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USDA asked to handle animal gene editing regulations

PhonlamaiPhoto/iStock/Getty Images gene editing strand of DNA
Agriculture groups again ask for USDA oversight in handling animal biotechnology regulatory approvals.

Livestock and crop groups sent a letter to USDA renewing calls for the department to advance its own animal gene editing regulations. Currently, the U.S. Food and Drug Administration regulates the DNA of genetically modified animals as “animal drugs.” This system leads to a long, cumbersome regulatory approach for developers and academics considering commercialization and imposes numerous post-market barriers on livestock producers looking to adopt animal innovations.

Despite the signing of a Memorandum of Understanding on animal biotechnology at the end of the Trump administration between the USDA and the Department of Health and Human Services, animal biotechnology approvals remain stalled. Secretary of Agriculture Tom Vilsack says he’s committed to working with the FDA on creating proper jurisdiction of animal biotech oversight, but concerns exist on the originally signed MOU.  

In the April 14 letter, the groups highlight numerous challenges facing livestock production, such as animal disease, climate change and feeding a growing global population. The groups contend U.S. livestock producers need access to genetic innovations such as gene editing to address these challenges, but the existing regulatory structure at FDA is unlikely to allow a path to market.

“The FDA’s current regulatory approach – an approach that producers, other stakeholders, and Congress have repeatedly expressed concern with – will only stifle U.S. producers’ access to much-needed innovations. Under the status quo, FDA regulators make case-by-case decisions on innovations to determine their regulatory pathway, data requirements, and ultimate market opportunities. The decades-long approval process for these technologies is based on FDA exercising enforcement discretion under agency guidance rather than through rulemaking. This is an untenable way to regulate,” the letter explains.

As the House Agriculture Committee noted in its October 2021 letter to USDA and FDA, “the existing system is not conducive to the timely adoption of these sorts of innovations.”

Related: Vilsack working with FDA on animal biotechnology

The latest letter urges USDA to continue work initiated under its December 2020 advanced notice of proposed rulemaking to establish a set of risk and science-based regulations for agricultural applications of genetically engineered livestock under the department.

While speaking to media following the National Pork Producers Council legislative fly-in April 7, Andrew Bailey, NPPC science & technology counsel, says NPPC is very supportive of USDA’s rulemaking efforts and NPPC is advocating to develop modern regulations that foster that technology. He explains gene editing in livestock offers the ability for producers to improve their environmental footprint, reduce antibiotic use or prevent against disease.

Bailey adds, “Having the right rules for this to go forward is key to us being competitive on the global market.”

The American Soybean Association, a signee of the letter, adds it is keenly interested in disease-resistance applications of the technology, which can offer livestock producers new tools to protect the health of flocks and herds. Animal disease outbreaks, such as high pathogenic avian influenza or African swine fever, can cause significant disruptions to soybeans and other grain markets used as feed sources by animal producers.

The latest letter was also signed by the American Farm Bureau Federation, National Cattlemen’s Beef Association, National Association of State Departments of Agriculture, National Council of Farmer Cooperatives, National Milk Producers Federation, National Sorghum Producers, National Turkey Federation and the American Sheep Industry Association.

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