This is no way to regulate GMOs

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This is no way to regulate GMOs

Scientists say they hope to avoid government regulation of genetically modified organisms, or GMOs, by using a variant on a powerful new method to knock out some plant genes. This thinking is worrisome - not so much for scientific reasons as for legal ones. When research is aimed at achieving a regulatory goal rather than a scientific one, it’s a sign that something is wrong with the regulations, and that they need to be changed sooner rather than later.

The research in question was done by scientists at Seoul National University in South Korea. They used a three-year-old technique called CRISPR, which enables scientists to edit a genome in a remarkably precise fashion using viral RNA.

What’s remarkable isn’t the science - CRISPR is already being widely used - but the objective. The researchers’ innovation has to do with how CRISPR is introduced into the genome scientists seek to modify.

Ordinarily, CRISPR is applied to a genome using a bacterium vehicle. This means that CRISPR-modified genomes ordinarily come under GMO regulations. Those regulations, enforced by the Animal and Plant Health Inspection Service (APHIS) of the Agriculture Department, apply when a “plant pest” is introduced into an existing genome. The bacterium vehicle, usually Agrobacterium tumefaciens, is regulated as a plant pest.

Korean researchers developed a technique to introduce the RNA necessary to do the editing without using Agrobacterium as a vehicle. The editing process would be the same - knocking out genes the researchers want to eliminate - but the delivery technique is different.

Their goal wasn’t scientific improvement, but regulatory avoidance. “In terms of science, our approach is just another improvement in the field of genome editing,” one of the scientists told the journal Nature. “However, in terms of regulations and public acceptance, our method could be path-breaking” because the new organisms “might be exempt from current GMO regulations.”

If this sentence doesn’t bother you, it should. The researchers were openly acknowledging that the point of their efforts is to work around existing GMO regulations.

And they might even conceivably be right about the law. In 2011, APHIS issued an official notice that excluded a genetically engineered form of Kentucky bluegrass from its regulatory scope. Its reasoning was that the agency was only authorized to regulate “plant pests,” which includes bacteria like those usually used to introduce CRISPR. Because the genetically engineered bluegrass was created by a different technique that didn’t introduce bacteria, APHIS said it wasn’t covered.

If the regulations don’t apply, it’s because they’re outdated. The APHIS regulations apply to “plant pests” because they themselves are an adaptation of traditional, pre-GMO regulatory authority.

But the scientific dangers of genetic modification using CRISPR don’t depend on the use of a bacterium to effectuate the editing process. The key risks associated with the use of CRISPR are so-called off-target effects.

To simplify, while CRISPR effectively knocks out genes selected by researchers, it also sometimes knocks out other genes that haven’t been targeted. Editing out other genes can produce unintended - and unknown - consequences.

The South Korean researchers’ delivery method would appear to bear exactly the same risks of off-target effects as the ordinary method for CRISPR delivery. It therefore makes no logical sense for the new technique not to be regulated while the traditional CRISPR delivery would be.

In essence, the category of regulated material is orthogonal to the scientific dangers. That’s a clear, indeed glaring, regulatory problem.

The answer is to change the regulations - and quickly. The Barack Obama administration announced in July that it would create a task force to review existing GMO regulations. The South Koreans’ CRISPR workaround is a sign that this review needs to take place as soon as possible.

Chinese researchers came in for serious criticism this year when they announced that they were using CRISPR on pre-implantation human embryos. That’s a persistent problem, made more serious by differences in international legal and ethical standards.

In contrast, the challenge of closing the “plant pest” loophole is nowhere near as great. Regulatory review of GMO innovations should be taking account of risks such as off-target effects and their unintended consequences. The regulatory change will in turn shift incentives. There’s no reason regulation of cutting-edge research should be outdated. And there’s no reason scientists should be designing their research to do an end-run around the regulatory system.

*The author, a Bloomberg View columnist, is a professor of constitutional and international law at Harvard University.

Noah Feldman

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