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Contents
Page CHAPTERS
Executive Summary i-ix 1. INTRODUCTION 1 2. METHODOLOGY 3 3. APPLICATIONS OF GMOs IN AGRICULTURE 6
3.1 Global Status 3.2 Status in India
4. REGULATORY FRAMEWORK IN INDIA 14
4.1 Government Rules for GMOs, 1989 4.2 Recombinant DNA Guidelines, 1990 4.3 Guidelines for Research in Transgenic Plants, 1998 4.4 Seed Policy, 2002 4.5 Prevention of Food Adulteration Act, 1954 4.6 The Food Safety and Standards Bill, 2005 4.7 Plant Quarantine Order 2003 4.8 Task Force on Application of Agricultural Biotechnology 4.9 Draft National Environment Policy, 2004 4.10 Draft National Biotechnology Strategy 2005
5. CARTAGENA PROTOCOL ON BIOSAFETY 35
5.1 Introduction 5.2 Objective 5.3 Elements of the Protocol 5.4 Status of Implementation in India 5.5 Other International Agreements
6. AREAS COVERED FOR TRAINING NEEDS ASSESSMENT 45
6.1 Development of GMOs 6.2 Risk Assessment 6.3 Risk Management 6.4 Regulatory Capacity Building 6.5 Identification of LMOs 6.6 Human Resources Development and Training 6.7 Public Awareness, Education and Participation 6.8 Information Exchange & Data Management 6.9 Scientific, Technical and Institutional Collaboration 6.10 Technology Transfer 6.11 Socio-Economic Considerations 6.12 Sustainable Use and Conservation of Biodiversity
Page
7. FINDINGS OF THE FIELD SURVEY 57
7.1 Priority Ranking of Areas and Suggestions for Capacity Building 7.2 Means of Sharing Information 7.3 Duration of the Training Programmes
8. IDENTIFICATION OF TRAINING NEEDS 74
8.1 Stakeholders 8.2 Training Needs Matrix
9. OVERVIEW OF EXISTING TRAINING PROGRAMMES 81
9.1 Series of Workshops 9.2 National Events 9.3 International Events 9.4 Training Programmes by Private Sector 9.5 Websites 9.6 Publications 9.7 Capacity Building Projects
10. PROPOSED TRAINING MODULES 91 ANNEXES 1. QUESTIONNAIRES 99 2. LIST OF RESPONDENTS 123 3. COMPILATION OF SUGGESTED AREAS 129 4. PROCEEDINGS OF THE STAKEHOLDER CONSULTATION 137 MEETING
TRAINING NEEDS ASSESSMENT SURVEY
Executive Summary
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.
There has been significant progress in building institutional capacities and
regulatory framework in India through the cumulative efforts and initiatives of many
organizations to keep pace with the advances in development and use of GMOs/LMOs.
However, there is an urgent need to take stock of the situation and identify major
components of capacity building requirements in terms of strengthening scientific
institutions, development of human resources, research and technology, legislation,
regulations, policies and programs for biosafety to have a consolidated action plan in
place to meet the obligations of the Cartagena Protocol and effective implementation of
the national regulatory framework.
Under the sponsorship of GEF-World Bank, MoEF has initiated a Capacity Building
project, to enhance India’s 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
i
assess the requirements in these areas through a process of consultation with various
stakeholders prior to initiating countrywide training programmes.
The objective of the survey is to identify the training needs of agricultural
biotechnology stakeholders in the public and private sectors as regards genetically
engineered crops including plants used for biopharmaceuticals products, livestock and the
products derived from these (including foods).
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
written responses to questionnaires as well as personal discussions with the respondents
were used for each area for assessment of the training needs.
Extensive desk research included collection of information on country’s obligations
to the Cartagena Protocol, existing regulatory systems of approval as well as trade of
LMOs/GMOs and overview of existing initiatives for capacity building etc. The status of
implementation of Cartagena Protocol in India and the requirements for each Article have
been studied. An overview of the existing training programmes has been prepared which
includes the stakeholders targeted, course content and the recommendations that
emerged out of such training programmes. Over 5000 participants have attended the
events organized by MoEF, DBT and BCIL in the last few years. 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 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. The members gave suggestions and
approved the report.
Review of regulatory framework in India for GMOs/LMOs including GM food is part
of the desk research. This includes rules notified by MOEF in 1989 under Environment
(Protection) Act, 1986 (EPA), guidelines issued by DBT in 1990 and 1998 and sections of
Seed Policy, 2002. Food control system under Prevention of Food Adulteration Act has
been studied with respect to applicability to food derived from GM crops. Provisions
related to GM food under Food Safety Standards Bill, 2005 prepared by Ministry of Food
Processing Industries have also been detailed. Report of the Task Force on Application of
Agricultural Biotechnology set up by the Ministry of Agriculture under chairmanship of Prof.
M.S. Swaminathan was also consulted. An overview of sections related to GM crops in
the Draft National Environment Policy, 2004 and Draft Biotechnology Strategy, 2005 have
iii
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.
The approval conditions for commercialization of Bt cotton in India in 2002 to
MAHYCO included undertaking awareness and education programme, interalia through
development and distribution of educational material on Bt cotton for farmers, dealers and
others. In view of the above, M/s. MAHYCO had conducted awareness programmes for
dealers, company executives, field assistants as well as agricultural department officials in
the various districts of Bt cotton growing states. In addition farmer education programmes
was organized in two phases i.e. pre sowing and post sowing through farmer meetings,
mailers, audio cassettes and pamphlets in local languages. The training programmes
covered information on various aspects related to cultivation of Bt cotton. Similar
programmes have been taken up by other industries who are marketing Bt cotton hybrids.
iv
In addition, representatives of private sector have been regularly participating in
various training programmes and also have sponsored various events.
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.
Several publications as background documents or proceedings of various events
have been widely circulated in the country. Industries such as Maharashtra Hybrid Seeds
Company Ltd., Monsanto, Syngenta etc. are also circulating newsletters covering
information about GMOs. MoEF has recently launched a quarterly biosafety newsletter in
association with BCIL for circulation amongst stakeholders all over the country. DBT and
BCIL have released a handbook for IBSC members.
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.
Under risk management, maximum emphasis has been given to detection,
management and prevention of unintentional transfer of LMOs. The committees and
v
institutions involved in the compliance and monitoring also need to be extensively trained
particularly at the functional level.
A multi pronged approach is required for human resource development in the
country through focused training programmes for specific categories of stakeholders,
participation in national and international events, circulation of various publications as well
as long term training programmes.
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. Development of handbooks and
manuals for specific target segments viz. health inspectors, agriculture officials, pollution
control board officials, border control and quarantine officials has also been suggested.
Public awareness and education, risk communication skills and strategies,
biosafety awareness documents (newsletters, bulletins, articles in the newspaper etc.) and
organizing of biosafety awareness activities have been indicated as priority areas. The
suggestions for achieving the same include training of risk communicators particularly
among members of regulatory bodies and institutions involved, seminars, radio and
television talk shows including reputed scientists, local case by case synthesis of
information and dissemination, regular meetings with media to give authentic information
etc.
Guidelines for safe handling, packaging and transport of LMOs need to be
developed along with methods and systems for their identification. Systems for inspection
and segregation of LMOs have been listed as the priority areas. The target segment for
providing training include organizations involved in trade and border control. Suggestions
have also been given for training of social and economic experts for undertaking analysis
of awareness levels in different strata of the society.
Based on the above priorities, a training needs matrix has been drawn for the
following stakeholders:
(i) Senior government officials (policy/decision makers);
vi
(ii) Regulators (e.g. application reviewers/assessors, advisors, administrators, etc,);
(iii) Enforcement officials (e.g. field inspectors health, food and agriculture departments,
custom and plant quarantine officers);
(iv) Scientists/technical personnel who review or prepare applications (public and
private sector);
(v) Legal experts;
(vi) Economists;
(vii) Information managers including IT specialists;
(viii) Graduate and undergraduate students;
(ix) Interest groups (e.g. consumer groups, farmer associations, professional
associations, NGOs);
(x) Mass media and outreach/extension workers (e.g. journalists and agricultural
extensionists) and
(xi) General public and political leadership
A variety of approaches have been proposed based on training need requirements,
preferred communication media and duration of the training programmes by various target
segments. These include a combination of national and international events, series of
workshops for various stakeholders, laboratory/technical training, studies/surveys,
publications and documents, use of electronic media, study tours, exchange of personnel
etc.
Extensive awareness programmes at the grass root level need to be initiated by
using both print and electronic media 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. Network
of scientific risks communicators to be created who will interact with the media as well as
deliver regular talks to different categories of stakeholders. Development of electronic
educational programmes for TV, radio, internet etc. as well as printed documents such as
primers/brochures/booklets/FAQs/glossary of terms in local languages will be extremely
useful in reaching out to specific stakeholders as well.
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.
National consultations may be organized among various stakeholders particularly
with those involved in trade and transboundary movements on various articles of
Cartagena Protocol particularly Article 7-8 (AIA procedures), Article 15 (risk assessment
and management), Article 18 (documentation requirements) and Article 27 (liability and
redress). National workshop on various crops under development (one crop at a time) to
review all aspects in a comprehensive manner are required for providing inputs for
effective and expeditious decision making.
Seminars on specific research areas pertinent to biosafety would help in planning
national biosafety research. The researchers working in SAUs, universities, research
institutions etc. may also be exposed to good laboratory practices by organizing
programmes conducted at selected institutions.
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.
Information on issues related to GMOs/LMOs needs to be provided in variety of
formats such as resource material on specific topics, brochures, pamphlets, booklets, peer
reviewed scientific publications, review articles/current expert opinions, conference
proceedings, reports and documents form international organizations etc. These can be
disseminated both through the print and electronic forms. Resource material on biosafety
issues and handbooks for various regulatory bodies should be prepared and circulated for
familiarizing specific categories of stakeholders about their responsibilities as well as to
viii
create awareness on various aspects. Dedicated websites on biosafety, video films on
successful case studies, CDs/videos on regulatory requirements are the other suggested
means for providing authenticated science based information.
Scientists and regulators should be encouraged to regularly participate in
international conferences to get exposure to the international developments and
procedures. Specific study tours may be undertaken to countries, which have approved
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.
It is proposed that a directory of resource persons may be prepared for undertaking
such wide ranging capacity building activities. Similarly, a compendium of biosafety
training programmes should also be prepared for circulating information about the same.
In addition to the short term training programmes, there is a need to plan and organize
long-term courses to provide both theoretical and practical training such as special post
graduate diploma/degree, distance training programmes for beginners as well as
advanced training modules and training programme for in service officials.
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.
There has been significant progress in building institutional capacities and
regulatory framework in India through the cumulative efforts and initiatives of many
organizations to keep pace with the advances in development and use of
GMOs/LMOs. However, there is an urgent need to take stock of the situation and
identify major components of capacity building requirements in terms of
strengthening scientific institutions, development of human resources, research and
technology, legislation, regulations, policies and programs for biosafety to have a
consolidated action plan in place to meet the obligations of the Cartagena Protocol
and effective implementation of the national regulatory framework.
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 GEF-
World 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
1
(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.
The objective of the survey is to identify the training needs of agricultural
biotechnology stakeholders in the public and private sectors as regards genetically
engineered crops (including plant used for biopharmaceutical production), livestock
and the products derived from these (including foods).
The survey has been conducted by collecting responses by various
stakeholders to questionnaires, personal discussions with the experts and extensive
desk research. Priority areas where training is required have been identified and
training modules suggested for various stakeholders for capacity building of the
country for implementation of the Cartagena Protocol.
Approximately 150 respondents including Central and State Governments,
research scientists, industry, social organizations and NGOs responded to the
questionnaire. However, biotechnology being an emerging sector in India, the
information from filled questionnaires was limited. This was supplemented by
extensive desk research and feedback from various stakeholders during earlier
interactions for identifying the priority areas and proposed training modules. 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 were suitably
incorporated in the report. The report was also presented to the Steering Committee
of the GEF-World Bank Project, which approved the report.
2
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.
The study was initiated by preparing a detailed questionnaire covering the
following areas for identifying the training needs as well as other capacity building
requirements in the area of LMOs/GMOs:
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 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
3
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.
A database of 400 target respondents covering different categories viz.
Central Government, State Government, research organizations, industry, regulatory
bodies, civil organizations, social experts, agriculture service providers and others
was prepared (Table 2.1). Table 2.1: Categories of target respondents
S.No. Category Component
1. Central government MoEF, DBT, MoA, MoC&I, MoH&FW, MoFPI, DST, ICAR, CSIR, APEDA
2. State government State departments of environment, agriculture, health, agriculture commissionerate, councils for science and technology
3. Regulatory bodies GEAC, RCGM, SBCCs and DLCs,
4. Private industry (including importers and exporters)
Seed companies, processed food companies
5. Public sector research organizations
R&D institutes affiliated to CSIR, ICAR, university departments, state agriculture universities
6. Social experts Social scientists, legal experts, media representatives
7. Agriculture service providers
Seed distributors and dealers, agriculture extension workers, input (agrochemicals) suppliers
8. Civil organizations and others
Farmers organizations, NGOs, consumer organizations, industry and trade associations
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.
About 150 responses to the questionnaires were collected from various
stakeholders. A computerized programme was prepared for analyzing the results of
the survey, which was extensively used to generate different query based reports.
4
The quantitative analysis on the priority ranking was done for total number of
responses as well as for individual stakeholders. The qualitative findings were
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.
Extensive desk research included collection of information on country’s
obligations to the Cartagena Protocol, existing regulatory systems of approval as
well as trade of LMOs/GMOs and overview of existing initiatives for capacity building
etc. The status of implementation of Cartagena Protocol in India and the
requirements for each Article have been studied. An overview of the existing training
programmes has been prepared which includes the stakeholders targeted, course
content and the recommendations that emerged out of such training programmes.
Over 5000 participants have attended the events organized by MoEF, DBT and BCIL
in the last few years. 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 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.
5
6
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. In everyday usage, LMOs are usually considered to be the
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:
Several commercially important transgenic crops such as maize, soyabean,
tomato, cotton, potato, mustard, rice etc. have been genetically modified. Table 3.1
lists these products along with the genetically improved trait and countries where
they have been approved.
7
Table 3.1: Transgenic crops approved for commercial use
S. No. Crop Uses Countries where approved 1. Alfalfa Herbicide tolerance U.S., Canada, Mexico
2. Argentine Canola
Herbicide tolerance and improved protection against weeds
Canada, US, Japan, Australia
3. Carnation
Increased shelf life by delayed ripening, modified flower colour and herbicide tolerance
Australia, European Union
4. Chicory Herbicide tolerance, improved protection against weeds and higher yields
European Union
5. Cotton Improved insect protection, herbicide tolerance and improved protection against weeds
Japan, Australia, US, China, Mexico, South Africa, Argentina, India, Indonesia, Philippines, Brazil
6. Flax, Linseed
Herbicide tolerance, antibiotic resistance and improved weed protection
Canada, US
7. Green pepper
Virus resistance China
8. Maize Herbicide tolerance, improved weed protection, resistance against insects and restored fertility of seeds
Canada, Japan, US, Argentina, European Union, South Africa, Philippines, Switzerland, Taiwan,China,U.K.,Korea,Russia,Uruguay
9. Melon Delayed ripening U.S.A 10. Papaya Virus Resistance U.S.A., Canada 11. Polish
Canola Herbicide tolerance and improved weed control
Canada
12. Potato Improved protection from insect and leaf roll virus
US, Canada ,Japan ,Australia ,Philippines
13. Rice Herbicide resistance US 14. Soybean Improved weed control and
herbicide tolerance, increased cooking quality
US, Argentina, Japan, Canada, Uruguay, Mexico, Brazil and South Africa, Czech Republic, European Union, Korea, Russia, Switzerland, Taiwan, U.K., Philippines and Australia
15. Squash Resistance against watermelon mosaic virus and zucchini yellow mosaic virus
US, Canada
16. Sugar beet
Herbicide tolerance US, Canada, Japan, Philippines ,Australia
17. Sunflower Herbicide tolerance Canada 18. Tobacco Herbicide tolerance US 19. Tomato Improved shelf life, taste,
color and texture, improved insect resistance, virus resistance
US, Mexico, Japan, China, Canada
20. Wheat Herbicide Tolerance U.S.
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.
Figure 3.1: Global area of transgenic crops from 1996 to 2004 (million hectares)
1.711.0
27.839.9 44.2
52.658.7
67.781.0
0102030405060708090
1996
1997
1998
1999
2000
2001
2002
2003
2004
Source: International Service for the 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).
8
Figure 3.2: Biotech crop countries and mega countries, 2004
Source: International Service for the Acquisition of Agri-biotech Applications (http://www.isaaa.org)
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.
There is intensive research going on to develop transgenic crops with more
direct benefits to consumers. It has been reported that 63 countries are in transgenic
crop research and development programs ranging from laboratory/greenhouse
experiments, field trials, regulatory approval and commercial production. 57 plants
divided into four groups i.e. field crops, vegetables, fruits and plants, have been
identified for further research. Some of products that are likely be available to
consumers in the near future are:
• Soybean and canola oils containing more unsaturated fatty acids
• Higher yielding peas that remain sweeter longer
• Smaller seedless melons
• Bananas and pineapples with delayed-ripening qualities
• Bananas resistant to fungi
• High protein rice
• Tomatoes with higher antioxidant content
• Fruits and vegetables with higher levels of vitamins 9
10
Further down the road are products that include:
• Crops tolerant to certain stresses e.g. drought, floods, salts, metals, heat, and
cold
• Safer foods through reduction of allergenic proteins
• Edible vaccines
• Nitrogen fixing crops
• Plants that produce latex
3.2 STATUS IN INDIA:
In view of the importance and potential of transgenic crops, extensive efforts
have been initiated in India for development of transgenic crops.
As of now, Bt cotton containing the Cry1Ac gene from Bacillus thuringiensis is
the only transgenic crop approved for commercial cultivation in India. The approval
was first accorded to M/s Maharashtra Hybrid Seeds Company Ltd. (MAHYCO) in
2002. Subsequently, several other companies have taken sub-licenses from
MAHYCO and as of now, 20 hybrids of Bt cotton are approved for commercial
cultivation in nine states in the country. The area under cultivation has increased
from 72,000 acres to 13,10,000 acres in 2004.
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.
11
Table 3.2: Transgenic crops under development and field trials S. No Crop Organization Transgene 1. Brinjal Mahyco, Mumbai cry1Ac
Sungro Seeds Ltd, New Delhi cry1Ac IARI, New Delhi cry1F 2. Cabbage Sungro Seeds Ltd, New Delhi cry1Ac 3. Cauliflower Sungro Seeds Ltd, New Delhi cry1Ac 4. Corn Monsanto, Mumbai Cry1Ab
Metahelix Life Sciences, Bangalore Modified Mu-element (Turbo-Mu)
5. Cotton Ajeet Seeds, Aurangabad cry1Ac, cryX Ankur Seeds P. Ltd., Nagpur cry1Ac, cryX
M/s Bioseed Research India Pvt Ltd, Hyd cry1Ac, cryX M/s Emergent Genetics India P. Ltd, Hyd cry1Ac, cryX
Ganga Kaveri Seeds Ltd, Hyderabad cry1Ac Green Gold Seeds Ltd, Aurangabad GFM cry1Aa JK Agri Genetics, Hyderabad cry1Ac M/s Kaveri Seeds Co. P. Ltd, S’bad cry1Ac Krishidhan Seeds, Jalna cry1Ac, cryX Mahyco, Mumbai cryX Metahelix Life Sciences, Bangalore cry1Ac Nandi Seeds Pvt. Ltd Mehbubnagar cry1Ac Namdhari Seeds Pvt. Ltd, Bangalore cry1Ac Nath Seeds, Aurangabad GFM cry1Aa Nuziveedu Seeds, Hyderabad cry1Ac, cryX Prabhat Agri Biotech Ltd. Hyderabad cry1Ac Pravardhan Seeds Pvt. Ltd Hyderabad cry1Ac Proagro Seeds Co. Ltd Hyderabad cry1Ac Rasi Seeds Ltd., Attur cryX
Syngenta India Ltd., Pune Vip-3A Tulsi Seeds, Guntur cry1Ac, cryX UAS, Dharwad cry1Ac Vibha Agrotech Ltd. Hyderabad cry1Ac
Vikki’s Agrotech, Hyderabad cry1Ac Vikram Seeds Ltd, Ahmedabad cry1Ac Zuari Seeds Ltd. Bangalore GFM cry1Aa 6. Groundnut ICRISAT, Hyderabad Coat protein of IPCV
Nucleo Capsid Protein of PBNV 7. Mustard UDSC, New Delhi barnase & barstar 8. Okra Mahyco, Mumbai cry1Ac,
9. Pigeonpea ICRISAT, Hyderabad cry1Ac, 10. Rice IARI, New Delhi cry1Ac, cry1Aa + cry1B
Mahyco, Mumbai cry1Ac Metahelix Life Sciences, Bangalore NHX gene
11. Tomato IARI, New Delhi antisense replicase gene of
tomoto leaf curl virus Mahyco, Mumbai cry1Ac Source: Department of Biotechnology, Government of India
12
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
1. Ajeet Seeds, Aurangabad
2. Ankur Seeds P. Ltd., Nagpur
3. Bioseed Research India Pvt Ltd, Hyd
4. Emergent Genetics India P. Ltd, Hyd
5. Ganga Kaveri Seeds Ltd, Hyderabad
6. Green Gold Seeds Ltd, Aurangabad
7. JK Agri Genetics, Hyderabad
8. Kaveri Seeds Co. P. Ltd, S’bad
9. Krishidhan Seeds, Jalna
10. Mahyco, Mumbai
11. Metahelix Life Sciences, Bangalore
12. Monsanto, Mumbai
13
13. Namdhari Seeds Pvt. Ltd, Bangalore
14. Nandi Seeds Pvt. Ltd Mehbubnagar
15. Nath Seeds, Aurangabad
16. Nuziveedu Seeds, Hyderabad
17. Prabhat Agri Biotech Ltd. Hyderabad
18. Pravardhan Seeds Pvt. Ltd Hyderabad
19. Proagro Seeds Co. Ltd Hyderabad
20. Rasi Seeds Ltd., Attur
21. Sungro Seeds Ltd, New Delhi
22. Syngenta India Ltd., Pune
23. Tulsi Seeds, Guntur
24. Vibha Agrotech Ltd. Hyderabad
25. Vikki’s Agrotech, Hyderabad
26. Vikram Seeds Ltd, Ahmedabad
27. Zuari Seeds Ltd. Bangalore
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
environment include impact of introduced traits introgressing into other related
species through out crossing, the potential buildup of resistance in insect
populations, effect on biodiversity and unintended effects on non-targeted
organisms.
These apprehensions arise because rDNA technology crosses the species
barrier as compared to classical selection techniques, thereby permitting the gene
transfer among microorganisms, plants and animals. The concerns associated with
use of GMOs/LMOs can differ greatly depending on the particular gene-organism
combination and therefore a case-by-case approach is required for risk assessment
and management.
These biosafety concerns have led to the development of regulatory regimes
in various countries for testing, safe use and handling of GMOs/LMOs and products
thereof. An overview of the regulatory framework in India governing GMOs/LMOs
and their applications in agriculture and food is given below:
4.1 GOVERNMENT RULES FOR GMOs:
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). These rules and regulations,
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. Recombinant DNA Advisory Committee (RDAC)
ii. Review Committee on Genetic Manipulation (RCGM)
iii. Genetic Engineering Approval Committee (GEAC)
iv. Institutional Biosafety Committees (IBSC)
v. State Biosafety Coordination Committees (SBCC)
vi. District Level Committees (DLC).
(i) The Recombinant DNA Advisory Committee (RDAC): This committee
constituted by the Department of Biotechnology takes note of developments in
biotechnology at national and international levels. The RDAC prepares
recommendations from time to time that are suitable for implementation for
upholding the safety regulations in research and applications of GMOs and
products thereof. This Committee prepared the Recombinant DNA Biosafety
Guidelines in 1990, which was adopted by the Government for conducting
research and handling of GMOs in India.
(ii) Institutional Biosafety Committee (IBSC): It is necessary that every institution
intending to carry out research activities involving genetic manipulation of
microorganisms, plants or animals should constitute the IBSC. All the IBSCs
have to induct one DBT nominee. The IBSC is the nodal point for interaction
within the institution for implementation of the guidelines. The main activities of
IBSCs are:
• To note and to approve r-DNA work.
• To ensure adherence of r-DNA safety guidelines of government.
• To prepare emergency plan according to guidelines.
• To recommend to RCGM about category III risk or above experiments and to
seek RCGM’s approval.
• To inform DLC and SBCC as well as GEAC about the experiments where
ever needed.
15
• To act as nodal point for interaction with statutory bodies.
• To ensure experimentation at designated location, taking into account
approved protocols.
(iii) Review Committee on Genetic Manipulation (RCGM): The RCGM under the
Department of Biotechnology has the following functions:
• To bring out manuals of guidelines specifying producers for regulatory
process on GMOs in research, use and applications including industry with a
view to ensure environmental safety.
• 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 authorize imports of GMOs/ transgenes for research purposes.
• To authorize field experiments in 20 acres in multi-locations in one crop
season with up to one acre at one site.
• To generate relevant data on transgenic materials in appropriate systems.
• To undertake visits of sites of experimental facilities periodically, where
projects with biohazard potentials are being pursued and also at a time prior
to the commencement of the activity to ensure that adequate safety measures
are taken as per the guidelines.
(iv) Genetic Engineering Approval Committee (GEAC): Genetic Engineering
Approval Committee (GEAC) functions as a body under the Ministry of
Environment and Forests and is responsible for approval of activities involving
large scale use of hazardous microorganisms and recombinant products in
research and industrial production from the environment angle.
• 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.
• To authorize large scale production and release of GMOs and products
16
thereof into the environment.
• To authorize agencies or persons to have powers to take punitive actions
under the EPA.
(v) State Biotechnology Coordination Committee (SBCC): This Committee,
headed by the Chief Secretary of the State is constituted in each state where
research and applications of GMOs are contemplated. It has:
• Powers to inspect, investigate and to take punitive action in case of violations
of statutory provisions through the State Pollution Control Board or the
Directorate of Health etc.
• To review periodically the safety and control measures in various institutions
handling GMOs.
• 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. This committee also nominates State Government
representatives in the activities requiring field inspection of activities
concerning GMOs.
(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:
• To monitor the safety regulations in installations.
• 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
In addition, Monitoring and Evaluation Committee set up by RCGM visits field
trial sites and recommends safe and agronomically viable transgenic crops to
RCGM/GEAC.
The notification orders compliance of the safeguards through voluntary as well
as regulatory approach and any violation and non compliance including non-
reporting of the activity in this area would attract punitive actions provided under the
EPA.
The approvals and prohibitions under Rules 1989 are summarized below:
• No person shall import, export, transport, manufacture, process, use or
sell any GMOs, substances or cells except with the approval of the GEAC.
• Use of pathogenic organisms or GMOs or cells for research purpose shall
be allowed under the Notification, 1989 of the EPA, 1986.
• Any person operating or using GMOs for scale up or pilot operations shall
have to obtain permission from GEAC.
• For purpose of education, experiments on GMOs IBSC can look after, as
per the guidelines of the Government of India.
• Deliberate or unintentional release of GMOs not allowed.
• Production in which GMOs are generated or used shall not be commenced
except with the approval of GEAC
• GEAC supervises the implementation of rules and guidelines.
• GEAC carries out supervision through SBCC, DLC or any authorized
person.
• If orders are not complied, SBCC/DLC may take suitable measures at the
expenses of the person who is responsible.
• In case of immediate interventions to prevent any damage, SBCC and
DLC can take suitable measures and the expenses incurred will be
recovered from the person responsible.
• All approvals shall be for a period of 4 years at first instance renewable for
2 years at a time.
• GEAC shall have powers to revoke approvals in case of:
18
i. Any new information on harmful effects of GMOs. ii. GMOs cause such damage to the environment as could not be
envisaged when approval was given. iii. Non-compliance of any conditions stipulated by GEAC.
To summarize, under Rules, 1989, the three committees involved in approval
of new transgenic crops are IBSC, RCGM and GEAC and SBCC and DLC have
monitoring functions. The procedures involved in the approval of GM crops in India
are summarized in the following flow chart:
Applicant
IBSC functions To note, approve, recommend & to seek approval of RCGM
IBSC
RCGM
GEAC
RCGM functions
To note, approve, recommendgeneration of appropriatebiosafety & agronomic data
MEC functions Visit trial sites, analyze data, inspect facilities, recommend safe and agronomically viable transgenics to RCGM/GEAC
MEC
GEAC functions: To approve for large scale use, open release in to environment
ICAR Trials To generate complete agronomic data and to recommend for commercial release of GM crops
ICAR
To inform decision to Ministry of Agriculture & to inform applicants to follow the relevant Acts and Rules
Seeds Act/ Rules
Release for commercial agriculture
Source: Department of Biotechnology
4.2 RECOMBINANT DNA GUIDELINES, 1990:
With the advancement of research work initiated in biotechnology in the
country by various Indian institutions and industry, Department of Biotechnology had
formulated Recombinant DNA Guidelines in 1990. These guidelines were further
revised in 1994. These revised guidelines included guidelines for R&D activities on
GMOs, transgenic crops, large-scale production and deliberate release of GMOs,
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, equipment and facilities necessary for safeguards in handling organisms,
plants and animals in various risk groups have been recommended. The guidelines
employ the concept of physical and biological containment and the principle of good
laboratory practices. For containment facilities and biosafety practices,
recommendations in the WHO laboratory safety manual on genetic engineering
techniques involving microorganisms of different risk groups have been incorporated
therein.
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-to-
case basis.
20
4.3 GUIDELINES FOR RESEARCH IN TRANSGENIC PLANTS, 1998:
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.
These guidelines cover areas of recombinant DNA research on plants
including the development of transgenic plants and their growth in soil for molecular
and field evaluation. The guidelines also deal with import and shipment of genetically
modified plants of research use.
To monitor over a period of time, the impact of transgenic plants on the
environment, a special Monitoring cum Evaluation Committee (MEC) has been set
up by the RCGM. The committee undertakes field visits at the experimental sites
and suggests remedial measures to adjust the trial design, if required, based on the
on-the-spot situation. This committee also collects and reviews the information on
the comparative agronomic advantages of the transgenic plants and advises the
RCGM on the risks and benefits from the use of transgenic plants put into
evaluation.
The guidelines include complete design of a contained green house suitable
for conducting research with transgenic plants. Besides, it provides the basis for
generating food safety information on transgenic plants and plant parts.
4.4 SEED POLICY, 2002:
In the Seed Policy, 2002, there is a separate section (No. 6) on transgenic
plant varieties. It has been stated that all genetically engineered crops/varieties will
be tested for environment and biosafety before their commercial release as per the
regulations and guidelines of the EPA, 1986. Seeds of transgenic plant varieties for
research purposes will be imported only through the National Bureau of Plant
Genetic Resources (NBPGR) as per the EPA, 1986. Transgenic crops/varieties will
be tested to determine their agronomic value for at least two seasons under the All
21
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. After the transgenic plant variety is
commercially released, its seed will be registered and marketed in the country as per
the provisions of the Seeds Act. After commercial release of a transgenic plant
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 PREVENTION OF FOOD ADULTERATION ACT:
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 consumer’s 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 Ministry of Health and Family Welfare (MOH&FW) in the Central
Government is the nodal Ministry for ensuring the quality and safety of food
marketed in the country. A comprehensive legislation called the Prevention of Food
Adulteration Act (PFA Act) has been enacted in 1954, which came into effect from
June 1, 1955, with the objective of assuring the quality and safety of food as well as
to encourage fair trade practices.
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
Director General of Health Services
PFA Cell
State/ Governments/
UTs
Central Committee
for Food Standards and
its Sub-Committees
for Framing of Rules/
Standards of food Articles
National Monitoring Agency for Irradiation
of Food
Coordination with National
and International
Organizations/ Consumer
Organizations/ Industries
Central Food
Laboratories (4)
National Codex
Committee and its
Shadow Committees
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:
Enhance the availability of safe and wholesome food.
Consumer protection from deception, fraud and food-borne diseases.
Risk analysis, risk management and risk communication.
Ensure safety of genetically modified food.
23
Enhance the involvement of NGOs and Home Science Institutes.
Educational authorities to ensure better consumer protection.
Promote a voluntary management system, the Code of Ethics, through principles
of GMPs and the HACCP.
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.
Regarding inspection and certification procedures for imported food, Section 5
of the PFA Act, 1954, prohibits the import of the following articles of food:
Food which is adulterated.
Food which is misbranded.
Food which contravenes any other provision of the PFA Act or any Rule.
The important provisions which are required to be followed essentially while
importing/clearing the food products are:
Authorized officers to check the imported food products.
Section 6 of the PFA Act, 1954, authorizes the custom collector to check the
imported food products.
The authorized officer, on suspicion, may detain any imported food product.
He will send the samples of the detained product to the Central Food Laboratory
for analysis.
Imported food is inspected at the ports of entry by personnel of the
Collectorate of Customs. If necessary, samples are further tested in the laboratories
designated/notified for this purpose by the Ministry of Health and Family Welfare to
24
verify the compliance with the requirements stipulated under the PFA Act, 1954 and
Rules.
With a view to streamline the checking of imported food products, the
Government of India has issued various instructions from time-to-time. Various
departments of the Government of India, including Health, Revenue, Commerce and
the Directorate General of Foreign Trade, have initiated several steps to streamline
the checking of imported food.
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 FOOD SAFETY AND STANDARDS BILL, 2005
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.
It will formulate mechanisms and guidelines for the accreditation of bodies
engaged in the certification of a food safety management system for the food
business. It will also set up food labelling standards, including claims on health,
nutrition and special dietary uses. The Bill seeks to regulate nutraceuticals and
dietary supplements. It has stressed on proper labelling and has said that
information should not be misleading. Imposing restrictions on advertising, it
specifies, "No advertisement shall be made of any food, which is misleading or
contravenous to the provisions of this Act." The Bill has imposed safeguards on
imports of food products. No person shall be allowed to import unsafe, misbranded
or sub-standard food and importing would require a licence. Stringent penalties have
also been proposed in the Bill.
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.
There is a provision for a separate scientific panel on genetically modified
organisms. As per the provisions of the Bill, no person shall manufacture, process,
26
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.
Various Acts/Orders which would stand repealed on commencement of this
Act, include the Prevention of Food Adulteration and sections relating to food under
the Environmental (Protection) Act, 1986 and the Environment Protection Rules,
1989.
4.7 PLANT QUARANTINE ORDER 2003
The provisions of Plant Quarantine (Regulation of Import into India) Order
2003, which came into force from April 1, 2004, are also applicable to import of
transgenic seeds. The issuance of import permit of transgenic material is extremely
important from the point of view of their potential impact on environment and on
agriculture in the country. National Bureau of Plant Genetic Resources (NBPGR)
has been designated as the competent authority to issue import permits for import of
seeds by public and private sector agencies for research purposes after getting
permission from DBT and MoEF as the case may be under 1989 Rules.
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
• No transgenic material is permitted for experimentation in open environment
without prior authorisation from the Government of India.
• 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 transgenic materials prescribed by he indentors may be available for
inspection, whenever required.
• 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.
The second mandatory requirement is that of Phytosanitary Certificate which
is to be issued by the National Plant Protection Agency of the donor country.
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
materials. All assembled healthy plant material is regularly transmitted to various
4.8
n illustrative list of
specific targets/traits has been included in the report that can be further
revised
tocol, feeding of
GM foods to livestock, use of livestock products from animals fed with GM foods,
extens
to ensure that the concerns of
researchers to make use of these valuable genetic resources.
TASK FORCE ON APPLICATION OF AGRICULTURAL BIOTECHNOLOGY:
Ministry of Agriculture had set up a task force under the chairmanship of
Prof. M.S. Swaminathan, Chairman, MSSRF to formulate a draft long-term policy on
applications of biotechnology in agriculture and suggest modifications in the existing
administrative and procedural arrangements for the approval of GM crops. The
report has covered issues related to biotechnology applications in agriculture, animal
husbandry and fishery sectors. It has been suggested that transgenic approach
should be considered as complimentary and resorted to when other options to
achieve the desired objectives are either not available or not feasible. There is a
need to priortise and reorient research programmes relating to transgenic research
in crops, animals and fishes as per the national requirements. A
/expanded on the basis of national and international data
The task force has suggested setting up of National Biotechnology Regulatory
Authority, a statutory and autonomous body with two wings -one for agricultural and
food biotechnology and the other for medical and pharmaceutical biotechnology. The
report has underlined the need for clear-cut policy, guidelines and protocols for
various GM products and their uses such as national food safety pro
ive biosafety guidelines for transgenic animals and fish etc.
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
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 well-
informed members of the public. An information campaign needs to be conducted to
generate public awareness on the benefits and risks associated with biotechnology
organizations/institutions/ universities/NGOs
asp
plant breeding and the need for
• traints of agricultural biotechnology
ulatory bodies before allowing release of GM crops.
Community and Farmers’ Rights and benefit sharing related to agro-
bio
h effective involvement of State Level and District Level Coordination
ommittees of the existing transgenic biosafety evaluation and management
mechanism.
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
may be sought to generate public awareness in the country on the following specific
ects of agricultural biotechnology:
• Concept of plant breeding, pressures on modern
novel genetic enhancement strategies
• Introduction to genetic engineering technology
The benefits, risks and cons
• Current status of national and global GM crops and other biotechnological
applications in agriculture
• Risk assessment procedures (regulatory mechanisms) for environmental and
food safety, and related legislations
• Social, economic, ethical, scientific, environmental and health issues which are
addressed by reg
• Current GM products under evaluation in India under biosafety, VCU and other
regulatory trials
•
technological applications
Post-release monitoring and management of GM crops and their products,
such as insect resistance management, transgene stability at the farm level, use of
transgenic diagnostic kits, and maintenance of transgenic seed quality, should be
organized wit
C
30
4.9 DRAFT NATIONAL ENVIRONMENT POLICY, 2004:
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 Bio-
safety Protocol.
The policy lays major emphasis on environmental awareness, education and
information which is essential not only to harmonize patterns of individual behaviour
with the requirements of environmental conservation but would also minimize the
demands placed on the monitoring and enforcement regimes; in fact, large-scale
non-compliance would simply overwhelm any feasible regulatory machinery.
The suggested actions would include mainstreaming scientifically valid
environment content in the curricula of formal education, at primary, secondary,
tertiary, and professional levels, focusing on the content appropriate at each stage,
and without increasing the course load overall. Special mid-career training
programmes may be conducted for groups with special responsibilities, e.g. the
judiciary, policy makers, legislators, industrial managers, city and regional planners,
voluntary and community based organizations, etc. It is proposed to prepare and
implement a strategy for enhancing environmental awareness among the general
public, and special groups, by professional production and airing of information
products through diverse media catering to the different target groups. The
production, as well as dissemination may involve public, private, and voluntary
agencies.
31
4.10 DRAFT NATIONAL BIOTECHNOLOGY STRATEGY 2005
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.
Choices are required to be made that reflect an adequate balance between
benefit, safety, access and the interest of consumers and farmers. It is also
important that biotechnology products that are required for social and economic good
are produced speedily and at the lowest cost. It stresses on a scientific, rigorous,
transparent, efficient, predictable, and consistent regulatory mechanism for biosafety
evaluation and release system/protocol for achieving these multiple goals. Strategic
actions include the implementation.
(i) It is proposed to set up an inter-ministerial group chaired by a reputed
scientist to address anomalies and issues that arise in regulation from time to
time. The mandate of the committee should be to vet any changes in policies,
procedures, protocols by departments dealing with regulation in biotech
products and processes; resolve issues emanating from the
overlapping/conflicting rules in various acts related to regulation of
biotechnology activities in research and development, import, export, releases
etc. and to review guidelines, protocols, standard operating procedures and
ensure their dissemination to all stakeholders from time to time
(ii) It is proposed to establish a competent single National Biotechnology
Regulatory Authority with separate divisions for agriculture
products/transgenic crops, pharmaceuticals/drugs and industrial products;
and transgenic food/feed and transgenic animals/aqua culture. The authority
is to be governed by an independent administrative structure with common
chairman. The inter-ministerial group will evolve suitable proposals for
consideration of the government.
32
(iii) A centre for in-service training of all professionals, irrespective of their
location, engaged in the regulatory process to be established by the
Department of Biotechnology in close collaboration with other concerned
departments and institutions.
(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) As an interim measure, a special regulatory cell will be created by the DBT to
build capacity in the country for scientific risk assessment, monitoring and
management, to foster international linkages, support biosafety research; to
obtain and review feedback from different stakeholders and provide support to
industry and R&D institutions. This cell will only have a promotional and
catalytic role
Regarding public communication and participation proposed strategic actions
include providing credible information based on scientific data, training media
personnel through Institutes of Mass Communication, colleges of journalism and
others and capacity building among extension personnel in agricultural, fisheries,
veterinary and medical sectors.
Involvement of Panchayati Raj institutions in the process of analysis and
understanding the risks and benefits associated with GMOs has been suggested as
they will be playing an important role in the local level management of bio-diversity,
access to benefit sharing etc.
33
Awareness generation among undergraduate and post-graduate students in
universities, colleges etc on issues related to biosafety and promoting a genetic
literacy movement within government and public schools through 50 genome club
nature clubs each year are some of other recommendations.
It has been proposed to create a media resource network to facilitate access
to information and empower policy makers by participation in regular training
programs.
34
CHAPTER 5 CARTAGENA PROTOCOL ON BIOSAFETY
5.1 INTRODUCTION:
Cartagena Protocol on Biosafety is an attempt to produce a globally
harmonized regime for biosafety under the Convention of Biological Diversity (CBD).
The objectives of the 1992 Convention on Biological Diversity are "the conservation
of biological diversity, the sustainable use of its components and the fair and
equitable sharing of the benefits arising out of the utilization of genetic resources".
When developing the Convention, the negotiators recognized that biotechnology can
make a contribution towards achieving the objectives of the Convention, if developed
and used with adequate safety measures for the environment and human health.
The Contracting Parties agreed to consider the need to develop appropriate
procedures to address the safe transfer, handling and use of any Living Modified
Organism (LMO) resulting from biotechnology that may have adverse effect on the
conservation and sustainable use of biological diversity (Article 19.3 of the CBD).
The Biosafety Protocol is the result of that process.
The full name of the Biosafety Protocol is "the Cartagena Protocol on
Biosafety to the Convention on Biological Diversity." Cartagena is the name of the
city in Colombia where the Biosafety Protocol was originally scheduled to be
concluded and adopted in February 1999. However, due to a number of outstanding
issues, the Protocol was finalized and adopted a year later on 29 January 2000 in
Montreal, Canada. The protocol entered into force on September 11, 2003. As on
date 130 countries largely comprising of developing countries, have ratified the
protocol. India ratified the protocol in January 2003. The full text of the protocol, list
of parties to the protocol and related information is available on the website
www.biodiv.org.
35
5.2 OBJECTIVE:
The objective of the Protocol is to contribute to ensuring an adequate level of
protection in the field of the safe transfer, handling and use of LMOs resulting from
modern biotechnology that may have adverse effects on the conservation and
sustainable use of biological diversity, taking also into account risks to human health,
and specifically focusing on transboundary movements.
5.3 ELEMENTS OF THE PROTOCOL:
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.
Various elements of the protocol that merit attention are:
(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
feed or for processing (such as corn or tomatoes). However, a country may,
under its domestic regulatory framework, and consistent with the objective of the
Protocol, decide to subject such GMOs
(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
appropriate action. Governments must establish official contact points for
emergencies as a way of improving international coordination.
(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
natural relatives. The Protocol promotes international cooperation to help
developing countries and countries with economies in transition to build human
resources and institutional capacity in biosafety. Parties are encouraged to assist
with scientific and technical training and to promote the transfer of technology,
know-how, and financial resources. Parties are also expected to facilitate private
sector involvement in capacity building. Biosafety activities under the Cartagena
Protocol are eligible for support from the Global Environment Facility – an
international fund that was established to help developing countries protect the
global environment.
(h) Public awareness and participation: It is clearly important that individual
citizens understand and are involved in national decisions on GMOs. The
Protocol therefore calls for cooperation on promoting public awareness of the
safe transfer, handling and use of GMOs. It specifically highlights the need for
education, which will increasingly have to address GMOs as biotechnology
becomes more and more a part of our lives. The Protocol also calls for the public
to be actively consulted on GMOs and biosafety. Individuals, communities and
non-governmental organizations should remain fully engaged in this complex
issue. This will enable people to contribute to the final decisions taken by
governments, thus promoting transparency and informed decision-making.
(i) Issue of non-Parties: The Protocol addresses the obligations of Parties in
relation to the transboundary movements of LMOs to and from non-Parties to the
Protocol. The transboundary movements between Parties and non-Parties must
be carried out in a manner that is consistent with the objective of the Protocol.
Parties are required to encourage non-Parties to adhere to the Protocol and to
contribute information to the Biosafety Clearing-House.
5.4 STATUS OF IMPLEMENTATION IN INDIA:
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
regulatory framework and human resources to ensure effective implementation of
the protocol and meet the international obligations. Table 5.1 describes the present
status of compliance and the capacity building needs with respect to the provision of
Cartagena Protocol in India.
Table 5.1 Present status of compliance and capacity building needs for various provisions of
the Cartagena Protocol
Article Provisions Present Status Capacity Building Needs Stakeholders Article 7 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
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
Customs and border control procedures mainly for import/export of LMOs for food, feed and processing, documentation and inspection systems for LMO shipments, development of methods and systems of identification of LMOs.
Scientists, regulators, customs and border control officials, traders (importers, exporters), food/feed processing industry,
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
Rules 1989 and competent authorities in place.
Harmonization of rules with the requirements of protocol. Incorporating the information requirements for regulating status of LMOs/GMOs in the documentation for export/import Training customs/port officials such as plant quarantine, etc. to review the information requirements
Regulators, border control officials, industry, importers/ exporters
Article 9 Acknowledgement of receipt of notification-The Party of import shall acknowledge receipt of the notification, in writing to the notifier
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)
Article 10
Decision Procedure- Decision taken by the Party of import shall be in accordance with Article 15
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 and associated scientists, IT managers
40
Article Provisions Present Status Capacity Building Needs Stakeholders Article 11
Procedure for LMOs intended for direct use as food or feed, or for processing
1989 Rules, procedures to be detailed
Capacity building for methods and systems of detection of LMOs
Regulators, officers from concerned ministries i.e. Ministry of Health, Ministry of Commerce etc. Importers/traders, researchers and technicians
Article 13
Simplified Procedure to ensure the safe intentional transboundary movement of LMOs
1989 rules - -
Article 14
Bilateral, regional and multilateral agreements and arrangements
-
Regional harmonization of biosafety-related sectoral laws/policies and with other international agreements such as WTO, IPPC.
-
Article 15
Risk assessment DBT Guidelines for research in plants
Laws/guidelines/policies to be developed for GM food/feed and products thereof. Environmental risk assessment procedures to be streamlined including the baseline information.
Policy makers, regulators, scientists, industry
Article 16
Risk management DBT Guidelines for research
Laws/guidelines to be developed particularly for food/feed crops, harmonization with the existing procedures.
Policy makers, regulators, scientists, industry
Article 17
Unintentional transboundary movements and emergency measures
1989 rules
Detection, testing and quantitative analysis of LMOs, Border control and inspection facilities, development of emergency plans.
Scientists, technicians and custom and port officials
Article 18
Handling, transport, packaging and identification
Detailed guidelines to be developed
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
Scientists, technicians and custom and port officials
Article 19
Competent National Authorities and National Focal Points
MoEF designated as Competent National Authorities and National Focal Point
- -
41
Article Provisions Present Status Capacity Building Needs Stakeholders Article 20
Information sharing and the Biosafety Clearing House
Biosafety Clearing House (BCH) set. A separate website on capacity building activities by MoEF
Web based databases, Non-internet based electronic exchange material (e.g. CD ROMs, etc.), publications and documents, handbooks, newsletters etc.
IT managers, scientists
Article 21
Confidential Information
Harmonization with Right to Information Act
Regulators
Article 22
Capacity building Ongoing including GEF-World Bank funded Capacity Building Project
Institutional capacity building (including national regulatory frameworks), Human resources development and training, Public awareness, education and participation, Information exchange and data management
All stakeholders including interest groups such as farmers, consumers, industry associations.
Article 23
Public awareness and participation
Ongoing including GEF-World Bank funded Capacity Building Project
Biosafety awareness activities (workshops, seminars, training programmes, etc.) and materials (newsletter, bulletins, newspapers, etc.), Risk communication skills and strategies
All stakeholders
Article 24
Non-Parties (transboundary movements of LMOs between Parties and non-Parties)
1989 rules in place for all import and export
Article 25
Illegal transboundary movements
Methods and mechanisms for detecting unintentional or illegal LMO movement, Border control and inspection facilities, compliance mechanisms to be strengthened.
Article 26
Socio-economic considerations
Socioeconomic analysis is an integral part of decision making
Mechanism for determining value-added to specific socio-economic groups/sectors, Mechanism and competence to review case-by-case cost benefit analysis
Regulators, economists, NGOs, social groups
Article 27
Liability and redress National Consultation initiated and ongoing
Deliberations on approach for the negotiations for liability and redress regime for transboundary movement of LMOs.
Regulators, legal experts particularly on international law.
42
5.5 OTHER INTERNATIONAL AGREEMENTS:
Although the Cartagena Protocol on Biosafety is the only international
instrument that deals exclusively with LMOs/GMOs, there are also a number of
separate international instruments and standards setting processes that address
various issues related to LMOs/GMOs. The Protocol states that its provisions are
intended neither to override nor to be subordinate to these existing international
agreements. A brief overview of these agreements is as follows:
• The International Plant Protection Convention (IPPC), which protects plant
health by assessing and managing the risks of plant pests. The IPPC is in the
process of setting standards to address the plant pest risks associated with
GMOs and invasive species. Any GMO that could be considered a plant pest
falls within the scope of this treaty. The IPPC allows governments to take action
to prevent the introduction and spread of such pests. It also establishes
procedures for analysing pest risks, including impacts on natural vegetation.
• The Codex Alimentarius Commission, which addresses food safety and
consumer health. The Commission has established an ad hoc Intergovernmental
Task Force on Foods Derived from Biotechnologies that is responsible for
developing standards and guidelines for genetically modified foods. The
Commission is also considering the issue of labeling biotech foods to allow the
consumer to make an informed choice.
• 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. The mandatory labeling of LMOs-FFPs under the
Protocol may also be in conflict with the WTO rules.
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
commercialization through regulatory steps requires varied facilities and expertise. It
is extremely important to have proficiency in the techniques for development of
GMOs/LMOs by both public and private sector organizations. The molecular biology
skills involve isolation of genes, preparation of construct along with development of
right cloning strategies. Capacities to discover genes by the production of cDNA
library, genomics library, bioinformatics alongwith capabilities to sequence natural
polymeric DNA pieces are extremely important. Transformation and isolation of
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
Although, many of these institutes are equipped with instruments and
equipments, it is generally felt that there is a need to strengthen capabilities from
gene isolation to preparation of the desirable constructs, efficient transformation and
ability to assess at each stage the extent of transgenic traits and associated
biosafety evaluation. Considerable training and cooperation in multidisciplinary
facets is required for development of products on a stand-alone basis by these
institutions as well as other institutions engaged in development of GMOs/LMOs. It
may be noted that these capabilities would also help in assessment of technologies
transferred from foreign institutions and their adaptation in Indian conditions.
Keeping in view the above, the following areas were listed for seeking
feedback from the stakeholders under the section on development of GMOs/LMOs.
• 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
6.2 RISK ASSESSMENT:
Risk assessment of GMOs/LMOs is a scientific process that makes use of the
best up-do-date scientific knowledge and experience. The assessment of the risk is
sequential and takes into account systematically the degree of danger multiplied by
probability at all steps. There is obviously no risk involved if there is no danger
inherent in an experiment/product. However, there is also no risk if the theoretical
consequences of an experiment are very dangerous but there is a zero probability. It
has been generally accepted that the details of risk assessment may vary from case
to case but there are few steps that need to be followed. These are:
i) Identification of potential adverse effects on human health and/or environment.
ii) An estimation of likelihood of these adverse effects being realized.
46
iii) An evaluation of the identified risks.
iv) Considerations of appropriate risk management strategies.
v) Assessment of the overall potential environmental impact, including a
consideration of the potential impacts that may be beneficial to human health or
the environment.
The methodology of risk assessment of GMOs generally cover the
characteristics of the organisms, effects on pathogenicity, toxigenicity, allergenicity
etc., substantial equivalence, effects related to gene transfer and marker gene and
ecological facts. Assessment of risks from the GMOs includes deeper understanding
of the behaviour of the GM microorganisms, plants and animals and therefore
requires a range of expertise from different discipline depending on the type of the
product. Environmental risk assessment capacities include study of extent of pollen
flow, implications of out crossing/ cross fertilization, the aggressiveness
characteristics of LMOs, susceptibility to diseases and pests, stability of the
transgenic genome, germination rates, resistance to abiotic stresses etc. Food safety
evaluation includes capabilities of determination of composition and assessment of
the quality of LMOs, compositional analysis and near equivalent studies of major
ingredients to assess substantial equivalence, impact on human health. It also
involves capacity to assess an LMO in terms of a component as well as a whole food
an approach distinct from risk assessment for conventional foods. For environmental
risk assessment and evaluation of food safety, a series of protocols are to be
developed, including post-marketing monitoring to address specific safety issues. In
case of food safety assessment, there is also a need to build infrastructure with
respect to assess the impact of LMOs on human health due to changes in key
nutrients or nutrients intake levels, detect the LMOs in the food chain, establish
network for inspection, right from the stage of import/development/ marketing
(monitoring and enforcement capacity), establish proper traceability, including
appropriate segregation and establish laboratory set up including appropriate
equipment/chemicals.
A detailed knowledge about essential elements of the risk assessment
process of the product is also required for the regulators. Detailed guidelines need
to be in place for risk assessment of GMOs developed in country or imported.
47
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:
• 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
6.3 RISK MANAGEMENT:
Risk management is the use or application of procedures and means to
reduce the negative consequences of a risk to an acceptable manner. Proper
handling and use of various preventive measures can limit the risk. In fact, the risk
management options are part of the process of developing and assessing the
GMOs. There has also been considerable focus on the monitoring to follow the fate
of GMOs and the transgene they carry and to be vigilant about the unanticipated
consequences. Monitoring programmes are classified corresponding to process
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:
• 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
48
6.4 REGULATORY CAPACITY BUILDING:
As mentioned earlier, India has a well-defined regulatory framework in place.
The apex committees at the central level for taking decisions are functioning
regularly. However, there is a need to develop more effective mechanism for
implementation of decisions. To assist the committees in the process of decision-
making, referral laboratories/institutions need to be established/notified for risk
assessment analysis and feedback on various parameters. Several important issues
like labeling, liability and redress, etc. need to be discussed at national level and
incorporated appropriately in the regulatory framework. Regular updating of
guidelines is also extremely important.
Further the regulators have to meet the challenges of biosafety, particularly, in
the context of the transboundary movement of LMOs covered in the Cartagena
Protocol. India has legal framework and expertise to deal with the transboundary
movements of seeds and plant materials for research purpose. National Bureau of
Plant Genetic Resources (NBPGR) is the nodal agency for import and export of seed
and planting material for use of plant breeders, researchers and other users in India
and abroad. The bureau has been engaged in import and export of such material,
undertaking their quarantine clearance and distribution of pest free germplasm to
user scientists. For the GMOs/LMOs and products thereof, the authorities to give
approval have also been notified. However, the national quarantine system needs to
be geared up for dealing with GMOs/LMOs and products thereof with respect to both
the infrastructure and trained manpower.
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
(i) Legislative and regulatory framework
• Strengthening of legal frameworks
• Compliance mechanisms
• Harmonization of biosafety-related 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
(ii) Administrative framework
• 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 socio-economic 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
(iii) Technical, scientific infrastructures and mechanism for follow-up
• Border control and inspection facilities
• Database infrastructure and protocols
• LMO* containment (quarantine) facilities
• LMO disposal facilities (e.g. incinerators)
• LMO testing laboratories and equipment
• Long-term LMO monitoring and surveillance
• Methods and mechanisms for detecting unintentional or illegal LMO
movement
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
transboundary shipments of LMOs. These documents identifying the LMOs and
providing contact details of persons responsible for such movement are expected to
provide a means to identify and track transboundary movements of LMOs, give
information to the party of import at the border and offer a contact point for further
information.
Some details of handling and packaging of GMOs are covered in
Recombinant Safety Guidelines, 1990. Projects on development of identification and
validation of kits have also been initiated by DBT. More attention needs to be given
in these areas for implementing the provisions of Cartagena Protocol particularly
when more and more GMOs/LMOs are being approved across the world. The areas
for which feedback was sought from the stakeholders are as follows:
• Documentation systems for LMOs shipments
• Guidelines for safe handling, packaging and transport of LMO shipments
• Inspection systems for LMO shipments
• Methods and systems for identification of LMOs e.g. unique identification systems
• Systems for segregation of LMOs
6.6 HUMAN RESOURCES DEVELOPMENT AND TRAINING:
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
Training of technical personnel is also essential for efficient biotechnological
developments. The trained personnel should have the complete capabilities from
gene isolation, preparation of desirable constructs, abilities to transform the hosts
efficiently, competence in transforming the transformed material into plants and
abilities to assess at each stage in the extent of transgenic trait.
There is also a need to have trained legal experts, administrators and
professionals, particularly in the areas of legislation and regulatory affairs, biosafety,
risk 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. Some of the specific areas on which training
need assessment has been attempted are as follows:
• 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 socio-economic considerations
• Assessment of trade impacts of biosafety-related measures
• Legal drafting and analysis
• Support for case-by-case 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
6.7 PUBLIC AWARENESS, EDUCATION AND PARTICIPATION:
Public opinion about GMOs/LMOs is sometimes affected by misperception of
risks fueled by insufficient or inaccurate information. More fully informed opinions
can arise when people have a better and more realistic understanding of how GMOs
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. Article 23 of the Cartagena
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:
• Biosafety awareness activities (seminars, radio talks, etc.)
• Biosafety awareness materials (newsletter/ bulletin, newspaper, etc.)
• Media engagement skills and strategies
• Public access to the Biosafety Clearing-House (BCH)
• Public participation in decision-making
• Risk communication skills and strategies
• Timely public access to information on impending LMO imports
6.8 INFORMATION EXCHANGE & DATA MANAGEMENT:
To facilitate the exchange of scientific, technical, environmental and legal
information on, and experience with LMOs, a Biosafety Clearing House (BCH) has
been established. The BCH is an international information repository and uses
electronic and other systems for the exchange of information relevant to the
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. The assessment of training
needs is required for the following areas:
• Biosafety Clearing House (BCH)
• Web based databases
• Non internet based electronic exchange material (e.g. CD ROMs, fax, etc.)
• Sub-regional and regional node of the BCH
• Print media
6.9 SCIENTIFIC, TECHNICAL AND INSTITUTIONAL COLLABORATION:
The application of biotechnologies in agriculture are said to have far reaching
consequences particularly in developing countries, in terms of food security and
nutritional improvement. Although, the research and development of GMOs have
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.
Therefore it is important to have scientific, technical and institutional
collaborations among public and private sector at national, regional and international
level which can be achieved by capacity building in the following areas:
• 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
54
6.10 TECHNOLOGY TRANSFER:
Biotechnology being highly capital intensive, there is an urgent need to
facilitate transfer of priority proprietary technology to public and private institutions as
well as promote enterprise partnerships for development of technologies. The areas
that need attention are as follows:
• 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
6.11 SOCIO-ECONOMIC CONSIDERATIONS: The production and development of any technology is not an isolated
scientific activity but is influenced by the social, economic and political conditions.
Socio-economic considerations mean a broad spectrum of concerns about the actual
and potential consequences of GMOs, such as impacts on farmers’ incomes and
welfare, cultural practices, community well-being, traditional crops and varieties, rural
employment, trade and competition, the role of transnational corporations, food
security, ethics and religion, consumer benefits etc. The Cartagena Protocol on
Biosafety allows specifically for taking into account of socio economic considerations
in biosafety decision making but limits such considerations to those that arise from
the impact of LMOs from modern biotechnology on the conservation and sustainable
use of biodiversity. However, countries may wish to take into account additional
socio economic considerations in biosafety regulations based on their specific
requirements.
Keeping in view the above the following areas have been included in the
study which can help in examining the socioeconomic impacts.
55
• Mechanism for determining value-added to specific sector/industry
• Mechanism for determining value-added to specific socio-economic group
• Mechanism for review of case-by-case cost-benefit analysis
• Competence to review/analyze cost-benefit assumptions
• Public Access to information covering cost-benefit analyses
6.12 SUSTAINABLE USE AND CONSERVATION OF BIODIVERSITY:
India is a mega biodiverse country and conservation of biodiversity is a major
concern. For ensuring the sustainable use and conservation of biodiversity in the
light of approving the use of GMOs/LMOs in the country, the following areas have
been included in the questionnaire:
• Mechanism for mainstreaming biosafety in the environment and natural
resources sector
• Assessment of impact on non-target organism (above and below ground
organisms)
• Assessment of impact on wildlife populations and native species
• Potential for weediness or invasiveness
• Awareness training on laws and policies on environment and natural resources
• Impact of GMO on traditional farming systems
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. The number of respondents
under different categories are given below (Figure 7.1) and the list is placed in
Annex-2.
Figure 7.1: Stakeholders contacted through questionnaires/interaction
719
12
17
54
6
15
20Central government
State government
Regulatory committees
Industry
Research organizations
Social experts
Agriculture service providers
Others
A computerized software was developed to analyse the data and the findings
based on both quantitative and qualitative responses are as follows:
7.1 PRIORITY RANKING OF AREAS AND SUGGESTIONS FOR CAPACITY
BUILDING:
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
Figure 7.2: Priority ranking of areas for training
0
50
100
150
200
250
300
350
400
450
500R
isk
asse
ssm
ent
Ris
km
anag
emen
t
HR
D &
trai
ning
Reg
ulat
ory
capa
city
bui
ldin
g
Inst
itutio
nal
colla
bora
tion
Sus
tain
able
use
of b
iodi
vers
ity
Pub
licaw
aren
ess
Tech
nolo
gytra
nsfe
r
Iden
tific
atio
n
Info
rmat
ion
exch
ange
Soc
io-e
cono
mic
cons
ider
atio
ns
Dev
elop
men
t of
LMO
s/G
MO
s
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
Priority areas Stakeholders
1 2 3
Central and state government
Risk assessment and management
Human Resource Development
Regulatory capacity building
Regulatory bodies Risk assessment and management
Scientific, technical and institutional collaboration
Regulatory capacity building
Research organizations
Risk assessment and management
Human Resource Development
Regulatory capacity building
Industry Risk assessment and management
Public awareness Scientific, technical and institutional collaboration
Others (social experts, agriculture service providers etc.
Risk assessment and management
Regulatory capacity building
Public awareness, education and participation
58
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.
1. Risk assessment: The important elements of risk assessment as prioritized by
respondents are as given below:
Figure 7.3 Risk Assessment
0
50
100
150
200
250
RA scientificexpertise
ScientificMethods
Audit RiskAssessment
Access toreferencematerial
National RAframework
NationalBiosafetyResearch
In the prioritization by individual stakeholders, industry has listed scientific
methods and protocols for risk assessment as the first priority followed by
competence to review and audit risk assessments.
59
Majority of the respondents have indicated that risk assessment capabilities in
India are limited particularly among molecular biologists that are engaged in
development of GMOs. Those currently involved in the risk assessment are mainly
agricultural scientists and members of the regulatory bodies i.e. IBSCs, RCGM and
GEAC. Since the scientific data needs to be generated by experts from several
disciplines (both for studying impact on human health and environment), there is a
need to provide training about risk assessment to multiple stakeholders. Foreign
collaborations/trainings have been recommended for the areas for development of
scientific methods and protocols for risk assessment, enhance competence to
review/ audit risk assessments and national biosafety research.
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.
Along with updating of scientific knowledge for risk assessment, strengthening
of national risk assessment frameworks, principles, procedures and mechanisms are
required, as the present status in this area has been rated as medium.
The target segments that need to be trained are regulators and scientists
working on transboundary and post release and monitoring of GMOs.
It has been suggested that course material/manuals should be prepared for
various categories of stakeholder viz. scientists, regulators engaged in approval,
compliance officers engaged in monitoring, industry, non-technical personnel etc.
Advanced training needs to be imparted for selected scientists and regulators aiming
at developing resource persons in the various areas of risk assessment. Efforts
should be made for redeployment for expertise available in the country in the
traditional subjects such as agronomy, botany, food toxicology, microbiology and
plant breeding and genetics to take up research on biosafety. This would help in
60
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.
2. Risk management: Detection management and prevention of unintentional
transfer of LMOs has been given the highest priority by all the stakeholders with
the present status in the country rated as low.
Figure 7.4: Risk management
201 194 190
148
0
50
100
150
200
250
Detection Management Tools Emergency Measures Risk Managementsframeworks
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:
a. Practical training on managing and monitoring risks assessed before,
during and after the development of LMO (IBSCs, monitoring committees
e.g. SBCCs, DLCs, State agriculture, health and environment
departments and SAUs and concerned research institutions.
b. Training on development of standards and limits of detection of LMOs for
molecular biologists and IBSCs.
61
c. Awareness about methods of detection, reporting and documentation of
LMOs for monitoring agencies and customs and border control
organisations.
d. Extensive efforts are required for development of policies and model
offsite and onsite emergency plans followed by extensive training across
the country.
e. Strengthening 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
90
95
100
105
110
115
120
Trai
ning
of
regu
lato
rs
Cos
t ben
efit
Lega
l Dra
fting
Inte
rnat
iona
lag
reem
ents
Det
ectio
n
Inte
grat
ion
ofS
ocio
eco
nmic
Dis
sem
inat
ion
of in
form
atio
n
Ex-
Ant
e ris
kbe
nefit
Cha
ract
eris
tics
of L
mo’
s
Trad
e Im
pact
62
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:
• Assessment of characteristics of LMOs for scientists, monitoring agencies,
customs, processing industry and quarantine personnel.
• Detection, testing and quantitative analysis of LMOs.
• Training in development of new detection methods for selected research
laboratories.
• Assessment and integration of socio-economic considerations.
• Studies on economic impact of import of LMOs by agriculture economists, NGOs
and other consumer organizations.
• Assessment of trade impacts of biosafety related measures such as risk vs.
benefits analysis, impact of labeling, cost of biosafety measures etc. mainly by a
joint teams of scientists and agricultural economists.
• Regular inter ministerial and other stakeholder consultations by trade related
bodies such as industry association, RIS etc.
• Training to wider segments of environmental lawyers and bureaucrats dealing
with policy makers on basic issues related to GMOs.
• Training of regulatory agencies for post commercialization monitoring including
state agricultural officials, health and food inspectors, food laboratories, SAUs
etc.
• Manuals on basic requirements of risk assessment, AIA procedures and
guidelines for transport, packaging etc.
• Handbooks on regulatory roles of various monitoring agencies such as SBCCs,
DLCs, border control officials etc.
4. Regulatory capacity building: India has a well-defined, comprehensive legal
and regulatory framework in place to deal with LMOs. The government has to
play a major role for regulatory capacity building for effective implementation of
regulations. Regulatory capacity building was divided into three areas i.e.
legislative and regulatory framework; administrative framework and technical and
scientific-infrastructures and mechanism for follow-up. The priorities in each of
these sub sections are given in the following Table 7.3.
63
Table 7.2: Priority areas for regulatory capacity building Legislative and regulatory framework
: • Strengthening of legal framework • Harmonization of biosafety related sectoral policies • Mainstreaming biosafety into other sectors • Regulatory training • Negotiation of bilateral, regional and multilateral agreements.
Administrative framework : • Institutional activities for handling biosafety issues • Customs and Border control procedures • Decision making systems • Mechanisms for private sector and community involvement • Administration of AIA procedures • Interagency consumer and coordination
Technical scientific infrastructure and mechanisms to follow up
: • Long term LMO monitoring and surveillance • LMO testing laboratory and equipment • LMO containment and disposal facilities • Methods and mechanism for detecting unintentional or illegal
LMO movement was on the top priority
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:
• Stakeholder dialogue for comprehensive GMO regulations and guidelines
particularly to deal with food crops
• State/District level officials to be trained to prevent proliferation of unauthorized
products
• Interaction of regulations with international experts for harmonization of biosafety
related sectoral laws/policies
• Extensive public awareness exercises for mainstreaming biosafety into other
sectors
• 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.
• Development of primers followed by manuals for specific target segments viz.
health inspector, agricultural official, pollution control board etc.
• 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.
• Reputed socio economic institutions and agricultural economists, civil society
organization to be sensitized about GMOs and studies to workout cost benefit
analysis
• Half yearly review reports on implementation of the Protocol.
• International conference on LMO testing methods, facilities and equipments in
association with industry.
• Study on facilities to be provided to compliance officers.
5. Scientific, technical and institutional collaboration: In this area,
establishment of inter-institutional networks/communications has been rated as
top priority. Access of information on available opportunities for collaboration and
sharing of experiences is extremely important followed by establishment of
mechanisms for regional and international cooperation.
Some of the suggestions include networking through online public access
databases and systems and regular academia-industry group discussion/
interactions to understand needs and capabilities of each other. Public private
partnerships need to be promoted in vigorous manner to achieve the fast results.
6. Sustainable use and conservation of biodiversity: Under this head, the
highest priority has been given to assessment of impact on non-target organisms
as depicted in Figure 7.6.
65
Figure 7.6: Sustainable use and conservation of biodiversity
151
102 101 10197 96
0
20
40
60
80
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120
140
160A
sses
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orga
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Mec
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rm
ains
tream
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bios
afet
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Ass
essm
ent o
fim
pact
on
wild
life
popu
latio
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tive
spec
ies
Aw
aren
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train
ing
onla
ws
and
polic
ies
onen
viro
nmen
tan
d na
tura
lre
sour
ces
Impa
ct o
f GM
Oon
trad
ition
alfa
rmin
gsy
stem
s
Pot
entia
l for
wee
dine
ss o
rin
vasi
vene
ss
Experts have indicated that studies on impact of GMOs on non-target organisms
are part of risk assessment procedures, but there is a need to conduct surveys
commissioned to compile the baseline data from available sources as well as
primary research. The environmental benefits and risks associated with GMOs
should be evaluated relative to appropriate baseline scenarios (e.g. transgenic
versus conventional crops), with due consideration of the ecology of the organism
receiving the trait, the trait itself, and the environment(s) into which the organism
will be introduced.
Training on newer methods of transformation that can help in minimizing the
adverse effects on biodiversity should be provided to the scientists involved in
development of GMOs. Ecologists, evolutionary biologists, and a wide range of
other disciplinary specialists should become more actively involved in research
aimed at quantifying benefits and risks posed by GMOs to the environment.
66
Taxonomic, inter-generic and inter-specific hybridization consequences and
population dynamics in self and cross-pollinated and wild populations should be
studied for which population geneticists can be actively involved.
Support for environmental risk assessment (including environmental benefits) by
both government and private sector should be enhanced. Training to
environmental biologists and legal specialists on implications of legal provisions
in regulatory framework should be studied.
Multidisciplinary interaction is required among ecologists, agricultural scientists,
molecular biologists etc. to give adequate importance to issues related to
sustainable use of resources.
7. Public awareness, education and participation: Biosafety awareness activities
(like seminars, workshops, etc.) have been given first priority followed by risk
communication skills and strategies and biosafety awareness materials
(newsletters/bulletins, newspapers, etc.). The other areas in the order of
preference are public participation in decision-making, media engagement skills
and strategies, timely public access to information on impending LMO imports
and public access to the Biosafety Clearing House (BCH).
Figure 7.7: Public awareness
209
176152
138 133 127 126
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Bios
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Med
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Tim
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info
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ion
onLM
O im
ports
Pub
lic a
cces
sto
BC
H
67
The present level of training/activities in the areas of public awareness, education
and participation has been rated as low by most of the respondents and the
suggestions include:
• Baseline surveys to understand the level of awareness
• Training of risk communicators for improvement of risk communication skills
and strategies particularly among regulatory agencies and members of
regulatory bodies
• National level events aimed at informing key stakeholders about various
developments.
• Seminars, radio and television talk shows involving reputed scientists.
• Publications still remain an important source of knowledge and information,
thus wider circulation of biosafety awareness materials like
newsletters/bulletins, newspapers, etc. backed by scientific data. The use of
local languages in all such endeavours is extremely important.
• Local case-by-case synthesis of information and dissemination. The target
segments suggested that could be involved in these activities were social
awareness campaigners, documentary producers, NGOs and other mass
communication experts.
• Regular meetings with media personnel informing them about authenticated
information about LMOs.
• Timely public access to information on impending LMO imports can also be
done through newspapers and by posting on to the government websites.
8. Technology transfer: Analysis of appropriate technologies and management of
intellectual property rights have been given the top priority for organizing training
programmes compare to other options which have been rated more or less at the
same level
68
Figure 7.8: Technology transfer
163 161
116 110 106 101 101 100
0
20
40
60
80
100
120
140
160
180An
alys
is o
f app
ropr
iate
tech
nolo
gies
Man
agem
ent o
f int
elle
ctua
l pro
perty
right
s
Enab
ling
polic
ies
and
ince
ntiv
es fo
rte
chno
logy
tran
sfer
Tech
nolo
gies
for r
isk
asse
ssm
ent o
fLM
Os
Tech
nolo
gies
for i
nfor
mat
ion
exch
ange
/dat
a m
anag
emen
t
Acce
ss to
pro
prie
tary
tech
nolo
gies
on
pref
eren
tial t
erm
s
Tech
nolo
gies
for m
onito
ring
of L
MO
s
Tech
nolo
gies
for h
andl
ing,
tran
spor
t,pa
ckag
ing
and
iden
tific
atio
n of
LM
Os
The suggestions for capacity building are:
• Participation in international seminars/conferences for awareness of
international developments by nodal scientific institutions involved in
development and biosafety of LMOs e.g. Centres for Plant Molecular Biology,
designated institutions for risk assessment etc.
• Identification of appropriate technology options by stakeholders consultations.
• Public private partnerships to be encouraged and funded
• International conferences regarding technologies for risk assessment and
management, transport and identification of LMOs for creating awareness
among designated agencies.
• Collaborative projects among various institutions should be funded on priority
basis.
9. Identification of LMOs: Status of documentation and inspection systems for
LMO shipments, methods and systems for identification of LMOs and systems for
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
communicated to the traders and industry through the industry associations.
10. Information exchange & data management: Information exchange through
web based databases and print media have been given equal ranking by the
respondents. The low priority given to Biosafety Clearing House which is also a
web based mechanism for information exchange may be because of non
familiarity with the terminology used. Some of the suggestions include:
• A national database/central portal be created listing national, regional and
international experts in fields relevant to risk assessment and management of
LMOs, information on their work related to biosafety of GMOs and make use
of their publications and experiences on these issues.
• Develop an electronic network [email list serve] to connect regulators on the
latest information on biosafety of GMOs.
• Tutorials on data acquisition and submission to database to be developed for
all stakeholders.
• Exchange and distribution of CDs related to the latest information on
development of GMOs and biosafety issues related to them to be
encouraged.
• Apart from electronic mode of communication for information exchange, print
media should be given equal importance. Research publications, articles,
reviews should also be widely circulated and exchanged among all the
stakeholders.
70
11. Socio-economic considerations: Mechanisms for determining value addition to
specific sector/industry as well as specific socio economic groups is the major
concern for which capacity building is urgently required.
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.
12. Development of LMOs/GMOs: Most of the institutes in India are working on
imported polynucleotide constructs including promoters, genes, terminator
sequence, plasmids etc. and local material of considerable economic value has
not yet been developed. It has been mentioned during the interaction with the
experts that the main reason for this is lack of trained people to carry out such a
developmental work. Trained manpower in this context means a minimum
number of people that have complete capabilities from gene isolation to
preparation of the desirable constructs, abilities to transform the hosts efficiently,
competence in transforming the transformed materials into plants, and abilities to
assess at each stage the extent of transgenic traits. These call for considerable
training of available scientific manpower in multidisciplinary facts of molecular
biology.
Assessment of genetic stability, limits of gene expression under different
conditions, multi-location field trials, analysis and interpretation for conditional
releases in specific environment with statistical consistency etc. were some of the
areas listed by respondents. Other specific areas that were suggested include:
• Training on determination of specific event, copy number, genome integration,
etc.
• Training on analysis vis a vis breeding behaviour and genetic segregation in
populations (proper sampling, etc.).
71
• Training on planning/designing of experiments to study the extent and effect
of gene flow.
• Training on population genetics of transgene pollen dissemination over
multiple generations.
• Training on interaction of modified plants in an environment.
• Knowledge on gene silencing, over-expression of a gene or inconsistent
behaviour in fixed and segregating populations of modified plants.
7.2 MEANS OF SHARING INFORMATION:
Feedback was sought from the respondents regarding preferred means of
sharing information on GMOs/LMOs with them. Internet and training/consultation
programmes emerged as the most preferred option followed by newspapers,
electronics media and newsletters/bulletins/publications.
Figure 7.9: Appropriate means for effective sharing of information for various stakeholders
020406080
100120140160180200
Ele
ctro
nic
med
ia
New
spap
ers
Thro
ugh
grou
ps a
ndas
soci
atio
ns
Thro
ugh
NG
Os
Inte
rnet
New
slet
ter,
bulle
tin,
libra
ry
Bus
ines
s or
wor
kas
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ates
Non
-Inte
rnet
elec
troni
cex
chan
ge
Trai
ning
/co
nsul
tatio
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ogra
mm
es
7.3 DURATION OF THE TRAINING PROGRAMMES:
Regarding the preferred duration of training programmes for various
stakeholders, most of the respondents opted for short duration programmes.
Regulators, scientists, industry and enforcement officials also felt the need for longer
training programe upto one week involving the laboratory training. One month or
longer training programmes were opted only by the scientists.
72
Table 7.3: Preferred duration of training programmes for various stakeholders
1-2 Days 1 Week 1 Month
Regulators √ √ -
Scientists √ √ √
Industry
√ √ -
NGOs √ - -
Farmers /Public/consumers
√ - -
Enforcement officials such as
Customs/port officials, agriculture/health
inspectors
√ √ -
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.
The record of the proceedings of the stakeholder consultation is placed in
Annex-4.
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:
Stakeholders to be involved in the commercial use/trade of GMOs/LMOs
and have an important role to play in the implementation of Cartagena Protocol in
India have been identified as given below:
1. Decision/ policy-makers: Senior government officials from the concerned
Ministries and Departments and the advisory bodies, which are involved in
decision making as well as drafting of national policy need to be informed
about the basics of biotechnology/GMOs, national regulatory framework and
international commitments. Some of the concerned Ministries and
Departments are Ministry of Environment & Forests, Department of
Biotechnology, Ministry of Agriculture, Ministry of Health and Family Welfare,
Ministry of Food Processing Industries, Ministry of Law etc.
Regular interaction/collaboration between different departments helps in
handling various issues within legislative and multilateral framework, thereby
avoiding of duplication of efforts.
2. Regulators: Members of various regulatory as well as administrative
committees have to be updated with advances in technology and regulatory
aspects at both national and global level. These officers include technical
advisors, administration and subject experts, application reviewers/assessors.
Their responsibilities include review/assessment of applications, providing
74
feedback for decisions, inputs for policymaking, formulation/updation of
various guidelines etc.
3. Scientists/technical experts: These include scientists and technical experts
from both public and private sector, who are involved in the research and
development of GMOs and biosafety studies.
4. Enforcement officials: Implementation of the regulatory decisions is vested
with State Biotechnology Coordination Committees and District Level
Committees constituted as per the rules 1989. In addition, use of agriculture
products is maintained by State Departments of agriculture, which includes
officers of Commissionerate of Agriculture, Seed Certification etc. Officials
from Department of Environment, Department of Health, Pollution Control
Board etc. also need to informed about developments and regulations of
GMOS as they involved in implementing decisions of GEAC as member of
SBCCs and DLCs. Health and food inspectors have an important role to play
in ensuring food safety. Officials involved in border control such as customs,
plant quarantine and other port officers, who are present at the point of entry
have an important role to play in the transboundary movement of GMOs.
These officials need to regularly updated about the development in the
regulation front as well as introduction of new products for planning
implementing mechanisms.
5. Legal experts: Selected group of lawyers particularly those who are
specializing in environmental law need to informed about biotechnology and
biosafety aspects of GMOs so that they can help in international negotiations
as well as harmonization of relevant laws/policies at both regional and
national level.
6. Economists: Socio economic considerations being an integral component of
decision making, economists particularly agriculture economists need to be
75
involved for evaluation of GM crops with respect to economic benefits at
various sections of the society.
7. Data/ information managers: Compilation of information and data
management is extremely important in this area where developments/
changes are taking place at a mind boggling pace. Training of information
managers will play a very crucial role for the success of training and
awareness programme by providing up-to-date and classified information as
per the requirements of specific stakeholders.
8. Researchers and technicians: The scientific staff at the level of researchers
and technicians are the main implementers with respect to widespread
laboratory requirements of field testing as well as identification of LMOs both
for domestic use and transboundary movement. There is already a network
of researchers and technicians at both the research institutions and
laboratories at both central and state level. The existing network can be
effectively used by training researchers and technicians by both short/long
term training programmes.
9. Graduate and undergraduate students: Students of various biotechnology
courses need to be informed about biosafety aspects as well as applicable
regulations of GMOs/LMOs in addition to the basic concepts. In fact, the
introduction to biosafety issues needs to start at the senior secondary level in
schools itself.
10. Interest groups: Various interest groups such as consumer organizations,
farmers, industry associations etc. need to be adequately informed about
specific risks and actions taken to alleviate them. Both formal and informal
dialogues by regulators/scientists and industry with these groups help in
increasing mutual trust and credibility and reducing controversies.
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.
12. General public and political leadership: Uninformed public is more
receptive to inaccurate and biased messages than those who have some
knowledge about GMOs. Therefore, it is very important to provide clear and
accurate information translated into everyday language to general public. The
interaction with political leadership is also required for communication with the
public.
8.2 TRAINING NEEDS MATRIX:
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
TRAINING NEEDS
(KEY COMPETENCES – KNOWLEDGE AND SKILLS REQUIRED)
Dec
isio
n/ p
olic
y-m
aker
s
Gov
ernm
ent r
egul
ator
s Sc
ient
ists
/tech
nica
l, ad
viso
rs
& e
xper
tsEn
forc
emen
t offi
cial
sC
usto
ms
offic
ials
Law
yers
Econ
omis
ts
Dat
a/in
form
atio
n m
anag
ers
Res
earc
hers
& te
chni
cian
sG
radu
ate
& u
nder
grad
uate
st
uden
ts
Inte
rest
gro
ups
(Con
sum
er
grou
ps, f
arm
ers,
NG
Os)
A
ssoc
iatio
nsM
ass
med
ia/ e
xten
sion
w
orke
rs
Gen
eral
pub
lic, p
oliti
cian
s
General biosafety/ biotech knowledge
Molecular biology skillsBiosafety research/ field trial techniques (e.g. buffer zone, isolation distance, etc.)
Risk assessment & managementAudit of risk assessment reports and risk management plans
Safety requirements and procedures for international and unintentional LMO releasesTools for monitoring the handling, transport, packaging and use of LMOsCompliance requirements under the CPBHarmonization of biosafety related sectoral laws/policies including international agreements
MAJOR TARGET GROUPS
78
79
TRAINING NEEDS
(KEY COMPETENCES – KNOWLEDGE AND SKILLS REQUIRED)
Decis
ion/ p
olicy
-mak
ersGo
vernm
ent re
gulat
ors
Scien
tists/
techn
ical, a
dviso
rs & e
xpert
sEn
force
ment
offici
alsCu
stoms
offic
ials
Lawy
ersEc
onom
istDa
ta/inf
ormati
on m
anag
ers
Rese
arche
rs &
techn
ician
sGr
adua
te &
unde
rgrad
uate
stude
nts
Intere
st gro
ups (
Cons
umer
group
s, far
mers,
NGOs
) As
socia
tionss
ien
st
ex/adiass
me
Mon
wo
rkers
Gene
ral pu
blic,
politi
cians
MAJOR TARGET GROUPS
Harmonization of biosafety related sectoral laws/policies including international agreements Regulatory training (legal, policy, enforcement, inspection, etc.)Preparation and presentation of LMO export or release applications/dossiersReview of applications and the accompanying dossiersAdministrative practices (including handling of requests for LMO imports or releases)
Decision-making practices, including assessment and integration of socio-economic considerations
TRAINING NEEDS
Data/
inform
ation
man
agers
Rese
arche
rs &
techn
ician
sGr
adua
te &
unde
rgrad
uate
stude
nts
Intere
st gro
ups (
Cons
umer
group
s, far
mers,
NGOs
) As
socia
tions
Drafting/use of technical manuals & guidelines
Procedures to be applied to LMO transboundary movements (including information on neighboring countries)Documentation requirements for LMO shipmentsLMO detection & quantitative analysisCost/ risk-benefit analysisSystems for identification of LMOs including traceability procedures Public awareness and participationData and information management, including use of the BCH
(KEY COMPETENCES – KNOWLEDGE AND SKILLS REQUIRED)
Decis
ion/ p
olicy
-mak
ersGo
vernm
ent re
gulat
ors
Scien
tists/
techn
ical, a
dviso
rs & e
xpert
sEn
force
ment
offici
alsCu
stoms
offic
ials
Lawy
ersEc
onom
ists
iMa
ss m
edia/
exten
son
worke
rs
Gene
ral pu
blic,
politi
cians
MAJOR TARGET GROUPS
80
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
participants included mainly scientists from research institutions and industry,
government officers, NGOs representatives were also participated.
Following the release of first transgenic crop, Bt cotton, in India in March
2002, MoEF, DBT and BCIL jointly organized a series of workshops at eight
locations all over the country. The objective of these workshops was to create a
better understanding of the rules and regulations related to biosafety with the focus
on applications both in agriculture and healthcare among the concerned
stakeholders. 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
In continuation of its efforts of creating awareness about transgenic crops and
to sensitize various stakeholders regarding monitoring of transgenic crops,
particularly the state government officials, MoEF sponsored a series of workshops, in
2003-2004. These workshops on biosafety issues related to transgenic crops were
organized by BCIL in the six states, namely, Andhra Pradesh, Gujarat, Karnataka,
Madhya Pradesh, and Tamil Nadu, where Bt cotton was being cultivated following
GEAC approval.
81
In addition to information about rules and regulations, these workshops also
included demonstration of monitoring techniques. The participants included
members of State Biotechnology Coordination Committee, District Level
Committees, state agriculture department and agriculture commissionerate, research
scientists form ICAR institutes, state agricultural universities, seed companies, seed
distributors, farmers cooperatives, NGOs and Bt cotton growing farmers identified
through the state agriculture department and the seed industry. Over 600
participants attended these workshops.
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 GEAC’s 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.
In addition to the six Bt cotton growing states, these workshops organized by
BCIL included three northern states of Haryana, Punjab and Rajasthan where large
scale field trials of Bt cotton were underway. The participants included
representatives from the state department of agriculture, agriculture
commissionerate and other related departments, scientists from ICAR, state
agricultural universities, and other institutions engaged in research on transgenic
crops in respective states, seed companies planning/undertaking regulatory
clearances/doing controlled field trials for introducing transgenic crops, distributors of
seed companies located in towns around major cities, farmers organizations, NGOs
and Bt cotton growing farmers identified through assistance from state government,
extension departments of state agricultural universities and seed industry. These
workshops were attended by more than 600 participants.
DBT and BCIL organized a series of six consultations on biosafety aspects
related to GMOs for the members of Institutional Biosafety Committees (IBSCs) and
DBT nominees in 2004. These consultations helped in capacity building as well as
82
awareness generation on the biosafety aspects and regulations of rDNA technology
within the country. The above consultations were attended by more than 600
participants.
In addition to Bt cotton, research is underway in various institutions and
industry for development of transgenic food crops. These crops are at different
stages with some of them currently in controlled field trials of RCGM. In 2005, a
series of workshops were organized by AGBIOS Inc., Canada in association with
BCIL under South Asia Biosafety Programme to apprise the participants about the
critical parameters used to evaluate potential risk(s) associated with GM food crops
based on international documents and case studies. More than 120 scientists from
the research institutions, industry and members of regulatory bodies attended the
four workshops.
Table 9.1 given an overview of the above series of workshops.
Table 9.1: Series of workshops on biosafety issues of GMOs
S. No.
Series of workshops
Organized by
Period/ Year
Objective Participants Locations
1. Biosafety issues related to GMOs
DBT and BCIL
1998 To sensitize about the developments in the area of GMOs, importance of biosafety issues and apprising them about regulations and guidelines
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
2003-2004
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.
Series of workshops
Organized by
Period/ Year
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.
the SBCCs, DLCs and Monitoring Committees; state department of agriculture, Research scientists, SAUs, seed companies, distributors, farmers, NGOs
Ahmedabad and Indore
4. National consultation on biosafety aspects for IBSC members and DBT nominees
DBT and BCIL
2004 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
Members of IBSCs and DBT nominees
Bangalore, Chennai, Hyderabad, New Delhi, Mumbai and Jalna
5. Biosafety issues related to transgenic crops with a focus on Bt cotton
MoEF and BCIL
Jan. – March 2005
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
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
6. Safety assessment of GM foods
AGBIOS Inc. Canada and BCIL
2005 To apprise about the critical parameters used to evaluate potential risk(s) associated with GM food products based on international documents and case studies
About 150 participants including scientists and regulators
New Delhi, Hyderabad, Chennai and Gurgaon
84
9.2 NATIONAL EVENTS:
MoEF has also sponsored conference/consultation/ workshops on various
issues related to the Cartagena Protocol. BCIL organized two such events on
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.
A list of these initiatives is presented in Table 9.2.
Table 9.2: National events on biosafety issues
S. No.
Event Organized by
Period/ Year
Objective Participants Locations
1. Orientation course on biosafety considerations for evaluation of transgenic crops
DBT and NBPGR
Annual since 2000
To provide training in the area of biosafety issues related to transgenics
20-30 participants from ICAR institutes, SAUs, universities etc.
New Delhi
2. National consultations on Cartagena Protocol on biosafety issues before MOP-2
MoEF and RIS
May 24, 2005
To discuss the issues related to biosafety of GMOs, especially political issues for the implementation of Cartagena Protocol
60-70 participants from government industry, institutions, trade organizations, etc.
New Delhi
85
S. No.
Event Organized by
Period/ Year
Objective Participants Locations
3. Conference on Capacity Building on Biosafety
MoEF and BCIL
March 23-24, 2005
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.
New Delhi
4. National Consultation on Liability and Redress in the context of Cartagena Protocol on Biosafety
MoEF, JNU and BCIL
March 28-29, 2005
To seek views of various stakeholders at the national level on the Article 27 of the Cartagena Protocol on Liability and Redress
50 participants from central government, state governments, industry, industry associations, NGOs, legal and technical experts, scientists from leading research institutions, universities
New Delhi
5. National Workshop on Management of Field Trials of Genetically Modified Crops
ISAAA and BCIL
August 9, 2005
To discuss various issues related to conducting field trials of genetically modified (GM) crops in India
About 140 participants which included government officials, scientists from research institutions and universities, industry and industry associations
New Delhi
6. Communications Training for Agriculture Extension Personnel
The Science Ashram and AGBIOS
September, 2005
To sensitize various stakeholders regarding issues related to GM crops
State agriculture department officials from Maharasthra, Gujarat and Andhra Pradesh, social groups and media
Maharashtra
86
9.3 INTERNATIONAL EVENTS:
BCIL has also organized several international events in association with
MoEF, DBT, ICMR and AGBIOS Inc., Canada where biosafety has been one of the
important topics (Table 9.3).
Table 9.3: List of international events
S. No.
Event Organized by
Period/ Year
Objective Participants Locations
1. Two regional workshops on Biosafety for the Asia-Pacific Region
UNEP/GEF 1998 To discuss biosafety issues at the regional level
Scientists/ regulators from Asia Pacific region
New Delhi
2. Workshop on biotechnology for environmental protection and sustainable development
MOEF, Environment Canada and BCIL
2003 Exchange of information between scientists, regulators on environment related issues including biosafety.
About 140 participants from govt., industry, academia, NGOs and experts from Canada
New Delhi
3. Biotec India International 2003
MoEF, DBT, BCIL
2003 To deliberate on emerging areas of biotechnology including agricultural biotechnology
More than 350 participants from industry, research institutes, university, central and state govt., international experts and students
Hyderabad
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
150 participants including international experts, central govt. ministries, regulatory agencies, research institutes, industry and industry associations and NGOs
New Delhi
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9.4 TRAINING PROGRAMMES BY PRIVATE SECTOR:
The approval conditions for commercialization of Bt cotton in India in 2002 to
MAHYCO included undertaking awareness and education programme, interalia
through development and distribution of educational material on Bt cotton for
farmers, dealers and others. In view of the above, M/s. MAHYCO had conducted
awareness programmes for dealers, company executives, field assistants as well as
agricultural department officials in the various districts of Bt cotton growing states.
In addition farmer education programmes was organized in two phases i.e. pre
sowing and post sowing through farmer meetings, mailers, audio cassettes and
pamphlets in local languages. The training programmes covered information on
various aspects related to cultivation of Bt cotton. Similar programmes have been
taken up by other industries who are marketing Bt cotton hybrids.
In addition, representatives of private sector have been regularly participating
in various training programmes and also have sponsored various events.
9.5 WEBSITES:
MoEF and DBT have prepared and launched the following websites for
information dissemination and awareness creation:
• Capacity building on biosafety
• Biosafety Clearing House (BCH)
• Indian GMO Research Information System (IGMORIS)
• Biosafety regulation website
In addition to the above, a few private organizations such as Foundation for
Biotechnology Awareness and Education (FBAE) and companies such as Monsanto
are also disseminating information through the internet.
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9.6 PUBLICATIONS:
Several publications as background documents or proceedings of various
events have been widely circulated in the country. Industries such as Maharashtra
Hybrid Seeds Company Ltd., Monsanto, Syngenta etc. are also circulating
newsletters covering information about GMOs. MoEF has recently launched a
quarterly biosafety newsletter in association with BCIL for circulation amongst
stakeholders all over the country. DBT and BCIL have released a handbook for
IBSC members.
9.7 CAPACITY BUILDING PROJECTS:
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.
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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.
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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.
In addition to these training programmes for scientists, regulators and
industry, massive campaign is required for promoting awareness among the public
about the applications of genetic engineering in agriculture and their potential
benefits as well as risks and constraints. A multi pronged strategy should be used to
target various stakeholders through both print and electronic media.
Training need requirements, preferred communication media and duration of
the training programmes by various target segments have been taken into account to
draw the following recommendations to strengthen the capacity for handling issues
related to national regulatory framework as well as obligations with respect to
international agreements particularly Cartagena Protocol on Biosafety:
1. Public awareness activities: Public awareness programmes are required to
educate and provide working knowledge to various stakeholders. Massive
audience and language friendly communication tools, training methods and
modules need to be developed in order to reach out to maximum targets.
Implementation of regulations also requires great awareness at the grassroots
level and a strong extension network, which can carry forward the message. This
requires capacity building in terms of both infrastructure and human resource
91
development at the grassroots levels. Some of the suggestions in this regard
include:
• 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.
• Network of scientific communicators to be created who will interact with the
media as well as deliver regular talks to different categories of stakeholders.
• Regulators need to be trained about risk communication strategies as per
international guidelines
• Development of TV, radio educational programmes on biosafety issues in
collaboration with the local as well as national level agencies
• Primers/brochures/booklets/FAQs/glossary of terms targeting various
stakeholders and in different languages to be extensively circulated.
• Regular interaction with media, political leadership and other stakeholders for
sensitization on important issues to ensure circulation of authentic
information.
• Awareness and participation of students in schools and universities through
interactive programmes and circulation of literature in easy to understand
language and formats.
2. National Workshops: There is an urgent need to target stakeholders across the
country by organizing events such as:
a. Series of events for custom, port, plant quarantine officials etc. with the focus
on the basics of GMOs/LMOs, biosafety issues, identification procedures,
national regulatory framework, international commitments etc. Visits to
scientific institutions should also be organized.
b. Series of workshops for scientists of state agricultural universities, agricultural
research institutions and related organizations focusing on:
- Environmental risk assessment procedures
- Management of field trials
- Risk communication strategies
c. Series of workshops for scientists of health and nutrition organizations on
92
- Food safety assessment procedures
- Communication strategies
d. Consultations/workshops on post release monitoring procedures and
emergency measures for unintentional movement of LMOs.
e. Series of events for health and food inspectors to sensitize about
developments and regulations in the area.
f. Programmes for training the trainers on biosafety issues for wider outreach
and dissemination of science based information.
g. National consultations among various stakeholders particularly with those
involved in trade and transboundary movements on various articles of
Cartagena Protocol particularly Article 7-8 (AIA procedures), Article 15 (risk
assessment and management), Article 18 (documentation requirements) and
Article 27 (liability and redress).
h. Regular inter-ministerial consultations on crosscutting issues regarding
Cartagena Protocol and other international agreements particularly WTO
i. National workshops on various crops under development (one crop at a time)
to study its characteristics in a comprehensive manner.
j. National consultations for development of guidelines in the area of
phytopharma, transgenic animals, transgenic fish etc.
The suggested approach in organizing above events is to have coordination at
the central level for interaction with the local/regional organizations for conducting
nationwide events in order to have uniformity and complimentarity with the
national approach. Involvement of representatives of both public and private
sector should be encouraged.
3. Regulatory strengthening: Training of the regulators is extremely important for
effective implementation of the regulatory framework. This includes capacity
building of the members of various statutory committees, secretariats operating
these committees in DBT and MoEF, DBT nominees in IBSCs and senior/middle
level officers in concerned ministries and the departments. Some of the
suggestions include:
(i) Brainstorming sessions may be organized for GEAC and RCGM members
along with national and international experts on latest developments in the
93
areas of research as well as international regulations and experiences of
other countries.
(ii) Officials handling biosafety issues in secretariats operating the statutory
committees such as RCGM in DBT and GEAC in MoEF may be
encouraged to participate in various events.
(iii) Regional IBSC consultations may be organized on a regular basis to
discuss the problems being faced by IBSCs and understand their
information needs. Experts can be invited in these consultations for
deliberations on the latest issues for guidance to IBSCs. Mechanisms to
provide regular updates to IBSCs on the decisions taken as well as
developments in the regulatory framework may be operationalized.
(iv) Similarly consultation among SBCCs and DLCs may be regularly
organized including interaction with officials from central Ministries,
members of RCGM and GEAC and leading experts to discuss the
problems being faced, understand their information requirements and
provide updates on both development and regulatory fronts.
(v) In addition to strengthening the capacity of the statutory committee
members, senior and middle level officers of other concerned Ministries
and Departments such as Ministry of Agriculture, Ministry of Health,
Ministry of Food Processing Industries, Ministry of Commerce etc. need to
be apprised of the information on GMOs through resource materials on
biosafety issues such as newsletters, bulletins, brochures, leaflets etc.
4. Laboratory training: There is an urgent need to hold a series of seminars that
would serve as brainstorming sessions in specific research areas pertinent to
GMO biosafety. These would include questions of immediate concern for GMOs
already commercialized or close to the commercial release stage. The
comparison of strategy and results obtained worldwide would help define
question requiring further research in the country. The seminars may be held in
both the areas of food and feed safety evaluation and environmental risk
assessments. The topics for food safety assessments may be toxicity,
allergenicity, nutritional enhancement etc. whereas the topics for environmental
risk assessment could be assessment of horizontal gene flow; impact on non
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.
Training programmes on good laboratory practices are also required to
understand the importance of biosafety. The researchers working in SAUs,
universities, research institutions etc. should be exposed to such practices by
organizing programmes conducted at selected institutions. The Centres of Plant
Molecular Biology could take a lead in this direction in association with institutions
such as ICGEB, which have excellent facilities.
5. Updation of rules/guidelines: In line with developments in the GMOs taking
place at a rapid pace and the transition 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 as well as notify additional policies/rules/guidelines.
Rules,1989 (including its annexures) may be updated keeping in view the
recommendations of Swaminathan committee, Mashelkar committee, National
Environment Policy and Draft National Biotechnology Strategy . Rules and
guidelines applicable in other countries may be compiled and analysed by
committees constituted on specific issues. Interaction with international experts
may also be a part of consultative exercise.
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
clinical trials of plant/animal based pharma products etc. need to be developed.
Issues such as delivery system for plant based recombinant edible/injectable
vaccines to the farmers need to be regulated taking into consideration the
requirement of storage, in terms of temperature and other physical parameters of
the edible plant including its transportation.
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:
- Study on review of guidelines for transport of LMOs
- Study on global status, impact and cost implications of labeling.
- 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.
- Baseline surveys for assessment of awareness among the user segments
such as consumers, farmers, processors etc.
7. Publication/documents/websites/video films: Information on issues related to
GMOs/LMOs needs to be provided in variety of formats such as resource
material on specific topics, brochures, pamphlets, booklets, peer reviewed
scientific publications, review articles/current expert opinions, conference
proceedings, reports and documents form international organizations etc. These
can be disseminated both through the print and electronic forms. The
regulations/decision documents from the national approval committees available
for public access, successful case studies and experiences of the users are rich
sources of information in identified risks and management options for particular
GM crops and products. These can be also used in preparation of publications/
video films etc. Some of the suggestions for immediate consideration include:
- Handbooks for various regulatory bodies
- Resource material on biosafety issues for specific stakeholders
- Manuals on risk assessment and management procedures
- Manual on AIA procedure
- Manuals on various detection methods and approaches for LMOs
- Newsletters/ Bulletins
96
- Video films on successful case studies
- CDs/videos on regulatory requirements
- Dedicated websites on biosafety
8. Study tours: Study tours /exchange programmes as well as participation in the
international conferences should be regularly undertaken by scientists, regulators
etc. to get exposed to the international developments and procedures. For
example, Government of Australia has enacted new Gene Technology
Regulation Act and has approved 25 GM products including food products. It has
a well planned consumer awareness programmes and also trained the science
communicators. Canada has well defined risk assessment and management
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. Several such interesting models should be studied by exchange
programmes i.e. interaction with the regulators and scientists by visiting them
and/or inviting in India.
9. International conferences: The following international conferences are
suggested for meeting the immediate capacity building requirements:
- LMOs testing methods, facilities and equipments including both private and
public sector
- Risk assessment and management procedures including case studies by
different countries
- Regional conference (Asia or Asia Pacific) on understanding and
harmonization of biosafety rules, guidelines and priorities/approach for
effective implementation of Cartagena Protocol.
- Regional conference on labeling approaches
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
update a directory of resource persons. The directory may provide information
on the experts classified on the basis of various subject areas as well as
locations.
11. Compendium of Biosafety Training Programmes: There is a need to have a
compendium of existing biosafety training and education programmes as it would
help to improve accessibility to available training and education opportunities to
stakeholders/professionals who require such training and also provide a general
overview of who is providing what training. It would also enable training
institutions to announce their new programmes and to have an overview of the
programmes offered by other institutions and plan accordingly. Compendium
needs to be a dynamic, flexible and up to date resource and not a static list. In
this regard, it is suggested that the compendium may be a searchable database,
which will allow users to search for courses that meet their specific needs and
competencies they require. It may clearly have search options to specify whether
the course/seminar is a standalone programme or part of a formal degree
programme. It may contain basic summary information about the different
courses and a link to the respective websites for further detailed information.
Common formats may be developed and all the training institutions (both
government and private) invited to provide information to the compendium using
the common format.
12. Training programmes: Training programmes, both short term and long term
need to be organized to provide both theoretical and practical training. Some of
the suggestions in this regard are:
i. Training programme for in service officials such as technicians in food testing
laboratories, seed testing laboratories, public analysts, plant quarantine
officials etc. at designated laboratories/research institutions for duration
ranging from 1-4 weeks depending on the level of training requirements.
ii. Distance training programmes for beginners as well as advanced training
modules.
iii. Special postgraduate diploma/degree course on risk assessment and
management, biosafety regulations etc.
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ANNEX-1 QUESIONNAIRES
1. MAIN QUESTIONNAIRE
I. General Information:
Name: ______________________________________________________ Organization: ______________________________________________________
Category (Please tick): (i) Scientist (ii) Central Government (iii) State Government (iv) Industry (v) Non Government Organisations (vi) Others (Please Specify) _________________________
II. Are you a member of any statutory regulatory body? (Please tick)
(i) Genetic Engineering Approval Committee (GEAC) (ii) Review Committee on Genetic Manipulation (RCGM) (iii) Institutional Biosafety Committee (IBSC) (iv) Monitoring cum Evaluation Committee (MEC) (v) State Biotechnology Coordination Committee (SBCC) (vi) District Level Committee (DLC) (vii) Any other ____________________________
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 Rank
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): * Scale 1 to 5 represents: 1-not important, 2- a little important, 3- relatively important, 4- fairly important, 5- very 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 status
Priority ranking
Need
Poor/Avg./Good
Existing training/activities/ facilities, if any
Suggested areas for
training/capacity building
Target segments
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, 4-
fairly 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 status
Priority ranking
Need
Poor/Avg./Good
Existing training/activities/ facilities, if any
Suggested areas for
training/capacity building
Target segments
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: .
Present status
Priority ranking
Need
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
D. Regulatory Capacity Building
(i) Legislative and regulatory framework Please prioritize the ranking on a scale of 1 to 5*, and fill in the information in the respected columns given below:
Present status
Priority ranking
Need
Poor/Avg./Good
Existing training/ activities, if any
Suggested Areas for training /capacity
building
Target segments
Strengthening of legal frameworks
Compliance mechanisms
Harmonization of biosafety-related 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):
*GMO-Genetically Modified Organisms, ** EIA- Environment Impact Assessment
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
(ii) Administrative framework Please prioritize the ranking on a scale of 1 to 5*, and fill in the information in the respected columns given below:
Present status
Priority ranking
Need
Poor/Avg./Good
Existing training / activities/ facilities, if any
Suggested areas for training/ capacity
building
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 socio-economic 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):
*AIA – Advanced Informed Agreement
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
(iii) Technical, scientific infrastructures and mechanism for follow-up Please prioritize the ranking on a scale of 1 to 5*, and fill in the information in the respected columns given below:
Present status
Priority ranking
Need
Poor/Avg./Good
Existing training/ activities/facilities, if any
Suggested areas for training/
capacity building
Target segments
Border control and inspection facilities
Database infrastructure and protocols
LMO* containment (quarantine) facilities
LMO disposal facilities (e.g. incinerators)
LMO testing laboratories and equipment
Long-term LMO monitoring and surveillance
Methods and mechanisms for detecting unintentional or illegal LMO movement
Other (specify):
* LMO-Living Modified Organisms
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 status
Priority ranking
Need
Poor/Avg./Good
Existing training/activities facilities, if any
Suggested areas for training/capacity
building
Target segments
Documentation systems for LMOs shipments
Guidelines for safe handling, packaging and transport of LMO 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:
Present status
Priority ranking
Need
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 socio-economic considerations
Assessment of trade impacts of biosafety-related measures
Legal drafting and analysis
Support for case-by-case 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):
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.
Comments:
107
G. Public awareness, education and participation Please prioritize the ranking on a scale of 1 to 5*, and fill in the information in the respected columns given below: .
Present status
Priority ranking
Need
Poor/Avg./Good
Existing training/activities/ facilities, if any
Suggested areas for
training/capacity building
Target segments
Biosafety awareness activities (seminars, radio talks, etc.)
Biosafety awareness materials (newsletter/ bulletin, newspaper, etc.)
Media engagement skills and strategies
Public access to the Biosafety Clearing-House (BCH)
Public participation in decision-making
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
H. Information exchange & data management (including the Biosafety Clearing-House) Please prioritize the ranking on a scale of 1 to 5*, and fill in the information in the respected columns given below: .
Present status
Priority ranking
Need
Poor/Avg./Good
Existing training/activities/ facilities, if any
Suggested areas for
training/capacity building
Target segments
Biosafety Clearing House (BCH)
Web based databases
Non internet based electronic exchange material (e.g. CD ROMs, fax, etc.)
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
I. Scientific, technical and institutional collaboration Please prioritize the ranking on a scale of 1 to 5*, and fill in the information in the respected columns given below: .
Present status
Priority ranking
Need
Poor/Avg./Good
Existing training/activities/ facilities, if any
Suggested areas for training/capacity
building
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:.
Present status
Priority ranking
Need
Poor/Avg./Good
Existing training/activities/ facilities, if any
Suggested areas for training/capacity
building
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:
Present status
Priority ranking
Need
Poor/Avg./Good
Existing training/activities/ facilities, if any
Suggested areas for training/capacity
building
Target segments
Mechanism for determining value-added to specific sector/industry
Mechanism for determining value-added to specific socio-economic group
Mechanism for review of case-by-case cost-benefit analysis
Competence to review/analyze cost-benefit assumptions
Public Access to information covering cost-benefit 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
L. Sustainable use and conservation of biodiversity Please prioritize the ranking on a scale of 1 to 5*, and fill in the information in the respected columns given below: .
Present status
Priority ranking
Need
Poor/Avg./Good
Existing training/activities/ facilities, if any
Suggested areas for training /capacity
building
Target segments
Mechanism for mainstreaming biosafety in the environment and natural resources sector
Assessment of impact on non-target organism (above and below ground organisms)
Assessment of impact on wildlife populations and native species
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, 5- very important.
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IV. Please tick most appropriate means for effective sharing of information for various stakeholders.
Regulators Means of
information sharing
Approval agencies
Monitoring agencies
Scientists Industry NGOs Farmers/ Public/
Consumers Electronic media (radio & TV)
Newspapers
Through Groups and associations
Through NGOs
Internet
Newsletter, bulletin, library
Business or work associates
Training/ consultation programmes
V. Preferred duration of training programmes for various stakeholders (1-2 days, 1
week, 1 month or any other, please specify): 1-2 Days 1 Week 1 Month Any Other
Regulators
Scientists
Industry
NGOs
Farmers /Public/consumers
Customs/Port officials
Any Other (Pl. specify)
IV. Any other suggestions for organizing countrywide training programmes:
______________________________________________________________________________
______________________________________________________________________________
114
2. QUESTIONNAIRE (For Farmers and seed distributors)
I. General Information:
Name: ___________________________________________________ Organization: ___________________________________________________ Contact details: ___________________________________________________ (including telephone, ___________________________________________________ fax, email) ___________________________________________________
II. Are you aware that:
What are genetically modified organisms (GMOs)/ Yes No living modified organisms (LMOs)? How to detect the presence of LMOs? Yes No GMOs and products thereof are regulated articles in India Yes No GMOs are commercially cultivated in several countries Yes No India is a Party to the Cartagena Protocol on Biosafety Yes No
III. Have you participated in any training programme/seminar/conference etc.
related to GMOs?
_____________________________________________________________________
IV. Please indicate by ticking your areas of interest for training programmes:
Development of GMOs at national and international levels Biosafety studies on impact of GMOs on human health and
environment Rules and Regulations on GMOs Identification and testing methods of GMOs Guidelines for safe handling, packaging and transport of GMOs Norms and facilities for disposal of GMOs Awareness on uses of GMOs and products thereof Reviewing/analyzing cost benefit of GMOs Long term monitoring and surveillance of GMOs Any other
_____________________________________________________________________
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. Any other suggestions for organizing countrywide training programmes:
_____________________________________________________________________
_____________________________________________________________________
116
3. QUESTIONNAIRE (For Plant Quarantine Officials)
I. General Information:
Name: ___________________________________________________ Organization: ___________________________________________________ Contact details: ___________________________________________________ (including telephone, ___________________________________________________ fax, email) ___________________________________________________
II. Are you aware about the following:
What are genetically modified organisms (GMOs)/ Yes No living modified organisms (LMOs)? How to detect the presence of LMOs? Yes No GMOs and products thereof are regulated articles in India Yes No GMOs are commercially cultivated in several countries Yes No India is a Party to the Cartagena Protocol on Biosafety Yes No
III. Have you participated in any training programme/seminar/conference etc.
related to GMOs?
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 Specific areas for training, if
any
A. Methods and systems for identification of LMOs B. Methods and protocols for risk assessment C. Risk management frameworks, strategies and mechanisms D. Inspection facilities for GMOs E. Methods and mechanisms for detecting unintentional or illegal LMO movement
F. Quarantine facilities for LMO G. Detection and testing of LMOs and laboratories and equipment facilities for them
H. LMO disposal Facilities I. Guidelines and tools for safe handling, packaging and transport of LMOs
F. Trade impacts of biosafety related measures of GMOs G. Long-term LMO monitoring and surveillance H. Customs and border control procedures Any other * Scale 1 to 5 represents: 1-not important, 2- a little important, 3- relatively important, 4- fairly 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. Any other suggestions for organizing countrywide training programmes:
_____________________________________________________________________
Please send the filled in questionnaire to:
Dr. Vibha Ahuja Deputy General Manager
Biotech Consortium India Limited Anuvrat Bhawan, 5th Floor,
210, Deen Dayal Upadhyaya Marg New Delhi - 110 002
Tel. No. ++91-11-23219064-67 (PBX); 23219059 (D) Fax No. ++91-11-23219063
Email: [email protected]
118
4. QUESTIONNAIRE (For Social Experts)
I. General Information:
Name: ___________________________________________________ Organization: ___________________________________________________ Contact details: ___________________________________________________ (including telephone, ___________________________________________________ fax, email) ___________________________________________________
II. Are you aware that:
What are genetically modified organisms (GMOs)/ Yes No living modified organisms (LMOs)? How to detect the presence of LMOs? Yes No GMOs and products thereof are regulated articles in India Yes No GMOs are commercially cultivated in several countries Yes No India is a Party to the Cartagena Protocol on Biosafety Yes No
III. Have you participated in any training programme/seminar/conference etc.
related to GMOs?
_____________________________________________________________________
IV. Please indicate by ticking your areas of interest for training programmes:
Risk assessment and management Development of GMOs at national and international levels Biosafety studies on impact of GMOs on human health and
environment Rules and Regulations on GMOs Identification and testing methods of GMOs Guidelines for safe handling, packaging and transport of GMOs Norms and facilities for disposal of GMOs Awareness on uses of GMOs and products thereof Reviewing/analyzing cost benefit of GMOs Long term monitoring and surveillance of GMOs Assessment and integration of socio-economic considerations Risk communication skills and strategies Any other
_____________________________________________________________________
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.
Regulators Means of
information sharing
Approving agencies
Monitoring agencies
Scientists Industry NGOs Farmers/ Public/
Consumers Electronic media (radio & TV)
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
VIII. Any other suggestions for organizing countrywide training programmes:
_____________________________________________________________________
120
5. QUESTIONNAIRE (For State Govt Officials)
I. General Information:
Name: ___________________________________________________ Organization: ___________________________________________________ Contact details: ___________________________________________________ (including telephone, ___________________________________________________ fax, email) ___________________________________________________
II. Are you aware about the following:
What are genetically modified organisms (GMOs)/ Yes No living modified organisms (LMOs)? How to detect the presence of LMOs? Yes No GMOs and products thereof are regulated articles in India Yes No GMOs are commercially cultivated in several countries Yes No India is a Party to the Cartagena Protocol on Biosafety Yes No
III. Have you participated in any training programme/seminar/conference etc.
related to GMOs?
_____________________________________________________________________ _____________________________________________________________________
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 Specific areas for training, if any
A. Risk assessment for impact on human health and environment B. Risk management strategies and framework C. Methods for identification of LMOs and availability of testing laboratories and equipments
D. Quarantine facilities for containment of GMOs E. Guidelines for handling, packaging and transport of LMOs F. Norms and facilities for disposal of LMOs G. Strengthening of regulatory bodies at monitoring/implementation level (SBCCs, DLCs)
H. Strengthening of state agricultural universities and related functionaries
I. Public awareness and education J. Analysis of socio-economic considerations K. Any other * Scale 1 to 5 represents: 1-not important, 2- a little important, 3- relatively important, 4- fairly 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. Suggestions for organizing countrywide training programmes:
_____________________________________________________________________
122
ANNEX-2 LIST OF RESPONDENTS
S. No. Name Organization Category
1. Agarwal, Dr. O. P. Indian Council for Medical
Research (ICMR), New Delhi Regulatory Committee
2. Agarwal, Shri Praful Kamal Agencies, Maharashtra Seed Distributor
3. Ahuja, Dr. S. L. Central Institute for Cotton Research Regional Station, Sirsa
Research Organisation
4. Antony, Dr. Usha Centre for Biotechnology, Anna University, Chennai
Research Organisation
5. Arumugachamy, Dr. S. Tamil Nadu Agricultural University (TNAU), Coimbatore
Research Organisation
6. Babu, Dr. Nirmal Indian Institute of Spices Research (ICAR) Calicut
Research Organisation
7. Balasubramanian, Dr. P. TNAU, Coimbatore Research Organisation
8. Banga, Mr. Satish Kumar Department of Agriculture, Haryana
State Government
9. Bapu, Dr. J. R. Kanan TNAU, Coimbatore Research Organisation
10. Bardi, Mr. C.N. Bardi Beej Bhandar, Maharashtra Seed Distributor
11. Bhalla, Dr. Shashi National Bureau of Plant Genetic Resources (NBPGR), New Delhi
Plant Quarantine Office
12. Bhat, Dr. A. Ishwara Indian Institute of Species Research, Calicut
Research Organisation
13. Bhatnagar, Prof. A.K. Department of Botany, University of Delhi, Delhi
Research Organization/ Regulatory Committee
14. Bhatt, Dr. Purvi Mehta The Science Ashram, Vadodara NGO 15. Bhattiprolu, Dr. Govinda Rao Acharya N. G. Ranga Agriculture
University (ANGRAU), Hyderabad
Research Organization
16. Brahmanandan, Shri B. Farmer, Guntur Farmer 17. Burma, Dr. Pradeep Kumar University of Delhi South
Campus, New Delhi Research Organisation
18. Chakravarthi, Mr. V.P. Nava Bharat Seeds, Andhra Pradesh
Seed Distributor
19. Chalam, Dr. V. Celia NBPGR, New Delhi Plant Quarantine Office
20. Chaudhuri, Dr. Birendra K. Central Pollution Control Board (CPCB), New Delhi
Central Government/ Regulatory Committee
21. Chawla, Dr. Anil K. Panacea Biotec Ltd., New Delhi Industry 22. Choudhary, Mr. Bhagirath International Services for the
Acquisition of Agribiotech Applications (ISAAA), New Delhi
NGO
23. Das Gupta, Dr. Partha R. Syngenta India Limited, Kolkata Industry 24. Das, Shri S. Farmer, Khammam, Andhra
Pradesh Farmer
123
25. Desai, Prof. Bharat H. Jawaharlal Nehru University, New Delhi
Legal Expert
26. Desai, Shri Yogesh Farmer, Ahmedabad Farmer 27. Dhage, Shri Dhanraoji J. Farmer, Nagpur Farmer 28. Dhawan, Dr. Vibha TERI- SAS, New Delhi Research Organisation
29. Dhillon, Dr. Santosh CCS Haryana Agricultural University, Hisar
Research Organisation
30. Dhillon, Prof. B. S. NBPGR, New Delhi Research Organization 31. Gadad, Mr. S. M. Department of Agriculture,
Karnataka State Government
32. Gajalakshmi, Ms. D. Dept. of Biotechnology, University of Madras, Chennai
Research Organisation
33. Gill, Shri Jaspal Singh Farmer, Fatehabad, Punjab Farmer
34. Gouri, Dr. P. V. S. M. Agricultural and Processed Food Products Exports Development Authority (APEDA), New Delhi
Central Government
35. Govila, Prof O.P. IARI, New Delhi (Reteried Prof. of Genetics)
Expert
36. Gupta, Ms. Ila PHD Chamber of Commerce Industry Association 37. Hegde, Mr. Govindraj National Law School of India
Universities, Bangalore Legal Expert
38. Himmat, Mr. Patil Surendra Department of Agriculture, Maharasthra
State Government
39. Hota, Dr. Manoranjan Ministry of Environment & Forests, New Delhi
Central Government
40. Ingole, Mr. Vilat T. Pragati Krishi Sewa Kendra, Amravati
Seed Distributor
41. Jain, Shri C. K. Department of Agriculture, Madhya Pradesh
State Government
42. Jayachandran, Dr. S. Department of Biotechnology, Pondicherry University, Pondicherry
Research Organisation
43. Jayachandran, Mr. D. Department of Agriculture, Tamil Nadu
State Government
44. Jayashree, Ms. S. Dept. of Biotechnology, University of Madras, Chennai
Research Organisation
45. Juwarkar, Dr. Asha A. National Environmental Engineering Research Institute (NEERI), Nagpur
Research Organisation
46. Kandhari, Dr. Sarbjit Singh Department of Agriculture, Punjab
State Government
47. Kanshubahi, Mr. K. N. Department of Agriculture, Gujarat, Jamnagar
State Government
48. Kapur, Dr. Manju Lata NBPGR, New Delhi Plant Quarantine Office
49. Karihaloo, Dr. J. L. NBPGR, New Delhi Research Organisation
50. Kedari, Mr. Thatikonda Manasa Seeds & Pesticides, Andhra Pradesh
Seed Distributor
51. Koundal, Prof. K. R. National Research Centre for Plant Biotechnology (NRCPB),
Research Organization/ Regulatory Committee
124
IARI, New Delhi
52. Krishnika, Ms. A. Dept. of Biotechnology, University of Madras, Chennai
Research Organisation
53. Kulkarni, Dr. R.S. University of Agricultural Science, Bangalore
Research Organisation
54. Kumar, Dr. Alok Monsanto India Ltd., New Delhi Industry 55. Kumar, Dr. Bachchan Nuziveedu Seeds Limited,
Secunderabad Industry
56. Kumar, Dr. C.S.K.Vijay Dept. of Plant Protection, Quarantine & Storage, Faridabad
Plant Quarantine Office
57. Kumar, Dr. P. Ananda NRCPB, IARI, New Delhi Research Organisation
58. Kumar, Dr. P. Sateesh Prabhat Agri Biotech Ltd., Hyderabad
Industry
59. Kumar, Dr. Rajesh Indian Institute of Vegetable Research, Varanasi
Research Organisation
60. Kumar, Mr. Vinod Pro Agro Seeds Co. Pvt.Ltd., Gurgaon
Industry
61. Lalage, Mr. S. B. Nirmal Seeds Pvt. Ltd., Jalgaon Industry 62. Maithal, Dr. K. Dabur Research Foundation,
Ghaziabad Industry
63. Mann, Dr. Anita CCS Haryana Agricultural University, Hisar
Research Organisation
64. Marwaha, Dr. S. S. Punjab State Council of Science and Technology, Chandigarh
State Government
65. Mehetre, Dr. Subhash S. Mahatma Phule Krishi Vidhyapeeth, Rahuri
Research Organisation
66. Mishra, Dr. D. S. Ministry of Agriculture, New Delhi Central Government 67. Mishra, Dr. Hari S. Bhabha Atomic Research Centre
(BARC), Mumbai Research Organisation
68. Misra, Prof. Ashok Indian Institute of Technology (IIT), Bombay
Research Organization
69. Mohan, Mr. D. V. R. Krishna Sri Krishna Agencies, Hyderabad Seed Distributor
70. Muralidharan, Mr. Y. G. Consumer Rights Education Awareness Trust, Bangalore
NGO
71. Murthi, Mr. Yada Kisan Enterprises, Andhra Prades
Seed Distributor
72. Muthusamy, Dr. A. School of Life Science, Jawaharlal Nehru University, New Delhi
Research Organisation
73. Muthuswamy, Dr. Vasantha ICMR, New Delhi Central Government/ Regulatory Committee
74. Nair, Dr. N. V. Sugarcane Breeding Institute, Coimbatore
Research Organisation
75. Nandi, Dr. S. K. G.B. Pant Institute of Himalayan Environment & Development, Kosi-Katarmal, Almora
Research Organisation
76. Pandey, Dr. Ashok Regional Research Laboratory, CSIR, Trivandrum
Research Organisation
125
77. Pandiyan, Mr. S. Sri Lakshmi Agro Centre, Salem Seed Distributor
78. Parida, Dr. Ajay M. S. Swaminathan Research Foundation, Chennai
Research Organisation
79. Parihar, Dr. Dwarkesh S. Bioseed Research India Pvt. Ltd., Hyderabad
Industry
80. Patel, Mr. Vikram R. International Agri Equipments, Himatnagar, Gujarat
Seed Distributor
81. Patil, Dr. Sudam C. Mahatma Phule Krishi Vidhyapeeth, Rahuri, Maharashtra
Research Organisation
82. Patil, Mr. P.S. Pioneer Overseas Corporation, Lucknow
Industry
83. Prabhu, Dr. K. V. Department of Genetics, IARI, New Delhi
Research Organisation
84. Prasad, Dr. Jagdish Plant Quarantine Station, Kandla Plant Quarantine Office
85. Purohit, Dr. Hemant J NEERI, Nagpur Research Organisation
86. Rafiulla, Mr. A. B. Directorate of Seed Certification, Coimbatore
State Government
87. Raj, Mr. Prithvi Department of Agriculture, Haryana
State Government
88. Rajan, Dr. NBPGR, New Delhi Plant Quarantine Office
89. Rajput, Dr. J.C. Nirmal Seeds Pvt. Ltd., Jalgaon Industry 90. Ramachandra, Dr. N. G. Pioneer Overseas Corporation,
Lucknow Industry
91. Ramanaiah, Dr. T.V. Department of Biotechnology, New Delhi
Central Government/ Regulatory Committee
92. Ramanathan, Dr. Vai Metahelix Life Sciences Pvt. Ltd., Bangalore
Industry
93. Ramasamy, Dr. K. TNAU, Coimbatore Research Organisation
94. Randhawa, Dr. (Mrs.) Gurinderjit NBPGR, New Delhi Research Organisation
95. Rao, Dr. C. Kameswara Foundation for Biotechnology Awareness and Education, Bangalore
NGO
96. Rao, Dr. Kota Venkateswara Distributors, Hyderabad Seed Distributor
97. Rao, Dr. Mala National Chemical Laboratory, Pune
Research Organisation
98. Rao, Dr. S. R. OSD to Minister of Science & Technology, New Delhi
Central Government
99. Raveendran, Dr. T.S. TNAU, Coimbatore Research Organisation
100. Reddy, Dr. V. Siva International Centre for Genetic Engineering & Biotechnology (ICGEB), New Delhi
Research Organisation
126
101. Reddy, Mr. V. Shyamsunder Mahyco Seeds Limited, Hyderabad
Seed Distributor
102. Sarala, Dr. K. Central Tobacco Research Institute (CTRI), Hyderabad
Research Organisation
103. Saxena, Dr. Sanjay The Energy & Resources Institute – School of Advanced Sciences (TERI-SAS), New Delhi
Research Organisation
104. Sengottaiyan, Mr. S. Department of Agriculture, Tamil Nadu
State Government
105. Shah, Shri J. V. Farmer, Ahmedabad Farmer
106. Shanmugam, Dr. T. R. TNAU, Coimbatore Research Organisation
107. Sharma, Dr. M. K. MAHYCO, Mumbai Industry 108. Sharma, Dr. R.P. NRCPB, IARI, New Delhi Research Organization/
Regulatory Committee 109. Sharma, Dr. T. R. NRCPB, IARI, New Delhi Research Organisation
110. Sharmili S., Ms. Aruna Dept. of Biotechnology, University of Madras, Chennai
Research Organisation
111. Shastry, Dr. P.P. Jawaharlal Nehru Krishi Vishwa Vidyalaya (JNKVV), Khandwa, Madhya Pradesh
Research Organisation
112. Shekar, Mr. V. B. Basant Agro Tech (I) Ltd., Akola Industry 113. Sheshu Madhav, Dr. M. CTRI, Hyderabad Research Organisation
114. Shirke, Mr. S. V. Nirmal Seeds Pvt. Ltd., Jalgaon Industry 115. Shrivastav, Dr. A. K. Ministry of Health & Family
Welfare, New Delhi Central Government
116. Shukla, Mr. Nitin M. Department of Agriculture, Gujarat
State Government
117. Siaag, Mr. Amar Singh Department of Agriculture, Punjab
State Government
118. Sidhu, Mr. B. S. Department of Agriculture, Punjab
State Government
119. Singh, Dr. A. K. Department of Genetics, IARI, New Delhi
Research Organisation
120. Singh, Dr. Baleshwar NBPGR, New Delhi Plant Quarantine Office
121. Singh, Dr. J.P. Directorate of Plant Protection Quarantine & Storage, Faridabad
Plant Quarantine Office
122. Singh, Dr. Yogendra Institute of Genomics & Integrative Biology, New Delhi
Research Organisation
123. Singh, Mr. Darshan Department of Agriculture, Punjab Punjab Agricultural University, Ludhiana
State Government
124. Singh, Mr. Mewa Punjab Agriculture University, Ludhiana
Research Organization
125. Singh, Mr. Sikandarjit Farmer, Muktsar, Punjab Farmer 126. Singh, Shri Gurdev The Smaj Bhalai Party, Mansa,
Punjab Seed Distributor
127
127. Singh, Shri Joginder Farmer, Hisar Farmer 128. Singh, Shri Surjit Department of Agriculture,
Punjab State Government
129. Sinha, Dr. P. P. Regional Plant Quarantine Station, Kolkata
Plant Quarantine Office
130. Sinha, Mr. R. K. All India Crop Biotechnology Association, New Delhi
Industry Association
131. Sivaramakrishna, Dr. S. Dept. of Biotechnology, ANGRAU, Hyderabad
Research Organisation
132. Sondarva, Mr. R. M. Office of the Deputy Director of Agriculture, Ahmedabad
State Government
133. Srivastava, Dr. Ranjana Central Drug Research Institute, Lucknow
Research Organisation
134. Subramonian, Dr. N. Sugarcane Breeding Institute (ICAR), Coimbatore
Research Organisation
135. Sudhakar, Dr. D. Tamil Nadu Agricultural University (TNAU), Coimbatore
Research Organisation
136. Sudhir R, Mr. Jagtap Pragati Agro Enterprises Pvt. Ltd. Amravati, Madhya Pradesh
Seed Distributor
137. Texla, Mr. Vinod Premraj The Khandesh Agro Agency, Jalgaon, Maharashtra
Seed Distributor
138. Thangam, Mr. P. Ramesh Dept. of Biotechnology, University of Madras, Chennai
Research Organisation
139. Tiwari, Shri Rajkumar Farmer, Jalgaon, Maharashtra Farmer 140. Tripathi, Dr. K. K. Department of Biotechnology,
New Delhi Central Government
141. Twate, Mr. Amit C. FDC Ltd., Mumbai Industry 142. Valani, Mr. P. J. Department of Agriculture,
Gujarat State Government
143. Valsala, Dr. P. A. Centre for Plant Biotechnology & Molecular Biology, College of Horticulture, Kerala Agricultural University, Thrissur
Research Organisation
144. Varshney, Mr. S.C. National Academy of Customs, Excise & Narcotics (NACEN), Faridabad
Central Government
145. Veluthambi, Dr. K. Department of Plant Biotechnology, Madurai Kamraj University, Madurai
Research Organization/ Regulatory Committee
146. Veluthambi, Dr. K. Madurai Kamraj University, Madurai
Research Organisation
147. Verma, Shri Desh Deepak Ministry of Environment and Forests, New Delhi
Central government/ Regulatory committee
148. Vijayan, Shri S. Department of Agriculture, Karnataka
State Government
149. Warrier, Dr. Ranjini Ministry of Environment & Forests, New Delhi
Central Government/ Regulatory Committee
150. Yadav, Dr. Neelam R. CCS Haryana Agricultural University, Hisar
Research Organisation
128
ANNEX-3 COMPILATION OF SUGGESTED AREAS
A. Development of LMOs/GMOs
Need Suggested areas for training/capacity building
Molecular biology skills (e.g. gene isolation, sequencing etc.)
• Isolation of gene responsible for important traits like abiotic stress, quantitative traits
• Gene discovery, cloning, transformation techniques through targeted research projects
Assessment of effects of promoter, enhancers, introns and terminator sequences
• Isolating and characterizing tissue specific promoters and their expression like during early and post-flowering phase in crops, promoter sequences from DNA viruses infecting plants
• Technologies for assessing expression elements
Assessment of marker genes
• Marker gene detection, selective elimination and regulation of expression at all stages from T0 to Tn
• Identification and development of alternative markers (non-antibiotic markers) for transformation
Assessment of genetic stability and limits of gene expression under different conditions
• Multiocation testing, analysis and interpretation for conditional releases in specific environments with statistical consistency
Analysis of molecular data
• Analysis vis a vis breeding behaviour and genetic segregation in populations (proper sampling, etc.)
• Determination of specific event, copy number, genome integration, etc.
Assessment of the extent and effects of gene flow
• Population genetics of transgene pollen dissemination over multiple generations
• Planning/ designing of experiments; short & long-term studies • Methods used to assess extent and effects of gene flow
Evaluation of genetic modifications
• Interactions of modified plants in an environment, silencing, over-expression or inconsistent behaviour in fixed and segregating populations
• Methods for evaluating genetic modifications
129
B. Risk assessment (impact on human health and environment) and other scientific and technical expertise
Need Suggested areas for training/capacity building
Access to reference materials/databases on risk assessment
• Information on archives utilization to access the available scientific data and information on risk assessment
• Compilation of data • Dedicated technical cells within DBT & MoEF to be equipped with
requisite IT tools • Development of international biosafety databases • Organization of symposia and workshops for increasing awareness • Training and guidance material in risk assessment and management
National risk assessment frameworks, principles, procedures and mechanisms
• Application of the framework, principle, and procedures • Revising and updating of existing frameworks, principles, and
procedures
Risk assessment scientific expertise
• Full course on risk assessment, management and communication • Advanced training aimed at developing resource persons
Scientific methods and Protocols for risk assessment
• Institution building and infrastructure and local protocol development • Application of methods and protocols • Development of Centres of excellence to evolve advanced scientific
methods & protocols Competence to review and audit risk assessments
• Full course on risk assessment and management vis a vis food and environment safety
• Advanced training aimed at developing resource persons
National biosafety research
• To be recognised as a national priority and promoted under govt funding
• Biosafety concerns, manifestations, levels and their regulations
C. Risk management .Need Suggested areas for training/capacity building
Detection, management and prevention of unintentional transfer of LMOs
• Practical training on managing and monitoring risks assessed before, during and after the development of LMOs
• Training on development of standards and limits of detection of LMOs
Emergency measures for unintentional LMO releases
• Emergency measures and surveillance of unintentional LMO (both plants and microbes)
• Training on precautionary principle/approaches
Risk management frameworks, strategies and mechanisms
• Operationalization of the risk management strategies on case by case basis
• Application of risk monitoring principles
Tools for monitoring the handling and use of LMOs
• Implication of implementation of the monitoring strategies • Methods of detection reporting and documentation • Methods and procedures for post-release monitoring of
environmental effects of LMOs • Post release monitoring systems
130
D. Regulatory Capacity Building
(i) Legislative and regulatory framework Need Suggested Areas for training /capacity building
Strengthening of legal frameworks
• Implications of implementation of existing provisions in the laws & act • Review of existing provision internationally
Compliance mechanisms
• Implications of implementation of existing provisions in the laws & act
Harmonization of biosafety-related sectoral laws/policies
• Strategies on coordination between and among concerned sectors/departments
• Review of policies and mechanism for monitoring at international level
• Training of industry in legal aspects & enforcement Mainstreaming biosafety into other sectors
• Streamlining jurisdictions and integration of biosafety features in agri product development and commercialization
• Information on principle, procedure and approach followed internationally
Negotiation of bilateral, regional and multi-lateral agreements
• Regional database management and sharing on a case by case basis
Regulatory training (legal, policy, enforcement, inspection etc.)
• Implementation and enforcement of regulation • Training of relevant officials on elements and approaches followed at
international level
Guidelines for the integration of GMO
evaluation in the EIA
System
• Principle, procedures and interpretation of provision in the law and process of evaluation
(ii) Administrative framework
Need Suggested areas for training/ capacity building
Administration of the AIA*
procedure • The whole concept of AIA procedure and risk analysis • Guidance material on handling applications for import and
release of LMOs like manuals on AIA procedures and risk assessment and management
Customs and border control procedures
• Methods on how to do sampling and detection • Guidelines and procedures for border control
Decision-making system and administrative procedures
• Technical and administrative mechanism to handle applications of LMOs
Institutional entities for handling biosafety issues
• Executive mechanisms and consequences
Inter-agency communication and coordination
Mechanisms for considering socio-economic impacts
• Parameter development for impact assessment
Mechanisms for private sector and community involvement
• A one-to-one involvement in integrating information exchange
Mechanisms for review of decisions
• Tools and development of easy fomats case by case sensitivity
131
Monitoring and reporting on implementation of the Protocol
• Post-release monitoring • Development of system for MIS (monitoring information system)
and implementation Emergency measures for unintentional movements
• Post-release monitoring • Identification and development of protocols
(iii) Technical, scientific infrastructures and mechanism for follow-up
Need Suggested areas for training/ capacity building
Border control and inspection facilities
• Infrastructure needs for commercial monitoring • Mechanism for monitoring of enforcement of the
biosafety regulatory regimes • Competence in undertaking inspection and
enforcement to ensure compliance with the biosafety regimes
• Enforcement actions required for handling, transport, use, transit and release of LMOs
Database infrastructure and protocols
• Infrastructure requirement from entry to retrieval and assessment
• Infrastructure for conducting biosafety research, e.g. to determine the effects of LMOs on non-target organisms and the aggressiveness studies for LMOscompared to their non-LMO counterparts
LMO containment (quarantine) facilities
• Detection and quarantine methods
LMO disposal facilities (e.g. incinerators)
• Facilities and equipments for handling LMOs in the greenhouses and confined trials
LMO testing laboratories and equipment
• Certified laboratories for LMO detection • Advancements for quantitative methods of testing
Long-term LMO monitoring and surveillance
• Process of monitoring long term implications of LMOs
• Identification and strengthening of centers of excellence
Methods and mechanisms for detecting unintentional or illegal LMO movement
• Methods and protocols for detection • Development of regulatory framework for it
132
E. Identification of LMOs . Need Suggested areas for training/capacity building
Documentation systems for LMOs shipments
• Registration, documentation and management of database
Guidelines for safe handling, packaging and transport of LMO shipments
• Guidelines for short term, medium and long term storage, assessment, transit material handling
• Policy and guidelines for labeling of GM products
Inspection systems for LMO shipments
• Development of infrastructure (equipment) and trained personnel
• National systems for inspection of LMO shipments • Testing or validation system to identify the presence
or concentration of LMOs Methods and systems for identification of LMOs e.g. unique identification systems
• Methods and systems for identification, detection and traceability of LMOs
• Interpretation and setting quantitation standard for contamination levels
• Development of unique identification systems Systems for segregation of LMOs
• A full programme on what segregation is about and methods of segregation from field to port and port to process/market
• Training of inspectors and custom officials in LMO identification systems
F. Human resources development and training: Legal, social and economic expertise . Need Suggested areas for training/capacity building
Assessment of characteristics of LMOs • Scientific and technical expertise in fields relevant to risk assessment and management
• Post-graduate training in biotechnology and biosafety
Detection, testing and quantitative analysis of LMOs
• Practical implementation of the methods of detection of LMOs
• Training of quarantine staff in handling the LMO imports
Analysis of the linkages between other international agreements and Protocol requirements
• Exchange programmes for the regulatory experts for understanding international agreements
Assessment and integration of socio-economic considerations
• Development of survey formats and evaluation protocols for GM technology applications
• Need for experts for legal, social and economic evaluation
Assessment of trade impacts of biosafety-related measures
• Evaluation of cost of biosafety implementation vis a vis the cost of risks involved with LMOs
Legal drafting and analysis
• Training of decision makers, scientists, administrative and technical staff on legal, scientific and technical issues
• Knowledge of international procedures in the biosafety area of LMOs
• Regulatory expertise including drafting of laws, law enforcement
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Support for case-by-case cost-benefit analysis, review of ethical considerations and relevance of LMOs in addressing societal needs (e.g. food security and nutritional requirements, etc.)
• Scientific appropriateness vis a vis ethical considerations in biotech applications
Dissemination of information to policy makers
• Training guides and manuals • Training in information management
Ex-ante risk benefit and cost-benefit analysis
• Evaluation of novel trait product value & worth vis a vis the cost of risks involved
Training of regulators and pre and post commercialization monitors
• The meaning and implementation methods of post commercialization monitoring
G. Public awareness, education and participation . Need Suggested areas for training/capacity building
Biosafety awareness activities (seminars, radio talks, etc.)
• Structured public awareness and education programmes on biosafety
• Ways to effectively communicate to the public about the national biosafety regulatory system and how it works
Biosafety awareness materials (newsletter/ bulletin, newspaper, etc.)
• Education and awareness materials on biosafety in local languages
• Training guide on public information and participation
Media engagement skills and strategies
• Media training to promote public information on biosafety; skills in engaging the media
• Communicating the risk without risking creation of a panic response
Public access to the Biosafety Clearing-House (BCH)
• Methods for information dissemination about BCH
Public participation in decision-making
• Means of stakeholder and public consultation, including the private sector
Risk communication skills and strategies
• Networks for public awareness through media, seminars, etc.
Timely public access to information on impending LMO imports
• Methodologies for effective outreach regarding biosafety
H. Information exchange & data management (including the Biosafety Clearing-House) . Need Suggested areas for training/capacity building
Biosafety Clearing House (BCH)
• Support for translation of data and reports for submission to the BCH
• Standards for producing and validating data related to LMOs to be entered in the BCH
Web based databases
• On line tutorials, make central portal or web-based resources for the scientific information available
• Creation and maintenance of national databases and information registries
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Non internet based electronic exchange material (e.g. CD ROMs, fax, etc.)
• Tutorials of data acquisition and submission to database
• Exchange and distribution of CDs
Sub-regional and regional node of the BCH
• Support for development of sub-regional and regional node of the BCH where country information can be accessed
Print media
• Access to available scientific information and case studies through journals
I. Scientific, technical and institutional collaboration Need Suggested areas for training/capacity building
Access to information on available opportunities for collaboration and sharing of experiences
• Networking with equal online access system to all stakeholders
• Needs to be shared through workshops/ seminars Establishment of inter-institutional networks and communications, and interaction with the public
• Opportunities for laboratory networking • Scientific cooperation in the field of biosafety (joint
research, establishment of joint biosafety laboratory and scholar exchange)
Establishment of mechanisms for regional and international cooperation and sharing of experiences
• Mechanisms for exchange of experts at the national and regional levels
• Mechanisms for international cooperation and communication in biosafety
J. Technology transfer Need Suggested areas for training/capacity building
Access to proprietary technologies on preferential terms
• No particular training required, but awareness camps on the implications required
Analysis of appropriate technologies
• Capability to handle the biosafety in terms of technology transfer and to absorb the technologies
Enabling policies and incentives for technology transfer
• Thorough education on policy shortcomings, implications
• Enabling policies and incentives for technology transfer
Management of intellectual property rights
• IPR regime and its implications, cost of application and violations (case studies)
Technologies for handling, transport, packaging and identification of LMOs
• Guidelines and methods based on risk levels and recommendations of release of the technology
Technologies for information exchange/data management
• Information from A to Z of the data management and information usage
Technologies for monitoring of LMOs
• Technologies for risk assessment and monitoring of LMOs
Technologies for risk assessment of LMOs
• Use and application formats for data generation, interpretation and management of the risk assessed
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K. Socio-Economic Considerations . Need Suggested areas for training/capacity building
Mechanism for determining value-added to specific sector/industry
• Primary mechanisms for in situ determination of value to our commodities
Mechanism for determining value-added to specific socio-economic group
• Critical analysis of value added to its impact on amelioration of target ailment, scarcity and inadequacy
Mechanism for review of case-by-case cost-benefit analysis
• Impact analysis of each new GM product upon usage in a social situation
Competence to review/analyze cost-benefit assumptions
• Skills and methods for risk-benefit analysis of LMOs
Public Access to information covering cost-benefit analyses
• Public access on information of loss-gain vis a vis cost involved in applying the GM use
L. Sustainable use and conservation of biodiversity . Need Suggested areas for training /capacity building
Mechanism for mainstreaming biosafety in the environment and natural resources sector
• Need for each transformation group to first undergo basic biosafety training before initiating transformation
Assessment of impact on non-target organism (above and below ground organisms)
• Studies on taxonomy and interspecific, intergeneric hybridization consequences
• Studies of impact of LMO on non-target organisms
Assessment of impact on wildlife populations and native species
• Population dynamics in self and cross pollinated populations, feral and wild populations
Potential for weediness or invasiveness
• Studies on pest potential, weediness and invasiveness consequences on ecology
Awareness training on laws and policies on environment and natural resources
• Implications of applying laws enacted on biotech industry and environment like IPCC guidelines, etc.
Impact of GMO on traditional farming systems
• Impact analysis of coexistence of GM and traditional varieties in an environment
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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 India’s 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 (viz-workshops/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.
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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.