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CHAPTERS
Executive Summary
i-ix
1. INTRODUCTION
2. METHODOLOGY
3.1
3.2
Global Status
Status in India
35
Introduction
Objective
Elements of the Protocol
Status of Implementation in India
Other International Agreements
14
Development of GMOs
Risk Assessment
Risk Management
Regulatory Capacity Building
Identification of LMOs
Human Resources Development and Training
Public Awareness, Education and Participation
Information Exchange & Data Management
Scientific, Technical and Institutional Collaboration
Technology Transfer
Socio-Economic Considerations
Sustainable Use and Conservation of Biodiversity
45
Page
10.
74
Stakeholders
Training Needs Matrix
57
81
Series of Workshops
National Events
International Events
Training Programmes by Private Sector
Websites
Publications
Capacity Building Projects
91
ANNEXES
1.
QUESTIONNAIRES
99
2.
LIST OF RESPONDENTS
123
3.
129
4.
In the recent past, there has been a rapid increase in research and development
activities involving genetically modified organisms (GMOs)/living modified organisms
(LMOs). At the same time, there has also been considerable apprehension and concern
about ensuring safety in use of GMOs, particularly with respect to their handling,
containment and the impact on human health and environment.
To address these
concerns, the Ministry of Environment and Forests (MoEF) and the Department of
Biotechnology (DBT), the two apex regulatory bodies, have formulated regulations and
brought out guidelines on biosafety. India has also ratified the Cartagena Protocol on
Biosafety, which has a specific focus on transboundary movements of LMOs so as to
ensure adequate level of protection in their safe transfer, handling and use.
Under the sponsorship of GEF-World Bank, MoEF has initiated a Capacity Building
project, to enhance Indias national capacity to implement the Cartagena Protocol on
Biosafety. The specific objectives of the project include strengthening the institutional and
legal framework, to improve capacity and coordination in decision making across
Ministries, improve capacity for risk evaluation and management etc. Training being one of
the key elements for achieving the above, MoEF has carried out a Training Needs
Assessment Survey with the assistance from Biotech Consortium India Limited (BCIL) to
assess the requirements in these areas through a process of consultation with various
stakeholders prior to initiating countrywide training programmes.
The survey was a combination of field studies through questionnaires and personal
discussions supplemented by extensive desk research. A detailed questionnaire was
prepared covering the following areas for identifying the training needs as well as other
capacity building requirements:
identification and development of LMOs/GMOs;
risk assessment (impact on human health and environment) and management;
regulatory capacity building;
human resource development and training;
public awareness, education and participation;
information exchange and data management;
scientific and institutional collaborations;
technology transfer;
socio-economic considerations; sustainable use and conservation of biodiversity
A scale of 1-5 was given for priority ranking in the above areas. Out of the detailed
questionnaire, short questionnaires were also drafted for state level officials, quarantine
officials, social experts etc. The questionnaire was prepared in such a way so as to get
inputs for assessment of training needs as well as designing the training programmes.
Personal interviews were held with selected stakeholders by visits and telephonic
conversation.
About 150 responses were received from various stakeholders viz. Central
Government, State Government, research organizations, industry, regulatory bodies, civil
organizations, social experts, agriculture service providers and others. A computerized
programme was prepared for analyzing the results of the survey, which was used to
generate different query based reports. Priority ranking of the areas for capacity building
has been done for total number of responses as well as for individual stakeholders. The
ii
The field survey findings have been combined with the above to workout the
requirements of various stakeholders by drawing a training needs matrix, based on which
the training modules have been proposed. A stakeholder consultation was organized to
discuss the field survey findings with experts from government, industry, institutions, etc.
The participants endorsed the field survey findings and gave suggestions. The inputs
received have been suitably incorporated in the report. The report was also presented to
Steering Committee of the GEF-World Bank project. The members gave suggestions and
approved the report.
also been included. It is evident from this review along with study of major provisions of
Cartagena Protocol on biosafety and corresponding capacity building requirements that
there is an urgent need for strengthening of institutional capacity and human resource
development, in addition to regulatory changes. Areas identified for training assessment
have been further divided into subsections to address capacity building requirements.
A review of the existing training programmes for various stakeholders has indicated
that there has been ongoing efforts in implementing training through organizing national
and international events, websites, publications etc. Most of these programmes have
been under the aegis of apex regulatory bodies i.e. MoEF and DBT. Over 5000
participants have attended about 50 events organized by MoEF, DBT and BCIL in the last
few years. There has been active participation of government officials, scientists, industry
representatives, NGOs, farmers etc. in these events. The feedback received from the
participants in these programmes through surveys conducted from time to time (for IBSCs,
State level officers, agriculture service providers, farmers etc.) as well as presentations
made by eminent experts have also been taken into account while drawing the
recommendations. Other institutions who have conducted trainings include: National
Bureau of Plant Genetic Resources (NBPGR), G.B. Pant University of Agriculture and
Technology and Central Food Technological Research Institute (CFTRI). Organizations
such as The Energy Resources Institute (TERI) and Research and Information System for
Developing Countries (RIS) have organized stakeholders consultations on some issues
related to GMOs/LMOs.
iv
MoEF and DBT have prepared various websites for information dissemination i.e.
Capacity Building on Biosafety, Biosafety Clearing House (BCH), Indian GMO Research
Information System (IGMORIS) and Biosafety regulations.
Risk assessment and management has emerged as the top most priority for
imparting training followed by human resource development, training and regulatory
capacity building. The other major priority areas listed are public awareness, education
and participation followed by scientific, technical and institutional collaborations.
Majority of the respondents have indicated that risk assessment capabilities in India
are limited among molecular biologists engaged in development of GMOs. Those currently
involved in the risk assessment are mainly agricultural scientists and the members of the
regulatory bodies i.e. IBSC, RCGM and GEAC. For studying the impact on human health
and environment, scientific data need to be generated by experts from several disciplines,
thereby clearly indicating the need to provide training to a multiplicity of stakeholders.
Foreign collaboration and training have been recommended not only for the areas for the
development of scientific methods and protocols for risk assessment, but also to enhance
competence to review/audit risk assessment and national biosafety research programmes.
It has been suggested that there should be a dedicated technical cell within the two apex
regulatory bodies i.e. DBT and MoEF equipped with requisite information technology tools
to have rapid access to reference material/databases on risk assessment for effective
review within the stipulated time.
institutions involved in the compliance and monitoring also need to be extensively trained
particularly at the functional level.
The status of regulatory capacity has been rated as medium in the legal framework
and low in compliance mechanisms. Regulatory capacity building has been divided into
three areas i.e. legislative, administrative and technical and scientific framework. Regular
training of both regulators and compliance officers by noted national and international
experts, at least once a year has been suggested.
manuals for specific target segments viz. health inspectors, agriculture officials, pollution
control board officials, border control and quarantine officials has also been suggested.
Based on the above priorities, a training needs matrix has been drawn for the
following stakeholders:
(i)
(ii)
(iii)
Enforcement officials (e.g. field inspectors health, food and agriculture departments,
custom and plant quarantine officers);
(iv)
(v)
Legal experts;
(vi)
Economists;
(vii)
(viii)
(ix)
(x)
(xi)
Series of events across the country are required for officials involved in compliance
of regulatory provisions such as customs, port, plant quarantine, agriculture, food with the
focus on the basics of GMOs/LMOs, biosafety issues, identification procedures, national
vii
regulatory framework, international commitments etc. The events may include visits to
scientific institutions for gaining first hand idea of the new technologies.
In view of the transitions of the world trade norms due to various international
agreements, such as Cartagena Protocol, WTO and Codex, there is an urgent need to
review and update the provisions of national rules and guidelines such as Rules, 1989,
rDNA Biosafety Guidelines 1990 as well as notify additional policies/rules/guidelines.
Detailed guidelines for new GMOs and products thereof as well as newer applications of
existing GMOs, e.g., transgenic animals including livestock and fish, use of plants and
animals for production of pharmaceuticals/ biochemicals etc. need to be developed.
Studies need to be conducted urgently for review of guidelines for transport of LMOs and
global status, impact and cost implications of labelling. Baseline surveys for developing
protocols for risk assessment particularly ecological issues such as impact on non-target
organisms for sustainable use and conservation of biodiversity are required.
GM crops particularly food for commercial use. International conferences on LMOs testing
methods, facilities and equipments and risk assessment and management procedures
including case studies by different countries (Issues related to impact on human and
animal health and impact on environment) need to be organized on priority. Regional
conferences (Asia or Asia Pacific) may be organized for understanding and harmonization
of biosafety rules, guidelines and priorities/approach for effective implementation of
Cartagena Protocol.
ix
CHAPTER 1
INTRODUCTION
India is a signatory to the Cartagena Protocol on Biosafety, which came into
force on September 11, 2003. The objective of the Protocol is to contribute to
ensuring an adequate level of protection in the field of safe transfer, handling and
use of Living Modified Organisms (LMOs) taking also into account risks to human
health, and specifically focusing on transboundary movement. There is a regulatory
mechanism in place in India since 1989 for development and evaluation of
genetically modified organisms (GMOs) and products thereof.
The Ministry of
Environment & Forests (MoEF) and the Department of Biotechnology (DBT) are the
two apex regulatory bodies.
In line with the above, MoEF is implementing a project for capacity building in
the area of biosafety related to use of LMOs/GMOs for effective implementation of
the Cartagena Protocol on Biosafety, sponsored by GEF and World Bank. The
specific objectives of the project include strengthening of the institutional and
regulatory framework and building capacity in relevant Ministries and State Agencies
and specialized organizations. Training constitutes a major component in the GEFWorld Bank capacity building project to achieve the above objectives. It has been
proposed that prior to initiating steps for countrywide training programmes, a realistic
assessment of the training needs should be made. MoEF carried out a Training
Needs Assessment Survey with the assistance of Biotech Consortium India Limited
(BCIL), a company promoted by the DBT and set up by all India financial institutions
including IDBI, ICICI, IFCI etc. to accelerate commercialization of biotechnology in
India.
stakeholder consultation was organized to discuss the field survey findings with
experts from government, industry, institutions etc. The participants endorsed the
field survey findings and gave suggestions.
incorporated in the report. The report was also presented to the Steering Committee
of the GEF-World Bank Project, which approved the report.
CHAPTER 2
METHODOLOGY
The present report of Training Need Assessment Survey is a combination of
field survey through questionnaires and personal discussions supplemented by
extensive desk research.
A scale of 1-5 was given for priority ranking by the respondents in the above
areas (1-not important, 2- a little important, 3- relatively important, 4- fairly important,
5- very important). Subsequently the detailed elements of each of the above
mentioned areas were elaborated for prioritization on the scale 1-5. Respondents
were requested to give their views on the present status, existing facilities/activities,
suggested areas for the training/capacity building and the target segments for each
of the listed areas.
Out of the detailed questionnaire, short questionnaires were drafted for some
specific stakeholders i.e. state level agricultural officials, agriculture service providers
(seed distributors), farmers, plant quarantine officials and social experts. The
questionnaires were prepared in such a way so as to get inputs in both quantitative
and qualitative terms for assessment of training needs as well as designing the
training programmes. The questionnaire was also placed on the BCIL and MoEF
websites for wider circulation and easy accessibility for the respondents. Copies of
questionnaires are placed in Annex-1.
Category
Component
1.
Central government
2.
State government
3.
Regulatory bodies
4.
5.
6.
Social experts
7.
Agriculture service
providers
8.
The questionnaires were sent by post, fax, email and courier and extensive
follow up was done by sending reminders and phone calls. An introductory note on
the Cartagena Protocol was attached with each questionnaire to familiarize the
respondents with the terms used in the questionnaire such as AIA procedure.
Personal interviews were held with selected stakeholders by both visits as well as
through telephonic conversation.
The quantitative analysis on the priority ranking was done for total number of
responses as well as for individual stakeholders.
based on both the written questions in the questionnaires as well as a set of open
questions, which were discussed with the respondents. The findings were compiled
for each of the identified areas for assessment of training needs.
programmes through surveys conducted from time to time (for IBSCs, state level
officers, agriculture service providers, farmers etc.) as well as presentations made by
eminent experts have also been taken into account for assessment of training needs.
The field survey findings have been combined with the above to workout the
requirements of various stakeholders by drawing a training needs matrix, based on
which the training modules have been proposed. A stakeholder consultation was
organized to discuss the field survey findings with experts from government,
industry, institutions, etc. The participants endorsed the field survey findings and
gave suggestions. The inputs received have been suitably incorporated in the report.
The report was also presented to Steering Committee of the GEF-World Bank
project which approved the report.
CHAPTER 3
APPLICATIONS OF GMOs IN AGRICULTURE
In modern science, a Genetically Modified Organism (GMO) is that in which
the basic genetic material (DNA) has been altered by rearranging, deleting or adding
genes by recombinant DNA technology. The term Living Modified Organism (LMO)
has been defined in the Cartagena Protocol on Biosafety as any living organism that
possesses a novel combination of genetic material obtained through the use of
modern biotechnology.
same as GMOs, but definitions and interpretations of the term vary widely.
Sequences from mammals or any other animals, plants, fungi, bacteria or even
sequences synthesized in vitro can be introduced into and expressed in almost any
other organism. The genetic manipulation using rDNA technology are more precise
and outcomes more certain over other methods resulting in faster production of
organisms with desired traits.
GMOs have been developed and applied successfully since early 1970s
under contained conditions and since mid 1980s for commercial applications in the
field and open environment. The areas of crop improvement currently being targeted
using transgenic techniques include resistance to a variety of pests, pathogens and
weed control agents, improvement in nutritional content and improved survival during
environmental stress. Research is also being carried out for the use of GM crops for
production of a wide range of products including medicines.
3.1
GLOBAL STATUS:
Crop
Uses
Alfalfa
Herbicide tolerance
2.
Argentine
Canola
3.
Carnation
4.
Chicory
European Union
5.
Cotton
6.
Flax,
Linseed
Canada, US
7.
Green
pepper
Virus resistance
China
8.
Maize
9.
Melon
Delayed ripening
U.S.A
10.
Papaya
Virus Resistance
U.S.A., Canada
11.
Polish
Canola
Canada
12.
Potato
13.
Rice
Herbicide resistance
US
14.
Soybean
15.
Squash
Resistance against
watermelon mosaic virus and
zucchini yellow mosaic virus
US, Canada
16.
Sugar
beet
Herbicide tolerance
17.
Sunflower
Herbicide tolerance
Canada
18.
Tobacco
Herbicide tolerance
US
19.
Tomato
20.
Wheat
Herbicide Tolerance
U.S.
1.
Source: http://www.agbios.com/
Out of the above, four major transgenic crops have come to market in various
countries namely maize or corn, cotton, soybean and canola.
Commercial
production of papaya, squash and tobacco has been initiated in USA. Others such
as chicory, tomatoes, rice, potatoes, flax etc. have been approved for commercial
use in one or more countries, but have not yet been marketed.
In the nine year period since the commercial cultivation of transgenic crops
started, the global area under these crops increased by more than 47 fold, from 1.7
million hectares in 1996 to 81.0 million hectares in 2004 (Figure 3.1). There has
been a 20% increase in 2004 in the area over the same in 2003 equivalent to 13.3
million hectares. Seventeen countries have so far adopted biotech crops.
81.0
67.7
52.6
39.9
44.2
11.0
2004
the
2003
for
2002
1999
Service
2001
International
1998
1997
1.7
2000
Source:
58.7
27.8
1996
90
80
70
60
50
40
30
20
10
0
Acquisition
of
Agri-biotech
Applications
(http://www.isaaa.org)
More than one third (34%) of the global biotech crop area of 81 million
hectares in 2004, which is equivalent to 27.6 million hectares was grown in
developing countries. In 2004, there were 14 countries referred to as biotech mega
countries which have 50,000 hectares or more under transgenic. These included
nine developing countries and five industrial countries.
In decreasing order of
hectarage under transgenics, they are USA, Argentina, Canada, Brazil, China,
Paraguay, India, South Africa, Uruguay, Australia, Romania, Mexico, Spain and the
Philippines (Figure 3.2).
Source: International
(http://www.isaaa.org)
Service
for
the
Acquisition
of
Agri-biotech
Applications
There is cautious optimism that the global area and the number of farmers
planting GM crops will continue to grow as new and novel products become
available for commercialization in the coming years.
Crops tolerant to certain stresses e.g. drought, floods, salts, metals, heat, and
cold
Edible vaccines
3.2
STATUS IN INDIA:
Besides, Bt cotton, ten food crops were under contained limited field trials in
India in 2005 (Table 3.2). The trials are being conducted by both public and private
sector institutions and are mainly for insect resistance using Cry genes.
10
Crop
Organization
Transgene
1.
Brinjal
Mahyco, Mumbai
Sungro Seeds Ltd, New Delhi
IARI, New Delhi
cry1Ac
cry1Ac
cry1F
2.
Cabbage
cry1Ac
3.
Cauliflower
cry1Ac
4.
Corn
Monsanto, Mumbai
Metahelix Life Sciences, Bangalore
5.
Cotton
6.
Groundnut
ICRISAT, Hyderabad
7.
Mustard
8.
Okra
Mahyco, Mumbai
cry1Ac,
9.
Pigeonpea
ICRISAT, Hyderabad
cry1Ac,
10.
Rice
11.
Tomato
Mahyco, Mumbai
Source: Department of Biotechnology, Government of India
11
Cry1Ab
Modified Mu-element
(Turbo-Mu)
cry1Ac, cryX
cry1Ac, cryX
cry1Ac, cryX
cry1Ac, cryX
cry1Ac
GFM cry1Aa
cry1Ac
cry1Ac
cry1Ac, cryX
cryX
cry1Ac
cry1Ac
cry1Ac
GFM cry1Aa
cry1Ac, cryX
cry1Ac
cry1Ac
cry1Ac
cryX
Vip-3A
cry1Ac, cryX
cry1Ac
cry1Ac
cry1Ac
cry1Ac
GFM cry1Aa
More than 50 institutions both in the public and the private sector are engaged
in research and development of transgenic crops, some of which are listed below:
A. RESEARCH INSTITUTIONS
1. Assam Agricultural University, Jorhat
2. Bose Institute, Kolkata
3. Central Institute for Cotton Research, Nagpur
4. Central Potato Research Institute, Shimla
5. Central Tobacco Research Institute, Rajahmundry
6. Centre for Plant Molecular Biology, Osmania Univ., Hyderabad
7. Delhi University South Campus, New Delhi
8. G B Pant University of Agriculture and Technology, Pantnagar
9. Indian Agricultural Research Institute, New Delhi
10. International Centre for Genetic Engineering and Biotechnology, New Delhi
11. International Crop Research Institute for Semi-Arid Tropics, Hyderabad
12. Indian Institute of Chemical Biology, Kolkata
13. Jawaharlal Nehru University, New Delhi
14. Madurai Kamraj University, Madurai
15. Mahatama Phule Krishi Vidyapeeth, Rahuri
16. National Botanical Research Institute, Lucknow
17. National Centre for Plant Genome Research, New Delhi
18. The Energy and Resources Institute (TERI), New Delhi
19. Tamil Nadu Agricultural University, Coimbatore
20. University of Agricultural Sciences, Dharwad
B. COMPANIES
13
CHAPTER 4
REGULATORY FRAMEWORK IN INDIA
As more and more GMOs/LMOs are released for field-testing and
commercialization, concerns have been expressed regarding potential risks to both
human health and environment. Risks to human health are related mainly to toxicity,
allergenicity and antibiotic resistance of the new organisms/products.
Risks to
4.1
The Ministry of Environment & Forests, Government of India notified the rules
and procedures for the manufacture, import, use, research and release of GMOs as
well as products made by the use of such organisms on December 5, 1989 under
the Environmental Protection Act 1986 (EPA).
commonly referred as Rules 1989 cover the areas of research as well as large scale
applications of GMOs and products made therefrom throughout India. The two main
agencies identified for implementation of the rules are the Ministry of Environment &
14
Forests and the Department of Biotechnology, Government of India. The rules have
also defined competent authorities and the composition of such authorities for
handling of various aspects of the rules. There are six competent authorities as per
the rules.
i.
ii.
iii.
iv.
v.
vi.
recommendations from time to time that are suitable for implementation for
upholding the safety regulations in research and applications of GMOs and
products thereof.
To inform DLC and SBCC as well as GEAC about the experiments where
ever needed.
15
(iii) Review Committee on Genetic Manipulation (RCGM): The RCGM under the
Department of Biotechnology has the following functions:
To review all on going r-DNA projects involving high risk category and
controlled field experiments.
To lay down producers for restriction or prohibition, production, sale, import &
use of GMOs both for research and applications.
To permit experiments with category III risks and above with appropriate
containment.
To permit the use of GMOs and products thereof for commercial applications.
To adopt producers for restriction or prohibition, production, sale, import & use
of GMOs both for research and applications under EPA.
16
To act as nodal agency at State level to assess the damage, if any, due to
release of GMOs and to take on site control measures.
The Committee coordinates the activities related to GMOs in the State with
the Central Ministries.
(vi) District Level Committee (DLC): This Committee constituted at the district level
is considered to be smallest authoritative unit to monitor the safety regulations in
installations engaged in the use of GMOs in research and applications. The
District Collector heads the Committee who can induct representatives from State
agencies to enable the smooth functioning and inspection of the installations with
a view to ensure the implementation of safety guidelines while handling GMOs,
under the Indian EPA. Its functions are:
Has powers to inspect, investigate and report to the SBCC or the GEAC about
compliance or non compliance of r-DNA guidelines or violations under EPA.
To act as nodal agency at District level to assess the damage, if any, due to
release of GMOs and to take on site control measures.
17
The approvals and prohibitions under Rules 1989 are summarized below:
Any person operating or using GMOs for scale up or pilot operations shall
have to obtain permission from GEAC.
If orders are not complied, SBCC/DLC may take suitable measures at the
expenses of the person who is responsible.
All approvals shall be for a period of 4 years at first instance renewable for
2 years at a time.
18
i.
ii.
iii.
Applicant
IBSC functions
To note, approve, recommend &
to seek approval of RCGM
IBSC
RCGM functions
MEC functions
RCGM
MEC
GEAC functions:
To approve for large scale
use, open release in to
environment
GEAC
ICAR
ICAR Trials
Seeds Act/
Rules
4.2
19
plants, animals and products into the environment, shipment and importation of
GMOs for laboratory research. The issues relating to genetic engineering of human
embryo, use of embryos and fetuses in research and human germ line, and gene
therapy areas have not been considered while framing the guidelines.
The research activities have been classified into three categories based on
the level of the associated risk. Accordingly, the requirement for the approval of
competent authority is envisaged. Category I activities include those experiments
involving self cloning using strains and also inter-species cloning belonging to
organism in the same exchanger group which are exempt for the purpose of
intimation and approval of competent authority. Category II activities which require
prior intimation of competent authority and include experiments falling under
containment levels II, III and IV (details of each containment level provided
separately in the guidelines). Category III activities that require review and approval
of competent authority before commencement include experiments involving toxin
gene cloning, cloning of genes for vaccine production, and other experiments as
mentioned in the guidelines. The levels of risk and classification of the organisms
within these categories have been defined in these guidelines.
Appropriate
practices.
For
containment
facilities
and
biosafety
practices,
The guidelines require the interested party to evaluate GMOs for potential risk
prior to application in agriculture and environment like properties of the organism,
possible interaction with other disease causing agents and the infected wild plant
species. An independent review of potential risks should be conducted on a case-tocase basis.
20
4.3
In 1998, DBT brought out separate guidelines for carrying out research in
transgenic plants called the Revised Guidelines for Research in Transgenic Plants.
These also include the guidelines for toxicity and allergenicity of transgenic seeds,
plants and plant parts.
4.4
India Coordinated Project Trials of ICAR, in coordination with the tests for
environment and bio-safety clearance as per the EPA before any variety is
commercially released in the market.
commercially released, its seed will be registered and marketed in the country as per
the provisions of the Seeds Act.
variety, its performance in the field, will be monitored for at least 3 to 5 years by the
Ministry of Agriculture and State Departments of Agriculture.
It has also been mentioned that transgenic varieties can be protected under
the PVP legislation in the same manner as non-transgenic varieties after their
release for commercial cultivation.
4.5
As the Government has the prime responsibility for the establishment and
operation of national food safety programs and quality control systems that must
ensure safe and wholesome food to meet the nutritional needs of consumers and do
not endanger the consumers health through chemical, biological or other
contaminants, it has set up a food control system that includes the national, state
and municipal organizations involved in either the regulation, inspection or analysis
of food and agricultural products, together with their supporting legislation and rules
and compliance activities.
The Act has been amended a number of times to make the provisions more
practical and consumer-oriented. This Act is the basic statute intended to protect the
consumer from the supply of adulterated food and it specifies food safety and quality
standards for consumer protection. The definition of adulteration includes the
22
addition of cheaper or inferior substances to deceive the consumer and the presence
of contaminants, which may make the food, unfit for human consumption. The
objective of this legislation is, therefore, not only to ensure pure and wholesome food
to the consumers, but also to prevent fraud or deception. It lays down that no person
shall manufacture, sale, store, or distribute adulterated or misbranded food products
not conforming to the standards laid down in the rules. The provisions apply to
imported food as well as to food produced in India.
The overall infrastructure includes the local food inspectors, the public
analysts, both at the municipal and state levels, their laboratory facilities, the four
central food laboratories designated under the PFA Act and the central PFA Division
in the MOH&FW in New Delhi. The central PFA Division is also designated as the
National Codex Contact Point for India.
Food Safety and Quality Control Organization
Ministry of Health and Family Welfare
State/
Governments/
UTs
Central
National
Coordination
Central
National
Committee
Monitoring
with National
Codex
Food
for Food
Agency for
and
Laboratori
Committee
Standards and
Irradiation
International
and its
es
its SubOrganizations/
(4)
Shadow
of
Food
Consumer
Committees
Committees
for Framing of
Organizations/
Rules/
Industries
Standards of
food Articles
Source: A contemporary approach to food quality and safety standards; Ministry of Health and Family
Welfare available at http://www.codexindia.nic.in
The responsibilities of the PFA cell in food control system are as follows:
23
Regarding laboratory facilities under the PFA Act, there are approximately 80
food laboratories in the country undertaking the analysis of samples of food articles
under the provisions of the PFA Act, out of which 13 are managed by local bodies
(municipalities). These are known as Public Analyst Laboratories. In addition, there
are four Central Food Laboratories notified under the PFA Act to carry out an
analysis of appeal samples whenever the report of the public analyst is challenged in
the court of law. These are situated in Kolkata, Ghaziabad, Mysore and Pune. These
laboratories analyze the bulk of the samples under the PFA Act.
verify the compliance with the requirements stipulated under the PFA Act, 1954 and
Rules.
Regarding procedures for food export inspection and certification, the Export
Inspection Council (EIC) of the Ministry of Commerce and Industry is the official
government inspection body for certifying food products for export. It carries out the
inspection of several food articles such as marine, milk products, meat, honey,
poultry, Basmati rice, black pepper and cashew meant for export.
4.6
The Ministry of Food Processing Industries has introduced The Food Safety
and Standards Bill, 2005 which seeks to consolidate the laws relating to food and
establish the Food Safety and Standards Authority of India. This step has been
taken keeping in view the fact that presently eight ministries are administering food
laws in diverse ways which has been found to be not conducive to the growth of the
food processing industry.
The proposed Food Safety and Standards Authority of India would facilitate
scientific standards for food articles and regulate their manufacture, storage,
distribution, sale and import to ensure the availability of safe and wholesome food for
human consumption. The authority will consist of members from various ministries,
and representatives from State Governments, the food industry, consumer
organisations and even farmers' organisations. Scientific committees and panels will
assist it in fixing standards, while a Central Advisory Committee will prioritise the
work.
25
The enforcement of the legislation will be through the State Commissioner for
Food Safety and Panchayati Raj/ municipal bodies. The Food Bill not only
incorporates the salient provisions of the Prevention of Food Adulteration (PFA) Act,
but is also based on international legislations, instrumentalities and Codex
Alimentaries Commission (related to food safety norms).
The proposed body will regulate the limits on the usage of food additives, crop
contaminants, pesticide residues, heavy metals, processing aids, myco-toxins,
antibiotics and pharmacological active substances.
The Bill has also mooted the establishment of a Food Safety Appellate
Tribunal to hear the appeals of disputed parties.
The genetically modified food has been defined in the Bill as the food, which
is produced through techniques in which the genetic material has been altered in a
way that does not occur naturally by mating or having adequate human intervention
or both. Techniques of Genetic Engineering or modification include, but are not
limited to recombinant DNA, cell fusion, micro and macro injection, encapsulation,
gene deletion, addition and doubling.
export, import or sell genetically modified articles of food, organic foods, functional
foods, neutraceuticals, health supplements etc. except in accordance with the
regulations made there for under this Act.
4.7
All plant breeders and researchers intending to import seed/ planting material
have to fulfill two mandatory requirements, i.e. (i) Import Permit before importing any
material, and (ii) Phytosanitary certificate from country of origin. These two
documents must accompany with every seed/ plant consignment imported from
abroad. NBPGR has been authorized to issue Import Permit on the basis of import
permission of DBT and receive imported materials from custom authorities for its
quarantine inspection and clearance on a prescribed application form. The Import
Permit issued is valid for six months and it remains valid. Before obtaining import
permit the indentor should furnish the information and provide the undertaking as
well as certificate from the supplier as per para 4 and 5 of the permission accorded
by the DBT from safety point of view. The details of para 4 and 5 are given below.
27
Para No.4
Full account of transgenic plants raised from the imported seeds is to be kept in
a bound book, which should he available for inspection by the authority in case
such a need arises.
All the unwanted transgenic materials may be destroyed by burning after the
experiments are conducted.
All precautions would be taken to prevent the escape of the genetic material into
the open environment and shall follow the Recombinant DNA Safety Guidelines
of the Government of India.
Para No.5
The supplier of the transgenic material shall certify that the transgenic has the
genes as has been described in the permission.
The supplier shall also certify that these transgenic materials do not contain any
embryogenesis deactivator gene sequence.
All indents for import of transgenics are registered for assigning the case
number and then forwarded to the Plant Quarantine (PQ) Division without opening
the parcel alongwith duly filled Import Quarantine (IQ) form for detailed quarantine
inspection and clearance. After clearance from PQ Division. the Samples are first
arranged taxonomically indicating their genus, species. common name and cultivar
name etc. for national accessioning in the national record. Each introduction/
accession is assigned an EC(Exotic Collection) number which remains unchanged
with information like name and address of donors, characteristics of the germplasm,
relevant references. date of arrival, condition of the material and distribution of the
28
4.8
Regarding
awareness
generation
of
matters
relating
to
agricultural
biotechnology, the task force report has indicated that an effective communication
strategy must be developed and a cohesive mechanism established to ensure that
messages are consistent with National policy on agricultural biotechnology and also
that all target groups are reached. Education and development communication must
receive high priority. Field research may be required to ensure that the concerns of
various groups of population are understood and addressed to see that the
messages are evidence based, simple and effective.
29
The issues in regard to the release of GM crops are not understood correctly
owing to the lack of information on this subject even amongst the otherwise wellinformed members of the public. An information campaign needs to be conducted to
generate public awareness on the benefits and risks associated with biotechnology
and the social, ethical, economic, scientific, environmental and health issues which
are addressed by regulatory bodies before allowing the cultivation of GM crops.
Active cooperation of various scientific organizations/institutions/ universities/NGOs
may be sought to generate public awareness in the country on the following specific
aspects of agricultural biotechnology:
Concept of plant breeding, pressures on modern plant breeding and the need for
novel genetic enhancement strategies
Social, economic, ethical, scientific, environmental and health issues which are
addressed by regulatory bodies before allowing release of GM crops.
Current GM products under evaluation in India under biosafety, VCU and other
regulatory trials
Community and Farmers Rights and benefit sharing related to agrobiotechnological applications
30
4.9
MoEF has released the Draft Environment Policy in December 2004. The
actions proposed in the policy include reviewing of the regulatory processes for
LMOs so that all relevant scientific knowledge is taken into account, and ecological,
health, and economic concerns are adequately addressed. Periodically review of the
National Bio-safety guidelines and Bio-safety Operations Manual has been
suggested to ensure that these are based on current scientific knowledge and
ensuring the conservation of bio-diversity and human health when dealing with
LMOs in transboundary movement in a manner consistent with the Multilateral Biosafety Protocol.
31
4.10
DBT has brought out National Biotechnology Strategy in 2005 which covers
regulatory mechanisms as well. The policy indicates that it has to be ensured that
research and application in biotechnology is guided by a process of decision-making
that safeguards both human health and the environment with adherence to the
highest ethical standards.
(i)
and
processes;
resolve
issues
emanating
from
the
(ii)
Authority
with
separate
divisions
for
agriculture
32
(iii)
(iv)
All existing guidelines are to be updated and made consistent with the
recommendations of the Swaminathan and Mashelkar committees in 2005.
New guidelines on transgenic research and product/process development in
animal, aqua culture, food, phyto-pharma and environmental application to be
put in place in 2005 by the concerned ministries/departments
(v)
33
34
CHAPTER 5
CARTAGENA PROTOCOL ON BIOSAFETY
5.1
INTRODUCTION:
35
5.2
OBJECTIVE:
5.3
The protocol features two separate sets of procedures, one for LMOs that are
to be intentionally introduced into the environment (Advanced Informed Agreement
Procedure) and one for those that are to be used directly as food or feed or for
processing. However, LMOs that are pharmaceuticals for humans are excluded from
the scope of the Protocol if they are covered by other international agreements or
arrangements.
(a) Advance Informed Agreement (AIA) Procedure: Under the biosafety protocol,
the most rigorous procedures are reserved for GMOs that are to be introduced
intentionally into the environment. These include seeds, live fish and other
organisms that are destined to grow and that have the potential to pass their
modified genes on to succeeding generations. It includes four components:
notification by the Party of export or the exporter, acknowledgment of receipt of
notification by the Party of import, decision procedure and review of decisions.
The purpose of this procedure is to ensure that importing countries have both the
opportunity and the capacity to assess risks that may be associated with the LMO
before agreeing to its import.
The AIA procedure applies only to the first intentional transboundary movement
of any particular GMO intended for introduction into the environment. It does not
apply to GMOs in transit through a country, GMOs destined for contained use (in
a scientific laboratory for example) or GMOs to be directly used as food or animal
36
(b) Simplified system for agricultural commodities: Instead of requiring the use
of the AIA procedure for commodities intended for direct use as food or feed or
processing and not as seeds for growing new crops, the Protocol establishes a
simpler system. Under this system, governments that approve these commodities
for domestic use have to communicate this decision to the world community via
the Biosafety Clearing- House. They must also provide detailed information about
their decision. In addition, countries may take decisions on whether or not to
import these commodities on the basis of their domestic law and must then
declare these decisions through the Clearing-House.
(c) Risk assessments: The Protocol empowers governments to make its decisions
in accordance with scientifically sound risk assessments. These assessments
aim to identify and evaluate the potential adverse effects that a GMO may have
on the conservation and sustainable use of biodiversity in the receiving
environments. They are to be undertaken in a scientific manner using recognized
risk assessment techniques. While the country considering permitting the import
of a GMO is responsible for ensuring that a risk assessment is carried out, it has
the right to require the exporter to do the work or to bear the cost. This is
particularly important for many developing countries.
(d) Risk management and emergency procedures: The Protocol requires each
country to manage and control any risks that may be identified by a risk
assessment. Key elements of effective risk management include monitoring
systems, research programmes, technical training and improved domestic
coordination amongst government agencies and services. The Protocol also
requires each government to notify and consult other affected or potentially
affected governments when it becomes aware that GMOs under its jurisdiction
may cross international borders due to illegal trade or release into the
environment. This will enable them to pursue emergency measures or other
37
(e) Export documentation: For GMOs intended for direct introduction into the
environment, the accompanying documentation must clearly state that the
shipment contains GMOs. It must specify the identity and relevant traits and
characteristics of the GMO; any requirements for its safe handling, storage,
transport and use; a contact point for further information; and the names and
addresses of the importer and exporter. In cases where a government agrees to
import a genetically modified commodity intended for direct use as food or feed or
for processing, the shipment must clearly indicate that it may contain living
modified organisms and that these organisms are not intended for introduction
into the environment.
(f) The Biosafety Clearing House (BCH): The Protocol established a Biosafety
Clearing-House (BCH) as part of the clearing-house mechanism of the
Convention, in order to facilitate the exchange of scientific, technical,
environmental and legal information on, and experience with, living modified
organisms; and to assist Parties to implement the Protocol. In addition to
enabling governments to inform others about their final decisions regarding the
import of GMOs, the Biosafety Clearing- House contains information on national
laws, regulations, and guidelines for implementing the Protocol. The Biosafety
Clearing-House also includes information required under the AIA procedure,
summaries of risk assessments and environmental reviews, bilateral and
multilateral agreements, reports on efforts to implement the Protocol, plus other
scientific, legal, environmental and technical information. Common formats are
used to ensure that the information collected from different countries is
comparable. The Biosafety Clearing-House has been developed largely as an
Internet-based system and can be found at http://bch.biodiv.org.
(g) Capacity-building and finance: Countries that trade in GMOs need to have the
capacity to implement the Protocol. They need skills, equipment, regulatory
frameworks and procedures to enable them to assess the risks, make informed
decisions, and manage or avoid any potential adverse effects of GMOs on their
38
5.4
India ratified the Cartagena Protocol on January 23, 2003. Although, there
has been considerable capacity building in the country with respect to research and
development of GMOs/LMOs and implementation of the domestic regulatory
framework, there is an urgent need to strengthen the institutional capacities,
39
Table 5.1 Present status of compliance and capacity building needs for various provisions of
the Cartagena Protocol
Article
Article 7
Provisions
Application of the
Advanced Informed
Agreement
procedure prior to
the first
transboundary
movement of LMOs
intended for direct
use as food or feed,
or for processing
Article 8
Notification-The
Party of export shall
notify, or require the
exporter to ensure
notification to, in
writing, the
competent authority
of the Party of import
prior to the
intentional
transboundary
movement of LMOs
that falls within the
scope of Article 7
Acknowledgement of
receipt of
notification-The
Party of import shall
acknowledge receipt
of the notification, in
writing to the notifier
Decision ProcedureDecision taken by
the Party of import
shall be in
accordance with
Article 15
Article 9
Article
10
Present Status
Competent
authority
notified. Border
control through
NBPGR
only
for
contained
use,
projects
initiated
for
strengthening
for identification
of LMOs for
capabilities by
DBT and MoEF
Rules 1989 and
competent
authorities in
place.
Stakeholders
Scientists,
regulators,
customs and
border control
officials, traders
(importers,
exporters),
food/feed
processing
industry,
Regulators,
border
control
officials, industry,
importers/
exporters
Point of contact
notified,
the
regulatory body
i.e. GEAC in
place
Strengthening of domestic
regulatory framework to
meet the timelines and
access to data
Regulators
(Members of
GEAC and other
officials working
in the relevant
ministries)
Regulatory
body GEAC is
already in place
Strengthening
of
the
decision-making procedures
including
access
to
databases (in terms of
enforcement, inspection and
assessing the risk) is
required
Regulators
associated
scientists,
managers
40
and
IT
Article
Article
11
Provisions
Procedure for LMOs
intended for direct
use as food or feed,
or for processing
Present Status
1989
Rules,
procedures to
be detailed
Article
13
Simplified Procedure
to ensure the safe
intentional
transboundary
movement of LMOs
Bilateral, regional
and multilateral
agreements and
arrangements
1989 rules
Article
15
Risk assessment
DBT Guidelines
for research in
plants
Article
16
Risk management
DBT Guidelines
for research
Article
17
Unintentional
transboundary
movements and
emergency
measures
1989 rules
Article
18
Handling, transport,
packaging
and
identification
Detailed
guidelines to be
developed
Article
19
Competent National
Authorities
and
National
Focal
Points
MoEF
designated as
Competent
National
Authorities and
National Focal
Point
Regional harmonization of
biosafety-related sectoral
laws/policies and with other
international agreements
such as WTO, IPPC.
Laws/guidelines/policies to
be developed for GM
food/feed and products
thereof. Environmental risk
assessment procedures to
be streamlined including the
baseline information.
Laws/guidelines
to
be
developed particularly for
food/feed
crops,
harmonization
with
the
existing procedures.
Detection,
testing
and
quantitative
analysis
of
LMOs, Border control and
inspection
facilities,
development of emergency
plans.
Customs and border control
procedures, Documentation
and inspection systems for
LMO shipments, Methods
and systems of identification
of LMOs including
traceability procedures,
Guidelines and technologies
for safe handling, packaging
and transport of LMO
shipments
-
Article
14
41
Stakeholders
Regulators,
officers
from
concerned
ministries
i.e.
Ministry
of
Health, Ministry
of Commerce etc.
Importers/traders,
researchers and
technicians
-
Policy
makers,
regulators,
scientists,
industry
Policy
makers,
regulators,
scientists,
industry
Scientists,
technicians and
custom and port
officials
Scientists,
technicians and
custom and port
officials
Article
Article
20
Provisions
Information sharing
and the Biosafety
Clearing House
Present Status
Biosafety
Clearing House
(BCH) set. A
separate
website on
capacity
building
activities by
MoEF
Article
21
Article
22
Confidential
Information
Capacity building
Article
23
Public
awareness
and participation
Ongoing
including GEFWorld Bank
funded
Capacity
Building Project
Article
24
1989 rules in
place for all
import and
export
Article
25
Non-Parties
(transboundary
movements of LMOs
between Parties and
non-Parties)
Illegal transboundary
movements
Article
26
Socio-economic
considerations
Socioeconomic
analysis is an
integral part of
decision
making
Article
27
National
Consultation
initiated and
ongoing
Ongoing
including GEFWorld Bank
funded
Capacity
Building Project
42
Stakeholders
IT
managers,
scientists
Regulators
All stakeholders
including interest
groups such as
farmers,
consumers,
industry
associations.
All stakeholders
Regulators,
economists,
NGOs,
social
groups
Regulators, legal
experts
particularly
on
international law.
5.5
The World Organization for Animal Health (OIE), which develops standards
and guidelines designed to prevent the introduction of infectious agents and
diseases into the importing country during international trade in animals, animal
genetic material and animal products. The OIE Standards Commission published,
in 2000, the Manual of Standards for Diagnostic Tests and Vaccines. Some of the
tests and vaccines described are genetically engineered. Likewise, the OIE
working group on biotechnology has produced several technical publications
relating to animal production and risk analysis. However, it has not as yet
approved international standards on biotechnology.
43
The World Trade Organization (WTO): The major WTO agreements that
contain provisions relevant to LMOs/GMOs are the Agreement on the Application
of Sanitary and Phytosanitary Measures (SPS) and the Technical Barriers to
Trade (TBT) Agreement.
Whereas both the Cartagena Protocol on Biosafety and WTO advocate the use
of science based risk assessments as a means to justify trade related measures,
there are areas of potential conflicts mainly with respect to application of
precautionary approach in the conditions that scientific evidence is insufficient
and the socio economic considerations in the decision of importing LMOs.
For example with regard to a certain biotechnology product, the details needed to
be considered for risk assessment under the Protocol and the SPS are very
different. The SPS does not specify exactly what a risk assessment is, but the
Protocol elaborates this in detail in Annex-III. Further, the SPS does not mention
risk management, but merely risk assessment. The scope of socio-economic
considerations under the Protocol is wide, while SPS puts strict limits on the
economic considerations.
44
CHAPTER 6
AREAS COVERED FOR TRAINING NEEDS ASSESSMENT
The rationale of areas covered in the survey is based on strengthening the
domestic regulatory framework as well as to meet the obligations of Cartagena
Protocol as explained below:
6.1
DEVELOPMENT OF GMOs:
Development
of
GMOs
and
products
thereof
from
laboratory
to
transformants with required properties are other related areas of expertise building.
There is also a need for understanding gene functioning alongwith molecular and
biochemical assay of the genes and gene products.
India has built a reasonably good infrastructure for work on GMOs at various
institutions including the following Centres for Plant Molecular Biology (CPMB)
supported by DBT:
1. Jawaharlal Nehru University, New Delhi
2. Madurai Kamaraj University, Madurai
3. Tamil Nadu Agricultural University, Coimbatore
4. Osmania University, Hyderabad
5. National Botanical Research Institute, Lucknow
6. Bose Institute, Kolkata
7. University of Delhi South Campus, New Delhi
8. National Centre for Plant Genome Research, New Delhi
45
Keeping in view the above, the following areas were listed for seeking
feedback from the stakeholders under the section on development of GMOs/LMOs.
6.2
RISK ASSESSMENT:
46
implications
of
out
crossing/
cross
fertilization,
the
aggressiveness
Capacity is also required to review the applications received from exporting countries
before any decisions are taken. Adequate capacity also needs to be developed for
biosafety research in the public research organizations. In line with the above, the
areas covered for assessment of the training needs in risk assessment were as
follows:
6.3
RISK MANAGEMENT:
scale up and commercial use. The designing of a monitoring plan needs to take into
account available knowledge about the organisms, environment, conditions of
release and potential risks as determined in a risk assessment and the regulatory
requirements, based on which specific sampling regime and testing procedures are
developed.
The specific areas of capacity building for risk management in the context of
release of GMOs and their transboundary movement include:
48
6.4
Keeping in view the above, the section on regulatory capacity building has
been divided into legislative and regulatory framework, administrative framework and
technical, scientific infrastructures and mechanism for follow-up. The areas for
assessment of training needs in these sections are as follows:
49
Compliance mechanisms
50
6.5
IDENTIFICATION OF LMOs:
As per the Cartagena Protocol there is a need to take measures for the safe
handling, packaging and transportation of LMOs that are subjected to transboundary
movement. The Protocol specifies requirements on identification by setting out what
information
must
be
provided
in
documentation
that
should
accompany
Methods and systems for identification of LMOs e.g. unique identification systems
6.6
India has well trained scientists engaged in biotechnology research, but there
is a shortage of manpower to work on hardcore molecular biology and related
biosafety evaluations. There is an urgent need to arrange advanced level training in
these areas.
51
assessment
and
management
and
negotiations
for
material
transfer
agreements. Considering the large number of institutional, state level and district
level committees, it is an enormous task and concerted and coordinated efforts are
required to accomplish the above.
6.7
52
will affect their immediate lives and the environment. Therefore, public awareness,
education and participation is extremely important in building public confidence in the
safety of GMOs and acceptance of GM products.
Protocol is also aimed at to promote and facilitate public awareness, education and
participation concerning safe transfer, handling and use of GMOs.
Limited efforts have been initiated in India to create public awareness and
education by giving unbiased views on available scientific information by the
concerned ministries. These include series of workshops for various stakeholders
since the first transgenic crop was approved in 2002. However, much more wider
mechanisms need to be developed to involve various networks available in the
country such as state agricultural universities, state agricultural departments, Krishi
Vigyan Kendras, Centre for Excellence, NGOs etc. to disseminate information about
the regulatory framework and decisions taken. It is essential to educate and provide
working knowledge to farmers, intermediaries such as distributors/retailers,
extension workers, consumers and their associations. The use of local languages in
all such endeavours is extremely important. Some of the important areas are as
follows:
6.8
53
Protocol. The central portal of BCH has been set up at www.bch.cbd.org. The Indian
BCH portal is in the preparatory phase and would shortly be launched. In addition,
some activities have been initiated by MoEF and DBT to develop the databases on
research, regulations, etc. for wider dissemination.
Non internet based electronic exchange material (e.g. CD ROMs, fax, etc.)
Print media
6.9
been initiated in several countries, commercial products so far have been released
only by mainly private sector in view of the huge costs involved not only in the
development but also the approval of GMOs. The dominance of private sector in
agricultural biotechnology research and commercialization has raised a number of
concerns about the benefits of biotechnology for resource poor farmers.
54
6.10
TECHNOLOGY TRANSFER:
6.11
SOCIO-ECONOMIC CONSIDERATIONS:
Keeping in view the above the following areas have been included in the
study which can help in examining the socioeconomic impacts.
55
6.12
56
CHAPTER 7
FINDINGS OF THE FIELD SURVEY
The findings of the field survey are based on about 150 responses from
various stakeholders viz. scientists, industry, central and state government
representatives, farmers and social organizations.
under different categories are given below (Figure 7.1) and the list is placed in
Annex-2.
20
19
Central government
State government
15
12
Regulatory committees
Industry
Research organizations
17
Social experts
Agriculture service providers
Others
54
A computerized software was developed to analyse the data and the findings
based on both quantitative and qualitative responses are as follows:
7.1
The areas listed in the questionnaire were ranked by the respondents and the
priorities have been worked out based on the number of points received. Figure 7.2
gives the ranking of the areas in terms of assessment by all the stakeholders.
57
Development of
LMOs/GMOs
Socio-economic
considerations
Information
exchange
Identification
Technology
transfer
Public
awareness
Sustainable use
of biodiversity
Regulatory
capacity building
Risk
management
Risk
assessment
Institutional
collaboration
50
As seen above, risk assessment and management has been listed as top
priority followed by human resource development and training and regulatory
capacity building. The points given by individual categories of stakeholders were
also studied and the top three areas listed by them are given in Table 7.1.
Table 7.1 Priority areas as per various stakeholders
Stakeholders
Priority areas
1
Risk assessment
and management
Human
Resource
Development
Regulatory bodies
Risk assessment
and management
Scientific, technical
and
institutional
collaboration
Research
organizations
Risk assessment
and management
Human
Resource
Development
Industry
Risk assessment
and management
Public awareness
Scientific,
technical
institutional collaboration
Others
(social
experts,
agriculture service
providers etc.
Risk assessment
and management
Regulatory
building
58
capacity
and
It may be seen that capacity building in the area of risk assessment and
management is the primary concern across the board clearly indicating that there are
apprehensions and concerns about the safety issues of GM crops and capacity to
handle the same in the country.
The main elements under each area were further analysed based on the
number of points received. In addition to the priority ranking, the respondents were
also requested to fill in the questionnaire in detail on the present status, existing
training/activities/facilities, suggested areas and target segments.
All the
suggestions received in the field survey have been compiled and given in Annex-3.
The results for each category are presented below in the sequence of priority
ranking.
200
150
100
50
0
RA scientific
expertise
Scientific
Methods
Audit Risk
Assessment
Access to
reference
material
National RA
framework
National
Biosafety
Research
59
It has been suggested that there should be dedicated technical cells within the
two apex regulatory bodies equipped with requisite IT tools to have rapid access to
reference material/database on risk assessment for effective review within the
stipulated time. As the data generated for risk assessment is multidisciplinary, all
stakeholders need to be sensitized. The sources for accessing information including
web addresses on risk assessment and management need to be compiled and
communicated.
The target segments that need to be trained are regulators and scientists
working on transboundary and post release and monitoring of GMOs.
developing core group of experts for generating local biosafety data in the local agro
ecological backgrounds. National biosafety research programme needs to be
recognized as a national priority under government funding by identifying the centers
similar to setting up of Centers of Plant Molecular Biology.
194
200
190
148
150
100
50
0
Detection Management
Tools
Emergency Measures
Risk Managements
frameworks
Respondents from industry have given higher priority to capacity building in the
area of emergency measures for unintentional LMO releases.
Some of the suggested areas for capacity building include:
61
of
risk
management
frameworks,
strategies
and
mechanisms. The status in this area has been rated as poor and needs
urgent attention. Interaction with the international experts along with site
visits by regulatory authorities along with representatives of concerned
institutions and industry should be undertaken.
3. Human resources development and training: India has well trained scientists
engaged in biotechnology research, but there is a need to have adequate trained
manpower to deal with other important aspects including risk assessment,
management and communication, custom and border control and socio economic
considerations. There is an urgent need to arrange both basic and advanced
level training in all these areas.
Figure 7.5: Human resources development and training
120
115
110
105
100
62
Trade Impact
Characteristics
of Lmos
Ex-Ante risk
benefit
Dissemination
of information
Integration of
Socio econmic
Detection
Legal Drafting
Cost benefit
Training of
regulators
90
International
agreements
95
As may be seen from the above figure, training of regulators has emerged as the
top priority followed by analysis of cost benefits and legal drafting. The suggestions
by the stakeholders for organizing training programmes include:
63
Administrative framework
Technical scientific
infrastructure and
mechanisms to follow up
Regulatory training
The status of regulatory capacity building has been rated as medium in the
legal framework and low in compliance mechanisms. Some of the suggestions for
capacity building are as follows:
Training for both regulators and compliance officers on regular basis (at least
once a year) by noted national and international expert. Training the trainers at
the national level followed by state level programmes.
Sensitization and development of training modules for border control officials and
other key agencies
64
Study to assess the available facilities and future requirements for border control
agencies.
5. Scientific,
technical
and
institutional
collaboration:
In
this
area,
65
151
140
101
101
100
97
96
Potential for
weediness or
invasiveness
102
Impact of GMO
on traditional
farming
systems
120
80
60
40
Awareness
training on
laws and
policies on
environment
and natural
resources
Assessment of
impact on
wildlife
populations
and native
species
Mechanism for
mainstreaming
biosafety
Assessment of
impact on nontarget
organism
20
66
138
133
127
126
Media skills
and strategies
Timely
information on
LMO imports
Public access
to BCH
152
150
Public
participation in
decision
making
176
100
50
Biosafetty
awareness
materials
Risk
communication
skills
Biosafety
awareness
activities
67
wider
circulation
of
biosafety
awareness
materials
like
68
180
163
161
160
110
106
101
101
100
116
120
140
100
80
60
40
20
Access to proprietary technologies on
preferential terms
Participation
in
international
seminars/conferences
for
awareness
of
69
segregation of LMOs in the country is virtually non-existent and all the options
given in the questionnaire were given high priority. It has been suggested that
extensive consultation must take place at the national level among all the
concerned officials to develop guidelines and other compliance mechanisms
followed by training of the concerned officials particularly those involved in border
control as well as enforcement within the country. These include customs
officials, plant quarantine authorities, health inspectors, food inspectors,
agriculture
extension
officers
etc.
Documentation
system
should
be
70
It has been suggested that well-defined economic models available with research
institutions and state agricultural universities can be appropriately used for
assessment of economic impact of GMOs. However, for achieving the same,
regular interactions between the economics and the scientists is required as they
need to be informed about the basic of GMOs/LMOs. It is also important to
develop simple statistics methods and tools for collecting information from
scientists and field workers.
71
7.2
7.3
Training/
consultation
programmes
Non-Internet
electronic
exchange
Business or
work
associates
Newsletter,
bulletin,
library
Internet
Through
NGOs
Through
groups and
associations
Newspapers
Electronic
media
200
180
160
140
120
100
80
60
40
20
0
72
1 Week
1 Month
Regulators
Scientists
Industry
NGOs
Farmers /Public/consumers
The findings of the field survey were discussed in consultation meeting with
experts from government, industry and institutions. Suggestions included working
out training needs in line with the provisions of the Cartagena Protocol as well as
categorizing requirements of various categories of stakeholders such as senior level
training for members of regulatory organizations and other administrative personnel,
middle level for universities and organizations involved in operations and junior level
for extension workers, farmers, consumers etc.
73
CHAPTER 8
IDENTIFICATION OF TRAINING NEEDS
Assessment of training needs in the area of agricultural biotechnology has
been considered in the context of countries broader regulatory policy and the
institutional framework in addition to the field survey findings and desk research.
8.1
STAKEHOLDERS:
commitments.
Some
of
the
concerned
Ministries
and
74
75
76
11. Mass media and outreach/extension workers: Media is the primary source
of information for general public. Sometimes articles related to biotechnology
are published without adequate scientific evidence.
Biotechnology and
biosafety being new areas, reporters need to be informed about the facts in
these areas on a regular basis. Therefore, interaction with the media is
extremely important in promoting informed discussions on the merits and
concerns associated with GMOs. In addition, the other outreach/extension
channels such as agricultural extension departments in the state agricultural
universities need to be educated about the latest developments and biosafety
issues so as to enable them to communicate effectively based on the facts.
These are extremely important segments for reaching out to the users such
as farmers, as they represent the trustworthy sources for delivering the
information to the users.
8.2
A matrix has been prepared to identify the training needs by marking the
competency, knowledge and skill required for major target groups. This matrix
will not only help in drawing the recommendations for training of various
stakeholders but also in devising the course content in these training modules.
77
3 3
3 3
78
3 3 3
Data/information managers
Lawyers
Enforcement officials
Customs officials
Scientists/technical, advisors
& experts
General biosafety/
biotech knowledge
Government regulators
KNOWLEDGE AND
SKILLS REQUIRED )
Decision/ policy-makers
Economists
TRAINING NEEDS
3 3 3
Data/information managers
Lawyers
Economists
3
Decision-making
practices, including
assessment and
integration of socioeconomic
considerations
Harmonization of
biosafety related
3
3
sectoral laws/policies
including international
agreements
Regulatory training
(legal, policy,
3 3 3
enforcement,
inspection, etc.)
Preparation and
presentation of LMO
3
export or release
applications/dossiers
Review of applications
3
and the accompanying
dossiers
Administrative practices
(including handling of
3
requests for LMO
imports or releases)
Customs officials
Government regulators
Scientists/technical, advisors
& experts
Enforcement officials
(KEY COMPETENCES
KNOWLEDGE AND
SKILLS REQUIRED)
Decision/ policy-makers
TRAINING NEEDS
3 3 3
79
Drafting/use of technical
manuals & guidelines
Procedures to be
applied to LMO
transboundary
3 3 3
movements (including
information on
neighboring countries)
Documentation
3 3
requirements for LMO
shipments
LMO detection &
3
quantitative analysis
Cost/ risk-benefit
3 3
analysis
Systems for
identification of LMOs
3
including traceability
procedures
Public awareness and
3 3 3
participation
Data and information
management, including
3 3
use of the BCH
3 3 3
3 3
3 3 3
3 3
3 3 3
80
3 3
Data/information managers
Lawyers
Economists
Customs officials
Government regulators
Scientists/technical, advisors
& experts
Enforcement officials
(KEY COMPETENCES
KNOWLEDGE AND
SKILLS REQUIRED)
Decision/ policy-makers
TRAINING NEEDS
3
3
3 3
CHAPTER 9
OVERVIEW OF EXISTING TRAINING PROGRAMMES
The training programmes conducted so far in India are mainly short-term
standalone workshops/events. Most of these programmes have been conducted
under the aegis of apex regulatory bodies i.e. MoEF and DBT with the involvement
of all stakeholders viz. central and state government officials, industry, scientists,
NGOs, farmers etc. A brief overview of various initiatives is presented below:
9.1
SERIES OF WORKSHOPS:
In 1998, DBT in association with BCIL organized the first series of workshops
on biosafety issues related to GMOs at five locations across the country.
The
The participants from all the states were invited. These included
scientists from universities and research institutions, industry (both seed and
pharma), government (concerned central ministries and state departments), NGOs,
industry associations, farmers associations, seed distributors/pharma products
distributors, media etc. Over 900 participants attended these workshops
of
State
Biotechnology
Coordination
Committee,
District
Level
The commercial approval for Bt cotton in 2002 was for a period of three years,
and in 2005, the continuation of the approval was coming up for GEACs review.
Therefore, MoEF sponsored the next series of workshops in 2005 with an objective
of generating a feedback regarding the performance of Bt cotton in the last three
years of cultivation from stakeholders like farmers, state agriculture department
officials etc. Biosafety issues related to transgenic crops with a focus on Bt cotton,
the rules and regulation related to biosafety of transgenic crops and demonstration of
diagnostic kits for detection of Bt cotton, were also part of the workshops.
from
the
state
department
of
agriculture,
agriculture
S.
No.
1.
Series of
workshops
Biosafety
issues
related to
GMOs
Organized
by
DBT
and
BCIL
Period/
Year
1998
Objective
Participants
Locations
About
600
participants
mainly were
scientists
from
R&D
institutes and
industry
New Delhi,
Pune,
Kolkata,
Hyderabad
and
Bangalore
2.
Biosafety
issues
related to
GMOs
MoEF,
DBT
and
BCIL
2002
To apprise various
stakeholders
about
rules and regulations,
sensitize the media and
provide a fora for
exchange of view in
both healthcare and
agriculture
About
800
participants
including
central
and
state
govt.
scientists,
industry,
farmers,
NGOs, media
New Delhi,
Pune,
Bhopal,
Kolkata,
Guwahati,
Hyderabad,
Banhgalore
and
Lucknow
3.
Biosafety
issues
related to
transgenic
crops
MoEF and
BCIL
20032004
To
share
the
experience
of
the
industry and farmers
with scientists, policy
makers,
state
More
than
600
participants.
Including
members of
Aurangabad
,
Coimbatore,
Hyderabad,
Dharwad,
83
S.
No.
4.
5.
6.
Series of
workshops
Organized
by
and
Period/
Year
National
consultation
on biosafety
aspects for
IBSC
members
and DBT
nominees
Biosafety
issues
related to
transgenic
crops with a
focus on Bt
cotton
DBT
BCIL
2004
MoEF and
BCIL
Jan.
March
2005
Safety
assessment
of GM foods
AGBIOS
Inc.
Canada
and BCIL
2005
Objective
Participants
Locations
governments
and
NGOs; to sensitize and
train state government
officials
and
other
stakeholders
for
effective monitoring of
transgenic
crops,
demonstration
of
monitoring techniques;
understanding
of
regulations
and
developments related
to transgenic crops in
India.
To
strengthen
the
biosafety
regulatory
system by defining the
role of the members of
IBSCs and to evolve an
effective
feedback
mechanism from them
to DBT
To generate a feedback
regarding
the
performance
of
Bt
cotton in the last three
years of cultivation from
stakeholders
like
farmers,
state
agriculture department
officials etc.; to create
awareness
regarding
biosafety issues related
to transgenic crops with
a focus on Bt cotton; to
inform about the rules
and regulation related
to
biosafety
of
transgenic crops; and
to
demonstrate
diagnostic
kits
for
detection of Bt cotton
the SBCCs,
DLCs
and
Monitoring
Committees;
state
department of
agriculture,
Research
scientists,
SAUs, seed
companies,
distributors,
farmers,
NGOs
Members of
IBSCs
and
DBT
nominees
Ahmedabad
and Indore
More
than
600
participants.
Including
members of
the SBCCs,
DLCs
and
Monitoring
Committees;
state
department of
agriculture,
Research
scientists,
SAUs, seed
companies,
distributors,
farmers,
NGOs
Nagpur,
Ahmedabad,
Hyderabad,
Coimbatore,
Hisar and
Ludhiana
About
150
participants
including
scientists and
regulators
New Delhi,
Hyderabad,
Chennai and
Gurgaon
84
Bangalore,
Chennai,
Hyderabad,
New Delhi,
Mumbai and
Jalna
9.2
NATIONAL EVENTS:
capacity building and liability and redress issues. Organizations such as National
Bureau for Plant Genetic Resources (NBPGR), G.B. Pant University of Agriculture
and Technology, Research and Information System (RIS) for Developing Countries,
The Science Ashram, Delhi University Botanical Society and The International
Services for Acquisition of Agri-biotech Applications (ISAAA), have also organized
workshops and conferences on biosafety issues at the national and state level. The
objective of the annual training programme conducted by the NBPGR is to provide
hand on training to 20 participants each year on the various biosafety aspects of
transgenic crops. The ISAAA in association with the International Crop Research
Institute for Semi-Arid Tropics (ICRISAT) organized workshops for the media on
biosafety at New Delhi and Hyderabad in 2005. Representatives from the national,
state and district level media groups from both electronic and print media
participated in these workshops were sensitized trained in various biosafety issues
related to transgenic crops.
2.
Event
Orientation
course
on
biosafety
considerations
for evaluation of
transgenic crops
National
consultations on
Cartagena
Protocol
on
biosafety issues
before MOP-2
Organized
by
DBT and
NBPGR
Period/
Year
Annual
since 2000
MoEF and
RIS
May
2005
24,
85
Objective
Participants
Locations
To
provide
training in the
area
of
biosafety
issues related
to transgenics
To discuss the
issues related
to biosafety of
GMOs,
especially
political issues
for
the
implementation
of Cartagena
Protocol
20-30
participants
from
ICAR
institutes,
SAUs,
universities etc.
60-70
participants
from
government
industry,
institutions,
trade
organizations,
etc.
New Delhi
New Delhi
S.
No.
3.
Event
Conference
Capacity
Building
Biosafety
on
Organized
by
MoEF and
BCIL
Period/
Year
March 2324, 2005
Objective
Participants
Locations
To
discuss
important
issues related
to
strengthening
the capacity of
various
stakeholders
and
identify
areas
for
further
development.
70 participants
from
government
officials, policy
makers,
research
scientists from
various
institutions and
universities,
representatives
from
biotech
and
pharmaceutical
companies,
NGOs, etc.
50 participants
from
central
government,
state
governments,
industry,
industry
associations,
NGOs,
legal
and
technical
experts,
scientists from
leading
research
institutions,
universities
About
140
participants
which included
government
officials,
scientists from
research
institutions and
universities,
industry
and
industry
associations
State
agriculture
department
officials
from
Maharasthra,
Gujarat
and
Andhra
Pradesh, social
groups
and
media
New Delhi
on
4.
National
Consultation on
Liability
and
Redress in the
context
of
Cartagena
Protocol
on
Biosafety
MoEF,
JNU and
BCIL
To seek views
of
various
stakeholders at
the
national
level on the
Article 27 of
the Cartagena
Protocol
on
Liability
and
Redress
5.
National
Workshop
on
Management of
Field Trials of
Genetically
Modified Crops
ISAAA
and BCIL
August
2005
9,
To
discuss
various issues
related
to
conducting
field trials of
genetically
modified (GM)
crops in India
6.
Communications
Training
for
Agriculture
Extension
Personnel
The
Science
Ashram
and
AGBIOS
September,
2005
To
sensitize
various
stakeholders
regarding
issues related
to GM crops
86
New Delhi
New Delhi
Maharashtra
9.3
INTERNATIONAL EVENTS:
S.
No.
1.
2.
Event
Two regional
workshops on
Biosafety for
the
AsiaPacific
Region
Workshop on
biotechnology
for
environmental
protection
and
sustainable
development
Organized
by
UNEP/GEF
Period/
Year
1998
Objective
Participants
To
discuss
biosafety
issues at the
regional level
Scientists/
regulators
from
Asia Pacific region
MOEF,
Environment
Canada and
BCIL
2003
Exchange
of
information
between
scientists,
regulators on
environment
related issues
including
biosafety.
To deliberate
on
emerging
areas
of
biotechnology
including
agricultural
biotechnology
About
140
participants from
govt.,
industry,
academia, NGOs
and experts from
Canada
New Delhi
Hyderabad
3.
Biotec India
International
2003
MoEF, DBT,
BCIL
2003
4.
International
Conference
on
Foods
derived from
GM Crops
AGBIOS,
ICMR and
BCIL
September
26-28,
2005
To provide an
introduction to
some of the
key issues that
need to be
addressed for
regulation
of
foods derived
from
genetically
modified plants
87
Locations
New Delhi
New Delhi
9.4
9.5
WEBSITES:
MoEF and DBT have prepared and launched the following websites for
information dissemination and awareness creation:
88
9.6
PUBLICATIONS:
9.7
MoEF has initiated a GEF-World Bank funded project on capacity building for
implementation of the Cartagena Protocol. This includes the assessment,
management and long term monitoring and documentation of the risks to the
sustainable use of biodiversity and to human health potentially posed by the
introduction of LMOs. The major objectives for GEF support are to improve capacity
across ministries and among key stakeholders to analyse, inform, and make
decisions to reduce potential risks related to LMOs, increase benefits to society, and
protect biodiversity. Specifically, the project will develop national capacities in
biosafety required to:
i) Strengthen the legislative framework and operational mechanisms for biosafety
management in India
ii) Enhance capacity for risk assessment and monitoring
iii) Establish the biosafety database system and Biosafety Clearing House
Mechanism
iv) Support centers of excellence and a network for research, risk assessment and
monitoring
v) Establish the Project Coordination and Monitoring Unit (PCMU).
South Asia Biosafety Programme has been initiated under the sponsorship of
USAID for capacity building in the area of safety issues related to GM food crops in
India and Bangladesh. The project is being implemented by AGBIOS Inc., Canada
and International Food Policy Research Institute (IFPRI), USA.
89
The objectives of all the training initiatives taken by different organizations has
been not only to create awareness and sensitize different stakeholders but also build
capacity in human resources who can comprehend, appreciate and play an active
role in tackling various biosafety issues related to GMOs used in agriculture and
pharmaceuticals, at the district, state, national and international level.
90
CHAPTER 10
PROPOSED TRAINING MODULES
Training programmes need to use a variety of approaches to support capacity
building for handling various activities involving biosafety issues related to genetically
modified organisms including import, export, manufacture, use etc. Whereas
seminars and consultations will help in highlighting the need for appropriate
government policies in this regard, educational conferences involving national and
international experts can be organized to raise awareness of various stakeholders
about potential benefits as well as environmental and food safety concerns
associated with biotechnology. Technical training for conducting biosafety reviews is
extremely important for building capacity in the critical area of implementation of
rules and regulations of biosafety.
91
Both print and electronic media should be used for awareness programmes
through the existing networks in the country such as agricultural extension
offices and departments, nutrition education departments, health education
programmes etc., which are traditionally trusted by the target groups.
Primers/brochures/booklets/FAQs/glossary
of
terms
targeting
various
Regular interaction with media, political leadership and other stakeholders for
sensitization on important issues to ensure circulation of authentic
information.
92
Communication strategies
(ii)
(iii)
(iv)
(v)
The
94
target organisms and studies of their interactions with pests and pathogens;
impact of novel organisms on agronomy and farming practice, effect on microbial
populations; means for reducing or managing risk etc. Strategies to generate
biosafety data in the local agro ecological background should be discussed to
make consolidated and coordinated plans for research. It is extremely important
to consider redeploying of researchers working in the traditional subjects as
agronomy, botany, microbiology, food toxicology and plant breeding and genetics
to take research in biosafety. Such seminars that will expose them to various
biosafety issues followed by focused training programmes would go a long way in
capacity building in the area of biosafety research.
Detailed guidelines for new GMOs and products thereof as well as newer
applications of existing GMOs e.g. transgenic animals including livestock and
fish, use of plants and animals for production of pharmaceuticals/biochemicals,
95
6. Studies and surveys: Studies and surveys are important instruments for
collecting information for planning various activities as well as implementing the
same. Some of the areas which need to be urgently taken up are:
-
The
Newsletters/ Bulletins
96
For
systems in place. Mexico is a mega biodiverse country and centre of origin for
maize and it has approved GM maize for cultivation. It is important to study how
the regulatory authorities are taking precautions to ensure the conservation of its
land races.
programmes i.e. interaction with the regulators and scientists by visiting them
and/or inviting in India.
LMOs testing methods, facilities and equipments including both private and
public sector
10. Directory of resource persons: For undertaking such wide ranging capacity
building activities, there is a need not only to develop a critical mass of experts at
all levels, but also provide information about these experts for organizing of
training programmes. A roster of 50 Indian experts will be available at BCH but
for a vast country like India, there is an urgent need to prepare and continuously
97
98
ANNEX-1
QUESIONNAIRES
1. MAIN QUESTIONNAIRE
I.
General Information:
Name:
______________________________________________________
Organization:
______________________________________________________
II.
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(vii)
III.
Please rank in terms of priorities (on the scale 1 to 5)* the main elements for
capacity building in the country for development and use of LMOs in the current
scenario as given below:
Areas
A. Development of LMOs/GMOs
B. Risk Assessment (Impact on human health & environment)
C. Risk Management
D. Regulatory capacity building
E. Identification of LMOs
F. Human Resource Development and Training
G. Public Awareness, Education and Participation
H. Information Exchange & data management
I. Scientific, Technical and Institutional Collaboration
J. Technology Transfer
K. Socio-Economic Considerations
L. Sustainable use and conservation of biodiversity
Others (please specify):
Rank
* Scale 1 to 5 represents: 1-not important, 2- a little important, 3- relatively important, 4- fairly important, 5very important.
99
The training/capacity building needs in each of the above elements are listed in
subsequent tables A to L. Kindly fill in the tables relevant to your area of
expertise/interest.
A. Development of LMOs/GMOs
Please prioritize the ranking on a scale of 1 to 5*, and fill in the information in the respected columns given
below:
.
Present
Priority Need
Existing
Suggested areas
Target
status
ranking
training/activities/
for
segments
training/capacity
Poor/Avg. facilities, if any
building
/Good
Molecular biology
skills (e.g. gene
isolation, sequencing
etc.)
Assessment of effects
of promoter,
enhancers, introns and
terminator sequences
Assessment of marker
genes
Assessment of genetic
stability and limits of
gene expression under
different conditions
Analysis of molecular
data
Assessment of the
extent and effects of
gene flow
Evaluation of genetic
modifications
Others (specify):
Comments:
The scale of ranking 1 to 5 represents: 1-not important, 2-a little important, 3-relatively important, 4fairly important, 5- very important.
100
B. Risk assessment (impact on human health and environment) and other scientific and
technical expertise
Please prioritize the ranking on a scale of 1 to 5*, and fill in the information in the respected columns given
below:
.
Present
Priority Need
Existing
Suggested areas
Target
status
ranking
training/activities/
for
segments
training/capacity
Poor/Avg. facilities, if any
building
/Good
Access to reference
materials/databases
on risk assessment
National risk
assessment
frameworks,
principles, procedures
and mechanisms
Risk assessment
scientific expertise
Scientific methods
and Protocols for risk
assessment
Competence to
review and audit risk
assessments
National biosafety
research
Others (specify):
Comments:
* The scale of ranking 1 to 5 represents: 1-not important, 2-a little important, 3-relatively important, 4- fairly
important, 5- very important.
101
C. Risk management
Please prioritize the ranking on a scale of 1 to 5*, and fill in the information in the respected columns given
below:
.
Priority
ranking
Need
Present
status
Poor/Avg.
/Good
Existing training/
procedures, if any
Suggested areas
for
training/capacity
building
Target segments
Detection,
management and
prevention of
unintentional
transfer of LMOs
Emergency
measures for
unintentional LMO
releases
Risk management
frameworks,
strategies and
mechanisms
Tools for
monitoring the
handling and use of
LMOs
Others (specify):
Comments:
* The scale of ranking 1 to 5 represents: 1-not important, 2-a little important, 3-relatively important, 4- fairly
important, 5- very important.
102
Need
Present
status
Poor/Avg.
/Good
Existing
training/
activities, if any
Target segments
Strengthening of
legal
frameworks
Compliance
mechanisms
Harmonization
of biosafetyrelated sectoral
laws/policies
Mainstreaming
biosafety into
other sectors
Negotiation of
bilateral,
regional and
multi-lateral
agreements
Regulatory
training (legal,
policy,
enforcement,
inspection etc.)
Guidelines for
the integration
of GMO*
evaluation in the
EIA** System
Others (specify):
Comments:
* The scale of ranking 1 to 5 represents: 1-not important, 2-a little important, 3-relatively important, 4- fairly
important, 5- very important.
103
Need
Present
status
Poor/Avg.
/Good
Existing training /
activities/
facilities, if any
Target
segments
Administration of
the AIA* procedure
Customs and
border control
procedures
Decision-making
system and
administrative
procedures
Institutional
entities for
handling biosafety
issues
Inter-agency
communication
and coordination
Mechanisms for
considering socioeconomic impacts
Mechanisms for
private sector and
community
involvement
Mechanisms for
review of decisions
Monitoring and
reporting on
implementation of
the Protocol
Emergency
measures for
unintentional
movements
Others (specify):
Comments:
* The scale of ranking 1 to 5 represents: 1-not important, 2-a little important, 3-relatively important, 4- fairly
important, 5- very important.
104
Need
Present
status
Poor/Avg.
/Good
Existing training/
activities/facilities,
if any
Suggested areas
for training/
capacity
building
Target
segments
Database infrastructure
and protocols
LMO* containment
(quarantine) facilities
LMO testing
laboratories and
equipment
Long-term LMO
monitoring and
surveillance
Methods and
mechanisms for
detecting unintentional
or illegal LMO
movement
Other (specify):
Comments:
* The scale of ranking 1 to 5 represents: 1-not important, 2-a little important, 3-relatively important, 4- fairly
important, 5- very important.
105
E. Identification of LMOs
Please prioritize the ranking on a scale of 1 to 5*, and fill in the information in the respected columns given
below:
.
Present
Priority Need
Existing
Suggested areas for
Target
status
ranking
training/activities
training/capacity
segments
building
Poor/Avg. facilities, if any
/Good
Documentation
systems for LMOs
shipments
Inspection systems
for LMO shipments
Methods and
systems for
identification of
LMOs e.g. unique
identification
systems
Systems for
segregation of
LMOs
Others (specify):
Comments:
* The scale of ranking 1 to 5 represents: 1-not important, 2-a little important, 3-relatively important, 4- fairly
important, 5- very important.
106
F. Human resources development and training: Legal, social and economic expertise
.Please prioritize the ranking on a scale of 1 to 5*, and fill in the information in the respected columns given
below:
Priority
ranking
Need
Present
status
Poor/Avg.
/Good
Existing
training/activities/
facilities, if any
Suggested areas
for
training/capacity
building
Target
segments
Assessment of
characteristics of LMOs
Detection, testing and
quantitative analysis of
LMOs
Analysis of the linkages
between other
international agreements
and Protocol
requirements
Assessment and
integration of socioeconomic considerations
Assessment of trade
impacts of biosafetyrelated measures
Legal drafting and
analysis
Support for case-bycase cost-benefit
analysis, review of
ethical considerations
and relevance of LMOs
in addressing societal
needs (e.g. food security
and nutritional
requirements, etc.)
Dissemination of
information to policy
makers
Ex-ante risk benefit and
cost-benefit analysis
Training of regulators
and pre and post
commercialization
monitors
Others (specify):
Comments:
a.
* The scale of ranking 1 to 5 represents: 1-not important, 2-a little important, 3-relatively important, 4- fairly
important, 5- very important.
107
Risk
communication
skills and strategies
Timely public
access to
information on
impending LMO
imports
Others (specify):
Comments:
* The scale of ranking 1 to 5 represents: 1-not important, 2-a little important, 3-relatively important, 4- fairly
important, 5- very important.
108
Need
Present
status
Poor/Avg.
/Good
Existing
training/activities/
facilities, if any
Suggested areas
for
training/capacity
building
Target segments
Biosafety Clearing
House (BCH)
Web based
databases
Sub-regional and
regional node of the
BCH
Print media
Others (specify):
Comments:
* The scale of ranking 1 to 5 represents: 1-not important, 2-a little important, 3-relatively important, 4- fairly
important, 5- very important.
109
Need
Present
status
Poor/Avg.
/Good
Existing
training/activities/
facilities, if any
Target
segments
Access to
information on
available
opportunities for
collaboration and
sharing of
experiences
Establishment of
inter-institutional
networks and
communications,
and interaction with
the public
Establishment of
mechanisms for
regional and
international
cooperation and
sharing of
experiences
Others (specify):
Comments:
* The scale of ranking 1 to 5 represents: 1-not important, 2-a little important, 3-relatively important, 4- fairly
important, 5- very important.
110
J. Technology transfer
Please prioritize the ranking on a scale of 1 to 5*, and fill in the information in the respected columns given
below:.
Priority
ranking
Need
Present
status
Poor/Avg.
/Good
Existing
training/activities/
facilities, if any
Target
segments
Access to
proprietary
technologies on
preferential terms
Analysis of
appropriate
technologies
Enabling policies
and incentives for
technology transfer
Management of
intellectual property
rights
Technologies for
handling, transport,
packaging and
identification of
LMOs
Technologies for
information
exchange/data
management
Technologies for
monitoring of
LMOs
Technologies for
risk assessment of
LMOs
Others (specify):
Comments:
* The scale of ranking 1 to 5 represents: 1-not important, 2-a little important, 3-relatively important, 4- fairly
important,5-veryimportant.
111
K. Socio-Economic Considerations
.Please prioritize the ranking on a scale of 1 to 5*, and fill in the information in the respected columns given
below:
Priority
ranking
Need
Present
status
Poor/Avg.
/Good
Existing
training/activities/
facilities, if any
Target
segments
Mechanism for
determining valueadded to specific
sector/industry
Mechanism for
determining valueadded to specific
socio-economic
group
Mechanism for
review of case-bycase cost-benefit
analysis
Competence to
review/analyze costbenefit assumptions
Public Access to
information
covering costbenefit analyses
Others (specify):
Comments:
* The scale of ranking 1 to 5 represents: 1-not important, 2-a little important, 3-relatively important, 4- fairly
important, 5- very important.
112
Potential for
weediness or
invasiveness
Awareness training
on laws and policies
on environment and
natural resources
Impact of GMO on
traditional farming
systems
Others (specify):
Comments:
* The scale of ranking 1 to 5 represents: 1-not important, 2-a little important, 3-relatively important, 4- fairly
important,
5very
important.
113
IV.
Please tick most appropriate means for effective sharing of information for
various stakeholders.
Means of
information
sharing
Electronic
media (radio &
TV)
Newspapers
Regulators
Approval Monitoring
agencies
agencies
Scientists
Industry
NGOs
Farmers/
Public/
Consumers
Through
Groups and
associations
Through NGOs
Internet
Newsletter,
bulletin, library
Business or
work associates
Training/
consultation
programmes
V.
1 Week
1 Month
Any Other
Regulators
Scientists
Industry
NGOs
Farmers
/Public/consumers
Customs/Port
officials
Any Other
(Pl. specify)
IV.
114
General Information:
Name:
___________________________________________________
Organization:
___________________________________________________
Contact details:
___________________________________________________
(including telephone, ___________________________________________________
fax, email)
___________________________________________________
II.
III.
Yes
No
Yes
Yes
Yes
Yes
No
No
No
No
IV.
115
V.
Please tick the preferred organization(s) for imparting training in the above
areas
State Agricultural Universities (SAUs)
Government departments (central and state)
Companies
NGOs
International agencies
Any other
____________________________________________________________________
VI.
Please tick the preferred means for effective information sharing with you
Websites/CDs
Groups and associations
Manuals
Internet
Newsletter, bulletin, library
Training/ consultation programmes
Any other
____________________________________________________________________
VII.
116
General Information:
Name:
___________________________________________________
Organization:
___________________________________________________
Contact details:
___________________________________________________
(including telephone, ___________________________________________________
fax, email)
___________________________________________________
II.
Yes
No
Yes
Yes
Yes
Yes
No
No
No
No
III.
IV.
Please rank in terms of priorities (on the scale 1 to 5)* the main elements of
training programmes to be organized and fill in the specific areas to be
included:
Areas
Rank
* Scale 1 to 5 represents: 1-not important, 2- a little important, 3- relatively important, 4fairly important, 5- very important.
117
V.
Please tick the preferred means for effective information sharing with you
Websites/CDs
Groups and associations
Manuals
Internet
Newsletter, bulletin, library
Training/ consultation programmes
VI.
_____________________________________________________________________
118
II.
General Information:
Name:
___________________________________________________
Organization:
Contact details:
(including telephone,
fax, email)
___________________________________________________
___________________________________________________
___________________________________________________
___________________________________________________
III.
Yes
No
Yes
Yes
Yes
Yes
No
No
No
No
IV.
119
V.
Please suggest areas for the following stakeholders where training can be
imparted for biosafety of GMOs in the country
Regulators
_______________________________________________
Scientists
_______________________________________________
Companies
_______________________________________________
NGOs
_______________________________________________
Farmers
_______________________________________________
Any other
____________________________________________________________________
VI.
Please tick the preferred organization(s) for imparting training in the above
areas
State Agricultural Universities (SAUs)
Government departments (central and state)
Companies
NGOs
International agencies
Any other
____________________________________________________________________
VII.
Please tick most appropriate means for effective sharing of information for
various stakeholders.
Means of
information
sharing
Electronic media
(radio & TV)
Regulators
Approving Monitoring
agencies
agencies
Scientists
Industry
NGOs
Farmers/
Public/
Consumers
Newspapers/Print
media e.g.
Newsletter,
bulletin, books
Through Groups
and associations
Through NGOs
Internet
Non-internet
based electronic
exchange
material (e.g. CD
ROMs, fax, etc.)
Seminars/
Conferences/
Consultations
120
II.
General Information:
Name:
___________________________________________________
Organization:
Contact details:
(including telephone,
fax, email)
___________________________________________________
___________________________________________________
___________________________________________________
___________________________________________________
III.
Yes
No
Yes
Yes
Yes
Yes
No
No
No
No
IV. Please rank in terms of priorities (on the scale 1 to 5)* the main elements of
training programmes you would be interested in and fill in the specific areas
to be included:
Areas
Rank
* Scale 1 to 5 represents: 1-not important, 2- a little important, 3- relatively important, 4fairly important, 5- very important.
121
V.
Are you aware of any existing efforts being undertaken in any of the above
listed areas:
_____________________________________________________________________
_____________________________________________________________________
VI.
Please tick the preferred organization(s) for imparting training in the above
areas
State Agricultural Universities (SAUs)
Government departments (central and state)
Companies
NGOs
International agencies
Any other
____________________________________________________________________
VII.
Please list the divisions and the levels in which personnel should be provided
training in the State Departments of Agriculture
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
VIII. Please tick the preferred means for effective information sharing with you
Websites/CDs
Groups and associations
Manuals
Internet
Newsletter, bulletin, library
Training/ consultation programmes
Any other
____________________________________________________________________
IX.
122
ANNEX-2
LIST OF RESPONDENTS
S. No.
Name
Organization
Category
1.
Agarwal, Dr. O. P.
Regulatory Committee
2.
3.
Ahuja, Dr. S. L.
4.
5.
Arumugachamy, Dr. S.
6.
7.
Balasubramanian, Dr. P.
8.
9.
Seed Distributor
Research Organisation
Department of Agriculture,
Haryana
TNAU, Coimbatore
State Government
Research Organisation
Research Organisation
Research Organisation
Research Organisation
Research Organisation
Farmer
Research Organisation
Central Government/
Regulatory Committee
Industry
NGO
123
Seed Distributor
Industry
Farmer
Farmer
Farmer, Nagpur
Farmer
Research Organisation
Research Organisation
Legal Expert
Research Organization
State Government
Research Organisation
Farmer
Central Government
Expert
Industry Association
Legal Expert
State Government
Central Government
Seed Distributor
Department of Agriculture,
Madhya Pradesh
Department of Biotechnology,
Pondicherry University,
Pondicherry
Department of Agriculture,
Tamil Nadu
Dept. of Biotechnology,
University of Madras, Chennai
National Environmental
Engineering Research Institute
(NEERI), Nagpur
Department of Agriculture,
Punjab
Department of Agriculture,
Gujarat, Jamnagar
NBPGR, New Delhi
Research Organisation
Seed Distributor
Research Organization/
Regulatory Committee
124
State Government
Research Organisation
State Government
Research Organisation
Research Organisation
State Government
State Government
Dept. of Biotechnology,
Research Organisation
University of Madras, Chennai
University of Agricultural Science, Research Organisation
Bangalore
Monsanto India Ltd., New Delhi Industry
Nuziveedu Seeds Limited,
Industry
Secunderabad
Dept. of Plant Protection,
Plant Quarantine Office
Quarantine & Storage, Faridabad
NRCPB, IARI, New Delhi
Research Organisation
Prabhat Agri Biotech Ltd.,
Hyderabad
Indian Institute of Vegetable
Research, Varanasi
Pro Agro Seeds Co. Pvt.Ltd.,
Gurgaon
Nirmal Seeds Pvt. Ltd., Jalgaon
Dabur Research Foundation,
Ghaziabad
CCS Haryana Agricultural
University, Hisar
Punjab State Council of Science
and Technology, Chandigarh
Mahatma Phule Krishi
Vidhyapeeth, Rahuri
Ministry of Agriculture, New Delhi
Bhabha Atomic Research Centre
(BARC), Mumbai
Indian Institute of Technology
(IIT), Bombay
Sri Krishna Agencies, Hyderabad
Industry
Research Organisation
Industry
Industry
Industry
Research Organisation
State Government
Research Organisation
Central Government
Research Organisation
Research Organization
Seed Distributor
NGO
Research Organisation
Seed Distributor
Central Government/
Regulatory Committee
Research Organisation
125
Research Organisation
M. S. Swaminathan Research
Research Organisation
Foundation, Chennai
Bioseed Research India Pvt. Ltd., Industry
Hyderabad
International Agri Equipments,
Seed Distributor
Himatnagar, Gujarat
Research Organisation
NEERI, Nagpur
Research Organisation
Industry
Research Organisation
Plant Quarantine Office
Industry
Industry
Central Government/
Regulatory Committee
Industry
Research Organisation
Research Organisation
NGO
Seed Distributor
Research Organisation
Research Organisation
126
Central Government
Research Organisation
TNAU, Coimbatore
Research Organisation
MAHYCO, Mumbai
NRCPB, IARI, New Delhi
Industry
Research Organization/
Regulatory Committee
Research Organisation
Dept. of Biotechnology,
University of Madras, Chennai
Jawaharlal Nehru Krishi Vishwa
Vidyalaya (JNKVV), Khandwa,
Madhya Pradesh
Basant Agro Tech (I) Ltd., Akola
CTRI, Hyderabad
Seed Distributor
Research Organisation
Research Organisation
Industry
Research Organisation
Industry
Central Government
State Government
State Government
State Government
Research Organisation
Plant Quarantine Office
Research Organisation
Farmer
Seed Distributor
127
State Government
Research Organization
Farmer, Hisar
Department of Agriculture,
State Government
Punjab
Regional Plant Quarantine
Plant Quarantine Office
Station, Kolkata
All India Crop Biotechnology
Industry Association
Association, New Delhi
Dept. of Biotechnology,
Research Organisation
ANGRAU, Hyderabad
Office of the Deputy Director of State Government
Agriculture, Ahmedabad
Central Drug Research Institute, Research Organisation
Lucknow
Sugarcane Breeding Institute
Research Organisation
(ICAR), Coimbatore
Tamil Nadu Agricultural
Research Organisation
University (TNAU), Coimbatore
Pragati Agro Enterprises Pvt. Ltd. Seed Distributor
Amravati, Madhya Pradesh
Farmer
Seed Distributor
Dept. of Biotechnology,
University of Madras, Chennai
Farmer, Jalgaon, Maharashtra
Research Organisation
Department of Biotechnology,
New Delhi
FDC Ltd., Mumbai
Department of Agriculture,
Gujarat
Centre for Plant Biotechnology &
Molecular Biology, College of
Horticulture, Kerala Agricultural
University, Thrissur
National Academy of Customs,
Excise & Narcotics (NACEN),
Faridabad
Department of Plant
Biotechnology, Madurai Kamraj
University, Madurai
Madurai Kamraj University,
Madurai
Ministry of Environment and
Forests, New Delhi
Department of Agriculture,
Karnataka
Ministry of Environment &
Forests, New Delhi
CCS Haryana Agricultural
University, Hisar
128
Farmer
Central Government
Industry
State Government
Research Organisation
Central Government
Research Organization/
Regulatory Committee
Research Organisation
Central government/
Regulatory committee
State Government
Central Government/
Regulatory Committee
Research Organisation
ANNEX-3
COMPILATION OF SUGGESTED AREAS
A. Development of LMOs/GMOs
Need
Molecular biology
skills (e.g. gene
isolation, sequencing
etc.)
Assessment of effects
of promoter,
enhancers, introns
and terminator
sequences
Assessment of marker
genes
Assessment of genetic
stability and limits of
gene expression
under different
conditions
Analysis of molecular
data
Assessment of the
extent and effects of
gene flow
Evaluation of genetic
modifications
129
B. Risk assessment (impact on human health and environment) and other scientific and
technical expertise
Need
Access to reference
materials/databases on
risk assessment
National risk
assessment
frameworks, principles,
procedures and
mechanisms
Risk assessment
scientific expertise
Competence to review
and audit risk
assessments
National biosafety
research
C. Risk management
.Need
Detection, management
and prevention of
unintentional transfer of
LMOs
Risk management
frameworks, strategies
and mechanisms
130
of
Strengthening of legal
frameworks
Compliance
mechanisms
Harmonization of
biosafety-related
sectoral laws/policies
Mainstreaming
biosafety into other
sectors
Negotiation of bilateral,
regional and multilateral agreements
Regulatory training
(legal, policy,
enforcement, inspection
etc.)
Guidelines for the
integration of GMO
evaluation in the EIA
System
131
Post-release monitoring
Development of system for MIS (monitoring information system)
and implementation
Post-release monitoring
Identification and development of protocols
132
E. Identification of LMOs
.
Need
F. Human resources development and training: Legal, social and economic expertise
. Need
Assessment of characteristics of LMOs
133
ethical
134
Print media
I.
Need
J. Technology transfer
Need
Access to proprietary technologies
on preferential terms
Analysis of appropriate
technologies
Enabling policies and incentives
for technology transfer
Management of intellectual
property rights
Technologies for handling,
transport, packaging and
identification of LMOs
Technologies for information
exchange/data management
Technologies for monitoring of
LMOs
Technologies for risk assessment
of LMOs
135
K. Socio-Economic Considerations
.
Need
Mechanism for determining valueadded to specific sector/industry
Mechanism for determining valueadded to specific socio-economic
group
Mechanism for review of case-bycase cost-benefit analysis
Competence to review/analyze
cost-benefit assumptions
Public Access to information
covering cost-benefit analyses
136
ANNEX-4
RECORD OF THE PROCEEDINGS OF THE STAKEHOLDER CONSULTATION
MEETING ON TRAINING NEEDS ASSESSMENT SURVEY
A consultation meeting to discuss the findings of the Training Needs Assessment (TNA)
Survey under the GEF-World Bank aided project on Capacity Building was held at 10.00 A.M. on
October 14, 2005 under the Chairmanship of Shri Desh Deepak Verma, Joint Secretary, MoEF and
Project Director.
Shri Desh Deepak Verma, Joint Secretary & Project Director welcomed the participants. He
informed the participants that as a part of the GEF-WB Capacity Building Project on Biosafety, an
exercise of the Training Need Assessment has been undertaken which will enable the Ministry of
Environment & Forests to identify the need, gaps and priority in imparting training in biosafety. The
draft report has addressed the technical training so also public participation and awareness. He
requested all the participants to give their valuable inputs for finalizing the Report for its
implementation which will be go a long way in building capacity in the Biosafety in the country.
Dr. Manoranjan Hota, Additional Director, MoEF and Project Coordinator gave the
background of the Training Needs Assessment Survey informing that this exercise has been initiated
by the MoEF under the GEF-World Bank aided project on Capacity Building to assess the capacity
building needs in the country with an objective to enhance Indias national capacity to implement the
Cartagena Protocol and that the exercise was carried out by M/s BCIL both by desk research and
through questionnaire and interviews. The views of all the representative stakeholders were taken
while preparing the draft report. The study took cognizance of the views expressed in earlier
workshops and meetings.
Dr. Vibha Ahuja, DGM, BCIL gave a presentation on the TNA detailing on the methodology
adopted for the survey. She informed that the assessment of training needs was done in combination
of field survey through questionnaires, personal discussions and desk research. A detailed
questionnaire was used covering 12 areas of capacity building including risk assessment and
management, human resource development, regulatory capacity building, socio economic
considerations etc. Responses were used for priority ranking on a scale of 1-5 as well as suggestions
for training requirements for various target segments. A short questionnaires were also used for state
level agricultural officials, quarantine officials, social experts etc. The analysis was based on about
150 responses from various stakeholders interalia, central and state government, regulators,
scientists, industry, NGOs etc. so also on extensive desk research on article wise requirements of the
Cartagena Protocol; existing systems of approval vis-a-vis trade of LMO/GMOs. The analyses also
had an overview of existing initiatives for capacity building; organization structures for identifying both
trainees and trainers etc. Dr. Ahuja also mentioned that the responses in the earlier events (vizworkshops/training programmes) organized by MoEF and DBT involving state agriculture officials,
agriculture scientists and service providers, farmers and Institutional Biosafety Committees members
were also referred to for working out the recommendations. The important suggestions made by
various experts in their presentations in over 50 events organized by MoEF, DBT and BCIL since
1998 have also been taken into account for recommendations.
Risk assessment and management emerged as the top priority for imparting training followed
by human resource development/ training and regulatory capacity building. The Other Priority areas
listed are public awareness, education and participation and scientific technical and institutional
collaborations. 12 sectors have been identified as priority areas for imparting training. Based on the
responses, a training needs matrix was drawn for various categories of stakeholders viz. government
officials; regulators; enforcement officials; scientists/technical personnel; legal experts; economists;
information managers including IT specialists; graduate and undergraduate students; interest groups
(e.g. consumer groups, farmer associations, professional associations, NGOs); Mass media and
outreach/extension workers (e.g. journalists and agricultural extensionists), politicians and general
public.
Recommendations have also emerged for organizing national and international events, series
of workshops for various stakeholders, laboratory training, studies/surveys, publications and
documents, use of electronic media, study tours, exchange of personnel, preferred communication
media and duration of the training programmes by various target segments.
137
While appreciating the efferts of the MoEF and BCIL in synthesizing the report Dr. R. P.
Sharma, INSA Fellow, Indian Agricultural Research Institute added that awareness at the grassroot
level about GMOs/LMOs should preferably be done using examples such as Bt cotton as it would
result in better understanding in view of the familiarity with the product. He further suggested that it is
extremely important to mention about the degree of probability of each risk while communicating
about the probable risks to consumers, farmers, processors etc., to allay the unfounded fear and
present the true picture. He also added that the training needs should also cover GM crops to be used
for biopharmaceutical production as well as microorganisms, which are likely to be available for
commercial use both through imports and local research in future.
Dr. Vibha Dhawan, Vice Chancellorm, TERI School of Advanced Studies while referring to the
preparation of resource material for training and public awareness mentioned in the report, suggested
that resource material may be prepared by giving overviews GMOs alongwith examples.
Shri Desh Deepak Verma suggested that some terminology used in the draft report may be
relooked so as to give more clarity. Shri Verma stressed that the training needs of various
stakeholders may be worked out keeping in view the provisions of Cartagena Protocol. He further
suggested that the present regulatory system needs harmonization with the provisions of the
Cartagena Protocol and therefore the regulatory bodies such as GEAC, RCGM etc. also need to be
trained.
Dr. S. R. Rao congratulated MoEF for taking this initiative which will help in planned approach
for ensuring the implementation of the Cartagena Protocol in the country and suggested that the
status terminology may be depicted as high/medium/low instead of poor/average/good. He also
suggested that the findings and the recommendations of the report may be divided into requirements
for strengthening the domestic law and meeting the international obligations. He further suggested
that the levels of capacity building may be catagorised appropriately e.g. senior level training for
members of regulatory bodies and other administrative personnel, middle level for universities and
organizations involved in operations and junior level etc. for extension workers, farmers, consumers
etc. Further he agrees that the training programmes/activities may also be divided into phases based
on immediate, short term and long term.
Dr. K.K. Tripathi, Advisor, DBT suggested that these phases may be divided further into
administrative, legislative and technical requirements.
Dr. T.V. Ramanaiah, Director, DBT agreed that training activities may be prioritized and the
resource materials may be prepared by experts.
Prof. A.K. Bhatnagar, from University of Delhi appreciated the efforts of MoEF and BCIL and
suggested that a wide cross section of stakeholders may be involved so that more expertise can be
generated.
Dr. Koundal from NRCPB suggested that the training activities need to address the critical
issues of biosafety and must reach masses in their language at the backdrop of the need of the
country. Some promotional policy without too much repetition may be initiated. School children,
media, NGOs and even politicians need to be made aware about the GMOs & its implications. The
activities need to be only informative rather than promoting any product.
Dr. Gurinder Randhawa from NBPGR suggested that Risk Communication has been urgently
addressed in the Report. She also suggested that time frame for each activity may be prepared for
implementation.
The broad framework of training needs and its implementation was endorsed by all the
participants.
The meeting ended with a vote of thanks to the Chair.
138