Recommendations for Science-Based Safety Assessment of Genetically Modified (GM) Plants for Food and Feed Uses

Since the commercial introduction of genetically modified (GM) plants in agriculture over two decades ago, technology developers and regulatory authorities have gained significant experience in evaluating their safety based on assessing potential impact to humans, animals and the environment. Over 3,500 independent regulatory agency reviews have positively concluded on the safety of GM plants for food and feed. Yet, divergent and increased regulatory requirements have led to delayed and asynchronous approvals and have restricted access to innovative products for farmers and consumers. With accumulated knowledge from safety assessments conducted so far, an enhanced understanding of plant genomes, and a history of safe use, it is time to re-evaluate the current approaches to the regulation of GM plants used for food and feed. A stepwise approach using weight-of-evidence should be sufficient for the safety assessment of newly expressed proteins in GM plants. A set of core studies including molecular characterization, expression and characterization of the newly expressed proteins (or other expression product), and safety assessment of the introduced protein, are appropriate to characterize the product and assess safety. Using data from core studies and employing a “problem formulation” approach, the need for supplementary hypothesis-driven or case-by-case studies can be determined. Employing this approach for the evaluation of GM plants will remove regulatory data requirements that do not provide value to the safety assessment, and provide a consistent framework for global regulation.