RISK ASSESSMENT AND MANAGEMENT
Sourioudong SUNDARA, Ph.D. in biochemistry
· Director General, Research Institute of Science
· Focal point and competent national authority
for the Cartagena Protocol on biosafety
Protocol on biosafety
Lao PDR don't have a research, development and commercialization
on the GMO's product and the Biosafety regulation will
be prepared under the National Biosafety Frameworks.
Protocol on biosafety
Lao PDR is a member of Convention on biological diversity
and the ratification of the Cartagena Protocol on biosafety
is on the procedure.
Convention on biological Diversity was signed in 1996.
As a signatory to this convention the Government of Lao
PDR agree to:
(a) develop a national strategy for the conservation and
sustainable use of the nation's biological diversity;
(b) develop regulatory provisions and economically and
socially sound measures for protecting threatened species,
populations and ecosystems;
(c) integrate conservation and sustainable use of biological
resources into national decision-making and planning processes;
(d) conduct environmental assessment (EA) of proposed
development projects with a view to minimizing negative
impacts on biological diversity;
(e) take measures to ensure that the sharing of benefits
arising from the use of traditional knowledge and genetic
resources is sustainable and equitable; and
(f) promote and encourage the understanding of the importance
of biological diversity.
Participation in the programme for developing ''National
Biosafety Framework'' initiated by UNEP-GEF is vital and
appropriate to help Lao PDR in developing the controlling
system and completing legal documents. Research Institute
of Science, STEA was designated as a single entity to
fulfil the functions of both focal point and competent
national authority for the Cartagena Protocol on Biosafety.
Science Technology and Environment Agency is mandated
with the overall responsibility for the oversight and
coordination of the Science, Technology and Environment.
This includes policy development, as well as the management
of international agreements and conventions. As such the
principle partner in undertaking the activities outlined
above is likely to be STEA. It is , however, clearly recognized
that effective implementation will not be possible without
the collaboration and support from other key line agencies
and NGOs such as:
(a) Ministry of Agriculture and Forestry (MAF),
(b) Ministry of Public Heath (MPH),
(c) Ministry of Education (MOE),
(d) Ministry of Industry and Handicrafts (MIH),
(e) Ministry of Trade (MOT),
(f) Ministry of Justice (MOJ),
(g) Ministry of Communication Post Transport and Construction
(h) State Planning Committee (SPC),
The objective, outputs and follow-up of this project are
The main Objective of this National Project is the preparation
/evaluation/revision of a National Biosafety Framework
in accordance with the relevant provisions of the Cartagena
Protocol on Biosafety.
The main elements of this framework would be
· a regulatory system
· an administrative system
· a decision making system that includes risk assessment
· mechanisms for public participation and information
following outputs will be required to achieve the objective
of the National Project
One of the national project (Months 1-6), which consists
of preparatory activities and the gathering of the necessary
information will be expected to produce the following
a. Inventories of the following:
i Current use of modern biotechnology as defined in the
Cartagena Protocol on Biosafety (including those techniques
that are covered in the Protocol but excluded from the
Advanced Informed Agreement procedure e.g contained use,
veterinary use and possibly human pharmaceuticals);
ii Existing legislation or legal instruments related to
iii Active or planned National Projects for capacity building
related to the safe use of biotechnology.
b. A report on existing sub-regional biosafety frameworks
and mechanisms for harmonization of risk assessment/management.
c. Rosters of relevant experts within the country, identifying
their experience and expertise so that adequate coverage
in all areas of expertise is obtained and potential gaps
can be identified.
Phase Two of the national project (Months 7-12), which
includes the necessary analysis for the preparation of
the NBF, will be expected to produce the following outputs:
d. Access to relevant information for all stakeholders
in accordance with the requirements of the Cartagena Protocol
e. Development of National Biosafety Database and linkages
to the Biosafety Clearing House.
f. Mechanisms for adequate involvement of all stakeholders,
including public and private sectors, on issues related
g. Identification of the components of the national Biosafety
Framework, in consultation with all relevant stakeholders.
Phase Three of the national project, (Months 13-18), during
which the draft NBF will be prepared, will be expected
to produce the following outputs:
h. Draft of legal instruments, including guidelines, as
i Systems for risk assessment and management, including
audit, which take into account national and sub-regional/regional
j Administrative system for compliance with the Cartagena
Protocol on Biosafety
k Mechanisms for public consultation in decision-making
processes regarding LMOs.
l Mechanisms for sharing of scientific assessments at
sub-regional levels, whilst allowing for decision-making
at the national level.
m Identification of country needs and mechanisms for participation
in the Biosafety Clearing House.
n Publication of inventories, reports of national meetings,
draft and/or final National Biosafety Framework, relevant
regulations and guidelines.
to guidance provided to the GEF by ICCP and, in future
by the Meetings of the Parties of the Cartagena Protocol
on Biosafety, the country may be eligible for further
assistance to implement its National Biosafety Framework.
The follow-up activities will benefit from the experience
gained in assisting pilot countries to implement their
respective biosafety frameworks. This further development
was set out in the GEF initial strategy on Biosafety adopted
by the November 2000 GEF Council meeting.