|The wolf is already genetically modified, and without FDA approval.|
The new gene-editing technology called CRISPR makes it relatively easy for anyone with access to even a moderately decent bio lab to "hack" a gene, thereby adding or deleting bits of code to either remove a disease, or add a new ability or mutation.
CRISPR is the most significant leap forward in genetics in the last 100 years, is low cost, is relatively ease, and has a very high rate of success.
That combination of good news has some folks nervously twirling their prayer beads. What if we create some sort of Frankenstein creature?
Right. And what if Mother Nature had already done that? In fact she already has. It's called the wolf that chased us through the woods, the lion that chased us across the savanna, and the thousands of diseases such as Ebola, Malaria, and HIV-AIDS that have decimated human kind since the dawn of time.
Frankenstein has always been with us, and we have always edited genes. Look at the dog in your kitchen -- that's a gene-edited wolf.
The question now is whether we are going to allow CRISPR free-reign or light-reign. Will scientists be allowed to create corn with short stalks that produce more grain with less loss and in a shorter season? Will we allow tomatoes to be bio-engineered so they are worm-resistant, thereby doing away with tons of pesticides? How about gene-editing mosquitoes so they cannot carry Malaria, Dengue, and Zika?
And what about dogs?
What if we gene-edited the Dalmatian so it did not have hyperuricemia and deafness? What if we bio-hacked the working Jack Russell to ensure small chests? What if we could make dogs resistant to heart worm, lyme, and bone cancer?
Those kinds of questions are now front and center. Earlier this year, David Ishee, a Mississippi kennel operator and member of the nascent "bio hacker" movement, put in a request to the FDA to use CRISPR to gene-edit the Dalmatian in order to repair a single DNA letter associated with hyperuricemia.
The FDA response was to put out a science-devastating proposal to regulate all cattle, pigs, dogs, and other domestic animals modified by gene editing.
The FDA's new proposal is to treat the edited portion of an animal’s genome as a veterinary drug.
That means a gene-edited animal cannot be sold or given away without going through millions of dollars worth of tests and studies.
It took 20 years and millions of dollars for the “AquaAdvantage” salmon to get to market. That might make some sense with an animal that could "go native" in the wild. But a Dalamatian? A sheep? A cow? These are unlikely threats to Mother Nature.
Adding stupidity to generalized fear-mongering is the fact that FDA rules will not apply to other countries where gene editing can be done without regulation. In short, we are guaranteeing that the U.S. will soon be massive losers in agricultural production even as we do nothing to keep the world even theoretically safe.
The notion that domestic CRISPR-modified animals should be regulated like a drug makes zero sense. Drugs are made in million-unit lots, shipped all over the world, are consumed internally by humans, and externalize their harm (if any). Gene-wrecked dogs have been born all over the world for a thousands years and the FDA has never given a damn about that. And why would they? A gene wrecked Dalmatian is a danger only to itself, is produced in very modest lots, and are not a consumable. It's hard to see how the Food and Drug Administration even has any standing in this arena. Is a Dalmatian a food? A drug? I think not!
The bottom line is that it's crazy to hamstring science in this arena, while doing absolutely nothing to require genetic diversity in farm stock, and while giving a business license to the American Kennel Club which requires breeding dogs within a closed gene pool that predictably leads to disease, deformity, and dysfunction.
The FDA is proposing we stay in the dark ages, and never mind the harm to animals.
We know, right now, how to make cows that produce no horns. That's a working CRISPR modification that could save the cost and discomfort of dehorning Holstein milk cows. But the new FDA rules threaten this bio-technology in the United States, while leaving other countries free to leap ahead. Why? What is the good, and what is the fear?
And what about humans? Last week news broke that scientists had used CRISPR to repair a genetic mutation linked to a devastating heart condition called hypertrophic cardiomyopathy in 36 human embryos. Will the FDA be a cheerleader for disease and death, or for genetic health and cost savings?
Ironically, the best hope for science may be the Trump Administration, which hates unnecessary regulation and which may veto these new FDA rules. If that happens it will be a small glimmer of good in what has otherwise been a chaotic and amateurish administration that seems hell-bent on pushing us to the brink of pointless war.
Whatever action is taken, however, may be irrelevant in the long run. The FDA does not have the the personnel to visit drug companies and food processing plants more often than once every five years now, and CRISPR is cheap enough and easy enough that it will be done with or without FDA approval. In fact because the genetic map of the dog is so well know, because dogs have so many diseases and defects, and because the dog is not an animal we eat or that is likely to escape into nature to breed with wild stock, it's really the perfect animal for CRIPSR research. Someone please tell the idiots at the FDA.