In January, in one of his last actions as acting U.S. Secretary of Agriculture, Sonny Perdue issued a memorandum of understanding (MOU) with the U.S. Department of Health and Human Services establishing that USDA, and not FDA, will oversee regulation of certain animals developed using genetic engineering that are intended for agricultural purposes, such as human food.
Perdue said in a statement that agricultural biotechnology holds tremendous potential to improve animal health, enhance farm productivity, improve nutrition, and even reduce the need for some animal health measures and, thus, the MOU was designed to clear a path to bring the regulatory framework into the 21st century. “In the past, regulations stifled innovation, causing American businesses to play catch-up and cede market share,” he said in the statement. “America has the safest and most affordable food supply in the entire world, thanks to the innovation of our farmers, ranchers, and producers. Establishing a new, transparent, risk and science-based regulatory framework would ensure this continues to be the case.”
The MOU also allows for the transition of portions of FDA’s pre-existing animal biotechnology regulatory oversight to USDA, and states that the agreement can be modified at any time, and could be terminated after three years.
Support from Industry
The National Pork Producers Council (NPPC), representing 42 state pork associations, is in full support of the USDA leading the way for regulating genetically engineered animals. “U.S. pork producers see tremendous potential in gene editing to address significant animal health issues, as well as assisting the industry in making continuous improvement in areas such as food safety, animal welfare, responsible antibiotic use, and sustainability,” says Howard Roth, president of the organization. “An appropriate and practicable regulatory environment is critical to ensuring that this promise can be realized. The USDA’s proposed pathway will foster innovation, allow for producer access to this technology, and preserve the preeminence of American agriculture globally.”
Moreover, the NPPC feels that the U.S. has been ceding advantage to foreign competitors, as no other country is attempting to regulate agricultural applications of genetic technologies in animals under a drug agency, such as FDA.
“Even the European Union, long viewed as a bastion against agricultural genetic innovation, is having meaningful discussion about accessing the benefits of gene editing,” Roth says. “This is already placing U.S. livestock and poultry producers at a disadvantage. We simply cannot allow U.S. farmers and ranchers to lack the same animal health and food safety advantages as producers in other countries.”
The American Soybean Association also supports the MOU. “Genetic solutions have the capability of protecting the health of our herds and flocks, and ASA continues to support predictable, timely, science-based processes for making these innovations available to producers,” says Kevin Scott, the organization’s president. “We have great confidence in USDA’s ability to develop an appropriate regulatory pathway for these important tools.”
However, Stephen Hahn, who wrapped up his service as FDA commissioner last week, is strongly against this idea. In a tweet, Hahn voiced his concern over the MOU. “FDA has no intention of abdicating our public health mandate,” he posted. “We’ll continue to stay focused on executing our vital public health mission entrusted to us by the American people.”
As of the end of January, it was unclear whether President Biden’s administration, and whomever will be the next FDA commissioner (Janet Woodcock is currently acting commissioner), would fight this going forward.