Historically, genetically engineered (GE) plants that have incorporated genes conferring
insect protection have primarily used Cry proteins derived from Bacillus thuringiensis
(Bt) to achieve their insecticidal phenotype. As a result, regulators have developed a
level of familiarity and confidence in reviewing plants incorporating these insecticidal
proteins. However, new technologies have been developed that produce GE plants
that incorporate pest protection by triggering an RNA interference (RNAi) response or
proteins other than Bt Cry proteins. These technologies have new modes of action.
Although the overall assessment paradigm for GE plants is robust, there are ongoing
discussions about the appropriate tests and measurement endpoints needed to inform
non-target arthropod assessment for technologies that have a different mode of action
than the Bt Cry proteins. As a result, increasing attention is being paid to the use of
sublethal endpoints and their value for environmental risk assessment (ERA). This review
focuses on the current status and history of sublethal endpoint use in insect-active
GE crops, and evaluates the future use of sublethal endpoints for new and emerging
technologies. It builds upon presentationsmade at theWorkshop on Sublethal Endpoints
for Non-target Organism Testing for Non-Bt GE Crops (Washington DC, USA, 4–5 March
2019), and the discussions of government, academic and industry scientists convened
for the purpose of reviewing the progress and status of sublethal endpoint testing in
non-target organisms.