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 The
Program for
Biosafety Systems (PBS) is a partnership program for biosafety
capacity development sponsored by the
U.S. Agency for International
Development. The aim of PBS is to assist developing countries by
enhancing biosafety policy, research, and capacity.
The Donald
Danforth Plant Science Center manages the Regulatory Approval
Strategies component of PBS. The goal of
the Regulatory Approval Strategies component is to facilitate the
regulatory approval of specific agricultural biotechnologies,
addressing environmental and food/feed safety issues. This
component aims to help public sector research and development
institutes incorporate biosafety into their product development
plans and to comply with regulatory requirements. It also aims to
help regulatory agencies carry out their roles in the review and
approval process.
 The International
Programs office implements this Program by providing training and
consultative guidance to governments in Africa and Asia to assist
them in developing workable biosafety
regulatory systems for the safe field-testing of transgenic crops,
and also assists in arranging for training of scientists from developing countries. To
date, the RAS component has provided training for over 250
individuals in more than 10 countries.
This component
also helps public sector research and development institutes
incorporate biosafety into their product development plans and to
comply with regulatory requirements. For the past 2 years, the
Office has provided continuing consultative guidance to
the Catholic
University of Leuven to develop and submit an application
for a confined field trial
of transgenic banana in Uganda.
In 2004, the
International Programs Office implemented biosafety workshops in
Nigeria, Uganda, Kenya, and Malawi. In Nigeria, a workshop taught
members of the National Biosafety Committee methods for assessing
the environmental and food safety of transgenic crops. In Kenya,
members of the research community were taught ways to design and
implement confined field trials that would conform to international
safety standards.
In 2005, the
Office worked with officials from the
Uganda National Council for
Science and Technology (UNCST) to create a Guide for
Conducting Confined Field Trials and an Inspector’s Manual for such
trials. In addition, the Office delivered biosafety training
workshops for regulators in
Mali,
Tanzania, and Ghana.
Activities planned for 2006 include training workshops for
participants from Uganda, Ghana, Kenya, Indonesia, Malawi, Nigeria,
Mali, and Tanzania. The Danforth Center will also host a Study Tour
in August for government Regulators from Ghana.
An
important task of the Regulatory Approval Strategies component is to
provide developing countries with the necessary resources to create
and streamline regulatory systems. A crucial step in this process is
having the necessary documents in place to conduct confined field
trials of genetically modified plants. Completed by RAS in early
2006,
a set of manuals called the Integrated Confinement System
for Genetically Engineered Plants provide a basis for conducting
and evaluating confined field trials. These documents will
serve as resource materials for any country interested in
conducting field trials of genetically-modified plants.
Integrated Confinement System for
Genetically Engineered Plants
(PDF)
Unit 1: Introduction to the Integrated Confinement System
(Word)
(PDF)
(French)
Unit 2: Confined Field Trial Guideline
(Word)
(PDF)
(Indonesian)
(French)
Unit 3: Trial Manager’s Handbook
(Word)
(PDF)
(French)
Unit 4: Inspector’s Handbook
(Word)
(PDF)
(French)
Unit 5: Resources for Regulators
(Word)
(PDF)
(French)
For additional
information, please contact:
Mr. Jeff Stein
Biosafety Advisor, PBS
jstein@danforthcenter.org
Phone:
(314) 587-1232
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