(This is an abstract of the full report as provided by the URL link above)

The environmental risk assessment is performed according to Annex II of European Directive 2001/18/EC (EU, 2001). The Guidance document on the Environmental Risk Assessment (ERA) of GM insects of the European Food Safety Authority (EFSA, 2013) is used to evaluate potential risks for human health and the environment. Where relevant, also other, guidance documents with respect to GM insects are considered.
This EFSA Guidance describes seven ‘areas of concern’ that are to be taken into account in the ERA of GM insects. For each of these areas of concern it is considered whether the release of OX513A in Saba could lead to adverse effects on human health and the environment, in comparison to effects of the non-modified Aedes aegypti. Effects are considered in the context of current vector control program.

These areas of concern are the following:
1. Persistence and invasiveness of GM insects, including vertical gene transfer
2. Horizontal gene transfer
3. Pathogens, infections and diseases
4. Interactions of GM insects with target organisms
5. Interactions of GM insects with non-target organisms
6. Environmental impact of the specific techniques used for the management of GM insects
7. Impacts of GM insects on human and animal health

The molecular characterization of OX513A together with its phenotypic and behavioral characteristics are considered to establish whether there are any intended or any unintended changes in OX513A, as a result of the genetic modification, that could lead to a potential adverse effect on human health and the environment. The result of this comparative safety assessment demonstrates that the only differences of biological relevance are the expression of the two introduced traits; the self-limiting trait (tTAV) and the fluorescent marker trait (DsRed2). Therefore the ERA focuses on potential adverse effects of these new traits in OX513A, in comparison to effects of the non-modified Aedes aegypti.

For all areas of concern (EFSA, 2013) there is sufficient information to conclude that adverse effects on human health and the environment are unlikely.  Adequate measures and controls are taken to prevent unintended environmental release of OX513A during rearing of OX513A Aedes aegypti before their release. Moreover, in all environmental releases to date OX513A has performed consistently with respect to parameters identified in risk assessments and no unanticipated results or unintended effects have been observed.

The GMO Office concludes that potential adverse effects on human health and the environment as a consequence of the potential release of genetically modified OX513A on the island of Saba, under the conditions as described in the documentation of Oxitec and in the context of standard vector control, are considered to be negligible as compared to effects of non-modified Aedes aegypti.  This is in line with recent related environmental risk assessments such as from Brazil and the United States Food and Drug Administration.