Gene Editing for Food and FDA Oversight

OMAHA (DTN) -- The Food and Drug Administration has made its first approval for gene-edited livestock to be processed for human consumption with a handful of hogs from Washington State University. But the researcher who led the project said regulatory oversight needs to change for the livestock or food industry to commercialize a food product from a gene-edited animal.

FDA authorized Washington State University with the first regulatory approval for a group of five gene-edited hogs to be approved for human consumption. The university highlighted that the pork from the hogs was used to make German-style sausages.

Jon Oatley, a professor in the School of Molecular Biosciences in WSU's College of Veterinary Medicine, used the gene-editing tool CRISPR for surrogate sires by knocking out a gene to make male swine sterile, but then implanting another male's stem cells to produce desired traits in the next generation of swine. The experiment was done to prove that food from those animals is safe to eat.

As a researcher, Oatley told DTN it's possible under the current regulatory process with FDA to demonstrate a "one-off proof of concept," but the regulatory system makes it nearly impossible to reach commercial scale for production.

"It's not that it's a totally negative experience, but it's an experience that tells me that as long as the regulations and regulatory landscape exists as it does now, we will never be able to get gene-editing applications in a commercial production setting," Oatley said. "It's just way too expensive, and it's too long and it's too cumbersome. So, something's got to change."

Reflecting some of the complications of the FDA process, getting approval was both timely and costly even though FDA waived some fees for the university. Oatley's team still spent two years and approximately $200,000 for the data needed by FDA for approval.

"The way it is set up now is that every animal that you want to get approved, you have to go through an independent review process," Oatley said. "You can never scale it up to be used in a production setting. There are just too many boxes right now that need to be checked with the FDA. It's not that it's the FDA's fault -- it's kind of the cards they were dealt -- because the architecture of what the regulatory system is like was built for a very different type of genetic engineering."

CRISPR gene editing can be used to improve growth efficiency or the palatability of an animal product, or it can help with disease resistance to a virus or some type of pathogen, Oatley said. There are also considerations for improving the welfare of animals or reproductive capacity.

"We can test this at a university research setting, but then getting it out there to the real world, that's the biggest challenge as long as we have the regulatory system that we are working with," he said.

Oatley's experience led to a letter in February with other land-grant university researchers to the Biden administration about gene editing and FDA oversight. The FDA requires gene-edited animals to go through a process almost the equivalent of treating the animal as a regulated drug. The regulatory framework is hindering the development of beneficial traits in animals while other countries are taking a lead. Some countries have determined that any sort of CRISPR modification or other gene edits -- something that could arise in nature -- are allowed in the food chain.

"One of the most progressive places actually is South America," Oatley said. "Argentina and Brazil, some of the big cattle-producing regions of the world, they are very progressive on this."

Livestock groups also have advocated for changing the regulatory structure of FDA or moving the oversight for gene-editing livestock over to the U.S. Department of Agriculture.

Current FDA rules add another layer over generational oversight because any progeny from a gene-edited animal also would have to be reviewed by FDA to be allowed into the food chain even though those animals themselves did not undergo gene editing.

The FDA approval "is investigational" and limited to the hogs in the study but highlights that gene editing can produce traits in animals to improve food production. WSU noted gene editing can make changes to an animal's DNA that could also occur in nature or selective breeding but would take longer without a tool such as CRISPR.

Chris Clayton can be reached at Chris.Clayton@dtn.com

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