NORMAL, Ill. — A proposed U.S. regulatory framework for how the FDA treats gene-edited livestock may do more than put U.S. livestock producers at a disadvantage globally. It already has proven to be a source of food waste.
Dr. Alison Van Eenennaam knows firsthand how the proposed framework under which U.S. researchers must operate — which regards gene-edited livestock as a new animal drug and thus subject to the FDA’s new drug approval process — is and will be a source of food waste on a major scale.
“Typically at the university, our milk and meat and eggs go into commerce. We sell our milk from the dairy to the creamery, we slaughter our animals and the meat goes in the food supply. That is part of what keeps the wheels running at the research establishment,” Van Eenennaam said.
So, when she and her graduate students at the University of California at Davis had bulls and their offspring who were gene edited to not grow horns, after she and her students had made their observations and had evaluated the cattle to ensure there weren’t any side effects, the natural next step was to finish them out and send them to slaughter.
In January 2017, the FDA released, for public comment, revised draft of Guidance for Industry #187, which concerns the regulation of animals produced through the use of gene editing and/or animals with intentionally altered genomic DNA.
That changed how Van Eenennaam could process the gene-edited bulls and their offspring at UC Davis. In short, she couldn’t. The proposed framework deemed those animals as new animal drugs and prohibited them from entering the food supply.
“Those animals, because they were unapproved animal drugs, couldn’t enter the food supply. Instead of going to the meat plant, they went over to the vet school to be incinerated, as you would do with a sick animal carcass,” Van Eenennaam said.
It was a loss at many levels.
“I think that makes the research very expensive and it is just a waste of perfectly good meat,” she said.
Van Eenennaam was a keynote speaker at the Illinois Farm Bureau’s Farm Income and Innovations Conference in Normal.
She spoke about the progress of innovation regarding technology like gene editing in the United States vs. the progress of it in other countries.
She said the current proposed framework, which regards gene-edited livestock as a new animal drug and subject to the FDA’s regulatory and approval process, but which doesn’t regard gene-edited plants the same way, could hinder public research into livestock gene editing in the U.S. and give other countries a leg up on livestock production.
“What I think is concerning is, from a competitive standpoint, other countries like those in Latin America, have got rules in place that are very analogous to the USDA approach for plants for their animals so potentially you will be able to use those technologies in those countries, which also have large cattle populations,” Van Eenennaam said.
Much of the research into livestock gene editing is going toward finding ways to prevent or cure debilitating livestock diseases and Van Eenennaam said that goes to both animal welfare and sustainability and could be a bridge to public acceptance of gene-edited livestock in the food supply.
“I think gene editing for disease resistance is a no-brainer. I think if we can make the point that this is actually also the animals’ welfare and it actually improves all three aspects of sustainability, I think people will be more supportive to those types of applications,” she said.