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.28/Inf.1
May 8, 2006
GEF Council
June 7-9, 2006







EVALUATION OF THE GEF SUPPORT TO BIOSAFETY



(Prepared by GEF Evaluation Office)

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Global Environment Facility
Evaluation Office
Evaluation of GEF Support
for Biosafety
Executive Version
January 2006
Evaluation Report No. 28

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© 2006 Global Environment Facility Evaluation Office
1818 H Street, NW
Washington, DC 20433
Internet: www.thegef.org
E-mail: gefevaluation@thegef.org
Al rights reserved.
The findings, interpretations, and conclusions expressed herein are those of the author(s) and do not necessarily reflect the views of the GEF
Council or the governments they represent.
The GEF Evaluation Office does not guarantee the accuracy of the data included in this work. The boundaries, colors, denominations,
and other information shown on any map in this work do not imply any judgment on the part of the GEF concerning the legal status of
any territory or the endorsement or acceptance of such boundaries.
Rights and Permissions
The material in this work is copyrighted. Copying and/or transmitting portions or al of this work without permission may be a violation of
applicable law. The GEF encourages dissemination of its work and wil normal y grant permission promptly.
ISBN: 1-884122-46-9
Global Environment Facility
Director of the GEF Evaluation Office: Robert D. van den Berg
Task Manager, GEF Evaluation Office: Jarle Harstad
Biosafety Evaluation Team:
Donald J. MacKenzie, Co-Chair, Consultant
Jeffrey A. McNeely, Co-Chair, Consultant
E. Jane Morris, Consultant
Harold Roy-Macauley, Consultant
Tomme R. Young, Consultant
Joshua E. Brann, GEF Evaluation Office
Dora Nsuwa Cudjoe, Administrative Consultant
Editing and layout: Nita Congress
Printing: Graphic Communications
Cover photo: Anvar Ilyasov
Evaluation Report No. 28
A FREE PUBLICATION

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Contents
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .v
1. Main Conclusions and Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2 Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2. Background, Scope, and Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.1 Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.2 Evaluation of GEF Biosafety Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.3 Initial LMO Country Capacity (National Baselines) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3. GEF Support for Biosafety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.1 Development of NBFs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.2 Implementation of NBFs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.3 Capacity Building for BCH Participation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4. Modalities of GEF Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
4.1 NBF Development Project . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
4.2 Individual NBF Implementation Projects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4.3 Agency Fee Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4.4 Comparative Advantages of the Implementing Agencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
5. Regional Col aboration, Harmonization, and Coordination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
5.1 Regional and Subregional Workshops . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
5.2 Regional Cooperation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
5.3 Coordination with Other Bilateral and Multilateral Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
5.4 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
6. Awareness Raising, Public Involvement, and Stakeholder Participation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
6.1 Awareness Raising and Public Involvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
6.2 Stakeholder Participation in the NCCs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
6.3 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
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7. Capacity Development in Risk Assessment and Risk Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
7.1 Risk Assessment in NBF Development Projects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
7.2 Risk Assessment in NBF Implementation Projects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
7.3 Capacity Building in Risk Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
7.4 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
8. Biosafety Policy and Regulatory Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
8.1 Indicators for Evaluating Policy and Regulatory Outputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
8.2. Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
9. Databases and Information: The Biosafety Clearing-House .....................................................................................25
9.1 Information Sharing and the BCH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
9.2 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
10. Effectiveness of Quality Assurance Tools and Mechanisms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
10.1 Technical Advice from Implementing Agencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
10.2 Review of the UNEP Toolkit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
10.3 Advice Provided by External Experts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
10.4 Effectiveness of the Global NBF Development Project Umbrel a Approach. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
10.5 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
11. The GEF's Contribution to Progress in Implementing the CPB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
11.1 Speed of Ratification of the Cartagena Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
11.2 Progress in Countries Related to Various Articles of the CPB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
11.3 Advancement toward Compliance and Implementation of CPB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Acronyms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Box 5.1: Regional and Subregional Workshops . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Figure 4.1: Suggested Flowchart for Development of a National Biosafety Framework . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Table 3.1: Al ocations under the GEF Initial Strategy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Table 3.2: Implementation Countries by Implementing Agency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Table 4.1: Total Al ocation under the GEF Initial Strategy for Biosafety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Table 6.1: Level of Public Involvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Table 6.2: Inclusiveness of Country NCCs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Table 9.1: Information Elements in the BCH (as of August 28, 2005). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Table 10.1: Quality, Usefulness, and Timeliness of Technical Advice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Table 10.2: Assessment of Toolkit Utility in NBF Development Countries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Table 11.1: Overal Progress Made in Countries to Implement the CPB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
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Evaluation of GEF Support for Biosafety ­ Executive Version

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Foreword
Biotechnology is probably as old as civilization itself. Spe-
nology industry or against the opponents of this industry.
cial methods of food preparation, such as developing drinks
Not surprisingly in these circumstances, given the amounts
from fermenting wheat or fruit, or making cheese, were
of money involved, the GEF Council at its November 2004
known in prehistoric times. In recent decades, this old
meeting requested the GEF Evaluation Office to initiate
science has seen dramatic new developments. With the
an evaluation of the biosafety activities financed under the
recent development of "new" biotechnologies, such as liv-
GEF's Initial Strategy. This report presents the results of this
ing modified organisms (LMOs), hope was raised that these
evaluation.
would contribute greatly to an increase in world agricultural
production and thereby help reduce hunger and diseases.
The evaluation found that the GEF's support was consistent
However, the emergence of LMOs has also led to concerns
with the Cartagena Protocol. As such it was "neutral" in
about potential harmful effects on the environment and
its approach. This wil not mean that the debate on how
human health. These concerns were addressed through the
to approach biosafety and living modified organisms will
Convention on Biological Diversity (CBD), which pro-
disappear--it means that the effort can continue to bring
vided a framework to negotiate the Cartagena Protocol on
more transparency and scientific know-how to these issues,
Biosafety, which regulates international transfers of LMOs
while at the same time al owing stakeholders to express their
and aims to reduce risks for human health and the envi-
interests in a clear way. It means that the Cartagena Protocol
ronment. The Protocol has only recently come into force
can continue to grow as the mechanism for international
and its provisions have not yet been ful y implemented.
cooperation on this highly controversial issue.
Concern about the safety of new biotechnologies and their
The evaluation contains many valuable findings that will
products continues and has led to heated debates among
al ow the GEF to improve and adapt its support. For exam-
many stakeholders.
ple, it was found that countries that already had consid-
The Global Environment Facility (GEF) is the designated
erable experience with biosafety issues were better able to
financial mechanism for the Cartagena Protocol. The GEF's
utilize the support. The needs of countries with little prior
initial financing of capacity-building activities in biosafety
biosafety experience were not as wel addressed. The GEF
began in 1997, but increased considerably after the GEF
has contributed to building scientific and management
Council's approval in 2000 of the GEF's Initial Strategy
capacities in biosafety in al countries evaluated, although
for Assisting Countries to Prepare for the Entry into Force
the effectiveness of the work varied. A majority of countries
of the Cartagena Protocol on Biosafety. Given the heated
had achieved notable stakeholder involvement. The progress
debate on biotechnology in many countries, it is not sur-
regarding regional col aboration had fal en short of the ini-
prising that opposing voices were also heard regarding the
tial planned level of achievement. Nevertheless, the GEF's
GEF's support, which was--according to these voices--"not
support has on the whole had a considerable effect toward
neutral" but then either perceived to be against the biotech-
preparing countries for ratification and implementation of
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the Protocol. The draft evaluation report was discussed in
preparing a national biosafety framework. The complete
the November 2005 GEF Council meeting, as wel as the
study is accessible on the website of the Evaluation Office.
elements for a new GEF biosafety strategy provided by the
GEF Secretariat. This final version of the evaluation wil be
The GEF Secretariat, the Implementing Agencies, and the
formal y submitted to the Council and wil hopeful y pro-
CBD Secretariat gave valuable comments as the evaluation
vide "food for thought" for the new biosafety strategy of
proceeded. Useful inputs were also received from the Global
the GEF. This means that the management response to this
Industry Coalition on the perspectives of the biotechnol-
evaluation wil be included in the new strategy document
ogy industry and the Third World Network on nongovern-
and wil not be included as an annex to this report.
mental organization perspectives. Thanks for their sincere
cooperation are especial y due to the many individuals in
The manager of the evaluation team was Jarle Harstad of the
the 18 countries that were visited or interviewed telephoni-
GEF Evaluation Office. Other members of the evaluation
cal y. Likewise, the management and staff of the UNEP/
team were Donald MacKenzie of Agbios; and Jeff McNeely
GEF Biosafety Office in Geneva were always very forth-
of IUCN as evaluation co-chairs; Jane Morris of the Afri-
coming in providing key documents, data, and information
can Centre for Gene Technologies; Harold Roy-Macauley
throughout the whole process. Thanks are also due to the
of the West and Central African Centre for Agricultural
11 national consultants who greatly helped the organization
Research and Development; Tomme Young of the IUCN
and implementation of the country field visits.
Law Centre; and Joshua E. Brann from the GEF Evaluation
Office. Dora Cudjoe assisted the team on administrative
Besides this executive report, which is available in hard copy
and organizational matters.
in English, and in electronic versions in English, Spanish,
and French, the ful report is available in English on the
Special mention should be made of the Athena Institute of
Evaluation Office's website and on a CD-ROM.
the Vrije Universiteit Amsterdam, which undertook a Del-
phi study of the consistency, usefulness, and professional
quality of the United Nations Environment Programme
Rob D. van den Berg
(UNEP) Toolkit that was prepared to support countries in
Director, Evaluation Office
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Evaluation of GEF Support for Biosafety ­ Executive Version

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1. Main Conclusions
and Recommendations
1.1 Conclusions
tion has been relatively rapid. The ratification process has
Conclusion 1: GEF support has been consistent with the
been directly influenced by the initiation, and especial y the
Cartagena Protocol.
completion, of the GEF projects.
The Global Environment Facility (GEF) has responded
Besides promoting ratification, the GEF has contributed to
very expeditiously and systematical y to the request from
considerable progress toward implementation of the Proto-
the Convention on Biological Diversity (CBD) for support
col by enhancing capacity on scientific, administrative, legal,
to the Cartagena Protocol on Biosafety (CPB). GEF sup-
and information management matters, as wel as promoting
port has at times operated in a sensitive policy environment.
cross-sectoral col aboration and col aboration between the
Questions have been raised regarding whether the GEF
public and private sectors as wel as the civil society.
support was neutral and in line with the Protocol. The eval-
uation team concluded that the United Nations Environ-
Conclusion 3: The NBF development project was not
adequately designed and funded to ful y take the complexi-
ment Programme (UNEP), United Nations Development
ties of national conditions and needs into account.
Programme (UNDP), and World Bank have taken pains to
remain neutral in this dynamic debate among the various
For each of the 100 National Biosafety Framework (NBF)
interest groups, and have succeeded in doing so.
development projects in the various countries, the initial
time al ocation of 18 months and their budget frames did
A separate Delphi study, carried out by Vrije Universiteit,
not match the complexity and high ambitions of the project
Amsterdam, shows that 78 percent of the respondents stated
document with regard, for example, to regional coopera-
that the Toolkit, which was prepared by UNEP as guidance
tion, capacity building, public participation, and prepara-
material for the countries, was very consistent/consistent
tion of the framework itself. It is likely that the countries
with the Cartagena Protocol. The Toolkit was judged by 79
on average wil require at least 28 to 30 months, even if one
percent of country participants to be very useful/useful to
of the key indicators on country project achievements had
their country. However, several of the Toolkit modules were
to be scaled down. This was partly due to over-optimistic
not sufficiently timely to be as useful to al countries as they
planning and insufficient supervision resources provided by
could have been.
the GEF.
Conclusion 2: The GEF has contributed to speeding up
There was a general recognition in the supported countries
ratification and has promoted implementation processes of
that the UNEP regional coordinators and support team
the Cartagena Protocol.
were highly committed and hardworking. However, their
There have been serious controversies about the Cartagena
large subproject portfolios meant that the level of admin-
Protocol, especial y among Organisation for Economic Co-
istrative and technical backstopping was too low relative to
operation and Development (OECD) countries. In view
the complex task of preparing, initial y, 100 NBFs. UNEP
of this, it is notable that the Cartagena Protocol's ratifica-
was not in a position to become ful y acquainted with the
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baseline condition of the countries, which weakened its abil-
Biosafety Clearing-House (BCH). The participation has
ity to give detailed technical advice under the NBF develop-
been initiated, even if most countries' data-sharing obliga-
ment project. Insufficient legal expertise among the UNEP
tions under the Protocol have not been ful y met at this
NBF project staff was also a contributing factor. In spite
stage. By September 2005, al the NBF implementation
of delays and weaknesses in some instances, there has been
countries and nearly a third of the NBF development coun-
noteworthy progress in the subprojects. Although there are
tries had established national project websites, which could
variations in quality, the completed NBF reports general y
be a useful step toward greater participation in the BCH.
provide a good basis for further efforts by the countries.
Conclusion 5: Capacity development in risk assessment
In contrast, the UNEP-administered NBF implementa-
and risk management has primarily been of a general and
tion projects had more realistic objectives and were better
introductory nature. Few countries have as yet effectively
integrated biosafety matters with other existing relevant risk
funded. The same applies to the four World Bank- and
management structures.
UNDP-administered implementation projects.
As planned, most NBF development projects have orga-
Conclusion 4: Awareness-raising and participation efforts
nized general introductory courses in risk assessment and
by different stakeholders have not been as broad as
risk management. The NBF implementation projects have
required by the Cartagena Protocol and advised by the GEF
project documents. Support for capacity building under the
mostly organized one week of intensive specialists' training.
Biosafety Clearing-House has increased general access to
information, even if the data-sharing obligations have not
Progress has been made on coordination of roles and
been ful y met.
responsibilities among existing regulatory bodies in coun-
tries, but this often remains a thorny issue and a significant
Nearly al countries have appointed national coordination
impediment.
committees (NCCs) comprising on average 10 to 15 mem-
bers, with representation from most of the relevant govern-
Most countries already have some level of risk assessment
ment departments and other institutions/organizations.
and risk management procedures in place for dealing with
However, in nearly half the countries, representation on the
other issues and commodities (for example, sanitary and
NCCs is not as broad as advised. At the NCC level, stake-
phytosanitary systems, environmental impact analysis, and
holder participation and involvement were highly variable.
so on). There have been few efforts to explore how capaci-
In a few cases, some committee members had an inflex-
ties under existing systems, such as those for customs and
ible attitude, making cooperation difficult. On the whole,
trade, can be extended to support risk assessment and risk
the NBF development projects have strengthened public
management of living modified organisms (LMOs).
participation. The evaluation of the 38 NBF reports com-
Conclusion 6: Subregional cooperation with the objective of
pleted to date showed that 82 percent of the countries have
information sharing has been satisfactory, but no subre-
included provisions for public participation mechanisms in
gional harmonization of scientific, legal, and regulatory
their national frameworks.
instruments has taken place, except in the European Union
accession countries.
Efforts aimed at participation and public awareness have
been broader in national and sometimes subnational work-
Under the NBF development project, UNEP organized 16
shops. The funds for this initiative were insufficient relative
regional and subregional workshops to promote informa-
to the overal needs expressed by the countries.
tion sharing and subregional harmonization. The work-
shops succeeded wel in terms of sharing information and
Significant funds have been al ocated by the GEF to pro-
establishing networks and communication lines among key
mote awareness raising and national participation in the
individuals and institutions in the region. However, there
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Evaluation of GEF Support for Biosafety ­ Executive Version

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has been little if any progress on formal regional intergov-
several countries have considered it in conjunction with the
ernmental col aboration or harmonization of scientific,
wider issues of biosecurity, agrobiodiversity, alien invasive
legal, and regulatory instruments.
species, or il egal transboundary movement of endangered
species.
Conclusion 7: The umbrel a modality for the NBF develop-
ment project has been effective in countries with prior bio-
safety experience and some level of existing competence,
1.2 Recommendations
but not as satisfactory in countries with less prior experi-
ence and competence.
Assuming that the GEF wil continue to support the Carta-
gena Protocol, the conclusions of this evaluation lead to the
The umbrel a approach entailed using a uniform coherent
fol owing recommendations for future support.
approach for al participating countries. Under the cir-
cumstances, it greatly facilitated the delivery of assistance
Recommendation 1: Future assistance should be better
planned and customized to each participating country.
expeditiously to the large number of countries requesting
assistance, and it entailed economies of scale.
The GEF has initiated important work on developing and
The umbrel a approach was especial y effective in countries
implementing NBFs in 142 countries. Future support
that could easily incorporate the support into their own
should be better customized to the respective country con-
biosafety systems; it was much less effective where the need
ditions and national support better integrated with regional
for support was greater.
col aboration where appropriate.
Conclusion 8: Consultation and coordination by the GEF
Recommendation 2: The GEF should consider providing
Secretariat at the global level have been weak. Little consid-
longer term training for building and sustaining specialist
eration has been given to whether biosafety could be better
capacity in risk assessment and risk management.
linked to related aspects of the GEF's biodiversity portfolio.
Biosafety is a highly technical and specialized area. The
Since 1999, total donor funding and government co-
required competence for the ful implementation of the
funding in biosafety projects in developing countries and
Cartagena Protocol requires systematic and longer term
countries with economies in transition has amounted to
training of staff than has taken place til now.
about $157 mil ion,1 of which GEF project funding and
Recommendation 3: The GEF should continue to emphasize
government co-funding to these projects represents about
awareness-raising and public participation issues, including
55 percent. The remainder has been al ocated by about 16
support to the Biosafety Clearing-House.
multilateral and bilateral agencies. Cooperation and col-
laboration among the donors is limited. Relatively little is
There is wide support for increased emphasis on awareness
known about complementarity or duplication among vari-
raising, public consultation, and information sharing.
ous actors in the donor community. The CBD Secretariat
Recommendation 4: The GEF should work toward a higher
has taken some leadership in information sharing among
degree of donor col aboration and other cost-sharing
some key actors at the global level. UNEP has been engaged
schemes at the global and national levels.
to some extent in information exchange with other donors,
mostly at the country level.
Future requests for funding in the biosafety area are likely to
increase. A large number of countries now expect to move
While most donors have treated biosafety separately from
from the NBF development phase to the implementation
related biodiversity, environment, and health matters,
phase, which wil entail investments in, for example, the
upgrading and equipping of relevant laboratories and other
1Al dol ar figures in this report are U.S. current dol ars.
facilities at the national, multi-country, or regional level.
Main Conclusions and Recommendations
3

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Recommendation 5: The GEF should seek advice from its
As the GEF role as the financial mechanism for environ-
Scientific and Technical Advisory Panel and other scientists
mental conventions and the number of focal areas expand,
as to whether and how biosafety could be better integrated
strategical y and programmatical y into the GEF biodiversity
further efforts need to be made for integration and the
portfolio.
building of synergies among various areas and programs.
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2. Background,
Scope, and Methodology
2.1 Background
The final Terms of Reference for the evaluation were
approved by the Director of the GEF Evaluation Office on
The GEF is the designated financial mechanism for the
April 20, 2005. Four key questions were identified in the
Convention on Biological Diversity, as wel as for the Carta-
evaluation's Terms of Reference:
gena Protocol on Biosafety which fal s under the CBD and
entered into force on September 11, 2003.
1. Is GEF support consistent with the Cartagena Protocol
conducted in a way that takes into account the needs of
The GEF began its initial financing of capacity-building
the recipient countries, and is it of sufficient professional
activities for biosafety in 1997, when the GEF Council
quality?
approved pilot projects in 18 countries. The evaluation of
this pilot phase contributed to the development in 2000 of
2. Is GEF support to capacity development efforts, includ-
the GEF's Initial Strategy for Assisting Countries to Prepare
ing stakeholder involvement and regional col aboration,
for the Entry into Force of the Protocol.
relevant and effective?
The Council subsequently approved funding for the global
3. What progress has been made in countries on build-
project, Development of National Biosafety Frameworks,
ing the requisite capacities toward their ratification and
which initial y covered development of frameworks for 100
implementation of the Cartagena Protocol?
countries; it also approved projects in 12 countries for NBF
4. Are the modalities and approaches of GEF support effec-
implementation. In 2004 and 2005, the Council expanded
tive and efficient compared to similar projects?
NBF development to first an additional 20 countries, and
then 10 more countries; it also al ocated support for the
This evaluation seeks to answer these questions as objec-
development of the Biosafety Clearing-House mechanism
tively and in the most balanced manner possible, given the
in 50 countries, with a subsequent add-on for 89 countries.
data available. The evaluation covers the fol owing GEF-
Table 3.1 provides a breakdown of al GEF-funded activi-
supported biosafety capacity-building activities:
ties for biosafety capacity building.
· Development of National Biosafety Frameworks Project
(100 countries),
2.2 Evaluation of GEF Biosafety Support
· Development of National Biosafety Frameworks Project
At its November 2004 meeting, the GEF Council requested
add-on (20 countries),
the GEF Office for Monitoring and Evaluation (since
renamed the GEF Evaluation Office) to undertake an eval-
· Projects for implementation of NBFs (12 countries),
uation of the biosafety activities financed under the GEF
· Certain aspects of GEF support for implementation of
Initial Strategy.
BCH mechanisms (50 countries).
5

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The evaluation does not cover the pilot phase projects,
toward preparation for implementation of the Carta-
the second add-on (10 countries) to the Development of
gena Protocol.
National Biosafety Frameworks Project, or the first add-on
(89 countries) to the BCH mechanism project.
The evaluation team reviewed a total of 53 countries at some
level; this is approximately 40 percent of the 132 countries
The evaluation was accomplished through several tasks:
involved in the NBF development and implementation
· Global Stakeholder Interviews. The evaluation team
projects. Of the 19 countries visited or reviewed, 15 had
conducted interviews with relevant global stakeholders,
projects implemented by UNEP, and 2 each by UNDP and
including the GEF Secretariat, UNEP, UNDP, World
the World Bank. Two of the countries evaluated are Small
Bank, Convention of Biological Diversity Secretariat,
Island Developing States (SIDS); three are large countries.
Global Industry Coalition on Biotechnology, and Third
Vrije Universiteit of Amsterdam undertook a subsidiary
World Network; representatives of other bilateral and
component of the evaluation by reviewing the UNEP Tool-
multilateral agencies were also interviewed. The team
kit used by countries as the primary input for developing
conducted several in-depth interviews with the UNEP
their NBFs. The reviewers conducted this evaluation using
development project team based in Geneva.
a questionnaire sent to 500 persons in 30 countries partici-
· Field Visits. The primary component of the evaluation
pating in the project as wel as other stakeholder groups.
was a series of field visits, each of which was conducted
by two members of the evaluation team. Eleven coun-
2.3 Initial LMO Country Capacity
tries--the Bahamas, Burkina Faso, China, Croatia,
(National Baselines)
Ethiopia, Guatemala, India, Mexico, Morocco, Tajiki-
stan, and Uganda--were visited. These countries were
The GEF biosafety project documents reveal that there
chosen to provide a geographic range, as wel as a range
were great variations among countries at project inception
of project stages and country sizes, and include al three
with regard to the initial level of LMO activities, as wel as
GEF Implementing Agencies.
availability of policies, institutions, and capacities (national
baselines). For the purpose of assessing the progress the
· Non-Field Reviews. To complement its field visits, the
GEF had contributed to with regard to implementation
evaluation team reviewed eight additional countries--
of the Cartagena Protocol, the evaluation team made an
Botswana, Bulgaria, Chile, Colombia, Cuba, Lebanon,
initial classification of the countries' initial situation with
Malaysia, and Turkey--mostly through three to five
regard to "high," "medium," or "low" baselines. The "high
telephone interviews with relevant stakeholders in each
baseline" countries were those that were actively involved in
country. Although less detailed than the field visits, these
the development and regulation of LMOs at the outset; the
reviews gave the team members a more comprehensive
"medium baseline" countries were those with some research
picture of the GEF's overal support.
and field trials; "low baseline" countries were those with
· Desk Reviews of NBF Reports. The evaluation team
little or no LMO involvement. Of the 18 countries that the
reviewed the 38 NBFs that had been completed as of
evaluation team visited or interviewed telephonical y, the
June 10, 2005. This in-depth review gave the team a
numbers of countries assigned to the high, medium, and
consistent means of evaluating each country's progress
low categories were 5, 4, and 9, respectively.
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3. GEF Support for Biosafety
The GEF Initial Strategy for Assisting Countries to Prepare
Table 3.1: Allocations under the GEF Initial Strategy
for the Entry into Force of the Protocol was based on a deci-
Number of
Allocation
sion in the Conference of the Parties (COP) to the CBD
Project
Countries
($ Millions)
that designated capacity building as a priority for GEF assis-
Pilot Phasea
17
2.7
tance. Further guidance has been provided by the CBD-
NBF Development
100
26.1
COP, especial y in decisions V/3, VI/17, and VII/20.
NBF Development add-on 1
20
5.2
NBF Development add-on 2a
10
2.6
The original GEF Initial Strategy aims to:
Implementation projects
12
9.2
BCH Mechanism
50
4.6
A. Assist countries to prepare for the entry into force
BCH Mechanism add-on 1a
89
8.9
of the Cartagena Protocol on Biosafety through the
establishment of national biosafety frameworks,
Totalb
59.4
including strengthening capacities for risk assess-
a. Not covered by this evaluation.
ment and management with a wide degree of stake-
b. Details may not sum to total because of rounding.
holder participation;
B. Promote information sharing and col aboration
3.1 Development of NBFs
at the regional and sub-regional level and among
countries that share the same biomes/ecosystems;
At its November 2000 meeting, the GEF Council al ocated
and
$26.1 mil ion to support up to 100 countries in develop-
ing NBFs and arranging for regional and subregional work-
C. Promote identification, col aboration and coordina-
tion among other bilateral and multilateral organi-
shops. Another $5.2 mil ion was al ocated in November
zations to assist capacity-building for the Protocol
2003 for the development of NBFs in 20 additional coun-
and explore the optimization of partnerships with
tries; $2.6 mil ion was al ocated in 2005 for another 10
such organizations.
countries. UNEP is the sole Implementing Agency for NBF
projects. The main components of the NBF projects are:
In addition to supporting activities in countries to develop
or implement NBFs, the GEF also set out to support coun-
· Development of frameworks through information gath-
try participation in the BCH, promote coordination with
ering (stocktaking), analysis, consultation, training, and
other donor organizations, and enhance scientific and tech-
preparation of a draft NBF, including legal instruments,
nical advice on biosafety matters.
administrative systems, risk assessment procedures, and
systems for public participation and information;
The GEF's total al ocation to capacity building for imple-
mentation of the Cartagena Protocol is shown in Table
· Arrangement of regional workshops that aim to increase
3.1.
understanding of the CPB and impart knowledge on the
7

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implications for risk assessment and decisionmaking at
The project period was typical y three years, and the GEF
national levels;
al ocation to each country ranged between $500,000 and
$1 mil ion.
· Arrangement of subregional workshops focusing on
capacity building, cross-national opportunities for col-
UNEP's implementation project participants are al coun-
laboration, mechanisms for sharing of risk assessment
tries that had previously participated in the pilot phase. Four
and management experiences, coordination of capacity-
countries were included in the NBF implementation phase
building activities, and networking to share lessons and
that had not participated in previous GEF-supported bio-
experiences.
safety activities. These were Malaysia and Mexico, assisted
by UNDP; and India and Colombia, assisted by the World
The range of funding for NBF development projects at
Bank. These four NBF implementation projects are the
the individual country level was between $91,500 and
only components of the GEF-supported biosafety activities
$220,000.
not implemented by UNEP.
The majority of countries provided co-financing of 50 per-
cent of the GEF budget, but there were exceptions; country
3.3 Capacity Building for BCH
co-financing ranged from $18,000 to $244,000. The global
Participation
average for the GEF funding was $145,184, and the global
average for co-financing was $74,762 (52 percent).
In November 2003 and 2005, the GEF Council al ocated
$13.5 mil ion through UNEP for assistance to 139 coun-
3.2 Implementation of NBFs
tries to participate in the Biosafety Clearing-House of the
Cartagena Protocol. The central web-based BCH portal is
In 2001, the GEF approved 12 individual country demon-
administered by the CBD Secretariat, but national-level
stration projects on NBF implementation (see Table 3.2).
components are to be developed by individual countries.
Table 3.2: Implementation Countries by Implementing
The objective is complementary to the overal biosafety
Agency
program's objectives, but aims more specifical y at devel-
Implementing Agency
Implementation Countries
oping core human and technical resources to establish the
UNDP
Malaysia, Mexico
appropriate BCH infrastructure to readily access scientific,
UNEP
Bulgaria, Cameroon, China, Cuba,
technical, environmental, and legal information on LMOs
Kenya, Namibia, Poland, Uganda
to ensure adequate protection in the safe transfer, handling,
World Bank
Colombia, India
and use of LMOs.
8
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4. Modalities of GEF Support
4.1 NBF Development Project
lize data, approve workplans, ensure information flow, and
approve various reports and the final NBF.
In the first module of the UNEP Biosafety Framework
Development Toolkit (Phase 0 ­ Starting the Project), which
The NCC is an essential component of the national orga-
was provided to nearly al countries when they began their
nization and ensures at least some level of involvement and
national NBF project, UNEP spel ed out the key principles
"buy in" for the project by key stakeholders in the country.
and operational and management implications for NBF
It also ensures a relatively broad sign-off to the NBF, espe-
development projects. Beyond ensuring safety and build-
cial y by government departments. There are considerable
ing professional and institutional capacity, UNEP's primary
variations in the breadth of NCC composition, member
programmatic documents also emphasize the need for sus-
competencies, and frequency of meetings.
taining capacity, promoting participation by al stakehold-
The national project coordinators (NPCs) were chosen by
ers, and enabling a country to make an informed choice
the NEA in consultation with UNEP. They were often a
on whether or not it wants to import and use LMOs. The
linchpin in the complex cooperation and coordination
Toolkit provides for the designation of a national execut-
structures and instrumental in keeping together the large
ing agency (NEA) to be the legal entity of the government
number of participants both from within and outside gov-
responsible for executing the national project. The NEA is
ernment. The NPCs have played a key role in the execu-
next required to establish a national coordinating commit-
tion of the NBF development projects. They have often had
tee to advise and guide the preparation of the NBF. In the
difficult tasks, given the novelty, complexity, time pressure,
countries evaluated, the NCC varied greatly in size between
and political sensitivity of the issues involved, with frequent
7 to more than 25 members. A typical NCC comprises
turf battles among various ministries.
representatives from the ministries of agriculture, environ-
ment, trade, foreign affairs, economy, planning, health,
The proposed time frame for the NBF development proj-
education, transportation, and justice; and includes various
ects was 18 months, with three phases comprising 6 months
government institutions and departments under the minis-
each. During the first phase, a country was expected to
tries, such as the customs service. In addition, one or two
prepare inventories and surveys of current uses of biotech-
members are general y from the academic community, the
nology, relevant existing legislation and regulation in the
biotechnology industry, and nongovernmental organiza-
country, and potential and mechanisms for cooperation
tions (NGOs) such as consumer and farmer associations;
and harmonization of risk assessment and risk management
in rare cases, committees also include advocacy NGOs.
systems on a regional and/or subregional basis. The second
The NCCs were assigned key roles--to develop a common
phase comprised further analyses of surveys and inventories,
understanding of the country's path forward, provide policy
development of national databases, and the planning and
and professional advice, provide a discussion forum, mobi-
implementation of wider awareness-raising campaigns and
9

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stakeholder involvement both within and outside govern-
tive) from the UNEP coordinators than was provided to
ment institutions. The last phase included the drafting of
the NBF development projects. The UNDP and World
national policies, legal instruments, risk assessment guide-
Bank projects, where operational, have been approached
lines and mechanisms, and publication of the final NBF
very differently. UNDP limited its role to administrative
report, together with inventories and guidelines.
oversight in the two implementation countries for which it
was responsible. By contrast, the World Bank has provided
The evaluation has identified some inherent weaknesses in
both administrative oversight and technical backstopping,
the approach and design of the NBF development project.
including sending initial and mid-term expert missions to
First, the time frame for completion of the national projects
address substantive issues and decisions.
was much too short. To date, the average duration of NBF
development projects has been 28 months among countries
4.3 Agency Fee Levels
that have finished the project thus far. These countries seem
to be the "best performers"; the remaining projects will
Contrary to the normal GEF fee level of 9 percent, the GEF
most likely require even more time, even if the scope of one
Secretariat negotiated a fee of 3 percent for the 100 initial
of the key indicators has been reduced.
NBF development countries. However, in addition to this
fee, the project budget included salaries and travel expenses
The UNEP Toolkits prepared a suggested flowchart for the
for four regional program coordinators. This indicates that
scoping and scheduling of an NBF. This is shown in Figure
UNEP's resources for implementation and execution of
4.1.
the projects were around 17 percent of the total project
As of August 31, 2005, 45 NBF projects were completed,
cost, which would be quite generous in a normal develop-
with the average duration for al projects being 28.4 months.
ment project, but may have been inadequate considering
Viewing the NBF projects from a regional perspective, proj-
the novelty of the subject matter, the breadth and scope of
ects in Africa have taken the longest to complete, requiring
project objectives, the lack of agreement on the science, the
an average of 32 months. Countries in Latin America and
dispersed geography of the projects, and the great diversity
the Caribbean have the shortest average completion time of
of opinions among countries--and especial y among the
24 months, but there were only two completed projects in
nongovernmental organizations and institutions--invited
this region.
to participate.
Initial y, each regional coordinator recruited by UNEP was
4.2 Individual NBF Implementation
responsible for managing and supervising a large number of
Projects
projects. One coordinator had responsibility for 39 coun-
tries, although not al of these had active projects at the
The NBF implementation projects initiative consisted of
same time.
a series of 12 separately created national interventions. Of
these, eight were UNEP-executed and -operated as a fol ow-
For the 30 additional NBF projects, the normal fee level of
up to the pilot projects. The World Bank and UNDP each
9 percent was reinstated.
executed two projects in countries that had not participated
in the pilot but that had some experience with LMOs.
Table 4.1 shows the actual dol ar amounts handled by each
of the Implementing Agencies, as wel as the respective
The UNEP NBF implementation projects have received
administrative fee received to support administration and
more direct assistance (substantive as wel as administra-
oversight of the respective projects.
10
Evaluation of GEF Support for Biosafety ­ Executive Version

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Figure 4.1: Suggested Flowchart for Development of a National Biosafety Framework
Sign National project document
PHASE ONE:
(Months 1­6 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 7­12 of project)
Training workshops on
Analysis and Consultation
dif erent NBF components as
required
Awareness workshops for
target groups
Regional and Sub-Regional
Workshops to assist in NBF
Stakeholder workshop to
process and content
identify key components of
----------------------------------------------------------------
N -B-F------------------------------------------
PHASE THREE:
Stakeholder workshop to
Prepare draft of
(Months 13­18 of project
discuss draft and final
National Biosafety
Preparation of draft
components of NBF
Framework
National Biosafety
Framework
Source: UNEP.
Modalities of GEF Support
11

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Table 4.1: Total Allocation under the GEF Initial Strategy
area remains weak. In contrast, biosafety has been a minor
for Biosafety
part of the World Bank and UNDP portfolios, and these
Implementing
Total GEF
Total Fees
Fee
two Implementing Agencies have not developed expertise
Agency
($ Millions)
($ Millions)
Percentage
equivalent to that of UNEP. Some participating coun-
UNDP
2.4
0.4
16
tries indicated that they would find it advantageous for
UNEP
55.0
3.4
6a
an Implementing Agency to have an in-country presence,
World Bank
2.0
0.3
15
which UNEP, for the most part, does not have.
Total
59.4
4.1
7b
Note: The fee percentage calculated here includes only the official
The World Bank points to its comparative advantage ema-
agency fee. The percentage does not, in the case of UNEP,
include any additional agreed-upon resources.
nating from its extensive engagement in agriculture and
a. In addition, UNEP received compensation for the positions
agricultural research. Regarding country presence, even
of four regional coordinators.
though the World Bank has a large office in India, its staff
b. Not adjusted to reflect the four regional coordinators cited
in Delhi has had little direct involvement with or oversight
above.
of the biosafety implementation project, which is instead
managed from World Bank headquarters in Washington,
4.4 Comparative Advantages of the
D.C. In this sense, then, relatively little advantage is taken
Implementing Agencies
of the World Bank's country presence.
While UNEP, UNDP, and the World Bank are al imple-
UNDP has limited itself to an administrative project over-
menting GEF biosafety projects, UNEP has by far the larg-
sight role and has drawn on the capacity of the UNEP team
est portfolio. UNEP has developed substantial capacity in
for substantive technical backstopping. UNDP central y
its project management office in Geneva, with two regional
decided not to develop as strong a technical capacity as
coordinators posted in Africa and a subregional coordina-
UNEP, and opted for a modest role in the GEF's biosafety
tor posted in both the Pacific and Latin American regions.
program. Through its decentralized structure, UNDP has a
Although UNEP now has considerable professional exper-
strong in-country presence, which has been advantageously
tise in many aspects of biosafety, its legal expertise in this
used by UNEP in some countries.
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5. Regional Collaboration,
Harmonization, and Coordination
The CPB supports and encourages regional cooperation,
The first series of four regional workshops aimed at a gen-
coordination, and harmonization on biosafety issues. Such
eral introduction of the CPB, the NBF development proj-
an approach is critical to achieving the Cartagena Protocol's
ect, and the main elements of work in the preparation of
overal objective of managing the transboundary movement
an NBF. The second series of six workshops was held at
of LMOs, particularly given the fact that many countries
the subregional level and aimed at providing insights into
may lack the technical and financial ability to develop, staff,
systems and methodologies for risk assessment and public
and operate the ful range of administrative institutions and
participation. These workshops also facilitated the exchange
mechanisms general y thought necessary to ful y comply
of practices, experiences, and lessons among the countries
with the Protocol.
in the subregion.
5.1 Regional and Subregional
The objective of the third series of six workshops was to help
Workshops
participants acquire a better understanding of the different
The regional and subregional workshops were expected to (1)
represent an efficient way of communicating and imparting
Box 5.1: Regional and Subregional Workshops
knowledge to, and exchanging experience among, a large
First Series (Regional Workshops)
number of country participants; and (2) promote regional
Nairobi, Kenya; January 16­19, 2002
Nitra, Slovak Republic; February 5­7, 2002
and subregional col aboration and harmonization of scien-
Beijing, China; March 4­8, 2002
tific, legal, and regulatory instruments, which could be a
Buenos Aires, Argentina; May 8­10, 2002
positive contribution to effective management of transfer of
Second Series (Subregional Workshops)
LMOs across borders.
Windhoek, Namibia; November 12­15, 2002
Mexico City, Mexico; December 10­13, 2002
Workshop Organization and Outputs
Kuala Lumpur, Malaysia; January 21­24, 2003
Nadi, Fiji; February 18­22, 2003
Three series of regional and subregional workshops were
Vilnius, Lithuania; May 27­30, 2003
held (see Box 5.1), for a total of 16 workshops in al . There
Dakar, Senegal; April 22­25, 2003
were more than 800 individual participants, and some
Third Series (Subregional Workshops)
were able to attend two or three of the workshops. These
Shiraz, Islamic Republic of Iran; October 19­22, 2003
were usual y representatives from the NEAs and the NPCs.
Santiago, Chile; November 25­28, 2003
Feedback gathered by the evaluation team through coun-
Antalya, Turkey; December 9­12, 2003
try visits, non-field reviews, and reviews of NBFs indicated
Dar-es-Salaam, Tanzania; March 9­12, 2004
that nearly al countries involved in the project were able to
Ouagadougou, Burkina Faso; April 20­23, 2004
Port of Spain, Trinidad and Tobago; May 11­14 2004
participate in at least one workshop.
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options for regulatory regimes and administrative systems
It is unclear how much knowledge transfer occurred once
for biosafety, as wel as the legal and administrative require-
participants returned to their home country. In the majority
ments of the Cartagena Protocol, and potentials for regional
of workshops, a maximum of four persons from any given
and/or subregional col aboration and harmonization.
country could attend. This smal number limited the effects
the workshops could have at the country level.
Workshop Outcomes
Capacity retention was another chal enge faced. Partici-
The workshops were viewed positively by the participants,
pants who have gained knowledge sometimes do not stay in
as indicated both by the post-workshop evaluations con-
their current position within government or may leave their
ducted by UNEP and feedback received by the evaluation
home country altogether to pursue opportunities abroad.
team. Participants in the first series of regional workshops
UNEP has recognized this as an ongoing chal enge faced by
indicated that these were "very useful" for those from coun-
the project, and has encouraged countries to find ways to
tries where the NBF project had not begun at the time of
keep their NPCs on staff fol owing project conclusion.
the workshop. The workshops provided a good understand-
ing of how to undertake the NBF process and produce an
5.2 Regional Cooperation
acceptable NBF document.
Another important aspect of the workshops was the facilita-
The NBF development project was expected to contribute
tion of network building and information sharing. Many
to potential regional and subregional interaction. In par-
participants indicated that this was achieved, and shared
ticular, it was supposed to:
their appreciation for this aspect as one of the key outcomes
· Establish the systems needed for risk assessment, audit
of the workshops. The workshops also played an impor-
of risk assessments and risk management, taking into
tant role in raising awareness and understanding of the
account national and subregional/regional needs; and
issues surrounding LMOs and biosafety among workshop
participants.
· Provide appropriate mechanisms for sharing scientific
assessments at subregional levels (while al owing for
Chal enges of the Workshop Approach
decisions at the national level, if necessary).
Despite the positive feedback from participants, it is unclear
These activities were expected to be funded at a level of
whether these workshops were the most effective means of
$15,000 per country participating in the NBF develop-
building the extensive regional cooperation on biosafety
ment project; it is unclear to what extent this provision
cal ed for in the GEF Strategy and NBF development project
was actually funded within the country subproject docu-
document. Budget resources only al owed for a few people
ments. Regional activities were not included as part of the
from each country to attend; moreover, their short duration
workplan for countries participating in implementation
(only three or four days long) did not provide much poten-
projects. UNEP had originally included this component
tial for meaningful dialogue on regional col aboration or
in implementation project planning, as well as activities
harmonization, or the development of regional approaches
supporting curriculum development on biosafety-related
to implementing biosafety. This was not surprising, given
issues. However, the GEF Secretariat decided that these
the level of funding available for this activity and the very
activities should not be included in the implementation
low level of initial awareness, knowledge, and capacity in
projects, and no budget al ocation was made to support
most countries.
these aspects.
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Achievements in Cooperation among Countries
5.3 Coordination with Other Bilateral
and Multilateral Organizations
Direct bilateral or regional activities took a number of dif-
ferent forms in the NBF project. Al European Union (EU)
The third objective of the GEF Initial Strategy on support
accession countries are harmonizing regulations to EU stan-
to the CPB is
dards; this does not, however, mean that countries not yet
acceded to the EU are necessarily col aborating and com-
promoting identification, col aboration and coordi-
nation among other bilateral and multilateral orga-
municating with other countries.
nizations to assist capacity-building for the Protocol
and explore the optimization of partnerships with
Countries face many chal enges when attempting to address
such organizations.
regional cooperation and col aboration on issues of bio-
safety. Inter-country dialogue on biosafety issues is currently
Pursuant to a request by the Intergovernmental Committee
difficult, at best, given the preliminary nature of national
for the Cartagena Protocol, the first coordinating meeting
policy decisionmaking on these issues in the vast majority
was held in December 2000, at which it was agreed that
of countries reviewed in this analysis.
the CBD Secretariat would establish a database directly
addressing biosafety capacity building--a process that has
Cooperation through Regional Organizations
been completed and is posted in the BCH. In addition to
information from agencies and organizations providing
The GEF Initial Strategy cal s on the NBF Development
capacity-building projects and support, about 50 countries
Projects to explore and maximize possibilities for coop-
have submitted data about their capacity-building needs.
eration through regional organizations, both in order to
exchange information and lessons, and to share the costs
The CBD Secretariat has further organized two Coordina-
and burdens of every country creating an operational
tion Meetings for Governments and Organizations Imple-
national system. Regional cooperation could be especial y
menting or Funding Biosafety Building Activities, in 2004
important for SIDS regions such as the Caribbean and the
and 2005. The meetings have addressed operational proce-
Pacific. While many SIDS are concerned about the poten-
dures and guidelines for coordination of biosafety activities,
tial effects of LMOs on their isolated and fragile ecological
which were subsequently approved at COP-MOP 2. It is
systems, the limited capacity of individual countries makes
expected that further coordination meetings wil be held
it difficult for any single nation to establish and maintain a
whenever necessary, at least once a year. In preparation for
cost-effective national regulatory system for biosafety. The
the next meeting and COP-MOP 3, the CBD Secretariat
potential for SIDS and other similarly positioned nations
wil carry out a comprehensive review and possible revision
to ensure effective implementation of the CPB is dependent
of the action plan for capacity building.
on their ability to address manpower and expertise deficien-
An ongoing study by the United Nations University had,
cies through col ective action and shared capacity.
by June 2005, identified al ocations since 1999 to biosafety
projects in developing countries and countries with econo-
Considerable efforts have been made toward exploring
mies in transition to the tune of about $157 mil ion, of
options for more regional col aboration under the auspices
which GEF funding and government co-funding combined
of subregional organizations in the Caribbean, the Pacific,
represented about 55 percent. The remainder had been al o-
South Asia, Central Asia, West Asia, West Africa, Southern
cated by some 16 multilateral and bilateral agencies.
Africa, and Latin America. However, the initiatives have
mostly been made by science institutions or individuals,
The GEF Initial Strategy's requirements for coordination
and most have not led to formal country commitments.
and col aboration with other multilateral and bilateral proj-
Regional Collaboration, Harmonization, and Coordination
15

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ects is important because, in their absence, there is the risk
and potential--for subregional cooperation, let alone for
of promoting competing subnational priorities or creating
in-depth training."
confusion and/or misunderstanding regarding the relative
The various subregions are at different stages of develop-
roles of different projects within the national strategy. In
ment with regard to regional col aboration and cooperation,
this context, coordination and col aboration imply more
and may need different types of support to create effective
than merely sharing information on respective project activ-
regional mechanisms. Although some consistent types of
ities. The GEF has not yet played an active role in promot-
technical or other support could be provided among all
ing col aboration and cooperation with other organizations
regions, a uniform approach to regional cooperation, col-
assisting the implementation of the Protocol.
laboration, and harmonization is not likely to be an effec-
tive way forward for al regions. Capacity-building activi-
5.4 Conclusions
ties, such as regional workshops, are most effective when
targeted toward a group of stakeholders with similar levels
The regional and subregional workshops provided partici-
of capacity and technical skil s.
pants with valuable opportunities for informal information
exchange and networking. To achieve the level of activity
Although some regional biosafety-related activities are under
cal ed for in the GEF Initial Strategy and NBF development
way, much more progress could be made in this area in the
project document, efforts to facilitate true bi- or multilateral
future. A number of organizations and multi-country agree-
col aboration and harmonization among institutions and
ments could play important roles in facilitating regional
high-level officials at the national level wil require a much
activities, and important synergies can be achieved through
longer term and more resource-intensive investment.
the integration of biosafety measures directly into nascent
programs for the promotion of biotechnology research.
The limitations of the regional workshops were recognized
already in 2003 in the mid-term evaluation of the NBF
Donor coordination at a global level has been quite weak;
development project, which stated: "the programmed funds
the objectives of the GEF Initial Strategy in this regard have
and events are insufficient to attend the strong demand--
not been reached.
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6. Awareness Raising,
Public Involvement, and Stakeholder Participation
6.1 Awareness Raising and Public
lic input in decisionmaking. Public participation is dis-
Involvement
tinguished from the majority of the Protocol's numerous
specific requirements by the fact that it is also a separately
A factor reported in virtual y al the countries visited (and
mentioned objective of the NBF development project. The
in most of the draft NBF reports reviewed) was the ongoing
GEF Initial Strategy underscores this requirement, noting
need to raise public awareness regarding biosafety issues. In
(para. 17[v]) the expectation that the projects will
many cases, the lack of awareness extended to parliamentar-
ians, relevant government officials, and academics.
improve public participation on the issues involved
in the release of living modified organisms to pro-
There were a variety of perspectives on the nature of aware-
mote informed debate and to ensure that where any
ness needed. Many NPCs and NCC members indicated
use of modern biotechnology is permitted, it is done
simply a need for heightened political awareness and pub-
in an open and transparent way.
lic consciousness of LMO issues. Others suggested a need
The NBF development projects incorporated concepts
to build acceptance among consumers. In stil other cases,
of public involvement and participation in two primary
the need was stated in terms of awareness of the advocacy
ways--participation in the work of the national subprojects
perspectives of various interest groups--whether a desire to
themselves, and the provisions and procedures implement-
heighten perceptions of potential dangers of LMOs to vari-
ing the public involvement requirement of the Cartagena
ous sectors or to better understand their benefits.
Protocol.
Almost al the projects organized workshops, which often
In reviewing both aspects of participation during the country
consumed a large number of person-days given the very
interviews, the evaluation team found that public participa-
limited resources available (approximately $15,000 per
tion objectives were only partial y achieved (see Table 6.1).
project). Most of these public awareness workshops were
open to government officials, special interest groups, and
Table 6.1: Level of Public Involvement
the general public. In a majority of national subprojects, the
Level of Public Involvement
workshops were arranged in the capital; several countries
Participation
High
Medium
Low
also made efforts to reach out at least to the main provin-
Development projects (12)
2
5
5
cial centers. Many projects also prepared video and audio
Implementation projects (6)
1
3
2
materials, training packets, and other awareness-raising
While an overwhelming majority of countries complied
measures.
with project requirements (creating an NCC, holding sub-
Effective public involvement comprises public access to
stantive workshops, seeking comments on relevant docu-
information, transparent decisionmaking by authorities/
ments), the actual "participation impact" of these structural
agencies and public participation, including direct pub-
components was less than the project designers may have
17

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expected. Participation chal enges arose both from lack of
The inclusion in some countries of fewer ministries on
appropriate stakeholder representation on the NCC (or
the NCC could indicate a lack of appropriate capacity in
implementation project steering committee) and from sys-
the particular country. However, the apparent absence, in
tematic practices limiting stakeholder participation in cer-
some cases, of representation from the ministries of health,
tain activities.
agriculture, and trade is curious. In some countries it may
be idealistic to expect al relevant stakeholder ministries
6.2 Stakeholder Participation in the NCCs
to col aborate in a highly effective manner. Ministries are
frequently competing for resources, and cooperation is not
One of the main tasks of the NCC is to represent key gov-
necessarily high on their respective agendas. Involving civil
ernment and nongovernmental stakeholder groups and
society can also raise potential chal enges to consensus; in
ensure that NBF reports and other documents, including
some cases, NGOs known to hold strong positions were
laws, reflect contributions from al government sectors as
excluded from the process.
wel as nongovernmental stakeholders.
The evaluation considered the actual project outputs with
The evaluation examined NCC composition, giving a gen-
regard to participation in formal governance for biosafety.
eral rating that assessed compliance with elements of NCC
The team found that about three-quarters (28) of the 38
membership--with particular attention to the inclusion of
completed NBFs examined included complete public
relevant government departments and nongovernmental
participation requirements for the country; several others
stakeholder groups. Table 6.2 summarizes the data. Most of
included specific measures addressing part of the participa-
the ratings are either high or low, with few at the medium
tion issue.
level. In most cases, representation was found to be wel bal-
anced; in a few particularly successful cases, dynamic pro-
6.3 Conclusions
cesses of stakeholder participation actual y evolved through
Project performance with regard to public awareness rais-
the NCC.
ing and participation mandates has been mixed, with few
Table 6.2: Inclusiveness of Country NCCs
countries achieving a high rating on this factor--both in
regard to project operations and in the development of par-
Inclusiveness of NCC
ticipation mechanisms for the implementation of biosafety
NCC Representation
High
Medium
Low
legislation.
In-country reviews
Development projects (7)
3
0
4
Given the low level of funding available for public aware-
Implementation projects (2)
1
0
1
ness activities, and high needs at the country level, perfor-
Non-field reviews
mance of this element was likely to be limited. With regard
Development projects (5)
2
3
0
to public awareness and participation, development projects
Implementation projects (2)
0
0
2
could have been more closely tailored to country needs.
Good
Poor
Multi-stakeholder cooperation processes on a topic as con-
Document reviews (development
projects only)
13
13
troversial as biosafety have at times been difficult. Neverthe-
Note: These results include only UNEP-implemented projects
less, the strong commitment on this matter by the Protocol,
reviewed by this evaluation.
as wel as the GEF, seems to have brought about a better
recognition of its importance. It is noteworthy that most
Wide differences in representation were found in the
of the completed NBF reports have taken the issues fur-
implementation projects managed by the World Bank and
ther to institutionalize and propose specific measures for
UNDP.
implementation.
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7. Capacity Development in
Risk Assessment and Risk Management
Capacity building is one of the prime elements expected
ready to develop and adopt specific risk assessment guide-
to facilitate effective and efficient implementation of the
lines and procedures, since they first needed to complete
Cartagena Protocol in developing countries and countries
their primary biosafety legislation. A few countries did
with economies in transition. On the complex issue of bio-
undertake such development, and al appeared to discuss it.
safety, capacity building involves the transfer of know-how,
Based on feedback from project personnel in countries vis-
and the provision of training, in sciences related to safety
ited or interviewed by telephone, it appears that the project
in biotechnology and in the use of risk assessment and risk
was not very helpful in providing examples of risk assess-
management techniques.
ment and management, although this had been expected
by some countries.
Various capacity-building tasks are addressed differently
under the NBF development and implementation projects:
Most countries have given consideration to establishing a
national committee for risk assessment. In nearly al coun-
· NBF development projects were intended to identify
tries, the mechanism for risk assessment takes the form of
existing capacity gaps with regard to drafting of legal
an expert committee, such as a multi-stakeholder national
documents, administrative systems, risk assessment pro-
biosafety committee, sometimes with more technical y
cedures, and systems for public participation. Al the
oriented subcommittees for conducting product-specific
NBF development countries visited by the evaluation
reviews.
team gave a medium to low rating of the GEF support
to capacity assessment; they gave a higher rating to sup-
The creation of national biosafety committees in countries
port in actual capacity building.
with low baselines is expected to be very difficult, both in
· NBF implementation projects were assumed to have
terms of staffing and financing. Alternatives to this approach
some prior basic capacity and were more selective in
do not appear to have been considered in the NBF devel-
strengthening specific areas of human capacity, as wel as
opment projects. The GEF support in the development
establishing needed infrastructure in terms of laborato-
project was not intended to build the capacity to undertake
ries and databases for participation in the BCH.
subsequent implementation of risk assessment systems.
7.1 Risk Assessment in NBF
As implemented through the NBFs to date, nearly all
Development Projects
national implementation of systems for risk assessment and
management require the creation or restructuring of expert
At the NBF development stage, the national subprojects
committees. Analysis of national stocktaking regarding the
were not expected to focus on providing detailed technical
level and location of capacity in risk assessment (which var-
training in risk assessment and management, as this would
ied greatly from country to country) should logical y have
be a priority during the subsequent implementation phase.
been a primary input into the development of this element
Similarly, many development phase projects were not yet
of the NBF.
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The project also cal ed for networking; this required, among
decisionmaking systems would work in the NBF, the plans
other things, creation of a roster of experts. This task was
have not been put into practice in low baseline countries.
undertaken by 17 (50 percent) of the 34 projects that had
For the majority of countries, internal issues regarding the
completed this aspect of the NBFs, although analysis of
designation of competent national authority/authorities
these rosters indicates that they were not always developed
and coordination among competent authorities once desig-
systematical y or subjected to evaluative criteria or peer
nated, remain yet to be satisfactorily resolved.
review.
7.4 Conclusions
7.2 Risk Assessment in NBF
Implementation Projects
The final selection of national agencies responsible for bio-
safety is stil a matter of political discussion in many coun-
The evaluation shows that at least India, Mexico, Cuba, and
tries. The main conflict identified at the moment of imple-
China have substantial technical capacity in both biotech-
menting an NBF is the coordination of the administrative
nology and biosafety, and have experience with introduc-
tasks and competencies of the institutions involved. Most
tions of LMOs both in experimental field trials and in more
NBF development countries have only arranged general
general agricultural contexts. Colombia, Bulgaria, Poland,
introductory courses in risk assessment and management.
and Kenya also have some experience in dealing with exper-
Most of the NBF implementation projects have provided
imental field trial introductions of LMOs; while Uganda,
a week of intensive training in risk assessment. Few efforts
Cameroon, and Namibia have not yet had this experience.
seem to have been directed at building a corresponding
For countries with limited experience, risk assessment and
administrative, inspection, enforcement, or monitoring
management systems created by the project have yet to be
capacity. Some country scientists, in both the public and
put into practice and tested with real applications.
private sectors, have undergone longer term, in-depth prac-
tical training in risk assessment and decisionmaking; this
7.3 Capacity Building in Risk
may be helpful in building sustainable capacity within
Management
regulatory agencies and expert committees. Many countries
need more time to make decisions about risk assessment
One important question raised in several aspects of the
guidelines and conduct more in-depth training for the staff
evaluation was the integration of biosafety-related risk man-
that wil be assigned to carry out these tasks.
agement with other risk management measures related to
introduced crops and other plant varieties and the intro-
Although synergistic national implementation of inter-
duction of animal species. Long before the LMO issue was
national agreements is general y seen as an increasingly
prominent, the commercial introductions of conventional y
important objective, the practice has proven difficult for
created species (hybrids, cross-bred species) and natural spe-
many countries, particularly where specific international
cies from other locations (alien invasive species) placed com-
agreements have trade impacts or are not accepted by all
mercial agriculture and food security issues within the realm
of the enacting country's trade partners. In the context of
of potential risks to environmental health, species conserva-
biosafety, however, the significant investments needed in
tion, and human health. The biosafety projects were rarely
developing expertise, physical capacity, and institutions sug-
connected to other international agreements/instruments
gest that it wil be important to consider potential options
under the Food and Agriculture Organization of the United
relating to integration with risk management procedures
Nations (FAO), World Health Organization (WHO), or
having basical y identical control mechanisms connected to
CBD addressing these issues. Although many NBF devel-
other international agreements under the FAO, WHO, and
opment countries have identified how administrative and
CBD.
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8. Biosafety Policy and
Regulatory Development
The Cartagena Protocol is general y neutral on the topic
8.1 Indicators for Evaluating Policy and
of LMO introduction--that is, it neither encourages
Regulatory Outputs
introductions nor opposes them. Rather, it is designed to
increase public confidence in the safety of proposed intro-
To evaluate national legislative implementation, it was
ductions and marketed products, while providing the public
necessary to define a set of indicators that could provide a
and private sectors that are involved in the LMO industry
basis for analyzing whether particular subprojects' legisla-
or markets, as wel as the farmers that use LMOs, with a
tive outputs provide relevant, nonbiased, and professional y
commercial y valuable legal right--a legal y valid permit to
adequate draft legislation implementing the CPB. To this
import, introduce, transport, or develop LMOs. In choos-
end, the fol owing four indicators were identified.
ing a permit mechanism as the primary method of creating
Indicator a: Draft Legislation Is Consistent with and Suf-
and mandating biosafety, the Protocol negotiators expected
ficient under the CPB
to provide a strong commercial law basis for addressing bio-
safety. This basis can be created, however, only where the
This analysis was conducted through desk review of 38
resulting permit system provides "legal certainty."
NBF reports, analyzing the inclusion and completeness of
specific requirements and provisions mandated in the Pro-
To this end, the Protocol requires parties to adopt a num-
tocol. It should be noted that some NBF reports did not
ber of legislative provisions that are more specific (both in
address al of these issues. In fact, more than 13 percent
content and operation) than those normal y found in inter-
were completely silent on some questions. It is not pos-
national instruments. While attempting to sort out their
sible to conclude with certainty the meaning of these omis-
concerns regarding biosafety legislation in a comprehensive
sions. In some cases, they may relate to an area that was not
manner, parties may adopt a narrower range of interim
addressed by the project because it is already covered in the
measures to solve their immediate needs.
general law of the country; however, lacking any reference,
it is not clear that the subproject and/or regional coordina-
The evaluation team studied 38 draft country NBF reports
tors considered the issue.
prepared as part of the NBF development project. Al of
these produced at least some draft legislation. The evalua-
The most basic Protocol requirements--the decisionmak-
tion focused on two factors: the quality/acceptability of the
ing systems for regular introduction decisions (and, where
legislation developed and the readiness of the countries to
included, for food, feed, and processing [FFP] decisions)--
engage in a legislative process addressing these issues. This
are general y addressed in al legislative outputs reviewed,
report considers and describes the results of the evaluation
whether in new legislative proposals or in existing law sum-
by considering several indicators of the effectiveness and
marized in the NBF reports as already consistent with the
quality of that process and its outputs.
Protocol. In general, the text of new draft legislation also
21

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addresses the requirements of an advanced informed agree-
cal y that the current law supersedes al other provisions,
ment process, including risk assessment procedures and sci-
or that it generical y does not supersede any) was found to
entific advisory bodies.
some extent in 9 of the 17 laws examined. It may be more
prevalent, however, as 12 out of the 17 created entire frame-
A few issues were more frequently omitted from the draft
works without specifical y identifying the extent to which
legislation. For example, less than 40 percent of the draft
other legislation might apply and/or conflict.
NBFs reviewed address or propose measures "preventing
and...penalizing transboundary movements of living modi-
Indicator c: Legislation Is Legal y Valid and Professional y
fied organisms carried out in contravention of its domes-
Adequate
tic measures to implement this Protocol" (article 25.1),
and only 45 percent address unintentional transboundary
For half (nine) of the countries visited and interviewed, the
movement (article 17).
national interviewees and the evaluation team members con-
ducting the national review reported that national legisla-
Indicator b: Legislation Responds to National Needs
tive procedures and processes were ful y sufficient. Similarly,
the technical review of a separate selection of 17 countries'
Response to national need is a very broad question; this eval-
NBF reports also resulted in 9 that were general y judged to
uation specifical y looked at the fol owing aspects, which are
be sufficient in terms of primary legal requirements.
potential y reflective of response to national need:
Functional inconsistencies were apparent in eight countries'
1. The inclusion or exclusion of separate processes for FFP;
legislative documents (47 percent of the sample). However,
and
the majority of these could be relatively easily al eviated
2. The choice between adoption of a single new legislative
through technical editing of the draft, or, if it has already
framework and the more focused approach of amending
been adopted, through statutory construction and remedial
and integrating existing legislation.
drafting in implementing regulations.
Element b-1: Food, Feed, and Processing. In low base-
Operative omissions (errors that would be sufficient to ren-
line countries, one element of national need relates to FFP
der the legislation inoperable on its face) were not found in
issues. These may need to be addressed at an early stage in
any of the documents reviewed.
each project, in light of both the high priority given to food
and livelihood issues in these countries, and because these
Indicator d: Legislation Would Be Practical y Implementable
countries' most immediate use of the legislation wil be the
importation of food, often in the form of aid packages. This
To evaluate this indicator, information was col ected from
point was evaluated by a more in-depth review of com-
country visits and telephone reviews concerning the basic
pleted NBF reports in a single super-regional area--Africa
capabilities of government and other resource persons in
(14 countries). Ten (71 percent) of the African countries
17 countries. In 62 percent of these countries, limitations
whose legislation was specifical y reviewed did include some
of scientific capacity and equipment are severe enough to
level of special and streamlined decisionmaking for FFPs,
seriously limit the country's ability to staff significant scien-
while four did not. None of the reviewed NBFs that omit-
tific bodies or engage in certain kinds of risk management
ted FFP provisions addressed that omission through any of
activities. Where the country's primary expectation relates
these other provisions.
to food imports, or where LMO development is unlikely in
the short term, a more streamlined law focused on the most
Element b-2: New Law or Law Revision. This practice of
needed provisions may be more appropriate. New project-
"regulating over" existing laws (either by providing generi-
created draft framework legislation and proposals uniformly
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Evaluation of GEF Support for Biosafety ­ Executive Version

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cal for a ful scientific advisory committee and development
enables action without appropriate levels of scrutiny and
of new institutions and mandates.
competent risk analysis. The development of insufficient,
flawed, invalid, or questionable legislation can be problem-
In participating countries with only a limited expectation
atic where it gives the unjustified impression of a rigorous
of LMO activities, an elaborate system may also create a
system that can create legal certainty.
more long-term implementability problem--continuing
capacity. In interviews with UNEP staff, it was noted that
Overal , the process of legislative development in national
two implementation project countries that have completed
subprojects and the provision of technical assistance to that
comprehensive biosafety frameworks have not yet had any
process were found to have mixed results. In high baseline
applications to process.
countries, where sufficient legal and legislative experience
with biosafety and previous legislative development existed,
8.2. Conclusions
the projects appeared to provide a forum for further discus-
sions and development. Where baselines were lower, how-
The objective of national legislation under the CPB is the
ever, the countries' needs for more specific legal advice and
creation of a commercial y valuable permit system that
assistance were less completely met.
conveys legal certainty to applicants and permit holders.
The objective of the GEF projects was to provide techni-
Project performance in legislative/policy development in
cal and legal assistance to that process, to enable countries
these countries was inexorably linked to issues of capacity
to apply biosafety principles and obligations in an effective
building; peer review; and the creation, review, and utiliza-
manner that neither unduly restricts LMO activity nor
tion of stocktaking processes.
Biosafety Policy and Regulatory Development
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9. Databases and Information:
The Biosafety Clearing-House
Information col ection, col ation, analysis, and sharing are
major contribution to national public outreach and partici-
major components of the Cartagena Protocol and primary
pation efforts.
mechanisms for achievement of its objectives. Through the
Biosafety Clearing-House, the Protocol is able to provide
9.1 Information Sharing and the BCH
a source of official records of national decisions and expe-
The NBF development project document includes an
rience. This information is particularly critical to develop-
indicative al ocation of $15,000 per country for the fund-
ing countries with limited ability to ful y generate relevant
ing of databases and information technology. The 12 NBF
information and/or evaluate individual varieties themselves.
implementation projects had higher goals related to the
Additional y, the BCH is intended to have other roles relat-
creation and use of electronic databases, information shar-
ing to international information sharing, domestic par-
ing by country stakeholders and the general public, as well
ticipation, and public awareness. It is also important for
as better and more secure access to and use of the central
maintaining a national regulatory memory--another key
portal. With GEF funding and country co-funding, each
to ensuring that the primary mechanisms of the NBF func-
country had in excess of $100,000 at its disposal for this
tion sustainably.
purpose.
Each party is required to provide a range of very specific
In NBF development countries, the perceived demand for
information in a program-compatible format. This format
more sophisticated capacity in electronic communications
is specified by the BCH unit of the Protocol Secretariat. To
beyond the initial al ocation has been increasing. In 2003
minimize the need for intensive technical database training,
and 2005, the GEF Council al ocated $13.5 mil ion for
the Secretariat has prepared a modular system for entering
BCH development in 139 countries.
information into a BCH-compatible database, which can
be modified for countries with limited capability to use
The evaluation team analyzed the amount of data posted
electronic communication or data input.
on the BCH by the 53 countries reviewed. This included
39 countries that had completed, and 6 countries that had
The evaluation included field or desk reviews of achieve-
not completed, their NBF development projects, as wel as
ments related to BCH in 53 countries. Of these, 12 coun-
8 NBF implementation countries.
tries had created national biosafety websites available in at
least one of the three GEF official languages (English, Span-
The number of postings by the 53 countries appears in Table
ish, and French). Although national biosafety websites are
9.1. The posted data were compared with the total number
not required in the Protocol, they form another key com-
of entries in the BCH by the 189 potential y contributing
ponent of national information systems and can provide a
countries ("control group"; see footnotes under Table 9.1).
25

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Table 9.1: Information Elements in the BCH (as of August 28, 2005)
Roster of Legisla-
Risk
Introduction
FFP
Other
Country
Expertsa
tion
Assessments
Decisions
Decisionsb
Decisionsc
Total number entering data (of 53 countries reviewed)
31
27
-
-
5
3
Total number of countries (parties, signatories, and
74
61
4
-
13
9
non-parties) providing recordsd
a. Rosters of experts are not central y 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 deci-
sions 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 potential y contributing countries: 125 parties, 63 countries that are parties to the CBD but not to the Pro-
tocol, and 1 country that is an active observer in both.
The data suggest that neither the 53 countries that have
9.2 Conclusions
received assistance from the GEF in the context of the
As yet, the information and data-sharing obligations under
CPB nor the control group have posted al the data that are
the Protocol have not been sufficiently addressed, neither
required. The low level of posting applies both to countries
general y by parties to the CPB as a whole nor by the work
supported by the GEF as wel as those not supported. This
under the projects, to enable the BCH to function. Although
suggests that compliance with the Protocol's BCH posting
not completely addressing many functional needs of the
may require more than the provision of additional funding
BCH, national websites do demonstrate progress in the col-
for information development.
lection of some relevant data. If posted in a specified format,
national websites can be the means by which information is
The UNEP development project team reports that further
uploaded by the Protocol Secretariat into the BCH's central
progress in this area, including the development of regional
node. Based on external evaluation of the websites, and the
BCHs (either regional nodes or regional websites meeting
fact that data from them have not been harvested into the
the BCH technical requirements), is ongoing, and wil be
BCH, it appears that subproject-created websites have not yet
posted and made accessible soon.
met the requirements for direct use by the BCH.
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10. Effectiveness of
Quality Assurance Tools and Mechanisms
The participating countries and the GEF Implementing
usefulness of the assistance advice provided by each of the
Agencies engage in a partnership and have a combined
GEF's three Implementing Agencies, partly because they
responsibility to ensure project quality and effectiveness.
operated quite differently and under very different circum-
In this endeavor, the partners have a number of tools and
stances. The main differences among the three are, first, that
mechanisms. This includes recruitment of long-term and
UNEP has had a much longer term engagement in biosafety
short-term staff, preparation and use of guidance materi-
matters and has a much wider professional experience and
als, organization of surveys and workshops, project plan-
competence; second, the two other agencies provided assis-
ning and reporting, procurement of long-term and ad hoc
tance mostly to high baseline (and larger) countries, which
technical advice, and organization of peer review of final
received higher GEF al ocations, while UNEP covered all
documents.
the low baseline countries.
The evaluation team analyzed the effectiveness of some
The World Bank supervised biosafety projects out of its
of the intervention tools and mechanisms available to the
headquarters in Washington, D.C., and sent relatively
two partners (GEF's Implementing Agencies as wel as the
strong teams of specialists to provide technical advice dur-
national executing agencies). The UNEP Toolkit was one of
ing semi-annual supervision missions, which resulted in aid
the principal mechanisms for providing both administrative
memoranda with clear recommendations. The approach
and substantive guidance to participating countries. Given
appeared to be relatively suitable to its partner countries,
the limitations to direct in-country interaction between
India and Colombia.
UNEP regional coordinators and NPCs, the Toolkit was
UNDP has made no efforts to build specialist biosafety
anticipated, at least partial y, to fil the gap.
competence among its regular staff, which consequently
provided very limited substantive input to its only ongoing
10.1 Technical Advice from Implementing
project in Mexico, except through the NPC. Since Mexico
Agencies
is a high baseline country, the approach was quite suit-
able in this case. A second UNDP project in Malaysia has
A comparison of the quality of advice given by each of the
not started yet, partly due to a change of government, but
three GEF Implementing Agencies (UNEP, UNDP, and the
also partly due to poor communication between the two
World Bank) must by necessity be restricted to NBF imple-
partners.
mentation projects, which were the only common project
modality. Since UNDP and the World Bank only managed
Since UNEP implemented the bulk of the biosafety portfo-
two projects each, a scientific analysis of relative effective-
lio, this assessment of agency performance is mainly based
ness is not possible. Based on general feedback provided by
on its performance. The data are not very comprehensive
the NPCs and other key project personnel, the evaluation
and do not take some important issues into ful account;
cannot point to statistical y significant differences in the
for instance, whether specific assistance was rendered at the
27

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request of the country or through generic support--for
in general, UNEP had to take a low-intensity oversight and
example, at regional workshops.
feedback approach.
The quality, usefulness, and timeliness of the technical
There are many examples of the UNEP project team mak-
advice provided to the countries were rarely rated "high."
ing every effort to be of help and giving measured assis-
The scores were especial y low in the low baseline countries,
tance directed toward countries with the greatest needs.
while the high baseline countries general y stated that the
The UNEP regional coordinators primarily had a scien-
advice and backstopping were adequate. This suggests first
tific background and were strong in project management,
that the level of advice was better suited to countries with
but for a considerable period there was no one with a legal
a high baseline than those with a low baseline. It does not
background. The UNEP project team is wel regarded for
necessarily mean that the advice was of low or medium qual-
its commitment and hard work.
ity in the majority of countries, but rather that good advice
was mostly not readily available in a form that was adapted
Concerning UNEP's involvement on subprojects, two
to the country's situation at a time when it was needed. The
activities to note in particular are the national stocktaking
scores on advice on risk assessment/risk management and
and the peer review system. The stocktaking exercises could
interim measures are very low; scores are markedly higher
have provided an opportunity for the regional coordinators
on legal aspects and public participation.
or Implementing Agency specialists to acquaint themselves
with the national situation and improve their ability to
Table 10.1 provides the ratings with regard to UNEP's tech-
provide guidance. However, this was neither planned nor
nical advice, given by participants interviewed in 17 coun-
financed as a separate activity in the NBF development
tries visited or interviewed telephonical y. (Note that some
projects. Further, it reduced the possibilities for pointing out
countries did not respond to al questions.)
potentials for col aboration and harmonization within the
subregion as wel as national legislative choices that could be
The project team was not able to visit and provide hands-
the most suitable to each country's needs and capacity.
on guidance to al 120 countries involved. According to
UNEP's records, as of August 31, 2005, 23 countries had
not been visited by UNEP project staff--these were primar-
10.2 Review of the UNEP Toolkit
ily countries included for al ocations by the GEF Council in
Between May and August 2005, an email survey of the
November 2003. In al , 62 countries had been visited once,
UNEP Toolkit was carried out by Vrije Universiteit of
27 countries had been visited twice, and 8 had been visited
Amsterdam. A questionnaire was distributed to 500 key
more than twice. Available project resources dictated that,
stakeholders in 30 countries, plus an additional 40 persons
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
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Evaluation of GEF Support for Biosafety ­ Executive Version

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at the global level, representing academia, other biosafety
ment (50). The last two topics were singled out as requiring
donors, the biotechnology industry, and NGOs. The pur-
most attention.
pose of the review was to assess whether the Toolkit was
consistent with the Cartagena Protocol, responsive to coun-
The main evaluation team assessed the use and utility of the
try needs, and of sufficient professional quality. The results
Toolkit through structured interviews with a wider group
show that 78 percent of the 102 respondents answered
of potential users in the seven NBF development countries
that the Toolkit was "very consistent" or "consistent" with
visited. The assessment included the Toolkit's consistency
the Protocol. Only one respondent answered "not so con-
with country needs, its availability to stakeholders, and
sistent," while the remainder gave no answer. There were
level of use in the country. The two surveys are not directly
also several questions related to "responsiveness to country
comparable because the issues raised and the selection of
needs"; 79 percent stated that the Toolkit had been or is use-
respondents were different. Table 10.2 sums up the evalu-
ful/very useful for their country, while most of the remain-
ation team's assessment of selected aspects of the Toolkit.
der gave no clear answer. On the question of whether the
Issue 1 was raised in countries both visited and interviewed
Toolkit was sensitive with regard to countries' available
by telephone and received 11 responses. The other issues
scientific expertise, 65 percent gave a positive answer, 15
were only raised in the seven NBF development countries
percent a negative, and 20 percent gave no answer or did
visited.
not know. Nine questions were related to the professional
In conclusion, it is the view of the evaluation team that the
quality of the Toolkit. More than 70 percent of the respon-
Toolkit was primarily used by, and proved to be quite use-
dents indicated that they were satisfied/very satisfied with
ful for, the NPC and some key members of the NCC. It
the clarity of aims, the selection of topics, and the depth and
was not widely disseminated and scarcely used by the wider
comprehensiveness of guidance on selected topics.
stakeholder groups in the countries.
Another aspect of quality surveyed was coverage of topics.
There were seven topics on which between 36 and 53 per-
10.3 Advice Provided by External Experts
cent of the respondents wanted more emphasis: protection
of biodiversity and human health (39); public awareness
Within each national subproject, about $50,000 was bud-
programs (37); risk assessment (37); organizing procedures
geted for engagement of professional advice or other exper-
for decisionmaking (38); designing a regulatory regime
tise. The amounts were expected to cover five stocktaking
(36); il egal introduction of LMOs into the country (53);
reports, as wel as advice through the drafting process and
and systems for monitoring, inspections, and law enforce-
peer review of the draft final NBF report.
Table 10.2: Assessment of Toolkit Utility in NBF Development 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 inter-
viewed 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 stil in process.
Effectiveness of Quality Assurance Tools and Mechanisms
29

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The evaluation team examined eight of the UNEP-funded
intensity fol ow-up and supervision strategy in each coun-
peer reviews with regard to the technical quality of these
try. This reduced the ability for extra support to low baseline
reviews and the experience/competence of the reviewers
countries. However, such fol ow-up was not necessarily an
themselves. Peer review quality was analyzed in terms of the
inherent feature of the umbrel a approach, which could have
contents of the review focusing on correctness, complete-
had more flexibility for adaptation at the national level, and
ness, relevance, and usability. In three of the eight cases, the
also included sufficient professional back-up and supervi-
quality of the reviews and the reviewers' qualifications were
sion for country-specific issues.
found to be unsatisfactory. This evaluation concluded that
the peer review system was of mixed quality.
10.5 Conclusions
10.4 Effectiveness of the Global NBF
In general, the UNEP Toolkit modules have been found
Development Project Umbrella Approach
satisfactory by the primary users (project staff and coordi-
nating committee members) in terms of consistency with
At the overal level, the GEF has used two al ocation mod-
the Cartagena Protocol and professional quality, although
els: 12 individual medium-sized country project al ocations,
less responsive to country needs. The main problem was
and one main umbrel a-type al ocation, which initial y
tardiness relative to project execution in a great many coun-
included NBF development projects in 100 countries; 30
tries, and the lack of access to and use of the modules by
more countries were later added.
various stakeholder groups at the country level.
The umbrel a approach was, under the circumstances, a
For a project as complex and contentious as developing a
necessary tool to deliver assistance expeditiously to the large
national regulatory framework for LMOs, a toolkit approach
number of countries requesting assistance, and it entailed
may have limitations when compared with more direct
economies of scale in administrative and financial manage-
mechanisms of providing guidance. Given limited funding
ment of subprojects on a global scale in the GEF's rapid
and time constraints, however, the toolkit approach was a
response. The alternative of organizing 100 individual
cost-effective, although not entirely satisfactory, means of
projects without a single coherent system would have been
providing basic guidance to a large number of countries
much more demanding both in terms of time and resources.
working toward the same or similar goals.
The objective of economizing on GEF funds by employing
economies of scale was an important contributing factor to
The quality, usefulness, and timeliness of the technical
the choice.
advice and backstopping by Implementing Agency staff and
external expertise were rated mostly at a medium to low
The umbrel a approach was especial y effective in countries
level. This does not necessarily mean that the advice itself
that could easily incorporate the support into their own
was of low quality in al cases, but rather that good advice
biosafety systems, but much less effective in countries where
was not readily available in a form that could be adapted to
the need for support was greater and/or the initial condi-
the country situation at a time when it was needed.
tions were less receptive. On the whole, the approach was
too ambitious in terms of high goals within limited time
The umbrel a approach was, under the circumstances, a
schedules, and it did not have a sufficient built-in flexibility
necessary tool to deliver assistance expeditiously under a
to adapt the level of funding and the measures of required
single project to 100 countries, although the approach was
technical assistance to the needs of each country. Due to
too ambitious and was much better adapted to high base-
resource constraints, UNEP was forced to employ a low-
line than low baseline countries.
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Evaluation of GEF Support for Biosafety ­ Executive Version

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11. The GEF's Contribution to
Progress in Implementing the CPB
The final step in this evaluation cal ed for an analysis of the
Based on these facts and other information, the evaluation
fol owing question: What progress has been made in coun-
concludes that participation in the GEF biosafety efforts
tries in building the requisite capacities toward their ratifi-
enhanced awareness of the Protocol at administrative and
cation and implementation of the Cartagena Protocol? This
political levels, and contributed to a speedier ratification by
section summarizes the evaluation team's assessment of the
many countries than would otherwise have been the case.
primary indicators of progress toward these goals and the
GEF's contribution in this regard.
11.2 Progress in Countries Related to
Various Articles of the CPB
11.1 Speed of Ratification of the
Another indicator is the GEF's support and coverage related
Cartagena Protocol
to various articles of the CPB.
Legislative and Regulatory Provisions
One way of evaluating the speed of the ratification process
is by comparing it to other international agreements. Both
Most NBFs have specifical y addressed nearly al proto-
the Cartagena and Kyoto Protocols have been topics of seri-
col-required legislative and regulatory provisions. In many
ous controversy among OECD countries. Such controversy
cases, issues not directly covered in legislation by the coun-
between or among OECD countries is likely to create a high
tries may have been omitted because they were addressed
level of insecurity in other countries regarding the political
in other existing law. However, these outputs are gener-
effects of their own ratification. Consequently, it is notable
al y stil in the form of interim drafts; in many cases, the
that the Cartagena Protocol's ratification by 125 countries
countries stil require significant professional assistance to
has been relatively rapid, in comparison with other contro-
make them sufficiently functional and effective in form and
versial instruments (in this case, the Kyoto Protocol), and
content to be put forward as legislative or regulatory pro-
with the Convention on International Trade in Endangered
posals. In many instances, national legislative development
Species of Flora and Fauna, whose ratification was delayed
has insufficiently integrated or addressed issues of national
by other political factors.
need, institutions, and capacity, so existing legislation may
not fit comfortably into national systems. In the worst case,
Another measure of the effect of GEF support on ratifica-
if such legislation were adopted without further technical
tion can be based on review of the Protocol status of coun-
assistance and advice, it would result in "paper compli-
tries that were non-parties when they received GEF funds.
ance"--where the law exists on the books but is general y
At the time of the evaluation, 81 percent (31 of 38) of
not implemented.
countries with completed NBFs had ratified the Protocol,
while ratification in countries with national subprojects still
In al cases evaluated, the GEF efforts have created a func-
in progress had been slower.
tional basis for further work, including reconsideration of
31

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the problems identified above. Viewed in this context, the
Capacity Development
NBF development project may be seen to represent a sig-
nificant contribution. At a minimum, 93 percent of devel-
The level of and need for capacity development were often
oping country parties (and many countries that have not
insufficiently assessed in countries. At the global level, sig-
yet ratified the protocol) have made at least some progress
nificant capacity-building efforts were directed at sensitizing
toward achieving their legislative and institutional objec-
a smal core group of actors in each participating country.
tives, and have developed a plan (reflected in each national
Ultimately, more specialized types of col egiate and post-
NBF report) for further regulatory development. This status
graduate training wil be needed in many countries. Pending
is significantly more advanced than for other conventions
that, however, other objectives, including efforts to develop
and protocols which have been in existence far longer.
regional and other networks among national actors, fil a
critical capacity development role.
Regional Harmonization and Cooperation
Progress Related to National Coordination and Cooperation
Although the GEF Initial Strategy recognizes that it is early
in most regions to expect formal harmonization of legislative
For many countries, it is evident that the envisioned scien-
and regulatory provisions, the countries did not undertake
tific and technical capacity required to implement the NBF
significant efforts toward investigating options for regional
does not exist, and is not likely to do so for some years.
cooperation and harmonization, frequently omitting con-
Practical y, in a number of low baseline countries, the need
sideration of this aspect from NBF development processes.
for such capacity is not currently recognized, since LMO
The more immediate goal of building a base of regional
development and introduction are not primary issues
and subregional networks that could enable the sharing of
in their national agendas. Although clearly the GEF has
expertise and information was attained to a much higher
enabled these countries to develop individual and institu-
extent. This might constitute an intermediate step toward
tional experience at some level, through the networking,
building formal regional institutional structures.
sensitization, and informational resources provided, further
attention to capacity issues wil be necessary in order them
Public Participation
to implement the Protocol.
Public participation was strongly promoted by the UNEP
An important institutional component of the GEF efforts
project team, and through the Toolkit and other Imple-
was the development of the national coordination com-
menting Agency documents. There have been some signifi-
mittees, created to provide primary domestic oversight
cant achievements in this regard, yet, in many cases, national
and guidance to operations. In many countries, the NCC
efforts at inclusiveness and cross-sectoral operations were
was both an effective steering committee and a nascent
evaluated to have been inadequate to the task, and many
network of key biosafety-related officials and other actors,
processes insufficiently open and responsive to the breadth
which provided important tools and experiences for cross-
of necessary perspectives, institutions, and stakeholder
sectoral and public-private partnerships. This process has at
groups. However, the evaluation shows that there is a wider
times proven so effective that the NCC has been restruc-
acceptance of awareness raising and more interest in broader
tured with a direct governmental mandate to operate as its
public participation in a number of countries, especial y in
national biosafety committee fol owing the end of the GEF
Eastern Europe and Latin America.
project activities.
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Evaluation of GEF Support for Biosafety ­ Executive Version

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11.3 Advancement toward Compliance and
given a medium rating. This is shown in Table 11.1; in the
Implementation of CPB
sample of 17 countries, 6 attained a high level of progress, 4
a medium level and 7 a low level.
The evaluation identified national baselines of the initial
situation regarding LMOs in the sampled countries at the
Table 11.1: Overall Progress Made in Countries to
outset of the project and assessed the rate of progress that
Implement the CPB
has been achieved during project implementation.
Item
Country
High
Medium
Low
Various aspects of the achievements have been described
Overal progress
Development
3
3
5
and analyzed above. The evaluation concludes that impor-
made on requisite projects (11)a
tant achievements have been reached by the GEF projects,
capacities to
Implementation
3
1
2
implement the
projects (6)
even if the results vary considerably among countries. The
protocol
majority of countries have achieved either a high or low rate
a. The level for one country has not been determined due to
of progress, while a smal er number of countries have been
lack of data.
The GEF's Contribution to Progress in Implementing the CPB
33

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Acronyms
BCH
Biosafety Clearing-House
LMO
Living Modified Organism
CBD
Convention on Biological Diversity
NBF
National Biosafety Framework
COP
Conference of the Parties
NCC
National Coordinating Committee
COP-MOP Conference of the Parties to the Convention
on Biological Diversity Serving as the
NEA
National Executing Agency
Meeting of the Parties to the Cartagena
NGO
Nongovernmental Organization
Protocol on Biosafety
NPC
National Project Coordinator
CPB
Cartagena Protocol on Biosafety to the
Convention on Biological Diversity
OECD
Organisation for Economic Co-operation
and Development
EU
European Union
SIDS
Smal Island Developing States
FAO
Food and Agriculture Organization of the
United Nations
UNDP
United Nations Development Programme
FFP
Food, Feed, and Processing
UNEP
United Nations Environment Programme
GEF
Global Environment Facility
WHO
World Health Organization
35

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Global Environment Facility
Evaluation Office
1818 H Street, NW
Washington, DC 20433
USA
www.theGEF.org

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