roject ocument s 1: project · pdf file1.12 project summary ... aims to cement the technical...

Annex 1: Project Document

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PROJECT DOCUMENT

SECTION 1: PROJECT IDENTIFICATION

1.1 Project title: Development of mechanisms to strengthen the implementation of the Cartagena Protocol in Guatemala

1.2 Project number: GFL/ 3630 PMS: 1.3 Project type: MSP

1.4 Trust Fund: GEF

1.5 Strategic objectives: GEF strategic long-term objective: BD3

Strategic programme for GEF IV: SP-6

1.6 UNEP priority: Environmental governance

1.7 Geographical scope: National Country: Guatemala

1.8 Mode of execution: External

1.9 Project executing organization: National Council of Protected Areas (CONAP)

1.10 Duration of project: 48 months (4 years) Commencing: Jan 2010 Completion: Jan 2014

1.11 Cost of project US$ % Cost to the GEF Trust Fund 616,364 47%

Co-financing 684, 232 53%

Cash

National Council for Protected Areas (CONAP) 131,000 10.1%

National Secretariat of Science and Technology (SENACYT) 32,000 2.5%

Sub-total (Cash) 779,364 60.0%

In-kind

National Council for Protected Areas (CONAP) 97,744 7.5%

National Secretariat of Science and Technology (SENACYT) 45,000 3.5%

Ministry of Agriculture (MAGA) 25,000 1.9%

Ministry of the environment (MARN) 17,988 1.4%

San Carlos University Faculty of Agronomy (FAUSAC) 50,000 3.8%

San Carlos University Faculty of Pharmacy 100,000 7.7%

Del Valle University of Guatemala (UVG) 35,500 2.7%


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Institute for Agricultural Science and Technology (ICTA) 150,000 11.5%

Sub-total (In Kind) 519,337 40.0%

Total 1,300,596 100%

1.12 Project summary

The goal of this Project is to facilitate compliance with and the implementation of the Cartagena Protocol through the establishment of a National biosafety system. Specifically, it aims to assist Guatemala to put in place a well articulated, effective and transparent national biosafety system through the development of the necessary policies, regulatory and technical instruments, and local capabilities in order to meet national development needs. The project is divided into four technical components: (1) Strengthening the legal, regulatory and policy framework on biosafety, (2) Implementing a functional national biosafety risk assessment and risk management system, (3) Creating the necessary institutional capacity and human resources for effective decision making and compliance in biosafety, and (4) Gaining experience in generating and managing biosafety information and public sensitization strategies.

The first component, strengthening the legal, regulatory and policy framework on biosafety to make it fully consistent with the CPB and national goals for sustainable development, will focus on assuring stakeholder participation in and facilitating the drafting of a National Biosafety Policy that will guide and orient the design of a national biosafety system and specify the types of legal instruments (governmental accords or ministerial agreements) required to implement it and make it operational. Additionally, it includes the drafting, approval and adoption of a comprehensive legal, regulatory and policy framework for biosafety.

The second component, implementing a functional national biosafety risk assessment and risk management system, aims to cement the technical foundations necessary to make a national biosafety system functional and efficient. These foundations include support structures and channels as well as adequate technical guidelines, tools, criteria and protocols for risk assessment and risk management.

The third component, creating the necessary institutional capacity and human resources for effective decision making and regulatory compliance in biosafety, is critical for achieving functional and effective biosafety system. This component aims to achieve capacity building through three strategies: defining research priorities that will generate locally important scientific information necessary to inform biosafety decisions and to identify funding mechanisms for them; intensively and continually training key personnel in stakeholder institutions on biosafety, risk assessment, risk analysis and risk communication, as well as the design and use of technical documents for this purpose; and providing the necessary laboratory infrastructure and scientific training so that the relevant stakeholders can meet the technical and scientific requirements of a National Biosafety System.

The fourth and last component, gaining experience in generating and managing biosafety information and public sensitization strategies, is critical not only for compliance with CPB guidelines but also for promoting public confidence in a national biosafety system. This component includes the joint development, with other stakeholders, of a national sensitization, communication and information strategy for biotechnology and biosafety; a revision and re-editing of relevant biosafety information to be communicated and adapted to different levels and local languages; renewed efforts to assure the participation of NCAs in the biosafety Clearing House, and the promotion of the BCH main and Guatemalan website as a useful tool and information source for risk assessment and management.

Although Guatemala has so far taken only basic steps to respond to its obligations under the Cartagena Protocol, the time is ripe to give further impulse to these initial efforts, given the foundations laid by previous projects and the growing interest of the private, public and scientific sectors to incorporate


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biotechnology applications, in a responsible fashion, as part of the country’s developmental process. This project therefore offers an opportunity to act proactively, rather than reactively, by setting up an operational national biosafety system before the pressure to utilize LMO applications augments or opportunities are lost as a result of inaction.


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TABLE OF CONTENTS

SECTION 1: PROJECT IDENTIFICATION .................................................................................................... 1 ACRONYMS AND ABBREVIATIONS ......................................................................................................... 5 SECTION 2: BACKGROUND AND SITUATION ANALYSIS (BASELINE COURSE OF ACTION) ...................... 6

2.1. Background and context ....................................................................................................... 6 2.2. Global significance ............................................................................................................... 9 2.3. Threats, root causes and barrier analysis ............................................................................ 10 2.4. Institutional, sectoral and policy context ............................................................................ 13 2.5. Stakeholder mapping and analysis ...................................................................................... 16 2.6. Baseline analysis and gaps .................................................................................................. 18 2.7. Linkages with other GEF and non-GEF interventions ........................................................ 21

SECTION 3: INTERVENTION STRATEGY (ALTERNATIVE) ...................................................................... 21 3.1. Project rationale, policy conformity and expected global environmental benefits ............. 21 3.2. Project goal and objective ................................................................................................... 23 3.3. Project components and expected results ............................................................................ 23 3.4. Intervention logic and key assumptions .............................................................................. 24 3.5. Risk analysis and risk management measures .................................................................... 27 3.6. Consistency with national priorities or plans ...................................................................... 29 3.7. Incremental cost reasoning ................................................................................................. 29 3.8. Sustainability....................................................................................................................... 30 3.9. Replication .......................................................................................................................... 31 3.10. Public awareness, communications and mainstreaming strategy ....................................... 31 3.11. Environmental and social safeguards .................................................................................. 32

SECTION 4: INSTITUTIONAL FRAMEWORK AND IMPLEMENTATION ARRANGEMENTS ......................... 33 SECTION 5: STAKEHOLDER PARTICIPATION ......................................................................................... 34 SECTION 6: MONITORING AND EVALUATION PLAN .............................................................................. 35 SECTION 7: PROJECT FINANCING AND BUDGET ................................................................................... 37

7.1. Overall project budget ......................................................................................................... 38 7.2. Project co-financing ............................................................................................................ 38 7.3. Project cost-effectiveness .................................................................................................... 39

APPENDICES .................................................................................................................................... 40 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 organogram ........................................................ Appendix 11: Terms of Reference ............................................................................................... Appendix 12: Co-financing commitment letters from project partners ....................................... Appendix 13: Endorsement letter of GEF National Focal Point .................................................. Appendix 14: Draft procurement plan .......................................................................................... Appendix 15: Tracking Tools .......................................................................................................

(see separate files for Appendices)


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ACRONYMS AND ABBREVIATIONS

National Council for Protected Areas CONAP National Secretariat of Science and Technology SENACYT National Council for Science and Technology CONCYT Ministry of Agriculture MAGA Ministry of the environment MARN Ministry of Health MSPAS Ministry of the Economy MINECO San Carlos University Faculty of Agronomy FAUSAC San Carlos University Faculty of Pharmacy FARMACIA Rafael Landívar University URL Del Valle University of Guatemala UVG Mariano Gálvez University UMG Institute for Agricultural Science and Technology ICTA Global environment Fund GEF United Nations Environment Programme UNEP United Nations Educational Scientific and Cultural Organization UNESCO United Nations Office for Project Services UNOPS Medium Sized Project MSP Project Identification Form PIF Evaluation and Oversight Unit EOU National Coordination Commission on Biosafety NCC National Competent Authority NCA Technical Office for Biodiversity OTECBIO Living Modified Organism LMO Cartagena Protocol on Biosafety CPB Convention on Biological Diversity CBD National Biosafety Framework NBF Biosafety Clearing House BCH Deoxyribonucleic acid DNA Polymerase chain reaction PCR Bacillus thuringensis Bt Standard Operation Procedure SOP


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SECTION 2: BACKGROUND AND SITUATION ANALYSIS (BASELINE COURSE OF ACTION)

2.1. Background and context

1. Modern biotechnology has, in the past forty years, had a widespread impact on economies and societies. Biotechnology applied to health and medicine has revolutionized healthcare and the medical industry, providing various breakthroughs and therapies to societies. Agricultural biotechnologies have already added tremendous economic value to crops, and can also add nutritional and health advantages if adopted. More recently, industrial biotechnologies are promoting more sustainable and environmentally friendly processes. The pace and potential of biotechnology research and commercialization is inextricably linked to guaranteeing a responsible use of this technology, one that respects the environment and human health. Biosafety is a key component for assuring the responsible and safe use of promising biotechnologies, especially of modern biotechnology and of living modified organisms (LMOs). Governmental policy, regulation, and capabilities regarding biosafety are crucial for a country’s ability to harness biotechnology for the benefit of the environment, the economy, and the general population.

2. Public acceptance of biotechnologies determines whether the benefits of new biotechnologies will be reaped by a particular country or society. This depends on how safe a population feels in regard to the State’s ability to discriminate between beneficial and detrimental activities, maintain oversight over such activities, and require accountability. Trusting institutions to successfully achieve these abilities only occurs if biosafety regulations, procedures and parameters are clear, fair and transparent. Obtaining economic and social advantages from biotechnology is possible only if the technology is accessible, local institutions can adapt it to local needs, and users can count on biosafety regulations and procedures to be user-friendly, clear and efficient, and most of all, achievable and adequate for decision-making. At the same time, assuring the safety and well being of the environment and human health requires that those regulations be technically sound and science-based, enforceable, and their impact and effectiveness monitored. Thus, the manner of regulating and managing biosafety can be central to a country’s development and conservation of the environment.

3. Guatemala began to set the bases for its biosafety framework through the Global Environment Fund (GEF) sponsored and United Nations Environment Program (UNEP) executed Project for the Development of a draft National Biosafety Framework (NBF) in 2002, and continued with the UNEP-GEF Biosafety Clearing House (BCH) project in 2007, to address specific BCH-related needs. One of the major outcomes of the Guatemala NBF project was the preparation of a proposal for a national biosafety law, which was submitted and presented by the Environmental and Natural Recourses Commission to the Guatemalan Congress, and the subsequent ratification of the CPB in 2004. Despite these milestones, full compliance with the country’s obligations as a Party has yet to be attained, as several barriers remain that need to be overcome. These include: a weak capacity and technical knowledge for assessing the risks and benefits associated with biotechnology products, and for making management decisions and enforcing them; only partial understanding of the tasks and responsibilities entailed in the full application of the CPB by the NCAs; poor technological infrastructure for ensuring compliance, especially in transboundary movements and monitoring; a high level of public misinformation on, and opposition to, LMOs; lack of effective means for strengthening public awareness on the safe use of LMOs; difficulties in achieving a balanced representation and participation of the different sectors of society in instances dealing with LMOs, and a poor science-base for decision making.

4. Guatemala is a mega diverse country and center of origin and domestication for several agricultural species of worldwide importance, including corn and beans. Environmental


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conservation and the establishment of protected areas are vital strategies for maintaining this rich biodiversity. Proper biosafety can play a key role in protecting biodiversity from exotic or invasive species. A growing population and an abundance of small and subsistence farmers continually apply pressure on protected areas and chip away at the country’s biodiversity through predation of natural environments. Technologies that improve yield per area, such as commercially available LMO crops could be beneficial both for small farmers and protected areas. Additionally, Guatemala’s economy has an important industrial agricultural component, making biotechnology, especially LMOs, attractive and potentially beneficial to this sector. LMO technology has proven in other countries to increase agricultural yields, reduce the application of herbicides harmful to humans, and reduce carbon emissions through reduced tilling and reduced application of various oil based or oil requiring inputs. Moreover, potential nutritional improvements of crops present interesting possibilities in a country where malnourishment is widespread. For example, the Guatemalan highlands have atypically high levels of births with neural tube defects (five times the world average), which have been linked to high consumption of fusarium infected corn. Establishment of this pathogen in corn can be prevented by the use LMO Bt corn.

5. In Guatemala, biotechnology applied to food, agriculture and health is widely adopted, mainly in the form of molecular biology-based diagnostics. Biotechnology applied to the environment is a budding area, focusing on non-LMO bacterial remediation and various enzymatic processes. Tissue culture, molecular biology, Polymerase Chain Reaction (PCR) and DNA sequencing capabilities exist in several academic, private and governmental institutions, to different extents. Transgenic bacterial strains are produced on a regular basis for confined laboratory use, as is common in academia worldwide. Only one academic institution has the capability and has experimented with the generation of plant and animal LMOs for the improvement of agriculture and public health, respectively, but this research has been confined to the laboratory and greenhouse. (Confined use, as defined by the CPB, includes laboratories and greenhouses, but the transboundary movements of LMOs destined for contained use are exempt from the advance informed agreement procedure of the CPB through article 6). At least two private institutions have expressed interest in the import and/or generation of agricultural LMOs for commercial use, but have been unable to do so due to incomplete regulation on the matter.

6. Guatemala ratified the CPB in 2004. Since its ratification, the country has developed some necessary tools and adopted certain strategies in order to implement the Protocol. However, it does not import LMOs for the purpose of growing them or releasing them into the environment, it does not produce LMOs locally, or therefore export locally produced LMOs. The import of LMOs for food is not regulated and is assumed to occur on a regular basis. It is important to note that most of Guatemala’s neighbours (El Salvador, Honduras, and Mexico) have already approved the use of LMOs to varying degrees. The porous nature of local borders (Honduras, El Salvador, and Guatemala are part of a free trade zone, for example) increases the probability that LMOs are growing in Guatemala in an unregulated manner.

7. Awareness of LMO technology and biotechnology in general is not uniform among the population and opinions regarding LMOs are varied and polarized. Most universities, public and private scientific research institutions, including the governmental advisory Biotechnology Commission, favour LMO technology and consider its responsible application safe and beneficial to the population and the environment. In contrast, several, but not all, environmental organizations oppose the introduction of LMOs and consider it a threat to the country’s biodiversity. Among the general population, understanding of biotechnology is scant; although newspaper media coverage of the issue is somewhat regular, it tends to be inaccurate.


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8. Previous GEF-funded biosafety projects collected valuable information regarding the legal, institutional and scientific status of biotechnology in Guatemala. A consultation process at the community level served as a basis for the drafting of a national biosafety law that was not approved by congress and was widely regarded by academic and private sectors as not science-based. However, parts of this proposed regulation have been adopted by the Ministry of Agriculture and the training and capacity building that resulted from this initial project have had a direct impact on the way that this particular Ministry was able to draft biosafety norms. Additionally, this first project spurred academic and private sectors to proactively get involved in biosafety and its regulation. Since this first law was proposed, many sectors have hosted international experts, attended training, and developed informed decisions and positions regarding different aspects of LMO biosafety. However, in the absence of an official state policy or the sufficient institutional and technical capacities needed to implement a biosafety framework, regulation in the area has been incomplete, slow to develop, and slow to adopt. A second project was successful in linking the country to the biosafety clearinghouse website, designating competent national authorities, promoting and educating them on the Cartagena Protocol, and developing a local biosafety website. Together, these projects identified and informed stakeholders, providing necessary communication channels and training for these stakeholders to develop certain biosafety guidelines and regulations. Most importantly, these projects have sensitized stakeholders as to the importance and urgency of establishing a national biosafety framework that is coordinated, well articulated, science-based, transparent and backed by a unifying national policy and adequate local scientific capabilities.

9. Stakeholder training and participation was circumscribed in previous projects to technical level positions which sometimes lack the scientific know how and/or institutional backing to make sound and binding biosafety decisions. Furthermore, overlapping legal mandates regarding institutions regulating biosafety have made it difficult for mid-level technical positions to negotiate and coordinate risk assessment and management responsibilities among these institutions. Thus, this next project seeks to reinforce institutional capacities and human resources, strengthening biosafety decision and management capabilities, at the same time that it promotes an inter-institutional effort to draft and implement a unifying state policy regarding LMOs, resulting in a concerted and institutionally backed strategy for the regulatory implementation of the Cartagena Protocol and the establishment of a functional biosafety risk assessment and management system.

10. Guatemala, through this project, intends to take biosafety to the next level, so that it can fully meet its obligations as a CPB Party; previous efforts were important first steps, but further progress needs to be made to bring the country to comply fully with the Protocol’s objectives. Firstly, this project will provide the coordination, funds and momentum to draft a National Biosafety Policy along with the regulatory framework required to back it, resulting in the necessary coordination for a national biosafety system that complies with CPB. Second, it will facilitate the necessary coordination and scientific advice to NCAs so that risk assessment and management can be carried out in a transparent and collaborative fashion, effectively implementing a comprehensive National Biosafety System that shares procedures and information, in contrast to the current isolated bureaucracies. Third, it will provide access to training and equipment, so that local capacities are strengthened and the proposed National Biosafety System can rely on informed and trained technical personnel, as well as the means to generate, analyze, and use locally generated biosafety information. Fourth, it will strengthen inter institutional biosafety information exchange so that it becomes comprehensive, focused and ongoing process. Finally, it will involve high level government officials in its steering committee, as well as technical level government personnel, academic and private sector representatives in two subcommittees, so that the steering and advisory structures are


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representative of political decision makers, public sector administrators and technical staff, and interested stakeholders.

2.2. Global significance

11. Guatemala’s biodiversity is immensely rich both in wild and cultivated species. Ecologically, Guatemala possesses seven biomes, one of which is unique to the country. Additionally, it houses fourteen different life zones, one of the highest levels in Central America. It ranks third on a list of thirty mega diverse countries worldwide. With regard to flora, it currently occupies third place for abundance of flora by unit area, which includes 7,754 species of reported plants, with 40% of these endemic to Mesoamerica. With respect to fauna, 62 species are endemic, with 2,027 registries of invertebrate’s species found in Guatemala. Its diversity of wild species is matched by its diversity in cultivated species. Guatemala is also center of origin for many economically important species, providing a natural reservoir of wild relatives important for humanity. Aside from being a genetic center of origin, it is also a center of domestication of several species that feed populations worldwide, such as maize, beans, squash and cassava (Yucca root or manioc).1 Importantly, 24% of all bean species, 43% of pumpkin species and 52% of all maize races known in Mesoamerica can be found in Guatemala, while certain cassava varieties are unique world-wide. This biodiversity is already considered to be highly threatened, by negative forces such as invasive exotic species and human intervention, thereby justifying the need to install effective protection, vigilance, and conservation mechanisms, including those preventing potential genetic erosion or natural habitat predation due to the adoption of improved varieties, including LMOs. This dual richness in biodiversity, comprising wild relatives and domesticated varieties, is of global significance and a valuable resource worldwide. A sound biosafety framework that protects the environment against the introduction of invasive, exotic or potentially harmful species is required for conservation.

12. Domestication of plants in Guatemala is inextricably linked to the culture and way of life of the peoples who domesticated them. The country’s indigenous peoples revere maize, as did their ancestors, as a seed that symbolizes life and rebirth. Images of the maize plant are present in ancient Mayan murals and pottery, and the sacred Maya book, the Popol Vuh, tells of how the gods created man from maize. The cultural importance of maize today is evident throughout Guatemala, regardless of ethnicity. It is the base for various drinks and foods such as stews, tortillas and tamales. The genetic diversity of domesticated maize varieties is evident especially in the highlands, where one can see a rainbow of maize varieties and food products, all stemming from the land race teosinte. Unfortunately, genetic diversity of wild relatives is quickly dwindling, due to predation of the teosinte plant’s natural habitat. Because of this cultural significance, conserving domesticated corn diversity is of primary importance to Guatemala, which in turn is of a global value. In this case, conserving a natural resource directly impacts the preservation of local cultures, unique and valuable in their own right, and part of the social fabric that has grown on the basis of the world’s agrobiodiversity.

13. Guatemala is also home to a growing population, more than half of which lives in some degree of poverty. More than half the population is less than 25 years old, resulting in a population momentum that the country will be ill equipped to deal with if natural resources are not better managed and better harnessed. Agricultural pressure on natural habitats is a growing problem, and improving the agricultural yield per area is of vital importance to the country’s people and environment. Hunger and malnourishment are common, highlighting the need of identifying or generating crops with high nutritional value. LMO technology promises to improve both

1 CONAP. 2006. Guatemala, un país megadiverso. Consejo Nacional de Áreas Protegidas. Guatemala. 22p.


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yield per area and nutritional value, making it an attractive technology for developing countries. Commercially available LMOs already improve yield per area, but the technology behind them can be expensive to acquire and transfer to local crops. Still, the local private sector has tried to import current LMO technology, creating a demand that cannot be met due to incomplete regulation in the matter. Some local universities and research institutions, however, are actively pursuing the identification of locally important traits for genetic transformation of local varieties and to address national priorities of little importance to international commercial sectors. In the long term, they aim to locally produce LMOs to address local agronomic and nutritional needs. For purposes of feeding a growing population, a sound biosafety framework is required to protect human health while making promising technologies accessible to populations that need them. Biosafety, then, can be a critical component of a country’s efforts in achieving at least two Millennium Development Goals: environmental sustainability and ending hunger and poverty.

14. The country’s main economic activity is agriculture. It is an important exporter of specialty vegetables, fruits, coffee and sugar. All of these agricultural sectors stand to benefit from biotechnology and at least some growers are actively pursuing LMO technology to remain competitive with their peers worldwide. Industrial agricultural activities can also pressure natural environments, and any technology that increases yield per area and could therefore limit transformation of natural habitats to agricultural land would benefit conservation efforts. An appropriate biosafety framework could enable the country’s ability to remain globally competitive and further its work in environmental management at the same time.

2.3. Threats, root causes and barrier analysis

15. Guatemala ratified the Cartagena Protocol in 2004, and is therefore required to monitor and regulate transboundary movements of LMOs. However, the country has been unable to do so and will most probably continue to lack necessary regulations, as well as adequate risk assessment and management capabilities in the absence of an inter-institutional and concerted effort. Maintaining this status quo implies having the technology in the country in an unregulated fashion while also not allowing the technology to be adopted in sectors that could benefit from it, because no regulation permits it. The main threats to biodiversity of concern to this project are therefore those elements that preclude achieving the objectives of the CPB. The biggest threat to implementing the CPB is the threat of not acting, or failing to implement adequate and sensible biosafety measures; the root cause of this is the lack of opportunity to plan and act in a coordinated manner. The main barrier to overcoming this threat is the difficulty that considering and weighing all the necessary view-points represents for NCAs, in order to reach agreements. Thus, sitting all interested parties at the same table and achieving a unifying policy that NCAs can agree to and jointly implement is a priority for the project.

16. Guatemala possesses some biosafety regulation but is far from possessing a functional and efficient biosafety system, capable of assessing and managing the potential risks posed by LMOs. There are several specific threats in the country to implementing such a system, such as incomplete or ambiguous regulation regarding biosafety, unclear processes and routes regarding potential approvals of LMOs, a lack of properly trained human resources, insufficient scientific infrastructure for adequate risk management, , incomplete scientific information about local environmental conditions to adequately inform decisions. However, the main systemic threat to implementing a National Biosafety System is a general uncertainty as to who is responsible for biosafety decisions and management. This situation undermines and even precludes the application of biosafety in the country. The main cause of this is the ambiguous and incomplete regulatory framework, and no clear political (policy) mandate.


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This is a direct result of the multiplicity of legal mandates that exist in several institutions regarding biosafety regulation. As long as all the institutions that can legally regulate biosafety remain in disagreement as to how to do so, there can be no unifying regulation or system that adequately assesses and manages risk. Additionally, this multiplicity of mandates severely hinders organized and efficient monitoring and enforcement of biosafety regulations, as the budget and personnel required for ensuring regulatory compliance discourages individual entities from assuming these roles in the absence of a clear mandate. Several barriers need to be overcome in order to address this threat, such as obtaining the necessary high-level political support, ensuring minimum sustained financing, and acting in a coordinated fashion. High level support and mandate for implementing a National Biosafety System would require all the relevant institutions to work together and determine individual responsibilities.

17. As three of the country’s neighbors, Mexico, Honduras and El Salvador, already approve LMO production, it is highly probable that LMO crops, specifically corn, is imported, planted and used in an unsupervised and unregulated manner in Guatemala. Guatemala is not self sufficient in terms of corn production and is dependent on imports to reach demand. El Salvador, for example, produces twice as much corn as Guatemala in much less area, and exports to Guatemala, as do Honduras and Mexico. The main source of imported corn in Guatemala is the United States, which cheaply exports corn for animal feed, most probably genetically modified. Of these countries, El Salvador and Mexico are parties to the CPB but Honduras and the United States are not.

18. A recent study aiming to identify the provenance of corn sold in the highland markets found that most comes from the lowlands or is imported. The study also focused on the quality of the corn and its fumonisin content (a toxic compound produced by corn infesting fungi, which causes neural tube defects in newborns). Commercially available varieties of LMO corn, however, are not currently suited for cultivation in Guatemalan highlands, where most corn genetic diversity lies. This makes it unlikely that corn purchased for food is also used by farmers for planting in the Guatemalan highlands. Although many lowland producers choose to buy certified seed every year, because of increased yields, it is impossible to estimate how many lowland farmers use imported corn bought as food for planting. It is also impossible to estimate how many farmers, if any, are purposefully using illegally obtained LMO corn seed for planting. In analyzing the quality and provenance of corn sold in highland markets, the aforementioned study found that lowland corn tended to be of poorer quality and was more prone to fungus infestations, which may indicate that Bt LMO corn is not reaching highland markets in significant proportions (since Bt corn is protected against insects that in turn permit fungus infestation).

19. The threat to CPB implementation, then, is possible unregulated planting of LMOs in Guatemala, as well as definite unreported import of LMOs as food. The root of the problem lies in lack of adequate regulation of biosafety and the absence of coherent risk assessment and management systems or protocols. Although import, planting and/or use of LMOs are not fully regulated, neither are they out rightly prohibited. This legal uncertainty regarding use of LMOs has hindered technology transfer in the agricultural sector and has also undermined public confidence in the government’s ability to apply proper biosafety procedures. The main barrier to resolving this uncertainty is, again, the lack of coordination in terms of regulatory instruments and guidelines. Inter-institutional and coordinated regulation is a key aspect for achieving a transparent and manageable National Biosafety System, and is part of this project’s goals. Another barrier to addressing unregulated use of LMOs is lack of farmer knowledge regarding the different seed types. Both these barriers will be addressed in the project, the first through implementing a National Biosafety System, derived from a National


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Policy and backed by appropriate regulations, and the second through a comprehensive sensitization strategy. Developing inter-institutional coordinated regulations is an indispensable requirement in order to achieve CPB compliance.

20. The country’s growing population pressure poses a risk to the environment and its biodiversity. There are special concerns that an increase in agriculture and adoption of foreign varieties or crops may lead to irreversible genetic erosion of native species. Agricultural activity is the single biggest cause of genetic erosion and loss of natural habitats and their biodiversity. Increased demand for agricultural land can destroy entire ecosystems, especially in a country as diverse as Guatemala, where an ecosystem can be limited to a specific valley or altitude range. Genetic erosion is a byproduct of the introduction of improved crops, which are quickly adopted and may displace locally developed varieties. Genetic erosion may occur as a result of the introduction of any improved crop, regardless of the technology used to generate it. Cost benefit analyses developed for and employed by an adequate biosafety system can therefore be applied to a variety of situations, not exclusively involving LMOs, but all involving the introduction of new species or varieties to the country. This may include exotic species, potentially invasive species, or improved varieties of native plants. Cost benefit analysis is currently not applied to non-genetically modified introductions, and promoting the application of cost benefit analysis and appropriate biosafety measures to non LMO new introductions is not the aim of the project. However, the capacity building expected from the project could easily inform and spur on risk management of all novel agricultural introductions.

21. Important barriers to addressing genetic erosion in the country are the lack of communication between stakeholders, the low impact of policies or initiatives to promote the use and conservation of local crop varieties, and the lack of a unifying government policy on the matter. A national biosafety strategy or policy must include conservation aspects, such as germplasm and seed banks, and in situ and ex situ conservation, which would complement a biosafety system and contribute to the conservation of genetic diversity as part of a concerted strategy. The National Biosafety policy, along with its implementation strategy, should contain biodiversity valuation and conservation aspects complementing biosafety measures.

22. The Guatemalan government is under intense pressure to fulfill education, health, security and other social obligations, and consequently assigns little or no budget for scientific or technical training, infrastructure or research. The capacity building required in order to design and implement a biosafety system appropriate for Guatemala’s needs would hence be difficult to achieve with current government funding. However, a National Biosafety System cannot function without the necessary human capacities to carry out proper risk assessment and management. In general, even among NCA technical and upper level staff, there is poor understanding of what proper biosafety is and little knowledge of the technologies that require regulation under the Cartagena Protocol. While most NCAs agree that the necessary regulatory and administrative tools for implementing a National Biosafety system need to be developed, they remain uncertain as to the technical and institutional requirements necessary for a well articulated system.

23. Thus, there are two related threats regarding expertise that could hinder proper CPB implementation. First, without adequate expertise, risk analysis and management measures will not be science or evidence-based. The root cause is misinformation, lack of trained personnel, and no official scientific advisory structure that NCAs can fall back on. The main barrier to overcoming this threat is lack of human capacity, which can be regarded as a threat in and of itself. In fact, lack of human capacity and training is a significant threat to implementing a National Biosafety System and CPB compliance. The root causes are lack of funding for human and institutional capacity building, the little importance given to the


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subject in various NCAs, and lack of personnel assigned specifically to biosafety aspects. The main barrier to overcoming this threat is sensitizing high level decision makers so that they assign personnel time and resources for training and capacity building. The project aims to overcome this barrier by providing training and capacity building, as well as sensitizing and lobbying institutional decision makers so that official agreements are made guaranteeing participation in training activities. Additionally, it aims to establish the necessary scientific advising structures to guide the development and use of adequate risk assessment and management tools and methodologies.

24. Unauthorized transfer, planting and use of LMOs can be a significant threat to consumer confidence and public perception of governmental institutions. Additionally, lack of clarity or transparency can increase risk perception of a given technology. Public sensitization strategies and information exchange are important aspects for public acceptance and confidence in new technologies, as well as the government’s ability to adequately protect the consumer. However, there are no concerted efforts among NCAs to educate the public on biosafety or to promote information exchange between NCAs and other stakeholders. This is a threat to CPB implementation, since information exchange is an important part of biosafety management. The root lies in poor understanding of NCAs as to the importance of biosafety information exchange and compliance with the Biosafety Clearing House (BCH), as well as little budget and know how destined to public sensitization strategies. The main barrier to this threat is that information exchange and public sensitization are low priority activities for NCAs, and that governmental institutions do not generally possess the necessary expertise to launch public communication campaigns. The project aims to promote information exchange and facilitate sensitization processes.

2.4. Institutional, sectoral and policy context

25. A 2002 GEF funded project identified the legal mandates of various institutions in terms of regulating biosafety. By law, the Ministry of Agriculture, Livestock and Food (Ministerio de Agricultura, Ganadería y Alimentación, MAGA) is responsible for regulating any animal or plant introduction into the country for the purpose of local production and environmental release. Whether regulation applies only to first time introductions or to subsequent ones as well varies depending on the species being introduced. Food safety and therefore the introduction of plant or animal products for direct consumption or processing are regulated by the Health Ministry (Ministerio de Salud Pública y Asistencia Social, MSPAS). However, the Ministry of the Environment (Ministerio de Ambiente y Recursos Naturales, MARN) can regulate, if it chooses to do so, any activity that affects the environment. Thus, the Ministry has a list of activities that require an environmental impact analysis (for example, all construction permits need to have a MARN approved environmental impact analysis in order to be issued).

26. This broad legal mandate creates an overlap in regulating abilities and generates confusion as to who should regulate biosafety. Currently, the Ministry of the Environment lists LMOs as items that need to be evaluated for environmental impact, not risk assessment, which is the type of analysis that MAGA and the CPB require. Since an environmental impact analysis is not applicable to LMOs, approvals of LMO introductions in Guatemala are virtually impossible. An environmental impact analysis is concerned with documenting the physical impacts that result directly from a particular activity (such as excavations, building of infrastructure, clearing of land) in order to determine if those impacts -that will definitely occur- should be allowed an how they should be handled. Risk analysis or assessment, in contrast, is concerned with documenting the potential or theoretical risks associated with a


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particular activity, which may or may not result in physical impacts, in order to determine whether those risks are acceptable and manageable. (Both use strategies to minimize the outcomes, but one will focus on probable impacts while the other on potential risks). It then becomes an arduous task to properly characterize the impacts that releasing an LMO will definitely have or not have.

27. In addition to MARN, the National Secretariat of Science and Technology (Secretaría Nacional de Ciencia y Tecnología, SENACYT) is, by law, responsible for developing and coordinating research policy, and regulating all research activities. It has legally constituted Biotechnology Commission, and multi-sectoral advising structure, whose purpose is to advice the government on biotechnology related scientific issues. This has also generated an overlap in mandates, since the previously proposed biosafety law attempts to regulate research activities involving the confined use of LMOs, something not mandated (as such) by the Cartagena Protocol. Finally, the Ministry of the Economy (Ministerio de Economía, MINECO) is in charge of quality standards and recommendations, and has expressed interest in exploring issues regarding LMO labelling. It is worth noting that none of these institutions have yet assumed monitoring and enforcement roles, since no LMO approvals have ever been granted.

28. The national council for protected areas (Consejo Nacional de Áreas Protegidas, CONAP), given its role as CBD and CPB focal point, has been tasked with the difficult job of leading the implementation of the Cartagena Protocol while having no constitutional legal mandate regarding biosafety. Because of this, CONAP has adopted a coordinating role, lobbying the necessary institutions for support in biosafety projects and promoting the importance of biosafety to different authorities, so that they assign the necessary personnel for training and implementation.

29. The main institutions relevant to biosafety are therefore: MAGA, MARN, MSPAS, SENACYT, MINECO and CONAP as the coordinating agent. All of these institutions have participated in previous GEF funded projects and have benefited from training, capacity building and information on the Cartagena Protocol. However, a lack of continuity in government posts poses a great challenge to maintaining a pool of informed and trained officials in the area of biosafety. The institutions with the most turnover have very limited understanding of biosafety and suffer from lack of high level internal support for developing these capabilities. In contrast, institutions like the Ministry of Agriculture, where technical personnel concerned with biosafety has endured over several administrations, there is an active pursuit to further biosafety regulation based on the guidelines set by the Cartagena Protocol.

30. Aside from institutions with a legal mandate to regulate biosafety, there are other institutions with an interest in biosafety and/or abilities to provide technical support for a biosafety system. The private sector, in general, supports LMO technology and has lobbied in favor of science-based biosafety regulation that permits LMO production in the country. The main parties interested in planting LMOs are corn seed producers, the sugar industry, and banana farmers. Academic sectors have, in recent years, become very involved in mobilizing experts and holding forums and seminars concerning LMO technology and Biosafety. Some of these activities have been funded by the Secretariat of Science and Technology. Environmental groups do not have a unified position. Some have an ideological opposition to even allowing biosafety regulation or protocols to be drafted, assuming biosafety equals LMO introductions. Others have opted for learning more on the subject and actively participating in biosafety events in order to inform their positions. In the public sector, there is publicly funded research institution for agricultural science and technology (Instituto de Ciencia y Tecnología Agrícola, ICTA). This semi-independent institute is part of the Ministry of Agriculture and, though it


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doesn’t explicitly have a legal mandate to regulate biosafety, would be the natural entity to provide the technical support for biosafety risk assessment and management.

31. There is no official government policy to guide biosafety decisions; however, various institutions have developed internal guidelines or positions. The only government backed policy that touches on the matter is the National Biotechnology Program (a sub program of the National Science, Technology and Innovation Plan), drafted by the Biotechnology Commission of the Secretariat of Science and Technology. Although this program is mainly concerned with defining research priorities and strategies to support and develop research capabilities, it explicitly states that one of its priorities is to support an appropriate legal framework that facilitates research and commercialization of biotechnology while protecting the environment, population and intellectual property. As part of that priority it indicates that it is necessary to (1) analyze existing regulations and promote the creation and implementation of a legal framework that differentiates between research and commercialization of biotechnology, and (2) encourage risk evaluation based on scientific evidence. It also considers outreach an important angle for promoting biotechnology adoption. Additionally, the Biotechnology Commission has officially released a statement endorsing agricultural biotechnology and its applications. Finally, the National Science, Technology, and Innovation Plan, specifically calls for a special sub-program on LMOs, which has yet to be drafted. The drafting of this program will take place during the implementation of the project and in collaboration with it. As part of the implementation of the National Biotechnology Program, the Biotechnology Commission has, in recent years, been the most active institution in mobilizing experts and organizing biosafety events.

32. The MAGA has, since the first GEF project was implemented, revised and re-drafted its regulations regarding biosafety. The currently approved regulation is the Ministerial accord 386, which regulates the import, field research, production and export of LMOs, but does not allow internal commercialization of LMO varieties. This regulation was drafted based on the capacity building which resulted from the first GEF funded project in Guatemala, and took on board elements from the law proposal which was drafted and presented to Congress, but not approved. The MARN has recently mandated that the necessary protocols for risk assessment be developed and applied to the appropriate situations. It is important that the appropriate technical and scientific support is provided to their effort.

33. Previous biosafety projects were useful in identifying the legal and sectoral context regarding biosafety regulation, as well as identifying key stakeholders and bringing them together. More importantly, the training provided during the first and second biosafety projects has had a direct impact on the current regulatory structure, since it was used by MAGA to draft its current regulations and by SENACYT’s Biotechnology Commission to define its position and recommendations regarding LMOs. However, the main result of the first National Biosafety Project, a proposed law to congress, was not approved or widely supported. This has to do with the intricacies of the Guatemalan government as much as with the law itself.

34. There are several hierarchies of regulation in Guatemala, the broadest and most permanent being a law passed by congress. This type of regulation trumps all other (except that stated in the constitution) and must be adopted by all parties. Less permanent but equally binding are governmental accords or decrees. This type of regulation is emitted by the president and endorsed by congress, but does not go through the congressional law making process and voting. It is less permanent than a law in that new presidents may abolish previous accords at will, without the approval of congress. A law, in contrast, must be revoked by a majority of congress members. However, it still supersedes internal or individual regulation by government entities such as ministries. Ministries are able to individually regulate through Ministerial accords or decrees. This type of regulation does not need to be adopted by other


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Ministries and is the least permanent form of regulation because a new Minister can abolish or change accords or decrees at will. Currently, existing biosafety regulation exists as ministerial accords, but different ministries are not in agreement over the regulations. Passing a law through congress is a very difficult process in Guatemala, especially if such law does not represent a priority to members of congress, as is usually the case with environmental regulation. For example, the law regulating transport, commercialization, protection, and access to plant seed material was proposed over 15 years ago and not yet approved. Therefore, although a law is a very permanent way of regulating, it is extremely difficult to regulate through laws from a practical point of view. Regulating through a law is probably not the best option for achieving CPB compliance. Regulating through governmental accords or coordinated ministerial accords is more feasible and achievable than proposing a law. Additionally, regulating through such means requires more consensus building, which, in this case, is a positive aspect that contributes to the implementation of the regulation.

35. The first biosafety Enabling Activity (NBF Development project) carried out in Guatemala collected valuable baseline information and proposed a national biosafety law that was never adopted. In that law, it was stated that a local National Coordinating Committee would oversee the drafting of a National Biosafety Policy. Five years later, it has become evident that the lack of a biosafety policy is one important reason why the proposed law was not passed nor its components adopted. A national policy, by necessity, needs to be inter-institutional, coordinated, and in line with existing national policies, laws and international obligations. A national biosafety policy could be, therefore, inserted into a wider biodiversity policy and institutionalized more easily than a stand-alone law. The inter-institutional nature of a policy inherently results in a role-clarification process, where different stakeholders affected by the policy must discuss and organize their respective roles, mandates and responsibilities. Such a process facilitates the approval and adoption of any regulation resulting from the policy. Furthermore, even if regulation is not approved, a National Policy reached through consultation and consensus is more likely to be implemented or adopted individually by participating stakeholders than independent regulation. Therefore, a lesson learned from that previous project and applied currently is that a National Policy must precede the proposal of any regulation, such that approval and adoption of such regulation is facilitated, biosafety guidelines can be drafted and implemented even in the absence of official regulation, and individual stakeholder roles, mandates and responsibilities are clarified.

36. A main objective of the current project is to obtain high level support for a unifying biosafety policy, which would require all the interested and legally obligated parties to clarify their roles, develop joint instruments and procedures, and establish a coordinated biosafety system. In this way, the project would not only build the necessary capacities for assessing and managing risk, but also lay the groundwork for a national biosafety system that clarifies roles and assigns discrete responsibilities to those institutions that should legally regulate biosafety.

2.5. Stakeholder mapping and analysis

37. As mentioned, there are four governmental institutions that, by law, can regulate or define policy regarding Biosafety: MAGA, MARN, MSPAS and SENACYT. CONAP acts as the coordinating entity for these institutions, and as the focal point for the purpose of external communications with the CBD Secretariat. Additionally, there are several interested parties with a say in biosafety and its regulation, including industry, academic institutions, and environmental organizations.


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38. Of these four governmental institutions, the leader in implementing biosafety regulation has been the Ministry of Agriculture. Its norms and regulations unit has trained personnel and have experience receiving requests for LMO introductions and assessing risk. It is important to note that their personnel were trained thanks to the first UNEP-GEF Biosafety Project, and that that training has been put to use and maintained over the past seven years. It is the only government entity that has officially approved regulation in terms of biosafety, as although the environmental regulation that exists encompasses LMOs, it is not specific for biosafety. In general, this Ministry supports science based regulation, analysis on a case by case basis, and has sought out the opinions of other stakeholders. For example, requests for LMO introductions received by MAGA have been referred to SENACYT and ICTA for consultation, even though no regulation requires this, and their expert opinions have been taken into account for approval purposes. However, it has not granted any official approvals, since they also believe in obtaining the consent of the Ministry of the Environment. The MAGA has thus emerged as a model of what cooperation in biosafety could look like in Guatemala. However, it lacks all the necessary regulation and support systems, such as monitoring and enforcement strategies, rightfully arguing that a biosafety system needs to be government-wide, not independently sectioned by Ministry. It is interesting to note that, while the Ministry possesses regulation, it does not have an official position or policy regarding LMO introductions.

39. The leader in policy applied to biotechnology is SENACYT. It is the only entity with an official policy that touches on biosafety and its regulation. Furthermore, this policy has been elevated to state policy, since the National Council for Science and Technology, which oversees the secretariat and approves its policies, is led by the vice president and includes participation from a representative of congress and representatives from private and academic sectors. The ability of the secretariat to draft state policy and gather high level officials to approve it presents an advantage that can be leveraged by involving the secretariat in this project. Additionally, the aims and scope of this project fit with the biotechnology program and present an opportunity to further implement it.

40. Biosafety, historically, has not been a priority for the Ministry of the Environment. This is not to say biosafety is not of interest to the Ministry. This relatively young Ministry has faced countless bureaucratic and environmental challenges as it tries to apply safeguards and appropriate oversight of activities with environmental impacts. It has had to do so while dealing with older ministries, who may have overlapping legal mandates with them and well established spheres of influence. All this with relatively little budget in comparison to its counterparts. Thus, biosafety is not a top priority. The MARN, however, is actively seeking to develop the necessary instruments and procedures to adequately assess risk and has accepted that environmental risk and environmental impact are two different concepts. It will be a challenge to sufficiently garner the Ministry’s attention and argue convincingly that dedicated personnel is needed for the issue of biosafety.

41. The Guatemalan Health Ministry is a large entity with a broad range of mandates, one of which is regulating and assuring food safety. Biosafety of LMO introductions is not of special interest to the Ministry, in part because there has been little or no demand for its involvement in the issue. Additionally, LMO food products and sub products have a history of entering the country in an unregulated manner, without any documented adverse health effects. In general, LMO food products have to go through an approval process in other countries prior to export. In this way, Guatemala relies on the food safety assessments carried out in LMO producing countries where those LMOs are also commercialized and consumed. However, no guidelines exist for any potential LMO food products developed internally. This Ministry has expressed


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its willingness to participate in this project and is especially interested in capacity building, since accurate knowledge on Biosafety is what the Ministry lacks the most.

42. The National Council for Protected Areas will be the entity in charge of executing the project and promoting the implementation of the CPB. As the national focal point for the Protocol, it must coordinate the stakeholders in a collaborative fashion. Its leadership will be critical in order for such a diverse group of entities to agree to clarify their competence on the matter and assign responsibilities. Furthermore, it will have to include other interested sectors who want to participate in the matter. The success of the project will rest on the Council’s ability to convoke and keep the stakeholders at the table and promote the adoption of the project results.

43. The ICTA is the government entity responsible for development of improved varieties and maintaining the national germplasm bank. It is potentially a key stakeholder in that it could provide the necessary scientific expertise to back a national biosafety system, including inputs for risk assessment and technical support necessary for risk management. It is a potential partner for scientific capacity building required by the national biosafety system. It stands to gain from eventual technology transfer in modern biotechnology, and will likely be interested in promoting a combination of pro-biosafety and pro-biotechnology measures in the country.

44. The academic sector, although not unified, is an influential stakeholder in biosafety. Not only would they be directly affected by any biosafety regulation concerning LMO research, they would also be responsible for generating the necessary information for assessing and monitoring risk in a science based manner. In recent years this sector has become more active in national discussions regarding biosafety, and has lobbied intensely for science based regulation and for differentiating between research and commercialization of LMOs. This sector is willing and interested in participating in this project.

45. The private sector, including industry and social and environmental organizations cannot be treated as a single stakeholder. Both are well connected and organized with international lobbying groups, but can have opposing interests. The private industry, especially agricultural industry, has a clear agenda of facilitating LMO technology and understands the critical aspects of biosafety that may affect it directly. This stakeholder group is interested in participating in the discussions and making sure their arguments are considered. Some environmental organizations, on the other hand, view the concept of biosafety as a threat in itself, because it considers risk management is possible and accepts case by case analysis. These organizations are a potential threat to this project; since they seek a prohibition of LMO technology, they view a national biosafety system as a path for LMO approvals and may seek to oppose it (biosafety, and hence the project) completely.

2.6. Baseline analysis and gaps

46. This project aims to (1) Strengthen the legal, regulatory and policy framework on biosafety, (2) Implement a functional national biosafety risk assessment and risk management system, (3) Create the necessary institutional capacity and human resources for effective decision making and compliance in biosafety (4) Gain experience in generating and managing Biosafety information and public sensitization strategies. The project’s logical framework comprises these four areas of work and describes a baseline for each (Appendix 4). These four components seek to address the threats, root causes, and barriers described in section 2.3, mainly lack of NCA coordination, a multiplicity of NCA legal mandates regarding biosafety, absence of tools, methodologies, and institutional and human capacity regarding biosafety decision making, and poor public sensitization and NCA information exchange.


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47. The biggest obstacle to a coherent national biosafety framework is the lack of a national policy that clarifies overlapping institutional mandates and specifies the types of legal and regulatory instruments necessary to implement such a framework (laws, governmental accords or ministerial accords). The first aim of the project will be to facilitate and coordinate the drafting of a national policy on biosafety and assist the preparation and adoption of the regulation defined as necessary by this policy. At this time, no unifying policy exists; rather, different institutions with overlapping legal mandates partially regulate biosafety, if at all. There are no established or official communication routes for biosafety information, requests, or files between ministries or competent authorities, or any joint instruments or procedures that indicate the existence of a biosafety system. Although some regulation regarding biosafety exists, it does not fully regulate necessary biosafety aspects. It will be necessary to build upon this existing regulation, which already follows the guidelines set forth by the Cartagena Protocol, to flesh out an adequate biosafety system.

48. Currently, there is uncertainty as to who is responsible for making final decisions regarding biosafety risk assessment and management. Additionally, no entity has a clear mandate for post-approval follow-up (enforcement of regulations and monitoring of authorized activities) or has assumed such a role. Only one Ministry, MAGA, has personnel whose job description includes dealing with biosafety issues, other institutions have not assigned any budget or personnel for this purpose. In order to complement such units or personnel, it may be necessary to establish a scientific advisory group on biosafety. Previous GEF funded projects established an ad hoc biosafety commission that has operated sporadically in the past years. This commission is representative of several institutions, but is not scientific. It may be necessary to build upon this commission to develop appropriate advisory mechanisms for biosafety decision-making. In the end, this project should be instrumental in the definition of a national biosafety policy, the design and implementation of a biosafety system which clearly defines who is responsible for decisions regarding biosafety and establishes scientific advising mechanisms, and the identification and drafting of the regulation required to make the system operational.

49. In order to implement the technical aspects of a national biosafety system, it is necessary to devise the specialized instruments, guides and processes associated with a science and evidence based risk assessment and management system. The second aim of this project will advise and promote the joint development of such documents between the stakeholders identified and assigned to do so by the national policy resulting from the first specific aim. Currently, only the Ministry of Agriculture has official guidelines as to how to assess and manage risk, applied only to the introduction of LMO plant seed. There are no joint or encompassing instruments or criteria designed for risk assessment and/or management of LMOs for environmental release. Additionally, there are no validated technical guidelines for laboratory based monitoring of LMOs, which in turn inform the effectiveness or appropriateness of risk management strategies. Reinforcing the technical aspects, criteria and guidelines for effective biosafety risk assessment and management, as a complement to drafting policy and regulation, will ensure that policy can be implemented and regulation enforced as soon as it is adopted. It will also provide the technical capacity to assess and manage biosafety risk independently of whether or when regulations and/or policy are adopted.

50. A coherent and effective national biosafety system can only be functional and its protocols applied if the necessary human resource, technical capacities and infrastructure exist to provide the necessary scientific expertise and evidence. The third aim of this project focuses on creating the necessary institutional capacity and human resources for effective decision making and compliance in biosafety. This involves setting research priorities regarding


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biosafety, training personnel in biosafety risk assessment and management, and equipping and training laboratories and their personnel in the techniques and procedures necessary to support an adequate biosafety system. Currently, research regarding LMOs and local biodiversity is defined by the particular researcher´s interest. There are no national priorities or funding incentives that orient or promote research that could inform, support and evaluate biosafety decisions.

51. Officials and scientists involved in national biosafety discussions agree that, even within the institutions that already regulate biosafety, expert personnel in biosafety is lacking in all the relevant institutions. A disparate level of knowledge among those concerned with biosafety in various institutions has been detected. The level of training and knowledge of different officials or personnel in stakeholder institutions can be considered a baseline gap. Various workshops and seminars have been conducted regularly by different stakeholders. However, the sometimes frequent change in government positions and officials warrants the establishment of a permanent training module on biosafety, as well as an intense preparation for those involved in drafting policy and supervising regulation and technical procedures. Additionally, long term training opportunities in biosafety exist abroad and have not been taken advantage of locally.

52. A functional biosafety system needs the support of technical capacities and infrastructure that can monitor risk, detect unapproved use or introductions of LMOs, and generate relevant information to evaluate if risk management procedures are effective. These technical capacities and infrastructure are interspersed among different universities and research institutes that have personnel trained in molecular biology and have acquired basic equipment such as PCR machines and other molecular biology and immunology equipment. Only one university currently has equipment and personnel dedicated specifically to evaluating if a particular material is genetically modified. However, it is important that several institutions have these capabilities to increase confidence in a biosafety system. Aside from this type of capabilities, scientific training in sampling and monitoring for unauthorized introductions, as well as validated and standardized protocols for sampling, monitoring and evaluation, do not exist in Guatemala and would be beneficial for strengthening a biosafety system.

53. Generating and managing biosafety information is basic for compliance with the Cartagena Protocol on Biosafety and for fostering public confidence on government abilities to guarantee biosafety. Additionally, the Biosafety Clearing House (BCH) can be a valuable resource should be promoted locally and can be modified to fulfill local needs. The biosafety clearing house website and its Guatemalan version (CIISB) provide an initial mechanism for information exchange but is underutilized. The last part of this project aims to gain experience in generating and managing biosafety information and public sensitization strategies. Communication and public sensitization of biosafety risk has been sporadic and uncoordinated with other entities. Consultation with stakeholders revealed a need for a concerted information strategy on biotechnology, with biosafety as an important part. Information regarding biosafety has been generated in previous projects, and could be updated and adapted for different technical levels and local languages. The current list of National Competent Authorities (NCAs) for the BCH does not encompass all the necessary stakeholders, and those who are represented do not input information regularly. In part, this is due to there not being an official procedure for LMO approvals, resulting in little information to report. On the other hand, NCAs need to be sensitized and encouraged to input the information they do generate or have. The BCH is also promoted as an information resource, but it is not used for that purpose locally. Adapting the local BCH website to fulfill local information needs is an interesting possibility.


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2.7. Linkages with other GEF and non-GEF interventions

54. At a regional level, GEF approved last year the project “Latin America: Multi-country Capacity-building for Compliance with the Cartagena Protocol on Biosafety” (project 2689, http://www.gefonline.org/projectDetailsSQL.cfm?projID=2689). This project also aims to contribute assessment experience that will help to coordinate and standardize biosafety procedures, as well as invest in capacity building, in five countries. It may be productive to coordinate training efforts and share technical documents, in order to minimize costs, improve technical tools, and link local capabilities with other regional resources for the continued sharing of strategies, techniques and information.

55. At the national level, UNESCO is currently funding the design of a human resource training strategy in biotechnology, coordinated by SENACYT. It is important that training in biosafety be included as a priority, so that long term training strategies, such as master’s and doctorate programs, become more accessible. The project will collaborate with this process to ensure that biosafety is represented as a training priority. SENACYT emerges as an integral partner for this project, since cooperation within the project on at least two initiatives will reinforce long term impacts and sustainability of project results. These initiatives include research priority setting regarding LMOs, which will over time provide valuable scientific information to inform risk assessment and management, and the drafting of a National Biotechnology and Biosafety Sensitization Strategy. Additionally, other cooperation strategies with local NCAs are outlined in section 5.

SECTION 3: INTERVENTION STRATEGY (ALTERNATIVE)

3.1. Project rationale, policy conformity and expected global environmental benefits

56. The components proposed in the current MSP aim to address gaps in capacity or barriers identified during previous projects and during the consultation process carried out as part of project preparation activities. By building on previous outcomes, they focus on priority needs relating to public awareness, defining and expanding the current regulatory framework, strengthening institutional mechanisms and structures already in place, putting into practice risk assessment and risk management practices, training (including the establishment of long-term programmes), monitoring and enforcement, and ensuring sustainability of results and full integration of relevant authorities. The establishment of a workable and cost effective biosafety system, through which each intentional transboundary movement or domestic use of LMO can be properly processed and the safe use of biotechnology can be promoted, will contribute to the conservation and sustainable use of biodiversity and reduce potential risks to wild relatives and agro-biodiversity in Guatemala, thus helping to achieve the global environmental goals of the CBD and CPB.

57. The first biosafety project centered on collecting baseline information, and then directly focused on drafting a law without a previous policy drafting process or discussion as to the necessary regulations needed for biosafety. The central theme of the current MSP is clarifying the different competences and responsibilities of the interested stakeholders, especially those with overlapping legal mandates to regulate biosafety, at the same time that capacities are built and reinforced within key institutions. In this way, the necessary institutions will have both a roadmap for coordinating biosafety efforts and the expertise necessary to do so, enabling them to take on their function as NCAs. This project will therefore strengthen the institutional capacity of relevant competent authorities and cement the coordinating role of the National Council of Protected Areas, given its status as both CPB and BCH Focal Points. Ultimately, competent authorities will be able to manage biosafety in a manner coherent with the


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objectives and procedures of the CPB. The installation of biosafety management within several institutions in the form of joint programmes, plans and campaigns, together with a better understanding of the issues at stake and the workings of the CPB, as well as the strengthening of decision-making structures and bases, will not only be key for ensuring the sustainability of the capacity being built, but also for making the decisions and safeguards taken in biosafety more effective, transparent, coordinated and technically-sound. For this the national biosafety policy, combined with new biosafety regulations, will be the main foundations on which institutional efforts will be based and sustained, as will the Training Program for the use, management and regulation of biotechnology, and the consolidation of various institutional agreements, such as that to increase capacity-building through cross-sectorial collaborations.

58. The scope and specific activities of the proposed MSP have been defined through a PPG, which included a proper stocktaking exercise characterized by stakeholder involvement that covered those areas defined in the GEF Strategy for Financing Biosafety. The project design responds to real country needs and priorities and therefore exhibits some fine tuning with respect to the original PIF. Extensive efforts taken to ensure stakeholder buy-in during project design have improved the original concepts, resulting in a more realistic and collective strategy for implementing the Cartagena Protocol.

59. Guatemala has been a Party to the CBD since 1995 and to the CPB since 2004 (Legislative decree 23-2004). Two previously GEF funded projects worked towards implementing the Cartagena Protocol and have linked these efforts to other national priorities, such as The National Policy on Food and Nutritional Safety, The Framework Policy on Environment Management, the National Strategy for the Preservation and Sustainable use of Biodiversity, the National Plan for Science, Technology and Innovation and the National Biotechnology program (further described in section 3.6). The creation of a solid biosafety framework is therefore fully concordant with several government policies, with the country’s conservation priorities, and with the fulfilment of Objectives I and VII of the Millennium Development Goals of Guatemala, which aim to eradicate extreme poverty and hunger (through development and adoption of new technologies), and guarantee the sustainability of the environment (by achieving development without jeopardizing nature).

60. A sound biosafety framework will also contribute significantly to preserving the rich genetic diversity of wild and cultivated species in the country, which represents a valuable global resource. Protecting the environment against the introduction of invasive, exotic or potentially harmful species and novel agricultural varieties is a core requirement for conservation of wild and domesticated biodiversity. A functional and science-based system that safeguards the environment and human health, and at the same time enables and facilitates transfer of beneficial technologies, may contribute to increasing crop yield per area and improving nutritional aspects, reducing population pressure on the environment and wild habitat conversion to agricultural land. As an opportunity to protect genetic diversity and as yet untouched ecosystems, conserving Guatemala’s biodiversity implies benefits far beyond the country’s borders.

61. Although Guatemala has so far taken only basic steps to respond to its obligations under the CPB, the time is ripe to give further impulse to these initial efforts. The foundations laid by previous projects and the growing interest of the private, public and scientific sectors to incorporate biotechnology applications, in a responsible fashion, as part of the country’s developmental process, offers an encouraging scenario. This project is therefore an opportunity to act proactively, rather than reactively, by setting up an operational national biosafety system before the pressure to utilize LMO applications augments or opportunities are lost as a result of inaction.


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3.2. Project goal and objective

62. The goal of this Project is to facilitate compliance with and the implementation of the Cartagena Protocol through the establishment of a National biosafety system. Specifically, it aims to assist Guatemala to put in place a well articulated, effective and transparent national biosafety system through the development of the necessary policies, regulatory and technical instruments, and local capabilities in order to meet national development needs.

3.3. Project components and expected results

63. The project is divided into four technical components: (1) Strengthening the legal, regulatory and policy framework on biosafety, (2) Implementing a functional national biosafety risk assessment and risk management system, (3) Creating the necessary institutional capacity and human resources for effective decision making and compliance in biosafety, and (4) Gaining experience in generating and managing biosafety information and public sensitization strategies.

64. The first component, strengthening the legal, regulatory and policy framework on biosafety, to make it fully consistent with the CPB and national goals for sustainable development, will focus on assuring stakeholder participation in and facilitating the drafting of a National Biosafety Policy that will guide and orient the design of a national biosafety system and specify the types of legal instruments (governmental accords or ministerial agreements) required to implement it and make it operational. Additionally, it includes the drafting, approval and adoption of a comprehensive legal, regulatory and policy framework for biosafety. The policy and regulatory framework will cover all aspect of LMO approvals, from assessments and decision-making, to monitoring and enforcement. The joint drafting of a national policy would promote the integration of biosafety into national programs, plans and strategies for sustainable development. Ultimately, this national biosafety framework would assure that the transboundary movement, transit, handling and use of LMOs is regulated consistent with the CPB Institutional mandates in biosafety and with the different sectoral policies, national regulations, and NCAs roles defined by the CPB. By necessity, this component will also result in a clarification of stakeholder roles and responsibilities, a valuable process for the smooth functioning of an inter-institutional biosafety system. It also requires high level written commitments from NCAs to back the Policy drafting process and its results, forcing NCAs to recognize biosafety as a priority.

65. The second component, implementing a functional national biosafety risk assessment and risk management system, aims to cement the technical foundations necessary to make a national biosafety system functional and efficient. These foundations include support structures and channels as well as adequate technical guidelines, tools, criteria and protocols for risk assessment and risk management. The end result would be a balanced and science based system for biosafety risk assessment and management in Guatemala that can successfully weigh potential risks and benefits of LMO use. Another result of this component would be the integration of biosafety risk management into the structure of NCAs, independently of whether a regulation or policy mandates it, since the appropriate technical tools and structures would exist. These tools, guidelines and criteria will be developed and applied in accordance with international guidance and national criteria, in a cooperative and concerted fashion. In this way, integration of Academic and Scientific stakeholders into the system will strengthen risk assessment and management through cooperation and support of actions relating to monitoring and enforcement from a technical point of view. Especially, there will be


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compliance with the CPB is achieved with regard to the Advanced Informed Agreement (Art. 7)

66. The third component, creating the necessary institutional capacity and human resources for effective decision making and regulatory compliance in biosafety, is critical for achieving functional and effective biosafety system. National policy cannot be implemented, regulations followed, and technical tools applied if the institutions that conform the system don’t have the trained human resources or infrastructure necessary to make and/or inform biosafety risk assessment and management decisions. Therefore, this component aims to achieve capacity building through three strategies: defining research priorities that will generate locally important scientific information necessary to inform biosafety decisions and to identify funding mechanisms for them; intensively and continually training key personnel in stakeholder institutions on biosafety, risk assessment, risk analysis and risk communication, as well as the design and use of technical documents for this purpose; and providing the necessary laboratory infrastructure (such as PCR technology and other molecular biology and immunology techniques) and scientific training so that the relevant stakeholders can meet the technical and scientific requirements of a National Biosafety System. Once the component is fulfilled, the institutional and administrative biosafety framework will be reinforced with the technical knowhow to allow for effective handling of requests and coordinated decisions. Institutions will be more proficient in risk /benefit analysis, and will have increased capacity for monitoring and enforcement of decisions. Setting and funding necessary research priorities will result valuable information necessary to inform risk assessment and risk management decisions, contributing to authorization procedures that are science-based, transparent, efficient, and technically sound. Laboratory infrastructure and training will ensure that local technological capacity is sufficient for in-house analysis of LMOs. Ultimately, capacity for the safe development and use of biotechnology will be strengthened in Guatemala.

67. The fourth and last component, gaining experience in generating and managing biosafety information and public sensitization strategies, is critical not only for compliance with CPB guidelines but also for promoting public confidence in a national biosafety system. This component includes the joint development, with other stakeholders, of a national sensitization, communication and information strategy for biotechnology and biosafety; a revision and re-editing of relevant biosafety information to be communicated and adapted to different levels and local languages; renewed efforts to assure the participation of NCAs in the biosafety Clearing House, and the promotion of the BCH main and Guatemalan website as a useful tool and information source for risk assessment and management. Ultimately, this component would assure that relevant information is managed in accordance with Art. 20 of the CPB. Information availability on biosafety will increase and contribute to public sensitization and participation processes. Increased access to and sharing of biosafety information will lead to greater transparency in biosafety decisions and management. These efforts will achieve collaboration with all NCA’s and the experiences gained in information management will be institutionalized and reinforced.

3.4. Intervention logic and key assumptions

68. The first GEF funded biosafety project resulted in proposed regulation that was not easily understood or readily enforceable by affected stakeholders. It has become evident that stakeholder cooperation is necessary in order to clarify overlapping legal mandates and that this participation is limited by the stakeholders’ understanding of biosafety and expertise in risk assessment and management. Therefore a multipronged approach is necessary in order to build capacity at the same time that national priorities and policies are being set, since both


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processes facilitate the other. The expected synergy between these two approaches dictates its development. In general, key assumptions refer to ensuring cooperation, political will and uninterrupted participation during the project. A more detailed list of assumptions directly linked to each project component and outcome can be found in Appendix 4.

69. The central theme of the project is clarifying the different competences and responsibilities of the interested stakeholders, especially those with overlapping legal mandates to regulate biosafety, at the same time that capacities are built and reinforced within key institutions. In this way, the necessary institutions will have both a roadmap of how to regulate and coordinate biosafety efforts and the expertise necessary to do so. This project will therefore strengthen the institutional capacity of relevant competent authorities and cement the coordinating role of the National Council of Protected Areas, given its status as both CPB and BCH Focal Points. As a result of the project, competent authorities will be able to manage biosafety in a manner coherent with the objectives and procedures of the CPB. The installation of biosafety management within several institutions in the form of joint programs, plans and campaigns, together with a better understanding of the issues at stake and the workings of the CPB, as well as the strengthening of decision-making structures and bases, will not only be key for ensuring the sustainability of the capacity being built, but also for making the decisions and safeguards taken in biosafety more effective, transparent, coordinated and technically-sound. For this the national biosafety policy, combined with new biosafety regulations, will be the main foundations on which institutional efforts are based and sustained, as will be the Training Program for the use, management and regulation of biotechnology, and the consolidation of various institutional agreements.

70. A lesson learned from that previous project and applied currently is that a National Policy must precede the proposal of any regulation, such that approval and adoption of such regulation is facilitated, biosafety guidelines can be drafted and implemented even in the absence of official regulation, and individual stakeholder roles, mandates and responsibilities are clarified. The GEF intervention for this component lies mainly on the funding, promotion and coordination of a national policy setting process. The GEF project provides an incentive for stakeholders to participate and cooperate, as all recognize the current situation as confusing and unsustainable, but none are willing to cede the leadership of the policy and regulatory setting process to one another. Additionally, none have the time or budget to coordinate such a process. The GEF project provides neutral ground, with funded, dedicated and accountable personnel to manage this process under stakeholder supervision.

71. This first component supposes that key stakeholders will actively and willingly participate, and then adopt, the policies and regulations resulting from this effort. For this to happen, stakeholders must recognize the importance of clarifying responsibilities and coordinating their efforts, actively participate in the policy drafting process, provide high level support for this effort, and consider the results of their efforts binding. Additionally, it is expected that stakeholders are able to provide in kind co-financing for some aspects of the project, especially its implementation and sustainability strategies, in the form of officially assigning biosafety duties and responsibilities to paid personnel and providing the necessary infrastructure and clerical/administrative support for biosafety procedures. The project assumes little disruption to the process through the election and transfer of power due to happen in 2012. The effectiveness of the proposed biosafety system can only be tested if there are actual requests for approval of LMOs. Because of this, a mock request will be submitted as part of a National Biosafety System validation process.

72. For the second component, the project will provide the necessary coordination and scientific advice to NCAs so that risk assessment and management can be carried out in a transparent and collaborative fashion, effectively implementing a comprehensive National Biosafety


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System. Currently, there are no inter-institutional or joint technical or administrative instruments for risk assessment or management among NCAs. Only NCA has carried out risk assessment, but their methodology is not necessarily accepted by other NCAs. Other NCAs with legal biosafety obligations have no validated procedures and the ones being developed are not science based. This complicates coordinated biosafety decisions and impedes the implementation of a National Biosafety System. A GEF intervention would provide the necessary incentives and funds for coordination and validation that would permit the drafting of inter-institutional coordinated and harmonized technical documents, guides, criteria and administrative formats for LMO applications as well as the required risk assessment and evaluation methodologies. In the absence of such an intervention, LMO approval requests will likely be subject to wildly different bureaucratic structures in each NCA, without a clear path to follow for approval or validation of individual NCA tools. Risk management as well as inspections (monitoring and enforcement) will also be strengthened through harmonized procedures. The drafting of technical and administrative instruments has purposefully been separated from policy and regulatory drafting, the technical aspects being overseen by a scientific subcommittee while the policy and regulatory aspects by an inter-institutional task force. In this way, technical documents can remain science based and component objectives will not be hampered by potential conflict which may arise during a policy and regulatory debate.

73. This second component relies on relevant stakeholders to assign permanent technical personnel to fulfill biosafety duties. These personnel would be the ones trained in biosafety aspects and involved in creating and/or adapting the necessary technical procedures, guidelines, criteria tools and scientific protocols to assess and manage biosafety risk. Furthermore, it is assumed that relevant stakeholders will agree to draft these technical documents in a coordinated fashion, which would include establishing the adequate channels and support structures for information sharing and decision-making. Scientific protocols can only be validated if the necessary LMO test tissue is legally available.

74. The third component aids in achieving the local capability of generating, analyzing, and applying scientific information to inform and implement risk assessment and risk management, including monitoring and other technical aspects of regulatory compliance. The project will facilitate access to training and equipment, so that local capacities are strengthened and the proposed National Biosafety System can rely on informed and trained technical personnel, as well as the means to generate, analyze, and use locally generated biosafety information. Training will involve not only NCAs, but also other stakeholders. Institutional and human resource capacity building will go beyond government entities, effectively creating a national pool of experts independent of their workplace, and temporally go beyond a project’s time table. It will also create continuous capacity building opportunities and permanent on-demand training and educational resources that can be used by current and future government technical personnel. Additionally, the project will invest in creating local technological capacities in order to prepare the country for LMO analysis, monitoring and detection even in the absence of demand, given that the rest of the project will create the adequate regulatory and institutional climate so that such technological capacities will be required eventually.

75. This third component requires significant cooperation and co financing from the National Secretariat of Science and Technology, so that it permits the project to take a leading role in coordinating the drafting and implementation of scientific research policy and then provides the necessary funds to implement such policy. The human resource capacity building hinges on institutions allowing key personnel to participate in time intensive training modules. Additionally, recipients of scientific equipment and training must provide the necessary co


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financing in order to guarantee the safety, maintenance, and optimal use of the equipment and training provided.

76. The fourth component contains education, awareness raising and compliance elements important for biosafety information exchange that would most likely be achieved to a lesser degree and in isolation without the project, but that would be better and more quickly obtained with the coordination and funding resulting from it. The project aims to result in a faster, more focused effort to produce public sensitization strategy and campaigns with emphasis on biosafety, as well as generate specific biosafety informative material in printed and digital formats, to make available to the public. These focused events will be aimed at agricultural, academic, and specialized government sectors at a technical level, and environment, health, and non-specialized government sectors at a non-technical level. This final component requires GEF intervention to assure that isolated and partial efforts are integrated into a larger effort and are quickly and fully completed.

77. In terms of compliance, the NCAs currently do not report or add entries to the BCH website. This is mainly a result of there not being any information to report, since LMO entry into the country for environmental release is not officially approved. Additionally, there are no incentives for NCAs to regularly input information to the BCH. Thus, the challenge remains as to how to sensitize NCAs as to their responsibilities towards the CPB, promote their participation in the BCH, and make the local BCH website more attractive and useful to users. The project recognizes that NCAs want to see or perceive some sort of advantage or incentive from using and reporting to the BCH, and such advantages or incentives must be created and promoted. This project aims to do this partly by adding informational modules of national importance to the local BCH website. As with other components, inter institutional cooperation and personnel dedicated to the matter are key assumptions. NCAs will have to assign the responsibility of uploading information to the BCH website, and also that of collecting and sorting the adequate information. Most importantly, it assumes that NCAs will have novel information to report.

78. Given that the biosafety capacity-building agenda for the country is longer and wider than what can be achieved through this project, the intention is to avoid being over-ambitious and only plan what is achievable and central to maintaining the country on the right biosafety track. Additionally, the general public in Guatemala is not sufficiently aware or concerned with LMOs in order to actively seek participation in the biosafety system. This reduces the project’s possibility of stimulating significant or even constructive levels of public participation in biosafety decision-making, but at the same time, lowers the expectations for a fully participatory biosafety system to be operating by the time of project completion. The project therefore does not expect behavioral changes in non-specialized sectors of society, is institutionally-orientated and has been designed in a highly targeted fashion.

3.5. Risk analysis and risk management measures

79. Each component of the project carries specific risks, but most of these can be catalogued generically and involve: participation, adoption of results, misinformation, and overlap of mandates among stakeholders. Many of the risks to the project are risks to the biosafety system itself, so finding the best means to reverse, minimize or mitigate these risks will be part of the project’s strategy. It is expected that, as the project achieves important milestones and goals, many of the risks outlined in this section will be minimized.


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Risk Components affected

Mitigation Measure

Stakeholders fail to adopt the policies, regulations and biosafety structures resulting from the project

Component 1 Project seeks high level government mandate and letters of commitment in addition to letters of support.

Component two aims to separate political and technical regulatory aspects to assure that development of technical procedures, guidelines, criteria tools and scientific protocols proceeds independently of any potential political conflicts regarding policies and regulations, and can be adopted independently as well.

Institutions do not assign sufficient personnel/personnel time to participate in project activities

Components 1, 2 and 3

Project timetable aims to space out the different initiatives to maximize stakeholder participation.

Letters of commitment include personnel and time commitments (dedication).

Significant personnel changes occur during the 2012 government transition, resulting in renewed training and sensitization.

Components 1, 2, 3, and 4

Biosafety training series includes the elaboration of an on demand virtual adaptation of the course that would be available to newcomers to the process.

M&E plan incorporates a second, abbreviated version of the training series scheduled to coincide with the power transition.

Lobbying effort is programmed to start after the government transition, in order to sensitize and inform new and continuing government personnel so as to accelerate adoption of project results.

Lack of reliable information on LMOs in Guatemala and widespread misinformation on the subject hamper project implementation

Component 1 and 4

Project seeks to build partnerships and institutional agreements for the provision of official, impartial and up-to-date information on biosafety that can be made public, and to ensure that it is managed in the correct manner.

A specialized online information module in the local BCH website regarding local biodiversity and LMOs will be created.

Duplication of efforts and overlap of functions between NCAs, and pressure by various groups who oppose any biotech legislation complicate project development

Component 1 and 2

The establishment of a multi-sectorial steering committee to guide project progress and to understand sectorial positions from the onset of the project will help to counteract this possibility


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3.6. Consistency with national priorities or plans

80. Guatemala has been a Party to the CBD since 1995 and to the CPB since 2004 (Legislative decree 23-2004). In addition, there are other political instruments relevant to biosafety. The National Policy on Food and Nutritional Safety provides a coordinated strategic framework to guarantee the availability and access, in a sustainable and culturally appropriate way, to healthy and nutritional food. This policy states in one of its items that Guatemala needs to regulate the import of genetically modified products. The Framework Policy on Environment Management aims among other things to prevent and minimize the impacts and risks to human beings and the environment resulting from production processes, while the National Strategy for the Preservation and Sustainable use of Biodiversity and the Action Plan of Guatemala seeks the reduction of threats to biodiversity and includes, in its scope, the protection, use and valuation of genetic resources, and the need to support population food safety through the preservation and availability of such genetic material. The creation of a solid biosafety framework is therefore fully concordant with these policies, with the country’s conservation priorities and with the fulfilment of Objective VII of the Millennium Development Goals of Guatemala, which aim to guarantee the sustainability of the environment, by achieving development without jeopardizing nature.

81. Additionally, establishing a science based national biosafety system and prioritizing research areas to inform biosafety decisions supports the National Secretariat of Science and Technology’s policies. The National Biotechnology Program explicitly states that one of its priorities is to support an appropriate legal framework that facilitates research and commercialization of biotechnology while protecting the environment, population and intellectual property. As part of that priority it indicates that it is necessary to (1) analyze existing regulations and promote the creation and implementation of a legal framework that differentiates between research and commercialization of biotechnology, and (2) encourage risk evaluation based on scientific evidence. Additionally, the national Program for Science, Technology, and Innovation, specifically calls for a special sub-program on LMOs, which would be fulfilled through this project.

3.7. Incremental cost reasoning

82. The GEF involvement adds value to this project by augmenting the extent to which the CPB would be implemented in Guatemala, the possibility of achieving transversal results in a fixed timeframe across several institutions, and the effectiveness of structures and processes created for the purpose of biosafety. Without GEF involvement, national implementation of the CPB would be much slower, due to low institutional capacity, lack of an approved national legal framework, uncertainties with regard to CPB interpretation, and little budget dedicated to biosafety concerns. Guatemala would be unlikely to engage fully in CPB activities, including COP/MOPs, or make full use of its Party status. The achievement of results in the desired time-span, the involvement of several competent institutions and the commitment to common financing of components would also be affected in the absence of GEF support, as a GEF-funded MSP will provide greater opportunity for institutional coordination, integration and results-based planning and follow-through. In the absence of a project, biosafety activities would likely be implemented sectorially (by each NCA), or under the coordination of the CONAP but without the prior commitment of many institutions, and would therefore have a much lower impact. Similarly, the effectiveness of participatory initiatives, as well as the reliability and confidence in decision-making processes and structures, would be lessened without GEF support.


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83. For the first component, GEF intervention lies mainly on the funding, promotion and coordination of a national policy setting process. The GEF project provides an incentive for stakeholders to participate and cooperate, as all recognize the current situation as confusing and unsustainable, but none are willing to cede the leadership of the policy and regulatory setting process to one another. Additionally, none have the time or budget to coordinate such a process. The GEF project provides neutral ground, with funded, dedicated and accountable personnel to manage this process under stakeholder supervision. Thus, the incremental benefit of GEF participation lies in providing a necessary space for a policy debate, fully funded, so that regulations and strategies resulting from that debate can be quickly drafted and approved, resulting in the necessary coordination for a national biosafety system that complies with CPB.

84. For the second component, GEF intervention lies in providing the necessary coordination and scientific advice to NCAs so that risk assessment and management can be carried out in a transparent and collaborative fashion, effectively implementing a comprehensive National Biosafety System. The incremental benefit of GEF participation is, in fact, a National Biosafety System that shares procedures and information, in contrast to the isolated bureaucracies that will emerge in the absence of GEF intervention.

85. For the third component, GEF intervention lies in facilitating access to training and equipment, so that local capacities are strengthened and the proposed National Biosafety System can rely on informed and trained technical personnel, as well as the means to generate, analyze, and use locally generated biosafety information. The incremental benefit lies in providing funding for training, making sure personnel from different NCAs and stakeholder institutions receive similar training, and reinforcing institutional capacities for LMO testing and research. In the absence of GEF intervention, capacity building would be limited to sporadic efforts and the occasional person that both obtains an opportunity to train abroad and is permitted to take a work leave to undergo training, while a GEF funded initiative would bring training into the country and actively lobby authorities to officially assign and facilitate personnel training. Existing laboratory equipment could be used occasionally to attend limited biosafety requirements, but scientific institutions and personnel would lack standardized training and dedicated equipment to fulfill biosafety needs, something a GEF initiative could provide.

86. Although there would still be institutional efforts to open spaces for public participation and to operate formal instances for technical and political decisions in biosafety, these measures would not achieve their desired long-term effects without the means to carry out training activities and campaigns to raise public awareness, as well as increase the availability of and public access to biosafety information. The concomitance of the GEF project activities would allow these instances and mechanisms to be more effective, and hence sustainable, by contributing to the improvement of biosafety management in Guatemala on the basis of participatory and technically-sound processes. Thus, the fourth and final component requires GEF intervention to assure that isolated and partial efforts are integrated into a larger effort and are quickly and fully completed. The GEF incremental benefit lies in providing the necessary inter institutional context to make biosafety information exchange a comprehensive and focused process.

3.8. Sustainability

87. Assuring the sustainability of the efforts undertaken during this project is of critical importance for the country. The continuity and sustainability will be assured through different efforts. First, stakeholders will have to adopt the policy resulting from this project and


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commit to implement it. This policy would be binding and elevated to national policy status. This would be reflected in the creation of special units or specially assigned personnel to biosafety obligations and responsibilities. Additionally, a continuity and sustainability strategy is required for the National Biosafety System. This strategy will include both financial and policy provisions so that the National Biosafety System can operate in the absence of GEF interventions, and will be supported through appropriate regulation when necessary.

88. The project seeks, wherever possible, to encompass its components within existing policies and permanent projects. For example, research priorities set during the project would be promoted, funded, reevaluated and updated by the Secretariat of Science and Technology’s Biotechnology Commission, assuring the continuity of this effort. The same can be applied to the biotechnology and biosafety communication strategy, where implementation and follow up responsibilities would be distributed among stakeholders. Thus, whenever possible, biosafety policy will be incorporated into general governmental policies.

89. Should the National Biosafety Policy decide to permanently create a National Coordinating Commission on biotechnology (NCC), as an advisory structure, it should be inserted into the existing institutional frameworks of several stakeholders, such that its operation after a project finalizes is assured and that efforts resulting from the NCC are more likely to be adopted by or channelled to the necessary decision makers through pre-established routes and processes than through independent efforts. In this way, key stakeholders effectively become responsible for the implementation of NCC projects. It may have to be linked to or fit within existing functional advisory structures, such as the National Biological Diversity Commission (CONADIBIO) or the National Biotechnology Commission.

90. Capacity building efforts would, whenever possible, result in guides, virtual modules or literature available in the local BCH website, so that training and learning about biosafety can be available continuously and on demand.

3.9. Replication

91. Training workshops, virtual teaching modules, improvements to the local BCH website and technical procedures, guidelines, criteria, tools and scientific protocols are all components of the project that could be replicated or used as models in other GEF funded biosafety projects or interventions, especially in Spanish speaking countries. Virtual resources, in particular, have the advantage of being directly replicable and requiring little adaptation. All aspects of the project will be evaluated in order to extract relevant lessons so that future local and/or regional projects can be better formulated and implemented, and Guatemala may replicate effective methods and processes in future GEF projects, whether or not they are for biosafety.

3.10. Public awareness, communications and mainstreaming strategy

92. This project includes coordinating the writing of and partly implementing a coordinated national sensitization, communication and information strategy for biotechnology and biosafety. This strategy would be part of the National Biotechnology Commission’s responsibilities, with the Project assuming a limited role in collecting, editing and distributing only information regarding biosafety. As this is a joint initiative between the project and SENACYT, through the National Biotechnology Commission, sensitization aspects regarding biotechnology, but not biosafety, will be the responsibility of the commission. Additionally, the human resource capacity aspect of the project will result in online and on demand learning modules, which will be important for maintaining incoming players and personnel informed


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on biosafety. A novel module is planned for the local BCH website, set to provide scientific information on local ecosystems and species that can inform biosafety decisions. This novel module would complement existing technical biosafety information available in the BCH, such as information on genes and organisms.

93. The project will lobby for stakeholders to adopt and incorporate biosafety policy into their institutional frameworks. A dedicated budget for biosafety activities (which may be in-kind) will be required as co financing from all entities receiving laboratory or computer equipment and training. Relevant stakeholders will be approached whenever appropriate so that they may take ownership of different aspects of the project, if these aspects actively further the fulfillment of a stakeholder internal policy or mandate.

94. Project activities will be promoted both to ensure participation and to create public awareness of the process. This will be done through CONAP’s established press and communications capabilities.

95. The emphasis on creating technical capacity while at the same time providing policy orientations, accompanied by the formulation of a strategy, as part of the National Biosafety Policy, to ensure the continuity and sustainability of the National Biosafety System, will serve to mainstream biosafety into the day to day environmental management of several institutions. Likewise, the project will make the best use of existing structures when setting up temporary structures required for its execution. Though temporary, these structures will not operate in an institutional or legal vacuum, nor will they be dependent solely on CONAP. As described in section 4 below, they will be inserted as a joint effort between into two pre-existing institutional commissions. Ultimately, this will contribute to mainstream biosafety into the agenda of more permanent institutional structures relating to biotechnology and biodiversity.

3.11. Environmental and social safeguards

96. As explained below, the project will be executed by the National Council for Protected Areas (CONAP), an entity that is dedicated to sustainable environmental management tasks, and whose mandate necessarily requires that environmental and social safeguards for any actions regarding Guatemala's natural resources or involving public participatory. Indeed, as a coordinating entity, CONAP has valuable prior experience in carrying out public processes and in mobilizing stakeholder groups, and as an environmental authority, has extensive knowledge regarding the value, distribution and vulnerability of the nation's biodiversity. Given its primary focus on institutional capacity building, the current biosafety intervention does not envisage any adverse environmental or social impacts as a result of project execution. On the contrary, the current project will serve to reinforce the need for safeguards and biosafety considerations in all activities entailing LMOs, and will set up the necessary framework.

97. With regards to research activities and contained use of LMOs, all the local laboratories or entities that receive capacity building equipment and training will be required to develop or present standard operating procedures (SOPs) regarding safe chemical and biological waste disposal as well as laboratory health and safety regulations, instructions and proof of adequate laboratory safety features.


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SECTION 4: INSTITUTIONAL FRAMEWORK AND IMPLEMENTATION ARRANGEMENTS

98. The present project will have UNEP as GEF implementing agency, and will be executed by the CPB National Focal Point, the National Council for Protected Areas (CONAP), and through delegation of functions, by the Technical Biodiversity Office (OTECBIO). However, this project involves many stakeholders and aims to be multi-institutional and multi-sectoral. Additionally, although CONAP is in charge of CPB implementation, it does not have the legal mandate to regulate biosafety or biotechnology. These legal mandates are split, to varying degrees, among four Ministries and a National Secretariat. Previous biosafety projects have demonstrated the need for inter institutional coordination at high decision-making levels and for the insertion of new biosafety structures into pre-existing councils, commissions or ministerial units, in order to guarantee the sustainability and durability of these structures once a project terminates. Because of this, all organizational structures proposed for the operation and execution of the project will be part of existing governmental structures, achieving two important results: 1) the organizational structures will have institutional and legal backing, and 2) those structures deemed necessary to continue after the project terminates will have the necessary administrative and institutional co financing permitting their continuous operation.

99. The current project proposes three advisory structures (see Appendix 10): 1) A steering committee composed of high level delegates from governmental institutions with legal mandates to regulate biosafety, 2) A policy task force or subcommittee, composed of technical delegates from all interested public, academic and private (industry and social organizations) entities desiring to contribute to the drafting of a national biosafety policy and structuring of a national biosafety system, 3) A scientific subcommittee composed of selected individuals who, through the necessary credentials, have demonstrated the required expertise and scientific capabilities to advise the drafting of scientific and technical documents to support and implement a National Biosafety Policy and System. Appendix 10 provides further explanation of the working model proposed. It is worth noting that the steering committee is involved not only in working through the policy and legal aspects of the project, but also in project oversight (Monitoring and Evaluation) functions.

100. The project will finance a coordinator and administrative assistant during the four years of implementation, as full-time staff dedicated to the project. Coordination will reside in the Technical Biodiversity Office of the CONAP. Fund administration services will also be subcontracted to support timely project operations and delivery of the four technical components, ensure specific and orderly book keeping, and aid in reporting tasks. Additionally, specific consultants will be hired on a temporary basis for specific project activities. A consultant will be hired to aid in the coordination and writing of a National Biotechnology policy, guided by a supervising working group comprised of interested stakeholders. Other consultants will be hired for the specific tasks of drafting regulation, technical documents, and lobbying stakeholders for their adoption and implementation. These efforts will also fall under the supervision of a stakeholder working group.

101. Human resource capacity building through workshops will also be coordinated by an individual consultant. This consultant will be responsible for coordinating and hiring the necessary experts to teach and design the workshops, as well as collecting and organizing the necessary teaching resources and information to replicate the workshops as a series of courses. Computer support, in the form of another consultant, will be available to convert this information into an online learning module.

102. In addition to the project’s full-time staff, temporary staff will be hired as needed by each component. For example, short-term facilitators will be recruited to coordinate and aid in the


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drafting of national biosafety research priorities and Biotechnology and Biosafety communication strategies. A permanent position will be created and filled for the purpose of improving and editing the local BCH website; this will be part of CONAP’s contribution both to the project and to fulfilling its biosafety mandate.

SECTION 5: STAKEHOLDER PARTICIPATION

103. The leadership role of the National Council of Protected Areas (CONAP), which will be politically supported by the Ministry of Environment and Natural Resources and channelled through the Technical Office for Biodiversity (OTECBIO), will be a key success factor behind the overall strengthening of the biosafety system, and in laying down the foundations for sustaining biosafety activities and functions over time. Component 1 will require a strong degree of coordination, support and consensus-seeking amongst government authorities, while Components 2 and 3 will imply more in-house work, joint tasks with the Ministry of Agriculture and close contacts with the scientific community. Finally, Component 4, which will benefit directly from the coordination initiated through Component 1, will rely strongly on the impetus and level of mutually supportive integration achieved by the Ministry of Environment and Natural Resources with other Ministries and sectors of society, with respect to how biosafety is viewed and managed in the country, and therefore informed and promoted to the wider public and stakeholders.

104. The project will aim to engage, whenever possible the participation and supervision of high-level decision makers and not only NCA technical staff. This is reflected in the steering committee structure.

105. The steering committee and subcommittees, comprising several national bodies, public (including CONAP), private and also academic and investigative institutions, all bound by the work on biotechnology and its safe use, will also play an important role. Although these advisory structures are meant to be temporary, and their continuity or transformation into different advising structures (such as an NCC) will be decided during the policy drafting and biosafety system structuring process, they will not operate in an institutional or legal vacuum, nor will they be dependent solely on CONAP. They will be constructed as a joint effort between into two pre-existing institutional commissions: The Biotechnology Commission of the National Secretariat of Science and Technology (SENACYT) and the National Biodiversity Committee (CONADIBIO). This will facilitate the advisory structures’ operation and continuity (or that of an equivalent biosafety advisory structure) during and after the project. The institutional framework into which the project’s advisory structures will be inserted is presented in Appendix 10.

106. The steering committee will be composed by members of both entities, as well as one member from each of the four concerned ministries (MAGA: Ministry of Agriculture; MARN: Ministry of the Environment and Natural Resources; MSPAS: Ministry of Public Health; CONAP: National Council for Protected Areas; SENACYT: National Secretariat of Science and Technology; MINECO: Ministry of the Economy), and will report to both entities, as well as to the four concerned ministries, so that these important stakeholders effectively become responsible for the project implementation. In this way, project results are more likely to be adopted by or channelled to the necessary decision makers through pre-established routes and processes than through independent efforts. For example, SENACYT is the executing arm of the National Council for Science and Technology, presided by the vice president and responsible for approving Science and Technology related policy.


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107. The Biotechnology Commission is, by law, the advising entity on biotechnology to the secretariat and the council, so carrying out the project under the umbrella of the Biotechnology Commission provides the advantage of an official communication channel to CONCYT and the vice president. In previous projects, results were presented and their adoption proposed by CONAP to different ministries. By making the relevant ministries partially responsible for the project, through their participation in the steering committee, we hope to not only promote ownership of the project, but also to benefit from the ability of ministries to regulate by ministerial agreements (Acuerdos Ministeriales) as a way of officially adopting project results.

108. The two pre-existing government commissions or committees have a long history of constancy in working on promoting biotechnology and safeguarding biodiversity. CONCYT’s biotechnology commission is legally the government advisory group responsible for promoting, directing and coordinating efforts conducive to the adoption of biotechnology research and applications. It is composed of interested institutions that conduct research and science education, and is coordinated by SENACYT. Importantly, it is responsible for drafting scientific policy regarding biotechnology policy decisions or proposals; such drafts prepared in the biotechnology commission are then elevated by SENACYT to be approved by CONCYT. For its political role, CONCYT is composed of the Vice President, the Minister of the Economy, the President of Congress’s science and education committee, the Chancellor of the National University (Universidad de San Carlos de Guatemala, USAC), the President of the National Academy of Sciences, a Chancellor representing the country’s private universities, and the Presidents of three important Chambers: Agriculture, Industry, and Business. Policy initiatives channeled through CONCYT are therefore analyzed by high level decision makers from the academic, public and private sectors.

109. CONADIBIO is integrated by a delegate from CONAP, a delegate from MARN, a delegate from the national university, a delegate from the nation’s private universities, a delegate from the Committee of Commercial, Industrial and Financial Associations (CACIF), and a delegate from the Association of Natural Resource and Environmental Organizations. Once again, decisions and policies elevated to this commission are considered by important actors representing different sectors concerned with the environment. Inserting the Steering committee under the sponsorship of these two entities will institutionalize the project, as well as socialize and elevate its results through official and pre-established channels to high-level decision makers.

SECTION 6: MONITORING AND EVALUATION PLAN

110. 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.

111. 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 outcome as well as mid-term and end-of-project targets. 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.


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112. 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 Project Manager 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.

113. The project 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.

114. At the time of project approval 100% percent of baseline data is available. Baseline data gaps are unlikely to require special attention, but should additional or specialized information be necessary, these gaps will be addressed during the first year of project implementation.

115. Project supervision will take an adaptive management approach. The 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.

116. A mid-term management review or evaluation will take place at the beginning of project year 3, estimated in January 2012, as indicated in the project milestones. The review will include all parameters recommended by the GEF Evaluation Office for terminal evaluations and will verify information gathered through the GEF tracking tools, 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 of the project document). 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.

117. 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.

118. The GEF tracking tools are attached as Appendix 15. These 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


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project PIR report. As mentioned above the mid-term and terminal evaluation will verify the information of the tracking tool.

119. Three additional and specific monitoring and evaluation activities are part of the project; these are: National Biosafety System validation and testing, Training Program evaluations, and Adaptive Management. These have been incorporated into project design in the interest of testing the effectiveness of the project’s proposed interventions and measure its performance not only in terms of activities and execution, but also in terms of qualitative results.

120. National Biosafety System validation and testing: Several outcomes, outputs and their activities pertaining to various aspects of the National Biosafety system (Outcomes 1.3, 2.1, 2.2 and 2.3) will be tested and evaluated through a mock approval requests and diverse risk assessment and analysis situations that will test administrative procedures, communication channels, and technical instruments developed. The mock approval requests and test situations will be administered in coordination with the project progress so that several outcomes may be evaluated with the same request/situation at three different points in the project. This will require the development of an evaluation plan, as well as the aid experts for the design of the requests/situation and evaluation of the results. International experts contracted for the training workshops (Component 3) will contribute to the design of such requests/situations as much as possible. Feedback and evaluation meetings will be held with NCAs at the end of each evaluation. Foreseen costs include: Preparation of requests and risk assessment and management situations; Evaluation of results, Feedback meetings, Office supplies and printing costs. These activities may or may not require the aid of a biosafety expert or consultant.

121. Training Program Evaluations: This project contains at least three training activities that will require evaluation: The training program for the use, management and regulation of biotechnology, Training in scientific techniques for LMO testing, and training in efficient biosafety information exchange and proper use of the BCH website. For each of these activities, evaluation methodologies will have to be designed and administered before and after training. In the case of BCH use and biotechnology management program, training will occur on at least two separate events with different participants, providing opportunities for comparative testing. Foreseen costs include: Preparation of evaluation strategies and methodologies, Assessment of results, Feedback meetings, Office supplies and printing costs.

122. Adaptive Management: The implementation time frame of this project will coincide with Guatemalan general elections and a transfer of power in Jan. 2011. Due to the potential change in government officials at the technical and decision-making levels, it will be necessary to re-evaluate projected progress during 2011 and conduct high level meetings with various government sectors to present and promote the project, as well as internal meetings to adapt project execution and activities to best fulfil the projected outcomes and outputs.


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SECTION 7: PROJECT FINANCING AND BUDGET

7.1. Overall project budget

Component Component GEF budget

Cofinancing amount

Total (cofinancing + GEF)

Component 1: Strengthening the legal, regulatory and policy framework on biosafety, to make it fully consistent with the CPB and national goals for sustainable development

136,605.00 90,800.00 227,405.00

Component 2: Implementing the technical foundations of a functional national biosafety risk assessment and risk management system

64,155.00 89,000.00 153,155.00

Component 3: Creating the necessary institutional capacity and human resources for effective decision making and regulatory compliance in biosafety

230,685.00 263,337.00 494,022.00

Component 4: Gaining experience in generating and managing biosafety information and public sensitization strategies and public awareness

62,055.00 100,540.00

162,595.00

Component 5: Monitoring and Evaluation 61,864.00 61,864.00

Component 6: Management requirements 61,000.00 140,555.00 201,555.00

Total Budget 616,364.00 684, 232.00 1,300,596.00

Further detail on the overall project budget, differentiated by component outcomes and activities, and shown in UNEP budget format, is provided in Appendix 1.

7.2. Project co-financing

Institution Cash In kind Total: Cash + in kind CONAP 131,000 97,744 228,744

SENACYT 32,000 45,000 77,000 MAGA 25,000 25,000 MARN 17,988 17,988

FAUSAC 50,000 50,000 FARMACIA 100,000 100,000

UVG 35,500 35,500 ICTA 150,000 150,000 Total 163,000 521,232 684,232

Further detail on co-financing contributions is provided in Appendix 2, with a half-yearly breakdown that considers types of activities as well as information on in kind contributions. Confirmed cofinancing shown with commitment letters in Appendix 12.


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7.3. Project cost-effectiveness

123. The project is cost-effective in its design, as it aims to achieve catalytic influences through building institutional capacity for various facets of environmental management. Policy changes and greater integration and coordination amongst governmental institutions, to reflect the transversal nature of biosafety and its relationship with commercial and productive issues in favour of a more sustainable development, will be the main drivers of change. Focusing the project on managerial tasks and needs will hence benefit other areas of biodiversity protection, and empower CONAP and other competent authorities through the experience gained. The projects also builds on progress made during previous UNEP-GEF projects, and targets those areas of the current NBF that are known to present the greatest deficiency, that are most important for full CPB implementation and compliance, and that will achieve the greatest long-term impacts. This targeted approach will be further refined through an initial stock-taking assessment, in order to tailor the project's final design as cost-effectively as possible to specific needs. By focusing on regulatory elements and technical capacity-building across several institutions, the project will establish legal mandates and internal structures for the sustainable management of the national biosafety framework, in an effective and coordinated manner, involving low-cost activities that will be characterised by consensus-seeking. Participation, transparency and information-related initiatives will also be combined with extensive stakeholder involvement to ensure high social support for the project and to increase the cost-effectiveness of each activity.

124. The project seeks, whenever possible, to maximize the investment made by GEF by extending and assuring the impact of activities as well as seeking complementary funds and contributions from stakeholders. For example, training programs and activities will result in training modules or material that can be used in the future. SENACYT will be partially responsible for funding and coordinating certain aspects of the project, such as research priority setting, the sensitization strategy, and the operation of the scientific subcommittee during the last year of the project.


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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: Tracking Tools

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