The U.S. Food and Drug Administration has authorized meat from gene-edited pigs, produced by researchers at Washington State University (WSU), for human consumption. The gene-editing tool CRISPR is being used to modify genetic traits of the line of pigs.

The work is led by Jon Oatley, Ph.D., Associate Dean for Research for the College of Veterinary Medicine and tenured Professor in the School of Molecular Biosciences. He undertook the investigational food-use authorization process for five gene-edited pigs to demonstrate that food made from the animals is safe to eat and that it is possible for an academic institution to achieve this type of FDA authorization.

Gene-editing can achieve changes to an organism’s DNA that could occur in nature or through selective breeding but would take much longer without a tool like CRISPR, explains WSU. The FDA authorization is investigational, and limited to the particular line of pigs included in Dr. Oatley’s research, but shows that gene-editing livestock to quickly produce desirable traits for improved food production is possible.

The 2-year-old pigs were processed at the WSU Meat Lab, and the U.S. Department of Agriculture (USDA) inspected the meat. Working with the Meat Lab, meat scientist Blake Foraker, Ph.D. processed some of the pork into sausages, which will be used in catering services that raise travel funds for the student members of the WSU Meat Judging team.

The pigs were originally gene-edited in a way that would enable researchers to use them to sire offspring with traits from another male pig. Known as surrogate sires, this technology first gene-edits male animals to be sterile by knocking out a gene called NANOS2 that is specific to male fertility. These animals can then be implanted with another male’s stem cells that create sperm with that male’s desired traits to be passed on to the next generation.

Essentially a high-tech form of selective breeding, surrogate sire technology can expand dissemination of valuable genetics in livestock. It has the potential to improve meat quality and the health and resilience of livestock in the face of changing environmental conditions, which is a goal for increasing protein sources in developing nations.

The surrogate sires’ progeny, which are themselves not gene-edited, have not yet been reviewed by FDA for possible inclusion in the food chain. Securing the investigational approval for these five pigs required clearing a number of hurdles. FDA waives some fees for nonprofits like universities, but by the time the process was completed, Oatley’s team had spent two years and approximately $200,000 collecting data for this authorization.

Only one other organization, the company Acceligen, has received FDA approval for a gene-edited animal. In 2020, FDA made a low-risk determination for products made from “Slick-Haired Cattle” that are gene-edited to have coats that increase the animals’ resilience to higher temperatures. Other companies have received FDA approval for genetically-modified animals, but for transgenic approaches, which involves a different technology that inserts DNA from outside species into the genome of an organism.

Gene-editing is an emerging technology that works only within a species’ DNA and can make changes that could come about naturally or through traditional breeding practices. Dr. Oatley hopes his work will improve public perception of gene-edited foods.