July 28, 2019

U.S Gene Editing Regulations

Animal scientists and producers question proposed U.S. gene editing regulations

Study after study has shown that products from gene-edited animals pose no extra risk to human health, but U.S. regulations for these products are still up in the air. Since 2017, the U.S. Food and Drug Administration has claimed that DNA from gene-edited animals (a phrase agencies have been using to also include “genetically engineered” animals) should be regulated as a new veterinary drug.

Now more and more experts are coming together in opposition to this proposal. They say the FDA’s lengthy drug approval process would harm animal health and America’s position in the global agriculture market.

Alison van Eenennaam, an extension specialist in the Animal Genomics and Biotechnology Program at the University of California, Davis, has long added scientific context to the gene-editing debate. Her work and many peer-reviewed studies have shown that gene editing can help producers breed animals with desirable traits while not posing any risk to human health. These include traits that advance sustainability, such as pigs modified to secrete less phosphorus and further improve animal wellbeing, such as breeding “polled” cattle that do not have horns.

In March, van Eenennaam and co-authors Kevin Wells of the University of Missouri and James Murray of the University of California, Davis, published an article in the journal npj Science of Food titled “Proposed U.S. regulation of gene-edited food animals is not fit for purpose.” The article summarizes the scientific evidence of the safety of gene-edited animal products and challenges the FDA’s proposal that all food animals whose genomes have been “intentionally altered using molecular techniques including gene-editing technologies” be subject to mandatory premarket new animal drug regulatory evaluation.

As the scientists point out, there is no reason to regulate the DNA of food animals as a drug. Humans consume DNA in every product we eat with no health risk, and altered DNA poses no harm. Regulators seem to understand this when it comes to gene-edited plant products, which are not regulated as drugs.

“Harmonizing the regulations associated with gene-editing in food species is imperative to allow both plant and animal breeders access to gene editing tools to introduce useful sustainability traits like disease resistance, climate adaptability, and food quality attributes into U.S. agricultural breeding programs,” write van Eenennaam and her co-authors.

The same proposal is currently troubling agriculture industry representatives. Feedstuffs recently reported that the pork industry is concerned that the proposed FDA regulations will limit efforts to use gene editing to improve swine health. Research has shown that gene editing could be a tool to enhance a pig’s natural immunity to disease and reduce the need for antibiotics in animal production.

The National Pork Producers Council (NPPC) launched a campaign in June to support the U.S. Department of Agriculture in handling all regulations of gene-edited animals. The USDA has already said that they would not subject gene-edited animals to drug regulations.

“We need to get USDA involved as this technology moves to farm so it’s regulated appropriately and addresses the safety of animals and food products,” Dan Kovich, NPPC director of science and technology told Feedstuffs. “NPPC is not asking the technology not to be regulated; we just want that right regulation to take advantage of all these benefits.”

Right now, the decision for how to regulate gene-edited animals is in Congress’s hands. In May, Greg Ibach, USDA undersecretary for regulatory affairs, testified before the House Agriculture Committee that he was concerned that the U.S. regulations could put U.S. producers at a competitive disadvantage. Feedstuffs note that many countries—led by Argentina, Brazil, and Canada—are working to commercialize products from gene-edited animals. China and the European Union are especially interested in gene editing as a way to combat devastating livestock diseases, such as African swine fever.

Van Eenennaam and her co-authors agree that overlooking solid science in favor of the FDA plan would hinder the ability of American farmers to improve animal health while contributing to the global market. “In the absence of regulatory harmony, breeders in some countries will have the ability to use gene editing in agricultural breeding programs, while those in other countries will not, resulting in disparate breeder access to these tools, and ultimately the potential for trade disruptions,” they write.