Transcript India: Capacity Building in Biosafety

Biosafety Capacity Building
Initiatives in India
Dr. Manoranjan Hota
[email protected]
Ministry of Environment an Forests
New Delhi
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GMOs are inherently different and carry special risks and
hazards, and hence need to be regulated nationally so
also internationally.
Countries always has the sovereign right to regulate
GMOs/LMOs and their products at the national level.
1. What are we intending to do with any genetically modified
organisms in the country?
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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
systemic levels
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In a global context, “capacity” refers to the ability of
individuals and institutions to make and implement
decisions and perform functions in an effective, efficient
and sustainable manner.
At the individual level, capacity building refers to the
process of changing attitudes and behaviors - imparting
knowledge and developing skills while maximizing the
benefits of participation, knowledge exchange and
ownership.
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In the field of biosafety, the kinds of capacity at this level
would refer to human expertise in the legal, scientific or
technical areas, for example, in risk assessment and risk
management.
Capacity building also refers to increased awareness of
biosafety issues.
At the institutional level it focuses on the overall
organisational performance and functioning capabilities,
as well as the ability of an organisation to adapt to
change. It aims to develop the institution as a total
system, including individuals, groups and the organisation
itself.
International Obligations
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In Agenda 21, as well as in the Convention on Biological
Diversity, Governments committed for international cooperation on biotechnology and relevant safety aspects
viz. sharing experience, capacity building, and
international agreement on principles for safety in
biotechnology or biosafety.
Article 22 of the Cartagena Protocol on Biosafety
“Capacity-Building” requires the Parties shall cooperate
in the development and/or strengthening of human
resources and institutional capacities in biosafety,
including biotechnology to the extent that it is required
for biosafety, for the purpose of the effective
implementation of this Protocol.
Biosafety & LMMC
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Colombia has placed a high priority on developing a
biosafety framework and coordination of the
implementation of the Biosafety Clearing House (BCH).
The project, inter alia, focused on to develop national
capacities in biosafety.
Malaysia has established a a Genetic Modification
Advisory Committee (GMAC) to ensure safety in the use,
handling and transfer of GMOs, and to advise the
Government about genetic modification technology.
Philippines, established a National Biosafety Committee
which marked the start of a regulatory regime to ensure
biosafety. Philippines developed guidelines for the
planned release of GMOs.
An analysis of the existing biosafety capacity
building information indicates
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A large number of countries have no national biosafety
frameworks regulating LMOs;
Existing national biosafety regulations address only
activities relating to the domestic handling and use of
LMOs (no address for CPB);
The biosafety frameworks should be credible, flexible,
transparent, predictable, focused on clear objectives,
adaptable to different socio-economic and cultural
conditions, and cost-effective.
Some areas identified in the Protocol requiring capacity
building/strengthening in developing countries,
including India
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Strengthening of regulatory framework
Training needs and human resource development
Public awareness
Risk assessment and management
Trans-boundary movement of LMOs
Handling transport packaging and identification
Information sharing
Capacity Building
&
Public Participation
Choices
General (all 3 stages)
Why are you inviting
people to participate?
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What
do citizens know,
what are they concerned
about?
Development
• Who should participate in
the design process?
• Are people enabled to
participate?
Processes
Tools
Clarifying
Information-gathering
purposes of a
process and how people’s
inputs will be used.
surveys.
Relevant,
Engaging with areas of
public concern (rather than
assuming what people need
to know).
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• Identify key stakeholders,
going beyond groups that
identify themselves as
Stakeholders.
• Ensuring adequate legal
frameworks (rights to
information, access to
decision-making) are in place.
• Ensuring people are
sufficiently informed about the
issues to engage meaningfully
with the process
targeted
information distributed in
appropriate media,
formats and styles.
Stakeholder
forums that are
accessible and widely
advertised.
• Local and regional
consultations to discuss
issues and solicit views.
• Laws enabling public
participation and access to
information.
• Decision trails showing how
views will be carried forward,
follow-up explanations about
how
and why inputs have or have
not been used.
Implementation
• How far to include people
in decisions about:
• The roles, duties and
powers of responsible
agencies
• Mechanisms of reporting,
public scrutiny and
accountability.
• The location and design of
biosafety trials
Monitoring
• How to involve people in
reflection and evaluation of
the adequacy of the
existing NBF framework?
• Openness about
applications
for biosafety review and
commercialisation.
• Openness about the
purpose,
location and design of
biosafety trials.
• Opportunities for public
comment.
• Using risk analogies with
which people are be more
familiar.
• Public registers of
applications under review,
with opportunities for
public comment and
obligations to respond to
public comments.
• Sharing and explaining
findings of trials, creating
feedback mechanisms and
procedures for acting upon
these
• Non-specialist
involvement
in advisory and review
committees
• Local level evaluations
with opportunities for
public comment.
• Constructing mechanisms
for ongoing participatory
(re)evaluation of the
biosafety system.
Institutional structures for developing
biosafety framework
National Executive Agency need to have:
 Strong technical & human resource capabilities
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Strong political mandate
Coordinating capabilities
Strong commitment
Sustainability
Government Commitment for
Biosafety
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Notified Rules in 1989 for activities relating to
research, development and use of Genetically
Modified Organisms (GMOs) and their products.
MoEF is the focal point for all biodiversity related
matters including biosafety; and
Ratified the Cartagena Protocol in January, 2003.
Baseline Capacity and Identified
Gaps
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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.
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Indian R & D institutions has expertise for conducting
research in this area. However,they need to be
strengthened to meet the challenges that are
emerging with the rapidly changing biosafety scenario.
Information sharing protocols and additional data
capacity are needed to be enhanced to keep pace with
the expected increase in trans-boundary movement of
LMOs.
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Capacity enhancement in assessment of risks associated
with LMOs and an understanding of the transgenic
sequence.
Increasing awareness building programmes for
participation of all stakeholder groups play an important
role.
Current Regulatory Mechanism for
GMOs: Statutory Bodies
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Recombinant DNA Advisory Committee (RDAC)
Institutional Biosafety Committee (IBSC)
Review Committee on Genetic Manipulation
(RCGM)
Genetic Engineering Approval Committee (GEAC)
State Biotechnology Coordination Committee
(SBCC)
District Level Committee (DLC)
Indian Regulatory Mechanism for GM Crops
Applicant / Investigators
R & D Funding
IBSC
Applic/Investi to
report periodically
Conveys its decision to
applicant / investigator
Applicant /
Investigator to
conduct trials
RCGM
• 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
GEAC
Large scale trials conducted/
Commercial release
Synergy between
CPB
EPA
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Linkage of National Policy and legislation
need to be dovetailed to the International
Agreements.
1989 Rules & the CPB
Capacity Developments need to be
catalyzed
Essence of the Protocol
This Protocol shall apply to the trans-boundary
movement, transit, handling and use of all living
modified organisms that may have adverse
effects on the conservation and sustainable use
of biological diversity, taking also into account
risks to human health.
Areas of Capacity Developments
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AIA
RA
RM
RC
Public awareness
BCH
Implementation of Regulations
Cartagena Protocol on Biosafety
(CPB)
Article 22 CAPACITY-BUILDING:
Development and/or strengthening of human
resources and institutional capacities in
biosafety, including biotechnology to the extent
that it is required for biosafety.
CPB….
Article : 23 :
PUBLIC AWARENESS
AND PARTICIPATION
Article: 26 :
SOCIO-ECONOMIC
CONSIDERATIONS
Article 27 :
LIABILITY AND REDRESS
CPB….
Art.: 15 Risk Assessment
Art.: 16 Risk Management
Art.: 18 Handling, Transport, Packaging
and Identification
Art.: 20 Information Sharing and the
Biosafety Clearing - House
(BCH)
Risk Assessment
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Most critical component of biosafety
implementation.
Used for assessment of environmental risk
and the reality.
Estimate the likelihood of these adverse
effects being occurred.
Consequences of the risk should the
identified.
Consider appropriate risk-management
strategies
Article 20: a Biosafety Clearing-House is to:
(a)
Facilitate the exchange of scientific,
technical, environmental and legal
information on, and experience with,
living modified organisms; and
(b)
Assist Parties to implement the Protocol,
taking into account the special needs of
developing and least developing country
Parties,
RANGE OF GM CROPS DEVELOPED/
BEING DEVELOPED
Capacity building initiatives
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How to Build……….
Institutional strengthening
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Develop multidisciplinary expertise to
improve core competence within
institutions.
Strengthening laboratories with
sophisticated equipment.
Training to improve skills in handling
sophisticated equipments.
Directed research.
Risk assessment capacities
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Develop protocols and guidelines for
various scenarios.
Development of standards/limits.
Training to carryout risk assessment and
risk management.
Information sharing and data base
management
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Networking with various institutes and
agencies.
Development of databases.
Web management for information
dissemination to various stakeholders.
Involvement of stakeholders
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Societal acceptance is the key element
for successful implementation of various
polices and adaptation of technologies.
Introduction of public consultation
mechanism.
Awareness programs.
Projects on Capacity Building in
Biosafety
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GEF-World Bank Project.
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FAO Regional Capacity Building Project.
GEF-World Bank Project:
Objectives
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Capacity building enhancement for effective
coordination between the responsible agencies
to assess and manage risks associated with the
trans-boundary movement of LMOs.
Knowledge and methodologies on Biosafety will
be shared and transferred to the state agencies
through training programmes.
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strengthen institutional capacity for coordination and
decision making across ministries, specialized agencies
and in state government in areas related to biosafety
and the CP.
strengthen technical capacity to assess, manage and
monitor risks associated with biosafety through the
provision of training for core capacity development in
relevant stakeholder ministries, specialized agencies
and in state governments.
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Establish biosafety database system and Biosafety
Clearing House Mechanism.
Support centers of excellence and a network for
research, risk assessment, and monitoring.
Improving capacity for risk evaluation
and management
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Develop field capacity to monitor possible gene flow
between introduced LMOs and semi domestic and wild
relatives.
Training for implementation of biosafety measures and to
identify potential gene flow, as well the effect on nontarget species.
Training on socio-economic impact assessment of LMOs.
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form the first part of a long-term national effort to
consolidate the Biosafety framework.
Each of the proposed activities addresses possible gaps
or barriers.
Designed to strengthen not only the capabilities of the
focal point to the CP, but also of key Ministries, agencies
and scientific research institutions.
Physical mile stones
Four institutions are being strengthened in
terms of institutional and technical
capacities to assess, manage and monitor
risks associated with biosafety
Project Life
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Start Year/Date:
2004
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Conclusion Year/Date: 2007
Current status of the project
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Developed a news letter
An information toolkit
Developed the Biosafety Project website
Developed the Biosafety Clearing House
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FAO Regional Capacity Building Project
on Biosafety of GM Crops
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Regional Consultation for Standardization of
procedures for risk assessment / management
(double verification and GMO detection).
Public awareness of GMOs including material
and methodologies for effective out reach.
Establishment of Asian Bionet.
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It is not too late, nor so the risk of Biosafety visà-vis the Management;
But, if the risks exceeds the Management of
the Techno-Socio-Political will then…….
Is it Safe – Let us think !
Thank You
Dr. Manoranjan Hota
[email protected]