New proposed rule offers pathway for USDA, rather than FDA, to oversee regulatory framework for animal biotechnology.
USDA is contemplating taking on regulatory oversight of food animals genetically modified for agricultural purposes. This was previously handled by the Food and Drug Administration who treated genomic modifications as drugs and created significant roadblocks for U.S. companies looking to blaze a path for future disease-resistant and nutritionally enhanced livestock species.
In an advanced notice of proposed rulemaking, the Trump administration announced Dec. 21 its intention for USDA to have primary oversight over gene-edited livestock. Gene editing is seen by those in the industry as a promising new technology that can help farmers breed healthier, more resilient animals, and many within the industry have been asking for USDA to take on the regulatory oversight from FDA.