Last week, the FDA proposed a new way to handle genetically modified animals: monitoring their safety the way new drugs are monitored.
The proposed regulation, one of three proposed last week before President Trump’s inauguration, would have immense consequences on the treatment of genome editing in regulations—as well as how companies go about bringing genetically modified foods to the market.
It’s worth emphasizing that this is merely a proposed regulation. And although food is indeed grouped together with drugs as something that can change the way your body functions—it’s called the Food and Drug Administration, after all—this proposal is raising some eyebrows in the world of genetics and bioethics.
Understanding the Genetically Modified Regulatory Environment
Nature.com points to the case of genetically modified salmon, which took twenty years of safety testing to approve. It’s still not available for sale as the FDA is yet to rule on how the fish should be labeled.
The ethics here are complicated. For nutrition enthusiasts, genetic modification is something that should be closely monitored and watched. But Nature also reports that a firm producing hornless dairy cattle is worried that these proposed regulations could make it difficult to do what they do, which reduces the need for “surgical dehorning”—which animals lovers aren’t crazy about, either.
If all genetic modifications are treated with the same hard-line skepticism from regulators, they argue that the consequences could result in red tape for any steps forward in the quality treatment of animals. That might push money out of the GMO world and into other controversial areas of animal treatment. According to Allison van Eenennaam, as quoted by Nature,
Because of measures like this, almost everything in genetic engineering will have to be done by huge multinational companies.”
Treating all gene modifications the same way makes for healthy skepticism, but is it enough to ensure that research resources are allocated the best way?
What’s the Alternative?
A subtle distinction must be made. Animals with genomes edited by specific tools are different than animals bred from more general DNA splicing. The proposed regulation would see no distinction between the two, which could prohibit smaller innovations under the guise of regulating the larger changes.
Currently, the FDA does not regulate these foods as drugs. And though in general terms, any food can alter the body’s chemistry, that has not always meant that the same regulatory environment existed for both.
For more information on this FDA proposal and to see what it would really mean in the world of genetic modification, you can go straight to the source with a release at the FDA’s website.