Cockett file (copy)

President Noelle Cockett delivers her State of the University address in this 2019 file photo.

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A task force chaired by Utah State University President Noelle Cockett is recommending an overhaul of federal regulations affecting gene-editing technology and U.S. livestock.

In June 2020, the American Association of Veterinary Medical Colleges and the Association of Public and Land-grant Universities formed the “Gene Editing in Agriculture Task Force” — a group of experts called up to analyze the regulatory processes surrounding gene editing.

Approximately one year later, the task force released a report recommending the U.S. Food and Drug Administration “streamline” the current regulatory framework. The current process, according to the report, is viewed by many as “ambiguous, glacial in pace, and cost-prohibitive” and doesn’t account for modern gene-editing technologies.

The task force advocates for “an evidence and logic-based decisionmaking process” that differentiates between gene-editing applications “that could have arisen in nature … and be propagated via selective breeding” from traditional transgenic technologies involving recombinant DNA.

“Humans have been consuming animal products with mutations in DNA that arose naturally and were propagated by way of selective breeding for thousands of years,” the report states. “Thus, the Task Force recommends that full consideration be given to developing a regulatory channel for approval of animals possessing gene edits that could have arisen in nature (e.g. insertions, deletions, rearrangements, and single nucleotide polymorphisms) as safe for human consumption.”

To update the antiquated framework, Cockett told The Herald Journal the FDA should focus its attention on the products of gene-editing technology, not the gene-editing tools themselves.

The FDA “shouldn’t regulate CRISPR, they should regulate what the genetic edit is,” Cockett said. “And they just don’t get it, they just don’t — they aren’t willing.”

CRISPR (an acronym standing for clustered regularly interspaced short palindromic repeats) is a system that utilizes enzymes to edit DNA sequences. Cockett said CRISPR differs from “the old ways” in that it “just edits the DNA,” while other technologies actually spliced into the DNA and left things behind in the process.

Nearly 25 years ago, Cockett said the U.S. Department of Agriculture was charged with regulating genetic modification in plants, while the FDA was set to monitor modified animals in a similar way. However, Cockett said there was “very little work in animals” at the time.

Since then, as the technology of gene-editing animals has advanced, Cockett said “we essentially have nothing still approved in animals” because of the FDA’s required process that differs from that of the USDA.

“This is a big issue for people that work in animal genomics,” Cockett said. “We are asking for more of an equitable approach to review, approval and regulation.”

Currently, Cockett said the FDA’s process characterizes genetic edits — regardless of the tools used to implement them — as a drug. Cockett said it has to be proven that the genetic edit does not harm the animal and is safe for human consumption, but must also be demonstrated over generations — which can take some time considering the gestation length of certain livestock.

“It’s not a drug. I didn’t inject anything. I’m not going to be able to look for residuals,” Cockett said.

Though the task force is calling for a significant change in the regulatory process, Cockett said reviewing and assessing genetic edits will still be crucial. Cockett said explanations should be necessary as to why a genetic edit project would be of value to food production and every project should have a sequence of the entire genome to ensure the edits turned out appropriately.

Cockett said additional tests would be required for edits that significantly differ from what exists in nature, but genetic edits that could have occurred in nature should be viewed differently. For example, Cockett spoke to lines of polled cattle — cows without horns — or cattle with a “slick mutation” that leads to lessened quantities of hair. Both occur in nature and could benefit cattle and humans in certain circumstances but would take generations of selective breeding to implement.

According to the task force report, the United Nations Population Division projects 9.8 billion people on earth by the year 2050, and providing quality food at sufficient quantities “will require major improvements in production efficiency for both plant and animal agriculture…”

For Cockett, having worked in genomics for around three decades, she and her colleagues in animal science have seen the magnitude of the new and advancing gene-editing technology.

“I wouldn’t be doing this if it was still the old way. But the new way … I believe in it,” Cockett said. “Will people create weird things? Well, that’s why you need this. It’s got to be reviewed, approved and then if it’s something different, regulate it.”

According to a press release from USU, Cockett earned her M.S. and Ph.D. in animal breeding and genetics from Oregon State University and researched beef cattle genetics in graduate school. She spent five years as a research geneticist at the USDA’s Agricultural Research Service, and U.S. Meat Animal Research Center in Clay Center, Nebraska.

Cockett was hired in 1990 as an animal geneticist at USU in the College of Agriculture and Applied Sciences and went on to focus on sheep genetics. According to the press release, she achieved multiple breakthroughs in the science of sheep genomics and gene editing.

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