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Genetically Engineered Insects – Regulatory Progress and Challenges

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Regulation of Agricultural Biotechnology: The United States and Canada

Abstract

Genetically engineered insects (GE) represent a potentially valuable new tool in the control of insect pests both in agriculture and public health.

Insects that are currently being regulated for non-laboratory use are based on the development of the Sterile Insect Technique (SIT) for pest population suppression, using genetics to enhance or replace aspects of current SIT methods. Genetics-based improvements include the provision of a heritable marker, replacement of radiation-sterilization, large-scale sex separation and improved biosecurity. In the USA, open field trials of genetically engineered pink bollworm (Pectinphora gossypiella), a serious economic pest of cotton, have been taking place since 2006 and the first Environmental Impact Statement on any genetically engineered organism, under the National Environmental Protection Act (NEPA), was developed and approved for GE pink bollworm and fruit flies. This chapter will look at the regulatory process and data requirements for moving GE insects from laboratory to field testing, and the current status of regulations and guidance documents on GE insects in plant pest control programs. Additionally it will discuss areas for further development in regulation of GE insects. Regulatory risk – uncertainty in timescale, cost and outcome – is cited by developers, investors and potential users of GE insects as the single biggest concern and obstacle to the development and deployment of novel products in this area.

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Notes

  1. 1.

    http://flystocks.bio.indiana.edu/Inst/history.htm. Accessed 7 Feb 2011.

  2. 2.

    Data presented at 59th Annual Meeting of the American Society of Tropical Medicine and Hygiene, Nov 2010; see also http://www.oxitec.com/wp-content/uploads/2010/11/Oxitec-MRCU-press-release.pdf. Accessed 21 Feb 2011.

  3. 3.

    http://bch.cbd.int/onlineconferences/guidancedoc_ra_mosquitoes.shtml. Accessed 21 Feb 2011.

  4. 4.

    Cayman Islands risk assessment for genetically modified mosquitoes:

    http://www.parliament.uk/deposits/depositedpapers/2011/DEP2011-0053.pdf Malaysian government opinion on open release of GM mosquitoes: http://bch.cbd.int/database/record-v4.shtml?documentid=101480 Brazilian government opinion on open release of GM mosquitoes (in Portuguese): http://www.jusbrasil.com.br/diarios/23935599/dou-secao-1-17-12-2010-pg-48

  5. 5.

    https://www.ippc.int/index.php?id=1110798&tx_publication_pi1[showUid]=184204&frompage=13399&type=publication&subtype=&L=0#item. Accessed 21 Feb 2011.

  6. 6.

    https://www.ippc.int/index.php?id=13399&tx_publication_pi1[showUid]=76047. Accessed 21 Feb 2011.

  7. 7.

    https://www.ippc.int/index.php?id=13399&tx_publication_pi1[showUid]=34163. Accessed 21 Feb 2011.

  8. 8.

    http://www.aphis.usda.gov/plant_health/ea/geneng.shtml

  9. 9.

    Federal Register Vol. 74 No 87, p21314-6, May 7, 2009, also available at http://www.aphis.usda.gov/plant_health/ea/geneng.shtml

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Authors and Affiliations

  1. Oxitec Limited, 71 Milton Park, Abingdon, OX14 4RX, UK

    Luke S. Alphey & Camilla J. Beech

  2. Department of Zoology, Oxford University, South Parks Road, Oxford, OX1 3PS, UK

    Luke S. Alphey

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  1. Luke S. Alphey
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  2. Camilla J. Beech
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Correspondence to Luke S. Alphey .

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  1. Office of Pesticide Programs, Biopesticides & Pollution, US Environmental Protection Agency, Pensylvania Ave. NW., 1200, WASHINGTON, 20460, District of Columbia, USA

    Chris A. Wozniak

  2. Dept. of Botany & Plant Sciences, University of California, Riverside, 92521, California, USA

    Alan McHughen

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Alphey, L.S., Beech, C.J. (2012). Genetically Engineered Insects – Regulatory Progress and Challenges. In: Wozniak, C., McHughen, A. (eds) Regulation of Agricultural Biotechnology: The United States and Canada. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-2156-2_13

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