Table 7.
Similarities and differences across disease vector/pest control strategies that involve the release of genetically modified insects [GMIs] (carrying a dominant [female lethal] transgene or containing an engineered gene drive), and non‐GMIs (sterile insect technique, Wolbachia‐mediated incompatible insect technique and pathogen interference, and biological control)
| Aspects | Disease vector/pest control strategies involving the release of living insects | ||||||
|---|---|---|---|---|---|---|---|
| Sterile insect technique (SIT) | Release of insects carrying a dominant lethal transgene (RIDL) or a dominant female lethal transgene (fsRIDL) | Wolbachia‐mediated incompatible insect technique (IIT) | Wolbachia‐mediated pathogen interference (PI) | Biological control | Engineered gene drives | ||
| Augmentative biological control (ABC) | Classical biological control (CBC) | ||||||
| Intended outcome | Population suppression | Population suppression | Population suppression | Population modification | Population suppression | Population suppression | Population suppression, or modification dependent on engineered gene drive system |
| Released insect | Species already present (or regularly invasive) in the receiving environment | Species already present in the receiving environment | Species already present in the receiving environment | Species already present in the receiving environment | Native (usually) or exotic species | Exotic species (e.g. predator, parasitoid) from the area of origin of the target organism | Species already present in the receiving environment |
| Males | Males | Males | Females only, or both sexes | Both sexes | Both sexes | Depending on engineered gene drive system | |
| Target organism | Within a species | Within a species | Within a species | Within a species | Another (exotic) species and another trophic level | Another (exotic) species and another trophic level | Within a species |
| Species‐specificity | High (mating) | High (mating) | High (mating) | High (mating) | Depending on host and environment specificity | Depending on host and environment specificity | High (mating) |
| Potential to spread * | Low (localised) | Low (localised) | Low (localised) | High (non‐localised) | Low (localised) | Intended (dependent on climatic, biological and ecological characteristics) | Depending on engineered gene drive system (localised or non‐localised) |
| Potential to persist * | Low (self‐limiting) | Low (self‐limiting) | Low (self‐limiting) | Intended (self‐sustaining) | Low (self‐limiting) | Intended (self‐sustaining) | Depending on engineered gene drive system (self‐limiting or self‐sustaining) |
| Scale of open releases | Area‐wide/decades | Local/years | Local/years | Local/years | Local/decades | Area‐wide/decades | No open releases at the time of writing |
| Regulatory context | Technology is not regulated per se | Subject to pre‐market ERA and regulatory approval in most jurisdictions. Regulated as GMO | Jurisdiction‐specific | Jurisdiction‐specific | Subject to pre‐market ERA and regulatory approval in most jurisdictions | Subject to pre‐market ERA and regulatory approval in most jurisdictions | Subject to pre‐market ERA and regulatory approval in most jurisdictions. Regulated as GMO |
| Primary (risk) assessment focus | Characterisation of insect for release, and an EIA dependent on the scale of release | Molecular characterisation, characterisation of insect for release, and case‐specific ERA (see EFSA, 2013) | Characterisation of insect for release, and assessment of non‐target and food web effects | Characterisation of insect for release, and assessment of non‐target and food web effects | For native species, characterisation of insect for release and quality assurance; for exotic species concerns are as is the case for CBC | Characterisation of insect for release and case‐specific ERA (e.g. assessment of non‐target and food web effects) | Molecular characterisation, characterisation of insect for release, and case‐specific ERA (see Section 5.1) |
| (Risk) Mitigation | Sterility and sex sorting quality assurance, and field population monitoring during releases. Stop the release | Case‐specific (susceptibility to common insecticides confirmed). Stop the deliberate release | Effective sexing technology is required to minimise the risk that Wolbachia‐infected females are released. Susceptibility to common insecticides confirmed. Stop the release | Susceptibility to common insecticides confirmed | Quality assurance in rearing and release to prevent contamination | Quality assurance in rearing and release to prevent contamination | Case‐specific |
| Post‐release monitoring | Sterilised insects should be marked to monitor release and SIT efficacy evaluation | Mandatory in some jurisdictions (e.g. EU) | Not mandatory. If monitoring is conducted, it focuses on efficacy evaluation | Not mandatory. If monitoring is conducted, it focuses on efficacy evaluation | Not mandatory. If monitoring is conducted, it focuses on efficacy evaluation | Expected in the NAPPO region and recommended by EPPO. Focus is on species establishment and efficacy of target population suppression | Mandatory in some jurisdictions (e.g. EU) |
EIA: environmental impact assessment; EPPO: European and Mediterranean Plant Protection Organization; ERA: environmental risk assessment; GMO: genetically modified organism; NAPO: North American Plant Protection Organization; NTO: non‐target organism; TO: target organism.
*
Of the genetic modification of interest or biological control agent.