January is National Biotechnology Month and as part of this recognition, last week the Food and Drug Administration (FDA) joined the U.S. Department of Agriculture (USDA) and the Environmental Protection Agency to create a collaborative tool for all three agencies to work on modernizing agricultural biotechnology regulation. As President Trump outlined in his June 2019 executive order, biotechnology can help the nation meet its food production needs, raise the productivity of the American farmer and enhance food safety. However, the country must employ a science-based regulatory system to avoid undue regulatory burdens. We hope FDA’s participation in this collaborative tool unlocks the current stalemate over regulatory oversight on a vital new technology: gene editing.
Gene editing technology allows for precise, small changes to specific genes. The technology will allow us to produce animals that are more resistant to disease, require less antibiotics and have a better environmental footprint. It also holds promise for food safety advancements.
Around the world, countries are experimenting, implementing, and – importantly – properly regulating gene editing in livestock. China has been pursuing gene editing since 2016, while Brazil, Canada, and Argentina are advancing the technology. Unfortunately, the future of gene editing is uncertain in the United States due to an archaic regulatory framework being advanced by FDA, stymying advancement and putting our competitors in the driver’s seat of agricultural innovation.
Currently, the FDA has regulatory control over this technology, but the USDA is the only agency equipped to regulate gene editing in livestock. As the regulatory body in charge of U.S. agriculture since 1862, USDA is the only organization with the understanding and history of working directly with livestock and agriculture. The FDA, by contrast, is an agency of the Department of Health and Human Services that oversees packaged food, drugs, and medical devices. Nevertheless, it is claiming the right to regulate gene-edited farm animals and their offspring as drugs under a decades-old administrative decision designed with laboratory animals in mind. The FDA has little experience with on-farm production, while the USDA has thousands of people solely dedicated to regulating farming operations, the health of livestock, and food safety.
Gene editing has the potential to lead us into a new era of livestock production that addresses many of society’s concerns. That only happens, though, if we stay ahead of the curve – or at least keep pace with it.
If the FDA emerges victorious in its regulatory overreach, the impact on America’s farms and farmers could be catastrophic. FDA regulation of livestock will hinder the advancement of gene editing technologies. As other countries gain more of a lead, the livestock industry that was once the pride of our heartland will not have the tools it needs to address new challenges and compete successfully on the global stage.
We urge FDA to stop standing in the way of progress. We hope the agency’s participation in the coordinated biotechnology process means it’s ready to yield oversight for livestock to the USDA. This is too important a technology to effectively throw away because of a broken regulatory framework. The livelihoods of thousands of American livestock farmers depend on it.
A National Pork Producers Council board member, Phil Borgic is a hog farmer from Nokomis, Ill., and owner of Borgic Farms, Inc.