I.Further guidance on specific
aspects of risk assessment
1.Commends the use of innovative methods under
the open-ended online forum on risk assessment and risk management
as an efficient means to maximize the use of limited financial
resources;
2.Takes
note of the conclusions and recommendations of the open-ended
online forum and the Ad Hoc Technical Expert Group on Risk
Assessment and Risk Management and welcomes the resulting
"Guidance on Risk Assessment of Living Modified Organisms"
(hereinafter referred to as "the Guidance");
3.Notes that the Guidance is a document in
evolution and that its objective is to provide a reference that may
assist Parties and other Governments in implementing the provisions
of the Protocol with regards to risk assessment, in particular its
Annex III and, as such, this Guidance is not prescriptive and does
not impose any obligations upon the Parties;
4.Decides to extend the current open-ended
online forum and the Ad Hoc Technical Expert Group on Risk
Assessment and Risk Management in accordance with the terms of
reference annexed hereto;
5.Urges Parties and invites other
Governments and relevant organizations to nominate further experts
with experience relevant to risk assessment to the open-ended
online forum and to actively participate in the online
discussions;
6.Further
notes that the first version of the Guidance requires further
scientific reviewing and testing to establish its overall utility
and applicability to living modified organisms of different taxa
introduced into different environments, and requests the
Executive Secretary to, prior to the first meeting of the Ad Hoc
Technical Expert Group on Risk Assessment and Risk Management, (i)
translate the first version of the Guidance into all United Nations
languages with a view to enabling a large number of experts to take
part in the reviewing process; (ii) coordinate with Parties and
other Governments, through their technical and scientific experts,
and relevant organizations, a review process of the first version
of the Guidance; (iii) make the comments of the review process
available through the Biosafety-Clearing House;
7.Requests the Executive Secretary to convene,
prior to the sixth meeting of the Conference of the Parties serving
as the meeting of the Parties to the Protocol, (i) ad hoc
discussion groups and real-time online conferences under the
open-ended online forum, and (ii) two meetings of the Ad Hoc
Technical Expert Group, and to compile the views and
recommendations submitted by participants in the online forum for
consideration by the Parties;
8.Further
requests the Executive Secretary to: (i) update the common
format for submission of records to the Biosafety Information
Resources Centre in order to link its records on risk assessment to
specific sections of the Guidance; and (ii) explore possible ways
to link background materials available in the "Scientific
Bibliographic Database on Biosafety" to specific sections of the
Guidance;
II.Capacity-building in risk
assessment
Welcoming the development of a
training manual on risk assessment of living modified
organisms,
Welcoming also the reports of the
Pacific Subregional Workshop on Capacity-building and Exchange of
Experiences on Risk Assessment (
UNEP/CBD/BS/COP-MOP/5/INF/16) held in Nadi, Fiji and of the
Asian Subregional Training Course on Risk Assessment of Living
Modified Organisms (
UNEP/CBD/BS/COP-MOP/5/INF/17) held in Siem Reap, Cambodia and
taking note of their recommendations,
9.Requests the Executive Secretary to:
(a)Submit the training manual to
experts and other reviewers from Parties and other Governments for
an assessment of its effectiveness;
(b)Convene, at the earliest
convenient date, further regional or subregional training courses
to enable countries to gain hands-on experience in the preparation
and evaluation of risk assessment reports in accordance with the
relevant articles and Annex III of the Protocol, and to further
test the first version of the Guidance and make the results of the
testing available through the Biosafety-Clearing House;
(c)Improve the training manual
"Risk Assessment of Living Modified Organisms" in cooperation with
relevant United Nations bodies, other relevant organizations and
expert reviewers by revising it on the basis of the recommendations
provided during the regional and subregional capacity-building
activities and feedback from Parties, in such a way that any
further improvements of the training manual, on the one hand, and
of the Guidance through the process outlined in paragraph 6 above,
on the other hand, is made in a coherent and complementary
manner;
(d)Develop an interactive learning
tool based on the training manual, and make it available through
the Biosafety Clearing-House in all United Nations languages with
the view to developing a more cost-effective way for delivering
training on risk assessment;
III.Identifying living modified
organisms or specific traits that may have adverse effects on the
conservation and sustainable use of biological diversity, taking
also into account risks to human health
Welcoming the views submitted by
Parties, other Government and relevant organizations regarding the
identification of living modified organisms or specific traits that
may have adverse effects on the conservation and sustainable use of
biological diversity, taking also into account risks to human
health and acknowledging the challenges in harmonizing the
divergent views,
Welcoming also the recommendations by
the Ad Hoc Technical Expert Group on Risk Assessment and Risk
Management regarding possible modalities for cooperation in
identifying living modified organisms or specific traits that may
have adverse effects on the conservation and sustainable use of
biological diversity, taking also into account risks to human
health, in particular the implementation of a step-wise approach
for this purpose that starts with the exchange of
information,
10.Urges Parties and invites other
Governments to submit to the Biosafety Clearing-House decisions and
risk assessments where potential adverse effects have been
identified, as well as any other relevant information that may
assist Parties in the identification of living modified organisms
or specific traits that may have adverse effects on the
conservation and sustainable use of biological diversity, taking
also into account risks to human health, including information, if
possible, when a decision is not taken due to the potential of a
living modified organism to cause adverse effects when introduced
into specific environments;
11.Requests the Executive Secretary to compile
the information for consideration by the Parties at their sixth
meeting;
IV.Identifying living modified
organisms that are not
likely to have adverse effects on the conservation and
sustainable use of biological diversity, taking also into account
risks to human health
Recalling the provisions of the
medium-term programme of work,
decision
BS-I/12 paragraph 7 (a) (i), to consider a modality that might
enable the identification of living modified organisms that are not
likely to have adverse effects on the conservation and sustainable
use of biological diversity, taking also into account risks to
human health, with a view to arriving at a decision in accordance
with paragraph 4 of Article 7,
12.Requests Parties and invites other
Governments and relevant organizations to submit to the Executive
Secretary (i) information on risk assessments, carried out on a
case-by-case basis with regards to the receiving environment of the
living modified organism, that might assist Parties in the
identification of living modified organisms that are not likely to
have adverse effects on the conservation and sustainable use of
biological diversity, taking also into account risks to human
health, and (ii) the criteria that were considered for the
identification of such living modified organisms;
13.Requests the Executive Secretary to compile
the information received and prepare a synthesis report for
consideration by the Parties at their sixth meeting.
Annex
TERMS OF REFERENCE FOR THE OPEN-ENDED
ONLINE FORUM AND AD HOC TECHNICAL EXPERT GROUP ON RISK ASSESSMENT
AND RISK MANAGEMENT
Methodology
1.The
open-ended online forum and the Ad Hoc Technical Expert Group on
Risk Assessment and Risk Management shall work primarily online to
(i) revise and test the first version of the Guidance on the basis
of the results of the scientific review process, the testing
associated with capacity-building activities and any testing
initiated by the Ad Hoc Technical Expert Group and organized by the
Executive Secretary, and (ii) assess the overall applicability and
utility of the Guidance to living modified organisms across
different taxa and receiving environments, with the view to
achieving the expected outcomes outlined below;
2.The
Ad Hoc Technical Expert Group on Risk Assessment and Risk
Management shall meet twice face-to-face prior to the sixth meeting
of the Conference of the Parties serving as the meeting of the
Parties to the Protocol;
Expected outcomes
3.The
open-ended online forum and the Ad Hoc Technical Expert Group on
Risk Assessment and Risk Management shall work together with the
view to developing and achieving the following:
(a)A revised version of the
"Guidance on Risk Assessment of Living Modified Organisms";
(b)A mechanism, including
criteria, for future updates of the lists of background
materials;
(c)Further guidance on new
specific topics of risk assessment, selected on the basis of the
priorities and needs by the Parties and taking into account the
topics identified in the previous intersessional period;
Reporting
4.The
open-ended online forum and the Ad Hoc Technical Expert Group on
Risk Assessment and Risk Management shall submit final reports
detailing their activities, outcomes and recommendations for
consideration by the sixth meeting of the Conference of the Parties
serving as the meeting of the Parties to the Protocol.
