training need analysis Tna Report
-
Upload
neeraj00715925 -
Category
Documents
-
view
223 -
download
0
Transcript of training need analysis Tna Report
-
7/23/2019 training need analysis Tna Report
1/154
-
7/23/2019 training need analysis Tna Report
2/154
-
7/23/2019 training need analysis Tna Report
3/154
-
7/23/2019 training need analysis Tna Report
4/154
-
7/23/2019 training need analysis Tna Report
5/154
-
7/23/2019 training need analysis Tna Report
6/154
Contents
Page
CHAPTERS
Executive Summary i-ix
1. INTRODUCTION 1
2. METHODOLOGY 3
3. APPLICATIONS OF GMOs IN AGRICULTURE 63.1 Global Status
3.2 Status in India
4. REGULATORY FRAMEWORK IN INDIA 144.1 Government Rules for GMOs, 19894.2 Recombinant DNA Guidelines, 19904.3 Guidelines for Research in Transgenic Plants, 19984.4 Seed Policy, 20024.5 Prevention of Food Adulteration Act, 19544.6 The Food Safety and Standards Bill, 20054.7 Plant Quarantine Order 20034.8 Task Force on Application of Agricultural Biotechnology4.9 Draft National Environment Policy, 20044.10 Draft National Biotechnology Strategy 2005
5. CARTAGENA PROTOCOL ON BIOSAFETY 355.1 Introduction5.2 Objective5.3 Elements of the Protocol5.4 Status of Implementation in India5.5 Other International Agreements
6. AREAS COVERED FOR TRAINING NEEDS ASSESSMENT 456.1 Development of GMOs6.2 Risk Assessment6.3 Risk Management6.4 Regulatory Capacity Building6.5 Identification of LMOs6.6 Human Resources Development and Training6.7 Public Awareness, Education and Participation6.8 Information Exchange & Data Management6.9 Scientific, Technical and Institutional Collaboration6.10 Technology Transfer
6.11 Socio-Economic Considerations6.12 Sustainable Use and Conservation of Biodiversity
-
7/23/2019 training need analysis Tna Report
7/154
Page
7. FINDINGS OF THE FIELD SURVEY 577.1 Priority Ranking of Areas and Suggestions for Capacity Building7.2 Means of Sharing Information7.3 Duration of the Training Programmes
8. IDENTIFICATION OF TRAINING NEEDS 748.1 Stakeholders8.2 Training Needs Matrix
9. OVERVIEW OF EXISTING TRAINING PROGRAMMES 81
9.1 Series of Workshops9.2 National Events9.3 International Events9.4 Training Programmes by Private Sector9.5 Websites9.6 Publications9.7 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 137MEETING
-
7/23/2019 training need analysis Tna Report
8/154
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 Indias national capacity to implement the Cartagena Protocol on
Biosafety. The specific objectives of the project include strengthening the institutional and
legal framework, to improve capacity and coordination in decision making across
Ministries, improve capacity for risk evaluation and management etc. Training being one of
the key elements for achieving the above, MoEF has carried out a Training Needs
Assessment Survey with the assistance from Biotech Consortium India Limited (BCIL) to
i
-
7/23/2019 training need analysis Tna Report
9/154
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
-
7/23/2019 training need analysis Tna Report
10/154
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 countrys 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
-
7/23/2019 training need analysis Tna Report
11/154
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, industryrepresentatives, 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 Btcotton 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
-
7/23/2019 training need analysis Tna Report
12/154
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 andBCIL 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
-
7/23/2019 training need analysis Tna Report
13/154
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 internationalexperts, 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
-
7/23/2019 training need analysis Tna Report
14/154
(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 agriculturalextensionists) 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
-
7/23/2019 training need analysis Tna Report
15/154
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 planningnational 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
-
7/23/2019 training need analysis Tna Report
16/154
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 harmonizationof 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
-
7/23/2019 training need analysis Tna Report
17/154
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 thetwo 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
-
7/23/2019 training need analysis Tna Report
18/154
(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
-
7/23/2019 training need analysis Tna Report
19/154
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
-
7/23/2019 training need analysis Tna Report
20/154
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 andtechnology
3. Regulatory bodies GEAC, RCGM, SBCCs and DLCs,
4. Private industry (includingimporters and exporters)
Seed companies, processed food companies
5. Public sector researchorganizations
R&D institutes affiliated to CSIR, ICAR, universitydepartments, state agriculture universities
6. Social experts Social scientists, legal experts, media representatives
7. Agriculture serviceproviders
Seed distributors and dealers, agriculture extensionworkers, input (agrochemicals) suppliers
8. Civil organizations andothers
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
-
7/23/2019 training need analysis Tna Report
21/154
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 countrys
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
-
7/23/2019 training need analysis Tna Report
22/154
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 evensequences synthesized in vitrocan 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.
-
7/23/2019 training need analysis Tna Report
23/154
7
Table 3.1: Transgenic crops approved for commercial use
S. No. Crop Uses Countr ies where approved
1. Al fal fa Herbicide tolerance U.S., Canada, Mexico
2. ArgentineCanola
Herbicide tolerance andimproved protection againstweeds
Canada, US, Japan, Australia
3. Carnation Increased shelf life by delayedripening, modified flowercolour and herbicide tolerance
Australia, European Union
4. Chicory Herbicide tolerance, improvedprotection against weeds andhigher yields
European Union
5. Cotton Improved insect protection,herbicide tolerance andimproved protection againstweeds
Japan, Australia, US, China, Mexico,South Africa, Argentina, India, Indonesia,Philippines, Brazil
6. Flax,Linseed
Herbicide tolerance, antibioticresistance and improvedweed protection
Canada, US
7. Greenpepper
Virus resistance China
8. Maize Herbicide tolerance, improvedweed protection, resistanceagainst insects and restoredfertility of seeds
Canada, Japan, US, Argentina, EuropeanUnion, 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., Canada11. Polish
CanolaHerbicide tolerance andimproved weed control
Canada
12. Potato Improved protection frominsect and leaf roll virus
US, Canada ,Japan ,Australia,Philippines
13. Rice Herbicide resistance US
14. Soybean Improved weed control andherbicide tolerance, increasedcooking quality
US, Argentina, Japan, Canada, Uruguay,Mexico, Brazil and South Africa, CzechRepublic, European Union, Korea,Russia, Switzerland, Taiwan, U.K.,Philippines and Australia
15. Squash Resistance againstwatermelon mosaic virus andzucchini yellow mosaic virus
US, Canada
16. Sugarbeet
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, improvedinsect resistance, virusresistance
US, Mexico, Japan, China, Canada
20. Wheat Herbicide Tolerance U.S.
Source: http://www.agbios.com/
http://www.agbios.com/http://www.agbios.com/ -
7/23/2019 training need analysis Tna Report
24/154
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
27.8
39.944.2
52.658.7
67.7
81.0
0
10
20
30
40
50
60
70
80
90
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
http://www.isaaa.org/http://www.isaaa.org/ -
7/23/2019 training need analysis Tna Report
25/154
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 toconsumers 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
http://www.isaaa.org/http://www.isaaa.org/ -
7/23/2019 training need analysis Tna Report
26/154
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 thuringiensisis
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, Btcotton, 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 Crygenes.
-
7/23/2019 training need analysis Tna Report
27/154
11
Table 3.2: Transgenic crops under development and field trials
S. No Crop Organization Transgene
1. Brinjal Mahyco, Mumbai cry1AcSungro Seeds Ltd, New Delhi cry1AcIARI, New Delhi cry1F
2. Cabbage Sungro Seeds Ltd, New Delhi cry1Ac
3. Cauliflower Sungro Seeds Ltd, New Delhi cry1Ac
4. Corn Monsanto, Mumbai Cry1AbMetahelix Life Sciences, Bangalore Modified Mu-element
(Turbo-Mu)
5. Cotton Ajeet Seeds, Aurangabad cry1Ac, cryXAnkur Seeds P. Ltd., Nagpur cry1Ac, cryXM/s Bioseed Research India Pvt Ltd, Hyd cry1Ac, cryXM/s Emergent Genetics India P. Ltd, Hyd cry1Ac, cryXGanga Kaveri Seeds Ltd, Hyderabad cry1AcGreen Gold Seeds Ltd, Aurangabad GFM cry1AaJK Agri Genetics, Hyderabad cry1AcM/s Kaveri Seeds Co. P. Ltd, Sbad cry1AcKrishidhan Seeds, Jalna cry1Ac, cryXMahyco, Mumbai cryXMetahelix Life Sciences, Bangalore cry1AcNandi Seeds Pvt. Ltd Mehbubnagar cry1AcNamdhari Seeds Pvt. Ltd, Bangalore cry1AcNath Seeds, Aurangabad GFM cry1AaNuziveedu Seeds, Hyderabad cry1Ac, cryX
Prabhat Agri Biotech Ltd. Hyderabad cry1AcPravardhan Seeds Pvt. Ltd Hyderabad cry1AcProagro Seeds Co. Ltd Hyderabad cry1AcRasi Seeds Ltd., Attur cryXSyngenta India Ltd., Pune Vip-3ATulsi Seeds, Guntur cry1Ac, cryXUAS, Dharwad cry1AcVibha Agrotech Ltd. Hyderabad cry1AcVikkis Agrotech, Hyderabad cry1AcVikram Seeds Ltd, Ahmedabad cry1AcZuari 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 + cry1BMahyco, Mumbai cry1AcMetahelix Life Sciences, Bangalore NHX gene
11. Tomato IARI, New Delhi antisense replicase gene of
tomoto leaf curl virusMahyco, Mumbai cry1Ac
Source: Department of Biotechnology, Government of India
-
7/23/2019 training need analysis Tna Report
28/154
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, Pantnagar9. 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, Sbad
9. Krishidhan Seeds, Jalna
10. Mahyco, Mumbai
11. Metahelix Life Sciences, Bangalore
12. Monsanto, Mumbai
-
7/23/2019 training need analysis Tna Report
29/154
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. Vikkis Agrotech, Hyderabad
26. Vikram Seeds Ltd, Ahmedabad
27. Zuari Seeds Ltd. Bangalore
-
7/23/2019 training need analysis Tna Report
30/154
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
-
7/23/2019 training need analysis Tna Report
31/154
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 RCGMs approval.
To inform DLC and SBCC as well as GEAC about the experiments where
ever needed.
15
-
7/23/2019 training need analysis Tna Report
32/154
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
-
7/23/2019 training need analysis Tna Report
33/154
-
7/23/2019 training need analysis Tna Report
34/154
-
7/23/2019 training need analysis Tna Report
35/154
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:
Appl icant
IBSC functionsTo 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 safeand agronomically viabletransgenics to RCGM/GEAC
MEC
GEAC functions:To approve for large scaleuse, open release in toenvironment
ICAR Trials
To generate complete agronomicdata and to recommend forcommercial release of GM crops
ICAR
To inform decision to Ministry of Agriculture& to inform applicants to follow the relevantActs and Rules
Seeds Act/Rules
Release for commercialagriculture
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
-
7/23/2019 training need analysis Tna Report
36/154
-
7/23/2019 training need analysis Tna Report
37/154
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
-
7/23/2019 training need analysis Tna Report
38/154
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 andmarketed 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 consumers health through chemical, biological or other
contaminants, it has set up a food control system that includes the national, state
and municipal organizations involved in either the regulation, inspection or analysis
of food and agricultural products, together with their supporting legislation and rules
and compliance activities.
The 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
-
7/23/2019 training need analysis Tna Report
39/154
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
CentralCommitteefor Food
Standards andits Sub-
Committeesfor Framing of
Rules/Standards offood Articles
NationalMonitoring
Agency forIrradiation
ofFood
Coordinationwith National
andInternational
Organizations/Consumer
Organizations/Industries
CentralFood
Laboratories(4)
NationalCodex
Committeeand its
ShadowCommittees
Source: A contemporary approach to food quality and safety standards; Ministry of Health and FamilyWelfare 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
http://www.codexindia.nic.in/http://www.codexindia.nic.in/ -
7/23/2019 training need analysis Tna Report
40/154
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
-
7/23/2019 training need analysis Tna Report
41/154
-
7/23/2019 training need analysis Tna Report
42/154
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, additionand 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
-
7/23/2019 training need analysis Tna Report
43/154
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
-
7/23/2019 training need analysis Tna Report
44/154
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 ina 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
-
7/23/2019 training need analysis Tna Report
45/154
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
-
7/23/2019 training need analysis Tna Report
46/154
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
-
7/23/2019 training need analysis Tna Report
47/154
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
-
7/23/2019 training need analysis Tna Report
48/154
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
-
7/23/2019 training need analysis Tna Report
49/154
(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
-
7/23/2019 training need analysis Tna Report
50/154
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
-
7/23/2019 training need analysis Tna Report
51/154
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 canmake 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
-
7/23/2019 training need analysis Tna Report
52/154
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