WASHINGTON, Sept. 21, 2016 - A White
House plan for updating federal regulation of agricultural biotechnology calls
for the FDA and EPA to clarify how they will treat products of gene editing.
The 19-page plan
also says that federal agencies are
working to better coordinate in the regulation of genetically engineered
mosquitoes and other insects.
The White House announced in July 2015
that it planned to overhaul the federal regulatory system for biotechnology
that is largely unchanged since it was first developed under the Reagan
administration three decades ago.
The update comes as scientists are
increasingly using techniques of genome editing, such as CRISPR-Cas9, to alter
crops and food animals rather than moving genes between species. Many in the
industry want gene-edited products excluded from federal regulation, smoothing
and accelerating their path to market.
USDA’s Biotechnology Regulatory Services already is undertaking an overhaul of its regulatory
process and has been considering a sweeping definition of biotechnology that
includes gene editing. A proposed rule is expected to move to the Office of
Management and Budget for review.
The White House document said FDA’s
plan will include clarifying what will be needed for gene-edited animals to
comply with “applicable statutory and regulatory requirements.”
FDA also will consider updating its industry
guidance for voluntary pre-market consultation.
Companies aren’t required to get FDA’s approval for new genetically engineered
crop traits but routinely do so on a voluntary basis.
The
plan is intended to ensure the government can efficiently assess any risks of
new biotech products “supporting
innovation, protecting health and the environment, promoting public confidence
in the regulatory process, increasing transparency and predictability, and
reducing unnecessary costs and burdens,” the document said.
EPA,
FDA and USDA are expected to lay out how each will divide up their
responsibilities for regulating biotech insects.
As
an example, the plan said, EPA would use its authority under the Federal
Insecticide, Fungicide and Rodenticide Act to regulate genetically engineered
mosquitos when the developer claims they would control population levels. FDA
could regulate the mosquitoes under the Food, Drug and Cosmetic Act if the
developer claims they would prevent disease such as the Zika virus.
Greg
Jaffe, who directs biotechnology policy for the Center for Science in the
Public Interest, welcomed the agencies’ commitment to clarifying how they will
regulate gene editing and to coordinating their handling of gene-altered
insects, but he said FDA needs to seek statutory authority to require
pre-market safety reviews of new products.
The
Biotechnology
Innovation Organization says it is
reviewing the plan. “BIO commends the White House for undertaking this effort
and for recognizing that coordination between the agencies that oversee the
approval of biotech products must be a priority to ensure public confidence in
the regulatory system and prevent unnecessary barriers to future innovation and
competitiveness, while continuing to protect health and the environment.”
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