Washington, DC
March 7, 2005
Conference proceedings on the impact which biotech regulation
has on small businesses and university research
Since agricultural biotechnology was first
introduced in the mid-1990s, stakeholders have debated whether
or not the regulatory system places undue burdens on small
businesses and university researchers, who typically lack the
financial and technical resources of larger companies. USDA’s
announcement in January 2004, that the Animal and Plant Health
Inspection Service (APHIS) at the United States Department of
Agriculture (USDA) would review the way it regulates
agricultural biotechnology can provide an opportunity to
reconsider the impacts of regulation on small businesses and
university research without jeopardizing product safety.
In June 2004,
the Pew Initiative on Food and Biotechnology and APHIS
co-sponsored a roundtable discussion to illuminate the many
concerns related to existing regulations for agricultural
biotechnology, the way those regulations are implemented and
potential changes. Proceedings from that discussion, titled
“Impacts of Biotech Regulation on Small Business and University
Research: Possible Barriers and Potential Solutions,” are now
available on the Pew Initiative website.
Highlights include:
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Executives from small biotech firms
discussed how regulatory costs affect business decisions and
how uncertainty in the regulatory system can dampen investor
interest and potentially deny firms the resources needed to
bring innovative new products to the marketplace.
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The current regulatory system is not one in
which university scientists fit easily. Not only are
university researchers generally not trained to deal with
the regulatory process, their career advancement is not
helped by conducting the kind of studies needed for
regulatory approvals. Consequently, many university
scientists are disengaged from the regulatory process and
are less likely to push basic research towards
commercializing products that could benefit farmers and
consumers alike.
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Participants noted a number of options which
could improve the regulatory process for small businesses
and university scientists. Suggestions included better
guidance from agency officials about what it takes to gain
approval; streamlining the regulatory approval process so
that genetic changes (‘events’) already approved for use in
one crop could be used in related crops with reduced
government oversight; and the creation of a public-private
partnership to foster innovation by small businesses and for
smaller market products by assisting the collection of field
trial data necessary for regulatory approval.
Proceedings and highlights from the conference
can be viewed and downloaded at
http://pewagbiotech.org/events/0602. |