Problem Formulation for Off-Target Effects of Externally Applied Double-Stranded RNA-Based Products for Pest Control.

Area of Science:

• Environmental Science
• Biotechnology
• Risk Assessment

Background:

• Double-stranded RNA (dsRNA)-based biocontrol products can potentially degrade messenger RNA (mRNA) in both target and non-target organisms.
• Comprehensive profiling of all potential off-target effects is impractical and ineffective for regulatory decision-making.

Purpose of the Study:

• To propose an effective framework for the regulatory risk assessment of dsRNA-based biocontrol products.
• To shift the focus from cataloging off-target effects to establishing criteria for acceptable risk.

Main Methods:

• Problem formulation to derive criteria for acceptable risk.
• Developing a hypothesis-testing plan to evaluate dsRNA product safety based on these criteria.

Main Results:

• The study argues that a comprehensive catalog of off-target effects is unnecessary and ineffective for risk assessment.
• Effective risk assessment hinges on determining if product properties indicate acceptable or unacceptable risk, irrespective of on-target or off-target origins.

Conclusions:

• Regulatory risk assessment for dsRNA biocontrols should prioritize defining acceptable risk thresholds.
• The focus should be on the inherent properties of the dsRNA product and its potential to cause harm, rather than exhaustively documenting every possible off-target interaction.