Table 2 Recommendations on ERA for gene drive applications

1.Additional guidance for ERA of gene drive applications should be developed by a broad range of actors

2.The definition of the term ‘Target Organism’ for gene drive applications involving species complexes requires more nuanced consideration than for other GMO applications

3.ERA for gene drive applications should be founded in a problem formulation approach and addressed using specific operational protection goals

4.Engagement, specifically in the problem formulation stage for ERAs of gene drive applications, should include actors with broad expertise

5.Use of ‘realistic worst case scenarios’ should be considered when testing risk hypotheses in pathways to harm in ERA for gene drive applications

6.A range of comparators should be considered in ERA for gene drive applications in order to contextualize risks

7.ERA for gene drive applications should draw on the range of probabilistic and qualitative analyses, depending on data availability, levels of uncertainty, and the nature of the risks being assessed

8.ERA of potential ecological risks from gene drive applications should use concepts of ecological interaction networks to assess the impacts on dynamic properties that have been defined as important on the basis of biological considerations and stakeholder values

9.Engagement in ERA for gene drive applications should complement engagement in (i) related impact assessments, (ii) risk governance frameworks and (iii) national policy-making contexts