training need analysis tna report

7/23/2019 training need analysis Tna Report

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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


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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


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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

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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

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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

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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.

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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

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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);

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(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

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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

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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.

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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

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(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.

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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

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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.

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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.

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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.


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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/


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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).

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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

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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.


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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


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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


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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


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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 &

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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.

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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

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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,

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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

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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

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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.

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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

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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,

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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.

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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

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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.

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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

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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.

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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.

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(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.

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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.

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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.

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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

training need analysis tna report

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