Development of a construct-based risk assessment framework for genetic engineered crops

Area of Science:

• Agricultural Biotechnology
• Genetics and Genomics
• Food Safety and Toxicology

Background:

• Extensive experience with genetically engineered (GE) crop risk assessment (RA) since the 1990s has prompted global agencies to re-evaluate RA criteria.
• A specific need for scientific discussion on GE crops developed with identical or similar genetic constructs was identified in Argentina.

Purpose of the Study:

• To discuss and define a science-based evaluation approach for new transformation events in GE crops that utilize genetic constructs identical or similar to those previously assessed.
• To cover both environmental and food safety aspects for these GE crops.

Main Methods:

• Convened a tripartite working group under the International Life Sciences Institute (ILSI Argentina) to discuss evaluation approaches.
• Defined a 'construct similarity' concept based on the biological function of introduced genes.
• Considered new transformation events in the same or different species.

Main Results:

• A construct similarity concept was defined, focusing on the biological function of introduced genes.
• Key factors for a construct-based RA process were identified, including environmental and dietary exposure, familiarity with the crop and trait, and crop biology.

Conclusions:

• A construct-based RA approach is feasible for GE crops using identical or similar genetic constructs.
• This approach enhances scientific discussion and provides a framework for evaluating new transformation events efficiently and safely.