From staff reports When discussing the benefits of gene editing in the cattle industry, University of California-Davis’ AllisonVan Eenennaam said regulatory issues from the Food and Drug Administration treat technology like a drug, slowing down approval processes.
“The regulatory approach this has been taken in the United States is to regulate all intentional alterations in the genome as new animal drugs under the Food and Drug Cosmetic Act,” Dr. Van Eenennaam said. “That is not the approach that has been taken by other countries.”
Van Eenennaam said the FDA announced that if anyone performs a targeted gene elimination in an animal’s genome, it will be evaluated case by case. If considered low-risk, persons in the U.S. can receive technical enforcement discretion, which allows product commercialization.
“There is this extra step associated with genome editing in the United States which is not the same in some of these other countries,” she said. “And some of our major competitors like Brazil and Australia are going to have a different and easier regulatory pathway, and it might incentivize moving the technology to those types of regulatory jurisdictions that are going through the system here.”
Van Eenennaam emphasized the safety of genetic alterations in the food supply.
She said that if gene editing and genome altering hazards cannot be found, then we shouldn’t spend a lot of our regulatory efforts on hypothetical hazards as heavy regulation disincentives commercial investment and gene editing in general.
“The fact that you use gene editing doesn’t make a product unsafe,” Van Eenennaam said.