Photo by Amy Bunse
I’m standing next to Alison Van Eenennaam, and she’s mad. I’m a bit starstruck, as Van Eenennaam is a well-known social media and documentary star, and I can only watch in admiration as she takes full flight.
In one of the final actions of the outgoing Obama administration, the FDA announced that they would regulate CRISPR technology as a drug. CRISPR edits DNA, not adding genes from other organisms, but rather using genes already present in an animal or plant. The new rule will slow down approval of gene editing techniques in livestock and increase the cost of receiving approval. According to Dr. Van Eenennaam, the costs will be so great that public institutions and small innovative companies won’t be able to afford the approval process, limiting access to this exciting new scientific breakthrough to only the largest of companies.
It’s not clear to a layman what exactly this new technology has in common with the compounds advertised without end on cable television. Calling CRISPR a drug makes no sense to the scientists who work with the new technology either, as I quickly learned after spending a few minutes with Allison.
Dr. Van Eenennaam has worked with a group of researchers who have perfected editing existing genes in dairy cattle so that they are naturally polled, or born without horns. Angus cattle are already polled, and the same gene sequence that makes sure that Angus cattle don't have horns is present in Holsteins, the leading dairy breed, but those genes have to be turned on for Holsteins to be polled. So, when polling happens as a result of some genetic good fortune long ago in Scotland, there is no regulation. When it happens on purpose in Holsteins because Alison is involved, it is somehow a drug, and it will take multiple millions of dollars and years of work to get approval.
Regulating CRISPR as a drug is a body blow to researchers all across the U.S., and will guarantee that we’ll fall behind other countries that are doing a tremendous amount of research on CRISPR techniques. Dr. Van Eenennaam is as exercised as her Aussie nature will allow. If you care about animal welfare it should matter to you as well. Dehorning is a nasty, painful process, and is dangerous for the animal involved and the cowboys who do the work. It’s necessary, because being gored by a 1500-pound Holstein is no fun, whether you are a fellow Holstein or a dairyman. Here in Missouri, Dr. Randy Prather has used the same techniques to develop hogs that have a natural resistance to the viral scourge PRRS, which causes untold suffering for pigs and costs the swine industry hundreds of millions of dollars per year. Prather’s pigs are in regulatory limbo as well because of the FDA rule.
CRISPR technology is more precise than traditional methods, and results can be achieved much more quickly. In fact, both polling and resistance to viruses like PRRS can and have been developed with traditional methods, but using the new gene editing techniques is quicker, cheaper, and safer. Regulation should evaluate risk and even ethical questions, but when the results are as risk free and as beneficial to both animals and humans as these two examples, approval should be quick, certain, and affordable. The last minute rule written by the outgoing administration is nearing the end of the comment period, and the Trump administration should withdraw the rule and adopt a more streamlined, risk-based approach to regulating gene editing techniques.