PROJECT DOCUMENT 1.1 Project Title: Panama: Consolidation of

PROJECT DOCUMENT
SECTION 1: PROJECT IDENTIFICATION
1.1
Project Title: Panama: Consolidation of national capacities for full implementation of the
Cartagena Protocol on Biosafety in Panama.
1.2
Project Number:
GFL/
PMS:
1.3
Project Type:
MSP
1.4
Financing:
GEF
1.5
GEF strategic objectives:
Long term strategic objective:
GEF strategic programme:
ADDIS N° 00369. GEF ID N° 3631
BD1
BD-SP6
1.6
UNEP Priority:
Environmental governance
1.7
Geographic Scope:
National
1.8
Execution Model:
External
1.9
Organization for Execution of the Project: National Environmental Authority (ANAM)
1.10
Project Duration:
1.11
Project Cost
GEF Trust Fund
Effective Co-financing
In Cash:
ANAM
ARAP
AUPSA
INDICASAT
MIDA
MINSA
SENACYT
Cash co-finance sub-total
- Panama
48 months
Commencing: Sept 2011
Completion: Sept 2015
US$ 1,954,927
100%
954,927
49%
(A)
1,000,000
51%
(B)
170,000
5,000
5,000
5,000
5,000
5,000
5,000
200,000
17% of (B)
0.5% of (B)
0.5% of (B)
0.5% of (B)
0.5% of (B)
0.5% of (B)
0.5% of (B)
20 % of (B)
1
In kind:
ANAM
ARAP
AUPSA
INDICASAT
MIDA
MINSA
SENACYT
In-kind co-finance sub-total
Total
307,700
82,700
82,700
81,700
82,000
80,800
82,400
800,000
US$ 1,954,927
30.77% of (B)
8.27% of (B)
8.27% of (B)
8.17% of (B)
8.20% of (B)
8.08% of (B)
8.24% of (B)
80 % of (B)
100%
1.12 Project Summary
1. The Republic of Panama ratified the Cartagena Protocol, with Law Nº 72 of December, 26, 1991 and
then with Law Nº 48 of August, 2002 as its main application tool. This latter law establishes the
National Biosafety Commission for LMO, defines institutional competences, and establishes the
creation of sectorial committees in the agricultural, environmental and public health sectors. Besides, it
establishes a framework for the development of specific regulations at sectorial level.
2. Through the UNEP-GEF Project for the development of a national Biosafety framework, proposals for
Biosafety regulations were created and recommendations included modifications to Law 48 of 2002, in
order to update the current regulating framework. ANAM has also proposed to incorporate the
application of the Cartagena Protocol as an action line within the National Environmental Plan,
supported by the IDB in 2008.
3. ANAM also approved, between 2005 and 2009, nine environmental public policies, among them:
environmental information; auditing, control and supervision; environmental management
decentralization; and biodiversity. The national biodiversity policy, through the conservation for
sustainable development strategy and its policy orientations for 2004-2009, highlights the need for the
establishment of a biosafety regulating framework in Panama.
4. The National Environmental Strategy “Environmental Management for Sustainable Development 2008
-2012” in guideline 1, objective 1 explains the consolidation of the legal framework and environmental
policies, specifically the Biosafety Regulating Framework and the elaboration of the biosafety policy
and its plan of action. Objective 2 prioritizes the functioning of the BCH National Website and the
creation of a scientific base on which to consolidate the Scientific, Technological and Environmental
Research Network. In guideline 4 of this strategy, one of the measures for conservation and appropriate
use of biodiversity includes the implementation of the Biosafety Regulating Framework and the
establishment of Biosafety Information Centres.
5. The current Project will help to consolidate national capacities for the full implementation of the
Cartagena Protocol on Biosafety (CPB) of the Convention on Biological Diversity (CBD) in Panama.
The emergence of new technologies in the mid 80’s, among them, crops based on Living Modified
Organisms (LMO), together with conventional technologies, will contribute to increase production,
productivity and quality of the agricultural products in those countries that adopt them. LMO crops
cause controversies because of the potential risks they may cause to biodiversity, farming activities, the
environment and human health. Panama has progressed with the adoption of appropriate biosafety
measures and has revised the national regulations.
2
6. Panama, through the National Environmental Authority (ANAM), the country’s focal point before the
CBD and the CPB, is responsible for implementing the “National Biosafety Framework” according to
criteria of efficiency, transparency, equity, competitiveness and participation of all involved actors in
the different consultation and elaboration stages.
7. The National Biodiversity Strategy establishes the fundamental need, in the short term, for creating an
appropriate mechanism for the adoption of decisions on the safe transfer, handling and use of LMO.
8. Panama has national regulations related to biosafety, such as: Law N° 2 of January 12, 1995, by which
Panama ratifies the Convention on Biological Diversity; Law N° 72 of December 26, 2001, which
ratifies the Cartagena Protocol on Biosafety of the Convention on Biological Diversity; Law N° 47 of
July 9, 1996, which establishes phytosanitary protection measures and adopts other regulations;
Executive Decree N° 137 of May 29, 2001, which creates the National Biosafety and Bioethics
Commission; 5. Law Nº 48 of August 8, 2002, which creates the National Biosafety Commission for
Living Modified Organisms and establishes other regulations.
9. Panama has expressed interest in receiving support from GEF for the implementation of the Cartagena
Protocol and the rest of specific regulations, including the implementation of Law Nº 48 of August 8,
2002, the implementation of which has been delayed because the National Biosafety Commission for
LMOs has not yet been set up; neither the 5 civil society members that will be part of the Commission
nor the members of the Environmental and Agricultural Biosafety Sector Committees have yet been
appointed. This situation has partly affected the implementation and progress of the topic in the
country. Nevertheless, the National Committee for Information Exchange in Biosafety, a technical
group involved in the execution of two previous UNEP/GEF projects (NBF Development and BCH),
has substituted as the entity through which biosafety issues are considered and coordinated, and has
functioned relatively well. In order to consolidate this group’s role, however, a proposal exists (to be
taken forward in this project) to create the National Biosafety Technical Committee (NBTC) as a more
operative and representative body that will replace the National Biosafety Commission to function as
the country’s sole biosafety coordination mechanism.
10. Thus, despite making some progress, problems with the safe transfer, handling and use of LMO still
persist in the country. These point to possible risks of “environmental pollution” and biodiversity
impacts due to the unauthorized use and transportation into the country of LMOs. Public and private
actors that participate or should participate in the biosafety of LMOs, by-products and products
containing them, or in transportation processes from their production or import sites to
commercialization points and final use sites, have not yet been defined. There is a lack of technical
guidelines to control actual LMO importation process (grains, seeds or any other reproduction
material) and to undertake the evaluation process and risk management in transfer, handling and use
with export countries, in the terms foreseen in the CPB.
11. In general terms, existing capacities in the country regarding biotechnology and biosafety are limited.
Everything related to the management, elaboration of regulations, regulatory compliance,
methodologies for the due assessment of risks and the R+D component on these topics are very
limited. The country does not have a National Policy for Development of Biotechnology and
Biosafety.
12. The current Project aims to achieve the effective application of the CPB by implementing Panama's
national biosafety regulatory framework and developing national capacities to properly handle Living
Genetically Modified Organisms (LMO) for the safeguard of biodiversity. It specifically supports key
priorities for reducing adverse effects to biodiversity, human health and negative socioeconomic
impacts and fosters sustainable environmental development. Likewise, it contributes to the efforts of
3
the Government of Panama to achieve one of the Millennium Development Goals: ensure
environmental sustainability through the integration of sustainable development into country policies
and programmes, reverse the loss of natural resources, specifically global importance biodiversity. This
Project is also fully in line with the Plan of Action for Capacity Building of the CPB, adopted during
the first COP MOP and modified during COP MOP IV.
13. Under the GEF’s Biodiversity Focal Area, the Project falls under Strategic Programme-6 but is also
related to Strategic Programme-1 through: (i) development of new capacities within ANAM for
coordination, monitoring, and supervision of Biosafety activities in the use of LMO; (ii) establishment
of criteria for activities with LMO (iii) establishment of capacity for long term sustainability for
biosafety; (iv) public/private capacity building; and (v) increase ANAM’s income base for monitoring
and management of LMO, as well as alternative financial mechanisms (e.g., research, among others).
Likewise, the Project promotes SP2 (Mainstreaming into Productive Sectors) strengthening the
capacity of ANAM, producers, NGOs and academic institutions for: (i) development of procedures and
regulations for the use of LMO at the local and national levels; (ii) help key actors in the
implementation of the CPB; (iii) promote principles and processes of natural resources administration
and protection of biodiversity in rural development.
14. Additionally, the Project will offer support for biodiversity conservation, avoiding the inadequate use
of LMO, as well as offering alternatives that generate environmental benefits at the local, national, and
global levels, and changes in soil use practices that reduce threats and overexploitation of critical
ecosystems, including buffer zones and ecological corridors of global importance.
15. The Project seeks to attain the alternative scenario of reducing the risks to biodiversity posed by LMOs
and will considerably increase global benefits by allowing Panama to fully exert its rights and
obligations under the CPB. The country has strengthened biodiversity protection measures at the
national and local levels, through the creation of protected areas, increasing from 65 management units
in 2006 to 89 in 2009. To reach global value biodiversity protection and work together with productive
sectors, additional support is required which will be covered by GEF, as part of the strategy to take
protection measures additional to those taken in normal circumstances.
16. The national government will cover costs for maintenance of the baseline and could manage to move
on with or without the GEF Project, but the incremental cost will be assumed by GEF, since the
country cannot be responsible on its own. Both the Government and GEF will assume the intervention
costs; that is to say, co-financed by the country and GEF, since it is understood that the creation of
institutional and inter-sectorial capacities for the implementation of the CPB will increase.
4
TABLE OF CONTENTS
SECTION 1: PROJECT IDENTIFICATION .......................................................................................................... 1
SECTION 2: BACKGROUND AND SITUATION ANALYSIS (BASELINE COURSE OF ACTION) ............ 8
2.1. 2.2. 2.3. 2.4. 2.5. 2.6. 2.7. BACKGROUND AND CONTEXT .................................................................................................................... 8 GLOBAL IMPORTANCE ................................................................................................................................. 9 THREATS, CAUSES, AND BARRIER ANALYSIS.............................................................................................. 10 INSTITUTIONAL, SECTORAL AND POLICY CONTEXT .................................................................................. 12 STAKEHOLDER MAPPING AND ANALYSIS ................................................................................................... 18 ANALYSIS OF BASELINE AND GAPS ............................................................................................................ 21 LINKS WITH OTHER GEF AND NON-GEF INTERVENTIONS ......................................................................... 24 SECTION 3: INTERVENTION STRATEGY (ALTERNATIVE) ....................................................................... 25
3.1. 3.2. 3.3. 3.4. 3.5. 3.6. 3.7. 3.8. 3.9. 3.10. 3.11. PROJECT JUSTIFICATION, POLITICAL ACCEPTANCE AND EXPECTED BENEFITS FOR THE WORLD
ENVIRONMENT .......................................................................................................................................... 25 PROJECT’S GOAL AND OBJECTIVES ........................................................................................................... 29 PROJECT COMPONENTS AND EXPECTED RESULTS....................................................................................... 30 INTERVENTION LOGIC AND KEY ASSUMPTIONS .......................................................................................... 33 RISK ASSESSMENT AND MEASURES FOR RISK MANAGEMENT ..................................................................... 35 CONSISTENCY WITH NATIONAL PRIORITIES AND PLANS ........................................................................... 38 INCREMENTAL COST REASONING .............................................................................................................. 40 SUSTAINABILITY ....................................................................................................................................... 44 REPLICATION ............................................................................................................................................. 45 PUBLIC AWARENESS, COMMUNICATIONS AND MAINSTREAMING STRATEGY .............................................. 45 ENVIRONMENTAL AND SOCIAL SAFEGUARDS ............................................................................................ 46 SECTION 4: INSTITUTIONAL FRAMEWORK AND IMPLEMENTATION ARRANGEMENTS.............. 47
SECTION 5: STAKEHOLDER PARTICIPATION .............................................................................................. 49
SECTION 6: MONITORING AND EVALUATION PLAN ................................................................................ 49
SECTION 7: PROJECT FINANCING AND BUDGET ........................................................................................ 51
7.1. 7.2. 7.3. OVERALL PROJECT BUDGET ....................................................................................................................... 51 PROJECT CO-FINANCING ............................................................................................................................ 51 PROJECT COST EFFECTIVENESS .................................................................................................................. 52 APPENDICES............................................................................................................................................................ 53 5
ACRONYMS AND ABBREVIATIONS
ANAM
ARAP
AUPSA
BCH
CATIE
CBD
CPB
DAPVS
DINASA
ENA
EOU
FTA
GEF
ICGES
IDIAP
IICA
INDICASAT
ISAAA
JIA
LMO
M&E
MEF
MICI
MIDA
MINREX
MINSA
NBC
NBF
NBTC
NEA
NGO
NPC
OIRSA
PHBB
R+D
SENACYT
UNARGEN
National Environmental Authority
Aquatic Resources Authority of Panama
Panamanian Food Safety Authority
Biosafety Clearing House
Centre for Tropical Agricultural Research and Teaching
Convention on Biological Diversity
Cartagena Protocol on Biosafety
Direction of Protected Areas and Wild Life (of ANAM)
Direction for Animal Health
National Environment Strategy (in Spanish: Estrategia Nacional del Ambiente)
Evaluation and Oversight Unit of UNEP
Free Trade Agreement
Global Environment Facility
Gorgas Memorial Institute of Tropical and Preventive Medicine
Agricultural Research Institute of Panama
Inter-American Institute for Cooperation on Agriculture
Institute for the Development of Innovation, Science and Technology
International Service for the Acquisition of Agri-Biotech Applications
Inter-American Agricultural Board
Living Modified Organism
Project Monitoring and Evaluation
Ministry of Economic and Finance
Ministry of Trade and Industry
Ministry of Agriculture
Ministry of Foreign Affairs
Ministry of Health
National Biosafety Committee
National Biosafety Framework
National Biosafety Technical Commission
National Executing Agency
Non-Governmental Organization
National Project Coordinator
International Regional Organization of Agricultural Sanitation
Hemispheric Programme on Biosafety and Biotechnology
Research and Development
Secretary of Science and Technology and Innovation
Unit for Access to Genetic Resources
UNDAF
UNEP
UP
United Nations Development Assistance Framework
United Nations Environmental Programme
University of Panama
6
USMA
WHO
Santa Maria La Antigua University
World Health Organization
7
SECTION 2: BACKGROUND AND SITUATION ANALYSIS (BASELINE COURSE OF ACTION)
2.1.
Background and Context
1. The National Biodiversity Strategy (2000) establishes the priority need, at the short term, for the
creation of an appropriate mechanism for adoption of decisions on the safe transfer, handling and use of
Living Modified Organisms (LMO). The Republic of Panama ratified the Cartagena Protocol on Biosafety
through Law 72 of December 28, 2001. Later on, Law 48 of August 8, 2002 is approved. Currently, there
are proposals for the Modification of Law 48 of 2002 and drafts for Executive Decrees regulating such
Law at the sector level.
2. In early 2001, the Ministry of Agriculture (MIDA), created the National Biosafety and Bioethics
Commission ad hoc, through Executive Decree No.137, of May 24, 2001, with the purpose of
disseminating and creating awareness on the different relevant aspects of its nature and for promoting
public actions tending to achieve the approval of Draft of the Law: “by which establishes national
regulations for the development of genetic engineering activities and application of corresponding
biosafety measures” y “which institutes the Biosafety and Bioethics National Code”. Both discussion and
analysis processes were key and served as the base for approval of Law 48 of August 8, 2002, “Which
creates the National Biosafety Commission for Living Modified Organisms and establishes other
regulations”.
3. The National Environment Authority (ANAM) is the National Focal Point for the Convention on
Biological Diversity (CBD) and for the implementation of the Cartagena Protocol on Biosafety (CPB).
Additionally, it is the Political and Operational Focal Point of the Global Environment Facility (GEF).
ANAM is responsible for implementing the “National Biosafety Framework” (NBF) according to criteria
of efficiency, transparency, equity, competency and participation for all involved actors.
4. With funding from GEF, through UNEP, the ANAM has executed two biosafety projects. The first
(“Development of a National Regulating Biosafety Framework for Panama”, known as the NBF
Development project) was a global initiative to assist developing countries to prepare for the entry into
force of the Cartagena Protocol on Biosafety (GEF/C.16/4). This project initiated in July 2005 and lasted
for 27 months ending in October 2007; its budget consisted in US$119,000 from the GEF and US$ 59,000
as national government allocation (co-finance). The project initiated in July 2005 and officially ended in
June 2008, with the submission to UNEP of a draft NBF.
5. Through the NBF Development Project, a Draft of a National Regulating Framework for Biosafety was
generated, in addition to two overarching diagnostic studies: Diagnosis of Current Situation of National
Institutional Capacity for Development on Biotechnology and Biosafety of LMOs in Panama; and the
Diagnosis of Trade of Transgenic Products in Panama. Proposals for a Training Programme in Biosafety
and for a preliminary database were also produced. Importantly, gaps in the legal framework were
identified and options to modernize it were put forward, with the intention of allowing to Panama to
authorize, follow-up and monitor all LMO movements transiting through national territory.
6. Institutions such as MIDA, MINSA, ARAP and AUPSA have incorporated biosafety and LMOs as part
of their functions, with MINSA forming 10 years ago a Biosafety Committee with an ample mandate for
biological safety under which LMOs can be (and are) considered, and MIDA creating an internal group for
coordination and discussion purposes for any concerns or decisions over biosafety that need to be taken
institutionally.
7. The second UNEP-GEF project, "Building capacity for the Effective Participation in the Biosafety
Clearing House (BCH)", consisted in an add-on project (for the sum of US$ 49,000) complementary to the
8
NBF Development project, through which 9 training workshops took place. Panama’s BCH web page
www.bch.gob.pa was designed and made operational, as part of the country’s commitment to maintain
interested parties informed about biosafety.
8. The Biosafety Committee of Panama, created and formalized as a result of the BCH project, is the only
institutionalized group with legal backing, able to exert an “official voice” in biosafety matters. This
Commission is currently following-up on the research projects for contained use of transgenic salmon that
the company Aqua Bounty of Canada is carrying out in the area of Bajo Mono in Boquete (western
Panama) and on guidance concerning a transgenic mosquito development project.
9. The National Environmental Strategy (ENA, in Spanish)“Environmental management for sustainable
development 2008 – 2012”, has four strategic guidelines, of which Guideline 1 (Strengthen the capacity of
ANAM to perform its duties regarding environmental matters) aims to consolidate the environmental legal
framework and public policies. Under this Guideline, the elaboration and execution of the national
biosafety public policy, plan and programme have been prioritized, as well as the start of the BCH.
Likewise, Guideline 4 highlights: Protection, recovery, restoration and improvement of ecosystems to
contribute to sustainable development, understood as a general improvement of population wellbeing and
generation of employment. This guideline considers a priority the implementation of the Biosafety
Regulating Framework and the establishment of Biosafety Information Centres within the country.
10. Despite Panama being well geared towards the implementation of regulations that establish
commitments and responsibilities to boost socioeconomic and commercial development, there is a need to
strengthen coordination and support among all institutions responsible for biosafety, ensuring that
commercial contracts and agreements do not contravene the spirit and objective of the current national
biosafety regulations, as a guarantee for all inhabitants of the country, regarding the safety of LMO
transfer, handling and use.
11. The interest of institutions in the establishment of rules and regulations has increased, as is the case
with ANAM and ARAP, as have the actions of monitoring research projects using transgenic organisms,
for instance by ARAP. However, increased institutional capacity is still required to meet the demand for
applications in the research field. Likewise, there still remains a need to adopt the national legal framework
for the biosafety, after a long process of consultation and development of proposals for consensus, with the
participation of public institutions, academia and research entities, with the creation of normative units and
resource allocation.
2.2.
Global Importance
12. Panama is a medium-high level income country acting as a bridge between North and South America,
located in the middle of the Atlantic and Pacific Oceans. About 40% of its population is poor or very poor,
making it one of the countries of the region with the highest inequalities. It is also one of the countries
with the highest biological diversity in the world, home to more than 10,400 plant species (1,300 endemic
and 600 endangered), that face serious threats for conservation of natural habitats. Of the vertebrate species
(2,950), more than 100 are endangered and 121 are endemic (and a much larger number share their
endemic origin only with Colombia or Costa Rica). Almost ten percent (10%) of bird species at a global
level are found in Panama, and twelve (12) bird species are found only in Panama. Of the twenty (20) bird
species considered endangered, four are endemic and nine can only be found in one other country. Almost
fifty (50) amphibious species are endangered, many of which are in critical danger in Panama and
neighbouring Costa Rica. These include numerous species of small and colourful arboreal frogs and
poisonous frogs, which have turned into a biodiversity symbol. The habitat of salamander Oedipina
maritima, critically threatened, is less than ten (10) km2 and declining. Panama is also home to a substantial
population of jaguars and harpy eagles, which require large territories covered with native vegetation in
order to survive.
9
13. For centuries, agriculture was the dominant economic activity for most of Panama's population; after
construction of the canal, however, agriculture declined. Panama’s agriculture caters mostly to internal
markets, though it has three key export crops: bananas as the leading export item, followed by sugar and
coffee which has steadily expanded since the 1980’s. Rice and corn production have also increased, to the
extent that Panama is self-sufficient in bananas, sugar, rice, corn (also used for poultry feed) and coffee,
but has to import large quantities of other foods. Typical food imports are wheat and wheat products,
because climatic conditions preclude wheat cultivation.
14. Panama's land area totals approximately 7.7 million hectares, of which forests account for 4.1 million
hectares, followed by pasture land and permanently cultivated field. Nearly all of the currently cultivated
and pasture land was originally forested, resulting in a large amount of virgin tropical forest being opened
up through slash-and-burn practices.
15. Panama's climate and geology impose major constraints on the development of agriculture. Heavy
rainfall throughout the year prevents cultivation of most crops on the Atlantic side of the continental
divide. The Pacific side has a dry season (December to April) and accounts for most of the cultivated land.
The mountainous terrain also restricts cropping. In addition, the country does not have high quality soils.
Most of the areas classified as cultivable are so considered on the assumption that farmers will practice
conservation measures, but many do not. The topsoil is thin in most areas, and erosion is a serious problem.
Given these challenges, biotechnology has the potential to provide agricultural solutions to problems of
productivity, in order to reduce the threats from unregulated and unsustainable practices.
16. Panama, like other countries of the Mesoamerican region, is nevertheless a centre of origin and
improvement of crops such as: corn, bean, potato, tomato, green pepper, pumpkins, manioc, yam, sweet
potato, cotton, tobacco, pineapple, cocoa, rubber, pepper and many other tuber, roots, cereals, fruits,
medicine and plants of other use.1 These crops are currently part of the diet and food habits of millions of
inhabitants in the region.
17. The agricultural diversity of Panama can be threatened by the possibility of modified gene transfer to
wild plants at the local level, since inserted genes have greater opportunity of passing on to other plants,
jeopardizing still existing genetic resources. Well managed LMO crops, subject to biosafety measures and
risk management, however, have the potential of alleviating still untouched ecosystems from extensive and
polluting agricultural practices.
18. Releasing LMO to the environment will be the greatest threat towards native species, since it is
impossible to contain natural crossbreeding between related plants, mainly by means of pollen, which may
fertilize sexually compatible plants in a determined area. Aquatic ecosystems are highly vulnerable to
productive activities with LMO, especially in lotus ecosystems that include endemic species or those
populations which are very low and may be threatened by the introduction of transgenic aquatic organisms,
competing for space and food. Any inappropriate release to the environment of a LMO, no matter how
small, may cause serious impacts to biodiversity, human health and local and national economy.
2.3.
Threats, causes, and barrier analysis
19. Threats and their root causes identified are shown in the next chart, as well as the barrier analysis.
Threats may be classified in relation to systemic or institutional capacities, or to political-legal and
technical factors.
1
www.ecoportal.net “Centers of origin and diversity shall be transgenic free regions 30-03-08 By Ymelda Montoro and Germán Vélez *
10
Chart 1. Threats, causes and barrier analysis
THREATS
1. Escape and dispersion of transgenes from
taxonomically related or similar species, between
individuals of the same species or that are sexually
compatible
2. Inadequate infrastructure and equipment for
doing LMO research or analyses.
CAUSES OF THREATS
1.1 Risk assessments for the introduction of LMO into the country
have not been carried out, and/or risk management (biosafety)
measures are not applied.
BARRIER ANALYSIS
1.2.Law 72 of 2001 and Law 48 of 2002 to be
regulated
2.1 Current research facilities do not have biosafety measures
2.2. Lack of infrastructure, equipment, reagents and supplies for
sampling and detection protocols.
2.3. Law 72 of 2001 and Law 48 of 2002 to be
regulated
2.4. Deficient infrastructure and equipment for
developing research.
3. Ignorance on biosafety procedures and
3.1. There are no clear procedures for carrying out risk assessment.
3.2. Law 72 of 2001 and Law 48 of 2002 to be
requirements, by both users and regulators
regulated
4. Lack of identification and documentation for
4.1. Information for the introduction of LMO does not indicate they 4.2. Law 72 of 2001 and Law 48 of 2002 to be
verifying introduction of LMO in the country.
are LMO. Very few or no control and monitoring custom measures. regulated, specifically, labelling and other
information on LMO
5. Lack of knowledge by consumers and decision 5.1. Little public disclosure and awareness on LMO.
5.3. There is no public awareness strategy related to
makers about LMO topics in the country.
5.2. There is no information on possible environmental and use and release of LMO;
biodiversity contamination risks due to the use, transport and 5.4. Lack of scientific information on impact and
handling of LMO.
loss of biodiversity and human health effects due to
environmental release and use of LMO.
6. Inter-institutional and inter-sectoral coordination 6.1. Lack of coordination, at the government level, for ensuring a
6.2. Lack of political will and decision for enforcing
mechanisms are inoperative.
country position at national and international forum.
Law 48 of 2002.
7. Lack of coordination for processing requests by
7.1. There is no Biosafety System.
7.4 Little capacity or little specialization of Units
some entities and lack of qualified personnel for
7.2. Incomplete institutional and administrative procedures
processing permits.
taking care of biosafety issues in related
7.3. More intra-institutional coordination is needed
7.5 Legal, institutional and sectoral gaps.
institutions.
8. Introduction of LMO without risk analysis and
8.1. Recommendations are not fully followed and specific funds for 8.4. Biosafety is not an operative priority, even
little capacity to carry out biosafety assessments
taking care of these issues have not been allocated.
though it is part of the environmental policy.
8.2 Limited technical capacity to carry out environmental risk
8.5. Not enough availability of human resources
assessments and LMO food safety assessments.
involved in biosafety.
8.3. Little information availability
8.6. Need for trained human resources
9. Lack of information on management of research 9. 1. Databases related to biosafety management which support the
9.2. The research private sector does not know about
and private sector use of LMO.
BCH are incomplete.
laws and CPB, or about Law 48 of 2002.
10. Limiting factors in LMO, their by-products and 10.1 Characterization of sector level procedures is missing.
10.2 Law 48 of 2002 to be regulated
product flow systems have not been identified for
their safe mobilization in Panama.
11. Missing information on possible LMO private
11.1 Private sector that participates or may participate in the use of 11.2. Direct speakers between authorities and private
sector users.
LMO and their by-products and products (including handling and sector are not clear about procedures.
mobilization processes) remains secretive and does not pass on 11.3. Lack of information in the private sector
information.
regarding LMO.
12. Lack of technical guidelines ruling the current
12.1 Lack of technical guidelines ruling the current LMO 12.2 Law 48 of 2002 to be regulated
LMO importation process
importation process (seeds, eggs or other reproductive material) for
risk assessment and management in LMO transfer, handling and use.
11
2.4.
Institutional, Sectoral and Policy Context
20. The Cartagena Protocol on Biosafety (CPB) was adopted in 2000 as a supplementary agreement
to the Convention on Biological Diversity (CBD) of 1992 and entered into force on September 11th,
2003. The government of Panama ratified the CPB by Law 72 of December 26, 2001, published in
Official Gazette 24,460. The objective of the CPB is “to contribute in guaranteeing an adequate level
of protection regarding the safe transfer, handling and use of living modified organisms resulting from
modern biotechnology that may have adverse effects for conservation and sustainable use of
biological diversity, also considering risks to human health and specifically focusing on transboundary movement”.
21. The Republic of Panama has been carrying out efforts for the last 7 years to adjust the national
regulation related to the biosafety regulating framework to face and foster the best use of modern
biotechnology and its wide potential in agriculture, human health, environment and industry. There
have been advances leading to implementing the CPB, such as: approval of Law 48 of August 8,
2002, which creates a National Biosafety Commission (NBC) for LMOs and establishes other
regulations, in order to establish and coordinate Panama’s State policies regarding regulation and
handling of LMOs as well as their products and by-products, for preventing risks and for minimizing
impacts on the environment, biological diversity, human health and agricultural production that may
be caused as a result of activities with these organisms. At the sectorial level, regulations have been
proposed to implement Law 72 of 2001 and Law 48 of 2002.
22. Currently, there exist 8 government entities (government sector) listed below, having direct
competence with the implementation of the Cartagena Protocol on Biosafety, according to Law 48 of
August 8, 2002 and other legal regulations. Their roles are more fully described in section 2.5.
 Ministry of Agriculture (MIDA, in Spanish)
 Ministry of Health (MINSA, in Spanish)
 Ministry of Commerce and Industry (MICI, in Spanish)
 National Environmental Authority (ANAM, in Spanish)
 National Secretariat of Science, Technology and Innovation (SENACYT, in Spanish)
 Agricultural Research Institute of Panama (IDIAP, in Spanish)
 The Gorgas Memorial Institute of Tropical and Preventive Medicine (ICGES)
 Ministry of Foreign Affairs (MINREX, in Spanish)
23. The National Environmental Authority (ANAM), created by General Law 41 of 1998, is the
autonomous public entity of the State that exercises power, authority and specialized tasks related to
the environment, and the sustainable management of natural resources. Article 12 of Law 48 of 2002
establishes that ANAM is the entity responsible for the country’s natural heritage, with competences
for regulating and controlling access to and use of biogenetic resources in general, and for enforcing
international contractual obligations regarding biosafety that have been ratified or accepted by the
Panamanian government.
24. ANAM adopted a framework of objectives and strategic guidelines that established the short term
priority need to create an appropriate mechanism for the adoption of decisions regarding the safe
transfer, handling and use of LMO, as well as conservation of in situ biodiversity2. Between 2005 and
2009, ANAM approved several environmental policies and strategies that cover environmental
information supervision, control and surveillance, decentralization of environmental management and
2
National Biodiversity Strategy, 2000.
12
biodiversity. Among them, the National Biodiversity Policy, through the conservation for sustainable
development strategy and its environmental policy orientations for 2004-2008, underscores the need to
establish a biosafety regulating framework in Panama and consolidate national capacities in biosafety.
With the subsequent approval of the ENA (“Environmental Management for Sustainable Development
2008–2012”), priority is given to the elaboration and execution of public policies, plans and strategies
regarding biosafety, as well as the functioning of the BCH.
25. On the other hand, articles 10 and 15 of Law 48 of 2002 establish specific competences for
MIDA for regulating and supervising research activities with LMO and technological developments
affecting agricultural production systems in the national territory. It also establishes coordination
between MIDA, MINSA, MICI, ANAM, SENACYT, IDIAP is required for elaborating regulations
and procedures (through Resolutions) for the introduction, production, use, handling, release,
commerce, research, biological development and quality control of LMOs of agricultural and
environmental interest, their by-products and products.
26. Law 48 of 2002 also establishes other competences for MIDA, through ANAM and IDIAP, for
issuing supervising regulations for activities carried out by national or foreign, public or private
entities, in the agricultural or environmental sectors, as well as for carrying out research on biosafety
for increasing basic knowledge, which will serve as a base for risk analysis of LMO in agricultural
activities in the national territory.
27. Additionally, there are other legal regulations related to biosafety and biotechnology, such as:
Law 44 of November 27, 2006 which creates the Aquatic Resources Authority of Panama (ARAP, in
Spanish), making reference in article 2, to linked activities related to fishing and aquaculture that, in
some manner, direct or indirect, complement it, such as research and evolution of aquatic resources,
fishing and aquaculture education and training; technology transfer; processing, transport and national
and international commerce of products and by-product of fisheries and aquaculture; food and supply
manufacturing as well as fishing boats and any other contributing to the development of fishing and
aquaculture chains. Article 4, numeral 7, establishes the function, within ARAP, of fostering,
organizing, coordinating and executing, by case, the strategy, plans and programmes related to fishing
and aquaculture inspections, for guaranteeing health and conservation of aquatic resources, in
coordination with corresponding authorities, according to current regulations.
28. It is the ARAP’s responsibility, through the General Direction of Research and Development, to
guide research activities for breeding transgenic fishes and to supervise adherence to the
recommendations of the National Committee for Information Exchange in Biosafety.
29. Law 29 of February 1, 19963, article 31, numeral 1, indicates that it is the supplier’s obligation to
provide clear and truthful information to consumers, when dealing with food products that require
warnings or specific precautions because they represent a risk to human health according to
determination of the Executive Body through the Ministry of Health. This information shall
necessarily appear in the label, in Spanish, as established by the labelling regulation. Although article
31 does not specify or mention transgenic products, it is at the time, the only legal framework we have
to approach labelling of this kind of products in the country, until regulations are established. Import
food requirements will be established by a Risk Assessment, based on international regulations of
3
Law 29 of February 1, 1996 “which establishes regulations on defence of competition and other adopts other measures”
13
which Panama is a Party. The Ministry of Health (MINSA), through its own Technical Biosafety
Committee4, is reviewing a draft on transgenic food labelling.
30. The Law Decree draft for regulation of Law Decree 11 of 2006 which creates the Panamanian
Food Safety Authority (AUPSA, in Spanish) and establishes other regulations, brings a new entity into
the biosafety arena and is currently being revised. The AUPSA has responsibility to prevent
introduction of pests and transmissible diseases by food, and will also establish phyto-zoosanitary
rules, requirements for introduction of food products to the country, of plant, animal and pre-packed
origin and will approve eligibility of areas, country, regions and compartments for import.
31. Competences on the importation of food, that were responsibility of MIDA (National Direction of
Plant Sanitation and the Executive Direction of Agricultural Quarantine) on one hand, and on the
other, the Ministry of Health (Department of Food Protection) were passed to AUPSA, meaning that
this new Authority will have to be incorporated in the regulating framework to be developed about
biosafety requirements for the importation of LMO food, their by-products or products.
32. The recently created entities, such as the AUPSA and ARAP, claim to be part of biosafety efforts
relating to new development schemes, such as Trade Promotion Treaties or Agreements, including the
adoption of procedures and agreements for LMO handling and use. However, the majority of
institutions related do not have a specific biosafety Unit or Section, except for the Ministry of Health.
Nevertheless, all relevant institutions participate actively in the monthly meetings of the National
Committee for Information Exchange in Biosafety, which take place each time in a different
institution, even though the presidency is held by ANAM, and has been functioning with the same
people for many years. Some of these institutions also have their own biosafety committee, such as the
internal coordination group of MIDA and MINSA’s biological safety committee.
33. As a result of the review of Law 48 of August 8, 2002, and all national regulations, it was
identified that such Law has not been properly implemented, and it was recommended to undertake as
priority action the elaboration of a biosafety policy for modern biotechnology, operative and
facilitating fulfilment of different institutional attributions related to biosafety. Largely due to the
growth of load transport through the country, added to the movement generated by the Duty-Free
Zone of Colon, the need for establishing systems for allowing a greater surveillance in the use of LMO
was acknowledged by competent authorities and with procedures agile and dependable enough for the
national and international user.
34. It is expected that regulation of Laws 72 of 2001 and 48 of 2002 will help defining plans of
action and national programmes according to priorities and treatment demanded by biosafety,
especially as a world transit country, and prone to environmental risks with multiple effects, due to the
increase in load and trans-boundary movement of LMO through the Panama Canal and the PanAmerican way.
35. Modifications and additions proposed to Law 48 of August 8, 2002, generated in previous
projects, have been the result of a very intense and complex participative thinking process, throughout
the last three years, with participation of all members of the National Committee for Information
Exchange in Biosafety and other key actors in this matter. Modification of current legislation aims to
establish and coordinate Panamanian State policies regarding biosafety, create the National Biosafety
4
Resolution 248 of September 15, 2000, “Creates the Technical Biosafety Committee”. This group, created 10 years ago,
deals mostly with biological safety in health installations, and covers LMOs only loosely.
14
Technical Commission (NBTC) as a replacement of the NBC and a more operative organ with a
mandate for the safe handling of LMO, to prevent risks and minimize impacts on the environment,
biological diversity, human health and agricultural production that may result from activities carried
out through the use of modern biotechnology.
36. Through the consultation processes carried out, consensus have been reached and criteria have
been defined regarding the objectives of the Project, according to the CNC, proposing administrative
and judicial schemes most convenient to local reality. It was taken into consideration the fact that
Panama, because of its geographic location would be more exposed to the adverse effects that the
trans-boundary movement of LMO could cause, and potential risks were to be assessed in their
magnitude, with due caution ensuring precise responses to these circumstances. That is to say,
Panamanian needs have prevailed, in the search for equilibrium between precaution in handling and
movement of LMO and scientific and biotechnological development. In that same sense, it is deemed
convenient that in the development of mechanisms for public awareness one can count with a clear
understanding of responsibilities assigned to each institution first, to then make the user familiar with
these new procedures. A Programme has been elaborated for training human resources and
institutional strengthening to be implemented in a term of three years.
37. Modifications to Law 48 of 2002 will be presented for consideration of the National Assembly.
These include changes in internal structures of National Government Institutions, together with
suitability of different related entities that participate in the implementation of commercial
Agreements imposing new commitments. Progress in the approval of modifications to Law 48 of 2002
has been slow, as a consequence of the country’s internal dynamics, adjusting to institutional changes
and shifting priorities, but there are some signs of progress especially in practical cases of importation
of LMO where involved institutions have had to respond in a very short period of time to received
requests.
38. ANAM also updated the environmental impact assessment legislation, which added
Environmental Impact Assessments for the development of breeding and farming of aquaculture and
agricultural species for commerce. However, it does not indicate that for breeding and farming LMO
in the country the approval of the NBC is required, therefore more coordination is necessary.
39. The government sector has been more involved in the implementation of the CPB and in the
development of the national biosafety framework. There has been greater emphasis on the use of first
generation biotechnologies than on agricultural and cattle activities. Activities with aquaculture LMO
and human health interest LMO have been oriented to research in confined use. Requirements and
regulations for Evaluation of Environmental Impact Assessments for the development of aquaculture
and agriculture breeding and crop projects with commercial purposes have been updated in general.
The development of skills in risk assessment and management by competent authorities such as
MIDA, IDIAP, MINSA, ANAM, INDICASAT, SENACIT, ARAP, AUPSA, AMP and other nontechnical institutions such as universities and their training centers, has also been prioritized
40. Government institutions that have had more participation in the design and development process
of the national biosafety regulating framework in Panama are: ANAM, MIDA, AUPSA, ARAP,
SENACYT, INDICASAT and MINSA. However, when applying the law, they have limited
themselves to reviewing very specific requests on the importation of LMO and provided specific
recommendations, analyzing case by case. These entities have acknowledged the advantages of
adjustment of information, notification, monitoring and follow up procedures executed by the BCH of
15
Panama, since this mechanism serves to assure not only fulfilment of international agreed
commitments, but also early warning for LMO load that may be transported to Panamanian territory.
41. According to the diagnosis carried out in 2006 and 2007, at least 9 entities linked to
biotechnology in Panama have been identified, of which 5 are public, 3 private and one represents an
international organization. It was expected that the greatest capacity in Biotechnology and Biosafety
of the country would be in the public and academic sectors. However, government entities as well as
universities have many limitations regarding human resources, equipment and budget; therefore they
will have to improve their organizational structures and functions, creating Biosafety Units5 justifying
financial and human resources allocation. In the case of ANAM, the Biosafety Unit would be within
the Biodiversity and Wildlife Department, and in addition to LMO it would cover exotic and invasive
species biosafety, among others.
42. Despite capacity limitations, there is nonetheless some experience already in both developing
biotechnology and in evaluating its products. The academic sector of Panama has some Institutes,
Research and Technological Innovation Centres and Universities carrying out “first generation”
biotechnology activities such as vitro-plant sanitation, micro-propagation, molecular markers, as a
complement to the varietal description processes in commercial interest crops and programmes of
conventional genetic improvement. For example, the Agricultural Research Institute of Panama
(IDIAP) carries out activities in “first generation” agro-biotechnology, applied to two key sectors:
a) Agriculture: activities for the isolation and fusion of yam protoplasts, yam somatic
embryogenesis, cryopreservation of cassava and sweet potato, germoplasm conservation of
roots and tubers, sanitation and micropropagation of pineapple, and methods of
micropropagation in “pifá”, “otoe” and yam.
b) Livestock: efforts are aimed at estrus synchronization and induction, semen freezing, transfer
and freezing of embryos, production of embryos by in vitro fertilization, micro manipulation of
embryos: production of identical twins, chimeras and sex. The molecular characterization of
Creole cattle in Panama is also performed.
43. The Animal Health Direction (DINASA) of the MIDA has also authorized the importation of
juvenile specimens of transgenic salmon (Salmón salar), introduced to the country by the Company
Aqua Bounty Technologies of Canada, with contained use research purposes. The Gorgas Memorial
Institute of Tropical and Preventive Medicine (ICGES) participates in a study with transgenic
mosquitoes, with research purposes for dengue control, in confined use, in the framework of an
international project supported by the WHO. The National Committee for Information Exchange in
Biosafety has issued criteria for carrying out said studies.
44. It is acknowledged that the country will have to invest in research and biotechnology innovation
and application of biosafety measures. The regulating framework will have to be developed with
urgency due to of the potential biotechnology has for the development of Panama.
45. Regarding the Universities’ role, the Santa Maria La Antigua University (USMA), the Genetics
and Molecular Biology Department of the Natural, Exact Science and Technology Faculty of the
University of Panama (UP) and the San Martin University focus their activities principally on teaching
5
Proposal for Modification of Law 48 of August 8, 2002.
16
biotechnology, since they have neither the facilities nor the resources to carry out research and
development (R+D) activities. USMA and the Department of Genetics and Molecular Biology of the
Natural and Exact Sciences and Technology of the UP have at their disposal certain facilities for
carrying out biotechnology and molecular biology activities. The University of San Martin uses for
teaching purposes, the Biotechnology and Molecular Biology Centre of INDICASAT under a
cooperation agreement reached with SENACYT.6
46. Panama, in view of its economic openness with other countries, has established control measures
for food safety, strengthening agricultural sanitation including adequate measures for preventing entry
of pests and diseases. A National Agenda for 2008-2012 was prepared for the Inter-sectorial
Committee of Sanitary and Phytosanitary Measures of Panama which includes MIDA, International
Regional Organization of Agricultural Sanitation (OIRSA), AUPSA, MINSA under the technical
support of the Inter-American Institute for Cooperation on Agriculture (IICA).
47. The National Foreign Commerce Strategy considers that signing a Free Trade Agreement (FTA)
is an important step towards permanent consolidation of opening markets to other countries, thus
generating new market opportunities for exportations and creation of more job positions, for greater
wellbeing of Panamanians. Panama has signed Commercial Agreements with several countries known
to be LMO producers and exporters:
 Bilateral Protocol El Salvador - Panama
 Free Trade Agreement Costa Rica - Panama
 Free Trade Agreement Chile – Panama
 Free Trade Agreement Honduras – Panama
 Free Trade Agreement Singapore - Panama
 Free Trade Agreement Republic of China (Taiwan) - Panama
48. Panama also recently completed negotiations with the Central American block, signing (or
renewing) a Commercial Agreement bilaterally with each Central American country (Costa Rica, El
Salvador, Honduras, Guatemala and Nicaragua) to establish a level of access in goods, services and
investments and specific rules of origin with each country for products included in the FTA. A Free
Trade Agreement with the USA is also in process. The trade relationship between Panama and the
European Union related to transgenic products is inexistent.
49. Among the main grains the country is importing, corn and soy stand out. In the world share, soy
represents 55% of LMO preferred for the elaboration of animal feed and corn 21%. Corn and soy
imported to Panama come from the United States and Argentina, the main producers of transgenic
crops in the world7; these imports are therefore very likely to be transgenic products.
50. The country’s internal policy establishes that imported corn shall not be used for human
consumption, which is supplied by national production, estimated on 1 million de quintals per year.
All imported corn is used for preparing rations for animals (birds, pork, cattle, among others). The
Consultation Commission on Corn and Sorghum agreed on the use of an innocuous red dye, for
treating all imported corn grains as a measure to ensure it is not used for human consumption, measure
currently not applied with no reason at all. In the case of labelling of LMO, the Ministry of Health
6
Diagnosis on the Current Situation of National Institutional Capacity for Development of Biotechnology and
Biosafety of Living Modified Organisms, ANAM, 2007.
7
Diagnosis on Trade of Living Modified Organisms in Panama, ANAM, 2007.
17
represents the country in negotiations on LMO labelling, not yet solved at the international level. Up
to date, no requests for LMO trade (commercialization) within the country have been received.
51. Regarding importations of derivatives to Panama, a large part of vegetable oils, flour and gluten,
(among others) are sold in country supermarkets and were probably elaborated from LMO crops, such
as corn, soy and canola.
52. The private sector has been careful regarding the development of activities with LMO in the
country. However, some private companies have introduced LMO to the country, meeting
requirements of competent authorities, such as: Animal Health, Agricultural Quarantine and Vegetal
Sanitation, which do not really focus on biosafety. Both Private Companies as well as Competent
Entities lack importation requirements mandatory according to the CPB. Risk assessments and
analysis have not yet been carried out for LMO; in the case of transgenic salmon, sugar cane and
transgenic rice, requirements for entry in the country have not been met either. The National
Committee for Information Exchange in Biosafety has nonetheless issued technical criteria for
carrying out such research studies under conditions of biosafety.
53. Therefore the importance of counting with regulations, instruments and equipment on risk
assessment, labelling and implementation of a tracking system of the whole productive chain until the
final user, so the information generated reaches the consumer. Likewise, the need for the
implementation of the Inter-sectorial Training Plan, elaborated during the Project for the Creation of
the “National Regulating Framework of Biosafety and Biotechnology in Panama”.
2.5.
Stakeholder mapping and analysis
54.
The Government Sector is paramount for development of this Project. Law 48 of 2002
establishes inter-institutional competences and coordination for the implementation of the CPB, and
considers specific expertise of each entity. Institutional roles for implementation of the CPB
according to the Law are:
 The Agricultural Development Ministry (MIDA) is the national entity competent for regulating,
controlling, authorize and supervise the use and management of living modified organisms of
agricultural use in the national territory. In the agricultural sector, MIDA, through the National
Agricultural Quarantine Direction, the National Vegetal Sanitation Direction and the National
Animal Health Direction, has designed protocols for pest control, pathogens and weeds for
agriculture and the sector in general;
 The Ministry of Health (MINSA) is the national entity competent for regulating, controlling,
authorizing and supervising the use and handling of living modified organisms and
biotechnological development, carried out in the national territory, affecting public health, as
well as the establishment of biosafety regulations required for human protection;
 The Ministry of Commerce and Industry (MICI) is the national entity competent for
guaranteeing that negotiations and international trade agreements involving the use of LMOs
and biotechnological transfer do not affect production and national investments, the
environment, biodiversity and human health, ensuring the best interest of the country;
 The National Environmental Authority (ANAM) has competencies in the national
implementation of the CPB, and in the environmental management of the country’s natural
patrimony and biodiversity. It has the competence to regulate and control access and use of
biogenetic resources in general, as well as to establish, approve and audit the fulfilment of
regulations and procedures of risk assessments for releasing into the environment, mitigation of
18
impacts to biodiversity and the environment. ANAM elaborated the Law and regulation for the
preparation of Environmental Impact Assessments, the law and regulation for wildlife,
including requirements for entry into the country of exotic species, and coordinates with other
entities the approval of EIAs;
 The National Secretariat of Science Technology and Innovation (SENACYT) is the entity
competent in promoting and fostering research for the development and transfer of
biotechnology in general;
 The Agricultural Research Institute of Panama (IDIAP) is responsible for carrying out required
biosafety research and doing risk analysis with LMO in the agricultural sector, as well as
issuing together with ANAM, regulations for supervision of activities done by other national or
foreign, public or private centres, in the agricultural and environmental areas, within the
national territory;
 El Ministry of Health (MINSA), through the National Health Biosafety Committee, is in charge
of preparing, coordinating and developing the topic on transgenic food labelling.2 Besides, it is
responsible for verifying supplier’s obligation of clearly and truly informing is pointed out,
when dealing with food products requiring specific warnings o precautions, because it
represents danger for human health according to determination of the Executive Body, through
the Ministry of Health;
 The Gorgas Memorial Institute of Tropical and Preventive Medicine (ICGES) by decision of the
Ministry of Health will be responsible for supervising, regulating and controlling all biosafety
research on living modified organisms affecting human health;
 The Ministry of Foreign Affairs (MIREX) is the national entity competent for coordination and
development of foreign policy of the Republic of Panama and therefore, is the Panamanian
State’s official communication body with other States and other international right subjects.
This Ministry will coordinate with competent government authorities regarding LMOs,
subscription of international agreements in this matter and will be the means of communication
between international organs and government entities in Panama regarding LMO topics8:
 The Panamanian Food Safety Authority (AUPSA) is the entity responsible for the importation,
transit and transhipment of LMOs destined for consumption as human food or animal feed. The
AUPSA prevents the introduction of pests and transmissible diseases via food; it also
establishes phyto-zoosanitary rules and has established the requirements for entry of vegetal,
animal and pre-canned food products, approving areas, regions and compartments for country
entry. The AUPSA has some functions that use to be the MIDA’s (National Direction of
Vegetal Sanitation and the Executive Direction of Agricultural Quarantine) and the Ministry of
Health’s (Department of Food Protection). The Proposal for Modification of Law 48 of 2002
includes now incorporating the AUPSA for development on biosafety requirements for LMO
food, their products or by-products;
 The Aquatic Resources Authority of Panama (ARAP) is the entity competent and responsible
for the authorization, control supervision, monitoring and release into the aquatic media of
aquatic organisms and commercial interest genetically modified marine organisms, located in
protected areas;
 The Institute for the Development of Innovation, Science and Technology (INDICASAT)
works on the development of advanced chemistry, having the most modern instrumentation of
the public sector and has the best reference laboratory equipment for the country, used by public
8
Law 48 of August 8, 2002, Article 11.
19
and private universities to do research and superior teaching activities under agreements
submitted among involved parties. Other laboratories in the country count with basic equipment
for molecular biology activities.
55. There are other entities that also have a stake in different areas of implementation of the CPB. In
the science sector, the role of universities is to train professionals on bachelor degrees in
biotechnology and R+D. Among them we highlight: Santa Maria La Antigua University (USMA),
University of Panama, through the Department of Genetics and Molecular Biology of the Faculty of
Natural, Exact and Technological Science and the University of San Martin.
56. The main institutions that participate in the current Project are: the Ministry of Agricultural
Development (MIDA), Ministry of Health (MINSA), National Environmental Authority (ANAM),
National Secretariat of Science, Technology and Innovation (SENACYT), Institute for the
Development of Innovation, Science and Technology (INDICASAT), Agricultural Research Institute
of Panama (IDIAP), Panamanian Food Safety Authority (AUPSA) and Aquatic Resources Authority
of Panama (ARAP); these last two have only joined in the last five years, while the rest have a longer
standing in biosafety.
57. It has been recommended to incorporate the following authorities in information exchange and
monitoring of LMO:
 Panama Canal Authority (ACP) is the Panamanian entity managing transit through the Panama
Canal. The Panama Canal works under ISO 9001 procedures, it is the largest geographic area
ISO certified, besides being the only “wonder of the world” that went through this process.
From the CPB point of view it is a LMO transit point.
 The National Customs Authority (ANA) is the superior body of the national customs service
and the State’s institution in charge of controlling, surveying and auditing the entry, exit and
movement of merchandise, people and transport means through borders, ports and airports of
the country, for the effects of tax recovery, or for applicable control, as well as preventing,
investigating and punishing customs infractions, working on statistics on foreign trade,
intervene on international goods traffic and meet other tasks assigned to it, through international
agreements ratified by the Republic of Panama9.
58. Non-governmental organizations (NGOs) in Panama do not seem to have biosafety on their radar;
if at all, their involvement in biosafety issues is sporadic and shifting. The productive sector on the
other hand has shown an incipient interest; some agricultural companies have approached government
entities to request information on the rules for introducing maize and for its subsequent
commercialization. In such cases, requests have been verbal and have not been pursued formally, so
no “responses” (decisions) have been emitted by the authorities. Interestingly, this informal scoping
has evidenced that authorities do not feel that the right conditions exist in the country (both legally and
technically speaking) for LMOs to be authorized commercially, prompting the private sector to
withhold -for now- from presenting any formal applications. This may change with the
implementation of the NBF, and may even jolt some NGOs into taking a stance. Apart from the
productive sector and NGOs, free competition and consumer protection authorities are considered
opponents to the use of transgenic organisms.
9
Decree Law No. 1 (February 13, 2008) “which creates the National Customs Authority and establishes regulations regarding the customs
regime”
20
2.6.
Analysis of baseline and gaps
59. The ANAM is the CPB and BCH Focal Point. Besides, through the Biodiversity and Wildlife
Department of the Protected Areas and Wildlife Direction, it is responsible for the Executive
Secretariat of the NBC established by Law 48 of August 8, 2002. Competent Authorities have not yet
assigned representatives for the National Biosafety Commission, according to Law 48 of 2002.
Representatives of sectorial committees have not been designated either, according to Law 48 of 2002
and Executive Decrees for sectorial regulations.
60. The ENA “Environmental Management for Sustainable Development 2008 – 2012”, approved in
2008, has established objectives, guidelines and general actions related to the Cartagena Biosafety
Protocol. It is important to highlight that ANAM has worked on getting funds to carry out activities
identified as proprietary proposals in this project. Nevertheless, the country has not defined a policy
for dealing with LMOs.
61. The country has made advances on some topics leading to the implementation of the Cartagena
Biosafety Protocol, such as Law 48 of August 8, 2002 (creates the NBC for LMOs and establishes
other regulations) and the current proposal of modification of this regulation. Gaps have been
identified in the legal framework as well as the means for modernization, in such way that Panama can
count on updated systems for authorizations, follow-up and monitoring of all LMO movements
transiting through the national territory. For the implementation of Law 48 of 2002, a modification
proposal of such Law has been elaborated; there are also draft regulations for the agricultural sector
elaborated by the MIDA.
62. There is a diagnosis of national legislation for development of Biotechnology and Biosafety of
LMO in Panama, on trade of LMO in Panama; on institutional capacities, current technology
(laboratories and infrastructure and equipment), as well as trained human resources, elaborated in
2006 and updated. Most institutions involved in the implementation of the CPB and the BCH have
been trained in current regulations and on the CPB in general. Competent authorities maintain links in
their Web pages related to the CPB. However, no baseline is available on risk assessment, risk
management, information systems, LMO monitoring, and surveillance upon entry. There is no
baseline for the communication strategy either, nor for socioeconomic aspects as established by the
CPB. At this time, we have a biosafety Plan of Action and the Project of Law, which establishes the
regulating framework and LMO Biosafety Inter-Sectorial National Commission. Moreover, the
Executive Decree Project which establishes the Agricultural and Environmental Biosafety Sector
Committee; The Ministry Resolution proposal for the establishment of the Procedure for carrying out
activities and executing follow-up, monitoring and control of activities with LMO in the National
territory; and a procedure mechanism for management of information required to perform Risk
Assessments.
63. In 2007, the National Committee for Information Exchange in Biosafety (also known as the
Biosafety Committee) was established, making official each representative of the Competent
Authorities to facilitate the adoption of decisions on notifications and requests for LMOs and
information exchange. This group was set up based on the NBF Development project’s coordinating
group, with the difference that in this case, its conformation and functions were fixed by Resolution.
However, even though the mandate of the National Committee for Information Exchange in Biosafety
does not explicitly include decision-making and resolving LMO cases, this is how it has functioned in
practice. The rationale is that this group has a legal backing, has biosafety expertise, and is able to
emit informed opinions on the basis of its information exchange mandate. Nevertheless, it is still the
21
case that procedures for receiving importation requests are lacking in order to improve the
consideration (and application) of appropriate biosafety measures at the national level.
64. With the ratification of the CBD (1995) and the CPB (2002), Panama has strengthened its work
in conservation in situ and sustainable use of wild and endemic species and protection of genetic
resources. The ANAM established the Unit for Access to Genetic Resources (UNARGEN), in charge
of the protection, use and conservation of genetic resources, patrimony of the State. To aid in
biosafety decision-making, there is a list of threatened flora and fauna species and very detailed
procedures for research uses, among others. It is expected that this information will serve as a base for
the elaboration of the threatened wild and endemic species map that will highlight the biodiversity to
be protected10 when deciding where LMO crops could eventually be released in a regulated manner.
In 2008, the list of threatened species was updated and through an Executive Decree protection of
more than 1000 species was established, including wild flora species. The Project will help identifying
wild species requiring measures to avoid genetic contamination, besides improving coordination for
implementing the CPB. In addition, LMO use will need to be mapped with regards to protected areas:
in Panama, 89 protected areas have been established (as of June 2009), covering close to 35% of the
national territory; 60% of this protected territory has management plans for conservation and
sustainable use of biological resources.
65. Entities such as ARAP, AUPSA established in the last 5 years have emerged under new
development schemes, such as Free Trade Agreements, demanding new procedures for assessment
and management of LMO. On the other hand, the Agricultural Research Institute of Panama (IDIAP)
has consolidated the development of “first generation” agro-biotechnology activities, oriented and
applied to the agricultural sector. With financial support for research development by SENACYT,
advances in the use of new biotechnologies are foreseen.
66. SENACYT has limited financial resources for the development of research on the use of new
biotechnologies. From the point of view of engaging the country’s youth, SENACYT develops the
“National Scientific Youth Fair for Inventiveness”, a non-profit event, not directly related to GEF
projects. This event has the objective of stimulating the interest of students on research and innovation
through the presentation of scientific projects, scientific challenge contests, training activities and
different activities on science, technology and innovation. The potential of the Fair for detecting
young people with talent that may require support to stand out to their maximum capacity is important
too. The main activity is the National Project Exhibit, which represents an excellent opportunity for
girls, boys and young people of Panama to project their scientific doubts and may serve as one of the
channels for the implementation of Component 5.
67. Though training efforts so far have been oriented towards the development of BCH skills, the
need for training and educating human resources in topics directly related to biosafety management
and biotechnology has also been identified. In biotechnology, training priorities for human resources
are at the post degree level, with specializations in disciplines such as: 1) Advanced molecular
biology, 2) Molecular Immunology, 3) Generation of monoclonal antibodies, 4) Laboratory animal
handling, 5) Protein Chemistry, and 6) Assisted reproduction in bovines, among others. A Programme
for the creation of national capacities in biosafety, on the safe use of LMO and on the CPB (through
training of professionals) has been designed, but not yet implemented.
10
Decree 25 of 2009
22
68. The only training material on CPB and LMO available are those provided under the BCH Project,
which ended in 2008. For other topics, there are no dissemination or education materials, reason why
the ANAM, through the Environmental Culture Promotion Direction, will coordinate the elaboration
of educative and dissemination materials on biosafety and biotechnology for all project beneficiaries
and sectors, in printed and electronic formats, for use in Web pages, forums, fairs, and other means.
69. One of the main gaps of the country in biosafety is the lack of dissemination and ignorance not
only by the general population, but also at decision levels and locally about LMO present in the
country. Information relevant to biosafety is either not generated, is scattered, or is generated without
considering its relevance for decision-making. Information available as reference studies generally
relate to research and tests carried out in other countries, under different conditions. Some information
is available on distribution of native and endangered species, but this still has to be linked to biosafety.
70. The national BCH contains information on national and international legislation on biosafety and
on competent national authorities. A list of professionals in different disciplines has been elaborated
and placed on the BCH main website (Central Portal), physically located at the CBD Secretariat in
Montreal, Canada.
71. Risk management is another of the main gaps to be addressed by the country. There is not
enough experience and expertise for the mitigation and communication of risks to the people; to date,
this topic has had a very low profile. Clear procedures for the process of LMO entry with research
purposes in containment conditions are not available either, nor national regulations on identification
and labelling of transgenic products.
72. The country has witnessed a growth in load transport through the isthmus, added to the
movement generated by the Duty-Free Zone of Colon. Up to date, there is neither an information,
monitoring and surveillance system for entry of LMO, nor procedures that are agile and dependable
enough for the national and international user.
73. Panama, through the Panama Canal Authority (ACP) has general information on the transit
through the Panama Canal of merchandise, tonnes in grains, country of origin and destination, but no
requirement is made to specify whether the contents is or not transgenic. There are many information
gaps regarding the mobilization of LMO from production up to end-consumer, and administrative
procedures to track the influx of these products into the national territory and through customs
controls are lacking.
74. In conclusion, the CPB has been deficiently implemented, with the preparation of national laws
but with the absence of related regulations. Competent Authorities have evaluated LMO research
requests, but recommendations have not been fully met. Those few LMO research requests that have
come through have been channelled through the BCH and the CPB Focal Point, and are analyzed on a
case by case basis. The MINSA has even identified red areas with species that may cause negative
impacts to human health. Regarding training, competent authority staff have received basic training on
the CPB and the BCH, and materials are being used to train further staff on these topics.
75. Overall, the implementation of the CBD (since 1995) has consolidated Panama’s Competent
Authorities for in situ conservation and sustainable use of wild and endemic species and protection of
genetic resources, but this has not occurred to the same extent with the CPB. For example, Competent
Authorities have still to formally appoint their representatives to the NBC, reason for which (in part)
this entity has never functioned. This Project will therefore be the means for the full implementation
23
of the CPB, including the elaboration of national, sectorial and institutional procedures that will take
care of aspects inherent to LMO flow and trade through and within the country. With the project, the
agreed national legal framework will be completed and institutional capacities in modern
biotechnology and biosafety will be strengthened.
2.7.
Links with other GEF and non-GEF interventions
76. The country doesn’t have other national initiatives in course for the implementation of the CPB.
However, the search for new synergic and complementary initiatives taking care of unattended needs
of the Project will be fostered during execution of the Project.
77. ANAM coordinated the first UNEP-GEF project for the effective participation of Panama in the
BCH (Biosafety Clearing House) of the Cartagena Protocol, and will continue this work during the
second phase of the global BCH project, in which Panama is one of 50 participating countries. This
work will require the collaboration of the same institutions that are part of the current project
(National Competent Authorities), ensuring that the project’s information component 4 complements
and gives continuity or permanence to the capacities created through the BCH project. Also important
is the continuity of open dialogue and coordination, achieved in part by nominating the biosafety
committee that participated throughout the definition and adjustment of the National Biosafety
Framework as the BCH Working Group. This group, expanded, will also function as the current
project's coordinating and supervisory committee, as it is recognized as the country's main biosafety
coordination mechanism. Internal coordination in this respect will be strongly reinforced and
consolidated through the continuum of these capacity-building efforts. The experience in training and
outreach activities gained through the BCH project was of great value when designing participatory
and information-related activities in the current project (Components 4 and 5). The second phase BCH
project will also serve to expose the areas and sectors that require further or continuous capacity
building efforts, allowing the current project to focus its efforts on those areas.
78. There is also opportunity for collaboration and harmonization with the two sub-regional World
Bank (WB)-GEF Projects approved under GEF-4, involving Brazil, Colombia, Costa Rica and Peru
("Multi-country capacity-building for CP compliance" and "Latin America: Communication and
Public Awareness Capacity-Building for Compliance with the CP"). The same is true for the cohort of
national biosafety UNEP-GEF projects, currently unfolding in the region that will likely be in
execution at the same time as the current project. Coordination and contact will be sought between
project teams, so as be informed, learn from their experiences and successful approaches, and share
outputs and tools if possible, once they have produced results. The importance of sharing lessons
learnt and best practices for more effective NBF implementation will a central theme. This
coordination will involve UNEP as the GEF Implementing Agency, with regional workshops expected
to take place to bring together project coordinators and begin pooling acquired knowledge and
building a community of practice in biosafety. These efforts could also include joint planning of subregional activities with the WB if convenient, as well as contact through neighbouring countries such
as Costa Rica and Colombia, with whom close ties are maintained.
79. At the regional level, the Inter-American Institute for Cooperation on Agriculture (IICA) has
formulated a Hemispheric Programme on Biotechnology and Biosafety (PHBB), by mandate of the
Inter-American Agricultural Board (JIA), which unites the Ministries of Agriculture of American
countries, fosters the training of working groups specialized in biotechnology and biosafety, and is
operative since 2005. The PHBB is oriented towards the incorporation of new technologies such as
agro-biotechnologies within national policies, as well as their contribution in competitiveness of the
24
agricultural sector with significant implication in trade and trans-boundary movement. The purpose of
the PHBB is to facilitate mechanisms for the development, management and safe use of agro
biotechnologies in favour of a competitive and sustainable agriculture for the countries of America.
According to the IICA, the specific objectives of the PHBB are: fostering studies, discussions and
analysis of the implications of national and international rules and regulations, as well as negotiations
and international agreements, in topics related to agro biotechnology and biosafety, with emphasis on
their impact on trade. Any activities undertaken by the PHBB will integrate well with the current
project.
80. Among other initiatives developed in Central America, there is also the Regional Strategy on
Biotechnology and Biosafety for Central America that is under development, in collaboration with
other international organizations such as OIRSA and the Centre for Tropical Agricultural Research
and Teaching (CATIE).
SECTION 3: INTERVENTION STRATEGY (ALTERNATIVE)
3.1.
Project justification, political acceptance and expected benefits for the world
environment
81. The results of the UNEP-GEF biosafety projects provided the baseline for the current Project,
which was updated during the formulation stage. The development of this Project is in line with the
GEF and UNEP strategy for providing assistance to developing countries in the implementation of the
CPB. The Project will help to revisit actions to match specific strategic guidelines and sectoral visions
for the application of modern biotechnology (production, research, transit, etc) and generate
specialized human resources. Currently, Panama’s biosafety Law (Law 48/2002) has not been
implemented and requires modification.
82. Biosafety for the safe use and control of LMO in Panama has been a challenge since 2000 and
was identified as one of the country priorities in the National Biodiversity Strategy and its National
Plan of Action. The Republic of Panama ratified the CPB through Law Nº 72 of December 26, 1991
and then Law Nº 48 of August 2002 turned into its first application instrument. This Law establishes
the NBC for LMOs, defines institutional competences, establishes the creation of sectorial committees
in the agricultural, environmental, and public health sectors and establishes a framework for
developing specific regulations. Through the NBF Development project, Panama also developed
biosafety regulations and legal modification proposals, in order to review its current regulating
framework. These proposals will be submitted to the Executive Body for approval, and are expected to
coincide with the execution of the current Project, as a country priority.
83. The ANAM has also proposed the incorporation of the application of the CPB as an action line
within the National Environmental Plan, supported by the IDB in 2008. Moreover, ANAM approved
between 2005 and 2009 several public policies and strategies that underscore the need to establish a
biosafety regulating framework in Panama, and consolidate national capacities in biosafety. Many of
these policies are in line with the CPB, regarding the need for information, coordination and greater
capacity of supervision in the environmental management arena.
84. Another Government priority is the modernization of customs services, linked to the expansion of
the Panama Canal that has already started, with a great need to achieve greater efficiency and
transparency in border control processes, a line of work that will be benefit for the application of the
25
CPB. Likewise, a National Science and Technology Plan was generated in order to promote R+D in
Panama, and to open spaces and mechanisms for the expansion of the scientific sector, where
biotechnology will have a strategic role and offers an opportunity to access benefits resulting from
native genetic resources. Such a Plan will help to raise the profile of biosafety issues, as the eventual
commercialization of biotechnology applications, while economically attractive, can be socially and
environmentally sensitive.
85. Therefore, the proposed project is in line with national mandates for conservation of biodiversity,
sustainable development and safe use of LMO, aiming to create conditions leading to the adequate use
of native genetic resources, generating information on the environment, customs modernization and
strengthening on environmental control and supervision.
86. Given the interest of Panama in generating economic benefits from increased commercial
activity, bio-prospection and the possibility of introducing LMO in a regulated manner, it is opportune
for the Government to ensure this happens in a framework that will contribute to safeguarding
biodiversity, human and animal health as well as ethical, social and cultural values. The proposed
project is, therefore, fully coherent with these objectives, and it already counts with coordination and
institutional mechanisms for facilitating its execution.
87. The Project here proposed is compatible with world interest in biodiversity conservation, by
meeting the objectives of the CPB, to which Panama is a Party. Panama is home to approximately
10% of the world’s biodiversity and is an important centre of origin of genetic and species diversity.
Panama’s biodiversity is unique because of its complex distribution and intensity; this important
wealth is vital for the economic and cultural future of the country. The emergence of the Isthmus of
Panama creates an exceptional surrounding, where speciation, extinction, delicate ecological balance
and rapid economic growth are characteristics that converge in this small sea-bound country. Panama
has an exceptional diversity of flora, with plant density rates well above those of many other
countries; its abundant flora is used as sources of food and medicines and construction materials for
houses, canoes, tools and crafts. Panama also has a key location in Central America, in trade terms, as
well as the constitution of a biological corridor for many species, including migratory birds.
88. The country intends to protect its biodiversity, in a scenario where international trade is
increasing and biotechnology applications are fast-evolving and becoming more and more attractive
for certain sectors. In Panama, bio-prospecting activities and development of biotechnology requiring
genetic resources as raw material are on the rise. The possibility of using agricultural biotechnology to
face limitations in national production is imminent. On the other hand, the expansion of the Panama
Canal will also lead to an increase in the flow of biotechnological products through the country.
89. Taking into consideration these scenarios and through the NBF Development Project finished in
2008, the biosafety situation throughout the country was analyzed, identifying weak areas that have
prevailed despite the establishment of initial capacities. These deficiencies include institutional aspects
regarding coordination and consolidation of technical-administrative capacity; the gathering of
information for decision making processes; LMO regulations for specific sectors; training needs;
creation of assessment, management and follow-up mechanisms; transit of LMO; and dissemination of
biosafety measures and raising awareness of the general public regarding the risks and benefits of
LMOs.
90. These deficiencies need to be addressed, if the country is to achieve an adequate and timely
management of biotechnology products, in order to minimize their possible adverse effects and
26
maximize their social, economic and environmental benefits. The country is also aware of the
importance of the Panama Canal in trade of LMO and its responsibility as part of the CPB to
contribute to the safe transit of LMO shipments through its territory without restricting international
trade.
91. The proposed Project therefore will follow the efforts initiated during prior UNEP-GEF projects
and will focus its application in line with the CPB, in order to allow the country to make decisions,
with a legal and scientific base, that will contribute to minimizing potential impacts of LMO on
biodiversity, human health and productive activities. The main results of this project will provide
knowledge on the capacity of the current legal framework for biosafety and how LMO will be
eventually introduced to Panama.
92. A capacity building plan was also proposed, focusing mainly on the needs of main competent
authorities and gaps that had to be closed on order to meet CPB requirements. It is also important to
point out that through the NBF Development Project, regulation proposals were elaborated for
improving and completing the existing biosafety framework. Therefore Panama expects to establish
new regulations and procedures, as well as the modification of existing regulations, regarding
biosafety. These regulatory drafts were generated in a participative fashion, were approved by
consensus between competent authorities at the technical level, are in line with demands of the CPB
and have been sent for legal review and approval.
93. The current Project will follow-up on the prior UNEP-GEF Projects in more ways than one.
While it will support inter-sectorial training relating to modern biotechnology that is still pending, as
well as the initial implementation of the Training Programme for Biosafety, this training will be
interactive, will include the development and dissemination of BCH tools, and will ensure that the
materials and contents of the National BCH are compatible with the BCH Central Portal. The BCH
will be a key mechanism not only for deepening the understanding of CPB operations, but also for
raising awareness on biosafety obligations amongst users and producers of modern biotechnology. As
a tool for biosafety management and a guide to Government tasks, the BCH will be at the core of the
Training Programme for Biosafety. This Programme will include an interactive guide of the BCH
Central Portal, information packages, a training manual for easy to use equipment, and a template of
the BCH database that could be used with existing software programmes to store data at the national
level in common BCH formats, including data exportation functions using different communication
media such as Internet and CD-ROM.
94. The current Project is also expected to consolidate and reinforce institutional coordination
processes, established through previous capacity building efforts. The same biosafety committee that
participated in defining and adjusting the NBF as well as during the BCH project will function in the
present project as a coordination group, as well as the main biosafety coordination mechanism in the
country. This coordination mechanism is already acknowledged by Law 48 of 2002, but a regulatory
modification is being proposed in order to integrate all relevant sectors and create a committee with a
more operative character. Likewise, Sectorial Commissions are also acknowledged by Law, and they
will be made official with specific functions. Therefore it is important to maintain participation of
sectors that will eventually participate in the National Biosafety Technical Commission. These are
mainly government, oriented to research and academic training, gathering operative, scientific and
regulating authorities.
95. Sectorial Committees will be information providers for biosafety and biodiversity, besides being
key actors in the application of the biosafety framework; they will have facilitator and advisory roles.
27
Their participation will also contribute to expanding the impact and dissemination of activities of the
Projects, stimulating participation of a more diverse public. The job of the Committees therefore, will
be fundamental for developing Components 1 and 5 but their intervention and supervision in other
Components will also be crucial for the success of the Project. On the other hand, participation of the
National Committee for Information Exchange in Biosafety will give continuity to coordination
efforts, although they are also a means for decentralizing administration of biosafety and guaranteeing
interested parties that functions and responsibilities can be shared between institutions, in a way that
benefits the application of the NBF.
96. The creation of Sectorial Committees, on the other hand, is also seen as a way of providing
participative platforms through which groups interested on LMO management can be integrated, and it
would be important for Component 5. Measures will be taken too to deposit part of the coordination
mechanism and management needs in other interested parties. Currently, there is a close collaboration
between ANAM and the SENACYT, the latter having strong links with the academic and research
sector. This sector will be appointed with specific biosafety functions, including gathering information
relevant for decision-makers responsible for the state of biodiversity and genetic resources in the
country and putting into practice a Laboratory Safety System for the contained use of LMOs. This
close collaboration with SENACYT regarding biotechnology safety issues is seen as a necessary step
for distributing responsibilities in biosafety, as well as a means for opening the CPB to other sectors
and users of biotechnology, as well as to offer access to scientific knowledge. Therefore, leadership
functions are being shared so capacities and experience do not only accrue within ANAM, and links
formed can bring scientific and social considerations closer to decision-makers, helping the integration
of biosafety into other matters related to research and biodiversity.
97. This collaborative approach, intended to be reproduced with other sectors, is expected to
substantially contribute to the sustainability of capacity building efforts. Links with SENACYT
therefore will be fundamental in the long run, but in the short-term are also crucial to Component 2,
which is about strengthening risk assessment and risk management methods, establishing enough
scientific and technical capacity within competent authorities, having access to relevant data and
situating native biodiversity, social factors and human health at the base of all national decisions
related to LMOs. This also applies to Component 4, which will generate and systematize biosafety
public information, and will establish an appropriate “language” for different groups, while at the
same time guaranteeing confidentiality and commercial transparency in Government’s decision
making.
98. Similar working links will also be established at an early stage with specific members of the
private sector, in order to integrate and discuss challenges in the production of food with commercial
and agricultural sectors. The aim is to guarantee that the importation and exportation of LMOs takes
place in conformity with the country’s NBF and the CPB, and that Components 2 and 3 of the Project
are executed with the participation of these key stakeholder groups.
99. Besides, the ANAM also integrates and articulates biosafety with other areas of biodiversity
protection. The UNARGEN recently created within ANAM will provide support by hosting the
Biosafety Unit to be created for the application of the CPB. This Unit will be in charge of
coordination, management and follow-up of biosafety regulations, notifications and requests relating
to LMO and shall support the Secretariat of the National Technical Biosafety Commission and the
Sectorial Committees. This Project will help to consolidate this Unit, as well as support the
improvement of capacities in qualified staff of related institutions, where these have Units or Sections
of their own that oversee biosafety topics.
28
100. ANAM’s Biosafety Unit will have a staff permanently dedicated to biosafety and administration
and management of the NBF in general. Administrative integration of biosafety into the institutional
structure will also respond to the mainstreaming objectives of the CBD, avoiding isolated and
disconnected management of biosafety to guarantee greater sustainability of biosafety capacity, and
will strengthen the protection and responsible use of genetic resources as a prodigious challenge for
ANAM. ANAM, as CPB Focal Point, will also be responsible for guaranteeing that regulatory
processes involving LMOs take into consideration public participation and access to information,
important requirements for the correct application of the biosafety framework, as indicated in
Components 4 y 5.
101. Thus, with the identification of gaps in the legal framework and means to update and articulate
the NBF, Panama can count with a modern system for authorizations, follow-up and monitoring of
LMOs entering into the country.
3.2.
Project’s Goal and Objectives
102. The strategic objective of this Project is to safeguard biodiversity and implement strategic
programmes of the GEF, specifically capacity building for the application of the CPB, which will
contribute to avoid risks to biodiversity, human health and national economy.
103. The goal or global objective of the current Project is to achieve an effective application of the
CPB by implementing Panama's national biosafety regulatory framework and developing national
capacities to properly handle Living Genetically Modified Organisms (LMO) for the safeguard of
biodiversity.
104. As reflected in its component structure and Logical Framework (Appendix 4), in order to
achieve this the Project has 5 technical components that respond to the following 5 specific objectives:
 Component 1: Implementation of legal and institutional biosafety frameworks to respond to
CPB and CBD requirements. Objective: To implement the biosafety legal and institutional
frameworks for complying with the Cartagena Protocol and the CBD;
 Component 2: Reinforcement of capacities for LMO risk assessment and risk management.
Objective: To apply risk assessment protocols and risk management measures that are
consistent with international state-of-the-art practices;
 Component 3: Creation of an integrated monitoring, inspection and response system.
Objective: To ensure monitoring of and compliance with biosafety measures established for
authorized LMOs;
 Component 4: Generation of national information on biosafety. Objective: To enable Panama
to comply with information-related Articles of the CPB;
 Component 5: Promote public awareness, education and public participation in matters
relating to biosafety. Objective: To increase general knowledge on and participation in
biosafety, including LMOs in Panama and their regulations, in specific groups;
105. The two remaining components focus on project requirements, namely monitoring and
evaluation activities (Component 6) and project management (Component 7), and are intended to
allow the project to be executed in line with GEF and UNEP standards.
29
3.3.
Project components and expected results
106. With this Project, the country seeks to attain a new stage in the national application of the CPB,
so it can make informed, transparent and adequate decisions regarding the use of LMO in Panama.
The current Project shall create the necessary capacities to manage LMO intended or likely to be
introduced into the environment, without jeopardizing the conservation of native genetic resources and
will thus help Panama in conciliating its economic and scientific development with the objectives and
articles of the CBD. In summary, 5 technical components have been structured (with 2 additional
project-related components) based on core tasks identified for the full application of the CPB in
Panama. The project has a total cost of US$1,954,927 of which US$954,927 is provided by the GEF
and US$1,000,000 corresponds to the national share cost.
107. Specifically, the current project aims to:
(i)
Strengthen and modify the National Biosafety Commission (NBC) and other structures, as
part of the national coordination mechanism;
(ii) Adopt rules and regulations in specific areas, such as the environmental release of LMO, their
contained use, inspections and traceability;
(iii) Articulate competences and institutional mandates on biosafety, while also creating well
functioning assessment and inspection structures;
(iv) Train staff in competent authorities, including customs authorities;
(v) Ensure the country’s ongoing participation in the BCH;
(vi) Make progress in gathering and managing information in support of biosafety decision
making;
(vii) Determine a zoning system to identify areas for biodiversity protection as criteria for release
of LMO into the environment;
(viii) Adopt LMO risk assessment methodologies and criteria;
(ix) Adopt protocols for LMO management, including field, transport and laboratory safety;
(x) Adopt protocols for the detection, surveillance and control of LMO and responses in
(xi) case of accidental release;
(xii) Adapt infrastructure and install analysis equipment for LMO detection;
(xiii) Stimulate communications, debates and public access to national biosafety and biotechnology
information;
(xiv) Raise awareness amongst the general public, private sector and judicial powers on LMO uses;
(xv) Promote training and specialization of professionals in biotechnology and biosafety; and
(xvi) Stimulate public participation in matters regarding biosafety.
108. By the end of the Project, the following will have been achieved:
 The national, institutional and sectorial capacities in the effectiveness of the implementation
of the CPB will have been improved (as per GEF BD SP 6) and legislation for agricultural,
health and environmental sectors will have been approved;
 At the sectorial level, biosafety aspects will have been incorporated to sectorial policies and
nationals plans and programmes, and regulations and protocols appropriate for an adequate
execution would have been adopted;
 Risk assessment and risk management mechanisms will have been established and
successfully applied, through manuals and protocols;
 The monitoring and follow-up system will be established and its implementation initiated,
with inspections and LMO detection tests;
 Specialists of all sectors and institutions will have received training on the CPB and its
application, including complementary rules and regulations;
30
 The Biosafety Communication (Outreach) strategy will be in implementation;
 Mock decisions will have been taken, as a means to verify and evaluate the functioning of the
biosafety system, and make improvements.
109. Component 1. Implementation of legal and institutional biosafety frameworks to respond to
CPB and CBD requirements
This component focuses on filling the gaps in existing regulatory and institutional frameworks, and
covers the need for coordination and integration of biosafety, in support of decision making processes
and law enforcement. Expected results (outcomes) are:
1.1 The legal framework is completed and implemented, and areas requiring institutional
strengthening are identified and addressed;
1.2 Panama's compliance with the CPB, including participation in the BCH, is coordinated,
visible and integrated within competent authorities.
By integrating and maintaining biosafety tasks within a range of competent authorities, including
participation in the BCH, and ensuring that policy coordination and technical assessments are
underway so that coordinated decision making can occur, Panama will be complying with the CPB in
a coordinated and timely fashion, and visibly contributing to meeting its objectives.
To achieve these results, consultancies, workshops and coaching will take place regarding the
international and national legal framework for the implementation of the CPB, while coordination
mechanisms and mock experiences for decision making and trying new regulations, procedures and
protocols will also unfold. These activities will involve competent authorities, experts and sectorial
representatives.
110. Component 2. Reinforcement of capacities for LMO risk assessment and risk management
This Component addresses the need for greater capacity in risk assessment and risk management, as
pre-release or pre-approval issues, with emphasis on reinforcing the basis on which decisions are
taken. The following key outcome is expected from this component:
2. Institutional capacity to evaluate and manage LMOs in different activities is increased
This means that decision making in biosafety will be based on scientific and social factors, including
the protection of native genetic resources, and will be transparent and consistent with international
state-of-the-art practices. It also means that the necessary structures, persons, tools and methodologies
will be in place to enable appropriate biosafety evaluations and decisions to take place. Importantly,
this component will look into improving the management of the biosafety system through evaluation
and feedback.
Component activities will focus on having the means and tools needed for risk assessment and
management and decision making, and will include consultancies, workshops, drills, consultations,
legal agreements and training courses, as well as the elaboration and validation of rules, procedures
and protocols for risk assessment and risk management, all involving mostly the academic sector.
111. Component 3. Creation of an integrated monitoring, inspection and response system
31
The Component 3 tackles the areas of monitoring and inspection, as post-release or post-approval
issues, and includes customs surveillance as well as emergency responses, as novel areas in the
biosafety framework. In this component, results related on the one hand to technical and technological
needs for LMO monitoring, and on the other to inspection capacities and experience with regulatory
enforcement, are expected. A single outcome brings together all these elements under this component:
3. Competent authorities have increased capacity to track authorized LMOs, enforce regulations
and respond to accidental releases
Thus, this component is expected to raise institutional capacity for follow-up of authorized LMOs,
covering from customs to post-authorization requirements and enforcement, to responses to accidental
release of LMO. In addition, the application of administrative procedures in cases of infringement may
also be piloted under the project, and experience will be gained in detecting the presence of LMOs
through laboratory and molecular analyses.
The design and creation of the monitoring and inspection system will be subcontracted, as well as the
training for facilitating implementation of regulations, mechanisms and procedures with participation
of the range of entities with competency in LMO authorizations, inspections (ie. enforcement) and
responses to involuntary and accidental releases.
112. Component 4. Generation of national information on biosafety
This component aims to generate up-to-date national biosafety information in a manner that will
promote transparency and accountability, and reflect the country's biosafety status. The following key
result (outcome) is expected:
4. Information management for LMOs provides regulatory bodies and stakeholders access to the
latest information on biosafety
This component will focus both on information management and information availability, thereby
balancing the obligations of the Government to safeguard confidential commercial information and
adequately track LMO applications as they progress along the biosafety system, with those obligations
that relate to public information, transparency and the need for impartiality. Dissemination materials
will also be produced under this component, and made publically available in digital and printed
formats (eg. as online data, brochures, posters and others forms). This will be done by hiring a
specialist in charge of the whole process, from designing the materials up to supervising their
production and distribution.
113. Component 5. Promotion of public awareness, education and public participation in matters
relating to biosafety
Component 5 is concerned with the stimulation of public participation through awareness-raising and
increasing opportunities for acquiring biosafety expertise. The expected outcome is:
5. Interest in biosafety is stimulated and the quality of the biosafety debate is elevated
As it would be premature to expect a surge in public participation in biosafety processes, this
component seeks, in the first instance, to raise the level of interest and awareness concerning
biotechnology, biosafety and LMOs in specific groups. It will also take advantage of the Web as a
32
means for outreach and exchanges, and will foster opportunities for specialization in biosafety or
biotechnology. Ensuring that public participation takes place prior to granting new LMO
authorizations and that the review of decisions is made possible in case it is justified by new evidence,
and putting in place a biosafety outreach programme, are also results expected from this component.
Professional consultancy services will be hired for the elaboration of the education and public
awareness programmes and the LMO communication strategy, as well as the organization of forums,
consultations, meetings and surveys to measure perception at the beginning and end of the project, at
the institutional, academic and productive level.
114. Components 6 and 7. Project M&E and management
The scope of these Components is circumscribed to project management and monitoring and
evaluation requirements. Component 6 caters exclusively for a National Project Coordinator who will
be appointed by the National Executing Agency after consultation with UNEP, while Component 7
covers monitoring, reporting, auditing and evaluation activities, including the inception workshop.
Under Component 6, the costs of the Coordinator, who will work on a full time basis for the duration
of the Project, will be covered in part by GEF (49%) and in part by the Panamanian Government
(51%). Further details on this and other execution arrangements are provided in Section 4.
3.4.
Intervention logic and key assumptions
115. At the heart of this project’s design is the opportunity to make progress in a step-wise fashion,
from NBF development to NBF implementation, with some steps also taken towards participating in
the BCH. This project therefore follows-on from previous efforts, focuses on the gaps and weaknesses
of the NBF, looks ahead at sustainability factors, and makes good use of lessons learnt as well as the
collaborations and momentum built up from previous projects.
116. The main responsibility for the Project will lie with the environmental authority (ANAM), also
the CPB and BCH Focal Point and the entity responsible for environmental policy coordination. The
ANAM will be supported by other Competent Authorities, namely MIDA, MINSA, MICI, AUPSA,
ARAP, ACP and Customs, but mainly by SENACYT as a key player in capacity building and in
ensuring the success of Project Components 2 and 4 in particular. This is an assumption that is
determinant for the project and that has to a great extent been confirmed, especially following the
recent change of Government. This support entails a sharing of technical responsibilities, and has been
agreed to as evidenced with the letters of co-finance provided for this project (Appendix 12). The
participation of the productive and academic sector, as well as civil society, will also be crucial for
solidifying a working relationship with these stakeholders and for opening up the biosafety debate.
Though the Project will look forward to the formalization of the NBTC and the Sectorial Committees,
informal cross-sectoral dialogues will be encouraged as a means of building trust and transparency
between different sectors.
117. Within ANAM, project coordination will be housed by the National Direction of Protected
Areas and Wildlife (DAPVS), and will be supported by specific staff from the Biosafety Unit and
UNARGEN, appointed as national counterparts for the Project to follow-up on project progress and
performance, to ensure the project meets its objectives, goals, work programmes and budgets. The
Project will therefore be well embedded within existing institutional structures and processes.
Ultimately, it is the Biosafety Unit that will give long term continuity to the implementation of the
CPB, having been strengthened by means of this Project.
33
118. With consolidation of the NBF, especially the legal component, a better application of the CPB
will be guaranteed and will also drive the implementation of the Training Programme for Biosafety.
This Programme homes in on the BCH and centres strongly on risk assessment and management, as
part of the work needed to avoid adverse effects on biodiversity conservation and human health, and
also to render the paperwork regarding LMO requests more agile and focused. In support of biosafety
decision making, up-to-date biodiversity information and tools will be compiled and institutional
know-how created, in order to make decisions technically-sound and transparent.
119. The project’s design takes heed of 2 strategic pillars intended to increase the success of NBF
implementation: a. human capital, for increasing the knowledge base but also building biosafety
sustainability; and b. regulatory compliance, through control and monitoring mechanisms that can
ensure biosafety standards are upheld without obtruding commerce or biotechnological research.
(i) The project will not only invest in training of staff in competent authorities, in the judicial
system and in customs offices, but will also target students and the young, seeking to raise
their interest in biotechnology and biosafety issues, will promote professional specialization in
biosafety and will build an alliance with the SENACYT, the country’s main driver of science,
technology and innovation as vehicles for a more sustainable development. Interestingly,
SENACYT maintains close ties with the private sector, the government and the academicresearch sector (its mission is to promote productivity, competitiveness and modernization in
these sectors, through scientific, technological and innovative means), which fits comfortably
with the strategic purpose of biosafety, which is to allow social, economic and environmental
benefits to accrue from the responsible and controlled use of modern biotechnology;
(ii) With regards to regulatory compliance, the project will also ensure that biosafety decisions
are coupled with adequate measures to reduce, mitigate and eliminate risks. Thus, together
with greater capacity for risk assessment, the country needs concomitant inspection and LMO
detection capacities, as well as management protocols to guide institutional actions and public
information to guide users (namely, the private and research sectors) with respect to normative
compliance. Efficient information management and administrative processes will be
cornerstones for effectual risk management, but having legal clarity, sufficient trained
personnel, the necessary technological and scientific capacity, and coordinated actions from
competent authorities will be paramount.
120. The key underlying assumptions in this project are two-fold: one relating to project design, the
other to execution. (a) For the project to attain its objectives, the legal modifications that have been
proposed must take place (be approved) early in the project. From this will follow a series of tasks,
entrusted to other institutions, to set up biosafety units or provide staff and facilities for biosafety. This
assumption is based on the fact that the modification of Law N° 48 of 2002 has long been discussed,
and a proposal already exists with the Executive, which is expected to go through without any
setbacks. (b) Previous experiences in executing UNEP-GEF projects required the services of an
external fund administrating entity, in order to avoid undue delays and overburdening internal
departments. However, the administrative capacity of ANAM has improved over time and become
more agile through the various international cooperation projects it has taken on. The assumption here
is that the current UNEP-GEF project will not have the same administrative set-backs as were had
with the NBF Development project.
34
121. The ANAM has presented, as a strategic action, the elaboration and implementation of a
biosafety public policy framework, which will be driven by this Project and will guide future biosafety
actions once the project is over. In fact, the elaboration of a Strategic Plan for application of the policy
and for defining different stages, processes and modalities on the use of LMO is expected to follow.
With the collaboration of a range of entities and actors, areas of the country that can be maintained
“transgenic free” will be defined, and based on the best scientific information available, definitions
will also be taken to guide future developments in modern biotechnology, based on the country’s
fundamental socio-economic needs and prevailing environment. Panama intends to reap the benefits
of modern biotechnology, only in as far as the risks can be handled. Through the effort of weaving
together scientific, technological, productive, commercial, social, legal and managerial actions, to
create an operational NBF, this project will take Panama one step closer to attaining a more
sustainable development.
3.5.
Risk assessment and measures for risk management
122. There are risks that may threaten the execution of the Project and some uncertainty concerning
political decisions and external influences that are beyond the reach of the Project. Among the risks
that can be mentioned, and the measures proposed to mitigate them, are the following:
RISKS IDENTIFIED
REASONING /RATING
RESPONSE
Inadequate commitment
of the national
government or budget
allocation of national
cost shares for the
execution of the project
LOW
ANAM’s relative independence will serve to
protect the project from institutional
deficiencies existing in public sector structures.
Participating institutions have identified share
costs (co-financing contributions) as a means
to formalize their participation in the project
(see Appendix 12). The fact that co-financing
letters are signed by the highest authority
figures also reinforces the fact that
commitments within the project are institutionwide, medium-term and across many public
institutions.
Annual co-financing (the
national government’s
cost shares) is modest to
guarantee fiscal viability.
Importantly, cash co-financing is earmarked by
the Ministry of Finance and once committed
for a fiscal year, must be spent by each
institution. In this case, having secured
US$200,000 as cash contributions guarantees
that in-kind contributions will follow.
MEDIUM to LOW
Insufficient political will
and fragmentation of
institutional mandates to A change of Government
support activities of the was due to occur during
the project preparation
project
period (2009). Current
fragmentation of functions
slows biosafety operations
35
The risk of low political will was identified in
view of the change of Government that was
due to take place in 2009, but was mostly
mitigated during the project preparation phase.
The current Government fully accepts and
supports the Project, as well as the intended
design and implementation arrangements for
its coordinated execution. The provision of
and raises costs
both cash and in kind co-financing is also a
sign of this support, as is the partnership with
SENACYT.
Moreover, competent authorities agree on the
need for coordinated action, and clear
mandates for more cost-effective biosafety
management, so that the fragmentation that
currently exists should dissipate as the project
progresses.
Lack of adequate
coordination between
entities or involvement
when executing project
activities
Once formalized, the National Biosafety
Technical Commission will orient the
Involvement of competent implementation of the Project and will provide
a channel for undertaking an integrated
authorities has been
approach to biosafety. It will also ensure the
relatively constant and
should continue to be, but participation of all relevant institutions focused
on meeting the objectives and outputs of the
coordination action in
project.
biosafety still needs
reinforcement
Institutional and sectorial capacities will be
gradually increased for the implementation of
biosafety
regulations,
policies
and
programmes. In fact, institutional capacity
building will emphasize coordination and the
importance of mutual support, and will be
prioritized for the application of regulations
and risk assessment on the use of LMOs. All
information will be put on the BCH, for due
monitoring and follow-up, and as a means of
“advertising” project activities.
LOW
Lastly, another factor that will help to mitigate
this risk is the recognition that biosafety
implies commitments acquired at the
international level, such as the CPB and
through the signature of inter-institutional and
regional agreements, as well as the
establishment of institutional alliances.
Increased pressure and
actions from the private
sector exceeding
institutional capacities.
Specifically relating to:
requirements arising
from the Free Trade
Agreements recently
This risk will be kept low by ensuring a fluid
dialogue with the private sector. Panama still
The risk of private sector has a small professional and business
community; everyone knows each other.
initiatives (in favour of
Sensitive subject matters, such as the impacts
biotech applications)
progressing at a faster rate of the NBF on R+D, LMO identification and
labelling, are currently discussed openly (and
than the work of the
will continue to be); information will always
public sector to regulate
such applications is not a be provided on request, and informal contacts
HIGH
36
minor one; in terms of
signed by Panama or
soon to be signed; rise in biodiversity, this would be
the risk of gravest impact.
commercial flux of
LMO products
exceeding the country's
capacity to manage
biosafety in accordance
with the Cartagena
Protocol.
Slow and complex
administrative hurdles
within the National
Executing Agency
hinder timely project
execution
Changes in the present
agricultural and energy
policies (including
climate change
adaptation) affect the
rate or scope of LMO
adoption in the country
MEDIUM to HIGH
Administrative obstacles
with PPG precluded
execution of these GEF
funds, creating an
unfavourable precedent
but also a learning
experience
fostered. The regulators will ensure that they
remain “approachable” throughout this effort.
The project’s communication strategy will
especially target producers, and a survey with
the private sector and researchers will be
included. These actions should ease the
possibility of unauthorized private activities
posing a threat to biodiversity, as both the
scientific community and the private sector
will be aware of the actions being taken to
regulate LMO use, and will be able to take
part.
Fluid modalities and communications, and
clear responsibilities are needed in order to
avoid delays and mishaps, as experienced
with the PPG. These lessons learnt will be
duly applied for project execution. Unlike
with the PPG, a specific department within
ANAM with prior experience in GEF
project financial execution and
administration has been designated. In this
unit, contact persons will be identified and
an appropriate reporting periodicity
established from the onset.
The country’s definition of eventual climate
change adaptation and mitigation measures
could potentially and negatively influence the
Global tendencies
could potentially influence project’s impact, insofar as these may
or diminish the project’s stimulate the introduction of large scale
biotechnological solutions, driven by global
impact
tendencies such as biofuels derived from LMO
or drought- and/or salinity-resistant crops,
given the potential availability of these
technologies in the near future.
LOW to MEDIUM
Under this eventual scenario, the project shall
consider the possible counter-position of
agriculture and energy policies, with the
policies for biosafety and access to genetic
resources. This in turn will require the
integration of visions and adoption of
decisions that are coherent with the regulatory
framework, in order not to reduce the
country’s options nor lose development
37
opportunities or environmental resources.
The mitigation of this risk also requires strong
elements of governmental coordination so that
biosafety is not considered on the margins of
economic development or sustainable
development issues, but under a more
integrated vision, with political support to
ensure its sustainability and continuity, and its
full integration into environmental public
policies and commercial practices, and into
ANAM’s permanent mandate. For this reason,
biosafety has been integrated into the revised
National Environmental Plan, the Cartagena
Protocol has been linked to a range of national
policies and competent institutions, a
permanent Unit in charge of biosafety and
genetic resources has been set up, and
collaborators for biosafety management are
being sought, so as to ensure coherent and
sustained government-wide support.
Stakeholder buy-in is also being assured
through the reinforcement of the Biosafety
Commission and the creation of Sectorial
Committees,
as
these
coordination
mechanisms contribute to mainstreaming
biosafety and will not only help to steer the
manner in which the Cartagena Protocol is
implemented in the country, but will also
allow greater sectorial understanding of the
issues at stake and of the country's biosafety
commitments.
3.6.
Consistency with National Priorities and Plans
123. Panama has diverse plans and programmes that explicitly mention biosafety. The National
Biodiversity Strategy of 2000 initially provided an overarching framework by establishing amongst its
strategic objectives the need to “increase knowledge, information and awareness of the population
regarding biodiversity, biotechnology, bio-prospection, biosafety and access to genetic resources”, as
well as to strengthen the General Law of the Environment for the promotion and formulation of
policies together with rules and regulations that would foster the conservation, sustainable use and
distribution of biodiversity benefits, according to commitments acquired under the CBD.
124. The Biosafety and LMO Control Sub-Program was developed as a component of the National
Biological Diversity Plan of Action of 2000, with the goal of implementing regulatory and policy
frameworks regarding biosafety in the introduction of species and LMO control, with the participation
38
of key actors such as: MIDA, ANAM, MINSA, the National Committee for Information Exchange in
Biosafety, civil society, as well as ARAP and AUPSA. These were very much the first steps taken to
create a biosafety agenda for Panama.
125. Subsequently, the ENA 2008–2012 has set forth several strategic guidelines, of which
Guideline 1 aims to “Strengthen the capacity of ANAM to perform its duties regarding environmental
matters” and prioritizes the elaboration and execution of a national biosafety public policy, plan and
programme, as well as BCH operations. Likewise, Guideline 4 highlights the “Protection, recovery,
restoration and improvement of ecosystems to contribute to sustainable development, understood as a
general improvement of population wellbeing and generation of employment” and considers NBF
implementation a priority as well as the establishment of other Biosafety Information Centres in the
country.
126. More specifically, Guideline 1 Objective 1 refers to the consolidation of environmental legal
and policy frameworks, citing in particular the Biosafety Regulating Framework and biosafety policy
with its plan of action. Objective 2 prioritizes the functioning of the National BCH website and the
creation and consolidation of a Scientific, Technological and Environmental Research Network.
Similar lines of work relating to biosafety regulations and information are laid out under Guideline 4,
as activities that contribute to biodiversity conservation and sustainable use.
127. The Objectives and Strategic Guidelines of the National Biodiversity Strategy and of the ENA
2008–2012 are in consonant with the country’s ratification of the CPB through Law Nº 72 of 2001,
later complemented with Law Nº 48 of 2002, as the principal instruments of application. The latter
Law establishes the NBC for LMOs, defines institutional competences, sets forth the creation of
Sectorial Committees in the agricultural, environmental and public health sectors, and establishes a
framework for the development of specific regulations. Other entities such as ARAP, MIDA, AUPSA,
MINSA as well as INDIACAST are involved and function actively in meeting strategic guidelines and
national regulations, and are in agreement with the objectives of the CPB, in as much as they focus on
the need for information, coordination and greater capacity for inspections in the area of
environmental management.
128. The above environmental Strategies are also complemented by initiatives from other sectors,
such as the National Science Plan generated in order to promote R+D in Panama, and open spaces and
means for the expansion of the scientific sector, where biotechnology is seen to play a strategic role
and offers an opportunity to access benefits derived from the use of native genetic resources. Another
government priority is the modernization of customs services, which is linked with the expansion of
the Panama Canal that has already begun and with the overall need for greater efficiency and
transparency in border control processes. Both these initiatives will be of benefit to the project and to
the implementation of the CPB.
129. Furthermore, ANAM approved between 2005 and 2007, nine environmental policies, among
them: Environmental Information; Supervision, Control and Inspection; Decentralization of
Environmental Management; and Biodiversity. The National Biodiversity Policy, through the Strategy
for the Conservation for Sustainable Development and its policy orientations for 2004-2009,
underlines the need to establish a biosafety regulatory framework in Panama. To date, other
institutions have also incorporated biosafety into their annual plans, either through the monitoring of
authorized activities, or through following-up on the CPB and training issues.
39
130. It is worth noting that in 2006, with the onset of GEF-4, Panama was one of the first countries
to determine, during the programming exercise with countries coordinated by the GEF Secretariat to
agree on project allocations under the newly-launched “Resource Allocation Framework” for the
Biodiversity Focal Area, that it would set aside close to $1,000,000 of its GEF resources for a
biosafety project. This is indicative of Panama’s long-standing plans to prioritize biosafety and the
CPB over other facets of biodiversity protection; biosafety has been on the “policy radar” even before
the start of GEF-4 and the finalization of the NBF Development Project.
131. Lastly, Panama is currently undertaking its United Nations Development Assistance Framework
(UNDAF) programming process, for the period 2012-2016. This framework, which sets priorities for
any future cooperation and development assistance to be received by Panama from Agencies of the
United Nations, will likely include an environmental chapter focusing -among other things- on the
national implementation of multilateral environmental agreements such as the CBD and its protocols.
The current UNDAF for the period 2007-2011 does not make any significant statements on the
environment but rather circumscribes core conservation issues to an issue of human rights.
3.7.
Incremental Cost Reasoning
132. Context and Wider Development Goals: Panama, a country of medium-high income serving
as a bridge between North and South America in the middle of the Atlantic and Pacific Oceans, suffers
from extreme economic inequalities: close to 40% of its population lives in poverty, highlighting it as
one of the countries with larger inequalities in the region. In terms of biological diversity, the country
is considered to be amongst those with the most biological diversity in the world, particularly
considering its size. It has more than 10,400 species of plants, 1,300 endemic and almost 200
endangered. Out of its 2,950 vertebrate species, more than 100 are threatened and 121 are endemic
(and a much larger number share their endemic origin only with Colombia or Costa Rica). Almost ten
percent (10%) of the bird species in the world are in Panama, and twelve (12) species are only found
in Panama, with almost 50 amphibious species classified as endangered, many of which are critically
endangered and only found in Panama and neighbouring Costa Rica. Panama also has habitats for
feline species such as jaguars and harpy eagles, which require large territories covered by native
vegetation for survival. These facts attest to the richness of Panama´s tropical forests, but do not
account for the range of biodiversity threats to which they are exposed. This rich and unique
biological diversity is facing increasing pressures and requires a joint effort of conservation and
protection. Habitat destruction and degradation caused by deforestation from slash-and-burn
agriculture, by invasive alien species, by soil and coastline erosion and by pressures from a growing
tourism industry are the main biodiversity threats faced by much of Panama’s tropical forests and
mangroves.
133. Biosafety is considered one of a battery of approaches needed to reduce the impacts of these
biodiversity threats, reason for which Panama is a Party to the CPB. Despite achievements with the
UNEP-GEF Project “Development of a National Biosafety Regulating Framework for Panama”
however, many tasks remain in the realm of biosafety. The main end results of this project were: (1)
the Draft of the National Biosafety Regulating Framework for Panama, to update Law 48 of 2002; (2)
three diagnoses on gaps in the legal framework, institutional capacities and trade of transgenic
products in Panama; (3) proposals for a Training Programme for Biosafety; and (4) a preliminary
database. Proposals and means for “modernizing” biosafety were also outlined.
134. Similarly, the UNEP-GEF project “Building Capacity for Effective Participation in the
Biosafety Clearing-House (BCH)” resulted in: (1) the establishment of the National Committee for
40
Information Exchange in Biosafety, (2) the design of Panama’s BCH website, (3) computer equipment
provided to institutions that are part of the national BCH, (4) technical and specialized assistance,
including equipment set-up, intra- and internet connectivity and choice of BCH modality, (5) training
workshops to train up to 20 national participants in the use and access of the BCH, and (6) further use
of the training materials provided. However, these achievements and goals are not enough for the full
implementation of the CPB.
135. The government’s strategy is based on: Law Nº 72 of 2001 for CPB ratification, Law Nº 48 of
2002 which creates the NBC; Forestry Law (1994); Environmental Impact Law (1994); Law 24 of
Wildlife (1995), General Environmental Act 41 (1998) which created the ANAM and detailed an
ambitious framework for the administration, conservation and preservation of natural resources and
environmental assets of Panama. More recently, the National Environmental Strategy 2008-2012 sets
out a five year vision oriented at: (i) strengthening ANAM’s capacity in exercising its environmental
matters guardianship; (ii) working in close collaboration with the State, the private sector and civil
society for fostering advantages sustained in human capital, social capital and technological
innovation in production and not excluding access to natural resources with subsidies; and (iii)
consolidating ANAM’s institutional and regulating capacity to act on biosafety matters. Panama is
also signatory of a series of international agreements regarding biodiversity (e.g. CBD, RAMSAR,
CITES, CMS, SPAW Protocol, Climate Change).
136. The Government of Panama, together with its partners (such as IDB, WB, FIS, IFAD) have
mobilized resources for many programmes and activities under planning or currently in process that
support the environmental and sustainable development agenda of the country, especially actions
concerned with the reduction of poverty levels, strengthening of the protected areas system,
sustainable rural development, establishment of environmental and rural Investment Funds,
strengthening of community organizations, territorial planning and zoning, and adequate use of
environmental resources; the current project aligns well with both the former and latter objectives.
137. Baseline Scenario: The Government of Panama, through Competent Authorities, in
collaboration with international financing organizations such as: UNEP, UNDP, FAO, among others,
has implemented institutional and legal capacity building projects covering the environmental,
agricultural and health sectors, as well as small-scale projects for information exchange on LMO, with
very little community participation and almost no private sector participation. Competent Authorities
such as the MIDA have established an internal group deal with the topic of biosafety; at the health
level, there is also a biosafety committee. In the environmental sector the emphasis has been on
establishing legal regulations that can serve as a base and platform to deal with the CPB.
Concomitantly, activities have also taken place to promote sustainable use and conservation of natural
resources and biodiversity of global importance; improve socioeconomic and environmental
conditions at the community level; integrate the concepts of sustainability and sustainable
development in all sectors; and conserve and monitor the state of biological diversity within Protected
Areas. In comparison with these lines of work, however, capacity building in biosafety has progressed
slowly. Biosafety implies tackling a rapidly evolving field, with new sets of technologies and options
emerging on a yearly basis, making it increasingly challenging to address biosafety from a position of
confidence.
138. The baseline of the current Project will focus on updating and applying national regulations for
CPB implementation. Baseline investments by the State (in the absence of GEF support) over a four
year period are expected to reach US$1 million, confirmed as project co-financing. Nevertheless, an
estimation of the required baseline investment came out at US$ 1.25 million, broken down as follows:
41
 Approximately US$ 250,000 will be destined to the initial implementation phase of the CPB
ratified by Panama (Law 72 of 2001), to approving the modification of Law 48 of 2002 and to
setting in motion Executive Decrees for sectorial regulations. The emphasis will be on the
establishment of procedures for LMO research in confined use and release into the
environment, liability and redress (for example under laws, decrees and resolutions) and
specific norms, as well as on training of the Judicial body regarding rules and regulations for
biosafety and LMO use;
 About US$ 300,000 can be allocated to strengthening Competent Authorities to carry out
LMO evaluations and follow-up on decisions taken. In this area of work, efforts would go
towards laying the technical, administrative and human foundations for a risk assessment and
management system. Clear mandates, effective coordination and exchange of information
would be at the heart of these efforts;
 The first steps in creating a Monitoring, Inspection and Follow-Up System would have an
approximate cost of US$ 300,000 covering features such as the analysis, case by case, of
LMO requests and following-up on recommendations. Much of this investment would relate
to the use and maintenance of basic laboratory facilities and access to scientific know-how,
and to the operational costs of carrying out on-site visits and inspections. With strong
limitations, the initial costs for implementing the Training Programme for Biosafety would
also be covered;
 The baseline for biosafety information generation, covering the maintenance of Panama’s
BCH site, is estimated to cost close to US$ 200,000. This line of work would include
periodically updating existing information and registering new information, but would be
limited in terms of processing information to support biosafety decision-making;
 The country’s investment in the promotion of public awareness, education and public
participation in matters relating to biosafety would likely be very limited, barely covering the
costs of initiating a biosafety communication strategy, calculated at about US$ 200,000.
139. The GEF alternative. GEF investment in the current project would allow the Government of
Panama, through its Competent Authorities, to be more effective and extensive in its biosafety actions,
and reduce risks to biodiversity conservation in order to increase the global benefits provided by the
Project. The country has strengthened biodiversity protection measures at the national and local level,
for example through the creation of protected areas, has gained experience through Environmental
Impact Assessments, and has invested in creating human resources and institutional mandates for
better management of natural resources. Yet the area of genetic resources protection, under which
biosafety fits well, is a more nascent field. It is also a complex field, and highly transversal; entailed in
the conservation and sustainable (and responsible) use of genetic resources are considerations as
onerous as intellectual property rights, access and benefit sharing, protection of associated traditional
knowledge, centres of origin, ex situ conservation, international commerce, food security and safety,
farmer’s rights, and biosafety. Notwithstanding initial steps to mainstream and integrate this array of
complex issues, through actions as diverse as creating institutional structures and work units to
advancing policy and national positions, much road remains to be travelled to be truly effective in the
sustainable use of genetic resources and contribute not only to national biodiversity benefits, but also
to global benefits as part of the international community.
140. To reach global value biodiversity protection, extra support is therefore required, especially
with the implementation of a precautionary instrument such as the CPB, which is unlikely to accrue
measureable global benefits in the lifetime of a single GEF project. Hence this “incrementality” can
be covered by the GEF, as a co-financier in the current (and other) projects together with the National
42
Government. Since it is understood that the creation of institutional and sectorial capacities for the
implementation of the CPB will increase, this can effectively induce Panama to undertake measures
that are additional to those that would be normally taken. Thus, the National Government could make
some progress in biosafety with or without GEF and as such, is able to finance the baseline, but the
incremental cost is best assumed by the GEF, since the country cannot assume the alternative alone.
141. Under the alternative scenario facilitated by the GEF, the Government of Panama could adopt a
more ambitious programme, generating global, national and local benefits in terms of biodiversity
conservation. Sectors involved in, and/or beneficiary of, the proposed Project are precisely those most
affected, in terms of stakes, rights and opportunities, by the entering into force of a new framework for
biosafety. Given the weight of their responsibilities, they are inherently part of the GEF alternative.
The GEF alternative will stimulate a wider range of measures to be undertaken promptly for the full
implementation of the CPB, and will open the door for Panama to link up with the NBF
Implementation projects of other Central and South American and Caribbean countries, currently
nascent, and join forces in the task of conserving biological diversity of national, regional and global
importance, through biosafety.
142. Total expenses associated with reaching the GEF Alternative Scenario are estimated to require
US$ 2,600,000 over 4 years, yet the overall investment here expected is for US$ 1,954,927. The
costed GEF scenario is to be co-financed between the Government -or more precisely the State- and
the GEF. With this sum, the expected results are as follows:
 The Project will aid in the operation, modification and completion of biosafety legislations, so
that research and environmental release of LMOs are adequately and promptly regulated, and
official decisions can be emitted and followed-through as a sign of a functional biosafety legal
framework. Next steps will be to “upgrade” the biosafety system from functional to efficient,
for which the current project will lay a base of institutional capacities and provide a 4-year
learning experience;
 The Project will support the strengthening of national capacities for risk assessment and
management of LMO, and for the definition of valid scientific criteria for biosafety decision
making, also considering socioeconomic aspects. It will also facilitate the development of
courses, workshops and technical meetings on risk assessment and management, for
institutional beneficiaries such as MIDA, IDIAP, MINSA, ANAM, INDICASAT, SENACIT,
ARAP, AUPSA and AMP and other scientific and educative entities, such as universities and
their information centres, as well as producers, the private sector and NGOs. The
implementation of a LMO Biosafety Plan of Action is proposed;
 The Project will support the creation of an integrated monitoring, inspection and response
system for improving procedures for information gathering, notification, control, monitoring
and follow-up, in coordination with the BCH structures; this tool will serve to ensure not only
fulfilment of international commitments but also as an early warning for LMO shipments that
could be brought into Panamanian territory;
 The Project will generate information to cover identified gaps as well as pinpoint limiting
factors in the handling systems of LMOs, and lay the foundations for a biosafety traceability
system that includes protocols, and sampling and detection techniques, and has the
participation of sectorial Competent Authorities;
 The Project will create mechanisms for raising public awareness, through application of a
CPB Communication Strategy that facilitates integration and awareness of the civil society
and all sectors, in LMO topics. These activities will be supported by Competent Authorities
and by communication media.
43
143. Administration, coordination and M&E of the Project: in addition to the activities seen in the
Baseline Scenario, activities under the GEF Alternative include the incremental costs of duly
administrating the Project, which will be jointly incurred by ANAM and the GEF to achieve the GEF
alternative.
144. The GEF alternative will strengthen Competent Authorities and sectorial level regarding LMO,
at the same time research and academic sectors regarding the use of modern biotechnologies, as well
as community organizations and general public, with more information and awareness on possible
effects for the use of LMO and will increase knowledge of the private sector. It will also help
strengthen biodiversity conservation and wild species of agricultural interest species of the country.
145. Incremental cost: The incremental cost will help the country reach global objectives for the full
implementation of the CPB and consolidation of Competent Authorities in biosafety and in situ
conservation matters and on the sustainable use of wild, endemic species and protection of genetic
resources, among others.
146. This Project is vital for the development of procedures and putting into practice biosafety
regulation, but mostly importantly, for bringing private and public know-how together in a cohesive
fashion. Raising the extent to which institutes, research and technological innovation centres,
universities and private companies invest in biosafety, through buy-in, multi-disciplinary decisionmaking, and even investments in research and biotechnological innovation, are expected incremental
effects of this project. Heightened participation in this project from non-public sectors, including civil
society, will accrue global benefits by consolidating NBF implementation and Panama’s role as a
Party to the CPB, and by raising inter-sectoral awareness of the significance of biosafety.
147. The incremental contributions of this project also include the provision of or access to training
opportunities, the increase in national -and not only sectoral- capacity for the definition of valid
scientific criteria for biosafety, taking better advantage of the BCH, promoting information exchange
as both inputs to decisions and a means for transparency and coordination, and refining procedures for
receiving importation requests. These incremental facets of the NBF can be better implemented
through GEF’s involvement. Overall, the incremental costs in this Project have been estimated in the
order of US$ 954,927 as the difference between the Baseline investment (US$1 million) and the
overall investment for the GEF alternative (US$1.95 millions). A full breakdown of estimated
incremental costs per component is provided in Appendix 3.
148. The proposed Project directly contributes to the Government’s strategy; the global
environmental objective of the Project is the development of national capacities for management of
living modified organisms, for safeguarding biodiversity, through full implementation of the CPB.
3.8.
Sustainability
149. The sustainability of the Project will be achieved through participation of agricultural,
environmental and health sectors, with full participation of government institutions, productive and
private sector, researchers and academic centres. Such participation will be formal, taking the form of
inter-institutional partnerships, multi-sectorial committees and administrative transparency, as well as
informal, through debate and consultations; a combination that reflects the way Panama envisages
biosafety moving forward in the future. Indeed, formal alliances will be encouraged as a means to
share and mainstream biosafety responsibilities. Cooperation agreements between interested parties
44
will define procedures for continuous follow-up and monitoring of activities carried out, thus
guaranteeing institutional and financial sustainability.
150. Informed participation of the general public also plays a key role in the decision making
process, and in the control and surveillance of LMO use approved in the country. The applicability of
the NBF (especially its regulations) will largely depend on the extent to which its promoters
(regulators) and users (regulated) are aware of and understand the framework. Activities of the Project
are designed to fill identified gaps and solve barriers, consisting mainly in institutional capacities and
know-how, but in particular, the Project seeks to guarantee long term effects by creating policies and
strategies that will mandate institutions to improve their administrative, research and productive
management of LMOs, with a view to increase their knowledge of biosafety and with this, prevent any
adverse effects from modern biotechnology on natural resources, biodiversity, human health and
economic activities.
151. As already pointed out in sections 3.1 and 3.4, the Project’s design amalgamates several factors
intended to increase the success of NBF implementation, and therefore the sustainability of the
capacity being built. These factors involve investments in, among others: (i) creating human capital (a
critical mass) for increasing the knowledge base and building biosafety sustainability; (ii) regulatory
compliance, through control and monitoring mechanisms and sufficient capacity to implement
biosafety beyond the paperwork; (iii) building alliances with key institutions, such as SENACYT, the
country’s main driver of science, technology and innovation, to share both project responsibilities and
biosafety agendas; (iv) setting up institutional structures and units able to articulate biosafety with
other areas of biodiversity protection, handle administrative tasks and achieve inter-agency
coordination; and (v) fortifying the role of ANAM, as the CPB and BCH Focal Point, and the main
biosafety “guarantor”.
3.9.
Replication
152. Lessons learned in the implementation process, analyzed and evaluated through independent
cases will be key aspects for optimizing the replication of the Project. Monitoring and evaluation of
Project activities can be systematized to derive best practices and effective actions worthy of
replication. They could even serve as case studies for similar projects, and be made available to within
the country and the region. It is also expected that the training and communication components of the
project will open opportunities for replication, for example, the experience of disseminating
knowledge and information can be replicated and improved when the strategy concerned is updated
and re-implemented. There is also potential for intra-regional exchanges between similar NBF
Implementation projects to prompt efficacious approaches from other countries to be replicated back
home.
3.10.
Public awareness, communications and mainstreaming strategy
153. The ENA 2008–2012 considers, as part of improving institutional management, the design and
implementation of a Training Programme for Biosafety aimed at strengthening the administrative,
scientific and technological savvy of the staff of ANAM and other public institutions that are part of
the environmental management system. As part of strengthening the services provided by ANAM,
databases, public information, websites, maps and a communication strategy will all come together to
facilitate public participation and outreach in biosafety.
45
154. ANAM will design and execute a communications strategy for disseminating biosafety
experiences and also sensitizing the media, the productive sector, NGOs and civil society
organizations to this topic. Likewise, mechanisms for accessing information will be made operative, or
improved, through Panama’s BCH website and in accordance with the country’s transparency Law
guidelines. Part of the strategy will involve promotion of informed and timely public participation in
decision making for LMO management and handling.
155. The Project will serve as a driver for the Science and Technology Programme at the national
level, providing important inputs such as biosafety and biotechnology contents (and lobbying) for
inclusion into higher education and graduate curricula, and fostering research opportunities related to
transgenic organisms. This will involve working closely with SENACYT and IDIAP, and will be a
sign of biosafety being mainstreamed by the science and technology sector. Likewise, the
communication strategy contemplates the establishment of a National LMO Forum, to strengthen links
between ANAM and main organizations for the generation, dissemination and application of
knowledge in the country and abroad. Another expression of biosafety being mainstreamed into the
national agenda is, to some extent, already taking place, yet will be further stimulated by the current
project. ANAM has begun to articulate biosafety with other areas of biodiversity protection, for
example, through the creation of UNARGEN as a mentor to the Biosafety Unit which is currently
being set up and which this Project will help to consolidate. Other public institutions are also doing so
-gradually- within their areas of competency, through permanents groups that have biosafety as part of
the work agenda.
3.11.
Environmental and social safeguards
156. Biosafety is a polemic topic with many facets, so it follows that NBF implementation could
affect some sectors of society more than others. For this reason, care will be taken this project to be
inclusive, egalitarian, and transparent, and above all, to provide the means to empower interested
parties, irrespective of race, gender and creed, to get involved in biosafety issues. By establishing
mechanisms to enable public access to information, consultations and exchanges, and by building
socio-economic and cultural considerations into biosafety decision making, the social impacts of
implementing the NBF, and thence this project, should be reduced.
157. From the perspective of project operations, equal employment opportunities will be given to
men and women. Project activities and training will not discriminate against any particular group or
gender, while target groups such as youth or private companies will receive special attention in the
development of the communication strategy and awareness raising materials. The project will not
finance any activity that may have negative impact in the field.
158. No environmental impacts are foreseen from project operations since building environmental
safeguards together with the precautionary principle will be fundaments of the project. As the
Executing Agency of this project and also the Focal Point for the CBD, CPB and BCH, ANAM is
mandated to ensure that environmental safeguards are incorporated into the implementation of all of
its projects. Environmental impacts will constitute one of the key decision-making criteria when
assessing biosafety management options. Some such criteria have already been devised and include:
(i) Prohibiting the introduction in protected areas of LMO that may have adverse effects in
biodiversity, human health; (ii) Restricting the use of LMOs in threatened, critical or vulnerable
ecosystems and where endemic or endangered species exist.
46
SECTION 4: INSTITUTIONAL FRAMEWORK AND IMPLEMENTATION ARRANGEMENTS
159. National Executing Agency – The National Environmental Authority, ANAM, acting as the
“National Executing Agency” (NEA) will be the entity legally responsible for the executing the
Project. ANAM was designated as the NEA by the central Government after consultation with the
GEF and CPB Focal Points. Brief Terms of Reference (TOR) for the NEA are in Appendix 11. Its
role and responsibilities centre on the effective coordination of project activities, on keeping the
project on track towards achieving its objectives and expected results, on maintaining high fiduciary
standards and reporting to UNEP, and on ensuring that the project does not counterpoise or contravene
Government actions in biosafety or in other related matters, in any way. The NEA will be supported in
its role by the SENACYT, offering technical cooperation and advisory services in biotechnology R+D
and biosafety matters.
160. ANAM, through its Direction of Protected Areas and Wildlife (DAPVS), will set up a Biosafety
Unit supported technically and administratively by UNARGEN and with qualified human resources
responsible for guiding project actions, reviewing project products, keeping track of benchmark results
and giving long term continuity to the implementation of the CPB. Specific staff from the Biosafety
Unit /UNARGEN will therefore be appointed as national counterparts for the Project. In addition,
project execution will be supported by the following ANAM structures:
A. Project Administration Unit: The administration of Project funds will be in charge of the
Administrative Unit of the DAPVS since it counts with experience in handling international
funds from GEF, BIRF and WB, and with qualified staff that will be in charge of
administrating both GEF and counterpart funds allocated to the Project. The Administrative
Unit, in coordination with the Direction of Administration and Finances of ANAM, will open
an exclusive account at a local bank for depositing GEF funds. Expenses of the project will go
under pre and post activity control.
B. Financial Support and Coordination Units: Will be available from ANAM’s Office of
Environmental Planning and Policy, in charge of guiding and giving proof of cost share funds
of the Project (co-financing), and of regularly submitting budget execution reports in
coordination with the Administrative Unit.
C. Legal Advice: Will be available upon request for the revision of legal documents and
regulations emerging from this project.
161. National Project Coordinator - The execution, coordination and supervision of all aspects of
the Project will be carried out by a National Project Coordinator (NPC), working full time for the
NEA. The NPC will technically report to the Director of Protected Areas and Wild Life, and
politically to the General Administrator of ANAM, if needed. The NPC will also report to UNEP and
to the Biosafety Committee to which a wider range of stakeholders will be invited in order to function
as the project’s Coordinating (Steering) Committee until such a time as the NBTC is constituted. The
NPC will also liaise closely with the chair and members of the Committee and the NEA in order to
coordinate the work plan for the Project and ensure the quality of its outputs.
162. The NPC will work closely with the Administration Unit to process procurement and payment
requests, once approved by the DAPVS. While the NPC will lead, orient and coordinate all activities
carried out under the current project, all operative plans, budgets, reports, terms of reference and
contracts, as well as final documents presented by the NPC, must be approved by the DAPVS. The
NPC shall be responsible for project management and supervision, and will maintain a close working
relationship with UNEP. He/she will provide general oversight of project operations; will supervise
47
staff (consultants, administrative staff and assistants) contracted under the Project or appointed for the
execution of specific NBF components; and will be responsible for the presentation of all substantial,
administrative and financial Project reports to UNEP, including an annual inventory of nonexpendable equipments acquired with Project (GEF) resources, which will be subject to external
audits under the financial audits to be carried out annually to the project. The NPC shall also elaborate
budgets and reports relating to the national share costs, to be endorsed by the DAPVS and approved
by ANAM’s Office of Environmental Planning and Policy. The Terms of reference (TOR) for the
NPC are in Appendix (11).
163. The Project’s Coordinating (Steering) Committee will be formed directly from the Biosafety
Committee (formally baptized: National Committee for Information Exchange in Biosafety), which is
presided by the ANAM (as its Secretariat) and to which new Government representatives will be
added11, as well as the UNEP Task Manager. Representatives from the productive sectors, private
sector, NGOs and civil society organizations will be invited on a collaborative and consultative basis,
but will not be formal members of the Steering Committee. This Committee will act as an advisory
group that supports the implementation of the Project, will review technical aspects to be considered
in the development of the Project, will facilitate communication and coordination between entities,
and will be multi-disciplinary and include representatives of all government entities with mandates
pertinent to the CPB. The NEA has a clear mandate for establishing work sub-groups, and may do so
when necessary.
164. The Coordinating /Steering Committee will be object of at least 4 meetings per year, with
participation of the responsible staff of the NEA and the UNEP Task Manager. The progress reports to
be presented by the NPC will serve as a base for annual and quarterly meetings.
165. Government decision makers will also be involved in this project at times when political
considerations come into play, and as a means of keeping the highest authorities within the following
Competent Authorities abreast with national progress made in biosafety: ANAM, MIDA, MINSA,
AUPSA and ARAP. Competent Authorities will have power of decision over specific aspects of the
Project and will offer advice on a needs basis. These horizontal and vertical mechanisms will be
especially important for tackling the implementation of international, national and sectorial regulations
for biosafety in an integral and coordinated fashion.
166. A scheme showing the “chain of command" for the Project is provided in Appendix 10,
indicating who executes, who are the decision makers, who gives support, who reports to whom, and
who are the external collaborators.
11
Current members: Ministry of Agriculture, Ministry of Health, Ministry of Commerce and Industry, Panamanian Food
Safety Authority, Aquatic Resources Authority of Panama. Members to be invited: Panama Canal Authority and the
National Customs Authority
48
SECTION 5: STAKEHOLDER PARTICIPATION
167. The Project considers participation of different interest groups (stakeholders) to put into
operation a “Participation Plan” with the purpose of maintaining a space for facilitating the flow of upto-date information, and stimulating cooperation and alliances between the key interested actors, such
as SENACYT, MINSA, MIDA and ANAM, in addition to other institutional actors. This will occur
mostly through Committees, such as the National Committee for Information Exchange in Biosafety,
later to become the National Biosafety Technical Commission complemented by Sectorial
Committees, but also through meetings, workshops, forum, and the media, combining active and
passive forms of communication as well as formal and informal means.
168. Participation in this Project will be fostered with all sectors; entities that participate will
formally designate their representatives in different levels of participation (eg. political or technical,
permanent or ad hoc) and in different process required for achieving national goals and those of the
current Project. Sectors involved in biotechnology management at the regional level will also
participate, such as IICA and the private research sector, together with new interested parties and
some organizations that express an opposition to LMO.
169. As providers of information for biosafety and biodiversity, the academic and scientific sector
will be a key player in the implementation of the NBF, and will take on both facilitative and advisory
roles. Their involvement will also contribute to widen the impact and outreach of project activities, by
stimulating the participation of a more diverse public. For example, the involvement of Universities
will be paramount for reaching to students and budding biotechnologists.
170. Central to the dimension of stakeholder participation is this project’s coordination committee
that will be formed on the basis of existing groups, until such a time as the NBTC can take over. The
main participants will be the members of the National Committee for Information Exchange in
Biosafety, thus giving continuity to previous coordination efforts, while also constituting a means to
de-centralize biosafety management and ensure stakeholder buy-in. The intention is to share roles and
responsibilities amongst institutions in a way that will benefit the implementation of the NBF. The
diligent work of the project’s Committee will be paramount to Components 1 and 5, notwithstanding
the importance of its inputs and supervision for the successful completion of other Components.
171. The creation of the Sectorial Committees is contemplated as another way of providing
participatory platforms through which to integrate stakeholder groups into LMO management
processes, and will be important for Component 5. On the other hand, the Project will also seek to
bring non-public sectors closer to biosafety issues, by stimulating information exchange, access to
databases, and guaranteeing the continuity of BCH functions.
SECTION 6: MONITORING AND EVALUATION PLAN
172. The project will follow UNEP standard monitoring, reporting and evaluation processes and
procedures. Substantive and financial project reporting requirements are summarized in Appendix 8.
Reporting requirements and templates are an integral part of the UNEP legal instrument to be signed
by the executing agency and UNEP.
173. The project M&E plan is consistent with the GEF Monitoring and Evaluation policy. The
Project Results Framework presented in Appendix 4 includes “SMART” indicators for each expected
49
outcome as well as mid-term and end-of-project targets (see also Appendix 7). These indicators along
with the key deliverables and benchmarks, included in Appendix 6, will be the main tools for
assessing project implementation progress and whether project results are being achieved. The means
of verification and the costs associated with obtaining the information to track the indicators are
summarized in Appendix 7. Other M&E related costs are also presented in the Costed M&E Plan and
are fully integrated in the overall project budget.
174. The M&E plan will be reviewed and revised as necessary during the project inception workshop
to ensure project stakeholders understand their roles and responsibilities vis-à-vis project monitoring
and evaluation. Indicators and their means of verification may also be fine-tuned at the inception
workshop. Day-to-day project monitoring is the responsibility of the project management team but
other project partners will have responsibilities to collect specific information to track the indicators. It
is the responsibility of the National Project Coordinator to inform UNEP of any delays or difficulties
faced during implementation so that the appropriate support or corrective measures can be adopted in
a timely fashion.
175. An expanded Biosafety Committee (and later, the National Biosafety Technical Commission)
will function as the project’s Steering Committee, will receive periodic reports on progress and will
make recommendations to UNEP concerning the need to revise any aspects of the Results Framework
or the M&E plan. Project oversight to ensure that the project meets UNEP and GEF policies and
procedures is the responsibility to the Task Manager in UNEP-GEF. The Task Manager will also
review the quality of draft project outputs, provide feedback to the project partners, and establish peer
review procedures to ensure adequate quality of scientific and technical outputs and publications.
176. At the time of project approval, baseline data is partially available. Baseline data gaps will be
addressed during the first year of project implementation, and if needed, a plan for collecting the
necessary baseline data will be prepared following inception.
177. Project supervision will take an adaptive management approach. The UNEP Task Manager will
develop a project supervision plan at the inception of the project which will be communicated to the
project partners during the inception workshop. The emphasis of the Task Manager supervision will
be on outcome monitoring but without neglecting project financial management and implementation
monitoring. Progress vis-à-vis delivering the agreed project global environmental benefits will be
assessed with the Steering Committee at agreed intervals. Project risks and assumptions will be
regularly monitored both by project partners and UNEP. Risk assessment and rating is an integral part
of the Project Implementation Review (PIR). The quality of project monitoring and evaluation will
also be reviewed and rated as part of the PIR. Key financial parameters will be monitored quarterly to
ensure cost-effective use of financial resources.
178. A mid-term management review or evaluation will take place in September 2013, as indicated
in the project milestones, or at latest, two years after the date of the first expenditure. The review will
include all parameters recommended by the GEF Evaluation Office for terminal evaluations and will
verify information gathered through the GEF tracking tool, as relevant. The review will be carried out
using a participatory approach whereby parties that may benefit or be affected by the project will be
consulted. Such parties were identified during the stakeholder analysis (see section 2.5). The project
Steering Committee will participate in the mid-term review and develop a management response to the
evaluation recommendations along with an implementation plan. It is the responsibility of the UNEP
Task Manager to monitor whether the agreed recommendations are being implemented.
50
179. An independent terminal evaluation will take place at the end of project implementation. The
Evaluation and Oversight Unit (EOU) of UNEP will manage the terminal evaluation process. A
review of the quality of the evaluation report will be done by EOU and submitted along with the report
to the GEF Evaluation Office not later than 6 months after the completion of the evaluation. The
standard terms of reference for the terminal evaluation are included in Appendix 9. These will be
adjusted to the special needs of the project.
180. The GEF tracking tool for biosafety is attached as Appendix 15. It will be updated at mid-term
and at the end of the project and will be made available to the GEF Secretariat along with the project
PIR report. As mentioned above, the mid-term and terminal evaluation will verify the information of
the tracking tool. In addition, annual reviews will take place to derive lessons learned, revise the
annual budget and verify the project workplan.
SECTION 7: PROJECT FINANCING AND BUDGET
7.1.
Overall project budget
181. As shown below, the total project budget comes to US$ 1,954,927 which consists in US$
954,927 from the GEF and US$ 1,000,000 in co-finance. This budget will cover the execution of five
technical components, as well as project management costs, across a 4 year period.
GEF Financing
($) a
%
Project Components
1. Implementation of the biosafety legal and
institutional frameworks for complying with the CPB
and the CBD
2. Reinforcement of capacities for LMO risk assessment
and risk management
3. Creation of an integrated monitoring, inspection and
response system
4. Generation of national information on biosafety
5. Promotion of public awareness, education and public
participation in matters relating to biosafety
6. Project M&E
7. Project management
Total Project Costs
7.2.
Co-Financing
($) b
%
Total ($)
(a+ b)
172,180
51
166,960
49
339,140
254,480
61
164,060
39
418,540
157,180
46
186,060
54
343,240
72,880
133,107
36
49
129,760
138,160
64
51
202,640
271,267
69,100
96,000
954,927
69
34
31,280
183,720
1,000,000
31
66
100,380
279,720
1,954,927
Project co-financing
Institution
ANAM
Cash (US$)
In-Kind (US$)
Total: Cash + In-kind
170,000
307,700
477,700
SENACYT
5,000
82,400
87,400
MIDA
5,000
82,000
87,000
AUPSA
5,000
82,700
87,700
51
ARAP
5,000
82,700
87,700
INDICASAT
5,000
81,700
86,700
MINSA
5,000
80,800
85,800
200,000
800,000
1,000,000
Total
182. The co-financing of the Project totals US$ 1,000,000 and consists in 20% in cash and 80% in
kind contributions from the Government of Panama. The institutions involved are ANAM (as
Executing Agency), ARAP, AUPSA, INDICASAT, MIDA, MINSA and SENACYT.
7.3.
Project cost effectiveness
183. This Project builds on previous work by following on directly from the UNEP-GEF NBF
project and BCH project, whereby the bases for the current project’s goals were already set through
these initiatives. The chosen structure for the results framework and the national implementation
arrangements for the project respond directly to the main components defined under the prior UNEPGEF projects, to the scheme of the Cartagena Protocol and the key elements of the “Updated Action
Plan for Building Capacities for the Effective Implementation of the CPB” (agreed at COP/MOP-3), to
the experience already gained in executing this type of project in the past, and to the Biodiversity
Policy now in implementation.
184. ANAM, the CPB and BCH Focal Point will act as Executing Agency and main coordinating
entity, and will involve an array of relevant stakeholders in the Project for the consolidation of a
biosafety system and biosafety capacities, not only by creating new and reinforcing old coordination
mechanisms, but also by founding a collaborative relationship in favour of biosafety with the
academic sector. Thus, project design foresees both sustainability and integration factors, so that
biosafety is managed in a de-centralized way that complements the country’s biotechnology and bioprospecting needs, involving institutions who have direct responsibilities in biosafety, in generating
biodiversity information, and in forming scientific know-how, and through structures that allow access
to scientific expertise and technological capacity when these is not available in-house.
185. As explained, the project contemplates the distribution of responsibilities and leadership roles as
a means to empower institutions to take on tasks relating to the Cartagena Protocol and LMO
management, so that neither effectiveness nor sustained action rely exclusively on a single institution.
Another important contribution to the project's cost-effectiveness is the experience gained by the
National Committee for Information Exchange in Biosafety and by the National Executing Agency,
through prior UNEP-GEF capacity-building efforts, in relation to consensus-seeking for the approval
of regulatory proposals, the conduction of participatory and outreach processes, and the execution of
UNEP-GEF projects. This acquired knowledge will be of significant value to the current project.
52
APPENDICES
Appendix 1:
Budget by project components and UNEP budget lines
Appendix 2:
Co-financing by source and UNEP budget lines
Appendix 3:
Incremental cost analysis
Appendix 4:
Results Framework
Appendix 5:
Workplan and timetable
Appendix 6:
Key deliverables and benchmarks
Appendix 7:
Costed M&E plan
Appendix 8:
Summary of reporting requirements and responsibilities
Appendix 9:
Standard Terminal Evaluation TOR
Appendix 10: Decision-making flowchart and organizational chart
Appendix 11: Terms of Reference
Appendix 12: Co-financing commitment letters from project partners
Appendix 13: Endorsement letters of GEF National Focal Points
Appendix 14: Draft procurement plan
Appendix 15: GEF Tracking Tool (Biosafety)
53
Annex 1: Project Document
APPENDIX 1 - RECONCILIATION BETWEEN GEF ACTIVITY BASED BUDGET AND UNEP BUDGET LINE (GEF FUNDS ONLY US$)
Project title: Panama: Consolidation of national capacities for full implementation of the Cartagena Protocol on Biosafety in Panama
Project number: GEF ID 3631
Project executing partner: ANAM
Expenditure by project component/activity (provide description)
Project implementation period: 4 years
Sep-11
Add additional components/activities as required
From:
Sep-15
To:
M&E
PM
ANUBIS
Comp 6
Comp 2
Comp 3
Comp 4
Comp 5
Total
BL
UNEP Budget Line
Comp 1
Comp 7
10
PERSONNEL COMPONENT
1100
Project personnel
1101
96,000
96,000
1101 Project coordinator
1102
1102 Technical support
1199
Sub-total
0
0
0
0
0
0
96,000
96,000
1200
Consultants
1202
11,520
11,520
11,520
11,520
11,520
57,600
1201 Technical specialist
1202
93,000
93,000
1202 Consultants for Comp 1 (biosafety regulatory framework)
1202
57,000
57,000
1203 Consultants for Comp 2 (LMO risk assessment and risk
+(1201)
management)
1202
1204 Consultants for Comp 3 (inspection, monitoring and response
75,000
75,000
+(1201)
system)
1202
9,600
9,600
9,600
9,600
9,600
48,000
1205 Support consultant (Assistant)
1299
Sub-total
114,120
78,120
96,120
21,120
21,120
0
0
330,600
1300
Administrative Support
1301 Driver
0
1302 Financial administration
0
1399
Sub-total
0
0
0
0
0
0
0
0
1600
Travel on official business
1601
10,000
10,000
1601 Travel costs of participant and organizer participation in 4 training
workshops for risk evaluation and management of LMOs
1601
1602 Travel expenses for meetings and workshops on creation and
2,000
2,000
integration of the monitoring and response system
1601
4,100
4,100
1603 Travel expenses to cover outreach activities and networking
1601
4,000
4,000
1604 Travel expenses for coordination with other biosafety projects in the
region
1699
Sub-total
0
10,000
2,000
0
4,100
4,000
0
20,100
1999 Component total
114,120
88,120
98,120
21,120
25,220
4,000
96,000
446,700
20
30
SUB-CONTRACT COMPONENT
2100
Sub-contracts (MOUs/LOAs for cooperating UN agencies)
2101
2199
Sub-total
2200
Sub-contracts (MOUs/LOAs for supporting organizations)
2201
2299
Sub-total
2300
Sub-contracts (for commercial purposes)
2301 Facilitation of training workshops and work meetings
2302 Sub-contracting LMO analysis laboratory services
2303 Reproduction and printing of pamphlets, brochures and outreach
materials on LMOs
2304 Informative material development and design, including national BCH
website contents
2305 Design and production of campaigns to implement communication
strategy
2399
Sub-total
2999 Component total
TRAINING COMPONENT
3200
Group training
3201 Briefing workshops for update, review and presentation of the
biosafety regulatory framework
3202 Training on evaluation and management of LMO risks
3203 Training workshops on LMO detection, inspections and on
implementing an LMO monitoring and response system
3299
Sub-total
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2301
18,800
2301
26,000
18,800
25,000
26,000
2301
24,000
24,000
2301
25,000
2301
60,000
0
0
3201
18,800
18,800
25,000
25,000
50,000
50,000
60,000
60,000
60,000
0
0
0
0
17,000
3201
17,000
130,000
3201
130,000
17,000
17,000
17,000
153,800
153,800
130,000
17,000
0
0
0
0
164,000
Annex 1: Project Document
Sep-15
To:
UNEP Budget Line
3300
Meetings/Conferences
3301 Work meetings for update, review and presentation of regulatory
framework, and for resolving CPB notifications
3302 Work meetings on methodologies for risk assessment and risk
management for LMOs, and for self-assessment
3303 Coordination and work meetings on LMO monitoring (detection,
inspections, accidental releases, etc)
3304 Coordination meetings for gap analyses, adopting proposals, setting
positions, CPB reporting, and deriving lessons learnt
3305 Dissemination seminars on biosafety
3306 Debate forums on LMOs, CPB, and other key biosafety issues (part
of communication strategy)
3307 Youth event, diplomatic gathering
3308 High-level meetings for networking and seeking agreements and
alliances
3309 Inception Workshop
3310 Meetings of the Sectoral Committees
3311 Meetings of the National Biosafety (Technical) Commission and
invitees, and of Commission members for other project meetings and
as Steering Committee
ANUBIS
BL
3301
50
3301
99
GRAND TOTAL
Comp 4
7,300
7,300
5,000
5,000
3301
3,500
8,700
12,027
8,700
12,027
5,500
3,200
5,500
6,700
3301
3301
5101
4101
3,000
10,000
14,800
8,000
3,000
6,100
15,800
145,800
15,300
32,300
0
0
32,427
32,427
9,100
9,100
0
0
108,927
272,927
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
360
400
760
360
400
760
360
400
760
360
400
760
360
400
760
0
1,800
2,000
3,800
0
10,000
6,000
1,000
1,000
1,000
1,000
1,000
1,000
1,000
1,000
1,000
1,000
16,000
0
10,000
6,000
5,000
21,000
3,000
3,000
0
0
0
0
0
0
3,000
3,000
0
0
0
0
13,700
13,700
0
0
13,700
13,700
0
0
14,000
12,000
14,000
40,000
81,500
96,000
954,927
5201
5301
3,000
10,000
31,900
36,300
53,300
5201
5201
Total
15,800
3301
3301
PM
Comp 7
15,800
3301
3301
M&E
Comp 6
Comp 5
3,000
3301
EQUIPMENT AND PREMISES COMPONENT
4100
Expendable equipment
4101
4199
Sub-total
4200
Non-expendable equipment
4201
4299
Sub-total
4300
Premises
4301 Cost of renting or maintenance of an office
4399
Sub-total
4999 Component total
MISCELLANEOUS COMPONENT
5100
Operation and maintenance of equipment
5101 Photocopier maintenance
5102 Materials for equipment
5199
Sub-total
5200
Reporting costs
5201 Targeted surveys
5202 Printing of reports (technical and financial)
5203 Print other reports
5299
Sub-total
5300
Sundry
5301 Communications
5399
Sub-total
5400
Hospitality and entertainment
5401 Cash prizes for knowledge contests
5499
Sub-total
5500
Evaluation
5501 Account auditing
5502 Mid terminal evaluation
5503 Terminal evaluation
5599
Sub-total
5999 Component total
Comp 3
3,000
3301
3399
Sub-total
3999 Component total
40
Comp 2
Comp 1
5302
5202
0
4,760
0
1,760
0
1,760
0
1,760
0
15,460
14,000
12,000
14,000
40,000
56,000
172,180
254,480
157,180
72,880
133,107
69,100
5303
5303
APPENDIX 2 - RECONCILIATION BETWEEN GEF BUDGET AND CO-FINANCE BUDGET
Project title: Panama: Consolidation of national capacities for full implementation of the Cartagena Protocol on Biosafety in Panama
Project number:
Project executing partner: ANAM
Project implementation period: 4 years
Expenditure by project component/activity (provide description)
1-Sep-11
Add additional components/activities as required
From:
1-Sep-15
M&E
PM
To:
UNEP Budget Line
Comp 1
Comp 2
Comp 3
Comp 4
Comp 5
Comp 6
Comp 7
Total
10
PERSONNEL COMPONENT
1100
Project personnel
1101 Project coordinator
0
1102 Technical support
11,200
11,200
11,200
11,200
11,200
56,000
1199
1200
1201
1202
Sub-total
Consultants
Technical specialist
Consultants for Comp 1 (biosafety regulatory framework)
11,200
11,200
11,200
11,200
11,200
0
0
26,000
1203 Consultants for Comp 2 (LMO risk assessment and risk management)
26,000
26,000
1204 Consultants for Comp 3 (inspection, monitoring and response system)
26,000
26,000
26,000
1205 Support consultant (Assistant)
1299
1300
1301
1302
1303
1304
Sub-total
Administrative Support
Office cost
Secretary
Driver
Financial administration
1399
Sub-total
1600
Travel on official business
1601 Travel costs of participant and organizer participation in 4 training
workshops for risk evaluation and management of LMOs
0
26,000
26,000
26,000
0
0
0
0
78,000
4,800
4,800
4,800
4,800
4,800
6,680
6,000
6,000
6,000
6,000
6,000
4,000
26,720
32,500
20,000
20,000
57,400
32,500
54,000
20,000
10,800
10,800
10,800
10,800
10,800
10,680
99,220
163,900
20,600
1602 Travel expenses for meetings and workshops on creation and
integration of the monitoring and response system
1603 Travel expenses to cover outreach activities and networking
1999
20
2999
30
1604 Travel expenses for coordination with other biosafety projects in the
region
1699
Sub-total
Component total
20,600
20,600
20,600
20,800
20,800
3,000
3,000
0
48,000
20,600
68,600
20,600
68,600
0
22,000
20,800
42,800
3,000
13,680
0
99,220
65,000
362,900
2199
Sub-total
2200
Sub-contracts (for supporting organizations)
2201
0
0
0
0
0
0
0
0
2299
2300
2301
2302
2303
0
0
0
0
0
0
0
0
SUB-CONTRACT COMPONENT
2100
Sub-contracts (for cooperating UN agencies)
2101
Sub-total
Sub-contracts (for commercial purposes)
Facilitation of training workshops and work meetings
Sub-contracting LMO analysis laboratory services
Reproduction and printing of pamphlets, brochures and outreach
materials on GMOs
2304 Informative material development design and production
2305 Design and production of campaigns to implement communication
strategy
2399
Sub-total
Component total
TRAINING COMPONENT
3200
Group training
3201 Briefing workshops for update, review and presentation of the biosafety
regulatory framework
3202 Training on evaluation and management of LMO risks
3203 Training workshops on LMO detection, inspections and on
implementing an LMO monitoring and response system
3299
Sub-total
3300
Meetings/Conferences
3301 Work meetings for update, review and presentation of regulatory
framework, and for resolving CPB notifications
3302 Work meetings on methodologies for risk assessment and risk
management for LMOs, and for self-assessment
3303 Coordination and work meetings on LMO monitoring (detection,
inspections, border control, accidental releases, etc)
3304 Coordination meetings for gap analyses, adopting proposals, setting
positions, CPB reporting, and deriving best practices
3305 Dissemination seminars on biosafety
3306 Debate forums on LMOs, CPB, and other key biosafety issues (part of
communication strategy)
3307 Youth event, diplomatic gathering
3308 High-level meetings for networking and seeking agreements and
alliances
3309 Inception Workshop
3310 Meetings of the Sectoral Committees
3311 Meetings of the National Biosafety (Technical) Commission and
invitees, and of Commission members for other project meetings
3999
56,000
3399
Sub-total
Component total
40,000
40,000
50,000
75,300
50,000
75,300
28,000
28,000
27,250
27,250
0
0
40,000
40,000
50,000
50,000
103,300
103,300
27,250
27,250
0
0
0
0
38,000
38,000
32,000
32,000
30,000
30,000
38,000
32,000
30,000
0
0
0
0
7,500
100,000
7,500
19,000
19,000
19,000
19,000
16,500
16,500
3,000
9,500
9,500
9,500
9,500
35,000
35,000
3,500
6,500
5,700
12,500
30,000
69,500
107,500
220,550
220,550
14,000
19,000
51,000
33,000
63,000
5,700
12,500
50,150
6,150
0
0
63,650
63,650
5,700
5,700
0
0
190,850
290,850
40
EQUIPMENT AND PREMISES COMPONENT
4100
Expendable equipment
4101 Office supplies
4102 Computer programs
4199
Sub-total
4200
Non-expendable equipment
4201
4299
4300
4301
4302
4999
50
Sub-total
Premises
Setting up facilities
Cost of renting or maintenance of an office
2,000
2,000
2,000
2,000
2,000
2,000
2,000
2,000
2,000
2,000
0
0
0
0
0
14,000
10,000
24,000
10,000
0
24,000
34,000
0
0
0
2,500
4,500
20,000
7,000
20,000
2,500
2,500
24,500
48,500
27,000
61,000
9,000
9,000
9,000
15,000
0
18,000
24,000
2,400
5,000
7,400
6,300
5,000
13,700
0
4399
Sub-total
Component total
0
2,000
0
2,000
0
2,000
0
2,000
0
2,000
MISCELLANEOUS COMPONENT
5100
Operation and maintenance of equipment
5101 Photocopier maintenance
5102 Materials for equipment
1,200
1,200
1,200
1,200
1,200
1,200
1,200
1,200
1,200
1,200
1,260
1,260
1,260
1,260
1,260
1,260
1,260
1,260
1,260
1,260
2,400
13,000
20,000
7,000
0
0
0
0
0
13,000
20,000
0
0
0
0
0
0
0
0
5199
5200
5201
5202
5203
Sub-total
Reporting costs
Targeted surveys
Printing of reports (technical and financial)
Print other reports
5299
Sub-total
5300
Sundry
5301 Communications
5399
Sub-total
5400
Hospitality and entertainment
5401 Cash prizes for knowledge contests
5499
5500
5501
5502
5503
Sub-total
Evaluation
Account auditing
Mid terminal evaluation
Terminal evaluation
5999
5599
Sub-total
Component total
99
GRAND TOTAL
7,000
0
2,500
2,000
2,500
2,500
2,000
2,500
0
9,460
0
2,460
0
2,460
0
2,460
0
2,460
7,000
9,400
0
36,000
7,000
64,700
166,960
164,060
186,060
129,760
138,160
31,280
183,720
1,000,000
APPENDICES
Appendix 3: Incremental cost analysis
Cost Categories
Required
investment US$
National
Benefits
Global
Benefits
Current
investments US$
% of
req
Component 1. Implementation of the biosafety legal and institutional frameworks for complying
with the Cartagena Protocol and the CBD.
Base line
250,000
x
x
166,960
67%
Alternative
500,000
x
339,140
Increase
250,000
x
172,180
69%
Component 2. Reinforcement of capacities for LMO risk assessment and risk management
Base line
350,000
x
164,060
47%
Alternative
800,000
x
x
418,540
Increase
450,000
x
x
254,480
57%
Component 3. Creation of an integrated monitoring, inspection and response system
Base line
300,000
x
x
186,060
62%
Alternative
600,000
x
x
343,240
Increase
300,000
x
x
157,180
52%
Component 4. Generation of national information on biosafety
Base line
200,000
x
x
129,760
65%
Alternative
350,000
x
x
202,640
Increase
150,000
x
x
72,880
49%
Component 5. Promotion of public awareness, education and public participation in matters
relating to biosafety
Base line
200,000
x
x
138,160
69%
Alternative
350,000
x
x
271,267
Increase
150,000
x
x
133,107
89%
Total
Base line
1,300,000
1,000,000
77%
Alternative
2,600,000
1,954,927
Increase
1,300,000
954,927
73%
The incremental costs are calculated as the difference between the estimated cost of the required
Baseline investment and the optimal GEF Alternative for maximum benefits, and are then
compared to the current investments being made.
1
Appendix 4: Results Framework
Objectives /
Outcomes
Indicators
Baseline
Mid-term Target
End-of-project Target
Source of Verification
Assumptions
Component 1. Implementation of the biosafety legal and institutional frameworks for complying with the Cartagena Protocol and the CBD
Component
Objective:
To implement the
biosafety legal and
institutional
frameworks for
complying with the
Cartagena Protocol
and the CBD
 Competent Authorities
are able to perform drills to
reach "mock decisions" for
LMOs intended for use in
agriculture, health and the
environment.
 The country reports
progress in CPB
implementation in its Third
National Report
 At least one drill (mock
 Decision taken so far
decision-making process)
have been ad hoc, even
has been performed
impromptu, and without
solid legal backing and
coordination
 The country has presented
the First National Reports to
the CPB in June 2010; the
Second National Report is
due by Sept 2011.
OUTCOME 1.1
Legal framework is
completed and
implemented, and
areas requiring
institutional
strengthening are
identified and
addressed
1.1 (a) The legal framework
for biosafety includes:
- Environmental, Phytoand Zoo-sanitary Technical
Norms (or Standards)
covering confined use of
LMOs, release into the
environment, and
production with LMOs
- A mechanism for review
of decisions, as per Article
12 of the CPB
- Proposal for dealing with
eventual cases of
environmental damage
- Proposal for LMOs in
transit.
 CPB ratification was
made effective by means of
Law Nº 72 of 2001 and the
NBC was created through
Law Nº 48 of 2002
 NBC has not functioned
well since its creation
 Panama has designated 5
main competent authorities
for biosafety: ANAM,
MIDA, MINSA, ARAP
and AUPSA.
 Diagnoses exist on the
gaps in the legal framework
and institutional capacities
 Confined use, release into
the environment, and
liability and redress are
regulated by sector and only
broadly (e.g. under laws,
decrees and resolutions), so
greater specificity is still
required.
 There is no mechanism
for review of decisions.
 The judicial organ has
only basic knowledge of the
implementation of
environmental standards,
and is in need of new
1.1 (b) The biosafety
decision-making body has
legal backing and is
functioning
1.1 (c) Mock-decisions
(drills) lead to capacity gaps
being reviewed and a
Government plan of action
(with responsibilities and
goals assigned) being put
into effect to address them.
 Specific regulations are
in the process of being
developed
 Administrative
procedures for requesting
LMO authorizations are
clearly laid out in
instrument(s) of law.
 At least 5 environmental
prosecutors / judicial
officers have been trained
 Capacity gaps have been
updated and reviewed,
based on the Second
National Report to the CPB
 Three "mock decisions"
for LMOs intended for use
in agriculture, health and
environment have been
taken by the end of the
project
 There is a significant
improvement in the
responses provided to the
third National Report to the
CPB, in comparison to the
first report.
 Dossiers, institutional
correspondence and decision
documents related to 3 drills
and "mock decisions" on
LMOs.
 Terminal Evaluator’s
judgment with respect to
improvement in responses
provided in National Reports
 Environmental, Phytoand Zoo-sanitary Technical
Norms (or Standards) are
ready by project year 3, and
cover confined use, release
into the environment, and
production with LMOs
 Proposal for dealing with
environmental damage in
cases with LMOs is
approved
 Voluntary declaration is
made possible for LMOs in
transit
 A legal mechanism for
review of decisions exists, as
per Article 12 of the CPB
 Decision-making body
has legal backing, is
functioning and has
experience in resolving
LMO applications
 Three "mock decisions"
for LMOs intended for use
in agriculture, health and
environment have been
taken by the end of the
project.
 An Action Plan to address
capacity gaps is being
 Drafts and reviews of
proposed regulations
 Resolutions of approval
and/or publications in
Official Gazette
 Official notification of
receipt
 Screening regulatory texts
(once official) for clauses
covering review of decisions
 Workshop materials and
minutes
 Meeting minutes of
National and Sectoral
Committees at least 3 times a
year and with quorum
 Third National Report to
the CPB
 Institutional documents
(drafts and approved) for
proposed procedures and
measures
 The technical
and commercial
documentation
required (LMO
dossiers) can be
compiled as
planned and at
reasonable cost.
 The 3rd
National
Report(s) will be
submitted to the
CPB before
project closure
 The correct
enabling
conditions will
prevail: Political
will; effective
inter-agency
coordination; and
sufficient
financial support
2
information on LMOs and
biosafety.
OUTCOME 1.2
Panama's
compliance with the
Cartagena Protocol,
including
participation in the
BCH, is
coordinated, visible
and integrated
within competent
authorities
1.2 (a) A national position
for COP/MOP-6 results
from inter-institutional
coordination
1.2 (b) Coordinated
decision-making in
biosafety follows on from
technical evaluations and
includes public participation
1.2 (c) Flow of official
information leads to new
and more information for
Panama on the BCH Central
Portal
 On the BCH Central
Portal Panama only has
information on contacts and
national competent
authorities
 Public participation has
not occurred so far in
biosafety decision making
 Panama submitted its
First National Report to the
CPB in June 2010, and
participated at COP/MOP-5
in October 2010.
implemented by at least 2
institutions
 New information
categories are filled on the
BCH Central Portal
 Panama prepares a
national position based on
multi-sectoral inputs prior
to COP/MOP-6 (Oct 2012)
 Results of public
participation that took place
as part of LMO decisionmaking processes are posted
on the biosafety Web site
 Three “mock decisions”
for LMOs are taken with the
participation of all relevant
competent authorities (see
above)
 Third National Report to
the CPB
 BCH Central Portal
 Preparatory documents for
COP/MOP-6 and Panama’s
attendance records
 Regular screening of
contents of Web site for
posting of outcomes of public
participation processes
 1.2 (b) assumes
that at least 1 new
LMO
authorization will
be granted in the
lifetime of the
project.
Component 1: OUTPUTS
1.1.1. Specific regulations for confined use, environmental release and production with LMOs, as well as procedures for dealing with cases of liability and redress, review of decisions, and
LMOs in transit
1.1.2. Agreed administrative processes between competent authorities with accompanying manuals
1.1.3. Environmental Prosecution Offices and Judicial Officers instructed on biosafety
1.1.4. Mock decisions for different LMO types with accompanying assessment of gaps and needs (eg. capacity gaps /training needs, procedural constraints, registry/information needs, etc) and
Action Plan to address them
1.2.1. Functional structures and annual work plans for inter-institutional coordination
1.2.2. Updated biosafety information posted on the BCH to comply with Art. 20 (BCH) and Art. 23 (Public Awareness and Participation)
1.2.3. Timely and coordinated responses to notifications and requirements from CPB Secretariat
Objectives /
Outcomes
Indicators
Baseline
Mid-term Target
End-of-project Target
Source of Verification
Assumptions
 Peer-reviewed risk
assessment protocols are
adopted for use by 5
competent authorities, in
line with their areas of
competence
 Biosafety measures are
accepted by at least 3 LMO
users who have been
granted authorization
 Institutional
correspondence showing
contacts with peer reviewers
 Peer reviewers’ comments
to draft protocols
 LMO authorizing
Resolutions include risk
management measures and
acceptance clause signed by
applicant
 Experts are
available to peer
review the draft
protocols within
the time required
 A minimum of
3 new LMO
authorizations
will be granted
in the lifetime of
the project
Component 2: Reinforcement of capacities for LMO risk assessment and risk management
Component
Objective:
To apply risk
assessment
protocols and risk
management
measures that are
consistent with
international stateof-the-art practices
 Protocols to be used for
risk assessment have been
peer reviewed by experts
and scientists.
 Biosafety measures (for
risk management) are an
integral part of LMO
authorizations
 There are no risk
assessment protocols
available covering all LMO
types of the CPB
 Risk management and
biosafety measures have
been applied in an ad hoc
manner, without a systemic
outlook or strategy
 Examples of risk
assessment protocols
developed and used by
other countries have been
studied
 Potential peer reviewers
have been identified and
contacted
3
OUTCOME 2.
Institutional
capacity to
evaluate and
manage LMOs in
different activities
is increased
2. (a) Designated
competent authorities
(ANAM, MIDA, AUPSA,
ARAP and MINSA) have:
(i) structures in place, (ii)
trained staff, and (iii)
methodologies, that enable
balanced and technicallysound biosafety evaluations
and decisions to occur
2. (b) Evaluations and
feedback take place for
improved management of
the biosafety system
 Panama has designated 5
main competent authorities
for biosafety
 Competent authorities
such as the MIDA and
MINSA have internal
groups for biosafety, and
ANAM has created a
Genetic Resources Unit
which covers biosafety.
 There are no formal
advisory structures at
present
 There is concern that
biosafety should link to the
protection of native genetic
resources and consider
social factors
 There are lists available
of native species and
sensitive crops
 No systemic tracking
takes place with regards to
authorized LMOs
 A preliminary proposal
exists for a Training
Programme in Biosafety
 The creation of 5
specialized Biosafety Units
within competent authorities
has been agreed to.
 Entities, experts or
scientists able and willing
to provide advisory
services to competent
authorities have been
identified and contacted.
 At least 3 professionals
from each competent
authority (5) have been
trained
 At least 4 competent
authorities have signed
agreements on the
methodologies and criteria
to be used for considering
social factors, agricultural
species, and native species
in biosafety decisionmaking
 Status of granted LMO
authorizations systematized
and management
improvements
recommended
 The creation of 5
specialized Biosafety Units
within competent authorities
is officialized by Resolution
by project year 3.
 At least 3 contracts
/MOUs have been signed
with entities, experts or
scientists for advisory
services to competent
authorities
 Status of granted LMO
authorizations is evaluated,
and adoption of prior
recommendations is verified
 Sensitive crops or
biodiversity zoning maps
 Trained professional and
created unit
 Institutional memos for
designation of staff
 Resolutions creating of
Biosafety Units
 Signed MOUs and/or
contracts
 Training invitation, agenda,
materials and attendee lists
 Documents with
conclusions and
recommendations on
managing status of LMO
authorizations
 There is
sufficient data
(quality and
quantity) to
agree on and
prepare the
required tools.
 The time
required to
officialize new
Units is less than
the duration of
the project.
End-of-project Target
Source of Verification
Assumptions
 Compliance with biosafety
measures has been verified
for 100% of LMO
authorizations granted in
the life of the project, or
prior to project start.
 100% of detected
infringements have either
been penalized or initiated
proceedings
 Monitoring plans that
establish modus operandi for
field visits, including
inspection protocols
 Notifications of field visit
/inspection to listed
authorized LMO users
 Inspection reports
highlighting compliance or
infringement
 A reasonable
time has elapsed
between
authorization
being granted
and inspection
taking place
 There are no
set-backs to
attaining all
Component 2: OUTPUTS
2.1. Technical staff designated and trained to handle LMO cases, information and applications
2.2. Risk assessment protocols and decision-making criteria for different activities using LMOs.
2.3. Legal agreements (contracts or MOUs) for advisory services to competent authorities
2.4. Self-assessment for improved management
Objectives /
Outcomes
Indicators
Baseline
Mid-term Target
Component 3. Creation of an integrated monitoring, inspection and response system
Component
Objective:
To ensure
monitoring of and
compliance with
biosafety measures
established for
authorized LMOs
 Compliance with the
biosafety measures specified
in each LMO authorizing
Resolution is verified
through monitoring visits
and inspections, and
sanctions applied if
necessary
 Improved score on GEF
Tracking Tool Question N°5
 Only authorizations for
confined use have been
granted (at Nov 2010);
there is nonetheless
experience in determining
biosafety measures.
 Inspections or monitoring
visits have not yet been
carried out.
 At the time of CEO
 Authorized LMO users
that will undergo
monitoring visits and
inspections have been
identified and notified; and
visits have initiated
4
relating to surveillance
mechanisms: Does an
operational follow-up and
monitoring system exist?
OUTCOME 3.
Competent
authorities have
increased capacity
to track authorized
LMOs, enforce
regulations and
respond to
accidental releases
3. (a) Compliance with
biosafety measures has been
verified for at least 80% of
LMO authorizations
granted, with administrative
procedures applied in cases
of infringement
3. (b) Customs proceedings
for LMOs have been
agreed to
3. (c) At least 1 plan of
action has been adopted in
response to an accidental
LMO release
Approval Request, baseline
score for Question N°5:
Follow-up and Monitoring
= 0 (No system for followup and monitoring exists)
 Only research with LMOs
under confined use has been
authorized so far (at Nov
2010).
 There is some experience
in competent authorities in
determining biosafety
measures.
 Inspections or monitoring
visits for authorized LMOs
have not yet taken place.
 Accidental LMO releases
have occurred, in the
absence of a response
system
 Technical, technological
and analytical capacities
needed for an integrated
monitoring system have
been diagnosed.
 Administrative and if
possible judicial capacity
gaps for ensuring
regulatory compliance
have been diagnosed.
3. (d) LMO analyses can be
carried out “in house”.
 Score for Tracking Tool
Question N°5 has reached at
least 2 = Compliance
mechanisms for Risk
Management established
 Compliance with
biosafety measures has been
verified for at least 80% of
LMO authorizations granted
in the life of the project, or
prior to project start.
 LMO analyses have been
carried out to test detection
technology and techniques
 At least 80% of detected
infringements have either
been penalized or initiated
administrative proceedings
 At least 1 plan of action
has been adopted in
response to an accidental
LMO release
 Customs proceedings for
LMOs have been agreed to
 Review of GEF Tracking
Tool progress as part of
Terminal Evaluation
outputs and
targets
 Technical documents
analyzing capacity gaps and
needs
 Monitoring plans that
establish calender for field
visits
 Notifications of field visit
/inspection to listed
authorized LMO users
 Test results from LMO
analyses, obtained from a
laboratory
 Inspection reports
(highlighting compliance or
infringement) and summary
reports
 Drafted and circulated
plan(s) of action for cases of
accidental release
 Meeting minutes and
working documents for
customs office
 A minimum of
1 new LMO
authorization
will be granted
in the lifetime of
the project.
 3.(a) assumes
that infringement
may be detected
and then
processed within
the period of the
project.
Source of Verification
Assumptions
Component 3: OUTPUTS
3.1. Initial diagnosis and analysis of specific LMO monitoring capacity gaps and needs
3.2. Institutional mechanisms and budgets for LMO inspection, tracking and monitoring.
3.3. Draft instruments for responding to accidental or illegal LMO releases
3.4. Trained personnel and demonstrated analytical capacity for LMO detection and monitoring.
Objectives /
Outcomes
Indicators
Baseline
Mid-term Target
End-of-project Target
N/A
Review of GEF Tracking Tool
Score for Tracking Tool
progress as part of Terminal
Question N°6 has reached
Evaluation
at least 2 = Information on
LMOs generally available in
at least one national
language and is kept
updated
Component 4. Generation of national information on biosafety
Component
Objective:
To enable Panama
to comply with
information-related
Articles of the CPB
Improved score on GEF
Tracking Tool Question N°6
relating to biosafety
information and public
awareness: Is information
on LMOs made available to
public?
At the time of CEO
Approval Request, baseline
score for Question N°6:
Awareness = 0 (Little or no
official information on
LMOs available to the
general public)
There are no setbacks to
attaining all
outputs and
targets
5
OUTCOME 4.
Information
management for
LMOs provides
regulatory bodies
and stakeholders
access to the latest
information on
biosafety
4.(a) A measurable increase
in the public’s use of the
biosafety Web site
4.(b) A National Registry
of LMO Applications is
created and functioning
4.(c) An increased number
of records are available on
the national BCH, all of
which lack confidential
commercial information
 Some key information
has begun to be compiled,
for instance: diagnosis on
the trade of transgenic
products in Panama, and
preliminary databases listing
national experts in fields
related to biotechnology and
biosafety, and detailing
relevant outputs of the
national diagnoses
 The current biosafety
site is the national BCH,
which lacks a project
section and hits /downloads
counters, but has interoperability with the BCH
Central Portal
 The number of records
available on the national
BCH at the time of project
start (inception workshop)
needs to be counted.
 There is a legal
framework for the
protection of intellectual
property and confidential
information
 Questions can be posted
via an easy-access
Questions-and-Answers
(Q&A) feature on the
national BCH Web site
 The National Registry of
LMO Applications is
created and is being testrun by a designated
institution
 At least a 25% increase
in the number of records
(stripped of confidential
data) available on the
national BCH, as
compared to project start
(inception workshop).
 A 20% increase is
measured in the monthly
rate of hits and downloads
from the biosafety Web site,
as compared to mid-term
 The National Registry of
LMO Applications has been
updated.
 At least a 50% increase in
the number of records
(stripped of confidential
data) available on the
national BCH, as compared
to project start (inception
workshop).
 Active and populated Q&A
feature of Web site
 Regular readings of hits and
downloads counters, starting at
project mid-term
 Regular tracking of
uploaded records, since project
start (inception workshop)
 Electronic and printed
versions of records uploaded
onto national BCH, noting
withdrawal of confidential
commercial data, where
relevant
 Data base files for National
Registry of LMO Applications
End-of-project Target
Source of Verification
Assumptions
 Meeting minutes and
institutional correspondence
with productive sector
representatives and academic
sector representatives
 Review of GEF Tracking
Tool progress as part of
Terminal Evaluation
There are no setbacks to
attaining all
outputs and
targets
Component 4: OUTPUTS
4.1. Internal tools for systematized and secure handling of LMO data
4.2. Official information on LMOs and of relevance to biosafety decision making, publically available
4.3. Dissemination materials and publications for outreach
Objectives /
Outcomes
Indicators
Baseline
Mid-term Target
Component 5: Promotion of public awareness, education and public participation in matters relating to biosafety
Component
Objective: To
increase general
knowledge on and
participation in
biosafety, in
specific groups
Improved scores on two
Tracking Tool Questions:
N°7 relating to education
(Has coursework and
training on biosafety been
integrated into higher
education?) and N° 8
relating to public
participation (Has the
public been engaged in
LMO decision-making?)
At the time of CEO
Approval Request, baseline
scores were: Question N°7:
Education = 1 (Basic
modern biotechnology and
biosafety information
included in the curricula at
technical and college
levels) and Question N°8:
Participation = 0 (Little or
no direct involvement of
Liaisons and work
methods have been
established with specific
groups to be targeted for
awareness raising
Scores have reached at least
2 for Tracking Tool
Questions N°7 (2=
Dedicated short-term
courses on biosafety
available for government
staff at technical schools
and higher education
institutions) and N°8 (2=
Mechanism for public
involvement in LMO
6
public in LMO decisionmaking)
OUTCOME 5.
Interest in biosafety
is stimulated and
the quality of the
biosafety debate is
elevated
5.1 (a) Awareness
concerning biotechnology,
biosafety and LMOs is
measurably increased in
specific groups
5.1 (b) A measurable
increase in the use of the
Questions-and-Answers
(Q&A) feature of the
biosafety Web site
5.1 (c) Opportunities are
created for specialization in
biosafety or biotechnology
 Capacity building
projects in biosafety have
been executed but with very
little civil society
participation and almost no
private sector participation
 The baseline number of
Q&As concerning biosafety
currently posted on the Web
site is zero
 The level of overall
knowledge /awareness of
biosafety is currently
unknown
 Training or specialization
courses for modern
biotechnology and biosafety
are only available abroad
decision-making
established)
 Target samples (of
producer and farmer
groups and of University
students from disciplines in
natural sciences,
economics and
environmental law) have
been selected
 The rate at which
questions are posted on the
Q&As feature of the
biosafety Web site has
increased 1.5-fold
 At least 2 cooperation
agreements have been
signed with academic
institutions or experts for
the formation and
specialization of
professionals, and for
supporting biosafety
outreach activities
 At least 20% more
knowledge is shown by a
sample of the private sector
(producers and farmers)
concerning biosafety
regulations
 At least 20% more
knowledge is shown by a
sample of University
students on the specific
benefits and risks of modern
biotechnology and its
products such as LMOs
 The rate at which
questions are posted on the
Q&As feature of the
biosafety Web site has
increased 2-fold, or
questions have become
notably more complex
 Questionnaire results from
sample of productive sector
representatives, before and
after sensitization activities.
 Questionnaire results from
sample of University students,
before and after sensitization
activities.
 Regular screening and
counting of contents of Q&A
section of Web site
 Institutional correspondence
concerning adoption and
purpose of cooperation
agreements
 Draft and signed versions
of cooperation agreements
 It is possible
to stimulate
learning and
interest in
biosafety in the
two selected
target groups.
Component 5: OUTPUTS
5.1. Annual Biosafety Dissemination (Outreach) Programme and its implementation
5.2. Alliances and partnerships for access to biosafety specialization courses, and for supporting biosafety dissemination /outreach activities
5.3. Incentives to raise awareness on biosafety and biotechnology, and tools that favor participation
7
Appendix 5: Workplan and timetable
1°
Responsi
ble party
Expected
Outcomes
Expected Outputs
GEF
Budget
ANUBIS
Activity
Timeline (annual trimesters of the project)
PY 2
PY 3
PY 4
PY 1
(expected: 2011/2012) (expected: 2012/2013) (expected: 2013/2014) (expected: 2014/2015)
Closure
6 months
1
2
3
4
5
6
7
8
9 10 11 16 13 14 15
16
Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3
Expected calender Q4 Q1 Q2 Q3
Q4 2015 +
Establishment of the project structures – Inception phase
ANAM
Orderly office
ANAM
Staff available to
work on the project
Recruitment of
National Project
Coordinator (NPC)
ANAM,
UNEP
ANAM
Orderly financial
management
ANAM,
UNEP
Clarity on
expectations and
goals of the project
and follow-up tasks
and mechanisms
ANAM has office and
equipment for the project
Appoint supervisor, and
administrative unit staff
NPC working full time for
the project
Project finance staff
appointed and account
operating
Inception workshop
Procurements and internal acquisitions
BL 4201
BL 1120
Finalize TORs, prepare contract,
announce vacancy, review applicants,
carry out interviews, select NPC and
formalize decision
Open project bank account
Set agenda, convoke, produce minutes
for 1-2 day workshop
BL 1101
BL 3301
$ 1,500
Component 1. Implementation of the biosafety legal and institutional frameworks for complying with the Cartagena Protocol and the CBD
NPC,
Competent
Authorities
NPC,
ANAM
1.1 Legal framework
is completed and
implemented, and
areas requiring
institutional
strengthening are
ANAM, identified and
Competent addressed
Authorities
ANAM,
Competent
Authorities
NPC.
ANAM
1.1.1. Specific regulations
for confined use,
environmental release and
production with LMOs, as
well as procedures for
dealing with cases of
liability and redress,
review of decisions, and
LMOs in transit
1.1.2. Agreed
administrative processes
between competent
authorities with
accompanying manuals
1.1.3. Environmental
Prosecution Offices and
Judicial Officers instructed
on biosafety
Consultancy on delivering new
regulatory framework
BL 1202
$ 15,000
6 work meetings for analysis and
discussion supported by above
consultancy
BL 3301
$ 3,000
Carry out 3 consultancies for obtaining
sectoral regulations /norms
BL 1202
$ 50,000
During and after assessment of border
control needs (see 3.1), coordinate with
Customs authorities, seek agreements,
and enable voluntary declarations for
transit of LMO goods
Analysis and discussion supported by
20 workshops, and by consultancies
above
Procedures formalized and developed
into user manuals and guidelines
Organize training and informative
workshops, and participation in
specific work meetings, for
environmental prosecution offices and
judicial officers. Supported by
consultancies above.
see
Comp 3
BL 3201
$ 10,000
BL 1202
$ 5,000
BL 3201
$ 7,000
8
NPC,
ANAM
Biosafety
Committee
1.1.4. Mock decisions for
different LMO types with
accompanying assessment
of gaps and needs (eg.
capacity gaps /training
needs, procedural
constraints,
registry/information needs,
etc) and Action Plan to
address them
Conceptualize drills, consult, obtain
LMO dossiers, seek coach(es), develop
budgeted proposal
Coached risk assessment conducted
and coordinated as part of mock
decision-making processes (drills)
BL 1202
$ 2,000
BL 5301
$ 1,000
BL 1202
$ 21,000
Meetings for feedback discussions and
for deriving best practices and
improvements to biosafety system
BL 3301
$ 1,000
(coord.)
High level meetings with authorities to
agree on optimizing management,
coordination and consultation
procedures for decision-making for
LMOs
Develop (and update) Action Plan in
line with project plans; use to guide
execution from PY3
ANAM
1.2.1. Functional structures NBC to be replaced by the National
NPC
and annual work plans for Biosafety Technical Commission
inter-institutional
(NBTC). Organize 48 meetings: Set
coordination
agenda, convoke, produce minutes
Sectoral Committees: Organize 20
meetings: Set agenda, convoke,
produce minutes
1.2 Panama's
ANAM
Prepare 4 Annual Plans for NBTC and
compliance with the
Sectoral Committees
Cartagena Protocol,
BCH-PA, including
1.2.2. Updated biosafety
Compile and clear publishable
Biosafety
information posted on the
information, create records, upload.
participation in the
Committee
BCH to comply with Art. 20 Links with BCH-II Global Project for
BCH, is
coordinated, visible (BCH) and Art. 23 (Public delivering BCH training to traditional
Awareness and
and integrated
and new stakeholder groups
Participation)
within competent
Windows for public participation in
authorities
LMO decision making created and
results uploaded onto website
ANAM
National Reports: coordinate working
1.2.3. Timely and
Biosafety
group (with competent authorities) and
coordinated responses to
Committee
prepare timely responses, obtain
notifications and
authority approval. Supported by
requirements from CPB
analysis of capacity gaps (1.1)
Secretariat
ANAM
National position for COP/MOP-6:
Biosafety
prepare with multi-sectoral inputs
Committee
Coordinate with Min. Foreign Affairs:
working groups, carry out
consultations, obtain authority
approval, disseminate, report back.
BL 3301
$ 1,000
Component 2. Reinforcement of capacities for LMO
Biosafety
Committee
2.1. Technical staff
designated and trained to
handle LMO cases,
information and
BL 5301
$1,000
BL 3301
$ 12,800
BL 3301
$ 8,000
See
Comp 4
BL 3301
$ 2,000
(coord.)
BL 3301
$ 2,000
(coord.)
BL 5301
$1,000
risk assessment and risk management
Define with NCAs structure of “core
unit” (specialized units) or equivalent
work structure. Lobby for formalization
in each Competent Authority
9
NPC,
ANAM,
applications
2. Institutional
capacity to evaluate
and manage LMOs
in different activities
is increased
NPC,
Biosafety
Committee
2.2. Risk assessment
protocols and decisionmaking criteria for
different activities using
LMOs.
NPC,
Biosafety
Committee
ANAM
2.3. Legal agreements
(contracts or MOUs) for
advisory services to
competent authorities
2.4. Self-assessment for
improved management
NPC,
Biosafety
Committee
BL 1201
Plan training workshops: Secure
$ 35,000
scholastic group (international and
national experts) and curricula, define
BL 1202
target group for trainings, obtain
S 2,000
nominations, screen, scope for resource
persons and institutions
BL 3201
Deliver 4 training workshops for risk
$ 130,000
assessments, decision-making, risk
communication and risk management
BL 1601
with LMOs, including a field trip to
$ 10,000
observe application of biosafety
measures in situ. Work with
BL 2301
international /national experts to carry
$ 7,500
out training, report and evaluate results.
BL 3301
Organize 16 work meetings to review
$ 12,800
risk assessment methodologies, and
discuss appropriate sectoral risk
BL 2301
management measures
$ 7,500
Reach agreements with Competent
Authorities on criteria to be used in
consideration of native species and
social factors, in decision making
processes
BL 1202
Carry out consultancy to obtain tools
that link sensitive crop areas and native $ 10,000
genetic resources to LMO assessments
and biosafety, with emphasis on a
zoning map identifying biodiversity
protection areas and distribution of
sensitive crops
Identify and contact entities, or experts
and scientists, able to provide advisory
services. Ensure signature of at least 5
agreements
Carry out work meetings and
consultancy to extract lessons learnt,
systematize status of LMO
authorizations granted, and review
biosafety methodologies used.
BL 1202
$ 10,000
BL 3301
$ 3,000
BL 2301
$ 3,800
Component 3. Creation of an integrated monitoring, inspection and response system
NPC,
ANAM,
NPC,
Competent
Authorities
NPC,
Biosafety
Committee
3. Competent
authorities have
increased capacity
to track authorized
LMOs, enforce
regulations and
respond to
accidental releases
3.1. Initial diagnosis and
analysis of specific LMO
monitoring capacity gaps
and needs
Set agenda for National Biosafety
(Technical) Commission and set up
working groups
BL 3301
$ 1,500
Consultancy for diagnosis of equipment BL 1202
S$ 5,000
needs and of analytical techniques
Assessment of border control needs for
LMO monitoring including evaluation
of shipping trade infrastructure,
procedures and regulations of relevance
to the CPB
BL 1202
$ 10,000
10
NPC,
ANAM,
3.2. Institutional
mechanisms and budgets
for LMO inspection,
tracking and monitoring.
NPC,
ANAM,
NPC,
Biosafety
Committee
NPC,
ANAM
NPC,
ANAM
NPC,
A NAM
NPC,
A NAM
3.3. Draft instruments for
responding to accidental or
illegal LMO releases
NPC,
Competent
Authorities
3.4. Trained personnel and
demonstrated analytical
capacity for LMO
detection and monitoring.
NPC,
ANAM,
NPC,
Biosafety
Committee
NPC,
Biosafety
Committee
Prepare /review monitoring plans
annually
Generate inspection protocols for
granted LMO authorizations
Confirm inspection timetable, compile
inspection reports for authorized LMOs
(eg. laboratory safety reports for LMOs
in confined use) and/or summary
reports from Competent Authorities.
BL 1202
Consultancy to design and articulate a
proposal for a biosafety monitoring and $ 23,000
response system. Consult, lobby, devise
finance sources, finalize design, and
follow to adoption.
BL 3301
Set up meetings of the National
$ 3,000
Biosafety (Technical) Commission and
working groups with experts and other
BL 1601
authorities invited
$ 1,000
Meetings with customs authorities and BL 3301
$ 7,300
border control officials to develop
biosafety proposals and ensure
signature of procedural agreements
Feasibility assessment and consultancy BL 1202
$ 10,000
for applying an auditors accreditation
scheme for monitoring and biosafety
auditing services
BL 3301
Set up meetings of the National
$ 1,500
Biosafety (Technical) Commission and
working groups to review criteria and
procedures for responding to accidental
or illegal LMO releases, and if
possible, prepare a draft action plan
Based on results of diagnosis (3.1)
ensure equipments and services for
LMO detection are in place and
functioning with standardized detection
protocols.
BL 2301
Subcontract detection services for
$25,000
verification of authorized or preapproved LMOs. Prepare reports of
detection tests
BL 1201
Plan training workshops: Secure
$ 12,000
scholastic group (international and
national experts) and materials, define
BL 1202
target group for training, obtain and
$15,000
screen nominations, secure supporting
resource persons and institutions.
BL 3201
Execute training and induction
$ 17,000
workshops: Train professionals for
LMO detection (use of analytic
equipments), monitoring and biosafety
inspections.
Component 4. Generation of national information on biosafety
11
4.1. Internal tools for
systematized and secure
handling of LMO data
NPC,
ANAM
NPC,
ANAM
NPC,
ANAM
4. Information
management for
LMOs provides
regulatory bodies
and stakeholders
access to the latest
information on
biosafety
NPC,
ANAM
NPC,
ANAM
NPC,
ANAM
Created and populate National
Registry of Authorizations; pilot the
data base and tracking system, and
ensure staff are assigned for sustained
use. Review performance and adjust.
Filing system for appropriate handling
of confidential information by
competent authorities. Agreements to
guarantee due diligence to private
sector.
4.2. Official information on Periodic updating, review and
LMOs and of relevance to
uploading of new records onto
biosafety decision making, National BCH
publically available
BL 2301
Create and populate searchable data
$ 8,000
base on national BCH website,
containing updated and explanatory
information on: LMOs authorized for
national use; national processes and
requirements for requesting LMO use;
native and agricultural species and
social factors of relevance to biosafety
decision making
BL 2301
Development of explanatory
$ 8,000
information on the processes and
requirements for LMO use in Panama
BL 2301
Technical studies and texts simplified
$ 8,000
for presenting data to the general
public; design for outreach via the web
and printed format
4.3. Dissemination
Design, reproduction and distribution BL 2301
materials and publications
of information materials, based on the $ 26,000
for outreach
above, and linked with dissemination
seminars (Comp 5)
Component 5. Promotion of public awareness, education and public participation in matters relating to biosafety
NPC,
ANAM
5. Interest in
biosafety is
stimulated and the
quality of the
biosafety debate is
elevated
5.1.1. Annual Biosafety
Dissemination (Outreach)
Programme and its
implementation
Set up meetings of the National
Biosafety (Technical) Commission and
working groups, and invite specialists,
to define Programme
Present Programme to authorities for
approval and budget-setting
Organize four debate forums (1 per
year) on LMOs, CPB, and other key
biosafety issues, targeted at different
sectors
Carry out campaigns for
implementation of communication
strategy, targeted at different sectors
NPC,
ANAM
5.1.2. Alliances and
partnerships for access to
biosafety specialization
courses, and for supporting
biosafety dissemination
Seek alliances and liaise with experts,
scientists, organizations and support
groups that can support biosafety
dissemination /outreach activities.
Ensure signing of agreements.
BL 3301
$ 2,000
BL 3301
$ 8,527
BL 2301
$ 50,000
BL 1601
$1,100
BL 1601
$ 1,000
12
/outreach activities
NPC,
ANAM
5.1.3. Incentives to raise
awareness on biosafety and
biotechnology
NPC,
ANAM
NPC,
ANAM,
Execute at least 5 biosafety
dissemination activities (eg. seminars)
on basis of above agreements
BL 3301
$ 5,200
Organize high-level encounters and
liaise with local and international
academic institutions. Ensure signing
of cooperation agreements
BL 3301
$ 1,200
Organize youth fair and diplomatic
event that include biosafety contests
Coordinate with IT Dept and above
partners to activate biosafety and
biotechnology Q&A section as a
feature on web sites.
Carry out knowledge questionnaires
with cash prizes with target groups
(eg. University students or productive
sector representatives) as part of
workshops and seminars. Organize
data collection method and timetable,
ensure human task force, carry out
survey, analyze results, and channel
cash prizes appropriately
BL 1601
$ 2,000
BL 3301
$ 3,500
BL 5201
$ 10,000
BL 5302
$ 13,700
Components 6 & 7. Project Management and M&E
NPC,
ANAM
NPC,
ANAM,
UNEP
UNEP,
ANAM
ANAM
UNEP,
ANAM
NPC,
ANAM
Project supervision
is multi-sectoral and
responsive to use
interests
Project backstopping and
ownership
Project progress and
accounting are
documented and
transparent
Timely, orderly and
favorable reports
Steering Committee meetings. Set
agenda, convoke, record minutes
($3100 for
set-up)
Prepare technical and financial reports
(Quarterly /Half-yearly), ensure
approval and submission to UNEP
PIRs
Financial audits
Independent
feedback on project
for adaptive
management
Project is closed
BL 3301
$ 4,100
Lessons learnt, opportunity
to share results, and
evaluation of project
impacts
Timely and orderly closure
process
External evaluations (mid-term and
project-end), measuring targets and
tracking tool
BL 5202
$ 14,000
BL 5303
$ 26,000
Ensure final project closing /terminal
documentation and submission to
UNEP
13
Appendix 6: Key deliverables and benchmarks
Component /Outputs
Significance
Timeline
1.1.1. Specific regulations for confined use,
environmental release and production with
LMOs
Important milestone for completing and
instrumentalizing regulatory framework.
End of PY3
1.2.1. Functional structures and annual work
plans for inter-institutional coordination
Having the National Biosafety Technical
Commission (NBTC) operational is an
important milestone for securing coordination
and “critical institutional mass”, and for
driving NBF implementation.
End of PY1
1.2.3. Timely and coordinated responses to
notifications and requirements from CPB
Secretariat
Having a national position for COP/MOP-6
prepared with multi-sectoral inputs is a visible
demonstration of internal order.
End of PY1
2.2. Risk assessment protocols and
decision-making criteria for different
activities using LMOs
End of project target is to have adopted
protocols for use by 5 competent authorities,
in line with their areas of competence.
End of PY4
2.4. Self-assessment for improved
management
Feedback process can initiate, once enough
experience has been acquired and evaluation
is possible. Lessons learnt can be derived
from systematizing status of LMO
authorizations granted and reviewing
biosafety methodologies used, amongst other
things.
End of PY4
3.2. Institutional mechanisms and budgets
for LMO inspection, tracking and
monitoring
Inspection reports for authorized LMOs (eg.
laboratory safety reports for LMOs in
confined use) provide evidence that inspection
capacity is in place, has been regularized and
is financially supported.
End of PY3
3.3. Draft instruments for responding to
accidental or illegal releases of LMOs
Developing protocols and procedures for
accidental and/or illegal releases of LMO is a
way of redressing a critical void.
End of PY3
3.4. Trained personnel and demonstrated
analytical capacity for LMO detection and
monitoring
The most critical capacity need (human
resources training) is being attended to.
End of PY3
4.2. Official information on LMOs and of
relevance to biosafety decision-making,
publically available
If the National BCH site is updated and
expanded, then it should be possible to attain a
target score of 2 for Tracking Tool Question
N°6 = Information on LMOs generally
available in at least one national language and
is kept updated.
Making available explanatory information on
the processes and requirements for LMO use
in Panama is important for regulations to be
understood and applied correctly.
End of PY2
and PY4
End of PY2
14
5.1. Annual Biosafety Dissemination
(Outreach) Programme and its
implementation
Outreach activities begin to take place under
an umbrella program, and can eventually be
sustained through State funding
End of PY1
5.2. Alliances and partnerships for access
to biosafety specialization courses, and for
supporting biosafety dissemination
/outreach activities
Providing opportunities and increasing access
to specialization in biosafety-related skills,
specifically for strengthening competent
authorities, is crucial for ongoing NBF
implementation
End of PY3
15
Appendix 7: Costed M&E plan
Results-Based Monitoring and Evaluation Framework
1. Monitoring Framework and Budget 1
Outcome
Indicator
Outcome 1.1
Legal framework
is completed and
implemented, and
areas requiring
institutional
strengthening are
identified and
addressed.
1.1 (a) The legal
framework for
biosafety includes:
- Environmental,
Phyto- and Zoosanitary Technical
Norms (or Standards)
covering confined use
of LMOs, release into
the environment, and
production with
LMOs
- A mechanism for
review of decisions,
as per Article 12 of
the CPB
- Proposal for dealing
with eventual cases of
environmental
damage
- Proposal for LMOs
in transit.
1
Baseline
Conditions
 CPB ratification
was made effective
by means of Law Nº
72 of 2001 and the
NBC was created
through Law Nº 48
of 2002
 NBC has not
functioned well
since its creation
 Panama has
designated 5 main
competent
authorities for
biosafety: ANAM,
MIDA, MINSA,
ARAP and AUPSA.
 Diagnoses exist
on the gaps in the
legal framework
and institutional
capacities
 Confined use,
1.1 (b) The biosafety release into the
decision-making body environment, and
has legal backing and liability and redress
is functioning
are regulated by
sector and only
1.1 (c) Mockbroadly (e.g. under
decisions (drills) lead
Mid point Target
(as relevant)
 Specific
regulations are in
the process of
being developed
 Administrative
procedures for
requesting LMO
authorizations are
clearly laid out in
instrument(s) of
law.
 At least 5
environmental
prosecutors /
judicial officers
have been trained
 Capacity gaps
have been updated
and reviewed,
based on the
Second National
Report to the CPB
End of Project
Target
 Environmental,
Phyto- and Zoosanitary Technical
Norms (or
Standards) are
ready by project
year 3, and cover
confined use,
release into the
environment, and
production with
LMOs
 Proposal for
dealing with
environmental
damage in cases
with LMOs is
approved
 Voluntary
declaration is
made possible for
LMOs in transit
 A legal
mechanism for
review of decisions
exists, as per
Article 12 of the
CPB
 Decision-
Means of
verification
Monitoring Location/ Responsibility
/ Sampling Group
for verifying
(frequency
/size)
Sample
Ministries National Project
 Drafts and
consists in and Govt Coordinator,
reviews of
official, legal institutions Project Steering
proposed
and technical in Panama Committee and
regulations
external
 Resolutions documents,
reports and Internet. evaluators
of approval
corresponde
and/or
publications in nce, and web
site contents,
Official
which
Gazette
should be
 Official
notification of reviewed at
mid-term
receipt
(before or
 Screening
during
regulatory
external
texts (once
evaluation)
official) for
and at
clauses
project end
covering
(before or
review of
during
decisions
terminal
 Workshop
materials and evaluation)
minutes
 Meeting
minutes of
National and
Sectoral
Committees at
Time Budget
frame (Object of
expenditure
& cost)
Once Part of project
every management
two
and project
years M&E costs
Detailed monitoring plan is included in the M&E project section. This table is primarily intended to reflect how the outcome level indicators will be tracked to facilitate monitoring of results (as opposed to monitoring of project
implementation progress). The implementation of the Results-based Monitoring Framework will be assessed at mid point and at end of project (through the Mid-Term review and Terminal Evaluation processes). The quality of
M&E implementation will be rated with the Project Implementation Review (PIR). The contents of this table should be validated and agreed upon at the project inception meeting.
16
Outcome
Outcome 1.2
Panama's
compliance with
the Cartagena
Protocol,
including
participation in the
BCH, is
coordinated,
visible and
integrated within
competent
authorities.
Indicator
Baseline
Conditions
to capacity gaps being
reviewed and a
Government plan of
action (with
responsibilities and
goals assigned) being
put into effect to
address them.
laws, decrees and
resolutions), so
greater specificity is
still required.
 There is no
mechanism for
review of decisions.
 The judicial
organ has only basic
knowledge of the
implementation of
environmental
standards, and is in
need of new
information on
LMOs and
biosafety.
1.2 (a) A national
position for
COP/MOP-6 results
from interinstitutional
coordination
• On the BCH
Central Portal
Panama only has
information on
contacts and
national competent
authorities
1.2 (b) Coordinated • Public
decision-making in
participation has not
biosafety follows on occurred so far in
from technical
biosafety decision
evaluations and
making
includes public
• Panama
participation
submitted its First
National Report to
1.2 (c) Flow of
the CPB in June
official information 2010, and
leads to new and
participated at
more information for COP/MOP-5 in
Panama on the BCH October 2010
Central Portal
Mid point Target
(as relevant)
End of Project
Target
making body has
legal backing, is
functioning and
has experience in
resolving LMO
applications
 Three "mock
decisions" for
LMOs intended for
use in agriculture,
health and
environment have
been taken by the
end of the project.
 An Action Plan
to address capacity
gaps is being
implemented by at
least 2 institutions
 New
 Results of public
information
participation that
categories are
took place as part
filled on the BCH of LMO decisionCentral Portal
making processes
are posted on the
 Panama
prepares a national biosafety Web site
position based on
 Three “mock
multi-sectoral
decisions” for
inputs prior to
LMOs are taken
COP/MOP-6 (Oct with the
2012)
participation of all
relevant competent
authorities (see
above)
Means of
verification
Monitoring Location/ Responsibility
/ Sampling Group
for verifying
(frequency
/size)
Time Budget
frame (Object of
expenditure
& cost)
least 3 times a
year and with
quorum
 3rd National
Report to the
CPB
 Institutional
documents
(drafts and
approved) for
proposed
procedures and
measures
 3rd National
Report to the
CPB
 BCH Central
Portal
 Nominations
and preparatory
documents for
COP/MOP-6
and Panama’s
attendance
records
 Regular
screening of
contents of
Web site for
posting of
outcomes of
public
participation
processes
17
Outcome
Indicator
Outcome 2
Institutional
capacity to
evaluate and
manage LMOs in
different activities
is increased.
2. (a) Designated
competent authorities
(ANAM, MIDA,
AUPSA, ARAP and
MINSA) have: (i)
structures in place,
(ii) trained staff, and
(iii) methodologies,
that enable balanced
and technically-sound
biosafety evaluations
and decisions to
occur.
2. (b) Evaluations and
feedback take place
for improved
management of the
biosafety system.
Baseline
Conditions
Mid point Target
(as relevant)
End of Project
Target
Means of
verification
Monitoring Location/ Responsibility
/ Sampling Group
for verifying
(frequency
/size)
Sample
Ministries National Project
 The creation of 5  The creation of 5  Sensitive
 Panama has
consists in and Govt Coordinator,
specialized
specialized
crops or
designated 5 main
official, legal institutions Project Steering
Biosafety Units
Biosafety Units
biodiversity
competent
and technical in Panama Committee and
within competent
within competent zoning maps.
authorities for
documents,
external
authorities has been authorities is
biosafety.
 Trained
evaluators
agreed to.
officialized by
 Competent
professional and and reports,
as well as
 Entities, experts Resolution by
authorities such as
created unit.
project year 3.
or scientists able
the MIDA and
 Institutional digital
material,
and willing to
 At least 3
MINSA have
memos for
provide advisory
contracts /MOUs designation of which
internal groups for
should be
services to
have been signed staff.
biosafety, and
with entities,
ANAM has created competent
 Resolutions reviewed at
mid-term
experts or
a Genetic Resources authorities have
showing
(before or
been identified and scientists for
Unit which covers
creation of
contacted.
advisory services Biosafety Units. during
biosafety.
external
to competent
 At least 3
 There are no
 Signed
evaluation)
professionals from authorities
formal advisory
MOUs and/or
and at
 Status of
structures at present. each competent
contracts.
project end
granted LMO
 There is concern authority (5) have
 Training
(before or
been trained
authorizations is
that biosafety
invitation,
during
evaluated, and
 At least 4
should link to the
agenda,
terminal
adoption of prior materials and
protection of native competent
evaluation)
recommendations
authorities have
genetic resources
attendee lists.
and consider social signed agreements is verified
 Documents
on the
factors.
with
methodologies and
 There are lists
conclusions and
criteria to be used
available of native
recommendatio
for considering
species and
ns on managing
social factors,
sensitive crops.
status of LMO
agricultural
 No systemic
authorizations.
tracking takes place species, and native
species in
with regards to
biosafety decisionauthorized LMOs.
making
 A preliminary
proposal exists for a  Status of granted
LMO authorizations
Training
systematized and
Programme in
management
Biosafety.
improvements
recommended
Time Budget
frame (Object of
expenditure
& cost)
Once Part of project
every management
two
and project
years M&E costs
18
Outcome
Indicator
Outcome 3
Competent
authorities have
increased capacity
to track authorized
LMOs, enforce
regulations and
respond to
accidental
releases.
3. (a) Compliance
with biosafety
measures has been
verified for at least
80% of LMO
authorizations
granted, with
administrative
procedures applied in
cases of infringement
3. (b) Customs
proceedings for
LMOs have been
agreed to
3. (c) At least 1 plan
of action has been
adopted in response
to an accidental LMO
release
3. (d) LMO analyses
can be carried out “in
house”.
Baseline
Conditions
Mid point Target
(as relevant)
End of Project
Target
Means of
verification
Monitoring Location/ Responsibility
/ Sampling Group
for verifying
(frequency
/size)
Sample
Ministries National Project
 Only research
 Technical,
 Compliance with  Technical
consists in and Govt Coordinator,
biosafety measures documents
with LMOs under technological and
official,
institutions Project Steering
confined use has
analytical capacities has been verified for analyzing
administrativ in Panama Committee and
at least 80% of
been authorized so needed for an
capacity gaps
e and
external
far (at Nov 2010). integrated
LMO authorizations and needs.
evaluators
monitoring system granted in the life of  Monitoring technical
 There is some
documents,
have been
the project, or prior plans that
experience in
corresponde
diagnosed.
to project start.
competent
establish
nce and
authorities in
calender for
 Administrative
 LMO analyses
reports,
determining
and if possible
have been carried
field visits.
out to test detection  Notifications which
biosafety measures. judicial capacity
should be
gaps for ensuring
technology and
of field visit
 Inspections or
reviewed at
regulatory
techniques.
/inspection to
monitoring visits for
compliance have
 At least 80% of listed authorized mid-term
authorized LMOs
(before or
detected
LMO users.
have not yet taken been diagnosed.
infringements have  Test results during
place.
external
either been
 Accidental LMO
from LMO
evaluation)
penalized
or
releases have
analyses,
initiated
occurred, in the
obtained from a and at
project end
administrative
absence of a
laboratory.
(before or
proceedings.
response system.
 Inspection
during
 At least 1 plan of reports
terminal
action has been
(highlighting
adopted in response compliance or evaluation)
to an accidental
infringement)
LMO
LMO release.
and summary
authorization
 Customs
reports.
proceedings for
 Drafted and s granted
before
LMOs have been
circulated
agreed to.
plan(s) of action project start
should be
for cases of
counted at
accidental
the time of
release.
inception,
 Meeting
and
minutes and
authorization
working
documents for s tracked
customs office. subsequently
Time Budget
frame (Object of
expenditure
& cost)
Once Part of project
every management
two
and project
years M&E costs
19
Outcome
Indicator
Outcome 4
Information
management for
LMOs provides
regulatory bodies
and stakeholders
access to the latest
information on
biosafety.
4.(a) A measurable
increase in the
public’s use of the
biosafety Web site.
Baseline
Conditions
 Some key
information has
begun to be
compiled, for
instance: diagnosis
4.(b) A National
on the trade of
Registry of LMO
transgenic products
Applications is
in Panama, and
created and
preliminary
functioning.
databases listing
national experts in
4.(c) An increased
fields related to
number of records are biotechnology and
available on the
biosafety, and
national BCH, all of detailing relevant
which lack
outputs of the
confidential
national diagnoses.
commercial
 The current
information.
biosafety site is the
national BCH,
which lacks a
project section and
hits /downloads
counters, but has
inter-operability
with the BCH
Central Portal.
 The number of
records available on
the national BCH at
the time of project
start (inception
workshiop) needs to
be counted.
 There is a legal
framework for the
protection of
intellectual property
and confidential
information.
Mid point Target
(as relevant)
End of Project
Target
Means of
verification
Monitoring Location/ Responsibility
/ Sampling Group
for verifying
(frequency
/size)
Sample
Ministries National Project
 Questions can be  A 20% increase is  Active and
posted via an easy- measured in the
populated Q&A consists in and Govt Coordinator,
access Questionsmonthly rate of hits feature of Web official web institutions Project Steering
site contents in Panama. Committee and
and-Answers
and downloads from site.
and technical
external
(Q&A) feature on
the biosafety Web  Regular
the national BCH
site, as compared to readings of hits files, which Internet. evaluators
Web site.
mid-term.
and downloads should be
reviewed or
 The National
 The National
counters,
counted at
Registry of LMO
Registry of LMO
starting at
project start
Applications is
Applications has
project mid(inception),
created and is being been updated.
term.
at mid-term
test-run by a
 At least a 50%
 Regular
(before or
designated
increase in the
tracking of
during
institution.
number of records uploaded
external
 At least a 25%
(stripped of
records, since
evaluation)
increase in the
confidential data)
project start
and at
number of records available on the
(inception
project end
(stripped of
national BCH, as
workshop).
(before or
confidential data)
compared to project  Electronic
during
available on the
start (inception
and printed
terminal
national BCH, as
workshop).
versions of
evaluation)
compared to project
records
start (inception
uploaded onto
workshop).
national BCH,
noting
withdrawal of
confidential
commercial
data, where
relevant.
 Data base
files for
National
Registry of
LMO
Applications.
Time Budget
frame (Object of
expenditure
& cost)
Once Part of project
every management
two
and project
years M&E costs
20
Outcome
Indicator
Outcome 5.1
Interest in
biosafety is
stimulated and the
quality of the
biosafety debate is
elevated.
5.1 (a) Awareness
concerning
biotechnology,
biosafety and LMOs
is measurably
increased in specific
groups.
Baseline
Conditions
 Capacity building
projects in biosafety
have been executed
but with very little
community
participation and
almost no private
sector participation.
5.1 (b) A measurable  The baseline
increase in the use of number of Q&As
the Questions-andconcerning
Answers (Q&A)
biosafety currently
feature of the
posted on the Web
biosafety Web site.
site is zero.
 The level of
5.1 (c) Opportunities overall knowledge
are created for
/awareness of
specialization in
biosafety is
biosafety or
currently unknown.
biotechnology.
 Training or
specialization
courses for modern
biotechnology and
biosafety are only
available abroad.
Mid point Target
(as relevant)
End of Project
Target
 • Target samples
(of producer and
farmer groups and
of University
students from
disciplines in
natural sciences,
economics and
environmental law)
have been selected
 The rate at which
questions are posted
on the Q&As
feature of the
biosafety Web site
has increased 1.5fold.
 At least 2
cooperation
agreements have
been signed with
academic
institutions or
experts for the
formation and
specialization of
professionals, and
for supporting
biosafety outreach
activities.
 At least 20%
more knowledge is
shown by a sample
of the private sector
(producers and
farmers) concerning
biosafety
regulations.
 At least 20%
more knowledge is
shown by a sample
of University
students on the
specific benefits and
risks of modern
biotechnology and
its products such as
LMOs.
 The rate at which
questions are posted
on the Q&As
feature of the
biosafety Web site
has increased 2fold, or questions
have become
notably more
complex.
Means of
verification
Monitoring
/ Sampling
(frequency
/size)
 Questionnaire Samples of
private
results from
sector
sample of
representativ
productive
es and of
sector
representatives University
before and after students will
be selected
sensitization
before midactivities.
 Questionnaire term
results from
Sample also
sample of
includes
University
students, before official and
technical
and after
documents,
sensitization
and web site
activities.
contents,
 Regular
which
screening and
should be
counting of
reviewed at
contents of
Q&A section of project start
(inception),
Web site.
 Institutional at mid-term
correspondence (before or
during
concerning
external
adoption and
evaluation)
purpose of
and at
cooperation
project end
agreements.
(before or
 Draft and
signed versions during
of cooperation terminal
evaluation)
agreements.
Location/ Responsibility
Group
for verifying
Time Budget
frame (Object of
expenditure
& cost)
Ministries National Project Once Part of project
and Govt Coordinator,
every management
and project
institutions Project Steering two
in Panama. Committee and years M&E costs.
external
General survey
Private
evaluators
or targeted
companies
questionnaire
and
will be
University
conducted as
faculties in
an add-on to
Panama.
public
activities
Internet
21
2. Cost of acquisition of essential baseline data during first year of project:
Knowledge surveys will be carried out with target stakeholder groups (eg. University students or productive sector representatives) but not in the
first year of the project (see Appendix 5). Initial questionnaires will set a knowledge baseline in targeted groups. Final questionnaires will allow
knowledge increase to be measured and cash prizes to be awarded appropriately. Project team will organize data collection method and timetable,
ensure human task force, supervise survey activities and participate in analyses of results.
Total cost estimated at: US$ 10,000 GEF
3. Cost of project inception workshop (please include proposed location, number of participants):
Total cost estimated at: US$ 3,000 GEF + US$ 5,700 co-finance = US$ 8,700
4. Cost of Mid-Term review/Evaluation:
Estimated at: US$ 12,000 GEF + US$ 2,000 co-finance = US$ 14,000
5. Cost of Terminal Evaluation:
Estimated at: US$ 14,000 GEF + US$ 2,500 co-finance = US$ 16,500
6. Any additional M&E costs:
Financial auditing (annual): US$ 14,000 GEF + US$ 2,500 co-finance = US$ 16,500
Facilities and mechanisms for performance reviews, regular reporting and deriving lessons learnt through the Steering Committee: US$ 12,100
GEF + US$ 15,580 co-finance = US$ 27,680
Travel for exchanging experiences between LAC projects: US$ 4,000 GEF + US$ 3,000 co-finance = US$ 7,000
Total costs (this figure should be included in the consolidated project budget and in the Request for CEO endorsement/approval in the M&E
budget line): GEF funds: US$ 69,100 + Co-financing: US$ 31,280 = TOTAL M&E COSTS: US$ 100,380
22
Appendix 8: Summary of reporting requirements and responsibilities
Format
appended to
legal
instrument as
Responsibility of
Reporting requirements
Due date
Procurement plan (goods and services)
2 weeks before project
inception meeting
N/A
Project Manager
Inception Report
1 month after project
inception meeting
N/A
Project Manager
Expenditure report accompanied by
explanatory notes
Half-yearly on or before 31
July and 31 January
Cash Advance request and details of
anticipated disbursements
Hal-yearly or when
required
Annex 7B
Project Manager
Progress report
Half-yearly on or before 31
July and 31 January
Annex 8
Project Manager
Audited report for expenditures for year
ending 31 December
Yearly on or before 30
June
N/A
Executing Agency to
contract firm
Inventory of non-expendable equipment
Yearly on or before 31
January
Annex 6A
Project Manager
Co-financing report
Yearly on or before 31 July
Annex 12
Project Manager
Project implementation review (PIR)
report
Yearly on or before 31
August
Annex 9
Project Manager, UNEP
Task Manager and FMO
Minutes of steering committee meetings
Yearly (or as relevant)
N/A
Project Manager
Mission reports and “aide memoire” for
executing agency
Within 2 weeks of return
N/A
UNEP Task Manager
and FMO
Final report
2 months of project
completion date
Annex 10
Project Manager
Annex 6A
Project Manager
Annex 6B
Project Manager
Final inventory of non-expendable
equipment
Equipment transfer letter
Project Manager
Annex 11
Final expenditure statement
3 months of project
completion date
Annex 11
Project Manager
Mid-term review or Mid-term evaluation
Midway though project
N/A
Task Manager or UNEPEOU (as relevant)
Final audited report for expenditures of
project
Within 6 months of project
completion date
N/A
Executing partner to
contract firm
Independent terminal evaluation report
Within 6 months of project
completion date
Appendix 9
to this
Project
Document
UNEP-EOU
23
Appendix 9: Standard Terms of Reference for the Terminal Evaluation
1. Objective and Scope of the Evaluation
The objective of this terminal evaluation is to examine the extent and magnitude of any project
impacts to date and determine the likelihood of future impacts. The evaluation will also assess project
performance and the implementation of planned project activities and planned outputs against actual
results. The evaluation will focus on the following main questions:
1. Did the project help to { } among key target audiences (international conventions and initiatives,
national level policy-makers, regional and local policy-makers, resource managers and practitioners).
2. Did the outputs of the project articulate options and recommendations for { }? Were these options
and recommendations used? If so by whom?
3. To what extent did the project outputs produced have the weight of scientific authority and credibility
necessary to influence policy makers and other key audiences?
Methods
This terminal evaluation will be conducted as an in-depth evaluation using a participatory approach
whereby the UNEP/DGEF Task Manager, key representatives of the executing agencies and other
relevant staff are kept informed and consulted throughout the evaluation. The consultant will liaise
with the UNEP/EOU and the UNEP/DGEF Task Manager on any logistic and/or methodological
issues to properly conduct the review in as independent a way as possible, given the circumstances
and resources offered. The draft report will be circulated to UNEP/DGEF Task Manager, key
representatives of the executing agencies and the UNEP/EOU. Any comments or responses to the
draft report will be sent to UNEP / EOU for collation and the consultant will be advised of any
necessary or suggested revisions.
The findings of the evaluation will be based on the following:
1. A desk review of project documents including, but not limited to:
(a) The project documents, outputs, monitoring reports (such as progress and financial reports to UNEP
and GEF annual Project Implementation Review reports) and relevant correspondence.
(b) Notes from the Steering Group meetings.
(c) Other project-related material produced by the project staff or partners.
(d) Relevant material published on the project web-site:{ }.
2. Interviews with project management and technical support including {NEED INPUT FROM TM
HERE}
3. Interviews and Telephone interviews with intended users for the project outputs and other
stakeholders involved with this project, including in the participating countries and international
bodies. The Consultant shall determine whether to seek additional information and opinions from
representatives of donor agencies and other organizations. As appropriate, these interviews could be
combined with an email questionnaire.
4. Interviews with the UNEP/DGEF project task manager and Fund Management Officer, and other
relevant staff in UNEP dealing with {relevant GEF focal area(s)}-related activities as necessary. The
Consultant shall also gain broader perspectives from discussions with relevant GEF Secretariat staff.
24
5. Field visits2 to project staff
Key Evaluation principles.
In attempting to evaluate any outcomes and impacts that the project may have achieved, evaluators
should remember that the project’s performance should be assessed by considering the difference
between the answers to two simple questions “what happened?” and “what would have happened
anyway?”. These questions imply that there should be consideration of the baseline conditions and
trends in relation to the intended project outcomes and impacts. In addition it implies that there should
be plausible evidence to attribute such outcomes and impacts to the actions of the project.
Sometimes, adequate information on baseline conditions and trends is lacking. In such cases this
should be clearly highlighted by the evaluator, along with any simplifying assumptions that were
taken to enable the evaluator to make informed judgements about project performance.
2. Project Ratings
The success of project implementation will be rated on a scale from ‘highly unsatisfactory’ to ‘highly
satisfactory’. In particular the evaluation shall assess and rate the project with respect to the eleven
categories defined below:3
A. Attainment of objectives and planned results:
The evaluation should assess the extent to which the project's major relevant objectives were
effectively and efficiently achieved or are expected to be achieved and their relevance.
 Effectiveness: Evaluate how, and to what extent, the stated project objectives have been met, taking
into account the “achievement indicators”. The analysis of outcomes achieved should include, inter
alia, an assessment of the extent to which the project has directly or indirectly assisted policy and
decision-makers to apply information supplied by biodiversity indicators in their national planning
and decision-making. In particular:
 Evaluate the immediate impact of the project on {relevant focal area} monitoring and in national
planning and decision-making and international understanding and use of biodiversity indicators.
 As far as possible, also assess the potential longer-term impacts considering that the evaluation is
taking place upon completion of the project and that longer term impact is expected to be seen in a
few years time. Frame recommendations to enhance future project impact in this context. Which will
be the major ‘channels’ for longer term impact from the project at the national and international
scales?
 Relevance: In retrospect, were the project’s outcomes consistent with the focal areas/operational
program strategies? Ascertain the nature and significance of the contribution of the project outcomes
to the {relevant Convention(s)} and the wider portfolio of the GEF.
 Efficiency: Was the project cost effective? Was the project the least cost option? Was the project
implementation delayed and if it was, then did that affect cost-effectiveness? Assess the contribution
of cash and in-kind co-financing to project implementation and to what extent the project leveraged
additional resources. Did the project build on earlier initiatives, did it make effective use of available
scientific and / or technical information. Wherever possible, the evaluator should also compare the
cost-time vs. outcomes relationship of the project with that of other similar projects.
B. Sustainability:
Sustainability is understood as the probability of continued long-term project-derived outcomes and
impacts after the GEF project funding ends. The evaluation will identify and assess the key conditions
or factors that are likely to contribute or undermine the persistence of benefits after the project ends.
2
3
Evaluators should make a brief courtesy call to GEF Country Focal points during field visits if at all possible.
However, the views and comments expressed by the evaluator need not be restricted to these items.
25
Some of these factors might be outcomes of the project, e.g. stronger institutional capacities or better
informed decision-making. Other factors will include contextual circumstances or developments that
are not outcomes of the project but that are relevant to the sustainability of outcomes. The evaluation
should ascertain to what extent follow-up work has been initiated and how project outcomes will be
sustained and enhanced over time.




Five aspects of sustainability should be addressed: financial, socio-political, institutional frameworks
and governance, environmental (if applicable). The following questions provide guidance on the
assessment of these aspects:
Financial resources. Are there any financial risks that may jeopardize sustenance of project
outcomes? What is the likelihood that financial and economic resources will not be available once the
GEF assistance ends (resources can be from multiple sources, such as the public and private sectors,
income generating activities, and trends that may indicate that it is likely that in future there will be
adequate financial resources for sustaining project’s outcomes)? To what extent are the outcomes of
the project dependent on continued financial support?
Socio-political: Are there any social or political risks that may jeopardize sustenance of project
outcomes? What is the risk that the level of stakeholder ownership will be insufficient to allow for the
project outcomes to be sustained? Do the various key stakeholders see that it is in their interest that
the project benefits continue to flow? Is there sufficient public / stakeholder awareness in support of
the long term objectives of the project?
Institutional framework and governance. To what extent is the sustenance of the outcomes of the
project dependent on issues relating to institutional frameworks and governance? What is the
likelihood that institutional and technical achievements, legal frameworks, policies and governance
structures and processes will allow for, the project outcomes/benefits to be sustained? While
responding to these questions consider if the required systems for accountability and transparency and
the required technical know-how are in place.
Environmental. Are there any environmental risks that can undermine the future flow of project
environmental benefits? The TE should assess whether certain activities in the project area will pose a
threat to the sustainability of the project outcomes. For example; construction of dam in a protected
area could inundate a sizable area and thereby neutralize the biodiversity-related gains made by the
project; or, a newly established pulp mill might jeopardise the viability of nearby protected forest
areas by increasing logging pressures; or a vector control intervention may be made less effective by
changes in climate and consequent alterations to the incidence and distribution of malarial
mosquitoes.
C. Achievement of outputs and activities:
 Delivered outputs: Assessment of the project’s success in producing each of the programmed outputs,
both in quantity and quality as well as usefulness and timeliness.
 Assess the soundness and effectiveness of the methodologies used for developing the technical
documents and related management options in the participating countries
 Assess to what extent the project outputs produced have the weight of scientific authority / credibility,
necessary to influence policy and decision-makers, particularly at the national level.
D. Catalytic Role
Replication and catalysis. What examples are there of replication and catalytic outcomes? Replication
approach, in the context of GEF projects, is defined as lessons and experiences coming out of the
project that are replicated or scaled up in the design and implementation of other projects. Replication
can have two aspects, replication proper (lessons and experiences are replicated in different
geographic area) or scaling up (lessons and experiences are replicated within the same geographic
area but funded by other sources). Specifically:
26

Do the recommendations for management of {project} coming from the country studies have the
potential for application in other countries and locations?
If no effects are identified, the evaluation will describe the catalytic or replication actions that the
project carried out.
E. Assessment monitoring and evaluation systems.
The evaluation shall include an assessment of the quality, application and effectiveness of project
monitoring and evaluation plans and tools, including an assessment of risk management based on the
assumptions and risks identified in the project document. The Terminal Evaluation will assess
whether the project met the minimum requirements for ‘project design of M&E’ and ‘the application
of the Project M&E plan’ (see minimum requirements 1&2 in Annex 4 to this Appendix). GEF
projects must budget adequately for execution of the M&E plan, and provide adequate resources
during implementation of the M&E plan. Project managers are also expected to use the information
generated by the M&E system during project implementation to adapt and improve the project.
M&E during project implementation

M&E design. Projects should have sound M&E plans to monitor results and track progress towards
achieving project objectives. An M&E plan should include a baseline (including data, methodology,
etc.), SMART indicators (see Annex 4) and data analysis systems, and evaluation studies at specific
times to assess results. The time frame for various M&E activities and standards for outputs should
have been specified.

M&E plan implementation. A Terminal Evaluation should verify that: an M&E system was in place
and facilitated timely tracking of results and progress towards projects objectives throughout the
project implementation period (perhaps through use of a logframe or similar); annual project reports
and Progress Implementation Review (PIR) reports were complete, accurate and with well justified
ratings; that the information provided by the M&E system was used during the project to improve
project performance and to adapt to changing needs; and that projects had an M&E system in place
with proper training for parties responsible for M&E activities.
Budgeting and Funding for M&E activities. The terminal evaluation should determine whether
support for M&E was budgeted adequately and was funded in a timely fashion during
implementation.

F. Preparation and Readiness
Were the project’s objectives and components clear, practicable and feasible within its timeframe?
Were the capacities of executing institution and counterparts properly considered when the project
was designed? Were lessons from other relevant projects properly incorporated in the project design?
Were the partnership arrangements properly identified and the roles and responsibilities negotiated
prior to project implementation? Were counterpart resources (funding, staff, and facilities), enabling
legislation, and adequate project management arrangements in place?
G. Country ownership / driveness:
This is the relevance of the project to national development and environmental agendas, recipient
country commitment, and regional and international agreements. The evaluation will:
 Assess the level of country ownership. Specifically, the evaluator should assess whether the project
was effective in providing and communicating biodiversity information that catalyzed action in
participating countries to improve decisions relating to the conservation and management of the focal
ecosystem in each country.
 Assess the level of country commitment to the generation and use of biodiversity indicators for
decision-making during and after the project, including in regional and international fora.
H. Stakeholder participation / public awareness:
27



I.





This consists of three related and often overlapping processes: information dissemination,
consultation, and “stakeholder” participation. Stakeholders are the individuals, groups, institutions, or
other bodies that have an interest or stake in the outcome of the GEF- financed project. The term also
applies to those potentially adversely affected by a project. The evaluation will specifically:
Assess the mechanisms put in place by the project for identification and engagement of stakeholders
in each participating country and establish, in consultation with the stakeholders, whether this
mechanism was successful, and identify its strengths and weaknesses.
Assess the degree and effectiveness of collaboration/interactions between the various project partners
and institutions during the course of implementation of the project.
Assess the degree and effectiveness of any various public awareness activities that were undertaken
during the course of implementation of the project.
Financial Planning
Evaluation of financial planning requires assessment of the quality and effectiveness of financial
planning and control of financial resources throughout the project’s lifetime. Evaluation includes
actual project costs by activities compared to budget (variances), financial management (including
disbursement issues), and co- financing. The evaluation should:
Assess the strength and utility of financial controls, including reporting, and planning to allow the
project management to make informed decisions regarding the budget and allow for a proper and
timely flow of funds for the payment of satisfactory project deliverables.
Present the major findings from the financial audit if one has been conducted.
Identify and verify the sources of co- financing as well as leveraged and associated financing (in cooperation with the IA and EA).
Assess whether the project has applied appropriate standards of due diligence in the management of
funds and financial audits.
The evaluation should also include a breakdown of final actual costs and co-financing for the project
prepared in consultation with the relevant UNEP/DGEF Fund Management Officer of the project
(table attached in Annex 1 to this Appendix Co-financing and leveraged resources).
J. Implementation approach:
This includes an analysis of the project’s management framework, adaptation to changing conditions
(adaptive management), partnerships in implementation arrangements, changes in project design, and
overall project management. The evaluation will:
 Ascertain to what extent the project implementation mechanisms outlined in the project document
have been closely followed. In particular, assess the role of the various committees established and
whether the project document was clear and realistic to enable effective and efficient implementation,
whether the project was executed according to the plan and how well the management was able to
adapt to changes during the life of the project to enable the implementation of the project.
 Evaluate the effectiveness and efficiency and adaptability of project management and the supervision
of project activities / project execution arrangements at all levels (1) policy decisions: Steering Group;
(2) day to day project management in each of the country executing agencies and {lead executing
agency}.
K. UNEP Supervision and Backstopping
 Assess the effectiveness of supervision and administrative and financial support provided by
UNEP/DGEF.
 Identify administrative, operational and/or technical problems and constraints that influenced the
effective implementation of the project.
The ratings will be presented in the form of a table. Each of the eleven categories should be rated
separately with brief justifications based on the findings of the main analysis. An overall rating for
the project should also be given. The following rating system is to be applied:
28
HS
S
MS
MU
U
HU
= Highly Satisfactory
= Satisfactory
= Moderately Satisfactory
= Moderately Unsatisfactory
= Unsatisfactory
= Highly Unsatisfactory
3. Evaluation report format and review procedures
The report should be brief, to the point and easy to understand. It must explain; the purpose of the
evaluation, exactly what was evaluated and the methods used. The report must highlight any
methodological limitations, identify key concerns and present evidence-based findings, consequent
conclusions, recommendations and lessons. The report should be presented in a way that makes the
information accessible and comprehensible and include an executive summary that encapsulates the
essence of the information contained in the report to facilitate dissemination and distillation of
lessons.
The evaluation will rate the overall implementation success of the project and provide
individual ratings of the eleven implementation aspects as described in Section 1 of this TOR.
The ratings will be presented in the format of a table with brief justifications based on the findings
of the main analysis.
Evidence, findings, conclusions and recommendations should be presented in a complete and
balanced manner. Any dissident views in response to evaluation findings will be appended in an
annex. The evaluation report shall be written in English, be of no more than 50 pages (excluding
annexes), use numbered paragraphs and include:
i)
ii)
iii)
iv)
v)
vi)



vii)
An executive summary (no more than 3 pages) providing a brief overview of the main conclusions
and recommendations of the evaluation;
Introduction and background giving a brief overview of the evaluated project, for example, the
objective and status of activities; The GEF Monitoring and Evaluation Policy, 2006, requires that a
TE report will provide summary information on when the evaluation took place; places visited; who
was involved; the key questions; and, the methodology.
Scope, objective and methods presenting the evaluation’s purpose, the evaluation criteria used and
questions to be addressed;
Project Performance and Impact providing factual evidence relevant to the questions asked by the
evaluator and interpretations of such evidence. This is the main substantive section of the report. The
evaluator should provide a commentary and analysis on all eleven evaluation aspects (A − K above).
Conclusions and rating of project implementation success giving the evaluator’s concluding
assessments and ratings of the project against given evaluation criteria and standards of performance.
The conclusions should provide answers to questions about whether the project is considered good or
bad, and whether the results are considered positive or negative. The ratings should be provided with
a brief narrative comment in a table (see Annex 1 to this Appendix);
Lessons (to be) learned presenting general conclusions from the standpoint of the design and
implementation of the project, based on good practices and successes or problems and mistakes.
Lessons should have the potential for wider application and use. All lessons should ‘stand alone’ and
should:
Briefly describe the context from which they are derived
State or imply some prescriptive action;
Specify the contexts in which they may be applied (if possible, who when and where)
Recommendations suggesting actionable proposals for improvement of the current project. In
general, Terminal Evaluations are likely to have very few (perhaps two or three) actionable
recommendations.
29
Prior to each recommendation, the issue(s) or problem(s) to be addressed by the recommendation
should be clearly stated.
A high quality recommendation is an actionable proposal that is:
1. Feasible to implement within the timeframe and resources available
2. Commensurate with the available capacities of project team and partners
3. Specific in terms of who would do what and when
4. Contains results-based language (i.e. a measurable performance target)
5. Includes a trade-off analysis, when its implementation may require utilizing significant resources
that would otherwise be used for other project purposes.
viii)
Annexes may include additional material deemed relevant by the evaluator but must include:
1. The Evaluation Terms of Reference,
2. A list of interviewees, and evaluation timeline
3. A list of documents reviewed / consulted
4. Summary co-finance information and a statement of project expenditure by activity
5. The expertise of the evaluation team. (brief CV).
TE reports will also include any response / comments from the project management team and/or the
country focal point regarding the evaluation findings or conclusions as an annex to the report,
however, such will be appended to the report by UNEP EOU.
Examples of UNEP GEF Terminal Evaluation Reports are available at www.unep.org/eou
Review of the Draft Evaluation Report
Draft reports submitted to UNEP EOU are shared with the corresponding Programme or Project
Officer and his or her supervisor for initial review and consultation. The DGEF staff and senior
Executing Agency staff are allowed to comment on the draft evaluation report. They may provide
feedback on any errors of fact and may highlight the significance of such errors in any conclusions.
The consultation also seeks feedback on the proposed recommendations. UNEP EOU collates all
review comments and provides them to the evaluators for their consideration in preparing the final
version of the report.
4. Submission of Final Terminal Evaluation Reports.
The final report shall be submitted in electronic form in MS Word format and should be sent to the
following persons:
Segbedzi Norgbey, Chief,
UNEP Evaluation and Oversight Unit
P.O. Box 30552-00100
Nairobi, Kenya
Tel.: +(254-20)762-4181
Fax: +(254-20)762-3158
Email: [email protected]
With a copy to:
Maryam Niamir-Fuller,
Director
UNEP/Division of GEF Coordination
P.O. Box 30552-00100
Nairobi, Kenya
Tel: +(254-20)762-4166
Fax: +(254-20)762-4041/2
30
Email: [email protected]
{Name}
Task Manager
{Contact details}
The Final evaluation will also be copied to the following GEF National Focal Points.
{Insert contact details here}
The final evaluation report will be published on the Evaluation and Oversight Unit’s web-site
www.unep.org/eou and may be printed in hard copy. Subsequently, the report will be sent to the GEF
Office of Evaluation for their review, appraisal and inclusion on the GEF website.
5. Resources and schedule of the evaluation
This final evaluation will be undertaken by an international evaluator contracted by the Evaluation
and Oversight Unit, UNEP. The contract for the evaluator will begin on ddmmyyy and end on
ddmmyyyy (# days) spread over # weeks (# days of travel, to {country(ies)}, and # days desk study).
The evaluator will submit a draft report on ddmmyyyy to UNEP/EOU, the UNEP/DGEF Task
Manager, and key representatives of the executing agencies. Any comments or responses to the draft
report will be sent to UNEP / EOU for collation and the consultant will be advised of any necessary
revisions. Comments to the final draft report will be sent to the consultant by ddmmyyyy after which,
the consultant will submit the final report no later than ddmmyyyy.
The evaluator will after an initial telephone briefing with EOU and UNEP/GEF conduct initial desk
review work and later travel to (country(ies)} and meet with project staff at the beginning of the
evaluation. Furthermore, the evaluator is expected to travel to {country(ies)} and meet with
representatives of the project executing agencies and the intended users of project’s outputs.
In accordance with UNEP/GEF policy, all GEF projects are evaluated by independent evaluators
contracted as consultants by the EOU. The evaluator should have the following qualifications:
The evaluator should not have been associated with the design and implementation of the project in a
paid capacity. The evaluator will work under the overall supervision of the Chief, Evaluation and
Oversight Unit, UNEP. The evaluator should be an international expert in { } with a sound
understanding of { } issues. The consultant should have the following minimum qualifications: (i)
experience in {} issues; (ii) experience with management and implementation of { } projects and in
particular with { } targeted at policy-influence and decision-making; (iii) experience with project
evaluation. Knowledge of UNEP programmes and GEF activities is desirable. Knowledge of
{specify language(s)} is an advantage. Fluency in oral and written English is a must.
6. Schedule Of Payment
The consultant shall select one of the following two contract options:
Lump-Sum Option
The evaluator will receive an initial payment of 30% of the total amount due upon signature of the
contract. A further 30% will be paid upon submission of the draft report. A final payment of 40%
will be made upon satisfactory completion of work. The fee is payable under the individual Special
Service Agreement (SSA) of the evaluator and is inclusive of all expenses such as travel,
accommodation and incidental expenses.
Fee-only Option
31
The evaluator will receive an initial payment of 40% of the total amount due upon signature of the
contract. Final payment of 60% will be made upon satisfactory completion of work. The fee is
payable under the individual SSAs of the evaluator and is NOT inclusive of all expenses such as
travel, accommodation and incidental expenses. Ticket and DSA will be paid separately.
In case, the evaluator cannot provide the products in accordance with the TORs, the timeframe
agreed, or his products are substandard, the payment to the evaluator could be withheld, until such a
time the products are modified to meet UNEP's standard. In case the evaluator fails to submit a
satisfactory final product to UNEP, the product prepared by the evaluator may not constitute the
evaluation report.
32
Annex 1 to Appendix 9: OVERALL RATINGS TABLE
Evaluato
Evaluator’s Summary
Criterion
r’s
Comments
Rating
A. Attainment of project objectives and
results (overall rating)
Sub criteria (below)
A. 1. Effectiveness
A. 2. Relevance
A. 3. Efficiency
B. Sustainability of Project outcomes
(overall rating)
Sub criteria (below)
B. 1. Financial
B. 2. Socio Political
B. 3. Institutional framework and
governance
B. 4. Ecological
C. Achievement of outputs and activities
D. Monitoring and Evaluation
(overall rating)
Sub criteria (below)
D. 1. M&E Design
D. 2. M&E Plan Implementation (use for
adaptive management)
D. 3. Budgeting and Funding for M&E
activities
E. Catalytic Role
F. Preparation and readiness
G. Country ownership / drivenness
H. Stakeholders involvement
I. Financial planning
J. Implementation approach
K. UNEP Supervision and backstopping
RATING OF PROJECT OBJECTIVES AND RESULTS

Highly Satisfactory (HS): The project had no shortcomings in the achievement of its objectives, in
terms of relevance, effectiveness or efficiency.

Satisfactory (S): The project had minor shortcomings in the achievement of its objectives, in terms of
relevance, effectiveness or efficiency.

Moderately Satisfactory (MS): The project had moderate shortcomings in the achievement of its
objectives, in terms of relevance, effectiveness or efficiency.
33

Moderately Unsatisfactory (MU): The project had significant shortcomings in the achievement of its
objectives, in terms of relevance, effectiveness or efficiency.

Unsatisfactory (U) The project had major shortcomings in the achievement of its objectives, in terms
of relevance, effectiveness or efficiency.

Highly Unsatisfactory (HU): The project had severe shortcomings in the achievement of its
objectives, in terms of relevance, effectiveness or efficiency.
Please note: Relevance and effectiveness will be considered as critical criteria. The overall rating of
the project for achievement of objectives and results may not be higher than the lowest rating on
either of these two criteria. Thus, to have an overall satisfactory rating for outcomes a project must
have at least satisfactory ratings on both relevance and effectiveness.
RATINGS ON SUSTAINABILITY
A. Sustainability will be understood as the probability of continued long-term outcomes and impacts
after the GEF project funding ends. The Terminal evaluation will identify and assess the key
conditions or factors that are likely to contribute or undermine the persistence of benefits after the
project ends. Some of these factors might be outcomes of the project, i.e. stronger institutional
capacities, legal frameworks, socio-economic incentives /or public awareness. Other factors will
include contextual circumstances or developments that are not outcomes of the project but that are
relevant to the sustainability of outcomes.
Rating system for sustainability sub-criteria
On each of the dimensions of sustainability of the project outcomes will be rated as follows.
Likely (L): There are no risks affecting this dimension of sustainability.
Moderately Likely (ML). There are moderate risks that affect this dimension of sustainability.
Moderately Unlikely (MU): There are significant risks that affect this dimension of sustainability
Unlikely (U): There are severe risks that affect this dimension of sustainability.
According to the GEF Office of Evaluation, all the risk dimensions of sustainability are deemed
critical. Therefore, overall rating for sustainability will not be higher than the rating of the dimension
with lowest ratings. For example, if a project has an Unlikely rating in any of the dimensions then its
overall rating cannot be higher than Unlikely, regardless of whether higher ratings in other
dimensions of sustainability produce a higher average.
RATINGS OF PROJECT M&E
Monitoring is a continuing function that uses systematic collection of data on specified indicators to
provide management and the main stakeholders of an ongoing project with indications of the extent of
progress and achievement of objectives and progress in the use of allocated funds. Evaluation is the
systematic and objective assessment of an on-going or completed project, its design, implementation
and results. Project evaluation may involve the definition of appropriate standards, the examination of
performance against those standards, and an assessment of actual and expected results.
The Project monitoring and evaluation system will be rated on ‘M&E Design’, ‘M&E Plan
Implementation’ and ‘Budgeting and Funding for M&E activities’ as follows:
Highly Satisfactory (HS): There were no shortcomings in the project M&E system. Satisfactory(S):
There were minor shortcomings in the project M&E system.
Moderately Satisfactory (MS): There were moderate shortcomings in the project M&E system.
Moderately Unsatisfactory (MU): There were significant shortcomings in the project M&E system.
Unsatisfactory (U): There were major shortcomings in the project M&E system.
34
Highly Unsatisfactory (HU): The Project had no M&E system.
“M&E plan implementation” will be considered a critical parameter for the overall assessment of the
M&E system. The overall rating for the M&E systems will not be higher than the rating on “M&E
plan implementation.”
All other ratings will be on the GEF six point scale.
GEF Performance Description
Alternative description on
the same scale
HS = Highly Satisfactory
Excellent
S
Well above average
= Satisfactory
MS
= Moderately
Satisfactory
Average
MU
= Moderately
Unsatisfactory
Below Average
U = Unsatisfactory
Poor
HU = Highly Unsatisfactory
Very poor (Appalling)
35
Annex 2 to Appendix 9: Co-financing and Leveraged Resources
Co financing
(Type/Source)






IA own
Financing
(mill US$)
Plan
Act
ned
ual
Government
Other*
Total
(mill US$)
Plan
Actu
ned
al
(mill US$)
Plan
Act
ned
ual
(mill US$)
Plan
Act
ned
ual
Total
Disbursement
(mill US$)
Plan
Actu
ned
al
Grants
Loans/Concessional (compared to market rate)
Credits
Equity investments
In-kind support
Other (*)
-
Totals
Co-financing (basic data to be supplied to the consultant for verification)
* Other is referred to contributions mobilized for the project from other multilateral agencies, bilateral development cooperation agencies,
NGOs, the private sector and beneficiaries.
Leveraged Resources
Leveraged resources are additional resources—beyond those committed to the project itself at the time of approval—that are mobilized later as
a direct result of the project. Leveraged resources can be financial or in-kind and they may be from other donors, NGO’s, foundations,
governments, communities or the private sector. Please briefly describe the resources the project has leveraged since inception and indicate
how these resources are contributing to the project’s ultimate objective.
Table showing final actual project expenditure by activity to be supplied by the UNEP Fund management Officer. (insert here)
36
Annex 3 to Appendix 9
Review of the Draft Report
Draft reports submitted to UNEP EOU are shared with the corresponding Programme or Project
Officer and his or her supervisor for initial review and consultation. The DGEF staff and senior
Executing Agency staff provide comments on the draft evaluation report. They may provide
feedback on any errors of fact and may highlight the significance of such errors in any conclusions.
The consultation also seeks agreement on the findings and recommendations. UNEP EOU collates
the review comments and provides them to the evaluators for their consideration in preparing the final
version of the report. General comments on the draft report with respect to compliance with these
TOR are shared with the reviewer.
Quality Assessment of the Evaluation Report
All UNEP GEF Mid Term Reports are subject to quality assessments by UNEP EOU. These apply
GEF Office of Evaluation quality assessment and are used as a tool for providing structured feedback
to the evaluator.
The quality of the draft evaluation report is assessed and rated against the following criteria:
GEF Report Quality Criteria
A. Did the report present an assessment of relevant outcomes and achievement
of project objectives in the context of the focal area program indicators if
applicable?
B. Was the report consistent and the evidence complete and convincing and
were the ratings substantiated when used?
C. Did the report present a sound assessment of sustainability of outcomes?
D. Were the lessons and recommendations supported by the evidence
presented?
E. Did the report include the actual project costs (total and per activity) and
actual co-financing used?
F. Did the report include an assessment of the quality of the project M&E
system and its use for project management?
UNEP EOU additional Report Quality Criteria
UNEP EOU
Assessment
Rating
UNEP EOU
Assessment
Rating
G. Quality of the lessons: Were lessons readily applicable in other contexts?
Did they suggest prescriptive action?
H. Quality of the recommendations: Did recommendations specify the actions
necessary to correct existing conditions or improve operations (‘who?’ ‘what?’
‘where?’ ‘when?)’. Can they be implemented? Did the recommendations
specify a goal and an associated performance indicator?
I. Was the report well written?
(clear English language and grammar)
J. Did the report structure follow EOU guidelines, were all requested Annexes
included?
K. Were all evaluation aspects specified in the TORs adequately addressed?
L. Was the report delivered in a timely manner
37
GEF Quality of the MTE report = 0.3*(A + B) +
0.1*(C+D+E+F)
EOU assessment of MTE report = 0.3*(G + H) +
0.1*(I+J+K+L)
Combined quality Rating = (2* ‘GEF EO’ rating + EOU
rating)/3
The Totals are rounded and converted to the scale of HS to HU
Rating system for quality of terminal evaluation reports
A number rating 1-6 is used for each criterion: Highly Satisfactory = 6, Satisfactory = 5, Moderately
Satisfactory = 4, Moderately Unsatisfactory = 3, Unsatisfactory = 2, Highly Unsatisfactory = 1, and
unable to assess = 0.
38
Annex 5 to Appendix 9
List of intended additional recipients for the Terminal Evaluation (to be completed by the IA Task
Manager)
Name
Aaron Zazuetta
Affiliation
GEF Evaluation Office
Email
[email protected]
Government Officials
GEF Focal Point(s)
Executing Agency
Implementing Agency
Carmen Tavera
UNEP DGEF Quality
Assurance Officer
39
Appendix 10: Decision-making flowchart and organizational chart
-------------------------------------------------------------------------------------------------------------------------Decision level (Decision Makers)
Decision Makers
ANAM-MIDA-MINSAAUPSA-ARAP
GEF – UNEP
(Evaluation and
Monitoring)
Regulating Competent Authorities
(ANAM, SENACYT, MIDA,
MINSA, IDIAP, AUPSA, ARAP)
ANAM
ANAM
Support and coordination:
Protected Areas and
(OPPA, UPO, Legal Advice)
Wildlife Direction
------------------------------------------------------------------------------------------------------------------------------Biosafety Unit
Executing Level
Project
Administration
Unit
Project’s Steering Committee
National
Project
Coordinator
--------------------------------------------------------------------------------------------------------------------External Collaborators
Productive, Private and Academic
Sector
Sectorial Committees
NGOs
40
Appendix 11: Terms of Reference (Draft)
The National Executing Agency (NEA), in addition to the other duties given to it by the national
Government, shall:

Establish the Steering Committee and ensure smooth operation, providing the necessary secretariat
support and offering any information available about government, private and public sector activities
that may impact (positively or negatively) on the project and on the use of modern biotechnology in
the country;

Appoint a full time National Project Coordinator (NPC) and supervise his/her work, taking into
account the sustainability of national biosafety activities on completion of the project;

Provide the necessary scientific, technical, financial and administrative support to the work of the
NPC, working in close cooperation with relevant government agencies, the scientific community and
the public and private sectors;

Ensure that regular reports, financial accounts, project implementation reviews and annual audits are
submitted to UNEP;

Review all documentation and products deriving from the project to ensure that these are consonant
with national Government policies and practices;

Clear and submit to UNEP the final versions of all outputs expected from the project.
The National Project Coordinator (NPC) /Project Manager shall:
1. Be responsible for the overall co-ordination, management and supervision of all aspects of the
Project, ensuring that all the activities are carried out on time and within budget to achieve the stated
outputs and outcomes;
2. Report to the National Executing Agency and UNEP, and liaise closely with the chair and members
of the Steering Committee in order to coordinate the work plan for the Project.
3. Be responsible for all substantive, managerial and financial reports to UNEP required for the Project.
4. Provide overall supervision for any staff in the project team as well as guidance and supervision of all
other staff appointed for the execution of the various Project components.
5. Prepare and oversee the development of terms of reference, and organize the contracting of
consultants, institutions and experts;
6. Coordinate, manage and monitor the delivery of products expected from local and international
experts, consultants, sub contracts and co-operating partners;
7. Organize Steering Committee meetings, and prepare detailed work plan and budgets for consideration
of the Steering Committee;
8. Ensure effective communication with the relevant authorities, institutions and government
departments in close collaboration with the NEA and Steering Committee;
9. Foster, establish and maintain links with other related national and international programmes and
projects in the region; and
10. Manage project finances, oversee overall resource allocation and where relevant, submit a proposal
for budget revision to the Steering Committee and UNEP.
41
The Technical Specialist (*) shall:
1. Act as technical advisor the Steering Committee and the NPC as needed;
2. Orient with regards to resource persons, institutions and experts of international, regional or national
origin that are important for specific topics or tasks, or as references and information sources;
3. Participate in the fine-tuning of consultancy Terms of References, and in the review of technical
reports and consultancy deliverables prior to approval;
4. Represent national interests, facilitate strategic information and ensure an adequate articulation
between the project and other relevant national processes;
5. Provide technical back-stopping and coordination support with consultants, stakeholder groups and
authorities in support of biosafety capacity building, especially for training activities and drills, as
well as national consultation and participatory processes;
6. Assist the NPC and National Competent Authorities in passing legislation and regulations, developing
and adopting methodologies, setting up structures for risk assessment and decision-making,
strengthening inspection and monitoring mechanisms, and improving information management,
amongst other topics of the NBF;
7. Support all efforts aimed as disseminating project results at the national level, and synthesizing best
practices and lessons learned.
8. Advise the National Competent Authorities, including the NEA, with regards to putting into effect
financing options that will cover the maintenance of NBF operations, including BCH functions;
9. Assist in seeking strategic alliances, for example, with the academic sector in the search for
opportunities for biosafety specialization, and with authorities for securing political commitment for
the adoption of new NBF elements.
(*) Given the complexities of biosafety, ideally the Project Manager should coordinate as well as offer technical
expertise and specialized inputs into project activities. However, it is assumed that a person fulfilling both profiles
may not be readily found. In such a situation, the Technical Specialist would be contracted for specific technical
support, leaving coordination and management aspects to the Project Manager. Alternatively, if a professional that
fulfills both roles can be found, that person would be contracted on the understanding that approx 1/3 of their time
would be dedicated to technical support and 2/3 to project management. To allow flexibility between these two
options, the Technical Specialist is listed as a separate but complementary consultancy, but may become part of
project personnel if the situation so requires.
The Support Consultant shall:
1. Act as technical advisor the Steering Committee and the NPC as needed;
2. Orient with regards to resource persons, institutions and experts of international, regional or national
origin that are important for specific topics or tasks, or as references and information sources;
42
Appendix 12: Co-financing commitment letters from project partners
Below is the main Letter of Co-financing from ANAM, as the Executing Agency, which covers 47.8% of the
total co-finance requirements.
43
44
45
46
47
48
49
Appendix 13: Endorsement letter (for PIF) of GEF National Focal Point
50
51
Appendix 14: Draft procurement plan
EXPECTED PURCHASES OF NON-EXPENDABLE EQUIPMENT
Description
N° of
Units
Expected
Date of
Purchase
Expected
Price (US$)
or budget
available
Laptop computer
2
Project year 1
2,950
1,950
1000
Desktop computer
2
Project year 1
2,950
1,950
1000
Camara (digital)
1
Project year 1
Datashow
1
Project year 1
1,500
1,500
0
Scanner
1
Project year 1
Office furniture
TBD
Project year 1
SUB-TOTAL
Computer Programs and TBD
Licenses (*)
Throughout
project years
TOTAL
Funding source
GEF
Govt
8,100
3,100
5,000
15,500
8,500
7,000
15,100
5,100
10,000
30,600
13,600
17,000
(*) This item in the UNEP budget is considered under “Expendable equipment”
52