The Food and Drug Administration (FDA) has made its first low-risk determination to allow marketing of products—including food—from two genome-edited cattle and their offspring. The decision comes after it was determined the intentional genomic alteration (IGA) did not raise any safety concerns.
The approved gene-editing results in a short-haired (slick) coat in cattle. This is the first time the FDA has made a low-risk determination for enforcement discretion for an IGA in an animal for food use. Previously, FDA has made low-risk determinations for IGAs in animals for non-food uses. The agency has also approved applications for five IGAs for other species.
“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,” said Steven M. Solomon, DVM, MPH, director of the FDA’s Center for Veterinary Medicine (CVM).
The agency’s review of scientific data determined the product is low risk, and FDA does not expect the product developer to pursue the FDA’s approval prior to marketing. FDA also does not expect farms or facilities owned by the developer to register with the agency.
However, FDA noted: “This decision is limited to the marketed products (e.g., live animals, semen, embryos, meat) derived from the existing two cattle containing the IGA for which FDA has reviewed data and their progeny.”
PRLR-SLICK cattle
IGAs are made using molecular technology that introduce changes to the genome of an animal, FDA said. The IGA for the cattle, known as PRLR-SLICK cattle, was introduced using the genome editing technique known as CRISPR. The IGA can be passed onto offspring, allowing the trait to be shared through conventional breeding.
Cattle with a slick coat are better able to withstand hot temperatures, leading to less temperature-related stress and therefore improving food production. Although the PRLR-SLICK cattle have the same trait as cattle with a naturally-occuring short coat, they were not able to be in commerce.
The product developer, Acceligen—a subsidiary of the biotech firm Recombinetics Inc.—plans to use the genetic products from the two cattle with customers in the global market soon. The company also anticipates meat products will be available for purchase by general consumers in as soon as two years.
“Both Acceligen’s and FDA’s analyses of the genomic data found evidence of unintended mutations in the genomic sequences of the founder calves,” the risk assessment read. “However, based on the types of unintended alterations identified and available information about their genomic locations, they are not expected to result in changes to protein expression.”
FDA therefore concluded the alterations do not pose any safety concerns for the PRLR-SLICK cattle or for people who consume the cattle’s products.
Background
In 2017, FDA released a draft for public comment regarding the regulation of IGAs in animals. The draft expanded the scope of existing guidance for gene-edited animals.
For IGAs in animals that are non-food producing and under government oversight or used for research purposes, CVM has said it will exercise enforcement discretion without a prior review of data. However, for other IGAs, CVM has said it may exercise enforcement discretion on a case-by-case basis if the product has been determined to be low risk to humans, animals and the environment. — Anna Miller, WLJ managing editor
