WASHINGTON, Nov. 25, 2015 - The Agriculture Department is
planning a landmark overhaul of the way it regulates biotechnology that could
allow companies and university scientists to develop and test many crops
without the USDA oversight that critics say has slowed innovation.
The new plan, which was outlined at a recent stakeholder meeting, is being applauded by
groups who say regulators are wasting resources on unnecessary scrutiny of many
new products. But the plan also is raising concerns among some in the industry
that it will create uncertainty among investors while the proposal is debated
over the coming months and years.
The plan would entail focusing the department’s
approval process and regulation of field trials only on plants and insects that
pose clear risks of becoming plant pests or noxious weeds, the two risks that
USDA is mandated to protect against under federal law, according to officials
with the Biotechnology Regulatory Services (BRS), an arm of USDA’s Animal and
Plant Health Inspection Service (APHIS).
USDA plans to issue a proposed rule by next August,
before the Obama administration leaves office, said Michael Firko, deputy APHIS
administrator for BRS. With that goal in mind, BRS will issue a notice of its
intent to do an environmental impact statement on the possible changes.
Under the plan Firko outlined at the stakeholder
meeting, companies and universities that are developing a new biotech trait
could check a database, or “regulatory status registry,” to determine up front
whether the product is subject to regulation. If not, the developer would be
free to test and commercialize the product. If the developer chooses, it could
request a letter from BRS verifying the regulatory status.
“This is
going to amount to regulatory relief for many people. I believe it will
dramatically stimulate innovation in new plant varieties,” Firko said.
“This will make it possible for folks who are creating products of
biotechnology that don’t represent a risk to American agriculture, that don’t
represent a risk as a plant pest or noxious weed, to go ahead and continue
development of their product.”
Many of the plan’s details remain unclear or
undecided. But Firko made clear that many of the traits the BRS now reviews on
a regulatory basis, such as herbicide tolerance, would likely receive less
scrutiny. Of the 115 traits the USDA has approved to date, 48 of them involved
resistance to either glufosinate or glyphosate herbicides.
Firko specifically said that none of the genetically
engineered wheat traits now under USDA purview likely “would be regulated in
the future” under the plan. That’s ironic, as Firko seemed to acknowledge,
because the department is currently tightening its oversight of biotech wheat
field trials because of discoveries of unapproved varieties in Oregon and
Montana. The Oregon finding led to a brief disruption in U.S. wheat exports.
Under the existing regulatory system, the use of an
agrobacterium to develop new traits in wheat, corn, soybeans and other crops
has forced BRS to review each of the products for their potential to become
plant pests even when agency scientists don’t believe they could. “History has shown over the last 28 years
that that (use of the bacteria gene) doesn’t necessarily mean the plant becomes
a plant pest, but we just keep asking that question over and over again,” Firko
said.
Agriculture Secretary Tom Vilsack has been regularly
updated on the plan, and the White House Office of Science and Technology
Policy “is in complete support,” Firko said.
While the rule is in development, APHIS is
separately acting to simplify and accelerate its review process through the use
of “extensions,” which eliminate the need for companies to obtain separate
approvals for the same trait when it’s used in different varieties of a crop
such as apples or when previously approved traits are combined in a crop.
The National Corn Growers Association (NCGA), which
had two representatives at the stakeholder meeting, said the overhaul of the
regulatory process would help get cutting-edge new products in farmers’ hands
more quickly. During a private session after the meeting, a BRS official
assured the NCGA representatives that foreign governments were being kept up to
speed on USDA’s plans.
“At this point they are very, very focused on making
sure that they don’t cause any trade disruptions with this process,” said one
of the NCGA representatives, John Linder, an Ohio farmer who chairs the group’s
trade policy and biotechnology action team.
Still, there also is some frustration within U.S. agribusiness
that USDA is moving ahead with the plan without more consultation, said an
industry source, who spoke to Agri-Pulse on condition of anonymity, and
companies also are concerned about the potential impact on trade if many
biotech crops are left unregulated by USDA. The source also said USDA is
underestimating the sheer number of crop traits that are in the research stage
that may need review.
“I don’t
think we have any problem with them trying to focus on regulatory relief,” the
official said. “The way they are designing the process we’re scratching our
head as to how it would work in practice.”
The official also said, “We’re all a little bit frustrated
that they seem to have made up their mind to move ahead with this plan.”
A company
representative and industry advocate raised concerns at the stakeholder
meeting about the uncertainty that the proposed rule would create. It could be
as many as three to four years into the next administration before the rule is
finalized, according to Firko.
“There’s no
doubt that there are challenges associated with changing. USDA is not afraid of
the future. We’re not afraid of changing,” Firko said. “The change is not going
to be easy for anybody.”
Greg Jaffe, biotechnology director for the consumer
advocacy group Center for Science in the Public Interest, said there are good
reasons for overhauling the current system but that there are a lot of
unanswered questions about what BRS is going to propose.
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