Assessment of genetically modified maize DP202216 × NK603 × DAS-40278-9 (application GMFF-2022-6232)

Area of Science:

• Agricultural Biotechnology
• Genetics and Molecular Biology

Background:

• Genetically modified (GM) maize events are developed to enhance crop traits.
• DP202216 × NK603 × DAS 40278-9 is a three-event stack maize combining DP202216, NK603, and DAS-40278-9 single events.
• These events confer herbicide tolerance and potential yield enhancement.

Purpose of the Study:

• To assess the food, feed, and environmental safety of the three-event stack maize DP202216 × NK603 × DAS 40278-9.
• To evaluate the safety of newly expressed proteins and altered endogenous proteins.
• To confirm the safety of sub-combinations and interactions between single events.

Main Methods:

• Molecular characterization of the stacked event.
• Comparative analysis of agronomic, phenotypic, and compositional characteristics.
• Toxicological, allergenicity, and nutritional assessments.
• Evaluation of potential interactions among single events in sub-combinations.

Main Results:

• Previous safety assessments of single events and a sub-combination found no concerns.
• No new data altered the original safety conclusions for single events.
• Molecular characterization, comparative analyses, and safety assessments indicate no food, feed, or nutritional concerns.
• Interactions among single events in sub-combinations are not expected to pose safety risks.
• Environmental release and accidental spillage are not expected to raise environmental safety concerns.

Conclusions:

• The three-event stack maize DP202216 × NK603 × DAS 40278-9 is as safe as its non-GM comparator and reference varieties for human and animal health.
• No post-market monitoring for food/feed is deemed necessary.
• Environmental safety concerns are not anticipated.
• The GMO Panel concludes the stacked maize and its sub-combinations are as safe as non-GM counterparts for human, animal, and environmental health.