Will Gene-Edited Food Be Government Regulated?
Will Gene-Edited Food Be Government Regulated?
Dan Charles May 10, 2019 5:01 AM ET
The company Calyxt, just outside St. Paul, Minn., wanted
to make a new kind of soybean, with oil that's a little healthier — more like
olive oil.
As it happens, some wild relatives of soybeans already
produce seeds with such "high oleic" oil — high in monounsaturated
fat. It's because a few of their genes have particular mutations, making them
slightly different from the typical soybeans that farmers grow.
Manoj Sahoo, the company's chief commercial officer, says
this led to an obvious question: "Can we have those same mutations in the
modern varieties which are grown by our farmers?"
The company turned to a gene-editing technique, TALEN,
that is similar to a more famous one called CRISPR. Sahoo describes it as a
genetic scissors that can go in and cut the soybean plant's DNA very precisely.
"It does the cut, and then it comes out. There is no foreign material or
foreign genes in the soybean," he says.
This is a vital point. If you take genes from another
kind of plant, or bacterium, and insert them into a crop like soybeans, the
result is considered a genetically modified organism. 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. The U.S., however, says it's
not. In fact, you may not need explicit government approval to sell that
product.
Companies and even university researchers can ask the
U.S. Department of Agriculture and the Food and Drug Administration to examine
their new products, and the results of these voluntary
"consultations" are public. The USDA has a website, for example,
where one can browse dozens of agency responses to such inquiries.
Calyxt went through this voluntary process with both 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, 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.
But Peter Beetham, the CEO of Cibus, goes further. If the
company created this same kind of canola using newer gene-editing tools, he
says, it also would not require any formal government review.
Greg Jaffe, director of the biotechnology project at the
Center for Science in the Public Interest, says it is a troubling precedent.
"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," he says.
A lot of consumers will find that unacceptable, he says.
Gene editing is new, it's powerful, and people will have a host of questions
about it. They'll want to know, for instance, whether their own food is
genetically edited. "The first step in having a discussion about
technology is knowing what's out there," Jaffe says.
Jaffe is calling on the government to maintain a
comprehensive and public list of every gene-edited crop that farmers are
harvesting and selling. "I think that there should be a registry of these
products, agricultural products that are going to go on the market, that have
been gene-edited," he says.
I reached out to several biotech companies to see what
they thought of Jaffe's idea. They were noncommittal.
Several of them said that they do want some kind of
government oversight of this technology. They say they have been convinced that
it is essential for public acceptance of the technology.
But the companies also are trying to avoid anything that
suggests to consumers that gene-edited food is somehow different from every
other food, and thus perhaps more dangerous.
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