Identification of legal frameworks and guidance documents in relation to GM vectors

1. Not to be circulated without written permission Identification of legal frameworks and guidance documents in relation to GM vectors WHO/TDR 2nd LATAM Biosafety Network Meeting Nov 2010 Camilla Beech Oxitec Limited, Oxford, UK

2. Regulation • Ideally regulation should be: • Transparent and open • Inclusive of all stakeholders • Proportionate to the potential risks and benefits • Predictable • Regulation should consider • Objective scientific risk assessment • Social and political issues • Ethical issues

3. Regulatory initiatives: 3 dimensions • SCOPE • NATIONAL or REGIONAL or INTERNATIONAL • REMIT • Risk Assessment and Risk Management • ESC • BOTH • STATUS • LEGAL • GUIDANCE • GUIDELINES

4. WHO Regulatory Initiatives • WHO TDR • Best Practice Guidance for Innovative Vector Control Strategies • www.mosqguide.com • International consortium for deployment of genetic vector control strategies. • Started 2008; 3 year project • Links with training centres • African, Asian and Latin American Regional Biosafety Training Centres and Coordinating Committee • WHO-EPR Epidemic and Pandemic Alert and Response • Laboratory Biosafety and Biosecurity of Modified Vectors “ Train the Trainers”

5. Guidance for contained testing • Definition • Release of organisms into the environment under specific conditions and restrictions intended to prevent establishment in or control the spread into the environment • Guidance • North American Plant Protection Organization (NAPPO) RSPM 27. Standard issued in 2007 • USDA Transgenic Insect Permit Guidance • Guidance for the contained field trials of vector mosquitoes engineered to contain a gene drive system (Vector Borne and Zoonotic diseases (2008))

6. United Nations Development Program • UNDP sponsored Workshop on Risk assessment of transgenic insects – Kuala Lumpur Nov 2008 • Consolidate national capacity for implementation of Cartagena Protocol on biosafety and National Biosafety Act • Discussion and workshop on risk assessment techniques and application of risk assessment to transgenic insects for open release • >70 scientists and decision makers • Proceedings published (Beech et al, 2009 Asia Pacific Journal of Molecular Biology and Biotechnology, Vol 17, No. 3)

7. Regulatory Initiatives • MRC Centre (Univ of Toronto) is looking at Ethical-Social-Cultural (ESC) aspects prior to and during deployment funded by the Gates Foundation GCGH initiative • Publications by Lavery J et al • FNIH/WHO Technical Meeting on GM Vector Control May 2009 • Framework Guidance Group developed – first meeting April 2010 • Publication likely early 2011

8. 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 • Lack of information should not necessarily be interpreted as indicating a level of risk, an absence of risk or acceptable risk • Road map for risk assessment of LMO’s to be developed for Annex III. • Points to consider and their rationale, supporting bibliography • Online forum and online conferences (Feb 2010) • To reported April 2010 • Final Draft Guidance available on website

9. EFSA – European Food Standards Agency • Contracted Austria Environment Ministry Consortium to examine criteria for use of GM insects in EU • Document published Oct 2010 • Available on EFSA website • Key findings: • Case by case risk assessment required • Self-limiting strategies will have less information requirement than self- sustaining

10. Open field trials: GM Mosquitoes – National decisions • Malaysia approved application for open field release of GM Aedes aegypti • Dossier submitted to institutional biosafety board and national committees in accordance with Biosafety Act 2007 • Public consultation process on trial • Publication in national newspapers • Community engagement in process • Cayman open field release • MRCU has legal status to review dossiers • Min of Ag permit and Min of Environment consulted • Community literature and video

11. Cayman Islands GM mosquito

12. National Decisions • GM Crops in Colombia • 2000 – GM carnation approved in Colombia for export markets • 2004 – Colombia approves first GM crop – Bt cotton • 2007 – more crops approved, Bt cotton and maize • Crop losses and civil society ( press, NGO etc) questioned BT crops • What is the situation today ???

13. Genetically Modified organisms in Latin America GM mosquitoes GM crops

14. Environmental Impact Assessment • Principles • Legal instruments • In place in over 100 countries e.g Mexico, USA, Malaysia • Purpose • To inform decision making at governmental level • To obtain citizen involvement • Environmental Impact Statements/Environmental Statements can be prepared for many situations: • Road building • Construction projects • Introduction of exotic species • Release of GM organisms

15. Environmental Impact Statement • Provides: • Full and unbiased analysis of significant environmental impacts • Informs decision makers and public • Examines all reasonable alternatives • Objective is to avoid or minimise risk to the environment ( this can include human health as well) • Weighs benefits with risks • Should be written in easily understandable language ( supported by a body of evidence on the environmental analyses conducted) • Includes broad stakeholder consultation

16. Case study: EIS on GE Pink Bollworm and Fruit Flies in USA • Conducted under USA National Environmental Policy Act 1969 and subsequent amendments (legal framework). • Alternatives to the use of GE PBW and FF considered • No action, maintain sterile insect technique through existing irradiation programs. • Expansion of the existing programs in size, capacity and species. • Extensive analysis of • Program costs • Critical habitat of threatened and endangered species • Impact on Indian Tribal Lands • Molecular Biology of Strain • Environmental Risk analysis • Use of Tetracycline and environmental impact • Did not include • Organic growers

17. Case study: EIS on GE Pink Bollworm and Fruit Flies in USA • Dec 2006 – USDA publishes intention to conduct EIS for the purpose of analysing the use of and alternatives to genetic engineering technology applied to sterile insect releases in agency pest control programs. • 2007 – Five public meetings held across USA plus opportunity to comment by internet • May 2008 – Draft EIS published in official register • ~18 months to prepare • Public comments invited until July 2008, extended to Aug 2008 • 7 public comments received

18. Case study: EIS on GE Pink Bollworm and Fruit Flies in USA • October 2008 – Final EIS distributed to stakeholders including the 7 who made public comments on the draft. • Nov 2008 – Final EIS published in the official register • Official 30 day public comment period • No comments received • May 2009 – Record of Decision (ROD) published in the official register. • Decision was that after examining all the alternatives that use of GE PBW and FF is to integrated into their pest control programs • Use of GE PBW and FF therefore was the environmentally preferable alternative. Oxitec Limited

19. 2009 Theregulatoryframeworkisdeveloping 2002

20. Worldwide Guidance and Training • WHO Epidemic and Pandemic Alert and Response (EPR) Biosafety Unit – Laboratory Biosafety • WHO/TDR BL5 Biosafety Training Centre (Africa) • WHO/TDR BL5 Biosafety Training Centre (Latin America) • WHO/TDR BL5 Biosafety Training Centre (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 • 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 • European Food Safety Authority – GMO Panel – Environmental Risk Assessment Criteria

21. Assignment Class work: Use this statement to understand why the genetically sterile insect technique is currently the ‘environmentally preferred alternative’ ?

23. Case Study • Why is the use of GE PBW and FF environmentally preferable ? • Reduces the need for insecticide applications • Decreases the need to produce both male and female strains of insect ( sex specific production) • Increase the production of the males that are more competitive in mating than the irradiated ones • Eliminate the need for the use, operation and maintenance of a gamma irradiation source. • Other factors • More efficient use of resources in mass rearing, trap monitoring etc, leads to lower cost program. Oxitec Limited