Public Research and the
Regulatory Review of Small-Market (Specialty) Biotechnology-Derived
Crops
Draft Proceedings of a Workshop, November
2004
A workshop on Public
Research and Regulatory Review of Small-Market
(or Specialty) Biotechnology-Derived Crops was
organized by the National Center for Food
and Agricultural Policy (NCFAP); Langston
University, Oklahoma; and three USDA agencies:
CSREES, ARS (the Agricultural Research
Service), and APHIS (the Animal Plant Health
Inspection Service). The workshop was held
November 8-9, 2004, at APHIS headquarters
in Riverdale, MD.
The purpose of the workshop was to discuss
how the public research sector, the regulatory
agencies, and the private sector can work
together to facilitate the regulatory review
of specialty (small market) biotechnology-derived
crops. Specific objectives were to:
- Identify aspects of in the current regulatory
process that are major sources of cost
and uncertainty.
- Identify researchable issues that can
help meet these requirements effectively
and at minimal cost.
- Consider existing models that have enabled
other small-market products, also subject
to regulation, to complete the requirements
necessary to come to market.
- Propose one of these models or a new
model for specialty transgenic crops.
Workshop participants identified aspects
in the current regulatory process that are
major sources of cost and uncertainty, and
researchable issues that could help meet
regulatory requirements effectively and at
minimal cost; and evaluated existing models
that have enabled other small-market products,
also subject to regulation, to complete the
requirements necessary to come to market.
Discussions topics included criteria for
prioritizing crops and traits to move through
the regulatory process, and areas of research
that could enhance and accelerate the deregulation
of small market crops.
Workshop participants recommended the development
of a concept for a public organization to
facilitate interactions between developers
of biotech specialty crops and regulatory
agencies to help provide advice and data
necessary for regulatory evaluation of those
crops. A second recommendation was the development
of a series of peer-reviewed white papers
that organize and evaluate current information
relevant to the regulatory process. A planning
committee formed at the workshop will coordinate
the first draft of an organizational plan
and organize a second workshop to add detail
to the plan through input from a broader
stakeholders group. Initiative funds were
awarded to the Chair of the Planning Committee,
Prof. Alan McHughen of the University of
California-Riverside.
This draft of the proceedings of the workshop
has been reviewed by all authors. A final
version is in the formatting stage and will
replace this draft version.
CSREES contacts for SCRI are Ann
Marie Thro and William
Goldner.
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