FDA is defending its regulatory turf in a battle over genetically engineered animals amid the farm lobby’s push for USDA to take control of the burgeoning technology, Pro Ag’s Liz Crampton reports this morning. At stake is the oversight of innovations like pigs that are resistant to certain diseases or dairy cows that are more productive. To date, FDA has only approved one biotech animal after two decades of review: AquAdvantage salmon, which has been genetically modified to grow faster.
The regulatory landscape: Factions of the farm lobby, led by the National Pork Producers Council, argue that transferring oversight can be done by amending an inter-agency agreement outlining the government’s responsibilities over biotechnology – known as the Coordinated Framework. FDA disagrees, however, contending that its authority stems from a law passed by Congress, which supersedes any changes to the Coordinated Framework.
Steve Solomon, director of FDA’s Center for Veterinary Medicine, said the agency has the right framework and expertise after decades of reviewing biotech applications and building teams that are steeped in the science.
NPPC and its allies – including the National Cattlemen’s Beef Association, American Farm Bureau Federation and National Association of State Departments of Agriculture – say FDA’s process is too cumbersome and slow.
Their public campaign to build support for USDA obtaining jurisdiction over biotech animals comes as African swine fever decimates China’s massive hog herd. U.S. producers point to the expectation that within a few years gene-editing technology will enable breeding of hogs that are resistant to diseases that threaten to wipe out entire herds.
FDA leaders said they’re taking steps to update guidelines so innovations in GE animals are balanced with its overarching goal of protecting public health and safety. For example, FDA has started to identify animals with altered DNA that would be low-risk, and therefore be exempt from a safety review.