Federal Regulatory Procedures Present Challenges in Gene Editing Progress

In this episode of Beef Buzz, Senior Farm and Ranch Broadcaster Ron Hays is back talking about gene editing with Dr. Alison Van Eenennaam of the University of California-Davis. Dr. Van Eenennaam was the keynote speaker on the first evening of Cattlemen’s Conference Part 2: Blueprint for the Future and was on a follow-up panel the next morning on the science and regulatory challenges of gene editing.

To listen to Part One of the conversation with Dr. Alison Van Eenennaam, CLICK HERE.

As discussed in part one of the conversation with Dr. Van Eenennaam, gene editing has tremendous potential for the beef cattle industry, but there are some substantial regulatory challenges in the way. Van Eenennaam said one issue is that the FDA has elected to treat gene editing technology like a drug, which slows down the approval process immensely.

“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,” Van Eenennaam said. “That is not the approach that has been taken by other countries.”

Van Eenennaam said there has been a recent announcement by the FDA that if someone does perform a targeted elimination of a gene in an animal’s genome, it will be evaluated on a case-by-case basis. If the procedure is low-risk, Van Eenennaam said persons in the U.S. can receive technical enforcement discretion, which means the product can be commercialized.

“There is this extra step associated with genome editing in the United States which is not the same in some of these other countries, 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 said.

In the case of genetic alterations in the genome, Van Eenennaam said there are no hazards when it comes to the food supply.

“Every meal you have ever eaten is genetically distinct,” Van Eenenaam said. “That is just genetic variation. We don’t differentiate between the milk of a Holstein and a Jersey as being somehow different from a food safety perspective. I feel like we are kind of inventing a hazard association with genome alterations that is just not seen with conventional breeding. I think if there is a unique risk or hazard, then that is what should be the trigger for doing extensive regulatory evaluations. If you can’t come up with a hazard for gene editing and altering the genome, then I don’t know that we need to spend a lot of our regulatory effort and expense providing all of this data when you can’t come up with hypothetical hazards associated with this technology.”

Van Eenennaam said creating a highly difficult regulatory process will disincentivize commercial investment and the use of gene editing technology in general.

“The fact that you use gene editing doesn’t make a product unsafe,” Van Eenennaam said.

Van Eenennaam also talked about where gene editing is going, and new developments. Click the listen bar above the story to hear the full conversation!

The Beef Buzz is a regular feature heard on radio stations around the region on the Radio Oklahoma Ag Network and is a regular audio feature found on this website as well. Click on the LISTEN BAR at the top of the story for today’s show and check out our archives for older Beef Buzz shows covering the gamut of the beef cattle industry today.

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