FDA approves first gene-edited PRRS-resistant pigs for U.S. food supply

USA – The U.S. Food and Drug Administration (FDA) has approved the first-ever gene-edited pigs resistant to Porcine Reproductive and Respiratory Syndrome (PRRS) for use in the American food supply.

The green light, granted to UK-based animal genetics company Genus and its subsidiary PIC, comes after years of intensive research and collaboration with federal regulators. 

PRRS is one of the most devastating diseases in the global pork industry, costing U.S. producers an estimated US$560 million annually due to reproductive failures in sows and deadly pneumonia in piglets.

“This marks a major milestone for consumers, farmers and the entire pork industry who have desperately hoped for a solution to PRRS,” said Matt Culbertson, PIC’s Chief Operating Officer. 

“We have spent years conducting extensive research, validating our findings and working with the FDA to gain approval.”

The approval allows Genus to commercialise its PRRS-resistant pigs, dubbed PRP, for the U.S. market, though sales are not expected until 2026 at the earliest. 

To fully unlock the market, Genus is also pursuing approvals in key U.S. export destinations, including Mexico, Canada and Japan, and is in discussions with regulators in China and other international markets.

Developed using CRISPR gene-editing technology, PIC’s breakthrough targets a specific receptor on pig cells that the PRRS virus uses to enter and infect the animal. 

By knocking out this receptor in pig embryos, the company has bred animals that are effectively immune to nearly all known strains of the virus. 

The resistance trait is passed down to future generations, making it a potentially permanent solution to one of the swine industry’s most costly challenges.

PRRS was first identified in the United States in 1987 and has since become the most important infectious disease among intensively raised pigs in North America, Europe, and increasingly in Asia. 

Its symptoms range from infertility and abortions in breeding females to severe respiratory distress in young pigs, often exacerbated by secondary infections.

Beyond disease prevention, the benefits of this genetic breakthrough could ripple across the pork value chain. 

“Addressing PRRS can allow us to improve animal welfare and reduce the environmental impact of raising pigs,” said Banks Baker, global director of product sustainability at PIC. 

“Recent research indicates that PRRS increases the need for antibiotics by more than 200%. Plus, a recent ISO-conformant lifecycle assessment found that eliminating PRRS could reduce greenhouse gas emissions by 5% in the U.S.”

The FDA’s decision follows a growing trend toward acceptance of gene-edited animals in the food system. In 2020, the agency approved Revivicor’s GalSafe pigs, engineered to eliminate a sugar molecule that can cause allergic reactions, for food and medical use. 

Genetically modified salmon also cleared regulatory hurdles in recent years. However, few such products have yet made it into mainstream grocery aisles, often delayed by slow regulatory pathways and public scepticism.

Still, Genus is optimistic that the simplicity and effectiveness of the PRRS resistance gene edit will smooth the path toward broader acceptance. 

Several countries, including Brazil, Colombia and the Dominican Republic, have already issued positive determinations, choosing to regulate PRP pigs the same as conventional ones.

With operations in more than 25 countries and research laboratories in Madison, Wisconsin, Genus is well-positioned to lead the commercial rollout of gene-edited livestock. 

If successful, PRRS-resistant pigs could become the first widely consumed gene-edited farm animals, ushering in a new era of disease resilience, improved animal welfare, and more sustainable pork production.

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