Molecular Breeding

, Volume 23, Issue 1, pp 99–112 | Cite as

Calling the tunes on transgenic crops: the case for regulatory harmony

  • Koreen Ramessar
  • Teresa Capell
  • Richard M. Twyman
  • Hector Quemada
  • Paul Christou
Article

Abstract

Genetically modified (GM) crops are now grown commercially in 23 countries, with another 29 granting approval for import and release into the environment. Despite the socio-economic and environmental benefits of the technology, further development is being hampered by differences in national regulatory frameworks relating to research, biosafety, and to the trade and use of GM crops. The biosafety regulations in different countries are based on five main international instruments that influence the development of national biosafety systems in terms of field trial permit requirements, risk assessment criteria, labeling, traceability, transparency, public awareness, post-monitoring and import regulations. The global harmonization of data collection, testing procedures and information exchange would help to remove artificial trade barriers, expedite the adoption of GM crops, foster technology transfer and protect developing countries from exploitation, instilling confidence and bringing the benefits of GM products to the consumer.

Keywords

GM crops Transgenic plants Regulatory process Precautionary approach Risk assessment 

References

  1. AGBIOS (2008a) GM crop database. http://www.agbios.com/dbase.php. Accessed 11th August 2008
  2. AGBIOS (2008b) Summary of regulatory approvals. MON810 environmental risk assessment case study. http://www.agbios.com/dbase.php?action=Submit&evidx=9. Accessed 11th August 2008
  3. Alexander TW, Reuter T, Aulrich K, Sharma R et al (2007) A review of the detection and fate of novel plant molecules derived from biotechnology in livestock production. Anim Feed Sci Technol 133:31–62. doi:10.1016/j.anifeedsci.2006.08.003 CrossRefGoogle Scholar
  4. AU Biosafety Project (2007) Case study on the African Union Commission-German Federal Ministry for Economic Cooperation and Development (AUC-BMZ), Africa-wide Biosafety Capacity-Building Project, presented at the 3rd coordination meeting for governments and organizations implementing or funding biosafety capacity-building activities, 26–28 February 2007, Lusaka, Zambia, Available online at http://www.africa-union.org/root/au/AUC/Departments/HRST/biosafety/DOC/doc1/Case%20study%20of%20the%20AU%20Biosafety%20Project-Lusaka%20Meeting.doc
  5. Aumaitre A, Aulrich K, Chesson A, Flachowsky G, Piva G (2002) New feeds from genetically modified plants: substantial equivalence, nutritional equivalence, digestibility, and safety for animals and the food chain. Livest Prod Sci 74:223–238. doi:10.1016/S0301-6226(02)00016-7 CrossRefGoogle Scholar
  6. Australian Government (2007) Website for general permit searches. http://www.apvma.gov.au/permits/permits.shtml. Accessed 11th August 2008
  7. Barrett K (1999) Canadian agricultural biotechnology: risk assessment and the precautionary principle. PhD dissertation, University of British, ColumbiaGoogle Scholar
  8. Baumüller H (2004) Domestic import regulations for genetically modified organisms and their compatibility with WTO rules. Asian Biotechnol Dev Rev 6:33–42Google Scholar
  9. Bernauer T (2003) Genes, trade and regulation: The seeds of conflict in food biotechnology. Princeton University Press, PrincetonGoogle Scholar
  10. Bernauer T (2005) Causes and consequences of international trade conflict over agricultural biotechnology. Int J Biotechnol 7:7–28. doi:10.1504/IJBT.2005.006442 CrossRefGoogle Scholar
  11. Bijman J (1994) Biosafety regulation. Biotechnol Dev Monit 18:1415Google Scholar
  12. Brenner C (2004) Telling transgenic technology tales: lessons from the Agricultural Biotechnology Support Project (ABSP) experience. ISAAA Briefs No. 31. ISAAA, IthacaGoogle Scholar
  13. Brent P, Bittisnich D, Brooke-Taylor S, Galway N et al (2003) Regulation of genetically modified foods in Australia and New Zealand. Food Contr 14:409–416. doi:10.1016/S0956-7135(03)00037-9 CrossRefGoogle Scholar
  14. Brookes G, Barfoot P (2006) GM crops: the first ten years—global socio-economic and environmental impacts. ISAAA Brief No. 36. ISAAA, IthacaGoogle Scholar
  15. Carter CA, Gruère GP (2006) International approval and labeling regulations of genetically modified food in major trading countries. In: Just R, Alston JM, Zilberman D (eds) Regulating agricultural biotechnology. Economics and policies. Springer, New York, pp 459–480CrossRefGoogle Scholar
  16. Christou P, Twyman RM (2004) The potential of genetically enhanced plants to address food insecurity. Nutr Res Rev 17:23–42. doi:10.1079/NRR200373 CrossRefGoogle Scholar
  17. Codex Alimentarius Commission (2003) Foods derived from biotechnology (CAC/GL 44-2003). FAO/WHO, RomeGoogle Scholar
  18. Conner AJ, Glare TR, Nap JP (2003) The release of genetically modified crops into the environment Part II. Overview of ecological risk assessment. Plant J 33:19–46. doi:10.1046/j.0960-7412.2002.001607.x PubMedCrossRefGoogle Scholar
  19. Cuite CL, Aquino HL, Hallman WK (2005) An empirical investigation of the role of knowledge in public opinion about GM food. Int J Biotechnol 7:178–194. doi:10.1504/IJBT.2005.006453 CrossRefGoogle Scholar
  20. Cummins J (2004) Bt toxins in genetically modified crops: regulation by deceit. Sci Soc 22:32Google Scholar
  21. Eizaguirre M, Albajes R, Lopez C, Eras J et al (2006) Six years after the commercial introduction of Bt maize in Spain: field evaluation, impact and future prospects. Transgenic Res 15:1–12. doi:10.1007/s11248-005-3998-1 PubMedCrossRefGoogle Scholar
  22. EPA/BPPD (1995) US Environmental Protection Agency, Office of Pesticide Programs, Biopesticides and Pollution Prevention Division. Memorandum from Kough J to Mendelsohn M, Review of product characterization and mammalian toxicology data submitted by Monsanto Corporation for corn expressing Cry IA(b) δ-endotoxinGoogle Scholar
  23. Flint J, Gil L, Verastegui J, Irarrazabal C, Dellacha J (2000) Biosafety information management systems. A comparative analysis of the regulatory systems in Canada, Argentina and Chile. Electron J Biotechnol 3:9–29Google Scholar
  24. Food and Drug Administration (1992) Statement of policy: foods derived from new plant varieties. US Fed Reg 57:22984–23005Google Scholar
  25. Fransen L, La Vina A, Dayrit F, Gatlabayan L et al (2005) Integrating socio-economic considerations into biosafety decisions: the role of public participation. World Resources Institute White Paper, WRI, WashingtonGoogle Scholar
  26. Gruère GP (2006a) A preliminary comparison of the retail level effects of labeling policies of genetically modified food in Canada and France. Food Policy 31:148–161. doi:10.1016/j.foodpol.2005.09.001 CrossRefGoogle Scholar
  27. Gruère G (2006b) An analysis of trade related international regulations of genetically modified food and their effects on developing countries, EPTD discussion papers 147. International Food Policy Research Institute (IFPRI)Google Scholar
  28. Jaffe G (2004) Regulating transgenic crops: a comparative analysis of different regulatory processes. Transgenic Res 13:5–19. doi:10.1023/B:TRAG.0000017198.80801.fb PubMedCrossRefGoogle Scholar
  29. James C (2007) Global status of commercialized biotech/GM crops: 2007. ISAAA Brief No. 37. ISAAA, IthacaGoogle Scholar
  30. König A, Cockburn A, Crevel RW, Debruyne E et al (2004) Assessment of the safety of food derived from genetically modified GM crops. Food Chem Toxicol 42:1047–1088. doi:10.1016/j.fct.2004.02.019 PubMedCrossRefGoogle Scholar
  31. Kuiper HA, Kleter GA, Noteborn HP, Kok EJ (2001) Assessment of the food safety issues related to genetically modified foods. Plant J 27:503–528. doi:10.1046/j.1365-313X.2001.01119.x PubMedCrossRefGoogle Scholar
  32. MacKenzie DJ (2006) Comparison of international regulatory regimes for food products of biotechnology. Canadian Biotechnology Secretariat, Agriculture and Biotechnology Strategies (Canada) Inc., CanadaGoogle Scholar
  33. MacKenzie D, McLean M (2002) Who’s afraid of GM feeds? Feed Mix 10:16–19Google Scholar
  34. Marvier M, McCreedy C, Regetz J, Kareiva P (2007) A meta-analysis of effects of Bt cotton and maize on non-target invertebrates. Science 316:1475–1477. doi:10.1126/science.1139208 PubMedCrossRefGoogle Scholar
  35. Maryanski JH (1995) Food and drug administration policy for foods developed by biotechnology. In: Engel K-H, Takeoka GR, Teranishi R (eds) Genetically modified foods: safety issues. ACS Symposium Series 605. American Chemical Society, Washington, pp 12–22Google Scholar
  36. McHughen A (2007) Fatal flaws in agbiotech regulatory policies. Nat Biotechnol 25:725–727. doi:10.1038/nbt0707-725 PubMedCrossRefGoogle Scholar
  37. Mitchell P (2003) EU biotech firms drastically cut back research. Nat Biotechnol 21:468–469. doi:10.1038/nbt0503-468 PubMedCrossRefGoogle Scholar
  38. Nap JP, Met PLJ, Escaler M, Conner AJ (2003) The release of genetically modified crops into the environment—Part I. Overview of current status and regulations. Plant J 33:1–18. doi:10.1046/j.0960-7412.2003.01602.x PubMedCrossRefGoogle Scholar
  39. OECD (2007) Consensus document on safety information on transgenic plants expressing Bacillus thuringiensis-derived insect control protein. OECD Environment, Health and Safety Publications Series on Harmonisation of Regulatory Oversight in Biotechnology no. 42Google Scholar
  40. Office of Gene Technology Regulator (OGTR) (2007) Website listing trial sites, intentional release and evaluation processes, monitoring and compliance, records of GMOs and GM product dealings. http://www.ogtr.gov.au/. Accessed 11th August 2008
  41. Organization for Economic Cooperation and Development (1993) Safety evaluation of foods produced by modern biotechnology. Concepts and principles. OECD, ParisGoogle Scholar
  42. Ramessar K, Peremarti A, Gómez-Galera S, Naqvi S et al (2007) Biosafety and risk assessment framework for selectable marker genes in transgenic crop plants: a case of the science not supporting the politics. Transgenic Res 16:261–280. doi:10.1007/s11248-007-9083-1 PubMedCrossRefGoogle Scholar
  43. Sanvido O, Romeis J, Bigler F (2007) Ecological impacts of genetically modified crops: ten years of field research and commercial cultivation. Adv Biochem Eng Biotechnol 107:235–278PubMedGoogle Scholar
  44. Shipworth D, Kenley R (1999) Fitness landscapes and the precautionary principle: the geometry of environmental risk. Environ Manage 24:121–131. doi:10.1007/s002679900220 PubMedCrossRefGoogle Scholar
  45. Suguru S (2006) Japan Biotechnology Annual Report 2006. USDA Foreign Agricultural Service (FAS) Global Agriculture Information Network (GAIN) Report no. JA6049Google Scholar
  46. The European Parliament the Council of the European Union (2002) EC 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. Off J Eur Communities L31:1–24Google Scholar
  47. World Health Organization (1995) Application of the principles of substantial equivalence to the safety evaluation of foods or food components from plants derived by modern biotechnology. World Health Organization, GenevaGoogle Scholar
  48. World Health Organization (2000) Safety aspects of genetically modified foods of plant origin. Report of a Joint FAO/WHO Expert Consultation on foods derived from biotechnology. World Health Organization, GenevaGoogle Scholar

Copyright information

© Springer Science+Business Media B.V. 2008

Authors and Affiliations

  • Koreen Ramessar
    • 1
  • Teresa Capell
    • 1
  • Richard M. Twyman
    • 2
  • Hector Quemada
    • 3
  • Paul Christou
    • 1
    • 4
  1. 1.Departament de Produccio Vegetal I Ciencia ForestalUniversity of LleidaLleidaSpain
  2. 2.Department of BiologyUniversity of YorkHeslington, YorkUK
  3. 3.Department of BiologyCalvin CollegeGrand RapidsUSA
  4. 4.Institucio Catalana de Recerca i Estudis AvancatsBarcelonaSpain

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