2. Enhancing system for Risk Assessment (RA), Risk Management (RM) and Risk (RC) TA 2.1 National institutions strengthened for RA, RM and RC including monitoring and enforcement 2.1.1 Methodologies for RA, RM and RC reviewed, refined and updated 2.1.2 Technical guidelines and manuals on RA and RM developed 2.1.3 Decision making tools prepared for RA, RM and RC 2.1.4 Training strategy for RA, RM and RC developed 2.1.5 Staff of relevant institutions trained on RA, RM and RC 2.1.6 National and regional institutional networks strengthened to implement National Biosafety System GEF TF 673,299 751,899
3. Developing technical capacity for detection and identification of living modified organisms (LMOs) and strengthening infrastructure TA 3.1 Improved capacity for detection and identification of LMOs 3.2 Laboratories fully operational with the necessary infrastructures to carry out risk assessment, and detection of LMOs, which allow Sri Lanka to meet its obligations under the CPB 3.1.1 Testing needs and capacities for LMO detection assessed and key public laboratories identified for upgrading and accreditation 3.1.2 Inspection plan prepared and inspectors trained 3.1.3 Personnel trained on LMO detection and identification 3.2.1 Key government laboratories identified, established, strengthened and appropriately equipped for risk management and detection of LMOs 3.2.2 Laboratories accredited by SLAB for risk assessment, LMO detection and identification based on ISO and ISTA standards GEF TF 990,000 897,000 4. Knowledge development, public awareness, education and participation TA 4.1 Enhanced awareness, education and public participation in decision-making on biosafety 4.1.1 Public awareness and participation strategy developed 4.1.2 Targeted activities implemented 4.1.3 Curriculum, syllabus and course materials prepared for post-graduate course for biosafety, and the gaps in primary (Ordinary Level), secondary and university level education for biosafety filled through improvement of curricula. 4.1.4 Information materials developed and disseminated through various media GEF TF 208,000 445,714 raising
PART iII: Approval/endorsement by gef operational focal point(s) and gef agency(ies) Record of Endorsement of GEF Operational Focal Point(s) on Behalf of the Government(s): ): (Please attach the with this form. For SGP, use this . A letter signed by Mr. Mostapha Zaher, dated May 20, 2013 was submitted at the PIF stage. Name Position Ministry Date (MM/dd/yyyy) B.M.J.D. Basenayake Secretary, National GEF Operation Focal Point MInistry of Environment and Renewable Energy 02/20/2014 B. GEF agency(ies) certification This request has been prepared in accordance with GEF/LDCF/SCCF/NPIF policies and procedures and meets the GEF/LDCF/SCCF/NPIF criteria for CEO endorsement/approval of project. Agency Coordinator, Agency Name Signature Date (Month, day, year) Project Contact Person Telephone Email Address Gustavo Merino Director, Investment Centre Division Technical Cooperation Department FAO Viale delle Terme di Caracalla (00153) Rome, Italy TCI-Director@fao.org 23/03/16 Roshini Gunaratne, Programme Officer, FAO Representative Office Sri Lanka, Bauddhaloka Mawatha, Colombo 7, Sri Lanka. Jeffrey Griffin Senior Coordinator FAO GEF Coordination Unit Investment Centre Division Technical Cooperation Department FAO - Rome, Italy 23/03/16 Kentaro Aoki, Asia and the Pacific Service, Investment Centre Division Technical Cooperation Department FAO - Rome, Italy +39 0 6570 56202 kentaro.aoki@fao.org
Output 1.1.1: National Biosafety Act enacted Number of workshops for enactment process; Number of Biosafety Act enacted by the established process; Awareness and training are required for the sound decision-making process and law enforcement; Biosafety Act drafted but not enacted; At least 4 workshops with about 20 decision-makers to ensure the enactment (at least 30% women) by year 1; 1 Biosafety Act enacted and printed by 2nd Quarter of Year 2; Workshop outcome documents; Biosafety Act of Sri Lanka enacted, published and uploaded on national BCH; Risks Delay in receiving approval from the Parliament or rejection; Changes in the national priorities resulting from change in government; Assumptions Smooth decision-making process established for the earliest enactment; Output 1.1.2: National Biosafety Master Plan (Strategy & Action Plan) elaborated and endorsed Number of stakeholder consultative meetings; Number of legal documents prepared through the stakeholder consultation as per recommendation in the National Biosafety Framework (I.e. Master Plan); Recommendation for setting up a National Biosafety Master Plan was given in National Biosafety Framework, 2005 and National Policy on Biosafety but does not exist At least 2 consultation meetings to elaborate Master Plan; 1 National Biosafety Master Plan endorsed; Assessment report of consultative meeting; National Biosafety Master Plan endorsed by the Government of Sri Lanka and published Uploaded on the national BCH Risks Delay in decision-making process for endorsement; Lack of priority as the thrust area of the concerned ministries/ departments/ agencies; Assumptions Active involvement of all concerned in consultation process as scheduled; Smooth decision-making process established with key decision makers for the earliest enactment;
Output 1.1.3: Relevant regulations reviewed, drafted and endorsed Number of regulations reviewed and set of regulations available to support Biosafety Act and Master Plan The draft Biosafety Act is yet to be approved by the Parliament; Several existing laws have relevant clauses; At least 20 related regulations reviewed and 1 set of biosafety regulations endorsed by ministry to support the Biosafety Act; Gazette Notification on Biosafety regulations Risks Delay in receiving feedback from respondents for review; Delay in decision-making process for adoption or rejection; Regulatory regime cannot be easily adopted because of resistance from interest groups; Assumptions Gaps and support options identified properly through the review process; Clear administrative guidance for drafting support policy available; Smooth coordination including several interest groups ensured for the adoption of related regulations; Outcome 1.2: Administrative systems for making biosafety fully functional Number of implementation examples using fully functional administrative system Administrative and operational procedures, which are consistent with the requirements of CPB do not exist; At least 5 implementation examples using a fully functional administrative procedure mechanism as per provisions of the draft Biosafety Act; Implementation records; Guidelines and manuals; Risks Procedures for the handling of requests are not clear, roles are not defined and do not cover all issues; Lack of trained personnel for the handling of applications; Assumptions Experts familiar with international best practices to be engaged;
regulatory requirements; Output 1.2.2: Guidelines developed to support the tasks of National Competent Authority (NCA) and Sectoral Competent Authorities (SCAs) Number of guidelines for handling applications and formats for application & communicating decisions in place At present, there is no guidelines available; Only some draft formats for application available; 1 comprehensive guideline available for handling applications related to GMOs/LMOs and products Guideline for handling applications related to GMOs/LMOs and products; Application formats; Risks Guidelines cannot be finalised because of the lack of active inputs by the project partners; Institutional arrangements not permanent; Trained and designated personnel replaced with new personnel in NCS/SCAs; Assumptions Guidelines are used to support tasks of NCA and SCAs. Experts familiar with implementing biosafety framework with NCA and SCAs are engaged; Designated personnel identified and remains the same; Output 1.2.3 Staff of NCA, SCAs and related organizations trained Number of members of regulatory committees and operational staff trained in administrative and operational procedures A National Coordination Committee on Biosafety (NCCB) is in place; Sectoral Competent Authorities (SCAs) are formed on case At least 40 committee members and operational staff trained with certificate (at least 30% women); Certificate of training Proceedings of training workshops Risks Insufficient number of trainers in various biosafety aspects; Participants for trainings are not appropriately selected; Assumptions International and national
by case basis; Committees on various aspect of biotechnology are in place consultants deployed properly; Individuals identified for trainings are responsible for handling biosafety related issues/applications; Outcome 1.3: National Biosafety Clearing House (BCH) operational Number of visitors accessing to BCH; Satisfaction with level of information and knowledge available in the national BCH; There is a national BCH established but not operational due to the lack of capacity to collect, process and manage the information required to run it; At least 500 individual accesses to the BCH; At least 70% of satisfaction rate received from multiple stakeholders; Access record to the national BCH; Assessment report including questionnaire and survey of user feedback; Risks Lack of capacity of the nodal ministry of Cartagena Protocol on Biosafety for the national BCH operation; Assumptions Active involvement and role definition of nodal ministry during the project; Ministry has information for collection and proper IT infrastructure for BCH; Output 1.3.1: An enhanced website established Number of national biosafety web-based information infrastructure linked to the central portal of CBD that included a roster of biosafety experts in the country and has database of globally approved LMOs; There is no dedicated website operational on biosafety in the country; Information related to biosafety is not available on web sites of the 1 national biosafety website available with sufficient contents; 1 roster of experts by concerned agencies; 1 online database of globally approved LMOs especially countries with whom Sri Lanka has trade ties (regular updating of the database); National website in place and operational with up-to-date information linked to BCH; Roster of experts in place and uploaded on BCH; Risks Lack of qualified technical personnel and required IT infrastructure; Delay in collection of information; Appropriate experts not selected for Roster; Assumptions Careful analysis on technical and
concerned ministries; information requirements for the website carried out; Information identified to be shared and make it easily accessible for public to promote transparency and accountability of decision-making process; Output 1.3.2: The BCH focal point trained to collect and manage information Number of trainings for BCH organized; Number of individuals trained; Availability of manual; The BCH focal point is not familiar with the process; No manual available; At least 20 individuals from BCH focal point, associate staff in NCA and nodal officers in SCAs and other scientific agencies trained and made capable to collect and upload information (at least 30% women) ; 4 training sessions for at least 10 IT staff for the management of IT infrastructure including website, roster and database (at least 30% women); 1 procedural manual ready to use for collecting, uploading and managing information on the national BCH; Procedural Manual for collecting, uploading and managing information; BCH focal point and associate staff trained; Risks Staff attrition and change in personnel; Availability of qualified staff; Assumptions Appropriate individuals identified for trainings/ Training of trainers; Proper working documents made available; Output 1.3.3: Stakeholders trained to access and share information through BCH Number of training modules; Number of training organized; No information available regarding the number of trained personnel At least 3 training modules for accessing information on the national BCH for the different stakeholders viz., scientists, regulators, customs and plant quarantine officials; Organize 4 training workshops with at least 30 participants for each module Training modules for different stakeholders; Certificate of training; Proceedings of training workshop; Risk Knowledge and interest of target stakeholders about the subject varied widely; Assumptions Proper working document to be prepared for the target stakeholder groups categorized for each training module;
Number of individuals trained; (in total about 120 individuals, at least 30% women); Train the trainer's approach; COMPONENT 2: ENHANCING SYSTEM FOR RISK ASSESSMENT (RA), RISK MANAGEMENT (RM), AND RISK COMMUNICATION (RC) Outcome 2.1: National institutions strengthened for RA, RM and RC including monitoring and enforcement Outcome 2.1: National institutions strengthened for RA, RM and RC including monitoring and enforcement Number of agencies that have institutionalised training on RA, RM and RC; Number of focal points for RA, RM and RC in each institution identified; The capacity of national institutions is limited to enable formulation and implementation of integrated and coherent biosafety regulatory mechanisms; All members, bodies and relevant agencies received institutionalized training and they are capable to work with the RA, RM and RC framework; At least 3 focal points identified for institutional RA, RM and RC; 1 institutional mechanism in place to deal with biosafety issues in the country; Training outcome report; Capacity development survey of focal points (e.g. before/ after training survey with annual review, (KAP) survey); Risks Lack of consensus for procedures/guidelines for RA, RM and RC among institutions; Lack of trained personals in each institution involved on how to perform RA and how to go about RM; Assumptions ToR of each institution available; Institutionalized training approach provided; Training program and guidelines developed based on both national and international experience; Output 2.1.1: Methodologies for RA, RM and RC reviewed, refined and updated Number of guidelines for contained use and Risk Analysis Framework developed; Guidelines for the safe use of Recombinant DNA technology in contained conditions available but not mandated; At least 1 comprehensive guideline available for GMOs/LMOs in contained conditions including green house, net house etc.; At least 1 Risk Analysis Framework Updated guidelines for the use of GMOs/LMOs under contained conditions in place and notified; Risk Analysis Framework in place Risks National experience in various cases of RA, RM and RC not available; Assumptions
Brief guidance document "Risk Assessment of GMO/FFPs – A Practical Guide" prepared but yet to be adopted by regulatory agencies; covering approach to RA, RM and RC available; and accepted by regulatory authorities; International expertise for risk infrastructure gathered; Output 2.1.2: Technical guidelines and manuals on RA and RM developed Number of technical guidelines in place covering various aspects of RARM No existing guidelines or manuals 5 guidelines available to regulate activities involving GMOs/LMOs for RARM: 1. Guidelines for Institutional Biosafety Committees 2. Guidelines for risk assessment of GM food and feed 3. Guidelines for environmental risk assessment of GE plants 4. Guidelines for conduct of confined field trials of regulated GE plants/crops 5. Guidelines for testing and release of GE insects such as mosquitoes Guidelines for IBSCs, food and feed safety, environmental risk assessment, confined field trials and GE mosquitoes are in place and accepted by regulatory authorities Risks National experience of formulating guidelines not available; Delays in receiving inputs; Assumptions Guidelines and manuals developed with international expertise and knowledge, and revised along with the country requirement; All concerned stakeholders participate for review; Output 2.1.3: Decision-making tools prepared for RA, RM and RC Number of tools for RA, RM and RC No existing decision-making tools available At least 1 decision-making tool kit available for regulatory agencies with required formats for each RA, RM and RC; Formats for to be used by regulatory committees are in place Risks Consensus about decision-making process of RA, RM and RC and role of participating institutions not made among institutions; Assumptions Decision-making process defined officially and/or legally;
Output 2.1.4: Training strategy for RA, RM and RC developed Number of training strategy/ manuals for RA, RM and RC in place No training strategy available for RA, RM and RC At least, 1 training needs assessment survey to be conducted; At least 2 training manuals for RA and RM; 1 RC strategy developed; Training needs assessment report; Training manual for RA and RM; RC Strategy; Risks Lack of experience in identifying critical areas to be covered by the training; Assumptions International knowledge and experience also considered; Output 2.1.5: Staff of relevant institutions trained on RA, RM and RC Number of individuals trained; Number of staff designated for risk infrastructure in each institution identified; Training programs were conducted in 2006, 2008, 2009 on RA at the university level; No trainings have been specifically been conducted for in the area of RM and RC At least 100 individuals (at least 30% women) trained including the members of NCCB, SCAs and other potential members/experts in RA (food and feed safety and ERA), with at least 15 trainings for the members of IBSCs and on confined field trials of GE plants (conduct and monitoring); Trained officials from relevant institutions; Certificate of training; List of designated staff; Risks Quality of training and timelines of delivery are unsatisfactory; Staff attrition and change in personnel; Resource person is not appropriate; Assumptions Training material to be jointly developed with national and international expertise Training program designed for institutional nominees at different levels; Appropriate individuals are identified for trainings;
inspection and monitoring of LMOs; Output 3.1.1: Testing needs and capacities for LMO detection assessed and key public laboratories identified for and accreditation Number of assessment report completed; Number of laboratories and facilities identified; Industrial Technology Institute (ITI) and a private lab, Genetech are carrying out limited work in LMO detection. National Plant Quarantine Station at Colombo has a mandate to do LMO detection and has basic lab facilities and manpower; University of Peradeniya has conducted trainings on detection methodology in 2006; 1 stocktaking assessment report ready for capacity needs, testing requirements, facilities, infrastructure, human resources and level of expertise required for LMO detection to be carried out for Sri Lanka; At least 3 public laboratories and 3 facilities for contained testing identified; 1 Operation and Maintenance mechanism including specifications and outline of manuals; Stocktaking assessment report Technical document for operation and maintenance of laboratories; Risks Delay in completion of the specified assessment/survey within the given timeframe; Lack of clarity and coordination between different agencies to enable them to carry out their responsibilities; Assumptions Roles and responsibilities of identified laboratories defined and agreed with criteria; Incentives available;
Output 3.1.3: Personnel trained on LMO detection and identification Number of individuals trained; Number of training modules developed; Identified laboratories have staff familiar with technical requirements for LMO detection. 30 scientists and technical staff trained in detection labs in 3 workshops (at least 30% women); 5 individuals conducted onsite training in labs functioning in other countries; 2 Training modules for LMO detection and identification prepared; Training modules; Certificate of training; Risks Quality of training material and timelines of delivery is inappropriate; Appropriate individuals not selected for trainings; Assumptions Workshop program and international laboratory visit program developed with national and international expertise; Outcome 3.2: Laboratories fully operational with the necessary infrastructures to carry out risk assessment, and detection of LMOs, which allow Sri Lanka to meet its obligations under the CPB Number of identified laboratories operational with international standard; Number of facilities for contained testing operational; Annual budget allocated for operation and maintenance of laboratories; The accreditation of laboratories and strengthening capacities of selected public sector laboratories are required; 2 public laboratories with improved infrastructure and facilities for LMO detection as per international norms and serve as central LMO research and detection lab; 1 upgraded analytical laboratory functional for compositional and nutritional analysis with state-of the-art analytical services equipment; These laboratories are showcased as technically viable examples; Efficient accreditation process in place; Institutions are strengthened with improved infrastructure and equipment. Outcome summary report; Annual financial report; Record of accredited laboratories; Risks Lack of capacity to use upgraded laboratory instruments; Lack of capacity to maintain the accredited laboratories; Assumptions Detailed system demonstration with sufficient trial operations carried out; Operation and maintenance mechanism of laboratory instruments ensured;
Output 3.2.1: Key government laboratories identified, established, strengthened and appropriately equipped for risk management and detection of LMOs Number of laboratories and facilities assessed; Number of identified laboratories and facilities for contained testing equipped; Some laboratories underwent LMO detection with limited work; Training programme in GM detection by ICGEB available in University of Peradeniya in association with Genetech; At least 3 public laboratories and 3 facilities for contained testing identified in the stocktaking assessment survey with laboratory equipment, chemicals and reagents, manpower and improve infrastructure and facility with guidelines; The 3 laboratories and 3 facilities are equipped for LMO detection and management as per assessment; In total 3 Operation and Maintenance manuals for identified laboratories prepared with international standards; An efficient LMO detection institutional network is established; Guidelines for sampling methodologies of LMO detection; Technical report on equipped laboratories and facilities; Operation and Maintenance Manuals; Risks Delay in procurement and installation of key instruments; Assumptions Specifications and required service for the laboratory instruments available prior to procurement process; Output 3.2.2: Laboratories accredited by SLAB for risk assessment, LMO detection and identification based on ISO and ISTA standards Number of laboratories accredited SLAB is a member of the mutual recognition arrangement (MRA) and in the process of seeking membership of the international accreditation forum (IAF). These have established ISO standards for GMO detection in addition to ISO 17025 At least 2 laboratories accredited as per SLAB/ISO standards; 1 Accreditation process clarified and streamlined for replication; At least 2 staff of the accreditation body trained internationally; Laboratories accredited; Certificated of accredited body trained; Risks SLAB not familiar with accreditation standards for GMO detection Accreditation failed; Assumptions Training of SLAB personnel, guidelines, SOPs etc. in place with detection labs Accreditation conditions and procedure ensured, and training provided accordingly;
COMPONENT 4: KNOWLEDGE DEVELOPMENT, PUBLIC AWARENESS, EDUCATION AND PARTICIPATION Outcome 4.1: Enhanced awareness, education and public participation in decision-making on biosafety Number of awareness raising events/campaigns with positive feedback from various stakeholders across the country; Annual budget allocated for continuous actions for biosafety in the country; Awareness of biosafety needs to be further enhanced to broader stakeholders strategically; Over 20 events/campaigns organized with At least 70% of activities received positive feedback from participants; Outreach material (both print and electronic); Proceedings of awareness programmes; Post graduates trained in biosafety; Knowledge assessment report including statistics and questionnaires of events; Annual financial reports; Risks Quality of events insufficient; Different category of audience and related needs are not identified correctly; Assumptions Awareness events conducted along with the needs of target stakeholder groups; Communication strategy applied properly; Replication mechanism in place to continue awareness raising after the project including potential funding support for the capacity building of biotechnology professionals;
Output 4.1.2: Targeted awareness-raising activities implemented Number of targeted activities accomplished; Awareness raising programmes were conducted during the National Biosafety Framework in 2006. Since then only a few activities have been organised by the research institutions 1 E-learning tool developed on guidelines/procedures for biosafety regulations; glossary of terms and other outreach material developed in local languages and 2000 copies disseminated; 1 audio visual educational material on awareness of biotechnology and biosafety issues for all stakeholders; 20 awareness workshops on biosafety for relevant stakeholders conducted (at least 30% women); E-learning tools available; Outreach material viz., primers, brochures, FAQs, etc.; Audio visual educational material available; Awareness workshop material and reports; Risks Population that can be reached could be limited due to time or funds constraints; Different category of audience and related needs are not identified correctly; Assumptions Strong government and public/private sector support and coordination for increasing public awareness; Needs assessment results available for each target stakeholder group; Output 4.1.3: Curriculum, syllabus and course materials prepared for course for biosafety, and the gaps in primary (Ordinary Level), secondary and university level education for biosafety filled through Number of training courses developed; The Postgraduate Institute of Agriculture (PGIA), University of Peradeniya, conducts the postgraduate course on Biosafety and now intends to start a postgraduate Diploma course on Biosafety 1 Modules/course material prepared for higher levels of education incorporation in syllabus of O and A level; Annual budget allocated for the new course; Modules/course material is available Risks The involvement of partner institutions is limited; Assumptions Incentive mechanism available; ToR prepared;
improvement of curricula. Output 4.1.4: Information materials developed and disseminated through various media Number of issues of the biosafety newsletter; Number of webpages with information sources; No dedicated mechanism for biosafety information 8 issues of Biosafety Newsletter will be circulated (six monthly); 1 website have copies of all material; Newsletter are circulated quarterly all over the country. Website with complete information resources Risks The quality of information materials insufficient; Assumptions The contents of information materials selected carefully to meet the needs of target readers; Output 4.1.5 and Output 4.1.6 are activities related to the Monitoring & Evaluation of the project.
Comments and alignment with GEF Secretariat questions and agency response at PIF Response Reference in Document Question 1-8, 10-13, 16-19 Cleared at PIF stage. The project has been further formulated along with the PIF comments. FAO Project Document: e.g. Sub-section 2.6, Question 9. Is there a clear description of: a) the benefits, including gender dimensions, to be delivered by the project, and b) how will the delivery of such benefits support the achievement of incremental/ additional benefits? a) Sri Lanka’s national socio-economic priorities have been considered while preparing the project activities and identification of stakeholder to be involved. In the project framework, a number of benefits have been translated into the result indicators that will address the issues of policy enactment and remove barriers to strengthen regulatory, institutional and technical capacities for the Cartagena Protocol on Biosafety. These benefits will be disseminated through the knowledge management activities and platform (e.g. national Biosafety Clearing House, for The project will endeavor to achieve gender mainstreaming by ensuring participation by all stakeholders including both men and women (as indicated in the results indicators). Efforts will be made to take into account impact on all sectors of society, including both men and women, while preparing regulations, guidelines and outreach material. b) The delivery of regulatory documents, extensive training and awareness activities will support safe and sustainable use of LMOs for various stakeholder groups. Gender aspect is considered in the activities such as gender balance in committee, ToR, and selection process of participants for the proposed events. FAO Project Document: Sub-section 2.3, 5.1 (social safeguards), Appendix 1 (Results Framework), Appendix 5 (ToR of Project Steering Committee) Request for CEO Endorsement: Section B.2 Question 14. Is the project structure/design sufficiently close to what was presented at PIF, with clear justifications for changes? The project design is in line with the PIF, the project activities have been formulated as per the approved project components, outcomes and outputs in the PIF. Co-financing has been increased according to the co-financing letters received. FAO Project Document: Section 2; Results Framework in Appendix 1; Request for CEO Endorsement: Section A
Question 15. Has the of the project been sufficiently demonstrated, including the cost effectiveness of the project design as compared to alternative approaches to achieve similar benefits? The cost effectiveness of the project has been provided appropriately by: a) Emphasis on inter-agency coordination and collaboration, b) Emphasis on establishment of a project team for project management, c) Mainstreaming project activities into the national development plans and actions and d) Regional cooperation as an effective method to share regional expertise and project outputs; FAO Project Document: Description in Sub-Section 2.8 (cost effectiveness); Appendix 4 (Incremental cost analysis); Request for CEO Endorsement: Section B.3 Question 21. Have the appropriate Tracking Tools been included with information for all relevant indicators, as applicable? The GEF tracking tool has been included in Appendix. FAO Project Document: Appendix 8 (GEF-BD Tracking Tool); Question 22. Does the proposal include a budgeted M&E Plan that monitors and measures results with indicators and targets? Yes, the M&E plan for project monitoring fulfilment of the project targets and indicators had been included FAO Project Document: Section 2, Section 6, Appendix 2 (Work Plan and Timetable), Appendix 3 (Results-based budget), Request for CEO Endorsement: Section C