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FDA Stalls U.S. Gene-Edited Livestock Efforts

Jennifer Shike


January 14, 2021



In public comments earlier this week, current FDA commissioner Stephen Hahn said he would refuse to sign the memorandum of understanding between the FDA and USDA addressing gene-edited livestock. Hahn cited “concerns about its legality and the potential health repercussions of relaxing oversight of certain genetically altered products,” Politico reports.


For the past two years, the FDA has stalled progress on the development of gene-edited livestock, an emerging technology with tremendous promise for livestock agriculture, causing American agriculture to fall behind in the global race to advance its development. Under a recently proposed rule, the USDA will have primary regulatory jurisdiction, which “will foster innovation, allow for producer access to this technology, and preserve the preeminence of American agriculture globally,” the National Pork Producers Council (NPPC) wrote in comments submitted Wednesday to the agency.


“…[M]any of our competitor nations have or are moving towards common sense, risk-based regulatory models that capture all agricultural applications and that offer clear pathways to commercialization … Even the European Union, long viewed as a bastion against agricultural innovation, is having meaningful discussion about accessing the benefits of gene editing. This is already placing U.S. livestock and poultry producers at a disadvantage,” NPPC wrote.


If left unaddressed, this disadvantage will set the U.S. back even further, supporters claim. Meanwhile, China, Brazil, Canada and other global competitors will move ahead in the race to pursue this technology.


“We simply cannot allow U.S. farmers and ranchers to lack the same animal health and food safety advantages as producers in other countries,” NPPC wrote.


Gene editing is used to make specific changes within an animal’s own genome. It allows livestock producers to raise animals that are more disease-resistant, require fewer antibiotics and have a smaller environmental footprint.


“The USDA has put forward an open and transparent process to establish regulatory certainty surrounding a promising technology,” NPPC President Howard “A.V.” Roth, a hog farmer from Wauzeka, Wis., said in a release. “We are disappointed that the FDA continues to engage in delay tactics that are holding back U.S. agriculture. U.S. pork producers are dedicated to rigorous, science-based policies to ensure food safety for all consumers.”


FDA regulation will result in an impractical, lengthy and expensive approval process, Roth explained.


“U.S. agriculture can’t continue to be sidelined while our competitors move ahead with this critical technology,” Roth said. “USDA needs to be in the driver’s seat on gene-edited livestock and we look forward to working with the Biden administration on its implementation.”


The USDA’s Animal and Plant Health Inspection Service (APHIS) has a review process in place for gene editing in plants, which can serve as a model for livestock, NPPC said in a release.


The U.S. pork industry acknowledges consumer acceptance is critical and the industry is committed to transparency when using this technology in the future, NPPC added. Currently, there are no gene-edited pigs entering the food supply. NPPC said it seeks a regulatory framework that will not stifle innovation and drive use of this breakthrough technology overseas.


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