WASHINGTON, DC, US — Several grain and oilseed coalitions recently submitted comments to the White House Office of Science and Technology (OSTP), calling for more transparency, better communication and broader accountability by government agencies in the development and commercialization of genetically engineered products.
The North American Millers’ Association along with the American Frozen Food Institute, the Corn Refiners Association, the Institute of Shortening and Edible Oils, the National Grain and Feed Association, the National Grocers Association, the National Oilseed Processors Association and the North American Export Grain Association collectively submitted a letter on Feb. 3 listing comments and recommendations in response to a request by the OSTP to help identify ambiguities, gaps, inefficiencies and uncertainties in the current Coordinated Framework for the Regulation of Biotechnology.
The Coordinated Framework, which was last updated in 2017, is the federal policy that provides guidelines for regulating the development and commercialization process of products produced by biotechnologies. Its intent is to ensure safety standards are upheld for humans, animals and the environment through the coordinated efforts of the US Department of Agriculture, the Food and Drug Administration and the Environmental Protection Agency.
In their comments, the agricultural groups affirmed their support for the utilization and advancement of biotechnology, but they expressed concerns about the framework’s lack of transparency, its ambiguity regarding agency jurisdictions and its inability to offer a predictable timeframe for biotechnology product approvals.
To address these concerns, the groups recommended several amendments to the Coordinated Framework, including mandatory notification and transparency, which would require all companies developing biotech products to notify the FDA and make their information public. They said the companies should also be required to inform the FDA when a genetically engineered trait contains an allergen, and the framework should give the FDA allergen oversight on these traits as well as mandate the FDA’s review of the biotech products’ safety, nutritional and functionality claims.
The groups also recommended involving additional agencies like the Agricultural Marketing Service, the Foreign Agricultural Service and the Office of the US Trade Representatives within the Coordinated Framework to support international marketability of innovative technologies as well as help define government strategies to overcome potential non-science-based barriers that might hinder commercial prospects.Additionally, the groups suggested a full reorganization of the FDA to improve the agency’s structure, leadership, culture, transparency and accountability; improvement in the agencies’ outreach and communication by developing straightforward guidance on the scope of regulations, data requirements, regulatory processes and bases for decision-making for regulatory reviews, to help bolster stakeholder certainty and public trust; and a periodic review of the Coordinated Framework at least every five years to stay current and relevant on rapidly advancing biotechnology innovations.