Small Market Biotech Crops
Initiative
Navigating the regulatory process and obtaining
approval from as many as three federal agencies
is a significant challenge in commercializing
a new biotechnology-derived crop. This can
be especially daunting for entities working
on specialty crops or developing products
with limited markets. On January 2005, the
Secretary of Agriculture awarded $35,000
for drafting and obtaining stakeholder input
on a proposed organizational plan for a Specialty
Crops Regulatory Initiative (SCRI) to assisting
developers of such crops through the scientific
regulatory approval process. The proposed
initiative will help clarify regulatory data
requirements, collect required data, maintain
a database of information for future applications,
and serve as a liaison with regulatory agencies.
The SCRI grew out of recommendations of
a workshop, “Public
Research and the Regulatory Review of Small-Market
(Specialty) Biotechnology-Derived Crops,” held
November 8-9, 2004, to discuss how the public
research sector, regulatory agencies and
the private sector could collaborate to facilitate
the regulatory review of specialty (small
market) biotechnology-derived crops. Over
125 federal, academic and private-sector
leaders participated.
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