Regulatory Initiatives on GM Insects

1. Regulatory Initiatives on GM Insects Camilla Beech MosqGuide Project ISBGMO11 Argentina Nov 2010

2. Worldwide Guidance and Training – GM insects • WHO Epidemic and Pandemic Alert and Response (EPR) Biosafety Unit – Laboratory Biosafety Training GM Vectors. • WHO/TDR BL5 Biosafety Training Centre (Africa, Latin America, Asia) • WHO/TDR BL5 Genetically Modified Vectors Projects Coordination Committee • WHO/TDR BL5 Project on Best-Practice Guidance for Deployment of Genetic Control Methods Against Mosquito Vectors in Disease Endemic Countries (MosqGuide) • UNDP-Sponsored Risk Assessment Workshop Series on Transgenic Insects, Malaysia • Ethical, Social and Cultural Program for the Grand Challenges in Global Health (GCGH) Initiative – MRC Centre, University of Toronto, Canada • Regional Standards for Phytosanitary Measures (RSPM) 27 published by the North American Plant Protection Organisation (NAPPO) • Environmental Impact Statement (EIS) prepared and published by the United States Department of Agriculture Animal and Plant Health Inspection Service (USDA/APHIS) • FNIH/WHO Technical Meeting on GM Vector Control. • Cartagena Biosafety Protocol – Ad Hoc Technical Group on Risk Assessment – guidance for LM mosquitoes • EFSA – Environmental Risk Assessment Criteria for GM Insects

3. Regulatory Initiatives • Key feature of all the initiatives is a desire to maintain a transparency, openness and inclusiveness of stakeholders • Regulation is desirable. • Regulation must be proportionate with a potential risk /benefit scenario as for other public health interventions. • Mosquito releases need to include: • Scientific considerations • Social and ethical considerations • Regulatory considerations

4. Regulatory Progress: Initiatives • WHO has set up 6 initiatives, mainly through TDR • MosqGuide’ best practice guidance for use of GM mosquitoes for disease control (www.mosqguide.org.uk) • African, Asian and Latin American Regional Biosafety Training Centres set up by WHO/TDR • Coordinating Committee • Laboratory Biosafety and Biosecurity of Modified Vectors “ Train the Trainers” • WHO/FNIH Technical Consultation on GM Mosquitoes • Gates Foundation Grand Challenges in Global Health • MRC Centre (Toronto) is looking at Ethical-Social-Cultural (ESC) aspects prior to and during deployment funded by the Gates Foundation GCGH initiative. • Large scale cage trials underway in Mexico

5. Malaysian Progress • UNDP sponsored Workshop on Risk assessment of transgenic insects – Kuala Lumpur Nov 2008 • >70 scientists and decision makers • Discussion and workshop on risk assessment techniques and application of risk assessment to transgenic insects for open release. • Proceedings published in Asia Pacific Journal of Molecular Biology and Biochemistry • Risk communication workshop – Mar 2010

6. Cartagena Biosafety Protocol • Cartagena Protocol on Biosafety -Ad Hoc Technical Expert Group on Risk Assessment preparing Guidance document on Living Modified Mosquitoes (April 2009) • Science based, transparent risk assessment • Case by Case approach • Points to consider and their rationale, supporting bibliography • Online forum and online conferences (Feb 2010) • Reported April 2010 • Review Japan Oct 2010 • Most countries will regulate GM mosquitoes under national implementation of Cartagena Protocol • Is this the right approach? (Marshall – Nature Biotechnology 2010)

7. USA • The USDA has published an Environmental Impact Statement (EIS) on the use of autocidal technology (RIDL) for GM fruit flies and PBW and Record of Decision (ROD) – 2009 “The environmentally preferable alternative for the use of sterile insect technique in plant pest control programs is the alternative that minimizes potential impacts to human health, non-target species, and environmental quality.” • This considered COMPARATIVE RISK. • FIRST EIS Completed on any GMO !! • 4 years of open field release of genetically modified pink bollworm in USA (2006-2009) • Insects modified for plant pest control programs fit within US regulations (Plant Protection Act) administered by Biotechnology Regulatory Services (BRS) • Mosquitoes don’t fit here.

8. USA • Mosquitoes for public health applications – a regulatory challenge ! • FDA regulates GM animals – but not insects • EPA regulates “biopesticides” – but not insects • USDA-APHIS BRS/PPQ regulates plant pests – but not mosquitoes Solution: USDA-APHIS Veterinary Services – Animal Health Protection Act • Co-ordinating agency with EPA, Centers for Disease Control, USDA-APHIS BRS Oxitec Ltd

9. USA • North American Plant Protection Organization (NAPPO) standard • RSPM 27 • Signed late 2007 • Mexico, USA and Canada agreement for import, transport and confined field release of GM insects in plant pest control. Oxitec Ltd

10. Europe • European Food Safety Authority (EFSA) • Considering criteria for Environmental Risk Assessment of GM Insects for commercial use (Oct 2009). • Report published by external consortium (Environment Agency Austria) published Sept 2010 • CT/EFSA/GMO/2009/03 • Next steps: Working group for further refinement, then public consultation

11. Summary • International and national guidance available for GM insects • Some countries are testing GM insects beyond the laboratory already • USA (Agriculture) • Mexico (Environment/CIBIOGEM) • Malaysia (Environment/GMAC) • Brazil (Health/CTNBio) • Cayman Islands (Agriculture, Mosquito Law) Oxitec Ltd