Sublethal Endpoints in Non-target Organism Testing for Insect-Active GE Crops

Area of Science:

• Environmental Risk Assessment
• Genetically Engineered (GE) Crops
• Arthropod Toxicology

Background:

• Traditional insect-resistant GE crops utilize Bacillus thuringiensis (Bt) Cry proteins, a technology with established regulatory familiarity.
• Emerging GE crop technologies employ novel pest protection mechanisms like RNA interference (RNAi) or non-Bt proteins, presenting new modes of action.
• Existing regulatory frameworks for GE plants are robust but require adaptation for these new technologies.

Purpose of the Study:

• To review the historical and current use of sublethal endpoints in assessing insect-active GE crops.
• To evaluate the future application of sublethal endpoints for novel GE crop technologies.
• To inform discussions on appropriate testing and measurement endpoints for non-target arthropod risk assessment.

Main Methods:

• Literature review focusing on sublethal endpoint studies in insect-active GE crops.
• Analysis of discussions and presentations from the Workshop on Sublethal Endpoints for Non-target Organism Testing for Non-Bt GE Crops (2019).
• Synthesis of expert opinions from government, academic, and industry scientists.

Main Results:

• Increasing attention is being paid to sublethal endpoints for environmental risk assessment (ERA) of GE crops.
• Sublethal endpoints offer valuable data for assessing the impact of novel GE technologies on non-target organisms.
• There is an ongoing need to refine testing strategies for non-target arthropod assessments for non-Bt GE crops.

Conclusions:

• Sublethal endpoints are crucial for the comprehensive environmental risk assessment of emerging GE crop technologies.
• Further research and consensus-building are needed to standardize the use of sublethal endpoints in regulatory science.
• Adapting risk assessment paradigms is essential to ensure the safety of novel pest-protected GE crops.