FDA to steer regulations for genetically edited meat animals

Sometimes referred to as “the next big thing in agriculture,” the gene editing of meat animals extends from research labs, livestock farms, and even the federal government’s right to our dinner plates. 

Last month, the Food and Drug Administration announced it would lead the regulatory process to bring gene-edited meat to market.

Tracey Forfa, director of the FDA’s Center for Veterinary Science, tied this agency role with its need “to keep our regulatory approach current with the evolution of science.”

“We recognize that innovations in animal biotechnology offer tremendous opportunities for advancing human and animal health,” she said.

What is gene editing?
Gene editing, often called CRISPR, allows researchers to disable a gene or add one for a desirable trait by modifying a gene in a specific place in a genome. Think of a pair of scissors; only in this case are enzymes that do the work instead. The enzymes allow researchers to precisely insert or delete genes in an animal or plant’s DNA, intending to improve its health, productivity, and nutritional benefits.

A genome is an organism’s complete set of DNA (genetic material). In the case of humans, for example, almost every cell in the body contains a complete copy of the genome. The genome contains all of the information needed for a person to develop and grow.

Not GMOS
Gene editing is not genetic modification, which involves a different technology altogether in that it involves inserting DNA from an outside species into an organism’s genome.

In the case of GMO salmon, for example, these fish (as well as any other GMO animals) possess foreign DNA that could never have arisen in nature without humans purposely inserting the foreign DNA.

In contrast, gene editing works only within a species’ own DNA. The goal is to bring about desired changes that in the past would only happen with traditional breeding practices. For centuries, farmers have relied on selective breeding, which involves breeding animals with desirable traits to others without those traits to improve food production and meat quality. It obviously takes a lot of hit-and-miss to achieve this goal, not to mention a lot of time — generations of time sometimes. That’s why gene-editing is often called “a high-tech form of selective breeding.”

Just last year, the FDA gave an initial thumbs up to pork from gene-edited pigs when it authorized allowing a specific group of gene-edited pigs enter the human food chain. 

The pigs were a mix of commercial breeds and reflective of what a standard pig operation would have.

Again, the goal was to develop desirable traits for improved food production.

“Our gene edits did not involve incorporation of foreign DNA; rather, they were changes that could arise in nature,” said WSU researcher Jon Oatley. 

He refers to gene editing as a modern “cutting-edge technology.”

Oatley said that his research team will be seeking food-use authorization for other meat animals such as cattle, sheep and goats and estimates that animals produced this way can achieve commercial scale within five years. In other words, consumers will have access to gene-edited meat before long. 

And, no, it won’t be labeled as such. at least not currently. 

“If a label would be required on edible products from an animal with CRISPR edited DNA, we should also have to a apply a label to all products because traditional selective breeding also generated genetic combinations that have arisen by way of human intervention,” said Oatley.

What about food safety?

Oatley said that just as long as standard food-safety practices are used in raising, packaging, and cooking the meat, it will be free of food-borne pathogens.

The Food and Agriculture Organization, which has reviewed food safety issues related to gene editing, points out that although approaches may vary, many countries have found a way to include gene-edited foods in the existing regulatory category to handle such issues.

In conclusion, says a recent FAO report, “the possible effects of gene editing on food safety, quality, and trade are not expected to be much different from such effects on foods derived from pre-existing breeding techniques.”

Not that there aren’t warnings about giving gene-edited meat animals an easy pass on this. According to a Friends of the Earth report, new genetic engineering techniques, such as gene editing, are risky and may result in surprise consequences for people and the planet.

In addition, the organization says that because gene editing involves “cutting” the DNA, followed by the cut DNA being repaired by the cell’s own repair mechanism, these techniques result in GMOs.

Although many scientists and scientific reports say GMOs are safe, controversy about this swirls around the subject, with some opponents claiming that GMOs are being introduced into the food supply either as a means to enrich agribusinesses or as a way to poison or pacify the population. 

Why the FDA?
According to scientists familiar with this subject, the FDA is the logical agency that leads the regulatory process. They point out that the agency is mandated to protect human and animal health, while the USDA “does not have the same kind of overriding public health mission,” said Dr. Peter G. Lurie, president of the Center for Science in the Public Interest.

In May 2024, the FDA released guidance saying that the agency will primarily be responsible for regulating genetically engineered animals.

In recent years, the agency has been ramping up the approval process for gene-edited meat.

In 2022, the agency ruled that there were little to no safety risks involved with Acceligen’s beef cattle, which are genetically modified to grow shorter hair and, therefore, are better equipped to deal with higher temperatures.

Last year, Washington State University also received FDA approval for German-style sausages made from pigs with genetically edited traits.

“These technologies hold great promise for many uses and public and animal health benefits, such as animal disease resistance, control of zoonotic disease transmission, improved animal husbandry, and increased food production and quality,” said Tracey Forfa, director of the FDA’s Center for Veterinary Medicine, in a statement.

“We’re just driving to the ballpark, said John Dombrosky, CEO of Ag Tech Accelerator, in an earlier interview with Bloomberg News. “Gene editing will be free to do tremendous things across the ag continuum, and the promise is just gigantic. We’ll be able to fine-tune food for amazing health and nutrition benefits.”

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