FDA Greenlights Commercialization of Gene-Edited Pig Resistant to Devastating Swine Disease PRRSV

The pigs contain an intentional genomic alteration (IGA) accomplished using CRISPR genome editing technology to delete a specific DNA sequence from the pigs’ genome that the PRRS virus (PRRSV) needs to cause infection, making the pigs resistant to PRRSV.

FDA’s review under the Federal Food, Drug, and Cosmetic Act (FFDCA) evaluated the safety and effectiveness of the IGA for its intended use, as well as the risk of environmental impacts. FDA’s evaluation of data submitted by the developer confirmed, among other findings, that (1) pigs containing the IGA are as healthy as pigs without it and (2) food from pigs containing the IGA is as safe, for both humans and animals, as food from conventionally bred pigs. FDA noted that the developer used selective breeding to eliminate any unintended alterations and provided data demonstrating that the intended alteration to the pigs’ genome was achieved to confer resistance to PRRSV. The developer further conducted a food safety assessment substantiating that there were no significant differences in the composition and nutritional content of food from pigs containing the IGA as compared to pigs that do not contain the IGA.

FDA’s environmental risk assessment evaluated the likelihood of escape, survival, dispersal, reproduction, and establishment in the natural environment and whether the alterations conferred greater survival or reproductive success. FDA’s assessment concluded that there is little to no fitness advantage to being resistant to PRRSV under natural conditions, meaning that the likelihood of survival, dispersal, reproduction, and establishment in the environment is no different between pigs with and without the IGA. Therefore, FDA concluded that “the risk to the environment resulting from exposure to pigs with the IGA is no different from the risk to the environment resulting from exposure to domestic pigs without the IGA,” and therefore there would be “no significant impacts on the quality of the human environment in the US.”

According to the developer’s press release, Colombia and Brazil have also issued positive determinations for the technology.

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