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Should CRISPR Be Regulated?

Gene editing technologies are helping to create new products, but regulation is a gray area

The Lempert Report

Should gene editing technologies such as CRISPR be regulated?

The way it works now, companies can ask the USDA and the FDA to examine their new products, and the results of these voluntary "consultations" are public.

These firms do not need explicit government approval to sell that product. And the FDA does not consider these gene-edited processes as GMOs. If you take genes from another kind of plant or bacteria and insert them into a crop, the result is considered a genetically modified organism, or GMO. You need government approval to sell a new GMO. Getting it can take years and millions of dollars. If you just take a snippet out of a gene without inserting anything new, though, the product falls into a gray area. The European Union has decided that it's still a GMO. 

More and more companies are using CRISPR or TALEN technologies, Manoj Sahoo, chief commercial officer of Calyxt, based near St. Paul, explains to NPR. It acts as genetic scissors that can go in and cut the soybean plant's DNA very precisely. "It does the cut, and then [the gene] comes out. There is no foreign material or foreign genes (inserted) in the soybean."

His company, NPR reports, is using TALEN to make a new kind of soybean, with oil that's a little healthier—more like olive oil that is high in monounsaturated fat.

Calyxt went through this voluntary process with the USDA and the FDA, and both agencies gave the company's high-oleic soybean a green light. 

"We think it is important to build consumer trust, and also [for] food safety, which is critical, to go through that oversight process," Sahoo says.

On the other hand, according to NPR, there's a gene-editing company called Cibus, in San Diego, that never asked the USDA or the FDA to formally approve its new line of canola.

Adding to the confusion is the fact that this canola was created using an older method of creating genetic mutations. The company induced lots of random mutations in canola plants by multiplying them in the lab in Petri dishes. Then it searched for and found exactly the mutation it wanted. Crops altered in this way have never been strictly regulated, so Cibus didn't need government approval for its canola.

Greg Jaffe, director of the biotechnology project at the Center for Science in the Public Interest, told NPR, "I don't think Cibus is violating any law, but I think that it points out the fact that this is a voluntary process and that, in the future, companies may not go through this process.”

A lot of consumers will find that unacceptable, he said. 

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