2018 SOT FDA Colloquium: Food from Genetically Engineered Plants: What Role for Metabolomics?—June 13, 2018

The Society of Toxicology in conjunction with the US FDA Center for Food Safety and Applied Nutrition (CFSAN) have partnered to provide this colloquia series. The series presents scientific information that is high-quality, cutting-edge, future-oriented toxicological science to provide a well-grounded foundation to inform the work of US FDA employees.

On June 13, 2018, SOT and US FDA hosted a colloquium describing the premarket safety assessments performed for foods from genetically engineered plants and examined the scientific factors important when considering whether metabolic profiling data would have utility or added value in the safety assessment of food from genetically engineered plants.

New plant varieties intended for commercial release have routinely been examined for agronomic characteristics and product quality (e.g., taste and suitability for processing) prior to commercialization. Foods from varieties that have passed these premarket analyses have historically been safe. In addition to these analyses, food safety assessments of genetically engineered crops routinely include, among other analyses, a targeted compositional analysis typically comparing the levels of toxicants, anti-nutrients and key nutrients in food from the new variety to those in food historically consumed. The intent of this analysis is to determine whether there have been changes in the levels of key substances in the food that would be important from a nutritional or toxicological perspective. While the methods historically used for this assessment have been reliable, new methods (referred to as metabolic profiling or sometimes metabolomics) provide the ability to produce a molecular profile of new varieties that spans more substances than typically examined in the focused biochemical analysis. Although metabolic profiling may provide more data about the composition of food from a new variety, it is not certain that metabolic profiling would routinely improve predictability of food safety assessments.
Plant composition may be affected by a wide range of factors (e.g., genetics, environment, life stage, etc.) that have not historically precipitated food safety issues in new varieties. Only in notable exceptions has food from new plant varieties contained harmful levels of endogenous substances.