The U.S. hog industry is going to the White House in its campaign for the USDA to supplant FDA as the federal regulator of gene-edited food animals, leaders said on Tuesday. The industry says American preeminence in science and agricultural exports will suffer if gene-edited advances such as disease-resistant pigs are hog-tied by a needlessly long and costly approval process.
“We’re looking for leadership from the White House,” said Dan Kovich, science director of the National Pork Producers Council, perhaps by convening a meeting where regulatory roles would be adjusted. “This should not require legislation.” The USDA, FDA and EPA currently share responsibility for review and approval of biotech products. “We are actively working with the administration and interested parties on (Capitol) Hill on ways to move forward,” Kovich said.
The NPPC began its “Keep America first in agriculture” drive almost as soon as President Trump signed an executive order on June 11 calling for streamlining of federal regulation of agricultural biotechnology. Referring to gene-edited crops and animals, the executive order told regulators to use their existing powers “to exempt low-risk products of agriculture biotechnology from undue regulation.” NPPC president David Herring said, “We are hopeful that this executive order breaks the FDA’s current grip on gene editing so a regulatory framework can be established at the USDA to ensure that American farmers – not our competitors in foreign markets – realize its vast potential.”
Since the early days of GMOs, the USDA has been in charge of biotech plants while FDA, with roles in food and medicine, oversees gene-altered animals. Dozens of biotech plants have been approved. The FDA was consumed for years in review and approval, in 2015, of AquaBounty Technologies’ GMO salmon, the first genetically engineered animal allowed into the U.S. food supply.
Kovich and other hog industry officials said FDA would impose unduly stringent rules on gene-edited animals. Andrew Bailey, an NPPC lawyer specializing in technology, said the agency would treat GE animals as drugs and farms as drug production facilities. In an essay this week, Herring called FDA control of GE livestock “regulatory overreach” based on a decision years ago that was aimed at laboratory animals. “Gene editing in livestock and poultry should be under the USDA’s jurisdiction.”
FDA officials said in April that gene editing hold tremendous potential for animal health, enhanced farm output, better nutrition and less use of antibiotics. The agency announced a risk-based regulatory framework for plant and animal biotechnology last October. “We expect regulations and data submissions will continue to become more streamlined and focused on assessing any residual uncertainties” as the technology becomes more familiar, said then-FDA commissioner Scott Gottlieb and deputy commissioner Anna Abram.
“It’s important to clarify that the FDA is not regulating an animal as a drug. Rather, the agency regulates the intentional genomic alteration in the animal, not the animal itself. We don’t consider farmers or producers who simply purchase and raise animals with intentional genomic alternations to be drug manufacturers or their farms to be drug-manufacturing sites in the traditional sense of those terms. And we won’t use nomenclature that could wrongly imply that the animals or the farms should be classified that way,” said Gottlieb and Abram.
Kovich was skeptical. Genomes are part of animals so FDA’s reach could be extensive, he told reporters.
NPPC and FDA officials separately mentioned similar potential advances through gene-editing; hogs resistant to Porcine Reproductive and Respiratory Syndrome and poultry that does not succumb to highly pathogenic avian influenza. The FDA mentioned Bovine Respiratory Disease and the NPPC cited African swine fever as areas where gene editing could be beneficial.
Agriculture Secretary Sonny Perdue told a farm meeting in Iowa that he would lobby Trump for FDA to share authority with USDA on gene-edited animals. “I’m going to try to persuade the president they need to share that ball. They need to hand it off sometimes,” Perdue said on Sunday according to DTN/Progressive Farmer.
According to the pork council, Brazil Argentina and Canada have regulatory regimes more congenial to gene editing than does the United States, so they might gain an advantage in producing hogs with less fear of disease and at lower cost. “It stretches credulity and no other country on earth is proposing to regulate editing as a drug,” said Alison Van Eenennaam, a researcher at UC-Davis who promotes gene editing as a way to produce dairy cattle without horns.
Nearly a quarter of U.S. pork is exported. The United States is the world’s largest agricultural exporter.