Agricultural biotechnology has the potential to help meet the world’s growing need for food, feed, and fiber while also decreasing the environmental footprint of agriculture. However, farmers in many countries are unable to access genetically modified (GM) products due to regulatory and commercialization constraints. Government policies and data requirements for the safety assessments of GM crops vary across regulatory authorities globally. In addition, technology developers use different study designs to generate the required data, resulting in varying data submitted. Differing timelines for regulatory approvals can cause delays in getting new and innovative products into farmer hands, while asynchrony in approvals can lead to trade disruption. After more than 25 years of safe use and numerous benefits to farmers, consumers and the environment, the time has come to modernize the safety assessment process for GM crops through the global alignment of these policies. The CropLife International regulatory harmonization project has aligned our members on the studies and approaches which constitute a science-based data package given the history of safe use of these crops and our familiarity with the technology. In our approach, data from a set of core studies is used to identify the need for supplementary hypothesis-driven studies. 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. Regulatory harmonization encompasses a range of alignment between national regulatory frameworks. Alignment could be anything from governments having consistent requirements for the regulatory review process, to sharing data and assessments, to mutual recognition or approving a product if it has already received approval from another regulatory agency. Harmonization between different regulatory authorities will reduce the redundancy in the GM approval process and bring products to market faster while maintaining safety standards.

Global regulatory harmonization for agricultural biotechnology

ACS Fall 2021

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.