The Food and Drug Administration (FDA) is defending its ground against livestock groups who want to see regulatory oversight of livestock gene editing transferred from the FDA to USDA.
The National Pork Producers Council (NPPC) says regulatory oversight should be in the hands of USDA, which oversees genetic changes in plants along with FDA and EPA.
FDA’s draft guidance on the issue states an intentional genomic alteration (IGA) meets the definition of a drug because it affects the structure and function of the animal, Capital Press reported.
Steve Solomon, director of FDA's Center for Veterinary Medicine, says 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 — disagree and claim FDA's process is too cumbersome and slow.
"Gene editing is a huge step forward for America's farmers, as it offers a powerful new way to combat animal disease," Dr. Dan Kovich, NPPC's director of science and technology, told reporters on a June 25 conference call to announce the gene editing campaign. "With gene editing, livestock breeders can knock out specific genes that make animals vulnerable to viral infections. Healthier animals benefit both farmers and consumers."
Under FDA regulation, gene editing faces an impractical, lengthy and expensive approval process, threatening hundreds of thousands of jobs and nearly 6% of U.S. Gross Domestic Product, Kovich says.
NPPC’s public campaign to build support for USDA obtaining jurisdiction over biotech animals comes as African swine fever (ASF) continues to spread rapidly in the Eastern Hemisphere. China and the European Union are devoting resources to explore how gene editing may be able to make pigs resistant to disease, including the ASF virus.
“If this situation were to occur and they were successful in doing this, they could protect their domestic production,” says Dr. Bradley Wolter, a leading pork producer and president of The Maschhoffs, a company that produces over 4 million market hogs per year. “Meanwhile, we here in the U.S. are concerned daily about the U.S. pig population being decimated by ASF. It’s a large business risk for us today and its hampering investment as we know it. The concern we have as producers is that the current FDA regulation precludes the use of gene editing in the U.S. as a means of mitigating that risk.”
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, Politico reported.
More from Farm Journal's PORK: