USDA Wants One-Stop Biotech Shop

Notice Pitches Plan to Shift Regulatory Control of Genetically Altered Animals From FDA to USDA

Chris Clayton
By  Chris Clayton , DTN Ag Policy Editor
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Just a week after FDA approved its first genetically altered pigs for food and medical use, USDA proposed a plan that would shift regulatory responsibility for genetically altered animals entirely over to USDA. The National Pork Producers Council has called for such changes, arguing FDA's process is too burdensome and slow. (DTN file photo)

OMAHA (DTN) -- Just a week after the Food and Drug Administration approved genetically altered pigs for food and medical use, USDA announced Monday the department is soliciting feedback to take over authority for overseeing regulations for animals produced through genetic engineering.

USDA's Animal and Plant Health Inspection Service (APHIS) already oversees biotechnology for crops. USDA, in issuing an "advance notice of proposed rulemaking" is seeking comments on setting regulations that would give APHIS control of regulations over animals developed through genetic modification as well.

Agriculture Secretary Sonny Perdue described it as a "groundbreaking proposal" that would transfer FDA's current animal biotechnology oversight over to USDA, "providing developers with a one-stop shop for their products at USDA," the department stated.

"Our livestock producers need all the tools in the toolbox to help protect against animal diseases and continue to meet the challenge of feeding everyone now and into the future. If we do not put these safe biotechnology advances to work here at home, our competitors in other nations will," Perdue said. "Science-based advances in biotechnology have great promise to continue to enhance rural prosperity and improve the quality of life across America's heartland and around the globe. With this effort, we are outlining a pragmatic, science-based and risk-based approach that focuses on potential risk to animal and livestock health, the environment, and food safety in order to provide our farmers and ranchers the tools they need to continue to feed, clothe and fuel the world."

The move is a nod to groups such as the National Pork Producers Council, which has repeatedly criticized FDA for its approach to gene editing and other technologies. NPPC has specifically called for USDA to take control of regulatory oversight for animals produced through biotechnology. In a statement, NPPC praised the prospect of USDA taking oversight of gene-editing technology, which the group states can "allow U.S. farmers to produce animals that are more disease-resistant, require fewer antibiotics and have a reduced environmental footprint. Many changes made through gene editing could be achieved through conventional breeding." NPPC, though, stated the costs and timeframe for approval of gene-edited animals under FDA oversight is too cost prohibitive. The group says China, Brazil and Canada are all moving ahead of the U.S. in this area.

"Today's announcement is a big step forward for America's farmers, who have weathered significant challenges over the past few years," said Howard "AV" Roth, a pork producer from Wauzeka, Wisconsin, and president of NPPC. "FDA regulation of gene editing will result in an impractical, lengthy and expensive approval process. Thankfully, that is not the administration's intended plan. This announcement represents a critical milestone to ensuring American agriculture maintains its global competitive edge."

Still, USDA's notice on Monday is simply asking for comments regarding what would happen if USDA moved forward with such a plan. It would be years into the Biden administration before such a rule on biotechnology would be finalized. USDA also noted it would "consult with FDA" on any reviews of biotechnology products involving animals.

A 2017 review of the biotechnology coordinated framework involving USDA, EPA and FDA pointed to complexities within the regulatory system that created challenges for small and mid-sized businesses trying to navigate the process. In 2019, President Donald Trump signed an executive order looking to streamline the regulatory controls of biotechnology among the agencies as well.

Currently, FDA regulates genetic alterations in animals as animal drugs, which the pork producers and others say adds complications to getting regulatory approval for the animals. Under USDA's plans, the department and FDA would sign a memorandum of understanding turning over oversight for genetically engineered animals for certain purposes to USDA. The department's posting in the Federal Register highlights several questions people should consider and submit comments as the potential for a proposed rule moves ahead. USDA opened an initial comment period for 60 days.

Last week, FDA approved its first genetically altered animals for both food and medical use, approving a line of pigs altered to eliminate the alpha-gal sugar, which can cause people to have allergic reaction to red meat. Revivicor, the company working on the "GalSafe" pigs, has been working on the project since 2007.

USDA's advance notice in the Federal Register:…

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Chris Clayton