Recalling Article 35 of the Protocol
which requires the evaluation of the effectiveness of the Protocol,
including an assessment of its procedures and annexes, to be
undertaken at least every five years,
Recognizing that the first assessment
and review, which was to be conducted in 2008, could not lead to a
meaningful evaluation of the effectiveness of the Protocol due to
the absence of a methodological approach and lack of sufficient
experience in the implementation of the Protocol,
Recalling decision BS-IV/15 which
requested the Executive Secretary to develop a methodological
approach, draft criteria or indicators that could contribute to an
effective second assessment and review of the Protocol,
1.Decides:
(a)That the scope of the second
assessment and review of the effectiveness of the Protocol focus
primarily on evaluating the status of implementation of core
elements of the Protocol as identified in the annex below;
(b)That the evaluation should be
based on information on the implementation of the Protocol gathered
through the second national reports, the Biosafety Clearing-House,
information that might be made available through the Compliance
Committee in relation to its functions to review general issues of
compliance, the capacity-building coordination mechanism and other
relevant processes and organizations;
2.Requests the Executive Secretary to collect
and compile information on the implementation of the Protocol and
to commission the analysis of such compilation of information with
a view to facilitating the second assessment and review of the
effectiveness of the Protocol;
3.Decides
also:
(a)To establish a regionally
balanced ad hoc technical expert group, subject to the availability
of funds, to: (i) review the analysis of information referred to in
paragraph 2 above; and (ii) submit its recommendations to the sixth
meeting of the Conference of the Parties serving as the meeting of
the Parties for its consideration; and
(b)That the third assessment and
review of the Protocol be conducted in conjunction with the mid
term review of the implementation of the Strategic Plan at the
eighth meeting of the Parties, using, among other things,
information collected through the third national reports;
4.Urges Parties and invites other
Governments and relevant international organizations to contribute,
as appropriate, to the data collection processes by completing and
submitting, in a timely manner, national reports, or by responding
to a questionnaire and providing complete information on the
implementation of the Protocol.
Annex
ELEMENTS AND CORRESPONDING INDICATORS
FOR SECOND ASSESSMENT AND REVIEW
A.Coverage
Element 1.
Geographic coverage of the Protocol and Protocol's coverage of
transboundary movements of LMOs:
(a)Number of Parties to the
Protocol;
(b)Number of Parties that have
designated national focal points;
(c)Number of Parties submitting
timely national reports on their implementation of the
Protocol;
(d)Number of Parties importing
LMOs from non-Parties;
(e)Number of Parties exporting
LMOs to non-Parties.
B.Domestic implementation of core
procedures and annexes
Element 2. AIA
procedures (or domestic regulatory frameworks consistent with the
Protocol), in accordance with the Protocol, are established for the
transboundary movement of LMOs for intentional introduction into
the environment:
(a)Number of Parties that have put
in place laws and regulations and/or administrative measures for
operation of the AIA procedure;
(b)Number of Parties that have
adopted a domestic regulatory framework consistent with the
Protocol as regards the transboundary movement of LMOs for
intentional introduction into the environment;
(c)Number of Parties that have
designated competent national authorities;
(d)Number of Parties importing or
exporting LMOs that do not have relevant laws and regulations in
place governing transboundary movements of LMOs for intentional
introduction into the environment;
(e)Regional trends in adopting AIA
procedures or domestic regulatory frameworks consistent with the
Protocol.
Element 3. AIA
procedures (or domestic regulatory framework consistent with the
Protocol) for the transboundary movement of LMOs for intentional
introduction into the environment are operational and functioning:
(a)Number of Parties with domestic
institutional and administrative (decision-making) arrangements in
place to deal with AIA applications;
(b)Number of Parties with a
budgetary allocation for the operation of their national biosafety
framework;
(c)Number of Parties with
permanent staff in place to administer their national biosafety
frameworks (including AIA applications);
(d)Number of Parties that have
processed AIA applications and reached decisions on import;
(e)Regional trends in operation
and functioning of AIA procedures.
Element 4.
Procedures for decision-making in relation to transboundary
movements of living modified organisms intended for direct use as
food or feed, or for processing (LMO-FFPs) are established and
operational:
(a)Number of Parties that have
taken final decisions regarding domestic use, including placing on
the market, of LMO-FFPs that may be subject to transboundary
movement;
(b)Number of Parties with a
decision-making procedure specific to the import of LMO FFPs.
Element 5. Risk
assessment procedures for LMOs are established and operational:
(a)Number of Parties with risk
assessment guidance in place for LMOs;
(b)Number of Parties that have
conducted risk assessments as part of a decision-making process
regarding an LMO;
(c)Number of Parties with an
advisory committee or other arrangements in place for conducting or
reviewing risk assessment;
(d)Number of decisions in the
Biosafety Clearing-House accompanied by a summary of the risk
assessment of the LMO;
(e)Number of Parties with the
necessary domestic capacity to conduct risk assessment;
(f)Number of Parties reporting
having used Annex III of the Protocol or any other guidance on risk
assessment agreed to by the Conference of the Parties serving as
the meeting of the Parties to the Protocol;
(g)Regional trends in relation to
risk assessment capacity.
Element 6.
Procedures for the establishment of appropriate LMO risk management
measures and monitoring are established and operational:
(a)Number of Parties that have
authorized introductions of LMOs into the environment and that have
requirements and/or procedures in place and enforced to regulate,
manage and control risks identified in risk assessments;
(b)Number of Parties with capacity
to detect and identify the presence of LMOs;
(c)Regional trends in relation to
risk management capacity.
Element 7.
Procedures for identifying and addressing illegal transboundary
movements of LMOs are in place and operational:
(a)Number of Parties with domestic
measures to prevent and penalize illegal transboundary movements,
including through the regulation of transit and contained
use;
(b)Number of Parties reporting
having received information concerning cases of illegal
transboundary movements of an LMO to or from territories under its
jurisdiction;
(c)Number of Parties with capacity
to detect illegal transboundary movements of LMOs (e.g. personnel,
technical capacity).
Element 8.
Procedures for preventing, identifying and addressing unintentional
transboundary movements of LMOs are established and operational,
including notification procedures and emergency measures:
(a)Number of Parties having
notified to the Biosafety Clearing-House their contact points
regarding unintentional transboundary movement of LMOs in
accordance with Article 17;
(b)Number of Parties with a
mechanism in place for notifying potentially affected States of
actual or potential unintentional transboundary movements of
LMOs;
(c)Number of instances of
unintentional transboundary movements identified;
(d)Number of Parties with a
mechanism to identify and determine significant adverse effects on
biological diversity of any unintentional transboundary movements
of LMOs;
Element 9.
Appropriate requirements are established and implemented in
relation to the Protocol's requirements on the handling, transport,
packaging and identification of LMOs:
(a)Number of Parties with
requirements for handling, transport, packaging and identification
of LMOs in place consistent with Article 18 of the Protocol and
relevant subsequent decisions of the Conference of the Parties
serving as the meeting of the Parties to the Protocol for:
(i)Contained use;
(ii)Intentional introduction into
the environment;
(iii)LMO-FFPs.
Element 10.
Procedures for notification of required information to the
Biosafety Clearing-House are established and operational:
(a)Number of Parties that have
allocated responsibilities for notification of information to the
Biosafety Clearing House;
(b)Number of Parties that have in
place systems for the management of biosafety information necessary
for the implementation of the Protocol.
Element 11.
Procedures and measures for promoting public awareness are being
implemented:
(a)Number of Parties implementing
public-awareness programmes or activities;
(b)Number of Parties providing for
some level of public participation in decision-making processes on
LMOs.
C.International level procedures
and mechanisms
Element 12.
Capacity-building Action Plan being effectively implemented:
(a)Amount of funding provided or
received for supporting biosafety capacity-building activities and
the impacts resulting from such funding.
(b)Number of Parties seeking
assistance to be able to use experts from the roster of experts and
number of Parties actually receiving such assistance;
(c)Number of Parties reporting
using local expertise to undertake or review risk assessments and
other activities relating to the implementation of the
Protocol.
Element 13.
Compliance Committee is functioning:
(a)Parties raise issues with the
Compliance Committee concerning their own compliance with Protocol
obligations;
(b)Compliance Committee has
decision-making rules of procedure in place.
Element 14. The
Biosafety Clearing-House is operational and accessible:
(a)Number of Parties and other
users accessing the Biosafety Clearing-House on a regular basis,
i.e. at least once a month;
(b)Number of Parties reporting
difficulties accessing or using the Biosafety Clearing-House;
(c)Extent to which information on
the Biosafety Clearing-House is reliable and up to date.
D.Impacts of transboundary
movements of LMOs on biological diversity, taking also into account
risks to human health
Element 15.
Consideration should be given to the work on biodiversity
indicators in the context of the Convention on Biological
Diversity.
