Skip to main content
SpringerLink
Log in

Commercialisation of GM Crops : Comparison of Regulatory Frameworks

  • Reference work entry
Encyclopedia of Sustainability Science and Technology

  • 268 Accesses

Definition of the Subject

This contribution describes and compares the regulation of GMOs and the underpinning legislative frameworks in selected countries from around the world. It also includes a description of the relevant international agreements related to biosafety and a description of the main characteristics and attributes of a modern biosafety regulatory framework in this area.

Introduction

The rapid development and deployment of modern biotechnology in the last decades have made biosafety a critical issue. Although modern biotechnology has the potential of benefiting agricultural interests in developing countries as well as overall human welfare, living modified organisms (LMOs) resulting from modern biotechnology or genetically modified organisms (GMOs) remain a source of concern with regard to the conservation and sustainable use of biodiversity, as well as to human health. The perceived risks, which relate to...

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 6,999.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Hardcover Book
USD 549.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Abbreviations

Cartagena protocol on biosafety (CPB):

The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is an international agreement which aims to ensure the safe handling, transport, and use of living modified organisms resulting from modern biotechnology that may have adverse effects on biological diversity, taking also into account risks to human health. It was adopted on 29 January 2000 and entered into force on 11 September 2003 (for full text, see http://bch.cbd.int/protocol/text/).

Convention on biological diversity (CBD):

The objectives of this Convention are the conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding (for full text, see http://www.cbd.int/convention/text/).

Convention/protocol/treaty:

A treaty is an agreement in written form between nation-states (or international agencies, such as the United Nations, that have been given treaty-making capacity by the states that created them) that is intended to establish a relationship governed by International Law. It may be contained in a single instrument or in two or more related instruments such as an exchange of diplomatic notes. Various terms have been used for such an agreement, including treaty, convention, protocol, declaration, charter, covenant, pact, act, statute, exchange of notes, agreement, modus vivendi (“manner of living” or practical compromise), and understanding. The particular designation does not affect the agreement’s legal character.

Genetically modified/genetically engineered/transgenic organisms:

Organisms, such as plants, animals, and microorganisms (with the exception of human beings), in which the genetic material (DNA) has been altered in such a way that does not occur naturally by mating and/or natural recombination (The terms “genetically modified” (GM), “transgenic,” “genetically engineered” (GE), and “living modified” (LM) are used in different legal instruments around the world. It is useful (and deliberate) in this document to essentially use them interchangeably).

Living modified organism (LMO):

Any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology (according to the CPB).

Modern biotechnology:

The application of [1] in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct introduction of nucleic acid into cells or organelles, or [2] fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection (according to the CPB).

Bibliography

  1. Cordonier Segger M-C, Perron-Welch F, Frison (eds) (2012) Introduction. In: Legal aspects of implementing the Cartagena protocol: Biosafety becomes binding. Cambridge University Press, UK

    Google Scholar 

  2. James C (2010) Global status of commercialized biotech/GM crops: 2010. ISAAA Brief No. 42. International service for the acquisition of agri-biotech applications (ISAAA), New York, USA. http://www.isaaa.org/resources/publications/briefs/42/executivesummary/pdf/Brief42-ExecutiveSummary-English.pdf

  3. James C (2009) Global status of commercialized biotech/GM crops: 2009. The first fourteen years, 1996 to 2009. ISAAA Brief No. 41. International service for the acquisition of agri-biotech applications (ISAAA), New York, USA. http://www.isaaa.org/resources/publications/briefs/41/executivesummary/pdf/Brief41-ExecutiveSummary-English.pdf

  4. Falck-Zepeda J, Cavalieri A, Zambrano P (2008) Delivering genetically engineered crops to poor farmers. Recommendations for improved biosafety regulations in developing countries. IFPRI Policy Brief 14. Washington DC, USA. http://www.ifpri.org/sites/default/files/publications/bp014.pdf

  5. Zarrilli S (2005) International trade in GMOs and GM products: National and multilateral legal frameworks. Policy issues in international trade and commodities study series, 29. United Nations conference on trade and development, New York, USA and Geneva, Switzerland. http://www.eldis.org/static/DOC18565.htm

  6. Mugabe J (2003) International trends in modern biotechnology: Entry by and implications for African countries. ATPS special paper series No. 15, African technology policy studies network (ATPS), Nairobi, Kenya. http://www.atpsnet.org/content/files/documents/SpecialPaperSeries15.pdf

  7. Anderson K, Valenzuela E, Jackson LA (2006) Recent and prospective adoption of genetically modified cotton: a global CGE analysis of economic impacts. World Bank policy research working paper 3917. http://www-wds.worldbank.org/external/default/WDSContentServer/IW3P/IB/2006/05/10/000016406_20060510092736/Rendered/PDF/wps3917.pdf

  8. US Department of Agriculture (2006) Argentina. Biotechnology Annual Report 2006. Foreign agricultural service GAIN Report AR6027, Washington DC, USA. http://www.fas.usda.gov/gainfiles/200610/146249372.pdf

  9. Trigo EJ, Cap EJ (2003) The impact of the introduction of transgenic crops in Argentinean agriculture. J Agro-biotechnol Manage Econ (AgBioForum) 6(3):87–94, http://www.agbioforum.org/v6n3/v6n3a01-trigo.pdf

  10. James C (2006) Global Status of Commercialized Biotech/GM Crops: 2006. ISAAA Brief No. 35. ISAAA, New York, USA. http://www.isaaa.org/resources/publications/briefs/35/executivesummary/pdf/Brief35-ExecutiveSummary-English.pdf

  11. Nap J, Metz P, Escaler M, Conner A (2003) The release of genetically modified crops into the environment. Part 1. Overview of current status and regulations. Plant J 33(1):1–18

    Article  Google Scholar 

  12. UNEP-GEF Biosafety Unit (2006) A comparative analysis of experiences and lessons from the UNEP-GEF biosafety projects. United Nations Environment Programme (UNEP)-Global Environment Facility (GEF), Geneva, Switzerland. http://www.unep.ch/biosafety/development/devdocuments/UNEPGEFBiosafety_comp_analysisDec2006.pdf

  13. Burachik M, Traynor P (2002) Analysis of a national biosafety system: regulatory policies and procedures in Argentina. ISNAR Country Report no. 63, International Service for National Agricultural Research, The Hague, The Netherlands. ftp://ftp.cgiar.org/isnar/Publicat/cr63.pdf

  14. BATS (2003) Genetically modified (GM) crops: molecular and regulatory details. Version 2. http://www.bats.ch/gmo-watch/GVO-report140703.pdf

  15. Baumüller H (2004) Domestic import regulations for genetically modified organisms and their compatibility with WTO rules. Asian Biotechnol Dev Review 6(3):33–42. http://www.ris.org.in/images/RIS_images/pdf/abdr_July044.pdf

  16. SAGPyA (2003) Resolution No. 39/03. Annex. Application for permit to release genetically modified plant organisms into the environment. Secretariat of agriculture, livestock, fisheries and food (SAGPyA), Argentina. http://www.sagpya.mecon.gov.ar/new/0-0/programas/biotecnologia/resolutionn39annex.pdf

  17. SAGPyA (2002) Resolution No. 412/02. Requisitos para la evaluación de la aptitud alimentaria de los de organismos genéticamente modificados. Secretariat of agriculture, livestock, fisheries and food (SAGPyA), Argentina. http://www.sagpya.mecon.gov.ar/new/0-0/programas/biotecnologia/marco_regulatorio/028_412.php

  18. Macdonald P, Yarrow S (2003) Regulation of Bt crops in Canada. J Invertebr Pathol 83:93–99

    Article  Google Scholar 

  19. Finstad K, Bonfils A-C, Shearer W, Macdonald P (2007) Trees with novel traits in Canada: regulations and related scientific issues. Tree Genet Genomes 3:135–139

    Article  Google Scholar 

  20. Agriculture and Agri-Food Canada (1994) Regulatory directive Dir94-08: Assessment criteria for determining environmental safety of plants with novel traits. Ottawa, Canada. http://www.inspection.gc.ca/english/plaveg/bio/dir/dir9408e.shtml#ch1

  21. Industry Canada (1998) The federal regulatory framework for biotechnology (1993), Annex C of the 1998 Canadian biotechnology strategy: an ongoing renewal process. http://www.biostrategy.gc.ca/CMFiles/1998strategyE49RAI-8312004-5365.pdf

  22. CFIA (2005) Long term testing/substantial equivalence. http://www.inspection.gc.ca/english/sci/biotech/reg/equive.shtml

  23. Health Canada (2006) Guidelines for the safety assessment of novel foods. Ottawa, Canada. http://www.hc-sc.gc.ca/fn-an/alt_formats/hpfb-dgpsa/pdf/gmf-agm/guidelines-lignesdirectrices_e.pdf

  24. CFIA (2006) Directive 96–13: import permit requirements for plants with novel traits (including transgenic plants), and their products. http://www.inspection.gc.ca/english/plaveg/protect/dir/d-96-13e.pdf

  25. Huang J, Wang Q (2002) Agricultural biotechnology development and policy in China. J Agro-biotechnol Manag Econ (AgBioForum) 5(4):122–135, http://www.agbioforum.org/v5n4/v5n4a01-huang.htm

  26. Karplus V, Deng XW (2008) Agricultural biotechnology in China: origins and prospects. Springer, New York

    Google Scholar 

  27. Chen ZL (2006) Chinese agricultural biotechnology in the field. In: Agricultural biotechnology: economic growth through new products, partnerships and workforce development, NABC Report 18. National agricultural biotechnology council (NABC), Ithaca, USA. http://nabc.cals.cornell.edu/pubs/nabc_18/NABC18_Chen.pdf

  28. Pray CE, Naseem A (2007) Supplying crop biotechnology to the poor: opportunities and constraints. J Dev Stud 43(1):192–217

    Article  Google Scholar 

  29. Pray C, Ramaswami B, Huang J, Hu R, Bengali P, Zhang H (2006) Costs and enforcement of biosafety regulations in India and China. Int J Technol Globalisation 2(1/2):137–157

    Google Scholar 

  30. Wang Y, Johnston S (2007) The status of GM rice R&D in China. Nat Biotechnol 25(7):717–718

    Article  CAS  Google Scholar 

  31. Wang Y, Johnston S (2007) Review on GM rice risk assessment in China. UNU-IAS Working Paper No. 152. United Nations University-Institute of Advanced Studies, Yokohama, Japan. http://www.ias.unu.edu/resource_centre/152YanqingWang.pdf

  32. US Department of Agriculture (2004) China, Peoples republic of: food and agricultural import regulations and standards (FAIRS) Country Report 2004. Foreign Agricultural Service GAIN Report CH4028, Washington DC, USA. http://www.fas.usda.gov/gainfiles/200408/146107026.doc

  33. OECD (2011) Adapting agriculture to climate change: what role for biotechnology? ENV/EPOC/WPCID(2011)2, Working party on climate, Investment and Development, Environment Policy Committee, Environment Directorate, Organisation for Economic Co-operation and Development (OECD), Paris, France

    Google Scholar 

  34. US Department of Agriculture (2005) China, Peoples Republic of: Biotechnology Annual Report 2005. Foreign Agricultural Service GAIN Report CH5069, Washington DC, USA. http://www.fas.usda.gov/gainfiles/200601/146176661.pdf

  35. Foster M, Berry P, Hogan J (2003) Market access issues for GM products. Australian bureau of agricultural and resource economics (ABARE) eReport 03.13, Canberra, Australia. http://abareonlineshop.com/PdfFiles/PC12559.pdf

  36. Conner A, Glare T, Nap J (2003) The release of genetically modified crops into the environment. Part II. Overview of ecological risk assessment. Plant J 33:19–46

    Article  Google Scholar 

  37. König A, Cockburn A, Crevel RWR, Debruyne E, Grafstroem R, Hammerling U, Kimber I, Knudsen I, Kuiper HA, Peijnenburg AACM, Penninks AH, Poulsen M, Schauzu M, Wal JM (2004) Assessment of the safety of foods derived from genetically modified (GM) crops. Food Chem Toxicol 42:1047–1088

    Article  CAS  Google Scholar 

  38. GEAC (2010) Yearwise list of commercially released varieties of Bt cotton hybrids by GEAC. Genetic engineering approval committee (GEAC), Ministry of Environment and Forests, Government of India. http://igmoris.nic.in/files/Final_commercially_approved.pdf

  39. APCoAB (2006) Bt cotton in India – a status report. Asia-Pacific consortium on agricultural biotechnology (APCoAB), New Delhi, India. p 34. http://www.apcoab.org/documents/bt_cotton.pdf

  40. Damodaran A (2005) Re-engineering biosafety regulations in India: towards a critique of policy, law and prescriptions. Law Environ Develop J 1(1):1–16, http://www.lead-journal.org/content/05001.pdf

  41. Government of India (1989) Rules for the manufacture, use, import, export and storage of hazardous micro organisms genetically engineered organisms or cells. Ministry of Environment and Forests, Government of India. http://www.envfor.nic.in/legis/hsm/hsm3.html

  42. Government of India (1998) Revised guidelines for research in transgenic plants & guidelines for toxicity and allergenicity evaluation of transgenic seeds, plants and plant parts. Department of Biotechnology, Ministry of Science and Technology, Government of India. August 1998. http://dbtindia.nic.in/policy/guidelines_98.pdf

  43. US Department of Agriculture (2005) India biotechnology annual 2005. Foreign Agricultural Service GAIN Report IN5078, Washington DC, USA. http://www.fas.usda.gov/gainfiles/200507/146130314.pdf

  44. Indira A, Bhagavan MR, Virgin I (2005) Agricultural biotechnology and biosafety in India: expectations, outcomes and lessons. Stockholm Environment Institute, Sweden. http://www.agbios.com/docroot/articles/05-268-001.pdf

  45. Gupta A (2002) Ensuring “Safe use” of biotechnology: key challenges. Economic and Political Weekly, 6 July 2002, pp 2762–2769. http://www.epw.org.in/epw/uploads/articles/9705.pdf

  46. Chaturvedi S, Chawii L (2005) RIS-DP # 99. Research and information system for developing countries, New Delhi, India

    Google Scholar 

  47. National Commission on Farmers (2006) Fifth and final report. Ministry of Agriculture, Government of India. http://krishakayog.gov.in/revdraft.pdf

  48. Bhan MK (2007) BIO 2007, Boston, 9 May 2007. http://www.ciionline.org/news_new/newsMain09-05-2007_2.asp

  49. Department of Biotechnology and the Ministry of Environment and Forests (2008) Guidelines & standard operating procedures (SOP) for confined field trials of genetically engineered (GE) plants. Government of India. http://igmoris.nic.in/Guideline_index.htm

  50. Indian Council of Medical Research (2008) Guidelines for the safety assessment of foods derived from genetically engineered plants. New Dehli, India. http://igmoris.nic.in/files%5CCoverpage.pdf

    Google Scholar 

  51. Department of Biotechnology (2008) Protocols for food and feed safety assessment of GE crops. Ministry of Science and Technology, Government of India. http://igmoris.nic.in/files%5CCoverpage1.pdf

    Google Scholar 

  52. Indian Ministry of Agriculture (2006) Protection of plant varieties and farmers’ rights regulations, 2006. The Gazette of India: Extraordinary (Part II Sec. 3(i)), 7th December 2006, New Delhi, India. http://www.plantauthority.in/PDFile/Indgazette.pdf

  53. Secretary of Agriculture, the Republic of the Philippines (2001) Policy statement on modern biotechnology. http://www.ncbp.dost.gov.ph/downloads/PSMB.pdf

  54. Republic of the Philippines (1998) Republic Act No. 8435, Agriculture and Fisheries Modernization Act, 10 June 1998. http://www.da.gov.ph/agrilaws/ra/afma.pdf

  55. APCoAB (2005) Commercialization of Bt corn in the Philippines. A status report. Asia-Pacific consortium on agricultural biotechnology (APCoAB), New Dehli, India. p 41. http://www.apcoab.org/documents/bt_corn.pdf

  56. Yorobe JM Jr, Quicoy CB (2006) Economic impact of Bt corn in the Philippines. The Philippine Agric Sci 89(3):258–267

    Google Scholar 

  57. US Department of Agriculture (2005) Philippines Biotechnology Annual Report 2005. Foreign Agricultural Service GAIN Report RP5027, Washington DC, USA. http://www.fas.usda.gov/gainfiles/200507/146130361.pdf

  58. Republic of the Philippines (1990) Executive Order 430 Constituting the NCBP, 1990. Government of Republic of the Philippines. http://www.ncbp.dost.gov.ph/index.php?option=com_remository&Itemid=55&func=download&filecatid=25

  59. Manalo AJ, Ramon GP (2007) The cost of product development of Bt corn event MON810 in the Philippines. J Agro-biotechnol Manag Econ (AgBioForum) 10(1):19–32, http://www.agbioforum.org/v10n1/v10n1a03-manalo.pdf

  60. de Leon A, Manalo A, Cielo Guilatco F (2004) The cost implications of GM food labeling in the Philippines. http://www.bcp.org.ph/downloads/CostImplicationsofGMFoodLabelinginthePhilippines.pdf

  61. Department of Agriculture’s Administrative Order No. 8, s. 2002. Government of Republic of the Philippines. http://www.ncbp.dost.gov.ph/downloads/commercialization.pdf.

  62. Andanda AP (2006) Developing legal regulatory frameworks for modern biotechnology: the possibilities and limits in the case of GMOs. Afr J Biotechnol 5(15):1360–1369, http://academicjournals.org/ajb/PDF/pdf2006/3Aug/Andanda.pdf

  63. Department of Science and Technology (2001) National biotechnology strategy for South Africa. Government of the Republic of South Africa. http://www.dst.gov.za/publications/reports/dst_biotechnology_strategy.PDF

  64. Cloete TE, Nel LH, Theron J (2006) Biotechnology in South Africa. Trends Biotechnol 24(12):557–552

    Article  CAS  Google Scholar 

  65. van der Walt WJ (2006) South African GM crop adoption in 2006. African Crops News Service. Newsletter May 2006. http://www.africancrops.net/news/may06/gm-southafrica.htm

  66. US Department of Agriculture (2005) Republic of South Africa. Biotechnology Annual Report 2005. Foreign Agricultural Service GAIN Report SF5024, Washington DC, USA. http://www.fas.usda.gov/gainfiles/200512/146131662.pdf

  67. Government of the Republic of South Africa (1997) Genetically Modified Organisms Act (No. 15 of 1997), Government Gazette, vol 383, no. 18029. 23 May 1997. http://www.info.gov.za/acts/1997/act15.htm

  68. Government of the Republic of South Africa (2005) The GMO Amendment Bill. Government Gazette 27913, 26 August 2005. http://www.info.gov.za/gazette/bills/2005/b34-05.pdf

  69. Gouse M, Pray CE, Kirsten J, Schimmelpfennig D (2005) A GM subsistence crop in Africa: the case of Bt white maize in South Africa. Int J Biotechnol 7(1/2/3):84–94, http://inderscience.metapress.com/media/7hxdqlmumk0y0qgunm13/contributions/j/d/2/p/jd2pphettplpyg50.pdf

  70. RSA Department of Agriculture (2004) Guideline document for use by the advisory committee when considering proposals/applications for activities with genetically modified organisms. Government of the Republic of South Africa (RSA). http://www.nda.agric.za/docs/geneticresources/GuidelinesforAC-May2004.pdf

  71. RSA Guidelines. Public notification in terms of the Genetically Modified Organisms Act, 1997 (Regulation 6). Republic of South Africa (RSA). http://www.nda.agric.za/docs/geneticresources/publicnotice.pdf

  72. Bernauer T, Meins E (2003) Technological revolution meets policy and the market: explaining cross-national differences in agricultural biotechnology regulation. Eur J Polit Res 42:643–683

    Article  Google Scholar 

  73. US Office of Science and Technology Policy (1986) Coordinated framework for regulation of biotechnology, United States Federal Register, 51:23302, June 26, 1986. http://usbiotechreg.nbii.gov/Coordinated_Framework_1986_Federal_Register.html

  74. MacKenzie DJ (2000) International comparison of regulatory frameworks for food products of biotechnology. Prepared for the Canadian Biotechnology Advisory Committee Project Steering Committee on the Regulation of Genetically Modified Foods. http://www.cbac-cccb.ca/epic/internet/incbac-cccb.nsf/vwapj/InternatComparisons_MacKenzie.pdf/$FILE/InternatComparisons_MacKenzie.pdf

  75. US Department of Agriculture (2001) Economic issues in biotechnology. economic research service, Agriculture Information Bulletin no. 762, Washington DC, USA. http://www.ers.usda.gov/Publications/aib762/

  76. US Department of Agriculture (1987) Introduction of organisms and products altered or produced through genetic engineering which are plant pests or which there is reason to believe are plant pests, 7 CFR Parts 330 and 340. United States Federal Register 52(115), June 16 1987. http://www.aphis.usda.gov/brs/687rule.txt

  77. US Department of Agriculture (1997) Simplification of requirements and procedures for genetically engineered organisms and products, 7 CFR Part 340. United States Federal Register 62(85), May 2 1997. http://www.aphis.usda.gov/brs/pdf/r597rule.pdf

  78. US National Research Council (2000) Genetically modified pest-protected plants, science and regulations. National Research Council, National Academy, Washington DC, USA, pp 104–207. http://newton.nap.edu/catalog/9795.html#toc

  79. US Environmental Protection Agency (2001) Plant incorporated protectants. US Environmental Protection Agency, Washington DC, USA. http://www.epa.gov/pesticides/biopesticides/pips/index.htm

  80. US Environmental Protection Agency (2001) Plant-incorporated protectants, final rules and proposed rule, 40 CFR Parts 152 and 174. United States federal register 66(139), 19 July 2001. http://www.epa.gov/pesticides/biopesticides/pips/pip_rule.pdf

  81. Jaffe G (2012) Crafting national biosafety regulatory systems. In: Cordonier Segger M-C, Perron-Welch F, Frison (eds) Legal aspects of implementing the Cartagena protocol: Biosafety becomes binding. Cambridge University Press, UK

    Google Scholar 

  82. Secretariat of the Convention on Biological Diversity (2000) Cartagena Protocol on Biosafety to the Convention on Biological Diversity. Montreal, Canada. http://www.cbd.int/biosafety/protocol.shtml.

  83. Secretariat of the Convention on Biological Diversity (1992) Convention on biological diversity. Montreal, Canada. http://www.cbd.int/doc/legal/cbd-en.pdf

  84. Secretariat of the Convention on Biological Diversity (2000) Decision EMI/3. Adoption of the Cartagena protocol and interim arrangements. First extraordinary meeting (ExCOP 1), 22–23 Feb 1999, Cartagena, Colombia 1999, and Montreal, 24–29 Jan 2000. http://www.cbd.int/doc/meetings/cop/excop-01/official/excop-01-03-en.pdf

  85. Secretariat of the Convention on Biological Diversity (2003) The Cartagena protocol on biosafety: a record of the negotiations. Montreal, Canada. http://bch.cbd.int/database/attachment/?id=10886

  86. Secretariat of the Convention on Biological Diversity (2011) Cartagena protocol on biosafety ratification list. Montreal, Canada. http://www.cbd.int/doc/lists/cpb-ratifications.pdf

  87. Secretariat of the Convention on Biological Diversity (2011) Nagoya – Kuala lumpur supplementary protocol on liability and redress to the cartagena protocol on biosafety. Montreal, Canada. http://bch.cbd.int/database/attachment/?id=10898

  88. Cabrera Medaglia J (in press) Biosafety regulatory frameworks in the Americas. In: Cordonier Segger M-C, Perron-Welch F, Frison (eds) Legal aspects of implementing the Cartagena protocol: Biosafety becomes binding. Cambridge University Press, UK

    Google Scholar 

  89. WTO (1994) Marrakesh agreement establishing the world trade organization. Final Act of the 1986–1994 uruguay round of trade negotiations. World Trade Organization (WTO), Geneva, Switzerland. http://www.wto.org/english/docs_e/legal_e/04-wto_e.htm

  90. WTO (1994) Agreement on the application of sanitary and phytosanitary measures (SPS Agreement) (Article 1 – 14). Final Act of the 1986 –1994 uruguay round of trade negotiations. Annex 1a, Multilateral agreements on trade in goods. World Trade Organization (WTO), Geneva, Switzerland. http://www.wto.org/english/docs_e/legal_e/15sps_01_e.htm

  91. WTO (1994) Agreement on technical barriers to trade (TBT Agreement) (Article 1 – 15). Final Act of the 1986 – 1994 Uruguay round of trade negotiations. Annex 1a, multilateral agreements on trade in goods. World Trade Organization (WTO), Geneva, Switzerland. http://www.wto.org/english/docs_e/legal_e/17-tbt_e.htm

  92. WTO (1994) Agreement on trade-related aspects of intellectual property rights (TRIPS Agreement). Final Act of the 1986 –1994 uruguay round of trade negotiations. Annex 1, Multilateral agreements on trade in goods. World Trade Organization (WTO), Geneva, Switzerland. http://www.wto.org/english/docs_e/legal_e/27-trips_01_e.htm

  93. WTO (1994) Understanding on rules and procedures governing the settlement of disputes. Final Act of the 1986 – 1994 uruguay round of trade negotiations. Annex 2, multilateral agreements on trade in goods. World Trade Organization (WTO), Geneva, Switzerland. http://www.wto.org/english/docs_e/legal_e/28-dsu_e.htm

  94. WTO (1994) General agreement on tariffs and trade. Final act of the 1986 –1994 uruguay round of trade negotiations. Annex 1A, multilateral agreements on trade in goods. World Trade Organization (WTO), Geneva, Switzerland. http://www.wto.org/english/docs_e/legal_e/06-gatt_e.htm

  95. CAC (1999) Summary and conclusions. Report of the twenty-third session, FAO headquarters, Rome, Italy, 28 June–3 July 1999. Codex Alimentarius Commission (CAC) of the World Health Organisation (WHO), Geneva, Switzerland, pp 124. www.codexalimentarius.net/download/report/518/Al99_37e.pdf

  96. CAC (2003) Alinorm 03/41. Report of the twenty-sixth session, FAO headquarters, Rome, Italy, 30 June–7 July 2003. Codex Alimentarius Commission (CAC) of the World Health Organisation (WHO), Geneva, Switzerland. ftp://ftp.fao.org/codex/alinorm03/al03_41e.pdf

  97. CAC (2003) Principles for the risk analysis of foods derived from modern biotechnology. CAC/GL 44–2003. Amended in 2008. Codex Alimentarius Commission (CAC) of the World Health Organisation (WHO), Geneva, Switzerland. http://www.codexalimentarius.net/download/standards/10007/CXG_044e.pdf

  98. CAC (2003) Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA plants. CAC/GL 45–2003. Codex Alimentarius Commission (CAC) of the World Health Organisation (WHO), Geneva, Switzerland. http://www.codexalimentarius.net/download/standards/10021/CXG_045e.pdf

  99. CAC (2003) Guideline for the conduct of food safety assessment of foods produced using recombinant DNA microorganisms. CAC/GL 46–2003. Amended in 2008. Codex Alimentarius Commission (CAC) of the World Health Organisation (WHO), Geneva, Switzerland. http://www.codexalimentarius.net/download/standards/10025/CXG_046e.pdf

  100. CAC (2008) Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA animals. CAC/GL 68–2008. Codex Alimentarius Commission (CAC) of the World Health Organisation (WHO), Geneva, Switzerland. http://www.codexalimentarius.net/download/standards/11023/CXG_068e.pdf

  101. CAC (2008) Alinorm 08/31/REP. Report of the thirty-first session, FAO headquarters, Rome, Italy, 30 June–4 July 2008. Codex Alimentarius Commission (CAC) of the World Health Organisation (WHO), Geneva, Switzerland. http://www.codexalimentarius.net/download/report/698/al31REPe.pdf

  102. CAC (2007) Alinorm 07/30/22. Report of the thirty-fifth session of the Codex committee on food labelling, Ottawa, Canada, 30 April–4 May 2007. Codex Alimentarius Commission (CAC) of the World Health Organisation (WHO), Geneva, Switzerland. http://www.codexalimentarius.net/download/report/682/al30_22e.pdf

  103. CAC (2007) Working principles for risk analysis for food safety for application by governments. CAC/GL 62–2007. Codex Alimentarius Commission (CAC) of the World Health Organisation (WHO), Geneva, Switzerland. http://www.codexalimentarius.net/download/standards/10751/CXG_062e.pdf

  104. FAO (1997) International plant protection convention. New revised text approved by the FAO conference at its 29th session, November 1997. Food and Agriculture Organization of the United Nations (FAO), Rome, Italy. https://www.ippc.int/file_uploaded//publications/13742.New_Revised_Text_of_the_International_Plant_Protectio.pdf

  105. Secretariat of the IPPC (2004) Pest risk analysis for quarantine pests including analysis of environmental risks and living modified organisms. International plant protection convention (IPPC), Food and Agriculture Organization of the United Nations, Rome, Italy. https://www.ippc.int/file_uploaded/1146658377367_ISPM11.pdf

  106. OIRSA (2000) Eighth meeting of the executive committee, 31 March 2000. Organismo Internacional Regional de Sanidad Agropecuaria (OIRSA), San Salvador, El Salvador. http://www.oirsa.org/documentos/actasyresoluciones/resoluciones/xiii-31-mar.-2000-recomendaciones.pdf

  107. CGRFA (2007) Code of conduct on biotechnology as it relates to genetic resources for food and agriculture. Commission on Genetic Resources for Food and Agriculture (CGRFA), Food and Agriculture Organization of the United Nations, Rome, Italy. http://www.fao.org/ag//CGRFA/biocode.htm

  108. UNECE (2001) UN recommendations on the transport of dangerous Goods – model regulations. Twelfth revised edition. United Nations Economic Commission for Europe (UNECE), Geneva, Switzerland. http://www.unece.org/trans/danger/publi/unrec/12_e.html

  109. UNECE (1998) Convention on access to information, public participation in decision-making and access to justice in environmental matters (Aarhus Convention), United Nations Economic Commission for Europe (UNECE), Geneva, Switzerland. http://www.unece.org/env/pp/welcome.html

  110. UNEP-GEF Biosafety Unit (2003) Guide for the implementation of national biosafety frameworks. United Nations Environment Programme (UNEP)-Global Environment Facility (GEF) Projects on Implementation of national biosafety frameworks, Geneva, Switzerland. http://www.unep.org/biosafety/Documents/Impl.Guide-RegReg.pdf

  111. McLean MA, Frederick RJ, Traynor P, Cohen JI, Komen J (2002) A conceptual framework for implementing biosafety: linking policy, capacity and regulation. Briefing paper No. 47, Program for biosafety systems, International Food Policy Research Institute, Washington DC, USA. http://programs.ifpri.org/isnararchive/publications/pdf/bp-47.pdf

  112. Burachik M, Traynor P (2002) An analysis of a national biosafety system: regulatory policies and procedures in Argentina. Country Report No. 63, Program for biosafety systems, International Food Policy Research Institute, Washington DC, USA. http://programs.ifpri.org/isnararchive/publications/pdf/cr63.pdf

  113. Jaffe G (2004) Regulating transgenic crops: a comparative analysis of different regulatory processes. Transgenic Res 13(1):5–19

    Article  CAS  Google Scholar 

  114. UNEP-GEF Biosafety Unit (2005) Toolkit for the development project, phase 3 – Drafting the NBF. Part I: Formulation of the regulatory regime, project on development of national biosafety frameworks. United Nations Environment Programme (UNEP) – Global Environment Facility (GEF), Geneva, Switzerland. http://www.unep.org/biosafety/Documents/Drafting_the_NBF_Formulation_of_the_regulatory_regime.pdf

  115. Garforth K (2005) When biosafety becomes binding. In: Cordonier Segger M-C, Weeramantry CG (eds) Sustainable justice: reconciling economic, social and environmental law. Martinus Nijhoff, Boston

    Google Scholar 

  116. Pew Initiative on Food and Biotechnology (2004) Issues in the regulation of genetically engineered plants and animals. Washington, DC, USA. http://www.pewtrusts.org/uploadedFiles/wwwpewtrustsorg/Reports/Food_and_Biotechnology/food_biotech_regulation_0404.pdf

  117. OECD (1986) Recombinant DNA safety considerations: safety considerations for industrial, agricultural and environmental applications of organisms derived by recombinant DNA techniques. Organisation for Economic Co-operation and Development (OECD), Paris, France. http://www.oecd.org/dataoecd/45/54/1943773.pdf

  118. US National Research Council (1987) Introduction of recombinant DNA-engineered organisms into the environment, Key Issues. White Paper. National Academies Press, Washington DC, USA

    Google Scholar 

  119. US National Research Council (2004) Safety of genetically engineered foods. National Academies Press, Washington DC, http://www.nap.edu/books/0309092094/html/

Download references

Author information

Authors and Affiliations

  1. Biosafety Unit, International Centre for Genetic Engineering and Biotechnology (ICGEB), Padriciano 99, 34149, Trieste, Italy

    Dr. Wendy Craig (Professor Environmental Law)

  2. ICGEB, Plant Biology: Plant Transformation Group, ICGEB Campus, Aruna Asaf Ali Marg, 110 067, New Delhi, India

    Dr. Siva Reddy Vanga

  3. Centre for International Sustainable Development Law, Lead Counsel on Biodiversity and Biosafety, Montreal Canada, University of Costa Rica, 3644 Peel Street, 317-3015, San Rafael de Heredia, Costa Rica

    Dr. Jorge Cabrera Medaglia

Authors
  1. Dr. Wendy Craig
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Dr. Siva Reddy Vanga
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Dr. Jorge Cabrera Medaglia
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Wendy Craig .

Editor information

Editors and Affiliations

  1. RAMTECH LIMITED, Larkspur, CA, USA

    Robert A. Meyers

Rights and permissions

Reprints and permissions

Copyright information

© 2012 Springer Science+Business Media, LLC

About this entry

Cite this entry

Craig, W., Vanga, S.R., Cabrera Medaglia, J. (2012). Commercialisation of GM Crops : Comparison of Regulatory Frameworks. In: Meyers, R.A. (eds) Encyclopedia of Sustainability Science and Technology. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-0851-3_837

Download citation

Publish with us

Policies and ethics

Search

Navigation