I.Further guidance on specific
aspects of risk assessment
1.Takes note of the
conclusions and recommendations of the open-ended online forum and
the Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and
Risk Management and
commends the progress made on the
resulting Guidance on Risk Assessment of Living Modified Organisms,
clearly understanding that:
(a)The Guidance is not
prescriptive and does not impose any obligations on Parties;
(b)The Guidance will be tested
nationally and regionally for further improvement in actual cases
of risk assessment and in the context of the Cartagena Protocol on
Biosafety;
2.Encourages Parties, other
Governments and relevant organizations, as appropriate, to
translate the Guidance into national languages and to make such
translated versions available through the Biosafety Clearing-House
for wide dissemination, in order to facilitate the testing of the
Guidance at national, regional and subregional levels;
3.Also encourages Parties,
other Governments and relevant organizations, through their risk
assessors and other experts who are actively involved in risk
assessment, to test the Guidance in actual cases of risk assessment
and share their experiences through the Biosafety Clearing-House
and the open-ended online forum;
4.Invites Parties, other
Governments and relevant organizations to provide financial and
technical assistance to developing country Parties and Parties with
economies in transition to undertake, as appropriate, the testing
activities referred to in paragraph 3 above;
5.Requests the Executive
Secretary to:
(a)Develop appropriate tools to
structure and focus the testing of the Guidance;
(b)Gather and analyse, in a
transparent manner, feedback provided as a result of testing on the
practicality, usefulness and utility of the Guidance, (i) with
respect to consistency with the Cartagena Protocol on Biosafety;
and (ii) taking into account past and present experiences with
living modified organisms; and
(c)Provide a report on possible
improvements to the Guidance for consideration by the Conference of
the Parties serving as the meeting of the Parties to the Protocol
at its seventh meeting;
6.Establishes the following
mechanism for regularly updating the list of background documents
to the Guidance in a transparent manner:
(a)On an annual basis, the
Executive Secretary will invite Parties, non-Parties, relevant
organizations and all Biosafety Clearing-House users, to propose
relevant background materials that can be linked to specific
sections of the Guidance;
(b)In the absence of any AHTEG on
risk assessment and risk management, a regionally balanced group of
fifteen experts in risk assessment (three experts per region) will
be nominated by the Parties and selected by the Bureau of the
Conference of the Parties serving as the meeting of the Parties to
the Protocol to work online to examine the relevance of the
proposed background documents. The members of the Group will work
on an ongoing basis, renewable every four years;
(c)The Group will nominate a chair
from among its members to lead deliberations transparently in
approving, updating, rearranging or rejecting the proposed
background materials in a justified manner;
(d)Documents on the list will be
re-validated by the Group every five years or as appropriate.
Documents not re-validated after this time period will, initially,
be flagged for one year as "possibly outdated" and will
subsequently be deleted from the list of background materials after
an additional year;
(e)The Group will submit a report
of its activities to each meeting of the Conference of the Parties
serving as the meeting of the Parties to the Protocol;
7.Decides to extend the
open-ended online forum, bring to a close the current AHTEG and
establish a new AHTEG, that will serve until the seventh meeting of
the Parties, in accordance with the terms of reference annexed
hereto;
8.Requests the Executive
Secretary to:
(a)With a view to achieving a
balance of current and new members, select experts for the new
AHTEG, in consultation with the Bureau of the Conference of the
Parties serving as the meeting of the Parties to the Protocol, in
accordance with paragraph 18 of the consolidated modus
operandi of the Subsidiary Body on Scientific, Technical and
Technological Advice of the Convention on Biological Diversity
(decision VIII/10, annex III);
(b)Invite other Governments and
relevant international organizations to participate in the
open-ended online forum;
(c)Ensure that the participation
of experts nominated by other Governments and relevant
organizations to the open-ended online forum and AHTEG is in
accordance with rules 6 and 7 of the rules of procedure for
meetings of the Conference of the Parties serving as the meeting of
the Parties to the Protocol;
(d)Ensure that all online
discussions of the open-ended online forum are moderated to enhance
their efficiency; and
(e)Undertake temporary measures
for updating the list of background documents in the time it takes
to establish the membership of the new AHTEG;
II.Capacity-building in risk
assessment and risk management
Acknowledging the revised training
manual on risk assessment of living modified organisms and the
concept of an e-training tool based on the revised training
manual,
Welcoming the reports of the
subregional workshops on capacity-building and exchange of
experiences on risk assessment held in the Caribbean, Latin
American and African (Anglophone countries) subregions and
taking note of the recommendations from the
workshops,
Taking note of the recommendations of
the open-ended online forum and the Ad Hoc Technical Expert Group
(AHTEG) on Risk Assessment and Risk Management regarding
capacity-building in risk assessment and risk management,
9.Requests the Executive
Secretary, subject to the availability of funds, to:
(a)Convene, at the earliest
convenient date, the remaining training courses on risk assessment
for the African (Francophone countries) and the Central and Eastern
Europe subregions to enable the countries concerned 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;
(b)Cooperate with the open-ended
online forum and AHTEG to develop a package that aligns the
Guidance on Risk Assessment of Living Modified Organisms (e.g. the
Roadmap) with the training manual "Risk Assessment of Living
Modified Organisms" in a coherent and complementary manner, with
the clear understanding that the Guidance is still being
tested;
(c)Follow up on training by
gathering additional feedback from Parties on the practicality,
usefulness and utility of the Guidance and training manual through
online discussions or other means, as appropriate; and
(d)Conduct workshops on risk
assessment and risk management at international, regional and/or
subregional levels, using the package to carry out training courses
for risk assessors, taking into consideration real case studies in
risk assessment and how to apply the Guidance in the context of the
decision-making process under the procedures of the Protocol;
10.Invites Parties, other
Governments and international organizations to provide financial
and technical assistance to developing country Parties and Parties
with economies in transition to implement the above
capacity-building activities, as appropriate;
III.Identification of living
modified organisms or specific traits that (i) may have or (ii) are
not likely to have adverse effects on the conservation and
sustainable use of biological diversity, taking also into account
risks to human health
11.Invites Parties and
encourages other Governments and relevant organizations to provide
the Executive Secretary with scientific information that may assist
in the identification of living modified organisms or specific
traits that may have or 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;
12.Requests the Executive
Secretary to create sections in the Biosafety Clearing-House where
such information could be submitted and easily retrieved;
IV.Status of implementation of risk
assessment and risk management provisions
13.Requests the Executive
Secretary to conduct an online survey on the status of the
implementation of operational objectives 1.3, 1.4 and 2.2 of the
Strategic Plan for the Cartagena Protocol on Biosafety for the
period 2011-2020, where data is missing and cannot be retrieved
through existing sources of information available to the
Secretariat, with a view to establishing baselines for, and
collecting data on, the indicators concerned.
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 on the following issues in
the given order of priority:
(a)Provide input, inter
alia, to assist the Executive Secretary in his task to
structure and focus the process of testing the guidance, and in the
analysis of the results gathered from the testing;
(b)Coordinate, in collaboration
with the Secretariat, the development of a package that aligns the
Guidance on Risk Assessment of Living Modified Organisms (e.g. the
Roadmap) with the training manual "Risk Assessment of Living
Modified Organisms" in a coherent and complementary manner, for
further consideration of the Parties, with the clear understanding
that the Guidance is still being tested;
(c)Consider the development of
guidance on new topics of risk assessment and risk management,
selected on the basis of the Parties' needs and their experiences
and knowledge concerning risk assessment.
2.Subject to the availability of funds, the Ad Hoc
Technical Expert Group on Risk Assessment and Risk Management shall
meet once face-to-face prior to the seventh 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 a view to developing and
achieving the following:
(a)Moderated online discussions
relating to the testing of the practicality, usefulness and utility
of the Guidance;
(b)A package that aligns the
Guidance on Risk Assessment of Living Modified Organisms (e.g. the
Roadmap) with the training manual "Risk Assessment of Living
Modified Organisms" in a coherent and complementary manner;
and
(c)A recommendation on how to
proceed with respect to the development of further guidance on
specific topics of risk assessment, selected on the basis of the
priorities and needs indicated by the Parties with the view of
moving toward the operational objectives 1.3. and 1.4 of the
Strategic Plan and its outcomes.
Reporting
4.The open-ended online forum
and the Ad Hoc Technical Expert Group on Risk Assessment and Risk
Management shall submit their final reports detailing the
activities, outcomes and recommendations for consideration by the
seventh meeting of the Conference of the Parties serving as the
meeting of the Parties to the Protocol.
5.The Ad Hoc Technical Expert
Group on Risk Assessment and Risk Management shall also operate the
mechanism set out in paragraph 6 of decision BS-VI/12 for the
regular updating of the background documents to the Guidance and
submit a report on its activities related to updating the
background documents to the Guidance to the seventh meeting of the
Conference of the Parties serving as the meeting of the Parties to
the Protocol.
