G l o b a l E n v i r o n m e n t F a c i l i t y
GEF/ME/C.27/Inf.1/Rev.1
November 1, 2005
GEF Council
November 8-10, 2005
FINAL DRAFT OF THE EVALUATION ON GEF'S SUPPORT
TO THE CARTAGENA PROTOCOL ON BIOSAFETY
(Prepared by the GEF Office of Monitoring and Evaluation)
Evaluation of GEF's Support
to the Cartagena Protocol on Biosafety
GEF Office of Monitoring & Evaluation
Final Draft
OCTOBER 2005
Contents
Chapter 1.
Main Conclusions and Recommendations.................................................. 1
1.1 Introduction......................................................................................................... 1
1.2
Study Design, Analytical Framework, and Methodology .................................. 1
1.3 Conclusions......................................................................................................... 2
1.4 Recommendations............................................................................................... 6
Chapter 2.
Background, Scope, and Methodology....................................................... 8
2.1 Background......................................................................................................... 8
2.2
GEF Council Request for and Timing of Evaluation.......................................... 8
2.3
Terms of Reference............................................................................................. 9
2.4 Global
Stakeholder
Interviews.......................................................................... 10
2.5 Field
Visits........................................................................................................ 10
2.6 Non-Field
Reviews ........................................................................................... 12
2.7
Desk Reviews of National Biosafety Framework Reports ............................... 13
2.8 Toolkit
Review.................................................................................................. 13
Chapter 3.
GEF Funding for Biosafety....................................................................... 14
3.1
Experiences of the Pilot Phase.......................................................................... 14
3.2 GEF
Strategy..................................................................................................... 15
3.3
GEF Biodiversity Strategic Priorities ............................................................... 17
3.4
Development of NBFs ...................................................................................... 18
3.5
Implementation of NBFs................................................................................... 19
3.6
Capacity Building for BCH Participation......................................................... 20
Chapter 4.
Modalities of GEF Support....................................................................... 21
4.1
The GEF's Quick Start and Responsiveness to the CBD ................................. 21
4.2 National
Baselines ............................................................................................ 21
4.3
NBF Development Project................................................................................ 22
4.4
Individual NBF Implementation Projects ......................................................... 26
4.5
Agency Fee Levels............................................................................................ 27
4.6
Comparative Advantage of the Implementing Agencies.................................. 28
Chapter 5.
Regional Harmonization, Coordination, and Collaboration ..................... 29
5.1
Background and Rationale................................................................................ 29
5.2
Regional and Subregional Workshops.............................................................. 31
5.3 Multi-Country
Cooperation .............................................................................. 35
5.4
Cooperation through Regional Organizations .................................................. 37
5.5
Coordination with Other Bilateral and Multilateral Organizations .................. 39
5.6 Conclusions....................................................................................................... 40
Chapter 6.
Awareness Raising and Stakeholder Participation ................................... 43
6.1 Awareness
Raising............................................................................................ 43
6.2
Stakeholder Participation in Projects ................................................................ 44
6.3
Public Involvement and Participation............................................................... 46
6.4
Stakeholder Participation in the NCCs ............................................................. 47
6.5
Legislative Provisions for Participation in Biosafety Decision Making........... 49
6.6 Conclusions....................................................................................................... 50
Chapter 7.
Capacity Development.............................................................................. 51
7.1
Capacity Development in Risk Assessment ..................................................... 51
7.2
Capacity Building in Risk Management ........................................................... 54
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7.3 Conclusions....................................................................................................... 57
Chapter 8.
Biosafety Policy and Regulatory Development........................................ 58
8.1
The Legal Context............................................................................................. 58
8.2
Lessons from the Pilot Phase ............................................................................ 59
8.3
National Preparation and Readiness ................................................................. 60
8.4
Contributions of Specialized Capacity and Expertise....................................... 61
8.5
Policy and Regulatory Outputs ......................................................................... 62
8.6 Conclusions....................................................................................................... 70
Chapter 9.
Databases and Information: The Biosafety Clearing-House .................... 72
9.1 Introduction....................................................................................................... 72
9.2
Information and the BCH.................................................................................. 73
9.3
Cooperation with the Biosafety Clearing-House .............................................. 75
9.4 Conclusions....................................................................................................... 79
Chapter 10. Effectiveness of Guidance and Quality Assurance in Country Projects... 80
10.1 Technical Advice and Backstopping to National Subprojects by the
Implementing Agencies ................................................................................................ 80
10.2 Effectiveness of UNEP's Organizational and Technical Support .................... 81
10.3 The
UNEP
Toolkit ............................................................................................ 83
10.4 Advice Provided by External Experts............................................................... 87
10.5 Effectiveness of the Global NBF Development Project Umbrella Approach .. 87
10.6 Conclusions....................................................................................................... 88
Chapter 11. The GEF's Contribution to Progress in Implementing the CPB............... 90
11.1 Speed of Ratification of the Cartagena Protocol............................................... 90
11.2 Significance and Results of Nationally Oriented Support ................................ 92
11.3 Scientific and Administrative Tools for Implementing the Protocol................ 96
11.4 Support for Participating Countries to Advance toward Compliance .............. 96
11.5 Consistency and Breadth of GEF Support to the CPB ..................................... 97
11.6 Conclusions....................................................................................................... 98
FIGURES
Figure 3.1: Participation in the NBF Development Project.............................................. 18
Figure 4.1: Suggested Flowchart for Development of a National Biosafety Framework 25
TABLES
Table 2.1: Focus of the Evaluation ................................................................................... 10
Table 2.2: Countries Selected for Field Visits .................................................................. 11
Table 2.3: Countries Selected for Non-Field Reviews ..................................................... 12
Table 3.1: Allocations under the GEF Initial Strategy ..................................................... 17
Table 3.2: GEF Individual Country Funding Range for the NBF Development Project, by
Region............................................................................................................................... 19
Table 3.3: Implementation Countries by Implementing Agency...................................... 20
Table 4.1: Baseline Levels of Countries Visited or Interviewed ...................................... 22
Table 4.2: Number of Countries Completing NBFs by Number of Months .................... 24
Table 4.3: Total Allocation under the GEF Initial Strategy for Biosafety........................ 27
Table 6.1: Level of Public Involvement ........................................................................... 46
Table 6.2: Inclusiveness of Country NCCs....................................................................... 48
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Table 8.1: Selection of Protocol-Required Provisions Addressed in NBF Reports
(percentages) ..................................................................................................................... 64
Table 9.1: Information Elements in the BCH ................................................................... 76
Table 9.2: Information Provided by National Websites ................................................... 78
Table 9.3: Contents of National Biosafety Websites for 12 Countries............................. 78
Table 10.1: Quality, Usefulness, and Timeliness of Technical Advice............................ 81
Table 10.2: Travel of UNEP Project Team to Countries .................................................. 82
Table 10.3: Comparison of Toolkit Module Publication Dates and NBF Subproject Status
........................................................................................................................................... 84
Table 10.4: Assessment of Toolkit Utility in NBF Development Phase Countries.......... 87
Table 11.1: Comparing CPB to Similar International Agreements .................................. 91
Table 11.2: Current Status of Countries Not Party to the Cartagena Protocol at Start of
NBF Development Project................................................................................................ 92
Table 11.3: Overall Progress Made in Countries to Implement the CPB......................... 97
BOXES
Box 3.1: Pilot Phase Key Lessons Learned ...................................................................... 15
Box 5.1: Regional and Subregional Workshops ............................................................... 32
Box 6.1: Tajikistan: A Dynamic Participation Process .................................................... 47
ANNEXES
Annex 1. Acronyms ........................................................................................................ 101
Annex 2. Terms of Reference of the Evaluation of GEF's Support to the Cartagena
Protocol on Biosafety...................................................................................................... 102
Annex 3. Contents of the UNEP Toolkit ........................................................................ 113
Annex 4. Countries with Completed NBFs Reviewed by the Evaluation Team ............ 114
Annex 5. Evaluation Team Members ............................................................................. 115
Annex 6. Interviewees .................................................................................................... 119
Annex 7. References ....................................................................................................... 131
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Chapter 1.
Main Conclusions and Recommendations
1.1 Introduction
The Global Environment Facility (GEF) is designated as the financial mechanism of the
Convention on Biological Diversity (CBD) as well as of the Cartagena Protocol on
Biosafety (CPB) under the CBD. The CPB's objective is to help ensure an adequate level
of protection in the field of safe transfer, handling, and use of living modified organisms
(LMOs) resulting from modern biotechnology that may have adverse effects on the
conservation and sustainable use of biological diversity, also taking into account risks to
human health, and specifically focusing on transboundary movements.
The GEF began its initial financing of capacity-building activities for biosafety in 1997
when the GEF Council approved allocations to 18 countries under a pilot phase. In 2000,
the council approved the GEF Initial Strategy for Assisting Countries to Prepare for the
Entry into Force of the Protocol. In accordance with the strategy, the council approved an
umbrella-type global project, including up to 100 countries, for the development of
national biosafety frameworks (NBFs) and individual projects in 12 countries for the
implementation of such frameworks.
During the period 200305, the GEF Council approved allocations for the development
of NBFs in 30 additional countries and support for building capacity in countries to
participate in the Biosafety Clearing-House (BCH) mechanism in 139 countries.
The GEF Council tasked the GEF Office of Monitoring and Evaluation with carrying out
the present evaluation. Four key questions were identified in the Terms of Reference:
1. Is GEF support consistent with the Cartagena Protocol conducted in a way that
takes into account the needs of the recipient countries, and is it of sufficient
professional quality?
2. Is GEF support to capacity development efforts, including stakeholder
involvement and regional collaboration, relevant and effective?
3. What progress has been made in countries on building the requisite capacities
toward their ratification and implementation of the Cartagena Protocol?
4. Are the modalities and approaches of GEF support effective and efficient
compared to similar projects?
1.2 Study
Design,
Analytical Framework, and Methodology
A team of seven members undertook the evaluation. Data collection included interviews
with relevant global-level stakeholders: the GEF Secretariat, the CBD Secretariat, the
World Bank, the United Nations Development Programme (UNDP), and, especially, the
United Nations Environment Programme (UNEP), which has major responsibility for
implementation of the projects. Further, interviews and viewpoints were sought from the
Global Industry Coalition on Biotechnology, the Third World Network, and
representatives of other bilateral and multilateral agencies.
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In all eleven NBF development and NBF implementation countries were selected for
field visits, and interviews were conducted by telephone with representatives from
another eight countries. The countries were chosen to provide geographic representation,
cover projects at various stages of implementation, and illustrate the work of the three
GEF Implementing Agencies: UNEP, UNDP, and the World Bank. The evaluation team
also undertook in-depth reviews of the 38 NBFs that had been completed as of June 10,
2005.
A component of the evaluation was carried out by the Free University of Amsterdam,
whose team conducted a review of the UNEP Toolkit used by countries as the primary
guidance material for the Development of National Biosafety Framework Project.
Questionnaires were sent to 500 people in 30 countries; of these, 102 individuals in 29
countries responded.
1.3 Conclusions
The main body of the evaluation report contains detailed answers to the questions raised
in the Terms of Reference. In this chapter, the main conclusions and recommendations
are highlighted for consideration by the GEF Council.
Conclusion 1: GEF support has been consistent with the Cartagena Protocol.
The GEF has, on the whole, responded very expeditiously and systematically to the
request from the CBD for support to the Cartagena Protocol. Only a few months after
adoption of the CPB, the GEF had a fully fledged support program in place, which to date
has reached 142 countries. GEF assistance has operated in a sensitive political
environment, with often diametrically opposite positions expressed by the biotechnology
industry and advocacy nongovernmental organizations (NGOs). At times, there have also
been different positions pursued by various government departments. In sometimes
heated public discussions about the modality, form, and substance of GEF support,
questions were raised regarding whether GEF support was neutral and in line with the
Cartagena Protocol.
The separate Delphi study carried out by the Free University of Amsterdam shows that 78
percent of the respondents stated that the Toolkit was very consistent with the Cartagena
Protocol. Only one respondent felt it was not consistent with the CPB; the remainder had
no opinion or did not know. Further, the Toolkit was judged by 79 percent of country
participants to be very useful and/or useful to their country. However, several of the
modules were not sufficiently timely to be as useful to all countries as they could have
been. In most cases, the modules were used by the national project coordinator (NPC)
and some members of the national coordinating committee (NCC). This study found that
utility for stakeholders beyond key project staff was not high.
There has been criticism that UNEP has provided insufficient space at awareness-raising
workshops for private sector and civil society participants to make presentations of their
respective views and perspectives. However, the evaluation team concludes that generally
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acceptable rules for giving access to the podium for organizations with observer status
have been followed. The evaluation team has also concluded that UNEP, UNDP, and the
World Bank have taken pains to remain neutral in this dynamic debate among the various
interest groups.
Conclusion 2: The GEF has contributed to speeding up ratification and has
promoted implementation processes of the Cartagena Protocol.
There have been serious controversies about the Cartagena Protocol, especially among
Organisation for Economic Co-operation and Development (OECD) countries. This has
created a level of insecurity in other countries regarding the political impact of their
potential ratification. In view of this, it is notable that the Cartagena Protocol's
ratification has been relatively rapid. The ratification process has been directly influenced
by the initiation, and especially the completion, of the GEF projects. Besides promoting
ratification, the GEF has, through the development and implementation of NBFs,
contributed to considerable progress toward compliance with the protocol, first, by
supporting capacity development on scientific, administrative, legal, and information
management matters; and second, by promoting cross-sectoral and public-private
collaboration at the country level. However, the allocated funds for some areas were only
sufficient for capacity development at a general or introductory level.
Conclusion 3: The NBF development project was not adequately designed and
funded to fully take the complexities of local conditions and needs into account.
For each of the 100 NBF development projects in the various countries, the initial time
allocation of 18 months and their budget frames did not match the complexity and high
ambitions of the project document with regard, for example, to regional cooperation,
capacity building, public participation, and preparation of the framework itself. It is likely
that the countries on average will require 28 to 30 months. The key indicators on
subproject achievements also had to be scaled down. This too is in part due to an
insufficient supervision fee allocated by the GEF for this complex task.
There was a general recognition in the supported countries that the UNEP regional
coordinators were highly committed and hardworking. However, their large subproject
portfolios meant that the level of administrative and technical backstopping was lower
than expected by most of the countries, especially those that had little prior experience
with the topic. UNEP's role was quite limited in some of the key assignments of the
countries. The stocktaking of initial country conditions were carried out by national
consultants, while the peer reviews were carried out by international consultants hired by
the countries, or by UNEP with the use of project funds. This meant that UNEP was not
fully acquainted with the baseline condition of the countries, which weakened its ability
to give detailed technical advice under the NBF development project. Insufficient legal
expertise among the UNEP NBF project staff was also a contributing factor. However, in
spite of delays and weaknesses, there has been noteworthy progress in the subprojects,
and it is expected that 80 NBFs will be completed by the end of 2005. Although there are
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variations in quality, the completed NBF reports generally provide a good basis for
further efforts by the countries.
The UNEP-administered NBF implementation projects had more realistic objectives and
were better funded. The same applies to the four World Bank- and UNDP-administered
implementation projects. Despite some initial delays, one of the four projects has been
completed, two are now on a promising track, while one has not started.
Conclusion 4: Awareness-raising and participation efforts by different stakeholders
have not been as broad as required by the Cartagena Protocol and advised by the
GEF project documents. Support for capacity building under the BCH has
increased general access to information.
Nearly all countries have appointed national coordination committees comprising on
average 10 to 15 members, with representation from most of the relevant government
departments and other institutions/organizations. A range of stakeholders have been
involved with the objective of contributing toward formulating the NBF and building
support within the respective countries. However, in nearly half the countries,
representation on the NCCs is not as broad as advised, since some key government
departments, academic institutions, the private sector, or civil society are not represented.
The NCCs have held substantive workshops and sought initial inputs and final comments
into the NBF or legal documents. At the NCC level, stakeholder participation and
involvement were highly variable. In a few cases, the positions by some representatives
were sometimes quite inflexible, making collaboration difficult. The evaluation of the 38
completed NBF reports showed that 82 percent of the countries have included provisions
for public participation mechanisms, with reference to article 23.2 of the Cartagena
Protocol.
Efforts aimed at participation and public awareness have been broader in national and
sometimes subnational workshops. However, the funds for this initiative were insufficient
relative to the overall needs expressed by the countries. In the NBF implementation
projects, awareness-raising and participation efforts varied, but were in relative terms
more limited than in the development projects.
Significant amounts have been allocated by the GEF to capacity building in information
handling and the creation of databases for participation in the BCH. By September 2005,
all the NBF implementation countries and nearly a third of the NBF development
countries had established national project websites. The posting of relevant information
on the national websites has at times provided useful information within and outside the
country, as well as for the CBD, even in cases where countries were formally required to
submit this information directly to the BCH's central portal.
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Conclusion 5: Capacity development in risk assessment and risk management has
primarily been of a general or introductory nature.
As planned, most NBF development projects have organized general introductory courses
in risk assessment and risk management. The NBF implementation projects have
organized one week of intensive specialist training. Fewer efforts have been directed at
building corresponding administrative, inspection, enforcement, and monitoring
capacities.
Coordination of roles and responsibilities among existing regulatory bodies in countries
is in the process of being resolved, but often remains a thorny issue and a significant
impediment. Most countries already have some level of risk assessment and risk
management procedures in place for dealing with other issues and commodities (for
example, sanitary and phytosanitary systems, environmental impact analysis, and so on).
There have been relatively few efforts to explore how capacities under these existing
systems can be extended to support risk assessment and risk management of LMOs.
Conclusion 6: Subregional cooperation with the objective of information sharing
has been satisfactory, but no subregional harmonization of scientific, legal, and
regulatory instruments has taken place, except in the European Union (EU)
accession countries.
Under the NBF development project, UNEP organized 16 regional and subregional
workshops. These had two objectives: information sharing and harmonization of
scientific, legal, and regulatory instruments. The workshops succeeded well in terms of
sharing information and establishing networks and communication lines among key
individuals and institutions in the region, either on a direct country-to-country basis or
through existing regional entities.
However, there has been hardly any progress on formal regional intergovernmental
collaboration or harmonization of scientific, legal, and regulatory instruments, which in
the GEF Strategy and GEF NBF development project design were seen as crucial for
effective management of transfer of LMOs across borders.
Conclusion 7: The umbrella modality for the NBF development project has been
effective in countries with prior biosafety experience and a minimum level of
existing competence, but not as satisfactory in countries with less prior experience
and competence.
The GEF employed an umbrella project modality for the 100 NBF development
subprojects. In all countries, the project established a full-time NPC and national
coordinating or steering committee, conducted national awareness or capacity-building
workshops, developed risk management and regulatory systems, and prepared websites
for public information and participation in the BCH. The umbrella approach was, under
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the circumstances, a necessary tool to deliver assistance expeditiously to the large
number of countries requesting assistance, and it entailed economies of scale. The
alternative of organizing 100 individual projects without a single coherent system would
have been much more demanding both in terms of time and resources. GEF has
previously had positive experience with its global Climate Change Support Program,
which represented a similar modality.
The umbrella approach was especially effective in countries that could easily incorporate
the support into their own biosafety systems; it was much less effective where the need
for support was greater, and/or the initial conditions were less receptive. On the whole,
the approach was too ambitious in terms of high goals within limited time schedules, and
it did not have a sufficient flexibility to adapt the level of funding and the measures of
required technical assistance to the needs of each country.
Conclusion 8: Consultation and coordination by the GEF Secretariat at the global
level have been weak. There has been little consideration as to whether biosafety
could be better linked to other related aspects of the GEF's biodiversity portfolio.
Since 1999, the GEF has allocated $59.4 million, or about 55 percent of total recorded
allocations, to biosafety efforts in developing countries and countries with economies in
transition. There is limited cooperation and collaboration between the donors, presumably
due to differences in donor policies and the engagement of special interests in project
execution, but also due to few initiatives having the objective of coordinating use of
scarce funds. Relatively little is known about complementarity or duplication among
various actors in the donor community. UNEP has been considerably engaged in
information exchange with other donors. The CBD Secretariat has held two Coordination
Meetings for Governments and Organizations Implementing or Funding Biosafety
Capacity Building Activities.
While most donors and participating countries have treated biosafety separately from
related biodiversity matters, several countries have considered it in conjunction with the
wider issues of biosecurity, agrobidiversity, alien invasive species, or illegal
transboundary movement of endangered species. In the context of biosafety, however, the
significant investments needed in developing expertise, physical capacity, and institutions
suggests that it will be important to consider potential options relating to integration with
basically identical control mechanisms.
The GEF Initial Strategy pointed to the need for the GEF to engage the scientific
community in considering opportunities for sharing lessons and building synergies. This
has not taken place to any significant extent.
1.4 Recommendations
Assuming that the GEF will continue to support the Cartagena Protocol, the conclusions
of this evaluation lead to the following recommendations for future support.
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Recommendation 1: Future assistance should be better planned and customized to
each participating country.
The GEF has initiated important work on developing NBFs in 130 countries. Future
assistance should be based on a better understanding of the needs and priorities of each
country. In customizing new support, the GEF should also actively seek to integrate
national support with regional collaboration where appropriate.
Recommendation 2: The GEF should consider providing longer term training for
building and sustaining specialist capacity in risk assessment and risk management.
Biosafety is a highly technical and specialized area. The required competence for the full
implementation of the Cartagena Protocol requires systematic and longer term training of
relevant specialists.
Recommendation 3: The GEF should continue to emphasize awareness-raising and
public participation issues, including support to the BCH.
Public consultation and information sharing are important elements in satisfactory
functioning of the Cartagena Protocol. At the country level there is also a strong
expression of further needs in this area.
Recommendation 4: The GEF should work toward a higher degree of donor and
partner collaboration and other cost-sharing schemes at the global and national
levels.
Future requests to GEF and other donors or partners for funding in the biosafety area are
likely to increase. A large number of countries now expect to move from the NBF
development phase to the implementation phase, which will entail investments in, for
example, the upgrading and equipping of relevant laboratories and other facilities at the
national, multicountry, or regional level. GEF should seek a broader level of
collaboration with donors and other partners in order to meet the demand in a satisfactory
way.
Recommendation 5: The GEF should seek advice from its Scientific and Technical
Advisory Panel of the GEF and other scientists as to whether and how biosafety
could be better integrated strategically and programmatically into the GEF
biodiversity portfolio.
The number of related international environmental agreements is high, and is continuing
to increase. The potentials for integration and synergies between the agreements should
be explored both within GEF and at country level.
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Chapter 2.
Background, Scope, and Methodology
2.1 Background
The GEF is designated as the financial mechanism for the Convention on Biological
Diversity, as well as for the Cartagena Protocol on Biosafety which falls under the CBD.
The Cartagena Protocol was adopted by the Conference of the Parties (COP) in January
2000, and entered into force on September 11, 2003.
The GEF began its initial financing of capacity-building activities for biosafety in 1997,
when the GEF Council approved pilot projects in 18 countries. Following the completion
of these projects, an evaluation of this pilot phase was conducted, which contributed to
the development of the GEF's Initial Strategy for Assisting Countries to Prepare for the
Entry into Force of the Protocol (GEF 2000; herein referred to as the "GEF Strategy").
The GEF Council subsequently approved funding for the global Development of National
Biosafety Frameworks Project, to be implemented by UNEP, which was intended to
cover the development of frameworks for 100 countries. The GEF Council also approved
projects in 12 countries for the implementation of the NBFs.
Additional GEF-financed initiatives included two add-on projects to the initial
Development of National Biosafety Frameworks Project (one for 20 countries, the other
for 10; approved by the GEF Council in January 2004 and June 2005, respectively), and a
project to support the development of the Biosafety Clearing-House mechanism in 50
countries, with a subsequent add-on for 89 countries. See Table 3.1 for a complete
breakdown of GEF-funded activities for biosafety capacity building.
2.2
GEF Council Request for and Timing of Evaluation
At its November 2004 meeting, the GEF Council requested that the GEF Office of
Monitoring and Evaluation undertake an evaluation of the activities financed under the
initial strategy approved by the Council in May 2000 for helping countries prepare for the
entry into force of the Cartagena Protocol. The GEF Office of Monitoring and Evaluation
planned for the evaluation to be completed in time to serve as an input to the council's
December 2005 meeting. Following the planning stages of the evaluation, the GEF
Council's December 2005 meeting was moved to November 2005. Given the complex
character of the evaluation, the final completion date could not be brought forward.
Instead, a draft version of this report will be made available to the council meeting in
November. The timing of the evaluation will allow the GEF Council to decide on
elements for future GEF financing for capacity building in biosafety activities as the GEF
moves into its fourth replenishment phase.
The evaluation is taking place at a time when a significant part of the work under the
initial Development of National Biosafety Frameworks Project has been completed. More
than 40 countries have posted their completed NBFs; there should be around 80
completed NBFs in all by the end of 2005.
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The GEF Strategy was originally expected to be in effect only until the Cartagena
Protocol entered into force, which occurred on September 11, 2003. In this respect, this
evaluation could have taken place one year earlier. However, the evaluation is timed to
coincide with the final phase of the majority of activities supported under the GEF
Strategy, rather than the termination of the strategy document itself. One consequence of
this schedule is that an operational gap between the time that many countries complete
their NBFs and when they undertake the next phase of GEF-supported activities may
cause significant discontinuities in the work of the national executing agency (NEA).
2.3 Terms
of
Reference
The final Terms of Reference for the evaluation were approved by the director of the
Office of Monitoring and Evaluation on April 20, 2005. The main objective of the
evaluation is to evaluate the efficiency, effectiveness, and relevance of the GEF Strategy.
Four key questions were identified in the evaluation's Terms of Reference:
1. Is GEF support consistent with the Cartagena Protocol conducted in a way that
takes into account the needs of the recipient countries, and is it of sufficient
professional quality?
2. Is GEF support to capacity development efforts, including stakeholder
involvement and regional collaboration, relevant and effective?
3. What progress has been made in countries on building the requisite capacities
toward their ratification and implementation of the Cartagena Protocol?
4. Are the modalities and approaches of GEF support effective and efficient
compared to similar projects?
This evaluation seeks to answer these questions as objectively and in the most balanced
manner possible, given the data available. The evaluation covers the following GEF-
supported biosafety capacity-building activities:
· Development of National Biosafety Frameworks Project (100 countries),
· Development of National Biosafety Frameworks Project add-on (20 countries),
· Projects for implementation of NBFs (12 countries),
· Certain aspects of GEF support for implementation of BCH mechanisms (50
countries).
The evaluation does not cover:
· pilot phase projects,
· the second add-on to the Development of National Biosafety Frameworks Project
(10 countries),
· the first add-on to the BCH mechanism project (89 countries).
The pilot phase projects were completed before the GEF Strategy was developed, and an
evaluation of these projects has already been conducted. The two add-on projects that are
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not covered had not begun at the time that this evaluation was initiated. The focus of the
evaluation is shown in Table 2.1 below.
Table 2.1: Focus of the Evaluation
NBF development
NBF implementation
Issue
projects
projects
BCH support
GEF support and UNEP Toolkit are
Main focus
Reduced attention
Not included
consistent with the Cartagena Protocol and
country needs
Support for capacity assessment and
Yes Yes Yes
strengthening, including stakeholder
participation and regional cooperation
Progress toward attainment of protocol goals Yes
Reduced attention
Not included
Effectiveness/efficiency of GEF support
Yes
Yes
Reduced attention
It is important to keep in mind throughout this evaluation report that the team's objective
was not to review the performance of countries per se. At the same time, national
institutions were and are responsible for the activities of the development and
implementation projects within each respective country. In some particular country
circumstances--political power shifts following elections, civil unrest, natural disasters--
country-level activities had to be delayed or were incomplete. Therefore, the evaluation
team reviewed countries' progress toward implementation of the Cartagena Protocol in
order to evaluate the relevance, effectiveness, and efficiency of the GEF's support to
countries. Multiple data collection strategies were used by the evaluation team; these are
described below.
2.4
Global Stakeholder Interviews
The evaluation team conducted interviews with relevant global stakeholders. These
included the GEF Secretariat, UNEP, UNDP, the World Bank, the CBD Secretariat, the
Global Industry Coalition on Biotechnology, the Third World Network, and
representatives of other bilateral and multilateral agencies on a more informal basis. The
evaluation team conducted several in-depth interviews with the UNEP development
project team based in Geneva, since UNEP is responsible for the majority of activities
related to the GEF biosafety strategy. Three group interviews were carried out with the
UNEP NBF development project coordinator and the regional coordinators. For a
complete list of persons interviewed, see annex 6.
In addition to actively seeking input from the above-mentioned stakeholders, the
evaluation team sought to ensure the possibility for input from all interested parties. To
this end, the Terms of Reference of the evaluation were published on the GEF Office of
Monitoring and Evaluation website, and comments were solicited from any stakeholders
wanting to provide feedback to the evaluation.
2.5 Field
Visits
The primary component of the evaluation was a series of field visits, each conducted by
two members of the evaluation team. The field visits took place between May 22 and July
16, 2005. The duration of each field visit was one week, and the two-person team
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assigned to a country was supported by a local country-based consultant. The local
consultant assisted in arranging the team's agenda for the week based on a generic outline
and stakeholder list provided by the team. The consultant also provided valuable insight
and knowledge into the particular country situation and context, and served as a translator
when necessary. The field visits were the evaluation team's main opportunity to gain
detailed information and data about project activities and execution at the country level.
During each visit, team members interviewed as wide a variety of relevant stakeholders
as possible, typically interviewing 20 to 40 persons in the course of a week.
Eleven countries were selected for field visits. These countries were chosen to provide
geographic representation, as well as to provide a view of projects at various stages in the
process of undertaking GEF-supported activities: namely, those participating in the
Development of National Biosafety Frameworks Project but not yet finished; those
participating in the Development of National Biosafety Frameworks Project and finished
with their NBF; and those participating in an NBF implementation project. Countries
were also selected in order to provide examples of projects implemented by each of the
Implementing Agencies; they were also selected on the basis of size, to include especially
large countries and small island developing states (SIDS). Countries selected for field
visits are listed in Table 2.2.
Table 2.2: Countries Selected for Field Visits
Project stage (at start
Implementing
Country
Region
of evaluation)
Agency
Size
Bahamas, The
Latin America and the Caribbean
Development
UNEP
SIDS
Burkina Fasoa Africa
Development
UNEP
China
Asia and Pacific
Implementation
UNEP
Large
Croatiaa
Central and Eastern Europe
Development
UNEP
Ethiopia Africa
Development
UNEP
Guatemala
Latin America and the Caribbean
Development project
UNEP
completed
India
Asia and Pacific
Implementation World
Bank
Large
Mexico
Latin America and the Caribbean
Implementation
UNDP
Large
Morocco Africa
Development
UNEP
Tajikistan
Asia and Pacific
Development project
UNEP
complete
Uganda Africa
Implementation UNEP
a.
These countries completed their NBF project during the course of the evaluation.
During the field visits, the categories of stakeholders the evaluation team sought to
interview included: national project coordinator; members of the national coordinating or
steering committee; NEA; biosafety focal point; GEF focal point; national competent
authority; parliamentarians; relevant ministries and government agencies (environment,
agriculture, health, trade, and so forth); scientific research institutions; academia; the
private sector, local, national, and international NGOs or other civil society groups;
consumer rights organizations; farmers associations; indigenous and local community
groups; bilateral and multilateral organizations; and any other relevant stakeholder groups
in a given country.
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2.6 Non-Field
Reviews
To complement the field visits, the evaluation team also planned to review an additional
10 countries in detail through telephone interviews with relevant stakeholders in the
country. Due to logistic issues, the team was only able to review eight countries. The goal
of these reviews was to expand the sample of countries examined in detail for the
evaluation, while recognizing that the time and resources available for the evaluation
were limited. These non-field reviews, although less detailed than the field visits, allowed
the evaluation team members a more comprehensive picture of GEF support to the
respective countries than would have been possible through basic desk reviews.
The non-field reviews were conducted from late July to early September 2005. Again,
two team members were assigned to each country and participated in phone interviews
with two to four persons in the selected country who had experience with and knowledge
of GEF-supported biosafety capacity-building activities. The stakeholders interviewed
generally included the NPC, technical experts directly involved in the project, NGO
representatives, other members of the NCC, the biosafety focal point, and NEA
representatives. These countries were selected based on similar considerations to those
used in selecting countries for field visits. The countries selected for non-field reviews
are listed in Table 2.3.
Table 2.3: Countries Selected for Non-Field Reviews
Project stage (at start
Implementing
Country
Region
of evaluation)
Agency
Size
Botswana Africa
Development
UNEP
Bulgaria
Central and Eastern Europe
Implementation
UNEP
Chile
Latin America and the Caribbean
Development
UNEP
Colombia
Latin America and the Caribbean Implementation
World
Bank
Cuba
Latin America and the Caribbean
Implementation
UNEP
SIDS
Lao PDRa
Asia and Pacific
Development project
UNEP
complete
Lebanon
Asia and Pacific
Development
UNEP
Malaysia
Asia and Pacific
Implementation
UNDP
Samoaa
Asia and Pacific
Development project
UNEP SIDS
complete
Turkeyb
Central and Eastern Europe
Development
UNEP
a.
Country was initially selected for inclusion, but logistic issues resulted in the evaluation team's being unable to
evaluate these countries in depth as originally planned.
b.
Country completed its NBF project during the course of the evaluation.
In total, the regional balance of the sample is five countries from Africa, seven countries
from Asia and Pacific (including Samoa as a SIDS representative), three countries from
Central and Eastern Europe (the region with the fewest countries), and six countries from
Latin America and the Caribbean (including The Bahamas as a SIDS representative).
There were nine countries selected that were participating in the NBF development
project but that had not yet finished, four countries that had completed their NBF, and
eight countries that were participating in NBF implementation projects. Regarding
Implementing Agencies, 17 projects implemented by UNEP were selected, and 2 each by
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UNDP and the World Bank. Two of the countries evaluated are SIDS; three are large
countries.
2.7
Desk Reviews of National Biosafety Framework Reports
The evaluation team undertook in-depth reviews of the 38 NBFs that had been completed
as of June 10, 2005. Examining the completed NBFs, which are the primary output for
each country participating in the Development of National Biosafety Frameworks
Project, provided the evaluation team with a consistent means to review each country's
progress toward preparation for implementation of the Cartagena Protocol. Review
protocols were developed to ensure that standardized review procedures were followed
by each team member. Each team member reviewed five to six NBFs. For a full list of
countries with completed frameworks that were reviewed, see annex 4.
Several of the countries with completed NBFs were also the subject of field visits or non-
field reviews. Therefore, the evaluation team reviewed a total of 53 countries at some
level; this is approximately 40 percent of the 132 countries involved in the NBF
development and implementation projects.
2.8 Toolkit
Review
A subsidiary component of the evaluation was carried out by the Free University of
Amsterdam. A review of the UNEP Toolkit used by countries as the primary input for the
Development of National Biosafety Frameworks Project was conducted through a
questionnaire sent to 500 persons in 30 countries participating in the project, as well as
other stakeholder groups. The questionnaires were sent out in late June 2005; by late July
2005, about 100 responses had been received for a 20 percent return rate. The results
from this review have been used to supplement other data described in this report.
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Chapter 3.
GEF Funding for Biosafety
Biotechnology and related biosafety aspects are important features of the Convention on
Biological Diversity. Article 8(g) provides that each contracting party shall, as far as
possible, establish or maintain means to regulate, manage, and control the risks
associated with the use and release of living modified organisms resulting from
biotechnology. Beyond this specific objective under the protocol, all protocol parties (as
contracting parties under the CBD) are further expected to
directly or by requiring any natural or legal person under its jurisdiction providing the
[living modified] organisms..., provide any available information about the use and
safety regulations required by that Contracting Party in handling such organisms, as well
as any available information on the potential adverse impact of the specific organisms
concerned to the Contracting Party into which those organisms are to be introduced.1
The third meeting of the Conference of the Parties of the CBD (COP-MOP 3) requested
the GEF to provide financial resources for capacity building in biosafety.
3.1
Experiences of the Pilot Phase
At its November 1997 meeting, the GEF Council allocated $2.7 million for the
development of NBFs in 18 countries in developing countries and countries with
economies in transition.2 UNEP was the Implementing Agency for this project, under
which each country received a grant of approximately $100,000. A second component of
the pilot phase project constituted support to four regional seminars on biosafety.
1 CBD Article 19.4. The convention also requires that national actions relating to the development of
LMOs should benefit both the country and entity developing the LMO, as well as the countries that are the
sources of the genetic resources used in the biotechnology work. The latter objectives are to be
accomplished through the requirement that users must ensure that source countries are allowed to
"effectively participate in biotechnological research" utilizing their genetic resources, and that each source
country should have "priority access on a fair and equitable basis...to the results and benefits arising from
biotechnologies based upon genetic resources" they provide (CBD articles 19.2 and 19.3, respectively).
These provisions link the development and utilization of LMOs with the obligations to share benefits under
articles 15, 16, 17, 20, and 21. Hence, the reference to "access to the results and benefits" is generally
believed to include both the social and livelihood benefits of the new organism and the financial benefits
arising from its commercialization.
2 All dollars cited in this report are U.S. dollars.
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In each country, the pilot phase Box 3.1: Pilot Phase Key Lessons Learned
was designed to last for 12
months, which proved to be far
· This was an ambitious project that was successfully
too ambitious. All projects were
executed.
extended to 18 months. An
evaluation of the pilot phase
· The regional workshops provided a good
understanding and appreciation of the type of
project concluded that the
assistance that countries might need to ensure the
regional workshops were
transparent and safe consideration of the use of
successfully conducted, products of modern biotechnology.
productive, and worthwhile. Box
3.1 summarizes the lessons
· The time scale of the project was severely limiting.
In an extended/expanded future program/project,
learned from the pilot phase
more realistic time scales need to be adopted.
evaluation. It was recognized that
both national and subregional
· The degree of public participation and involvement
capacities needed to be
in the project at the national level differed
strengthened. The evaluation
substantially among countries, largely reflecting
emphasized strongly that realistic
differing traditions, difficulties caused by country
size and geographical conditions, number of
time scales were of great
languages, and educational deficiencies.
importance for the NBF
development phase. The tight
· There is a strong need for strengthening national
schedule for the pilot phase
capacities and an urgent need for establishing and/or
limited the attainment of the
strengthening subregional centers of expertise with
relevant capacities, facilities, and human resources to
objectives, since most countries
support national-level risk assessment and risk
were not able to pass the
management activities.
legislation that had been drafted.
The evaluator also recommended Adapted from UNEP-GEF 2000, Executive Summary.
a further review of the 1995 UNEP International Technical Guidelines for Safety in
Biotechnology, which provides direction for implementation of the pilot phase.
The evaluation report recommended five areas of assistance for continued support:
· National projects for the development of NBFs in 60 countries;
· National projects for the implementation of NBFs in 25 countries, including the
18 that had gone through the pilot phase;
· Regional and subregional awareness-raising workshops;
· Establishment/strengthening of regional/subregional centers of excellence;
· Integrated multi-pronged global, regional, or subregional workshops.
In its subsequent projects, the GEF broadly accepted the first three recommendations, but
not the last two. These latter were aimed at capacity developing at the subregional and
regional levels.
3.2 GEF
Strategy
The GEF Initial Strategy for Assisting Countries to Prepare for the Entry into Force of
the Protocol (GEF 2000) was based on a decision in the Conference of the Parties to the
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CBD that designated capacity building as a priority for GEF assistance (CBD 1996).
Further guidance has been provided by CBD-COP especially in decisions V/3, VI/17, and
VII/20.
For ease of cross referencing, the list below is formatted in accordance with the original
GEF initial strategy (GEF 2000). The GEF Strategy aims to:
A. Assist countries to prepare for the entry into force of the Cartagena Protocol on Biosafety through
the establishment of national biosafety frameworks, including strengthening capacities for risk
assessment and management with a wide degree of stakeholder participation;
B. Promote information sharing and collaboration at the regional and sub-regional level and among
countries that share the same biomes/ecosystems; and
C. Promote identification, collaboration and coordination among other bilateral and multilateral
organizations to assist capacity-building for the Protocol and explore the optimization of
partnerships with such organizations.
The following activities were proposed:
I. Assist countries to establish national biosafety frameworks;
II. Individual country projects to implement national biosafety frameworks;
III. Coordination with other multilateral and bilateral organizations providing assistance in the area of
biosafety;
IV. Support for country participation in the Biosafety Clearing-House (BCH); and
V. Enhancement of scientific and technical advice to the GEF on biosafety issues.
The preparation of NBFs would, according to the GEF Strategy, include:
(a) assessment/stocktaking to provide information on the status of existing biosafety practices;
(b) assessment of any existing legal instrument or guidelines that might impact on the use, import or
export of LMOs;
(c) identification and involvement of all relevant stakeholders to the extent possible;
(d) identification of actions needed to enable countries to implement the Protocol, and options and
priorities for filling such gaps;
(e) preparation of a legal framework and/or guidelines for the implementation of the Protocol;
(f) establishment of a roster of experts and means of including them in regional networks;
(g) assessment of options for implementation of various elements of the biosafety frameworks, for
example at the regional level;
(h) identification of opportunities for harmonization at the regional and subregional level; and
(i) additional features that may be identified.
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All developing countries and countries with economies in transition that are parties to the
Cartagena Protocol were considered eligible for funding on biosafety from the GEF.
Following CBD-COP decision 7/20, parties to the CBD that were not yet parties to the
protocol but had provided a clear political commitment toward becoming parties were
also considered eligible. The allocations made by the GEF under its initial strategy are
shown below in Table 3.1.
Table 3.1: Allocations under the GEF Initial Strategy
Project
Number of countries
Allocation ($ millions)
Pilot Phasea 17
2.7
NBF Development
100
26.1
NBF Development add-on 1
20
5.2
NBF Development add-on 2a 10
2.6
Implementation projects
12
9.2
BCH Mechanism
50
4.6
BCH Mechanism add-on 1a 89
8.9
Totalb
59.4
a.
Not covered by this evaluation.
b.
Details may not sum to total because of rounding.
3.3
GEF Biodiversity Strategic Priorities
As part of the third GEF replenishment (GEF-3),3 the biodiversity program of the GEF
Secretariat developed a series of four strategic priorities to help sharpen the focus of the
GEF's investment in biodiversity conservation (GEF 2003). The third of these priorities
is Capacity Building for the Implementation of the UN Convention on Biological
Diversity Cartagena Protocol on Biosafety. This strategic priority is general in its focus
and is framed as a separate pillar, unlinked to the rest of the GEF's biodiversity portfolio.
The stated rationale for the strategic priority is that "There is recognition of the potential
risks posed by modified living organisms and therefore biosafety constitutes a high
priority for recipient countries. This priority also responds to the guidance from the CBD
and it is consistent with the decisions of the Intergovernmental Committee for the
Cartagena Protocol" (GEF 2003).
The generality of the focus on biosafety in the strategic priorities document can be
interpreted as reflective of the GEF waiting to receive additional guidance from a
meeting of the parties to the CPB, since the protocol had not entered into force at the time
the document was developed. According to the strategic priorities document, the protocol
was expected to enter into force early in GEF-3. Also by this time, the GEF Council had
approved the Development of National Biosafety Frameworks Project for 100 countries,
based on the experience from the pilot phase.
Under the biodiversity strategic priorities being developed for GEF-4, the biosafety
priority is pending and will be modified once the results from this evaluation are
3 GEF-3 covers GEF fiscal years 200306; GEF-4 will cover fiscal years 200710.
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published. It is anticipated that the GEF Secretariat will develop a revised strategy for
biosafety taking into consideration the decisions and viewpoints expressed by the GEF
Council.
3.4
Development of NBFs
At its November 2000 meeting, the GEF Council allocated $26.1 million to support up to
100 countries in developing NBFs and arranging for regional and subregional workshops.
Another $5.2 million was allocated in November 2003 for the development of NBFs in
20 additional countries; $2.6 million was allocated in 2005 for another 10 countries.
UNEP is the sole Implementing Agency for NBFs.
The GEF's total allocation to capacity building for implementation of the Cartagena
Protocol is shown in Table 3.1. Of the total investment of $59.4 million, $45.1 million of
the allocation is covered by this evaluation. This does not include the pilot phase, the
second NBF development add-on project, and the BCH add-on project.
Figure 3.1 shows the number of countries participating in the NBF development project
for each region, including countries participating as part of the second add-on project.
Figure 3.1: Participation in the NBF Development Project
All NBF Countries By Region (N=130)
Africa
42
Latin America &
Caribbean
29
Asia & Pacific
37
Central and Eastern
Europe
22
The main components of the NBF projects are:
· Development of frameworks through information gathering, analysis,
consultation, training, and preparation of a draft NBF, including legal instruments,
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administrative systems, risk assessment procedures, and systems for public
participation and information;
· Arrangement of regional workshops that aim to increase understanding of the
CPB and impart knowledge on the implications for risk assessment and decision
making at national levels;
· Arrangement of subregional workshops focusing on capacity building, cross-
national opportunities for collaboration, mechanisms for sharing of risk
assessment and management experiences, coordination of capacity-building
activities, and networking to share lessons and experiences.
Table 3.2 shows the range of funding for NBF development projects at the individual
country level in each region. Overall, the lowest allocation to any individual country was
$91,500; the highest allocation was $220,000.
Table 3.2: GEF Individual Country Funding Range for the NBF Development Project, by Region
Region
Lowest country allocation
Highest country allocation
Africa $118,000
$220,000
Asia and Pacific
$91,500
$203,000
Central and Eastern Europe
$100,000
$200,000
Latin America and the Caribbean
$91,800
$200,000
All countries
$91,500
$220,000
The majority of countries provided co-financing of 50 percent of the GEF budget, but
there were exceptions; country co-financing ranged from $18,000 (15 percent) to
$244,000 (122 percent). The global average for GEF funding was $145,184, and the
global average for co-financing was $74,762 (52 percent).
3.5
Implementation of NBFs
In 2001, the GEF approved 12 individual country demonstration projects on NBF
implementation (see Table 3.3). The project period was typically three years, and the
GEF allocation to each country ranged between $500,000 and $1 million. The NBF
implementation projects have been adapted to country-specific conditions, with the
generic activities including the following:
· Reviewing NBFs and drafting regulations and guidelines to support its implementation;
· Making operational a regulatory and administrative system for handling applications and related
biosafety matters
· Setting up decision-making mechanisms to handle applications for releases and transboundary
movements of LMOs;
· Development and publishing of technical guidelines for risk assessment and risk management,
monitoring and enforcement;
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· Strengthening capacity of risk assessment/management, including as needed, setting up and/or
improving and equipping special laboratories for this purpose;
· Strengthening information systems on LMOs;
· Enhancing public awareness, public education, and participation; and
· Setting up of biosafety databases for the purpose of the BCH (GEF 2001).
UNEP's implementation project participants are all countries that participated in the pilot
phase as well. Although these countries made progress during that phase, it is
acknowledged that many had to carry out more detailed stocktaking of national policies
and relevant competencies and to train personnel at a basic level in risk assessment, risk
management, public awareness, and participation.
Table 3.3: Implementation Countries by Implementing Agency
Implementing Agency
Implementation Countries
UNDP Malaysia,
Mexico
UNEP
Bulgaria, Cameroon, China, Cuba, Kenya, Namibia, Poland, Uganda
World Bank
Colombia, India
Four countries were included in the NBF implementation phase that had not participated
in previous GEF-supported biosafety activities. These were Malaysia and Mexico,
assisted by UNDP; and India and Colombia, assisted by the World Bank. These four NBF
implementation projects are the only components of the GEF-supported biosafety
activities not implemented by UNEP.
3.6
Capacity Building for BCH Participation
At its November 2003 meeting, the GEF Council allocated $4.6 million through UNEP
for assistance to 50 countries to participate in the Biosafety Clearing-House of the
Cartagena Protocol. The central web-based BCH portal is administered by the CBD
Secretariat, but national-level components are to be developed by individual countries.
The objective is complementary to the overall biosafety program's objectives, but aims
more specifically at developing core human and technical resources to establish the
appropriate BCH infrastructure to readily access scientific, technical, environmental, and
legal information on LMOs to ensure adequate protection in the safe transfer, handling,
and use of LMOs. Whereas the CBD Secretariat is focusing its work on the establishment
of a central portal, the GEF is supporting development of national BCH components and
capacities to access and use the BCH. About three-fourths of the funds were assigned for
training country officials in managing and operating the mechanism; the remaining one-
fourth was allocated to procuring equipment. In May 2005, the GEF allocated $8.9
million to an additional 89 countries to promote their participation in the BCH.
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Chapter 4.
Modalities of GEF Support
4.1
The GEF's Quick Start and Responsiveness to the CBD
UNEP was chosen as the sole Implementing Agency for the 100 initial NBF development
projects as well as for the subsequent 30 projects approved in 200405. This was
primarily due to UNEP's long-term interest and involvement in biosafety issues. At the
same time, the other Implementing Agencies did not demonstrate interest in addressing
the apparent demand for capacity building in biosafety identified by the COP-MOP.
Compared to its previous support of enabling activities in climate change, biodiversity,
and persistent organic pollutants, the GEF responded expeditiously to the request by the
CBD to support biosafety by allocating funding to 142 countries. Recent reviews have
shown that "regular" GEF projects take between two and five years to be developed and
approved (GEFOME 2005). By contrast, in spite of the bureaucratic routines under which
the multilateral organizations are required to operate, UNEP-GEF had a fully fledged
support system in place for executing the NBF development phase in the majority of the
initial 100 countries by June 2001. This was five months after the adoption of the CPB,
and more than two years before its ratification.
This achievement seems in large part to be due to UNEP's long involvement in biosafety
matters during CBD meetings and otherwise, as well as the drafting of UNEP's initial
guidelines. UNEP played a very decisive role in initiating the pilot project and
formulating both the GEF Strategy and its subsequent proposal to support NBF
development in up to 100 countries. It is rare in the GEF's history to carry out a pilot
project and approve an initial strategy before the relevant convention is adopted. Even
countries that had not acceded to the protocol, but that gave assurances that they would
do so, were eligible to receive GEF funding. This may have been due to the high level of
international attention and concern surrounding biotechnology, as well as a clear
recognition that this technology is developing at an extremely rapid rate which is
expected to increase in coming years in selected countries. For example, India gave its
first approval for commercial release of LMOs (for Bt cotton) in 2002. In 2003, the
country received fewer than 10 applications; but by 2004, there were 30 applications, and
so far in 2005, India has received well over 200 applications for field trials.
4.2 National
Baselines
One aspect of this evaluation is an assessment of the initial (baseline) level of preparation
for entry into force and implementation of the Cartagena Protocol at the individual
country level. It is recognized that countries participating in the project represent a broad
spectrum of pre-existing baseline preparations for project work.
The countries visited or interviewed in the course of this evaluation were generally
grouped into three baseline categories, depending on the information available for review
in terms of the extent of LMO-related activities within the country and the extent to
which current regulatory frameworks and administration were available and operating to
address issues and concerns covered by the protocol:
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· "High" baseline countries were those that are actively and significantly involved
in the development of LMOs and have regulatory systems that are at least
partially effective in addressing primary biosafety issues.
· "Medium" baseline status refers to those countries that are undertaking a low
level of domestic research or field trials, but whose safety systems relating to
biotechnology are not as yet fully or mostly functional.
· "Low" baseline status refers to countries whose primary current expectation with
regard to LMOs will be their possible importation as food or feed, or for
processing, with relatively limited expectation of formal LMO introduction in
agriculture and no current system or ability to consider control of "informal" or
illegal introduction.
The results of this initial categorization of the 18 countries visited or telephoned in this
evaluation are tabulated in Table 4.1.
Table 4.1: Baseline Levels of Countries Visited or Interviewed
Baseline level
Type of Project
High
Medium
Low
Countries with Development projects (12)
1
3
8
Countries with Implementation projects (6)
4
1
1
These statistics suggest some very fundamental differences among the countries. A
country with a high baseline state of development (significant agricultural or activities
involving LMOs ongoing and regulated at project inception) would need, and be capable
of, implementing a far more ambitious and higher level of action than one whose baseline
level was low (primary LMO activities being food importation and/or a few trials or
introductions). Baseline data provides a useful yardstick for much of the analysis to
follow, as the expected outcomes of project activities will be significantly different
among countries depending on their baseline conditions.
4.3
NBF Development Project
Organizational Set-up at Country Level
In the first module of the UNEP Biosafety Framework Development Toolkit (Phase 0
Starting the Project), which was provided to nearly all countries when they began their
national NBF project, UNEP spelled out the key principles and operational and
management implications for NBF development projects. Beyond ensuring safety and
building professional and institutional capacity, UNEP's primary programmatic
documents also emphasize the need for sustaining capacity, promoting participation by
all stakeholders, and enabling a country to make an informed choice on whether or not it
wants to import and use LMOs. The Toolkit provides for the designation of a national
executing agency to be the legal entity of the government responsible for executing the
national project. The NEA is next required to establish a national coordinating committee
to advise and guide the preparation of the NBF. In the countries evaluated, the NCC
varied greatly in size between 7 to more than 25 members. A typical NCC comprises
representatives from the ministries of agriculture, environment, trade, foreign affairs,
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economy, planning, health, education, transportation, and justice, and includes various
government institutions and departments under the ministries, such as the customs
service. In addition, one or two members are generally from the academic community,
the biotechnology industry, and NGOs such as consumer and farmer associations; in rare
cases, committees also include advocacy NGOs. The NCCs were assigned key roles--to
develop a common understanding of the country's path forward, provide policy and
professional advice, provide a discussion forum, mobilize data, approve workplans,
ensure information flow, and approve various reports and the final NBF.
The NCC is an essential component of the national organization and ensures at least some
level of involvement and "buy in" for the project by key stakeholders in the country. It
also ensures a relatively broad sign-off to the NBF, especially by government
departments. As shown in the more detailed analysis in Chapter 6, there are considerable
variations in the breadth of NCC composition, member competencies, and frequency of
meetings.
The NPCs were chosen by the NEA in consultation with UNEP. They were often a
lynchpin in the complex cooperation and coordination structures and instrumental in
keeping together the large number of participants both from within and outside
government. Given that NPCs are recipients of a large fraction of the total benefit and
capacity development under the NBF development project, UNEP strongly encouraged
the selection of NPCs who would stay with the issue after project completion and made
efforts to ensure this by keeping NPCs in a relevant full-time government position after
project closure. In the cases evaluated, the NPCs stayed on for the duration of the project.
Retention of NPCs following project completion is more difficult to evaluate. The extent
of this continuity may be a key determinant of the progress that countries will make
following project completion and may also enhance the potential sustainability of project
results. UNEP influence on such national-level decisions, however, is limited.
The NPCs have played a key role in the execution of the NBF development projects.
They have often had difficult tasks, given the novelty, complexity, time pressure, and
political sensitivity of the issues involved, with frequent turf battles among various
ministries. However, as the NPCs themselves represented almost the only communication
channel with UNEP's regional coordinator, some key points of concern may not have
been identified, particularly where the NPC did not function well. This illustrates the
frailty of UNEP's less intensive approach--to be less directly involved in oversight of
substantive project activities--although (as noted above) this approach was welcomed by
some NEAs, especially those in high baseline countries.
The proposed time frame for the NBF development projects was 18 months, with three
phases comprising six months each. During the first phase, a country was expected to
prepare inventories and surveys of current uses of biotechnology, relevant existing
legislation and regulation in the country, and potentials and mechanisms for cooperation
and harmonization of risk assessment and risk management systems on a regional and/or
subregional basis. The second phase comprised further analyses of surveys and
inventories, development of national databases, and the planning and implementation of
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wider awareness-raising campaigns and stakeholder involvement both within and outside
government institutions. The last phase included the drafting of national policies, legal
instruments, risk assessment guidelines and mechanisms, and publication of the final
NBF report, together with inventories and guidelines.
An analysis of the pilot phase evaluation reveals some inherent weaknesses in the
approach and design of the NBF development project. First, the time frame for
completion of the national projects was much too short. In review of the pilot phase, it
was determined that the countries needed 50 percent more time than initially allocated. In
planning for the NBF development project, however, it appears that the lessons of the
pilot phase were not heeded. To date, the average duration of NBF development projects
has been 28 months among countries that have finished the project thus far. To some
extent, it must be assumed that these are the "best performers" and that the remaining
projects may require additional time. See Table 4.2 for the timeframes in which countries
finished as of August 31st, 2005 had completed their NBF development project.
The time requirement is not surprising and was in fact predicted, as noted above. In
addition to factors discussed later (complexity, low baseline capacity, and the need to
develop internal cooperation), the relaxation of the project qualification requirements
(allowing non-signatory countries to be eligible for support)--while perhaps encouraging
quicker ratification and securing preliminary national endorsement of the CPB--
extended the project to a group of countries that were even less certain about national
priorities and less informed about biosafety matters. For the countries included in the
NBF add-on project, the anticipated time frame has been extended to 24 months.
Table 4.2: Number of Countries Completing NBFs by Number of Months
Number of months
Number of countries
018 3
1921 5
2224 10
2527 6
2830 7
3133 5
More than 33
6
As in the pilot phase, the primary goal of the NBF development and implementation
projects has proven to be too ambitious even with the extensions provided. As noted in a
GEF project brief (GEF 2001, annex III), the "objectively verifiable success indicator of
the NBF development project was that legislation, regulation and/or guidelines will be in
place to allow for the assessment and management of risk associated with the use of
modern biotechnology" During the course of the project, the goal was scaled down and
aimed only at completing preparation of the draft NBF, not at having the actual
mechanisms in place.
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Figure 4.1: Suggested Flowchart for Development of a National Biosafety Framework
Sign National project docume nt
PHASE ONE:
(Months 1-6 of project)
Preparatory Activities &
Gathering Information
Appoint full-time NPC
Establish NCC
Surveys of:
Programmes for safe Existing status of
Relevant
Regional
Other issues as
use of
biotechnology &
legislation
mechanisms for
identified by
biotechnology
LMOs
harmonization
country
---------------------------------------------------------------------------------------------------------------------
Inventories of:
Existing capacity
Current status of
Existing
Regional mechanisms for
building programs
biotechnology
legislation
harmonization
Biosafety Database:
roster of national
experts
National workshop for stakeholders to: review findings,
identify gaps and needs, and to decide priorities for NBF
PHASE TWO:
(Months 7-12 of project)
Training workshops on
Analysis and
different NBF components as
Consultation
required
Awareness workshops for
target groups
Regional & Sub-Regional
Workshops to assist in NBF
Stakeholder workshop to
identify key components of
process and content
NBF
---------------------------------------------------------------------------------------------------------------------
PHASE THREE: (Months
13-18 of project
Stakeholder workshop to
Prepare draft of
Preparation of draft
National Biosafety
discuss draft and final
National Biosafety
Framework
components of NBF
Framework
Source: GEF 2001.
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As of August 31, 2005, 45 NBF projects were completed, with the average duration for
all projects being 28.4 months. Viewing the NBF projects from a regional perspective,
projects in Africa have taken the longest to complete, requiring an average of 32 months.
Although countries in Latin America and the Caribbean have the shortest average
completion time at 24 months, there are only two completed projects in this region. It is
likely that the average required project time for the region will be much higher once more
countries have completed their projects. In the Asia and Pacific region, the average
project completion time is 28 months. In Central and Eastern Europe--the region with
the largest percentage of countries reaching completion--the average project completion
time has been 25 months. According to figures provided by the UNEP project team it is
estimated that the actual average completion time for countries in this region will be 30
months, once all currently existing projects have been completed.
4.4 Individual
NBF
Implementation Projects
Unlike the NBF development project, which operated through a set of similarly created
and mandated national subprojects, the NBF implementation projects initiative consisted
of a series of 12 separately created national interventions. Of these, eight were UNEP-
executed and -operated as a follow-up to the pilot projects. The projects were designed
more individually for countries that had already completed NBFs (in this case, referring
to establishing a national legislative/administrative framework, often including a draft
legal framework, rather than simply a plan for later creation of that framework). The
World Bank and UNDP each executed two projects in countries that had not participated
in the pilot but that had some experience with LMOs.
In practice, although UNEP pilot countries had completed significant work, most had not
fully drafted all relevant instruments needed in order to have a functional national legal
framework in place. Many of these projects thus include substantial legislative drafting
components. In at least one country, legislation developed in the pilot phase has been
abandoned and a new primary legislative drafting process is being undertaken.
UNDP and World Bank implementation projects were directed at countries that had
developed national frameworks without project assistance and were deemed ready for the
NBF implementation phase. In some cases, national political and other factors have later
proven to be obstacles; for example, two projects have undertaken little work toward
completion of their Terms of Reference.
The UNEP NBF implementation projects have received significantly more direct
assistance (substantive as well as administrative) from their UNEP coordinator than was
provided to the NBF development projects. The UNDP and World Bank projects, where
operational, have been approached very differently. UNDP limited its role to
administrative oversight in the two implementation countries for which it was
responsible. By contrast, the World Bank has provided both administrative oversight and
technical backstopping, including sending initial and mid-term expert missions to address
substantive issues and decisions.
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4.5
Agency Fee Levels
Contrary to the normal GEF fee level of 9 percent, the GEF Secretariat negotiated the fee
down to 3 percent for the 100 initial NBF development countries. However, in addition to
this fee, the project budget included salaries and travel expenses for four regional
program coordinators. This indicates that UNEP's resources for implementation and
execution of the projects were around 17 percent of the total project cost, which would be
quite generous in a normal development project, but may be inadequate considering the
novelty of the subject matter, the breadth and scope of project objectives, the lack of
agreement on the science, the dispersed geography of the projects, and the great diversity
of opinions among countries--and especially among the nongovernmental organizations
and institutions--invited to participate.
The distribution of direct oversight responsibility varied over the course of the NBF
development project. Initially, each regional coordinator recruited by UNEP was
responsible for managing and supervising a large number of projects. One coordinator
had responsibility for 39 countries, although not all of these had active projects at the
same time.
Later, the GEF Secretariat provided additional administrative resources, some of which
were used to increase the number of regional coordinators. For the 30 additional NBF
projects, the normal fee level of 9 percent was reinstated. UNEP oversees 93 percent of
the GEF's support for biosafety, while the World Bank and UNDP implement much
smaller percentages--3 percent and 4 percent, respectively.
Table 4.3 shows the actual dollar amounts handled by each of the Implementing
Agencies, as well as the respective administrative fee received to support administration
and oversight of the respective projects. The table also shows the ratio of the fee received
relative to the total size of each agency's biosafety portfolio. On the whole, UNEP's
share of fees received has been proportionally less than that of the other agencies.
Overall, the Implementing Agencies have received fees representing 7 percent of the total
GEF investment.
Table 4.3: Total Allocation under the GEF Initial Strategy for Biosafety
Implementing Agency
Total GEF ($ millions)
Total fees ($ millions)
Fee percentage
UNDP
$2.4 $0.4 16
UNEP $55.0 $3.4
6a
World
Bank
$2.0 $0.3 15
Total $59.4 $4.1 7b
Note: The fee percentage calculated here includes only the official agency fee. The percentage does not, in the case of
UNEP, include any additional agreed-upon resources.
a.
In addition, UNEP received compensation for the positions of four regional coordinators.
b.
Not adjusted to reflect the four regional coordinators cited above.
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4.6
Comparative Advantage of the Implementing Agencies
While UNEP, UNDP, and the World Bank are all implementing GEF biosafety projects,
UNEP has by far the largest portfolio. UNEP has developed substantial capacity in its
project management office in Geneva, with two regional coordinators posted in Africa
and a subregional coordinator posted in both the Pacific and Latin American regions.
UNEP has developed considerable professional expertise in many aspects of biosafety,
although its legal expertise in this area remains weak. In contrast, biosafety has been a
minor part of the World Bank and UNDP portfolios, and these two Implementing
Agencies have not developed expertise equivalent to that of UNEP. Some participating
countries indicated that they would find it advantageous for an Implementing Agency to
have an in-country presence, which UNEP, for the most part, does not have. The UNEP
biosafety project team has partially offset a lack of country presence by being highly
available and responsive by phone and electronic communication.
The World Bank has begun to develop its biosafety portfolio (with a project proposal
under way for a regional center of excellence in Latin America), and has indicated that it
anticipates that its biotechnology/biosafety portfolio will grow in the near future. The
World Bank also points to its comparative advantage emanating from its extensive
engagement in agriculture and agricultural research. Regarding country presence, even
though the World Bank has a large office in India, its staff in Delhi has little direct
involvement with or oversight of the biosafety implementation project, which is instead
managed from World Bank headquarters in Washington, D.C. In this sense, then, there is
relatively little advantage taken from the World Bank's country presence.
Of the two UNDP NBF-implemented projects, one (Malaysia) has yet to commence
project start-up. In the other project (Mexico), UNDP has limited itself to an
administrative project oversight role and drawn on the substantive capacity of the UNEP
team for substantive technical backstopping. While one or two of its country offices have
articulated a strong interest in handling client country demands regarding biosafety
issues, UNDP centrally decided to draw on the strong technical capacity of UNEP rather
than attempt to duplicate such technical capacity itself. Through its decentralized
structure, UNDP does have a strong in-country presence, which could play an important
part in administrative backstopping. This has been advantageously made use of by
UNEP in some countries.
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Chapter 5.
Regional Harmonization, Coordination, and
Collaboration
5.1
Background and Rationale
Regional Opportunities under the Cartagena Protocol
Given the Cartagena Protocol's overall objective of managing the transboundary
movement of LMOs--coupled with the fact that many countries may lack the technical
and financial ability to develop, staff, and operate the full range of administrative
institutions and mechanisms generally thought necessary to fully comply with the
protocol--the CPB supports and encourages regional cooperation, coordination, and
harmonization on biosafety issues. The protocol text touches on this aspect in numerous
places. For example, article 14, Bilateral, Regional and Multilateral Agreements and
Arrangements, specifically discusses aspects of regional cooperation, stating that parties
may enter into these types of agreements regarding the international transboundary
movement of LMOs, as long as such agreements do not result in a lower level of
protection than is consistent with the protocol.4 For purposes of national implementation,
however, the primary provision is article 22.1, Capacity Building. In this provision, the
protocol specifically requires the parties to "cooperate in the development and/or
strengthening of human resources and institutional capacities in biosafety...including
through existing global, regional, sub-regional and national institutions and organizations
and, as appropriate, through facilitating private sector involvement." The protocol's
provisions regarding illegal and unintentional transboundary movement of LMOs create a
positive obligation for inter-country cooperation, although they specifically do not
require any formal or informal collaborative action. Inter-country cooperation is strongly
mandated in provisions that require the posting of information regarding LMO
introductions and use in the Biosafety Clearing-House discussed below.
Pilot Phase Experience
With regard to regional action, the pilot phase demonstrated the real and potential
benefits of collaboration through regional activities such as awareness-raising workshops.
It presented two workshops each in the Africa, Asia and Pacific, Latin America and the
Caribbean, and Central and Eastern Europe regions. The activities of the pilot phase are
further described in section 5.2.
The evaluation of the GEF-funded pilot phase activities recognized the value of these
workshops (UNEP-GEF 2000, Executive Summary), stating, "The workshops provided a
good understanding and appreciation of the type of assistance that the countries might
need to ensure the transparent and safe consideration of the use of products of modern
4 This provision does not enable, nor does it constitute permission for, all sovereign nations to have the
right to enter into agreements subject to good faith requirements of consistency among them. Rather it is a
mechanism for "smoothing the road" in the case of frequent import-export arrangements among countries
whether within a region or more generally. Although it might be thought to enable the development of
harmonized standards within a region, such development requires formal international negotiations and the
creation of a separate legal instrument. As such, it is not a mechanism of the protocol.
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biotechnology." The evaluation concluded that "[the project] has stimulated regional
cooperation."
GEF Approach to Regional Aspects
The activities of the pilot phase, and their subsequent evaluation (as well as a review of
pilot phase activities by the GEF Scientific and Technical Advisory Panel), provided a
significant portion of the basis for the GEF Strategy on biosafety, which was adopted by
the GEF Council in November 2000. The strategy strongly emphasizes regional and
subregional objectives and activities, stating that:
National biosafety decisions and activities need to take into account legislative measures
and biosafety regulatory systems of adjacent countries. Sub-regional cooperation in
information sharing and harmonizing legal and regulatory instruments is crucial for
effective management of transfer of LMOs across borders. Information to assist countries
in decision making is not necessarily available within a single country. Maximizing the
use of institutional, financial, technical and human resources within a region will enhance
a country's ability to implement the Protocol and will facilitate an exchange of best
practices and experiences (GEF 2000).
One of the three main objectives of the GEF Strategy is the promotion of "information
sharing and collaboration at the regional and subregional level and among countries that
share the same biomes/ecosystems" (GEF 2000). Set out in more detail (GEF 2000),
specific regionally and subregionally focused activities planned for GEF support could
include the following:
· Establishment of a roster of experts in a transparent manner and modalities for
including them in national, sub-regional and/or regional networks;
· Assessment of options for implementation of various elements of the biosafety
frameworks, for example at the regional level;
· Identification of sub-regional and regional opportunities for harmonizing regulatory
frameworks, identifying regional expertise, and exchanging information on
initiatives, collaboration and priority areas for capacity building.
The GEF Strategy largely focuses on activities and opportunities for communication and
cooperation. Its references to harmonization of regulatory mechanisms, especially risk
assessment guidelines, are appropriately limited in scope--calling only for "identification
of opportunities in this regard"--a wise choice, give the political disparities that may
exist among countries in a region and given the fact that many developing countries are
still not entirely fixed in their policy choices on LMOs. Emphasis on actual legal
harmonization among countries is relatively modest. Legal harmonization can take
significant amounts of time, since it necessarily involves international negotiations
among sovereign nations, and, in some cases, delegation of national authority to a
regional or subregional body. Moreover, few countries even had legislation relating to
LMOs at the time the GEF Strategy was developed.
Given the strong priority of regional objectives and the significant needs encountered, the
NBF project documents include a survey on existing mechanisms for harmonization of
risk assessment/risk management, mutual acceptance of data, and data validation, as one
of the specified activities at the national level. Therefore, it can be expected that countries
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participating in the NBF project have conducted some exploration regarding the
possibility of collaboration through less formal mechanisms and through the medium of
existing regional cooperation structures.
5.2
Regional and Subregional Workshops
Following the model of the pilot phase project, the first component of the Development
of National Biosafety Frameworks Project is Promoting Regional and Subregional
Collaboration and Exchange of Experience, to be achieved through a series of regional
workshops. According to the project document (GEF 2001, pp. 36), "The expected
outcome of the workshops will be a clear understanding by participating countries of the
obligations placed upon them by the protocol. This will require an understanding of the
risk analysis and management procedures that are needed to ensure the safe use of
relevant living modified organisms."
The project document further elucidates the expected outcomes of both the regional and
subregional workshops, respectively. The regional workshops will be held to:
· Identify the tasks required of countries that have signed the Protocol;
· Decide on those issues that may be addressed at a regional, sub-regional or national
level and the methods that are to be used to address each of these issues;
· Identify key players in each country, and the way in which expertise and experience
may be used across the region;
· Designate sub-regions and decide on those issues to be referred to sub-regional
meetings (GEF 2001).
Following this, the expected outcomes of the subregional workshops are:
· Identify sub-regional priorities to enhance existing capacities and expertise;
· Discuss ways to collaborate in utilizing human resources and relevant expertise and
to provide mechanisms for sharing national experience;
· Provide information leading to the harmonization of procedures for the assessment
and management of risks and benefits of living modified organisms and review of
applications for field trials and field releases;
· Ensure complementarity and coordination with the capacity building efforts of
individual governments and other international, bilateral and multi-lateral agencies
(GEF 2001).
The regional and subregional workshops were anticipated to have two functions: (1) to
represent an efficient way of communicating and imparting knowledge to, and exchange
experience among, a large number of country participants; and (2) to promote regional
and subregional collaboration and harmonization of scientific, legal, and regulatory
instruments, which could be a positive contribution for effective management of transfer
of LMOs across borders. The full description of the planned activities and outcomes of
the workshops can be found in the NBF development project document (GEF 2001).
According to this document, $1.14 million of GEF funds were budgeted for promotion of
regional and subregional collaboration and exchange of experience, with an additional
$0.89 million budgeted for country in-kind support.
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Workshop Organization and Outputs
Overall, three series of regional and Box 5.1: Regional and Subregional Workshops
subregional workshops were held (see Box
5.1), for a total of 16 workshops in all. First Series (Regional Workshops)
There were more than 800 individual Nairobi, Kenya; January 1619, 2002
participants, and some were able to attend Nitra, Slovak Republic; February 57, 2002
Beijing, China; March 48, 2002
two or three of the workshops. These were Buenos Aires, Argentina; May 810, 2002
usually representatives from the national
executing agencies or were the national Second Series (Subregional Workshops)
project coordinators. Although both the Windhoek, Namibia; November 1215, 2002
number of workshops and number of Mexico City, Mexico; December 1013, 2002
Kuala Lumpur, Malaysia; January 2124, 2003
participants is significant when taken as a Nadi, Fiji; February 1822, 2003
whole, the total number of participants per Vilnius, Lithuania; May 2730, 2003
country was relatively limited. The Dakar, Senegal; April 2225, 2003
majority of participants were government
representatives, covering a range of Third Series (Subregional Workshops)
Shiraz, Islamic Republic of Iran; October 1922,
ministries and agencies. Regional 2003
organizations, NGOs, the private sector, Santiago, Chile; November 2528, 2003
and academia were also represented.
Antalya, Turkey; December 912, 2003
Dar-es-Salaam, Tanzania; March 912, 2004
The first series of four regional workshops Ouagadougou, Burkina Faso; April 2023, 2004
Port of Spain, Trinidad and Tobago; May 1114
aimed at a general introduction of the 2004
CPB, the NBF development project, and
the main elements of work in the
preparation of an NBF. The second series of six workshops were held at the subregional
level; these aimed at providing insights into systems and methodologies for risk
assessment and public participation. These workshops also facilitated the exchange of
practices, experiences, and lessons among the countries in the subregion.
The objective of the third series of six workshops was to help participants acquire a better
understanding of the different options for regulatory regimes and administrative systems
for biosafety, as well as the legal and administrative requirements of the Cartagena
Protocol, and potentials for regional and/or subregional collaboration and harmonization.
It was emphasized particularly at the joint workshop for the Pacific and Caribbean SIDS
that mechanisms for closer collaboration on a subregional level (one in the Pacific and
one in the Caribbean) would significantly increase the potential of individual small
countries to pool resources and enhance the development of policies, laws, science,
regulatory systems, and institutional capacities. A report was produced after each
workshop, which provided a summary of workshop activities; annexes to the workshop
reports include the results of the workshop evaluation questionnaires.
Workshop Outcomes and Other Results
As a whole, the regional and subregional workshops were viewed positively by the
participants, as indicated both by the post-workshop evaluations conducted by UNEP and
feedback received directly by the evaluation team. Participants in the first series of
regional workshops indicated that these were "very useful" for those from countries
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where the NBF project had not begun at the time of the workshop. The workshops
provided a good understanding of how to undertake the NBF process and produce an
acceptable NBF document. Feedback gathered by the evaluation team through country
visits, non-field reviews, and reviews of NBFs indicated that nearly all countries involved
in the project were able to participate in at least one workshop.
Another important aspect of the workshops was the facilitation of network building and
information sharing. Many participants indicated that this was achieved, and shared their
appreciation for this aspect as one of the key outcomes of the workshops. One participant
of the workshop held in Tanzania stated that simply knowing people in other countries
who were going through or who had gone through a similar process was very helpful
because then there were people to contact when questions arose about how to deal with
some aspect of the NBF development project.
The workshops also played an important role in raising awareness and understanding of
the issues surrounding LMOs and biosafety among workshop participants.
Challenges of the Workshop Approach
While the workshops were considered useful or helpful in the development of NBFs, it is
unclear whether they were the most effective means of building the extensive regional
cooperation on biosafety called for in the GEF Strategy and NBF development project
document. Budget resources only allowed for a few people from each country to attend
the workshops; these were mostly NPCs and NEA representatives. Given that the
workshops were only for three or four days, there was little potential for meaningful
dialogue on regional collaboration or harmonization, or the development of regional
approaches to implementing biosafety. This was not surprising, given the level of funding
available for this activity and the very low level of initial awareness, knowledge, and
capacity in most countries.
On the other hand, some difficulties were encountered by the UNEP project team in
identifying individuals with sufficient capacity to attend the workshops. In planning the
workshops, UNEP set strict guidelines about which individuals were qualified to
represent their respective country so as to ensure that the training would have the greatest
benefit at the country level when the participants returned home. These stringent criteria
sometimes made it difficult to ensure participation by the desired number of people,
especially for workshops in Africa. Furthermore, given the low level of initial awareness
and capacity of the majority of workshop participants, the short time frame of the
workshops was insufficient for participants to develop a good understanding of complex
scientific issues such as risk assessment and risk management of LMOs.
As previously described, workshops did provide participants with a valuable opportunity
for informal information exchange and networking. However, to achieve the level of
activity implied in the GEF Strategy and NBF development project document, efforts to
facilitate true bi- or multilateral collaboration and harmonization among institutions and
high-level officials at the national level will require a much longer term and more
resource-intensive investment. The UNEP project team members indicated that, based on
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their experience, countries are unlikely to begin thinking about subregional cooperation
until they have a clear understanding of what biosafety means in their national context,
have achieved consensus among diverse interests at the national level, and have
developed their own NBF document. It is also noteworthy that the potential for regional
cooperation and harmonization is only mentioned in a small subchapter in UNEP's
Toolkit.
The limited utility of the workshops in terms of addressing regional aspects was also
reflected in the participant feedback received by UNEP. In the first series of regional
workshops, respondents indicated that the workshops were only marginally useful on the
issue of regional and subregional resources and priorities. Focusing on regional aspects
was a specific goal of the third series of workshops, and this component received a
slightly higher rating from those participants, thereby indicating improvement over the
first series of workshops. The third series dealt with regulatory regimes and legal and
administrative systems, addressing much more directly the practical options for
subregional cooperation. But rather than discussing direct cooperation among countries,
the participants saw the solution in using existing subregional organizations and
institutions, which had mostly not been formally involved in the project. This series of
workshops took place in the fourth quarter of 2003 and first half of 2004--somewhat late
in the NBF development process.
It is unclear how much knowledge transfer occurred from workshop participants to in-
country nonparticipants once participants had returned to their home country. In the
majority of workshops, a maximum of four persons from any given country could attend.
This small number limited the effects the workshops could have at the country level.
Some interviewees indicated that direct bilateral exchanges of technical experts between
both developed and developing countries could be a useful mechanism for building more
extensive capacity at the national level and encouraging bilateral or regional cooperation.
Other activities that have been identified as potentially useful include information and
experience exchange workshops conducted on a bilateral basis, training of trainers in
technical aspects of biosafety, and joint training of border control and customs officers
among countries sharing borders. These approaches could possibly be addressed through
existing mechanisms such as the Southern Africa Customs Union, the Andean
Community Customs Union, or other such agreements related to the transboundary
movement of goods.
Capacity retention was another challenge faced in the execution of the workshops. This
challenge is faced by all such capacity-building mechanisms. Participants who have
gained knowledge sometimes do not stay in their current position within government or
may leave their home country altogether to pursue educational or other professional
opportunities abroad. It is difficult to quantify the degree to which capacity is retained in
a country following workshops such as the ones conducted for this project. One
indication is the movement of NPCs to other positions inside or out of government.
UNEP has recognized this as an ongoing challenge faced by the project, and has
encouraged countries to find ways to keep their NPCs on staff following project
conclusion.
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The budget for the regional component was quite small, constituting only $2.1 million
out of the total allocation of $26.1 million, or about 8 percent of total GEF project costs.
The evaluation of the pilot phase recommended an allocation of about $27 million for
regional and global collaboration.
5.3
Multi-Country Cooperation
As noted above, it was expected that the NBF development project would contribute to
potential regional and subregional interaction. In particular, the project was supposed to
foster two critical actions cited as expected outcomes of country projects (GEF 2001):
· establish the systems needed for risk assessment, audit of risk assessments and
risk management, taking into account national and subregional/regional needs;
· provide appropriate mechanisms for sharing scientific assessments at subregional
levels (while allowing for decisions at the national level, if necessary).
These activities were expected to be funded at a level of $15,000 per country
participating in the NBF development project; it is unclear to what extent this provision
was actually funded within the country subproject documents.
Regional activities were not included as part of the workplan for countries participating
in implementation projects. UNEP had originally included this component in
implementation project planning, as well as activities supporting curriculum development
on biosafety-related issues. However, the GEF Secretariat decided that these activities
should not be included in the implementation projects, and no budget allocation was
made to support these aspects. According to the GEF Secretariat, the rationale behind this
decision was that having only two implementation projects in each region offered little
scope for regional cooperation. This logic ignores the fact that other biosafety-related
activities were taking place in many countries, including the Development of National
Biosafety Frameworks Project in countries in every region. In some cases, the relative
inequality among countries (which may have been increased by the designation of only
one country for pilot and implementation project funding) is frequently a factor in
preventing such cooperation. Even in situations where implementation projects were
ongoing in neighboring countries, there was no evidence of bilateral coordination.
Achievements in Cooperation among Countries
Direct bilateral or regional activities took a number of different forms in the NBF project.
All EU accession countries (countries that have already acceded or are planning to do so
sometime in the future) are harmonizing regulations to EU standards, creating de facto
regional harmonization; the EU countries specifically analyzed as part of this review are
Bulgaria, Croatia, Czech Republic, Estonia, Latvia, Lithuania, former Yugoslav Republic
of Macedonia, Moldova, Slovak Republic, Slovenia, and Turkey. Although some of these
countries are not yet part of the EU, they have all made efforts to harmonize their
national biosafety policies, legislation, and regulations to EU standards. On the other
hand, while the focus on EU harmonization has helped set a minimum level of regulation
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among countries, this does not mean that countries not yet acceded to the EU are
necessarily collaborating and communicating with other EU or non-EU countries. This
evaluation saw relatively little evidence of in-depth, meaningful discussions among these
countries on biosafety issues. The evaluation did not inquire in detail into intra-European
cooperation, but did learn of EU-based peer review services and the involvement of many
countries in the Aarhus Convention (the United Nations Economic Committee for
Europe's Convention on Access to Information, Public Participation in Decision-Making
and Access to Justice in Environmental Matters, adopted in 1998), which has important
applications for the biosafety protocol.
Another example of regional cooperation in biosafety was in central Asia, where, in
October 2004, six Central Asia countries met in Dushanbe and shared experiences on the
development of NBFs and formulated a resolution on biosafety collaboration in the
region. This resolution was presented at the meeting of the Commonwealth of
Independent States International Committee on Sustainable Development. In Latin
America, countries have established an annual symposium on transgenic products, with
the fourth session held in late September 2005 in Porto Alegre, Brazil. UNEP participated
in this meeting, which discussed the approaches countries were taking on biosafety issues
and a comparison of laws, regulations, and communication strategies.
As part of the NBF development project, most countries obtained and reviewed the laws
of both neighboring and distant countries. The primary purpose of this activity, however,
appears to have been to study them as potential models for legislative development rather
than as a first step to harmonization or even development of coordination. When gathered
from within the region, much of this information was relevant to two other specific
activities listed in the suggested workplan of the national project documents--a survey on
existing NBFs in the countries of the subregion and a survey on existing mechanisms for
harmonization of risk assessment/risk management, mutual acceptance of data, and data
validation. These activities were carried out in a rather sporadic manner. At least eight
(21 percent) of the completed NBFs reviewed under this evaluation reported that one or
both of these surveys was completed within their national projects. Within the completed
NBF documents, discussions or analysis of regional collaboration and harmonization are
largely absent. Approximately three-quarters of the completed NBFs did not include any
discussion of regional aspects of biosafety. In Central and Eastern European country
NBFs, regional analysis was easier than in other areas and was considered more essential,
since their primary regional cooperation related to integration with EU directives on
LMOs and biosafety.
One possible future means of collaboration in various subregions could be through the
development of regional "centers of excellence" for biosafety. A proposal is under
development by the World Bank for this type of mechanism in northern Amazonian
countries, through the International Center for Tropical Agriculture, which is one of the
regional centers of the Consultative Group on International Agricultural Research.
Regionally based approaches involving other such subregional organizations are
discussed in section 5.4.
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Challenges to Future Progress
There have been a few positive examples of bilateral or regional discussions in Central
Asia and Eastern Europe, but considering the national project budget allocation for this
type of activity, there was relatively little scope for direct bilateral discussions. NPCs or
other member of the NEA could use national project funds to visit neighboring countries,
but UNEP had no budget provision to support this type of activity outside of the funding
for the national project. The time frame for the national projects was also highly
compressed, and some NEAs indicated that the project was so focused on meeting the
requirements of the NBF within the allotted time frame there was not sufficient time to
deal with other aspects such as regional cooperation. Agencies in many countries have
expressed interest in exploring regional cooperation, and the GEF should be in a position
to help facilitate this process when conditions are appropriate.
Countries face many challenges when attempting to address regional cooperation and
collaboration on issues of biosafety. Inter-country dialogue on biosafety issues is
currently difficult, at best, due to the preliminary nature of national policy decision
making on these issues in the vast majority of countries reviewed in this analysis. One
significant difficulty is language barriers, which were seen as a particular problem in
eastern Asia. China is one of the more advanced countries with regard to the level of
biotechnology activity being undertaken. Individuals interviewed as part of this
evaluation expressed concern that China's ability to cooperate and share information on
biosafety with other countries in the region was consistently hampered by language
barriers. Despite these challenges, in the future the national Biosafety Clearing-House
mechanism should help facilitate some degree of regional cooperation.
5.4
Cooperation through Regional Organizations
The GEF Strategy calls on the NBF development project to explore and maximize
possibilities for working with regional and subregional organizations to enhance
implementation through regional cooperation on biosafety. This conclusion arises from
provisions of the GEF Strategy (1) requiring that the regional and subregional workshops
should enable and encourage the development of opportunities for regional collaboration,
and (2) calling upon the NBF development project to work with multilateral and bilateral
institutions to further the goals of the strategy (GEF 2000, paras. 20 and 26).
Regional cooperation could be especially important for SIDS regions such as the
Caribbean and the Pacific. While many SIDS are concerned about the potential effects of
LMOs on their isolated and fragile ecological systems, the limited capacity of individual
countries makes it difficult for any single nation to establish and maintain a cost-effective
national regulatory system for biosafety. The potential for SIDS and other similarly
positioned nations to ensure effective implementation of the CPB is dependent on their
ability to address manpower and expertise deficiencies through collective action and
shared capacity.
Notable developments toward regional collaboration involving subregional organizations
include the following:
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· UNEP-GEF support contributed to the development of regional approaches to
biosafety in two regional meetings held in collaboration with the Caribbean
Community, with support from the Caribbean Agricultural Research and
Development Institute, the primary body within the community related to
biosafety. In addition, as an output of the NBF project in Dominica, a formal
proposal for Regional Coordination of Biosafety in the Context of the CPB was
developed. This proposal has been circulated to other Caribbean Community
member states for possible approval.
· In the Pacific, the project formed an agreement with the Secretariat of the Pacific
Regional Environment Programme to host a regional node of the BCH
mechanism for Pacific island nations.
· A meeting for the South Asia subregion was held in Kathmandu in November
2004 to open preliminary discussions on the establishment of a regional
cooperative framework for biosafety. These preliminary discussions were held
under the auspices of the South Asian Association for Regional Cooperation,
which organized this meeting, and are documented in SAARC 2004.
· A second regional meeting organized by the government of Sri Lanka on
completion of its NBF project was held in April 2005. The aim of this meeting
was to exchange information on NBFs in the region and to work out areas for
inclusion in the regional agreement on biosafety, including cooperation on sharing
and exchange of information.
· Working with the Association for South Eastern Asian Nations Secretariat, the
NBF project brought together the association's 10 member states in June 2004 in
Manila to discuss their experiences in developing their NBFs and to explore areas
for cooperation. The possible areas for collaboration identified included
cooperation on development of regulations, sharing of information on biosafety
through the BCH, and a regional information network on biodiversity.
· The UNEP project team is working with the Economic and Social Commission
for West Asia and the International Center for Agricultural Research in the Dry
Areas on promoting regional cooperation on biotechnology and biosafety. The
initial activities in this area include an e-forum on biotechnology and biosafety in
West Asia and North Africa; this will be followed by a regional meeting in early
2006.
In addition to these formal activities, the staff of the UNEP-GEF projects, as well
individual countries participating in the NBF project, have had informal information
exchanges and discussions with a few other relevant regional organizations, such as the
Economic Community of West African States, the Association for Strengthening
Agricultural Research in Eastern and Central Africa, and the Association of Southeast
Asian Nations.
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Although there are some regional biosafety-related activities under way, there is room for
much more progress to be made in this area in the future. Numerous organizations in
many regions could play important roles in facilitating regional activities; these include
the centers of the Consultative Group on International Agricultural Research, the West
and Central African Council for Agricultural Research and Development, and the
Southern Africa Development Community. Many of these organizations are focused on
agricultural technology and research, including biotechnology. Some organizations, such
as the Southern Africa Development Community, are beginning to consider how to deal
with biosafety. Although addressing biosafety is an additional level of activity, there may
be important synergies achieved through the integration of biosafety measures directly
into nascent programs for the promotion of biotechnology research.
An important question moving forward will be to what degree GEF support for biosafety-
related activities can catalyze or encourage initiatives within regional bodies, and the
most effective mechanisms for engaging them. Additionally, some regionally focused
institutions may not be appropriately positioned to achieve buy-in by all stakeholders.
5.5
Coordination with Other Bilateral and Multilateral Organizations
The third objective of the GEF's initial strategy on support to the CPB is "promoting
identification, collaboration and coordination among other bilateral and multilateral
organizations to assist capacity-building for the Protocol and explore the optimization of
partnerships with such organizations" (GEF 2000). This goal seems to have been
prompted by statements by several donors about their intention to provide financial
support to the CPB at the Ministerial Round Table in Nairobi in May 2000. The GEF
Strategy proposes that the GEF Secretariat, in conjunction with the Implementing
Agencies and the CBD Secretariat, convene annual meetings of interested organizations
to build synergies and establish complementarities in capacity building. Pursuant to a
request by the Intergovernmental Committee for the Cartagena Protocol, the first such
meeting was held in December 2000. It was agreed that the CBD Secretariat would
establish a database directly addressing biosafety capacity building--a process that has
been completed and is posted in the BCH. In addition to information from agencies and
organizations providing capacity-building projects and support, about 50 countries have
submitted data about their capacity-building needs. Practically all respondents expressed
the need for enhanced institutional capacity building in risk assessment, risk
management, regulatory systems, awareness raising, education, and public participation.
A second meeting, Coordination Meeting for Governments and Organizations
Implementing or Funding Biosafety Building Activities, was held in 2004. At this
meeting, participants prepared operational procedures and guidelines for coordination of
biosafety activities, which were subsequently approved at COP-MOP 2. It is expected
that further coordination meetings will be held whenever necessary, at least once a year.
In preparation for the next meeting and COP-MOP 3, the CBD Secretariat will carry out a
comprehensive review and possible revision of the action plan for capacity building
(CBD 2005).
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An ongoing study by the United Nations University Institute of Advanced Study has
compiled data on all funding by donors and co-funding by governments of biosafety
capacity-building projects (UNU forthcoming). According to the current information
available, total allocations since 1999 amount to about $157 million, of which GEF
funding and government co-funding represents about 55 percent combined. The
remainder is allocated by about 16 multilateral and bilateral agencies. The areas
addressed in projects by agencies that have contributed in excess of $1 million are
biosafety regulatory implementation and capacity building (U.S. Agency for International
Development--USAID); training in biosciences (Canadian International Development
Agency); capacity building in biotechnology, biosafety, and biotech policy, research, and
education (Swedish International Development Agency, Department of Research
Development), biosafety policy, awareness raising, participation (German Federal
Ministry for Economic Cooperation and Development); holistic biosafety assessment and
master of science course (Norwegian Agency for International Development); biosafety
systems in Poland (European Union); 19 assorted biotechnology and biosafety initiatives
(Rockefeller Foundation); strengthening capacity building in Asia, Bolivia, and Grenada
(Food and Agriculture Organization of the United Nations--FAO); and a global training
course in genetic engineering, biotechnology, and biosafety (International Centre for
Genetic Engineering and Biotechnology).
Many countries with implementation projects are also recipients of other bilateral or
multilateral biosafety projects with the same or similar objectives, often working with the
same in-country partner institutions. For example, Uganda and Kenya are also
participating in USAID's Program for Biosafety Systems; Namibia has participated in the
Southern Africa Regional Biosafety program; India is a participant in USAID's South
Asia Biosafety Program; and Bulgaria and Poland have both benefited from the Dutch
government's Matra project on implementation of biosafety frameworks. Poland has also
been supported through an EU twinning program.
The GEF Strategy's requirements for coordination and collaboration with other
multilateral and bilateral projects is important because, in its absence, there is the risk of
promoting competing subnational priorities or creating confusion and/or
misunderstanding regarding the relative roles of different projects within the national
strategy. In this context, coordination and collaboration imply more than merely sharing
information on respective project activities. As indicated in the NBF development project
document (GEF 2001), one of the objectives of the regional workshops was to "ensure
that activities undertaken under this project are implemented in coordination with other
biosafety capacity-building efforts of individual governments and other international
bilateral and multilateral agencies."
5.6 Conclusions
Regional workshops were the primary tool by which the project addressed the regional
component of its mandate. Based on the stage of national policy development and
technical capacity, it was appropriately determined that the workshops would focus on
the cooperative/collaborative elements of that mandate, rather than expending significant
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efforts in promoting the development of regionally harmonized legislation and
standards--a process for which the countries were not yet ready.
The workshops were intended as a cost-efficient way of imparting essential information
to the national project coordinator and key members of the NCC, and of establishing
useful contacts. Given the low level of initial awareness and capacity of many workshop
participants, the workshops functioned as a mechanism for primary awareness-raising--a
much less cost-effective result. In general, the workshops' main positive contribution was
the creation and education of a small node of experts and interested officials in each
country--the kernels from which an entire biosafety framework will ultimately grow.
The limitations of the regional workshops were recognized in the mid-term evaluation of
the NBF development project (Navajas and Seyami 2003): "the programmed funds and
events are insufficient to attend the strong demand--and potential--for subregional
cooperation, let alone for in-depth training." Disregarding demand and potential, it also
appears as though the programmed funds and events were too limited to meet the
ambitious objectives to facilitate regional cooperation on biosafety among parties as
outlined in the project document and the GEF Strategy.
The various subregions are at different stages of development with regard to regional
collaboration and cooperation, and may need different types of support to create effective
regional mechanisms. Although there may be some consistent types of technical or other
support that can be provided among all regions, a uniform approach to regional
cooperation, collaboration, and harmonization is not likely to be an effective way forward
for all regions. Capacity-building activities, such as regional workshops, are most
effective when targeted toward a group of stakeholders with similar levels of capacity
and technical skills.
In the process of NBF development, the national subprojects appear (based on reports
submitted) to have given little attention to bilateral or subregional aspects. Given the
baseline levels of knowledge, awareness, and capacity in many countries at the beginning
of the NBF development project, it was likely premature to call for high levels of regional
integration in the GEF Strategy--despite the obvious need for longer term activities in
this direction. It was important to recognize the potential benefits and synergies from
regional coordination, collaboration, and harmonization with regard to biosafety and the
Cartagena Protocol, but at the time the Development of National Biosafety Frameworks
Project was conceived, many countries had yet to even ratify the protocol. In this context,
the envisioned level of activity under the GEF Strategy and NBF development project
was ambitious to a fault. Yet the potential for regional collaboration exists at the stage
when countries begin moving into implementation; to limit this aspect in the NBF
implementation phase projects was possibly a missed opportunity.
The NBF development project's work on developing coordination at a global level
among bilateral and multilateral organizations embodies only an initial foray, in
coordination with other international initiatives for such coordination. While further work
is clearly necessary, initial efforts have been notable.
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GEF support for biosafety capacity building, including the regional workshops and other
activities dealing with regional aspects of biosafety, have had positive outcomes.
However, the limited budget for these activities has also limited the potential benefits. In
the future, it will be important to promote the sustainability of the benefits gained thus
far, including addressing the problem of capacity retention.
Donor coordination at a global level has been quite weak. Some reasons for this are
differences in policies, special country interests, and variations in focus among various
donor agencies. Other reasons are engagement of institutions in the donor and recipient
countries that are not closely involved in the GEF-supported projects. The Secretariat of
the CBD and the GEF Secretariat are the two bodies that could play a larger role in this
context.
At the country level donor coordination has also been limited in some cases. In some
countries, the evaluation noted a lack of concerted cooperation or collaboration with
other similar projects. In others, there are examples of coordination among some projects,
although certainly not all. In Asia, the NBF project has worked closely with the FAO
regional project for capacity building for biotechnology and biosafety.
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Chapter 6.
Awareness Raising and Stakeholder Participation
6.1 Awareness
Raising
Article 23 of the CPB states that parties
shall promote and facilitate public awareness, education and participation concerning the
safe transfer, handling and use of living modified organisms in relation to the
conservation and sustainable use of biological diversity, taking also into account risks to
human health. In doing so, the Parties shall cooperate, as appropriate, with other states
and international bodies; (and) endeavor to ensure that public awareness and education
encompass access to information on living modified organisms identified in accordance
with this Protocol that may be imported (CBD 2000b).
The article also expects the parties to "consult the public in the decision-making process,
make the results of such decisions available to the public." In addition, parties are called
upon to inform the public about the means of public access to the BCH.
The NBF development project seeks to achieve two primary objectives--NBF
development and the promotion of regional cooperation through, among others, "[r]aising
public awareness...on the issues involved in the release of living modified organisms to
promote informed debate and to ensure that where any use of modern biotechnology is
permitted, it is done in an open and transparent way" (GEF 2000). Specifically, the
subproject activities were to encompass "(in cooperation with the relevant international
industry organizations, NGOs and consumer associations), neutral and objective
information material for the public, [including]... provi[sion of] information on media
coverage to the project management" (CBD 2000b). A newsletter and other publications
(including video and electronic materials) were also suggested. Several other project
activities described in this report (including public workshops, the BCH, and a website)
are also undertaken partly for public awareness purposes.
The estimated budget allocated to each country to support public participation included
$15,000 for tools to raise public awareness and information on media coverage and
$20,000 for developing methods to involve the public and private sectors at all stages of
the project. The actual allocations decided in consultation with each country were
slightly higher.
A factor reported in virtually all countries visited (and in most of the draft NBF reports
reviewed), including those that had completed all public awareness-raising activities
under their national subprojects or implementation projects, was the ongoing need to
raise public awareness regarding biosafety issues. In many cases, the lack of awareness
also extended to parliamentarians, relevant government officials, and even academics.
There were a variety of perspectives on the nature of awareness needed. Many NPCs and
NCC members indicated simply a need for heightened political awareness and public
consciousness of LMO issues so that they could engage in the political process on either
side of the issue. Some have suggested a need to build acceptance among consumers,
building a clearer knowledge of the market for LMO food products, for example. In some
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cases, the need was stated in terms of awareness of the advocacy perspectives of various
interest groups--whether a desire to heighten perceptions of potential dangers of LMOs
to various sectors or to better understand their benefits. For these purposes, biosafety is
not simply a scientific concern, but involves significant cultural, social, and political
components.
As the subprojects progressed, an additional awareness objective often arose: to ensure
that the public is sufficiently informed about biotechnology policies and practices and the
biosafety measures being proposed for public comment.
In furtherance of this mandate, virtually all projects presented workshops, which often
consumed a large number of person-days of training and awareness raising, considering
the very limited resources available. In most cases the public awareness workshops were
open to government officials, special interest groups, and the general public. In a majority
of national subprojects, the workshops were arranged in the capital; several countries also
made efforts to reach out at least to the main provincial centers. Beyond these primary
tools, many projects prepared video and audio materials, training packets, and other
awareness-raising measures.
The limited funding available within the subproject budgets has meant that these
activities typically amounted to only a small contribution in a larger body of awareness-
oriented work within each country. Often, these efforts could not compare in number or
impact to efforts by other groups. For this reason, a few projects took a longer term
view--directing their energies to the creation of a plan for awareness raising, rather than
simply presenting workshops and creating materials with a shorter useful life.
Based on interviews and country visits, the evaluation results suggest that awareness
raising was a complex challenge, and the project results were self-evaluated by
subproject staff in virtually every country to be insufficient to achieve the ambitious
goals. The public awareness component of the national subproject documents has often
been the basis for a project's primary interaction with the social sciences, and with
experts and activists working in these issues. Despite anticipated difficulties in this area,
the NBF development project design appears to focus on the scientific, technical, and
institutional aspects of biosafety, with less direct connection to issues of greatest interest
to the public.
6.2
Stakeholder Participation in Projects
The interest in public participation as a mandatory component of international
agreements arises out of a combination of international emphasis on democratic
governance, along with the continuing evolution and growth of national legislative and
administrative practice. As the distance increases between primary parliamentary
(democratically controlled) bodies and the administrative bodies they are charged with
overseeing, public involvement takes on increasing importance. Effective public
involvement consists of three components:
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· Access to information: Public involvement in governance can only be meaningful
when the public is able to be fully informed. This may require more than just
availability of documents. To enable true access to information, governments may
need to provide other kinds of assistance (for example, independently created
summaries of key documents, and ombudsman programs).5
· Transparency: Decision making must happen through open, noticed, and reported
meetings and decision processes to ensure that government functions by rule of
law rather than at one official's or agency's discretion.
· Public participation: Direct public input (public hearing or comment processes,
representative commissions, or working groups) are often necessary to ensure that
those most affected have a right to be heard in decision making. National
legislation sets standards and procedures for ensuring appropriate participation,
and for government response to such input. Where affected groups are rural,
indigenous, remote, or disadvantaged, special action may be needed to actively
promote and enable the participation of these persons.
Paragraph 23.2 of the Cartagena Protocol requires public involvement in LMO-related
decision making, stating that "The Parties shall, in accordance with their respective laws
and regulations, consult the public in the decision-making process regarding living
modified organisms and shall make the results of such decisions available to the public,
while respecting confidential information." Other provisions clarify that parties must
provide access to information and transparency as a component of this responsibility.6
The GEF Strategy and project documents include an intrinsic and primary mandate to
ensure the development and application of appropriate measures for ensuring public
participation in the regulatory and decision-making processes relating to LMOs and
biotechnology, including participation in the primarily governmental process of NBF
development through the national subprojects.
Participation is distinguished from the majority of the protocol's numerous specific
requirements, however, by the fact that it is also a separately mentioned objective of the
NBF development project. The GEF Strategy underscores this requirement, noting the
expectation that the projects will "improve public participation on the issues involved in
the release of living modified organisms to promote informed debate and to ensure that
5 In commercial legislation, access to information is part of a triple balance: Applicants often must retain a
right to keep some information confidential; governments need to review all relevant information; and the
public needs access and the ability to ensure that government lives up to its mandates.
6 Recognizing that access to information and transparency are essential components that make public
participation meaningful, other provisions of article 23 require the parties to "promote and
facilitate...participation concerning the safe transfer, handling and use of living modified organisms in
relation to the conservation and sustainable use of biological diversity, taking also into account risks to
human health"; "endeavor to ensure that public awareness and education encompass access to information
on living modified organisms identified in accordance with this Protocol that may be imported"; and
"endeavor to inform its public about the means of public access to the Biosafety Clearing-House."
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where any use of modern biotechnology is permitted, it is done in an open and
transparent way" (GEF 2000, para. 17(v)). The national subproject documents similarly
single out these requirements, calling on the countries to create "mechanisms for public
participation and information" (GEF 2000, para 3.1.2). The UNEP Toolkit also identifies
participation mechanisms as a separate requirement of the completion of a satisfactory
NBF, in addition to the legislative framework (UNEP 2004b).
6.3
Public Involvement and Participation
The NBF development projects incorporated concepts of public involvement and
participation in two primary ways--participation in the work of the national subprojects
themselves, and the provisions and procedures implementing the public involvement
requirement of the Cartagena Protocol.
The evaluation team addressed both aspects of participation during the country
interviews. In general, these data indicate that public participation objectives were only
partially achieved through the project (see Table 6.1).
Table 6.1: Level of Public Involvement
Level of public involvement
Participation
High
Medium
Low
Development projects (7)
2
5
5
Implementation projects (4)
1
3
2
While an overwhelming majority of countries complied with project requirements
(creating an NCC, holding substantive workshops, seeking comments on relevant
documents), the actual "participation impact" of these structural components was less
than the project designers may have expected. Participation challenges arose both from
lack of appropriate stakeholder representation on the NCC (or implementation project
steering committee) and from systematic practices limiting stakeholder participation in
certain activities.
Given that biotechnology and biosafety are both controversial and relatively new in many
countries, public involvement offers an important element--promoting both buy-in and
awareness. Practices that limited stakeholder participation, or failed to take legitimately
provided stakeholder comments into account (for example, printing a document in final
book form before providing it to stakeholders for comment), can negate some of these
potential benefits of the national projects.
At the same time, however, in some countries it was felt that the national projects created
an unnecessarily high profile for predrafting legislation--an activity that is usually
undertaken in a less participatory manner--particularly where the resulting document
will be submitted to parliament, and there face democratic scrutiny. Some of the involved
persons who commented during the course of the in-country and telephone reviews stated
that the project may have actually stirred up controversy where it had not previously
existed.
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6.4
Stakeholder Participation in the NCCs
As discussed in section 4.1 above, the national subproject documents (which are
essentially contracts between the countries and UNEP) committed the NEAs to
establishing an oversight committee (NCCs) consisting of a mix of government officials
and "likely...representations from the private and civil society sectors" (UNEP 2003d).
The UNEP Toolkit provides a much stronger mandate for inclusion of representatives of
all relevant government agencies as well as representatives from civil society and the
private sector (UNEP 2001). This kind of formulation obviously seems intended to
enable the NCC to liaise with all government departments with interests in and
information about biotechnology and with stakeholder groups (including farmer
organizations and NGOs, as well as scientists). An important role of the NCC could be to
ensure that each subproject was driven from an inter-ministerial (cross-sectoral) and
national perspective rather than from the perspective of a single ministry or organization.
In response to this requirement, Box 6.1: Tajikistan: A Dynamic Participation Process
nearly all NBF development Tajikistan's NCC was a dynamic body involving a full range of
projects reviewed in this stakeholders. The NCC met once a week for six months, with a
evaluation set up an NCC. different member giving an expert presentation on a topic of
relevance each week. The individuals involved found the process
Within NBF implementation to be very useful and beneficial, not only for the country, but
projects, there is a greater also for their own professional development and capacity.
variety in organization, given
that some of these projects are The current level of LMO and biotechnology activity in
implemented by UNDP and the Tajikistan is very low, with no varieties approved for field trials
or commercial release. Because of the low level of domestic
World Bank. Regardless of activity, the country's primary concern regarding LMOs is the
which Implementing Agency labeling of imported LMOs or products that contain LM
was involved, all
components. It is expected that biotech activity in the country
implementation projects
will expand in the future, but there is also a significant concern
included some kind of that the country's unique biodiversity resources be safeguarded
from the influence of LMOs.
nationally created project
steering committee. In projects implemented by the World Bank and UNDP, however,
the civil society stakeholders involved have not included the full range of organizations
concerned with biosafety issues.
One of the main tasks of the NCC is to represent key government and nongovernmental
stakeholder groups and ensure that NBF reports and other documents, including laws,
reflect contributions from all government sectors as well as nongovernmental
stakeholders.
The UNEP Toolkit recommended representation of the key ministries, academic
institutions, the private sector, producer and consumer interests and/or other NGOs
aiming for a total membership of 10-15 individuals. The evaluation focused primarily on
adequate representation of each of the most active governmental sectors (environment,
agriculture, health, and economy/trade). In most cases, representation was found to be
well balanced, but there were variations in NCC representation from just a few ministries
(Belarus, Estonia) to 11 ministerial-level bodies (Mexico). In a few cases, such as in
Tajikistan (see Box 6.1), dynamic processes of stakeholder participation evolved through
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the NCC. Where fewer ministries were included, this might have been because of lack of
appropriate capacity in the country. However the apparent absence, in some cases, of
representation from the ministries of health (Niger, Senegal), agriculture (Lao PDR,
Uganda) and trade (Latvia, Slovak Republic, Lithuania) is curious. An appropriate
balance among the various ministries would be an indicator that a diversity of viewpoints
was taken into account.
The evaluation examined NCC composition, giving a general rating that assessed
compliance with elements of NCC membership--with particular attention to the
inclusion of relevant government departments and nongovernmental stakeholder groups.
Table 6.2 below summarizes the data. Most of the ratings are either high or low, with few
at the medium level.
Table 6.2: Inclusiveness of Country NCCs
Inclusiveness of NCC
NCC representation
High
Medium
Low
In-country reviews:
Development projects (7)
3
0
4
Implementation projects (2)
1
0
1
Non-field reviews
Development projects (5)
2
3
0
Implementation projects (2)
0
0
2
Good
Poor
Document reviews (development projects only)
13
13
Note: These results include only UNEP-implemented projects reviewed by this evaluation.
In the case of the implementation projects managed by the World Bank and UNDP, there
were wide differences in representation. In India (a World Bank project), a project
steering committee was formed but it had only met only once by July 2005 and is not a
cohesive body as yet. The Colombia project (also World Bank) is managed by an inter-
ministerial coordination committee containing representatives of many government and
intergovernmental institutions, but with an imbalance among ministries in that most
representatives are from agencies and boards under the agriculture ministry, and there is
little representation of civil society. There was sufficient inter-ministerial contention in
that case that long negotiations were needed to even establish voting rules. Mexico (a
UNDP-managed project) has only a small and relatively inactive managing committee.
This level of oversight was all that was needed in view of the strength of the country's
NEA--the Inter-ministerial Commission on Biosecurity and Genetically Modified
Organisms (CIBIOGEM).7 This body, which is also Mexico's national biosafety focal
point, brings together 11 ministerial-level bodies for the purpose of national biosafety
oversight. To some extent, CIBIOGEM has been cited as a role model for intra-
governmental collaboration, particularly in countries with significant existing LMO
activities, experts, and regulatory bodies.
7 CIBIOGEM was formed by presidential decree in 1999 and was recently formally codified in Mexican
law as part of the country's new Biosafety Act, which was adopted in March 2005.
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Only one of the countries reviewed in depth (Colombia) addressed ministry
representation questions procedurally--that is, developed formal voting procedures that
were written in a way that ensured that ministries with a low level of representation could
not be outvoted by a more numerous ministry group. None of the other countries visited
or interviewed had, or indicated a need for, a formal voting system.
In some countries, it may be idealistic to expect all relevant stakeholder ministries to
collaborate in a collegial manner. In many cases, ministries are competing for resources,
and cooperation is not necessarily high on their respective agendas. Involving civil
society can also raise potential challenges to consensus--for example, in countries where
NGOs are so strongly against the objectives of the project that they effectively prevent
significant progress from being made. In some cases, NGOs known to hold strong
positions were excluded from the process.
6.5
Legislative Provisions for Participation in Biosafety Decision Making
The evaluation considered the actual project outputs with regard to participation in formal
governance for biosafety. Specifically, in its review of all completed NBF reports, it
noted that about three-quarters (28 of the 38 completed NBFs examined) included
complete public participation requirements for the country; several others included
specific measures addressing part of the participation issue.
Actual performance may be higher than suggested by this survey, however, since most
countries already recognize participation as a primary tool of democratic governance.
Some countries have already passed general legislation legitimizing public participation
in all administrative decision-making processes within the country. Many European
countries are also parties to the Aarhus Convention, for example, and noted that the
national implementation of that convention is directly applicable to their biosafety
frameworks. Other countries (for example, Cuba) include public involvement rights,
responsibilities, and procedures in laws of general applicability and higher priority than
their biosafety law, so new legislative instruments cannot supersede or contradict these
primary responsibilities.
The prominence of participation in the GEF Strategy and project documents may well
have been intended to focus special attention on participation and indicate the GEF's
desire to strongly promote compliance with this critical component of modern
governance. As a consequence, omissions relating to the development of participation
mechanisms in project documents should probably have triggered special attention.
Public participation was less prominent in implementation project activities. In three of
eight implementation projects examined by this evaluation, neither the legislative aspect
of participation nor provisions for representation in steering committees were included in
project design.
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6.6 Conclusions
Project performance with regard to public awareness raising and participation mandates
has been mixed, with few countries achieving a high rating on this factor--both in regard
to project operations and in the development of participation mechanisms for the
implementation of biosafety legislation.
Given the low level of funding available for public awareness activities, performance of
this element was likely to be limited. With regard to public awareness and participation,
development projects could have been more closely tailored to country needs.
In several countries, NGOs and the private sector provided feedback that their views were
not adequately considered in project outputs and activities. This is not surprising, given
the highly polarizing and scientifically uncertain nature of the issues surrounding
biosafety.
Multi-stakeholder processes on a topic as controversial as biotechnology are inherently
difficult, leading some country project managers to exclude controversial views from the
NCC altogether; however, the national workshops did seem to involve a wider range of
views. Inclusion of holders of opposing viewpoints, although often increasing the
difficulty in the short term, can also increase buy-in and support over the longer term of
post-project activities.
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Chapter 7.
Capacity Development
Capacity building is one of the prime elements expected to facilitate effective and
efficient implementation of the Cartagena Protocol in developing countries and countries
with economies in transition.8 As discussed earlier in section 5.5, an international
framework for capacity building has been agreed upon and adopted under the CPB that
will guide the implementation of the GEF Strategy (ICCP 2000, para. 2). On a complex
issue such as biosafety, the human element of capacity building involves the transfer of
know-how, and the provision of training, in sciences related to safety in biotechnology
and in the use of risk assessment and risk management techniques. In addition, physical
capacity in biosafety implementation will often require the development of appropriate
facilities (UNEP 1995). Elements of capacity building, which may contribute to
effectiveness, include systematic assessment of needs and identification of options,
development and strengthening of relevant institutions, development of skills and
expertise in human resources, and establishment of necessary scientific and information
management facilities, including transfer of technology.
Various capacity-building tasks are addressed differently under the NBF development
and implementation projects:
· NBF development projects were intended to identify existing capacity gaps with
regard to drafting of legal documents, administrative systems, risk assessment
procedures, and systems for public participation. All the NBF development
countries visited by the team gave a medium to low rating of the GEF support to
capacity assessment; they gave a higher rating to support in actual capacity
building.
· NBF implementation projects were assumed to have some prior basic capacity
and were more selective in strengthening specific areas of human capacity, as
well as establishing needed infrastructure in terms of laboratories and databases
for participation in the BCH.
7.1
Capacity Development in Risk Assessment
The need to ensure biosafety through national systems of risk assessment and risk
management was recognized as an international priority within the 1992 Convention on
Biological Diversity, signed in Rio de Janeiro at the UN Conference on Environment and
Development. It was also explicitly addressed in Chapter 16 of Agenda 21 (UNCED
1992). Article 15 of the Cartagena Protocol requires that scientifically sound risk
assessment be performed for every decision taken under the protocol, and that the
purpose of such assessments shall be "to identify and evaluate the possible adverse
effects of living modified organisms on the conservation and sustainable use of biological
8 Ministerial Round Table on "Capacity-Building in Developing Countries to Facilitate the Implementation
of the Protocol" held in Nairobi 23 May, 2000, during the 5th Conference of the Parties to the CBD; the
GEF Workshop on the UNEP/GEF Pilot Biosafety Enabling Activity, held 24 May, 2000 in the margins of
the CBD COP5.
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diversity, taking also into account risks to human health." Although intentionally not
imposing rigid international standards for risk analysis, the protocol stresses that
"recognized risk assessment techniques" shall be taken into account, including guidelines
developed by relevant international organizations. For small countries, which may have
limited institutional capacity, the ability to access external expertise and information
and/or make use of regional or subregional mechanisms for risk assessment and risk
management may be crucial for implementing the protocol.
Annex III of the Cartagena Protocol provides guidance and basic principles and
objectives for a scientifically sound risk assessment. While a country's risk analysis
procedures need not follow or adopt the contents of the annex, they must be "consistent"
with it. The GEF support was intended to help the participating countries achieve the
required consistency through the development and implementation of their own risk
assessment capacity, guidelines, and modalities for creation of expert committee(s) that
would be responsible for this aspect.
The NBF development projects are somewhat different from the implementation projects
with respect to their role and activities to promote functioning systems for risk
assessment and risk management.
NBF Development Projects
Within the NBF development project document, the objectives and activities related to
risk assessment and risk management include the following, in addition to the regional
and subregional workshops and efforts to develop regional collaboration as discussed
above:
· the identification of national and/or subregional expertise for risk assessment and
developing appropriate roster(s) of experts;
· the establishment of systems needed for risk assessment and the audit of risk
assessments and risk management to ensure the safe use of modern
biotechnology, taking into account national and subregional needs.
At the NBF development stage, the national subprojects were not expected to focus on
providing detailed technical training in risk assessment and management, as this would
be a priority during the subsequent implementation phase. Similarly, many development
phase projects were not yet ready to develop and adopt specific risk assessment
guidelines and procedures, since they first needed tocomplete their primary biosafety
legislation. A few countries, such as Ethiopia, did undertake such development, and all
appeared to discuss it. Based on feedback from project personnel in countries visited or
interviewed by telephone, it appears that the project was not very helpful in providing
examples of risk assessment and management, although this had been expected by some
countries. (Ten countries rated UNEP support as medium in this respect; seven rated it as
low.) As evaluated in section 10.1, Toolkit Module 3 outlines the risk assessment criteria
(UNEP 2004c).
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Based on telephone and in-country interviews with NPCs, members of the NCC, and
other stakeholders, and desk reviews of various NBF documents, it is apparent that most
countries have given consideration to establishing a national committee for risk
assessment. In nearly all countries, the mechanism for risk assessment takes the form of
an expert committee, such as a multi-stakeholder national biosafety committee,
sometimes with more technically oriented subcommittees for conducting product-specific
reviews. For many countries, staffing of this committee alone will be a challenge, and, at
project completion, the risk assessment and risk management structures are often just a
plan on paper or are in the formative stages. For example, Burkina Faso has created a
new national biosecurity agency with a legal mandate for coordination and monitoring of
all activities pertaining to the implementation of biosafety, but budgetary and technical
capacity constraints currently limit its effectiveness.
The creation of national biosafety committees in countries with low baselines is expected
to be very difficult, both in terms of staffing and financing. Alternatives to this approach
do not appear to have been considered in the NBF development projects. The GEF
support in the development project was not intended to build the capacity to undertake
subsequent implementation of risk assessment systems. As surveyed in the evaluation
visits to development project countries, five out of seven countries (71 percent) received
a low rating on the survey evaluation of support for risk assessment capacity
strengthening.
As implemented through the NBFs to date, nearly all national implementation of systems
for risk assessment and management require the creation or restructuring of expert
committees. Analysis of national stocktaking regarding the level and location of capacity
in risk assessment (which varied greatly from country to country) should logically have
been a primary input into the development of this element of the NBF.
The project also called for networking; this required, among other things, creation of a
roster of experts. This task was undertaken by 17 (50 percent) of the 34 projects with
completed NBFs, although analysis of these rosters indicates that they were not always
developed systematically or subjected to evaluative criteria or peer review.
The second series of subregional workshops (discussed in section 5.2) introduced the
topics of risk assessment and risk management. Given their focus on the creation of NBF
risk assessment components (a regulatory drafting task), they were not structured to give
participants hands-on experience of risk assessment--which, in any case, could not likely
have been meaningfully addressed in the short time frame of the workshops. In addition,
workshop discussions did not distinguish the risk assessment and management systems
necessary for handling general broad-scale releases of LMOs from those required to deal
with much more limited confined field tests. These two are very different, both in content
and in the degree to which they are needed, especially in low baseline countries.
NBF Implementation Projects
The countries participating in the NBF implementation projects were generally further
advanced, with most having established systems for risk assessment and risk
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management. Some of these countries had significant experience in dealing with
biosafety prior to the start of the implementation projects.
India, Mexico, Cuba, and China have substantial technical capacity in both biotechnology
and biosafety, and have experience with introductions of LMOs both in experimental
field trials and in more general agricultural contexts. Colombia, Bulgaria, Poland, and
Kenya also have some experience in dealing with experimental field trial introductions of
LMOs; while Uganda, Cameroon, and Namibia have not yet had this experience. For
countries with limited experience, risk assessment and management systems created by
the project have yet to be put into practice and tested with real applications.
The GEF contribution to capacity building in risk assessment and the development of
guidelines or manuals varied considerably from country to country. For example,
Mexico's project document indicates a budget of $575,000 for capacity building in risk
assessment, compared with a budget of $180,000 for all aspects of training (including
risk assessment) in Kenya. Some countries (for example, Cuba, Bulgaria, Mexico, China,
and India) included the publication of risk assessment manuals in their project
documents, while this aspect did not feature in the project documents from Uganda,
Kenya, or Namibia.
The GEF support to capacity building in risk assessment and management has been
primarily implemented through the usual approach of short-term (three- to five-day)
workshops, although some countries (for example, Mexico) held longer (two-week
seminars) sometimes working directly in laboratories. The utility of shorter workshops,
while positive in the context of raising awareness, is minimal as a tool for establishing
sustainable institutional capability and the confidence for sound regulatory decision
making.
Many countries with implementation projects are also recipients of other bilateral or
multilateral biosafety projects with the same or similar objectives; these initiatives often
work with the same in-country partner institutions as the GEF-supported project (see
section 5.5).
7.2
Capacity Building in Risk Management
Risk management includes not only the application of relevant national laws and
regulatory standards, but also the imposition of appropriate risk mitigation measures (for
example, crop-specific isolation distances to minimize pollen-mediated gene flow in the
case of experimental field trials, or requirements for post-commercial monitoring or the
imposition of insect-resistance management plans) and requirements for inspection and
controls at ports of entry. These activities are normally embodied in an administrative
system that includes one or more competent authorities with specified jurisdiction (for
example, import, export, domestic use, commercialization, field trials, contained use),
mechanism(s) for processing requests or applications, mechanism(s) for risk assessment
(for example, via national expert committees or by risk evaluators within the competent
authorities), and mechanism(s) for enforcement of LMO-related laws and decisions.
Well-functioning administrative systems have a number of qualities, including clarity,
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transparency, consistency, practicality, authority, participation, predictability,
enforceability, and adaptability (UNEP 2004c).
One important question raised in several aspects of the evaluation was the integration of
biosafety-related risk management with other risk management measures related to
introduced crops and other plant varieties and the introduction of animal species. Long
before the LMO issue was prominent, the commercial introductions of conventionally
created species (hybrids, cross-bred species) and natural species from other locations,
placed commercial agriculture and food security issues within the realm of potential risks
to environmental health, species conservation, and human health. International
instruments addressing these issues (including the International Plant Protection
Convention, the FAO Codex Alimentarius, the WHO's International Health Regulations,
the standards set by the Office International des Epizooties, and the CBD's Guiding
Principles for the Prevention, Introduction and Mitigation of Impacts of Invasive Alien
Species) have generally not been addressed or referred to under this project.
Here also, there were significant differences between the development and
implementation projects.
NBF Development Projects
The GEF Strategy specifically proposes to help countries strengthen capacity for risk
management, monitoring, and inspection services. Within the NBF development project
document, the objectives related to risk management and administrative systems were
tightly linked to risk assessment, and, in addition to the activities described in the
previous section, would be achieved by:
· strengthening national capacity in order to implement biosafety procedures and
take competent decisions through establishing systems needed for risk
assessment, audit of risk assessment, and risk management, to ensure the safe use
of modern biotechnology taking into account national and subregional/regional
needs;
· applying biosafety procedures to enhance environmental management.
Issues related to the establishment of risk management and administrative systems for
implementing an NBF were addressed during the third series of subregional workshops,
discussed in section 5.2.
The workshops intentionally did not address, or only partially addressed, several other
points, including:
· how to develop specific risk assessment guidelines;
· mechanisms for risk management;
· post-release monitoring of LMOs;
· how best to make use of data generated in other countries;
· coordination among different national institutions;
· systems for handling LMOs in transit;
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· national capacities for implementation, including strengthening of customs,
quarantine, and environmental assessment systems.
Although many NBF development countries have identified how administrative and
decision-making systems would work in the NBF, at this stage of development low
baseline countries have not put theory into practice. Higher baseline countries, of course,
have experience in dealing with environmental introductions of LMOs under existing
systems.
The final selection of responsible agency remains a matter of political discussion in many
countries. As indicated during the third Latin America subregional workshop, "the main
conflict identified at the moment of implementing NBF is the coordination of the
administrative tasks and competencies of the institutions involved in them" (UNEP
2003c, para. 118). This was also stressed in the Asia subregional workshop, wherein it
was "noted that much of the administrative system seemed to be in place in many
countries, and that coordination was the major challenge where different agencies were
working separately" (UNEP 2003b, para. 62). For the majority of countries, internal
issues regarding the designation of regulatory authority and coordination among
competent authorities once designated remains a significant issue yet to be addressed; this
was cited as a concern.
While many countries have identified that existing regulatory institutions (for example,
customs officials, phytosanitary or seed certification bodies) would be utilized for
biosafety inspection, enforcement, and monitoring, few have undertaken a systematic
training needs assessment for these organizations. Five of the countries whose NBFs
were reviewed above indicated that they had undertaken some systematic training needs
assessment; a few have identified front-line regulatory inspectors or customs officials for
training.
NBF Implementation Projects
Among implementation projects, there is a wide range of differing experience and
capacity. Project objectives with respect to the establishment and strengthening of
administrative and risk management systems differ across countries.
For example, in India, which has long-established systems for risk assessment and
decision making, the support for inspection and monitoring has, to date, been limited to
building laboratory infrastructure (that is, the purchase of new equipment) for detection
and traceability. India is currently undertaking a comprehensive training needs
assessment, which is scheduled for completion during fall 2005. Mexico has used its
project both to increase coordination mechanisms for risk assessment and to provide
training for officials implementing risk management requirements (specifically, training
field officials and assisting in the development of the national database that is used in
these processes). Cuba focused on training of inspection officials, as well as drafting of
regulatory standards to which such inspections will apply.
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In Uganda, project staff are currently working on mechanisms for handling requests.
With respect to inspection, monitoring, and enforcement, the needs are still emerging,
and existing mechanisms will be used. The project is focusing on developing standard
operating procedures, guidelines, and manuals for this purpose. In Namibia, the project
trained the relevant inspectorates and provided them with model standard operating
procedures for biosafety inspection and monitoring, although the system has yet to be put
into practice because of a lack of applications.
7.3 Conclusions
The final selection of responsible national agencies is still a matter of political discussion
in many countries. The main conflict identified at the moment of implementing an NBF
is the coordination of the administrative tasks and competencies of the institutions
involved. Most NBF development countries have only arranged general introductory
courses in risk assessment and management. Most of the NBF implementation projects
had only provided a week of intensive training in risk assessment, at best. Few efforts
seem to have been directed to building a corresponding administrative, inspection,
enforcement, or monitoring capacity. Some country scientists have undergone longer
term in-depth practical training in risk assessment and decision making; this may be
helpful in building sustainable capacity within regulatory agencies and expert
committees. Many countries need more time to make decisions about risk assessment
guidelines and conduct more in-depth training for the staff that will carry out these tasks.
Although synergistic national implementation of international agreements is generally
seen as an increasingly important objective, the practice has proven difficult for many
countries, particularly where specific international agreements have trade impacts or are
not accepted by all of the enacting country's trade partners. In the context of biosafety,
however, the significant investments needed in developing expertise, physical capacity,
and institutions suggests that it will be important to consider potential options relating to
integration with basically identical control mechanisms.
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Chapter 8.
Biosafety Policy and Regulatory Development
8.1
The Legal Context
The Cartagena Protocol is generally neutral on the topic of LMO introduction--that is, it
neither encourages introductions nor opposes them. Rather, it is designed to increase
public confidence in the safety of proposed introductions and marketed products, while
providing the public and private sectors that are involved in the LMO industry or
markets, as well as the farmers that use LMOs, with a commercially valuable legal
right--a legally valid permit to import, introduce, transport, or develop LMOs. In
choosing a permit mechanism as the primary method of creating and mandating
biosafety, the protocol negotiators expected to provide a strong commercial law basis for
addressing biosafety. This basis can be created, however, only where the resulting permit
system provides "legal certainty."
For purposes of this evaluation, legal certainty might be described as "commercially
reasonable expectations" and explained as follows: Where a legal system is clear and
based on standards rather than unlimited discretion, a company is able to make
commercially rational decisions regarding matters governed by that legal system. In a
system that provides LMO-related legal certainty, for example, a company that
demonstrably complies with its permit and relevant law will be legally protected or
subject to limited liability (or be free from all liability), in the event of an accident or
oversight arising from the introduction of LMOs. On the other hand, a company that
introduces LMOs without first obtaining or complying with its permit can be subject to
penalties, forfeitures, and potentially limitless liability, even if there has been no accident.
To this end, the protocol requires parties to adopt a number of legislative provisions that
are more specific (both in content and operation) than normally found in international
instruments. In particular, these provisions impose very specific requirements on national
decision-making processes, setting time limits on the process, specifying the nature and
limits on national rights to alter permissions after they are obtained, and generally
attempting to create a level of commercial predictability in the process. These specific
provisions (CBD 2004a), requiring national implementation, envision a broad complex of
integrated legal instruments and institutions in countries that engage in significant LMO-
related activities. In countries with less LMO activity and lower expectation of such
involvement in the near term (referred to here as low baseline countries), only a limited
number of these legislative tasks are urgently needed to be accomplished within the next
few years. The protocol text provides special assistance for these countries as an
alternative to immediate development of fuller legislation:
· As an alternative to immediate development of a law addressing the "introduction
of LMOs,"9 parties may decide to directly use article 10 of the protocol, adopting
it by reference as an interim measure for implementing the protocol.10
9 The protocol of course limits its provisions to the first international introduction, but there is no legal
reason why these provisions cannot be applied to later introductions or to introductions by domestic
entities. See articles 2.12.4.
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· As an alternative, to develop a streamlined decision-making process to address
LMOs used as food, feed, or for processing (LMO-FFPs),11 parties may decide to
directly utilize the provisions of article 11.6 of the protocol in the same way.
While attempting to sort out their concerns regarding biosafety legislation in a
comprehensive manner, parties may adopt a narrower range of interim measures to solve
their immediate needs. Other step-by-step approaches could be used to issue legally
certain permits, slowly building up to a full national decision-making system.
The CPB provides further tools and options to help developing countries. Of these, the
BCH is most notable. By requiring official (government-authorized only) posting of
LMO introduction decisions, the protocol enables countries with limited scientific
capacity to apply scientific analysis developed and governmentally tested elsewhere in
their risk analysis and as inputs into other aspects of decisions.12
The Evaluation studied 40 draft country NBF reports prepared as part of the NBF
development project. All of these produced at least some draft legislation.13 The analysis
in this evaluation focused on two factors: the quality/acceptability of the legislation
developed and the readiness of the countries to engage in a legislative process addressing
these issues. This report considers and describes the results of the evaluation by
considering several indicators of the effectiveness and quality of that process and its
outputs.
8.2
Lessons from the Pilot Phase
The pilot phase used a team of internationally known experts in biosafety law to review
every law created under the pilot project. The resulting laws were consequently
competently drafted. It is not clear whether any stocktaking information was provided to
the reviewers; thus, it may not have been possible as a general matter for the external
review process to determine whether the laws were particularly appropriate and/or
implementable. These issues were left for legislative backstopping by legal experts
staffing the pilot project at the global level and national experts, where available. This
multi-expert and multi-stage peer review process was found to have yielded generally
positive results.
10 The assumption underlying this provision is that the CBD Secretariat or some other body will adopt
interim risk analysis and decision-making standards to assist countries using this authority. See article 9.
11 The same assumption noted above underlies this provision.
12 In this way, Country A, when considering the utilization of Country B's decisions or decision-inputs in
Country A's decisions on the same LMO, may determine whether and how Country B's standards and
policies accord with its own and utilize the information accordingly.
13 The evaluation team concluded that all projects reviewed adopted some form of legislative instruments,
whether new law, regulations, subregulations, appendices, or amendments to existing instruments. Not all
legislation appears to have been submitted in full text version to the UNEP NBF project team. Many final
NBF reports provide brief summaries of general objectives of legislation; some only note that it exists and
was created as part of the NBF development project.
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This report does not attempt to evaluate the pilot phase, but has compiled information
from several sources on the operational work and some outputs of those projects. Several
of the implementation countries reviewed in this evaluation had been supported in the
pilot phase. Their NBF implementation projects appear to have drafted legislation, but in
most cases (for example, Cuba and Bulgaria), this legislation was focused and designed
to promote and/or enable biosafety implementation. This result was not universal,
however, as at least one NBF implementation project wrote an entire framework law,
despite having a very complete existing framework. In this evaluation's review of that
country's implementation project, it was noted that there is little expectation that this law
will ever be adopted. In another case of legislative drafting during the pilot phase, a law
was produced that reportedly did not address local needs and institutions, so the NBF
implementation project found it necessary to recommence the drafting process at a later
stage of the project.
8.3
National Preparation and Readiness
It was apparent throughout this evaluation--particularly in interviews and field visits--
that the national subprojects (and regional coordinators) generally believed that the
production of legislation was a mandatory requirement of completion of the national NBF
development project. These perceptions were not directly created by the global project
documents, but may have been derived from them. For example, the global project
specifically described its activities as the "drafting of legal instruments, including
regulatory frameworks and guidelines as appropriate" (GEF 2001, para. 29).
Toolkit 3i, for example, initially states that its goal is not to decide any elements of
national legislation in advance (UNEP 2004b). It notes specifically that "different
countries will use a diversity of approaches, legal instruments, and terminology that are
best suited to their own situation." On this basis, the Toolkit identifies many primary
tasks for the legislative drafters, and ultimately for decision makers. However, the
manner in which these tasks are stated suggests the need for legislative drafting, and in
fact, expresses all of its suggestions and recommendations in the context of the creation
of comprehensive national biosafety legislation. It notes, for example, that the countries'
primary task under the project is "to draft their NBF, and particularly the regulatory
regime, which forms the central pillar of the NBF" (UNEP 2004cb, para. 1.2.1). It goes
on to define "national biosafety framework"14 as "a combination of policy, legal,
administrative and technical instruments that are developed to ensure an adequate level of
protection" (UNEP 2004b, para. 1.3).
These documents and statements, and their implications for national subproject staff, may
have combined with the low level of technical support from the global project to create
an impression among NPCs and NEAs, as well as some regional coordinators. Low
baseline countries, in particular, appear to have adopted relatively comprehensive
framework laws. These are often similar in coverage and content--necessitating
14 The term "national biosafety framework" does not appear in the Cartagena Protocol and appears to have
been used as a generic term in its early appearance in the GEF Strategy. In the context of the NBF
development project, however, it is a defined term.
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relatively high levels of further administrative development (regulations operational
structures, and other legal needs) and detailed institutional and regulatory requirements
for risk assessment. In a sample of 17 NBF reports containing legislation, nine countries
self-reported that they have relatively low baselines in LMO issues.15 All nine created
comprehensive framework legislation calling for more than one committee, at least one
of which should be composed of LMO-specialized scientists, and should meet very
frequently (in many cases, monthly).
In the course of interviews and in-country reviews relating to 17 national subprojects,
there were indications that some countries may not yet have been ready for
comprehensive legislative development. A number of other reasons have been suggested
to explain the national desire to develop comprehensive legislation immediately,
including the possibility that some NEAs might have perceived the project as an
opportunity to increase their portfolio/mandate in the biosafety area. It remains probable
that a more "hands-on" approach could have enabled the presence of more constructive
options at an early point, increasing the project's effectiveness by ensuring that the work
done in each country was directed to actual needs and ability to implement.
Among high and medium baseline countries, there was more diversity of approach.
Although three of the eight such countries whose legislation was surveyed in this
evaluation developed comprehensive frameworks duplicating and/or overlapping with
existing national laws regulating biotechnology development and activities, the other five
engaged in more focused legislative development processes. They adjusted existing
systems to consider relevant issues, and to reconfigure or revise relevant documentation
so that it could more easily support and conform to CPB requirements; or they developed
specific mechanisms for integration or coordination among existing legal instruments,
mandates, processes, and agencies.
8.4
Contributions of Specialized Capacity and Expertise
The project's legislation work was intended to address many needs--research, legislative
drafting, and--especially--sustainably building awareness and capacity to address
biosafety issues beyond the 18 months of subproject operations. Capacity development in
biosafety policy and legislation proved to be an unexpectedly difficult task, for three
reasons:
· As commercial permit legislation, biosafety law is qualitatively different from
normal types of biodiversity-oriented legislation and policy, particularly in that its
primary objective is the creation of legal certainty--a task that requires very
complex legislative and legal expertise.
· Many countries were still in the throes of significant controversy relating to
biotechnology and biosafety issues during the term of their subproject. These
15 NBF reports selected for this part of the analysis were from Argentina, The Bahamas, Bulgaria,
Cambodia, China, Cuba, Georgia, Ghana, Guatemala, the Islamic Republic of Iran, Jordan, DPR Korea,
Madagascar, Mozambique, the Philippines, Samoa, and Slovenia.
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countries (as well as some where such controversy did not exist or where it had
been debated and generally resolved) were not ready to consider difficult issues,
options, and challenges regarding legal implementation.
· Most of the NPCs did not have significant experience with law and legislative
development issues and processes. Often, where legislative experts were
identified by the subprojects, those experts had no prior experience with biosafety
or, more generally, with the national implementation of technical international
objectives.
Accordingly, in many countries, the national subproject's most significant contributions
to national legislative development were as follows:
· initiation of relevant discussions on biosafety policies in key forums and among
key officials unfamiliar with biosafety policies and principles;
· highlighting the practical and legal issues of how national biosafety policies could
be implemented in an fair, legally defensible, and commercially justifiable way;
· in particular, developing an initial core (NPCs and NCCs) of biosafety
implementation expertise, and connecting that group to relevant decision makers,
technical experts, regional counterparts, and international sources of information
and assistance.
This last contribution was particularly important, given that, in most countries, neither
this core group nor the key individuals and agencies most active in the field had
considered legal or legislative issues or been sensitized to the needs of legislative
development.
The NBF development project's legislative efforts can be seen as beneficial, even where
the project's draft legislation and other specific legislative proposals prove unsuitable to
the primary needs of a biosafety framework (legal certainty). Quite apart from the
specific professional outputs of the project, its commencement of key capacity building,
discussion, and sensitization processes with regard to the various relevant legal issues
within a field formerly focused entirely on scientific concerns is recognized as a key
contribution. In this connection, it is noted that the legislative stocktaking process is a
critical and important element of national legislative development, particularly in
countries with ongoing technical and commercial regulatory activities relating to
biotechnology and/or biosafety. Where stocktaking processes and reviews were
participatory, or were used in detail in later work of the project, the resulting focus on
integration and cooperation among relevant agencies may lead to more productive work
in future--despite the fact that, during the project, stocktaking efforts were often not fully
utilized or professionally evaluated.
8.5
Policy and Regulatory Outputs
National legislative implementation in the area of biosafety must necessarily address
commercial objectives. As such, it must use particular types of legislative tools and
mechanisms that are not normally thought of as environmental law, and which are thus
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unfamiliar to many environmental law practitioners. The ability to convey legal certainty
arises primarily through the creation of legislative instruments that are of unquestionable
legal validity and that are put into practice in a consistent and legally defensible way.
To evaluate this process, it was necessary to define a set of indicators that could provide a
basis for analyzing whether particular subprojects' legislative outputs provide relevant,
nonbiased, and professionally adequate draft legislation implementing the CPB. Based on
the objectives of the GEF Strategy, the mandates of this evaluation, the sources available
(primarily document review, supplemented by in-country and telephone reviews), and the
specific objectives of the convention, the following four indicators were identified:
a. Draft legislative outputs are consistent with and would at least satisfy the
minimum requirements under the CPB.
b. Draft legislative outputs respond to the national needs in a country.
c. Draft legislative outputs are legally valid and professionally adequate.
d. If adopted, the draft legislative outputs would be practically implementable in
that country's legal system.
These four indicators are briefly examined below.
Indicator a: Draft Legislation Is Consistent with and Sufficient under the CPB
Consistency with the protocol is an essential requirement under the NBF development
project and every national subproject. However, consistency is a relatively minimal set of
requirements, in light of article 2.4 of the protocol, which specifically allows parties to
enact legislation that is stricter than the protocol.
Analysis of this issue occurred through desk review of 38 NBF reports, analyzing the
inclusion and completeness of specific requirements and provisions mandated in the
protocol. Table 8.1 provides the result of that initial determination--whether the
minimum coverage of the draft law is the same as, or stricter than, the national actions
required by the relevant provisions under the protocol. It should be noted that some NBF
reports did not address all of these issues. More than 13 percent of the NBF reports were
silent on some questions. It is not possible to conclude with certainty the meaning of
these omissions. In some cases, they may relate to an area that was not addressed by the
project because it is already covered in the general law of the country; however, lacking
any reference, it is not clear that the subproject and/or regional coordinators considered
the issue.
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Table 8.1: Selection of Protocol-Required Provisions Addressed in NBF Reports (percentages)
Reports
Generally
Reports not
addressing
sufficient
addressing
Selection of required provisions
this issue
coveragea
this issue
Risk assessment (article 15)
38
92 0
Decision procedure on import (article 10)
38
87 0
Public participation mechanisms (article 23.2)
36
82 5
Risk management (article 16)
38
82 0
Application of advanced informed agreement (articles 7, 8, 10, 11, 15 )
37
79 3
Review of decisions (article 12)
33
59 11
Handling, transport, packaging, identification (article 18)
33
50 13
Exporter notification (article 8)
33
45 13
Unintentional movements (article 17)
36
45 5
Illegal transboundary movements (article 25)
34
34 11
a.
The survey called for reviewers to rate national legislative framework as reflected in the NBF report. Ratings for each
item were full coverage, partial coverage, rudimentary coverage (mention), no coverage. A few reviewers did not
answer some questions. The above table provides the percentage of NBFs that were rated as having full or partial
coverage for each type of provision.
The most basic protocol requirements--the decision-making systems for regular
introduction decisions (and, where included, for FFP decisions16)--are generally
addressed in all legislative outputs reviewed, whether in new legislative proposals or in
existing law summarized in the NBF reports as already consistent with the protocol. In
general, the text of new draft legislation also addresses the requirements of an advanced
informed agreement process, including risk assessment procedures and scientific advisory
bodies.
A few issues were more frequently omitted from the draft legislation. For example, less
than 40 percent of the draft NBFs reviewed address or propose measures "preventing
and...penalizing transboundary movements of living modified organisms carried out in
contravention of its domestic measures to implement this Protocol" (article 25.1), and
only 45 percent address unintentional transboundary movement (article 17). While many
countries are aware that they cannot fully police these matters, the lack of a provision
could prevent them (or other governments) from applying penalties in the event that a
violation is found (despite limited or nonexistent formal policing). This statistic,
however, may be unduly negative, given that in many countries, relevant penal provisions
are contained in a separate code and may have addressed these matters. The failure to
mention these provisions in draft NBF reports suggests that this is not the case.
Indicator b: Legislation Responds to National Needs
As noted above, the question of legal need and readiness to adopt legislation appears to
be an important indicator of the value of investing project funds in legislative
implementation in a country. As noted in section 4.2, national readiness levels, capacity,
and perceived needs varied greatly among countries participating in the NBF
development project. However, at the time that national subprojects were created,
specific information on need-related issues was very limited and did not figure into the
16 The issue of separate FFP provisions is discussed under indicator b-1.
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negotiation of subproject activities, schedules, and Terms of Reference. It was often left
to consultants and others involved in a project's legislative drafting processes to
determine each country's needs.17 The ability of legislative instruments to provide legal
certainty is partially dependent on both how well they reflect national needs and how
clearly they provide mandates for national implementation.
Response to national need is a very broad question, and best answered through national
technical assistance, backstopping, and careful creation and use of stocktaking analyses.
To gain an indication of this factor, however, this evaluation considered two aspects,
which are potentially reflective of response to national need:
1.
the inclusion or exclusion of separate processes for food, feed, and processing;
2.
the choice between adoption of a single new legislative framework and the more
focused approach of amending and integrating existing legislation.
Element b-1: Food, Feed, and Processing. In low baseline countries, one element of
national need relates to FFP issues. These may need to be addressed at an early stage in
each project, in light of both the high priority given to food and livelihood issues in these
countries, and because these countries' most immediate use of the legislation will be the
importation of food, often in the form of aid packages. The Cartagena Protocol
specifically addresses the different needs and objectives that may apply to food products,
and contains a separate set of special provisions (article 11) enabling a more streamlined
decision-making system for imports of LMO-FFPs.
Analysis of this element occurred in stages. In the first stage, reviewers did not examine
FFP provisions per se, instead looking only to see if food and/or feed were mentioned in
the draft. As a second step, it was necessary to look more closely at what these provisions
actually provide, and consider the reasons underlying the creation of this streamlined
process for addressing food imports--to enable food transactions to occur in a more
expedited way. This point was examined by a more in-depth review of completed NBF
reports in a single super-regional area--Africa (14 countries). In evaluating this issue, it
was important to look for other potential sources of FFP streamlining. In this connection,
the UNEP project team suggested that where FFP provisions were omitted, these matters
might be covered in other provisions--particularly emergency measures, labeling, and, as
noted in article 18, "placing on the market."
On the basis of this analysis, it appeared that 10 (71 percent) of the African countries
whose legislation was specifically reviewed did include some level of special and
streamlined decision making for FFPs, while 4 did not. None of the reviewed NBFs that
omitted FFP provisions addressed that omission through any of these other provisions.
17 Primary legislative drafting decisions are not typically left to externally funded projects. Where such
projects are created to draft legislation, the primary decision would usually have been made earlier, at a
more appropriate level of government.
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This factor is clearly not an indicator of inconsistency with the protocol. The omission of
article 11's FFP provisions is not a violation of the protocol, as there is no legal
requirement for countries to adopt FFP provisions, so long as FFPs are included within
the basic coverage of the primary provisions adopted to satisfy the article 10 decision
process--"stricter legislation" under article 2.4 is always permitted. Rather, the question
to be considered is whether this "simplification" operates in the best interests of the
country. One objective of article 11--to enable low baseline countries to process
decisions on necessary or desired FFPs in a more expeditious manner--would appear
important enough to warrant the effort involved in creating and applying separate
provision.
Element b-2: New Law or Law Revision. Another key point relating to responsiveness
to national need relates to each country's choice of legislative activities, particularly in
countries already possessing some level of national biosafety legislation. The decision
between adopting entirely new legislation or integrating biosafety requirements into
existing institutions and processes may have a critical impact on the effectiveness of
legislation. The practice of adopting a broad new law covering matters subject to
regulation in other sectors, agencies, or ministries can be legally problematic. Without
significant legal and legislative research and policy development, this approach results in
multiple laws addressing the same points, and can create legal uncertainty both within
government and applicants seeking a valid and defensibly legal permit.
This point demonstrates the critical importance of legislative stocktaking. This process
must include not only a compilation of information on existing provisions, but also a
rigorously detailed analysis of their functioning, to ensure that the proper choice is made
and effectively undertaken. Beyond a simple listing of relevant laws, a very detailed
identification of all provisions and processes that address or partly duplicate biosafety
procedural requirements, as well as an analysis of how they can be revised, repealed, or
integrated into a new system, is essential.
This practice of "regulating over" existing laws (either by providing generically that the
current law controls over all other provisions, or that it generically does not supersede
any) was found to some extent in 9 of the 17 laws examined. It may be more prevalent,
however, as 12 out of the 17 created entire frameworks without specifically identifying
the extent to which other legislation might apply and/or conflict.
Indicator c: Legislation Is Legally Valid and Professionally Adequate
A legal framework does not acquire legal certainty through the adoption of a checklist of
provisions. A biosafety framework is comprised of a complex of legislative approaches,
systematic analysis, and creativity, focused by the need to achieve a specific kind of
objective: a system of permits and oversight mechanisms that is legally valid and
protected, consistent, and defensible. As such, it must meet high professional standards--
that is, it must be:
· unambiguous and specific in primary provisions,
· internally consistent in operative provisions,
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· appropriately inclusive of all necessary operative language.
Inexpertly drafted legislation that does not meet these basic requirements--that creates
insufficient or legally uncertain permits and processes, for example--may deter external
investors and importers from future attempts to act within the country. It may fail to
provide users with appropriate levels of confidence that their acquired rights will protect
them.
Analysis of this issue was necessarily a task for legal experts. Consequently, the breadth
of this evaluation's analysis of the professional quality of legal and legislative documents
under the project was limited by the number of experts on the team. In addition, a full
analysis of these issues is not easily quantifiable, owing to the range of potentially serious
errors or flaws that might affect a law's validity or professional quality. To address these
constraints, this evaluation focuses only on the three critical factors listed above, rather
than considering the full range of points that might be suggested. It is based on two
primary sources of information:
· evaluations obtained through in-country and telephone interviews of national
subproject staff, NCC members, and other participants in 17 national subprojects;
· detailed expert legal evaluation of a random selection of draft national legislative
documents from 17 of the countries reviewed during the evaluation.18
For half (nine) of the countries visited and interviewed, the national interviewees and the
evaluation team members conducting the national review, reported that national
legislative procedures and processes were fully sufficient. Similarly, the technical review
of a separate selection of 17 countries' NBF reports also resulted in 9 that were generally
adjudged to be sufficient in terms of primary legal requirements.
The latter review also provided more detailed information and analysis of the three
factors:
· Limited primary ambiguities appeared in five of the national legislative
documents reviewed, but proliferated only in two of them. The most serious
ambiguities involved:
The development of a clear and consistent scoping system (for defining which
actions require permits of each type) and then adding additional terms
(undefined both at law and in normal use), which make it impossible to know
with legal certainty whether a permit is needed and when it expires, or to
make other determinations.
The definitions of key terms used in a standard setting with reference to the
"probability of harm," or by setting a case-by-case standard that permits are
required for any introduction "which is likely to cause environmental damage
18 The random selection resulted in the evaluation of legislation from three countries executing UNEP
implementation projects, and 14 executing development projects; these included four African, four Asian,
three Central and Eastern European, three Latin American, and three SIDS countries.
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or an irreversible change to ecological balance." If relying on such legislation,
the applicant can only know for certain if a permit is required by applying for
one.
Creating specific mandatory language that states the precautionary principle's
application as "not restricting government from refusing or conditioning a
permit, where there is not yet sufficient scientific information regarding
potential risks" on the one hand, but stating that a permit is required for LMOs
"whose dangerous nature...is scientifically proven" on the other.
· Functional inconsistencies were apparent in eight countries' legislative
documents (47 percent of the sample). However, the majority of these could be
relatively easily alleviated through technical editing of the draft, or, if it has
already been adopted, through statutory construction and remedial drafting in
implementing regulations where laws are already adopted. Examples include
drafts that called for:
regulation of "LMOs and derivatives"--there is no objective way to identify
LMO derivatives, except where they are LMOs themselves;
failure to develop a clear legal/procedural basis for repeal of portions of other
ministries' legislation;
apparent creation of separate permit requirements that must be obtained at
essentially the same time from the same agency;
enabling the issuance of "generic permits" (not limited to a particular area),
but stating that permits cannot be issued where abutting land is used for
organic agriculture;
failure to make it clear which agency is authorized to receive applications.
· Operative omissions (errors that would be sufficient to render the legislation
inoperable on its face) were not found in any of the documents reviewed.
Professional adequacy is also measurable by examining the use of examples. Legislative
drafting that meets a checklist or follows a model act is rarely a positive contribution to
national development. Although copies of other countries' legislative documents may be
more useful, this approach too can backfire if not overseen by expert backstopping.
This evaluation discerned a spectrum of responses regarding the provision and use of
models and other legislation in the interviewed/visited countries. A few countries
received specific models, or considered the Toolkit to be a model. Approximately half of
the countries claimed to have reviewed the legislation of several other countries, although
most acquired these documents themselves and expressed a wish that UNEP had
provided more help with this (about one-third claimed to have received little or no other
legislation or assistance with obtaining examples of other laws).
In addition to selecting and providing useful samples of other legislation, backstopping
could have provided guidance on their use. For example, Guatemala's draft legislation
includes many organizational provisions "borrowed" from Mexico's recently adopted
legislation. This system is excellently functional in Mexico, where it grew organically as
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a means of coordinating the already active LMO regulatory activities from more than 11
different government agencies and ministries, each of which is staffed with (or supported
by) several highly qualified scientists and other biosafety experts. It is not clear that it
will function as effectively when imported without this background.
Indicator d: Legislation Would Be Practically Implementable
Perhaps the most important element of legislation is its adaptation to the institutional
needs and capacities within the country. Decisions can only provide legal certainty when
made in an institutional framework, and thus be more firmly anchored in the rule of law.
Many factors may affect implementability in the context of biosafety; the most obvious
limiting factor is the availability of persons with scientific and technical expertise as well
as the existence of laboratory facilities and other kinds of equipment. In many countries,
more general limitations of manpower and financial support may also restrict options.
The question of implementability is sometimes misunderstood. Adopting legislation
beyond a country's ability to implement is not merely wishful thinking, it creates serious
problems of legal uncertainty. In this connection, it is noted that nearly every project-
developed draft law or proposal for the creation of a primary biosafety framework calls
for an advanced informed agreement to be based on a risk assessment conducted by a
fully staffed scientific advisory committee, specifying the scientific competencies that
must be included on that committee. Many of the low baseline countries examined in this
evaluation are unlikely to be able to create and staff such a committee. A decision made
under the biosafety law may raise primary validity issues, since a critical component of
the process cannot be completed in the manner required by law.
The project's legislative activities demonstrate their lowest level of effectiveness with
respect to implementability--the matching of national legislative proposals to the
national resources and capability to put them into practice. This lower showing is
probably a result of the fact that the question of implementability was not addressed in
project toolkits or national analyses.
Evaluation of implementability must depend on factual information regarding capabilities
and obstacles within the country. To evaluate this indicator, information was collected
from country visits and telephone reviews concerning the basic capabilities of
government and other resource persons in 17 countries. In 62 percent of these countries,
limitations of scientific capacity and equipment are severe enough to seriously limit the
country's ability to staff significant scientific bodies or engage in certain kinds of risk
management activities. Where the country's primary expectation relates to food imports,
or where LMO development is unlikely in the short term, a more streamlined law focused
on the most needed provisions may be more appropriate. New project-created draft
framework legislation and proposals uniformly call for a full scientific advisory
committee and development of new institutions and mandates.
In participating countries with only a limited expectation of LMO activities, an elaborate
system may also create a more long-term implementability problem--continuing
capacity. In interviews with UNEP staff, it was noted that two implementation project
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countries that have completed comprehensive biosafety frameworks have not yet had any
applications to process. If ever called on to make biosafety decisions, decision makers
and advisors may require significant retraining at the time such applications are received.
8.6 Conclusions
The project design and legislative module of the Toolkit provided a useful approach to
investigate national needs and options--particularly through their comprehensive
treatment of the need for and scope of stocktaking. The national subprojects' legislative
activities met with varying levels of success in terms of meeting these primary activities.
Many primary actors in national subprojects as well as regional coordinators perceived
that the development of policy, law, and regulatory instruments was expected for all
countries where significant biosafety regulations did not already exist. Although this
perception was not strictly correct, based on the specific contractual provisions and the
objectives identified in the global strategy, it was understandable in light of the low level
of technical backstopping from the project. The legislative drafting process may have
been premature in many cases, suggesting that this perception may have led to a less than
optimal expenditure of project funds.
Although most legal stocktaking documents could not be reviewed, the stocktaking tool
remains the primary instrument for developing legally effective and appropriate biosafety
frameworks. Regardless of the fate of project-created legislative documents and
proposals, the underlying research embodied in national stocktaking efforts may serve as
the beginning for more technically appropriate efforts in future.
The objective of national legislation under the CPB is the creation of a commercially
valuable permit system that conveys legal certainty to applicants and permit holders. The
development of insufficient, flawed, invalid, or questionable legislation can be
problematic where it gives the impression of a rigorous system that can create legal
certainty, with that impression later shown to have been false. Based on four primary
indicators, the potential effectiveness of legislative instruments prepared under the
project is mixed. In particular:
· The draft legislation and proposals generally address the majority of requirements
under the CPB; however, a few key issues are insufficiently addressed. The
primary areas of deficiency relate to illegal transboundary movement of LMOs
and unintentional movement of LMOs.
· There are some instances in which proposed legislation does not adequately
address or reflect the national needs in a country.
· While the projects contain few fatal legal flaws that would make them invalid on
their face if adopted, a number of inadequacies were discerned that would affect
the ability of those laws to function as a commercially certain system.
· There are some instances of "legislating over" existing legislation, without
addressing whether and how other/pre-existing legislation will apply.
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· Most telling, in many situations, the drafted legislative outputs in many countries
are not sensitive to the countries' ability to implement detailed technical
regulatory systems, and would face problems of implementation if adopted.
The project's low level of technical backstopping, as further described in Chapter 9,
minimized the NBF development project's ability to help NPCs and NEAs ensure the
high legislative standards necessary to create a system of legally certain commercial
permits. Brief examination of the approach taken and results achieved by the pilot
projects suggests that the latter may have been more effective.
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Chapter 9.
Databases and Information: The Biosafety
Clearing-House
9.1 Introduction
Information collection, collation, analysis, and sharing are major components of the
Cartagena Protocol and primary mechanisms for achievement of its objectives. Through
the Biosafety Clearing-House, the protocol is able to provide a source of official records
of national decisions and experience. This information is critical to the functioning of the
protocol, especially in developing countries with limited ability to fully develop relevant
information and/or evaluate individual varieties themselves. In addition to its role as a
primary decision-making input, the BCH is intended to have other roles relating to
international information sharing (articles 6, 10, 11, 12, 13, 17, and 20), domestic
participation, (article 23.2), and public awareness (article 23.3).19 It is also important for
maintaining a national regulatory memory--another key to ensuring that the primary
mechanisms of the NBF function sustainably. Accordingly, the CBD COP identified the
creation of the BCH as one of its immediate priorities on the date that the protocol's final
text was adopted; this recommendation was reiterated in the following COP meeting, and
in decisions of the COP-MOP (CBD 2000a, para. 13; CBD 2000c, para. 3, CBD 2004b,
para. 3).
As the BCH is a major implementation tool for the protocol, the specific information that
must be posted on it is found in several different provisions. Many of these relate to the
posting of various kinds of decisions and notifications on LMO importation--provisions
that are (or should become) indicative of the level of LMO activity in the country, but
whose use will only be immediately required of countries already active in LMOs (these
provisions are given in articles 6.1, 10.3, 12, 13, 17.1, 17.2, 20.3c, 20.3d, and 25.3. In
addition, however, all parties are required (and non-parties are allowed) to post more
general information, including existing laws, regulations, and guidelines applicable to
LMOs (as per articles 11.5 and 20.3a); bilateral, regional, and multilateral instruments of
relevance (article 20.3b); and decisions to rely on the general provisions of article 11.6, in
lieu of a national framework, for LMOs for food, feed, or processing. The protocol also
authorizes (and the BCH contains) a list of relevant specialists in biosafety.
The mechanisms of the BCH were mandated in very general terms, and later clarified by
the parties to be implemented through the creation of a central node, which may be
surrounded by a distributed network of national nodes, and all of which together shall be
considered the mechanism.20 Each party is required to provide a range of very specific
information in a program-compatible format. This format is specified by the BCH unit of
the Protocol Secretariat, whose data provision guidelines include four options for
integration into the BCH (Secretariat of the Convention on Biological Diversity 2003):
19 National implementation of the protocol requires public participation in biosafety issues generally as well
as of particular applications and proposals. Additionally, the protocol specifies rights of public access to
information on LMOs--a separate requirement that is specifically tied to the BCH.
20 See COP-MOP decisions BS I/3 and II/2, and CBD 2004a. These decisions recognize that many
countries will not be able to create national nodes and provide other options.
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· "Register data in the central portal using the Management Centre"--that is, enter
information directly through an Internet connection with the central node.
· "Register data locally using database templates and send data to the central
portal"--that is, provide information by sending an e-mail, diskette, or CD-ROM
copy to the central portal. (Countries that cannot provide electronic outputs may
provide hard copies of their materials.)
· "Make data available through a local website and allow the central portal to crawl
to retrieve metadata" (enabled by applying specific parameters in posting material
on national websites).
· "Store data on national BCH databases, and actively make those data available
through the central portal using BCH interoperability protocols"--the creation of
a national (or presumably regional)21 node of the BCH that can seamlessly
interconnect with the central node.22
The objective of this approach is that all parts of the BCH will be available and
interoperable--that is, they can be searched by any party through a single search. To
minimize the need for intensive technical database training, the Secretariat has prepared a
modular system for entering information into a BCH-compatible database, which can be
modified for countries with limited capability to use electronic communication or data
input tools (see Secretariat of the Convention on Biological Diversity 2003).
Although national biosafety websites are not required in the protocol, they form another
key component of national information systems and can provide a major contribution to
national public outreach efforts (and serve as a source of information for public
participation), as required under article 23 of the protocol. While the creation of national
websites does not in itself satisfy the protocol's BCH requirements--even if they are
populated by all of the necessary information--it is expected that the UNEP-GEF's
technology/training-focused BCH project will enable countries to conform their websites
to the criteria of the second option for BCH data entry cited above.
9.2
Information and the BCH
Design of the NBF development project recognized the importance of the BCH, the
urgency of populating it with relevant data, and the fact that the initial development of a
country's biosafety database (and website) can require a one-time development of
capacity and commitment of personnel that may be very difficult for many developing
countries. The NBD Development sub-project document (UNEP 2003d) includes an
indicative allocation of $15,000 per country for the funding of databases and information
21 While regional action is not specifically authorized in the CBD or protocol, article 14.a of the protocol
specifically allows regional and bilateral cooperation, "regarding intentional transboundary movements of
living modified organisms." According to interviews with the UNEP-GEF project team, the project is
supporting the creation of regional nodes of the BCH.
22 At present, there are six interoperable nodes functioning in conjunction with the BCH, presented by two
international bodies (the OECD and the International Centre for Genetic Engineering and Biotechnology),
three parties (Switzerland, Belgium, and Republic of Korea) and one non-party (the United States).
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technology. This allocation is used in the national subprojects to address specific
performance requirements related to the goal of database development and linkage to the
BCH:
· "Identify how information should be stored and managed for input in the BCH
and for promoting public participation."23
· "Create a database listing national experts in fields related to biotechnology and
biosafety...risk assessment and risk management of LMOs."24
· "Create a database detailing relevant outputs of the national surveys" (UNEP
2003d).
The council also set forth a more general requirement that countries should, through their
national projects, "develop...a National Biosafety Database and link [it] to the Biosafety
Clearing House," (UNEP 2003d, para. 3.2). but did not specify the contents of such a
database. The Phase 1 Toolkit module, however, is specifically based on the Protocol
Secretariat's guidance for entering data into the BCH (UNEP 2002). Subprojects are also
called on to develop national websites for public awareness and other purposes, as
reflected in the GEF Council document as well as in the national subprojects agreed upon
between UNEP and the countries. As noted above, national websites can be used as a
means of uploading information to the central node of the BCH, so long as the database
of information for the BCH conforms to special technical standards in the Secretariat's
guidance. Through these provisions, the project sought to address the most urgent
component of the protocol's information and BCH requirements--the collation of
information and documents, and assurance of the availability of necessary information.
The 12 NBF implementation projects had higher goals related to the creation and use of
electronic databases, information sharing by country stakeholders and the general public,
as well as better and more secure access to and use of the central portal. With GEF
funding and country co-funding, each had in excess of $100,000 at its disposal for this
purpose.
In NBF development countries, the perceived demand for more sophisticated capacity in
electronic communications beyond the initial allocation has been increasing. At its
November 2003 meeting, the GEF Council allocated $4.6 million to 50 NBF
development countries, with the following specific objectives:
· to strengthen capacity in eligible parties through support for capacity building
including training activities for key stakeholders; these programs will cover data
management, identification and access to information required for decision
23 The project and its Toolkit do not focus particular attention on the role of electronic tools for "promoting
public participation." See UNEP 2003a, box 1; and general references to articles 23 (public awareness and
participation) and 21 (confidential information).
24 Although there is no provision in the Cartagena Protocol regarding the creation of a roster of experts, this
tool is recognized in the GEF Strategy, which specifically lists the development and sharing of such a roster
among the components of NBF development; see GEF 2000, para. 24(f).
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making under the CPB, and access to and registration of information in the BCH;
· to create an enabling environment for parties to meet the obligations for protocol
implementation by providing participating countries with appropriate computer
hardware and software (at a cost of $25,000 per country), as well as appropriate
software for the storage and exchange of data with the BCH through Internet
connectivity or other means;
· to support further capacity-building activities through the development and
dissemination of an interactive computer-based training package, including the
BCH Toolkit, which will be developed at the global level and used for training as
well as distributed in participating countries (at a cost of $29,000 per country).
UNEP carried out a survey of needs for support in this area. Based on guidance from
COP VII/20, UNEP submitted a proposal to the November 2004 council meeting to
extend assistance for capacity building in relation to the BCH to an additional 89
countries, with a GEF contribution of $9.9 million. Some initial objections were raised by
council members about the level of support, but approval was finally given to this
allocation in May 2005.
The BCH project has, to date, developed training manuals and modules, and recently
began training processes. At this stage in its operations, it is far too early to assess its
effectiveness and impact, particularly since it is designed to provide detailed technical
and equipment capacity in BCH focal points--a process that has only begun.
The database and information requirements of the national subprojects represent an
example of the manner in which project design and project actualization were markedly
different. The national subprojects did not address most of the immediate data-related
issues that have been identified as critical to bringing the protocol into operation.
9.3 Cooperation
with
the
Biosafety Clearing-House
The performance of the NBF development and implementation projects with regard to the
BCH and information development offers an example of the manner in which the over-
optimistic project design affected its implementation. In the face of a need to produce
many significant outputs with relatively limited funding and with time limit of 18 months
per country, the database and data-sharing requirements of the project were accorded
relatively low priority, despite strong COP and COP-MOP emphasis on the urgent need
to bring the BCH into full operation.
Two relevant information sources were available to the team. First, although it may not
accurately describe the national subprojects' performance, one set of informative
statistics was obtained by review of the BCH itself.25 Table 9.1 examines some
information elements in the BCH for the 53 countries reviewed.
25 The accessible portions of the BCH do not provide detailed data about the specific source or date of
many records.
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Table 9.1: Information Elements in the BCH (as of August 28, 2005)
Roster
of
Risk
Introduction
FFP
Other
Country
expertsa
Legislation assessments
decisions
decisionsb
decisionsc
Completed development
21 18 -
-
4
-
project (39 reviewed)
Development project in
5
3
-
-
-
-
progress (6 reviewed)
Implementation project
2
3
-
-
1
2
completed (3 reviewed)
Implementation project in
3
3
-
-
-
1
progress (5 reviewed)
Total number entering data
31 27 -
-
5
3
(of 53 countries reviewed)
Total number of countries
74 61 4
-
13
9
(parties, signatories, and
non-parties) providing
recordsd
a.
Roster of experts listing are not centrally vetted. Some countries that the review found to be very low in technical
capacity listed dozens of experts; other countries of extremely high capacity (India, Malaysia) did not have any
listings in the BCH.
b.
The five evaluated countries reviewed that have already posted decisions are Mexico (35 decisions under article 11),
Argentina (8), Lesotho (1), Czech Republic (3), and Republic of Korea (33). The fact that other countries within the
evaluation have not posted decisions might be evidence of a limited level of decision activity, rather than failure to
comply.
c.
This includes general notices, moratoriums, and a variety of other nonstandard notifications.
d.
There were a total of 189 potentially contributing countries: 125 parties, 63 countries that are parties to the CBD but
not to the protocol, and 1 country that is an active observer in both.
The foregoing statistics indicate weak, or at best mixed, performance regarding
fulfillment of BCH requirements. Specifically, the first two columns of Table 9.1
represent information that must be published, whether by CPB or project requirement. As
noted above, every country was required to undertake at least two activities that
guarantee that they will have material to post on the BCH, and those same documents
required that this information be compiled and posted. Although many countries have not
completed their development or implementation projects and have not formally adopted
the legislation drafted under their projects, all have, at a minimum, compiled a list of
existing national legislation or legislative information relevant to biosafety (the national
stocktaking). Yet only 21 (less than 50 percent) of countries with completed projects have
posted anything in the legislation section of the BCH. Similarly, although not required
under the protocol, every national subproject was called upon to create a roster of experts.
A review of 36 of the draft NBFs submitted by completed projects to date shows that 16
(44 percent) of these countries not only completed such rosters, but affirmatively vetted
and evaluated the individuals listed. Of the full 53 countries examined, 31 countries (58
percent) have posted either type of information on the BCH.
Even countries that have met these basic posting requirements have not posted any
decisions; this suggests that there has been no action within these countries relating to
LMO introduction in at least the past two years (the posting of pre-protocol decisions is
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allowed but not required).26 If this assumption is correct, it may have significant
relevance to other questions examined within this report relating to the level of activity
countries will engage in under this protocol.
The control data (the last row of the table) suggest that this situation is not limited to the
project, as only 48 percent of CPB parties appear to have posted legislation as required.
The project was arguably expected to promote better performance than could be expected
without GEF assistance; however, this overall statistic suggests that compliance with the
protocol's BCH may require more than the provision of additional funding for
information development. Hence, the GEF has funded a more focused project relating to
providing technical training, support, and equipment to further encourage BCH
compliance.
The UNEP development project team reports that further progress in this area, including
the development of regional BCHs (either regional nodes, as described above or regional
websites meeting the BCH technical requirements) is ongoing, and will be posted and
accessible soon. The current project staff has significant expertise in database
development and information-sharing technologies and approaches.
A second source utilized in this evaluation is national biosafety websites. In nearly all
countries evaluated, project staffs have interpreted the database components to be
satisfied by their work under other project components in establishment of national
websites. In many of these, the website produced to date is a "project website"--posted
to provide information about project activities, but not necessarily serving as the source
of official information on biosafety, which would make the website satisfy BCH
requirements. Although most of the national biosafety websites do not yet appear to be
interoperable with the BCH (due to language, accessibility, and other problems), the most
complete of these sites may serve as precursor or interim mechanisms through which the
countries can compile relevant data that will eventually be entered in the BCH, while also
addressing the public awareness and participation elements of the protocol.
Consequently, review of these national websites may be a useful indicator of progress
toward database development and information sharing.
Table 9.2 summarizes information collected from national websites in the course of this
review.
26 Project staff reports that only two of the completed implementation projects have not yet used the
decision-making processes under their NBFs; neither of these were investigated in this evaluation. This
suggests that decisions may have been made that are not yet recorded in the BCH.
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Table 9.2: Information Provided by National Websites
Website available
Website exists, but not posted, not
in accessible
reviewable due to technical problems,
No website reported
Country
languagea
or not in an accessible languagea
in NBF or BCH
Development project
7 8
24
completed (39 reviewed)
Development project in
2 0
4
progress (6 reviewed)
Implementation project
3 2
3
(8 reviewed)b
Total (53 reviewed)
12
10
31
a.
Accessible language refers to English, French, or Spanish.
b.
Given the prerequisites of implementation projects, they are comparable to completed development projects for
purposes of this table.
For this analysis, only national biosafety websites (as opposed to project-focused
websites) identified by the evaluation team, as well as all websites for any of the 53
evaluated countries listed under the "national contacts" section of the BCH were
examined. The specific contents provided in these websites are relevant in demonstrating
the level of utilization of websites for the compilation of data required, in addition to the
public awareness purposes on which the website requirements were focused in the
national subprojects.
As a further step beyond this evaluation, the 12 websites identified in Table 9.2 as being
accessible and available were examined to determine how much of their current content
satisfies the CPB's requirements for the BCH. This information is provided in Table 9.3.
Table 9.3: Contents of National Biosafety Websites for 12 Countries
Website components
Number of websites that include component
Roster of experts
9
List of LMO-connected institutions
6
Legislation 10
Introduction decisions
4
FFP decisions
5
Note: For the purposes of this table, a website was considered to have posted information on a topic if it contains a
reporting site for that subject, even if the report was, for example, "to date there have been no [introduction decisions
made under this system] in this country."
These results suggest that some projects have collected some relevant information in
electronic form that they will ultimately post on the BCH. The low performance levels on
posting risk assessments and various decisions may not be an indication of non-
performance, but rather an indicator that many countries have not yet processed an
application for LMO introduction or other activity that is supposed to be regulated under
the protocol.
As noted, the low levels of performance in preparing and posting biosafety data may be
explained in many cases by a lack of technical capacity and confidence. Although the
Secretariat has provided a user's tool to enable initial data entry into the BCH, project
staff may have lacked confidence to enter data into the system. As discussed above, a
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separately funded project is in its initial phases of providing equipment and training for
BCH implementation.
9.4 Conclusions
Given the integral role of the BCH in the international functioning of the protocol, as well
as its domestic functions relating to public participation and awareness, the BCH was
designated for immediate priority by the CBD COP and the COP-MOP. As yet,
however, the information and data-sharing obligations under the protocol have not been
sufficiently addressed, neither generally nor by the work under the projects, to enable the
BCH to function.
The NBF development project was designed to directly facilitate initial progress in BCH
implementation through the development of national databases. Ultimately, however, the
national subprojects focused instead on the creation of national websites.
Although not completely addressing many functional needs of the BCH, websites
demonstrate progress in the collection of some of the relevant data. If posted in a
specified format, national websites can be the means by which information is uploaded
by the Protocol Secretariat into the BCH's central node. Based on external evaluation of
the websites, and the fact that data from them has not been harvested into the BCH, it
appears that subproject-created websites have not yet met the requirements for direct use
by the BCH. Although less than half of the national subprojects reviewed have posted a
website, this may reflect a de-prioritization of database development and data-sharing
issues, in light of scarce time and professional resources, and the hope that the BCH
projects (which are primarily directed at increasing human capacity and providing
equipment and support) will also contribute to the population of the BCH and national
databases, using information compiled by the NBF development subprojects.
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Chapter 10. Effectiveness of Guidance and Quality Assurance
in Country Projects
The GEF's overall guidance is provided by the Conference of the Parties to the
Convention of Biological Diversity and the CPB. This guidance is operationalized in the
GEF Strategy and GEF Council allocation documents. The overall objectives, operational
principles, and budgets are integrated into specific country level project documents,
mostly accompanied by memoranda of understandings, and administrative and technical
guidelines. The Implementing Agencies have provided detailed guidance and quality
assurance through reporting and supervision tools, including contents, schedules, and
sharing of responsibilities among the GEF Implementing Agencies and the national
executing agencies. The documents also spell out the responsibility for technical
advice/backstopping, as well as criteria and procedures for recruitment of internal and
external expertise. The effectiveness of these tools and mechanisms used by the
Implementing Agencies at the country level is analyzed in this chapter.
10.1 Technical Advice and Backstopping to National Subprojects by the
Implementing Agencies
In a new, complex, and controversial regulatory area, the need for expert assistance is
obvious. Technical advice is either provided by the regional coordinators or specialists of
the Implementing Agencies, or by consultants hired by the Implementing Agencies or the
countries, using GEF and counterpart funds. The evaluation obtained two kinds of
information regarding technical advice and expert assistance:
· evaluation in the 17 countries, based on in-country and telephone interviews,
primarily reflecting national satisfaction with the quality of technical inputs into
NBF processes by the Implementing Agencies;
· primary review of the quality of external peer reviews of the final draft NBF
development reports and the qualifications of the peer reviewers commissioned or
recommended by UNEP.
The results of the evaluation's review of technical inputs in the 17 countries are
summarized in Table 10.1 below. This summary is based on feedback provided by the
NPCs and other key project personnel during in-country visits and telephone interviews.
The data below are necessarily subjective, and do not take some important issues into full
account; for instance, whether information was supplied at the request of the country or
through generic support (for example, at subregional workshops). The evaluation shows
that there are no significant differences in the quality and usefulness of the technical
advice provided by any of the GEF's three Implementing Agencies. The table shows that
the quality, usefulness, and timeliness of their technical advice were rarely rated "high."
The scores were especially low in the low baseline countries (see section 2.4), while the
high baseline countries generally stated that the advice and backstopping was adequate.
This suggests first that the level of advice was better suited to countries with a high
baseline than those with a low baseline. It does not necessarily mean that the advice was
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of low or medium quality in the majority of countries, but rather that good advice was
mostly not readily available in a form that was adapted to the country's situation at a time
when it was needed. The scores on advice on risk assessment/risk management and
interim measures are very low; scores are markedly higher on legal aspects and public
participation.
Table 10.1: Quality, Usefulness, and Timeliness of Technical Advice
Quality, usefulness, and timeliness
Area of Implementing Agency advice
High
Medium
Low
Scientific, risk assessment, and enforcement aspects
1 6
10
Legal aspects
5
4
7
Public awareness programs
4
7
6
Provision of relevant documentation
2
5
4
Provision of examples of laws and regulations from other countries
4
5
7
Provision of examples of risk assessment and management procedures
0
10
7
Provision of examples of interim measures that could be adopted
1
0
11
The three GEF Implementing Agencies managed the NBF development projects and
implementation projects in different ways. The team has made a separate assessment of
UNEP's performance in this regard since it implemented the majority of all projects.
The Word Bank supervised biosafety two projects out of its headquarters in Washington,
D.C., and sent relatively strong teams of specialists to provide technical advice during
semi-annual supervision missions, which resulted in aid memoranda with clear
recommendations. There was little technical advice offered in the intervening periods.
UNDP has made no efforts to build specialist biosafety competence among its regular
staff, choosing instead to ensure contact between its projects and UNEP's strong technical
Biosafety unit for providing of substantive input to its only ongoing project in Mexico.
The second UNDP project in Malaysia has not started yet, partly due to a change of
government, but partly also due to poor communication between the two partners.
10.2 Effectiveness of UNEP's Organizational and Technical Support
As elaborated in section 4.1, UNEP quickly developed a fully fledged management and
operating system for the NBF development subprojects, spelling out in great detail the
administrative requirements countries were advised to follow. The countries were
required to select a national executing agency as the entity responsible for executing the
NBF, and to appoint an intergovernmental and intra-country national coordinating
committee to guide and coordinate the work. UNEP required that it be consulted on the
hiring of the national project coordinator, who is responsible for management,
coordination, oversight, monitoring, and reporting. UNEP's main operational and
technical responsibilities during the project cycle were agreed to be as follows:
1. consultation on the appointment of the NPC;
2. approval of the quarterly technical and financial reports and workplans (five to
eight per project);
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3. consultation on organization of national workshops to present the findings of the
stocktaking surveys (see Figure 4.1).
4. consultation on national workshops in risk assessment and public awareness, and
consultation on the NBF report;
5. receipt, forwarding and discussion of peer reviews in most cases.
Apart from the mandatory management system and guidance of the Toolkit--which at
times provided relatively clear suggestions on how countries were to proceed, and at
other times listed possible options--UNEP chose generally a low-intensity oversight and
feedback approach. This worked well for high baseline countries, but not so well in
countries with little or no prior experience. The UNEP project team was not able to visit
and provide hands-on guidance to all 120 countries involved. According to UNEP's
records, as of August 31, 2005, 23 countries had not been visited by UNEP project
staff--mostly, those included for allocations by the GEF Council in November 2003. In
all, 62 countries had been visited once, 27 countries had been visited twice, and 8 had
been visited more than twice. Apart from consultations during country visits, the advice
and guidance had taken place primarily by e-mail and phone communication, at regional
workshops, and during CBD COP-MOPs. Management problems in some countries
would often have necessitated significantly more time-consuming responses and actions,
at times almost on a daily basis. This was particularly the case in Africa, which had the
greatest needs and the least UNEP supervisory resources per country in the initial period.
There are many examples of the UNEP project team making every effort to be of help
and giving measured assistance directed toward countries with the greatest needs. The
UNEP regional coordinators primarily had a scientific background and were strong in
project management, but for a considerable period there were none with a legal
background. Despite the logistical and other weaknesses, the UNEP project team is well
regarded for its commitment and hard work.
Table 10.2: Travel of UNEP Project Team to Countries, as of August 31, 2005
Country
Average visits per country
Total missions
Development project
1.2
145
Implementation project
3.5a 38
a.
This includes missions to implementation project countries during the time they were participating in the pilot phase
of the GEF-supported activities. This average is also calculated by replacing the outlier of Kenya (13 visits) with the
average of all the other countries.
In general, the regional coordinators had to budget their time between general
administration and professional backstopping, and necessarily had to prioritize the
former. In a number of countries, NPCs remarked on the lack of UNEP feedback on
issues of substance highlighted in the quarterly reports. Other times, UNEP staff
complained that quarterly reports were often very sketchy and lacking in sufficient detail
for a proper evaluation of progress to be made. UNEP's complaints about lack of
adherence to agreed-upon standards and criteria are apparently accessible only in
informal and personal communication and not recorded in publicly accessible documents,
such as aid memoranda, as is the case for the World Bank.
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Concerning UNEP's involvement on subprojects, two activities to note in particular are
the national stocktaking and the peer review system (the latter is dealt with in section
10.4). The stocktaking exercises could have provided an opportunity for the regional
coordinators or Implementing Agency specialists to acquaint themselves with the national
situation and improve their ability to provide guidance. However, this was neither
planned, nor financed, as a separate activity in the NBF development projects. The
regional coordinators did not always receive nor systematically review the stocktaking
reports. Similarly, the inability to undertake backstopping visits at decisive stages in the
substantive data-gathering period of the subprojects also limited the quantity and value of
inputs from agency staff. Further, it reduced the possibilities for pointing out potentials
for collaboration and harmonization within the subregion as well as national legislative
choices that could be the most suitable to each country's needs and capacity.
10.3 The UNEP Toolkit
The UNEP Toolkit was one of the principal mechanisms for providing both
administrative and substantive guidance to participating countries. As stated in UNEP's
introductory letter to the publication of the first Toolkit module in December 2001, the
aim of this toolkit is to provide a practical `how-to' guide for countries to assist them in
developing their draft National Biosafety Framework.
The Toolkit product was not originally identified or budgeted, but was independently
developed by the UNEP biosafety team as a means of responding to frequently asked
questions from countries and to assist them in structuring project execution. For UNEP,
the Toolkit provided a mechanism to formalize and generally share advice that was
provided on an ad hoc basis by regional coordinators or outside experts through e-mail
and other communications with NPCs. Given the limitations to direct in-country
interaction between UNEP regional coordinators and NPCs, the Toolkit was expected, at
least partially, to fill the gap.
The development of the Toolkit was viewed as a priority activity within the NBF
development project at the first meeting of the steering committee in February 2002. The
overall structure, as described in the first module released on December 20, 2001, was
organized as a series of individual modules, each addressing a particular phase listed in
the national project document. A brief description of the various Toolkit modules is
provided in annex 3.
Toolkit Timeliness
The development of the various Toolkit modules occurred over a 35-month period. The
following table presents the status of the national subprojects at the time of publication of
the various modules.27
27 At the time of the midterm evaluation of the global project in August 2003 (Navajas and Seyani 2003).
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Table 10.3: Comparison of Toolkit Module Publication Dates and NBF Subproject Status
NBF subprojects
NBF subprojects started
completed at
Toolkit module
Publication datea
at publication dateb
publication dateb
Phase 0 Starting the Project
December 20, 2001
1
0
Phase 1 Taking Stock
May 17, 2002
12
0
Phase 2 Consultation and Analysis
September 26, 2003
99
0
Phase 3(i) Regulatory Regime
September 11, 2004
114
17
Phase 3(ii) Administrative Systems
November 30, 2004
118
18
a.
Publication dates were provided by UNEP.
b.
For the purposes of this evaluation, the project start date was defined as the effective date of the double-signed
national project document as provided by UNEP.
c.
The date of project completion was defined as the date the draft NBF was posted to the UNEP website, as provided
by UNEP.
By UNEP's estimation, 34 (29 percent) of the 118 participating countries had begun
drafting their NBF prior to the final publication of the last Toolkit module. According to
the evaluation team's assessment, of the 46 countries that had posted draft NBFs by July
21, 2005, 17 (37 percent) had completed this activity prior to the publication of the first
Phase 3 module. This information may not convey the full story, however, given that
"final publication" is not equivalent to "first unveiling." Earlier drafts of the Phase 2
module were circulated November 2002 and May 2003, and drafts of the Phase 3(i) and
3(ii) module were circulated by their primary author in the 2003 workshops. Moreover,
the contents of the Phase 3(i) and 3(ii) module relate to substantive drafting, and can
theoretically be used as additional input throughout the drafting and review of key NBF
documents.
The late availability of Toolkit modules was identified as a concern in the 2003 midterm
review, where it was noted that "toolkits began to appear after many countries were
already well into the project" and the "absence of the phase 2 Toolkit was cited as a big
drawback by many countries, since they lacked guidelines for carrying out phase 2
activities" (Navajas and Seyami 2003). This comment, however, underscores the value
countries were expecting from the final modules, further suggesting strong positive
reactions to the first two modules. Although the Phase 0 module dealing with project
startup and organization discussed why a country needs an NBF and dealt at some length
with the participatory process in developing one, there was no factual description of what
an NBF was. This description of the various components of an NBF was not addressed
until the Phase 3(i) module, which was published almost three years later. Similarly, the
description of rights and obligations of parties to the Cartagena Protocol that was
provided in the Phase 3(i) module would have been a valuable component of the Phase 0
module, where this topic was afforded only cursory treatment.
Delphi Review of the Toolkit
Between May and August 2005, a review of the Toolkit was carried out by Vrije
Universiteit of Amsterdam. The purpose of the review was to assess whether the Toolkit
was consistent with the Cartagena Protocol, responsive to country needs, and of sufficient
professional quality. The university used a questionnaire, which was distributed to 500
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respondents in 30 countries plus an additional 40 respondents representing global actors:
the biotechnology industry, other donor organizations, NGOs, and academic institutions.
Responses were received from 102 individuals from 29 participating countries. Some of
the reasons for the low response rate were i) the university did not have as much time to
carry out the study as it had wanted; ii) the study was conducted partly during vacation
time for many respondent; iii) some respondents had insufficient internet connections; iv)
language problems (the questionnaire was available only in English, French and Spanish;
v) some of the global actors had not very thorough experience with the Toolkit. Even if
the response rate was on the low side, a systematic data gathering approach was used.
However, of those who responded, 91 percent stated that they were well informed about
the Cartagena Protocol and 78 percent stated they were well informed about the Toolkit.
The Delphi study addressed the consistency of the project with the Cartagena Protocol
through seven separate questions. The results show that 78 percent of the respondents
answered that the Toolkit was "very consistent" or "consistent" with the protocol. Only
one respondent answered "not so consistent," while the remainder gave no answer. There
were also several questions related to "responsiveness to country needs"; 79 percent
stated that the Toolkit had been or is useful/very useful for their country, while most of
the remainder gave no clear answer. On the question of whether the Toolkit was sensitive
with regard to countries' available scientific expertise, 65 percent gave a positive answer,
15 percent a negative, and 20 percent gave no answer or did not know. Nine questions
were related to the professional quality of the Toolkit. More than 70 percent of the
respondents indicated that they were satisfied/very satisfied with the clarity of aims, the
selection of topics, and the depth and comprehensiveness of guidance on selected topics.
Another aspect of quality surveyed was coverage of topics. There were seven topics on
which between 36 and 53 percent of the respondents wanted more emphasis: protection
of biodiversity and human health (39); public awareness programs (37); risk assessment
(37); organizing procedures for decision making (38); designing a regulatory regime (36);
illegal introduction of LMOs into the country (53); and systems for monitoring,
inspections, and enforcement (50). The two last topics were singled out as requiring most
attention.
The Delphi review also incorporated some open questions about advantages,
disadvantages, and challenges that respondents experienced with the Toolkits. Especially
the problem of timeliness was seen as a challenge. More than half of the National Project
Coordinators who responded to the Delphi study saw timeliness of Toolkits availability
as the most important constraint. Other issues that were identified by all respondents
included lack of country specifics taken into account; too narrow focus; no attention
given to issues of NBF implementation; and not enough focus on science/LMO
development. In addition to these critical remarks there were also different and opposing
positive views about the Toolkits: a guiding step-by-step approach; flexibility to specific
conditions; clear explanations; information on harmonization of LMO legislation and
procedures; and better awareness of biosafety issues.
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The Delphi review also identified some of the same challenges noted by the evaluation
team, especially with regard to timeliness. More than half of the NPCs who responded to
the Delphi study saw timeliness of Toolkit availability as its most important constraint.
Other issues identified included lack of country specifics taken into account, too narrow a
focus, no attention given to issues of NBF implementation, and not enough focus on
science/LMO development. Balancing these were a number of positive views on Toolkit
strengths: a guiding step-by-step approach, flexibility to specific conditions, clear
explanations, information on harmonization of LMO legislation and procedures, and
better awareness of biosafety issues.
Review of the Toolkit by the Evaluation Team
The evaluation team assessed the Toolkit also, but had a considerably smaller sample of
countries; even though it interviewed a much wider group of potential users in each
country (e.g. most members of the NCC). The evaluation team focused essentially on the
use of the Toolkit. This may explain that there are some divergences between the two
reviews. During its interviews in 7 countries, the evaluation team made assessments of
toolkit consistency with country needs, its availability to participants, level of use in the
country, and dissemination of the Toolkit to relevant stakeholders, as well as level of
guidance it offered on particular issues.
There were no responses indicating that the Toolkit was inconsistent with the Cartagena
Protocol, incorrect, or confusing, or that it possessed other negative qualities. The users
of the toolkits generally provided two responses; these were either:
(1) strong appreciation--the Toolkit was found to be very useful and well used;
(2) generally positive comments about the Toolkit, but admission that it was not
used, whether because the respondent did not need or want it, or for other
reasons.
In general, the most positive reviews came from NPCs, many of whom (especially in
small countries and SIDS) were practically alone in completing or ensuring the
completion of many elements of the project design and substantive outputs. Several of
these made such comments as "I wish all projects provided this kind of assistance."
Usually the strongest praise was reserved for the Phase 0 module, which provided very
detailed assistance on how the project should operate and be administered. Other key
participants, such as members of the NCC, and other stakeholders claim to have seen the
Toolkit, but to have rarely applied it. The overall utility of the Toolkit to the countries
visited was therefore judged as mostly medium to low.
Apart from the Phase 0 module, the remaining modules were less utilized; the reasons for
this may range from timing (discussed above), distribution, or the fact that the Toolkit--
geared as it was for the "average" national project--was either too sophisticated or too
simple to address a specific need. Although many respondents were comfortable with the
complexity level of the Toolkit, some felt that they had received insufficient explanation
in its use. While the Toolkit modules were disseminated to members of the NCC in most
cases, there was generally no awareness of them among the broader stakeholder group.
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UNEP made the Toolkit available in English, French and Spanish, and the Toolkit was
translated into Russian by the Tajikistan NBF development project.
Table 10.4 sums up the evaluations team's assessment of various aspects of the Toolkit.
Issue 1 was raised in countries both visited and interviewed by telephone and received 11
responses. The other issues were only raised in the seven NBF development countries
visited.
Table 10.4: Assessment of Toolkit Utility in NBF Development Phase Countries
Issue
Low
Medium
High
1. Consistency with country needs
7
1
3
2. Explanation of how to use Toolkit
3
3
1
3. Relevance to country process
5
1
1
4. Level of use
4
2
1
5. Efforts of dissemination to various stakeholders
6
1
0
Note: The countries visited were The Bahamas, Burkina Faso, Croatia, Ethiopia, Guatemala, Morocco, and Tajikistan.
Countries interviewed by telephone were Botswana, Chile, Lebanon, and Turkey. At the time of the on-site interviews,
four of the countries visited had completed their NBFs; three were still in process.
10.4 Advice Provided by External Experts
Within each national subproject, about $50,000 was budgeted for engagement of
professional advice or other expertise. The amounts were expected to cover five
stocktaking reports, as well as advice through the drafting process and peer review of the
draft final NBF report. For the stocktaking phase UNEP encouraged the countries to use
national, and in some cases regional, experts, with the aim of building national capacity.
A number of countries requested assistance from UNEP for peer reviews of the draft
NBFs, which led to the engagement of peer reviewers in 40 of the 54 draft final NBFs,
according to project staff tabulations.
By August 2005, peer reviews had been carried out for all completed reports in Africa,
and for about two-thirds of the reports completed in Asia and Eastern Europe, but only
two countries in Latin America. The peer reviewers were sometimes NPCs from other
countries in the region; other times, they were international experts.
The evaluation team examined eight of the UNEP-funded peer reviews with regard to the
technical competence of these reviews, and the technical quality of the reviewers
themselves. In three cases, the reviewers' qualifications and the quality of the reviews
were found to be technically unsatisfactory. Peer review quality was analyzed in terms of
the contents of the review focusing on correctness, completeness, relevance, and
usability. This evaluation concluded that the level of expertise of peer reviewers varied.
10.5 Effectiveness of the Global NBF Development Project Umbrella
Approach
At the overall level, the GEF has used two allocation models: 12 individual medium-
sized country project allocations; and one umbrella-type allocation, which initially
included NBF development projects in 100 countries, to which 30 were later added. The
support to create capacity for participation in the BCH is also of the umbrella type, since
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the project initially included 50 countries, to which 89 countries were added. This
evaluation does not fully assess the capacity building for participation in the BCH, since
this project is only in its initial stage.
The GEF has previously employed a global project allocation type in similar areas of
GEF enabling activities. Although the individual project approach was chosen from 1996
to 2000 as the main modality in the GEF support to enabling activities in biodiversity and
climate change, UNDP--and partly UNEP--were also tasked with giving additional
assistance to the same countries through global support programs, especially based on
regional and global networking, websites, and help desks.
For the NBF development initiative, the umbrella project modality employed essentially
the same approach to all countries: execution by the NEA, recruitment of a full-time
NPC, overall guidance and coordination by an NCC, national awareness raising and
capacity-building workshops, development of risk management and regulatory systems,
and preparation of websites for public information and participation in the BCH. The
umbrella approach was, under the circumstances, a necessary tool to deliver assistance
expeditiously to the large number of countries requesting assistance, and it entailed
economies of scale. The alternative of organizing 100 individual projects without a single
coherent system would have been much more demanding both in terms of time and
resources. The objective of economizing on GEF funds by employing economies of scale
was an important contributing factor to the choice.
The approach was especially effective in countries that could easily incorporate the
support into their own biosafety systems, but much less effective in countries where the
need for support was greater and/or the initial conditions were less receptive. On the
whole, the approach was too ambitious in terms of high goals within limited time
schedules, and it did not have a sufficient inbuilt flexibility to adapt the level of funding
and the measures of required technical assistance to the needs of each country. Due to
resource constraints, UNEP was forced to employ a low-intensity follow-up and
supervision strategy in each country. This reduced the ability for extra support to low
baseline countries. However, such follow-up was not necessarily an inherent feature of
the umbrella approach, which might have had an inbuilt flexibility and also included
sufficient professional back-up and supervision and specific country features.
10.6 Conclusions
In general, the UNEP Toolkit modules have been found satisfactory in terms of
consistency with the Cartagena Protocol and professional quality, although less
responsive to country needs. The main problem was tardiness relative to project
execution in a great many countries, and the lack of access to and use of the modules by
the broader stakeholder groups at the country level.
For a project as complex and contentious as developing a national regulatory framework
for LMOs, a toolkit approach may have limitations when compared with more direct
mechanisms of providing guidance. Given limited funding and time constraints, however,
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the toolkit approach may have been a cost-effective, although not entirely satisfactory
means, of providing basic guidance to a large number of countries working toward the
same or similar goals.
The quality, usefulness, and timeliness of the technical advice and backstopping by
Implementing Agency staff and external expertise were rated mostly at a medium to low
level. This does not necessarily mean that the advice itself was of low quality, but rather
that good advice was not readily available in a form that could be adapted to the country
situation at a time when it was needed.
The umbrella approach was, under the circumstances, a necessary tool to deliver
assistance expeditiously under a single project to 100 countries, although the approach
was too ambitious, and was much better adapted to "high baseline" than "low baseline"
countries.
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Chapter 11. The GEF's Contribution to Progress in
Implementing the CPB
The final step in this evaluation calls for an analysis of the third question in the
evaluation's Terms of Reference: What progress has been made in countries on building
the requisite capacities toward their ratification and implementation of the Cartagena
Protocol? In general, each of the activities discussed in the previous chapters was
undertaken with the object of promoting the objectives of the Cartagena Protocol in
developing countries and countries in transition. This chapter considers the overall effect
of those activities on national and international progress toward implementation.
Analysis of this issue requires the consideration of both the effectiveness of the national
subprojects and global activities in achieving progress, and also a more general look
beyond the specific outputs of the project--documents created, workshops and other
materials presented, and interviews conducted--to consider wider indicators of the extent
of changes in governance, policy, public opinion, and priorities in supported countries.
This chapter examines five primary indicators of change and development in regard to
the objectives of international action on biosafety and of the GEF's influence on such
change:
· speed of ratification/accession to the protocol;
· the significance of the GEF's support for NBF development, NBF
implementation, and capacity building for participation in the BCH;
· the degree to which the GEF-funded projects have contributed to compliance
with, and full implementation of, the CPB;
· consistency and neutrality of the GEF's role and support;
· breadth of coverage of GEF support.
11.1 Speed of Ratification of the Cartagena Protocol
One overall indicator relates to the status of ratifications of the protocol. In addition to
being a question of this analysis, and an objective of the GEF Strategy, the extent and
speed of ratification may provide a measure of the effectiveness of GEF support,
particularly when compared to the status of similar international agreements.
Regardless of the difficulty and length of negotiations necessary to create an international
instrument, one key factor evidencing its acceptance, value, and effectiveness is the
number of affected countries that agree to become party to it. A country's consent to
adopt or sign a protocol is not as reliable an indicator as ratification, which embodies its
full and formal commitment to become party. As such, the process of ratification,
accession, or other acceptance of party status in an environmental convention or protocol
is sometimes quite slow. A commitment of (and possible restraint on) a country's
national sovereignty, this process usually requires the approval of the highest national
body or bodies in the country. These formalities can take time, in light of the role of
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relevant documents, their execution, and their formal delivery to the international
depository both as legal processes and as political/public relations opportunities.
One way of evaluating the speed of the ratification process is by comparing it to other
international agreements (see Table 11.1).
Table 11.1: Comparing CPB to Similar International Agreements
Factor
CPB
CITESa
Kyoto
Montreal
POPs
Protocol
Protocol
Convention
Current number of parties
125
169
156
189
110
Date of adoption
Jan. 29,
March 3,
Sept. 16,
Dec. 11, 1997
May 22, 2001
2000
1973
1987
Date of 50th accessionb
Sept. 2003
June 1979
Feb. 2005
Dec. 1989
May 2004
Months from adoption to 50th
43 63 62
27 36
accession1
Ratifications in year 1
2
1
5
10
5
Ratifications in year 2
10
7
16
37
25
Ratifications in year 3
28
13
10
16
30
Ratifications in year 4
42
10
15
9
37
Ratifications in year 5
29
10
54
12
13
Ratifications in years 610
14
37
56
77
---
Ratifications in years 1115
14
--- 22
---
Ratifications in years 16present 77
6
a.
The four other instruments listed above--Convention on International Trade in Endangered Species of Flora and
Fauna (CITES), the Kyoto Protocol to the UN Framework Convention on Climate Change; the Montreal Protocol to
the Vienna Convention for the Protection of the Ozone Layer, and the Stockholm Convention on Persistent Organic
Pollutants (POPs Convention)--are included because each is similar to the CPB in terms of the kinds of compliance
required (development of national legislation designed to control transboundary movement of specific environmental
species and subspecies that may be difficult to identify), although none demands a level of detailed compliance
equal to the CPB.
b.
Each international instrument requires a different number of parties in order to enter into force. For example, the
Montreal Protocol called for only 11 parties (although with some special requirements), and was in force 15 months
after adoption. By contrast, the Kyoto Protocol needed 55 and was subject to some special requirements, so more
than 86 months elapsed before it entered into force. For comparison, this table notes the amount of time it took each
of these instruments to garner 50 ratification/accessions.
Both the Cartagena and Kyoto Protocols have been topics of serious controversy among
OECD countries, although arguably the Cartagena Protocol has been more directly
politically sensitive of the two. Such controversy between or among OECD countries can
sometimes create a high level of insecurity in other countries regarding the political
effects of their own ratification. Consequently, it is notable that the Cartagena Protocol's
ratification has been relatively rapid, in comparison with other controversial instruments
(in this case, the Kyoto Protocol), and with CITES whose ratification was delayed by
other political factors.
Another measure of the effect of GEF support on ratification can be based on review of
the protocol status of countries that were non-parties when they received GEF funds.
When the decision was made to allocate funding to such countries, a proviso was added
that such countries must be parties to the CBD, and that they must deposit with the GEF
chair and the Secretary General of the CBD a signed declaration that they "intended to
ratify the protocol before the completion of the GEF project." Table 11.2 describes the
status of this subgroup of countries.
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Table 11.2: Current Status of Countries Not Party to the Cartagena Protocol at Start of NBF
Development Project
Countries not party to CPB at NBF project commencement (total 38)
Now CPB Party
Not yet CPB party
...which have now completed NBFs (31):
26 (84%)
5 (16%)
...with projects still in progress (7):
4 (57%)
3 (43%)
These data indicate that completion of the project bears a strong relationship to
ratification of the protocol. This relationship was borne out in incidental cases throughout
the evaluations. In some of the countries visited or interviewed, the NPCs indicated that
they had devoted significant amounts of project time, and especially of post-project time,
to interacting with government officials and encouraging ratifications, often with positive
results. Although several countries have not yet taken action on their commitment to
swift ratification, such post-project efforts may still be ongoing. At present, 81 percent
(31 of 38) of countries with completed NBFs have ratified the protocol; ratification in
countries with projects still in progress has been slower. It seems reasonable to conclude
that project participation enhanced awareness of the protocol at administrative and
political levels, and gave officials sufficient assurance in their protocol-related capability
that they could more confidently recommend ratification.
In general, the national political situation with regard to accession to the protocol was not
discussed in the NBF reports, and, as noted above, the process may be lengthy. Preparing
the NBF and implementation of the protocol are relatively complex processes, requiring
significant human and financial resources. As international law, a decision to ratify the
protocol would create a national obligation to incur these costs. In a decade of shrinking
national budgets, two of the most frequently trimmed budget items are those of the
environment and agriculture ministries. The choice among competing priorities within
these ministries may also be delaying or sidelining necessary intra-governmental efforts
to promote ratification.
11.2 Significance and Results of Nationally Oriented Support
As detailed in Chapter 1, the GEF support was largely directed to providing assistance to
the development of national legal frameworks, and the development of institutions and
capacity for their implementation. This section does not repeat the report's earlier
analysis of GEF support in these areas, but considers the international significance of that
work.
Development of Biosafety Policies, Systems, and Regulations
As explained in Chapter 1, the development of the instruments and internal institutional
agreements comprising the country's overall biosafety framework is a large and difficult
task. In attempting to address this aspect of the GEF Strategy, specific choices were made
directed at maximizing the amount of work to be undertaken with the minimum cost and
most immediate results.
As demonstrated in Table 8.1 and discussed in section 8.4, evaluation of the legal
instruments and NBF reports demonstrated that, at minimum, most NBFs have
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specifically addressed most protocol-required legislative and regulatory provisions. In
many cases, issues not directly covered in legislation developed through the project may
have been omitted because they were addressed in other existing law. However, these
outputs are generally still in the form of interim drafts; in many cases, the countries still
require significant professional assistance to make them sufficiently functional and
effective in form and content to be put forward as legislative or regulatory proposals. In
many instances, national legislative development has insufficiently integrated or
addressed issues of national need, institutions, and capacity, so existing legislation may
not fit comfortably into national systems. In the worst case, if such legislation were
adopted without further technical assistance and advice, it would result in "paper
compliance"--where the law exists on the books but is generally not implemented.
In all cases evaluated, the project's work has created a functional basis for further work,
including reconsideration of the problems identified above. Regardless of the extent of
direct legislative drafting undertaken by a national subproject, its NBF report includes a
plan describing additional legislative work needed and identifying and prioritizing next
steps for the country. Relatively few countries have indicated how they intend to support
and fund these activities--perhaps owing to the frequently expressed expectation that
there would be a subsequent phase of the project, in which countries could take further
steps toward full implementation of the protocol.
In evaluating the significance of these results as a contribution to progress in
implementing the Cartagena Protocol, it is reasonable to consider the progress
experienced by similar multilateral environmental agreements that require parties to
adopt and implement technical regulatory frameworks.
· The Convention on International Trade in Endangered Species of Flora and
Fauna.28 In the most recent analyses of national implementation, it was found that
only 41 percent of parties are fully in compliance with CITES legislative
requirements, after 30 years since adoption (CITES 2004). Forty-seven parties
have been required to develop or improve legislation, and/or to provide a
legislative plan describing how and when they will address deficiencies in their
legislative framework.
· The Convention on Biological Diversity. Although covering a very broad range of
issues, the CBD requires legislative measures in very few, of which only the
provisions regarding access to genetic resources and equitable benefit sharing
relate to trans-border activities.29 To date, only 35 of the 188 CBD parties have
posted any legislation or references to it, and only about 18 countries (10 percent
28 CITES is similar to the protocol in that its primary mandate relates to the control of biological materials
moving among countries; it requires formal permits from both the exporting and importing countries; and it
requires the adoption of national legislation (although at a much lower level than the CPB--it has only four
primary requirements).
29 In this connection, the convention requires parties to adopt 10 different kinds of "legal, administrative, or
other measures," primarily in article 15, but also in articles 16, 17, 19, 20, and 21.
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of CBD parties) have yet adopted substantial national legislation implementing
Access and Benefit Sharing (see Cabrera 2004).
· The Basel Convention on the Control of Transboundary Movements of Hazardous
Wastes and Their Disposal.30 This convention is beginning, in its 16th year of
operations, its first systematic examination of national implementation. As of the
date of this report, only about 86 countries (52 percent of parties) have so far
responded to the call to provide or summarize their existing legislation relevant to
hazardous wastes. No analysis has yet been completed to determine whether and
to what extent these laws comply with the convention.
Viewed in this context, the project's work in NBF development may be seen to represent
a significant contribution. At a minimum, through the project, 93 percent of developing
country parties (and many countries that have not yet ratified the protocol) have made at
least some progress toward achieving their legislative and institutional objectives,31 and
have developed a plan (reflected in each national subproject's NBF report) for further
regulatory development. This status is significantly more advanced than other
instruments mentioned above which have been in existence far longer.
Within the primary objectives of the project, one further critical contribution relates to the
development of sources of expertise and information sharing at the governmental and
implementation levels. Although the GEF Strategy recognizes that it is early in most
regions to consider formal harmonization, the project did not engage in significant efforts
toward investigating options for regional cooperation, frequently omitting consideration
of this aspect from NBF development processes, and limiting global efforts to the
cultivation of limited contacts with a random selection of existing regional and
subregional intergovernmental bodies. The project performed well on the more
immediate goal of building a base of regional and subregional networking that will
enable the sharing of expertise and information, even before regional structures can be
agreed upon.
Awareness and Participation
As noted in Chapter 1, the project and GEF Strategy gave priority to three key factors
relating to public consciousness of and participation in LMO-related activities: public
awareness raising, cross-sectoral and stakeholder participation in project decisions and
activities, and the development of legislative provisions for public participation in
decisions made under the NBF.
30 The Basel Convention is similarly directed at controlling the commercial movement of substances across
boundaries. Its objectives are environmental protection and safety. Its primary legislative requirements call
for measures implementing controls of the movement in customs and penalties. Unlike biosafety, the
scientific issues and standards underlying the Basel Convention are clear and well accepted internationally,
and the governmental mandates for pollution control already existed very generally.
31 It was assumed that a country is making "at least some progress" once it has an NEA, NPC, and NCC in
place and is clearly moving forward on the project.
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The level of public awareness on biosafety issues, and public awareness of the project,
could not be reliably assessed within the scope of this evaluation. Significant efforts were
directed in national subprojects at public awareness raising, sometimes at the most
general level, and in other cases more focused on particular activities and issues relevant
to the project. This work included not only direct awareness raising and participation, but
the building of long-term mechanisms for public information, including national
biosafety websites and the BCH.
While the achievements on public participation in project activities were mixed, the
national subprojects clearly expressed a desire to broaden their activities to include a
cross-sectoral mix of agencies and perspectives. Public participation was strongly
promoted by the UNEP project team, and through the Toolkit and other project
documents. Yet, in many cases, national efforts at inclusiveness and cross-sectoral
operations were evaluated to have been inadequate to the task, and many processes
insufficiently open and responsive to the breadth of necessary perspectives, institutions,
and stakeholder groups.
The primary impetus behind the protocol's creation was the need to build confidence
among governments and their citizens that LMO-related decisions were taken on a sound
and precautionary basis. If it succeeds in this mission, the protocol may make an
important contribution to building acceptance of LMOs and acceptance by the LMO
industry of the value of publicly recognized compliance with these standards. As such,
public awareness and participation are a critical element of the work of the project.
The extremely limited budgetary allocation to these issues suggested that the project was
not intended to create full media campaigns and awareness activities. In a few cases,
countries focused their efforts on designing strategies for longer term efforts to develop
awareness and participation.
Capacity Development
The majority of countries had a low initial level of biosafety capacity. Capacity building
was therefore an essential element of all GEF biosafety projects. The level of and need
for capacity development, however, were often insufficiently assessed in the course of
national subproject development and operations. At the global level, significant capacity-
building efforts were directed at sensitizing a small core group of actors in each
participating country. This kind of development, while certainly insufficient to provide
the full level of capacity each country will need to have or access to implement the
protocol, does represent a first step in that process.
Given the complex technical specialties involved, it is not a short process to truly raise
capacity in this area. Ultimately, more specialized types of collegiate and postgraduate
training will be needed in many countries. Pending that, however, other project mandates,
including efforts to develop regional and other networks among national actors, fill a
critical capacity-development role.
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11.3 Scientific
and
Administrative
Tools for Implementing the Protocol
Given the variance among countries' baseline level of preparation in implementing the
protocol at the start of their projects and subprojects, it is perhaps not surprising that fully
operational risk assessment processes and risk management systems are not yet available
in the majority of countries involved. Despite very detailed information regarding these
processes in the protocol and its annexes, the fact remains that risk assessment decision
making is dependent to a large extent on governmental decisions regarding the level of
risk that will be considered acceptable and how that determination is to be made.
Consequently, in many countries, project work in developing implementation bodies,
standards, and protocols was primarily focused on building awareness and initial
understanding of the relevant issues and the nature of the decisions and technical support
needed in order to bring them into functional existence when the national situation and
capacity are ready to do so. For many countries, it is evident that the envisioned scientific
and technical capacity required to implement the NBF does not exist, and is not likely to
for some years. Still, however, the countries have gained important value through the
networking, sensitization, and informational resources provided by the project.
As noted above, based on the on-site and telephone evaluations of 17 countries, the
evaluation team concluded that six have made a high degree of progress toward
implementation of the protocol, four a medium degree, and seven a low degree. The
countries with the greatest initial capacity have made the greatest progress, suggesting
that on-the-ground progress is most likely in countries that begin with a high level of
national capacity and involvement in LMO issues, and (resulting in) governmental
commitment to moving forward.
An important institutional component of the project was the development of the national
coordination committees, created to provide primary domestic oversight and guidance to
project operations. In many countries, the NCC was both an effective project steering
committee and a nascent network of key biosafety-related officials and other actors. This
process has at times proven so effective that the NCC has been restructured with a direct
governmental mandate to operate as its national biosafety committee following the end of
project activities.
11.4 Support for Participating Countries to Advance toward Compliance
In the course of this evaluation, an analysis was conducted in 18 countries providing a
variety of statistical and evaluative results. As a concluding factor in each national
review, the evaluation team members were asked to rate the countries reviewed on their
level of preparation for entry into force of the protocol and on the overall progress made
toward building capacity to implement the protocol; see Table 11.3.
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Table 11.3: Overall Progress Made in Countries to Implement the CPB
Item
Country
High
Medium
Low
Current level of preparation for
Development projects (10)
1
5
4
entry into force and
implementation of the protocol
Implementation projects (6)
3
1
2
Overall progress made on requisite
capacities to implement the
Development projects (11)
3
3
5
protocol
Implementation projects (6)
3
1
2
In analyzing these data, it should be noted that 6 of the 12 NBF development project
countries, and four of the six implementation project countries, visited or interviewed for
this evaluation had not yet completed their projects. With this caveat, it is apparent that
these evaluations compare to the baseline evaluation described in section 4.2, which
showed that 8 of the 12 NBF development project countries evaluated began at a low
baseline, 3 began at a medium baseline, and only one was considered to be high baseline.
The influence of the project can thus be seen to have been relatively positive, with two
countries advancing to a medium level of preparation, and half the countries being seen
to have made medium or high levels of progress, despite the overwhelmingly low
baselines at the beginning.
These data clearly indicate that project progress was most effective in high baseline
countries. Comparing these results to the evaluations of project outputs and outcomes
supports this point. Among NBF implementation projects, those that were at a high
baseline level of involvement in LMO activities and regulation were found to have the
best performing projects, scoring almost exclusively in the medium and high ranges in
evaluation of project outputs, outcomes, and impacts. Those identified as having a
medium or low baseline level performed relatively inadequately, generally receiving low
(or infrequently medium) scores on evaluations of project outputs, outcomes, and
impacts. In NBF development projects, ratings of outputs were correspondingly higher
for countries starting with a high or medium baseline than for those with medium or low
baseline levels. The incidence of negative findings regarding project results (for example,
that one or more of a subproject's outputs were ineffective, of unacceptable professional
quality, lacking in some elements of consistency with the protocol, or of questionable
implementability) was significantly greater for countries with low initial baseline ratings.
The effectiveness of the GEF support may have been diminished by decisions to use
generally identical requirements, capacity-building processes, support services, and
oversight mechanisms for all national subprojects regardless of the baseline levels of the
countries involved, and without any in-depth pre-project analysis of the specific needs
and capacity in each case.
11.5 Consistency and Breadth of GEF Support to the CPB
As detailed in Chapter 1, GEF support was generally rated highly with regard to
consistency with the protocol and its objectives. As discussed in section 10.3, the project
Toolkit was evaluated for consistency with the protocol in several different ways,
receiving a generally high rating in the assessment survey and a more mixed rating from
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the wider group of participants interviewed in the evaluation visits, as well as notable
praise from particular interviewees with regard to protocol consistency and value.
In light of the overall neutrality of the protocol on questions of biotechnology and LMO
introductions generally, the issues of sectoral or other bias constitute a further element of
the consistency analysis. One of the most difficult challenges perceived by the UNEP
project team arose from the need to maintain neutrality with regard to the highly
controversial issues that surround and often interact with the question of biosafety
implementation. The project team was aware of the need to avoid taking a substantive
position on these issues in order to maintain their ability to provide services to countries
that may in some cases have been firmly committed to one side or the other, or in others
resistant to taking advice from strong proponents of either side.
In the end, although the UNEP project team was challenged at times by advocacy groups
claiming bias, the nature of those opposing claims may actually demonstrate general
impartiality. Both strong biotechnology proponents and strong opponents have submitted
such complaints, often addressed at the same project components (workshops or Toolkit).
This fact suggests that UNEP's work was balanced and unbiased in either direction.
11.6 Conclusions
National progress toward implementation of the Cartagena Protocol has been a very
difficult task, in part because of the time involved between commencement of these
activities and concrete formal results (national ratification, adoption of policy and
legislative frameworks, and creation and operation of implementing institutions and
standards). It is important to recognize the significantly different potential time horizons
for countries to be able to fully implement the protocol. Some countries may be able to
implement their NBFs, as envisioned, within three to five years. For other countries,
however, 10 years or longer may be necessary. As noted in earlier chapters, this fact is
not inherently problematic. The actual biosafety requirements of many countries with
little capacity may be relatively low. By contrast, countries that have the capacity
necessary to implement their NBFs quickly are also much more likely to engage in
significant biotechnology activities, and therefore have a greater need to have a fully
operational biosafety framework in place.
These differences among countries aside, it is clear that most countries are, at a
minimum, more aware of biosafety and biotechnology issues and farther along the path to
addressing them than they were at the time of protocol adoption in 2000. The GEF, by far
the world's largest provider of support for biosafety implementation in developing
countries, has clearly made an important contribution to the international effort toward
implementation of the Cartagena Protocol, moving quickly and effectively to bring
prompt assistance to the largest possible number of countries.
Future progress will turn on enhancing cooperation with regional and subregional
initiatives, intergovernmental and bilateral donors, and spontaneous national and regional
proposals that derive from specific needs and demands rather than external
recommendations. To ensure implementability and appropriateness, activities to address
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biosafety need to move forward in a logical progression, at a rate that makes sense for
countries based on their level of capacity and degree of need. The attempt to provide
support to so many countries within a compacted timeline, in a consistent and substantive
manner, represents an unprecedented effort for the GEF--and perhaps for any
organization in the world.
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Annexes
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Annex 1. Acronyms
BCH
Biosafety Clearing House
CBD
Convention on Biological Diversity
CIBIOGEM Mexico's Inter-ministerial Commission on Biosecurity and Genetically
Modified Organisms (Comisión Mexicana Intersecretarial sobre
Bioseguridad y Organismos Genéticamente Modificados)
CITES
Convention on International Trade in Endangered Species of Flora and
Fauna
COP
Conference of the Parties
COP-MOP
Meeting of the Parties of the Cartagena Protocol
CPB
Cartagena Protocol on Biosafety to the Convention on Biological
Diversity
EU
European
Union
FAO
Food and Agriculture Organization of the United Nations
FFP
Food, Feed, or Processing
GEF
Global Environment Facility
GEFSEC
Secretariat of the Global Environment Facility
GMO
Genetically Modified Organism
LMO
Living Modified Organism
NBF
National Biosafety Framework
NCC
National Coordinating Committee (as organized through one of the
national subprojects under the UNEP GEF, WB-GEF or UNDP-GEF
Projects)
NEA
National Executing Agency (organization administering one of the
national subprojects under the UNEP GEF, WB-GEF or UNDP-GEF
Biosafety Projects)
NGO Nongovernmental
Organization
NIA
National Implementing Agency (organization administering one the
national subprojects under the UNEP GEF, WB-GEF or UNDP-GEF
Biosafety Projects)
NPC
National Project Coordinator (nationally designated person with primary
responsibility for implementing one the national subprojects under the
UNEP GEF, WB-GEF or UNDP-GEF Biosafety Projects)
OECD
Organisation for Economic Co-operation and Development
SIDS
Small Island Developing States
UNDP
United Nations Development Programme
UNEP
United Nations Environment Programme
USAID
U.S. Agency for International Development
WB
World
Bank
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Annex 2. Terms of Reference of the Evaluation of GEF's Support
to the Cartagena Protocol on Biosafety
Background and GEF's Strategy
At its November 2004 meeting, the GEF Council requested the GEF Office of
Monitoring and Evaluation (OME) to undertake an evaluation of the activities financed
under the initial strategy approved by the Council in May 2000 for assisting countries to
prepare for the entry into force of the Cartagena Protocol.
The Cartagena Protocol for Biosafety under the Convention of Biological Diversity
(CBD) was adopted in January 2000 and the Global Environment Facility (GEF) became
its Financial Mechanism. The objective of this Protocol (see Article 1) is "to contribute to
ensuring an adequate level of protection in the field of the safe transfer, handling and use
of living modified organisms (LMOs) resulting from modern biotechnology that may
have adverse effects on the conservation and sustainable use of biological diversity,
taking also into account risks to human health, and specifically focusing on trans-
boundary movements"32.
The GEF strategy for assisting countries to prepare for the entry into force of the Protocol
(GEF/C.16/4/Rev.1) was based on a decision in the Conferences of the Parties (COP) to
the Convention on Biodiversity (CBD), which designated capacity-building as a priority
for GEF assistance (decision III/5 paragraph 2 (a), 1996). Further guidance has been
provided by COP-CBD especially in decisions V/3, VI/17 and VII/20. The GEF strategy
aims at:
D. Assisting countries to prepare for the entry into force of the Cartagena Protocol on
Biosafety through the establishment of national biosafety frameworks, including
strengthening capacities for risk assessment and management with a wide degree
of stakeholder participation,
E. Promoting information sharing and collaboration at the regional and sub-regional
level and among countries that share the same biomes/ecosystems, and
F. Promoting identification, collaboration and coordination among other bilateral
and multilateral organizations to assist capacity-building for the Protocol and
explore the optimization of partnerships with such organizations.
The following activities were proposed:
VI. A project to assist interested signatories to the Cartagena Protocol in establishing
national biosafety frameworks;
32 "Living modified organisms" means any living organism that possesses a novel combination of genetic
material obtained through the use of modern biotechnology (Protocol Article 3). The Protocol entered into
force on in September 2003.
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VII. Individual, country-based demonstration projects through any of the GEF
Implementing Agencies, to assist in capacity-building to implement national
biosafety frameworks;
VIII. Coordination with other multilateral and bilateral organizations providing assistance
in the area of biosafety;
IX. Support to enable countries to participate in the Biosafety Clearing House (BCH),
once the terms of reference are agreed upon by the Parties; and
X. Enhancement of the scientific and technical advice to the GEF on biosafety issues.
The GEF Council, at its November 1997 meeting, approved a Pilot Biosafety
Enabling Activity project of US$ 2.7 million, aimed mainly at assisting eighteen
eligible countries to prepare National Biosafety Frameworks (NBFs). Based on the
experience of the pilot phase and the provisions of the Protocol, the preparations of
national biosafety frameworks would, according the GEF's initial strategy, include:
(j) assessment/stocktaking to provide information on the status of existing biosafety
practices;
(k) assessment of any existing legal instrument or guidelines that might impact on the
use, import or export of living modified organisms (LMOs);
(l) identification and involvement of all stakeholders relevant to the implementation
of the Protocol, to the extent possible;
(m) identification of actions that need to be undertaken to enable countries to
implement the Protocol as well as options and priorities for filling such gaps;
(n) preparation of a legal framework and/or guidelines necessary for the
implementation of the Protocol, including strengthening capacity for risk
assessment and risk management, monitoring and inspection services;
(o) establishment of a roster of experts in a transparent manner and modalities for
including them in national, sub-regional and/or regional networks;
(p) assessment of options for implementation of various elements of the biosafety
frameworks, for example at the regional level, and
(q) identification of sub-regional and regional opportunities for harmonization of
regulatory frameworks, identifying regional expertise, and exchanging
information on initiatives, collaboration and priority areas for capacity-building;
and
(r) additional features that may be identified by the Intergovernmental Committee for
the Cartagena Protocol (ICCP).
All developing countries and countries with economies in transition, which are parties to
the Cartagena Protocol, are eligible for funding from GEF--and following the CBD-COP
decision 7/20--also parties to the Convention on Biodiversity which were not yet parties
to the Protocol, but had provided a clear political commitment towards becoming parties.
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II. Program Components
Preparation of National Biosafety Frameworks (NBFs)
At its November 2000 meeting the GEF Council allocated US$ 26 million to support
about 100 countries to develop NBFs. Another US$ 5.2 million was allocated in
November 2003 for the development of NBFs in 20 additional countries. UNEP is the
sole Implementing Agency (IA) for NBFs. Their main project components are:
a) Development of frameworks through information gathering, analysis, consultation,
training and preparation of a draft NBF, including legal instruments, administrative
systems, risk assessment procedures, systems for public participation and information;
b) Arrangements of regional workshops, which aims at increasing the understanding of
the Cartagena Protocol on Biosafety and imparting knowledge on the assessment of
implications for risk assessment and decision-making at national levels; and
c) Arrangements of sub-regional workshops focusing on capacity building, cross-national
opportunities for collaboration, mechanisms for sharing of risk assessment and
management experiences, the coordination pf capacity building activities and networking
to share lessons and experiences.
Implementation of National Biosafety Frameworks
In 2001 GEF approved 12 individual country demonstration projects on implementation
of the NBFs. The project periods are usually three years. The GEF allocation to each
country is mostly in the range of US$ 500.000 to 1 mill. The "Implementation
Projects" are to be adapted to the country specific situation. The generic activities
include:
(a)
Reviewing NBFs and drafting regulations and guidelines to support its
implementation;
(b)
Making operational a regulatory and administrative system for handling
applications and related biosafety matters
(c)
Setting up decision making mechanisms to handle applications for releases
and transboundary movements of LMOs;
(d)
Development and publishing of technical guidelines for risk assessment and
risk management, monitoring and enforcement;
(e)
Strengthening capacity of risk assessment/management, including as needed,
setting up and/or improving and equipping special laboratories for this purpose;
(f)
Strengthening information systems on LMOs;
(g)
Enhancing public awareness, public education and participation; and
(h)
Setting up of biosafety databases for the purpose of the BCH.
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UNEP has the responsibility for the NBF Implementation Projects in Bulgaria, Cameron,
China, Cuba, Kenya, Namibia, Poland and Uganda. UNDP has the responsibility for the
Implementation Projects in Malaysia and Mexico. The World Bank is responsible for
NBF Implementation Projects in India and Colombia.
CAPACITY BUILDING FOR PARTICIPATION IN BIOSAFETY CLEARING HOUSE (BCH)
At its November 2003 meeting the GEF Council allocated US$ 4.6 million through
UNEP for assistance to 50 countries to effectively participate in the BCH of the
Cartagena Protocol, whose central portal is administered by the CBD Secretariat. The
objective is complementary to the overall biosafety program's objectives, but aims more
specifically at developing core human resources to establish the appropriate BCH
infrastructure to readily access scientific, technical, environmental and legal information
on LMOs to ensure adequate protection in the field of safe transfer, handling and use of
LMOs. Whereas the CBD Secretariat is focusing its work on the establishment of a
central portal, GEF has supported the development of national BCH components and
capacities in the countries to access and use the BCH. About three fourth of the funds
were assigned for the training of country officials in managing and operating the
mechanism, while one fourth was assigned for procuring equipment (i.a. computers). A
proposal by UNEP to extend assistance to an additional 89 countries in the BCH is
currently being revised before it will be re-submitted to the GEF Council for comments
and the GEF/CEO for endorsement.
I. Objective and Key Questions of the Evaluation
The main objective is to evaluate the efficiency, effectiveness and relevance of the GEF's
initial support strategy. The evaluation aims first and foremost to enable decision making
in the GEF Council on biosafety activities. The focus will be on four key questions:
1) Is the GEF support consistent with the Cartagena Protocol, conducted in a way
that takes into account the needs of the recipient countries and is it of sufficient
professional quality?
2) Is the GEF support to capacity development efforts, including stakeholder
involvement and regional collaboration, relevant and effective?
3) What progress has been made in countries on building the requisite capacities
towards their ratification and implementation of the Cartagena Protocol?
4) Are the modalities and approaches of the GEF support effective and efficient
compared to similar projects?
The four key questions will guide the choice of methodology for the evaluation as well as
selection of countries for desk and field review.
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II. Scope of the Evaluation
The first key issue will focus mainly on the support given to enable recipient countries to
develop draft National Biosafety Frameworks (umbrella project for more than 100
countries). The second issue on capacity development will be studied for all three
program components. The third issue on results relative to the project objectives will
focus mainly on the NBF development project, since the NBF Implementation and BCH
projects are not yet sufficiently advanced. The question concerning the cost-effectiveness
will compare both NBF development and NBF Implementation approaches with similar
approaches in other international efforts to support recipient countries. The focus of the
evaluation is shown in the following table.
NBF development
NBF Implementation
Biosafety Clearing
Issues
projects
projects
House support
Are GEF/UNEP toolkits
Main focus
Reduced attention
Not included
consistent with the
Cartagena Protocol and
country needs?
Support for capacity
Yes Yes Yes
assessment and
strengthening, including
stakeholder participation
and regional cooperation.
Progress towards
Yes
Reduced attention
Not included
attainment of the goals of
the Protocol
Effectiveness/efficiency
Yes Yes Reduced
attention
of GEF support
The following schematic presentation of the logic of intervention of the three program
areas will be used to further develop concrete sub-questions under each key question.
NBF Implementation
Biosafety Clearing
NBF Development projects
projects
House support
Inputs
GEF/UNEP's toolkits, regional
Training, advice, national
Training
and sub-regional seminars.
seminars, etc.
technical advice/backstopping
Outputs
Capacity in place to draft NBFs Capacity in place to
Capacity to access and
implement NBFs
use the BCH
Outcomes NBFs
NBF in force and
Effective use of the
implemented
BCH
Impact
Countries well prepared for
Countries have the capacity to Countries are able to
entry into force of the Protocol. fulfill the requirements under
exchange information
the Protocol
and experience with
LMOs and fulfill the
information provision
requirements under the
Protocol.
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An initial list of sub-questions of the evaluation is contained in Annex 1. The issues will
be further refined and operationalized in subsequent inception reports in an early phase of
the evaluation.
III. Approach and Methodology
The Evaluation will be carried out in two parts. The first part will be based on the Delphi
method, which is a review method for mapping various opinions and exploring further
the attitudes of the respondents to specific issues related to the TOR of the evaluation
(Annex I, 1.1.). After a first research phase--mainly consisting of a facilitator sending a
questionnaire to a group of about 10 selected experts--the facilitator will seek feedback
from a bigger group of 50-150 respondents. On the basis of the responses, the facilitator
will prepare a synthesis, which he/she sends back to the respondents and asks them to
indicate the extent to which they agree with the synthesis, and to make changes if any
in their own response to the previous questionnaire. After several research and feedback
rounds (usually three) the final responses will be edited and reported.
Traditional evaluation methods will be employed by the evaluation team to address the
three remaining issues: capacity development; progress towards compliance and cost-
effectiveness. The issues of capacity building will be addressed both through desk
reviews and field visits. It is estimated that more than 30 NBFs will be available for
review by the team. The team will also assess mid-term reviews, progress reports and
reports from the regional workshops. The team will select a representative sample of
about 20 countries which are in the process of preparing their NBF and some which have
reached the next stage and are engaged in the Implementation Projects. About half of
these countries will be visited by the evaluation team, while the other half will be
interviewed via telephone and mail. The selection of countries for field visits will be been
made on the basis of a careful analysis of the existing portfolio. The main selection
criteria will be geographical coverage, country size, stage of implementation. The
evaluation will cover the overall GEF follow up of its initial strategy as well as efforts at
the country level implemented by all the three IAs. The evaluation team will address the
issue of effectiveness/efficiency of project approaches/modalities partly through the desk
and field reviews and partly through comparisons with similar enabling activity projects
within and outside the GEF (e.g. enabling activities in climate change and biodiversity).
Both the facilitators of the Delphi approach and the evaluation team will prepare
inception reports, which will give further details of approaches and methodology within a
period of 4 weeks. The evaluation team will prepare a combined draft final and final
report of the whole evaluation.
IV. Organization
The Delphi Review will be tendered to a competent institution. The other parts of the
evaluation may be tendered or be managed by the Office of Monitoring and Evaluation.
The team members will have a relevant scientific background, evaluation experience as
well as work experience in the countries/regions to be covered.
The required competencies of the evaluation consultants are:
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· Masters degree or higher qualification in relevant subjects in the social and/or natural
sciences;
· Minimum 10 years of experience in evaluation and research in the areas of
environment and development;
· Documented experience in the areas of biological diversity and biosafety.;
· Work experience in developing countries and countries with economies in transition;
· Good analytic and writing skills and interpersonal communication skills;
· No conflict of interest with planning or implementation of any GEF support for
biosafety.
· Fluency in English; knowledge of Spanish or French is desirable; and
Both the participants in the Delphi methodology and the evaluation team will be vetted
on their independent position and to prevent conflict of interest with any GEF support in
biosafety or otherwise. Comments to the draft TOR will be solicited from the GEF
Secretariat, GEF IAs, the Convention for Biological Diversity, and all other interested
parties and groups. The draft TOR will be posted on the website for the Office of
Monitoring and Evaluation.
V. Sample of Countries for Field and Non-field Visits
The criteria for country selection are the following, in order of importance:
1. Geographic representation
2. IA representation
3. Stage of implementation
4. Country size
5. Logistical considerations.
The following countries will be covered in the evaluation:
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FIELD VISITS
Country Region IA
Pilot
Development
NBF Complete Implementation
Country size
Uganda AFR
UNEP
X
X
Burkina
AFR UNEP
X
Faso
China Asia
UNEP
X
X Large
India Asia
WB
X Large
Croatia ECA
UNEP
X
Tajikistan ECA
UNEP
X
X
Ethiopia AFR
UNEP
X
Morocco MENA
UNEP
X
Mexico LAC
UNDP
X
Guatemala LAC UNEP
X
X
Bahamas LAC
UNEP
X
SIDS
NON-FIELD REVIEWS
Colombia LAC WB
X
Malaysia LAC
UNDP
X
Lao PDR
Asia
UNEP
X
X
Botswana AFR
UNEP
X
Bulgaria ECA
UNEP
X
X
Chile LAC
UNEP
X
Lebanon MENA
UNEP
X
Cuba LAC
UNEP
X
X
Turkey ECA
UNEP
X
Samoa Pacific
UNEP
X
X
SIDS
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Appendix 1.
LIST OF SUB-QUESTIONS.
The sub-questions are organized in accordance with the two above-mentioned evaluation
methods, the three biosafety programs to be evaluated, and a concluding issue which
addresses the overall effectiveness and efficiency of the programs.
1. Adequacy of GEF/UNEP Toolkits
Through the use of Delphi method:
Assess the degree to which the UNEP/GEF toolkits used for the development of national
biosafety frameworks are consistent with the Cartagena Protocol, responsive to
country needs, and of sufficient professional quality
2.
Development of National Biosafety Frameworks
The evaluation team will assess progress made in selected countries, as well as the
adequacy of UNEP's guidance and backstopping efforts. It will especially assess the
efforts for:
2.1
stocktaking of initial technical and legal capacities and identification of actions
necessary for the implementation of the Protocol and the filling of capacity gaps;
2.2
general awareness raising of the relevant issues and an enhancement of
stakeholders' involvement in the decision-making processes by public and private
sector actors, including producers, consumers, academia, NGOs, etc;
2.3
strengthening of national capacity for decision-making and implementation of
biosafety procedures, including legal and regulatory frameworks, and systems for
risk assessments and risk management, monitoring and enforcement;
2.4
harmonizing guidelines, regulations or laws through sub-regional agreements,
where relevant.
3.
Implementation of National Biosafety Frameworks
The evaluation team will review the overall project progress in the 12 projects currently
implemented by UNDP, UNEP and the World Bank, including:
3.1
Assess the effectiveness and efficiency of the support provided by the
Implementing Agencies and the achievements till now by the countries, in terms
of capacity development and other efforts for:
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- drafting supportive policies and regulations--in the short and/or long term;
- setting up of regulatory, institutional and administrative systems for handling
of applications and other biosafety matters;
-
development, dissemination and use of technical guidelines for risk
assessment, risk management, monitoring and enforcement;
- achievements in strengthening capacities of risk assessment/management,
including setting up and equipping special laboratories, including (prospects
for) their use;
- setting up of information databases to benefit in-country coordination and the
BCH.
3.2
Assess achievements with regard to strengthening information systems on LMOs
and increased public awareness of biosafety issues, and establishment of systems
for participation by relevant stakeholders in the various tasks, including public
and private sector actors: producers, consumers, academia, NGOs, etc.
4. Biosafety Clearing House of the Cartagena Protocol
In selected countries the evaluation team shall review initial efforts by UNEP in
establishing national systems and capacities for the BCH, including:
4.1
Consider UNEP's stocktaking efforts (i.a. the questionnaire survey);
4.2.
Assess efforts to integrate and coordinate GEF support to the BCH with existing
biodiversity and environmental communication and management capacities and
tools.
4.3.
Assess coordination efforts between BCH capacity building efforts in countries
and the central portal operated by the CBD Secretariat.
5. Overall Effectiveness and Efficiency of Program Approaches
The evaluation team shall:
5.1.
Assess the overall progress made in the implementation of GEF's initial strategy;
5.2.
Assess complementarity and synergy between GEF's efforts and related activities
by other multilateral and bilateral organizations, and whether opportunities for
joint actions and/or the pooling of resources have been utilized, as well as GEF's
achievements in facilitating collaboration and coordination;.
5.3. Assess coordination and complementarity between GEF support at the sub-
regional, regional and national levels, and achievements in promoting information
sharing and collaboration;
5.4.
Assess timeliness and cost-effectiveness of the Implementing Agencies' efforts,
including efforts for delivering co-funding by the three IAs;.
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5.5. Assess systems for financial management, budgeting and accounting and the
division of expenditures and costs at the national, regional and overall levels.
5.6. Consider the effectiveness of evaluation, monitoring and other feed-back
mechanisms;
5.7. Analyze the comparative advantage of organizing GEF's assistance as global
umbrella projects vs. more limited national or regional programs.
5.8.
Assess efforts for the enhancement of scientific and technical advice to the GEF
on biosafety issues.
6. Issues for Follow-up
The evaluation team shall identify key issues for further follow-up by the GEF.
Appendix II
Timetable for Biosafety Evaluation
April 4-7, 2005
First team meeting to prepare draft Inception Report, including
protocols for interviews, formats for responses and final choice
of 20 countries for desk and field reviews.
April 25
Finalization of interview protocols/questionnaires to be sent to
GEFSEC/IAs for comments
April 15-30
Interview with the GEF Secretariat, Implementing Agencies,
CBD Secretariat, selected other donors
May 2-July 15
Teleconferences with 10 countries
May 2-July 15
Field visits to 10 countries; each country studied by two team
members and one local consultants
August 10
All field reports completed
August 22-25-
Full team meeting to decide on report outline and main
issues/discussion points/tentative conclusions
September 30
First draft report to be sent to GEFSEC and IAs for comments.
Sections on specific countries to be viewed by countries
October 15
Deadline for comments
Oct. 15Nov. 4
Redrafting and submission of final draft report to Council
January 15, 2006
Final report for printing
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Annex 3. Contents of the UNEP Toolkit
In response to an unmet demand for technical and operational guidance at the country
level, UNEP decided it was advantageous to develop a Toolkit. The Toolkit comprises
five modules which were completed between December 2001 and November 2004. The
contents are as follows:
· Phase 0 Starting the Project (December 20, 2001): This first module provides
guidance to key project participants (NEA, NPC, NCC) regarding how the project
should be managed, including their respective roles, and hiring and/or
composition of the NPC/NCC. It also addresses basic questions of government
and stakeholder participation in formulation of the NBF.
· Phase 1 Taking Stock (May 17, 2002): The second module is intended to
provide guidance on completing the various national surveys and preparation of
inventories in the different sectors pertaining to biosafety and biotechnology.
· Phase 2 Consultation and Analysis (September 26, 2003): This module
provides guidance on the identification of stakeholders, the consultation process
and analysis of survey findings, and training activities needed to identify the
priorities and parameters for drafting the NBF. The module also provides brief
advice on priority setting for NBF development, on and identifying and filling
gaps from survey finding analyses.
· Phase 3(i) Developing the Regulatory Regime (September 11, 2004): This
module describes the components of an NBF and presents a number of illustrative
examples of various approaches to biosafety regulation. The module also
examines broader questions of regulatory decision making and the role of
nonsafety considerations, approaches to transparency and public participation,
labeling, and inspection and enforcement.
· Phase 3(ii) Administrative Systems (November 30, 2004): This module
describes establishment of an administrative system to handle applications,
locating the risk assessment function, decision-making procedures, public
involvement, and other administrative duties of the competent authority(ies). The
module also provides examples from different countries related to monitoring,
inspection, and enforcement, and explains the common attributes of well-
functioning regulatory systems.
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Annex 4. Countries with Completed NBFs Reviewed by the
Evaluation Team
COUNTRY
COUNTRY
1
Argentina
20
Lao People's Democratic Republic
2 Armenia 21 Latvia
3 Belarus 22 Lesotho
4 Burkina
Faso 23
Liberia
5 Cambodia 24 Lithuania
6
Republic of Congo
25
Former Yugoslav Republic of
Macedonia
7
Côte d'Ivoire
26
Mali
8 Croatia 27 Moldova
9 Czech
Republic 28
Niger
10 Estonia 29
The
Philippines
11 Georgia 30 Samoa
12 Ghana 31 Senegal
13 Guatemala 32
Slovak
Republic
14 Indonesia 33 Slovenia
15
Islamic Republic of Iran
34
Tajikistan
16 Jordan 35 Tanzania
17 Kazakhstan 36
Togo
18
Democratic People's Republic of
37 Tonga
Korea
19
Republic of Korea
38
Vietnam
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Annex 5. Evaluation Team Members
Jarle Harstad, Evaluation Manager, GEF Evaluation Office
Jarle Harstad, lead monitoring and evaluation specialist in the GEF's Office of
Monitoring and Evaluation is the manager of, and a participant in, this evaluation. After
graduate studies in geography and economics, he served as a research assistant and
assistant lecturer at the University of Oslo, Norway. He has conducted longer term
research work in Kenya and Botswana and has also worked for the Kenyan and Ugandan
governments. Mr. Harstad has been a senior planning officer and a research and
evaluation officer in the Norwegian Agency for International Development and was head
of the evaluation division in the Norwegian Ministry of Foreign Affairs, before he joined
the GEF in 1996 to establish its monitoring and evaluation unit. Among his other duties
are coordination and drafting of monitoring and evaluation policies and methodologies,
and management of program, cross-cutting, and GEF-wide organizational evaluations.
Donald MacKenzie, Evaluation Co-Chair, Consultant
Donald MacKenzie is the executive vice president of AGBIOS, a private consulting firm
dedicated to providing biotechnology policy, regulatory, and risk assessment expertise.
Before joining AGBIOS, Dr. MacKenzie was head of the Science Policy Division within
Health Canada and was responsible for the development and coordination of
biotechnology policy within the Health Products and Foods Branch. He has also worked
in the Canadian Food Inspection Agency as associate director of the Program Issues
Coordination Office, where he was responsible for the management of high-visibility
issues in the areas of animal and plant health and production, food safety, and consumer
protection. Earlier, Dr. MacKenzie had a productive research career spanning the
disciplines of biochemistry, plant virology, and plant molecular biology within
Agriculture and Agri-Food Canada's Research Branch. He was among the first Canadian
researchers to apply plant transformation techniques for the production of transgenic crop
species with resistance to plant virus infection. From 1992 to 1997, Dr. MacKenzie was
chief of the Biotechnology Section at the Plant Protection Division's Centre for Plant
Health.
Jeffrey A. McNeely, Evaluation Co-Chair, Consultant
Jeffrey A. McNeely is chief scientist at IUCN, based in Gland, Switzerland, where he has
worked since 1980. He has been deeply involved in the Convention on Biological
Diversity from the earliest days, helping to draft the first concept of the convention and
attending most of its meetings until the present. He was a co-founder of the Global
Biodiversity Forum, which sought to enable civil society to contribute to the work of the
CBD. He is the author or editor of over a dozen books on biodiversity, and has recently
been working on enhancing the relationship between biodiversity and other fields such as
agriculture, human health, and energy. His 2003 book (with Sara Scherr), Ecoagriculture,
identifies research priorities for linking agriculture with wild biodiversity. He is on the
Scientific and Technical Council of the International Risk Governance Council, a
member of the Advisory Board of the Sustainable Agriculture Initiative, and a member of
the Bureau of the International Assessment of Agricultural Research and Technology for
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Sustainable Development. He is also on the editorial advisory board of eight international
journals. He has done field work or provided technical advice in over 70 countries.
Joshua E. Brann, GEF Evaluation Office
Joshua Brann has worked with the Global Environment Facility for more than three
years, first as a member of the GEF Secretariat biodiversity team, and then as a member
of the GEF Office of Monitoring and Evaluation. Prior to becoming involved in the
evaluation of GEF biosafety activities, Mr. Brann was a primary contributor to the
Biodiversity Program Study and the Overall Performance Study of the GEF. He has also
been involved in the GEF Office of Monitoring and Evaluation's annual performance
review, and evaluations of the GEF project cycle and the GEF Operational Program on
Integrated Ecosystem Management.
Before joining the GEF, Mr. Brann worked for numerous NGOs, including the World
Wildlife Fund. He received his M.A. in international relations and economics from the
Johns Hopkins University School of Advanced International Studies.
Jane Morris, Consultant
Jane Morris gained her training in biochemistry in Scotland. She worked in the CSIR in
South Africa for several years before moving to the University of British Columbia in
Canada. On returning to South Africa, she joined a large chemical company, AECI Ltd,
where she took responsibility for biotechnology R&D in an industrial environment. She
rejoined the CSIR in 1999 and managed its Strategic Technology Group in the division of
Food, Biological, and Chemical Technologies before taking on her current role as
director of the African Centre for Gene Technologies, a joint initiative of the CSIR and
the University of Pretoria to establish a platform in gene discovery.
Ms. Morris has a long association with biotechnology and biosafety in South Africa,
having chaired SAGENE, the advisory committee on genetically modified organisms
(GMOs) before the GMO Act was passed. In this role, she was actively involved in the
drafting of the GMO Act. She assists the South African Department of Agriculture in
reviewing applications for use or release of GMOs under the GMO Act, and was recently
a member of an appeal board constituted under the act. She has acted as a resource person
in various international training activities involving biotechnology and biosafety. She has
also served on the national board of the International Council for Science, and has
participated in various South African government delegations involved in establishing
biotechnology links with other countries.
Harold Roy-Macauley, Consultant
Harold Ransford Roy-Macauley, a native of Sierra Leone, has over 15 years' experience
in scientific leadership and has contributed to enhancing the scientific capacity of
national agricultural research systems of developing countries--mainly in Africa--in the
areas of plant biodiversity improvement and agricultural development. He has work
experience with public and private research, training and development
institutions/organizations, farmers, and civil society organizations at the Africa-wide and
international levels. He is involved in several coordination, planning, and evaluation
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processes for the application of modern biotechnology in agricultural research in West
and Central Africa. He is also coordinating the Forum for Agricultural Research in Africa
initiative for improving and accelerating the development and implementation of
biosafety systems for modern agricultural biotechnology. Dr. Roy-Macauley is bilingual
in English and French.
Tomme Rozanne Young, Consultant
Tomme R. Young is senior legal officer at the IUCN Environmental Law Center in Bonn,
Germany. Throughout her 23 years as a lawyer, she has developed a specialized expertise
in environmental law and policy, with a focus on natural resource management and
integration of environmental legislation with other legislation addressing social policy
and commercial objectives. In the field of biosafety, she has focused on issues of national
policy and decision making, and the special needs of development of technologically,
environmentally, and commercially appropriate legislation in this complex and technical
area. Ms. Young has served as a special advisor on environmental and sustainable
development issues to foreign governments, under the auspices of several UN agencies.
She has advised the governments of more than 30 countries in Europe, Africa, Asia,
Oceania, and the Americas on legislative drafting and negotiations and regulatory
development. She has participated in the negotiation of international and regional
agreements, and has served on the IUCN delegation to several of them. She has prepared
advisory white papers on key elements of the Biodiversity Convention and its
implementation, as well as on sustainable development, invasive species, environmental
protection, resource development, conservation finance, certification, environmental
liability/enforcement, and coastal zone management. Prior to entering international work,
she represented numerous multinational corporate clients while in private practice.
Dora Nsuwa Cudjoe, Administrative Consultant
Dora Cudjoe joined the GEF Monitoring and Evaluation Office as a consultant with the
biosafety evaluation team. Prior to this appointment, she gained experience in monitoring
and evaluation with the energy and environment unit of the UNDP country office in
Ghana, where she undertook mid-term tripartite review of UNDP-sponsored projects.
Earlier, Ms. Cudjoe worked with the Environmental Protection Agency in Ghana
monitoring health and socioeconomic impacts of certain industrial activities. She
reviewed environmental impact assessments for projects.
Ms. Cudjoe holds a master's degree from the Yale University School of Forestry and
Environmental Studies in environmental management, focusing on the science and policy
of cross-cutting environmental issues. She is Ghanaian.
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REVIEW FOR THE DELPHI STUDY OF THE UNEP TOOLKIT
Review Team, Vrije Universiteit, Amsterdam:
Professor T. de Cock Buning, PhD
F. Haker, MSc
Professor P. Bereano (University of Washington)
Dr. J. de Boer, PhD
Professor J. Bunders, PhD
Advisory Panel to the Research Team:
Dr. J. Cohen
International Food Policy Research Institute, USA
Dr. G. Fuller
Croplife Asia (China)
Dr. O.M. El-Tayeb
University of Cairo
Dr. T. Young
World Conservation Union, Germany
Dr. K. Chnon Lek
Nanyang Technological University, Singapore
D.
Mackenzie
Agbios,
Canada
J. Mayr
Former Minister of Environmental Affairs, Colombia
P. Phifer
U.S. Fish and Wildlife Service, USA
Dr. E. Bravo
Red por una Americana Latina Libre de Transgenicos,
Ecuador
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Annex 6. Interviewees
A. GLOBAL ENVIRONMENT FACILITY SECRETARIAT
1. Gonzalo Castro, Team Leader, Biodiversity
2. Patricia Bliss Guest, Deputy Chief Executive Officer
3. Paz Valiente, Senior Environmental Specialist
B. UNEP/GEF BIOSAFETY UNIT
1. Christopher Briggs, Global Development Program Manager, UNEP/GEF
Biosafety Unit, Switzerland
2. David Duthie, Information Officer, UNEP/GEF Biosafety Unit, Switzerland
3. Liina Eek, Assistant Regional Coordinator for Central and Eastern Europe,
UNEP/GEF Biosafety Unit, Switzerland
4. Giovanni Ferraiolo, Regional Coordinator for Latin American and Caribbean
Region, UNEP/GEF Biosafety Unit, Switzerland
5. Charles Gbedemah, Regional Coordinator for African Region, UNEP/GEF
Biosafety Unit, Kenya
6. Nizar Mohamed, Regional Coordinator for Asia Pacific Region, UNEP/GEF
Biosafety Unit, Switzerland
7. Fee Chon Low, Implementation Project Manager, UNEP/GEF Biosafety Unit,
Switzerland
C. UNDP
1. John Hough, UNDP Senior Technical Advisor for Biodiversity, New York, USA
D. WORLD BANK
1. Matthew A. McMahon, Lead Agriculturist
2. Mary Ellen Foley, Task Manager, Biosafety Projects
3. Indira Janaki Ekanayake, Lead Agriculturist
4. Eija Pehu, Adviser, Agriculture and Rural Development
5. Morven Mclean, Consultant to the World Bank, AGBIOS, President
E. CBD SECRETARIAT, MONTREAL, CANADA
1. Cyrie Sendashonga, Head of Biosafety Programme
2. Kirsty McLean, Programme Officer
3. Ryan Hill, Programme Officer
4. Erie Tamale, Programme Officer
STAKEHOLDER GROUPS
F. GLOBAL INDUSTRY COALITION ON BIOTECHNOLOGY, USA
1. Sarah Lukie, Senior Advisor
G. THIRD WORLD NETWORK
1. Lim Li Lin, Researcher
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H. GLOBAL BIOSAFETY CONSULTANTS
1. Julian Kinderlerer, Evaluator of the Pilot Phase
2. Pietvander Meer, Biosafety Consultant
I. REGIONAL CONSULTANTS
1. Mexico, and Guatemala: Maria Amanda Galvez Mariscal, Professor,
Department of Food Science and Biotechnology, Faculty of Chemistry;
Coordinator, University Food Science Program, National Autonomous University
of Mexico
2. Croatia: Jasmina Nicola Ginovska, Local Coordinator, Agriconsulting, Europe
S.A Brussels, Macedonia
J. NATIONAL CONSULTANTS
1. Bahamas: Sharrah T. Moss, Environmental Education Officer, Exuma Education
Resource Centre, Exuma
2. Burkina Faso: Jeremy Tinga Ouedraogo, Researcher, Institut de
l'Environnement et Recherches Agricoles
3. China: Yan Xie, Associate Research Professor, Institute of Zoology, Chinese
Academy of Sciences
4. Croatia: Meira Bosni, (formerly) National Project Coordinator for the
UNEP/GEF Project
5. India: Pushpam Kumar, Lecturer/ Department of Environmental Biology,
University of Delhi; Associate Professor, Institute of Economic Growth, Dehli
6. Morocco: Ismail El Hadrami, Researcher, Faculte de Sciences Semnalia,
Unversite Cadi Ayyad Marrakech, Morocco
7. Tajikistan: Shavkat Ismailov, Water and Sanitation Program Manager,
International Society of Red Cross and red Crescent Society
8. Uganda: Patrick Rutimbanzigu Rubaihayo, Professor, Makerere University
FIELD VISITS
I. BAHAMAS
1. Stacey Moultrie, National Project Coordinator
2. Marcus Bethel, Minister, Health and Environment
3. Elma Garroway, Permanent Secretary, Health and Environment
4. Kenneth Richardson, Chair, National Coordinating Commission (BEST)
5. Donald Cooper, Undersecretary, GEF Operational Focal Point
6. John Hammerton, (retired) Chief Scientist, BEST
7. Maurice Isaacs, Veterinary Officer, Department of Agriculture
8. Ramould Ferreira, Attorney in private practice; Consultant
9. Lynne Gape, Director, Education and Communications, Bahamas National Trust
II. BURKINA FASO
1. Bertrand Zida, Secretary General, Ministry of Environment
2. Samuel Yeye, The Project Coordinator
3. Lompo Zourata, Director Biosafety National Agency
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4. Bancé Soumaila, Focal Point, Cartagena Protocol on Biosafety
5. Lambert Ouedraogo, Member, National Coordinating Committee
6. Kabore Marguerite, Member, National Coordinating Committee
7. Albert Ouedraogo Member, National Coordinating Committee
8. Zangré Roger, Consultant
9. Francis Massimbo, Consultant
10. Sourabié Ibrahim, Technical Adviser of the Ministry of Agriculture
11. Zongo Jean Didier, University of Ouagadougou
12. Basile Guissou, Director General, CNRST
13. Boly Hamidou, Director, INERA
14. J. D. Zogo, Coalition veille OGM
15. François Traoré, UNPCB/CPF ; Farmer and Producer Organisations
16. Toguieni, Consumer Organizations
III. CHINA
1. Guangqing Zhu, National Coordinator, GEF Project; Director, Biodiversity and
Biosafety Project, State Environmental Protection Agency (SEPA)
2. Andrew Laurie, CTA, GEF-UNDP China Wetland Biodiversity Project
3. Beiwei Zeng, (retired) Hunan Environmental Protection Bureau
4. Bentai Wan, Director General, Department of Natural Protection and Ecology
Conservation, SEPA
5. Bill Bleisch, Director, China Program, Fauna and Flora International (FFI)
6. Bin Li, Officer, IUCN, China
7. Biqing Li, Director, Department of Science and Technology, Ministry of
Commerce
8. Changju Yang, Professor, College of Environmental Sciences, People's
University, China
9. Chaode Ma, Program Manager, Project Management Division, Foreign Economic
Cooperation Office, SEPA
10. Dayuan Xue, Researcher, Nanjing Institute of Environmental Sciences, SEPA
11. Dongsheng Liu, Officer, GTZ Project Office, Division of Agro-Resources and
Environment, Department of Science, Education and Rural Environment,
Ministry o f Agriculture
12. Fei Xie, Director of the GEF China Office
13. Guiling Wang, Deputy Director, Project Management Office, UNDP/GEF
Conservation and Greenhouse Gas Emissions Reduction in Chinese Township
and Village Enterprises, Ministry of Agriculture
14. Haibin Xu, Professor, National Institute for Nutrition and Food Safety, Chinese
Center for Disease Control and Prevention
15. Haigen Xu, Researcher, Nanjing Institute of Environmental Sciences, SEPA
16. Haijun Zhao, Program Officer, Project Management Division, Foreign Economic
Cooperation Office, SEPA
17. Jianzhi Zhang , Contact person, GEF Project; Officer, Biodiversity and Biosafety
Office, SEPA
18. Jie Gong, Project Coordinator, German Technical Cooperation (GTZ)
19. Keping Ma, Deputy Director, Institute of Botany, Chinese Academy of Sciences
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20. Kongming Wu, Executive Director, Institute of Plant Protection, Chinese
Academy of Agricultural Sciences
21. Lu Yan, Program Officer, Fauna and Flora International
22. Ninan Wu, Program Officer, Project Management Division IV, Foreign Economic
Cooperation Office, SEPA
23. Qin Wang, Program Officer, Project Management Division, Foreign Economic
Cooperation Office, SEPA
24. Qin Wang, Translator, Program Officer, Project Management Division IV,
Foreign Economic Cooperation Office, SEPA
25. Seth Cook, Director, IUCN, China
26. Shuang Gao, Project Assistant, Project Management Office, UNDP/GEF CBD
Implementation, Ministry of Agriculture
27. Shuifang Zhu, Deputy Director General, Institute of Animal and Plant Quarantine,
Chinese Academy of Quality Inspection and Quarantine
28. Sung Wang, Professor, Institute of Zoology, Chinese Academy of Sciences
29. Sze Pang Cheneung, Campaign Manager, Greenpeace
30. Wang Canfa, Professor, University of Political Science and Law, China
31. Wenjuan Zhang, Executive Assistant, UNEP Office in Beijing, UNEP
32. Wenxuan Yu, Volunteer, Center for Legal Assistance to Pollution Victims
33. Xin Zhi, Division of Transgenic Safety Department, Centre for Science and
Technology Development, State Forestry Administration
34. Xingguo Han, Director, Institute of Botany, Chinese Academy of Sciences
35. Xinwu Wang, Deputy Director, Biosecurity Division, Department for Supervision
on Animal and Plant Quarantine, General Administration of Quality Supervision,
Inspection and Quarantine
36. Xuefeng Sun, Director, Project Management Division IV, Foreign Economic
Cooperation Office, SEPA
37. Xuemin Shao, UNEP/GEF Coordinator, UNEP China Office, UNEP
38. Yexu Wang, Senior Program Officer, Foreign Economic Cooperation Office,
SEPA
39. Yexu Wang, Senior Program Officer, Project Management Division IV, Foreign
Economic Cooperation Office, SEPA
40. Yingfeng Guo, Senior Program Officer, Project Management Division IV,
Foreign Economic Cooperation Office, SEPA
41. Zhang Jianzhi, Senior Project Officer, Biodiversity and Biosafety Office, SEPA
42. Zhuyun Wang, Director, Office for Management of Invasive Alien Species,
Division of Agro-Resources and Environment, Department of Science, Education
and Rural Environment, Ministry o f Agriculture
43. Rusong Li, Program Officer, Energy and Environment Cluster, UNDP
44. Ning Li, Director, Biosafety Office of Agricultural GMO, Development Centre
for Science and Technology, Ministry of Agriculture
45. Jiancheng Shao, Deputy Director, Biosafety Office of Agricultural GMO,
Development Centre for Science and Technology, Ministry of Agriculture
46. Kai Wei, Officer, Biosafety Office of Agricultural GMO, Development Centre for
Science and Technology, Ministry of Agriculture
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47. Andres Liebenthal, Sector Coordinator, Environment and Social Development
Sector, World Bank, Beijing, China
IV. CROATIA
NCC Members
1. Davorin Markovic, National Focal Point for Cartagena Protocol on Biosafety
2. Irina Zupan, State Institute, State Institute of Nature Protection
3. Meira Bosni, National Project Coordinator, National Executing Agency
4. Sanela Ljubenko Mihelj, Croatian National Institute for Public Health
5. Srecko Jelenic, Faculty of Science, University of Zagreb
6. Vida Posavec, Project Assistant, State Institute for Nature Protection
7. Vinko Kozumplik, Faculty of Agriculture, University of Zagreb
8. Vladimir Lay, Institute of Social Sciences Ivo Pilar
9. Zoran Zgaga, Faculty of Food Technology and Biotechnology, University of
Zagreb
NGO Members
10. Helen Lipanovic, Green Istria
11. Irena Brnada, REC Country Office for Croatia
12. Jadranka Pelikan, Eko Zadar
13. Jagoda Munic, Green Action
14. Ksenija Pavlekovic, Society IQL BIOVEGA Company
15. Nediljko Landeka, Green Istria
16. Sonja Karoglan Todorovic, Ecologica
17. Zdenka Kocmur, Croatian Association for Consumers Protection
18. Zlatko Pejic, Society for Improvement Quality of Living
NEA and Ministry Representatives
19. Jasminka Radovic, Head, Expertise Division and BFP for CBD, State Institute for
Nature Protection
20. Zoran Sikic, Assistant Minister, Minister of Culture
Industry Representatives
21. Damir Janic, Manager, Biotechnology Products, PLIVA HRVATSKA-
Pharmaceutical Company
22. Ita Juros, Croatian Chamber of Economy
23. Maja Zecevic, PODRAVKA d.d.
24. Slaven Racki, Investments Specialist; Environment Protection, PLIVA
HRVATSKA- Pharmaceutical Company
Representatives from Croatian Food Agency
25. Domagoj Simic, Member, Institute for Agriculture, University of Osijek
26. Gordan Lauc, Member of the Panel, Faculty of Medicine, University of Osijek
27. Jelena Zafran Novak, Member, Croatian National Institute for Public Health
28. Krunoslav Capak, President, National Coordinating Committee
29. Sanja Milos, Coordinator, Croatian Food Agency
30. Srecko Jelenic, Member, Faculty of Agriculture, University of Zagreb
Members of the Committee for drafting by-laws for contained use of GMO
31. Duska Vujaklija, Rudzer Boskovic Institute
32. Gordan Lauc, Faculty of Medicine, University of Osijek
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33. Hrvoje Fulgosi, Member, National Coordinating Committee
34. Hrvoje Zorc, Deputy Minister, Ministry of Science, Education and Sport
35. Vladimir Delic, Faculty of Science, University of Zagreb
36. Zoran Zgaga, Faculty of Food Technology and Biotechnology, University of
Zagreb
Representatives of the Ministry of Health and Social Welfare
37. Ivana Vrhovec, Sanitary Inspector
38. Ivo Africh, Deputy Minister
39. Natasha Fischbach, Sanitary Inspector
40. Ptichek, Sanitary Inspector
41. Zeljko Slemenshek, Sanitary Inspector
There are seven additional sanitary inspectors who's names are not known.
Ruder Boskovic Institute
42. Duska Vujaklija, Division of Molecular Biology
43. Hrvoje Fulgosi, Division of Molecular Biology
44. Magdalena Grce, Division of Molecular Biology
45. Mladen Zunic, Director
GEF Focal Point:
Ministry of Environment Protection, Physical Planning and Construction
46. Nikola Ruzinski, State Secretary, GEF Political Focal Point
47. Gordana Ruklic, GEF Operational Focal Point
Ministry of Agriculture, Forestry and Water Management (MAFWM)
48. Branka Bukovic Sosic, Veterinary Department, MAFWM
49. Darka Hanel, Institute for Plant Protection, Zagreb
50. Davor Samota, Member of NCC, BIOPA-Osijek
51. Delfa Rados, Forestry Department, MAFWM
52. Djuka marik, Agricultural Inspector, MAFWM
53. Jadranka Micka, Department for Food Industry, MAFWM
54. Miljenko Deskovic, Forestry Department, MAFWM
55. Miljenko Rakic, Division of Agriculture, MAFWM
56. Robert Smolec, Section of Phytosanitary Inspection, MAFWM
57. Snjezana Keresha, Faculty of Agriculture
58. Stanislav Volenik, State Institute for Seed and Seedlings
Members of Parliament
59. Boris Varga, External Member, Agriculture and Forestry Committee
60. Miljenko Doric, Member, European Integration Committee
61. Silvano Hrelja, Member, Committee on Labor, Social Policy and Health
62. Zeljko Kurtov, Member, Agriculture and Forestry Committee
Vegetable Producers and Traders at the Green Market, Zitnjak
63. Drazen Cacic, Consultant Head, Vegetable Growers Association, Agricultural
Extension Institute
UNDP Representative
64. Sandra Balent, Department of Environment Protection
V. ETHIOPIA
Members of the National Administration and National Competent Authority
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1. Tewolde Berhan G. Egziabher
2. Desalegn Mesfin
3. Solomon Kebede
4. Wondweson Sintayehu
5. Belete Geda
6. Mahlet Teshome
7. Tarik Kassa
Members of the National Coordinating Committee
8. Hailu Tefera
9. Berhe G. Egzihabeher
Technical Experts
10. Zerihun Woldu, Addis Ababa University
Members of the National Coordinating Committee
11. Eshetu Lemma
12. Tsegaye Kidane Mariam
13. Negusu Aklilu
14. Ayele Kebede
Members of the National Coordinating Committee
15. Girma Yosef, Ethiopian Science and Technology Commission
16. Mered Kumsa, Ministry of Agriculture & Rural Development
17. Million Habte, International Law
18. G. Medhin Birega, MoARD
19. Alemu Jote, MoARD
20. Ato Desalegn Mesfin, Environmental Protection Authority
VI. GUATEMALA
National Coordinating Committee
1. Roberto Cobaquil, Chair, National Coordinating Committee
2. Ana Luisa Noguera SE- Consejo Nacional de Áreas Protegidas
3. ( National Executing Agency)
4. Juan Mario Dary, Ministerio de Ambiente y Recursos Naturales
5. Alvaro Orellana, Agricultural Research Institute
6. Nicolás Alfredo Pelíco, Centro de Acción Legal Ambiente y Social de Guatemala
7. Juan de Dios Calle, Vice Ministro del Ambiente y Recursos Naturales
8. Ana del Rosario Aragón, Ministerio de Economía
9. Pablo Eduardo Calderón, (Consejo Nacional de Áreas Protegidas);
10. Consejo de Investigación para el Desarrollo de Ciencias Agrícolas
11. Ana Lucia Orozco, Consultant
12. Joana Cabrera, Liga Del Consumidor (not a member of the NCC)
Instituto de Ciencia y Technología Agrícola
13. Luis Gerardo Molina, Director, Instituto de Ciencia y Tecnología Agrícola
14. Aura Elena Suchini, President, Comité de Biotechnología
Risk Assessment Focus Group
15. Ricardo Avila, Technical University, CONAP
16. Hiram Aragones
17. Cesar Azurdia, Consultant
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18. Guillermo Godiñez, CONOCyT
Law and Risk Management Focus Group
19. Alexandra Sobenes, Consultant
20. Juan de Dios Calle, Vice Ministro Recursos Naturales (MARN)
21. Milton Cabrera, MARN
22. Catalina López-Gálvez, National Project Coordinator
Laboratorio de Fitopatología, Universidad de Valle
23. Margarita Palmieri, Profesora, Department Head
24. Carlos Rolz, Dean
Industry representatives and others
25. Ingrid Barillas, Ministerio de Economía
26. Cristina Rodas, MAGA
27. Fidel Us, Academia de Lenguas Mayas
28. Ricardo Avila, Technical University/CONAP
29. Manuel Rivas, Monsanto
30. Laureando Figueroa, Syngenta
31. Joventino Flores, CONAGRAB
32. Horacio Villavicencio, Algdones Maya
33. Donal Rogozinski, SEMECA
Delegation of Central American NGOs Red de Coodinación en Biodiversidad
34. Julio Sanches, Friends of the Earth, Nicaragua
35. Fabian Pacheco, Alianza Centroamericano de Protegida a la Biodiversidad, Costa
Rica
36. Mario Godínez, Asoc. Ceiba. Guate (also working in El Salvador)
37. Juvencio Chom, Alianza de Protrgida a Biodiv (U. San Carlos) Guatemala
38. Representative from Madreselva, Honduras
VII. INDIA
1. Suman Sahai ,Gene Campaign
2. Tilak R. Sharma, Senior Scientist, National Research Centre on Plant
Biotechnology, Indian Agricultural Research Institute
3. V. P. Sharma Meghnad Saha, Distinguished Fellow, The National Academy of
Sciences
4. Manju Sharma, Board Member, United Nations University-Institute of Advanced
Studies, Japan
5. Prodipto Ghosh, Secretary, Ministry of Enlivenment and Forests
6. Ashok Khosla, President, Development Alternatives
7. K. Vijaya Lakshmi , Manager, Environment Systems Branch, Development
Alternatives
8. K. Bhan, Secretary, Department of Biotechnology Ministry of Science &
Technology
9. George C. Varughese, Vice-President, Development Alternatives
10. Rachid Benmessaoud Operations Adviser, The World Bank, India
11. Vibha Dhawan, Vice-Chancellor, Teri School of Advanced Studies
12. Sachin Chaturvedi, Fellow, Research and Information System for Developing
Countries
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13. Bilal H. Rahill, Lead Environmental Specialist, The World Bank, India
14. Manoranjan Hota, Additional Director, Ministry of Environment and Forests
15. M.S. Swaminathan, Chairman, National Commission on Farmers, Ministry of
Agriculture
16. G. Kalloo, Deputy Director General, Horticulture and Crop Science
17. C. R. Babu, Vice Chancellor, University of Delhi
18. Suresh Babu, Research Scholar, Centre of Environmental Management of
Degraded Ecosystem, University of Delhi
19. Inderjit, Professor, Centre of Environmental Management of Degraded
Ecosystem, University of Delhi
20. Meena Gupta, Additional Secretary, Ministry of Environment and Forests
21. R. S. Sharma, Scientist, Centre of Environmental Management of Degraded
Ecosystem, University of Delhi
22. D. D. Verma Jt. Secretary, Additional Secretary, Ministry of Environment and
Forests
23. Amit Love, Research Scholar, Centre of Environmental Management of
Degraded Ecosystem, University of Delhi
24. Prem Narayan Jt. Secretary, Ministry of Agriculture
25. Samar Singh, Executive Director General, WWF India
26. K. Kahrialoo, National Bureau of Plant Genetic Resources, Indian Agricultural
Institute
27. Raju Barwale, Managing Director, Mahyco Industries, Mumbai
28. R. K. Sinha Coordinator, All India Crop Biotechnology, New Delhi
VIII. MEXICO
1. Agustín Lopez, National Project Coordinator
2. Omar Trujillo Vazques, Assistant to the National Project Coordinator
3. Manuel Robert, Executive Director, National Biosafety Focal Point
4. Perla Pineda, UNDP Focal Program Officer
5. Jonathan Ryan, UNDP liaison, SEMARNAT
6. Manuel Robert, Executive Director, CIBIOGEM
7. Jose Luis Solleiro, CCADET, Mexico
8. Juan Manuel de la Fuente, Monsanto
9. Francisca Acevedo, Comisión Nacional para el Conocimiento y Uso de
Biodiversidad (CONABIO)
10. Johathan Ryan, UNDP/SEMARNAT
11. Concepción Rodriguez, UNAM
12. Maria Colin, Greenpeace
13. Cati Mirelle, GEA
14. Marcelo Signorini Porchietto, Subdirector Exectivo de Efectos Poblacionales,
Comissión de Evidencia y Manejo de Riesgos Sanitarios, Secretaria de Salud
15. Rocío Madrid, Secretaria de Salud
16. Representative from SAGARPA
17. Mindahi Muñoz Bautista, Director, Desarrollo Sustentable, Universidad
Intercultural del Estado de México
18. Marco Cotero, SAGARPA
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19. Adelita San Vicente, Advisor, Environmental Sub-Committee in Congress.
20. Fernando Ulises Adame, Diputado, Chair, Comisión de Recursos Hidràulicos;
Chair, Science and Technology Commission
21. Gloria Margarita Alvarez López, Subdirectora, Centro de Estudios para
Desarrollo Rura Sustentable y Soveranía Alimentaria, Càmara de Diputados
22. Marco Meraz Rioz, Investigation Director, Consejo Nacionàl de Ciencia y
Tecnología (CONACYT)
23. Elleli Huerta, SEMARNAT
24. Patricia Tovar, SEMARNAT
25. Claudia Grayeb, GEF Focal Point
26. Cesar Chavez, GEF Focal Point
27. Irene Pisanty, National Institute for Environment
28. Jose Carlos Fernandez, National Institute for Environment
29. Sol Ortiz, INE
30. Gustavo Alanis, Presidente, Centro Mexicano de Derecho Ambiental (CEMDA)
31. Thierry Lamaresquier, Resident Representative, UNDP México
32. Rosa Santizo
33. Jonathan Ryan, UNDP/SEMARNAT
34. Maria Amanda Galvez Mariscal , Director, (PUAL),Universidad Nacional
Autonomia de México (UNAM); Chair, Consejo Consultativo de Biosecuridad
(organized under CIBIOGEM)
IX. MOROCCO
1. Mostapha Terzaz, Ministère de l'Aménagement du Teeritoire, de l'Eau et de
l'Environnement (MATEE) / DSPR.
2. Abdenachid Boutouba, MADRPM / DAP
3. Grini Ahmed, DELNCMV
4. Fouad Ziadi, MATEE / DRC
5. Ismaïl El Hadrami, Faculté des Sciences, Semlalia, Marrakech
6. Hassan Bendahmane, ANCRE
7. Abdelfetah Sahibi, MATEE / Division Coopération
8. Mohamed Sabir, Ecole Nationale Forestière d'Ingénieurs
9. Najat Hazaoud, MAEC
10. Abderrahmane Kabbaj, CRF/HCEFLCD
11. Jaafar Boulejiouch, MATEE / DPEI
12. Jaouad Mouhabib, MATEE / CNB
13. Said Izrar, Ministère de l'Intérieur / DGCL/DEA
14. Halila Habib, Représentant de la FAO au Maroc
15. Fouad Guessous, IAV Hassan II
16. Hassan Sbay, Eaux et Forêts / HCEFLD
17. Abdelhak Seddas, SERDIAG
18. Abdelkarim Filali, Faculté des Sciences, Rabat
19. Noreddine Benkerroum, IAV Rabat
20. Abdelaziz Bencheikh, S.G du Forum 21 du Dialogue et du Développement
21. Hammou Jader, Secrétaire Général, Haut Commissariat aux Eaux et Forêts et à la
Lutte contre la Désertification
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22. Hassan Sbay, Eaux et Forêts / HCEFLD
23. Mohamed Kamal, Inspecteur Général, INRA
24. Abdelmajid El Idrissi Ammari, Secrétaire Général, INRA
25. Amar Tahiri, Ingénieur en Chef, Chef du Service de contrôle des semences et
plants
26. Mohamed Belhadri, Igénieur Agronome, Service du Contrôle des Semences et
Plants
27. Chercheurs: Mohamed Sabir, Zine El Abidine, Khattabi, Benrahmoun and El
Idrissi, Directeur, ENFI
28. Mustapha Labhilili,Driss Iraqi, Meriem MdarhriAlaoui, Ghizlan Diria, Rabha
Abdelwahed, Directeur, Chercheurs du Laboratoire de Biotechnologies Végétales,
INRA-Rabat
29. Jaafar Boulejiouch, Agence d'exécution du Projet, MATEE
30. Mohamed Akallal, Agence d'exécution du Projet, MATEE
31. Benahmed Chihab, Coordonnateur du Projet, MATEE
32. Mustapha Ait Chitt, Directeur du Laboratoire de Biotechnologie Appliquée,
Domaines Agricoles, Meknès
33. Noureddine Ouazzani, Ecole nationale d'Agronomie-Meknes
X. TAJIKISTAN
1. Neimatullo Safarov, National Project Coordinator
2. Anastasia Idrisova, Consultant, National Executing Agency
3. Tatyana Novikova, Consultant, National Biodiversity and Biosafety Center
4. Rakhmatullo Khairullaev, Member, National Coordination Committee
5. Mukimov Erkin, Member, National Coordination Committee
6. Jamilya Ruzieva, Member, National Coordination Committee
7. Tolib Irgashev, Agricultural Expert, Tajik Research Institute for Cattle Breeding
8. Zafar Raimnazarov , Agricultural Expert, State Committee for Plant Quarantine
9. Davlatier Salomov, Agricultural Expert, Farmer's Association
10. Kurbon Aliev, Expert, Institute of Plant Physiology and Genetics
11. Vahob Bobojanov, Expert, Biotechnology and Genetics, Tajik State University
12. Mavjuda Kholmatova, Expert, Institute of Plant Physiology
13. Timur Idrisov, Representative of NGO and mass media, NGO "For the Earth"
14. Svetlana Blagoveshenskaya, "Kuhiston" Foundation
15. Zamira Makhmudova, Representative of NGO and mass media, Medical College,
16. Mr. Karimov Abduvohid, Focal Point, Institute of Ecology
17. Mr. Sattorov Izatullo, Agriculture Expert, Tajik Agrarian University
18. Mr. Igor Bosc, Deputy Resident Representative, UNDP
XI. UGANDA
Members of the National Coordinating Committee and National Biosafety
Committee
1. Johnson Nkuuhe, Member of Parliament; Vice-Chair, Science and Technology
Committee
2. Members of the Consumer Education Trust led by Richard Kimera,
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3. Tilahun Zeweldu Abebe, Agricultural Productivity Enhancement Program
(APEP)/USAID
4. David L.N. Hafashimana, Focal Point, Convention for Biological Diversity
5. B.K. Kabanda, Permanent Secretary, Ministry of Water, Lands and Environment
6. B. Apuuli, Director, Ministry of Water, Lands and Environment
7. Fiona Bayiga, Attorney General's Office, Ministry of Justice
8. John Joseph Otim, President, Agricultural Council of Uganda; Senior Advisor to
His Excellency, the President of Uganda
9. Chebet Maikut, President, Uganda National Farmers Federation
10. Josephine A. Okot, Managing Director, Victoria Seeds Limited
11. Gabriel Iputo, Manager, Victoria Seeds Limited
12. Nine members of the Agriculture Committee of Parliament led by Chairperson
Honorable Odit
13. Isaac Isanga Musumba, Minister of State for Finance, Planning & Economic
Development
14. Minister of State for Agriculture
15. Theresa Sengooba, Member, National Coordinating Committee; Regional
Coordinator, (USAID/PBS)
16. Emmanuel Iyamulemye Niyibigira, Senior Agriculture Inspector, Phytosanitary,
Department of Crop Protection, Ministry of Agriculture
17. Afedrarie Lominda, Reporter, Monitor Press
18. Patrick Luganda, Chief Editor, Farmers Voice Newspaper
19. Cirace Musimami, Journalist, Farmers Voice
20. Peter Wamboga-Mugirja, Chief Reporter, Farmers Voice
21. Paul Nampala, Project Officer, Uganda National Commission for Science and
Technology
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