The U.S. government’s system for regulating animal biotechnology – currently under Food & Drug Administration oversight – is broken and is driving beneficial innovations to other countries, according to discussions taking place this week as part of the Animal Health in the Heartland virtual symposium.
Dr. Clint Nesbitt, senior director of science and regulatory affairs for food and agriculture at the Biotechnology Innovation Organization (BIO), addressed symposium participants Wednesday morning during the presentation on “U.S. Oversight of Animal Biotechnology & the Need for Change.”
“Animal biotechnology holds tremendous potential for improving animal health and well-being, transforming our farming and food systems, boosting our bioeconomy and even helping to prevent and respond to zoonotic diseases such as COVID-19, but these breakthroughs are dependent on a clear, timely and science-based approval process that includes a viable path to market,” Nesbitt said.
In more than two decades, only one food animal has been approved by FDA’s biotechnology process. “This does not foster confidence in the U.S. system for investors and developers,” Nesbitt stated.
Nesbitt, as well as other presenters on the symposium program, made a strong case for overhauling the current system via a joint agreement between the FDA and the U.S. Department of Agriculture, which recently updated and streamlined its review process for plant biotechnology.
“FDA’s approach to animal biotechnology is inconsistent with the Administration’s efforts to modernize regulations. As a result, investment, research, jobs and animal biotech innovation has abandoned the United States for other countries such as China, Brazil and Argentina, where developers have a clearer understanding of the approval process,” Nesbitt said. “A joint agreement between FDA and USDA will reassure developers that the United States wants to be an innovation leader and deliver new tools and technologies to our nation’s farmers and ranchers.”
BIO sent a letter earlier this year to President Donald Trump calling for changes to animal biotechnology oversight in a way that more appropriately draws upon existing legal authorities to safeguard animal health, food safety and the environment. In a similar letter sent to leaders of Congress, BIO joined with 27 members of the Council of State Bioscience Associations to call for legislative action.
BIO is part of a diverse coalition of producer groups, academics, developers and agriculture commissioners supporting animal innovation and an improved process for getting beneficial products into the marketplace.
“There have been a number of proposals brought forward by the stakeholder community. We are hopeful that the Administration will settle on a solution that will enable the United States to meet its innovation goals and position animal biotechnology to help us solve big challenges,” Nesbitt said. “The status quo is unacceptable.”
The National Pork Producers Council (NPPC) said in its Aug. 14 "Capital Update" that agriculture needs White House support on gene-edited livestock oversight. NPPC director of science and technology Dr. Dan Kovich said for more than two years, USDA and FDA have been in a regulatory tug-of-war over which agency has authority over genetic editing in livestock, and the White House should ensure that USDA has regulatory oversight over gene-edited livestock.
“Unfortunately, U.S. farmers are caught in the middle, allowing China, Brazil, Canada and other global competitors to move ahead in the race to utilize this new technology,” he said.
“Gene editing is used to make specific changes within an animal’s own genome and will allow us to produce animals that are more disease resistant, require fewer antibiotics and have a better environmental footprint,” Kovich said.