biosafety capacity building initiatives in india biosafety capacity building initiatives in india...
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BiosafetyBiosafety Capacity Building Capacity Building Initiatives in IndiaInitiatives in India
Ministry of Environment an ForestsMinistry of Environment an Forests
New DelhiNew Delhi
Dr. Manoranjan [email protected]
GMOs are inherently different and carry special GMOs are inherently different and carry special risks and hazards, and hence need to be risks and hazards, and hence need to be regulated nationally so also internationally. regulated nationally so also internationally.
Countries always has the sovereign right to Countries always has the sovereign right to regulate GMOs/LMOs and their products at the regulate GMOs/LMOs and their products at the
national level.national level.
1. What are we intending to do with any genetically modified organisms in the country?
Are we producing transgenic organisms for research? Are we producing transgenic organisms for commercial use? If not, do you intend to produce transgenic organisms?
Do we intend to import or are you already importing transgenic organisms?
Do we intend to export or are you already exporting transgenic organisms?
2. What is the current state of the biotechnology industry?
3. Are any research institutes working with, or manufacturing, living modified organisms?
4. What are the national priorities in relation to LMOs?
5. Are there existing laws, legal and institutional/administrative systems, local, national and international obligations related to Biosafety, even in a peripheral manner?
• What government departments (including local government) may have jurisdiction in relation to LMOs?
• What is the legal system, knowing that a legal system may contain one or more of the following: common law, civil law, mixed system, federal laws and state laws? What are the levels of competence held by different bodies
• Where these may cover areas such as: laws, bylaws, guidelines, regulation, guidance, codes of practice administered at federal, state or regional level?
• What are the possible range of responsibilities and overlap between different agencies and departments, led, as well as the gaps where there is no, or inadequate, coverage?
• What are the current or planned environmental laws that could impact on health, trade, agriculture, food, feed, worker protection, etc?
Capacity: individual, institutional and Capacity: individual, institutional and systemic levelssystemic levels
In a global context, In a global context, “capacity”“capacity” refers to the ability refers to the ability of of individuals and institutionsindividuals and institutions to make and to make and implement decisions and perform functions in an implement decisions and perform functions in an effective, efficient and sustainable manner.effective, efficient and sustainable manner.
At the At the individual levelindividual level, capacity building refers to , capacity building refers to the process of changing attitudes and behaviors - the process of changing attitudes and behaviors - imparting knowledge and developing skills while imparting knowledge and developing skills while maximizing the benefitsmaximizing the benefits of participation, knowledge of participation, knowledge exchange and ownership.exchange and ownership.
In the field of biosafety, the kinds of capacity at In the field of biosafety, the kinds of capacity at this level would this level would refer to human expertise in the refer to human expertise in the legal, scientific or technical areaslegal, scientific or technical areas, for example, in , for example, in risk assessment and risk management. risk assessment and risk management.
Capacity building also refers to increased Capacity building also refers to increased awareness of biosafety issues. awareness of biosafety issues.
At the institutional level it focuses on the overall At the institutional level it focuses on the overall organisational performance and functioning organisational performance and functioning capabilities, as well as the ability of an capabilities, as well as the ability of an organisation to adapt to change. It aims to develop organisation to adapt to change. It aims to develop the institution as a total system, including the institution as a total system, including individuals, groups and the organisation itself.individuals, groups and the organisation itself.
International ObligationsInternational Obligations In Agenda 21In Agenda 21, as well as in the , as well as in the Convention on Convention on
Biological Diversity,Biological Diversity, Governments committed for Governments committed for international co-operation on biotechnology and international co-operation on biotechnology and relevant safety aspects viz. sharing experience, relevant safety aspects viz. sharing experience, capacity building, and international agreement on capacity building, and international agreement on principles for safety in biotechnology or biosafety. principles for safety in biotechnology or biosafety.
Article 22 of the Cartagena Protocol on BiosafetyArticle 22 of the Cartagena Protocol on Biosafety “Capacity-Building” requires the Parties shall “Capacity-Building” requires the Parties shall cooperate in the development and/or cooperate in the development and/or strengthening of human resources and strengthening of human resources and institutional capacities in biosafety, including institutional capacities in biosafety, including biotechnology to the extent that it is required for biotechnology to the extent that it is required for biosafety, for the purpose of the effective biosafety, for the purpose of the effective implementation of this Protocol.implementation of this Protocol.
Biosafety & LMMCBiosafety & LMMC
ColombiaColombia has placed a high priority on developing a has placed a high priority on developing a biosafety framework and coordination of the biosafety framework and coordination of the implementation of the Biosafety Clearing House implementation of the Biosafety Clearing House (BCH). The project, inter alia, focused on to develop (BCH). The project, inter alia, focused on to develop national capacities in biosafety.national capacities in biosafety.
MalaysiaMalaysia has established a a Genetic Modification has established a a Genetic Modification Advisory Committee (GMAC) to ensure safety in the Advisory Committee (GMAC) to ensure safety in the use, handling and transfer of GMOs, and to advise the use, handling and transfer of GMOs, and to advise the Government about genetic modification technology.Government about genetic modification technology.
PhilippinesPhilippines, established a National Biosafety , established a National Biosafety Committee which marked the start of a regulatory Committee which marked the start of a regulatory regime to ensure biosafety. Philippines developed regime to ensure biosafety. Philippines developed guidelines for the planned release of GMOs. guidelines for the planned release of GMOs.
An analysis of the existing biosafety capacity An analysis of the existing biosafety capacity building information indicatesbuilding information indicates
A large number of countries have no national A large number of countries have no national biosafety frameworks regulating LMOs; biosafety frameworks regulating LMOs;
Existing national biosafety regulations address Existing national biosafety regulations address only activities relating to the domestic handling only activities relating to the domestic handling and use of LMOs (no address for CPB); and use of LMOs (no address for CPB);
The biosafety frameworks should be credible, The biosafety frameworks should be credible, flexible, transparent, predictable, focused on flexible, transparent, predictable, focused on clear objectives, adaptable to different socio-clear objectives, adaptable to different socio-economic and cultural conditions, and cost-economic and cultural conditions, and cost-effective.effective.
Some areas identified in the Protocol requiring capacity Some areas identified in the Protocol requiring capacity building/strengthening in developing countries,building/strengthening in developing countries,
including India including India
Strengthening of regulatory frameworkStrengthening of regulatory framework Training needs and human resource Training needs and human resource
development development Public awareness Public awareness Risk assessment and managementRisk assessment and management Trans-boundary movement of LMOsTrans-boundary movement of LMOs Handling transport packaging and Handling transport packaging and
identificationidentification Information sharingInformation sharing
Capacity Building Capacity Building
& &
Public ParticipationPublic Participation
ChoicesChoices ProcessesProcesses ToolsTools
General (all 3 stages) Why are you inviting people to participate? What do citizens know,what are they concernedabout?
Clarifying purposes of a process and how people’s inputs will be used.
Engaging with areas of public concern (rather than assuming what people needto know).
Information-gathering surveys.
Relevant, targeted information distributed in appropriate media,formats and styles.
Stakeholder forums that are accessible and widely advertised.
DevelopmentDevelopment
• • Who should participate inthe design process?
• Are people enabled toparticipate?
• Identify key stakeholders,going beyond groups thatidentify themselves asStakeholders.
• Ensuring adequate legalframeworks (rights toinformation, access todecision-making) are in place.
• Ensuring people aresufficiently informed about theissues to engage meaningfullywith the process
• Local and regional consultations to discussissues and solicit views.
• Laws enabling publicparticipation and access toinformation.
• Decision trails showing how views will be carried forward, follow-up explanations about howand why inputs have or have not been used.
Implementation
• How far to include people in decisions about:• The roles, duties andpowers of responsibleagencies• Mechanisms of reporting,public scrutiny andaccountability.• The location and design ofbiosafety trials
• Openness about applicationsfor biosafety review andcommercialisation.• Openness about the purpose,location and design ofbiosafety trials.• Opportunities for publiccomment.
• Using risk analogies withwhich people are be morefamiliar.• Public registers ofapplications under review,with opportunities forpublic comment andobligations to respond topublic comments.
Monitoring
• How to involve people inreflection and evaluation ofthe adequacy of theexisting NBF framework?
• Sharing and explainingfindings of trials, creatingfeedback mechanisms andprocedures for acting uponthese
• Non-specialist involvementin advisory and reviewcommittees• Local level evaluationswith opportunities forpublic comment.• Constructing mechanismsfor ongoing participatory(re)evaluation of thebiosafety system.
Institutional structures for developing Institutional structures for developing biosafety frameworkbiosafety framework
National Executive Agency need to National Executive Agency need to have:have: Strong technical & human resource capabilitiesStrong technical & human resource capabilities Strong political mandateStrong political mandate Coordinating capabilitiesCoordinating capabilities Strong commitmentStrong commitment SustainabilitySustainability
Government Commitment for Government Commitment for BiosafetyBiosafety
• Notified Rules in 1989 for activities relating Notified Rules in 1989 for activities relating to research, development and use of to research, development and use of Genetically Modified Organisms (GMOs) and Genetically Modified Organisms (GMOs) and their products.their products.
• MoEF is the focal point for all biodiversity MoEF is the focal point for all biodiversity related matters including biosafety; andrelated matters including biosafety; and
• Ratified the Cartagena Protocol in January, Ratified the Cartagena Protocol in January, 2003.2003.
Baseline Capacity and Baseline Capacity and Identified GapsIdentified Gaps
India, being,one of the 12 mega-diversity countries, attaches great importance to the biotechnology and biosafety.
After entry into the force of the CP, possibility of increased movement of the LMOs. Therefore, there is a need for enhancing the capacity in the context of the CP.
Indian R & D institutions has expertise for Indian R & D institutions has expertise for conducting research in this area. However,they conducting research in this area. However,they need to be strengthened to meet the need to be strengthened to meet the challenges that are emerging with the rapidly challenges that are emerging with the rapidly changing biosafety scenario.changing biosafety scenario.
Information sharing protocols and additional Information sharing protocols and additional data capacity are needed to be enhanced to data capacity are needed to be enhanced to keep pace with the expected increase in trans-keep pace with the expected increase in trans-boundary movement of LMOs.boundary movement of LMOs.
Capacity enhancement in assessment of risks Capacity enhancement in assessment of risks associated with LMOs and an understanding of associated with LMOs and an understanding of the transgenic sequence.the transgenic sequence.
Increasing awareness building programmes for Increasing awareness building programmes for participation of all stakeholder groups play an participation of all stakeholder groups play an important role.important role.
Current Regulatory Mechanism for Current Regulatory Mechanism for GMOs:GMOs: Statutory BodiesStatutory Bodies
1.1. Recombinant DNA Advisory Committee Recombinant DNA Advisory Committee (RDAC)(RDAC)
2.2. Institutional Biosafety Committee (IBSC) Institutional Biosafety Committee (IBSC) 3.3. Review Committee on Genetic Manipulation Review Committee on Genetic Manipulation
(RCGM)(RCGM)4.4. Genetic Engineering Approval Committee Genetic Engineering Approval Committee
(GEAC)(GEAC)5.5. State Biotechnology Coordination State Biotechnology Coordination
Committee (SBCC)Committee (SBCC)6.6. District Level Committee (DLC)District Level Committee (DLC)
Applicant / Investigators
IBSC
RCGM
Conveys its decision to applicant / investigator
Applicant / Investigator to conduct trials
Applic/Investi to report periodically
• To Note• To Approve• To recommend &• Seek approval of RCGM
• To Note•T o Approve / recommend Permits.• To monitor trials• To recommend course of action
R & D Funding
Indian Regulatory Mechanism for GM Crops
GEAC
Large scale trials conducted/ Commercial release
Synergy betweenSynergy betweenCPBCPB EPAEPA
Linkage of National Policy and Linkage of National Policy and legislation need to be dovetailed to legislation need to be dovetailed to the International Agreements.the International Agreements.
1989 Rules & the CPB1989 Rules & the CPB
Capacity Developments need to be Capacity Developments need to be catalyzedcatalyzed
Essence of the ProtocolEssence of the Protocol
This Protocol shall apply to the trans-This Protocol shall apply to the trans-boundary movement, transit, handling and boundary movement, transit, handling and use of all use of all living modified organismsliving modified organisms that that may have adverse effects on the may have adverse effects on the conservation and sustainable use of conservation and sustainable use of biological diversity, taking also into biological diversity, taking also into account account risks to human healthrisks to human health..
Areas of Capacity Areas of Capacity DevelopmentsDevelopments
AIAAIA RARA RMRM RCRC Public awarenessPublic awareness BCHBCH Implementation of RegulationsImplementation of Regulations
Cartagena Protocol on Cartagena Protocol on Biosafety (CPB)Biosafety (CPB)
Article 22 CAPACITY-BUILDINGArticle 22 CAPACITY-BUILDING::
Development and/or strengthening of Development and/or strengthening of human resources and institutional human resources and institutional capacities in biosafety, including capacities in biosafety, including biotechnology to the extent that it is biotechnology to the extent that it is required for biosafety.required for biosafety.
CPB….CPB….
Article : Article : 23 : 23 : PUBLIC AWARENESS PUBLIC AWARENESS AND PARTICIPATIONAND PARTICIPATION
Article: Article: 26 :26 : SOCIO-ECONOMIC SOCIO-ECONOMIC CONSIDERATIONSCONSIDERATIONS
Article Article 27 :27 : LIABILITY AND LIABILITY AND REDRESSREDRESS
CPB….CPB….
Art.:Art.: 15 Risk Assessment15 Risk Assessment
Art.: 16 Risk ManagementArt.: 16 Risk Management
Art.: 18 Art.: 18 Handling, Transport, Handling, Transport, Packaging Packaging and Identificationand Identification
Art.: 20 Art.: 20 Information Sharing and Information Sharing and the the Biosafety Clearing -Biosafety Clearing -House House (BCH)(BCH)
Risk AssessmentRisk Assessment Most Most critical componentcritical component of biosafety of biosafety
implementation.implementation. Used for Used for assessment of environmental assessment of environmental risk risk and the reality. and the reality. Estimate the Estimate the likelihoodlikelihood of these of these adverse adverse effects being occurred.effects being occurred. ConsequencesConsequences of the risk should the of the risk should the
identifiedidentified. . Consider appropriate Consider appropriate risk-management risk-management
strategiesstrategies
Article 20: a Biosafety Clearing-House is Article 20: a Biosafety Clearing-House is toto::
(a) (a) Facilitate the exchange of scientific, Facilitate the exchange of scientific, technical, environmental and legal technical, environmental and legal
information on, and experience with, information on, and experience with, living modified organisms; andliving modified organisms; and
(b) (b) Assist Parties to implement the Assist Parties to implement the Protocol, Protocol, taking into account the special taking into account the special needs of needs of developing and least developing developing and least developing country country Parties, Parties,
RANGE OF GM CROPS DEVELOPED/ RANGE OF GM CROPS DEVELOPED/ BEING DEVELOPEDBEING DEVELOPED
Capacity building Capacity building initiativesinitiatives
How to Build……….How to Build……….
Institutional strengtheningInstitutional strengthening
Develop multidisciplinary expertise Develop multidisciplinary expertise to improve core competence within to improve core competence within institutions.institutions.
Strengthening laboratories with Strengthening laboratories with sophisticated equipment.sophisticated equipment.
Training to improve skills in handling Training to improve skills in handling sophisticated equipments.sophisticated equipments.
Directed research.Directed research.
Risk assessment capacitiesRisk assessment capacities
Develop protocols and guidelines for Develop protocols and guidelines for various scenarios.various scenarios.
Development of standards/limits.Development of standards/limits. Training to carryout risk assessment Training to carryout risk assessment
and risk management.and risk management.
Information sharing and data Information sharing and data base managementbase management
Networking with various institutes Networking with various institutes and agencies.and agencies.
Development of databases. Development of databases. Web management for information Web management for information
dissemination to various dissemination to various stakeholders.stakeholders.
Involvement of Involvement of stakeholdersstakeholders
Societal acceptance is the key Societal acceptance is the key element for successful element for successful implementation of various polices implementation of various polices and adaptation of technologies.and adaptation of technologies.
Introduction of public consultation Introduction of public consultation mechanism. mechanism.
Awareness programs.Awareness programs.
Projects on Capacity Building in Projects on Capacity Building in BiosafetyBiosafety
GEF-World Bank Project.GEF-World Bank Project.
FAO Regional Capacity Building Project.FAO Regional Capacity Building Project.
GEF-World Bank Project:GEF-World Bank Project: Objectives Objectives
Capacity building enhancement for Capacity building enhancement for effective coordination between the effective coordination between the responsible agencies to assess and responsible agencies to assess and manage risks associated with the trans-manage risks associated with the trans-boundary movement of LMOs.boundary movement of LMOs.
Knowledge and methodologies on Knowledge and methodologies on Biosafety will be shared and transferred to Biosafety will be shared and transferred to the state agencies through training the state agencies through training programmes.programmes.
strengthen institutional capacity for strengthen institutional capacity for coordination and decision making across coordination and decision making across ministries, specialized agencies and in state ministries, specialized agencies and in state government in areas related to biosafety and government in areas related to biosafety and the CP.the CP.
strengthen technical capacity to assess, strengthen technical capacity to assess, manage and monitor risks associated with manage and monitor risks associated with biosafety through the provision of training for biosafety through the provision of training for core capacity development in relevant core capacity development in relevant stakeholder ministries, specialized agencies and stakeholder ministries, specialized agencies and in state governments.in state governments.
Establish biosafety database system and Establish biosafety database system and Biosafety Clearing House Mechanism.Biosafety Clearing House Mechanism.
Support centers of excellence and a network for Support centers of excellence and a network for research, risk assessment, and monitoring.research, risk assessment, and monitoring.
Improving capacity for risk Improving capacity for risk evaluation and managementevaluation and management
Develop field capacity to monitor possible gene Develop field capacity to monitor possible gene flow between introduced LMOs and semi domestic flow between introduced LMOs and semi domestic and wild relatives.and wild relatives.
Training for implementation of biosafety Training for implementation of biosafety measures and to identify potential gene flow, as measures and to identify potential gene flow, as well the effect on non-target species.well the effect on non-target species.
Training on socio-economic impact assessment of Training on socio-economic impact assessment of LMOs.LMOs.
form the first part of a long-term national effort to form the first part of a long-term national effort to consolidate the Biosafety framework. consolidate the Biosafety framework.
Each of the proposed activities addresses Each of the proposed activities addresses possible gaps or barriers.possible gaps or barriers.
Designed to strengthen not only the capabilities Designed to strengthen not only the capabilities of the focal point to the CP, but also of key of the focal point to the CP, but also of key Ministries, agencies and scientific research Ministries, agencies and scientific research institutions.institutions.
PhysicalPhysical mile stonesmile stones
Four institutions are being Four institutions are being strengthened in terms of institutional strengthened in terms of institutional and technical capacities to assess, and technical capacities to assess, manage and monitor risks associated manage and monitor risks associated with biosafetywith biosafety
Project LifeProject Life
Start Year/Date: Start Year/Date: 2004 2004
Conclusion Year/Date: Conclusion Year/Date: 20072007
Current status of the projectCurrent status of the project
Developed a news letterDeveloped a news letter An information toolkitAn information toolkit Developed the Biosafety Project Developed the Biosafety Project
websitewebsite Developed the Biosafety Clearing Developed the Biosafety Clearing
HouseHouse
2.2. FAO Regional Capacity Building FAO Regional Capacity Building
Project on Biosafety of GM CropsProject on Biosafety of GM Crops Regional Consultation for Standardization Regional Consultation for Standardization
of procedures for risk assessment / of procedures for risk assessment / management (double verification and GMO management (double verification and GMO detection).detection).
Public awareness of GMOs including Public awareness of GMOs including material and methodologies for effective material and methodologies for effective out reachout reach..
Establishment of Asian Bionet.Establishment of Asian Bionet.
It is not too late, nor so the risk of It is not too late, nor so the risk of Biosafety vis-à-vis the Management;Biosafety vis-à-vis the Management;
But, if the risks exceeds the Management But, if the risks exceeds the Management of the Techno-Socio-Political will then…….of the Techno-Socio-Political will then…….
Is it Safe – Let us think !Is it Safe – Let us think !
