FDA greenlights use of gene-edited cattle as food

U.S – Following a safety review based on scientific data, food safety watchdogs in the U.S have given a go ahead for beef from gene-edited cattle to be used for food.

The decision regarding the Slick-Haired Cattle marks the Food and Drug Administration’s (FDA’s) first time to permit an intentional genomic alteration (IGA) in an animal for food use.

“This decision underscores our commitment to using a risk and science-based, data-driven process that focuses on safety to the animals with intentional genomic alterations and safety to the people who eat the food produced by these animals,” says Steven Solomon, Director of the FDA’s Center for Veterinary Medicine.

This determination was provided to Acceligen, a precision breeding company that addresses long-standing challenges in animal health and wellbeing.

The IGA in these cattle, known as PRLR-SLICK, was introduced using a genome-editing technique known as CRISPR. PRLR refers to mutations in prolactin (PRL) and its receptor (PRLR) cattle.

IGAs are alterations made using molecular technologies that introduce changes to the genome of an animal.

It can be passed onto offspring, allowing the trait to be shared through conventional breeding. There are conventionally bred cattle with naturally-occurring mutations that result in the same extremely short, slick-hair coat.

Reports in scientific literature indicate that cattle with this extremely short, slick-hair coat are potentially able to better withstand hot weather.

Cattle that are comfortable in their environment are less likely to experience temperature-related stress and may result in improved food production.

Although PRLR-SLICK cattle have an equivalent trait to those cattle with a naturally-occurring short hair coat, they are not currently in commerce, as reported by Food Ingredients 1st.

Based on the agency’s review of scientific data, the FDA has determined that the product is low-risk and does not raise any safety concerns, and the FDA does not expect the product developer of the IGA to pursue the its approval prior to marketing (enforcement discretion).

Low-risk determinations for animals

To date, the FDA has made low-risk determinations for enforcement discretion for many other IGAs in animals for non-food uses and also has approved applications for five IGAs in groups of goat, chicken, salmon, rabbit and, most recently, in a line of pigs.

In 2020, the FDA approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs, referred to as GalSafe pigs, which may be used for food.

The IGA in GalSafe pigs is intended to eliminate alpha-gal sugar on the surface of the pigs’ cells. People with Alpha-gal syndrome (AGS) may have mild to severe allergic reactions to alpha-gal sugar found in red meat e.g., beef, pork, and lamb.

Solomon also explained that the decision also demonstrates their ability to identify low-risk IGAs that don’t raise concerns about safety, when used for food production.

“We expect that our decision will encourage other developers to bring animal biotechnology products forward for the FDA’s risk determination in this rapidly developing field, paving the way for animals containing low-risk IGAs to more efficiently reach the marketplace,” he said.

After reviewing genomic data and other information submitted by the product developer, the FDA confirmed that the IGA in genome-edited PRLR-SLICK cattle is equivalent to naturally occurring mutations that have arisen in several breeds of cattle as an adaptation to being raised in tropical or subtropical environments.

The data established that the food from the IGA cattle is the same as food from conventionally bred cattle that have the same slick-hair trait.

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