use on the new cultivar.[4] The EPA examines the construct used to transform the plant and the biology of recipient plant. The sequence of the resulting protein must be described, expression pattern and intencity verified and any modifications to the protein reported. The EPA considers the potential allergenicity of the product, issues surrounding gene flow into wild species, possible effects on non-target organisms, likelihood of it persisting in the environment and the potential for insect resistance developing when assessing submissions.[4]

Oceania

Australia

Genetic engineering in Australia was originally (since 1987) overseen by the Genetic Manipulation Advisory Committee, before the Office of the Gene Technology Regulator (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.[59][60] 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.[61]

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.[62] GM canola was approved in 2003[63] and was first grown in 2008.[64] 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.[61] 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.[62] 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.[62] Trials of GM canola were carried out in 2003 and in 2010 the Western Australian governemnt allowed the commercialisation of GM canola.[65] South Australia and Tasmania extended their moratoriums on all genetically modified crops until 2019 and 2014.[66][62]

New Zealand

Part of a protest march held in 2003 voicing opposition to genetic engineering, making its way up Queen St, the main thoroughfare of Auckland.
See also: Genetic engineering in New Zealand

In New Zealand, no genetically modified food is grown and no medicines containing live genetically-modified organisms have been approved for use.[67] 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 organisms (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 brassicas have attracted negative public reaction.[68][69]

Labeling

One of the key issues concerning regulators is whether GM products should be labeled. Labeling can be mandatory up to a threshold level (which varies between countries) or voluntary. A study investigating voluntary labeling in South Africa found that 31% of products labeled as GMO-free had a GM content above 1.0%.[70]

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  60. ^ Rosemary Polya (17 October 2008). "Chronology of genetic engineering regulation in Australia: 1953–2008". Commonwealth of Australia: Science, Technology, Environment and Resources Section. {{cite web}}: |access-date= requires |url= (help); Missing or empty |url= (help)
  61. ^ a b Agriculture - Department of Primary Industries
  62. ^ a b c d http://www.afaa.com.au/pdf/IssuePaper5-GE_free_zones.pdf
  63. ^ "GM canola gets the green light". The Sydney Morning Herald. 2003-04-01.
  64. ^ [http://www.grdc.com.au/director/events/groundcover?item_id=67278EF9D750B353D5562DE39DD1DBFF&article_id=7D2BC2C9D63DBC44598EDDA91EF44F8E GRDC - Australia�s first GM canola crop comes off]
  65. ^ "WA approves GM canola". The Sydney Morning Herald. 2010-01-25.
  66. ^ Crothers, Lindy (29 June 2011) Australia, Agricultural Biotechnology Annual, 2011 USDA Foreign Agricultural Service, Global Agricultural Information Network Report Number AS 1120, Retrieved 29 September 2011
  67. ^ Genetically modified medicines and food New Zealand Ministry for the Environment
  68. ^ "Rotorua GE Tree Trial Remains Environment Threat". Soil and Health Association. 2008-03-17. Retrieved 2009-01-23.
  69. ^ Williams, David (2009-01-20). "GE activists call for trials to be ended". The Press. Retrieved 2009-01-27.
  70. ^ Attention: This template ({{cite doi}}) is deprecated. To cite the publication identified by doi:10.1016/j.foodchem.2008.06.050, please use {{cite journal}} (if it was published in a bona fide academic journal, otherwise {{cite report}} with |doi=10.1016/j.foodchem.2008.06.050 instead.


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