1. Biosafety Capacity Building Initiatives in India
Dr. Manoranjan Hota
Ministry of Environment an Forests
New Delhi

2. 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.

3. Are we producing transgenic organisms for research?
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?

4. 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?

6. Capacity: individual, institutional and systemic levels
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.

7. 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.

8. International Obligations
In Agenda 21, as well as in the Convention on Biological Diversity, Governments committed for international co-operation 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.

9. Biosafety & LMMC
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.

10. An analysis of the existing biosafety capacity building information indicates
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.

11. Some areas identified in the Protocol requiring capacity building/strengthening in developing countries, including India
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

12. Capacity Building
&
Public Participation

13. Development General (all 3 stages) Choices Processes Tools
Why are you inviting people to participate?
What do citizens know,
what are they concerned
about?
Clarifying purposes of a process and how people’s inputs will be used.
Engaging with areas of public concern (rather than assuming what people need
to know).
Information-gathering surveys.
Relevant, targeted information distributed in appropriate media,
formats and styles.
Stakeholder forums that are accessible and widely advertised.
Development
• Who should participate in
the design process?
• Are people enabled to
participate?
• 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
• 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.

14. Implementation Monitoring
• 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
• 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.
Monitoring
• How to involve people in
reflection and evaluation of
the adequacy of the
existing NBF framework?
• 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
public comment.
• Constructing mechanisms
for ongoing participatory
(re)evaluation of the
biosafety system.

15. Institutional structures for developing biosafety framework
National Executive Agency need to have:
Strong technical & human resource capabilities
Strong political mandate
Coordinating capabilities
Strong commitment
Sustainability

16. Government Commitment for Biosafety
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.

17. Baseline Capacity and Identified 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.

18. 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.

19. 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.

20. Current Regulatory Mechanism for GMOs: Statutory Bodies
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)

21. Indian Regulatory Mechanism for GM Crops
Applicant / Investigators
To Note
To Approve
To recommend &
Seek approval of RCGM
R & D Funding
IBSC
To Note
T o Approve / recommend Permits.
To monitor trials
To recommend course of action
Applic/Investi to
report periodically
RCGM
Conveys its decision to
applicant / investigator
GEAC
Applicant /
Investigator to
conduct trials
Large scale trials conducted/
Commercial release

22. Synergy between CPB EPA
Linkage of National Policy and legislation need to be dovetailed to the International Agreements.
1989 Rules & the CPB
Capacity Developments need to be catalyzed

23. 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.

24. Areas of Capacity Developments
AIA RA RM RC
Public awareness
BCH
Implementation of Regulations

26. 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.

27. CPB…. Article : 23 : PUBLIC AWARENESS AND PARTICIPATION
Article: 26 : SOCIO-ECONOMIC CONSIDERATIONS
Article 27 : LIABILITY AND REDRESS

28. 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)

29. Risk Assessment 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

30. 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,

31. RANGE OF GM CROPS DEVELOPED/ BEING DEVELOPED

32. Capacity building initiatives
How to Build……….

33. Institutional strengthening
Develop multidisciplinary expertise to improve core competence within institutions.
Strengthening laboratories with sophisticated equipment.
Training to improve skills in handling sophisticated equipments.
Directed research.

34. Risk assessment capacities
Develop protocols and guidelines for various scenarios.
Development of standards/limits.
Training to carryout risk assessment and risk management.

35. Information sharing and data base management
Networking with various institutes and agencies.
Development of databases.
Web management for information dissemination to various stakeholders.

36. Involvement of stakeholders
Societal acceptance is the key element for successful implementation of various polices and adaptation of technologies.
Introduction of public consultation mechanism.
Awareness programs.

37. Projects on Capacity Building in Biosafety
GEF-World Bank Project.
FAO Regional Capacity Building Project.

38. GEF-World Bank Project: Objectives
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.

39. 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.

40. Establish biosafety database system and Biosafety Clearing House Mechanism.
Support centers of excellence and a network for research, risk assessment, and monitoring.

41. Improving capacity for risk evaluation and management
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 non-target species.
Training on socio-economic impact assessment of LMOs.

42. 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.

43. Physical mile stones
Four institutions are being strengthened in terms of institutional and technical capacities to assess, manage and monitor risks associated with biosafety

44. Project Life
Start Year/Date:
Conclusion Year/Date: 2007

45. Current status of the project
Developed a news letter
An information toolkit
Developed the Biosafety Project website
Developed the Biosafety Clearing House

49. 2. FAO Regional Capacity Building Project on Biosafety of GM Crops
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.

50. It is not too late, nor so the risk of Biosafety vis-à-vis the Management;
But, if the risks exceeds the Management of the Techno-Socio-Political will then…….

51. Is it Safe – Let us think !

52. Thank You
Dr. Manoranjan Hota