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With a free pass, CRISPR-edited plants reach market in record time

CRISPR–Cas9-edited plants can be culti–
vated and sold free from regulation, the US
Department of Agriculture (USDA) is mak–
ing increasingly clear. The agency gave a free
pass to Camelina sativa, or false flax, with
enhanced omega-3 oil. And more recently,
in October, said that a drought-tolerant
soybean variety developed with CRISPR
falls outside of its regulatory purview.
This laissez faire attitude from the agency
shaves years and tens of millions of dollars
off the cost of bringing a biotech plant to
market. “It eliminates that huge barrier to
entry for agbiotech companies,” says Oliver
Peoples, CEO of Woburn, Massachusetts–
based Yield10 Bioscience (formerly
Metabolix) which developed the camelina.
It would have taken Yield10 at least six
years and $30–۵۰ million to test and col–
lect the data necessary to bring genetically
engineered camelina through the full USDA
regulatory process, says Peoples. “We did this
in two years and [USDA’s decision] took two
months, and I assure you we didn’t spend
$۳۰ million on it,” he says. The company
will present its technology to the US Food
and Drug Administration’s voluntary review
process, he says.
Yield10’s strategy is to allow CRISPR-Cas9
to make double-stranded breaks in the plant’s
DNA without a template to direct insertion
of a specific DNA sequence. As a result, the
plant’s own repair mechanisms rejoin the
DNA, giving rise to single-nucleotide inacti–
vating insertions in all three copies of the tar–
get gene. Peoples would not disclose which
gene his company manipulated in camelina.
Camelina oil is used as a biofuel and as a
substitute for fish oil in aquaculture. Yield10
will likely make three or four additional edits
to the plant line in order to boost camelina’s
oil content 25%, and translate the technology.