This International workshop examined the basic elements of
biosafety regulatory frameworks, explored the experience gained in
countries with economies at different stages of development in
implementing a biosafety framework and reviewed current
capacity-building initiatives. Special emphasis was placed on
identifying the emerging needs of developing countries and
countries with economies in transition to implement the basic
elements of a biosafety regulatory system as envisaged by the
Biosafety Protocol.
Papers on the experience to date were presented by Canada, the
United States, the United Kingdom, Mexico and the Russia
Federation. Cameroon, India, Malaysia, and Brazil presented papers
on their emerging needs to manage biosafety. Papers by UNEP, ISNAR,
the European Commission, Australia, Canada, the United States, and
Japan described and assessed current capacity-building
efforts.
Participants discussed four topics in workshops, each of which
produced a summary report of discussions: 1) regulation; 2) risk
assessment and risk management; 3) administrative implementation
and 4) information supply and public participation. These workshops
are described briefly below.
Workshop 1: Emerging needs in regulation: different ways of
implementing biosafety regulations- The workshop focus included
biosafety regulations on LMO-related development activities that
range from regulations on contained uses to confined releases,
small- and large- scale field trials, deliberate field releases,
and the consumption of products, including transboundary movement,
in order to safeguard the biologically diverse resources and the
environment as well as human and animal health. Emerging needs for
biosafety regulation in developing countries and countries with
economies in transition depend largely on the existing level and
anticipation of the development of modern biotechnology within
respective countries and/or regions. Of immediate concern are the
regulations on notification and applications for importation for
contained use and field trials of transgenic plants or animals from
developed countries to be carried out in countries with no
biosafety regulation or guidelines available or being enforced. In
addition to the lack of appropriate biosafety regulation, these
countries also lack required human resources and experience to
handle such tasks and responsibility.
Workshop 2: Risk assessment and risk management The workshop
identified risk assessment needs including: (a) Identification of
necessary experience and training for risk assessment using the
following strategies: use of the UNEP Guidelines as starting points
to identify disciplines; having flexibility to bring in other
disciplines as necessary; identifying personnel to be trained- a
core group who can then train others to maximize continuity;
provision of hands on training through an iterative process which
builds on existing efforts; and using existing regional efforts as
models for other regions; (b) Identification of information that is
needed - e.g., on biodiversity, on local crops, on centres of
origin and diversity, using the following strategies: regional
efforts on centres of origin; and collection of information on
crops used at local or regional level; (c) Identification of
information that is available and systems for accessing the
information in real time, using the following strategies:
compilation of websites; provision of Internet access points that
can then disseminate information to the rest of country; mailings
of risk assessment reviews; and establishing closer links between
government, private, and research institutes; (d) Access to experts
through rosters at the regional and international levels. Risk
management and risk mitigation needs include: (a) Appropriate
facilities and technical resources, to be addressed through centres
of excellence on a regional basis; (b) Human-resource training
through: hands-on training, remembering that those to be trained
may differ from those people involved in risk assessment; and use
of regional institutions to help with national programmes; (c)
Sharing of experiences through workshops at regular time frames at
the regional and international levels, and the provision of
internships; (d) Risk management communication through effective
use of media, public information meetings, and use of industry to
communicate risk management to users.
Workshop 3: Administrative aspects of implementing biosafety
regulations The lack of experts in the field was identified as a
key constraint. This is reflected by the general insufficiency of
knowledge of the subject matter, as well as by the gaps in specific
areas of biosafety in the different countries. These deficiencies
can be observed both at the level of the competent authorities and
at the level of the advisory bodies. A number of approaches were
proposed to address these, including a national-level mentoring
programme, in addition to educating and training people within the
country. At the regional level, it was proposed to create regional
groups of experts in order to fulfil the needs for expertise in
subjects important in the different geographic regions. At the
global level. the workshop agreed that a possible solution might
consist of putting a list of independent experts at the disposal of
the countries, to be included in the mechanism already in place for
the exchange of information under the Convention on Biological
Diversity. With regard to handling of notifications.
Workshop 4: Information supply and public participation Discussions
were broad in scope and emphasized the importance of education and
dissemination regarding biotechnology and biodiversity more than
information supply and public participation in the decision-making
processes regarding biosafety.
National level activities
Development of national biosafety frameworks
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