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USDA Oversight of Gene-Edited Livestock: A Seismic Shift for Agriculture

Jennifer Shike

December 21, 2020

USDA announced its intention on Monday to have primary oversight over gene-edited livestock. Secretary of Agriculture Sonny Perdue said this would be a significant step in modernizing regulations of agricultural animals modified or produced by genetic engineering.

“This would be a seismic shift for agriculture,” Greg Ibach, USDA undersecretary for marketing and regulatory programs, told AgriTalk’s host Chip Flory on Monday. “This provides an opportunity for U.S. animal agriculture to catch up with our competitors worldwide, since Canada, Argentina, Brazil and China all have paths forward for animal biotechnology that improve animal health and animal welfare and we do not. This will help our producers be able to use less antibiotics, treat fewer sick animals, and be able to eliminate traits that like horns that cause animal stress in the production cycle.”

Last year, President Trump ordered federal agencies to streamline the approval process for biotechnology products used in farming. Secretary Perdue announced that USDA will move forward with an Advanced Notice of Proposed Rule-making (ANPR) to solicit public input and feedback on a contemplated regulatory framework that would modernize our system into a scientifically-sound, risk-based, and predictable process that facilitates the development and use of these technologies for U.S. farmers and ranchers under USDA’s authorities.

“Earlier this year we moved forward with the secure rule which paved the way for the first update for plant biotechnology regulation in 30 years. We've continued to work and using APHIS’ animal health authorities and FSIS’ food safety authorities, we now have a proposal that we would like to take comments on where we would use those authorities to be able to provide a safe, seamless, predictable, science-based way forward to approve animal biotechnology trade,” Ibach explained.

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

“FDA has taken a look at the food animal biotechnology trade and has attempted to regulate them under their drug authority,” Ibach said. “As we know, these don’t represent drugs, they are alternations that enhance health, enhance animal welfare – traits like the hornless Holstein cow that was developed by Alison Van Eenennaam. Working with FDA to identify a path forward using our animal health and food safety regulatory authority for food animals is progress.”

FDA would still maintain authority over animals that have biotechnology traits that allow for biomedical or pharmaceutical uses, he added.

“It seems like common sense to have this at USDA rather than FDA. But that's from a farm boy’s perspective,” Flory said.

So, how do you explain this to a consumer?

“Each and every day and for the past 30 years, USDA has regulated plant biotechnology and we've identified traits and advances in plants that have improved the availability of food for consumers across the world and lessened the amount of herbicides and pesticides used to produce crops,” Ibach said. “And we've done that successfully without any adverse side effects.”

USDA plans to use the same food safety and animal health statutes where they have authority to regulate animals and apply them to animal biotechnology.

A Quantum Leap Forward The U.S. has long been a leader in livestock genetics. Unfortunately, without a clear path forward, researchers are going to Canada, Brazil, Argentina and China to be able to commercialize these technologies because we do not have a clear path forward in the U.S., Ibach said.

“This will help us be able to put American farmers and ranchers first – put them in the driver's seat – if we can develop a predictable regulatory authority that will give them access to these traits and not their foreign competitors,” Ibach added.

Without this change, it will become continually harder for the U.S. to compete. Moving oversight to USDA will make the process better to advance technology to develop immunities that would reduce the use of antibiotics, develop traits that would ensure continued humane treatment and maybe even enhance humane treatment on our farms, and decrease animal suffering and all those things would be good for consumers, he said.

The Federal Register will publish this posting on Dec. 28, beginning a 60-day comment period. Ibach encouraged all interested parties to give input about what they would like to see and what the advantages they see to USDA moving forward with a rule-making and what factors would be important in a proposed rule from USDA.

“We think this is something that is very good for agriculture, and that it's not administration-driven. It will be just as good for agriculture today as it will be in 3060 or 360 days from today. We believe that we'll see a strong response from agriculture and animal agriculture especially. We anticipate that the comments that we will receive will be used by the next administration as they contemplate moving forward with a rule,” Ibach said.



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