1. Data Requirements for Field Release and Monitoring Jon Knight Imperial College London j.d.knight@imperial.ac.uk

2. Overall Aim Guidance on standardised procedures for data collection and a structure to collect and access data to support best practice for monitoring and management of field release and deployment

3. Why collect data? Inform target groups – policy makers, researchers, programme managers, regulators, stakeholders Support objective – provide supporting data for risk assessment and project management from project initiation to maturity Address risk perception of various groups at relevant times

4. Key Phases Project initiation – baseline data Project implementation – real time data collection for decision making Project operation – continued monitoring for safe and efficient operation of project Long term monitoring – continued monitoring to ensure impacts are maintained and that risk management is appropriate

5. Monitoring Plan Import Permit Field Release Permit Ethics Review EIA Impact Evaluation Genetic DataPopulation DataRelease Area DataOperational ProtocolsEfficacy and Impact Genetic Modification Modification Experimental protocol Source of genetic material Phenotypic effects Stability of construct Genetic stability Extent of gene drive Wild mosquito population Baseline data Human context Socioeconomic/cultural Health (disease incidence or threat) Risk perception/acceptance Environmental conditions Non-target organisms Endangered or protected sites Field release plans Monitoring plans Facility biosecurity Standard Operating Procedures Production protocol Contingency plans Options for monitoring Efficacy of option chosen Mechanism for ongoing data review Models for predictive monitoring scale and location, adjustment to real data Phenotypic stability Life tables and fitness Mating competitiveness Rate of Introgression Pilot Programme Maintenance Field Trials Laboratory Confined Trials Genetic DataPopulation Data Release Area Data Operational Protocols Efficacy and Impact Pilot Programme Maintenance Field Trials Laboratory Confined Trials Import Permit Field Release Permit Ethics Review EIA Impact Evaluation Monitoring Plan Import Permit

6. Understand the target vector - Vector species presence - Vector density and abundance - Vector distribution (GPS) - Habitat Baseline data

7. Health & Socio-economic indicators – Number of people in area, age, earnings, etc Epidemiology – Incidence of disease – Distribution of disease Perceptions of people – Disease – Control methods Vectors Medicines

8. Baseline data Current control methods – Location of activities – Types of activities – Cost of activities (and who is paying) Current biodiversity – Ecosystem services

9. Project implementation Insect vector monitoring – Monitoring of modified insects Apparent density and survival Mobility and dispersal Dispersion (niche occupation) Persistence of gene in environment Other biosafety indicators – Monitoring of wild types As above

10. Project implementation Monitoring and surveillance in and around production facility (escapes for sterile forms) Most of the above require reliable and quantifiable trapping systems Epidemiology

11. Project Operation Monitoring insect numbers (direct sampling) Monitoring disease incidence (indirect) “Success” of programme – Sampling and detection of transgene in target insect population – Establishing absence of vectors Recording of production and release costs Monitoring and surveillance in and around production facility (escapes for sterile forms)

12. Long term monitoring Trapping network for detecting reinvasion Disease prevalence monitoring If continued releases – Ensure impacts continue (strain still effective)

13. Long term monitoring Acquisition of a new and undesirable capability/behaviour – increased capacity to transmit a pathogen – increased blood-feeding frequency, altered host preference Disruption of any essential or beneficial function – food chain in some environments, etc Reproductive effects in a non-target organism – sterility, mutations, etc Alteration or disruption of normal interactions of organisms in the environment (ecosystem effects)

14. Data management Deliver timely information to decision makers – Clear data recording and reporting structures – Standardised data sheets – Geo-referencing of data (where appropriate) – Spatial data stored in a Geographic Information System (GIS) facilitating rapid mapping – Compilation in standard structures within Excel, Access, etc Data analysis at regular intervals relevant to the project

15. Thank you Any questions? ¿Preguntas?