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Regulation of genetic engineering

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Regulation of genetic engineering

The regulation of [1]

History

The development of a regulatory framework concerning genetic engineering began in 1975, at Office of Science and Technology (OSTP) to develop mechanisms to regulate the developing technology.[5] In 1986 the OSTP assigned regulatory approval of genetically modified plants in the US to the USDA, FDA and EPA.[7]

The [9] One hundred and fifty-seven countries are members of the Protocol and many use it as a reference point for their own regulations.[10]

Approval to conduct experiments

Institutions that conduct certain types of scientific research must obtain permission from government authorities and ethical committees before they conduct any experiments. Universities and research institutes generally have a special committee that is responsible for approving any experiments that involve cloning any genes that code for vertebrate toxins or using hosts that are capable of causing disease in humans. Licensed dealings require the approval of the national regulator.[11]

In the laboratory

Work with exempt GMOs do not need to be carried out in certified laboratories. All others must be contained in a Physical Containment level 1 (PC1) or Physical Containment level 2 (PC2) laboratories. GMOs classified as low risk include knockout mice as long as the modification does not confer an advantage to the animal or it does not secrete any infectious agents. If a laboratory strain is used that is not covered by exempt dealings or the inserted DNA could code for a pathogenic gene it must be carried out in a PC2 laboratory.[11]

Release

The approaches taken by governments to assess and manage the risks associated with the use of Coordinated Framework for Regulation of Biotechnology[12] The policy has three tenets: "(1) U.S. policy would focus on the product of genetic modification (GM) techniques, not the process itself, (2) only regulation grounded in verifiable scientific risks would be tolerated, and (3) GM products are on a continuum with existing products and, therefore, existing statutes are sufficient to review the products."[13] European Union by contrast enacted regulatory laws in 2003 that provided possibly the most stringent GMO regulations in the world.[14] 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 criteria for authorization fall in four broad categories: "safety," "freedom of choice," "labelling," and "traceability."[15]

For a genetically modified organism to be approved for release in the USA, it must be assessed by the [16] and the EPA regulates genetically modified plants with pesticide properties, as well as agrochemical residues.[17] In Europe 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.[14] However, even after authorization, individual EU member states can ban individual varieties under a 'safeguard clause' if there are "justifiable reasons" that the variety may cause harm to humans or the environment. The member state must then supply sufficient evidence that this is the case.[18] The Commission is obliged to investigate these cases and either overturn the original registrations or request the country to withdraw its temporary restriction.

The level of regulation in other countries lies in between Europe and the USA. Office of the Gene Technology Regulator, 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 can then assess the impact of release on markets and trade and apply further legislation to control approved genetically modified products.[27][28][27]

One of the key issues concerning regulators is whether GM products should be labeled. Labeling can be mandatory up to a threshold GM content 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%.[29] In Canada and the USA labeling of GM food is voluntary,[30] while in Europe all food (including [31]

Trade

The Cartagena Protocol sets the requirements for the international trade of GMO's between countries that are signatories to it. Any shipments contain geneticially modified organisms that are intended to be used as feed, food or for processing must be identified and a list of the transgenic events be available.

References

  1. ^ Kathy Wilson Peacock (2010). Biotechnology and Genetic Engineering. Infobase Publishing. 
  2. ^ 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". Science 185 (4148): 303.  
  3. ^ 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.  
  4. ^ Hutt, P.B. (1978). "Research on recombinant DNA molecules: the regulatory issues". South Calif Law Rev 51 (6): 1435–50.  
  5. ^ a b McHughen A, Smyth S (2008). "US regulatory system for genetically modified [genetically modified organism (GMO), rDNA or transgenic] crop cultivars". Plant biotechnology journal 6 (1): 2–12.  
  6. ^ Bull, A.T., Holt, G. and Lilly, M.D. (1982). Biotechnology : international trends and perspectives. Paris: Organisation for Economic Co-operation and Development. 
  7. ^ U.S. Office of Science and Technology Policy (1986). "Coordinated framework for regulation of biotechnology". Fed Regist. 51 (123): 23302–50.  
  8. ^ http://bch.cbd.int/protocol/background/
  9. ^ Redick, T.P. (2007). "The Cartagena Protocol on biosafety: Precautionary priority in biotech crop approvals and containment of commodities shipments, 2007". Colorado Journal of International Environmental Law and Policy 18: 51-116. 
  10. ^ http://www.agbioforum.org/v13n3/v13n3a02-gruere.htm#R13
  11. ^ a b http://www.uow.edu.au/research/rso/ethics/UOW009392.html
  12. ^ United States Regulatory Agencies Unified Biotechnology Website
  13. ^ Emily Marden, Risk and Regulation: U.S. Regulatory Policy on Genetically Modified Food and Agriculture, 44 B.C.L. Rev. 733 (2003)[1]
  14. ^ a b c John Davison (2010)"GM plants: Science, politics and EC regulations" Plant Science 178(2):94–98[2]
  15. ^ GMO Compass: The European Regulatory System. Retrieved 28 July 2012.
  16. ^ FDA page for GM Food
  17. ^ "Guide to U.S. Regulation of Genetically Modified Food and Agricultural Biotechnology Products". The Pew Initiative on Food and Biotechnology. Washington, DC: The Pew Charitable Trusts. 2001. Retrieved 2012-06-02. 
  18. ^ "Health and Consumers: Food and feed safety." (under "What are the National safeguard measures?") Link. Retrieved 28 July 2012.
  19. ^ Transgenic harvest Editorial, Nature 467 , pages 633–634, 7 October 2010, doi:10.1038/467633b. Retrieved 9 November 2010
  20. ^ ISAAA Brief 37-2007 - Slides & Tables > ISAAA.org
  21. ^ AgBioForum 5(4): Agricultural Biotechnology Development and Policy in China
  22. ^ http://agritech.tnau.ac.in/bio-tech/biotech_gmcrop_gmregulation.html
  23. ^ Slides & Tables : Global Status of Commercialized Biotech/GM Crops: 2010 - ISAAA Brief 42-2010 | ISAAA.org
  24. ^ a b BASF presentation
  25. ^ Canadian Food Inspection Agency - Regulating Agricultural Biotechnology
  26. ^ http://www.thecanadianencyclopedia.com/articles/genetically-modified-foods Genetically Modified Food.
  27. ^ a b Agriculture - Department of Primary Industries
  28. ^ "Welcome to the Office of the Gene Technology Regulator Website". Office of the Gene Technology Regulator. Retrieved 25 March 2011. 
  29. ^ Gerda M. Botha and Christopher D. Viljoen (2009) "South Africa: A case study for voluntary GM labelling" Food Chemistry 112(4):1060–1064[3]
  30. ^ The Regulation of Genetically Modified Foods
  31. ^ Northwestern.edu Northwestern Journal of Technology and Intellectual Property Paper on: "Consumer Protection" Consumer Strategies and the European Market in Genetically Modified Foods
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