Vilsack working with FDA on animal biotechnology

Bipartisan letter also calls on USDA and FDA leadership to find workable regulatory framework.


Jacqui Fatka, National Hog Farmer

Oct 08, 2021


Despite the signing of a Memorandum of Understanding on animal biotechnology at the end of the Trump administration between the USDA and the Department of Health and Human Services, animal biotechnology approvals remain stalled. Secretary of Agriculture Tom Vilsack says he’s committed to working with the Food and Drug Administration on creating proper jurisdiction of animal biotech oversight, but concerns exist on the originally signed MOU.


Animal biotechnology refers to genetic altering of animals through a range of potential processes, including recombinant DNA techniques and genome editing, to improve certain traits or characteristics of these animals. These practices have the potential to develop resistance and mitigate diseases including zoonotic infections like SARS-CoV-2 and avian influenza, to reduce methane emissions, improve heat tolerance, and much more.


Currently, these technologies are regulated by FDA under its animal drug authority, through a process that has proven prohibitively onerous. To date, only two animals intended for agricultural purposes have ever been approved by the FDA for domestic use, both taking decades for full approval.


The National Pork Producers Council says it supports giving USDA regulatory authority over gene editing in food animals, pointing out that the agency’s Animal and Plant Health Inspection Service already has a review process in place for gene editing in plants, which can serve as a model for livestock. Under a USDA-proposed rule, the agency would have “primary” regulatory jurisdiction of gene-edited animals.


Ahead of a hearing...