Regulatory Initiatives on GM
Insects
Camilla Beech
MosqGuide Project
ISBGMO11 Argentina Nov 2010
Worldwide Guidance and Training – GM
insects
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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
Regulatory Initiatives
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Key feature of all the initiatives is a desire to maintain a
transparency, openness and inclusiveness of
stakeholders
Regulation is desirable.
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Regulation must be proportionate with a potential risk /benefit
scenario as for other public health interventions.
Mosquito releases need to include:
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Scientific considerations
Social and ethical considerations
Regulatory considerations
Regulatory Progress: Initiatives
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WHO has set up 6 initiatives, mainly through TDR
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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
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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
Malaysian Progress
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UNDP sponsored Workshop on Risk
assessment of transgenic insects – Kuala
Lumpur Nov 2008
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>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
Cartagena Biosafety Protocol
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Cartagena Protocol on Biosafety -Ad Hoc Technical
Expert Group on Risk Assessment preparing Guidance
document on Living Modified Mosquitoes (April 2009)
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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
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Is this the right approach? (Marshall – Nature Biotechnology
2010)
USA
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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.”
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This considered COMPARATIVE RISK.
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FIRST EIS Completed on any GMO !!
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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.
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USA
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Mosquitoes for public health applications – a
regulatory challenge !
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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
USA
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North American Plant Protection Organization (NAPPO) standard
 RSPM 27
 Signed late 2007
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Mexico, USA and Canada agreement for import, transport and
confined field release of GM insects in plant pest control.
Oxitec Ltd
Europe
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European Food Safety Authority (EFSA)
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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
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CT/EFSA/GMO/2009/03
Next steps: Working group for further refinement, then
public consultation
Summary
International and national guidance available for
GM insects
 Some countries are testing GM insects beyond
the laboratory already
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USA (Agriculture)
Mexico (Environment/CIBIOGEM)
Malaysia (Environment/GMAC)
Brazil (Health/CTNBio)
Cayman Islands (Agriculture, Mosquito Law)
Oxitec Ltd