Creating Horn-Free Cows Using Gene Editing: Is It Acceptable Under Federal Regulation?

As the human population continues to increase, mankind faces challenges in food security. Several approaches were made to increase crop and livestock productivity, and one of the technologies that provide promising opportunities is novel gene editing. While these technologies generate social controversies and opposition, experts continue to utilize them to boost the meat industry.

Producing Hornless Dairy Cattle with Gene Editing

Scientists from the University of California, Davis (UC Davis) decided to create horn-free dairy cattle through gene-editing instead of emerging generations of routine breeding. Nine cows were created using gene editing tools such as CRISPR-Cas9 and TALENS with selected desirable traits.

Lead researcher Alison Van Eenennaam collaborated with the Minnesota agtech startup, Recombinetics, to produce hornless dairy cattle from 2015 to 2017. This was done by inserting an allele or gene variant into two Angus bulls. The traits created as multigenerational breeding were passed on to the calves. However, they still need to seek the approval of the FDA before the animals can be included in the food supply.

A large population of beef cattle is born without horns every year. The absence of horns is a natural trait that emerged in Scottish land in the 16^th century and has since protected many people from being gored.

The project aims to reduce the stress, time, and pain in dehorning the calves. However, it did not receive positive feedback from federal regulators. Because of this, the experiment was stopped, and the cows, which cost $1,200 each, were burned.

How FDA Regulations Come into Play

During the early stage of the genomic revolution, strict federal regulations were established under the Obama administration. Under these rigorous rules, genetically modified animals are categorized as a new kind of veterinary pharmaceutical and therefore need approval from the FDA. Otherwise, the food supply cannot include their meat and milk products.

Committed to protecting consumer health, the FDA's Center for Veterinary Medicine mandates that genetic editing and other changes that can affect the structure or function of a food animal be classified as a veterinary drug. Before the researchers can market meat or milk, they must undergo a rigorous New Animal Drug Application process. Even if the trait is designed to improve animal welfare or exists in other animals of the same breed, this rule still applies.

The tough regulation from the FDA was established when gene editing tools were in their initial stages, and scientists had little understanding of the ability and interaction of individual genes. Nowadays, experts can add, delete, and rearrange DNA more precisely, but the FDA's policy remains the same.

The approval process is less lengthy and less costly in countries such as Canada, Australia, and Japan. Gene editing in plant species is also more loosely regulated. However, the FDA remains firm in its stand that edited DNA changes how the human bodies work, the same things a drug can do. Unintended changes can have serious consequences regardless of the size of the alterations or how it was produced.

According to Hanky Greely, director of the Center for Law and the Biosciences at Stanford University, the strictness of the policy seriously impairs innovation which could benefit the animals, the economy, and the environment.

At Washington State University, scientists earned FDA approval for the human consumption of five pigs that have been genetically altered for sterility. The application took two years to complete and costs the team $200,000.

On the other hand, Van Eenennaam firmly believes that DNA is not a drug, and the regulations for gene-edited research animals are unworkable. As a result of this disagreement, an alliance of animal bioscience research universities wrote a letter to the Biden administration asking for reform in FDA regulation. They propose to modernize the application of genetic engineering to livestock production.

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