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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]

By continent

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]

South America

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.

Europe

See also: Genetic engineering in Europe

The European Union (EU) has possibly the most stringent GMO regulations in the world.[20] 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.[20] 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.[21]

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[22] and was grown in Germany, Sweden and the Czech Republic that year.[23] 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.[24] 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).[20] 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.[24]

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.[25] 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.[20] 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.[20]

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).[26] Smaller amounts were produced in the Czech Republic, Slovakia, Portugal, Romania and Poland.[26] 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.[27] 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.[28] Poland has also tried to institute a ban, with backlash from the European Commission.[29] Bulgaria effectively banned cultivation of genetically modified organisms on March 18, 2010.[30]

France

France adopted the EU laws on growing GMOs in 2007[31] and were fined €10 million by the European Court of Justice for the six year delay in implementing the laws.[32] 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.[33] 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.[34] 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".[35] 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.[20][36]

Germany

In April 2009 German Federal Minister Ilse Aigner announced an immediate halt to cultivation and marketing of MON810 maize under the safeguard clause.[37] The ban was based on "expert opinion" that suggested there was reasonable grounds to believe that MON810 maize presents a danger to the environment.[38] 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.[39]

North America

See also: Genetic engineering in the United States

The USA is the largest commercial grower of genetically modified crops in the world.[26] 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.[40]

Mainland Canada is one of the world's largest producers of GM canola[41] and also grows GM maize, soybean and sugarbeet.[8] Health Canada, under the Food and Drugs Act, and the Canadian Food Inspection Agency[42] 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.[43] 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.[44]

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.[45] 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.[46] Mexico is the center of diversity for maize and concerns have been raised about the impact genetically modified maize could have on local strains.[47][48]

Oceania

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.[49][50] 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.[51]

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.[52] GM canola was approved in 2003[53] and was first grown in 2008.[54] 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.[51] 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.[52] 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.[52] Trials of GM canola were carried out in 2003 and in 2010 the Western Australian governemnt allowed the commercialisation of GM canola.[55] South Australia and Tasmania extended their moratoriums on all genetically modified crops until 2019 and 2014.[56][52]

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.[57] 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.[58][59]

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%.[60]

References

  1. ^ Berg P, Baltimore D, Boyer HW, Cohen SN, Davis RW, Hogness DS, Nathans D, Roblin R, Watson JD, Weissman S, Zinder ND (1974). "Letter: Potential biohazards of recombinant DNA molecules" (PDF). Science. 185 (4148): 303. doi:10.1126/science.185.4148.303. PMID 4600381.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  2. ^ Berg, P., Baltimore, D., Brenner, S., Roblin, R. O., and Singer, M. F. (1975). "Summary Statement of the Asilomar Conference on Recombinant DNA Molecules". Proc. Nat. Acad. Sci. USA. 72 (6): 1981–1984. doi:10.1073/pnas.72.6.1981. PMC 432675. PMID 806076.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  3. ^ Hutt, P.B. (1978). "Research on recombinant DNA molecules: the regulatory issues". South Calif Law Rev. 51 (6): 1435–50. PMID 11661661.
  4. ^ a b c Attention: This template ({{cite doi}}) is deprecated. To cite the publication identified by doi:10.1111/j.1467-7652.2007.00300.x, please use {{cite journal}} (if it was published in a bona fide academic journal, otherwise {{cite report}} with |doi=10.1111/j.1467-7652.2007.00300.x instead.
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  7. ^ Transgenic harvest Editorial, Nature 467 , pages 633–634, 07 October 2010, doi:10.1038/467633b, Retrieved 9 November 2010
  8. ^ a b c Slides & Tables : Global Status of Commercialized Biotech/GM Crops: 2010 - ISAAA Brief 42-2010 | ISAAA.org
  9. ^ AgBioForum 10(3): Biofortified Foods and Crops in West Africa: Mali and Burkina Faso
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  11. ^ Denge, Mark and Gachenge, Beatrice (4 July 2011) Kenya approves law to allow GM crops Reuters Africa, Retrieved 9 November 2011
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  14. ^ a b Attention: This template ({{cite doi}}) is deprecated. To cite the publication identified by doi:10.1146/annurev-ento-120709-144810, please use {{cite journal}} (if it was published in a bona fide academic journal, otherwise {{cite report}} with |doi=10.1146/annurev-ento-120709-144810 instead.
  15. ^ AgBioForum 5(4): Agricultural Biotechnology Development and Policy in China
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  17. ^ "Govt says no to Bt brinjal for now". The Times of India. February 9, 2010. Retrieved February 9, 2010.
  18. ^ a b http://www.eurofins.com/media/11753/dcontri.pdf
  19. ^ Argentina poised to update seed law-Argentina, seed, GM, crop, biotech
  20. ^ a b c d e f Attention: This template ({{cite doi}}) is deprecated. To cite the publication identified by doi:10.1016/j.plantsci.2009.12.005, please use {{cite journal}} (if it was published in a bona fide academic journal, otherwise {{cite report}} with |doi=10.1016/j.plantsci.2009.12.005 instead.
  21. ^ European Commission. "Food Safety: From the farm to the fork (What are the National safeguard measures)". EUROPA.
  22. ^ "European Commission approves Amflora starch potato - BASF - The Chemical Company - Corporate Website". BASF. Retrieved 2010-09-24.
  23. ^ Scientific background report AMFLORA potato VIB (Flemish Institute for biotechnology), Belgium, Retrieved 20 October 2010
  24. ^ a b GMO Safety. "New coexistence - Guidelines in the EU: Cultivation bans are now permitted".
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  26. ^ a b c Clive James (2009). "ISAAA Brief 41-2009: Executive Summay: Global Status of Commercialized Biotech/GM Crops The first fourteen years, 1996 to 2009".
  27. ^ Elisabeth Rosenthal (July 24, 2007). "A Genetically Modified Potato, Not for Eating, Is Stirring Some Opposition in Europe". The New York Times.
  28. ^ "Germany joins ranks of anti-GMO countries". EurActiv. Retrieved 2010-03-08.
  29. ^ "EU lawyers take action against Poland over GMO ban | Green Business | Reuters". Uk.reuters.com. 2008-01-31. Retrieved 2010-03-08.
  30. ^ "Bulgaria parliament bans GMO crops to soothe fears". Reuters. 2010-03-18.
  31. ^ Sybille de La Hamaide (Tue Mar 20, 2007). "France adopts disputed EU laws on GMO crop growing". Reuters. {{cite news}}: Check date values in: |date= (help)
  32. ^ Zoë Casey (09.12.2008). "France fined over GM law". {{cite web}}: Check date values in: |date= (help)
  33. ^ (AFP) – Feb 8, 2008 (2008-02-08). "AFP: French GM ban infuriates farmers, delights environmentalists". Afp.google.com. Retrieved 2010-03-08.{{cite web}}: CS1 maint: multiple names: authors list (link) CS1 maint: numeric names: authors list (link)
  34. ^ GMO Compass. "Maize MON 810: France triggers safeguard clause".
  35. ^ GMO Compass. "EFSA: ban on cultivating MON810 maize in France is unfounded".
  36. ^ Caroline Scott-Thomas (30-Nov-2009). "France defines GMO-free labelling threshold". {{cite web}}: Check date values in: |date= (help)
  37. ^ Thorsten Severin and Michael Hogan (2009-04-14). "Germany to ban cultivation of GMO maize-Minister". Reuters. Retrieved 2010-03-08.
  38. ^ GMO compass. "German ban on MON810 maize: will the courts now decide?".
  39. ^ Attention: This template ({{cite doi}}) is deprecated. To cite the publication identified by doi:10.1007/s11248-009-9297-5, please use {{cite journal}} (if it was published in a bona fide academic journal, otherwise {{cite report}} with |doi=10.1007/s11248-009-9297-5 instead.
  40. ^ Attention: This template ({{cite doi}}) is deprecated. To cite the publication identified by doi:10.1007/s10460-008-9176-3, please use {{cite journal}} (if it was published in a bona fide academic journal, otherwise {{cite report}} with |doi=10.1007/s10460-008-9176-3 instead.
  41. ^ GMO Compass Rapeseed July 27, 2010. Retrieved August 6, 2010.
  42. ^ Canadian Food Inspection Agency - Regulating Agricultural Biotechnology
  43. ^ The Regulation of Genetically Modified Foods
  44. ^ Making the Market "Safe" for GM Foods: The Case of the Canadian Biotechnology Advisory Committee | Prudham | Studies in Political Economy
  45. ^ Mexico approves planting and sale of GM crops - SciDev.Net
  46. ^ Mexico: controlled cultivation of genetically modified maize
  47. ^ Warning issued on GM maize imported to Mexico - SciDev.Net
  48. ^ GM maize found ‘contaminating’ wild strains - SciDev.Net
  49. ^ "Welcome to the Office of the Gene Technology Regulator Website". Office of the Gene Technology Regulator. Retrieved 25 March 2011.
  50. ^ 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)
  51. ^ a b Agriculture - Department of Primary Industries
  52. ^ a b c d http://www.afaa.com.au/pdf/IssuePaper5-GE_free_zones.pdf
  53. ^ "GM canola gets the green light". The Sydney Morning Herald. 2003-04-01.
  54. ^ [http://www.grdc.com.au/director/events/groundcover?item_id=67278EF9D750B353D5562DE39DD1DBFF&article_id=7D2BC2C9D63DBC44598EDDA91EF44F8E GRDC - Australia�s first GM canola crop comes off]
  55. ^ "WA approves GM canola". The Sydney Morning Herald. 2010-01-25.
  56. ^ 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
  57. ^ Genetically modified medicines and food New Zealand Ministry for the Environment
  58. ^ "Rotorua GE Tree Trial Remains Environment Threat". Soil and Health Association. 2008-03-17. Retrieved 2009-01-23.
  59. ^ Williams, David (2009-01-20). "GE activists call for trials to be ended". The Press. Retrieved 2009-01-27.
  60. ^ 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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