BIOSAFETY ISSUES RELATED TO

TRANSGENIC CROPS
(With Focus on Bt Cotton)

PREPARED BY

BIOTECH CONSORTIUM INDIA LIMITED,

NEW DELHI

IN ASSOCIATION WITH

MINISTRY OF ENVIRONMENT AND FORESTS

GOVERNMENT OF INDIA

JANUARY 2005
 FOREWORD
Commercial cultivation of Bt cotton as the first transgenic crop in the country was
approved by Government of India in March 2002. In the same year, BCIL in
association with the Ministry of Environment & Forests (MoEF) and the Department
of Biotechnology (DBT) organized a series of eight workshops at selected locations
in the country to create awareness about the biosafety issues related to genetically
modified organisms (GMOs). These were attended by stakeholders including
scientists, industry, policy makers, farmers and NGOs and helped in a close
interaction and appreciation of the issues involved.

In 2004, another series of workshops on transgenic crops was organized by BCIL

and MOEF in Aurangabad, Coimbatore, Hyderabad, Dharwad, Ahmedabad and
Indore. The locations chosen were in the six Bt cotton growing states. The
participants also visited Bt cotton fields or transgenic crops research facilities near
four of the centers for interaction with the farmers and the scientists. Thus, these
workshops helped in capacity building for effective monitoring.

Since 2002, through the three seasons of cultivation, the area under Bt cotton grew
from 30,000 Ha to 5,30,000 Ha in 2004. Prima facie, the growth clearly points to a
general acceptance of the crop by the farmers and the cotton processing industry.

The present series of six workshops is expected to bring much greater clarity on the
value of transgenic crops through the experience of the farmers and other
stakeholders. Apart from the six Bt cotton growing states of Andhra Pradesh,
Gujarat, Karnataka, Madhya Pradesh, Maharashtra and Tamil Nadu, it is proposed
to cover Punjab, Haryana and Rajasthan where large-scale field trials of Bt cotton
are under way.

In this document, BCIL has attempted to cover briefly the science and applications of
transgenic crops, biosafety issues to be addressed, the regulatory framework and
the present status of commercial cultivation in India as well as globally. The
compilation was done by Dr. Vibha Ahuja, Deputy General Manager assisted by Mr.
Anil Kumar Bhushan, Manager and others at BCIL. We gratefully acknowledge the
valuable guidance from Shri. Desh Deepak Verma, Joint Secretary and Dr. Ranjini
Warrier, Additional Director, MoEF and Dr. K.K. Tripathi, Adviser and Dr. T.V.
Ramanaiah, Director, DBT.

New Delhi Dr. S. R. Nair

January 20, 2005 Managing Director, BCIL
 Contents

Page

CHAPTERS

1. INTRODUCTION 1

2. PRODUCTION OF TRANSGENIC CROPS 4

2.1 What are transgenic crops? 4
2.2 Why make transgenic crop plants? 4
2.3 How to produce transgenic crops? 5

3. APPLICATIONS AND BENEFITS OF TRANSGENIC 11

CROPS
3.1 Insect resistance 12
3.2 Herbicide tolerance 13
3.3 Disease resistance 14
3.4 Product quality improvement 14
3.5 Resistance to environmental stresses 16
3.6 Yield improvement 16
3.7 Plant based pharmaceuticals 17

4. CONCERNS 18
4.1 Risk to human health 18
4.2 Risk to environment 19

5. BIOSAFETY REGULATIONS IN INDIA 21

5.1 Rules, 1989 21
5.2 Recombinant DNA Guidelines, 1990 23
5.3 Guidelines for Research in Transgenic Plants, 25
1998
5.4 Seed Policy, 2002 27

6. SAFETY ASSESSMENT OF GM CROPS 28

7. GLOBAL STATUS OF COMMERCIAL TRANSGENIC 31

CROPS
7.1 Crops approved for commercial use 31
7.2 Area under cultivation 33
8. STATUS OF TRANSGENIC CROPS IN INDIA 38
8.1 In commercial use 38
8.2 Ongoing field trials 38
8.3 Crops under research and development 40
8.4 Organizations engaged in transgenic research 41

9. CASE STUDY OF Bt COTTON 43

9.1 Background 43
9.2 Global status 44
9.3 Indian status 45

ANNEXES

1. Ministry of Environment and Forests’ Notification: 51

Rules for the manufacture, use/import/export and storage
of hazardous microorganisms/genetically engineered
organisms or cells, 1989

2. National Seeds Policy 2002 72

3. Notification dated November 12, 2002 designating 88

Central Institute of Cotton Research as the referral
laboratory for Bt cotton seeds
 CHAPTER 1
INTRODUCTION

Bt cotton was approved by Government of India in March

2002 as the first transgenic crop for commercial cultivation for a
period of three years. Bt cotton incorporates a gene from a
bacterium Bacillus thuringiensis, which is effective against the
American bollworm, the major pest on cotton. Bt cotton has since
been grown in six states, i.e., Madhya Pradesh, Gujarat,
Maharashtra, Andhra Pradesh, Karnataka and Tamil Nadu. The
area under Bt cotton from 72,000 acres in 2002 increased to
2,30,000 acres in 2003 and 13,00,000 acres in 2004. Initially,
three hybrids produced by M/s Maharashtra Hybrid Seeds
Company Ltd. (MAHYCO) were approved in 2002. Other seed
companies such as M/s Rasi Seeds, M/s Ankur Seeds, M/s.
Krishidhan Seeds and M/s Ajeet Seeds have initiated
development of Bt cotton hybrids in association with MAHYCO.
On April 1, 2004, one hybrid of M/s Rasi Seeds has been
accorded approval for commercial cultivation and 12 more
varieties are under large scale field trials. Companies such as
Nath Seeds, Syngenta and J.K. Agrigenetics are developing
transgenic cotton using different genes/events.

Apart from cotton, there are more than 20 crops under

research and development in about 50 public and private sector
organizations in India. These include rice, potato, brinjal,
cabbage, cauliflower, groundnut and pigeon peas. The target traits
include insect resistance, herbicide tolerance, viral and fungal
disease resistance and stress tolerance. Out of these, 13 crops
have been approved for contained limited field trials in India.
These are mostly related to insect resistance using Cry genes.

These first generation transgenic crops afford higher crop

yields, reduced farm costs, increased profit and improvement in
the environment. Next generation of transgenic crops which
feature increased nutritional and/or industrial traits are expected to
have more direct benefits to consumers. Examples are rice
enriched with iron and vitamin A, potatoes with higher starch

1
content, edible vaccines in maize and potatoes and healthier oils
from soybean and canola.

However, as more and more transgenic crops are being

released for field-testing and commercialization, concerns have
been expressed about the potential risks associated with their
impact to human health, environment and biological diversity.
Questions centre around increased toxicity and allergenicity,
impact of introduced traits introgressing into other related species
through out crossing, the potential buildup of resistance in insect
populations to engineered insecticidal traits, unintended
secondary effects on non-target organisms, and potential effects
on biodiversity

Biosafety legislation and regulatory institutions to

implement them have been put in place by many countries
including India, engaged in transgenic research and
commercialization. There are elaborate steps to manage these
risks and it is the responsibility of the scientists, industry, and the
government to assure the public of the safety of the novel
products commercialized.

India has a well-defined regulatory mechanism for

development and evaluation of GMOs including transgenic crops
and the products thereof. Rules notified in 1989 under
Environmental Protection Act, 1986 (EPA) define the competent
authorities and composition of such authorities for handling
regulation of GMOs and products thereof. Presently, there are six
competent authorities:

i. Recombinant DNA Advisory Committee (RDAC)

ii. Review Committee on Genetic Manipulation (RCGM)
iii. Genetic Engineering Approval Committee (GEAC)
iv. Institutional Biosafety Committees (IBSC) attached to
every organization engaged in rDNA research
v. State Biosafety Coordination Committees (SBCC)
vi. District Level Committees (DLC).

2
 Guidelines for safety in biotechnology have been issued by
the Department of Biotechnology (DBT) in 1990 covering
research, field trials and commercial applications. DBT also
brought out separate guidelines for research in transgenic plants
in 1998. The National Seed Policy, 2002 also has a separate
section on transgenic plant varieties.

As the first commercial transgenic crop in the country, Bt

cotton has been subject to extensive monitoring by both at the
central and the state levels during the last three years of
commercial cultivation. Simultaneously, there have been various
initiatives towards capacity building of various stakeholders. A
series of eight workshops on “Biosafety issues related to GMOs”
was organized in 2002 by Biotech Consortium India Limited in
association with Ministry of Environment & Forests (MoEF),
Government of India and Department of Biotechnology, Govt. of
India. MoEF sponsored another series of workshops on
“Biosafety issues related to transgenic crops” in 2003 in the six Bt
cotton growing states covering various stakeholders such as
government officials, research institutions, agricultural universities,
NGOs and farmers for sensitization and creation of awareness.

In the present second series of workshops being organized

in the states where Bt cotton is grown during the last three years,
MoEF proposes to interact with all the stakeholders to share the
experience of first transgenic crop in the country. In addition, two
workshops are proposed to be held in the Northern region for the
states of Punjab, Haryana and Rajasthan where large scale trials
of Bt cotton are underway. This background document prepared
by Biotech Consortium India Limited (who are organizing these
workshops) in association with MoEF aims to provide an update
and overview of transgenic crops, their applications and the status
of regulations and approvals.

3
 CHAPTER 2
PRODUCTION OF TRANSGENIC CROPS

For thousands of years, farmers have relied on selective

breeding and cross-fertilization to impart desirable traits in plants
such as higher yields and resistance to pests. Through trial and
error, plant varieties have been developed with altered and stable
genetic traits. However, over the past 30 years, the ability to alter
life forms have been revolutionized by modern biotechnology.
Using sophisticated techniques of genetic engineering or
recombinant DNA technology, it is now possible to precisely
manipulate the intricate genetic structure of individual living cells
by incorporating genes from totally different species. Bacterial
genes can be used to make insect resistant crops or genes from a
coldwater fish can be used to create frost resistant plants. The
resulting organisms are known as genetically modified organisms
(GMOs) or living modified organisms (LMOs). When the GMO is a
crop plant, it is a GM crop or transgenic crop.

2.1 WHAT ARE TRANSGENIC CROPS?

A transgenic plant contains a gene or genes of a different

species artificially inserted in its genome. The inserted gene
sequence known as ‘transgene,’ may come from an unrelated
plant or from a completely different species. For example, Bt
cotton is a transgenic cotton plant, which incorporates a gene from
the bacterium Bacillus thuringiensis. Bt produces crystalline
inclusions (parasporal body) during sporulation. The parasporal
body comprises crystal proteins of various size, shape and
morphology. The biological use of Bt in insect pest control is
centered on the exploitation of these crystal proteins especially ∂-
endotoxins. These crystalline proteins are found to be highly toxic
to agriculturally important pests at very low concentrations

2.2 WHY MAKE TRANSGENIC CROP PLANTS?

Conventional plant breeding involves exchange of genes

between plants of the same species or from closely related plants
to produce a hybrid having desired traits. This crossbreeding

4
however is limited to exchange between the same or closely
related species. Therefore, it requires a long time to achieve the
desired results as sometimes a related species having the
characteristics of interest may not be found and incorporation of
undesired characters such as origin of new pest and disease
incidences may occur. Genetic engineering enables transfer of
genes more easily across taxonomic boundaries. The useful
genes can be introduced not just from within the crop species or
from closely related plants but even from a wide range of other
organisms. This gives a wider range of traits to choose from with
the transfer being undertaken in a more controlled and predictable
way. Transgenic crop plants can therefore incorporate the desired
traits more quickly and more reliably than through conventional
methods.

2.3 HOW TO PRODUCE TRANSGENIC CROPS?

Transgenic crops are produced through genetic

engineering in which genes that code for desirable traits are
transferred from one organism to another.

The universal presence of DNA (deoxyribonucleic acid) in

the cells of all living organisms is the basis for development of
transgenic plants (Figure 2.1). This molecule stores the
organism’s genetic information which further is responsible for
metabolic processes.

5
Phosphate P
Sugar (ribose) S
Bases

guanine G
cytosine C
adenine A
thymine T

Figure 2.1: DNA double helix

Source: Eric S. Grace, “Biotechnology Unzipped”, Universities Press, Hyderabad, 1997

6
 Genetic information is specified by the sequence of four
chemical bases (adenine, cytosine, guanine and thymine) along
the length of the DNA molecule, joined with deoxyribose and
phosphate groups. The combined unit is a nucleotide. These
bases couple selectively, that is adenine with guanine (A-G) and
cytosine with thymine (C-T).

Genes are a sequence of nucleotides. Once the sequence

is defined, the gene has no special relationship with the organism
in which it is found. The combinations of the bases form the
genetic words called codons. The genetic information is
expressed in the form of proteins via intermediary molecules of
ribonucleic acid (RNA) and the properties of every organism are
determined by the proteins it is made of. Since the genetic code
is a universal code, a DNA segment from one organism (e.g.
bacteria) can be interpreted and transmitted into a functional
protein in another organism (e.g. plant).

Genetic engineering begins with the identification of the

gene(s) responsible for a trait of interest. The most important
tools for genetic engineering are enzymes that perform specific
functions on DNA. Restriction enzymes recognize and cut the
DNA at a specific region and the other enzymes known as ligases
join the ends of two DNA fragments. The use of these enzymes
enables the manipulation of DNA even in unrelated organisms
(Figure 2.2).

7
 Figure 2.2: DNA fragmenting by restriction enzymes
Source: Eric S. Grace, “Biotechnology Unzipped”, Universities Press, Hyderabad, 1997

Identifying and locating genes for agriculturally important

traits is currently the most limiting step in the development
process. Relatively little is known about the specific genes
required to enhance yield potential, improve stress tolerance,
modify chemical properties of the harvested product, or otherwise
affect plant characters. Further, identifying a single gene related to
a trait alone is not sufficient; it is also important to understand how
the gene is regulated, what other effects it might have on the
plant, and how it interacts with other genes active in the same
biochemical pathway.

Once a gene has been isolated and cloned (amplified in a

bacterial vector), it must undergo several modifications before it
can be effectively inserted into a plant. A promoter sequence
must be added for the gene to be correctly expressed (i.e.,
translated into a protein product). The promoter is the on/off

8
switch that controls when and where in the plant the gene will be
expressed. Sometimes, the gene is also modified to achieve
greater expression in a plant. The termination sequence signals to
the cellular machinery that the end of the gene sequence has
been reached. A selectable marker gene is added to the gene
"construct" in order to identify plant cells or tissues that have
successfully integrated the transgene. This is necessary because
incorporation and expression of transgenes in plant cells is a rare
event, occurring in just a small portion of the targeted tissues or
cells.

Two primary methods currently exist for introducing

transgenes into plant genomes, a process also referred to as
transformation.

The first involves a device called a ‘gene gun.’ The DNA to

be introduced into the plant cells is coated onto tiny particles.
These particles are then physically shot onto plant cells. Some of
the DNA comes off and is incorporated into the DNA of the
recipient plant. The second method uses a bacterium i.e.
Agrobacterium tumefaciens to introduce the gene(s) of interest
into the plant DNA (Figure 2.3). Whichever method is used, the
success rate of the transformation is rarely more than one in ten
thousand cells. Furthermore, it is difficult to determine where the
new gene (or perhaps several copies of it) has been incorporated.

9
 Figure 2.3: Methods of producing transgenic plant
Source: McKanzie, D (2004). Presentation by AGBIOS

Following the gene insertion process, plant tissues are

transferred to a selective medium containing an antibiotic or
herbicide, depending on which selectable marker was used. Only
plants expressing the selectable marker gene will survive and it is
assumed that these plants will also possess the transgene of
interest. Thus, subsequent steps in the process use these
surviving plants.

To obtain whole plants from transgenic tissues, they are

grown under controlled environmental conditions in a series of
media containing nutrients and hormones by tissue culture. Once
whole plants are generated and they produce seeds, their
evaluation begins.

10
 To verify whether the inserted gene has been stably
incorporated without detrimental effects to other plant functions,
product quality, or the intended agroecosystem, initial evaluation
includes attention to activity of the introduced gene; stable
inheritance of the gene and unintended effects on plant growth,
yield, and quality.

The position of the inserted gene in the genome of the

plant is referred to as ‘event’ is also extremely important. While
two events might be responsible for the same trait, they may act
somewhat differently in the plant. For example, there are a
number of Bt events that have been developed, and they may
result in formation of the Bt protein but in different concentration in
different plant parts, or at different times during the life of the
plant. Different events for the same target gene thus represent
some “genetic diversity” for the trait, and this may be useful in
making the trait better adopted and in specific cases benefits such
as less development of resistance to pests.

The selected plant is then crossed with improved varieties

of the crop because only a few varieties of a given crop can be
efficiently transformed, and these generally do not possess all the
producer and consumer qualities required of modern cultivars.
The initial cross to the improved variety must be followed by
several cycles of repeated crosses to the improved parent, a
process known as backcrossing. The goal is to recover as much
of the improved parent's genome as possible, with the addition of
the transgene from the transformed parent.

The next step in the process is multi-location and multi-

year evaluation trials in greenhouse and field environments to test
the effects of the transgene and overall performance. This phase
also includes evaluation of environmental effects and food safety.

11
 CHAPTER 3
APPLICATIONS AND BENEFITS OF
TRANSGENIC CROPS

Transgenic crops have been developed to incorporate

various traits such as insect pest resistance, herbicide tolerance,
disease resistance, altered nutritional profile, enhanced storage
life etc. The benefits of their use include increased crop yields,
reduction in farm costs and thereby increase in farm profit as well
as protection of the environment. Research is focused on a
second generation of transgenic crops that feature increased
nutritional and/or industrial traits such as easy processability.
These varieties are expected to bring in more direct benefits to
consumer such as correction of dietary deficiencies. Figure 3.1
summarizes the potential benefits of various traits incorporated in
the transgenic crops.

Traits Potential Benefits

Pest resistance
Cheaper
food Availability of
Herbicide resistance Improved more crops
farming
Stress(cold/ drought)
tolerance More
food Better quality
products
Delayed ripening

Increased nutrition Improvement in

health

Plant pharmaceuticals Reduced use of

chemicals and
herbicides
Figure 3.1: Potential benefits of transgenic crops

Source: TO BE ADDED

The range of crops being targeted for genetic improvement

include several commercially important transgenic crops such as
maize, soybean, tomato, cotton, potato, mustard and rice.

11
3.1 INSECT RESISTANCE:

Some organisms provide natural protection for plants, as

they are toxic to target pests but do not harm humans, animals,
fish, birds or beneficial insects. Using recombinant technology,
the gene that makes these organisms lethal to certain insects can
be transplanted into the plants on which that insect feeds. The
plant that once was a food source for the insect now kills it,
reducing the need for chemical pesticides to control infestation.

For example, the spores of Bacillus thuringiensis (in short

Bt) contain a crystalline protein (Cry), which breaks down to
release a toxin, known as delta-endotoxin. This toxin binds to and
creates pores in the intestinal lining of lepidopteran pests such as
American bollworm, resulting in paralysis of the digestive system,
and consequent death. This bacterial Cry gene has now been
incorporated into the plants DNA itself so that the plant’s cells
produce the toxin. When the insect feeds on a leaf or bores into a
stem of Bt containing plant, it ingests the toxin and dies (Figure
3.2).

Caterpillar consumes foliage with Bt

protein

Protein binds to receptors in the gut

wall

Gut wall breaks down, leading to

leaching of ingested material

Caterpillar dies in 1-2 days

Figure 3.2: Bt toxin: Mechanism of action

12
 Different versions of the Cry genes have been identified
which are effective against different orders of insects or act on the
insects in different ways.

Bt based insecticides in the form of sprays and powders

have been in use for many years and are considered safe for
mammals, birds, and for non-target insects.

Bt cotton and maize have been developed and cultivated

since 1996. The use of Bt varieties has dramatically reduced the
amount of chemical pesticides applied to these crops.

3.2 HERBICIDE TOLERANCE:

Good planting conditions for crops also sustain weeds that

can reduce crop productivity as they compete for the same
nutrients the desired plant needs. To prevent this, herbicides are
sprayed over crops to eliminate the undesirable weeds. As the
crop plants themselves are affected by a high concentration of
herbicides, these herbicides are required to be applied several
times during the growth cycle leading to not only increased
expenditure to the farmers but also harmful effects to the
environment. Further, many effective broad spectrum herbicides
do not distinguish between weeds and crops.

Crop plants can be genetically engineered to be resistant

to herbicides, so as to eliminate weeds more selectively. When
the herbicide is sprayed, it will kill the weeds but have no effect on
the crop plants. Therefore, the herbicide can be applied in a
single dose or a fewer doses of higher concentration. For
example, Monsanto’s strain of soybeans genetically modified
require only one application of weed killer Roundup® instead of
multiple applications, reducing farming cost and environmental
damage (Figure 3.3).

13
 Figure 3.3: Comparison of a weed-infested soybean plot (left) and
Roundup Ready® soybeans after Roundup treatment (right).
Source: http://www.colostate.edu/programs/lifesciences/TransgenicCrops/current.html#Bt/
Monsanto

Herbicide tolerant crops have been developed by

incorporating genes that provide resistance to different herbicides
such as glyphosate, oxynil, phosphenothricine, sulfonyl urea etc.

3.3 DISEASE RESISTANCE:

Plants are susceptible to viral, bacterial and fungal

diseases. Much progress has been made in evolving transgenic
plants resistant to viruses. For example, expression of a gene that
encodes the coat protein of tobacco mosaic virus (TMV) in
transgenic tobacco plants has been shown to enable the plants to
resist TMV infection. A number of other virus resistant plant
species have been developed including squash and potatoes.

Genetic engineering of crop plants for resistance to fungal

and bacterial infections has been more difficult. However, by
studying the defensive genes that are expressed in naturally
disease-resistant plants, encouraging progress has been made.

3.4 PRODUCT QUALITY IMPROVEMENT:

There are several areas where GM techniques are being

applied to improve product quality as well as improved nutritional
profiles such as:

14
i. Improved flavour
ii. Increased shelflife
iii. High nutritional value
iv. Greater processability
v. Changes in composition

One of the most successful and initial research efforts to

change the characteristics of a plant product was carried out with
tomatoes. Tomatoes need to be picked while still green so that
they are firm enough to withstand mechanical handling and
transport. Unfortunately, they do not develop the same flavor and
texture of vine-ripened tomatoes. Transgenic tomatoes have
been developed that have normal color and flavor but they soften
more slowly and can be picked and processed after they are ripe.
They also have higher content of soluble solids and are therefore
better than normal tomatoes for further processing.

Improvement in nutritional characteristics includes

increasing the contents of vitamins, minerals and other
micronutrients, modifying fats and oils, altering the starch and
sugar content or protein/amino acid profiles etc. Transgenic lines
of potato with increased levels of starch have been developed by
introducing a gene from bacteria for enhancing starch
biosynthesis. A promoter from a potato gene that encodes the
major protein in potato tubers has been used, so that the
expression of the introduced gene is limited to the tuber. Tubers
accumulate approximately 3 to 5% more starch than normal
potatoes and when they are deep-fried absorb less oil and yield
chips having fewer calories.

Rice with enhanced level of beta carotene (the precursor of

vitamin A) and iron are being developed to address the problems
of vitamin A deficiency. Other products in the pipeline include
canola containing high levels of oleic and lauric acids, staple crops
with improved protein content and vegetable and fruits with
delayed ripening as well as modified flavour characteristics.

15
3.5 RESISTANCE TO ENVIRONMENTAL STRESSES:

In addition to the biological challenges to plant growth and

development, crops plants need to cope up with abiotic stresses
such as drought, cold, heat and soils that are too acidic or saline
to support plant growth. While plant breeders have successfully
incorporated genetic resistance to biotic stresses such as
diseases into many crop plants through crossbreeding, their
success at creating crops resistant to abiotic stresses has been
more limited, largely because few crops have close relatives with
genes for resistance to these stresses.

Therefore crop biotechnology is being increasingly used to

develop crops that can tolerate difficult growing conditions. For
example, researchers have genetically modified tomato and
canola plants that tolerate salt levels 300 percent greater than
non-genetically modified varieties. Other researchers have
identified many genes involved in cold, heat and drought tolerance
found naturally in some plants and bacteria and are trying to
incorporate them in crops.

3.6 YIELD IMPROVEMENT:

Attempts are being made through the use of biotechnology

to improve crop yields directly. Researchers in Japan added
maize photosynthesis genes to rice to increase its efficiency at
converting sunlight to plant starch and increased yields by 30
percent. Other scientists are altering plant metabolism by blocking
gene action in order to shunt nutrients to certain plant parts. Yields
increase as starch accumulates in potato tubers and not leaves, or
oil-seed crops, such as canola, allocate most fatty acids to the
seeds.

Crops that are better at accessing the micronutrients they

need are also being developed. For example genetically modified
plants have been developed to secrete citric acid, a naturally
occurring compound, from their roots. In response to the slight
increase in acidity, minerals bound to soil particles, such as

16
calcium, phosphorous and potassium, are released and made
available to the plant.

Nitrogen is the critical limiting element for plant growth and,

step-by-step, researchers from many scientific disciplines are
working on the details of the symbiotic relationship that allows
nitrogen-fixing bacteria to capture atmospheric nitrogen and
provide it to the plants that harbor them in root nodules.

3.7 PLANT BASED PHARMACEUTICALS:

Plants are among the most efficient bioreactors which

produce quantities of material with sunlight and soil based
nutrients as inputs. Attempts are being made to replace the
traditional fermentation procedure for the production of
biopharmaceuticals to plant based production. The benefits of
using plants are the ability to increase production at low cost by
planting more acres, rather than building fermentation capacity,
lower capital and operating cost, simplified downstream
processing etc.

Therapeutic drugs to treat cancer, infectious diseases,

autoimmune deficiencies, cardiovascular diseases and other
conditions and several vaccines can potentially be grown in
plants. Transgenic technology is being used to produce a plant
whose seed can express a desired therapeutic protein. The
desired protein can be extracted from the seed to make a
biopharmaceutical. Plant based therapeutics are expected to be
highly cost effective.

17
 CHAPTER 4
CONCERNS

Although the development of transgenic crops using

recombinant DNA techniques is relatively recent, their applications
are increasing rapidly because of advantages over the
conventional crops. However, as more and more transgenic crops
are released for field-testing and commercialization, concerns
have been expressed regarding potential risks to both human
health and environment.

These apprehensions arise because transgenic technology

crosses the species barrier as compared to classical selection
techniques, thereby permitting the gene transfer among
microorganisms, plants and animals. There is no evidence that
any unique hazards exist in the development of transgenic crops,
because of novel combinations of genes. Transgenic crops are
not toxic nor are likely to proliferate in the environment. However,
specific crops may be harmful by virtue of novel combinations of
traits they possess. This means that the concerns associated with
use of GMOs can differ greatly depending on the particular gene-
organism combination and therefore a case-by-case approach is
required for risk assessment and management.

Potential risks from the use of transgenic crops broadly fall

under two categories.

i. Human health
ii. Environment

4.1 RISK TO HUMAN HEALTH:

Risks to human health are related mainly to toxicity,

allergenicity and antibiotic resistance.

The risk of toxicity may be directly related to the nature of

the product whose synthesis is controlled by the transgene or the
changes in the metabolism and the composition of the organisms
resulting from gene transfer. Most of the toxicity risks can be

18
assessed using scientific methods both qualitatively and
quantitatively.

The introduction of newer proteins in transgenic crops from

the organisms, which have not been consumed as foods,
sometimes has the risk of these proteins becoming allergens.
However, it may be noted that there is no evidence that transgenic
crops pose more risks than conventional products in triggering
allergies. Further, the new transgenic crops can be tested for
allergens prior to their commercial release. For example, when it
was found that the consumption of transgenic soybean with a
methionine-producing gene from brazil nut could trigger an allergic
response in those allergic to brazil nut, the product was not
released for sale.

The use of genes for antibiotic resistance as selectable

markers have also raised concerns regarding the transfer of such
genes to microorganisms and thereby aggravate the health
problems due to antibiotic resistance in the disease causing
organisms. Although, the probability of such transfer is extremely
rare, steps are being taken to reduce this risk by phasing out their
use.

4.2 RISK TO ENVIRONMENT:

Risks to environment due to release of TRANSGENIC

crops include impact of imparted traits on other related species,
the potential build up of resistance in insect populations, effect on
biodiversity and unintended effects on non-targeted organisms.

Accidental cross breeding between transgenic crops and

traditional varieties through pollen transfer can contaminate the
traditional local varieties with transgenes. The consequences
associated with such gene transfer may increase weediness if
transferred to compatible weedy relatives or lead to extinction-
endangered varieties of the same genera. However, these risks
can be anticipated easily and then evaluated by experiments prior
to any commercial release.

19
 The gene transfer into a crop or the resultant products can
actually remain in environment leading to environmental problems
e.g. in case of Bt crops, it was suspected that insecticidal proteins
can persist in the environments but experiments have proved that
they were degraded in the soil. Further, there are concerns about
possible interaction that may occur between other organisms in
the environment following the release of a transgenic crop.

Environmental concerns have also been raised about the

development of increased insect resistance, virus resistance and
weediness following the introduction of transgenic crops.

20
 CHAPTER 5
BIOSAFETY REGULATIONS IN INDIA

Biosafety regulations cover assessment of risks and the

policies and procedures adopted to ensure environmentally safe
applications of biotechnology. A national biosafety regulatory
system to regulate production and release of genetically modified
organisms (including transgenic crops) is considered essential in
any country with a biotechnology programme. The regulatory
framework for transgenic crops in India consists of the following
rules and guidelines.

1. Rules and policies • Rules 1989 under Environment

Protection Act (1986)
• Seed Policy 2002

2. Guidelines • Recombinant DNA guidelines, 1990

• Guidelines for research in transgenic
crops, 1998

5.1 RULES, 1989:

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. A copy of the rules is
placed at Annex-1.

The Rules, 1989 order compliance of the safeguards

through voluntary as well as regulatory approach and any violation
and non-compliance including non-reporting of the activity in this
area would attract punitive action provided under the EPA.

21
 The two main agencies identified for implementation of the
rules are the Ministry of Environment & 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).

Out of these, the three agencies that are involved in

approval of new transgenic crops are:

1. IBSC set-up at each institution for monitoring institute level

research in genetically modified organisms.
2. RCGM set-up at DBT to monitor ongoing research activities in
GMOs and small scale field trials.
3. GEAC in the Ministry of Environment and Forests set-up to
authorize large-scale trials and environmental release of
genetically modified organisms.

The Recombinant DNA Advisory Committee (RDAC)

constituted by DBT takes note of developments in biotechnology
at national and international level and prepares suitable
recommendations. The State Biotechnology Coordination
Committees (SBCCs) set up in each state where research and
application of GMOs are contemplated, coordinate the activities
related to GMOs in the state with the central ministry. SBCCs
have monitoring functions and therefore have got powers to
inspect, investigate and to take punitive action in case of
violations. Similarly, District Level Committees (DLCs) are
constituted at district level to monitor the safety regulations in
installations engaged in the use of GMOs in research and
application.

22
 The approvals and prohibitions under Rules 1989 are
summarized below:

• No person shall import, export, transport, manufacture,

process, use or sell any GMOs, substances or cells except
with the approval of the GEAC.
• Use of pathogenic organisms or GMOs or cells for research
purpose shall be allowed under the Notification, 1989 of the
EPA, 1986.
• Any person operating or using GMOs for scale up or pilot
operations shall have to obtain permission from GEAC.
• For purpose of education, experiments on GMOs IBSC can
look after, as per the guidelines of the Government of India.
• Deliberate or unintentional release of GMOs not allowed.
• Production in which GMOs are generated or used shall not be
commenced except with the approval of GEAC
• GEAC supervises the implementation of rules and guidelines.
• GEAC carries out supervision through SBCC, DLC or any
authorized person.
• If orders are not complied, SBCC/DLC may take suitable
measures at the expenses of the person who is responsible.
• In case of immediate interventions to prevent any damage,
SBCC and DLC can take suitable measures and the expenses
incurred will be recovered from the person responsible.
• All approvals shall be for a period of 4 years at first instance
renewable for 2 years at a time.
• GEAC shall have powers to revoke approvals in case of:
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.

5.2 RECOMBINANT DNA GUIDELINES, 1990:

With the advancement of research in biotechnology

initiated by various Indian institutions and industry, Department of
Biotechnology had formulated Recombinant DNA Guidelines in
1990. These guidelines were further revised in 1994 to cover
R&D activities on GMOs, transgenic crops, large-scale production

23
and deliberate release of GMOs, plants, animals and products into
the environment, shipment and importation of GMOs for laboratory
research.

For research, the guidelines have been classified into

three categories, based on the level of the associated risk and
requirement for the approval of competent authority.

• Category I activities include those experiments involving self

cloning using strains and also inter-species cloning belonging
to organism in the same exchanger group which are exempt
for the purpose of intimation and approval of competent
authority.

• Category II activities which require prior intimation of

competent authority and include experiments falling under
containment levels II, III and IV (details of each containment
level provided separately in the guidelines).

• Category III activities that require review and approval of

competent authority before commencement include
experiments involving toxin gene cloning, cloning of genes for
vaccine production, and other experiments as mentioned in
the guidelines.

The levels of risk and classification of the organisms within

these categories have been defined in these guidelines.
Appropriate practices, equipment and facilities necessary for
safeguards in handling organisms, plants and animals in various
risk groups have been recommended. The guidelines employ the
concept of physical and biological containment and the principle of
good laboratory practices.

For containment facilities and biosafety practices,

recommendations in the WHO laboratory safety manual on
genetic engineering techniques involving microorganisms of
different risk groups have been incorporated therein.

24
 The guidelines categorize experiments beyond 20 liters
capacity for research and industrial purposes as large-scale. In
case of cultivation of plants, this limits is 20 acres area. The
guideline gives principles of occupational safety and hygiene for
large-scale practice and containment. Safety criteria have also
been defined in the guidelines. Physical containment conditions
that should be ensured for large-scale experiments and production
have been specified in the guidelines.

For release to the environment the guidelines specify

appropriate containment facilities depending on the type of
organisms handled and potential risks involved. The guidelines
require the interested party to evaluate rDNA modified organism
for potential risk prior to application in agriculture and environment
like properties of the organism, possible interaction with other
disease causing agents and the infected wild plant species. An
independent review of potential risks should be conducted on a
case-to-case basis. A copy of the guidelines can be accessed at
http://www.dbtindia.nic.in.

5.3 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 purposes.

Genetic engineering experiments on plants have been

grouped under three categories.

25
• Category I includes routine cloning of defined genes, defined
non-coding stretches of DNA and open reading frames in
defined genes in E. coli or other bacterial/fungal hosts which
are generally considered as safe to human, animals and
plants.

• Category II experiments include experiments carried out in lab

and green house/net house using defined DNA fragments non-
pathogenic to human and animals for genetic transformation of
plants, both model species and crop species.

• Category III includes experiments having high risk where the

escape of transgenic traits into the open environment could
cause significant alterations in the biosphere, the ecosystem,
plants and animals by dispersing new genetic traits the effects
of which cannot be judged precisely. This also includes
experiments having risks mentioned above conducted in green
houses and open field conditions.

To monitor the impact of transgenic plants on the

environment over a period of time, 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 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 under
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.

A copy of the guidelines can be accessed at

http://www.dbtindia.nic.in.

26
5.4 SEED POLICY 2002:

The Seed Policy 2002 contains 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 on
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 India
Coordinated Project Trials of ICAR, in coordination with the tests
for environment and bio-safety clearance as per the EPA before
any variety is commercially released in the market. After the
transgenic plant variety is commercially released, its seed will be
registered and marketed in the country as per the provisions of the
Seeds Act. After commercial release of a transgenic plant variety,
its performance in the field, will be monitored for at least 3 to 5
years by the Ministry of Agriculture and State Departments of
Agriculture.

It has also been mentioned that transgenic varieties can be

protected under the PVP legislation in the same manner as non-
transgenic varieties after their release for commercial cultivation. A
copy of seed policy is placed in Annex-2.

In addition the above, Ministry of Agriculture has issued a

notification on November 12, 2003 nominating the Central Institute
of Cotton Research (CICR) to act as a referral laboratory for Bt
cotton seeds (Annex-3).

27
 CHAPTER 6
SAFETY ASSESSMENT OF TRANSGENIC CROPS

Commercial production of a transgenic crop is the

culmination of a four step process. The first step begins in
government or private research laboratories and greenhouses,
where scientists investigate potential beneficial traits, identify
genes and carry out genetic transformations. If these lab results
are successful, the plant may advance to the second step i.e.
open field trials, where breeding and testing continue in a real life
environment. The third step is securing regulatory approval in the
country where the plant will be grown, and/or its products
consumed by humans or animals. The fourth and final step is
market acceptance and large scale production.

Safety assessment of a transgenic crop is the most

important step in this development process. Extensive testing and
a long approval process precede every transgenic crop
introduction. The approval process includes comprehensive
analysis of the risks and their scientific management to ensure
food, feed and environmental safety before introduction into the
market.

Safety assessment of a transgenic crop start with

determining whether the product is substantially equivalent
(except for defined differences) to conventional varieties. Further
analysis then focuses on the evaluation of the defined differences
by assessing potential safety risks of the host plan, gene donor(s)
and the protein introduced.

Experiments are designed to systematically identify the

hazards, to assess risks and to take steps to manage the risk by
applying logical strategies. Information on the following aspects is
required to be generated on a case-to-case basis:

i. Characteristics of the donor organisms providing the target

gene such as identification, pathogenicity, toxicity and
allergenicity, the geographical origin, distribution pattern and

28
 survival mechanisms and the method of transfer of its genetic
material to other organisms.

ii. Characteristics of the vectors used such as the origin, identity

and habitat, sequence, frequency of mobilization and the
ability to get established in other hosts.

iii. Characteristics of the transgenic inserts such as the specific

functions including the marker gene inserts, the expression
levels and the toxicity of the expressed product on the host
plant, humans or animals.

iv. Characteristics of the transgenic plants including methods of

detection of the transgenic plant as well as the escaped
transgenic traits in the environment, toxicity and pathogenicity
of the transgenic plants and their seeds to other plants, human
and animals, possibility of and the extent of transgenic pollen
escape and pollen transfer to wild near relatives, and the
impact on the environment

While information on some of these aspects may be

available but many others need to be investigated using
appropriately designed experiments. Toxicity and allergenicity
data are generated using standard protocols devised by national
and international agencies.

For minimizing the risk arising from the limited release of

transgenic plants, the following may be taken into consideration:

i. Special separation for isolation, for preventing reproduction/

fertilisation and seed setting.
ii. Biological prevention of flowering by making use of sterility
properties
iii. Human intervention for removal of reproductive structures of
flowers.
iv. Controlling the reproductive structures of transgenic plants like
the seeds and the plant propagules from unaccounted spread.
v. Controlling and destroying volunteer plants from experimental
field.

29
vi. To take into account the proximity to human activity in case
the transgenic plants have allergenic properties to human and
animals.
vii. Appropriate training of field personnel handling the transgenic
plants.
viii. Plans for handling unexpected events.
ix. Documentation of previous published information, if any,
including any documented evidence of effects of the release to
the ecosystem.

All the data generated by the developing organizations is then

submitted in detailed formats to the government for seeking
permission for commercial release of the transgenic crop. The
initial risk assessment in India begins at the institutional level
itself. The Institutional Biosafety Committee evaluates the
proposal for research or commercialization following which it is
passed on to Review Committee on Genetic Manipulation and
then Genetic Engineering Approval Committee. At the
commercialization phase, another round of assessment with
respect to agronomic benefits is undertaken under the ICAR
system. In fact, even after the release of the crop there is
continuous monitoring by Monitoring and Evaluation Committees
at the center and the state levels.

30
 CHAPTER 7
GLOBAL STATUS OF TRANSGENIC CROPS

7.1 CROPS APPROVED FOR COMMERCIAL USE:

The first commercial transgenic crop was “Flavr Savr”

tomato with delayed ripening characteristics introduced in USA in
1995. Seventeen crops have so far been approved in various
countries for planting in various countries across the world
incorporating one or more of the basic phenotypical characteristics
such as herbicide tolerance, insect resistance, male sterility,
modified colour, delayed ripening and virus resistance. Table 7.1
lists these products alongwith the genetically improved trait and
countries where they have been approved.

Table 7.1: Transgenic crops approved for commercial use

S. Crop Uses Countries where
No. approved
1. Argentine Herbicide tolerance and Canada, US, Japan,
Canola improved protection against Australia
weeds
2. Carnation Increased shelf life by Australia, European
delayed ripening, modified Union
flower colour and herbicide
tolerance
3. Chicory Herbicide tolerance, European Union
improved protection
against weeds and higher
yields
4. Cotton Improved insect protection, Japan, Australia,
herbicide tolerance and US, China, Mexico,
improved protection South Africa,
against weeds Argentina, India,
Indonesia

31
S. Crop Uses Countries where
No. approved
5. Flax, Herbicide tolerance, Canada, US
Linseed antibiotic resistance and
improved weed protection
6. Green Virus resistance China
pepper
7. Maize Herbicide tolerance, Canada, Japan,
improved weed protection, US, Argentina,
resistance against insects European Union,
and restored fertility of South Africa,
seeds Philippines,
8. Melon Delayed ripening
9. Polish Herbicide tolerance and Canada
Canola improved weed control
10. Potato Improved protection from US, Canada,
insect and leaf roll virus
11. Rice Herbicide resistance US
12. Soybean Improved weed control and US, Argentina,
herbicide tolerance, Japan, Canada,
increased cooking quality Uruguay, Mexico,
Brazil and South
Africa
13. Squash Resistance against US
watermelon mosaic virus
and zucchini yellow mosaic
virus
14. Sugar Herbicide tolerance US, Canada
beet
15. Sunflower Herbicide tolerance Canada
16. Tobacco Herbicide tolerance US
19. Tomato Improved shelf life, taste, US, Mexico, Japan,
color and texture, improved China
insect resistance, virus
resistance
Source: http://www.agbios.com/

32
 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, flex etc. have been approved for
commercial use in one or more countries, but have not yet been
marketed.

7.2 AREA UNDER CULTIVATION:

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 7.1). 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 7.1: Global area of transgenic crops from 1996 to
2004 (million hectares)
100
81.0
80 67.7
58.7
60 52.6
39.9 44.2
40 27.8
Series1
20 11.0
1.7
0
96

97

98

99

00

01

02

03

04
19

19

19

19

20

20

20

20

20

Source: International Service for the Acquisition of Agri-biotech Applications

(http://www.isaaa.org)

33
 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 order of
hectarage, they are USA, Argentina, Canada, Brazil, China,
Paraguay, India, South Africa, Uruguay, Australia, Romania,
Mexico, Spain and the Philippines (Figure 7.2).

Figure 7.2: Biotech crop countries and mega countries, 2005

Source: International Service for the Acquisition of Agri-biotech Applications

(http://www.isaaa.org)

34
 Growth continued in all four commercialized biotech crops
in 2004. Biotech soybean occupied 48.4 million Ha (60%), maize
19.3 million Ha (23%), cotton 9 million Ha (11%) and canola 4.3
million Ha (6%b of the global transgenics area. The proportion of
transgenic crops vis-à-vis total global cultivation is also increasing
rapidly. In 2004, 56% of the total soybean planted globally was
transgenic (Figure 7.3).

Figure 7.3: Percentage adoption of four transgenic crops in 2004

Source: International Service for the Acquisition of Agri-biotech Applications

(http://www.isaaa.org)

Herbicide tolerance has consistently been the dominant

trait introduced followed by insect resistance. In 2004, herbicide
tolerant soybean, maize, cotton and canola occupied 72% and Bt
crops 19%. Stacked genes for herbicide tolerance and insect
resistance deployed in both cotton and maize covered 9% of the
global transgenic area in 2004.

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.

35
 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, to
field trials, to regulatory approval and commercial production. 57
plants divided into four groups i.e. field crops, vegetables, fruits
and other plants, have been identified for further research and are
listed below:

Table 7.2: Transgenic crops under research and development

Field Crops Vegetables Fruits (16) Miscellaneous

(16) (14) (11)
Alfalfa Broccoli Apple Chicory
Barley Cabbage Banana Cocoa
Canola Carrot Cantaloupe Coffee
Cassava Cauliflower Cherry Garlic
Clover Cucumber Citrus Lupins
Cotton Eggplant Coconut Mustard
Flax Lettuce Grape Oil palm
Maize Onion Kiwi Oilseed poppy
Rice Pea/Bean Mango Olive
Safflower Pepper Melon Peanut
Sorghum Potato Papaya Tobacco
Soybean Spinach Pineapple
Sugar beet Squash Plum
Sugar cane Tomato Raspberry
Sunflower Strawberry
Wheat Watermelon

A variety of traits are targeted for these crops. The

following products with direct benefits to the consumers are likely
be available in the near future:

• 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

36
• Bananas resistant to fungi
• High protein rice
• Tomatoes with higher antioxidant content
• Fruits and vegetables with higher levels of vitamins

Further down the road the products include:

• Crops tolerant to 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

37
 CHAPTER 8
STATUS OF TRANSGENIC CROPS IN INDIA

In view of the importance and potential of transgenic crops,

extensive efforts have been initiated in India for development of
transgenic crops.

8.1 IN COMMERCIAL USE:

As of now, Bt cotton containing the Cry1Ac Bt gene is the

only transgenic crop approved for commercial use in India. Three
Bt cotton hybrids developed by Maharashtra Hybrid Seeds
Company (MAHYCO) were granted approval in March 2002 for
commercial cultivation for a period of three years. The approval
was granted after extensive field trials. Bt cotton has since been
grown in the fields of six states i.e. Andhra Pradesh, Gujarat,
Madhya Pradesh, Maharashtra, Karnataka and Tamil Nadu.
Starting from an area of 30,000 Ha under Bt cotton cultivation in
2002, the area under cultivation in 2004 is 5,30,000 Ha.
MAHYCO has subsequently sublicensed this technology to other
seed suppliers for incorporation of the gene in their own hybrids.
Several Bt cotton hybrids developed by these companies are
under large-scale trials and would be ready for commercial
production in the near future.

Permission has also been given to MAHYCO for large

scale trials of four Bt cotton hybrids containing both Cry1Ac and
Cry2Ab2 at 80 locations per hybrid in southern and central India.

8.2 ONGOING FIELD TRIALS:

Thirteen crops have been approved for contained limited

field trials in India (Table 8.1). The trials are being conducted by
both public and private sector institutions and are mostly related to
insect resistance using cry genes.

40
 Table 8.1: Transgenic crops approved for conducting contained
limited field trials (including multi-location field trials)
S. Crop Trait Organization
No
1. Brinjal Insect resistance Indian Agricultural Research
Institute (IARI), Tamil Nadu
Agricultural University (TNAU),
MAHYCO
2. Cotton Insect resistance UAS, Dharwad, Ankur Seeds
P.Ltd., JK Agri Genetics,
Krishidhan Seeds, MAHYCO,
Nath Seeds, Rasi Seeds Ltd.,
Syngenta India Ltd.,
Nuziveedu Seeds, Mahendra
Herbicide Hybrid Seeds Ltd., Tulsi
tolerance Seeds, Ganga Kaveri Pvt. Ltd.,
Vikki’s Agrotech, Pravardhan
Seeds, Prabhat Agri Biotech
Ltd., Ajeet Seeds

MAHYCO
3. Cabbage Insect resistance IARI, MAHYCO
4. Cauliflower Insect resistance MAHYCO
5. Groundnut International Crop Research
Institute for Semi Arid Tropics
(ICRISAT)
6. Mustard Superior hybrid IARI, National Research
cultivars, Centre on Weed Sciences
resistance to (NRCWS), Jabalpur, Proagro
fungal attack, PGS (India) Ltd., The Energy
plants with high and Resources Institute
level of Beta (TERI), University of Delhi
carotene, abiotic South Campus (UDSC)
stress tolerant
plants
7. Okra Insect resistance MAHYCO
8. Potato Insect resistance, Central Potato Research
nutritionally Institute (CPRI), Jawaharlal
enriched with high Nehru
protein content University(JNU)/National
Centre for Plant Genome
Research (NCPGR)

41
S. Crop Trait Organization
No
9. Rice Resistance to Directorate of Rice Research,
lepidopteran Hyderabad, Osmania
pests, bacterial University, IARI, MAHYCO,
blight and sucking Madurai Kamaraj University, M
pests, fungal S Swaminathan Research
infection, insect Foundation, TNAU
resistance, salt
tolerance
10. Pigeonpea Resistance to ICRISAT, MAHYCO
fungal pathogens
11. Sorghum Insect resistance MAHYCO
12. Tobacco Insect resistance Central Tobacco Research
Institute (CTRI)
13. Tomato Insect resistance, IARI, JNU/NCPGR, MAHYCO
resistance to
fungal infection,
viral resistance
Source: Department of Biotechnology, Government of India

8.3 CROPS UNDER RESEARCH AND DEVELOPMENT:

There are more than 20 crops under research in India as

listed below:
i. Bhendi xii. Mustard/rapeseeds
ii. Blackgram xiii. Pigeonpea
iii. Blackgram xiv. Potato
iv. Brassica xv. Rice
v. Brinjal xvi. Sorghum
vi. Cabbage xvii. Sugarcane
vii. Cauliflower xviii. Sunflower
viii. Chickpea xix. Tobacco
ix. Cotton xx. Tomato
x. Groundnut xxi. Watermelon
xi. Muskmelon xxii. Wheat

The target traits include insect resistance, herbicide

tolerance, viral and fungal disease resistance and stress
tolerance.

42
8.4 ORGANIZATIONS IN THE AREA:

In view of the importance and potential of transgenic crop,

extensive efforts have been initiated under the aegis of the
Department of Biotechnology (DBT) for promoting research and
development in this area. DBT supported the establishment of
Centres for Plant Molecular Biology (CPMB) as early as in 1990.
A total of six such centers were set up initially at various
universities/institutions namely Jawaharlal Nehru University (New
Delhi), Madurai Kamaraj University (Madurai), Tamil Nadu
Agricultural University (Coimbatore), Osmania University
(Hyderabad), National Botanical Research Institute (Lucknow) and
Bose Institute (Kolkata). A seventh center was established at the
University of Delhi South Campus in 1997. DBT has supported
over the last 12 years a large number of research projects which
deal with the development of in vitro regeneration and genetic
transformation protocols of important crops species grown in India
and the development of transgenics with genes of agronomic
importance. To further strengthen research in the area of crop
biotechnology, a new institute National Centre for Plant Genome
Research (NCPGR) has been established in New Delhi with a
mandate to strengthen plant biotechnology research in India.

More than 50 institutions in public and private sector are

engaged in transgenic crops and development. This include 34
research institutions and 20 private companies.

A. RESEARCH INSTITUTIONS
1. Assam Agricultural University, Jorhat
2. Bose Institute, Kolkata
3. Central Agricultural Research Institute, Port Blair
4. Central Food Technological Research Institue, Mysore
5. Central Institute for Cotton Research, Nagpur
6. Central Potato Research Institute, Shimla
7. Central Tobacco Research Institute, Rajahmundry
8. Centre for Cellular and Molecular Biology, Hyderabad
9. Centre for Plant Molecular Biology, Osmania Univ., Hyderabad
10. Central Rice Research Institute, Cuttack
11. College of Basic Sciences and Humanities, Pantnagar
12. Delhi University South Campus, New Delhi
13. Directorate of Oil Seeds Research, Hyderabad
14. Directorate of Rice Research, Hyderabad
15. G B Pant University of Agriculture and Technology, Pantnagar

43
16. Indian Agricultural Research Institute, New Delhi
17. IARI sub-station, Shillong
18. International Centre for Genetic Engineering and Biotechnology,
New Delhi
19. International Crop Research Institute for Semi-Arid Tropics,
Hyderabad
20. Indian Institute of Chemical Biology, Kolkata
21. Indian Institute of Horticultural Research, Bangalore
22. Jawaharlal Nehru University, New Delhi
23. Madurai Kamraj University, Madurai
24. Mahatama Phule Krishi Vidyapeeth, Rahuri
25. M.S. University, Baroda
26. Narendra Dev University of Agriculture, Faizabad
27. National Botanical Research Institute, Lucknow
28. National Centre for Plant Genome Research, New Delhi
29. Punjab Agricultural University, Ludhiana
30. The Energy and Resources Institute (TERI), New Delhi
31. Tamil Nadu Agricultural University, Coimbatore
32. University of Agricultural Sciences, Bangalore
33. University of Hyderabad, Hyderabad
34. Vasantdada Sugar Institute, Pune
35. Y.S. Parmar University of Horticulture and Forestrym, Solan

B. COMPANIES
1. Ajeet Seeds Ltd., Aurangabad
2. Ankur Seeds Ltd., Nagpur
3. Bejo Shetal Seeds Pvt. Ltd., Jalna
4. De-Nocil, Mumbai
5. Hybrid Rice International Ltd., Gurgaon
6. Indo-American Hybrid Seeds, Bangalore
7. J K Seeds, Secunderabad
8. Krishidhan Seeds Ltd., Jalna
9. MAHYCO, Mumbai
10. Maharashtra State Seeds Corporation Ltd., Akola
11. Metahelix Life Sciences Pvt. Ltd., Bangalore
12. Monsanto India Ltd., Mumbai
13. Nath Seeds Ltd., Aurangabad
14. Nuziveedu Seeds Company Ltd., Hyderabad
15. Proagro PGS (India) Ltd., Gurgaon
16. Rallis India Limited, Bangalore
17. Rasi Seeds Co. Ltd., Attur
18. SPIC Foundation, Chennai
19. Syngenta India Ltd., Pune

44
 CHAPTER 9
CASE STUDY OF Bt COTTON

9.1 BACKGROUND:

Cotton is a very important crop in India. Nearly nine million

hectares of land in India is used to produce 14.2 bales of cotton
lint under diverse agro climatic conditions. It contributes 29.8% of
the Indian agricultural gross domestic products and provides a
livelihood to more than 60 million people by way of support in
agriculture, process and use of cotton in textile. The major cotton
growing states are Andhra Pradesh, Gujarat, Haryana, Karnataka,
Madhya Pradesh, Maharashtra, Punjab, Rajasthan and Tamil
Nadu.

Although India ranks first globally area wise but with regard
to production it ranks third next to USA and China. The major
reason for this low productivity is damage caused by insect pests,,
notably, Helicoverpa armigera, commonly referred to as American
bollworm. It has been estimated nearly Rs. 12 billion worth of
pesticides are used in India to control bollworms in cotton crop.
Still it is a known fact that all the pesticide molecules, except the
latest ones like Spinosad and Indoxacarb, failed to effectively
control cotton bollworm.

In view of the above, alternative ways of dealing with these

plant pests were sought. One option is the use of Bacillus
thuringiensis, which produced insecticidal proteins. Bt is easily
cultured by fermentation and thus over the last 40 years it has
been used as an insecticide by farmers worldwide. It is applied
either as spray or granules but the efficiency of both applications
is quite limited as the target organism do not often come in contact
with an insecticide. This is because the larvae are found on the
underside of leaves or have already penetrated the plant. To
overcome this problem, transgenic cotton was developed using
biotechnology by introducing the insecticidal gene from the
bacterium to cotton plant, commonly referred to as Bt cotton.
These plants have a built in mechanism of protection against
targeted pests and the protein produced by the plants does not

46
get washed away nor is destroyed by sunlight. The plant is thus
protected from the bollworm round the clock and throughout its
life.
The advantages of Bt cotton with genes integrated in the
plant versus the spray of Bt powder are as follows:

• Active protein provides moderate to high dose control that

allows fair to excellent control of selected important
lepidopteran pests
• Active protein expressed in all plant parts
• Active protein expressed throughout the season, hence timing
of insecticide applications in relation to an infestation is not an
issue
• Wash off of insecticide during rain, and degradation in sunlight
are not issues as they are with spray formulations
• Less farmer exposure to insecticide
• Labor saving technology, due to elimination or reduction of
insecticide sprays
• Decreases production risks and provides peace of mind and
insurance to farmers at cost-effective control rates
• Contributes to, and provides the foundation for an integrated
pest management (IPM) strategy.

9.2 GLOBAL SCENARIO:

Since its introduction in 1996 in USA, Bt cotton has found

extensive acceptance world over. Currently, Bt cotton is grown in
most of the major cotton growing countries, including USA,
Australia, South Africa, Argentina, Mexico, Indonesia and India.
Extensive field testing is underway in countries such as Brazil,
Colombia, Thailand and Zambia. The total area under Bt cotton
cultivation has been estimated to be 9.0 million Ha in 2004 and
which is approximately 28% of the global area under cotton.

The Bt genes that have been commercialized world over

are mainly from two sources. The first is Monsanto company
which developed and deployed the Cry1Ac gene from the isolate
B. thuringiensis, ssp kurstaki into Coker 312 cotton designated
MON 531 and later named Bollgard® cotton and the second

47
source is the Bt fused gene that was developed by the public
sector Chinese Academy of Agricultural Sciences (CAAS) in
Beijing, China. Subsequently, Monsanto has developed second
generation of Bt cotton technology, which contains two different
genes that encode proteins from B. thuringiensis i.e. Cry2Ab and
Cry1Ac. This dual gene cultivars are expected to provide growers
with a broader control over a wider variety of insects than
achieved with the first generation Bt cotton products. In addition,
it can serve as a new tool to combat the potential development of
insect resistance in cotton fields by providing a second mode of
action to control these pests. Research is also underway on
various other genes to impart insect resistance properties in
cotton such as vegetative insecticidal proteins (vip) genes by
Syngenta. Combination of genes have also being developed such
as Bollgard II by Monsanto which has a combination of Cry1Ac
and Cry2Ab2 genes.

9.3 INDIAN SCENARIO:

In India, Maharashtra Hybrids Seed Company (MAHYCO)

first imported the parental cotton cultivar Coker 312 from
Monsanto and then carried out contained breeding programme to
incorporate the Bt gene into their elite cotton in bred lines. The Bt
trait was successfully transferred into more than 60 cotton lines by
traditional backcrossing method. The biosafety of the Cry1Ac Bt
gene in these hybrids was assessed and then field testing was
permitted by DBT.

MAHYCO have conducted extensive field trials throughout

India under different agro-climatic conditions including under the
All India Coordinated Cotton Improvement Project of ICAR.
Government of India through GEAC, Ministry of Environment &
Forests has approved on March 26, 2002, three Bt cotton hybrids
(MECH12Bt, MECH162Bt and MECH184Bt) for commercial
cultivation for a period of three years with the following approval
conditions.

• Valid for three years: April 02 to March 05

48
• Three hybrids namely MECH12Bt, MECH162Bt and
MECH184Bt
• Provide same non Bt seed to meet refuge requirements
• Conduct studies to monitor resistance development
• Provide information to government on distribution of the seed
through its dealers and agents
• Labeling requirements such as GEAC number, etc.
• Develop Bt based IPM program
• Conduct educational and awareness programs
• Meet other requirements as stipulated

The Bt transgene in the converted Indian inbred lines

behaves as a single dominant -Mendelian factor and is a stably
integrated in the plant genome. The advantages of Bt cotton
include improved pest management, reduction in insecticide use
and therefore greater net return to the farmers. Healthy growth of
the plants helps in a better boll size and quality as well as
reduction in picking costs. The comparative growth of a Bt cotton
plant versus the non Bt hybrid is depicted in Figure 9.1

49
 Figure 9.1: Comparison of Bt versus non Bt hybrids

Bt cotton has been grown in six states i.e. Madhya

Pradesh, Gujarat, Maharashtra, Andhra Pradesh, Karnataka and
Tamil Nadu since 2002. Approximately 72,000 packets of seeds
containing Bt cotton hybrids and its non Bt cotton hybrid
counterparts for covering one acre each was sold by MAHYCO in
the Kharif season 2002-2003. In the second year of launch, the
acreage under Bt cotton increased to three fold of the last year
and approximately 2,30,000 packets of seeds were sold. In 2004,
one more company M/s Rasi Seeds got approval for its hybrids.
The total sales of Bt cotton in 2004 are to the tune of 13 lakhs
packets, an increase of six times over the previous year. The state
wise sale of Bt cotton hybrids is given in Table 9.1.

50
 Table 9.1: State wise sale of approved Bt cotton hybrids in last three years

(in numbers)

Avg.
State Sales quantity in packs No. of Farmers purchase/farmer

2002 2003 2004 2002 2003 2004 2002 2003 2004

Andhra 12,894 13,000 1,80,000 12,000 13,000 1,65,000 1 1 1.1
Pradesh
Madhya 3,676 33,000 2,20,000 2,016 17,000 70,000 1.82 1.94 3.1
Pradesh
Gujarat 22,577 103,000 3,30,000 13,269 60,000 1,07.000 1.70 1.72 3

Maharashtra 30,699 54,000 5,10,000 15,935 36,000 2,30,000 1.88 1.91 2.2

Karnataka 5,401 7,500 45,000 2,960 4,000 28,000 1.82 1.88 1.6

Tamil Nadu 925 19,000 25,000 295 4,000 18,000 3.14 4.75 1.5
Total 72,6822,30,00013,10,000 41,328 1,25,000 6,18,000 1.76 1.84 2.2

The performance of Bt cotton vis-à-vis non Bt cotton can

be viewed from the following picture:

51
 Other seed firms viz., M/s Rasi Seeds, Ankur Seeds,
Krishidhan and Ajeet seeds have come forward to develop Bt
cotton hybrids as a sub-license of M/s Mahyco-Monsanto. In
addition, M/s Nath Seeds, Syngenta and other seed firms are
seeking technologies for imparting insecticidal resistance to
cotton. Seven Indian companies namely Nuziveedu Seeds,
Ganga Kaveri Seeds, Pravardhan Seeds, Prabhat Agri Biotech,
Kaveri Seeds, Nandi Seeds, and Vikki's Agro Tech have formed a
consortium by the name Swarna Bharat Biotechnics Private Ltd
(SBBPL) and has entered into an agreement with the Lucknow-
based, National Botanical Research Institute (NBRI) for
development of Bt cotton technology.

The benefits of Bt cotton in India are in line with those

enjoyed by farmers worldwide who have cultivated Bt cotton. The
area under Bt cotton cultivation is expected to increase further in
coming years leading to increased production and reduced costs
in an environmentally favorable manner. This will positively affect
the livelihood of millions of farmers by improving their net
incomes.

The safety aspects of Bt cotton has been most extensively

studied. Rigorous scientific studies conducted in India and abroad
demonstrate that Bt cotton and its products are safe for the
environment, humans, animals, and agriculture. In fact, the use of
Bt cotton is a positive step towards environmental protection
because it makes possible the reduction of the insecticide load in
the environment and reduces handling of such chemicals by
farmers. This reduced use of insecticides will enhance the
effectiveness of biological controls and implementation of
Integrated Pest Management (IPM) programs. The higher farm
income observed in the experiments has now been demonstrated
by the large-scale use of Bt cotton by Indian farmers, and the
incorporation of the gene is proving an effective and
environmentally friendly plant protection tool resulting in greater
cultivation of Bt cotton in the coming years. As newer products are
approved in the regulatory system, it is likely that farmers will have
greater choice to plant hybrids according to the requirements of
quality and needs of the market.

52
 There is a misconception among the farmers that Bt cotton
does not need any plant protection and also apprehensions that
terminator Genes associated with Bt cotton. Hence, there is an
urgent need to make the cotton farmers understand that Bt gene
is only one of the most effective tools in pest management and not
a panacea for total pest control in cotton. Based on the
requirements, the use of other IPM technologies such as
management of sucking pest through seed treatment or through
resistant cultivars has to be suitably used for sustainability of
higher crop yields and successful adoption of Bt cotton
technologies.

53
 ANNEX-1
MINISTRY OF ENVIRONMENT & FORESTS

NOTIFICATION
New Delhi, the 5th December, 1989

RULES FOR THE MANUFACTURE, USE/IMPORT/EXPORT

AND STORAGE OF HAZARDOUS MICRO ORGANISMS/
GENETICALLY ENGINEERED ORGANISMS OR CELLS

(To be notified under the EP Act, 1986)

G.S.R. 1037 (E).- In exercise of the powers conferred by sections 6,8

and 25 of the Environment (Protection) Act, 1986 (29 of 1986) and with a
view to protecting the environment, nature and health, in connection with
the application of gene technology and micro-organisms, the Central
Government hereby makes the following rules, namely:-

1. SHORT TITLE, EXTENT AND COMMENCEMENT

(1) These rules may be called the Rules for the Manufacture,
Use, Import, Export and Storage of Hazardous micro-
organisms/Genetically engineered organisms or cells.
(2) These rules shall come into operation on the date to be
notified for this purpose in the Official Gazette.

2. APPLICATION

(1) These rules are applicable to the manufacture, import and

storage of micro-organisms and Gene-Technological
products.
(2) These rules shall apply to genetically engineered
organisms/micro-organisms and cells and correspondingly to
any substances and products and food stuffs, etc., of which
such cells, organisms or tissues hereof form part.
(3) These rules shall also apply to new gene technologies apart
from those referred to in clauses (ii) and (iv) of rule 3 and
these rules shall apply to organisms /micro-organisms and
cells generated by the utilisation of such ether gene-

51
 technologies and to substances and products of which such
organism and cells form part.
(1) These rules shall be applicable in the following specific
cases:
(a) sale, offers for sale, storage for the purpose of
sale, offers and any kind of handling over with
or without a consideration:
(b) exportation and importation of genetically
engineered cells or organisms:
(c) production, manufacturing, processing, storage,
import, drawing off, packaging and repackaging
of the Genetically Engineered Products:
(d) production, manufacture etc. of drugs and
pharmaceuticals and food stuffs distilleries and
tanneries, etc. Which make use of micro-
organisms/ genetically engineered
microorganisms one way or the other.
(4) These rules shall be applicable to the whole of India.

3. DEFINITIONS

In these rules unless the context requires.

(i) “Biotechnology” means the application of scientific and

engineering principles to the processing of materials by
biological agents to produce goods and services;
(ii) “Cell hybridisation” means the formation of live cells with
new combinations of genetic material through the fusion
of two or more cells by means of methods which do not
occur naturally;
(iii) “Gene Technology” means the application of the gene
technique called genetic engineering, include
selfcloning and deletion as well as cell hybridisation;
(iv) “Genetic engineering” means the technique by which
heritable material, which does not usually occur or will
not occur naturally in the organism or cell concerned,
generated outside the organism or the cell is inserted
into said cell or organism. It shall also mean the
formation of new combinations of genetic material by
incorporation of a cell into a host cell, where they occur
naturally (self cloning) as well as modification of an

52
 organism or in a cell by deletion and removal of parts of
the heritable material;
(v) “microorganisms” shall include all the bacteria, viruses,
fungi, mycoplasma, cell lines, algae, protodoans and
nematotes indicated in the schedule and those that
have not been presently know to exist in the country or
not have been discovered so far.

4. COMPETENT AUTHORITIES

(1) Recombinant DNA Advisory Committee (RDAC): This

committee shall review developments in Biotechnology at
national and international levels and shall recommend
suitable and appropriate safety regulations for India in
recombinant research, use and applications from time to
time. The Committee shall function in the Department of
Biotechnology.
(2) Review Committee on Genetic Manipulation (RCGM):
This committee shall function in the Department of
Biotechnology to monitor the safety related aspects in
respect of on-going research projects and activities involving
genetically engineered organisms/hazardous
microorganisms. The Review Committee on Genetic
Manipulation shall include representatives of (a) Department
of Biotechnology (b) Indian Council of Medical Research (c)
Indian Council of Agricultural Research (d) Council of
Scientific and Industrial Research (e) other experts in their
individual capacity. Review Committee on Genetic
Manipulation may appoint sub groups.

It shall bring out Manuals of guidelines specifying procedure

for regulatory process with respect to activities involving
genetically engineered organisms in research, use and
applications including industry with a view to ensure
environmental safety. All ongoing projects involving high risk
category and controlled field experiments shall be reviewed
to ensure that adequate precautions and containment
conditions are followed as per the guidelines.

The Review Committee on Genetic Manipulation shall lay

down procedures restricting or prohibiting production, sale,

53
 importation and use of such genetically engineered
organism of cells as are mentioned in the Schedule.

(3) Institutional Biosafety Committee (IBSC): This committee

shall be constituted by an occupier or any person including
research institutions handling microorganism/genetically
engineered organisms. The committee shall comprise the
Head of the Institution, Scientists engaged in DNA work, a
medical expert and a nominee of the Department of
Biotechnology. The occupier or any person including
research institutions handling microorganisms/genetically
engineered organisms shall prepare, with the assistance of
the Institutional Biosafety Committee (IBSC) an uptodate on
site emergency plan according to the manuals/guidelines of
the RCGM and make available copies to the District Level
Committee/State Biotechnology Co-ordination Committee
and the Genetic Engineering Approval Committee.

(1) Genetic Engineering Approval Committee (GEAC):

This committee shall function as a body under the

Department of Environment, Forest and Wildlife for
approval of activities involving large scale use of
hazardous microorganisms and recombinants in
research and industrial production from the environ-
mental angle. The Committee shall also be responsible
for approval of proposals relating to release of
genetically engineered organisms and products into the
environment including experimental field trials.

The composition of the Committee shall be

(i) Chairman-Additional Secretary, Department of

Environment, Forests and Wild life Co-
Chairman-Representative of Department of Bio-
technology
(ii) Members: Representative of concerned
Agencies and Departments, namely, Ministry of
Industrial Development, Department of
Biotechnology and the Department of Atomic
Energy:

54
 (iii) Expert members: Director General Indian
Council of Agricultural Research, Director
General-Indian Council of Medical Research,
Director General-Council of Scientific and
Industrial Research, Director General-Health
Services, Plant Protection Adviser, Directorate
of Plant Protection, Quarantine and storage,
Chairman, Central Pollution Control Board and
three outside experts in individual capacity.
(iv) Member Secretary: An official of the Department
or Environment, Forest and Wild life.

The committee may co-opt other members/experts as necessary.

The committee or any person/s authorised by it shall have powers to

take punitive action under the Environment (Protection) Act.

(4) State Biotechnology Co-Ordination Committee (SBCC):

There shall be a State Biotechnology Coordination
Committee in the States wherever necessary. It shall have
powers to inspect, investigate and take punitive action in
case or violations of statutory provisions through the Nodal
Department and the State Pollution Control
Board/Directorate of Health/Medical Services. The
Committee shall review periodically the safety and control
measures in the various industries/institutions handling
genetically engineered Organisms/Hazardous
microorganisms. The composition of the Coordination
Committee shall be:

(i) Chief Secretary - Chairman

(ii) Secretary, Department of Environment -
Member Secretary
(iii) Secretary, Department of Health - Member
(iv) Secretary, Department of Agriculture - Member
(v) Secretary, Department of Industries and
Commerce - Member
(vi) Secretary, Department of Forests - Member
(vii) Secretary, Department of Public works/Chief
Engineer, Department of Public Health
Engineering - Member
(viii) State microbiologists and Pathologists - Member
(ix) Chairman of State Pollution Control Board

55
 The Committee may co-opt other members/experts as
necessary.

(5) District Level Committee (DLC): There shall be a District

Level Biotechnology Committee (DLC) in the districts
wherever necessary under the District Collectors to monitor
the safety regulations in installations engaged in the use of
genetically modified organisms/hazardous microorganisms
and its applications in the environment.

The District Level Committee/or any other person/s

authorised in this behalf shall visit the installation engaged
in activity involving genetically engineered organisms,
hazardous microorganisms, formulate information chart, find
out hazards and risks associated with each of these
installations and coordinate activities with a view to meeting
any emergency. The District Level Committee shall regularly
submit its report to the State Biotechnology Co-ordination
Committee/Genetic Engineering Approval Committee.
The District level Committee shall comprise of:

(i) District Collector - Chairman

(ii) Factory Inspector - Member
(iii) A representative of the Pollution Control Board -
Member
(iv) Chief Medical Officer (District Health Officer) –
Member (Convenor)
(v) District Agricultural Officer - Member
(vi) A representative of the Public Health Engineering
Department - Member
(vii) District Microbiologists pathologist (Technical
expert) - Member
(viii) Commissioner Municipal Corporation - Member

The Committee may co-opt other member/s/experts as

necessary.

5. CLASSIFICATION OF MICROORGANISMS OR
GENETICALLY ENGINEERED PRODUCT

(i) For the purpose of these rules, microorganisms or

genetically engineered organisms, products or cells shall be
dealt with under two major heads; animal pathogens and

56
 plant pests and these shall be classified in the manner
specified in the Schedule.
(ii) If any of the microorganism, genetically engineered
organism or cell falls within the limits of more than one risk
class as specified in the Schedule, it shall be deemed to
belong exclusively to the last in number of such classes.

6. MICROORGANISMS LAID DOWN IN THE SCHEDULE ARE

DIVIDED INTO THE FOLLOWING

(i) Bacterial agents:

(ii) Fungal Agents:
(iii) Parasitic Agents
(iv) Viral, Rickettsial and Chlamydial Agents:
(v) Special Category

7. APPROVAL AND PROHIBITIONS

(1) No person shall import, export, transport, manufacture,

process, use or sell any hazardous microorganisms or
genetically engineered organisms/substances or cells except
with the approval of the Genetic Engineering Approval
Committee.
(2) Use of pathogenic microorganism or any genetically engi-
neered organisms or cell for the purpose of research shall
only be allowed in laboratories or inside laboratory areas
notified by the Ministry of Environment and Forests for this
purpose under the Environment (Protection) Act, 1986.
(3) The Genetic Engineering Approval Committee shall give
directions to the occupier to determine or take measures
concerning the discharge of micro-organisms/genetically
engineered organisms or cells mentioned in the schedule
from the laboratories, hospitals and other areas including
prohibition of such discharges and laying down measures to
be taken to prevent such discharges.
(4) Any person operating or using genetically engineered organ-
ism microorganisms mentioned in the schedule for scale up
or pilot operations shall have to obtain licence issued by the
Genetic Engineering Approval Committee for any such
activity. The possessor shall have to apply for licence in
prescribed proforma.

57
 (5) Certain experiments for the purpose of education within the
field of gene technology or microorganism may be carried
out outside the laboratories and laboratory areas mentioned
in sub-rule (2) and will be looked after by the Institutional
Biosafety Committee.

8. PRODUCTION

Production in which genetically engineered organisms or cells or

micro-organism are generated or used shall not be commenced
except with the consent of Genetic Engineering Approval
Committee with respect of discharge of genetically engineered
organisms or cells into the environment. This shall also apply to
production taking place in connection with development, testing
and experiments where such production, etc, is not subject to
rule 7.

9. DELIBERATE OR UNINTENTIONAL RELEASE

(1) Deliberate or unintentional release of genetically engineered

organisms/hazardous microorganisms or cells, including
deliberate release for the purpose of experiment shall not be
allowed.
Note: Deliberate release shall mean any intentional transfer
of genetically engineered organisms/hazardous
microorganisms or cells to the environment or nature,
irrespective of the way in which it is done:
(2) The Genetic Engineering Approval Committee may in
special cases give approval of deliberate release.

10. PERMISSION AND APPROVAL FOR CERTAIN

SUBSTANCES

Substances and products, which contain genetically engineered

organisms or cells or microorganisms shall not be produced,
sold, imported or used except with the approval of genetic
engineering approval committee

58
11. PERMISSION AND APPROVAL FOR FOOD STUFFS

Food stuffs, ingredients in food stuffs and additives including

processing aids containing or consisting of genetically engi-
neered organisms or cells, shall not be produced, sold, imported
or used except with the approval of the Genetic Engineering
Approval Committee.

12. GUIDELINES

(1) Any person who applies for approval under rules 8-11 shall,
as determined by the Genetic Engineering Approval
Committee submit information and make examinations or
cause examinations to be made to elucidate the case,
including examinations according to specific directions and
at specific laboratories. He shall also make available an on-
site emergency plan to GEAC before obtaining the approval.
If the authority makes examination itself, it may order the
applicant to defray the expenses incurred by it in so doing.
(2) Any person to whom an approval has been granted under
rules 8-11 above shall notify the Genetic Engineering
Approval Committee of any change in or addition to the
information already submitted.

13. GRANT OF APPROVAL

(1) In connection with the granting of approval under rules 8 to

11 above, terms and conditions shall be stipulated, including
terms and conditions as to the control to be excercised by
the applicant, supervision, restriction on use, the layout of
the enterprise and as to the submission of information to the
State Biotechnology Co-ordination Committee or to the
District Level Committee
(2) All approvals of the Genetic Engineering Approval
Committee shall be for a specified period not exceeding four
years at the first instance renewable for 2 years at a time.
The Genetic Engineering Approval Committee shall have
powers to revoke such approval in the following situations:

(a) If there is any new information as to the harmful

effects of the genetically engineered organisms or
cells.

59
 (b) If the genetically engineered organisms or cells
cause such damage to the environment, nature or
health as could not be envisaged when the
approval was given, or
(c) Non compliance of any condition stipulated by
Genetic Engineering Approval Committee.

14. SUPERVISION

(1) The Genetic Engineering Approval Committee may

supervise the implementation of the terms and conditions
laid down in connection with the approvals accorded by it.
(2) The Genetic Engineering Approval Committee may carryout
this supervision through the State Biotechnology
Coordination Committee or the State Pollution Control
Boards/District Level Committee or through any person
authorised in this behalf.

15. PENALTIES

(1) If an order is not complied with, the District Level Committee

or State Biotechnology Co-ordination Committee may take
measures at the expenses of the person who is responsible.
(2) In cases where immediate interventions is required in order
to prevent any damage to the environment, nature or health,
the District level Committee or State Biotechnology
Coordination Committee may take the necessary steps
without issuing any orders or notice. The expenses incurred
for this purpose will be repayable by the person responsible
for such damage.
(3) The State Biotechnology Co-ordination Committee /District
Level Committee may take samples for a more detailed
examination of organisms and cells.
(4) The State Biotechnology Co-ordination Committee/District
Level Committee shall be competent to ask for assistance
from any other Government authority to carry out its
instructions.

60
16. RESPONSIBILITY TO NOTIFY INTERRUPTIONS OR
ACCIDENTS

(1) Any person who under rule 7-11 is responsible for conditions
or arrangements shall immediately notify the District Level
Committee \State Biotechnology Co-ordination Committee
and the state medical officer of any interruption of operations
or accidents that may lead to discharges of genetically
engineered organisms or cells which may be harmful to the
environment, nature or health or involve any danger thereto.
(2) Any notice given under sub-rule (1) above shall not lessen
the duty of the person who is responsible to try effectively to
minimise or prevent the effects of interruptions of operations
of accidents.

17. PREPARATION OF OFF-SITE EMERGENCY PLAN BY THE

DLC

(1) It shall be the duty of the DLC to prepare an off-site

emergency plan detailing how emergencies relating to a
possible major accident at a site will be dealt with and in
preparing the plan, the DLC shall consult the occupier and
such other person as it may deem necessary.
(2) For the purpose of enabling the DLC to prepare the
emergency plan required under sub-rule(I), the occupier
shall provide the DLC with such information relating to the
handling of hazardous microorganisms/genetically
engineered organisms under his control as the DLC may
require including the nature, extent and likely off-site affects
of a possible major accident and the DLC shall provide the
occupier with any information from the off-side emergency
plan which relates to his duties under rule 16.

18. INSPECTIONS AND INFORMATIONS REGARDING FINANCE

(1) The State Biotechnology Co-ordination Committee or the

Genetic Engineering Approval Committee/the DLC or any
person with special knowledge duly authorised by the State
Biotechnology Co-Ordination Committee or the Genetic
Engineering Approval Committee or the DLC where it is
deemed necessary, at any time on due production if identity

61
 be admitted to public as well as to private premises and
localities for the purpose of carrying out supervision.
(2) Any person who is responsible for activities subject to rules
7-11 above shall at the request of District level Committee
or State Biotechnology Coordination Committee or the
GEAC submit all such information including information
relating to financial conditions and accounts, as is essential
to the authority’s administration under these rules. He shall
also allow supervision or inspection by the Authorities or
persons indicated in sub-rule(I).
(3) The Genetic Engineering Approval Committee may fix fees
to cover, in whole or in part, the expenses incurred by the
authorities in connection with approvals, examinations,
supervision and control.

19. APPEAL

(1) Any person aggrieved by a decision made by Genetic

Engineering Approval Committee/State Biotechnology Co-
ordination Committee in pursuance of these rules may
within thirty days from the date on which the decision is
communicated to him, prefer an appeal to such authority as
may be appointed by Ministry of Environment and Forests
provided that the appellate authority may entertain the
appeal after the expiry of the said period of thirty days if
such authority is satisfied that the appellant was prevented
by sufficient cause from filing the appeal in time.

20. EXEMPTION

The Ministry of Environment and Forests shall, wherever

necessary, exempt an occupier handling a particular
microorganism/genetically engineered organism from rule 7-11.

62
A. ANIMAL AND HUMAN PATHOGENS

BACTERIAL
Risk Group II

− Acinetobacter calcoacetieus − Letionella

− Actinobacillus-all species − Leptospira interrogans-all
except A mallei, which is in serotypes reported in India
Risk Group III − Listeria, all species
− Aeromonoas hydrophila − Mima polymorpha
− Arizona hinshawii-all − Moraxella-all species
serotypes − Mycobacteria-all species including
− Bacillus anthracis Mycobacterium avium
− Bordetella − M.Bovis M.tuberculosis, M.Leprae
− Borrelia recurrentis.B.Vincenti − Mycoplasma-all species except
− Campylobacter fetus M.Mycoides and M.angalactiae
− Camphylobacter jejuni, − Meosseroc gonorrhoea,N. Leprae
Chalamydia psittaci − Mycoplasma-all species except
− Cheamydia trachomatics M.Mycoides and M.angalactiae
− Clostridium chauvoei, − Neisseric gonorrhoea,N. meningitis
Cl.difficile Cl/fallax. Cl − Pasteurella-all species except
haemolyticum Q.histolyticum, those listed in Risk Group III
CI novyi (CI,Pefringes) − Salmonella-all species and all
Cl.speticum, Cl.sordelli setotypes
− Corynebacterium diptheriae, − Shigella-all species and all
C.equi, C. haemolyticum, serotypes
C.Pseudotuberculosis, − Sphaerophorgs necrophorus
C.pyogenes, C.renale − Staphylococcus aureus
− Diplococcus (Streptococcus) − Streptobacillus moniliformis
pneumoniae − Streptococcus pneumoniae
− Edwardsiila tarda − Streptococcus pyogenes.S.equi
− Erysipelothix insidiosa − Streptomyces madurae,s.pelleteri,
− Escherichia Coli-all s.somaliensis
enteropathogenic serotypes, − Treponema carateum, T.pallidam
enterotoxigenic and T.pettenue
− Haemophilus ducrevi, − Vibrio foetus V.comma including
H.influenzae, H. pneumoniae biotype EI Top and
− Herellea vaginicola − V. parahemolyticus
− Klebsiella-all species and all − Vibrio cholerae
serotypes
− Legionlla pneumophila

63
Risk Group III:
− Actinobacillus mallei − Pasteurella multocida type
− Bartonella-all species B(“buffalo” and other foreign
− Brucella-all species virulent strains)
− Clostridium botulium Cl.tetani − Pseudomonas pseudomallai
− Francisella tularensis − Yersinia pestis
− Mycobacterium avium,.
M.bovis, M.tuberculosis,
m.leprae

FUNGAL

Risk Group II
− Actinomycetes (including − Epidermophyton madurella,
Nocardia SP, Actinomyces microsporon
species and Arachina − Paracoccidiodes brasiliensis
propinica) − Sporothrix
− Aspergillus fumigatus − Trichoderma
− Blastomyces dermatitis − Trichophyton
− Cryptococcus neoformans C.
fersiminosos

Risk Group III

− Coccidioides immitis
− Histoplasma capulatum
− Histoplasma capsulatum var duboiss

PARASITIC

Risk Group II
− Entahoeba histolytica − Toxoplasma gondii
− Leishmania species − Toxocana canis
− Naegleria gruberia − Trichinella spiralis
− Plasmodium theilera, P. − Trichomanas
babesia, P. falcoparum − Trypanosoma cruzi
− Plasmodium babesia
− Schistosoma

Risk Group III

− Schisistosoma mansoni

64
VIRAL RICKETTSIAL AND CHALMYDIAL

Risk Group II
− Adenoviruses - Human all − Measles virus
types − Mumps virus
− Avian loukosis − Newcastle disease virus (other than
− Cache Valley virus licenced strain for vaccine use)
− CELO (avian adenovirus) − Parainfluenza viruses - all type
− Coxsackie A and B viruses except parainfluenza virus 3, SF4
− Corona viruses strain, which is in Risk Group I.
− Cytomegalo viruses − Polio viruses - all types, wild and
− Dengue virus, when used for attenuated
transmission experiments − Poxviruses - all types except
− Echo viruses - all types Alastrim, monkey pox, sheep pox
− Encephalomyocarditis virus and white pox, which depending on
(EMC) experiments are in Risk Group III or
− Flanders virus IV.
− Hart Part virus − Rabies virus - all strains except
− Hepatitis - associated antigen rabies stret virus, which should be
material - hepatitis A and B classified in Risk Group III when
viruses, non A and non B, inoculated into cornivores
HDV − Reoviruses - all types
− Herpes viruses - except − Respiratory syncytial virus
herpesviruses simiae − Rhinoviruses - all types
(monkey B virus) which is in − Rinderpest (other than vaccine strain
Risk Group IV. in use)
− Infectious Bovine − Rubella virus
Rhinotraechitis virus (IBR) − Stimian viruses - all types except
− Infectious Bursal diseases of herpeavirus simlae (Monkey Virus)
poultry and Infectious which is in Risk Group IV.
Bronchitus − Simian virus 40 -
− Infectious Laryngotraechitis − Ad 7 SV 40 (defective)
(ILT) − Sindbis virus
− Influenza virus - all types, − Tensaw virus
except A PR 834 which is in − Turlock virus
Risk Group I − Vaccinia virus
− Langat virus Leucosis − Varicella virus
Complex − Vole rickettsia
− Lymphogranuloma venereum − Yellow fever virus, 17D vaccine
agent
− Marek’s Disease virus

65
Risk Group III
− African House Sickness − HIV-I & HIV-2 and strains of SIV
(attenuated strain except − Infectious Equine Anaemia
animal passage) − Lymphocytic choriomeningitis virus
− Alastrim, monkey pox and (LCM)
whitepox, when used in vitro − Monkey pox, when used in vitro
− Arboviruses - All strains − Nen-defective Adeno-2 SV-40
except those in Risk Group II hybrids
and IV. − Psittacosis-ornithosis-trachoma
− Blue tongue virus (only group of agents
serotypes reported in India) − Pseudorabies virus
− Ebola fever virus − Rabies street virus, when used
− Feline Leukemia Epstein-Barr inoculations of carnivores
virus − Rickettsia-all species except Vole
− Feline sarcoma rickettsia and Coxiell burnetti when
− Foot and Mouth Disease virus used for vector transmission or
(all serotypes and sutbypes) animal inoculation experiments
− Gibbon Ape Lymphosarcoma − Sheep pox (field strain)
− Herpesvirus ateles − Swine Fever virus
− Herpesvirus saimiri − Vesicular stomatitis virus
− Herpes simplex 2 − Woolly monkey Fibrosarcoma
− Yaba pox virus

Risk Group IV
− Alastrim, monkeypox, − Herpesvirus simlae (monkey B
whitepox, when used for virus)
transmission or animal − Tick-borne encephalitis virus
inoculation experiments complex, including - Russian
− Hemorrhagic fever agents, − Spring Summer Encephalitis,
including Crimean Kyasanur Forest Diseast, omsk
hemorrhagic fever (congo) hemorrhagic fever and Central
− Korean hemorrhagic fever European encephalitis viruses.
and others as yet undefined

SPECIAL CATEGORY

BACTERIAL
− Contagious Equine Metritis (H. equigenitalis)
− Pestis petit de ruminantium

66
VIRAL RICKETTSIAL AND CHLAMYDIAL
− African Horse Sickness virus − Murrey valley encephalitis virus
(serotypes not reported in − Rift Valley Fever virus
India and challenge strains) − Smallpox virus - Archieval storage
− African Swine Fever and propagation Swine Vesicular
− Bat rabies virus Disease
− Blue tongue virus (serotypes − Veneseulan equine encephalitis
not reported in India) virus - epidemic strains
− Exoitic FMD virus types and − Western Equine encephalitis virus
sub-types Yellow fever virus - Wild strain
− Junin and Machupo viruses − Other Arboviruses causing
− Lassa virus epizootics and so far not recorded
− Marburg virus in India

B. PLANT PESTS

Any living stage (including active and dormant forms) of insects,

mites nematodes, slugs, snails, bacteria, fungi, protozoa, other parsitic
plants or reproductive parts thereof: viruses; or any organisms similar to
or allied with any of the foregoing; or any infectious agents or
substances, which can directly or indirectly injure or cause disease or
damage in or to any plants or parts thereof, or any processed,
manufactured, or other products of plants are considered plant pests.

Organisms belonging to all lower Taxa contained within the

group listed are also included.

1. Viruses:

All viroids

All bacterial, fungal, algal, plant, insect and nematode viruses;

special care should be take for:
(i) Geminiviruses,
(ii) Caulimoviruses,
(iii) Nuclear Polyhedrosis viruses,
(iv) Granulosis viruses, and
(v) Cytoplasmic polyhedrosis viruses.

67
2. Bacteria:

Family Pseudomonadaceae Gram-negative xylem-

Genus Pseudomonas limited bacteria associated
Genus Xanthomonas with plant diseases
Genus Azotobacter Cyanobacteria-All members
of blue-green algae
Family Rhizobiaceae Mollicutes
Genus Family Spiroplasmataceae
Rhizobium/Azorhizobium Mycoplama-like organisma
Genus Bradyrhizobium associated with plant
Genus Agrobacterium diseases
Genus Phyllobacterium Mycoplasma-like organisms
Genus Erwinia associated with insect
Genus Enterobacter diseases
Genus Klebzieller
Algae
Family Spirollacea Family Chlorophyceae
Genus Azospirillum Family Euglenophyceae
Genus Acquspirillum Family Pyrophyceae
Genus Oceonospirillum Family Chrysophyceae
Family Phaephyceae
Family Streptomycetaceae Family Rhodophyceae
Genue Streptomyces
Genue Nocardia Fungi
Family Plasmodiophoraceae
Family Actinomycetaceae Family Chytridiaceae
Genue Actinomyces Family Olpidiopsidaceae
Family Synchytriaceae
Coryneform Group Family Catenariaceae
Genus Clavibacter Family Coelomomycetaceae
Genus Arthrobacter Family Saprolegniaceae
Genus Curtobacterium Family Zoopagaceae
Genus Bdellovibro Family Albuginaceae
Family Peronosporaceae
Family Rickettsiaceae Family Pythiaceae
Rickettsial-like organisms Family Mucoraceae
associated with insect Family Choanephoraceae
diseases Family Mortiercllaceae
Gram-negative phloem- Family Endogonaceae
limited bacteria associated Family Syncephalastraceae
with plant diseases Family Dimargaritaceae
Family Kickxellaceae

68
Family Saksenaeaceae Family Eistuliniaceae
Family Entomophthoraceae Family Clavariaceae
Family Ecerinaceae Family Polyporaceae
Family Taphrinaceae Family Tricholomattaceae
Family Endomycetaceae Family Ustilaginaceae
Family Saceharomycetaceae Family Sporobolomycetaceae
Family Eurotiaceae Family Uredinaceae
Family Gymnoascaceae Family Agaricaceae
Family Aseophaeriaceae Family Graphiolaceae
Family Onygenaceae Family Pucciniaceae
Family Microascaceae Family Melampsoraceae
Family Protomycetaceae Family Gandodermataceae
Family Elsinoeaceae Family Labonlbeniaceae
Family Myriangiaceae Family Sphaeropsidaceae
Family Dothidiaceae Family Melabconiaceae
Family Chaetothyriaceae Family Tuberculariaceae
Family Parmulariaceae Family Dematiaceae
Family Phillipsiellaceae Family Moniliaceae
Family Hysteriaceae Family Aganomucetaceae
Family Pleosporaceae
Family Melamomataceae Parasitic Weeds
Family Ophiostomataceae Family Balanophoraceae-
Family Aseosphaeriaceae parasitic species
Family Erysiphaceae Family Cuscutaceae-
Family Meliolaceae parasitic species
Family Xylariaceae Family Ttydonoraceae-
Family Diaporthaceae parasitic species
Family Hypoereaceae Family Lauraceae-parasitic
Family Clavicipataceae species Genus Cassytha
Family Phacidiaceae Family Lennoaceae-parasitic
Family Ascocorticiaceae species
Family Hemiphacidiaceae Family Loranthaceae-
Family Dermataceae parasitic species
Family Sclerotiniaceae Family Myzodendraceae-
Family Cyttariaceae parasitic species
Family Helosiaceae Family Olacaceae-parasitic
Family Sarcostomataceae species
Family Sarcoscyphaceae Family Orobanchaceae-
Family Auricolariaceae parasitic species
Family Ceratobasidiaceae Family Rafflesiaceae-
Family Corticiaceae parasitic species
Family Hymenochaetaceae Family Santalaceae-
Family Echinodintiaceae parasitic species

69
 Family Scrophulariaceae- Superfamily Tydeoidea
parasitic species Superfamily Erythraenoidea
Superfamily Trombidioidea
Protozoa Superfamily Hydryphantoidea
Genus Phytomonas Superfamily Tarasonemoidea
And all protozoa associated Superfamily Pyemotoidea
with insect diseases. Superfamily Hemisarcoptoidea
Superfamily Acaroidea
Nematodes Order Polydesmida
Family Anguinidae Family Sminthoridae
Family Belonolaimidae Family Forfieulidae
Fmaily Caloosiidae Order Isoptera
Family Criconematidae Order Thysanoptera
Family Dolichodoridae Family Acrididea
Family Fergusobiidae Family Gryllidae
Family Hemicycliophoridae Family Gryllacrididae
Family Heteroderidae Faily Gryllotalpidae
Family Hoplolaimidae Family Phasmatidae
Family Meloidogynidae Family Ronaleidae
Family Neotylenchidac Family Tettigoniidae
Family Nothotylenchidae Family Tetragidae
Family Paratylenchidae Family Thaumastocoridae
Family Pratylenchidae Superfamily Piesmatoidea
Family Tylenchidae Superfamily Lygacoidea
Family Tylenchulidae Superfamily Idiostoloidea
Family Aphelenchoidiae Superfamily Careoidea
Family Longidoridae Superfamily Pentatomoidea
Family Trichodoridae Superfamily Pyrrhocoroidea
Superfamily Tingoidea
Mollusca Superfamily Miroidea
Superfamily Planorbacea Order Homoptera
Superfamily Achatinacea Family Anobiidae
Superfamily Arionacea Family Apionidae
Superfamily Limacacea Family Anthribidae
Superfamily Helicacea Family Bostrichidae
Superfamily Veronicellacea Family Brentidae
Family Bruchidae
Arthropoda Family Buprestodae
Superfamily Ascoidea Family Byturidae
Superfamily Dermanyssoidea Family Cantharidae
Superfamily Erjophyoidea Family Carabidae
Superfamily Tetranychoidea Family Ceambycidae
Superfamily Eupodoidea Family Chrysomelidae

70
 Family Coecinellidae Family Lonchaeidae
Family Curculionidae Family Muscidae
Family Dermestidae Family Otitidae
Family Elalteridae Family Syrphidae
Family Hydrophilidae Family Tephritidae
Family Lyctidae Family Tipulidae
Family Meloidae Family Apidae
Family Mordellidae Family Caphidae
Family Platypodidae Family Chalcidae
Family Scarabaeldae Family Cynipidae
Family Scolytidae Family Eurytomidae
Family Selbytidae Family Formicidae
Order Lepidoptera Family Psilidae
Family Agromyzidae Family Sircidae
Family Anthomiidae Family Tenthredinidae
Family Cecidomiidae Family Torymidae
Family Chioropidae Family Xyloiopidae and
Family Ephydridae

Also unclassified organisms and/or organisms whose

classification is unknown and all other organisms associated with plant
and insect diseases.

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 ANNEX – 2
NATIONAL SEEDS POLICY, 2002
INTRODUCTION

Indian Agriculture has made enormous strides in the past 50 years,

raising food grains production from 50 million tonnes to over 200 million
tonnes. In the process, the country has progressed from a situation of
food shortages and imports to one of surpluses and exports. Having
achieved food sufficiency, the aim now is to achieve food and nutritional
security at the household level.

The increase in agricultural production, however, has brought in its wake,

uneven development, across regions, crops, and also across different
sections of farming community. In the decade of the 'nineties', a marked
slackening in the pace of growth has occurred, pointing to the need for
infusing a new vitality in the agricultural sector.

Seed is the most important determinant of agricultural production

potential, on which the efficacy of other agriculture inputs is dependent.
Seeds of appropriate characteristics are required to meet the demand of
diverse agro-climatic conditions and intensive cropping systems.
Sustained increase in agriculture production and productivity is
dependent, to a large extent, on development of new and improved
varieties of crops and an efficient system for timely supply of quality
seeds to farmers.

The seed sector has made impressive progress over the last three
decades. The area under certified seeds has increased from less than
500 hectares in 1962-63 to over 5 lakh hectares in 1999-2000. The
quantum of quality seeds has crossed 100 lakh quintals.

The Seeds Act, 1966 and Seeds Control Order promulgated thereunder,
and the New Policy on Seeds Development, 1988, form the basis of
promotion and regulation of the Seed Industry. Far-reaching changes,
however, have taken place in the national economic and agricultural
scenario and in the international environment since the enactment of the
existing seed legislation and the announcement of the 1988 Policy.

72
AIMS AND OBJECTIVES

It has become evident that in order to achieve the food production

targets of the future, a major effort will be required to enhance the seed
replacement rates of various crops. This would require a major increase
in the production of quality seeds, in which the private sector is expected
to play a major role. At the same time, private and Public Sector Seed
Organisations at both Central and State levels, will be expected to adopt
economic pricing policies which would seek to realise the true cost of
production. The creation of a facilitative climate for growth of a
competitive and localised seed industry, encouragement of import of
useful germplasm, and boosting of exports are core elements of the
agricultural strategy of the new millennium.

Biotechnology will be a key factor in agricultural development in the

coming decades. Genetic engineering/modification techniques hold
enormous promise in developing crop varieties with a higher level of
tolerance to biotic and abiotic stresses. A conducive atmosphere for
application of frontier sciences in varietal development and for enhanced
investments in research and development is a pressing requirement. At
the same time, concerns relating to
possible harm to human and animal health and bio-safety, as well as
interests of farmers, must be addressed.

Globalization and economic liberalization have opened up new

opportunities as well as challenges. The main objectives of the National
Seeds Policy, therefore, are the provision of an appropriate climate for
the seed industry to utilize available and prospective opportunities,
safeguarding of the interests of Indian farmers and the conservation of
agro-biodiversity. While unnecessary regulation needs to be dismantled,
it must be ensured that gullible farmers are not exploited by
unscrupulous elements. A regulatory system of a new genre is,
therefore, needed, which will encompass quality assurance mechanisms
coupled with facilitation of a vibrant and responsible seed industry.

THRUST AREAS:-

1. VARIETAL DEVELOPMENT AND PLANT VARIETY

PROTECTION

1.1 The development of new and improved varieties of plants and

availability of such varieties to Indian farmers is of crucial
importance for a sustained increase in agricultural productivity.

73
 1.1.1 Appropriate policy framework and programmatic
interventions will be adopted to stimulate varietal
development in tune with market trends, scientific-
technological advances, suitability for biotic and abiotic
stresses, locational adaptability and farmers' needs.

1.2 An effective sui generis system for intellectual property

protection will be implemented to stimulate investment in
research and development of new plant varieties and to facilitate
the growth of the Seed Industry in the country.

1.2.1 A Plant Varieties & Farmers' Rights Protection (PVP)

Authority will be established which will undertake
registration of extant and new plant varieties through the
Plant Varieties Registry on the basis of varietal
characteristics.
1.2.2 The registration of new plant varieties by the PVP
Authority will be based on the criteria of novelty,
distinctiveness, uniformity and stability.
1.2.3 The criteria of distinctiveness, uniformity and stability
could be relaxed for registration of extant varieties,
which will be done within a specified period to be
decided by the PVP Authority.
1.2.4 Registration of all plant genera or species as notified by
the Authority will be done in a phased manner.
1.2.5 The PVP Authority will develop characterisation and
documentation of plant varieties registered under the
PVP Act and cataloguing facilities for all varieties of
plants.

1.3 The rights of farmers to save, use, exchange, share or sell farm
produce of all varieties will be protected, with the proviso that
farmers shall not be entitled to sell branded seed of a protected
variety under the brand name.
1.4 The rights of researchers to use the seed/planting material of
protected varieties for bonafide research and breeding of new
plant varieties will be ensured.
1.5 Equitable sharing of benefit arising out of the use of plant genetic
resources that may accrue to a breeder from commercialisation
of seeds/planting materials of a new variety, will be provided.
1.6 Farmers/groups of farmers/village communities will be rewarded
suitably for their significant contribution in evolution of a plant

74
 variety subject to registration. The contribution of traditional
knowledge in agriculture needs to be highlighted through suitable
mechanisms and incentives.
1.7 A National Gene Fund will be established for implementation of
the benefit sharing arrangement, and payment of compensation
to village communities for their contribution to the development
and conservation of plant genetic resources and also to promote
conservation and sustainable use of genetic resources. Suitable
systems will be worked out to identify the contributions from
traditional knowledge and heritage.
1.8 Plant Genetic Resources for Food and Agriculture Crops will be
permitted to be accessed by Research Organisations and Seed
Companies from public collections as per the provisions of the
'Material Transfer Agreement' of the International Treaty on Plant
Genetic Resources and the Biological Diversity Bill.
1.9 Regular interaction amongst the Private and Public Researchers,
Seed Companies/Organisations and Development Agencies will
be fostered to develop and promote growth of a healthy seed
industry in the country.
1.10 To keep abreast of global developments in the field of Plant
Variety Protection and for technical collaboration, India may
consider joining Regional and International Organisations.
1.11 The PVP Authority may, if required, resort to compulsory
licensing of a protected variety in public interest on the ground
that requirements of the farming community for seeds and
propagating material of a variety are not being met or that the
production of the seeds or planting material of the protected
variety is not being facilitated to the fullest possible extent.

2. SEED PRODUCTION

2.1 To meet the Nation's food security needs, it is important to make

available to Indian farmers a wide range of seeds of superior
quality, in adequate quantity on a timely basis. Public Sector
Seed Institutions will be encouraged to enhance production of
seed towards meeting the objective of food and nutritional
security.

2.2 The Indian seed programme adheres to the limited three

generation system of seed multiplication, namely, breeder,

75
 foundation and certified seed. Breeder seed is the progeny of
nucleus seed.

2.2.1 Nucleus seed is the seed produced by the breeder to

develop the particular variety and is directly used for
multiplication as breeder seed.
2.2.2 Breeder seed is the seed material directly controlled by
the originating or the sponsoring breeder or Institution
for the initial and recurring production of foundation
seed.
2.2.3 Foundation seed is the progeny of breeder seed.
Foundation seed may also be produced from foundation
seed. Production of foundation seed stage-I and stage-II
may thus be permitted, if supervised and approved by
the Certification Agency and if the production process is
so handled as to maintain specific genetic purity and
identity.
2.2.4 Certified seed is the progeny of foundation seed or the
progeny of certified seed. If the certified seed is the
progeny of certified seed, then this reproduction will not
exceed three generations beyond foundation stage-I and
it will be ascertained by the Certification Agency that
genetic identity and genetic purity has not been
significantly altered.

2.3 Public Sector Seed Production Agencies will continue to have

free access to breeder seed under the National Agriculture
Research System. The State Farms Corporation of India and
National Seeds Corporation will be restructured to make
productive use of these organisations in the planned growth of
the Seed Sector.

2.4 Private Seed Production Agencies will also have access to

breeder seed subject to terms and conditions to be decided by
Government of India.

2.5 State Agriculture Universities/ICAR Institutes will have the

primary responsibility for production of breeder seed as per the
requirements of the respective States.

2.6 Special attention will be given to the need to upgrade the quality
of farmers’ saved seeds through interventions such as the Seed
Village Scheme.

76
2.7 Seed replacement rates will be raised progressively with the
objective of expanding the use of quality seeds.

2.8 DAC, in consultation with ICAR and States, will prepare a

National Seed Map to identify potential, alternative and non-
traditional areas for seed production of specific crops.

2.9 To put in place an effective seed production programme, each

State will undertake advance planning and prepare a
perspective plan for seed production and distribution over a
rolling (five to six year) period. Seed Banks will be set up in
non-traditional areas to meet demands for seeds during natural
calamities.

2.10 The 'Seed Village Scheme' will be promoted to facilitate

production and timely availability of seed of desired
crops/varieties at the local level. Special emphasis will be given
to seed multiplication for building adequate stocks of
certified/quality seeds by providing foundation seed to farmers.

2.11 For popularising newly developed varieties and promoting seed

production of these varieties, seed minikits of pioneering seed
varieties will be supplied to farmers. Seed exchange among
farmers and seed producers will be encouraged to popularise
new/non-traditional varieties.

2.12 Seeds of newly developed varieties must be made available to

farmers with minimum time gap. Seed producing agencies will
be encouraged to tie up with Research Institutions for
popularization and commercialization of these varieties.
2.13 As hybrids have the potential to improve plant vigour and
increase yield, support for production of hybrid seed will be
provided.

2.14 Seed production will be extended to agro-climatic zones which

are outside the traditional seed growing areas, in order to avoid
unremunerative seed farming in unsuitable areas.

2.15 Seed Banks will be established for stocking specified quantities

of seed of required crops/varieties for ensuring timely and
adequate supply of seeds to farmers during adverse situations
such as natural calamities, shortfalls in production, etc. Seed

77
 Banks will be suitably strengthened with cold storage and pest
control facilities.
2.15.1 The storage of seed at the village level will be
encouraged to facilitate immediate availability of seeds
in the event of natural calamities and unforeseen
situations. For the storage of seeds at farm level,
scientific storage structures will be popularised and
techniques of scientific storage of seeds will be
promoted among farmers as an extension practice.

2.16 Seed growers will be encouraged to avail of Seed Crop

Insurance to cover risk factors involved in production of seeds.
The Seed Crop Insurance Scheme will be reviewed so as to
provide effective risk cover to seed producers and will be
extended to all traditional and non-traditional areas covered
under the seed production programme.

3. QUALITY ASSURANCE

3.1 The Seeds Act will be revised to regulate the sale, import and
export of seeds and planting materials of agriculture crops
including fodder, green manure and horticulture and supply of
quality seeds and planting materials to farmers throughout the
country.

3.2 The National Seeds Board (NSB) will be established in place of

existing Central Seed Committee and Central Seed Certification
Board. The NSB will have permanent existence with the
responsibility of executing and implementing the provisions of
the Seeds Act and advising the Government on all matters
relating to seed planning and development. The NSB will
function as the apex body in the seed sector.

3.2.1 All varieties, both domestic and imported varieties, that

are placed on the market for sale and distribution of
seeds and planting materials will be registered under the
Seeds Act. However, for vegetable and ornamental
crops a simple system of varietal registration based on
“breeders declaration” will be adopted.
3.2.2 The Board will undertake registration of kinds/varieties
of seeds that are to be offered for sale in the market, on
the basis of identified parameters for establishing value
for cultivation and usage (VCU) through testing/trialling.

78
 3.2.3 Registration of varieties will be granted for a fixed period
on the basis of multilocational trials to determine VCU
over a minimum period of three seasons, or as
otherwise prescribed as in the case of long duration
crops and horticultural crops. Samples of the material for
registration will be sent to the NBPGR for retention in
the National Gene Bank.
3.2.4 Varieties that are in the market at the time of coming into
force of the revised Seeds Act, will have to be registered
within a fixed time period, and subjected to such testing
as will be notified.
3.2.5 The NSB will accredit ICAR, SAUs, public/private
organisations to conduct VCU trials of all varieties for
the purpose of registration as per prescribed standards.

3.2.6 The NSB will maintain the National Seeds Register

containing details of varieties that are registered. This
will help the Board to coordinate and assist activities of
the States in their efforts to provide quality seeds to
farmers.
3.2.7 The NSB will prescribe minimum standards (of
germination, genetic characteristics, physical purity,
seed health, etc.) as well as suitable guidelines for
registration of seed and planting materials.
3.2.8 Provisional registration would be granted on the basis of
information filed by the applicant relating to trials over
one season to tide over the stipulation of testing over
three seasons before the grant of registration.

3.3 Government will have the right to exclude certain kinds or

varieties from registration to protect public order or human,
animal and plant life and health, or to avoid serious prejudice to
the environment.

3.4 The NSB will have the power to cancel the registration granted to
a variety if the registration has been obtained by
misrepresentation or concealment of essential data, the variety is
obsolete and has outlived its utility and if the prevention of
commercial exploitation of such variety is necessary in the
public interest.

79
3.5 Registration of Seed Processing Units will be required if such
Units meet the prescribed minimum standards for processing the
seed.

3.6 Seed Certification will continue to be voluntary. The Certification

tag/label will provide an assurance of quality to the farmer.

3.6.1 The Board will accredit individuals or organisations to

carry out seed certification including self-certification on
fulfillment of criteria as prescribed.

3.7 To meet quality assurance requirements for export of seeds,

Seed Testing facilities will be established in conformity with ISTA
and OECD seed certification programmes.

3.8 The State Government, in conformity with guidelines and

standards specified by the Board, will establish one or more
State Seed Testing Laboratories or declare any Seed Testing
Laboratory in the Government or non-Government Sector as a
State Seed Testing Laboratory where analysis of seeds will be
carried out in the prescribed manner.

3.9 Farmers will be encouraged to use certified seeds to ensure

improved performance and output.

3.10 Farmers will retain their right to save, use, exchange, share or
sell their farm seeds and planting materials without any
restriction. They will be free to sell their seed on their own
premises or in the local market without any hindrance provided
that the seed is not branded. Farmers’ right to continue using
the varieties of their choice will not be infringed by the system of
compulsory registration.

3.11 Stringent measures would be taken to ensure the availability of

high quality of seeds and check the sale of spurious or
misbranded seeds.

4. SEED DISTRIBUTION AND MARKETING

4.1 The availability of high quality seeds to farmers through an

improved distribution system and efficient marketing set-up will
be ensured to facilitate greater security of seed supply.

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4.2 For promoting efficient and timely distribution and marketing of
seed throughout the country, a supportive environment will be
provided to encourage expansion of the role of the private seed
sector. Efforts will be made to achieve better coordination
between State Governments to facilitate free Inter-State
movement of seed and planting material through exemption of
duties and taxes.

4.3 Private Seed Sector will be encouraged and motivated to

restructure and reorient their activities to cater to non-traditional
areas.

4.4 A mechanism will be established for collection and dissemination

of market intelligence regarding preference of consumers and
farmers.

4.5 A National Seed Grid will be established as a data-base for

monitoring of information on requirement of seed, its production,
distribution and preference of farmers on a district-wise basis.

4.6 Access to term finance from Commercial Banks will be facilitated

for developing efficient seed distribution and marketing facilities
for growth of the seed sector.

4.7 Distribution and marketing of seed of any variety, for the purpose
of sowing and planting will be allowed only if the said variety has
been registered by the National Seeds Board.

4.8 National Seeds Board can direct a dealer to sell or distribute

seeds in a specified manner in a specified area if it is considered
necessary to the public interest.

5. INFRASTRUCTURE FACILITIES

5.1 To meet the enhanced requirement of quality/certified seeds,

creation of new infrastructure facilities along with strengthening
of existing facilities, will be promoted.

5.2 National Seed Research and Training Center will be set up to

impart training and build a knowledge base in various disciplines
of the seed sector.

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5.3 The Central Seed Testing Laboratory will be established at the
National Seed Research and Training Center to perform referral
and other functions as required under the Seeds Act.

5.4 Seed processing capacity will be augmented to meet the

enhanced requirement of quality seed.

5.5 Modernisation of seed processing facilities will be encouraged in

terms of modern equipment and latest techniques, such as seed
treatment for enhancement of performance of seed, etc.

5.6 Conditioned storage for breeder and foundation seed and

aerated storage for certified seed would be created in different
regions.

5.7 A computerized National Seeds Grid will be established to

provide information on availability of different varieties of seeds
with production agencies, their location, quality etc. This network
will facilitate optimum utilisation of available seeds in every
region.

5.7.1 Initially, seed production agencies in the public sector

would be connected with the National Seed Grid, but
progressively the private sector will be encouraged to
join the Grid for providing a clear assessment of demand
and supply of seeds.

5.8 State Governments, or the National Seeds Board in consultation

with the concerned State Government, may establish Seed
Certification Agencies.

5.9 State Governments will establish appropriate systems for

effective execution and implementation of the objectives and
provisions of the Seeds Act.

6. TRANSGENIC PLANT VARIETIES

6.1 Biotechnology will play a vital role in the development of the

agriculture sector. This technology can be used not only to
develop new crops/varieties, which are tolerant to disease, pests
and abiotic stresses, but also to improve productivity and
nutritional quality of food.

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6.2 All genetically engineered crops/varieties will be tested for
environment and bio-safety before their commercial release, as
per the regulations and guidelines of the Environment Protection
Act (EPA), 1986.

6.3 The EPA, 1986, read with the Rules, 1989 would adequately
address the safety aspects of transgenic seeds/planting
materials. A list will be generated from Indian experience of
transgenic cultivars that could be rated as environmentally safe.

6.4 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.

6.5 Transgenic crops/varieties will be tested to determine their

agronomic value for at least two seasons under the All 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.

6.6 After the transgenic plant variety is commercially released, its

seed will be registered and marketed in the country as per the
provisions of the Seeds Act.

6.7 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.

6.8 Transgenic varieties can be protected under the PVP legislation

in the same manner as non-transgenic varieties after their
release for commercial cultivation.

6.9 All seeds imported into the country will be required to be

accompanied by a certificate from the Competent Authority of the
exporting country regarding their transgenic character or
otherwise.

6.9.1 If the seed or planting material is a product of transgenic

manipulation, it will be allowed to be imported only with
the approval of the Genetic Engineering Approval
Committee (GEAC), set up under the EPA, 1986.

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6.10 Packages containing transgenic seeds/planting materials, if and
when placed on sale, will carry a label indicating their transgenic
nature. The specific characteristics including the
agronomic/yield benefits, names of the transgenes and any
relevant information shall also be indicated on the label.

6.11 Emphasis will be placed on the development of infrastructure for

the testing, identification and evaluation of transgenic planting
materials in the country.

7. IMPORT OF SEEDS AND PLANTING MATERIAL

7.1 The objective of the import policy is to provide the best planting
material available anywhere in the world to Indian farmers, to
increase productivity, farm income and export earnings, while
ensuring that there is no deleterious effect on environment,
health and bio-safety.

7.1.1 While importing seeds and planting material, care will be

taken to ensure that there is absolutely no compromise
on the requirements under prevailing plant quarantine
procedures, so as to prevent entry into the country of
exotic pests, diseases and weeds detrimental to Indian
agriculture.
7.1.2 All imports of seeds will require a permit granted by the
Plant Protection Advisor to the Government of India,
which will be issued within the minimum possible time
frame.

7.2 All import of seeds and planting materials, etc. will be allowed
freely subject to EXIM Policy guidelines and the requirements of
the Plants, Fruits and Seeds (Regulation of import into India)
Order, 1989 as amended from time to time. Import of parental
lines of newly developed varieties will also be encouraged.

7.3 Seeds and planting materials imported for sale into the country
will have to meet minimum seed standards of seed health,
germination, genetic and physical purity as prescribed.

7.4 All importers will make available a small sample of the imported
seed to the Gene Bank maintained by NBPGR.

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7.5 The existing policy, which permits free import of seeds of
vegetables, flowers and ornamental plants, cuttings, saplings of
flowers, tubers and bulbs of flowers by certain specified
categories of importers will continue. Tubers and bulbs of
flowers will be subjected to post-entry quarantine.

7.5.1 After the arrival of consignments at the port of entry,

quarantine checks would be undertaken; which may
include visual inspection, laboratory inspection,
fumigation and grow-out tests. For the purpose of these
checks, samples will be drawn and the tests will be
conducted concurrently.

8. EXPORT OF SEEDS

8.1 Given the diversity of agro-climatic conditions, strong seed

production infrastructure and market opportunities, India holds
significant promise for export of seeds.

8.2 Government will evolve a long term policy for export of seeds
with a view to raise India's share of global seed export from the
present level of less than 1% to 10% by the year 2020.

8.2.1 The export policy will specifically encourage custom

production of seeds for export and will be based on long
term perspective, dispensing with case to case
consideration of proposals.

8.3 Establishment and strengthening of Seeds Export Promotion

Zones with special incentives from the Government will be
facilitated.

8.4 A data bank will be created to provide information on the

International Market and on export potential of Indian varieties in
different parts of the world.

8.5 A data base on availability of seeds of different crops to assess

impact of exports on domestic availability of seeds will be
created.

8.6 Promotional programmes to improve the quality of Indian seeds

to enhance its acceptability in the International Market will be
taken up.

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 8.6.1. Testing and certification facilities will be established in
conformity with international requirements.

9. PROMOTION OF DOMESTIC SEED INDUSTRY

9.1 Incentives will be provided to the domestic seed industry to

enable it to produce seeds of high yielding varieties and hybrid
seeds at a faster pace to meet the challenges of domestic
requirements.

9.2 Seed Industry will be provided with a congenial and liberalized

climate for increasing seed production and marketing, both
domestic and international.

9.3 Membership to International Organisations and Seed

Associations like ISTA, OECD, UPOV, ASSINSEL, WIPO, at the
National level or at the level of individual seed producing
agencies, will be encouraged.

9.4 Emphasis will be given to improving the quality of seed produced

and special efforts will be directed towards improving the quality
of farmers' saved seeds.

9.5 Financial support for capital investment, working capital and

infrastructure strengthening will be facilitated through NABARD/
Commercial Banks/Cooperative Banks.

9.6 Tax rebate/concessions will be considered on the expenditure

incurred on in-house research and development of new varieties
and other seed related research aspects. In order to develop a
competitive seed market, the States will be encouraged to
remove unnecessary local taxation on sales of seeds.

9.7 To encourage seed production in non-traditional areas including

backward areas, special incentives such as transport subsidy will
be provided to seed producing agencies operating in these
marginalised areas.

9.8 Reduction of import duty will be considered on machines and

equipment used for seed production and processing which are
otherwise not manufactured in the country.

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10. STRENGTHENING OF MONITORING SYSTEM

10.1 The Department of Agriculture & Cooperation (DAC) will

supervise the overall implementation and monitoring of the
National Seeds Policy.

10.2 The physical infrastructure in terms of office automation,

communication facilities, etc., in DAC will be augmented in a
time bound manner.

10.3 The technical capacity of DAC need to be augmented and

strengthened to undertake the additional work relating to
implementation of National Seeds Policy, implementation of
PVP&FR Bill, Seeds Act, Import and Export of Seeds, etc.

10.4 Capacity building, including National and International training

and participation in Seminars/Workshops will be organized for
concerned officials.

11. CONCLUSION

The Government of India trusts that the National Seeds Policy

will receive the fullest support of State Governments/Union
Territory Administrations, State Agricultural Universities, plant
breeders, seed producers, the seed industry and all other
stakeholders, so that it may serve as a catalyst to meet the
objectives of sustainable development of agriculture, food and
nutritional security for the population, and improved standards of
living for farming communities.

The National Seeds Policy will be a vital instrument in attaining

the objectives of doubling food production and making India
hunger free. It is expected to provide the impetus for a new
revolution in Indian agriculture, based on an efficient system for
supply of seeds of the best quality to the cultivator.
The National Seeds Policy will lay the foundation for
comprehensive reforms in the seed sector. Significant changes
in the existing legislative framework will be effected accompanied
by programmatic interventions. The Policy will also provide the
parameters for the development of the seed sector in the Tenth
and subsequent Plans. The progress of implementation of the
Policy will be monitored by a High Level Review Committee.

87
 ANNEX – 3
MINISTRY OF AGRICULTURE

(Department of Agriculture and Co-operation)

NOTIFICATION

New Delhi, the 12th November, 2003

S.O. 1300(E). – In exercise of the powers conferred by Sub-section (1) of

Section 4 of the Seeds Act, 1966 (54 of 1966), the Central Government
hereby declares the laboratory of Central Institute of Cotton Research
(CICR), Indian Council of Agricultural Research (ICAR), Nagpur as the
Central Seed Laboratory to carry out the functions of ascertaining the
presence or absence of Cry1AC gene in Cotton seeds under the said Act
with effect from the date of publication for the whole of India.

2. In pursuance of clause (c) of rule 5 of the Seeds Rules, 1968, the

Central Government also entrusts the Central Institute of Cotton
Research, Indian Council of Agricultural Research, Nagpur to act as a
referral laboratory for Bacillus thuringiensis Cotton seeds (Bt. Cotton
seeds).

[F.No. 2-7/2003-SD.IV]

ASHISH BAHUGUNA, Jt. Secy. (Seeds)

88
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1. Barwale, R.B. et. al, 2004, Prospects for Bt Cotton Technology in

India, AgBioForum, November 18, 2004.

2. Biosafety issues related to transgenic crops, 2004, Biotech

Consortium India Limited, New Delhi

3. James, C., 2004, Global Status of Commercialized Biotech/GM

Crops, International Service for the Acquisition of Agri-biotech
Applications, Report No. 32.

4. Lead papers, Asia regional workshop on risk assessment and risk

management in implementing the Cartagena Protocol on Biosafety,
2002, organized by Department of Biotechnology, Govt. of India,
New Delhi and International Union for the Conservation of Nature,
Sri Lanka.

5. Sharma, M., Charak, K.S. and Ramanaiah, T.V., 2003, Agricultural

biotechnology research in India: Status and policies, Current
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6. The State of Food and Agriculture (2003-2004), 2004, Food and

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13. http://www.isaaa.org

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