International issues and implications of using genetically modified organisms for biocontrol of vertebrate pests Henderson, W and Murphy, E (2006). Project Number: 12D4 Project Title: International issues of using GMOs for biocontrol of vertebrate pests Project Leader: Elaine Murphy Date: October, 2006 International issues and implications of using genetically modified organisms for biocontrol of vertebrate pests This project was managed by Dr Elaine Murphy and Dr Wendy Henderson –Invasive Animals Cooperative Research Centre. Disclaimer: The views and opinions expressed in this report reflect those of the author and do not necessarily reflect those of the Australian Government or the Invasive Animals Cooperative Research Centre. The material presented in this report is based on sources that are believed to be reliable. Whilst every care has been taken in the preparation of the report, the author gives no warranty that the said sources are correct and accepts no responsibility for any resultant errors contained herein any damages or loss, whatsoever caused or suffered by any individual or corporation. Published by: Invasive Animals Cooperative Research Centre. Postal address: University of Canberra, ACT 2600. Office Location: University of Canberra, Kirinari Street, Bruce ACT 2617. Telephone: (02) 6201 2887 Facsimile: (02) 6201 2532 Email: [email protected] Internet: http://www.invasiveanimals.com Web ISBN: 0-9775707-7-0 © Invasive Animals Cooperative Research Centre 2006 This work is copyright. The Copyright Act 1968 permits fair dealing for study, research, information or educational purposes. Selected passages, tables or diagrams may be reproduced for such purposes provided acknowledgement of the source is included. Major extracts of the entire document may not be reproduced by any process. This document should be cited as: Henderson W and Murphy E (2006). International issues and implications of using genetically modified organisms for biocontrol of vertebrate pests. Invasive Animals Cooperative Research Centre, Canberra. ii Contents Executive Summary .................................................................................................1 Acronyms and abbreviations ..................................................................................2 1. Introduction....................................................................................................3 2. GM biocontrol research ................................................................................5 2.1 Carp and exotic fish ..............................................................................5 2.2 Mice ......................................................................................................6 2.3 Cane Toads ..........................................................................................6 2.4 Possums...............................................................................................6 2.5 Rabbits..................................................................................................6 2.6 Foxes....................................................................................................7 3. National regulation of GMOs ........................................................................8 3.1 Regulation in Australia..........................................................................8 3.2 Regulation in New Zealand.................................................................10 3.3 Regulation in the USA.........................................................................12 3.4 Regulation in Europe ..........................................................................13 3.5 Regulation in other countries ..............................................................14 4. International regulations and guidelines...................................................15 4.1 Convention on Biological Diversity (CBD)...........................................15 Development and release of GM biocontrols ......................................15 Liability and redress for biodiversity damage......................................16 Principles on alien species..................................................................17 4.2 The Cartagena Protocol on Biosafety .................................................19 iii 4.3 The International Plant Protection Convention (IPPC)........................20 4.4 The World Organisation for Animal Health (OIE) ................................20 4.5 The Sanitary and Phytosanitary (SPS) Agreement.............................22 4.6 Other international instruments...........................................................22 4.7 Interactions between international authorities.....................................23 5. International issues.....................................................................................24 5.1 ‘Pest’ or ‘prized possession’?..............................................................24 5.2 Issues raised by the Biosafety Clearing House online conference ..........................................................................................25 Education and resources in less-developed countries........................25 Information for risks assessment ........................................................26 International consultation....................................................................27 Safety issues ......................................................................................29 Liability and redress issues.................................................................30 Conclusions ........................................................................................30 5.3 Issues raised by the RHD symposium ................................................31 5.4 Other international issues concerned with GM biocontrols .................32 The concept of ‘pest’...........................................................................32 Trade issues .......................................................................................32 Pathways for transborder entry...........................................................33 Intellectual property rights...................................................................33 Lack of an international authority ........................................................33 Ethical concerns .................................................................................34 Gaps and constraints at a national level .............................................34 6. Acknowledgements.....................................................................................34 7. References ...................................................................................................35 Appendix: Status of the Cartagena Protocol on Biosafety..............................41 iv International issues of using GMOs for biocontrol for vertebrate pests Executive Summary This report provides an overview of current research, regulations and issues concerning genetically modified organisms (GMOs) for use as biological controls of vertebrates. GMO research for the management of rabbits, mice, possums, cane toads and exotic fish are outlined. Regulations and ethics guidelines presently in effect at the national level are described for Australia, New Zealand, Europe and the USA. International agreements relevant to the use of biocontrol agents and GMOs are also described, including the Convention on Biological Diversity, International Plant Protection Convention, the World Trade Organization’s Sanitary and Phytosanitary Agreement and requirements of the World Organisation for Animal Health. International issues of using biocontrol GMOs, particularly disseminating organisms, have been raised in the recent literature and at two key conferences: the 2003 International Wildlife Management Congress in New Zealand and an online conference hosted by the Convention of Biological Diversity in 2004. They include concerns of transboundary movement, non-target effects and the need for an international body to consult with and regulate the use of biocontrol GMOs. 1 Acronyms and abbreviations APHIS Animal and Plant Health Inspection Service (USA) CBD Convention on Biological Diversity ERMA/NZ Environmental Risk Management Authority of New Zealand FDA Food and Drug Administration (USA) FAO Food Agriculture Organization of the United Nations GISP Global Invasive Species Programme GM genetically modified GMO genetically modified organism HSNO Act Hazardous Substances and New Organisms Act (New Zealand) IPPC International Plant Protection Convention LDC less-developed countries MAF Ministry of Agriculture and Forestry (New Zealand) NIH National Institute of Health (USA) OECD Organisation for Economic Cooperation and Development OGTR Office of the Gene Technology Regulator (Australia) OIE World Organisation for Animal Health (formerly Office International des Épizooties) RHD rabbit haemorrhagic disease SPS Sanitary/Phytosanitary Agreement UNEP United Nations Environment Programme USDA United States Department of Agriculture WTO World Trade Organization 2 1. Introduction The introduction of invasive plants, animals and microorganisms has caused huge economic and environmental losses in many countries (Pimentel et al 2001, Seamark 2001). It is estimated that exotic species in Australia, Brazil, India, South Africa, the United Kingdom and United States cost more than $445 billion per year in damages (Pimentel et al 2001). The impact of invasive species on biodiversity and