Biotechnology

The USDA has rescinded a regulatory strategy for biotech products that would have officially exempted certain modern gene-edited plants from being regulated. The proposed plan was withdrawn due to concerns from groups in industry and academia that the strategy would have increased the number of burdensome requirements for safety assessments in the early development stage of biotech products. In its announcement of the plan’s withdrawal, the USDA stated that it is reexamining the rules to bolster public confidence and create a review process that will not interfere with biotechnological innovation.

The strategy was proposed in January and was meant in part to clarify where the Agency stands in regards to the regulation of plants made through new genetic technologies, such as CRISPR. Certain gene-edited plants would have been exempt from the definition of gene editing. The regulation would have required the USDA’s Animal and Plant Health Inspection Service to begin evaluating plants for their potential of transforming into toxic weeds that are a danger to crops, animals, agriculture, the environment or human health. Risk assessment requirements would have also increased, with small companies and academics being affected the most due to the high costs associated with meeting the conditions. The USDA announced it will begin new discussions with stakeholders to explore alternative approaches.

Source: Science

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