WASHINGTON, Feb. 10, 2016 - The
Agriculture Department has formally launched what would be the most
far-reaching overhaul of its biotechnology regulations since they were first
developed decades ago.
The idea is to accelerate the
development of new crop traits that USDA believes pose little risk to the
environment, with the side benefit of making it easier for public researchers
and small companies to get their ideas to market. The new system USDA envisions
would end or at least curtail what scientists consider unnecessary, redundant
reviews of essentially the same traits.
However, USDA’s
outline of the plan in a 14-page document released last week for public comment is raising some
concerns and questions in the industry.
The document proposes a sweeping
definition of “biotechnology” that includes not just the traditional transgenic
crops commonly known as GMOs but also new techniques such as genome editing,
which don’t require inserting genes from other species into a plant. Genome
editing allows researchers to switch genes off in a plant or to introduce
traits from a wild relative of the plant, essentially doing in a faster, more
precise manner what plant breeders have been doing for generations.
The USDA document, which is formally
known as a “notice of intent to prepare an environmental impact statement,”
goes on to lay out in broad terms a new two-step process for analyzing new crop
traits and deciding which ones would be subject to regulation.
(The plan is labeled the “second
alternative” in the document. There are three other, essentially throw-away
alternatives outlined -- one is to leave the current system unchanged, another
is to replace it with a much more stringent system, and the third is to
essentially deregulate biotechnology.)
Almost no one argues that the current
system should be left alone, even groups such as the Center for Food Safety
that argue federal regulation of biotechnology is much too weak.
The fear among some
is that defining gene editing as “biotechnology” will mean the public will see
the products as GMOs or genetically engineered.
USDA’s current regulations focus
almost exclusively on “transgenic” species, plants that have been altered
through the introduction of genes from other species, such as a bacterium.
Despite the broad definition, USDA is
proposing to exempt some gene editing techniques from the regulatory process,
but industry officials say it’s not entirely clear how that would work. It’s
also possible that whatever exemptions the department could implement could be
withdrawn by a later administration.
Still, something needs to be done, according to scientists
and industry officials, who say that the existing uncertainty
over how gene editing is going to be treated by regulators is holding back
advances in plant breeding.
The “regulatory processes for
transgenic GE crops (the so-called GMOs) are largely broken in many parts of
the world,” and the use of gene editing could “provide new opportunities for
innovation” with a “reduced degree of regulatory oversight,” Iowa State
University scientists argued in a paper published in Plant Biotechnology Journal last year.
“If we’re faced with a regulatory
landscape that’s similar to what we see in transgenics that means a lot of
companies won’t be able to play in that arena,” said Bernice Slutsky, senior
vice president of domestic and international policy for the American Seed Trade
Association. “There’s a lot of promise there and there’s research being done,
but in terms of actively moving it forward it really depends on what happens
from a policy perspective.”
Another potential issue is how USDA
would interpret its authority to analyze the potential of new biotech crops to
become “noxious weeds.” The Plant Protection Act, which is the basis of USDA’s
regulatory authority for biotech crops, lays out a broad definition of “noxious
weed” that includes a plant or plant product that could harm not just
agriculture but also the “natural resources of the United States, public health
or the environment.”
Critics of biotechnology, citing the
language in the Plant Protection Act, want the department to consider those
broader concerns in analyzing the risks of new biotech crop.
The biggest question of all may be
when, or even if, the department ever implements this overhaul. It could take
years to finalize the plan.
USDA officials have said that the
administration wants to issue a proposed rule for the new regulatory system
before the fall. But even getting it done by next January, when Obama leaves
office, would be a heavy lift. And it would still be up to the new administration
whether to actually implement the plan.
The industry and other stakeholders
have been given 30 days to comment on the current document, but they plan to
ask for at least 60 days more. Industry and farm groups also are planning to
meet in the next week or two to discuss how to address the USDA proposal.
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